cyrilzakka/clinical-trials huggingface dataset:
Effect of Craniocervical Neural Mobilization on Quality of Life in Patients With Primary Tension Headache

this study will be conducted to investigate the effect of craniocervical neural mobilization on quality of life in patients with primary tension headache.

The World Health Organization estimates that the three most prevalent neurologic disorders worldwide are tension-type headache (1.5 billion), migraine (958.8 million), and medication overuse headache (58.5 million). Collectively, these three disorders contribute approximately 17% to the global burden of neurologic diseases, with migraine the second most disabling disease overall. TTH (Tension Type of Headache) is defined as mild to moderate band-like pressure headache with few associated symptoms. It varies considerably in frequency and duration, from rare, short-lasting episodes of discomfort to frequent, long-lasting, or even continuous disabling headaches.Physiotherapy treatment based on manual therapy achieved positive outcomes in pain intensity and frequency, disability, impact of headache, quality of life, and craniocervical range of motion in adults with TTH. Although pervious findings showed a clinical improvement, there is no clear evidence that one technique is superior to another.Neurodynamic techniques can improve mechanical functions in nerve structures, such as tension and sliding functions. When the nerve structure experiences clamping and disrupts mobility, pain occurs along the nerve. Neurodynamic sliding techniques play a major role in improving blood circulation and axonal transport, as well as increasing nerve integrity and reducing the pressure caused by intraneural and extraneural fibrosis. thirty patients with tension headache will be allocated randomly into two equal groups. the first one will receive craniocervical mobilization and a selected physiotherapy program and the control group will receive selected physiotherapy program for one month.

Eligibility Criteria:
Inclusion Criteria:

* The type of headache will be primary tension type of headache.
* Age of subjects will range from 25-40 years.
* The duration of headaches swill be one years ago.
* Body mass index from 25 to less than 30.

Exclusion Criteria:

* Major neurological conditions (e.g. stroke, multiple sclerosis, epilepsy, brain tumor, meningitis, and hypertension).
* Patients with cervical spinal cord injury, recent trauma of head.
* Patients with auditory and visual impairments.
* Smoker and addicted subjects.
A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma

The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.

A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required.
* Ability to read and write in Turkish
* Female or male outpatients aged 18 years
* Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition
* Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1
* Either: daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment

Exclusion Criteria:

* Previous treatment with Symbicort Single inhaler Therapy
* Use of any b-blocking agent, including eye drops
* Use of oral GCS as maintenance treatment
* Known or suspected hypersensitivity to study therapy or excipients
* A history of smoking 10 pack years
* Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
* Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study
A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients

The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 2 Diabetes Mellitus
* 20\~69 years old
* BMI \< 30kg/m2
* HbA1c between 7% and 11%
* receiving no oral antihyperglycemic agent for more than seven days for at least 8 weeks
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

* Subjects with Type 1 Diabetes Mellitus
* FPG \> 270mg/dL
* Subjects having insulin treatment
* Subjects with acute or chornic metaboic acidosis
* Subjects with cardiovascular disease
* Subjects with chronic GI disease
* Subjects with a history of substance or alchol abuse within 1 year
* Subjects with a history of hypersensitivity to biguanide or a-GI
* Subjects with hypopituitarism or hypocorticalism
* Subjects with cancer
* Subjects who take corticosteriods or plan to take corticosteroid
* AST and ALT \> 2.5 times the upper limit of normal
* Creatinine level \> 1.5mg/dL in male and 1.4mg/dL in female
* SBP \> 150mmHg or DBP \> 90mmHg
* Subjects who work the night shift
* Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
* Subjects who have participated in other study within 3 months
* Subjects judged to be unsuitable for this trial by investigator
Efficacy and Safety of VVZ-149 Injections in Patients Undergoing Laparoscopic Colectomy

The purpose of this phase 3 study is to evaluate the efficacy and safety of VVZ-149 Injections for the treatment of postoperative pain following laparoscopic colectomy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women who are at least 18 years of age
* Female subjects who are not pregnant or breastfeeding
* Subjects undergoing a planned first laparoscopic colectomy
* Subjects classified in American Society of Anesthesiologists (ASA) risk class of I or II
* Subjects who report the pain intensity ≥ 5 on the NRS measured after surgery
* Subjects who have the ability to understand study procedures and communicate clearly with the investigator and staff
* Subjects who provide written informed consent prior to participation in the study

Key Exclusion Criteria:

* Subjects undergoing emergency or unplanned surgery
* Subjects who had a previous laparoscopic colectomy procedure, or who had any laparoscopic resection procedure
* Subjects with pre-existing conditions causing preoperative pain at the site of surgery
* Female subjects who are pregnant or breastfeeding
* Diagnosis of chronic pain (e.g., persistent pain with the intensity of NRS ≥ 5 at baseline)
Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to identify potential sites for ablation. Furthermore, this study could help demonstrate the efficacy of this technology's ability to terminate or slow AF.

The Investigator will test this technology on ten subjects undergoing a second ablation procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable activity and ablate the area. The Investigator believes that the study could produce acute AF termination or AF cycle length slowing. In addition to testing the real-time electrogram morphology recurrence mapping, the study would also like to determine the acute effects of radiofrequency ablation of areas of high recurrence rates and determine long term freedom from AF following ablation of areas of high recurrence rates.


Eligibility Criteria:
Inclusion Criteria:

* Male and female at least 21 years of age
* persistent Afib with one prior failed ablation for persistent or long standing persistent Afib

Exclusion Criteria:

* Inability to sign consent
* Patients with a life expectancy less than one (1) year
* Patients with chronic kidney disease with sufficiently low GFR that precludes either CT angiogram of the heart or contrast MRI study
* Pregnant women and women that are breast feeding
* Patients with multiple (2 or more) prior failed ablations
* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Vitamin D, Insulin Resistance, and Cardiovascular Disease

In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes

This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* 25 (OH) vitamin D levels \< 25 ng/ml
* Age 25 to 80 years
* Not on insulin for diabetes treatment
* HbA1c 5.5% -9.5%
* Mild/moderately increased blood pressure (systolic 120-160, diastolic 80-100) off BP medications

Exclusion Criteria:

* Pregnancy
* Patients with systolic \>160 or diastolic \>100 mmHg
* High urine calcium or history of recurrent kidney stones
* Cardiovascular disease
* Stage 3 or worse chronic kidney disease
Polydeoxyribonucleotide for Elbow Lateral Epicondylitis

The goal of this clinical trial is to investigate the synergistic effect of polydeoxyribonucleotide (PDRN) on extensor muscle strengthening exercise (EMSE) combined with extracorporeal shockwave therapy (ESWT) for treating lateral epicondylitis (LE) of the elbow in adults aged 18 to 65 years. The main questions it aims to answer are:

Does the addition of PDRN improve pain reduction as measured by the Visual Analog Scale (VAS)? Does the addition of PDRN enhance functional outcomes such as the Mayo Elbow Performance Score (MEPS) and Hand Grip Strength Index (HGSI)?

Researchers will compare two groups to see if PDRN provides additional benefits:

Group 1: EMSE + ESWT + saline injection Group 2: EMSE + ESWT + PDRN injection

Participants will:

Perform extensor muscle strengthening exercises Receive extracorporeal shockwave therapy Receive either a saline injection or a PDRN injection at the first outpatient department visit Attend follow-up visits at 6 and 12 weeks for assessments


Eligibility Criteria:
Inclusion Criteria:

Adults aged 18 to 65 years Diagnosed with chronic lateral epicondylitis (LE) of the elbow Willing to perform extensor muscle strengthening exercises Able to attend follow-up visits at 6 and 12 weeks

Exclusion Criteria:

History of elbow surgery Significant trauma to the elbow Current use of corticosteroids for LE Current use of other treatments for LE Pregnant or breastfeeding women Participation in another clinical trial within the last 30 days
Suture-Tight™ First-in-Human Safety and Performance Study

Single center, open label, prospective, single-arm, first-in-human (FIH), pre-market clinical study with the objective of validating the safety and performance of the Suture-Tight™ Suture Delivery System in an EVAR procedure.

Single center, study conducted at the Prince of Wales Private Hospital in Randwick, Australia. Up to 6 subjects may be enrolled. 1 to 3 subjects will complete initial enrollment and be followed for 30-days evaluating procedure and device safety. Additional subjects may be enrolled following the safety review to complete the 6-subject study. All subjects will be followed for six (6) months.

Subjects meeting all inclusion and exclusion criteria will be consented to receive an elective endovascular aortic aneurysm repair (EVAR) with graft anchoring utilizing the Suture-Tight device. Procedure and device safety and performance will be evaluated at 1- and 6-months by completing CT scans and KUB x-rays.

Data may be used to support a pivotal study of the investigational device and future global regulatory submissions.

Eligibility Criteria:
Inclusion Criteria:

* Currently scheduled for an elective endovascular repair of an abdominal aortic aneurysm (AAA) by EVAR with CT scan from within last 4 months. Acceptable AAA parameters include: AAA ≥ 5.0 cm in diameter OR AAA ≥ 4.5 cm in diameter with an increase of ≥ 0.5 cm within the past 6-months or ≥ 1.0 cm over the past 12-months
* Neck diameter, length and angulation that meets labeling requirements for the endograft used
* Successful EVAR graft placement with no evidence of EVAR-associated serious adverse event.

Exclusion Criteria:

* Mycotic or inflammatory AAA
* Prior surgical repair of an AAA
* Renal dialysis or significant chronic renal failure
* Evidence of recent acute coronary disease, thrombotic disease, or cerebral infarct
* Pregnancy
Effect of Transcutaneous Vagal Stimulation (TVS) on Endothelial Function and Arterial Stiffness in HFrEF

Heart failure (HF) is the leading cause of hospitalization in the US. Endothelial dysfunction, characterized by the decreased vasodilatory capacity of the vascular endothelium, is rampant in atherosclerotic diseases such as coronary artery disease and also in HF. Endothelial dysfunction also correlates with HF severity, progression, and mortality. It is postulated that endothelial dysfunction may in part be due to enhanced sympathetic drive, diminished parasympathetic drive, chronic inflammatory state thereby leading to reduced nitric oxide synthase activity in the vascular endothelium. Low-level vagus nerve stimulation (LLVNS) is an invasive way to modulate autonomic tone. Recent experimental and clinical data suggest that low-level transcutaneous vagal stimulation (TVS) (by stimulating the auricular branch of the vagus nerve located at the tragus of the external ear) may produce the same desired neuromodulator effect compared to LLVNS. The objective of this study is to determine the impact of TVS on endothelial dysfunction and arterial stiffness. The study population will include patients with chronic HFrEF. After performing baseline flow-mediated dilation (FMD), laser speckle contrast imaging(LSCI) and pulse wave analysis (PWA) testing, patients will be randomized to TVS or sham stimulation with a crossover design at different time points. The patient randomized to TVS arm will undergo stimulation for 1 hour followed by immediate measurement of FMD,LSCI and PWA. There will be a washout period of at least 24 hours with patient crossing over to the other arms thus serving as their self-control.


Eligibility Criteria:
Inclusion Criteria:

1. Patients (18 years or older) with Heart failure with reduced ejection fraction (HFrEF), which is a history of symptomatic heart failure with left ventricular ejection fraction (LVEF) of \< 40%.

Exclusion Criteria:

1. patients in overt congestive heart failure / recent acute myocardial infarction (\< 3 months) or Unstable angina
2. Active malignancy
3. Perimenopausal women and post-menopausal women on hormone supplements.
4. unilateral or bilateral vagotomy
5. Patients with bilateral upper extremity amputation
6. pregnant patients
7. End-stage renal disease
8. End-stage liver disease
9. history of recurrent vasovagal syncope, Sick sinus syndrome, 2nd- or 3rd-degree atrioventricular (AV) block.
10. patients with clinically documented upper extremity arterial disease
11. patients with BMI\>34
Pedal Movement - Implementing Cycling as a Mobility Option

Cycling has been a proven exercise for decades as a low impact option to strengthen the lower body and improve cardiovascular health. There is also evidence that cycling helps to stimulate the contraction of the muscles in the intestine. Other outcomes frequently examined when considering benefits of ambulation include decreased rates of venous thromboembolic events, pneumonia, and decreased hospital length of stays. Therefore, there is added value to consider alternate mobility modalities.

Ileus is a common post operative occurrence, one that not only causes patient discomfort but also contributes to considerable economic impact and can potentially progress to other serious complications. Historically ileus has been difficult to define. Review of the literature produces a general definition to include a varying time frame upon which a patient is not tolerating an oral diet, unable to pass flatus or stool, symptoms of nausea, vomiting, and sometimes abdominal pain. Small bowel obstruction, while different pathophysiology than ileus, presents similar manifestations. Often ileus and small bowel obstruction follow the same pathway aimed at attempted resolution with attempts at conservative management. Efforts to resolve ileus and nonoperative small bowel obstruction include bowel rest, nasogastric decompression, and encouraging mobility. Many studies support the practice of mobilization through ambulation as an effort to encourage return of bowel function. What is lacking in review of the literature however are other modalities to offer the patient in efforts to assist and encourage patients to mobilize outside of ambulation.

Eligibility Criteria:
Inclusion Criteria:

* Admission to NorthEast Acute Care Surgery
* Admitted on Post Surgical Care 1 unit
* Diagnosis of small bowel obstruction
* Diagnosis of ileus
* Any patient that has had intestinal surgery
* Age 18-90

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Incarceration
* Non-English speaking
Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined

The objective of this study is to collect heart rate, respiration data and motion data of patients admitted to sleep lab and to determine the current accuracy level of the EarlySense system vs. the standard system, and predicate device for EarlySense (Embla) used in sleep lab in monitoring heart rate and respiration rates monitors (ECG, respiratory belts, oximeter) that are currently used in the sleep lab among different population (Obese, patients with or without apnea, patients with or without arrhythmia). It is emphasized that no interpretations or clinical decisions will be made based on data received from the ES study device.

The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18 years or more 2. Is willing to sign the consent form.

Exclusion Criteria:

* Age \< 18 years
* Is not willing to sign the consent form.
Interest of an Early Rehabilitation Program in Liver Transplant Surgery

Monocentric, prospective study to evaluate 10 liver transplanted patients

The improvement of perioperative technics and the prevention of complications with immunosuppression allowed for the development with success of liver transplant. 1322 liver transplants occurred in 2016 in France to 806 in 2000. Centre Hospitalier Universitaire (CHU) of Rennes became a reference with 122 liver transplants in 2016 being the second liver transplant center in France.

Early rehabilitation concept is a multidisciplinary approach (surgical, anesthetic...) that aims to reduce the length of hospital stay and peri operative morbidity/mortality. These programs have first been developed in colorectal surgery before extending to complicated surgery like cephalic duodeno-pancreatectomy or hepatectomy. There are poor data in the literature on early rehabilitation program in liver transplant.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years old
* First liver transplant
* Liver transplant alone
* MELD (Model for End stage Liver Disease) score ≤ 15
* CHILD-PUGH score ≤ 8 if cirrhosis
* Body Mass Index \< 30 kg/m2
* No history of transplant nor immunosuppression
* Absence of ascites nor hydrothorax drain
* Absence of treatment for diabetes
* Absence of renal insufficiency (glomerular filtration flow \> 60 mL/min)
* Family help at home

Exclusion Criteria:

* Cold ischemia time \> 8 hours
* Grafts from type III Maastricht
* Super urgent liver transplantation
* Perioperative blood transfusion \> 4 packed red blood cells and/or 3 fresh frozen plasma
* Arterial anastomosis in splenic artery, in aorta or in coeliac artery
* Bilio-digestive anastomosis
* Persons deprived of liberty
* Pregnant or breastfeeding women
The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

This study was designed to determine whether post-operative pain following a tonsillectomy can be reduced by adding an antacid-like medication to the medications taken after surgery. It is hypothesized that even a small amount of stomach acid backing up and entering the mouth can increase post-tonsillectomy pain. Therefore, the use of an antacid-like medication should help to decrease pain and reduce the amount of narcotic medication required for pain control.

This study has been limited to children and adolescents ages 5-18 who are undergoing tonsillectomy for an indication of obstructive sleep disturbance (snoring, choking/gasping or pauses in breathing during sleep.)

Study participants will be randomized to two groups: study medication (Lansoprazole) or an inactive substance(placebo).

Participants will be asked to do all of the following:

1. Take the study medication twice a day for 14 days.
2. Keep a log book which will include:

   * Record the medications and amount of each medication taken each day for 14 days. This includes pain medication and the study drug.
   * Record your child's activity level daily for 14 days.
   * Collect your child's urine one time daily and test it using special medicated strips to monitor their daily liquid intake for 14 days.
3. Meet with a Research Assistant or Study Physician 14-21 days after the study to collect the log book and perform a post-operative examination.

Eligibility Criteria:
Inclusion Criteria:

* All healthy children ages 5-18 years scheduled for tonsillectomy and /or adenotonsillectomy for sleep disturbance secondary to airway obstruction at Children's Hospital Boston

Exclusion Criteria:

* Patients on any medications other than the study drug (Lansoprazole or placebo), Amoxicillin®, and acetaminophen with or without codeine
* An underlying medical condition which would necessitate an alteration in the anesthetic regimen
* Patients allergic to any of the medications in the protocol
* History of chronic tonsillitis
* History of chronic pain conditions
* History of active gastro-esophageal reflux disease
* Surgery in addition to tonsillectomy/adenotonsillectomy (except for myringotomy)
* Cognitive/developmental disorders
* Inability to use a self-report pain scale