cyrilzakka/clinical-trials huggingface dataset:
Can a Specific OMT Protocol Influence Patient Pain and Associated Analgesia Use for Primary Headache Disorders?

The purpose of this study is to see if osteopathic manipulation or light touch can reduce either or both frequency of headaches or use of pain medication. Osteopathic manipulative treatment (OMT) has been shown to help headache symptoms. The investigators like to see if regular OMT sessions can help reduce headache discomfort and also reduce use of pain medication like over-the-counter medications, migraine medications, and opioids. In this randomized controlled trial, a set sequence of OMT will be compared to light touch sham protocol. Investigators will compare participant responses to questionnaires that assess items including pain levels and reported pain medication use for the course of the study period to see if there are any shifts.

The purpose of this study is to evaluate the effectiveness of osteopathic manipulative treatment protocol (OMT) or light touch protocol in reducing headache frequency and the use of pain medication for headache pain. Previous research has suggested that OMT may alleviate headache symptoms. This randomized controlled trial aims to determine whether regular OMT sessions can decrease headache discomfort and reduce the use of pain medications, including over-the-counter medications, migraine-specific treatments, and opioids. The study consists of a ten-week period, including 2 weeks of observation, 6 weeks of intervention, and 2 weeks of washout. Participants will be randomly assigned to either receive OMT or a light touch protocol. Investigators will compare questionnaires assessing quality of life and functionality scales. Pain levels and medication use will be logged daily throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age
* takes opioids or any other pain medication for headaches more than 10 times a month (including over the counter and prescription medications for headaches).
* 3 months or greater history of headaches or migraines
* Patient able to tolerate OMT based on osteopathic physician discretion and with consideration of absolute and relative contraindications to OMT

Exclusion Criteria:

* current diagnosis of neoplasm
* history of headache secondary to trauma or concussion
* history of brain/cranial surgery, cerebral vascular events/disease (e.g., stroke, Brain arteriovenous malformation (AVM), vertebral artery disease)
* acute psychiatric diagnosis
* pregnancy
* history of substance use disorder
Molecular and Structural Imaging in Alzheimer's Disease: A Longitudinal Study

This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain of patients with typical and atypical Alzheimer's Disease and how burden may change over a one year period.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 21
* Must have an informant who will be able to provide independent evaluation of functioning
* English is primary language
* All subjects must have insidious onset, report progression of their symptoms, and meet current clinical diagnostic criteria for typical amnestic AD or an atypical AD syndrome such as Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
* All subjects with Logopenic Aphasia (LPA) must present with early and dominant impairments in language
* All subjects with typical amnestic AD must have relative preservation of episodic memory compared to impairment in the non-episodic memory domain

Exclusion Criteria:

* If you have had a stroke or tumor that could explain your symptoms
* Subjects that present with early episodic memory impairment or meet clinical criteria for mild cognitive impairment will not be recruited into the study
* Subjects that meet specific criteria for another neurodegenerative disorder, including behavioral variant frontotemporal dementia, semantic dementia, primary progressive apraxia of speech, probable corticobasal syndrome, or progressive supranuclear palsy, will be excluded
* Subjects will be excluded if they have poor vision (20/400)
* Women that are pregnant or post-partum and breast-feeding will be excluded
* Subjects will be excluded from the study if they are unable to undergo the tau-PET scan due to a prolonged QT interval on ECG, or if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, and Down's syndrome
* Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm), or if they are medically unstable or are on medications that might affect brain structure or metabolism,(e.g. chemotherapy)
Optical Brain Pulse Monitor: Validation of Cerebral Oximetry Monitoring (OBPM:VOCOM) Study.

The purpose of this study is to calibrate and validate a cerebral oximeter product from Cyban Pty. Ltd. The study will involve comparing cerebral oximeter signals against reference arterial and jugular bulb blood gas measures.

The primary objective of the study is to measure the absolute and relative accuracy of the StO2 device by comparing the NIRS-derived brain tissue oxygen saturation with blood-referenced CO-oximeter oxygen saturation values. The CO-oximeter oxygen saturation values from paired arterial and jugular bulb blood samples are combined into a weighted-equation to derive the reference SavO2. Accuracy is reported over a range of oxygen saturations with study subjects exposed to a controlled oxygen desaturation with serial sampling of paired arterial and internal jugular venous blood gas samples.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, male or female subjects between the ages of 18 to 45 years;
* Completion of a health screening for a medical history by a licensed physician, nurse practitioner, or physician assistant;
* Minimum weight 40kg;
* BMI within range 18.0 - 35.0;
* Assigned American Society of Anesthesiologists (ASA) Physical Status 1 by Principal Investigator or delegate

Exclusion Criteria:

* Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self- reported\];
* Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\];
* Taking any medication other than birth control\[self-reported\];
* Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study \[self- reported\];
* Has a negative Allen\&#39;s Test to confirm non-patency of the collateral artery \[clinical assessment by PI or delegate\];
* Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\];
* Is female with a positive pregnancy test \[serum or urine\], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breast feeding;
* Has anemia \[lab values specific for gender\];
* Has heparin allergy
* Has a history of sickle cell trait or thalassemia \[self-reported\];
* Has an abnormal hemoglobin electrophoresis result \[lab measurement\];
* Has a positive urine cotinine test or urine drug screen or oral ethanol test;
* Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\]
* Has a clinically significant abnormal EKG \[assessment by PI or delegate\];
* Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\];
* Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co- oximetry\].
* Students and Employees under the direct supervision of PI or Sub-I.
Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)

Primary objective:

To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients

Secondary objective:

To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment


Eligibility Criteria:
List of Inclusion and Exclusion Criteria:

Inclusion Criteria:

* Type 2 Diabetes Mellitus patients on metformin monotherapy
* 7% ≤ HbA1c ≤ 12%
* 20 kg/m² ≤BMI ≤ 35 kg/m²
* Diabetes duration: at least 6 months

Exclusion Criteria:

* Type 1 Diabetes Mellitus patients
* Clinical evidence of active liver disease, or serum Alanine AminoTransferase 3 times the upper limit of the normal range
* Serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females
* Acute and chronic metabolic acidosis, including diabetic ketoacidosis
* History of alcohol or other substance abuse
* Pregnancy or not using contraceptive in childbearing aged women
* Known hypersensitivity to Lantus, SU or metformin
* Any disease or condition that in the opinion of the investigator may interfere with completion of the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Characterization of Secondary Hyperalgesia in Healthy Volunteers

In this prospective trial we aim to investigate the intra-individual and inter-individual variance in secondary hyperalgesia following pain elicited by the experimental pain model: Brief Thermal Sensitization.

Furthermore we wish to investigate how precise the psychological tests, Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years and \<35 years
* Speak and understand Danish
* Male gender
* Test subjects who have understood and signed the informed consent
* No prescription medicine during the last 30 days

Exclusion Criteria:

* Test subjects that cannot cooperate to the test
* Test subjects with an alcohol and/or substance abuse, assessed by the investigator
* Test subjects, who have consumed one or several types of analgesics 2 \<days before the study
* Test subjects, who have consumed antidepressant medication during the last 30 days before the study
* Test subjects with chronic pain
* Test subjects with psychiatric diagnoses
* Test subjects with tattoos on the extremities
* Body Mass Index of \>30 or \<18
Clinical Study to Compare Cold Snare Underwater Polypectomy to Cold Snare Conventional Polypectomy for Colon Polyps [COLDWATER Study]

Colon cancer is internationally the third cause of deaths from a malignant disease. Screening colonoscopy in adults \>45 years of age aims at the early diagnosis and treatment colon polyps that are precancerous lesions. Endoscopic polyp removal (polypectomy) can be done with various techniques depending on the size, morphology, location of the polyp etc. According to updated guidelines, non-pedunculated polyps of small size are treated with a cold snare in air dilated intestinal lumen (conventional cold snare polypectomy - CCSP).In recent years, several studies have described the benefits of water aided colonoscopy, as well as safety and efficacy of underwater polypectomy in large colon polyps. However, there is not enough data on small polyps which are the most commonly diagnosed.This is a prospective randomized double-blind clinical trial to compare the safety and efficacy of CCSP to underwater cold snare polypectomy (UCSP)for non-pedunculated polyps of size of 5-10 mm. A total of 398 polyps will be randomized and randomization will be performed via random numbers method of Microsoft Excel 2016. Primary outcome of this study is to determine muscularis mucosa resection rate. Secondary outcomes are the depth and percentage of R0 excisions and possible complications.

The investigators expect UCSP to ensure a higher muscularis mucosa resection rate and they attempt to examine the resection depth in the submucosal layer.These results will provide useful data for the development of guidelines in polypectomy techniques for non-pedunculated polyps 5-10mm.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 20years
2. Non pedunculated polyps (Paris classification Isp, Is, IIa, IIb)
3. Polyp size: diameter of 5 to 10mm
4. Endoscopic diagnosis of mucosal lesions - must not present malignant submucosal infiltration evidence like deepening, ulceration / ulcer, abnormal vessels, irregular surface, (NICE 1, NICE 2A, BASIC)
5. Informed consent
6. Patients who receive antiplatelet / anticoagulant therapy are included in the study only if their therapy has been modified according to ESGE guidelines

Exclusion Criteria:

1. Age \<20 years old
2. Pedunculated polyps
3. Lesions with macroscopic elements of high-grade dysplasia or submucosal infiltration
4. Sites with previous polypectomy
5. Patients with idiopathic inflammatory bowel disease
6. Patients with coagulation disorders
7. Patients with severe organ failure

7.Patients who during endoscopy will undergo any technique using electrocautery / electrocoagulation will not be eligible for participation in the study.
Aspirin Resistance Reversibility in Diabetic Patients

The aim of the study is assessing the prevalence of aspirin resistance in a cohort of diabetic patients. Those found resistant has been undergone pharmacological tests using different drug formulations to investigate the reversibility of aspirin resistance.


Eligibility Criteria:
Inclusion Criteria:

* diabete mellitus type 2
* asa since 30 days at least
* plts \>150000 and \<450000

Exclusion Criteria:

* recent ACS (within 30 days)
* anticoagulant therapy
* haemorragic diathesis
Effectiveness of Recovery Protocols Combination in Soccer Players

The main objective of this project is to compare the effectiveness of combining different recovery methods on perceptual and physical performance on soccer players.

A crossover study will be performed and players will be assigned to different recovery methods combinations after their participation in a football game. The investigators will take baseline measures before the game and post-competition measures 24 hours after the game (one hour before the recovery intervention). Moreover, another two measure moments will be used, 24 and 48 hours after the recovery intervention.

Eligibility Criteria:
Inclusion Criteria:

* semi-professional soccer players
* 75 minutes game participation (minimum)
* 5 years of experience practicing soccer

Exclusion Criteria:

* goalkeepers
* injured players
Golf Instruction Versus Tai Chi for People With Parkinson's Disease

The purpose of this study is to determine the feasibility and tolerability of golf instruction for participants with moderate to advanced Parkinson's disease (PD). Other forms of exercise have been shown to be beneficial for PD. Golf is a low impact sport that utilizes balance and strength. Currently, there are no data looking at the effects of golf on PD. This pilot study aims to test the effects of golf in the PD patient population, particularly its effect on balance. In this study, we will be comparing group golf instruction to group Tai Chi lessons (the gold standard balance exercise for patients with PD).

Approximately, 40-50 participants with Parkinson's Disease (H\&Y stage 2 to 3) will be enrolled in this study. Participants who provide informed consent will be randomized 1:1 to either group golf instruction or group Tai Chi classes. Participants will be evaluated before and after the intervention with a battery of cognitive, motor and balance assessments including the UPDRS, the Mini-BESTest of balance, and timed up and go tests. They will participate in classes twice weekly for 10 weeks which will be provided free of charge. At the end of the intervention period they will repeat the assessments. The primary outcomes of the study are feasibility and tolerability. The key secondary objectives are to measure the efficacy of golf instruction on measures of balance, risk of falls.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants with a diagnosis of Parkinson's disease by a Movement Disorders specialist, H\&Y stage II-III in the "On" state treated with Parkinson's disease medications
* Participants must be capable of providing informed consent and complying with trial procedures including transportation to and from classes.
* Participants must be willing and able to participate in group exercise classes.
* Participants who are engaged in physical therapy or other exercise programs must be at a stable regimen for 60 days prior to the start of the study and must be willing to maintain their current regimen for the duration of the study.

Exclusion Criteria:

* Clinical evidence of unstable medical or psychiatric illness which would prevent them from engaging in exercise
* Participants who are already active golfers or currently active in Tai Chi would be excluded.
Physical Activity Program for Counteracting Sarcopenia

Sarcopenia is a pathophysiological process associated with aging and some metabolic conditions characterized by progressive muscle tissue loss, which may lead to loss of strangth and performance and increase risk of falls and fractures, physical disability and premature death. Therefore, it is necessary to identify personalized programs of physical activity and supplementation for elderly population in order to improve their physical functions, muscle strengh and body composition.

With the present project we aime to assess the effect of a feasible home-based exercise program coupled with food supplementation to improve muscle strength, muscle volume and muscle physical performance potentially associated with sarcopenia in elderly people.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary lifestyle.
* Cognitively intact.
* Autonomous walking.
* Acceptance of informed consent.

Exclusion Criteria:

* Body mass index lower than 18.5 and uppen than 40 kg/m2.
* History of cancer.
* Pacemaker user.
* History of epileptic episodes.
* Endocrine-metabolic, neurological, muscular and ortopedic pathologies that affect movement functions.
* Bone fractures that influence movement functions.
* Smoking.
* Surgical treatments in the prior 6 months.
* Use of antieptilectics, glucocorticoids, rhGH and testosterone.
* Hepatic and muscular pathologies
The Effect of Hepatic Vein Pressure Gradient(HVPG)-Guided Therapy in Cirrhotic Patients With Esophagogastric Varices

The purpose of the study is to compare the effect of HVPG-guided individualized therapy and non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.

The study is a randomized controlled trial of Zelen-design. Patients randomly enter two treatment groups: 1) the HVPG group and 2) the non-HVPG group. Treatment allocation is by block randomization with an equal number for both groups. The results are concealed in opaque envelopes.After randomization, patients will have a second chance to decide if they want to stay in the current group.Patients can switch to another group according to their will. If they are in the HVPG group，they will receive HVPG measurement before treatment. If they are in the non-HVPG group, they start treatment without HVPG measurement and receive endoscopic treatment plus Carvedilol.The mortality rate and rebleeding rate will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis diagnosed by histology, radiological evidence of cirrhosis, and endoscopic evidence of varices;
* Patients with a previous history of variceal hemorrhage;
* Patients admitted to Zhongshan Hospital and other 6 tertiary centers in Shanghai from Dec 1, 2015 to Sep 31,2018

Exclusion Criteria:

* Patients already taken secondary prophylactic treatment including endoscopic, pharmacological, surgical and interventional therapies;
* Patients with severe systemic diseases such as chronic heart failure or chronic renal failure that will have impact on survival;
* Patients in pregnancy and lactation;
* Patients already diagnosed with hepatic cellular carcinoma or other malignant tumors;
* Patients with contraindication to treatment of endoscopy, surgery and TIPS: severe coagulation defects, allergic to contrast medium used in TIPS, hepatic encephalopathy, spontaneous bacterial peritonitis;
* Patients with conditions that will influence the accuracy of HVPG measurement: Cavernous transformation of portal vein, diffused portal vein thrombosis, severe shunt;
* Patients refuse to give consent to the study.
Degenerative Achilles Tendon Rupture Repair With Regeneten Augmentation

Retrospective Case Series to investigate the effect a bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy

Retrospective Case Series. Investigate the effect a bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy.

Acute Achilles tendon rupture patients all underwent pre-operative ultrasound; those with tendinopathy enrolled into study.

Standard Achilles tendon repair performed; augmented with a bioinductive collagen patch (Regeneten)

Eligibility Criteria:
Inclusion Criteria:

* Pre-operative ultrasound confirmation of tendinopathy

Exclusion Criteria:

* Underwent lower limb intervention with past 3 months
* Physical or psychological condition impairing ability to consent
* Physical or psychological condition impairing ability to adhere to rehabilitation protocol
* allergy to bovine material
* pregnant individuals
Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment

The purpose of this study is to evaluate the safety of intravenously (IV) administered adipose-derived mesenchymal stem cell (AD-MSC) in patients with type 1 diabetes mellitus (T1D)

Adipose derived mesenchymal stem cells (AD-MSCs) has many advantages, i.e. the greater ease of access and harvesting by means such as subcutaneous lipoaspiration, a much less painful procedure than harvesting bone marrow stem cells, and a much less ethical concern because they are harvested from autologous fat. The purpose of this study is to evaluate the safety of intravenously (IV) administered adipose-derived mesenchymal stem cell (AD-MSC) in treatment 10 patients with type 1 diabetes mellitus (T1D) at Vinmec International Hospital, Hanoi, Vietnam.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed T1D (according to the instructions of the Ministry of Health No: 5481/QD-BYT dated December 30, 2020)
* Aged from 5 years and over.
* The time from the diagnosis of type 1 diabetes to enrollment ≤ 12 months.
* Blood testing conducted at the time of diagnosis:

  * Fasting blood glucose ≥ 7 mmol / L,
  * HbA1C ≥ 6.5%.
  * Have at least one antibodies associated with T1D such as ICA; GAD; ZnT8 or IAA.
* At the time of screening at Vinmec for study enrollment, patients are actively managing their blood glucose levels with insulin.
* The patient does not have other serious acute illness requiring treatment
* The patient agrees to use stem cell transplant for treatment
* The patient's parent (parent or legal guardian) can read, write, understand the ICF form and agree to sign a consent to participate in the study.

Exclusion Criteria:

* Having evidence related to renal dysfunction: creatinine \> 1.5 mg/dl or (\>133 mmol/L) for boys, creatinine \> 1.4 mg/dl or (\>124 mmol/L) for girls
* In case of kidney failure. Proteinuria within the range of nephrotic syndrome (\>3.5 g/day or ratio of protein/creatinine in urine \>2.7)
* In case of kidney failure
* Having severe infection or infected with hepatitis B virus, hepatitis C virus, HIV virus, or tuberculosis
* Cardiovascular disease, respiratory disease (pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer or neurological disease
* Blood clotting disorders (INR\> 1,5, PTT\> 40, PT\> 15).
* Taking any anticoagulant
* Taking systemic steroids
* Participate in another clinical study involving experimenting drugs and/or medical equipment
* History of allergic reaction to anesthetic agents and/or antibiotics