cyrilzakka/clinical-trials huggingface dataset:
Effect Observation Study of COX-2 Inhibitor to Treat Primary Hypertrophic Osteoarthropathy

The purpose of this study is to determine whether COX-2 inhibitor is effective in the treatment of primary hypertrophic osteoarthropathy

Patients with primary hypertrophic osteoarthropathy(PHO) were diagnosed based on clinical manifestations and symptoms. PHO patients were treated with COX-2 inhibitor after signing informed consent. The extend of alleviation, the change of the markers on prostaglandin E metabolic pathway and the adverse event on different time points were recorded to identify the efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with primary hypertrophic osteoarthropathy clinically
* over 16 years old
* no other medication intake
* informed consent signed

Exclusion Criteria:

* below 16 years old
* active gastric ulcer
* inflammatory bowel disease
* New York Heart Association classification（NYHA） II to IV
* liver or renal failure
* allergic to nonsteroid anti-inflammatory drugs
* not willing to participate
Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow.

104 patients with unilateral tennis elbow from both genders (57 females and 43 males) referred by orthopaedist with age ranged between 20 and 60 years.

hey were recruited in the study from October 2020 to September 2021 and allocated randomly into two groups. Group A received premodulated current in addition to exercises, and group B received diadynamic current with the same exercises. Each patient signed the informed consent form approved by the faculty of physical therapy, October 6 university, Egypt and prospectively registered (Clinical Trials.gov, Identifier NCT03338283). Patients was selected according to the following criteria.

Inclusive criteria

* Patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension
* lasting of the symptoms for 3 months
* no previous physiotherapy interventions.

Exclusive criteria

Internal or external fixation

* arthritis of elbow
* contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension
* lasting of the symptoms for 3 months
* previous physiotherapy interventions.

Exclusion Criteria:

* Internal or external fixation
* arthritis of elbow
* contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.
Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall heRnias (ROCSTAR)

In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.


Eligibility Criteria:
Inclusion Criteria:

- All patients requiring treatment of a wide ventral incisional hernia (of more than 8 centimetres in width)

Exclusion Criteria:

* Pregnant or suspected pregnancy
* Not-curatively treated malignancy, with life expectancy less than 24 months
* Patients unable to give informed consent or complete study specific questionnaires
* Emergency surgery
* Primary ventral hernia repair
* Exclusively lateral hernias not involving the midline
* Incisional hernia repair after open abdomen or enterocutaneous fistula
* Active wound infection
* Previous anterior or posterior component separation
* Patients with an existing ostomy
* Patients with a life expectancy of less than 24 months
* Patients suspected of being unable to comply with the study protocol
Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070. Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.


Eligibility Criteria:
Primary Inclusion Criteria:

* Healthy Smokers
* Subjects must smoke a minimum of 10 but not more than 25 cigarettes per day for at least 3 months prior to enrollment
* Written informed consent

Primary Exclusion Criteria:

* Prior exposure to nicotine vaccines
* Female subjects of childbearing potential
* Current use of immunosuppressive agents
* History of or current autoimmune disorder of immunosuppressive condition (e.g. HIV infection)
* Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study.
Artificial Intelligence-based Video Analysis to Detect Infantile Spasms

Infantile spasms are a type of seizure linked to developmental issues. Unfortunately, they are often misdiagnosed, causing delays in treatment. The purpose of this study is to develop a computer program that can reliably differentiate infantile spasms from similar, yet benign movements in videos. This computer program will learn from videos taken by parents of study participants. Quickly recognizing and treating infantile spasms is crucial for ensuring the best developmental outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Participant age less than 24 months
* Participant evaluated in the Johns Hopkins Outpatient Center, Johns Hopkins Pediatric Emergency Department or Johns Hopkins Inpatient Units due to spells of abnormal movement or seizure
* Participant evaluated by a pediatric neurologist during the outpatient or inpatient visit at Johns Hopkins Hospital
* At least one video recording of the spell of abnormal movement produced by the parent/guardian available for provider review

Exclusion Criteria:

* Poor video recording quality
* Entire patient is not in frame
Brain Outcomes With Lifestyle Change in Down Syndrome

The goal of this study is to determine if weight loss or changes in dietary intake can help prevent of delay adults with Down syndrome from developing Alzheimer's Disease

Adults with Down syndrome without dementia will be randomized to either a weight loss group or a general health education control group. The weight loss group will be asked to follow a reduced energy diet, attend monthly education sessions delivered remotely and self-monitor diet and body weight using commercially available web-based applications. The control group will be asked to attend remotely delivered monthly education sessions on general health education topics.

All participants will come to the University of Kansas Medical Center, 3 times across 12 months for a blood draw, cognitive testing, a MRI, assessment of height and weight, and assessment of diet intake.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Down syndrome
* BMI of 25 to 45 kg/m2
* Ability to communicate through spoken language.
* Ability to come to the University of Kansas Medical Center 3 times across 1 year for outcomes testing
* Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner including providing transportation to our facilities for study assessments.

Exclusion Criteria:

* Diagnosis of dementia
* Insulin dependent diabetes
* Participation in a weight management program involving diet or physical activity in the past 6 mos.
* Dairy allergy
* Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
* Unwilling to be randomized
* Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position
* Use of GLP-1 medications
* Use of anti-amyloid medications
The Relationship Between Left Atrial Pressure and Cardiac Function After Atrioventricular Node Ablation

Effects of left atrial pressure-guided ventricular rate changes on cardiac function after atrioventricular node ablation combined with left bundle branch pacing

Effects of left atrial pressure-guided ventricular rate changes on cardiac function after atrioventricular node ablation combined with left bundle branch pacing. For patients with non-valvular atrial fibrillation who received atrioventricular node ablation combined with left bundle branch pacing in our hospital, a left atrial pressure catheter was used to monitor atrial pressure during the operation, and a lower average atrial pressure was obtained by adjusting the pacing frequency of the pacemaker. In a randomized controlled manner, the postoperative echocardiography, cardiothoracic ratio, cardiac function, etc. were compared between patients without atrial pressure monitoring and those who received atrial pressure adjustment, in order to clarify the effect of left atrial pressure-guided ventricular rate adjustment on atrioventricular node ablation combined with left bundle Benefit of pacing patients.

Eligibility Criteria:
Inclusion Criteria:

18-85 years old atrial fibrillation patients

Exclusion Criteria:

There is a history of pacemaker implantation; patients after coronary artery bypass grafting; severe coronary stenosis or occlusion cannot be treated with reperfusion;
Study of Letrozole Plus Tipifarnib or Placebo in the Treatment of Advanced Breast Cancer

The purpose of this study is to determine if the addition of tipifarnib to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.

This clinical study involves two groups of patients with advanced breast cancer. One group (2/3rds of all the patients) will be taking tipifarnib in combination with another anticancer drug called letrozole, and the other group (1/3rd of all the patients) will be taking letrozole plus a placebo (an inactive substance given in the same form as a real drug). The assignment to one of these two groups will be by chance (like flipping a coin). Unless the need arises, neither the patient nor the study staff will know whether the patient is receiving tipifarnib with the letrozole. Comparisons between the two groups will be made for patients who have achieve a confirmed Complete Response (CR) or Partial Response (PR). The interval between the date of randomization and the earliest date of disease progression will also be assessed. The study will include evaluations of safety and tolerability. Patients should expect their participation in this trial to last a minimum of 4 to 8 weeks. Their participation could continue for several months or beyond a year, depending on how their disease responds to the treatment. After completing study treatment, patients will be asked to attend for an End of Treatment visit and then a posttreatment Follow-up visit 4 to 6 weeks after stopping the medication. Patients will be randomly assigned to treatment with either 2.5 mg letrozole once daily plus placebo to match tipifarnib twice daily, or 2.5 mg letrozole once daily plus 300 mg tipifarnib twice daily. Both tipifranib and matching placebo will be given in 28-day cycles of 21 days of treatment followed by 7 days rest. All patients will receive continuous treatment with letrozole.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced, inoperable loco-regionally-recurrent, or metastatic breast cancer
* Estrogen and/or progesterone positive disease
* Progression of disease after antiestrogen therapy
* Measurable disease
* Postmenopausal
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

Exclusion Criteria:

* Previous endocrine therapy, other than antiestrogen therapy
* More than 1 prior chemotherapy regimen
* Previous therapy with farnesyl transferase inhibitor
* Presence of rapidly progressive, life-threatening metastases
* Concomitant anticancer treatment
* Other malignancy within the past 5 years
* Symptomatic peripheral neuropathy.
Breast Feeding Analgesia in Preterm Infants

The purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure

Hypothesis:

1. When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
2. Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.

Research Method:

In a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.

Eligibility Criteria:
Inclusion Criteria:

* born between 30-36 weeks gestational age
* breastfeeding
* mother has fluent English

Exclusion Criteria:

* CNS injury
* congenital anomaly
* active infection
* has had surgeries or analgesics/sedatives in last 72 hours
* history of maternal drug exposure
Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients

Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these patients receive enteral feeding. There is controversy about ideal carbohydrate composition of these diets. The aim of this study was to compare an enteral formula with the same proportion of carbohydrates with and without fructose on blood glucose levels.

Randomized, cross-over, controlled, double-blind clinical trial without washout. Adult patients admitted to the ICU who presented capillary glycemia values\> 180mg / dl with a full and exclusive enteral diet. They were randomized and observed for 4 days (2 days with each diet: with / without fructose). Capillary glycemia was measured 4 / 4h.

Eligibility Criteria:
Inclusion Criteria:

* Critical Illness
* Exclusive enteral diet
* Enteral diet with full nutritional value
* Hyperglycemia ≥180 mg / dl

Exclusion Criteria:

* Oral feeding
* NPT (Total or Partial Parenteral Nutrition)
* Patient without indication of use of study diets
Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction

Comparing of the intraoperative blood loss between group rectal misoprostol group and control group

This open-labeled randomized controlled trial was conducted at the Department of Obstetrics and Gynecology, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand, from February 2022 to September 2022, after approval of the Institution of Review Board of Queen Savang Vadhana Memorial Hospital (IRB No. 001/2565).

Fifty six (56) women with diagnosis of benign uterine disease who were scheduled to perform total abdominal hysterectomy with or without bilateral salpingo-oophorectomy between February 2022 to September 2022 at Queen Savang Vadhana Memorial Hospital were enrolled in this study.

The participants were randomly allocated into two groups, study and control group. The randomization list was kept in a sealed opaque envelope. Study group received two tablets of 200 mcg misoprostol; The drug was inserted rectally 1 hour before operation. Few drops of normal saline were used to dissolve tablets before insertion. Control group that did not receive the drug. The drug was administered by a nurse at Gynecologic ward. The primary outcome was intraoperative blood loss that recorded by measuring amount of blood on the surgical gauzes and swabs by standardized scales and another was recorded from blood in suction container. The secondary outcome was hemoglobin differentiation, rate of blood transfusion and adverse events of misoprostol usage.

Eligibility Criteria:
Inclusion Criteria:

Female undergoing total abdominal hysterectomy (elective case) with

* No history of bleeding tendency
* No history of anticoagulant drug used within 7 days before surgery
* No contraindications of Misoprostol drug used
* No history of allergic to misoprostol

Exclusion Criteria:

* Can not communicate with Thai language
* Malignancy case
* Emergency case
Neurotoxicity of Spinal Anesthesia With Ropivacaine and Bupivacaine

Consenting patients, scheduled for orthopaedic surgery under spinal anesthesia will be randomly assigned (1:1) to receive ropivacaine or bupivacaine as a single shot before the start of surgery, followed by bolus doses of the same local anesthetic as required during the surgery, and continuous infusion of the same local anesthetic for 24 hours postoperatively.

Primary Outcome Measures: Evaluation of changes in concentrations of glutamate in the cerebrospinal fluid and in the blood. Secondary outcomes: : Evaluation of changes in concentrations of selected mediators of inflammatory response (IL-1β, IL-6, TNF and others) and selected chemokines as markers of the glia damage.

Hemodynamic stability during the surgery, and efficacy of postoperative analgesia will be also evaluated.

With the approval from the Bioethical Committee of the University of Rzeszow, informed written consent will be obtained from all patients.

A sample size of 60 patients was calculated to obtain at least 25% reduction of glutamate concentration in the cerebrospinal fluid in the ropivacaine group with 0,05 significance and power of 0,8.

Consenting patients, scheduled for orthopaedic surgery under spinal anesthesia will be randomly (1:1) assigned using closed envelopes to receive intrathecally ropivacaine or bupivacaine as a single shot before the start of surgery, followed by bolus doses of the same local anesthetic as required during the surgery, and continuous infusion of the same local anesthetic for 24 h for postoperative pain relief. All block will be performed in the sitting position, and the drug will be administered in supine position through the catheter in the intrathecal space. Blood and cerebrospinal fluid samples will be drawn at predetermined time intervals centrifuged as required and frosen in -70deg C until analysis.

Eligibility Ages eligible for study 18 years and older (Adult, Senior) Sexes Eligible for the Study: All Accepts Healthy Volunteers: No

Inclusion Criteria:

Orthopedic procedures in the lower limbs Written informed consent Exclusion criteria Patients' refusal Known allergies to study medications Anatomic, posttraumatic and postoperative deformations of the spinal column making placement of intrathecal catheter impossible Neurological contraindications Any other contraindications for spinal anesthesia (coagulations disorders, antiplatelet or anticoagulant treatment, infection at the puncture site.

Inability to comprehend or participate in pain scoring scale

Eligibility Criteria:
Inclusion Criteria:

- Orthopedic procedures in the lower limbs Written informed consent

Exclusion Criteria:

* Patients' refusal Known allergies to study medications Inability to comprehend or participate in pain scoring scale Anatomic, posttraumatic and postoperative deformations of the spinal column making placement of intrathecal catheter impossible Neurological contraindications Any other contraindications for spinal anesthesia (coagulations disorders, antiplatelet or anticoagulant treatment, infection at the puncture site.
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)

This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.

Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions: MK0518-004-10 (NCT00100048), which extended the study to 144 weeks, and MK0518-004-20 (NCT00100048), which extended the study to 240 weeks. Participants who had been randomized to MK0518 in the base study continued at 400 mg MK0518 twice daily.

Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study. The doses of open label tenofovir and lamivudine continued unchanged.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be HIV positive who must have received less than 7 days total of any antiretroviral therapy (HIV related therapy)

Extension Studies:

* First extension: Patient completed the 48-week base study
* Second extension: Patient completed the first 144-week extension study

Exclusion Criteria:

* Less than 18 years of age
* Individuals who currently do not test positive for HIV
Long Term Physical Training in Asthma

This controlled study is undertaken to investigate the effects of a long term outpatient training program on physical fitness and quality of life in elderly asthmatics.

Physical training is well known to support a healthy lifestyle. Patients with asthma are often unnecessarily restricted of physical activities or avoid exercise due to the unpleasant experience of exercise-induced dyspnea. As a consequence both children and adults with asthma are less fit than their peers. Like in healthy individuals, regular training supports health in asthmatics. In short-term training programs improvements of physical capabilities have been achieved in children and young adults with asthma. Programs of longer durations than 3 months have not been published in controlled trials. Effects of exercise training on quality of life in adult asthmatics are lacking.

Eligibility Criteria:
Inclusion Criteria:

* physician diagnosed asthma
* non-smoker
* stable condition
* informed consent

Exclusion Criteria:

* participation in pulmonary rehabilitation in the past 12 months prior to study inclusion
* unability to attend training sessions on a regular basis for one year
* symptomatic coronary heart disease
* uncontrolled heart failure
* hemodynamically relevant cardiac rhythm disorders
* hemodynamically relevant cardiac valvular disorders
* uncontrolled arterial hypertension
* hypercapnic respiratory failure
* severe hypoxemia (i.e. PaO2 \<50 mm Hg resp. SaO2 \<80% at rest)
* history of decompensated right heart failure
* pulmonary arterial hypertension (PA mean pressure at rest \>20 mm Hg)
* severe osteoporosis
* severe airway obstruction (FEV1 \<50% predicted, FEV1 \<60% predicted following bronchodilatation)
* maximum work rate of less than 50 watt during ergometer testing
* uncontrolled asthma
* COPD exacerbation
* severe adipositas (BMI \>35 kg/m2)