cyrilzakka/clinical-trials huggingface dataset:
An Exploratory Genetic Study in Participants With Psoriasis

The purpose of this study is to evaluate the association between genetic factors and response to treatment (guselkumab, ustekinumab, adalimumab, or etanercept) and psoriasis (scaly skin rash).

This is a Phase 0, exploratory (intended to be conducted early in Phase 1, involve limited human exposure, have no therapeutic intent and are not intended to examine clinical tolerability), multicenter (when more than one hospital or medical school team work on a medical research study) and pharmacogenomics study in participants with psoriasis. Participants who were treated in study Phase 2 NCT01483599 (X-PLORE), Phase 3 NCT00267969 (PHOENIX 1), Phase 3 NCT00307437 (PHOENIX 2) or Phase 3 NCT00454584 (ACCEPT), will be returning to their study site where a deoxyribonucleic acid (DNA) sample will be obtained for pharmacogenomics assessment. There will be no follow-up beyond the study site visit.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have been randomly assigned and treated in the NCT01483599 (X-PLORE), NCT00267969 (PHOENIX 1), NCT00307437 (PHOENIX-2) , or NCT00454584 (ACCEPT) studies
* Sign an informed consent document indicating that they understand the purpose of and procedures required for this study and are willing to participate in this study

Exclusion Criteria:

* Participants has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA)

The overall aim of this study is to develop and test a psychodynamic Internet--delivered psychological treatment for patients with social anxiety disorder and compare its efficacy to a waiting list.

Participants with social anxiety disorder (MINI telephone interview) will be recruited via mass media and randomly allocated to psychodynamic Internet--delivered psychological treatment or to a waiting list control condition.

Eligibility Criteria:
Inclusion Criteria:

* Social anxiety disorder as diagnosed by the MINI diagnostic interview

Exclusion Criteria:

* Severe depression
The Role of Muscle in Knee Stability

This project aims to compare the difference in muscle strength, muscle elasticity and muscle coordination of quadriceps and hamstring muscle and their association with knee biomechanics during single leg hop landing in patients with anterior cruciate ligament reconstruction.

In Hong Kong, over 3000 cases of Anterior Cruciate Ligament Reconstruction (ACLR) are operated annually to restore knee stability. Despite recovery of knee passive laxity and muscle strength, dynamic knee stability is often not restored. In additional to muscle strength, muscle elasticity and muscle coordination may also play an important role in knee stability. However, there is no evidence regarding the changes in muscle elasticity after ACLR and its contribution to dynamic knee stability. This study is a cross-sectional study designed to compare the the difference in muscle strength, muscle elasticity and muscle coordination of quadriceps and hamstring muscle in 30 ACLR patients and investigate its relationship with knee biomechanics during single leg hop landing. Patient selection was base on medical records and subjective knee functional scores. Patient enrollment and informed consent was conducted first. Muscle strength was measured by isokinetic muscle testing(Biodex) at two speeds. Muscle elasticity was assessed by ultrasound shear wave elastography. Muscle coordination evaluated by electromyography(EMG) and knee biomechanics including kinematics and kinetics was measured by 3D motion analysis system(VICON) and all the assessments were done in CUHK-ORT Sports Injury Research Laboratory in the Prince of Wales Hospital, Hong Kong. All data was collected and analyzed by qualified personnel.

Eligibility Criteria:
Inclusion Criteria:

* (1) Male aged 18-35 (2) With pre-injury activity level of more than 6 in Tegner score (3) Within their post-operative 6-18 months (4) Without injury history for the contralateral limb

Exclusion Criteria:

* (1) With concomitant fracture, meniscus injury or chondral lesion (2) With preoperative radiographic signs of arthritis (3) With revision ACL surgery (4) With injury history of the spine or hamstring strain during the past 6 months.
Polycystic Ovary Syndrome and Education

Aim: This research is being designed to determine the effect of Polycystic Ovary Syndrome (PCOS) education given to women on their quality of life. In this context, the aim of the project is; The aim is to determine the impact of the education given to women with PCOS on the quality of life of the training given to women with the disease, such as psychosocial and emotional status, fertility, sexual function, obesity and menstrual irregularity, and hair growth.

Method: Within the scope of this research, quantitative research method is used as the research method. In addition, it is planned as a randomized controlled quasi-experimental, which is one of the quantitative research methods. In calculating the sample size, type 1 error, research power and effect size parameters are determined before the research begins. Studies generally need to have at least 80% power. In order to find a significant difference, it is calculated that there should be at least 30 students in each group at 80% power and 95% confidence level. Considering the possible risks, it is planned to include 70 women in total in 2 groups (study and control), with 35 women in each group. All individuals who want to respond to the survey are included in the sample. The process of finding a subject continues until the desired size is reached. In addition, during the data collection process, participants were asked; They are asked whether they are diagnosed with PCOS and those who answer "yes" are included in the sample. Within the scope of the research, the voluntariness of the participants is essential and both written and verbal consents are obtained from each participant through an informed consent form. "Personal Information Form" and "Polycystic Ovary Syndrome Quality of Life-50 Scale" created by the researchers were used as data collection tools.


Eligibility Criteria:
Inclusion Criteria:

Individuals who are over 18 years of age, open to communication, diagnosed with PCOS, have no mental problems that require treatment, have no physical, mental or five sense disabilities, speak Turkish and can read and write, and volunteer to participate in the study.

Exclusion Criteria:

Individuals who are under 18 years old, not open to communication, diagnosed with PCOS, require treatment for significant mental health issues, have physical, mental, or sensory impairments, cannot speak or read and write Turkish, and are not willing to participate in the study.
Thrombolysis and Deferoxamine in Middle Cerebral Artery Occlusion

Iron overload has been associated with greater brain injury in ischemia/reperfusion experimental stroke models and ischemic stroke patients, especially in those treated with thrombolytic treatment. Deferoxamine administration, an iron chelator, offers a neuroprotective action in ischemia/reperfusion animal models.

Primary objective: To evaluate the security and tolerability of deferoxamine endovenous treatment in acute ischemic stroke patients treated with iv. tPA.

Secondary objectives: To study pharmacokinetics of deferoxamine given by endovenous bolus (10 mg/Kg) followed by 72-hour continuous intravenous infusion (20, 40 o 60 mg/Kg). To evaluate the deferoxamine effect in clinical outcome, infarct volume and hemorrhagic transformation and brain edema development.

Methodology: Double-blind, randomized, placebo controlled, dose-finding phase II clinical trial. Study stages: 1st: bolus+20 mg/Kg/day vs. Placebo (n=15:5); 2nd: bolus+40 mg/Kg/day vs. Placebo (n=15:5); 3rd: bolus+60 mg/Kg/day vs placebo (n=15:5). These doses will be increased according to security results of the previous stage. Patients will be continuously monitored in stroke units. Laboratory parameters will be measured at baseline, 24h, 72h and 30 days to evaluate adverse events related to the drug. Serum deferoxamine and feroxamine concentrations will be measured along time after the injection in a subgroup of patients to the pharmacokinetics study. CT scan will be performed at 24-36h to assess hemorrhagic transformation and brain edema. The NIH Stroke Scale will be evaluated during hospitalization, and the Rankin score at discharge and 3 months.

If deferoxamine demonstrate to be secure and well tolerated treatment in acute stroke patients, it may be a new therapy option to lower the brain injury after ischemia and reperfusion.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old
* Acute Ischemic Stroke on the middle cerebral artery territory
* Treatment with iv tPA in the first 3 hours from symptoms onset

Exclusion Criteria:

* Modified Rankin Scale more or equal to 2
* Infectious, inflammatory, neoplastic or hematologic disease
* Anemia (Hto\<34% or Hb\<10g/dl)
* Previous renal failure
* Previous treatment with oral iron supplement
* Minor stroke (NIHSS less than 4), lacunar or posterior territory
* Alcohol consumption (more than 40mg/Kg)
* Pregnancy
* Participation in other clinical trials
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)

To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication


Eligibility Criteria:
Inclusion Criteria:

* 8 years of age or older
* Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
* Diagnosis of FFKC
* History of Radial Keratotomy with fluctuating vision.
* Ability to provide written informed consent
* Likely to complete all study visits
* Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam

Exclusion Criteria:

* Severe corneal scarring that markedly affects vision
* Contraindications to any study medications or their components
* Pregnancy or breast feeding
* Active Herpes Corneal Disease
Evaluation of a Marine OXYgen Carrier for Organ Preservation

Preventing ischemia/reperfusion injuries (IRIs) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRIs is delayed graft function (DGF).

The medical device HEMO2life®, an oxygen carrier developed by the Hemarina French Company, is a natural extracellular hemoglobin (Hb) isolated from the marine lugworm Arenicola marina. This biopolymer of high molecular weight (\~3,600 kDa) has a large oxygen binding capacity, carrying up to 156 oxygen molecules when saturated (4 for human Hb). It releases oxygen according to a simple gradient and exhibits an intrinsic superoxide dismutase-like activity preventing both the occurrence of potentially harmful heme-protein-associated free radical species and the release of Hb degradation products.

Recently a safety study in 60 renal grafts using HEMO2life® as additive to organ preservation solution (Oxyop study, NCT02652520) was completed, that confirmed that the use of HEMO2life® is safe for patients and grafts.

In the Oxyop study, even if the protocol was not designed to show a benefit of the use of HEMO2life®, significantly less delayed graft function (DGF) and a shorter renal function recovery was observed.

The present research focuses on the efficacy of HEMO2life®, which is an oxygen carrier added in preservation solution in kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* For Kidney graft:
* Any pair of kidneys retrieved in an adult donor in one of first line participating centers.
* Any pair of kidneys from a deceased donor after brain or cardiac death
* For Patient:
* Male or female renal allograft recipients at least 18 years old
* Patient who signed an inform consent form
* Patient receiving one graft from an included pair of kidneys

Exclusion criteria :

* For kidney :
* Graft from a living donor
* Graft dedicated to a multi-organ transplantation or dual kidney transplantation,
Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer

Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for both patients and physicians. Weekly carboplatin may have similar efficacy with weekly cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in patients with locally advanced cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated, histologically confirmed cervical cancer
* One of following histologic types Squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
* Age: 20-75 years
* GOG performance status: 0-2
* Adequate organ function Bone marrow: WBC ≥ 3,000/mm3, ANC ≥ 1,500/mm3, Platelet ≥ 100X103/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine \< 1.25 × UNL, Liver : AST, ALT \< 3 × UNL, T- bilirubin \< 1.5 mg/ mm3
* Contraception during study treatment
* Informed consent

Exclusion Criteria:

* Previous chemotherapy or pelvic radiation therapy
* Hormone therapy within 4 weeks
* Concomitant malignancy within 5 years except cured basal cell carcinoma of skin
* Uncontrolled medical disease
* Pregnant or lactating woman
* Etc.
Stretching in Water and on Land for Patients With Ankylosing Spondylitis

The aim of the study is to investigate the effectiveness stretching exercises in ankylosing spondylitis.

Ankylosing spondylitis is a chronic, progressive disease with an unknown etiology which characterize with inflammation that leads to bone fusion in spinal joints. Besides the systemic manifestations, chronic pain acquired kyphosis, diminished exercise capacity may cause pulmonary dysfunction, muscle imbalance, reduced quality of life, sleep disruptions and depression. There are strong evidence and advice on exercise should start with diagnosis. Although stretching exercises are the most common exercises in this group the literature on the effectiveness of stretching exercises is scarce. The aim of the study is to investigate the effectiveness stretching exercises in ankylosing spondylitis.

The study was carried on patients with ankylosing spondylitis followed by Division of Rheumatology and Immunology, Department of Internal Medicine, Dokuz Eylül University School of Medicine. 57 patients were assessed and randomized into two group control and intervention. Control group informed on the importance of exercise and given a home exercise brochure. The intervention group was also randomized into an aquatic and land stretching group and received stretching exercises two days a week for eight weeks. Two patients from the control group and nine patients (three from aquatic, six from land) from the intervention group were excluded.

At the end of eight weeks, except FEV1, FVC, VC all results of the intervention group improved whereas an quality of health was the only result improved in the control group. When aquatic and land stretching groups the results were improved similarly. The improvements of BASFI and MIP of the aquatic group are superior to the land group.

Home exercises are playing an important role in the management of ankylosing spondylitis. Addition of stretching exercises to home exercises enhances the effectiveness of the treatment. Aquatic stretching exercises have some benefits than land stretching exercises.

Eligibility Criteria:
Inclusion Criteria:

* AS diagnosed according to 1988 Modified New York criteria volunteered with a BASDAI score of 3 or 4

Exclusion Criteria:

* Patients followed any physical exercise within the last 3 months prior to this study, history of cardiovascular and pulmonary disease were excluded.
Highly Suppressive Treg in Delayed and Slow Graft Function After Kidney Transplantation

Delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/slow graft function. Delayed/slow graft function, however, is associated with an increased risk of acute rejection and graft failure. There are currently no clinically accepted biomarkers and no specific treatments for delayed/slow graft function. Regulatory T cells are protective in ischemia-reperfusion injury and rejection by suppressing pathologic immune responses. We hypothesize that the pre-transplant measurement of highly suppressive regulatory T cell is an accurate biomarker for delayed/slow graft function and its immunologic consequences. Ultimately, marginal kidney graft allocation could be directed to regulatory T cell-robust recipients and regulatory T cell-directed therapies could decrease marginal kidney graft discards without increasing delayed/slow graft function or impacting outcomes.


Eligibility Criteria:
Inclusion Criteria:

- Adult kidney transplant candidates immediately prior to their kidney transplant surgery

Exclusion Criteria:

* \< 18 years old
* Active immunosuppressive drug use
* Hepatitis C
* HIV
Patient Factors Impacting Adherence to Oral Chemotherapy

The purpose of this study is to identify what makes it easier and what makes it harder to take oral chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary breast cancer or gastrointestinal cancer
* Currently prescribed capecitabine
* Age 21 years or older
* Able to understand written and oral English

Exclusion Criteria:

* Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Assessment of Heart Rate Measurement Accuracy for the PreemptiveAI SDK in Adults

The goal of this clinical trial is to assess the accuracy of the PreemptiveAI SDK to measure heart rate for adults as compared to an FDA-approved ground truth device.

Participants will:

* Complete a demographics and health history survey
* Apply and wear ground truth equipment such as a pulse oximeter and ECG
* Measure their heart rate 8 times with 4 different smartphones using the PreemptiveAI SDK


Eligibility Criteria:
Inclusion Criteria:

* Adults with both normal and abnormal heart rates

Exclusion Criteria:

* Under 18 years of age
* Unable to speak and read English
* Deemed not suitable to participate by Investigator due to cognitive impairment, acute illness, or serious physical or mental health condition
* Essential tremor in left or right hand
* Raynaud's disease
* Severe calluses on left or right index finger
* Unable to produce a heart rate measurement due to low signal quality during the training phase (i.e. low perfusion, unable to hold hand steady, etc)
Positive Psychology Intervention to Improve Quality of Life in Stem Cell Transplant Survivors and Their Caregivers

This trial studies a positive psychology intervention designed to improve quality of life in stem cell transplant survivors and their caregivers. Positive psychology (PP) uses systematic exercises (e.g., gratitude letters, acts of kindness) to potentially boost levels of optimism, resilience, and life enjoyment. PP interventions are often enjoyable, easy to understand, and can be delivered via telephone. PP intervention may improve the quality of life of participants who have undergone a stem cell transplant or their caregivers.

PRIMARY OBJECTIVES:

I. Pilot a positive psychology intervention delivered to hematopoietic cell transplantation (HCT) survivors and interested caregivers over an 8 week period.

II. Determine the proportion of patients who enroll and the immediate benefit to participants, as measured by pre- and post-exercise measures of happiness and optimism.

III. Pilot outcome data collection mechanisms in preparation for a randomized clinical trial.

OUTLINE:

Participants and caregivers receive a positive psychology exercise manual, complete positive psychology exercises every week, and participate in phone sessions over 30 minutes every week for 8 weeks.

After completion of study, participants are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* English as primary language
* At least 1 year after HCT

Exclusion Criteria:

* Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach.
* Medical conditions precluding participation in the intervention or likely to lead to death within 6 months, as determined by the principal investigator (PI)
Robotic Versus Laparoscopic Sleeve Gastrectomy

Sleeve gastrectomy is the most commonly performed bariatric procedures. Robotic surgery seems to add more precision to the surgical interventions. However, robotic bariatric procedures appear to be burdened by longer operative time.

Aim of the investigators is to prospectively and randomly submit patients suffering from obesity to robotic or laparoscopic surgery in order to compare outcomes.


Eligibility Criteria:
Inclusion Criteria:

* According to IFSO (International Federation for the Surgery of Obesity)/ASMBS (American Society for Metabolic and Bariatric Surgery) 2023 guidelines

Exclusion Criteria:

* Previous bariatric or abdominal surgery
Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency

The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL

In this open study, patients will enter a baseline period of 6 days where the pancreatic enzyme therapy will be discontinued and a standard diet given. After the baseline period, patients will enter a treatment period of 6 days where a fixed dose of BSSL will be administered. The primary efficacy measurements will be made by collecting stool during the last three days of each period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cystic fibrosis and pancreatic insufficiency who are able to refrain from their ongoing pancreatic enzyme treatment for a period of 7 days and are able to produce stools \>= 5 times per week
Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance

This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.

This substudy aims to investigate the impact of, and subsequent change of, joint inflammation, articular cartilage composition, overall knee morphology, and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.


Eligibility Criteria:
Inclusion Criteria:

* Same as parent trial (NCT02905864)

Further Exclusion Criteria:

* Same as parent trial (NCT02905864)
* Usual exclusion criteria for MRI (i.e. pacemakers etc.)