cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Effect in Rheumatoid Arthritis.

Regulatory T (Tregs) cells play an important role in the maintenance of immunological tolerance. It decrease in the peripheral blood of rheumatoid arthritis patients. Vitamin D has an immunomodulatory and anti-inflammatory effect in rheumatoid arthritis.

Vitamin D supplementation significantly enhances Tregs percentage in the peripheral blood of RA patients. So supplementation of Vit D improves rheumatoid arthritis disease activity.

Background: Regulatory T cells (Tregs) play an important role in the maintenance of immunological tolerance, so Tregs deficiency or decrease suppressor functions may be associated with development of autoimmune diseases.

Vitamin D is essential for normal bone mineralization and growth, prevention of osteopenia, osteoporosis, and nonspecific painful musculoskeletal conditions . Vitamin D is thought to have an immunomodulatory and anti-inflammatory actions, as its receptors are widely expressed in peripheral mononuclear blood cells, also its deficiency associated with several autoimmune disorders, including rheumatoid arthritis

Methods: 40 patients with active RA were randomly assigned into two groups. Group I received MTX plus hydroxychloroquine, group II received MTX and hydroxychloroquine plus vitamin D supplementation for 3 months, in addition to 30 healthy volunteers as control group. Peripheral blood Tregs were measured by Flow Cytometry.

Statistical Analysis. The collected data analyzed by SPSS software (version 16). The range, mean and standard deviation were calculated for quantitative variables. Categorical variables were expressed as number and percentages; Chi square was used as a test of their significance. Skewness, kurtosis; Shapiro-Wilk, and The Kolmogorov-Smirnov tests were used to test the normality for the data. The difference between two means was analyzed using the students (t) test (paired and unpaired samples- T tests). Significance was considered at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* disease duration less than 3 years from the time of diagnosis, age more than 18 years, a diagnosis of RA according to the 2010 ACR/ EULAR Classification criteria for RA diagnosis , active disease according to DAS-28, for those receiving nonsteroidal anti-inflammatory drugs and corticosteroids, the dosage had to be stable for at least 2 weeks before screening.

Exclusion Criteria:

* Patients with allergic, and infectious diseases, patients receiving steroids for the first time within 2 weeks before the study, patients with hypercalcemia, hypercalciuria, nephrolithiasis, or neoplastic diseases were excluded from the study. We also excluded patients on any biologic therapy and patients with prior use of leflunomide, hydroxychloroquine, or sulphasalazine for more than 2 months.
Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.


Eligibility Criteria:
Inclusion Criteria:

* Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs.

Exclusion Criteria:

* Pregnancy
* Non compliance
* Heart Failure (NYHA 3-4)
* LV ejection fraction \< 50 %
* Renal insufficiency (eGFR\<30)
* Unstable coronary heart disease
* Coronary intervention within 6 months
* Myocardial infarction within 6 months
* Claudication
* Orthostatic syncope within 6 months
* Secondary Hypertension
* Permanent atrial fibrillation
* Significant Heart Valve Disease
* Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
* Second and third degree heart block
* Macroscopic haematuria
* Proximal significant coronary stenosis
* Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter \< 4 mm, length \< 2 cm, multiple renal arteries, severe calcifications)
Liver Cancer Registry Platform

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Hepatocellular Carcinoma (HCC) or Cholangiocarcinoma (CCC) in Germany.

JADE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of HCC or CCC in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life in patients with HCC / CCC will be evaluated for up to three years.

Eligibility Criteria:
Inclusion criteria:

* Confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) als early, intermediate or advanced/metastatic stage
* Age ≥ 18 years
* Signed and dated informed consent (IC):

  * For participation in the PRO module: Before primary locoregional therapy or start of first systemic treatment
  * For no participation in the PRO module: No later than 8 weeks after primary locoregional therapy or start of first systemic treatment

Exclusion criteria:

Patients treated with best supportive care (BSC) only (i.e. no surgery, no radiotherapy, no ablative procedures, no systemic anti-tumoral therapies)
Effect of Treatment on Connective Tissue in Low Back Pain

The purpose of the study is to investigate the effects of instrument assisted soft tissue mobilization (IASTM) and kinesiology taping (KT) that are additional treatment to the conservative treatment for the lumbar region and hamstrings and connective tissue thickness in patients with chronic non-specific low back pain (CNSLBP).


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 30 and 50
* who had low back pain for at least 12 weeks,
* received no physical therapy in the last 6 months,
* received no IASTM or chemotherapy,
* had normal movement of the hip joint
* Visual Analog Scale value above 3

Exclusion Criteria:

* the presence of allergy and skin diseases,
* pregnancy,
* major structural spinal deformity (scoliosis, kyphosis, stenosis),
* inflammatory disease,
* presence of extruded and sequestered herniation, -signs of neurological disease, -
* presence of orthopedic diseases such as fracture
* a history of spinal surgery.
Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants

Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants

Rapid feeding advancement achieves full enteral volume of feedings earlier than the slower advancement.They received significantly fewer days of parenteral nutrition, exhibited a shorter time to regain birth weight and shorter duration of hospital stay. The incidence of NEC and the number of episodes of feeding intolerance were not significantly different between rapid and slow advancement. while the incidence of culture-proven late onset sepsis was significantly less in infants receiving a rapid feeding advancement

Eligibility Criteria:
Inclusion Criteria:

- All preterm neonates admitted to NICU with gestational age less than 36 weeks, and haemodynamically stable

Exclusion Criteria:

* gastrointestinal tract anomalies,
* haemodynamically unstable infants,
* gestatinal age equal or more than 36 weeks,
* preterms who develop NEC,
* preterms on mechanical ventilation.
Cognitive-behavioural Treatment of Chronic Back Pain

The purpose of the study:

* to compare two cognitive-behavioral treatments

128 patients suffering from chronic back pain were randomly assigned to either Wait List Control, Cognitive Behavioral Treatment or Cognitive Behavioral Treatment and Biofeedback.

Measures were conducted 6 months before treatment (Wait List Control) immediately before and after treatment and at 6-months follow-up.

25 weekly 1-hr sessions of individualized outpatient cognitive behavioral treatment of chronic back pain

Treatment elements:

Cognitive treatment: identification, evaluation and correction of dysfunctional beliefs about themselves and pain by cognitive restructuring, problem-solving training and coping skills training

Behavioural treatment: increasing activity levels (sports, social activities, work), reducing medication intake and unnecessary health care utilization Relaxation training: progressive muscle relaxation, biofeedback.

Eligibility Criteria:
Inclusion Criteria:

* Back pain since 6 months

Exclusion Criteria:

* Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol
Yoga-mindfulness for Pain Management in Inflammatory Arthritis

This study evaluates the potential effects on pain, pain-related symptoms and quality of life of a yoga-mindfulness program, compared to patient education and physiotherapy, for patients with inflammatory arthritis and persistent pain problems.

Earlier studies has indicated that body-mind therapies such as yoga and tai chi might be beneficial in the management of chronic pain syndromes. Chronic pain affects a large number of patients with inflammatory arthritis. Effective treatments are lacking for this patient group, so new treatment strategies are warranted.

The study is designed as randomized controlled trial where participants are allocated on a 1:1 ratio to either a 15 week intervention program of yoga-mindfulness or 15 weeks of patient education and mild physiotherapy.

Study outcomes include pain levels and other pain-related features such as fatigue, sleep problems, mood disturbances and functional disability as well as measurements of health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older
* Subject has a diagnosis of either rheumatoid arthritis or psoriatic arthritis
* Subject has a total score on SIQR above 33
* Subject has not changed anti-rheumatic or analgetic treatment strategies during the three months preceding study inclusion (dose changes of ongoing treatments are accepted)

Exclusion Criteria:

* Subject has another medical condition that might prevent the subjects full participation in the interventions
* Subject has more than four swollen joints
* Subject has a C-Reactive Protein more than 20 mg/L
* Subject is currently practicing yoga or has practiced yoga regularly during the last six months prior to study inclusion
* Subject does not speak Swedish
* Subject is unwilling to comply with the study protocol
* Subject is considered, by the investigator, to be an unsuitable candidate for the study
Effects of FOR-Care Model on Preventive Medicine

This study aims to address the prevalence of undiagnosed hypertension and diabetes by assessing the impact of the FOR-Care model on preventive medicine. The model focuses on improving the documentation of blood pressure, height, and weight in outpatient settings. Through a cluster randomized trial at National Taiwan University Hospital, clinics will either implement the FOR-Care model or continue with usual care. The trial will evaluate the effectiveness of the intervention in documenting these measurements and its impact on diagnosing hypertension and diabetes. The outcomes will provide valuable insights into enhancing preventive medicine and improving care for chronic diseases.

Background: The prevalence of undiagnosed hypertension and diabetes among adults is considerable. For those already diagnosed with hypertension and diabetes, monitoring blood pressure and controlling body weight are recognized as essential methods for risk assessment. However, in outpatient settings, there is still room for improvement in the on-site documentation of blood pressure, height, and weight.

Objective: This cluster randomized trial (CRT) will assess the effects of preventive medicine following the implementation of the FOR-Care model, a technique designed for facilitating on-site recordings of office blood pressure, height, and weight.

Methods: The investigators will conduct a pragmatic CRT at the outpatient clinics of the Department of Family Medicine, National Taiwan University Hospital. A total of 42 clinics with over 15 patients will be randomized into two groups. The intervention group will adopt a FOR-Care model, required to measure and record blood pressure, height, and weight before consultations; while the control group receives usual care. The protected medical information will be accessed through the National Taiwan University Hospital Integrative Medical Database (NTUH-iMD). The quality improvement outcome is documentation of on-site blood pressure, height, and weight recordings of both groups at 12 and 24 weeks (cluster-level parameter). The primary preventive medicine outcome is newly diagnosed hypertension and diabetes mellitus (individual-level parameter). The secondary preventive medicine outcomes are clinical indicators of hypertension and diabetes mellitus in those with these diagnoses (individual-level parameters).

Expected Outcomes: The results of this pragmatic CRT will shed new insight into preventive medicine and quality of care in the management of common chronic diseases.

Eligibility Criteria:
Cluster-level inclusion criteria:

* clinic sessions with at least 15 patients, but fewer than 40 patients

Cluster-level exclusion criteria:

* travel, hospice, vaccination, or health examination clinics
* special-appointed clinics

Patient-level exclusion criteria

* patients aged less than 18
* patients with active catastrophic illness or terminal malignancies
* patients with major adverse cardiac events within 3 months before the index dates
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.


Eligibility Criteria:
Inclusion Criteria:

* Over eighteen years old
* Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature
* Pre-placement of seton required for at least 6 weeks prior to surgical treatment
* Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer

Exclusion Criteria:

* Recurrent fistula tracts
* J-pouch fistulas
* Superficial fistulas
* Fistulas with active abscess, infection, or acute inflammation
* History of Chron's Disease
* History of Ulcerative Colitis
* History of HIV or other immune system disease
* History of collagen disease
* History of radiation to the anorectal region
* Allergies to pig tissue or pig products
* Religious or cultural objection to the use of pig tissue
Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy

The purpose of this study was to explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and intestinal microflora structure detection.

This is a monocentric prospective cohort study in which 50 patients treated for malignant tumors will be included. All participants will be followed for 6 months after the initiation of oncology drug therapy. Echocardiography and 2D speckle tracking will be performed and stool and blood samples will be tested before treatment initiation and at 3 and 6 months after initiation.

Eligibility Criteria:
Inclusion Criteria:

* With malignant tumors
* Will receive antitumor drugs
* Could receive regular follow-up for 6 months
* Written informed consent

Exclusion Criteria:

* Satisfactory echocardiographic images could not be obtained
* Cardiomyopathy
* Coronary artery disease
* Heart failure
* Arrhythmia requiring intervention
* Moderate or severe valvular disease
* Acute myocarditis
* Refractory hypertension
* Participating in other studies of drug intervention
Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT

We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer 11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and patients with cholestatic disorders.

The purpose of the study is the development of PET/CT protocols using 11C-CSar for human use. PET/CT methods developed in the pig studies are translated to studies in healthy humans and patients with cholestatic disorders. Dynamic PET/CT scans of the liver and biliary system are combined with measurements of tracer concentrations in a radial artery and a liver vein and measurements of hepatic blood flow by intravenous infusion of indocyanine green (ICG)/Ficks principle. Kinetic parameters from PET/CT measurements and invasive measurements are compared for validation of the PET estimated parameters and refinement of the PET modeling, if required.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cholestatic disorders and healthy subjects

Exclusion Criteria:

* Body weight above 110 kg (catheterization problematic).
* Diabetes
* Pregnant or breast feeding women.
Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study

A two-step multi-centre study with 240 rheumatoid arthritis patients.

A two-step multi-centre study containing:

A test-retest study including 180 patients filling in questionnaires and performing joint assessments to assess reliability of patient generated data

AND

An agreement study focusing on questionnaires and joint assessments performed by 60 patients, a medical student, a physician and by an ultrasound-examinator assessing agreement between the four assessors

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with RA ≥ 12 months
* DAS28-CRP \< 5,1

Exclusion Criteria:

* Dementia or other linguistic/cognitive/physical deficiency that prevents participation
* Vision impairment that prevents the use of the devices and computer
Pilates on Dynamic Balance in Flexible Flat Feet

Flexible flatfoot is one of the most common types of flatfeet. It has an arch that is present in open kinetic chain and lost in closed kinetic chain Balance is defined as the process that maintains the center of gravity within the body's support base.

Pilates exercises is a whole body conditioning program which was initially used for managing low back pain and improving balance in elderly. Now-a-days it is used for posture correction and fitness training.

Individuals with flatfeet are more unstable when compared with normal individuals during quiet standing. About 10% to 25% of population exhibits a flat foot to varying degrees. In clinical practice, some subjects become symptomatic with feet pain or lower extremity soreness and limitation in their functional activities such as limitation of long-distance walking or running and high-impact sports.Patients with flexible flat feet have poorer static and dynamic balance than healthy individuals. Taking into consideration effect of flat feet on body alignment, the implication of flat feet on balance have received little attention to date Pilates is an individual body-based exercise, it has an advantage in that exercise load can be controlled according to the body's center of balance.Pilates based exercise works on the principles of trunk stability, also known as "core stability". "Core is described as a box, with the abdominals (transversus) in front, paraspinals (multifidus) in back, diaphragm in top and pelvic floor at the bottom". Pilates is a popular form of exercise training program which includes series of stretching and strengthening exercises with proper trunk control and breathing.

Eligibility Criteria:
Inclusion Criteria:

1. Subject's age ranged from 18-21 years old
2. Subjects had bilateral pronated feet posture according to the Navicular Drop Test by Brody method: normal feet (between five and nine mm of navicular drop), a pronated foot (more than 10 mm of navicular drop)
3. Body Mass Index (MBI) ranged from 18.5 to 25 kg/ m2

Exclusion Criteria:

* 1-Repeated lower extremity injuries as fractures or deformities. 2-History of surgery to the lower extremity. 3- Any neurological deficit affecting balance. 4-Any medication can affect the balance. 5- pregnant and breast feeding females
Enhancing Protection Against Vector-borne Diseases in Forcibly Displaced Communities: Evaluating the Efficacy of Spatial Repellents for Cutaneous Leishmaniasis Control in North-East Syria

The aim of this study is to determine the efficacy of Mosquito Shield (spatial repellent) in reducing cutaneous leishmaniasis case incidence among internally displaced persons and sandfly density in temporary shelters and camp settings in Ar-Raqqa governorate, North-East Syria.


Eligibility Criteria:
Inclusion Criteria:

Known history of cutaneous leishmaniasis in camp Sleeping under same shelter type (all UNHCR tents / plastic sheets) Camp easily accessible by road Camps a minimum of 5km apart Adequate security levels

Exclusion Criteria:

Camps closer than 5km from a camp included in the study Camps with no previously recorded cases of cutaneous leishmaniasis Displaced communities living outside of defined camp settings
Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

The purpose of this study is to evaluate the effects of conservative treatments of obesity with surgery (gastric bypass).

The aim of this study is to evaluate 3 different treatments of obesity with gastric bypass. Two groups will be treated in different clinics and 1 group will be treated at our outpatient clinic. Sixty patients will participate in each group. Behavioural changes and weight loss over 4-5 years will be followed. We will also analyse changes in hormones, mental status, sexual behaviour, effect of training and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \> 40 or BMI \> 35 with complications

Exclusion Criteria:

* Unstable atherosclerotic disease
* Psychologically unstable
* Unable to participate in the training program