cyrilzakka/clinical-trials huggingface dataset:
Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study

Recent data suggest that gut microbiota can function as an environmental factor that modulates the amount of body fat and obese individuals have an altered gut microbiota.The results of previous animal studies have suggest that a probiotic strain Lactobacillus paracasei K56 have reduced high-fat diet induced obesity.

In this before-after pilot study, the participants were randomly assigned to 8 groups to compare the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing different product prototypes , and screen the best probiotic K56 prototype with the effect of fat reduction.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>=30kg/m2,or percent of body fat(PBF) \>=25% for male, \>=30 for female.
* Age: 18 - 60 years old adults

Exclusion Criteria:

* patients with severe chronic diseases (coronary heart disease, diabetes, hypertension, immune deficiency, mental disorders, tumors, liver and kidney dysfunction, etc.) and complications;irritable bowel syndrome
* History of intervention with fat-reducing drugs or health products in the past 2 months
* take weight control measures (diet, exercise, etc.) within the past month
* Those who cannot guarantee to maintain their current lifestyle during the trial period
* Those who fail to consume the tested samples as required, or fail to follow up on time, resulting in failure to determine the efficacy
Effect of Aromatase Inhibitors on Ultrasonographic Measurements and Static and Dynamic Balance Scores in Breast Cancer

To evaluate the effects of aromatase inhibitors on lower extremity ultrasonographic measurements, static and dynamic balance scores in breast cancer patients using aromatase inhibitors

Breast cancer is the most common cancer in women. 2/3 of breast cancer patients are estrogen and progesterone receptor positive. Tamoxifen or aromatase inhibitors are preferred in most of these patients depending on menopausal status. The increase in the life expectancy of breast cancer patients with medical treatments pushes us to find the cause of the drug side effects encountered during this extended life span and work on preventing/correcting them. It has been proven that aromatase inhibitors cause arthralgia in 40-50% of patients and a loss in bone mineral density, leading to a tendency towards osteoporosis. In this patient group, changes in the tendon and tendon sheath were also observed in ultrasonographic and magnetic resonance imaging and were stated to be the cause of the current symptoms.

In the literature, breast cancer patients have been evaluated in detail in terms of balance, and it has been shown that static and dynamic body balance is worse in this group compared to the control group. Among the breast cancer population, the presence of arthralgia in the patient group using aromatase inhibitors causes an increased risk of falls. In addition, it is thought that lower extremity tendon changes may be a factor in balance and proprioception disorders.

Based on this information, quantitative evaluation of static and dynamic balance in patients is important since there is an increase in the frequency of falls and a tendency to osteoporosis in patients using aromatase inhibitors in breast cancer. No similar study has been found in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal Woman
* Between 40-70 ages
* Stage 1-3 breast cancer
* Chemotherapy treatment due to breast cancer (Last dosage at least 6 months ago)
* Using an aromatase inhibitors for at least 1 year for group 1
* Never using an aromatase inhibitors at all for group 2
* Volunteers must sign and agree to participate in the study.

Exclusion Criteria:

* Stage 4 breast cancer
* Having active chemotherapy
* Older age patient (over 70 years old)
* Using of steroid
* Presence of diabetes mellitus that lasts longer than 3 years or insulin usage
* Neuropathic complaints
* Lack of vitamin B12 and thyroid dysfunction
* Dn4 (dolour neuropathic 4 question) score of 4 and above
* History of stroke
* Presence of polyneuropathy diagnosis
* Medication due to polyneuropathy diagnosis (gabapentin, pregabalin, duloxetine)
* Loss of motor function in the lower extremity
* Use of assistive devices for walking
* Presence of vestibular disorder
* Presence of cognitive impairment
Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura

Multicentric non-randomized phase II opened prospective study (10 centres involved).

Primary endpoint:

* To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges.

Secondary endpoints:

* To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma exchange sessions required to achieve a durable complete remission, and to determinate the duration of B-cell depletion.
* To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.

Duration of the study:

3 years and 2 months, including 1 year of inclusion and 2 years of participation for the patient.

Experimental plan:

Patients fulfilling the inclusion criteria of the study will be treated according to the recommendations of the Reference Centre for the management of thrombotic microangiopathies. If patients present refractory TTP, infusions of rituximab (375 mg/m2) will be added to this treatment at day 1, 4 and 15, immediately after plasma exchange sessions.On diagnosis, during treatment and after remission achievement, the following values will be explored: ADAMTS13 activity, ADAMTS13 inhibitors and anti-ADAMTS13 antibodies, B-cell lymphocytes quantification by immunophenotyping, and serum gammaglobulin level by serum protein electrophoresis. Rituximab will also be quantified.

Number of patients:

Each participating centre may recruit and include 1 patient/year.Amongst 10 participating centres, a total number of 10 patients should be included.

Specific activities during the study:

Three infusions of rituximab (375 mg/m2 /infusion), immediately after plasma exchange sessions on day 1, 4 and 15. Blood samplings at day 1, 4 and 15, at 1 month and then every 3 month until month 24.

Expected results and perspectives:

This study should provide evidence as to whether the association of rituximab to plasma exchanges allo an efficient B-cell depletion. If yes, a randomized study should be performed to evaluate the role of rituximab at the acute phase of acquired idiopathic TTP, immediately after the diagnosis was established.

Eligibility Criteria:
Inclusion Criteria:

* Microangiopathic hemolytic anemia (\< 12 g/dL) with thrombocytopenia \<50 G/L, and mild or no renal failure (Serum creatinine \< 150 µmol/L),
* negative Beta HCG and ongoing contraception during treatment and during the 24 months following the last infusion of rituximab,
* refractory TTP (after 4 days of standard treatment)
* \> 18 year old
* and signed written informed consent.

Exclusion Criteria:

* Hemolytic uremic syndrome (platelet count ³ 50 G/L and serum creatinine ³ 150 micromol/L),
* TTP associated with another condition (HIV infection, cancer and/or chemotherapy, transplantation),
* previous treatment with vincristine or cyclophosphamide or other immunomodulatory drugs (except steroids), within 2 months before inclusion ;
* ongoing or planned pregnancy, lactation
Comparison of Vibration and Dry Needle in Trigger Point Therapy

The aim of this study is to compare the effects of localized vibration and dry needling applied to the trigger point in the individuals with acute myofascial pain syndrome.Pressure pain threshold (PPT) was used for the primary outcome measure of the study, and pain intensity, pain tolerance and short form (SF-36) were used for secondary outcome measures.

The patients were divided into two groups as dry needling and localized vibration using the permuted block randomization method. The study was completed with 20 (17 women, 3 men) in the dry needling group and 20 in localized vibration (15 women, 5 men). In both applications, a total of 3 sessions were made to the patients at 1-day intervals.Patients' age, gender, duration of pain, localization, presence of additional disease, drug use were questioned and recorded. Pressure pain threshold (PPT) was used for the primary outcome measure of the study, and pain intensity, pain tolerance and short form (SF-36) were used for secondary outcome measures. All evaluation criteria except SF-36 were made before, immediately after and 1 day after each session, 1 week after the last session. SF-36 was evaluated before the 1st session treatment, after the 3rd session treatment and 1 week after the 3rd session treatment.

Eligibility Criteria:
Inclusion Criteria:

* At least one active myofascial trigger point in the upper trapezius muscle
* Symptoms lasting 1 day to 2 weeks
* Cases who did not receive any physical therapy or medication to relieve pain

Exclusion Criteria:

* Sensory defect in the area to be treated with vibration
* Active inflammatory, rheumatological or infectious disease
* Peripheral nerve lesions such as polyneuropathy, radiculopathy
* Having a cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease)
* Diagnosis of fibromyalgia or other common musculoskeletal pain syndromes with an intact skin surface in the area to be vibrated
* Patients with a history of panic attacks
A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)

The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form and HIPAA document
* Willing and able to comply with all study procedures
* Be at least 18 years of age
* Patient-reported history of dry eye in both eyes
* Demonstrate a positive response when exposed to the Controlled Adverse Environment model
* A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

* Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
* Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the study period
* Any blood donation or significant loss of blood within 56 days of Visit 1
* Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
* Use of any topical ophthalmic preparations (including tear substitutes) 72 hrs prior to screening assessments and through the entire study period
* Any significant illness that could interfere with study parameters
* History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; or any scheduled ocular surgical procedure during the study period.
* Known history of alcohol and/or drug abuse
Effects of Wearable Sensor Based Virtual Reality Game on Balance for Stroke

Pablo is a new virtual reality (VR) game combined with wearable motion sensor system which can targeted intervention in an interactive environment, immediate and sensitive feedback about the user's performance, a motivating effect due to game-based feature. Unlike commercial camera systems such as Kinect or force platforms, the systems require a continuous sightline or restrict the base of support which may increase risk of falling. Few of studies had investigated the rehabilitation effects on balance with Pablo for patients with stroke. The purpose of this study is to investigate the effects of virtual reality training through Pablo system in patients with chronic stroke.

Pablo is a new virtual reality (VR) game combined with wearable motion sensor system which can targeted intervention in an interactive environment, immediate and sensitive feedback about the user's performance, a motivating effect due to game-based feature. Unlike commercial camera systems such as Kinect or force platforms, the systems require a continuous sightline or restrict the base of support which may increase risk of falling. Few of studies had investigated the rehabilitation effects on balance with Pablo for patients with stroke.

PURPOSE: The purpose of this study is to investigate the effects of virtual reality training through Pablo system in patients with chronic stroke.

METHODS: A prospective, randomized, controlled, blinded assessor design was used. Patients with stroke were recruited and randomly assigned to a "virtual reality(VR) group" (n = 20) and "functional balance training (FBT) group" (n = 20). After 18 training sessions (60 minutes per session, 2 sessions per week), outcome measures which included the Berg Balance Scale, the Timed Up and Go Test (cognition), a gait analysis, the Activities-Specific Balance Confidence scale, Stroke Impact Scale (SIS), Level of pleasure, and frequency of adverse events. The data were analyzed using nonparametric tests, and significance was indicated at α \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they had first stroke with hemiplegia.
* Could stand for 5 minutes without support.
* Chronicity of \>6 months.
* Could understand instructions.
* Brunnstrom stage of LE ≥Ⅲ.

Exclusion Criteria:

* Patients who were aged \<20 years and \>75 years
* Patients with visual or auditory impairment who were unable to see or hear the feedback from the device clearly
* Montreal Cognitive Assessment \<16
* Modified Ashworth Scale score of \>2
* Patients with other medical symptoms that can affect movement.
Web-Based Treatment of Heavy Drinking Among Women With a History of Sexual Trauma

The goal of this study is to empirically evaluate a web-based intervention to reduce heavy drinking among college women with a history of sexual assault who display elevated levels of psychological distress. College women with a history of sexual assault often report more heavy drinking and psychological distress than women without a history of assault. Moreover, women with assault histories often have difficulty regulating their emotions and tolerating distress which can lead to a pattern of drinking to cope distress. Trauma exposure, negative mood, and poor coping strategies have been associated with poor treatment outcomes and relapse following alcohol treatment. Incorporating distress tolerance and emotion regulation skills with an alcohol intervention may enhance treatment effects among women with a history of sexual assault by decreasing their motivation to drink to cope with depression or anxiety and by building adaptive coping strategies. Therefore, the web-based intervention will include cognitive behavioral skills for reducing alcohol consumption and incorporate emotion regulation and distress tolerance skills from Dialectical Behavior Therapy.

For the small randomized controlled trial, heavy drinking college women with a history of sexual assault will be recruited and randomized to receive the intervention or an assessment only control. Online surveys will be administered at baseline, and post-treatment as well as 1-month and 6-months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment at the University of Washington,
* female,
* 18 or older,
* lifetime history of sexual assault (defined as unwanted attempted or completed oral, vaginal, or anal penetration but excluding unwanted sexual contact only),
* at least 2 instances of heavy episodic drinking (defined as 4 or more drinks in 2 hours) in the past 30 days,
* average consumption equal or greater than 7 drinks per week in the past 30 days.

Exclusion Criteria:

* None
The Effect of Acute Intermittent Hypoxia on Motor Learning

The goal of this pilot study is to examine the effect of repetitive acute intermittent hypoxia on motor learning in persons with chronic, incomplete spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old (the latter to reduce likelihood of heart disease);
* Medically stable with medical clearance from physician to participate;
* Motor-incomplete spinal cord injuries at or below C2 and at or above L5;
* AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.);
* More than 1 year since iSCI to minimize confounds of spontaneous neurological recovery;
* Ability to advance one step overground with or without assistive devices;

Exclusion Criteria:

* Severe concurrent illness or pain;
* Recurrent autonomic dysreflexia;
* History of cardiovascular/pulmonary complications;
* Concurrent physical therapy;
* Pregnant at time of enrollment or planning to become pregnant;
* Untreated painful musculoskeletal dysfunction, fracture or pressure sore;
* History of seizures or epilepsy;
* Recurring headaches;
* Concussion within the last six months;
* Depression or manic disorders
* Metal implants in the head, or pacemaker.
The Effects of Light on Glucose Metabolism

This study evaluates the effect of bright light on postprandial blood glucose metabolism in obese subjects with impaired fasting glucose and/or impaired glucose tolerance.

Light has a major influence on the biological clock and several studies suggest that bright light during the day and dim light in the evening are beneficial for the circadian timing system. Nowadays, large parts of the population spend 90% of their time indoors and are thereby exposed to artificial lighting instead of daylight. The artificial light levels are relatively low during the day and continue relatively late in the evening. The lack of a clear natural light-dark cycle could results in delayed timing of the biological clock relative to the behaviour. Optimizing the lighting conditions under controlled laboratory settings might lead to better alignment of the biological clock, which in turn could improve metabolic parameters such as glucose control.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* BMI 25-35 kg/m2
* Stable weight (+/- 3 kg in the last 3 months)
* One of the four criteria for prediabetes:

  * Impaired fasting glucose (6.1 mM to 6.9 mM)
  * Blood glucose values 7.8 - 11.1 mM 2h after glucose drink consumption during the oral glucose tolerance test (OGTT) in screening
  * Insulin Resistance: glucose clearance rate ≤ 360 ml/kg/min, as determined using the oral glucose insulin sensitivity (OGIS120) index
  * HbA1c of 5.7 - 6.4%.

Exclusion Criteria:

* Fasting plasma glucose ≥7.0 mM
* Blood donation one month prior to study and three months after finishing study.
* Participants with extreme chronotypes (going to bed extremely late/early).
To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

To evaluate the long-term safety and tolerability of pregabalin in patients with partial seizures.


Eligibility Criteria:
Inclusion Criteria:

* Must have met the inclusion criteria for preceding double-blind study
* Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

* Cannot have absence seizures
Group Therapy Supported Internet-based CBT for Adolescents With Social Anxiety Disorder - A Feasibility Trial

The primary objectives of this study is to test the feasibility and efficacy of group-therapy supported internet-delivered CBT for adolescents (13 - 17 years) with social anxiety disorder. Investigators will conduct an open trial with N = 30 participants. Participants will be assessed at baseline, immediately after treatment and at a 6-month follow-up.

Social anxiety disorder (SAD) among youths is highly prevalent and causes significant impairment in the lives of the affected. In spite of CBT being the most effective treatment, evidence suggests that many young people with this disorder do not have access to good-quality CBT. Internet-based CBT is, as numerous prior studies have shown, an effective method to treat psychiatric conditions in adults, but little is known about ICBT for adolescents and there are but a few controlled studies on ICBT for children and adolescents with anxiety disorders. This pilot trial will evaluate the feasibility and efficacy of a blended ICBT-treatment where internet-based and group-based sessions are combined. Furthermore, as ICBT is a novel format in the treatment of psychological problems in young people, it is essential to evaluate the feasibility and acceptability of the technical solutions that carry the active treatment. The study will also include genotyping of participants to further our understanding of etiology of SAD and to explore the relationship between genetic variations and treatment outcome. Additionally, as there is little known about the affect of ASD symptoms on treatment outcome in face-to-face CBT in general, and in ICBT in particular, the association between autistic traits and treatment outcome will be evaluated. Lastly, the role of attentional processes in the maintenance of social anxiety has been scarcely studied and an aim with the current study is to further our understanding of the cognitive factors that underlie SAD

Eligibility Criteria:
Inclusion Criteria:

* A principal diagnosis of social anxiety disorder, as defined by DSM-5
* Ability to read and write Swedish
* Daily access to the internet through a computer or similar device
* A parent or caregiver that is able to co-participate in the treatment
* Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

* Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
* Present risk of suicide
* Ongoing substance dependence
* Occurrence of domestic violence
* Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)
the Hypertrophic Scar Prevention of BMT101.

An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial

As a comparative evaluation between the control group (untreated-control) and the study group (treatment) within a subject, it was decided to assign ten subjects to each of the three dose groups.

Eligibility Criteria:
Inclusion Criteria:

* male and female adults aged 19-55 years
* Those who plan to undergo a revision surgery to remove hypertrophic scar resulted from a previous abdominal surgery
* Those who voluntarily signed the written consent and agreed to participate in the study.

Exclusion Criteria:

* Pregnant or lactating women
* Those with clinically significant systemic disease (e.g. diabetes, hematologic disease, allergic or immunogenic systemic skin disease)