cyrilzakka/clinical-trials huggingface dataset:
The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury

Aim 1: Determine the neurophysiologic impact of Transcutaneous Spinal Cord Stimulation (TSCS) within a single session. The investigators hypothesize that subjects will demonstrate increased volitional muscle activity and strength with TSCS. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC) and measurement of gait speed. Subjects will be tested in both TSCS and sham conditions.

Aim 2: Determine the impact of TSCS and gait training on walking function. The investigators hypothesize that concurrent TSCS and gait training will augment walking function in subjects with iSCI, as compared to gait training alone. Subjects will participate in an eight-week program of gait training with TSCS and be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* \>1 year post SCI
* Non-progressive SCI
* Neurological level above T10
* Tolerates upright position for \>30 minutes
* Medically stable (no hospitalizations in last 3 months)
* Able to comply with procedures and follow up
* Are legally able to make their own health care decisions

Exclusion Criteria:

* Progressive SCI/D (MS, ALS, ADEM, etc.)
* Open wounds at stimulation site
* Pregnant women
* ROM limitations impacting gait training
* Cardiac pacemaker/defibrillator
* Active cancer diagnosis
* Currently receiving TSCS
* Evidence of uncontrolled autonomic dysreflexia
* Non-English speaking subjects will not be targeted
Combined CBM For Social Anxiety in Turkey

In this study, it was examined whether or not combined attentional and interpretational bias modifications with university students who display social anxiety symptoms may lead to a decrease in social anxiety-related complaints. The study was conducted with 84 participants who were university students displaying social anxiety symptoms. The participants were randomly assigned into two conditions; cognitive bias modification group (E) and placebo-control group (C). Participants in group-E were subjected to attentional and interpretational bias modifications twice a week, eight sessions in total. Participants in group-C were subjected to a similar process, but without any modification. The levels of social anxiety, anxiety, depression, nonfunctional thinking of the participants were evaluated three times; just before the first session, just after the last session and two months after the last session. In addition, levels of attentional and interpretational bias of the participants were evaluated twice, just before the first session and just after the last session.

A 2 (group: experimental, control) × 3 (time: pretest, posttest, follow-up) experimental design was employed. All participants were presented with informed consent form beforehand, and also verbally informed about the procedure. They were assigned to experimental (E) or attention placebo control (C) groups for 2 sessions per week, 8 sessions in total. Before the first session (pretest) and after the last session (posttest), participants were asked to answer self-report questionnaires, and their attentional and interpretational biases were assessed. And finally, participants were asked only to answer to the same questionnaires for the follow up measurements after two months.

Chi square test and independent t-test for dependent variables were run beforehand to check if participants were equally distributed to Bias Modification group-E and group-C. No statistically significant difference between group-E and group-C was observed with regards to gender distribution, social anxiety, anxiety, depression, dysfunctional thoughts, automatic thoughts, and attentional and interpretational biases.

To see the effect of 8 sessions of manipulation on attentional and interpretational bias (independent variable) created a significant difference between experimental and control groups, 2 (group: experimental \[E\] and control \[C\]) × 3 (time: pre \[t1\] / post \[t2\] / follow-up \[t3\]) mixed ANOVA was conducted for each dependent variable in self-report measurements, and 2 (group: experimental \[E\] and control \[C\]) × 2 (time: pre \[t1\] / post \[t2\]) mixed ANOVA were conducted for attentional and interpretational biases.

Eligibility Criteria:
Inclusion Criteria:

* Scoring above 68 on the Liebowitz Social Anxiety Scale

Exclusion Criteria:

* Having any psychiatric disorder
* Receiving a psychiatric/psychological treatment
Immunogenicity Induced by COVID-19 Vaccines in Mexican Population

To determine the gene expression of anti-spike IgG through PCR-RT in patients vaccinated with the 4 types of vaccines available in Mexico Oxford/AstraZeneca (ChAdOx1 nCoV-19), Centro Nacional Gamaleya (Sputnik V), Pfizer/BioNTech (BNT162b2) and Sinovac (CoronaVac).

80 subjects with full vaccination schedule will be included, 20 per group To know the gene expression of IgG anti-spike through PCR-RT in patients vaccinated with the 4 types of vaccines available in Mexico Oxford/AstraZeneca (ChAdOx1 nCoV-19), Centro Nacional Gamaleya (Sputnik V), Pfizer/BioNTech (BNT162b2) and Sinovac (CoronaVac).

Eligibility Criteria:
Inclusion Criteria:

1. - Mexican people.
2. - Over 18 years of age.
3. - With complete vaccination schedule against COVID-19.
4. - Allowing peripheral blood samples to be taken.
5. - To sign an informed consent form.
6. - To agree to participate in the protocol.

Exclusion Criteria:

1. - Persons with incomplete vaccination schedule against COVID-19.
2. - Persons who have 30 +/- 5 days of having completed the vaccination scheme against COVID-19.
3. - People under treatment with any immunosuppressive drug.
4. People who refuse to sign the informed consent form.
Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?

The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and collecting outcome data on CLBP patients within the Veterans Affairs Community Based Rochester Outpatient Center who undergo an 8 week active exercise class with mindfulness (yoga) and without mindfulness (stretching class)

The study will approach all new or existing patients within the chiropractic clinic between the ages of 18 and 89 who have low back pain greater than 12 weeks and pain greater than or equal to 3, who have no contraindications to active exercise. Patients will be queried as to interest and those interested will be consented. The investigators will recruit a total of 20 patients. Patients will then be randomized to receive either an 8 week active exercise class with mindfulness (yoga) or an 8 week active exercise class without mindfulness (stretching class). Both groups will have home exercise requirements and will be held accountable through the use of a home practice log. Outcomes will include: Pain (PEG), Quality of Life (PROMIS Global Health Survey GHS), Self Efficacy (2 Question), Fear Avoidance Belief, Castrophizing and Social Engagement. Outcomes will be collected at baseline, and again at the end of the 8 week intervention. Clinician open ended questionnaire will be given to both study clinicians at the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Adult Veterans between the ages of 18-89
* Lower back pain \> 12 weeks
* Have the ability to exercise independently.

Exclusion Criteria:

* Subjects will be excluded if
* They are currently enrolled in or maintain a home meditation practice
* If they are currently involved in a mindfulness or cognitive behavioral therapy group.
* If they have participated in a structured group yoga class in the last three months.
* If they have an open workers compensation or no-fault case or have undergone spinal surgery in the past 6 months.
Height Loss, Kyphosis Indicators, Bone Mineral Density and Vertebral Fractures in Chinese Postmenopausal Women

This is an observational and cross-sectional study on the height loss, kyphosis indicators, bone mineral density and vertebral fractures in Chinese postmenopausal women

Postmenopausal women (N=255) aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs All participants were interviewed using a standard questionnaire. Body weight and height were measured to the closest 0.1 kg and 0.5 cm, respectively, with subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. All subjects provided basic information, including current age, age at the start of menopause, years since menopause (YSM), weight, and their tallest recalled height. The current measured height subtracted from the tallest recalled height was subjects' HHL.The RPD, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. For the kyphosis assessment, subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance (C7WD) , and wall-tragus-distance (WTD) was defined as the horizontal distance from the participant's tragus to the wall . All RPD and anthropometric indicators of kyphosis were measured in increments of 0.1 cm by two trained physicians.BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. VFs were assessed using lateral spine imaging from T4 to L4 on X-ray.

Eligibility Criteria:
Inclusion Criteria:

Postmenopausal women aged ≥50 years (Menopause was defined as the absence of menstrual cycles for at least one year)

Exclusion Criteria:

Morphological abnormalities or skeletal distortions
Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers

This study aims to investigate the early metabolic effects and acute phase response of an oral clear supplement containing whey protein plus carbohydrates in young healthy volunteers during fasting-induced organic response

The investigators will enroll young male healthy volunteers. In this controlled crossover clinical trial, after a 12-hour fast, subjects will be randomized to consumed either: a) 200ml of carbohydrates enriched with whey protein (CHO+WP; n=30); or b) 200ml of water plus maltodextrin (CHO group, n=30); or c) remained fasting (Fast group; n=30). Blood samples will be collected after 12h-fast and three hours after the ingestion of the supplements (or 3h fast in Fast group) for blood glucose; glycated hemoglobin; serum insulin; C-reactive protein; beta-hydroxybutyrate; triglycerides; albumin; chlorine and sodium assays. After a temporal break of seven days an inversion of the groups will performed so all subjects entered in the three groups. Group CHO+P will drink a clear non-residual supplement (698 mOsm/L) having 100% whey protein isolated from total proteins, with various vitamins (B1, B6, C, D, niacin and folic acid) with a "lemon tea" flavor (Nutren Fresh; Nestlé, São Paulo, Brazil). The formula contains no lactose or lipids; is formulated with a volume of 200ml, with a caloric density of 1.28kcal/ml; protein: 10g in 200ml of the product (100% whey protein isolate); and carbohydrate: 54g in 200ml of the product (74% glucose syrup and 26% maltodextrin); Group CHO will received a clear supplement containing 200 mL of water combined with unflavored 25 g of 100% maltodextrin (CarboCH - Prodiet, Curitiba, Brazil) at 12.5% dilution (101 mOsm/kg; 95kcal/200ml). The third group (Fast group; n=10) will not consume any food or supplement.

Eligibility Criteria:
Inclusion Criteria:

* Male young healthy volunteers

Exclusion Criteria: or will be excluded.

* Individuals with obesity (calculated body mass index above 30 kg/m2)
* Participants reporting consumption of alcoholic beverages
* Consumption of any nutritional supplement during the study period
Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma

The purpose of this study is to characterize the clinical pharmacokinetic and pharmacodynamic profiles of the 2 doses of VELCADE (bortezomib) for Injection. Patients who volunteer to participate in the pharmacogenetic portion of the study, an additional blood sample will be collected before the Cycle 1 Day 1 dose of bortezomib to assess the genotype of drug metabolizing enzymes.


Eligibility Criteria:
Male and female adult patients 18 years or older with a diagnosis of relapsed multiple myeloma requiring therapy will be eligible for this study.

Key inclusion criteria include:

Karnofsky Performance Status (KPS) equal to or greater then 70%, normal liver function tests (aspartate transaminase \[AST\] or alanine transaminase \[ALT\] equal to or less then 2 x upper limit of normal \[ULN\], total bilirubin equal to or less then 1.5 x ULN), hemoglobin equal to or greater then 10 g/dL, platelets equal to greater then 50 x 10 to ninth power/L, and absolute neutrophil count (ANC) equal to or greater then 1000/uL; calculated creatinine clearance equal to or greater then 50 mL/min, and normal serum calcium.

Key exclusion criteria include:

Patients with significant cardiac disease, equal to or greater then Grade 2 neuropathy, active hepatitis, HIV infection, secondary malignancy, POEMS syndrome, plasma cell leukemia, or who are transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment will be excluded. Patients taking concurrent medications at entry that may act as inducers or inhibitors of CYP 3A4 are excluded. Patients receiving thalidomide must discontinue that drug at least 2 weeks prior to enrollment. Patients receiving concurrent corticosteroids must have tapered their dose of corticosteroid to to equal to or less then 10 mg/day of prednisone or prednisone equivalent at least 2 weeks prior to enrollment.
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma

Clinical trial to evaluate the performance characteristics(sensitivity and specificity) of AnchorDx's urine DNA methylation/somatic mutation profiling assay for detecting urothelial carcinoma compared to pathology in patients.

This is a prospective study that involves 11 centers in China and 1200 participants. The assay analyzes the DNA methylation/somatic mutation profiles of bladder cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The performance characteristics(sensitivity and specificity) of the assay for detection of urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Urothelial carcinoma group:

   * Any male or female patient aged 18 or older.
   * Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
   * Diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgery.
2. interference group:

   * Any male or female patient aged 18 or older.
   * Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
   * Diagnosed with incident or recurrent bladder cancer other than urothelial carcinoma (including bladder squamous cell carcinoma/bladder adenocarcinoma/other bladder-related cancers/prostate cancer/rectal cancer) by surgery.
3. Control group:

   * Any male or female patient aged 18 or older.
   * Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
   * Diagnosed with urinary disease such as Urinary calculi, urinary tract infection (except urinary tuberculosis), benign prostatic hyperplasia, glandular cystitis. All enrollee are able to provide legally effective informed consent.
4. Healthy volunteers group:

   * Any male or female patient aged 18 or older.
   * Able to provide urine specimen (100ml for both first void and non-first-void urine) before physical examination.

exclusion criteria:

1. Urothelial carcinoma/Interference group/Control group

   * Has had diagnosed with other cancers.
   * Patients diagnosed with non-urological cancer.
   * Failed to provide a written informed consent.
2. Healthy volunteers group:

   * Volunteers with abnormal test results of urine analysis or urological ultrasound test.
   * Volunteers sceptical of cancers from non-urological origin in a normal results of urine analysis or urological ultrasound.
   * Failed to provide legally effective informed consent.
Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years

This trial will study three doses of reslizumab versus placebo in children with eosinophilic esophagitis (EE). The objectives of the trial will be to study the effectiveness of reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils as well as assessing the safety profile compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent obtained
* male or female patients aged 5 to 18 years at time of screening
* of non-childbearing potential, of childbearing potential and willing to use specific barrier methods outlined in the protocol
* confirmed active EE (at Screening or within six weeks prior to Baseline Visit) as defined by esophageal mucosal eosinophils greater than or equal to 24 per high power field (hpf; 400X magnification)
* within the week prior to dosing, patient has one of the following symptoms of moderate (or worse) severity: vomiting, regurgitation (acid taste or feeling material movement upward), abdominal, chest pain/heartburn (burning or pain behind the sternum), or difficulty swallowing
* been on a therapeutic dose of proton pump inhibitors (PPIs; with or without histamine H2 receptor antagonists)for at least four weeks without resolution of symptoms, or by negative pH probe (with or without having failed a course of PPIs)

Exclusion Criteria:

* another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome \[HES\],Churg Strauss vasculitis, eosinophilic gastroenteritis \[EG\], or a parasitic infection)
* history of abnormal gastric or duodenal biopsy or documented gastrointestinal \[GI\] disorders (e.g., celiac disease, Crohn's disease or Helicobacter pylori infection)
* history of the following GI surgeries: fundoplication, gastric surgery or surgery for intestinal atresia
* use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E \[IgE\] monoclinal antibody \[mAb\], methotrexate, cyclosporin, interferon alpha \[α\], or anti tumor necrosis factor \[TNF\] mAb) within six months prior to study entry
* received attenuated live attenuated vaccines (e.g., measles, mumps, rubella \[MMR\], bacillus Calmette-Guerin \[BCG\], varicella, FluMist or polio) within three months prior to study entry
* use of swallowed inhaled corticosteroids for the treatment of EE within one month prior to study entry. Note: Inhaled and nasal corticosteroids for the treatment of asthma and allergies, respectively, are permitted provided that the dose remains the same during the study
* a stricture on endoscopy that prevents passage of the endoscope
* participation in any investigational drug or device study within 30 days prior to study entry
* female subjects who are pregnant or nursing
* concurrent infection or disease that may preclude assessment of EE
* concurrent immunodeficiency (human immunodeficiency \[HIV\], or acquired immunodeficiency syndrome \[AIDS\] or congenital immunodeficiency)
Comprehensive Care in Type 1 Diabetes and Associated Outcomes

Quasi-experimental, retrospective, before and after study, with a control group, to evaluate the effect of an intervention based on disease management, on metabolic control and hospitalizations, in a group of patients with type Diabetes 1, attended in a Provider Institution of Health Services of the city of Medellin - Colombia.

Evaluate the effect of an intervention based on the management of the disease, on metabolic control and the number of hospitalizations related to diabetes, in a group of patients with Type 1 Diabetes attended in a specialized Health Services Provider Institution in the city of Medellin - Colombia.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type 1 diabetes.
* Patients affiliated to the Entity Administrator of Health Benefits Plans (EPS Sura)
* Patients with age greater than or equal to 15 years, who had been referred to the institution at the discretion of the treating physician, for poor metabolic control and had to enter a hemoglobin glycated (HbA1C) ≥ 7.0%.

Exclusion Criteria:

* Patients who at the time of recruitment were treated with continuous insulin infusion device (insulin pump) and patients with gestational diabetes were excluded.