cyrilzakka/clinical-trials huggingface dataset:
Menopausal Sleep Fragmentation and Body Fat Gain

This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.

While obesity is highly prevalent in midlife and older women, with rates increasing markedly after age 40 and body fat increasing in half of women during and after the menopause transition, factors causing these changes are not well understood. Reduced total sleep time has been shown to adversely impact biomarkers of obesity, but the effect of the highly prevalent menopause-related sleep fragmentation secondary to hot flashes on metabolism and eating behaviors in humans is not known. We will use experimental paradigms to isolate the impact of menopause-related sleep disruption, as well as that of hot flashes and estrogen withdrawal, metabolic biomarkers of body fat gain and on eating behaviors, results of which will inform strategies to prevent body fat gain and improve cardio-metabolic health outcomes in women.

Eligibility Criteria:
Inclusion Criteria:

* Healthy premenopausal women 18-45 years old
* Regular sleep schedule
* Limited alcohol and caffeine intake
* Regular monthly menstrual cycles
* No lifetime history of hot flashes
* Willingness to use approved methods of contraception during study
* Not obese
* Good general health

Exclusion Criteria:

* Contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists
* Pregnancy
* Breastfeeding
* Tobacco use
* Contraindicated systemic hormone medications or centrally active medications
* Shift workers or recent/expected time zone travel
* Obstructive sleep apnea
* Insomnia symptoms
* Diagnosis of osteoporosis or osteopenia
* Hypothalamic-pituitary-adrenal axis disorders
* Diabetes
* Gastric bypass, metabolic disorders, or other related conditions
* Abnormalities on screening laboratory tests
* Substantial hearing impairment
* Cardiovascular illness
* Neurological illness
* Recent psychiatric illness or substance-use disorder
Three-dimensional (3D) Printed Hemodialysis Vascular Model

Infiltration of a surgically-placed hemodialysis vascular access (HVA) is recognized as a major contributor to the high hospital re-admission rate in dialysis-dependent patients. Three dimensional modeling has been demonstrated as a critical tool for procedurists in preparation for surgical interventions but no such modeling is yet available for dialysis specialists to avoid the common complication of HVA infiltration. Contrast enhanced magnetic resonance angiography (MRA) can be used to generate a three dimensional image data that could render a three dimensional resin-based model of a vascular access.

Hemodialysis is the most common treatment for End Stage Renal Disease (ESRD). For an optimal renal replacement therapy, a patent vascular access (VA) is essential. The importance of good vascular access maintenance has been strongly supported by the guidelines (1). Various hinderances render this goal unachievable. A well-known cause of VA failure is access infiltration, which is usually overlooked in clinical practices (2). The calculated economic burden attributable to VA complication is between $16,864 -US$20,961 and more than 50% is due to access infiltration alone (3). Imaging has a pivotal pre- and post-operative role in evaluating vascular access complications. Imaging modalities such as ultrasound (US), Digital Subtraction Angiography (DSA) and Magnetic Resonance Angiography (MRA) are available but their use is limited due to the limited view of plane available for visualization of vessel anatomy(4) and because of the deleterious side effects of the contrast agents used (5,6). Contrast enhanced Magnetic Resonance Angiography (MRA) provides an excellent means of imaging the vasculature (7) which can be reconstructed in a three- dimensional(3D) print. The skill set of dialysis technician nurses play a considerable role in achieving successful cannulation of the fistula. Due oftentimes to complicated vascular anatomy, cannulation based on cutaneous anatomic landmarks and physical examination can be deceiving. Even a minor error in cannulation can impair access longevity(3). The 3D image reconstruction provides a practical solution to generate a 3D VA model which can be used by the procedurists to cannulate the patients, reducing the complications and rate of re admissions. Overall, a significant reduction in the health care cost can be achieved

Eligibility Criteria:
Inclusion Criteria:

* Patients with a surgically placed hemodialysis access which has been used in the last 90 days or is being prepared for use in the next 90 days

Exclusion Criteria:

* Patients with only failed hemodialysis surgical access(es) that has/have not been used for \>90 days.
Effectiveness of Tofacitinib in Systemic Sclerosis

The goal of this clinical trial is to compare efficacy of tofacitinib with cyclophosphamide in skin thickening in early diffuse cutaneous systemic sclerosis .

compare tofacitinib 5mg twice daily with cyclophosphamide 500mg/m2/month in early diffuse cutaneous systemic sclerosis

Eligibility Criteria:
* Inclusion criteria:

  1. Diagnosis of SSc, as classified using the 2013 American College of Rheumatology
  2. dcSSc as defined by 2001 LeRoy and Medsge
  3. Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation)
  4. mRSS units ≥ 10 and ≤ 45 at screening.
  5. Oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) are permitted if the patient is on a stable dose regimen for ≥ 2 weeks prior to and including the baseline visit.
  6. Calcium channel blocker and PDFE-5 inhibitors for Raynaud's and digital ulcers are permitted to use as oral monotherapy
  7. Age ≥ 18 years and ≤ 70 years
  8. Ability to provide informed consent.

Exclusion Criteria:

Subjects with any of the following characteristics/conditions will not be included in the study:

1. Any infection at screening .
2. Oral corticosteroids \>10 mg/day of prednisone or equivalent.
3. Pulmonary disease with FVC ≤ 35% of predicted.
4. Subjects at risk for tuberculosis (TB).Specifically excluded from this study with a history of active TB within the last 3 years and current clinical, radiographic, or laboratory evidence of active TB.j
5. Latent TB at or within 30 days of screening.
6. Positive for hepatitis B surface antigen at or within 30 days of screening.
7. Positive for hepatitis C antigen at or within 30 days of screening.
8. Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
9. History of diverticulitis or chronic, ulcerative lower GI disease such as Crohns disease, ulcerative colitis, or other symptomatic, lower GI conditions that might predispose a patient to perforations.
10. Pregnant or breastfeeding female subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 28 days after discontinuation of study drug.
11. History of any malignancy in the last 5 years with the exception of adequately treated or excised basal cell or squamous cell or cervical cancer in situ.
12. History of SSc Renal Crisis within the 6 months prior to baseline.
13. History of live/attenuated vaccine ≤ 6 weeks prior to baseline
14. Any of the following lab results at screening:

    * Hemoglobin \<9 g/dL or Hematocrit \<30%
    * White Blood Cell count \<3.0 x 109/L;
    * Absolute Neutrophil count \<1.2 x 109/L;
    * Platelet count \<100 x 109/L;
    * Absolute Lymphocyte count \<0.75 x 109/L.
    * ALT or AST \> 3 × the upper limit of normal (ULN) of normal at screening or any
    * Total bilirubin \> ULN at Screening.
    * Estimated glomerular filtration rate \[GFR\] \<40mL/min/1.73 m2
The Metabolomics of Intestinal Polyps of Different Pathological Types and TCM Syndromes and TCM Constitution Types

The aim of this study is to confirm the TCM syndrome types and TCM constitution classifications of the patients with intestinal polyps via on-site epidemiological survey, to analyze metabolomics of the serum samples of intestinal polyps and healthy volunteers, and to study the metabolomics differences of the two populations and the metabolomics variations of the patients with intestinal polyps of pre-polypectomy and post-polypectomy. Finally, this study is to investigate the serum metabolomics variations of patients with intestinal polyps of pre-polypectomy and post-polypectomy and the relationship with their TCM syndrome types and TCM constitution classifications, to determine the correlation among pathology, TCM constitution, TCM syndrome types and the metabonomics variations of patients with intestinal polyps.


Eligibility Criteria:
Inclusion Criteria:

1. Age 20 to 80,all genders;
2. Intestinal polyps were found by colonoscopy;
3. The patients are scheduled for polypectomy;
4. Preoperative examinations were completed;
5. Performance status 0-1;
6. Diet has well controlled prior to the operation;
7. Patients or their statutory agent have signed the informed consent forms.

Exclusion Criteria:

1. The patient has not diagnosed by colonoscopy;
2. The patient has surgical contraindication;
3. Patients in pregnant or lactational period ;
4. Psychopath;
5. The patient is in drug trial.
Host Immune Response to Clostridium Difficile Infection (ICD)

Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. The host immune responses can influence the severity of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of antibodies directed against the toxins A\&B of C. difficile have been associated with a higher risk of recurrence. However, there are conflicting reports.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized
* Suffering from diarrhea related to C. difficile
* Confirmed diagnosis of CDI
* Informed consent by the patient
* Affiliated to the social security regime

Exclusion Criteria:

* Out-patient
* No confirmed diagnosis of CDI
* Decline of participation
* Patient not affiliated to the social security regime
Transvaginal Versus Transobturator Paravaginal Repair

Clinical trial comparing the new technique for paravaginal repair versus the traditional technique

trial comparing the transobturator paravaginal repair versus the traditional technique

Eligibility Criteria:
Inclusion Criteria:

paravaginal defect cystocele

midline and paravaginal defect cystocele

Exclusion Criteria:

* uterine descent previous cystocele surgery
Exercise Capacity Before and After AF Ablation in Patients With HFpEF

In a prospective, observational pilot study of patients scheduled for an atrial fibrillation (AF) ablation at the University of Vermont Medical Center the investigators will compare exercise capacity before and four months after AF ablation.

Patients ≥ 18 years of age who are scheduled for an AF ablation at the University of Vermont Medical Center will be screened for the following inclusion criteria: H2FpEF score of ≥ 6 (corresponding to ≥90% probability of HFpEF (19)) AND echocardiogram within the past 2 years that reported a LV ejection fraction ≥ 50% AND at least one symptom of HF (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea). Exclusion criteria: (1) Life expectancy \<12 months, (2) moderate or more valvular disease, (3) inability to walk on a treadmill. Patients with early recurrent AF (defined as AF after a 12-week post-procedural blanking period accounting for post-ablation inflammation) will be withdrawn from the study and not proceed to the 4 month follow up visit.

Eligibility Criteria:
Inclusion Criteria:

* H2FpEF score of ≥ 6 (corresponding to \>90% probability of HFpEF (19))
* echocardiogram within the past 2 years that reported a LV ejection fraction ≥ 50%
* at least one symptom of HF (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea).
* AF ablation scheduled at UVMMC

Exclusion Criteria:

* Life expectancy \<12 months
* moderate or more valvular disease
* inability to walk on a treadmill
AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period

Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing

Post market, multi-centre, randomised, open label, multi-national, prospective study to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing

Eligibility Criteria:
Inclusion Criteria:

* Venous insufficiency as defined by CEAP Classification of C6
* One wound amendable to treatment with either AQUACEL® Ag+ Extra™ or Cutimed® Sorbact®
* Wounds that have been present for at least 2 months
* Reliable and available for follow-up
* 18 years or older
* Able and willing to provide informed consent
* Able to tolerate compression therapy for Venus Leg Ulcer
* Must be able to be compliant with compression therapy

Exclusion Criteria:

* Known sensitivities or allergies to components of the AQUACEL® Ag+ Extra™ or Cutimed® Sorbact®
* Continued use of petroleum gel/ creams/ oil-based products
* Active treatment for cancer or completed within the last 3 months
* Documented severe malnutrition
* Malignant wounds
* Systemic infection actively treated with antibiotics
Hypofractionated Brain Radiation In EGFR Mutated Adenocarcinoma Cranial Disease (Hybrid)

A multi-center phase III randomized controlled study to evaluate the efficacy of Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from non-small cell lung cancer (NSCLC). Assuming that HFSRS is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), evaluation of cognitive function, quality of life (QoL) and adverse events.

WBRT remains to be standard of care for NSCL patients. Long term survival from WBRT may have noticeable cognitive dysfunction. The EGFR TKI has reasonable control for intracranial disease, but the duration of EGFR TKI control disease is variable due to tendency of drug resistance. To maintain intracranial disease control and improve cognitive function, the investigators propose using hypofractionated SRS in multiple brain metastases or large brain lesions alone with TKI.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of non-small cell lung cancer (NSCLC);
* Diagnosis of brain metastases on a Gadolinium-enhanced MRI.
* More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 4 cm.
* Positive EGFR mutation.
* Life expectancy ≥3months.
* Have one or more measurable encephalic lesions according to RECIST.
* Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.
* Adequate renal function: Serum creatinine ≤1.5 x ULN, or ≥ 50 ml/min.
* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases.
* Female subjects should not be pregnant.
* All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
* Written informed consent provided.

Exclusion Criteria:

* Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
* CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
* Allergic to Icotinib.
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
* Pregnancy or breast-feeding women.
* Participate in the other anti-tumor clinical trials in 4 weeks.
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus \[HPV\] \[Type 6, 11, 16 and 18\] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Japanese
* No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts
* Other inclusion criteria will be discussed with the investigator during screening

Exclusion Criteria:

* History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
* History of external genital warts
* History of severe allergic reaction that required medical intervention
* Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study
* History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
* Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
* Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
* Ongoing alcohol or drug abuse within the past 12 months
Effect of ctDCS During Balance Training on Cerebellar Ataxia

Cerebellar ataxia is a neurologic symptom caused by damage or dysfunction in the cerebellum and its pathways that results in loss of coordination, balance and postural control. There is a high rate (93%) of fallings for this population that could limit daily life activities. Pharmacological interventions are not able to modify the balance, therefore, new approaches to rehabilitate must be studied. ctDCS is a non-invasive brain stimulation that seems to be a new and innovator technique to restore ataxia symptoms. The purpose of this study is to evaluate the effects of ctDCS associated with balance training on cerebellar ataxia patients. A counterbalanced crossover, sham-controlled, triple blind trial will be performed. All subjects will receive the real and sham ctDCS associated to balance training. The anodal ctDCS (2 mA, 20 minutes) or sham (2mA, 30 seconds) will be applied during balance training at Biodex Balance System (BBS). The balance will be the primary outcome and will be evaluated through Posture Control at Biodex Balance System. Ataxia' severity and functional mobility will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA) and 10 meters walking test, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Cerebellar ataxia
* Score \> 1 ≤ 4 on posture of Scale for assessment and rating of ataxia

Exclusion Criteria:

* Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;
* Pacemaker;
* History of seizures;
* Metallic implants in the head or neck;
* Medication change (3 months) during the period of study
Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

To evaluate the changes in serum aldosterone and plasma renin activity on Day 0 and on Days 1 and 10 after administration of 100 mg of eplerenone daily for 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant disease
* Subjects with a supine BP greater than or equal to 140 mm Hg systolic or greater than or equal to 90 mm Hg diastolic or \<100 mm Hg systolic and \<60 mm Hg diastolic on a single measurement, as described in the protocol
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing
* History of sensitivity to eplerenone, spironolactone or related compounds.
* Serum potassium \>5.0 mEq/L at screening or Day 0
Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures

The study is a prospective, trial to test the safety and feasibility of injecting autologous, isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non union/delayed fractures. Another objective is to turn this procedure to a standard care protocol in our department .


Eligibility Criteria:
Inclusion Criteria:

1. Ages: 18 to 65
2. Males- not involved in active military duty.
3. Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.
4. Subjects must be available for follow-up for 1 year. 5"Hard to heal" fracture include the following: A. Fracture of the distal third of the tibial bone B. Segmental or open (II, IIIa an IIIB) fractures of the the tibia or femur diaphysis C.Articular fracture of the lower extremity (distal femur, tibial plateau and tibial pilon fractures) with significant metaphyseal comminution and/or bone loss.

Exclusion Criteria:

1. Active systemic or local infection.
2. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
3. Pathological Fractures.
4. Prior Fracture or Prior operation in the current fracture
The Six Minute Walk Test: Influence of Instruction on Results

Two - four 6MWT performed according to ATS standards. Each walk however had specifically altered wording and coaching performed in random order to determine differences in outcomes. One walk was done in the standard ATS fashion. One was done coaching to walk as fast as the patient can walk. One was coached to walk at the patients normal walking pace. One was coached to walk at the patient's leisure walking pace.

Alternate 6MWT where subjects will be asked to walk as fast as they can, walk as normal as they can and walk leisurely as they can in 6 minutes compared to standard of care 6MWT which is walk as far as you can in 6 minutes.

Eligibility Criteria:
Inclusion Criteria:

* advanced lung disease such as COPD, ILD, IPF, or PAH

Exclusion Criteria:

* inability to walk, requiring supplemental oxygen, cardiac disease preventing successful 6MWT