cyrilzakka/clinical-trials huggingface dataset:
Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.

OBJECTIVE: To evaluate the efficacy of vibro-oscillatory therapy through an electromedical equipment in improving body contour and appearance of cellulite.

SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with cellulitis. Patients will be submitted to data collection and evaluation and before and after vibration-oscillatory therapy.

HYPOTHESES: Patients are expected to show improvement in body contour and cellulite after vibration-oscillatory therapy.

STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measures will be used. Tukey's test will be used to compare the groups. The significance level adopted for the statistical tests will be 5% or p \<0.05.

After approval by the institutional committee of Research Ethics, the subjects will be approached by the researcher responsible on the day of their evaluation, where they completed the registration form, after a brief analysis of the inclusion and exclusion criteria of the present study, the individuals included in the study will be collection of anthropometric data: weight, height, BMI, perimeter of the treated region, assessment of the degree of gynoid lipodystrophy, clinical inspection and photographic study of the treated area, ultrasound examination to assess the thickness of the dermis and hypodermis and the examination with Cutometer ® to assess the viscoelasticity of the skin.

Patients will be divided according to the degree of cellulite they present and will be treated with vibration therapy, such as the Modellata® electromedical equipment (Ibramed- Brazilian Industry of Electronic Equipment), being performed three times a week for two months totaling 16 sessions by a dermato-functional physiotherapist.

Data collection and evaluation will be performed before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female gender, over 18 years of age;
* With body mass index considered eutrophic;
* Cellulite carriers;
* Non smokers;
* That they agree to participate and sign the TCLE.

Exclusion Criteria:

* Male gender;
* Menopausal women;
* Have undergone aesthetic treatment in the gluteal region and thighs in the last 6 months;
* Patients with skin lesions, such as dermatitis and dermatoses;
* Patients with capillary fragility;
* Patients with acute deep vein thrombosis (DVT);
* On or near cancerous lesions;
* Patients with cardiac pacemaker or other implanted electronic device
Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV

The study is a randomized controlled trial to evaluate the social capital intervention versus a general health promotion intervention (Health for Life; H4L) among groups of Young black men who have sex with men (YBMSM) and to measure the social capital and engagement in care with the HIV-positive YBMSM at 3 and 9 months.

Young black men who have sex with men (YBMSM) have high rates of HIV infection, and are also at risk for falling out of clinical care. Social capital, which refers to the resources in a person's social network, has been shown to be beneficial for people living with HIV in other places. The study wants to understand and build upon social capital in the YBMSM population in Atlanta, with the goal of ultimately improving HIV-related outcomes for these youth.

To achieve this study is conducted in 3 phases. In Phase I, study will conduct interviews with YBMSM and community leaders to get advice about developing a social capital intervention that will improve social capital. Phase II is a randomized controlled trial of groups of YBMSM implementing the social capital intervention versus groups of YBMSM receiving a general health promotion intervention (Health for Life; H4L). This is followed by Phase III which is mainly to measure the social capital and engagement in care with the HIV-positive YBMSM at 3 and 9 month timepoints.

The study plan to enroll 180 total participants (120 in the randomized controlled trial and 60 in preliminary interviews) over the four year study period.

Eligibility Criteria:
Inclusion Criteria:

* Age \<= 29 years and \>= 18 years
* Self-identify as Black/African-American (inclusive of multiracial identities)
* Male sex at birth
* Endorse history of sex with men ever (inclusive of gay and bisexual men)
* HIV-positive (self-reported by participant and confirmed by medical record)
* Able and willing to provide written consent and participate in surveys, interviews, and/or group intervention

Exclusion Criteria:

* Age \< 18 years or \>= 30 years
* Unwilling or unable to provide written informed consent
* Enrollment in one phase of the study is an exclusion criteria for enrollment in other phases
Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect.

Idiopathic membranous nephropathy is most common cause of glomerulonephritis in adults. Persistent high grade proteinuria or progressively decrease of renal function is a risk factor for end stage renal disease in idiopathic membranous nephropathy. It has been reported that cyclosporin in patients with idiopathic membranous nephropathy decreases proteinuria and improve renal function. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer side effect than cyclosporin. In this study patients with high risk group of progressive idiopathic membranous nephropathy will be treated with mycophenolate mofetil and low dose prednisone. The outcome will be compared to controls treated with cyclosporin and low dose prednisone.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with idiopathic membranous nephropathy
2. The duration of disease is less than twelve months
3. Patients with persistent proteinuria more than 8 grams per day
4. Patients who provided informed consent
5. The cases that satisfy more than three of following items even if proteinuria is less than 8 grams per day:

   * eGFR \< 60 ml/min/1.73m2
   * Hypertension (BP above 140/90mmHg or BP above 120/80 in patients taking anti-hypertensive agents)
   * 24 hours urine protein or spot urine protein/creatinine ratio \> 5.0 g/day
   * Serum albumin (g/dL) \< 3.0
   * Selectivity index \> 0.2

Exclusion Criteria:

1. Severe digestive organ disease
2. Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently.
3. Clinical history of treatment with other immunosuppressive medication
4. Probability of pregnancy, breast feeding woman
5. Uncontrolled hypertension (more than 160/100mmHg)
6. Uncontrolled systemic disease
7. Drug addiction or alcoholics within 6 months
8. eGFR is less than 30ml/min at screening
9. Abnormal liver function test (more than 3 times above compared with normal value)
10. Absolute neutrophil count \<1,500/mm3 or leukocyte \<2,500/mm3 or platelets \<100,000/mm3
11. Secondary membranous nephropathy
12. Expected life expectancy is less than 1 year
A Study of PD1 Combined With DC-NK Cell in the Treatment of Solid Tumors

clinical study on the safety and efficacy of PD1 combined with dc-Nk in the treatment of solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. Previously receiving ≥ first-line regimen chemotherapy;
2. Age over 3 years old and less than 14 years old;
3. The expected survival period is more than 3 months;
4. ECOG≤2;
5. Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%; creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg / dl;
6. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L; There are measurable target lesions.

Exclusion Criteria:

1. Liver and kidney function:

   * Total bilirubin \> 2 x ULN (Gilbert syndrome \> 3 x ULN)
   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN
   * Serum creatinine clearance \>60mL/min
2. Serological examination:

   * Absolute neutrophil count (ANC) \<0.75x109/L
   * Platelet count (PLT) \<50x109/L
3. Active hepatitis B (HBV-DNA \> 1000 copies / ml), hepatitis C, or uncontrolled infection;
4. The number of days of chemotherapy medication and the administration of hormones below 5mg is ≤3, and the number of days of withdrawal of hormones greater than 5mg is ≤5;
5. Active CNS disease (tumor cells in CSF);
6. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
7. creatinine \> 1.5 times the upper limit of normal or ALT / AST \> 3 times the upper limit of normal or bilirubin \> 2 times the upper limit of normal;
8. The New York Heart Association (NYHA) is classified as Level III or higher;
9. Uncontrolled diabetes;
10. With other uncontrolled diseases, the investigator believes that it is not suitable for joining;
11. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results.
Impact of Respiratory Rehabilitation on Quality of Life in Patients With Hyperventilation Syndrome

The hyperventilation syndrome is a quite frequent pathology, affecting up to 10% of the general population and 40% of the asthmatic population. Its physiopathology is still badly known and even if it is a benign affection, its associated comorbidities and symptomatology greatly decrease the patients' quality of life. Yet, no medicinal treatments have been proved useful, but prescribers noticed improvements after physiotherapy. Given that the physiotherapy impact on hyperventilation syndrome is not well described in the literature, this study aims to scientifically ascertain physiotherapy benefits on quality of life and symptomatology in hyperventilation syndrome-suffering patients.


Eligibility Criteria:
Inclusion Criteria:

* Positive hyperventilation syndrome diagnosis
* Having a social security insurance
* Being at least 18 years old
* Having given their written consent

Exclusion Criteria:

* Being put under guardianship or curatorship
* Having seen a physiotherapist for a respiratory rehabilitation in the last three months
* Suffering from a chronic and degenerative pathology (chronic obstructive pulmonary disease, Parkinson's disease, idiopathic fibrosis, ...)
* Not being able to receive the respiratory rehabilitation from our care providers
* Already having received a rehabilitation for hyperventilation syndrome
* Not speaking French or not being unable to complete the questionnaires
Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia


Eligibility Criteria:
Inclusion Criteria:

* Euvolemic or hypervolemic (edematous) based on clinical presentation
* Serum sodium between 115 and 130mEq/L at baseline

Exclusion Criteria:

* Clinical presentation of volume depletion or dehydration
One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening

Our study will assess if there is a difference in incidence of gestational diabetes using different screening approaches, either using a one-step approach with a 2 hour glucose tolerance test or using a two-step approach. Prior studies have proven similar incidences including a randomized controlled trial.

Gestational Diabetes is screened for in pregnancy by drinking a solution containing a certain amount of glucose and testing blood glucose level one hour after drinking it. If this value is above a certain cut-off (\>135mg/dl), the patient is subjected to another test involving drinking a solution containing a higher amount of glucose and checking blood glucose while fasting, 1 hour after drinking the solution and 2 hours after drinking the solution. (Two step approach).

Cut off values will be: 3 hour\>180 mg/dl, 2 hour \> 155 mg/dl, 1hour \>140 mg/dl, fasting \>95mg/dl. Two abnormal values will meet the diagnosis of gestational diabetes.

In other parts of the United States, and most of the rest of the word, screening for gestational diabetes uses a one-step approach by drinking a solution containing 75g of glucose (As recommended by the American Diabetic Society, the Endocrine Society, WHO and the International Association of Diabetes and Pregnancy Study groups1-3). Blood glucose values are checked at fasting, one hour and two hours after solution drinking.

The diagnosis of gestational diabetes is based on one elevated values. (cut off: Fasting ≥92mg/dl, 1hour ≥180 mg/dl, 2 hours ≥153 mg/dl).

Our study will assess if there is a difference in incidence of gestational diabetes using these different screening approaches. Prior studies have proven similar incidences including a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* 16-50 year of age
* Pregnant women (limits the participants to female gender)

Exclusion Criteria:

* Pregestational Diabetes Mellitus
* History of bariatric surgery
A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.

This study is being conducted to meet regulatory post-marketing commitments.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumor (according to World Health Organization \[WHO 2000\] classification).
* Disease progression within 12 months prior to study enrollment.
* Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.

Exclusion Criteria:

* Patients with poorly differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification).
* Prior treatment with any tyrosine kinase inhibitors, anti vascular endothelial growth factor (VEGF) angiogenesis inhibitors, non VEGF targeted angiogenesis inhibitors, or mammalian target of rapamycin (mTOR) inhibitors.
Comparison of Analgesic Efficacy of US Guided ESP Block With Port Site Infiltration Following Laparoscopic Cholecystectomy

To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.


Eligibility Criteria:
Inclusion Criteria:

* patients with the American Society of Anesthesiologists (ASA) physical status I/II,
* Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2,
* Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Allergy to local anaesthetics,
* Infection at the site of injection,

  •, Coagulopathy,
* Chronic pain syndromes,
* Prolonged opioid medication,
* Patients who received any analgesic 24 h before surgery
Dermatologic Tacrolimus Ointment on Eyelids in the Treatment of Refractory Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis

To evaluate the therapeutic effects of dermatologic tacrolimus ointment on eyelids to treat refractory vernal keratoconjunctivitis and atopic keratoconjunctivitis.

Treatment of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) is a challenge for the ophthalmologist and patients because of its wide variation in presentation and recurrence in nature. Patients has to be dependent on long term steroid control and suffered from complications, such as steroid glaucoma and secondary infection. About 32% of VKC patients is refractory to steroid treatment and another 35.4% of patients showed partial response. Tacrolimus ointment or eye drops are promising anti-inflammatory agents that have been shown very effective against VKC for patients suffering from severe VKC resistant to topical cyclosporine. Although tacrolimus eye drops is very effective in severe cases of VKC, unfortunately, it is only available in limited countries. Because of the unavailability of tacrolimus eye drops and side effect of long-tern steroid use, we tried to find other options for these severe VKC and AKC. Because there will be concomitant atopic dermatitis in the eyelid of severe cases of VKC and AKC, we retrospectively collected in cases using topical tacrolimus dermatological ointment on the skin of upper eye lid in the treatment of severe VKC and AKC with concomitant atopic dermatitis. Here, we reported 10 cases with either VKC or AKC whose symptoms resolved significantly with dermatologic tacrolimus ointment applying on eyelids.

Eligibility Criteria:
Inclusion Criteria:

* all patients diagnosed as severe vernal keratoconjunctivitis or atopic Keratoconjunctivitis and received topical dermatological tacrolimus ointment on upper eyelids between January, 2016 and January, 2018 at National Taiwan University Hospital.

Exclusion Criteria:

* none
Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care

The purpose of this study is to determine whether a brief (12 week) psychological treatment program, based in primary care, can help youths struggling with anxiety and/or depression. This brief cognitive behavioral therapy program will be compared to enhanced referral to specialty mental health care.

Mood and anxiety disorders in childhood and adolescence are disabling, distressing, and prevalent and produce added costs to health systems. This two-site randomized controlled trial will test the effects of a brief cognitive behavioral therapy (BCBT) protocol (8-12 sessions) in a large sample (N=210) of children and adolescents (age 8-16) presenting with anxiety and/or depression in primary care. Clinical and cost-effectiveness of BCBT will be compared to a plausible public health alternative - enhanced referral to specialty mental health care (SMHC). This investigation is noteworthy in adopting a deployment-focused model and testing this intervention early in its development within a real world context (primary care) and against a plausible public health comparison condition (SMHC) relevant for future treatment dissemination.

Eligibility Criteria:
Inclusion Criteria:

* meet full or probable diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, Major Depression, Dysthymic Disorder, or Minor Depression
* age 8.0 to 16.9
* live with legal, consenting guardian for at least 6 months

Exclusion Criteria:

* youths requiring alternate intervention (e.g., youths with bipolar disorder, psychosis, active suicidal ideation with plan, PTSD, substance dependence, current physical or sexual abuse, or mental retardation
* suffer from serious or unstable physical illness (e.g., uncontrolled diabetes)
* currently in active, alternate intervention for anxiety or depression (e.g., antidepressant use)
A Prospective Study of the Relevance of the HLA-G Immune Checkpoint in Cancer Immunotherapy

Therapeutic targeting of immune checkpoints PD-1/PD-L1 and/or CTLA-4 is efficient in several solid cancer subtypes, however only some patients do experience clinical benefit from these treatments. One explanation could be that multiple redundant checkpoints are present within the tumor, simultaneously keeping in check the patient's immune response. The immune checkpoint HLA-G is neo-expressed in over 50% of cases in some cancer subtypes and associated with more dismal prognosis. The immunosuppressive effects of HLA-G may result in resistance to current immunotherapy drugs.

The GEIA study explores the impact of HLA-G tumor expression on the efficacy of cancer immunotherapy in solid cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Social insurance
* Ability to provide signed consent
* Histologically proven solid cancer (non-small cell lung cancer, urothelial carcinoma, renal cell carcinoma, other)
* Advanced and/or metastatic disease not accessible to local treatment
* At least one target lesion according to iRECIST
* Available fixed tumor sample for immunohistochemistry studies
* Treatment with anti-PD(L)1 immunotherapy with or without anti-CTLA4 immunotherapy

Exclusion Criteria:

* Women pregnant or breastfeeding
* Inability to consent to this research
* Previous cancer immunotherapy (except BCG instillations for non-muscle infiltrative bladder cancer)
* Patients chronically infected with HIV, HBV or HCV
Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial)

Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)

Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* metastatic renal cell carcinoma (a clear-cell/ not clear-cell)
* Progression to previous treatment with tyrosine kinase inhibitors
* Patients candidates for II-line therapy with Nivolumab (or tyrosine kinase inhibitors-in the control arm)

Exclusion Criteria:

none
Evaluation of the Pharmacokinetic Drug-drug Interactions Between VX-993 and Metformin in Healthy Adults

The purpose of this study is to evaluate the pharmacokinetic drug-drug interactions, safety, and tolerability of co-administration of VX-993 and metformin in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 Kilogram per square meter (kg/m\^2)
* A total body weight of more than (\>) 50 Kg
* Nonsmoker or ex-smoker for at least 3 months before the first study drug dose

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.