cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients With Severe Hypoglycemia

This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.


Eligibility Criteria:
Key Inclusion Criteria

* Adult 18 to 65 years with a clinical history of T1D
* Diagnosis of T1D at \<40 years of age
* insulin dependence for ≥5 years at pre-screening
* Recurrent severe hypoglycemia
* Willingness to use continuous glucose monitoring

Key Exclusion Criteria

* Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening
* Weight loss medication(s) within 3 months of Screening

Other protocol defined Inclusion/Exclusion criteria may apply
Human Papilloma Virus DNA Self-Test

HPV DNA testing by a clinician has been shown to be highly sensitive in detecting cervical disease. Can we prove that HPV self-testing will be sufficiently sensitive to detect disease in high risk population who for various reasons would not have routine pap smear screening?

Women between the ages of 18 years to post-menopausal with documented abnormal pap smear atypical squamous cells of undetermined significance and higher will be enrolled into the study. Patients will be taught how to collect vaginal samples with dacron swab and vaginal tampons by means of instructional video and manufacturer's instruction guide respectively. Physicians will perform pap smear and colposcopy. All samples will be sent to the University of Louisville lab for processing for HPV DNA detection by Hybrid capture 2 method.

Eligibility Criteria:
Inclusion Criteria:

Abnormal pap smear ASCUS or higher

Age 18-postmenopausal

Exclusion Criteria:

Less than 18 years old

Prior hysterectomy

Pregnancy

Use of corticosteroids

HIV positive
Validation of In-Ear Sensor

The purpose of this study is to clinically validate noninvasive in-ear sensor.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have the ability to understand and provide written informed consent
* Subject is an adult over 18 years of age (18 to 50 for Induced Febrile Subjects)
* Subject must be willing and able to comply with study procedures and duration. Subject must be willing and able to comply with study procedures and duration. Must be available for at least 2 visits for ear molds and study conduct.
* Male or female of any race

Exclusion Criteria:

* Subject is considered as being morbidly obese (defined as BMI \>39.5)
* Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
* Females who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study (For Induced Febrile Subjects only)
* Subjects with known respiratory conditions such as:

  * uncontrolled / severe asthma,
  * flu,
  * pneumonia / bronchitis,
  * shortness of breath / respiratory distress,
  * respiratory or lung surgery,
  * emphysema, COPD, lung disease
* Subjects with self-reported heart or cardiovascular conditions such as:

  * Resting high blood pressure: systolic \>140 mmHg or diastolic \>90 mmHg on 3 consecutive readings (For Induced Febrile Subjects only)
  * have had cardiovascular surgery
  * chest pain (angina)
  * heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
  * previous heart attack
  * blocked artery
  * unexplained shortness of breath
  * congestive heart failure (CHF)
  * history of stroke
  * transient ischemic attack
  * carotid artery disease
  * myocardial ischemia
  * myocardial infarction
  * cardiomyopathy
* Self-reported health conditions as identified in the Health Assessment Form

  * diabetes,
  * thyroid disease (controlled and uncontrolled)
  * kidney disease / chronic renal impairment,
  * history of seizures (except childhood febrile seizures),
  * epilepsy,
  * history of unexplained syncope,
  * recent history of frequent migraine headaches,
  * recent head injury within the last 2 months,
  * Cancer / chemotherapy
* Subjects with medical inflammatory conditions/taking antiinflammation medications

  * Barbiturates
  * Antipsychotics
  * Recent immunizations (within 1 month)
  * Subjects who have taken antipyretics in the last 240 minutes (aspirin, acetaminophen, ibuprofen)
* Other known health condition, should be considered upon disclosure in health assessment form
The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc in Men With Idiopathic Asthenozoospermia

The aim of this study was to investigate the therapeutic effect of co-administration of pentoxifylline and zinc on sperm apoptosis in men with idiopathic infertility

This study is being performed as a double-blind randomized clinical trial on idiopathic infertile men referred to the infertility clinic of Shafa Clinic. Patient satisfaction, non-use of contraceptives, men aged 25 to 43 years, and idiopathic infertility according to WHO criteria (World Health, 2010) are our study criteria. Any medication that may affect the course of spermatogenesis should be discontinued during the study. Semen samples are taken from patients (before and after interventions) and apoptosis tests are performed on semen samples.

Eligibility Criteria:
Inclusion Criteria:

* infertile men
* have had at least one year of unprotected intercourse infertility
* asthenozoospermia

Exclusion Criteria:

* Men with varicocele
* Hypersensitivity to pentoxifylline \& zinc,
* pelvic organic pathologies
* congenital adrenal hyperplasia
* thyroid dysfunction
* Cushing's syndrome
* hyper prolactinemia
* androgen secreting neoplasia
* severe hepatic
* pancreatitis
* kidney diseases
* gallbladder diseases
* Patients with alcohol consumption
* Patients who use cigarettes and drugs
Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1

Randomized, double-blind, placebo-controlled, 16-week study designed to explore the safety and efficacy of IMC-1 for the treatment of patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* The patient is female, 18 to 65 years of age, inclusive.
* The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
* The in clinic 7-day recall VAS scale average daily pain intensity score at Screening visit within protocol defined range.

Exclusion Criteria:

* Any underlying medical or psychiatric condition that could impact their safe participation per protocol.
Improving Activity in Adults With Chronic Pain With Online Resources

A randomized controlled study will test whether adults with chronic pain have improved outcomes when receiving a User Guide and weekly prompts for a newly designed Online Pain-Management Resource when compared to an active-control group that receives access to the Online Pain-Management Resource, but no User Guide or prompts. Outcomes of interest include measures of activity, sleep, pain and level of use of the online pain-management resource.

Participants with chronic pain will be randomized in this pilot study to an intervention group that receives a User Guide and weekly prompts to use an Online Pain-Management Resource or an active-control group that receives access to the Online Pain-Management Resource, but no User Guide or prompts. Outcomes of interest include:

i. Changes in activity and sleep over time when online resources are paired with using a wearable activity tracker (Fitbit Inspire 3®); ii. Self-reported pain and pain-related measures; and iii. Level of use of the online pain-management resource. All participants will also be asked to provide feedback on the online pain-management resource. The information collected throughout the study will inform the development team on the website's usefulness and whether guided use is superior to unguided self-directed use of the online pain resource.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* chronic pain at least 3 months
* interested in increasing activity level
* able to read and speak English
* reside within US
* willing to have activity tracker shipped to address
* able to download Fitbit app onto phone or computer
* willing to use Fitbit device for most days and nights during 8 weeks study

Exclusion Criteria:

* medical or psychological conditions that would prevent study participation
* planned surgery or procedure that would prevent study participation
Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients

This study evaluates the efficacy isolated and combinaded of photobiomodulation therapy with low level laser therapy and the transcutaneous electrical nerve stimulation.

Non-specific chronic neck pain patients will be treated with low-level laser therapy and/or trancutaneous electricam nerve stimulation. They will receive 10 sessions of treatment. Before and after the treatment physical measures and psychosocial factors will be evaluted to verificy the efficay these electrophysical agents.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-specific chronic neck pain, defined as pain or discomfort in the posterior cervical region between the superior nuchal line and the first thoracic spinous process and / or shoulder girdle;
* Neck pain for at least 3 months;
* Neck Disability Index (NDI) score of 5 points or higher;
* Numeric Rating Scale (NRS) score of 3 or higher to pain intensity;
* Aged between 18 and 65 years;
* Men and women

Exclusion Criteria:

* Neck pain associated with nerve root compromise (measured by clinical examination of dermatomes, myotomes and reflexes);
* Previous spinal surgery;
* Patients treated with physical therapy for neck pain in the last 3 months previous the study;
* Severe spinal disorders such as fractures, tumors, inflammatory and infectious diseases;
* Any contraindication to low level laser therapy or transcutaneous electrical nerve stimulation;
* Rheumatic, metabolic, neurological or cardiopulmonary diseases;
* Patients who require artificial cardiac pacemakers;
* Skin diseases, mainly at the current application site;
* Tumors or cancer historic in the last 5 years;
* Pregnancy;
* If the patient started any physical activity in the last 2 weeks.
Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis

This protocol aims to evaluate the feasibility and benefit of Intrapulmonary Percussive Ventilation (IPV) to improve deposition of inhaled radiolabelled aerosols in fibrotic lung regions of patients with Idiopathic Pulmonary Fibrosis (IPF).

Phase 1 of the protocol aims to identify the highest IPV pressure that is tolerated by individual patients. Secondary endpoints explore safety of IPV in IPF patients.

Phase 2 of the protocol is a crossover randomized trial where patients will inhale 99mTc-labelled DiethyleneTriamine PentaAcetate (DTPA) aerosols with or without IPV. Aerosol deposition in HRCT-defined fibrotic regions of interest (ROI) is described by Single Photon Emission Computed Tomography (SPECT).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines
* Affiliation to health insurance
* Signed informed consent

Exclusion Criteria:

* Other chronic lung disease
* Airflow obstruction (FEV1/FVC\<0.7)
* History of congestive heart failure
* History of IPF exacerbation
* History of lung cancer
* Chronic cough precluding aerosol delivery and radioprotection
* Claustrophobia
* 24h/24 oxygen therapy
* Any acute lung disease
* Any potentially transmissible lung infection
* Current or possible pregnancy and breastfeeding
* Contra-indications to IPV : Emphysema, recent barotrauma, pneumothorax, pneumomediastinum
* History of pneumothorax or pneumomediastinum
* Patient unable to hold a mouthpiece tightly
* Patient under legal protection (guardianship, curatorship)
* Contraindication to the administration of Technescan DTPA
Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients with and Without Polyneuropathy

The aim of this study is to show how whole body vibration training practiced for 12 weeks affects the levels of inflammatory biomarkers such as C reactive protein (CRP) and, interleukin-6 (IL-6), in Type 2 diabetic patients (T2DM) with and without peripheral neuropathy.

Volunteers with type 2 diabetes mellitus with and without peripheric neuropathy will be evaluated in terms of any contra-indication that will restrain them from making exercise with whole body vibration device. 60 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 20 participants. 1st group will include type 2 diabetic patients with peripheric neuropathy and 2nd and 3rd groups will include type 2 diabetic patients without neuropathy. Patients in group 1 and 2 will make static isometric exercises on vibration platform whereas patients in group 3 will make the same exercises on land in the hospital setting. Participants will be requested to complete 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with physical measures such as waist and hip circumference, 6-minute walk test, body composition measured by bioimpedance, muscle thickness, and blood tests to measure inflammatory biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must stand and walk o without using an assistive device.
2. Participants must have a weight of less than 120 kg.

Exclusion Criteria:

1. T2DM patients with advanced cardiovascular, renal, hepatic disease
2. T2DM patients with diabetic retinopathy or nephropathy
3. T2DM patients with untreated hypertension, rhythm disorders, and those who have undergone bypass surgery
4. T2DM patients with ischemic changes in the resting ECG
5. T2DM patients with untreated hypoglycemia or orthostatic hypotension
6. T2DM patients who are unable to walk independently, or use of canes, crutches or wheelchairs
7. T2DM patients who have open ulcers or wounds on load-bearing surfaces
8. T2DM patients with inflammatory rheumatic diseases such as rheumatoid arthritis
9. T2DM patients with active infectious disease
10. T2DM patients with high risk of thrombosis, those with deep vein thrombosis
11. T2DM patients who carry a pacemaker, prosthesis, intrauterine device or metal implant,
12. T2DM patients with a history of cancer
13. T2DM patients with severe migraine, epilepsy, stroke or other neurological disorders, those who have undergone brain surgery
14. T2DM patients with non-diabetic neuropathy due to reasons such as HIV, AIDS, alcohol, uremia
15. T2DM patients with cognitive impairment
16. T2DM patients who are on psychotropic or neurotoxic therapy
17. T2DM patients with advanced balance problems
18. T2DM patients who are pregnant or breastfeeding mothers
19. T2DM patients who are organ transplant recipients
20. T2DM patients with hernia
21. T2DM patients with kidney or bladder stones
22. T2DM patients who are exposed to mechanical vibration due to their job
The Effects of Supervised Aerobic Training on Dyslipidemia Among Diabetic Older Patients

In this study, we are trying to explore the potential effects of moderate aerobic exercise for six months on the severity values of blood sugar, HbA1c, insulin, lipid profile, and highly sensitive CRP (hs-CRP) in a total of 50 subjects diagnosed with diabetes for more than five years with an age range of 30-70 years.

This study explored the influence of 6 months of moderate-intensity supervised aerobic training on diabetic control parameters, serum lipid profile, hs-CRP, and variable-related correlations in prediabetic and type 2 diabetic patients (T2MD). The patients were classified into two groups: the prediabetes group (HbA1c ≤ 6.5, n = 25) and the T2MD group (HbA1c ≥ 6.5, n = 25). The values of blood sugar, HbA1c, insulin, lipid profile, and highly sensitive CRP (hs-CRP) were measured in all subjects by using colorimetric and immunoassay techniques respectively at baseline and postintervention of moderate aerobic exercise for six months. Participants performed the exercise test three times per week for 6 months. The training set comprised of a warming phase by stretching exercises and walking for 5 to 10 minutes, the participants were allowed to reach their precalculated training heart rate (THR) in bout form with a total time of 45 to 60 minutes performed as circuit training using a treadmill, bicycle, and stair master. All patient groups were subjected to estimate diabetic control parameters such as FBS, FI, HbA1c, serum lipid profile, hs-CRP, and BMI as anthropometric changes before and after moderate aerobic exercise training for six month

Eligibility Criteria:
Inclusion Criteria:

diagnosed with type 2 diabetes (DM2) for more than 5 years according to the American Diabetes Association criteria

Exclusion Criteria:

* Patients with a history of smoking, abnormal alcohol intake, anemia, overt complications of diabetes like nephropathy, neuropathy, retinopathy, and other heart complications, and are suffering from viral infections, chronic liver disease, hypothyroidism, and drugs (diuretics; oral contraceptives) were excluded from this study
Impaired Regulation of Energy Balance in Elderly People (Balance Study)

Over the past century life expectancy has risen rapidly. As a result, the proportion of elderly people continues to grow. Elderly people probably have an impaired regulation of energy balance (energy intake versus energy expenditure) whereby the underlying physiological mechanisms are not fully understood.

The first objective of this study is to provide further evidence for an age-related failure to regulate energy balance in elderly. If the hypothesis of impaired regulation of energy balance in elderly is confirmed then the second objective becomes to elucidate the underlying physiological mechanisms of the age-related failure to regulate energy intake in elderly.


Eligibility Criteria:
Inclusion Criteria:

* men
* healthy
* 20-40 and 65-85 years of age
* normal weight
* free-living in Wageningen and surrounding

Exclusion Criteria:

* anemia
* diabetes
* restrained eating
* dementia
* weight changes of \> 2 kg during the last 2 months
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma

This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or Metastatic renal cell carcinoma (RCC)
* Predominant clear cell histology:

  1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments
  2. No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting
  3. Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible
* Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor
* Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation
* Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)
* All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed

Exclusion Criteria:

* Subjects with any active autoimmune disease or a history of known autoimmune disease
* History of severe hypersensitivity reaction to other monoclonal antibodies
* Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured
* Known HIV or AIDS-related illness
* Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection

Other protocol-defined inclusion/exclusion criteria apply
Aspirin vs Clopidogrel After TAVR

Currently, the optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains still unknown., The purpose of the study is to compare aspirin versus clopidogrel monoantiplatelet therapy for preventive effect on leaflet thrombosis in patients undergoing TAVR for severe aortic stenosis. This study is designed as a prospective, multicenter, open label, randomized controlled study. Eligible patients will be randomized to aspirin or clopidogrel monotherapy after TAVR. Patients will have dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 4 weeks after TAVR and then subsequent monoantiplatelet therapy of either aspirin 100 mg or clopidogrel 75 mg according to the randomization. Leaflet thrombosis will be assessed with cardiac computed tomography (CT) and transthoracic echocardiography at 3 months after TAVR. Patients will be clinically followed for 6 months. The primary endpoint is the Incidence of leaflet thrombosis on cardiac CT at 3 months.

1. Prospective, multicenter, open label, randomized controlled study
2. Eligible patients will be randomized to aspirin or clopidogrel monotherapy after TAVR
3. All patients will have dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 4 weeks after TAVR and then subsequent monoantiplatelet therapy of either aspirin 100 mg or clopidogrel 75 mg.
4. Leaflet thrombosis will be assessed with cardiac computed tomography (CT) and transthoracic echocardiography at 3 months after TAVR
5. Clinical follow-up up to 6 months

Eligibility Criteria:
Inclusion Criteria:

1. Patients \>19 years old
2. Patients who underwent TAVR symptomatic severe AS
3. Provision of informed consent

Exclusion Criteria:

1. Patients requiring dual antiplatelet therapy longer than 4 weeks
2. Any conditions requiring specific antiplatelet therapy aspirin or clopidogrel
3. History of stroke or transient ischemic attack (TIA) within 6 months
4. Planned major surgery
5. Cardiogenic shock or hemodynamic instability
6. Chronic kidney disease stage 4 or 5 (eGFR \<30mL/min)
7. Valve-in-valve TAVR procedure
8. Hypersensitivity or contraindication to aspirin or clopidogrel
9. Indication for anticoagulation therapy