cyrilzakka/clinical-trials huggingface dataset:
Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds

This case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients with hypo pigmented skin or surgical skin wounds.

This study evaluates a novel micrografting technique to determine how it will influence the repigmentation of selected areas of hypopigmentation, and how it will influence the healing and pigmentation of surgical skin wounds. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile FDA cleared wound dressing for application to the subject's acute wound or prepared recipient site. The sponsor hypothesizes that applying expanded micrografts to target sites will result in rapid healing of acute wounds and in repigmentation of hypopigmented skin as well as and provide improved cosmetic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult subject between 18 and 99 years of age
* Subject having an area of hypopigmentation or surgical wound considered appropriate by physician to receive epidermal micro grafting
* Willingness to participate in study by evidence of informed consent

Exclusion Criteria:

* Female subjects self-reported to be breastfeeding, pregnant or planning to become pregnant during the course of the study.
* Subject showing clinical signs of infection
* Subjects currently on immunosuppressive medications, chemotherapy or cytotoxic agents
* Subject participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned entry into another investigational study within 90 days after entrance into this study
Church-based Intervention to Improve Blood Pressure in African Americans

This is a 12-month behavioral cluster-randomized trial testing a church-based intervention to reduce blood pressure in African Americans with uncontrolled blood pressure.


Eligibility Criteria:
Inclusion Criteria:

Churches:

* At least 75 members and ability to recruit 15 study participants
* Predominantly African American congregants

Participants:

* Age 18 or older
* Has blood pressure readings with uncontrolled blood pressure, defined as exceeding the blood thresholds for initiation of antihypertensive medication according to the 2017 American College of Cardiology/ American Heart Association (ACC/AHA) guidelines.

  - The thresholds are 140/90 for the general population \< 65 years old, and 130/80 for individuals ≥ 65 or with diabetes, chronic kidney disease, or high cardiovascular risk (self-report of prior diagnosis of myocardial infarction, coronary heart disease, stroke or heart failure)
* Attends church (virtually or in-person) at least once per month
* Able to attend weekly Zoom meetings
* Consents and completes all baseline assessments

Exclusion Criteria:

Churches:

• Pastor unwilling to conduct Bible study

Participants:

* Unable to make dietary changes due to lack of control over their food source (i.e., eat meals at shelter, nursing home)
* Has a medical condition that prohibits or severely restricts ability to eat vegetables (i.e., renal disease, Crohn's disease)
* Has a medical condition with an uncertain 6-month prognosis
* Inability to give informed consent (i.e., cognitive impairment, does not speak Englis
* Plans to move within the 6 months following enrollment
* Participated in prior ALIVE intervention
* Member of household participating in another church
Pilot Study of Velcade® in IgA Nephropathy

The primary objective of this study is to investigate the ability of Velcade® (bortezomib) to induce complete or partial remission in patients with severe IgA nephropathy.

The secondary objectives are to assess clinical outcomes relating to safety and efficacy, such as infection, malignancy, preservation of renal function, partial responders, relapse rate, and to study mechanistic assays to predict remission.

This exploratory single center, open-label, single treatment group assignment, safety and efficacy study will enroll 15 patients with severe IgA nephropathy. Subjects will receive 1 cycle of Velcade® to induce clinical remission. Follow-up visits will occur monthly for a year.

For this pilot study, the proportion of patients with clinical remission or partial response will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years of age or older.
2. Must have IgA nephropathy documented by kidney biopsy.
3. Must have greater than 1gm of proteinuria a day.
4. Must be on a stable dose of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocking agent (ARB) for at least 4 weeks prior to screening.

Exclusion Criteria:

1. Low platelet count and neutrophil count within certain limits defined for enrollment.
2. Underlying peripheral neuropathy.
3. Having cardiac problems, such as myocardial infarction, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
4. Allergic to VELCADE®, boron or mannitol.
5. Female subjects who are pregnant or breast-feeding.
6. Recent use of investigational drug within 14 days before enrollment.
7. Having serious medical conditions and infections (including HIV,or hepatitis B or C) or psychiatric illness likely to interfere with participation in the study.
8. Diagnosed or treated for cancer within 3 years of participation in the study, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy.
Usefulness of the Variation of the CLIF-C ACLF Score in Patients With Acute on Chronic Liver Failure

Patients with Acute on Chronic Liver Failure (ACLF) have high short-term mortality. The use of a severity score could define the patient's prognosis and would help determine in whom the treatment is effective or futile.

Acute on Chronic Liver Failure (ACLF) is a syndrome characterized by the presence of an acute decompensation of cirrhosis, associated with failure of at least one other organ or extra hepatic system. It is characterized by high mortality in the short term and its prevalence varies between countries and regions.

It is an extraordinarily dynamic entity in which more than 50% of patients with less severe forms improve, while in those with 3 or more organ failures, the transplant rate is low and mortality is 90%. It is important to highlight that those patients with ACLF who manage to be transplanted have the same survival as cirrhotic patients without ACLF. There is no specific treatment, only life support and early determination of the precipitating factor and its eventual resolution.

Having tools that define the short-term prognosis of these patients, especially the variation of the score (CLIF-C ACLF) during the first week, would have an important clinical relevance, because it can help define the patients who benefit from the supportive treatment and in whom the therapeutic effort is futile.

The biomarker Neutrophil Gelatinase-Associated Lipocalin (NGAL) is increased in plasma and urine in patients with ACLF and could help improve the prognostic ability of the CLIF-C ACLF score.

Eligibility Criteria:
Inclusion Criteria:

* Acute on Chronic Liver Failure

Exclusion Criteria:

* Acute liver failure, terminal disease, pregnancy, previous liver transplant
Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response

We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS) combination product on protection from allergic triggers in asthma.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
* Females of non-child bearing potential.
* Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation
* Pre-bronchodilator FEV1 \>70% of predicted at screening
* Subjects who are current non-smokers
* Methacholine challenge PC20 \< 8 mg/mL at screening
* Screening allergen challenge demonstrates that the subject experiences an early asthmatic response

Exclusion Criteria:

* Current or chronic history of liver disease, or known hepatic or biliary abnormalities
* Subject is hypertensive at screening
* Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
* History of life-threatening asthma
* Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
* Unable to abstain from short acting beta agonists
* Unable to abstain from antihistamines
* Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever medication
* The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months
* undergoing allergen desensitisation therapy
Safety Study of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old

This study of live attenuated mumps vaccines is an observational study in which active monitoring and passive monitoring were combined to conduct safety observation.The live attenuated mumps vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the safety of live attenuated mumps vaccines after large-scale application and accumulate safety data for the application of live attenuated mumps vaccines,and provide scientific basis for the formulation of vaccine immunization prevention strategies.

This study of live attenuated mumps vaccines is an observational study in which active monitoring and passive monitoring were combined to conduct safety observation.The live attenuated mumps vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.Bao'ji, Xian'yang, Yan 'an and Han'zhong of Shaanxi Province were selected as the research center.A total of 10000 junior high school students under 14 years old who voluntarily received a dose of live attenuated mumps vaccines were be enrolled.Adverse reactions/events at 30 minutes, 14 days and 30 days after vaccination of live attenuated mumps vaccine were were collected by face-to-face or telephone follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Junior high school students under 14 years old;
* The subjects and guardians of the subjects can understand and voluntarily sign the informed consent form ;
* Subjects and their legal guardians are able to attend follow-up visits and follow all study procedures (such as cooperating in completing safety observation notes)

Exclusion Criteria:

-
Evaluate a Medication on How Hunger and Appetite Are Influenced by Smell

The purpose of this study is to determine whether the blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray which will then reduce food intake.

You will fast on your first visit. Complete questionnaire about taste and smell to insure you don't have a cold or anything that would interfere with sense of smell. Your nose will be checked. Blood pressure taken, and administer to you a spray with diltiazem 2, 4, 8 mg or a placebo. Your sense of smell will be tested at different time points.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 25 and 40 kg
* Blood pressure in within normal range

Exclusion Criteria:

* Used tobacco products in the past month
* Used a calcium channel blocker medication in the last month
* used nasal sprays in the last month
* have an abnormal sense of smell or abnormalities of the lining in your nose
* female and have irregular menstrual periods
* female and are nursing a baby or pregnant
* female and have had a partial hysterectomy (still have ovaries)
TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery

To compare of atrial arrhythmia incidence in patients with coronary artery disease and atrial fibrillation history, undergoing either coronary artery bypass grafting plus temporary spinal cord stimulation or coronary artery bypass grafting alone

The study includes 60 patients. Patients are randomized into 2 groups: coronary artery bypass grafting plus b-blocker treatment (according to guidelines; group I) and coronary artery bypass grafting plus b-blocker treatment (according to guidelines) plus temporary spinal cord stimulation (group 2). Temporary spinal cord stimulation is performed for 3 days before surgery and 7 days after coronary artery bypass grafting. Continuous ECG during intensive care unit stay, daily ECG and 24-h Holter monitor recordings at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit until 30 days after coronary artery bypass grafting. Rhythm status and clinical outcome assessment at 12 month follow up

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years;
* indications for coronary artery bypass grafting according to guidelines;
* pre-operative history of paroxysmal atrial fibrillation;
* absent of contraindications for spinal cord stimulation;
* signed inform consent.

Exclusion Criteria:

* previous heart surgery or atrial fibrillation ablation procedure;
* emergency coronary artery bypass grafting;
* left ventricle ejection fraction \<35%;
* unstable angina or heart failure;
* persistent atrial fibrillation or atrial fibrillation at the time of screening;
* planned Maze procedure or pulmonary vein isolation;
* use of class I or III antiarrhythmic drugs within 5 elimination half-lives of the drug;
* need for concomitant valve surgery;
* Inability to control the device for spinal cord stimulation;
* coagulopathy, immunosuppression, or other condition associated with an unacceptable surgical risk for spinal cord stimulation;
* Need for therapeutic diathermy in the area of leads placement;
* Need for pacemaker/ICD/CRT-D implantation;
* unwillingness to participate.
Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea

To evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea

Pregnant women undergo various anatomical and physiological changes so that they can cope with the increased physical and metabolic demands of their pregnancies. Cardiovascular, respiratory, haematological, renal, gastrointestinal and endocrine systems undergo important physiological adaptations needed to allow development of the fetus and to allow the mother and fetus to survive the demands of childbirth . On the other hand, dyspnea can be caused by pregnancy complications, thus requiring specific medical treatment. Shortness of breath is common during pregnancy, occurring in 60% to 70% of healthy pregnant women . The aim of the study is to evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea

Eligibility Criteria:
1. Inclusion criteria: pregnant women presented with physiological dyspnea.
2. Exclusion criteria:

   1. Non physiological causes of dyspnea in pregnancy

      * Cardiac: arrhythmia, constrictive pericarditis , pericardial effusion , coronary heart disease , congestive heart failure , intracardiac shunt , cardiomyopathy , valvular heart disease.
      * Chest wall, pleura, lungs: bronchial asthma, bronchiectasis ,bronchiolitis ,chronic obstructive pulmonary disease, pulmonary emphysema, interstitial lung disease, sarcoidosis ,lung tumor narrowing or compressing the airways , pleural effusion , pulmonary right-to-left shunt , pulmonary hypertension ,elevated hemi diaphragm, phrenic nerve palsy, kyphoscoliosis
      * CNS and neuromuscular: amyotrophic lateral sclerosis , mitochondrial disease polymyositis/ dermatomyositis
      * Metabolic: renal failure , thyroid disease
      * Head and neck : laryngeal tumor ,vocal cord paralysis , vocal cord dysfunction , tumor compressing the upper airways , tracheal stenosis , goiter
      * Others: anemia , anxiety disorder, panic attacks, , ascites , obesity, abdominal wall hernia
   2. Refusal to participate
Evaluation of the Water Vapor Thermal Therapy System for the Treatment of Benign Prostatic Hyperplasia

To evaluate the efficacy and safety of the Water Vapor Thermal Therapy system for the treatment of Benign Prostatic Hyperplasia under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related (serious) adverse events. The primary effectiveness endpoint will be changes (treatment group vs control group) from baseline in International Prostate Symptom Score (IPSS) 3 months after medical device intervention.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 45-80 years (inclusive) with symptoms secondary to BPH and requiring invasive intervention.
* International Prostate Symptom Score (IPSS) ≥13 points.
* Maximum urinary flow rate (Qmax): ≤15 ml/s, with a minimum urine volume of ≥125 ml.
* Post-urination residual urine volume (PVR): ≤250 ml.
* Prostate volume measured by MRI: 30\~80 cm³ (including 30 cm³ and 80 cm³).
* Voluntarily participate in the clinical trial and sign the informed consent form.

Exclusion Criteria:

* Malignant lesions of the urinary system, such as prostate cancer or bladder cancer, or other systemic advanced malignant tumors (e.g., gastric cancer, liver cancer, lung cancer).
* Patients with difficulty inserting instruments due to urethral stenosis or bladder neck contracture.
* Severe coagulation disorder.
* Urinary incontinence caused by reduced sphincter function or severe urge urinary incontinence.
* Patients with a history of severe cardiovascular disease, including but not limited to:

  * Second/third-degree heart block.
  * Severe ischemic heart disease.
  * Congestive heart failure with New York Heart Association (NYHA) heart function grade ≥ II (mild physical activity limitation; comfortable at rest, but normal activities can cause fatigue, palpitations, or dyspnea).
* Prostate biopsy within 2 months before enrollment.
* Unstable angina, myocardial infarction, transient ischemic attack, or cerebrovascular accident in the past 6 months.
* Patients with previous invasive prostate treatment, such as:

  * Radiofrequency (RF) ablation.
  * Balloon dilation.
  * Microwave therapy.
  * Laser treatment.
  * Electroreception.
  * Prostate urethral stent.
  * Suspension procedures.
* History of previous rectal surgery (except hemorrhoidectomy) or history of rectal disease that affects the treatment method or efficacy evaluation in this study.
* Acute urinary and reproductive system infections that are not effectively controlled.
* Neurogenic bladder or neurological diseases that affect bladder function, sphincter function, or detrusor function, as assessed by the researcher.
* Bladder stones.
* Subjects who cannot undergo MRI examination.
* Subjects who are:

  * Currently participating in clinical trials.
  * Have participated in other drug clinical trials within 3 months.
  * Have participated in other medical device clinical trials within 30 days.
* Other situations that the researcher believes are unsuitable for participation in the study.
National Multicentric Observatory of Low Bowel Preparations in Patients With IBD

National multicentric observatory of low bowel preparations in patients with IBD

Prospective french multicentre observational study, during one month: from March 6th to April 6th 2017, under the auspice of the IBD group of the Société Française d'Endoscopie Digestive- SFED. All French gastroenterologists in charge of IBD patients in public or private endoscopy centers were reached out through various professional and scientific associations to participate in the study via e-mail, web sites, and national congresses. Investigators were asked to prescribe the bowel preparation independently from the study, as per their usual habits. The achievement of low residue diet, the split and the timing of the preparation were left free to the investigator according to local protocols.

Data recording The physicians participating in the study completed data on an online questionnaire via an internet-based tool (CleanWeb software, hosted by Besançon university hospital research center) or through a questionnaire sheet. The questionnaire included a medical record and a self-reported patient questionnaire. The medical record included physicians and centers characteristics, patient's demographics, disease characteristics, modality of bowel preparation (diet, split dose, type of bowel preparation, delay before colonoscopy), and colonoscopy findings and outcomes. Patients self-administered questionnaires assessed preparation tolerability by symptoms and satisfaction recording.

Clinical endpoints The efficacy of the preparation was evaluated by the Boston's score (efficacy was defined as a Boston's score was ≥ 7 without any segment \<2)23, the rate of caecal or anastomosis intubation and the necessity or not to repeat the colonoscopy.

The tolerance was evaluated by the quantity of preparation actually absorbed by the patient, (quantity of active preparation and quantity of clear liquid), patients and investigators visual analogue scale evaluation of tolerance (VAS), a self-administered validated bowel-preparation tolerability questionnaire 24 and by the patients' wish to take the same preparation for the next colonoscopy.

Safety data: adverse events were collected per preparation and per endoscopic procedure, at 24 hours and 30 days later. A special focus was made on aphtoid lesions as they were previously reported as adverse preparation-induced mucosal lesions possibly associated with some solutions.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18-75 years,
* symptoms of IBD for at least 3 month,
* inidcation of colonoscopy independent from the study.

Exclusion Criteria:

* Congestive heart failure,
* severe renal failure,
* gastro intestinal symptomatic obstruction or occlusive bowel stenosis (a non-occlusive stenosis was not an exclusion criterion),
* severe acute colitis,
* severe dehydration or electrolyte disturbances,
* patient's refusal to participate in the study.