cyrilzakka/clinical-trials huggingface dataset:
Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks

Diving disorders and particularly Decompression sickness (DCS) represent a major concern in recreational and occupational pressure-related activities. As a result of decompression from higher to lower ambient pressure bubbles which are formed in vascular flow and in tissues take part in embolism then resulting in DCS. Individual factors such as vascular or respiratory defects are now considered to increase the risk of this dysbarism disease.

2 groups of occupational divers will be separated after a fitness medical examination by regarding DLCO decrease or not.

The divers will be evaluated before and 30, 60, 180 minutes after a 20 meters air dive. Venous bubbles will be detected by precordial Doppler 30 minutes after the dive.

In association with this Doppler, Flow Mediated Dilation, blood samples analysing inflammatory and thrombotic factors and other biomarkers will be explored before and after the dive in order to know how vascular and respiratory tracts in this environment react.

Eligibility Criteria:
Inclusion Criteria:

* Be professional and voluntary diver
* Man or woman aged 18 years or older
* Diffusing Lung Capacity for Carbon Monoxide measured beforehand in the study
* No medical contraindication for hyperbaric
* No hyperbaric constraint in 3 days before the dive
* No prior Decompression sickness
* Not to follow medicinal treatment modifying the vascular endothelial and/or the coagulation and/or the respiratory function
* Patient affiliated to social security
* Informed and signed

Exclusion Criteria:

* Concomitant pathology identified by the Investigator, justifying a contraindication for hyperbaric
* Pregnant and nursing mothers
* Patient who refuse to sign consent form
Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus
* Painful distal symmetric polyneuropathy
* Average daily pain score is great than or equal to 4

Exclusion Criteria:

* HbA1c greater than 9.0
Maximal Leg Press Strength Training Study for Coronary Artery Disease Patients

Maximal strength training has been shown to increase muscular strength, muscular volume and work economy. An 8 week maximal leg press training regime will be conducted on cardiac heart failure patients to evaluate whether they increase their maximal leg press strength, work economy, serum testosterone and quality of life. The study hypotheses are that:

1. Aerobic work capacity will increase due to increased work economy, without increases in maximal oxygen uptake.
2. Strength training will increase serum testosterone.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed coronary artery disease
* Stable coronary artery disease
* 1.5 mm depression in ST segment during a cycling strain test
* Between 18-70 years of age

Exclusion Criteria:

* Unstable coronary artery disease
* Other limitations to exercise than coronary artery disease
* Participants in other study interventions
Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old to 65 years old, diagnosis of primary headache

Exclusion Criteria:

* Allergy to study medications, pregnant, breast-feeding, prisoners, non-english speaking, not eligible to receive droperidol based on ED protocol (see below), patients in whom head trauma, infection, vascular disorders, and disorders of facial or cranial structures are suspected

ED Droperidol Protocol

Droperidol must NOT be used in patients with any of the following:

* Known or suspected QT prolongation, including congenital long QT syndrome
* Cardiac Disease \[cardiomyopathy, congestive heart failure, hypertension, ischemic heart disease, myocardial infarction, bradycardia (\< 50 bpm)\]
* History of the following:

  * Renal failure
  * Cerebrovascular disease
  * Diabetes or hypoglycemia
  * Alcoholism/alcohol abuse
  * Pituitary insufficiency
  * Hypothyroidism
  * Hypothermia
  * Anorexia
* Advanced age (\>65 yrs)
* Use of the following medications: digoxin, benzodiazepine, diuretics, IV opiates, or other medications known to prolong the QTc interval.
Evaluation of an Automated Smartphone-based Digital Auscultation Application for Detecting Abnormal Heart Sounds Using Deep Learning Techniques

This pilot study is to investigate the feasibility of obtaining medical grade audio phonocardiogram (PCG) recordings using a smartphone-based auscultation device in the first step. The ability to determine Valvular Heart Disease (VHD) (i.e., presence or absence of cardiac murmurs) using novel handheld CAA-devices shall be analyzed and first data on a smartphone-based auscultation in a hospital setting shall be collected. In further studies, the data provided from this study can be used to investigate the potential diagnostic use of such devices in the ambulatory and stationary care scenarios.

Cardiac auscultation is considered to be highly subjective with substantial varying sensitivities and specificities in regard of the practitioners' expertise. Computer-assisted auscultation (CAA) aims to provide increased objectivity. CAA makes auscultation procedure less operator-dependent, approximate inter-examiner differences and may reduce uncertainties in the course of the examination. With the introduction of modern Machine Learning software libraries and ever-growing computational resources CAA has advanced significantly and is now able to classify heart sounds and murmurs into normal and abnormal, using complex spectro-temporal signal processing techniques and neural network pathways. CAA has simultaneously made the shift from the deployment on computers to consumer smartphones. A benefit of CAA can be expected from the smartphone alone in terms of cost, application range, the clinical validity of such algorithms should now be measured in this pilot study. This pilot study is to investigate the feasibility of obtaining medical grade audio phonocardiogram (PCG) recordings using a smartphone-based auscultation device in the first step. In further studies, the data provided from this study can be used to investigate the potential diagnostic use of such devices in the ambulatory and stationary care scenarios.

Eligibility Criteria:
Inclusion Criteria:

* Older or equal than 18 years of age
* Referred for an echocardiogram
* Able to provide informed consent

Exclusion Criteria:

* Confirmed arrythmia
* Prior valvular intervention
* Evidence of congenital heart disease
Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups

Study will test the use of a short virtual reality driven goggle test as a means of detecting mTBI in a diverse group of athletes


Eligibility Criteria:
Inclusion Criteria:

1. Participants from 18 - 90 years of age who participate in all amateur athletics at the University of Miami to include all levels of sports whether National Collegiate Athletic Association (NCAA) or Club. Initial recruitment will include high intensity sports, including but not limited to Men's football, Men's and Women's Soccer, Men's and Women's Basketball, Men's and Women's Volleyball, Men's Baseball and Women's Softball, and Club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey).
2. Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member.
3. Participants from 18-90 years of age who are engaged in professional sports as an active participant or formerly as a team member. Initial recruitment will include all motor sports, ice and field hockey, football, soccer, basketball, and rugby.

Exclusion Criteria:

1. History of brain injury resulting from a penetrating wound to the head.
2. Presence of aphasia and/or inability to give informed consent for participation
3. History of diagnosed neuropsychiatric disorders
4. Documented neurodegenerative disorders
5. Prior disorders of hearing and balance including:

   1. Meniere's disease
   2. Multiple sclerosis
   3. Vestibular neuritis
   4. Vestibular schwannoma
   5. Sudden sensorineural hearing loss
6. Cerebrovascular disorders
7. History of ear operation other than myringotomy tube in the past
8. Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc.
9. Presence of intra-cranial structural findings on imaging studies
10. Prisoners
fNIRS, Listening Effort, and Motivation

The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Participants will be instructed to listen to sentences in noise at a challenging signal-to-noise-ratio, and to indicate what they heard using a closed-set response interface. Participants will complete 4 sessions: a training session, and a session for each condition. During each test session, participants will be instructed to listen to at least 100 sentences. Oxygenation, response times, and listening accuracy will be measured throughout.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18-99) years
* Binaural, symmetrical, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
* Experienced hearing aid users
* Fluent in English

Exclusion Criteria:

* Minors (17 years or less)
* Hearing status that did not fall within inclusion criteria
* Vulnerable populations
Study of Nicotinamide in Early Onset Preeclampsia

Phase II Study of 2.5 gm of nicotinamide, given daily in 3 divided doses, to measure effect on maternal blood pressure in women with early onset preeclampsia and to determine peak and trough levels of nicotinamide. We will compare peak and trough levels in healthy non-pregnant and healthy pregnant participants.

See brief summary above

Eligibility Criteria:
Diagnosis and Inclusion Criteria

* Maternal age 18-55 years
* Singleton pregnancy with no known fetal anomalies
* Early-onset preeclampsia OR early-onset severe gestational hypertension defined as:

  * Early-onset: between 24 weeks 0 days and -33 weeks 3 days, based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable;
  * Preeclampsia:
* New onset hypertension and proteinuria, with systolic BP \> 140 mm Hg and/or diastolic BP \> 90 mm Hg on two occasions 6 hours apart and \> 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio \>0.3;
* New onset hypertension and NO proteinuria, with systolic BP \> 140 mm Hg and/or diastolic BP \> 90 mm Hg on two occasions 6 hours apart and one or more of the following: serum creatinine \>1.1 mg/dL or doubling from baseline ,or central nervous system symptoms or visual changes
* Severe preeclampsia defined as new onset systolic BP \> 160 mm Hg and/or diastolic BP \> 105 with proteinuria as above or or without proteinuria and one or more of the following criteria listed above

  * Candidate for expectant management for at least 48 hours
  * Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery) for at least 48 hours;
* Maternal liver function tests \< 2x ULN
* Maternal platelet count \> 100,000 mm³
* Planned expectant management
* Pre-existing medical diseases such as hypertension, diabetes, endocrine disorders, gastrointestinal diseases, are well controlled
* Fetal well-being established by estimated fetal weight \> 5th %tile; normal amniotic fluid volume (MVP \> 2 cm); normal Umbilical Artery (UA) Dopplers; or reactive Non Stress Test (NST) or Biophysical Profile (BPP) \> 6
* Delivery not anticipated within 48 hours of enrollment

Exclusion Criteria

* Pre-existing renal disease (creatinine \> 1.5 mg/dL)
* Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV; Isoniazid (INH) use)
* Eclampsia; cerebral edema on CT/MRI; headache unrelieved by analgesics
* Evidence of liver dysfunction (LFTs \> 2x ULN)
* Thrombocytopenia (platelets \< 100,000 mm³)
* Pulmonary edema
* HELLP syndrome
* Evidence of fetal compromise: Estimated Fetal Weight (EFW) \< 5th percentile; or BPP \< 6; or absent or reverse diastolic UA blood flow; or oligohydramnios (MVP \< 2 cm)
* Placental abruption defined as unexplained vaginal bleeding
* Preterm labor defined as regular contractions and cervical change
* Any condition deemed by the investigator to be a risk to mother or fetus in completion of the study
* Any condition deemed by the investigator to require delivery within 48 hours
Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function

The pandemic of obesity has become a serious issue of public health worldwide as the size of the obese population has almost tripled over the last four decades and continues to riseزThe epidemic of obesity has led to a significant increase in the prevalence of non-alcoholic fatty liver disease (NAFLD). NAFLD is currently the most common chronic liver disease, with an estimated global prevalence at 25-30%, rising up to 90% in morbidly obese patients

Anesthesia and surgery may deteriorate liver function in patients with elevated liver enzyme levels; therefore, in these patients, choosing anaesthetics with less hepatotoxicity may be important. Halothane, which is a typical inhalational anesthetic, is known for its liver and kidney toxicity. The latest anesthetic agents, including sevoflurane and desflurane, are associated with less hepatotoxicity, although rare cases of acute liver injury have been reported with these agentsزPropofol (2,6-diisopropylphenol) is an intravenous anesthetic. Its pharmacokinetic profile makes it very suitable for total intravenous anesthesia (TIVA) and this is a widely used technique in many centers. Its use results in a rapid onset and offset with fewer side effects including postoperative nausea and vomiting, making it particularly favorable in the ambulatory setting

Eligibility Criteria:
Inclusion Criteria:

* Obese patients
* had ASA I-III
* diagnosed with non-alcoholic steatohepatitis (NASH) liver disease
* undergoing laparoscopic sleeve gastrectomy

Exclusion Criteria:

* cases wherein surgeries were performed using anesthetic methods that were not clearly identified as TIVA or INHA
* heart surgery or cesarean section, and cases of neuromuscular diseases
Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as tamoxifen may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.

OBJECTIVES: I. Determine whether high-dose tamoxifen initiated at the beginning of conventional radiotherapy improves the median survival time of adults with newly diagnosed, supratentorial glioblastoma multiforme. II. Determine the feasibility and toxicity of high-dose tamoxifen in these patients. III. Determine the overall survival with respect to protein kinase C lab correlates in patients treated with this regimen.

OUTLINE: This is a multicenter study. Beginning within 5 weeks after surgery, patients undergo radiotherapy to the brain 5 days a week for 6 weeks. Patients receive high-dose oral tamoxifen every 6 hours beginning on day 1 of radiotherapy and continuing in the absence of disease progression. Patients are followed every 3 months through year 1, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven newly diagnosed, supratentorial glioblastoma multiforme (with areas of necrosis) Diagnosis must be made by surgical biopsy or excision within the past 5 weeks No recurrent malignant gliomas No metastases below the tentorium or beyond the cranial vault

PATIENT CHARACTERISTICS: Age: Adult Performance status: Karnofsky 70-100% OR Zubrod 0-1 Life expectancy: At least 8 weeks Hematopoietic: Hemoglobin at least 10 g/dL (transfusion allowed) Hematocrit at least 30% (transfusion allowed) Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal Renal: Blood urea nitrogen no greater than 25 mg/dL Creatinine no greater than 1.5 mg/dL Cardiovascular: No active thrombophlebitis Other: Recovered from any postoperative infection or other complications No major medical illnesses or psychiatric impairments that would preclude study participation No active connective tissue disorder, such as lupus or scleroderma No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or bladder No prior endometrial cancer or atypical endometrial hyperplasia No AIDS Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 12 months since prior tamoxifen Radiotherapy: See Disease Characteristics No prior radiotherapy to head or neck Surgery: See Disease Characteristics Recovered from prior surgery
AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)

dBM-dev study is a multicentre low-intervention research study which concerns REM sleep behaviour disorder (RBD) who is the best predictor for neurodegenerative diseases including Parkinson's disease (PD). RBD can only be confirmed by polysomnography, which is a cumbersome procedure. The main objective of this study is to identify a novel, robust dBM for the detection of RBD using smartwatch-based recordings of passive data.The study is conducted step-wise on two subsequent cohorts referred to as the development cohort and the confirmation cohort.

The development cohort comprises 30 patients with RBD and 30 matched controls on sex and age with patients RBD.

The confirmation cohort comprises 30 patients with PD. Following a baseline visit comprising standard clinical evaluation and Parkinson questionnaires, participants will undergo daily-life dBM tracking over a duration of 4 weeks for development cohort and 3 months for confirmation cohort. Additionally, PD patients enrolled in the confirmation cohort will receive a polysomnography which permits to verificate if they have a RBD. The investigation is conducted in four European sites.

Eligibility Criteria:
Inclusion Criteria for development cohort:

Group of RBD patients

* Diagnosis of RBD (confirmed by polysomnography)
* Able to use a compatible smartphone with the study app
* Having a care partner with whom they share their bedroom at night

Group of Healthy matched controls:

* Healthy volunteers age and sex matched to the enrolled RBD patients.
* Able to use a compatible smartphone with the study app
* No history of RBD.

Inclusion Criteria for confirmation cohort

* Clinical confirmed diagnosis of PD
* RBD Screening Questionnaire score : 3 - 12 points
* Absence of dementia
* Able to use a compatible smartphone with the study app
* Having a care partner with whom they share their bedroom at night

Exclusion Criteria for all cohorts:

Inability to consent for study procedures as judged by the investigator. Lacking motivation to participate in study procedures as judged by the investigator.

Lack of social security.
A NEW MECHANICAL DECONTAMINATION METHOD IN PERI-IMPLANTITIS, TI-BRUSH, A RANDOMIZED CONTROLLED CLINICAL TRIAL

Objective:

The objective of this study was to evaluate a new mechanical method (Ti-Brush, Straumann, AG, Basel, Switzerland) of implant surface decontamination.

Material and methods:

A randomized double-blinded controlled clinical trial with a 1-year follow-up it is being carried out. After a hygienic phase, defects were randomly assigned to a control (n=18) or to a test group (n=18). In control group, implant surface was decontaminated both mechanically and chemically with 3% H2O2 and plastic ultrasonic scalers, respectively, while in test group Ti-Brush was added. Infrabony defects in both groups were regenerated with BoneCeramic (Straumann, AG, Basel Switzerland) and collagen barrier membrane Cytoplast (Osteogenics, Lubbock, United States). Clinical and radiographic parameters were measured at baseline, 6, and 12 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Healthy or treated periodontal patients
* A good level of oral hygiene (Plaque Index ≤ 25%) (O'Leary et al., 1972).
* Presence of at least one titanium implant exhibiting peri-implantitis (peri-implant bone loss \> 30% and Implant PPD ≥ 6 mm with bleeding and/or pus suppuration on probing)
* Osseous defect had to be circumferential, or present at least two walls and 3mm depth.
* Presence of \>1 mm of keratinized peri-implant mucosa
* Absence of systemic diseases that could influence the outcome of the therapy.

Exclusion Criteria:

* Pregnant or lactating women
* Esthetically compromised patients
* Patients who received systemic antibiotics in the past 3 months or treatment of peri-implantitis in the last 12 months.
* Smokers of more than 10 cigarettes a day
The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil

Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.


Eligibility Criteria:
Inclusion Criteria:

* Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
* For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
* Ages between 18 and 80 years old;
* Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
* Agree to participate in the study and sign the informed consent term.

Exclusion Criteria:

* Use of any leishmanicidal drugs six months prior;
* Clinical or laboratorial evidences of electrocardiographic disorders;
* Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
* Hypersensitivity to meglucamine antimoniate;
* Pregnancy or lactation;
* Fertile females that do not agree to use contraceptive methods;
* Patients that do not agree to the informed consent term.