cyrilzakka/clinical-trials huggingface dataset:
Autonomic Cardiovascular Control in Response to Blood Volume Reduction in Blood Donors

The function of the autonomic nervous system can be assessed using baroreflex sensitivity (BRS) and heart rate variability (HRV). Decreased HRV has been shown to be predictive of morbidity and mortality in diverse medical conditions such as acute myocardial infarction, aneurysmal subarachnoid haemorrhage, autoimmune diseases, sepsis and surgery.

The function of the autonomic nervous system has not yet been investigated in a "pure hypovolemia" model. The aim of the current study is therefore to investigate and describe the function of the autonomic nervous system prior to, during and after reduction of blood volume in healthy blood donors.


Eligibility Criteria:
Inclusion Criteria:

* Volonteers eligable for blood donation following the Danish legislation
* Male
* Age 30-45
* Written informed consent
* Speak and understand Danish

Exclusion Criteria:

Volonteers not eligable for blood donation following the Danish legislation, among others due to:

* Alcohol and drug abuse
* Cognitive dysfunction
* Use of anxiolytic or antipsychotic drugs
* Arrhythmias or heart failure
* Diabetes mellitus type I
* Diabetes mellitus type II
* Use of opioids
* History of following diseases in the autonomic nervous system: Parkinson disease, multiple sclerosis, autonomic neuropathies
* History of cerebral apoplexy or transitory cerebral ischemia
* Dementia
* American Society of Anesthesiologists (ASA) score ≥ 4

Furthermore:

* History of orthostatic intolerance and/or orthostatic hypotension
* Use of following vasodilator antihypertensive drugs: beta-blockers, angiotensin converting enzyme inhibitors (ACEI), angiotensin 2 receptor blockers (ARBs), calcium channel blockers
* Use of loop diuretics, thiazid diuretics and potassium-sparing diuretics
Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue

This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females
2. Age: 18-75 years, inclusive
3. Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria:

   1. Screening - defined as first colonoscopy or consecutive colonoscopy without previous findings, previous colonoscopy performed at least 10 years ago (- 1 year);
   2. Patient with finding of colorectal adenoma or sessile serrated polyp in previous colonoscopy (must be documented in patient's medical history).
4. Able to comprehend and provide informed consent.

Exclusion Criteria:

1. Subject who is not a suitable candidate for a colonoscopy
2. Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes
3. Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration
4. Patients with a disability to extend their tongue.
5. Patients with tongue piercings.
A Multi-Disciplinary Technology-Based Care for Diabetic Ketoacidosis in Patients with Type 1 Diabetes

The study team proposes that use of a novel multi-disciplinary approach with continuous glucose monitoring technology can significantly improve glycemic control and reduce readmissions among those with type 1 diabetes mellitus (T1DM) admitted for Diabetic ketoacidosis (DKA). This will also help promote a pathway for care of these patients after admission utilizing resources which are available within the Endocrinology, Diabetes and Metabolism department at the Cleveland Clinic.

Diabetic ketoacidosis (DKA) is a serious complication of type 1 diabetes mellitus (T1DM) with significant cost to the United States of $2.2 billion over the past decade. Readmissions are very common with a 20.2% readmission rate within 30 days of discharge and 86% of those admitted with DKA having a subsequent 1-3 admissions in the following year. While predictors have been identified (i.e. lower socioeconomic status, Medicaid/Medicare, younger age, female, leaving against medical advice, etc.), few interventions have been able to concretely show a reduction in the rate of readmission apart from endocrinology consultation. Very few studies have assessed the use of a multi-disciplinary approach in this context. The only study in adults with T1DM which made use of such a team (i.e. ketoacidosis case manager, educators to provide immediate post-discharge contact and follow up along with behavioral health, education and endocrinology follow up) was done in the UK and was able to show significant improvement in readmission and glycemic control over the year-long intervention, but notably had to shut down due to lack of funding. None of these interventions consistently applied technology (i.e. continuous glucose monitoring \[CGM\]) which is known to be able to significantly improve glycemic control within the first month of use in those with poorly controlled T1DM.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or older
* Diagnosis of Type 1 Diabetes
* Admitted to the hospital with confirmed diabetic ketoacidosis treated with intravenous insulin infusion
* No prior use of continuous glucose monitoring (CGM)
* Compatible smart phone with CGM
* Allergy to any component of the CGM

Exclusion Criteria:

* Condition which, in investigator judgement would limit their ability to participate safely
A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients

In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.

Design: single center, double-blind, randomized, placebo-controlled, crossover study.

Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.

Population: Eight (8) PD subjects.

Eligibility Criteria:
Main Inclusion Criteria:

* Men and women with idiopathic Parkinson's disease
* Subjects must experience motor fluctuations associated with LD/CD dosing
* Modified Hoehn and Yahr stage \< 5
* Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
* Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
* Subjects must be age 30 or older.
* Subjects must be willing and able to give informed consent.

Main Exclusion Criteria:

* Subjects with a clinically significant or unstable medical or surgical condition
* Subjects with clinically significant psychiatric illness.
* Pre-menopausal women, not using birth control method.
* Subjects who have taken experimental medications within 60 days prior to baseline.
* Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
Harm Reduction for Smokers With Mental Illness

To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from SWITCH IT


Eligibility Criteria:
Diagnostic Criteria (must have one to be eligible):

* Schizophrenia
* Bipolar disorder
* Major Depressive Disorders
* Posttraumatic disorder
* Other anxiety disorders

Additional Inclusion Criteria:

* 21 years or older;
* English-speaking;
* Daily smoker (at least 10 cigarettes/day);
* At least one quit attempt in the past 5 years using evidence- based pharmacotherapy or behavioral cessation support;
* Not currently interested in quitting.

Exclusion Criteria:

* Currently residing in a nursing home;
* Current diagnosis of Asthma;
* Cognitive impairment (score \<26 on the Telephone Interview for Cognitive Status (TICS);
* Current use of e-cigarettes (\>once a week);
* Psychiatric instability (hospitalized in the past month);
* Current AND moderate to severe substance use disorder;
* Pregnant or planning to become pregnant;
* Use of any smoked products other than cigarettes;
* Current unstable medical illness making e-cigarette unsafe (e.g., recent heart attack, cancer);
* Participation in SWITCH IT pilot study.
Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6

Labor induction is the stimulation of uterine contractions during pregnancy, before labor begins on its own to achieve a vaginal birth.

A health care provider might recommend labor induction for various reasons: primarily when there's concern for a mother's health or a baby's health.

Combined with oxytocin infusion, amniotomy is commonly used in the induction of labor. However the perfect timing of amniotomy is still unknown.

The aim of this study is to determine whether the early amniotomy followed by oxytocin, or initiating induction of labor with oxytocin followed by late amniotomy, is effective to reach active phase of labor.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Full term (36 weeks and 3 days of gestation reached)
* Singletion gestation in cephalic presentation
* Bishop score of ≥ 6

Exclusion Criteria:

* Prior uterine surgery, previous cesarean section
* Ruptured membranes
* Spontaneous labor
* Multifetal pregnancy
* Dystocic presentation
* Fetal head not fixed at pelvic brim
* Macrosomia
* Hydramnios
* Severe fetal growth restriction
* Major fetal anomaly
* Women with HIV, hepatitis C, hepatitis B
* Women with medical conditions contraindication to a vaginal delivery
* Women with COVID-19 infection
Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic

The aim was to examine the effectiveness of hypochlorous acid on postoperative wound healing in 24 systemically healthy gingivectomy participants aged 12-30. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and their wound healing was evaluated on the 1st, 3rd and 7th days.

The aim of this study was to investigate the effectiveness of hypochlorous acid on postoperative wound healing in 24 participants aged 12-30 who underwent gingivectomy involving the 6 anterior teeth of the upper or lower jaw with chronic inflammatory gingival overgrowth. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and were called for control on the 1st, 3rd and 7th days to evaluate wound healing. Periodontal indexes, visual analog scale (VAS), H2O2, plaque staining agent test, and histological analyzes were used to evaluate wound healing. The data were analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* Gingival overgrowth affecting at least six teeth symmetrically in the mandibular or maxillary anterior area
* No attachment and bone loss
* 7 days before the surgery, full-mouth plaque index (PI) \< 25% and a full-mouth gingival bleeding index (GBI) \< 25%.
* the keratinized tissues surrounding the teeth are at least 2 mm wide.

Exclusion Criteria:

* Smoking or alcohol use
* Patients who have undergone systemic antimicrobial therapy and surgical procedures within the last 3 months
* Pregnancy or lactation
* Immunodeficiency or immunosuppressive drug therapy
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults

This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS).

This is a randomized, double-blind, placebo-controlled phase 2 study for long-term evaluation of fostamatinib for the treatment of adult patients with acute respiratory distress syndrome. Subjects will be randomly assigned 1:1 to either standard of care treatment plus fostamatinib or standard or care plus placebo. Th study drug will be taken twice daily for 14 days.

The primary objective will be to evaluate drug safety in hospitalized patients with severe ARDS. Other objectives include assessment of the efficacy and clinically relevant endpoints, such as mortality and effects on resolution of this disease entity. The ability of fostamatinib to impact the short term and long term outcomes for patients with ARDS will be directly evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Subject (or legal representative) provides informed consent to study participation.
* Subject (or legal representative) understands and agrees to comply with planned study procedures.
* Hospitalized with acute respiratory failure from ARDS with ratio of partial pressure of arterial oxygen to fraction of inspired oxygen PaO2/FiO2 of 200 mm of Hg or less with positive end expiratory pressure (PEEP) equal to or higher than 5 cm of H2O and requiring invasive mechanical ventilation or extracorporeal support.
* Functional respiratory imaging (FRI) compatible CT scan of the chest within the prior 7 days.
* Duration of invasive mechanical ventilation \< 10 days.
* Females of childbearing potential must agree to be abstinent or seek a highly effective form of contraception from the time of enrollment through 30 days after the last day of study drug.

Exclusion Criteria:

* Severe hepatic impairment (Child-Pugh Class C).
* Abnormal liver function tests (AST or ALT \> 3x ULN or AST or ALT \> 3x ULN)
* Pregnant or nursing.
* Participation in any other clinical trial, or receipt of an investigational medicinal product within 30 days prior.
* Known concomitant life-threatening disease with a life expectancy \< 6 months.
* Known hypersensitivity to fostamatinib.
* Uncontrolled hypertension (Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
* Neutrophil count \< 1000/uL
* Death expected within 72 hours
* Received a live vaccine in the last 30 days
* Those who were cognitively impaired or mentally disabled prior to acute illness
* Patients with acute coronary syndrome, ejection fraction \<30%, or active unstable arrhythmias
A Trial of SHR-1905 in Healthy Subjects and Subjects With Mild Asthma

This study is a phase 1 single dose escalation study of SHR-1905 in healthy subjects and subjects with mild asthma. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1905 in healthy subjects and subjects with mild asthma.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent, be able to comply with all the requirements and able to complete the study.
2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
3. Total body weight ≥ 45 kg, body mass index (BMI) between 18 and 28 kg/m2 at screening.
4. For healthy subjects, no clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function and thyroid function) and ECG at the investigator's discretion during screening and baseline.

Exclusion Criteria:

1. Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental, nerve, hematology, metabolic disorders, etc.
2. Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial.
3. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
4. Hyper/Hypotension which define as Systolic blood pressure (SBP) \>140mmHg or \<90mmHg, or Diastolic blood pressure (DBP)\>90mmHg or \<40mmHg at screening and at check in.
5. Clinically significant abnormalities in 12-Lead ECG (e.g., For male QTcF \> 450msec, for female QTcF \> 470msec) at screening and at check in
6. Positive alcohol breath test during baseline visit.
7. Positive nicotine test during screening.
8. Positive urine drug screen during screening.
9. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer (according to the date of signed consent form) which is defined as have consented and used other investigational drugs (including placebo) or trial medical devices
10. Any other circumstances that, in the investigator's judgment, may increase the risk to the subject, or associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response
Tadalafil in Subjects With Mild to Moderate Hypertension

Purpose: The primary objective of this study is to evaluate the efficacy and safety of tadalafil when administered once daily at doses of 5 and 20 mg to adult subjects for 8 weeks with mild to moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented medical history of hypertension.
* Have cuff seated diastolic blood pressure values greater than or equal to 95 and less than or equal to 104 mm at study entry
* Have a negative serum pregnancy test at the time of enrollment and agree to use two medically reliable methods of contraception until study completion, if female is of child-bearing potential, between menarche and 1 year post menopause and not surgically sterilized.
* Are able to comply with study procedures and visits

Exclusion Criteria:

* Have resistant hypertension or systolic hypertension.
* Are obese, defined as having body mass index (BMI) greater than or equal to 35.
* Are females who are pregnant or breast feeding.
* Have a history of severe renal insufficiency or significant thyroid, renal or hepatic disease.
* Have a glycosylated hemoglobin A1c (HbA1c) greater than or equal to 10% during the screening period.
* Have significant anemia.
* Have a significant or unstable cardiac history such as history of heart attack, unstable angina, or stroke within 6 months of study entry, history of angina that was treated with long- or short-acting nitrates within 90 days of study entry, history of coronary artery bypass graft surgery or cardiac angioplasty within 90 days of study entry, history of abnormal heart rhythms such as sick sinus syndrome or 2nd- or 3rd-degree AV block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia, a history of recurrent ventricular tachycardia, or symptomatic bradycardia, a history of sudden cardiac arrest.
* Have symptomatic heart failure requiring treatment, or significant disease of the heart valves.
* Have been treated for severe asthma, bronchospasm, or COPD within 3 months of study entry.
* Have severe peripheral vascular disease.
* Have a documented diagnosis of sleep apnea.
Observational Study of Patients With Duchenne Muscular Dystrophy Theoretically Treatable With Exon 53 Skipping

PreU7-53 is a natural history study. The objective is to monitor the clinical and radiological course of upper limb muscle impairment in patients with Duchenne Muscular Dystrophy (DMD), potentially treatable with AAV-mediated exon 53 skipping.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Duchenne muscular dystrophy confirmed by at least genetic testing, theoretically treatable by exon 53 skipping.
* Age between ≥ 12 and \<20 years old.
* Non ambulant patients (i;e; inability to walk more than 10 meters without any of assistance).
* Patients covered by a national health insurance scheme.
* Signed informed consent.

Exclusion Criteria:

* Patient incapable of sitting upright in a wheelchair for at least one hour.
* Patients with severe intellectual impairment preventing them from fully understanding the exercises to be performed.
* Recent (less than 6 months ago) upper limb surgery or trauma This criteria is however no definitive. Patients who have undergone upper limb surgery or trauma may nonetheless be enrolled once the 6 month period is over.
* Known immune deficiency.
* Contraindications to NMR exams
High Versus Low Frequency rTMS on Motor Dysfunction in PD

The aim of the study is to compare high versus low frequency rTMS on motor dysfunction in PD. Forty patients with PD participated in the study.

The patients were randomly assigned into two groups; the first group received 1Hz and the 2nd one received 20 Hz rTMS daily for 10 days 5 sessions every week. The doctors who assess the patients clinically is blind for the frequency of rTMS, also patients don't know which type of stimulation they received. The patients were followed up before and after the 10 sessions and one month later.

The aim of the study is to compare high versus low frequency rTMS on motor dysfunction in PD. Forty patients with PD participated in the study.

The patients were randomly assigned into two groups; the first group received 1Hz and the 2nd one received 20 Hz rTMS daily for 10 days 5 sessions every week and 2 days off per week. The doctors who assess the patients clinically is blind for the frequency of rTMS, also patients don't know which type of stimulation they received. The patients were followed up before and after the 10 sessions and one month later.

Eligibility Criteria:
Inclusion Criteria:

* All PD patients who were diagnosed according to UK bank criteria for PD.

Exclusion Criteria:

* History of repeated head injury.
* History of repeated cerebrovascular strokes
* History of defined encephalitis
* Oculogyric crisis, supra nuclear gaze palsy.
* Family history of more than one relative
* severe dementia, MMSE \< 23, severe depression
* Cerebellar signs
* Babiniski sign
* Hydrocephalus or intracranial lesion on neuroimaging
* Patients with intracranial on neuroimaging
* Patients with intracranial metallic device or pacemaker
* Patients who were unable to give informed consent because of severe anesthesia, or cognitive deficit