cyrilzakka/clinical-trials huggingface dataset:
Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder

Background: Most psychotropic medications that are effective in the treatment of Bipolar Disorder (BD) are associated with endocrine-metabolic changes (EMCs). To date, there is no long-term study in BD that has examined specifically the association of inflammation with EMCs in BD. Specific aims: 1) to identify predictors of EMCs among adolescents and adults with BD who are being started on a medication ; 2) to compare change in EMCs in youth and adults treated for BD; 3) to measure change in EMCs associated with use of different medications for BD. Research Design: Participants: 30 adolescents (14-18 years old) with BD and 30 adults (19-65 years old) with BD. Measures: Blood levels of biomarkers that are associated with EMCs will be measured.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent
2. Diagnosis of BD type I, II, or NOS as determined by DSM-IV diagnostic criteria (confirmed using SCID or K-SADS)
3. Both females and males, age14 to 65 years
4. Decision by physician and patient to initiate pharmacotherapy with a traditional mood stabilizer or atypical antipsychotic
5. Able to understand and comply with requirements of the study
6. Proficient in English.

Exclusion Criteria:

1. A primary psychiatric disorder other than bipolar disorder I, II or NOS (comorbid Axis I or II disorders are permitted, as long as clinician judges that bipolar disorder is the primary condition)
2. Initiation of an antipsychotic, mood stabilizer or other medication with known endocrine-metabolic effects within 4 weeks prior to baseline visit
3. Patients who, in the investigators opinion, are unlikely to adhere to pharmacotherapy for at least 4 weeks after baseline visit
4. Significant medical condition that would contraindicate the use of mood stabilizers or atypical antipsychotics
5. Patients who are receiving pharmacological treatment for diabetes mellitus (DM), hyperlipidemia, or obesity
6. Acute or chronic medical illness (e.g. urinary tract infection, bronchitis, rheumatoid arthritis) that, as judged by the investigator, would significantly alter inflammatory, metabolic, or endocrine indices
7. Screening bloodwork that identifies any other clinically significant deviation from the reference range in clinical laboratory test results, as judged by the investigator.
Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop

The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.

The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.

Patients with severe acute exacerbation of COPD requiring hospitalization will be included in this randomized controlled study and will be managed with either manual oxygen titration or automated oxygen titration (FreeO2 arm).

The impact on the hospital length of stay will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* COPD or suspected COPD ( Age\>40, active or smoking history \> 10pack/years), -
* Acute exacerbation (increasing dyspnea recently)
* One or more of the following criteria: increased sputum, modification of sputum purulence,increased dyspnea,
* Moderate oxygen therapy: Oxygen flow \< 8 lpm (or FiO2 \< 0.60) to maintain a SpO2 \>or = 92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow to maintain SpO2 \> or = 92%)

Exclusion Criteria:

* Patient refusal
* COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac pulmonary edema, pneumothorax or sedative overdose
* No SpO2 signal
* Encephalopathy score \> 2
* Delirium
* Other respiratory support needed (intubation or NIV)
* Patient on withdrawal life support
* Advance neoplasia (palliative stage) or terminal respiratory distress
* Unavailability of FreeO2 device at the randomisation
* Non optimal patient collaboration
Improving the Early Detection of Cardiometabolic Disease Risk

The goal of this observational study is to reduce an individual's cardiometabolic disease risk by improving the ability to detect cardiometabolic disease risk in young adults through the use of novel technologies that increase access to and examine the utility of, a continuous metabolic syndrome severity score. An additional goal of this study is to understand the barriers to engagement in health-promoting behaviors and beliefs about interventions aimed at mitigating metabolic syndrome risk through a brief online lifestyle intervention.

The main question\[s\] it aims to answer are:

* Can a smartphone-based imaging system accurately predict a continuous metabolic syndrome severity score, in addition to other markers of cardiometabolic disease, in young adults?
* What is the relationship between autonomic dysfunction and metabolic syndrome severity in a cohort of young adults?
* What is the relationship between peripheral vascular dysfunction and metabolic syndrome severity in a cohort of young adults?
* What are the associations between metabolic syndrome severity and gait and functional ability in young adults using novel markerless motion capture technology?
* What are the attitudes and barriers towards lifestyle interventions targeted to reduce metabolic syndrome severity?
* What are the treatment-seeking and willingness to engage behaviors toward a webpage focused on lifestyle interventions to reduce metabolic syndrome severity?

Participants will be asked to undergo several assessments across four separate days which are design designed to determine the associations between cardiometabolic health markers and components of:

* body composition
* cardiovascular function
* functional ability
* attitudes and behaviors towards health-related interventions


Eligibility Criteria:
Inclusion Criteria:

- adults between the ages of 18-39 years of age

Exclusion Criteria:

* Younger than 18 or older than 39
* Pregnant
* Breastfeeding or lactating
* Missing any limbs or part of a limb
* Having a substantial amount of metal implants (metal plates or complete joint replacements)
* Having a pacemaker or any other electrical implant
* Type I diabetes
* Gestational diabetes
* Taking insulin
* Diagnosed heart failure, cardiomyopathy (dilated or hypertrophic), valvular disease
* Any history of severe traumatic brain injury or mild traumatic brain injury within the last two years
* Kidney disease
* Liver disease
* Thyroid disease
* Any diagnosed neurological or neurodegenerative diseases
* Having received ionizing radiation from a medical procedure within the last 30 days
* Being on a medically prescribed diet
* Having donated blood or plasma in the last 20 days prior to blood collection procedures
* Taking any supplements/medications that may interfere with the results of the study
* Any injury or physical impairment that would prevent performing any functional measures for this study
Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG

This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study two armed RCT for on pump CABG patient.

The intervention arm will be injected with Calcium chloride in the four major atrial ganglionic plexus The control arm will be injected with sodium chloride to determine the effect of Calcium chloride on Post CABG Atrial fibrillation

This study hypothesize that injecting calcium chloride into the major atrial ganglionic plexus (GPs) during On pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation by calcium-induced autonomic neurotoxicity, the incidence of Post operative Atrial fibrillation can be reduced by suppressing the function of the major atrial GPs and the surrounding neural network that play an important role in initiating Post operative Atrial fibrillation. The study is designed to be prospective interventional study two armed RCT for on pump CABG patient. The plan of work will include dividing the patients into 2 randomized control groups In the intervention group patients will be injected with 5% Calcium chloride in the 4 Major atrial ganglionic plexus The other arm will be Coronary artery bypass graft patients who will be injected with sodium chloride 0.9% to compare the two groups to evaluate to evaluate the effect of Calcium chloride in post CABG atrial fibrillation between the 2 arms of the study.

Eligibility Criteria:
Inclusion Criteria:

1) Patients more than 18 years old 2 ) patients undergoing On pump CABG

Exclusion Criteria:

1. patients \>75 years of age
2. Patients with Pre operative Atrial fibrillation
3. Patients with Significant valvular disease

5. Ejection fraction \<30% 6. Combined surgery of any kind 7. Congenital heart disease 8. Abnormal severe liver or kidney dysfunction. 9. Patients undergoing Off-pump CABG 10. Poorly controlled hyperthyroidism 11. Refusal to enrollment.
Osteoclast Inhibition and Bone Formation

This protocol addresses: 1) How gene expression changes in bone cells are affected by aging? 2) Is aging associated with decreased signaling between bone cells? 3) How does treatment with the osteoporosis medication denosumab affect bone cell signaling?

This protocol collectively addresses the following goals: 1) What are the changes in gene expression in osteoblasts and osteocytes that lead to impaired bone formation with aging; 2) Since recent work from the investigators' group has demonstrated that osteoclasts produce a number of growth factors and cytokines (coupling factors) that enhance osteoblast proliferation and/or differentiation, is aging associated with reduced osteoclast coupling factor production; and 3) If osteoclasts are markedly reduced using the FDA-approved medication for osteoporosis, denosumab, how does that effect the quantity of coupling factors in the bone microenvironment and the target genes of these coupling factors in osteoblasts?

Eligibility Criteria:
* Inclusion Criteria:

  * normal premenopausal women aged 25-40 years
  * normal postmenopausal women aged 60-80 years
  * at least 5 yrs since their last menses
  * follicle stimulating hormone (FSH) \> 20 IU/L
* Exclusion Criteria:

  * Abnormality in any of the screening laboratory studies
  * Presence of significant liver or renal disease
  * Malignancy (including myeloma)
  * Malabsorption
  * Diabetes
  * Hypoparathyroidism
  * Hyperparathyroidism
  * Acromegaly
  * Cushing's syndrome
  * Hypopituitarism
  * Severe chronic obstructive pulmonary disease
  * Undergoing treatment with any medications that affect bone turnover, including the following:
* adrenocorticosteroids (\> 3 months at any time or \> 10 days within the previous yr)
* anticonvulsant therapy (within the previous year)
* pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal)
* calcium supplementation of \> 1200 mg/d (within the preceding 3 months)
* bisphosphonates (within the past 3 yrs)
* denosumab
* estrogen (E) therapy within the past year
* treatment with a selective E receptor modulator within the past year
* teriparatide within the past yr

  * Clinical history of osteoporotic fracture (vertebral, hip, or distal forearm)
  * Recent (within the past 6 months) fracture
  * Serum 25-hydroxyvitamin D levels of \< 20 ng/ml
Pilot Study of Whole Body Vibration for Children With Cerebral Palsy (CP) From 12 Months of Age

Cerebral Palsy (CP) is the most common cause of physical disability in childhood. Up to day the investigators have treated children diagnosed cerebral palsy with side-alternating whole body vibration (System Galileo®) from the age of two years on. Considering verticalisation (standing and walking) at about 12 months of age in a normal developing child the investigators suggest the introduction of verticalisation with whole body vibration to a child with CP at this early age in order to enhance motor development and participation.

In this pilot study the investigators will test the feasibility and the effect on motor development of whole body vibration in children with CP from 12 months of age. The investigators will investigate the effect of whole body vibration on motor performance, independence in all day living situations, quality of life and contractures compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed CP
* ≥ 12 months and ≤ 24 months of age (prematures corrected age)
* GMFCS level II, III, IV
* Inability to stand and walk
* Written informed consent of legal guardian

Exclusion Criteria:

* Chronic infectious disease
* Epilepsy not responding to therapy
* Additional severe congenital disorder (e.g. congenital heart disorder)
* Surgery in previous three months
* Hernia requiring surgery
* Treatment with Botulinumtoxin
* Acute Thromboses
* Implants and tendinitis in body parts to be trained
* Acute inflammation in the musculoskeletal system
* Slipped disc
* Rheumatoid arthritis
* Fractures in previous three months
* Intracerebral bleeding in previous three months
* Planned surgery in study period
* Participation at another interventional trial
* Gall stones, kidney stones and pregnancy of the person who trains with the child
Effectiveness of Video-assisted Cardiopulmonary Resuscitation

Sudden cardiac arrest is a major public health problem worldwide and it is one of the leading causes of death in industrialized countries. Emergency Medical Services (EMS) dispatchers play an important role to recognize cardiac arrest and give help to the lay first responder via telephone CPR (T-CPR) which improves survival rates. The current technology allows the live video connection between the scene and the dispatcher which provides the opportunity for video-assisted CPR (V-CPR) via the bystander smartphone.

Effectiveness of V-CPR has only been investigated to a limited extent. Comparing effectiveness of V-CPR (effectiveness of chest compression, time parameters eg. time to first chest compression) to T-CPR and non-instructed CPR can be useful to implement V-CPR technology.

Sudden cardiac arrest is a major public health problem worldwide and it is one of the leading causes of death in industrialized countries. EMS dispatchers play an important role to recognize cardiac arrest and give help to the lay first responder via telephone CPR (T-CPR) which improves survival rates. The current technology allows the live video connection between the scene and the dispatcher which provides the opportunity for video-assisted CPR (V-CPR) via the bystander smartphone.

Effectiveness of V-CPR has only been investigated to a limited extent. Comparing effectiveness of V-CPR (quality of chest compressions: depth, rate, hand position), time parameters: time to recognize cardiac arrest, time of check breathing, total no-flow time, to first chest compression) to T-CPR and non-instructed CPR can be useful to implement V-CPR technology.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer

Exclusion Criteria:

* healthcare professionals (paramedics, nurses, etc.)
* pregnant women
* people with cardio-pulmonary and musculoskeletal diseases or any other impairment that would risk harm for the volunteer while performing CPR for 2 minutes
* psychological disabilities
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19

Recombinant human angotensin-converting enzyme 2 (rhACE2) as a treatment for patients with COVID-19 to block viral entry and decrease viral replication.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized male or female
2. Diagnosed to be COVID-19 POSITIV
3. Signed Inform Consent Form

Exclusion Criteria:

1. Any patient whose clinical condition is deteriorating rapidly
2. Known history of positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody
3. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
4. Pregnant females as determined by positive serum or urine hCG test prior to dosing
5. Lung transplantation
6. Pre-existing renal failure, i.e. requiring renal replacement therapy with hemodialysis or peritoneal dialysis
7. There are other uncontrolled co-morbidities that increase the risks associated with the study drug administration, that are assessed by the medical expert team as unsuitable
8. Patient in clinical trials for COVID-19 within 30 days before ICF
9. Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell transplants)
A Novel Technique For Gall Bladder Fundus Retraction In Single Incision Laparoscopic Cholecystectomy

The investigators describe a novel technique for GB fundus retraction.

few methods are available for gall bladder (GB) retraction in SILC to replace the usage of ancillary ports imitating retraction from conventional technique, e.g. trans-parietal stitches mini-loop retractor , a Kirschner wire . This technical note describes a novel way to retract the gall bladder fundus.

Eligibility Criteria:
Inclusion Criteria:

* all cases underwent single incision cholecystectomy

Exclusion Criteria:

* none
Long-term Venous Catheterization in Pediatric Anesthesia: Prevalence and Risk Factors of Dysfunction

To evaluate the prevalence of long-life catheters dysfunction and identify the risk factors associated to premature withdrawal in pediatric population.

For that: retrospective study, during 3 years, in CHU Nancy. Data collection by informatics file after patient agreement. Primary objective: mesure prevalence of long-life catheter dysfunction

Secondary objectives:

* identify risk factors associated to premature withdrawals by thrombotic, infectious, accidental, mechanical complications.
* mesure de time spent by anethesist to put long-life catheters in emergency. Benefit of creating à vascular access unit.


Eligibility Criteria:
Inclusion Criteria:

* long-life catheter (midline, piccline, central venous catheter)
* placed in operating room
* by anesthesist
* in pédiatric population: 0 to 18 years

Exclusion Criteria:

* more than 18 years
* peripheral venous access
* not placed by anesthesist
* placed outside operating room
Study of Telitacicept in Patients With Refractory IgA Nephropathy

The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy.

The main questions it aims to answer are:

* To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy.
* To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy.

Participants will be subcutaneously injected with 240mg of Telitacicept once per week.

Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign the informed consent form.
2. IgA nephropathy was confirmed by pathological biopsy.
3. Age range: ≥ 18 years old, ≤ 70 years old, male or female.
4. During the screening period, the 24-hour urine protein of Visit 1 and Visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at Visit 3.
5. Measured glomerular filtration rate or estimated GFR (using the CKD-EPI formula) \> 35 mL/min/1.73 m2.
6. Participants had received a basic regimen including ACE inhibitors/ARBs for 12 weeks prior to randomization, and the dose of ACE inhibitors/ARBs (within the maximum tolerated range) was stable for 4 weeks prior to randomization.

Exclusion Criteria:

1. Abnormal laboratory indicators of participants need to be excluded.
2. Secondary IgA nephropathy need to be excluded.
3. Specific pathologic or clinical renal disease types, and IgA nephropathy that may require hormone therapy.
4. Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening.
5. Use of systemic corticosteroids within 3 months prior to randomization (except local, nasal inhalation, etc.)
6. Immunosuppressants were used within 3 months prior to randomization.
7. Patients requiring hospitalization for active infection or intravenous anti-infective therapy within 3 months prior to randomization.
8. Previously or currently diagnosed active tuberculosis Untreated latent tuberculosis.
9. Herpes zoster HIV antibody positive or HCV antibody positive during the screening period.
10. Those who currently have active hepatitis or have severe liver disease and medical history.
11. Patients with malignant tumors.
12. Pregnant and lactating women, and men or women with planned children during the trial period.
13. Those who could not avoid the use of nephrotoxic drugs during the trial.
14. Allergic to human biological products.
15. Patients who have been given any of the clinical trial drugs 4 weeks prior to randomization or within 5 times the half-life of the experimental drug (whichever is longer).
16. Patients deemed ineligible for the trial by the investigator.
Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects

A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects


Eligibility Criteria:
Inclusion Criteria:

* Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures.
* Korean males and females ≥ 19 and ≤ 60 years of age at the Screening visit

Exclusion Criteria:

* Subject with a history or presence of clinically significant active diseases.
* Subject who has participated in other clinical studies (including bioequivalence tests) within 6 months before the Screening visit and has received IPs
Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients

To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who have completed LUN01S and need to continue eszopiclone
Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome

Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis.

This study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.


Eligibility Criteria:
Inclusion Criteria:

1. 20-60 years old patients with ASA class I-II
2. Scheduled for drug induced sleep endoscope after diagnosed with sleep apnea syndrome

Exclusion Criteria:

1. Patients having hearing difficulties, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale \< 15
2. Patients with severe cardiopulmonary dysfunction
3. Patients refusal