cyrilzakka/clinical-trials huggingface dataset:
Treatment of Intrapartum Depression Using Non-invasive Photobiomodulation

Depression during pregnancy can cause fetal and maternal problems such as growth restriction, preterm labor, low birthweight, poor compliance and suicide. Since antidepressant medications have the potential to harm the baby, but since treatment of intrapartum depression is essential to maternal and fetal wellbeing, a non-pharmacological approach would be ideal. This project seeks to apply infrared light noninvasively to depressed patients during pregnancy in order to treat depressive symptoms through alteration of mitochondrial function and modulation of neural cell receptors.

Depression is common in pregnancy and affects about 70% of women and, for many women, pregnancy can lead to the first episode of major depression. Complications of intrapartum depression include intrauterine growth restriction, preterm labor, low birthweight, gestational diabetes, preeclampsia, decreased prenatal follow-up and suicide. For this reason, the standard of care has been to screen for depression during pregnancy and treat this illness, reducing maternal and fetal morbidity. Unfortunately, many first-line pharmacological approaches, such as serotonin reuptake inhibitors, may cause fetal malformations, persistent pulmonary hypertension and withdrawal syndrome. Thus, a non-pharmacological approach, without risk of fetal complications, would be ideal. The investigators propose a photobiomodulation based approach that uses non-ionizing near-infrared light (IRL) to upregulate mitochondrial function (through modulation of cytochrome c oxidase activity), which in-turn increase neurosteroid production and modulates GABAA receptor activity, thus alleviating depression. The investigators will perform a pilot study using IRL for the treatment of intrapartum depression. While other trials have shown success using IRL for depression in non-pregnant patients, this will confirm that photobiomodulation can modulate mitochondrial function and mitigate depressive symptoms compared to untreated controls in pregnancy by using real-time app-based depression scoring system and neuroimaging.

Eligibility Criteria:
Inclusion Criteria:

* Viable intrauterine pregnancy \<16 weeks, PHQ-9 or Edinburg Score\>10.

Exclusion Criteria:

* pregnancy \> 20 weeks
* history of seizures
* history of migraines
* history of multiple sclerosis
* prior traumatic brain injury
* prior history of preeclampsia/toxemia
* elevated blood pressure greater than 140/90
* proteinuria (as defined by urine proteins \>300 mg/24 h)
* headaches
* visual changes
* right upper quadrant pain
* history of bipolar disease
* currently taking psychotropic medications (including antidepressants) and
* prior history of attempted suicide
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants

The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be first generation Japanese (4 grandparents, biologic parents, and subject born in Japan and of Japanese heritage)
* Male and female participants must be ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 25.0 kg/m\^2 at the time of screening

Exclusion Criteria:

* Participant with history of prior malignancy within the last 5 years except malignancy (in situ) fully excised or treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician, non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
* Participants with a known history of autoimmune disease
* Participants who have donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP
* Participants with any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1
* Positive for Hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
* Participant has positive test results for Human Immunodeficiency Virus (HIV)
* Participant has a positive test for tuberculosis during screening defined as either a positive purified derivative (PPD) (\>= 5 mm of induration at 48 to 72 hours after test is placed) OR a positive QuantiFERON test
Individualized Functional Imaging-Guided Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Postural Gait Disorders in Patients with Amyotrophic Lateral Sclerosis (ALS): a Randomized, Crossover, Controlled, Double-Blind Clinical Study

This study is a randomized, crossover, controlled, double-blind clinical trial. Patients (n=45) were randomly divided into Group A and Group B. Patients in Group A will receive 2 weeks (10800 Hz daily, 5 days×2) of Transcranial magnetic stimulation（TMS） treatment, while patients in Group B will receive sham stimulation with the same frequency. After a 4-week washout period, the two groups cross over. Patients in Group A will receive sham stimulation, and patients in Group B will receive TMS treatment for 2 weeks (10800 Hz daily, 5 days×2). Clinical functional scales, imaging evaluations, and gait analysis will be conducted at baseline, after 2 weeks of treatment, before crossover treatment, and after 2 weeks of crossover treatment. The therapist, patients, and assessors will be all blinded throughout the study.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 years;
2. Diagnosis of motor neuron disease at probable level or above based on Estorial criteria;12
3. Meet UMND ALS diagnosis criteria: at least three segments of upper motor neuron damage localized to 1-2 muscles, or EMG indicating loss of innervation in 1-2 muscles;13
4. Presence of lower limb dysfunction: Berg balance scale score below 40;
5. Capable of standing independently for more than 30 seconds and able to walk or walk with assistance;
6. Stable medication dosage for at least one month;
7. FVC \> 60%;
8. Signed informed consent.

Exclusion Criteria:

1. History of substance abuse within the past 6 months;
2. History of epilepsy or first-degree relative with epilepsy;
3. Patients with severe systemic diseases in the heart, lungs, liver, or kidneys that cannot be controlled with routine medications, based on laboratory results;
4. Patients with severe depression or anxiety (HAMD-17 score ≥18; HAMA score ≥21) or diagnosed with other mental illnesses;
5. Patients with a life expectancy of less than one year due to reasons other than neurodegenerative diseases;
6. Pregnant women or those planning to become pregnant;
7. Individuals with a pacemaker, cochlear implant, or other metallic foreign bodies and any implanted electronic equipment, or those with contraindications for MRI scanning or TMS treatment, such as claustrophobia;
8. Patients who have received TMS, transcranial electrical stimulation, transcranial focused ultrasound, or other neuromodulation treatments within three months prior to enrollment;
9. Other abnormal examination results deemed unsuitable for participation by the research investigator;
10. Inability to cooperate for follow-ups due to geographical or other reasons;
11. Participation in other clinical research trials.
Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial

To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement.

see summary

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective transfemoral TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV)
* Common femoral artery diameter \> 5.0mm (14 - 22F compatible)

Exclusion Criteria:

* Symptomatic leg ischaemia
* Previous thromboendarterectomy or plastic patch of the common femoral artery
* Previous implantation of a suture-based VCD less than 30 days before, or a plug-based VCD within 6 months
* Unilateral or bilateral lower extremity amputation
* Systemic infection or a local infection at or near the access site
* Allergy to the components any of both devices (i.e. bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel)
* Active bleeding or bleeding diathesis including thrombocytopenia (platelet count \<50,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
* Patients in whom continuous oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR \>1.8 at the time of the procedure
* Patient unable to be adequately anti-coagulated for the procedure
* Morbidly obese or cachectic (BMI \>40 kg/m2 or \<20 kg/m2)
* Anatomical and procedural contraindication for suture-based or Manta closure (lack of proper puncture site in the common femoral artery in terms of calcification, size, and atherosclerotic disease)
* Absence of computed tomographic data of the access site before the procedure
* Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease
* Known pregnancy at time of randomization (in women of childbearing potential a negative pregnancy test is mandatory)
* Participating in trials in which the primary endpoint includes bleeding or vascular complications
Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy

The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug). It will also learn about the effect of esketamine in emergence delirium. The main questions are:

Dose esketamine lower the incidence of postoperative negative behavior changes compared to placebo? Dose esketamine lower the incidence of emergence delirium compared to placebo? Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium.

Participants will:

Receive intravenous esketamine or placebo (a look-alike substance that contains no drug) during anesthesia induction; Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 7, and 30

Approximately half of children who undergo general anesthesia experience emergence delirium (ED) and postoperative negative behavioral changes (PNBC). There was a positive correlation between delirium during recovery and the change in negative behaviour after the operation.

Esketamine has sedative, analgesic and anti-traumatic stress effects. Based on literature analysis and preliminary trials, this study suggests that intraoperative use of low-dose esketamine may reduce the incidence of emergence delirium and postoperative negative behavior changes in children.

This prospective randomized controlled trial was conducted to compare the effect of intravenous esketamine in the incidence of emergence delirium and postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug) to provide a reference for optimizing clinical anesthesia medication regimens.

Eligibility Criteria:
Inclusion Criteria:

* American society of Aneshesiologists physical status I or II;
* Aged 3-7 years;
* Scheduled for elective tonsillectomy and (or) adenoidectomy.

Exclusion Criteria:

* Parents refusing to allow their children to participate;
* Intake of sedative or analgesic medication within 48 hours before surgery;
* Developmental delay;
* Psychosis;
* Body mass index \> 30 kg/m2;
* Allergy to study drugs;
* Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.;
* Any other conditions that precluded study inclusion.
Implementation of Physiotherapy on COVID-19 Patients in ICU

Despite new charachersitics of COVID-19 patients, critical care implementation seems to be similar to those with Acute Respiratory Distress Syndrome (ARDS) in intensive care units (ICU).

Regarding the initial gravity of these patients, sedation and neuromuscular blockers are usually administrated, increasing the risk to develope an ICU-acquired weakness which is directly correlated to morbi-mortality and a burden during recovery.

Respiratory symptoms are mostly related to dyspnoea and non-productive cough, with only 33% of COVID-19 patient having a bronchial hypersecretion ; consequently, chest physiotherapy is only implemented in after case-by-case evaluation.

This unprecedented situation requires to identify how physiotherapy is being implemented in COVID-19 patients in ICU.

This retrospective, multicentric study aims to identify the charactheristics of physiotherapy (type and time spent) implemented in Argentina, Belgium, Chili, France, Italy and Spain

* Demographics data : hospitalisation date, ICU date, COVID+ date, extubation date, discharge date, mortality
* ICU data : ventilatory mode, type of physiotherapy implemented (early rehabilitation, chest physiotherapy, time spent (minutes), number of interventions per day.

Eligibility Criteria:
Inclusion criteria:

* Age \> 18 years
* Patient admitted in ICU
* Patient with COVID-19 diagnosis

Exclusion criteria:

- Explicite denie to participate in the study
A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease

This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.


Eligibility Criteria:
Inclusion criteria

For inclusion in the study patients should fulfil the following criteria:

1. Provision of informed consent prior to the time of registration.
2. Aged 20-74 years male or female who are diagnosed with NAFLD and FibroScan shows CAP score ≥ 252 dB/m (≥Steatosis grade 2).

3.30 or more mL/min/1.73 m2 of estimated glomerular filtration rate 4.Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study (from the time they sign consent) and for 1 month after the last dose of IP to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.

5.Subjects who are blood donors should not donate blood during the study and for 1 month following their last dose of IP.

Exclusion criteria

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

1. Viral hepatitis or other types of liver disorder (e.g. drug-induced or autoimmune hepatitis).
2. Alcohol consumption above recommended limits (male: more than 30g/ day; female: more than 20g/day converting to ethanol).
3. Serious liver dysfunction (Child-Pugh B or C).
4. History of any other malignancy within 1 years (with the exception of successfully treated non-melanoma skin cancers).
5. Patients with a known hypersensitivity to investigator product (IP).
6. Participation in another clinical trial within the previous 30 days or involvement in the planning and/or conduct of the study.
7. Previous enrolment or randomisation in the present study.
8. Active gallbladder diseases
9. For women is currently pregnant (confirmed with positive pregnancy test) or breast feeding.
CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System

The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.

Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.

As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.

The Primary Objective of this post-market registry is to collect specific health and patient characteristics to understand the indication for TA-TAVI and to further evaluate the safety and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population, consisting of 200 consented patients.

Eligibility Criteria:
Inclusion criteria:

* Symptomatic patients with severe aortic stenosis;
* Institution heart team determines that aortic valve replacement ACURATE neoTM device using its transapical delivery system is appropriate;

Exclusion criteria:

- Patients unable or unwilling to give inform consent;
Response and Remission to Treatment With Anti-IL5/IL5R Antagonists

The aim of this retrospective observational study is to compare the response and remission rate after treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials.

This study will be performed using the charts of the patients.

Objective To compare the response and remission rate after treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original RCTs.

After having obtained authorization from the ethics committee of the CIUSSS du nord de l'île de Montréal and from the director of the Professional Services, all the charts of patients who received anti IL5/IL-5R at the tertiary asthma clinic of the Hôpital du Sacré-Coeur de Montréal will be reviewed.

Patients aged 75 years or younger, with a smoking history of less than 10 pack-year, and a FEV1 \<80% predicted with reversibility in the previous year will be considered to fulfill the RCTs criteria. Response to treatment was defined by at least a 50% reduction in asthma exacerbations or in oral corticosteroids (OCS) doses in the year following the initiation of IL5/IL5R antagonists. Clinical remission on treatment at one year was defined as no exacerbation, no OCS and la 10% or less decrease in pre-bronchodilator FEV1 compared with baseline value.

Eligibility Criteria:
Inclusion Criteria:

Patients 18 years and older who were followed at the outpatient asthma clinic of Sacre-Cœur Hospital and have been treated with anti-IL5/il5R between 2016 and 2020.

Exclusion Criteria:

None
Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.

* Study Population- Patient with cirrhosis with any aetiology with sarcopenia visiting ILBS OPD/IPDs who are willing to visit ILBS gymnasium twice weekly for first month.
* Study Design- A Prospective Randomized Controlled Trial
* Study Period- Study will be conducted at ILBS from April 2019 to Oct 2019

  * Sample Size:As shown by Eva Roman et al - in cirhotics with sarcopenia exercise increases mean lean appendicular mass , by 0.38 kg (14 patients, p \< 0.03), and Sinclair et al has shown testosterone (22 patients, p \<0.05)) to increase mean Appendicular lean mass by +1.69 kg - for 10% increase in APLM
  * we need to enroll 40 patients in each arm, and considering a los to follow up approx.10% , will require minimum 44 patients in each arm
  * We will therefore enroll and randomize 100 patients with 50 in each arm.

Intervention - Testosterone Supplementation - Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations.

Monitoring and assessment - On every visit patient will be inquired or evaluated for side effects like local site pain or hematoma , hypertension, headache, allergic reactions, acne, nausea , mood swings, pedal edema , breast enlargement and others.


Eligibility Criteria:
Inclusion Criteria:

* Men with cirrhosis of any etiology
* Sarcopenia
* CTP 6-12

Exclusion Criteria:

* Hepatocellular carcinoma
* Other known malignancy,
* CTP \> 12
* Acute liver injury
* Prostate disease,
* Known hypersensitivity to testosterone therapy,
* Polycythaemia (haematocrit \>55%),
* Uncontrolled hypertension (\>160/90 mmHg despite treatment),
* Uncontrolled obstructive sleep apnoea,
* Severe renal dysfunction (estimated glomerular filtration rate \<30ml/min)
* Uncontrolled epilepsy, migraine, or significant cardiac insufficiency (New York Heart Association class III or IV or LVEF \< 45-50%.
* CKD (Chronic Kidney Disease) - eGFR (Glomerular Filtration Rate) \<60%
* Platelet count below 30,000 or taking warfarin
* Failure to give consent.
The Benefit of Enhanced Day Care of Traditional Chinese Medicine: A Retrospective Study of Medical Records

We collected medical records since June 2017 to November 2019., used pair-T test for questionnaire of CTCAE, BFT-I, WHOQOL to evaluate the benefit of enhanced day care of TCM for cancer patients.

using TCM method as Complementary and Alternative Medicine is worldwide. we collected medical records that using TCM methods for adverse event from cancer therapies. we used CTCAE BFI-T and WHOQOF-BREF to evaluate the benefit.

Eligibility Criteria:
Inclusion Criteria:

- The medical records since June 2017 to December 2019 needed to meet the following criterial: (1)age\>20 years old, (2)diagnosis meet ICD10:C00.0-C97 (3) needed to do Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE), scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T) and scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF), and those scales needed to be done pretest when patient came to the clinics and posttest when case end.

Exclusion Criteria:

- The subjects will be excluded if they do not complete pretest and posttest of the following scales:(1) Taiwan brief version scale of CTCAE, (2) BFI-T scale (3) WHOQOL-BREF scale
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease

Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD). This trial is designed to assess the efficacy and safety of the drug in the treatment of CLI.


Eligibility Criteria:
Inclusion Criteria:

* Critical leg ischemia (CLI) defined as distal extremity pain at rest, or peripheral ischemic ulcer(s), with severe hemodynamic impairment as diagnosed by ankle systolic pressure, toe systolic pressure or TcPO2
* The subject has exhausted all standard revascularization treatment options at this time.

Exclusion Criteria:

* Subjects with a previous major amputation (at or above ankle)
* Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by estimated creatinine clearance of \< 20 cc/min, or receiving chronic hemodialysis therapy.