cyrilzakka/clinical-trials huggingface dataset:
Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract

This was a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in HCT recipients with acute RSV infection and symptoms of URTI.


Eligibility Criteria:
Inclusion Criteria:

* Received an autologous HCT (within 6 months of signing ICF) or an allogeneic HCT (any time) using any conditioning regimen
* Absolute lymphocyte count (ALC) \<500 cells/ µL in allogeneic HCT recipients. Absolute lymphocyte count (ALC) \<300 cells/ µL in autologous HCT recipients.
* Laboratory confirmed RSV diagnosis from a respiratory sample obtained within 3 days before signing the ICF.
* New onset of at least one of the following respiratory symptoms within 3 days before signing the ICF: nasopharyngeal discharge, nasopharyngeal congestion, sneezing, sinus congestion, sore throat, hoarseness, earache, cough, shortness of breath, respiratory wheeze, or worsening of one of these symptoms if present chronically (associated with a previously existing diagnosis \[eg, chronic rhinorrhea, chronic lung disease\]) in the 3 days before signing the ICF or at Screening.
* No evidence of new abnormalities consistent with LRTI on a chest imaging (chest x-ray and/or computed tomography) performed in the 2 days before signing the ICF or at the Screening visit if there is no chest X-ray and/or computed tomography available in the 2 days before signing the ICF.
* Oxygen saturation \>95% on room air.
* A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.
* A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Exclusion Criteria:

* Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the Investigator.
* Known to be concurrently infected with other respiratory viruses (eg, severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\] or other coronavirus, influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus) within 7 days before signing the ICF, as determined by local testing.
* Clinically significant viremia, bacteremia, or fungemia, or bacterial or fungal pneumonia within 2 weeks before signing the ICF that has not been adequately treated, as determined by the Investigator.
* Known positive human immunodeficiency virus (HIV).
* Any clinical manifestation resulting in QT prolongation.
To Study and Compare the Clinical Course and Development of Organ Failure in Severe Acute Hepatitis Without Ascites, Non-cirrhotic and Cirrhotic Patients With Ascites [Acute on Chronic Liver Failure] and Acute Deterioration of Previously Decompensated Cirrhosis.

The study will be conducted on patients admitted to Department of Hepatology from MARCH 2015 to DECEMBER 2016 at ILBS, New Delhi.All patients presenting to ILBS fulfilling the inclusion criteria will be included in the study and will be categorized and evaluated. The patient will followed over a period of 3 months.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients presenting to hospital with bilirubin ≥5 and INR≥1.5
* Cirrhosis with or without Decompensation presenting with acute deterioration in less than 3 month

Exclusion Criteria:

* Cirrhosis with chronic decompensation.
* Patient on anticoagulant
* Hepatocellular carcinoma
* Septic shock
* Post-liver transplant or resection
Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy

This study is a prospective, randomized, controlled trial. In this study, 30 patients who underwent endotracheal tumor resection under rigid bronchoscope or stent placement for acquired tracheoesophageal fistula were selected as the subjects. The patients were randomly divided into remazolam general anesthesia group (R group) and propofol general anesthesia control group (P group). Remazolam general anesthesia group (R group): Remazolam 0.4 mg/kg, oxycodone 0.2 mg/kg and rocuronium 0.9 mg/kg were given for anesthesia induction. Propofol general anesthesia control group (P group): Propofol 1.5mg/kg, oxycodone 0.2mg/kg and rocuronium 0.9mg/kg were given for induction of anesthesia. After induction, high-frequency jet ventilation was used in both groups, the respiratory rate was 30-60 times/min, the inspiratory-to-breath ratio was 1:2, and the driving pressure was 0.8-1.0 KPa. Group R was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance. Group P was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance. The dosage of propofol or remazolam was adjusted according to BIS and intraoperative hemodynamic changes. Rocuronium bromide 10 mg was added every half hour. Intraoperative application of vasoactive drugs to maintain mean arterial pressure above 60mmHg to avoid perioperative hypotension. Blood oxygen saturation and end-tidal carbon dioxide were monitored to avoid perioperative hypoxemia and hypercapnia, and warm measures were used to maintain the patient's intraoperative body temperature above 36.0°C. After surgery, group R was treated with sugammadex sodium 2-4 mg/kg to antagonize rocuronium bromide, and 0.5 mg of flumazenil was used to antagonize remazolam by intravenous injection; group P was treated with sugammadex 2-4 mg/kg to antagonize rocuronium.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bronchoscopy endotracheal tumor resection or stenting of acquired tracheoesophageal fistula within a limited time
* \>18 Years
* ASA Ⅱ-Ⅳ

Exclusion Criteria:

* \<18Years
* Refuse to participate
* A history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis;
* Severe hepatic dysfunction (Child-Pugh class C)
* Severe renal dysfunction (requiring dialysis)
* Patients with ASA grade Ⅴ and above
* Emergency Surgery
Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia

The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.

Phase I/II, prospective, single-center study, with consecutive inclusion of 20 diabetic patients with critical limb ischemia due to bellow-the-knee extensive arterial disease.

After the inclusion, patients are submitted to a bone-marrow aspiration (30 ml) under sedation. Autologous bone-marrow mononuclear cells (minimum 80 millions mononuclear cells) are infused intraarterially at popliteal artery by blocking antegrade perfusion during 3 minutes.

Clinical and angiographic follow-up will be performed at 3 months after the infusion to assess the efficacy of autologous mononuclear cells transplantation in terms of:

* Changes in below-the-knee angiography from baseline to 3 months follow-up.
* Changes in Ankle-Brachial pressure Index, transcutaneous oxygen pressure, and size of main ischemic ulcer will be also assessed at target limb.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients under treatment (type I or II)
* Critical limb ischemia (rest pain and/or non-healing ischemic ulcers lasting more than 4 weeks, and/or Ankle-Brachial Index \< 0,8)
* Not suitable to be revascularized (surgical and interventional consensus)

Exclusion Criteria:

* Neoplastic disease and/or hematologic disease during the last 2 years
* Diabetic retinopathy
* Ischemic ulcer greater than 10 cm2
* Major amputation at target limb
* Life expectancy \> 2 years
Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment

To report the surgical results of primary rhegmatogenous retinal detachment (RRD) repaired by 27G pars plana vitrectomy (PPV) combined with Healaflow patch and air tamponade, and do not need prone position postoperation.

To improve the success rates of pars plana vitrectomy(PPV) which is the most common surgical procedure for the repair of primary rhegmatogenous retinal detachment (RRD) and to avoid silicon oil tamponade and face-down position, all eyes enrolled into this clinical trail undergo 27G PPV combined with Healaflow patch and air tamponade which do not need face-down position in the postoperative period. Healaflow® (Anteis S.A., Plan Les Ouates, Switzerland) consists of over 97% water, sodium hyaluronic acid (22.5 mg/ml) of nonanimal origin cross-linked with BDDE (1.4-Butanediol diglycidyl ether), and phosphate- and NaCl-salts to maintain a physiological pH (7.0) and osmolarity (305 mOsm/kg).

At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure(IOP) will be measured and fundoscopy, OCT, B-ultrasound will be performed.

The patients are going to be followed up for at least 3 months, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications.

Eligibility Criteria:
Inclusion Criteria: - patients with primary RRD

Exclusion Criteria: - proliferative vitreoretinopathy grade C or more, dialysis, retinoschisis, eyes with secondary RRD, significant corneal or lens opacity precluding vitrectomy, giant retinal tears, a follow-up period of less than 3 months, and visual loss from causes other than RRD
microEEG for Neonatal Apnea, Bradycardia and Desaturation

The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events. This project will also assess the feasibility of using the microEEG device in the Neonatal Intensive Care Unit (NICU) setting and the feasibility of remote centralized interpretation in this setting.

Most preterm infants have episodes of apnea (cessation of breathing), bradycardia (low heart rate), and desaturations (low levels of oxygen in the blood) (ABD events). The resolution of ABD episodes depends to a large extent on the maturation of the central nervous system (CNS). The electroencephalogram (EEG) is a reliable and noninvasive tool for recording the electrical activity of the CNS. The relationship between ABD events and cerebral electrical activity has not been well investigated. The investigators seek to examine the relationship between EEG findings and the resolution of ABD events in the developing premature infant.

To investigate this relationship and obtain findings which are relevant to clinical care, a variety of obstacles need to be overcome. Among these obstacles is the high cost of standard EEG machines, inability of most standard machines to operate in electrically-noisy environments such as the NICU, and the absence of full-time coverage neurologists for prompt EEG interpretation. The investigators seek to determine the feasibility of obtaining an artifact-free EEG in the NICU with accurate detection of background rhythm abnormalities. The investigators will utilize an existing digital wireless telemetry unit, the "microEEG" for the NICU for this purpose. The microEEG device is specifically designed to overcome obstacles to standard EEG recording.

To address the shortage of trained pediatric neurophysiologists, the investigators will investigate the feasibility of a case management system for centralized EEG interpretation using off-site neurologists.

Finally, the investigators will examine the inter-rater reliability of EEG interpretation in the developing premature infant. This will allow the development of consensus guidelines for EEG interpretations.

Eligibility Criteria:
Inclusion Criteria:

1. gestational age (GA) 24-32 weeks
2. postnatal ages 0-30 days. The patients will be recruited upon manifesting one of the following

   * apneas (cessation of breathing \> 10 seconds) x2 in a 12 hour span
   * bradycardias (HR \< 100/min) x2 in 12 hours
   * oxygen desaturations (\<80%) x 2 in 12 hours
   * a single ABD event that does not resolve with stimulation or an increase in fractional oxygen delivery (FiO2).

Exclusion Criteria:

1. major malformations
2. The infant has exposed dermis on the scalp due to immaturity
3. Any scalp skin lesions such as pustules, large abrasions The patient will be Withdrawn if

   * Informed consent is withdrawn
   * adverse events (i.e..scalp lesions) develop
Elevated FFA and Skeletal Muscle Lipid Content

There is increasing evidence that skeletal muscle lipid content (IntraMyoCellular Lipid, IMCL) markedly increases the risk of metabolic complications, including insulin resistance and cardiovascular events. The investigator hypothesizes that skeletal muscle is passively taking up FFAs when the availability is high, thereby leading to an increased storage. To test this hypothesis, the investigator wants to manipulate FFA levels, by means of exercise, and monitor intramuscular lipid content.

Therefore the objective is to examine the effect of an exercise-induced elevation of FFA on skeletal muscle lipid content in healthy lean men. To this end, skeletal muscle lipid content will be investigated at baseline and after an exercise protocol and again after a four-hour recovery period from exercise, once in a condition with high FFA concentration, once with low FFA concentration. To achieve high- versus low FFA concentrations, an exercise protocol was chosen and participants had to perform this protocol once with a glucose supplementation and once without.

Skeletal muscle lipid content will be determined before, directly after exercise and 4 h post exercise (from muscle biopsies) with or without glucose supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 18-30 years
* Lean, BMI 18-25 kg/m2
* Healthy
* Stable dietary habits
* No medication use

Exclusion Criteria:

* Female sex
* Engagement in programmed exercise \> 2 hours total per week
* Cardiac problems, such as angina pectoris, cardiac infarction and arrhythmias
* First degree relatives with type 2 diabetes mellitus
* Any medical condition requiring treatment and/or medication use
* Unstable body weight (weight gain or loss \> 3 kg in the past three months)
* Participation in other biomedical study within 1 month prior to the screening visit
* Subjetcs, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician is informed, cannot participate in the study
Apneic Oxygenation for Morbid Obese Parturient in cs

The aim of this study is to compare the effect of apneic preoxygenation to conventional preoxygenation on the oxygen desaturation in morbid obese parturient performing elective caesarean section under general anesthesia.

Anesthetic management of the obese parturient is challenging. Both pregnancy and obesity are risk factors for a difficult airway and anesthesia-related maternal mortality. There is increased risk of difficult intubation associated with an increased difficultly in mask ventilation and increased risk of accelerated desaturation during apnea.

The use of apneic oxygenation for the optimization of peri-intubation conditions is a promising means of preventing hypoxemia.

Despite the recommendation of the use of nasal prongs to insufflate oxygen at flows of 5 L/min to 15 L/min during the apneic period randomized controlled trial is still not available in the morbidly obese parturient.

Eligibility Criteria:
Inclusion Criteria:

1. Morbid obesity parturient defined as a body mass index (BMI) above 40 kg/m2.
2. ASA physical status I-II
3. Age above 18 years.
4. Scheduled for elective caesarean section under general anesthesia.

Exclusion Criteria:

1. Parturient of ASA physical status III or above.
2. Suspected or known difficult airway (Mallampati class \> 2, reduced neck movement, reduced mouth opening, or Cormack-Lehane grade 4 recorded during a previous intubation procedure).
3. Any contraindication for nasal prong use, for example, tumours, fractures or trauma.
4. SpO2 ≤ 97% prior to preoxygenation.
The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)

Observation of the effects of Cawthorne-Cooksey exercises applied after the Epley maneuver on balance, vertigo symptoms, and quality of life in BPPV patients.

Study Objective:

To observe the efficacy of Cawthorne-Cooksey exercises applied after the Epley maneuver on balance, vertigo symptoms, and quality of life in patients with posterior canal BPPV.

Study Design:

Single-blind randomized controlled study

Sample Size:

Thirty-six patients were recruited in the study and were randomized equally into Epley maneuver (EpleyM) and Epley maneuver and exercise (EpleyM\&Exe) groups.

Study Method:

All patients were treated with the Epley maneuver, while CawthorneCooksey exercises were given to the EpleyM\&Exe group as home exercises for 6 weeks. Static and dynamic balance, vertigo and associated symptoms, and quality of life were assessed with the Nintendo Wii Balance Board, Berg Balance Test, Vertigo Symptom Scale, and Dizziness Handicap Inventory, respectively. The assessments were repeated at the 1st, 3rd, and 6th weeks.

Eligibility Criteria:
Inclusion Criteria:

1. having posterior semicircular canal BPPV with upbeating-torsional nystagmus and positional vertigo as evaluated by the Dix-Hallpike Test
2. agreeing to undergo the Epley maneuver after that test
3. agreeing to participate in the study

Exclusion Criteria:

1. having history or symptoms of vestibular system disorders other than BPPV or central nervous system disorders causing dizziness
2. having cervical and/or lumbar pathology due to which the Epley maneuver could not be performed
3. having lower extremity pain or an operation that prevented standing and/or weight bearing
4. having anterior or horizontal canal BPPV
5. having previously undergone a vestibular rehabilitation program
Department of Defense PTSD Adaptive Platform Trial - Intervention B - Vilazodone

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design.

Intervention B - Vilazodone will assess the safety and efficacy of vilzodone in participants with PTSD.

Please see NCT05422612 for information on the S-21-02 Master Protocol.

The general structure of this Adaptive Platform Trial (APT) consists of a 30-day Screening Period, a 12-week Platform Treatment Period, and a 4-week Safety Follow-up. The S-21-02 Platform Trial will evaluate the safety and efficacy of multiple investigational products for the treatment of PTSD (see NCT05422612 for Master Protocol information). Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control subjects, where all interventions may be compared to a common control (placebo). This record only includes information relevant to the vilazodone cohort.

Once a participant meets all eligibility criteria for the Master Protocol, eligibility for each currently enrolling intervention cohort is assessed. Eligible participants will be randomized with equal probability into a cohort. Participants randomized to the vilazodone cohort are then randomly assigned to receive either vilazodone or placebo (in a ratio of 5:3; intervention:placebo), for the duration of the 12-week treatment period.

Parties interested in having their intervention considered for testing within the M-PACT should complete a request for information form using this webpage https://citeline.qualtrics.com/jfe/form/SV_8eTQKw6TNug4z42.

Eligibility Criteria:
Inclusion Criteria:

No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).

Exclusion Criteria:

The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).

1. History of treatment for PTSD with vilazodone at doses of 20 to 40 mg daily, for at least 4 weeks.
Identification of Predictive Factors for observAnce of Transcutaneous Electrical NeuroStimulation (TENS) in Chronic Pain

This is a retrospective and transverse multicenter study to identify predictive factors for adherence to TENS by chronic pain patients followed in structures specialized in Chronic Pain management (SPC).

The study contains 2 parts:

* A retrospective part of data collection in the patient follow-up file of the SPC during the 6 months elapsed after the first rental prescription.
* A transversal part, aimed at collecting additional information on the use of TENS, satisfaction and quality of life during a telephone interview after 6 months of use.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over when TENS was implemented.
* Suffering from chronic pain.
* Follow-up in nurse consultation within a centre specialized in chronic pain management identified and labeled by a local regulatory agency.
* Benefiting from the implementation of TENS for more than 6 months by a nurse from a centre specialized in chronic pain management.
* Affiliate or Beneficiary of a health insurance scheme.
* For patients in the study population: Having expressed their non-opposition to participate in the study.
* Patient used to verify the representativeness of the population studied: Unable to be contacted by phone and not having expressed their refusal to participate or for which the mail has not returned undelivered

Non-inclusion criteria

* Minor.
* Major incapable to oppose to the use of their data during the study due to medical or legal decision.
* Having language impairment.
* Having difficulties understanding the French language.
* Unable to participate in the phone survey.
* Not affiliated with Health Insurance / Social Security.
MRS Probe Study of Alcohol

This protocol will investigate the neurobiological underpinnings of alcohol craving in recently detoxified alcoholic drinkers utilizing novel functional brain imaging. This clinical magnetic resonance spectroscopy (MRS) study will investigate whether glutamate and other brain metabolites correlate to measures of alcohol craving severity


Eligibility Criteria:
Inclusion Criteria: (Minimal or No Alcohol Group)

1. Male or female age 21-70
2. Consume less alcohol then what is described in this protocol as a "higher dose drinker", or consume no alcohol at all.
3. Able to complete a 60 min. MRS brain scan.

Exclusion Criteria:

1. Inability to speak English
2. Inability or unwillingness to provide written informed consent
3. Diagnosis of active substance dependence other than nicotine (e.g. alcohol, cannabis, caffeine, prescription use of barbiturates, benzodiazepines, opiates, or stimulants) this will be determined using a PRISM (Psychiatric Research Interview for Substance and Mental Disorders) interview.
4. Any unstable active medical or additional psychiatric condition as determined by the investigator
5. Active suicidal ideation as determined by the PHQ-9 question 9 indicating response #2 or higher (several days; more than half the days; or nearly every day).
6. History of encephalopathy, hepatic failure, or HIV seropositivity
7. History of claustrophobia
8. History of major head trauma with loss of consciousness \>5 minutes or skull fracture
9. History of previous neurological event (e.g. epilepsy, stroke, transient ischemic attack)
10. Implanted metal objects (e.g. pacemakers; aneurysm clips; metal prostheses, joints, rods, or plates)
11. Contraindication to MRI scanning
12. Pregnancy or breast-feeding