cyrilzakka/clinical-trials huggingface dataset:
Use of Virtual Reality in Pain Management in Pediatric Oncology

DOREVI is a monocentric randomized controlled study that will evaluate the efficacy of virtual reality helmets for pain prevention during invasive care on 78 oncologic pediatric patients. Two groups of children (between 6 and 11 and between 12 and 18 years old) will be randomized to use helmet plus standard care or standard care alone during invasive procedures (central venous catheter puncture, lumbar puncture, or bone marrow aspiration). The pain intensity will be evaluated using a visual analogic scale during three invasive procedures, and results will be compared between the patients with or without virtual reality.


Eligibility Criteria:
Inclusion Criteria:

* patient who tolerates the virtual reality headset
* patient followed in pediatric oncology
* patient with a diagnosis of benign tumor or cancer
* patient who needs to have painful medical procedure during their treatment
* patient whose parents have signed the informed consent
* patient affiliated with social security or equivalent

Exclusion Criteria:

* patient with visual or hearing impairement
* patient with epilepsy or other neurological disease
* patient with psychiatric disease
Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency

The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.

The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels. The primary objectives of the study are to measure the changes in tissue hormones and other biomarkers in the prostate tissue specimens.

Eligibility Criteria:
The screening evaluation consisted of:

1. medical history, which included the androgen deficiency of the aging male questionnaire
2. physical examination
3. multiphasic serum panel
4. measurement of total serum testosterone and PSA levels

Exclusion criteria included:

1. use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis
2. serum PSA level greater than 10.0 ng/mL
3. refusal or inability to undergo prostate biopsies
4. presence of prostate cancer on initial biopsy results.
The Role of Rheumatological Evaluation in the Management of Patients With Interstitial Lung Disease

We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients would lead to a more accurate diagnosis and consequently alterations in treatment regimens that may lead to improved outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old
* ILD according to ATS/ERS guidelines
* Signed inform consent

Exclusion Criteria:

* Previous lung surgery
* Other significant systemic disease
A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) With an Interference Screw for Thumb Carpometacarpal Arthritis - Pilot Study

A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) with an interference screw for thumb carpometacarpal arthritis

This study will be a prospective randomized trial done in a single academic center. The patients who meet the inclusion criteria and agree to participate in the trial will be scheduled for a first CMC joint procedure. The procedure, standard LRTI or LRTI with a biotenodesis screw, will be allocated in a randomized fashion in the operating room using a sealed opaque envelope. After the surgery the patient will be placed in a spica splint for 1-2 weeks. Following suture removal, a thumb spica cast will be applied for immobilization for a total of 6 weeks of post-operative immobilisation.

The potential population for this study will include all patients with first carpometacarpal joint arthritis that have failed a conservative treatment. The primary outcome will be the thumb subsidence measured as the percentage of trapezial height, which correlates with stability. Subsidence will be measured on stress x-ray under a standard pinch load. Secondary outcomes will be function measured in 4 different ways: the range of motion compared to the contralateral side, pinch and grip strength compared to the other side, the Disabilities of the Arm Shoulder and Hand (DASH) score and the pain score on a visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* First CMC primary osteoarthritis refractory to conservative treatment
* Patient \>age 18
* Able to read and understand English
* Available for 2 year follow up

Exclusion Criteria:

* Inflammatory Arthritis
* Active infection in the first CMC joint
* Concomitant neuropathy
* Previous surgical procedure on the thumb
* Active or status post CRPS
* Severe ¨Z ¨deformity that requires palmar plate advancement
* Unwilling to participate in a research project
* Contralateral first CMC joint surgery
Duodenoscope Disinfect Study

This study is investigating the most effective way to sterilize duodenoscopes ("scopes") used at Beth Israel Deaconess Medical Center (BIDMC). Right now, BIDMC uses the standard method of high level disinfection to sterilize scopes. Because infections have been passed by scopes at other institutions in the U.S., the investigators are exploring whether or not adding two different sterilization processes will reduce this risk of contamination.

Bacteria may be passed from a patient's intestines to the scope. Or, if the scope is contaminated, bacteria may be passed from the scope to the patient. In order to understand how bacteria are passed, the investigators will be taking samples of the patient's intestinal bacteria to compare to the bacteria, if any, found on the scope.

Study Design

This study is designed to evaluate the effect of supplementing standard high-level disinfection with additional high level-disinfection or sterilization procedures on the frequency of duodenoscopes contamination. Duodenoscopes will be randomly assigned to one of three arms:

* Standard high-level disinfection currently performed at BIDMC (standard HLD)
* Standard high-level disinfection with an additional exposure time to disinfectant (double HLD)
* Standard high-level disinfection followed by ethylene oxide (HLD/ETO)

The study will be conducted with the following elements:

1. All duodenoscopes will be randomly assigned to a study arm before the duodenoscope is used for an Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedure included in the study, including duodenoscopes introduced during the study.
2. All duodenoscopes used for ERCP will have the following cultures obtained in a sterile fashion
3. Patient study consent for obtaining patient rectal surveillance and clinical cultures will be obtained at the time of ERCP procedure consent among all patients undergoing ERCP. Patients will be blinded to duodenoscope disinfection/sterilization assignment.
4. The ERCP procedure will be performed according to standard clinical practice. Among patients consenting to specimen collection, a duodenal aspirate will be obtained during the procedure.
5. Among consenting patients, a rectal surveillance swab will be collected post-procedurally by ERCP staff.
6. After ERCP completion, current BIDMC-employed trained technicians will perform the assigned disinfection/sterilization procedure.

Eligibility Criteria:
Inclusion Criteria:

1. A duodenoscope used for any intended ERCP procedure will be included in the study
2. All adult patients (age ≥18 years) scheduled to undergo ERCP will be offered participation in patient specimen collection component of the study

Exclusion Criteria:

1. Patients in whom ERCP or endoscopy with a duodenoscope is medically contra-indicated will not be included in the patient specimen collection portion of the study
2. Patients with surgically altered anatomy in whom ERCP is performed using an enteroscope (and not a duodenoscope) will not be included in the study
A Phase Ⅰb Study of Remimazolam Tosylate in Healthy Volunteers

The purpose of this study is to evaluate the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.

1. Study the Pharmacokinetics/Pharmacodynamics of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.
2. Study the reversal effect and time required of Flumazepine on Rimazolam'effect.
3. Study the Safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 and ≤55 years.
* Weight range 50 to 100 kg and body mass index (BMI) 18 to 26 kg/m2.
* Willing and able to comply with the requirements of the protocol.
* Provide written informed consent to participate in the study.

Exclusion Criteria:

* Abnormal results of physical or laboratory examination with clinical significance
* With a history of laboratory results that show the presence of hepatitis B surface antigen (HBs Ag), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV).
* With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor.
* Subject with clinically significant abnormalities in baseline 12-lead electrocardiogram (ECG) or vital signs（SBP \<90 mmHg or \>140 mmHg，DBP \<50 mmHg or \>90 mmHg；Hr \<50 bpm or \>100 bpm；SpO2 \<95%）.
* Has a known sensitivity to benzodiazepines, flumazenil, or anesthetic agents, or a medical condition such that these agents are contraindicated.
* Receipt of other medication within 14 days of the first study day.
* Blood donation greater than 200 ml or participation in a clinical study of an unlicensed drug in the previous 3 months.
* History of smoking or alcohol abuse within 6 months of screening.
* History of grapefruit juice or any other foods affect the activity of cytochrome P450 3A4（CYP3A4） within 7 days of screening.
* Pregnant,lactating.
* Mallampati score ≥3.
* Patients who in the opinion of the investigator may not be able to comply with the requirements of the study are not eligible
Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis

The primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in forced expiratory volume in one second (FEV1), or an increase in methemoglobin.

Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A cycle of chronic, persistent infections with CF-related pathogens and an excessive inflammatory response progressively damages the airways and lung parenchyma, resulting in widespread bronchiectasis and ultimately, respiratory failure. Despite tremendous advances in understanding the CF gene and the CFTR protein, it is not known exactly how mutations in the gene and defects in CFTR lead to persistent airway infection and inflammation.

Inhaled nitric oxide (NO) has potential to be an effective treatment in CF lung disease. Inhaled NO has been studied in other airways diseases characterized by infection and /or inflammation such as COPD and idiopathic pulmonary fibrosis.

NO has been shown to activate CFTR and alternative chloride channels, thereby increasing chloride current in epithelial cells. Therefore, NO treatment may be beneficial in individuals with CF.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF
* 12 years of age and older
* FEV1 greater than 40% of predicted
* Resting awake oxygen saturation of at least 88%
* Stable pulmonary disease as defined by both clinical impression and having had no recent hospitalizations or changes in antibiotic regimen within 1 month prior to enrollment
* Signed informed consent form

Exclusion Criteria:

* Pulmonary exacerbation resulting in antibiotic treatment (except prophylactic antibiotics) within 1 month of enrollment
* Isolation of B. cepacia from a respiratory tract culture within 6 months
* Severe nasal obstruction at the time of screening
* Receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment
* Pregnancy (a negative pregnancy test must be documented prior to enrollment if applicable)
* Patients who have received treatment with nitric oxide for inhalation within 24 hours prior to study initiation or other investigational medications within 24 hours.
Influenza Vaccine Post Allogeneic Transplant

Study Design:

This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Patient Population

  * HSCT recipients who are greater than 60 days post transplant.
  * Age 6 months and older who are greater than 60 days post post allogeneic hematopoietic cell transplant
  * Show neutrophil recovery, platelet count \> 50,000/mm3 (may be transfused), no known disease relapse
  * No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
  * No flu vaccine in previous 4 months, no Campath in previous 6 months, no intravenous immune globulin (IVIG) in previous 3 months
* Controls:

  * Age 18 to 50 years
  * No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
  * No flu vaccine in previous 4 months
PAP Therapy in Patients With Obesity Hypoventilation Syndrome

The role of different levels of compliance and long-term effects of positive airway pressure (PAP) therapy on gas exchange, sleepiness, quality of life, depression and death rate in patients with obesity hypoventilation syndrome (OHS).

Various forms of positive airway pressure (PAP) therapy are effective in providing short and long-term benefits in these patients with or without obstructive sleep apnea (OSA). However, there are limited data concerning the impact of long-term effects of PAP therapy on survival and functional status in individuals with obesity hypoventilation syndrome (OHS) and OSA. Therefore we aimed to assess the role of different levels of compliance and long-term effects of PAP on gas exchange, sleepiness, quality of life, depression and death rate in patients with OHS, two year after PAP initiation.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 80 years
* Obesity hypoventilation syndrome diagnosis (OHS)
* clinically stable for at least 4 weeks prior to the enrolmenT
* above-elementary school education.

Exclusion Criteria:

* refusal to participate
* refusal of PAP therapy
* central sleep apnea syndromes
* restrictive ventilation syndromes
* severe congestive heart failure
* a history of life-threatening arrhythmias
* severe cardiomyopathy
* significant chronic kidney disease
* untreated hypothyroidism
* family or personal history of mental illness
* drug or alcohol abuse
* sedative use
* severe cognitive impairment
* concurrent oncological diseases
* history of narcolepsy or restless legs syndrome.
Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures

This is a study which seeks to develop a novel therapeutic approach, Intersectional Short Pulse (ISP) stimulation for seizure termination. The device embodiment of ISP is a scalp EEG recording system which also delivers spatially precise electrical stimulation in short pulses to the targeted brain region. The study team has already collected safety and tolerability data in human subjects, demonstrated ISP efficacy in terminating seizures in rodents, and have tested the efficacy of this device to modulate normal human brain activity. Now this study proposes to test the device's efficacy in stopping seizures in a within-subject randomized, sham-controlled study design.


Eligibility Criteria:
Experiment 3: Epilepsy patients

Inclusion criteria:

* Adult patients (age 18-65).
* Fluent in English.
* Epilepsy patients with poorly controlled (\>=2 seizures per week).
* Focal onset seizures.
* Seizure onset zone in the mesial temporal or neocortical onset as determined by \>2 concordant criteria, without discordant criteria (semiology, MRI Brain, and EEG).
* Able to give informed consent.

Exclusion criteria:

* Patients with skull defects.
* Patients with implanted neurostimulator or other implanted cerebral hardware.
* Patients with multifocal onset epilepsy.
* Patients who are non-verbal or incapable of providing informed consent.
* Current substance abuse.
* Pregnancy.
* Patients with non-MRI compatible implants (for Experiments 2 and 3).
Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy

A 100 units of botulinum toxin was injected in both parotid and submandibular glands for children (2 - 12 years) with incapacitating sialorrhea in juvenile cerebral palsy patients and they are followed up for 1 year

This was a prospective, longitudinal analysis with 1-year follow-up of 52 children with juvenile cerebral palsy (JCP) suffering from sialorrhea enrolled from 3 tertiary pediatric neurology rehabilitation centers (two in Cairo and one in Alexandria) and subjected to repeated BoNT-A injection.

The recruitment period was between June 30, 2021, until May 1, 2022 (the last patient follow-up ended on April 30, 2023).

Intervention: 100 units of OnabotulinumtoxinA (Botox®) were injected in the parotid and submandibular glands Follow-up visits: mo 1 post-injection (for every injection session) and every 3 months thereafter

In each visit; the following efficacy variables were assessed:

Primary outcome measures: The severity and frequency of sialorrhea evaluated by Drooling Severity Scale (DSS), and Drooling Frequency Scale (DFS) and visual-analogic ratings of familial distress (VAS-FD).

Secondary outcome measure: The carers' Global Impression of Change Scale score measured on a 7-point Likert scale from -3 (very much worse) to +3 (very much improved)

Also, adverse events were assessed in each visit

Eligibility Criteria:
Inclusion Criteria:

* Juvenile cerebral palsy with age range (4 - 12 years)
* Having severe drooling (DFS \> 4)
* Signing written informed consent by the legal guardians.

Exclusion Criteria:

* Previous BoNT-A injection in the last three months
* Patients receiving systemic medicine for the treatment of sialorrhea in the last 6 weeks
* Any contraindications to treatment with BoNT
Treatment of Intraocular Retinoblastoma

This study compares the effects of balloon technology and microcatheter technology on the eye protection rate of neuroblastoma

Retinoblastoma is the most common intraocular malignant tumor in childhood, with an incidence of about 1/15,000-20,000, accounting for 4% of all childhood cancers. All patients with bilateral reticuloblastoma and approximately 10%-15% of children with unilateral disease have germline mutations that can be passed on to their offspring.In developed countries, the survival rate is close to 98%. However, due to the limitations of health care in low-income countries, this proportion is much lower, about 40%. Before the 1990s, retinoblastoma was mainly treated with enucleation and external beam radiation therapy (EBRT). However, these methods are associated with many complications, including vision loss and serious side effects. At present, the first-line conservative treatment of retinoblastoma has changed from EBRT and enucleation to Intravenous chemotherapy (IVC) or intra-arterial chemotherapy (IAC), and it has been consolidated through focal treatment. There are two different surgical procedures for intra-arterial chemotherapy, namely balloon technique and microcatheter technique. Investigators observe their effects through a retrospective case-control study.

Eligibility Criteria:
Inclusion Criteria:

1. 1 year old \<age ≤ 18 years old;
2. After biopsy, histopathology and immunohistochemistry tests refer to the COG recommended neuroblastoma diagnostic criteria, pathological classification (INPC), and international neuroblastoma staging (INSS)
3. Patients who were diagnosed with RB for the first time or received chemotherapy in our hospital for the first time after diagnosis
4. ECOG scale (ECOG-PS) ≤ 2;

Exclusion Criteria:

1. No antibiotics and no gastrointestinal surgery within 3 months.
2. Patients with autoimmune diseases;
3. Patients with immunodeficiency;
4. Patients who have been treated for relapsed/refractory diseases; relapsed NB is the appearance of new lesions at the primary site or other sites 4 weeks after the multidisciplinary comprehensive treatment reaches CR. Refractory NB is defined as induced by 2 to 4 courses of treatment The post-effect evaluation is progression disease (PD) during chemotherapy;
5. Multiple organ failure;
6. Uncontrolled infection and diarrhea
Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction

The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. The investigators expect to observe which products and constituents lead to greater smoking reduction.

The study includes 5 visit and assessments over 6 weeks. The intake visit will take approximately 60 minutes and subsequent visits will take approximately 30 minutes. The study is proposed to run for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* 21+ years old
* English literate
* Currently smoking cigarettes, biochemically confirmed
* Not planning a smoking cessation attempt or to use smoking cessation pharmacotherapies (NRT, bupropion, varenicline) in the next month.

Exclusion Criteria:

* Currently using any smoking cessation services and/or pharmacotherapies
* Currently pregnant or breastfeeding
* Significant current medical or psychiatric condition
* Known hypersensitivity to propylene glycol.