louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03370783: Acute Neuroimmune Effects of Alcohol Using Free Water Imaging
Official title: Acute Neuroimmune Effects of Alcohol Using Free Water Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2017-12-12
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study examines the effects of moderate alcohol intake on the brain, the immune system, and cognition.

Detailed description: The study involves a within-subjects, pre/post design to assess the effects of a moderate dose of alcohol on immune biomarkers, neurobiological measures, and cognitive functioning. The study recruits healthy adults (ages 21-45) from the community to complete the experimental protocol. Participants complete magnetic resonance imaging scans, blood sample collection, and cognitive testing in the context of alcohol consumption.

Eligibility criteria: Inclusion Criteria:

* Ages 21-45 years
* Able to speak and read English at least at 8th grade level
* Moderate self-reported alcohol use in the past year
* Body mass index in normal to overweight range
* Right-handed

Exclusion Criteria:

* History of heavy drinking
* Currently seeking alcohol or drug treatment
* Chronic disease requiring use of medication
* Recent antibiotic or probiotic use
* Chronic daily use of NSAIDs
* Chronic GI disorder
* Use of illicit drugs
* Major psychiatric disorder or suicidality
* Fainting, weakness, infection, excessive bruising, or distress resulting from standard blood draw
* Safety contraindication for MRI scan
* Inability to abstain from use of tobacco products prior to or during study
* Inability to abstain from use of cannabis prior to or during study
* Pregnant, nursing, or may become pregnant

Primary outcomes:
measure: Immune biomarkers
timeFrame: 1-3 hours after alcohol intake
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
References:
Clinical trial NCT05435183: Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving Carbon Dioxide Clearance in AECOPD Patients
Official title: Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving Carbon Dioxide Clearance in AECOPD Patients : a Clinical Crossover Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Non-invasive Ventilation
Keywords: Noninvasive high frequency oscillatory ventilation
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients were randomized to receive one hour each of the two non-invasive ventilation modes before and after, and one hour of washout after receiving the first mode of ventilation before receiving the second intervention.
Primary purpose: TREATMENT

Brief summary: High-frequency oscillatory ventilation (HFOV), as an ideal lung-protecting ventilation method, has been gradually used in neonatal critical care treatment, and is currently recommended as a rescue method for neonatal acute respiratory distress syndrome (ARDS) after failure of conventional mechanical ventilation. . Although its ability to improve oxygenation and enhance carbon dioxide (CO2) scavenging has been repeatedly demonstrated in laboratory studies, its impact on clinical outcomes in these patients remains uncertain. Non-invasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation methods, and has become a current research hotspot in this field. It is recommended to be used to avoid intubation after conventional non-invasive ventilation therapy fails. For the treatment of intubation, there is still a lack of large-scale clinical trials to systematically explore its efficacy. The gradual increase in the clinical application of nHFOV has also enriched its use in the treatment of other diseases.


Eligibility criteria: Inclusion Criteria:

1. Age 40-80, males and females;
2. Stage III and IV COPD and PaCO2≥50mmHg;
3. Similar with non-invasive ventilation;
4. Willing to participate in the study;
5. Able to provide informed consent.

Exclusion Criteria:

1. Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
2. Intolerant with NIV

Primary outcomes:
measure: Transcutaneous partial pressure of CO2
timeFrame: 1 hour
Secondary outcomes:
measure: Asynchrony index
timeFrame: 1 hour
Other outcomes:
Locations:
city: Guangdong
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University.
Study officials:
References:
Clinical trial NCT01795183: Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia
Official title: The Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia - A Prospective Open-Label Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia

Secondary Objective:

To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.

Detailed description: The study duration by subject will include a 8-week treatment period with 3 follow-up visits.

Eligibility criteria: Inclusion criteria :

* Satisfying International Classification of Disease-10 (ICD) diagnostic criteria of schizophrenia;
* Positive and Negative Syndrome Scale (PANSS) total score ≥ 60

Exclusion criteria:

* Refractory schizophrenia or Patients treated with sufficient clozapine for a minimum period of 6-8 weeks without improvement;
* Participation into another clinical trial within the last month;
* Patients previously or currently treated with amisulpride;
* Patients receiving clozapine within the past 1 month or treated with long-acting formulation of antipsychotic medication within the past 2 months;
* Patients receiving electric convulsive therapy or physical therapy within the past 1 month;
* Patients with coexisting severe systemic diseases;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Effective percentage (PANSS score reduced rate≥50%)
timeFrame: Week 8
Secondary outcomes:
measure: Early response rate (PANSS score reduced rate: at least 20%)
timeFrame: week 2
measure: Positive and Negative Syndrome Scale (PANSS)-total score improvement
timeFrame: Baseline, Week 8
measure: Clinical Global Impression Scale- Improvement (CGI-I)
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Liang Y, Yu X. Effectiveness of amisulpride in Chinese patients with predominantly negative symptoms of schizophrenia: a subanalysis of the ESCAPE study. Neuropsychiatr Dis Treat. 2017 Jun 28;13:1703-1712. doi: 10.2147/NDT.S140905. eCollection 2017.
citation: Liang Y, Yu X. The effectiveness and safety of amisulpride in Chinese patients with schizophrenia who switch from risperidone or olanzapine: a subgroup analysis of the ESCAPE study. Neuropsychiatr Dis Treat. 2017 Apr 21;13:1163-1173. doi: 10.2147/NDT.S132363. eCollection 2017.
Clinical trial NCT05098483: Regenerative Endodontics for Non-vital Primary Molars
Official title: Clinical and Radiographic Evaluation of Regenerative Endodontics Using MTA and Biodentine for Non-vital Primary Molars Compared to Conventional Root Canal Treatment. (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulp and Periapical Tissue Disease
Keywords: Regenerative endodontic treatment
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 39
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-vital primary molars will be treated with regenerative endodontic idea using different capping materials aiming to replace the necrotic pulp tissue with biological one and to provide perfect seal over the scaffold

Detailed description: Non-vital primary molars that fulfill the eligibility criteria will be randomly assigned into one of the 3 study groups:

Group 1: conventional root canal treatment Group 2: Regenerative endodontic treatment using MTA Group3: Regenerative endodontic treatment using Biodentine Each group will be followed up for 12 months

Eligibility criteria: Inclusion Criteria:

* Non-vital mandibular primary second molar.
* Restorable tooth

Exclusion Criteria:

* Patients allergic to medicaments or antibiotics necessary to complete the procedure.
* Special Health Care Needs
* Excessive mobility
* Presence of internal or external root resorption.

Primary outcomes:
measure: Clinical measures
timeFrame: 12 months
measure: Radiographic measures
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Mai Mahmoud Hasaballah
Study officials:
affiliation: AinShams University
name: Mai Hasaballah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02010983: Achalasia and Dysplasia
Official title: Screening for Dysplasia in Longstanding Idiopathic Achalasia: a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysplasia in Longstanding Achalasia
Relation Between Food Stasis and Dysplasia
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patient with achalasia have a 10-50 fold increased risk to develop esophageal squamous cell carcinoma (ESCC). Early diagnosis of ESCC is essential, and detection of an earlier dysplastic stage is preferred. Endoscopic detection is however difficult and often delayed. Chromoendoscopy with Lugol dye increases detection rates dysplasia and ESCC to 91-100%. The aim of this study was therefore to evaluate a screening program using chromoendoscopy with Lugol to detect dysplasia in patients with idiopathic achalasia.

A second objective is to study the relationship between foodstasis and the development op dysplasia


Eligibility criteria: Inclusion Criteria:

* longstanding achalasia (\> 15y)
* \> 18y old
* informed consent

Exclusion Criteria:

* allergy to iodine
* esophageal carcinoma

Primary outcomes:
measure: incidence of dysplasia in patients with longstanding achalasia
timeFrame: 1 year
Secondary outcomes:
measure: additive value of chromoendoscopy in comparison with lugol stain
timeFrame: 1 year
measure: relationship between food stasis and dysplasia
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZleuven
Study officials:
References:
Clinical trial NCT04705883: Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors
Official title: Vaginal Prasterone In The Treatment Of Vaginal Atrophy In Patients With Breast Cancer Treatment With Aromatase Inhibitors (Vibra Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vulvar Atrophy
Breast Cancer
Genitourinary Syndrome of Menopause
Keywords: Breast Cancer
Genitourinary Syndrome of Menopause
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 10
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)

Detailed description: Verify a clinical improvement of AVV without increasing levels of ultrasensitive blood estradiol in breast cancer survivors treated with aromatase inhibitors by administering vaginal prasterone.

Eligibility criteria: Inclusion Criteria:

* Breast cancer treated with anti-hormonal therapy based on inhibitors of aromatase (IA) (letrozole, anastrozole or exemestane) ± analogues of the GnRH (aGnRH)
* Menopause (natural or induced) and signs / symptoms of vulvovaginal atrophy
* Cytology and / or determination of Human Papillomavirus (HPV) negative
* Intention or willingness to have sex

Exclusion Criteria:

* To have received topical hormonal treatment in the last 6 months or Have used vaginal moisturizers and / or lubricants during the 30 days prior to the study treatment
* To have received treatment with laser, radiofrequency, hyaluronic acid, etc. in the vagina during the last two years at the beginning of the study
* To Have: an active infection of the genital tract; an intraepithelial neoplasm of the cervix, vagina or vulva; suspected of suffering or having been treated for cancer of the genital tract; suffer a genital prolapse of II degree or greater

Primary outcomes:
measure: Estradiol
timeFrame: 12 months
Secondary outcomes:
measure: Vaginal pH
timeFrame: 12 months
measure: Vaginal maturation index
timeFrame: 12 months
measure: Vaginal health index
timeFrame: 12 months
measure: Female Sexual Function Index
timeFrame: 12 months
measure: Social Functioning Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Camil Castelo-Branco
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00285883: Directly Observed Therapy in High Risk Populations in Newark, NJ
Official title: Directly Observed Therapy in High Risk Populations in Newark, NJ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Directly Observed Therapy
HIV Infections
Keywords: Invirase
HIV
DOT
Treatment Experienced
Lead sponsor: Saint Michael's Medical Center
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-02-02
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michael's Medical Center and be given Directly observed therapy.

Detailed description: 30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michael's Medical Center. Consent will be obtained, their regimens will be switched to QD based on previous therapies and resistance patterns if available. Patients will be placed on direct observed therapy.Each patient will be placed on Fortovase/Ritonavir (1600mg/100mg)QD plus two or three NRTIs based on a phenotypic baseline testing to a protease inhibitor. Patients will visit the office at baseline, weeks 1, 4, 8, 12, 16, 24, 32, 40, and 48. Patients will also be visited daily by the social worker (or designee) to observe patients taking their antiretroviral therapy for 6 months. After six months of direct observed therapy patients will be given a diary card to record administration of medications and the social worker ( or designee) will visit the home twice weekly. If the patient experiences a change in therapy secondary to virologic failure, the patient will return to baseline visit for the new once a day regimen. Virologic failure will be defined as \< .5 log drop between each visit or \> 400 copies/mL at week 24 on two separate occasions at least 14 days apart

Eligibility criteria: Inclusion Criteria:

1. Men and Women \> 18 years of age with a confirmed HIV-1 diagnosis 2. CD4 count \<350 and or history of opportunistic infection 3. HIV PCR \>55000 and \>55,000 on one occasion in last 12 months 4. Patients with poor compliance (Poor compliance will de defined as taking less than 80 percent of prescribed medication 5. Patients with mental illness, HIV dementia, substance abuse or social factor prohibiting compliance 6. Willingness to sign informed consent or legal guardian

-

Exclusion Criteria:

1. ALT/AST \> 5X ULN
2. CReatinine \>2.0 -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
Study officials:
affiliation: Saint Michael's Medical Center
name: Jihad Slim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01713283: Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
Official title: A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.


Eligibility criteria: Inclusion Criteria:

* First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
* Treatment-experienced or treatment-naive
* Chronic genotype 4 HCV infection
* Not co-infected with HIV
* Screening laboratory values within defined thresholds
* Use of highly effective contraception methods
* Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion Criteria:

* History of any other clinically significant chronic liver disease
* Pregnant or nursing female or male with pregnant female partner
* History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
* Excessive alcohol ingestion or significant drug abuse

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants Experiencing On-treatment Virologic Failure
timeFrame: Up to 24 weeks
measure: Percentage of Participants Experiencing Viral Relapse
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
Study officials:
affiliation: Gilead Sciences
name: Kathryn Kersey, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01152983: Safety and Performance Evaluation of the Rapid Ring Device
Official title: Single Center, Open Label, Prospective, Non-comparative, Non-randomized Study to Assess the Safety and Performance of the Rapid Ring Device (Comparative Study to Assess the Pain Reduction)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Finger sticks
Rapid Ring
Finger sticks method of obtaining blood for diagnostic testing
Lead sponsor: RapiDx Ltd.
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety, performance and initial efficacy of the RapiDx device.

Detailed description: The study will be a single center, open label, prospective, non-comparative, randomized trial and assess the safety and performance of the Rapid Ring device. In order to assess pain reduction, a comparative study will be performed and each subject will serve as his/her own control.

Clinical assessment for all 100% patients will occur at baseline. All participants will be men and women above the age of 18. The trial will be conducted at a Medical Center.

Eligibility criteria: Inclusion Criteria:

* Subject is healthy
* Subject's age is between 18 to 70 years old
* Subject must be capable of providing informed consent

Exclusion Criteria:

* Clotting disorders
* Subject has a clinically significant untreated chronic disease which may unable him/ her to participate in the study.
* Subject is taking anti-coagulant medication
* Non-intact finger tip (left middle/ring finger)
* Skin disease on the subject finger
* Abnormal blood pressure
* Pregnant or lactating women
* Menstrual period
* Previous diagnosis of HIV or Hepatitis
* Participation in other clinical investigations within previous 30 days
* Peripheral blood vessels diseases
* Diabetes
* Neuropathic pain

Primary outcomes:
measure: Collection of at least 2 drops (approximately 50microliter) of blood within one minute.
timeFrame: approximately 6 months
Secondary outcomes:
measure: Reduction in pain
timeFrame: approximately 6 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Chairman of the Hematology Institute and the Department of Hematology and Bone Marrow Transplantation at Tel Aviv Sourasky Medical Center.
name: Ella Naparstek, Prof.
role: PRINCIPAL_INVESTIGATOR
References: