louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000320: Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1
Official title: Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Opioid-Related Disorders
Keywords: opioid dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."

Detailed description: 1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form

Eligibility criteria: Inclusion Criteria:

M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.

Primary outcomes:
measure: blood level
timeFrame: across study duration
Secondary outcomes:
measure: drug use
timeFrame: across study duration
measure: craving
timeFrame: across study duration
measure: withdrawal symptoms
timeFrame: across study duration
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02844920: Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
Official title: Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Fibroids
Adhesions
Lead sponsor: Gynesonics
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who desire treatment of intrauterine fibroids with RF ablation via the Sonata System.

Brief summary: This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.

Detailed description: Patients who agree to participate in this observational trial will have selected fibroid treatment with the Sonata System. Research participants will undergo hysteroscopy at 6 weeks following treatment to evaluate presence or absence of intrauterine adhesions.

Research participants will be asked to complete a quality of life questionnaire prior to and 6 weeks following treatment. Research participants will also complete a satisfaction survey and a diary that tracks their return to normal daily activities.

Eligibility criteria: Inclusion Criteria:

* Have selected Sonata for treatment of fibroids in the presence of heavy menstrual bleeding
* Presence of at least one submucous myoma (type 1, type 2) or transmural fibroid (type 2-5)
* Willing and able to read, understand, and sign the informed consent form and to adhere to all study follow-up requirements

Exclusion Criteria:

* Preexisting adhesions within the endometrial cavity as indicated by an ESH score ≥ I as determined by the investigator
* One or more Type 0 fibroids and/or endometrial polyps of any size
* Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in this study

Primary outcomes:
measure: Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids
timeFrame: 6 weeks
Secondary outcomes:
measure: Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum (MMC)
city: Bern
country: Switzerland
facility: Universitätsklinik für Frauenheilkunde Inselspital Bern
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
References:
Clinical trial NCT01406574: Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
Official title: A Multicenter, Open-label, Non-randomized, Dose-escalation, Therapeutic Exploratory Trial to Evaluate the Safety and Efficacy of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy


Eligibility criteria: Inclusion Criteria:

* Patients with histopathologically or clinically confirmed diagnosis of hepatocellular carcinoma
* Patients with Child-Pugh classification A or B
* Patients unresponsive to standard therapy or for whom standard therapy is intolerable, or for whom there is no appropriate therapy
* Patients who are able to take oral medication
* Patients age 20 to 79 years (inclusive) at time of informed consent
* Patients with an ECOG performance status score of 0-2
* Patients have the eligible organ function.

Exclusion Criteria:

* Patients with a primary malignant tumor
* Patients with a history of liver transplant
* Patients with brain metastases
* Patients with a complication of uncontrolled
* Patients with a psychiatric disorder that might cause difficulty in obtaining informed consent or in conducting the trial

Primary outcomes:
measure: Subjects With Treatment Emergent Adverse Events
timeFrame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
measure: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
timeFrame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
Secondary outcomes:
measure: Best Overall Response
timeFrame: From first dose of study medication up to 28 weeks
Other outcomes:
Locations:
city: Chiba
country: Japan
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT06081374: The Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems
Official title: Determining the Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Postpartum Complication
Caesarean Section;Stillbirth
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the literature, there are studies conducted to determine the effect of simulation-based and different training techniques models given in the prenatal period on postpartum breastfeeding self-efficacy. However, no study was found that evaluated the effects of simulation-based and different training techniques given in the prenatal period on breastfeeding self-efficacy and breastfeeding problems. Therefore, this study was planned to determine the effect of simulation-based breastfeeding education on breastfeeding self-efficacy and breastfeeding problems in the prenatal period.


Eligibility criteria: Inclusion Criteria:

* Pregnants between32nd-36th gestational weeks,
* Primigravida,
* Planning to breastfeed,
* Can speak and understand Turkish,
* Pregnant women who agreed to participate in the study were included.

Exclusion Criteria:

* Breastfeeding contraindications,

  * Having a risky pregnancy, Having received a planned breastfeeding training before,
  * Premature birth (before 37th weeks of gestation),
* Having a systemic/chronic disease

Primary outcomes:
measure: simulation affect on breastfeeding self-efficacy
timeFrame: postpartum 7th week
measure: simulation affect on breastfeeding problems
timeFrame: postpartum 7th week
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Seda Karaçay Yıkar
state: Sarıcam
Study officials:
References:
Clinical trial NCT04985474: Impact of Pulmonary Rehabilitation After Lung Resection for Cancer on Patients' Level of Anxiety and Depression
Official title: Impact of Pulmonary Rehabilitation After Lung Resection for Cancer on Patients' Level of Anxiety and Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Resection
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 133
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a standardized approach (or thoratomie videothoracoscopy)

Brief summary: The interest of pulmonary rehabilitation for patients who underwent lung resection for cancer remains controversial. The investigators studied the effects of the RR and its impact on quality of life and level of anxiety and depression in patients.

In 2011 and 2012 , an RR was proposed to the patients referred to our center after lung resection for cancer. Patients were assessed at entry and departure by 6minutes walk test , a visual analog pain scale , a quality of life questionnaire ( EORTC QLQ C30 ) and an anxiety questionnaire and Depression (HAD) . These same questionnaires were mailed 6 months after the end of the pulmonary rehabilitation .


Eligibility criteria: Inclusion Criteria:

* Patient with pulmonary resection
* Patients undergoing a standardized approach (or thoratomie videothoracoscopy)

Primary outcomes:
measure: level of depression with scale
timeFrame: At 6 months
measure: level of anxiety withe scale
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00713674: Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx
Official title: Comparison of Decolonization of MRSA Using Theraworx
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Methicillin-Resistant Staphylococcus Aureus
Keywords: Methicillin resistance
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2008-07-11
Enrollment: 0
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 examine treatment method of Methicillin-resistant Staphylococcus aureus (MRSA) decolonization in patients.

Detailed description: Decolonization therapy is indicated for management of patients with MRSA. Theraworx is reported to be an effective antimicrobial against multiple organisms. In this study, patients with positive MRSA colonization culture will be treated with Theraworx to evaluate decolonization duration capability.

Eligibility criteria: Inclusion Criteria:

* Positive MRSA culture

Exclusion Criteria:

* Patients currently on or start antibiotic therapy directed for MRSA.(Prophylaxis antibiotic for surgical procedure not considered therapy.)
* Patients with MRSA infected wounds
* Patients under the age of 18 years
* A woman currently pregnant or nursing a child
* Patients participating in another study within 30 days of randomization

Primary outcomes:
measure: Evidence of decolonization confirmed by intranasal culture
timeFrame: Up to 14 days post treatment (+/- 1-2 days)
Secondary outcomes:
measure: Economic-Cost comparison of treatment Evidence of decolonization
timeFrame: 5 days of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Mercy/St. John's Hospital - Springfield
name: Roger E Huckfeldt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04483674: Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
Official title: Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV Primary Infection
Keywords: Human Immunodeficiency Virus
HIV Primary Infection
Biktarvy
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 66
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: The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection

Detailed description: After providing informed consent, patients will undergo to a screening visit. If they meet the inclusion criteria and none of the exclusion will be included in this trial. Patients will take one tablet of Biktarvy at day for 48 weeks. Then the results will be compared with a cohort of 66 patients treated with 2 nucleoside analogues and one integrase chain transfer inhibitor.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18-65 years
* ART naïve
* HIV infection of less than 100 days post-infection (documented 3 month previous negative serology or incomplete WB test with negative p31 band)
* Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner.

Exclusion Criteria:

* Known hypersensitivity to any drug included in Bictegravir/FTC/TAF regimen
* AST \>5 times UNL
* Creatinine Clearance \<30 mL/min/1.73m2
* Any end-stage organ disease
* Acute or chronic HCV co-infection
* Use of PrEP with Truvada® until 4 weeks before the onset of symptoms of PHI (risk of acquired-drug resistance to FCT or TDF).

Primary outcomes:
measure: Portion of patients with a VL (viral load)< 50 Copies at week 48
timeFrame: 48 weeks
Secondary outcomes:
measure: Viral Load at 4,8,12,24 y 48 weeks
timeFrame: weeks 4,8,12,24,48
measure: Portion of patients with > 900 cells CD4+
timeFrame: weeks 24 and 48
measure: Days elapsed between diagnosis and bictegravir/FTC/TAF initiation
timeFrame: week 48
measure: Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population
timeFrame: week 48
measure: AE (adverse event) leading to discontinuation rate
timeFrame: week 48
measure: CD4, CD4/CD8 ratio
timeFrame: weeks 4,8,12,24,48
measure: AE rate
timeFrame: week 48
measure: Number of required regimen changes
timeFrame: week 48
measure: Quality of life and satisfaction: questionnaire
timeFrame: day 0, week 4 and 48
measure: Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
timeFrame: weeks 0,48
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
Clinical trial NCT03758274: Talk Therapy by Phone to Promote Treatment for Alcohol Problems
Official title: Cognitive Behavioral Treatment by Phone to Promote Use of Alcohol Related Care and Reduce Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol Abuse
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Medical University of South Carolina
name: Syracuse University
First posted: 2018-11-29
Enrollment: 400
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: A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related care despite research showing that treatment is effective. This randomized controlled trial tests the efficacy of a brief, phone based cognitive behavioral intervention to increase treatment engagement, improve alcohol related outcomes, and show that treatment engagement is a mechanism for the improved outcomes in individuals with AUD.


Eligibility criteria: Inclusion Criteria:

* age 18-plus;
* score ≥ 16 on AUDIT;
* within the past 30 days, exceeding the limits for low-risk drinking adopted by NIAAA: \>3 standard drinks on any occasion or \>7 drinks per week (women); \>4 drinks on any occasion or \>14 drinks per week (men).

Exclusion Criteria:

* unable to communicate with the researcher in English;
* unable to comprehend the nature of the study;
* history of alcohol-related care;
* alcohol withdrawal necessitating medical evaluation;
* residency outside of The Greater Rochester Area.

Primary outcomes:
measure: Average Drinks Per Drinking Day
timeFrame: prior 30 days (at 3-month follow-up)
measure: Days Abstinent
timeFrame: prior 30 days (at 3-month follow-up)
measure: Number Initiating Alcohol Use Disorder Treatment
timeFrame: over 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT01357174: ROTATEQ™ Post-Marketing Surveillance in the Philippines
Official title: Protocol for ROTATEQ™ Post-Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rotavirus Infections
Gastroenteritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 915
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants in the Philippines who received ROTATEQ.™ Information will be provided by the physicians who administered the vaccine.

Brief summary: This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.


Eligibility criteria: Inclusion Criteria:

* Received ROTATEQ™

Primary outcomes:
measure: Number of participants with adverse events following administration of ROTATEQ™
timeFrame: Three-year period following vaccine marketing approval (August 2007 to August 2010)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00231374: Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning
Official title: In Vivo Analysis of Intradural Pressure Variation With Patient Positioning
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Back Pain
Keywords: cerebrospinal fluid
pain in cervical spine
pain in lumbar spine
myelogram
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study looking at pressure changes in the fluid that surrounds the spine when a person is positioned in 2-3 different ways.

Detailed description: Volunteers who need a myelogram of their spine as part of their routine medical care are being asked to be in this study. A myelogram is an imaging study with x-rays after an agent is put into the spine that shows spinal fluid on the x-ray. It requires insertion of a needle into the cerebrospinal fluid (CSF) inside the spine. CSF is a bodily fluid that bathes the brain, spinal cord, and nerve roots. This study is being conducted to measure CSF pressure changes with different patient positioning.

We are motivated to do this research study to better treat patients who develop a spinal fluid leak during a myelogram or other spine procedure. The tissue that holds the cerebrospinal fluid (CSF) is called the dura. During surgery or other procedures, the dura can develop a tear. Dural tears can result in a leakage of CSF. CSF leaks are a recognized complication of spinal surgery. Currently, there is no evidence on whether or not a specific postoperative spine position is beneficial, especially for cervical (neck spine) CSF leaks. The process of dural healing after a dural tear is influenced by CSF pressure. High CSF pressure may inhibit dural healing. We want to find the patient position (sitting, lying down, or reclining) that reduces the CSF pressure the most. To do this, we want to attach a pressure monitor to the needle that is normally placed in the spine for a myelogram and measure the CSF pressure.

Eligibility criteria: Inclusion Criteria:

* Need a lumbar or cervical myelogram as part of routine care.

Exclusion Criteria:

* Not needing a myelogram in the cervical or lumbar spine.

Primary outcomes:
measure: CSF pressure measurements on 5 patients having a cervical myelogram in 3 positions.
measure: CSF pressure measurements on 5 patients having a lumbar myelogram in 2 positions.
Secondary outcomes:
measure: Safety measurements of one position over another.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Orthopaedics & Spine Center
state: Georgia
Study officials:
affiliation: Emory University
name: Tim Yoon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: