louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00199121: A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
Official title: An Open, Single-Arm, Multi-Center, Phase IV Pilot Study of Treatment of Antiretroviral Naive HIV-1 Infected Patients With Tenofovir Disoproxil Fumarate in Combination With Emtricitabine and Zidovudine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antiviral effect and durability of antiviral response (HIV-1 RNA PCR) and safety of a triple NtRTI/NsRTI therapy in antiretroviral naive patients. Patients will receive TDF plus FTC plus AZT for at least 48 weeks. Further objectives are to evaluate resistance pathways in failing patients treated with TDF/FTC/AZT and to evaluate a treatment strategy of sparing PIs and NNRTIs for later treatment.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* HIV-1 positive
* antiretroviral treatment naive
* one CD4 count \>200/ul within 14d prior to study drug administration
* one HIV-1 RNA PCR value \>5000 and \<100.000 cop/ml within 14d prior to study drug administration
* women of child bearing potential: negative serum pregnancy test within 14d of study
* ability to understand and provide written informed consent
* overall stable disease
* absence of clinical signs of lipodystrophy

Exclusion Criteria:

* alcohol or illicit drug use
* malabsorption syndrome or other gastrointestinal dysfunction
* clinically relevant pancreatitis/hepatitis within the last 6 months
* receiving other investigational drugs
* abnormal hemoglobin, neutrophil, platelet, AST/ALT, pancreatic amylase, creatinine clearance, total bilirubine levels within 14d prior to study
* pregnancy/breast-feeding
* radiation therapy or cytotoxic chemotherapeutic agents within 30d of study
* prior antiretroviral therapy at any time, investigational antiretrovirals trial at any time, HIV vaccine within 90d prior to study
* immunomodulating agents
* serious medical condition (diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction)
* active diagnosis of AIDS (except for cutaneous Kaposi Sarcoma)
* foscarnet therapy or other agent with documented activity against HIV-1

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main
state: Hesse
Study officials:
affiliation: Head of the HIV Treatment & Research Unit, Dept. of Internal Medicine II, Hospital of the Johann Wolfgang Goethe University Frankfurt/Main, Germany
name: Schlomo Staszewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06337721: Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults
Official title: Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol; Harmful Use
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Will conduct a randomized controlled trial of the SPEAR intervention vs. control group.
Primary purpose: PREVENTION

Brief summary: This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT).

Detailed description: Pacific Islander young adults bear elevated risk for alcohol use disorders (AUD) and alcohol-related harms, yet lack effective interventions to reduce their risk. Grounded in the social development model, this study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults from existing evidence-based AUD prevention strategies; then (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT) with at-risk Pacific Islander young adults across multiple Pacific Islander communities in the US.

Eligibility criteria: Inclusion Criteria:

1. Of full or part self-reported Pacific Islander heritage;
2. Fluent (oral and reading) in English
3. For young adult participants: 18 - 30 years of age
4. Current drinking (1+ drink in past 30 days)
5. High AUD risk (AUDIT-C score # 4 for men, # 3 for women)
6. Not currently in alcohol treatment (medication, therapeutic).

Exclusion Criteria:

1. Do not meet inclusion criteria
2. Are unwilling to participate
3. Fail to provide or retracts consent
4. Reside outside the target Pacific Islander communities

Primary outcomes:
measure: Heavy Episodic Drinking (HED) Days
timeFrame: Up to 30 weeks
Secondary outcomes:
measure: Alcohol Consumption
timeFrame: Up to 30 weeks
Other outcomes:
Locations:
city: Riverside
country: United States
facility: UC Riverside
state: California
Study officials:
affiliation: UC Riverside
name: ANDREW SUBICA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105921: Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma
Official title: Intérêt de l'électroporation irréversible Dans le Traitement de l'adénocarcinome du pancréas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Adenocarcinoma
Interventional Imaging
Keywords: Locally advanced pancreatic carcinoma
Irreversible electroporation
Interventional radiology
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the use of irreversible electroporation in the treatment of locally advanced cancers of the head of pancreas with vascular spread. This technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven adenocarcinoma of the head of the pancreas (fine needle aspiration or biopsy)
* Pancreatic adenocarcinoma locally advanced on imaging at diagnosis
* Tumor of less than 7 cm in largest diameter
* No chemotherapy or abdominal radiotherapy within five years before the inclusion in the study

Exclusion Criteria:

* Pancreatic adenocarcinoma of more than 7 cm of diameter or immediately operable on imaging data
* Patient with contraindication of NanoKnife use
* Patient with neurostimulator
* Epileptic patient or with a myocardial infarction lasting less than 2 months
* Presence of visceral or lymph node metastases or peritoneal carcinosis at the initial workup
* Patient who cannot be treated with muscle blockers (curare)
* Patient with a metallic stent or a medical device implanted near the area treated by electroporation

Primary outcomes:
measure: R0 resection rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References:
Clinical trial NCT02154321: Electroencephalogram and Attention Deficit Hyperactivity Disorder Study
Official title: EEG and ADHD Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Attention Deficit Hyperactivity Disorder
Healthy Controls
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 adult participants will be recruited for this study: 50 adults diagnosed with Attention Deficit Hyperactivity Disorder and 50 healthy controls.

Brief summary: The purpose of this research is to assess and determine brain oscillations or "brain signatures" of adult participants with Attention Deficit Hyperactivity Disorder (ADHD) relative to adult participants without ADHD using the technique electroencephalogram (EEG). Electroencephalogram is entirely non-invasive way of tracking brain activity.The main goal of this study is to establish biological factors for determining the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD).


Eligibility criteria: Inclusion Criteria for all:

* Right-handedness

Inclusion Criteria for Attention Deficit Hyperactivity Disorder (ADHD) group:

* Currently unmedicated adults with ADHD. To be given a full diagnosis of adult ADHD, the participant must have full Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R) criteria: (1) described a chronic course of ADHD symptomatology from childhood to adulthood, and (2) endorsed a moderate or sever level of impairment attributed to the ADHD symptoms.

Exclusion Criteria for all:

* Currently taking psychoative medications
* Any clinically significant neurological problem (e.g., tics, seizures, serious head injury)
* Alcohol or substance abuse (current or in the past 2 years)
* Any current Axis I psychiatric diagnosis (other than ADHD) as verified by clinical interview

Primary outcomes:
measure: Brain Wave Measurements
timeFrame: Two years
Secondary outcomes:
measure: Default Network Signatures
timeFrame: two years
Other outcomes:
measure: Comparison of dependent measurements between Attention Deficit Hyperactivity Disorder and healthy controls
timeFrame: two years
Locations:
city: Ann Arbor
country: United States
facility: Rachel Upjohn Building
state: Michigan
Study officials:
affiliation: University of Michigan
name: Chandra S Sripada, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02627521: Optimizing Timing of CABG in Patients Presenting With ACS and Treated With Ticagrelor
Official title: Optimizing Timing of Coronary Artery Bypass Surgery in Patients Presenting With Acute Coronary Syndrome and Treated With Second Generation ADP Receptor Antagonist
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 260
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: The administration of Ticagrelor have demonstrated superiority to Clopidogrel in patients presenting with acute coronary syndrome (ACS) and remains a first line therapy as an adjunct to aspirin for patients admitted with ACS. The patient population treated with Ticagrelor at an early time point includes non ST elevation myocardial (NSTEMI) patients and those undergoing primary angioplasty for ST elevation myocardial infarction (STEMI). It is estimated that 10-15% of patients presenting with ACS have advanced coronary artery disease requiring Coronary Artery Bypass Surgery (CABG). The treatment guidelines recommend a delay of 5-7 days for CABG surgery in these patients for normalization of Ticagrelor induced platelet inhibition to reduce the risk of peri-operative bleeding. This delay may expose these high risk patients to adverse cardiac events while waiting for Ticagrelor effect to wean off. Furthermore, this empirical application of 5-7 day delay in all patients may be unnecessary due to the significant inter individual variability in response to Ticagrelor. There is limited data to determine the optimum timing of CABG surgery in ACS patients treated with Ticagrelor. The present study will determine the optimum timing of CABG in ACS patients treated with a loading and/or maintenance dose of Ticagrelor.


Eligibility criteria: Inclusion Criteria:

* Accepted for CABG surgery
* Treatment with Ticagrelor within 48 hours

Exclusion Criteria:

* Anticoagulation therapy
* Prior CABG.
* Active bleeding or at high risk of bleeding
* Severe liver or renal disease.
* Hypersensitivity to ticagrelor
* History of intracranial hemorrhage

Primary outcomes:
measure: Length of hospital stay
timeFrame: up to 30 day
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Asim Cheema, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02943421: Transverse B-Lynch in Management of Placenta Accreta
Official title: Evaluation of the Efficacy of Transverse B-Lynch in Management of Placenta Accreta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decrease Maternal Morbidity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study encompassing women managed by conservative transverse B-Lynch during cesarean section due to placenta accreta

Brief summary: Placenta accreta is considered a severe pregnancy complication that may be associated with massive and potentially life-threatening intrapartum and postpartum hemorrhage. Life-threatening bleeding is the most common complication to be associated with this condition; the average blood loss at time of delivery is reported to be 3000-5500 mL, which leads to significant postoperative morbidity and death.


Eligibility criteria: Inclusion Criteria:

1. All pregnant women with placenta previa as diagnosed by ultrasound with suspicion of abnormal placentation by Doppler us, confirmed intraoperatively undergoing either emergent or elective cesarean

Exclusion Criteria:

1. Patients who will be managed by hysterectomy
2. Patients who will be managed by conservative leaving the placenta in-situ

Primary outcomes:
measure: Estimated intraoperative blood loss
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT06861621: STRucturation of Transcript Analysis of Genes Involved in Hereditary Cancers
Official title: STRucturation of Transcript Analysis of Genes Involved in Hereditary Cancers in Normandy and Hauts de France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: hereditary predisposition to cancer
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 1000
Sex: ALL
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: Consecutive people seen in oncogenetic consultations for a hereditary predisposition to breast, ovarian or digestive cancer.

Brief summary: Molecular diagnosis using high throughput sequencing has become an essential part of oncogenetic care, making it possible to identify people at risk, to guide surveillance, and to direct preventive surgery and treatment. The quality of this 'precision' care depends on the quality of the interpretation of the genomic variants identified. To be usable in oncogenetics, a genomic variant must be correctly interpreted: pathogenic, benign or of uncertain significance (VSI). The impact of these DNA variants (VSI) on RNA is particularly important for interpretation. Today, due to a lack of resources, joint and systematic DNA/RNA analysis is never carried out. This has inevitably meant that a number of situations of interest have been overlooked. It is now important to go a step further and organise a visible and reliable circuit, allowing routine access to these studies for patients.

Detailed description: Systematic DNA/RNA analysis is never carried out using the current approach, due to a lack of resources. Strategies recommend pre-screening variants using in silico analysis, followed by RNA studies targeting variants of interest.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Patients seen in oncogenetic consultations and who have given their informed consent for genetic analysis in the context of a major predisposition to breast, ovarian or digestive cancer.
* Person who has read and understood the information note and does not object to taking part in the study
* Membership of a social security scheme

Exclusion Criteria:

* Minors
* Persons deprived of their liberty or adults under guardianship or incapable of giving their consent
* Failure to obtain informed consent

Primary outcomes:
measure: Relevance of a joint systematic DNA/RNA study
timeFrame: Baseline
Secondary outcomes:
measure: Structuring the transcript analysis circuit
timeFrame: 6 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Service Oncogénétique Centre François Baclesse
city: Lille
country: France
facility: Clinique de génétique médicale Guy Fontaine de l'hopital de Flandre CHRU de Lille
Study officials:
affiliation: Molecular Genetics Department, UH of Rouen
name: Claude HOUDAYER, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03709121: A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber
Official title: An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Conjunctivitis, Allergic
Keywords: reproxalap
ADX-102
allergic conjunctivitis
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age of either gender and any race
* have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
* have a positive skin prick test to ragweed pollen within the past year of screening

Exclusion Criteria:

* known contraindication or hypersensitivities to any components of the investigational product medication or components
* history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
* presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
* presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
* presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
* diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
* woman of childbearing potential who is pregnant or nursing

Primary outcomes:
measure: Subject-Reported Ocular Itching Score
timeFrame: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
Secondary outcomes:
measure: Subject-Reported Ocular Tearing Score
timeFrame: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
measure: Investigator-Assessed Conjunctival Redness Score
timeFrame: Efficacy was assessed from 0 to 210 minutes in the allergen chamber.
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Inflamax Research Limited
state: Ontario
Study officials:
References:
Clinical trial NCT03742921: ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma
Official title: ISTODAX® for Intravenous Infusion 10mg Drug Use Results Survey - Relapsed or Refractory Peripheral T-Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, T-Cell, Peripheral
Keywords: Istodax
Survey
Relapsed or refractory
Peripheral T-Cell Lymphoma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-11-15
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Since the number of patients with PTCL was 48 and 131 in the Japanese and overseas clinical studies, respectively, the number of subjects to be surveyed was established at 130 to allow comparison of results between this survey and Japanese clinical study, or between this survey and overseas clinical study.

Among events that were established as the key survey items of this survey, QT interval prolonged had the lowest incidence (3.8%) in the overseas/Japanese clinical studies of Istodax in patients with PTCL. When 130 subjects are collected, it would be possible to collect at least 1 case of an event that occurs at the frequency of 2.3% with a reliability of 95%. Thus, assuming that adverse events occur under the actual use conditions at similar frequencies as in clinical studies, it would be possible to obtain at least 1 case of all events that have been established as the key survey items.

Brief summary: To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax.

1. Planned registration period 4 years
2. Planned surveillance period 5 years and 6 months


Eligibility criteria: Inclusion Criteria:

- Patients who have been diagnosed with relapsed or refractory PTCL who receive Istodax for the first time.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Nihon Seimei Hospital
Study officials:
affiliation: Celgene
name: Jinshu Cho, MD
role: STUDY_DIRECTOR
References: