louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01002820: A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
Official title: A Treatment Protocol for Ganaxolone as add-on Therapy in Adult Patients With Uncontrolled Partial-onset Seizures Deriving Benefit From Protocol 1042-0601
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy, Complex Partial
Keywords: Epileptic Seizures
Seizure Disorder
Seizures
Convulsions
Anticonvulsant
Anticonvulsive
Antiepileptic
Ganaxolone
Lead sponsor: Marinus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.


Eligibility criteria: Inclusion Criteria:

* subjects who have completed all study visits from previous protocol 1042-0601 and have been deemed eligible by the Investigator as:
* having had no major adverse events thought to be drug related
* deriving benefit from ganaxolone treatment
* be properly informed of the nature and risks of the study and give written informed consent prior to study entry
* must be willing to use a medically acceptable method of birth control and if female of child-bearing potential, have a negative qualitative serum pregnancy test

Exclusion Criteria:

* significant medical or surgical condition at screening or that develops during protocol participation that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems, or other conditions that would place the subject under increased risk
* unwilling to use a double-barrier method of birth control or submit to a serum pregnancy test
* history of chronic non-compliance with drug regimens
* females currently breastfeeding
* AST or ALT levels greater than 3 times the upper limit of normal at screen
* Inability to withhold grapefruit or grapefruit products during the study

Primary outcomes:
measure: Investigators Global Assessment
timeFrame: Screening through 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California, Dept of Neurology
state: California
city: Lexington
country: United States
facility: University of Kentucky, Dept of Neurology
state: Kentucky
city: Albany
country: United States
facility: Albany Medical Center, Dept of Neurology
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Riddle Health Care Center II
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Comprehensive Epilepsy Center
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References:
Clinical trial NCT06439420: CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
Official title: Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Primary Brain Tumor
Glioblastoma
Astrocytoma
Oligodendroglioma
Meningioma
Primary Central Nervous System (CNS) Lymphoma
Keywords: Brain Tumor
Insomnia
Glioma
Sleep
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 70
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 seeks to investigate an evidence-based, manualized, behavioral health intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I), in individuals with primary brain tumors (PBT) and insomnia. Our project will assess the feasibility and acceptability of recruitment, enrollment, data collection procedures, and retention of individuals with PBT and insomnia in the behavioral health intervention, CBT-I, and investigate the potential benefits of CBT-I within this at-risk and understudied population. In the long term, the goals are to expand treatment options for neuro-oncology patients and improve their mission readiness and overall wellbeing.


Eligibility criteria: Inclusion Criteria:

* Primary brain tumor diagnosis (grade I-IV)
* \>/=2weeks post-cranial resection (if applicable)
* \>/=1 month post-radiation therapy (if applicable)
* Able to understand, speak, and read English
* Absence of major cognitive concerns
* Meet Diagnostic and statistical manual of mental disorders version 5 (DSM-V) diagnostic criteria for insomnia
* Reliable internet connection

Exclusion Criteria:

* Major communication difficulties that would prohibit effective intervention
* Inability to attend weekly virtual group meetings
* Inability to understand and provide informed consent
* Currently a prisoner or residing in a correctional facility

Primary outcomes:
measure: Rate of consent to screening procedures
timeFrame: Baseline (Day 1)
measure: Rate of those eligible enrolling
timeFrame: Baseline (Day 1)
measure: Rate of baseline assessment completion
timeFrame: Week 1
measure: Rate of post-intervention assessment completion
timeFrame: Week 6
measure: Rate of follow-up assessment completion
timeFrame: Week 18
measure: Rate of intervention attrition
timeFrame: Week 6
measure: Acceptability of quantity of assessments
timeFrame: Week 18
measure: Acceptability of timing of assessments
timeFrame: Week 18
measure: Acceptability of duration of assessments
timeFrame: Week 18
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ashlee Loughan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198820: Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome
Official title: Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome in the Saint-Luc Bouge Hospital
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Femoral Neck Fractures
Keywords: Femoral Neck Fractures
Perioperative Care
Perioperative Period
Postoperative Complications
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 0
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: All patients admitted at the Saint-Luc Bouge Hospital for a femoral neck fractures

Brief summary: Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015.

Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome.

Detailed description: Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015.

Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome.

This comparison includes preoperative parameters (hemoglobin, creatinine, mini-mental test) and intraoperative parameters (such as type of anesthesia).

Eligibility criteria: Inclusion Criteria:

* All patients admitted at the Saint-Luc Bouge Hospital for a femoral neck fractures between 10/01/2014 and 30/09/2014

Exclusion Criteria:

* None

Primary outcomes:
measure: Preoperative assessment
timeFrame: 1 month
Secondary outcomes:
measure: Perioperative assessment
timeFrame: 1 month
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Clinique Saint-Luc de Bouge
Study officials:
affiliation: Astes
name: Eric P DEFLANDRE, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416920: A Smartphone-based Application Post-myocardial Infarction to Manage Cardiovascular Disease Risk
Official title: A Smartphone-based Application Post-myocardial Infarction to Manage Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Coronary Intervention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: Wellframe, Inc.
First posted: 2018-01-31
Enrollment: 167
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Enroll and onboard 150 patients with the Wellframe application
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators aim to evaluate Wellframe, a patient engagement platform that includes a mobile phone application for patients, for its impact on supporting patients who have undergone a percutaneous coronary intervention. The patient mobile app has articles about cardiovascular disease and other health related topics, patient-reported outcomes surveys, physical activity tracking, reminders for medications and upcoming appointments, and two-way communication with a Wellframe Health Advocate. The Wellframe Health Advocate encourages patients to achieve their health goals and stay engaged in their health. The feasibility of onboarding patients to the app and the clinical efficacy of the platform will be evaluated.


Eligibility criteria: Inclusion Criteria:

English-speaking PCI: balloon angioplasty, bare-metal stent, or drug-eluting stent at MGH Smartphone or Tablet (iOS or Android)

Exclusion Criteria:

Recent (within 1mo) illicit substance use or alcohol abuse In-hospital AMI Known pregnancy Dementia or cognitive disability Incarceration

Primary outcomes:
measure: Number of Participants With Readmission at 30 Days
timeFrame: 30 Days
Secondary outcomes:
measure: Number of Participants With Readmission at 90 Days
timeFrame: 90 Days
measure: Number of Participants Enrolled in Clinic-based Cardiac Rehab at 90 Days
timeFrame: 90 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetss General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Pradeep Natarajan, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paruchuri K, Finneran P, Marston NA, Healy EW, Andreo J Jr, Lynch R, Blood AJ, Jones-O'Connor M, Lander B, Kelly N, Vivaldi MT, Traynor K, Wiviott S, Natarajan P. Outcomes of a smartphone-based application with live health-coaching post-percutaneous coronary intervention. EBioMedicine. 2021 Oct;72:103593. doi: 10.1016/j.ebiom.2021.103593. Epub 2021 Oct 14.
Clinical trial NCT05725720: Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy
Official title: Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diffuse Large B Cell Lymphoma
Keywords: Gut microbiome
CAR T-cell therapy
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: Associazione Italiana per la Ricerca sul Cancro
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
First posted: 2023-02-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 90 relapsed/refractory diffuse large B-cell lymphoma adult (≥18 years) patients undergoing CAR-T cell therapy will be enrolled over 3 years, treated and followed up with fecal sample collection until 18 months after CAR-T cell infusion.

Brief summary: Despite impressive outcomes in selected patients, significant heterogeneity in clinical response to CAR-T cell therapy remains. The gut microbiome (GM) has recently emerged as one of the key modifiable factors of prognosis and response to treatment in cancer patients, with high-diversity profiles rich in health-associated taxa while poor in pathobionts generally associated with better response and longer survival. Currently, it is unknown if GM also modulates anti-tumor responses to CAR-T cells and related toxicities in lymphomas.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Patients affected by histologically confirmed DLBCL.
3. Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products).
4. Patients must provide written informed consent.

Exclusion Criteria:

1. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
2. Concurrent second malignancy.

Primary outcomes:
measure: Characterization of GM heterogeneity (taxa) in diffuse large B-cell lymphoma patients undergoing CAR-T cell therapy.
timeFrame: 24 months
Secondary outcomes:
measure: Correlation between GM and CAR-T cell therapy outcomes in terms of response, toxicity and disease control.
timeFrame: 4 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Institute Of Hematology "Seràgnoli"
Study officials:
References:
Clinical trial NCT00069420: Cognitive Motivational Behavior Therapy for Gamblers
Official title: Cognitive-Motivational Behavior Therapy for Gamblers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gambling
Lead sponsor: University at Albany
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of cognitive motivational behavior therapy (CMBT) in treating pathological gamblers.

Detailed description: Pathological gambling is developing into a serious public health problem. The rise in gambling problems has stimulated treatment studies, but little progress has been made. A particular concern is the high dropout rates from treatment studies; gamblers often seek treatment, but fail to complete it and relapse. This study will test the effectiveness of CMBT in helping to increase retention rates in gambling treatment studies.

The first step in this study is designed to enhance gamblers' readiness for change. When participants are committed to change, CMBT will then address specific cognitive biases regarding the notion of randomness, which is thought to lie at the heart of gambling problems. Behavioral components will also be used to enhance gamblers' coping skills.

The participants in this study will be randomly assigned to either CMBT or a Gambler's Anonymous control group. Participants will be assessed prior to and after treatment and at 3- and 6-month follow-up visits. Interviews and questionnaires will be used to assess participants.

Eligibility criteria: Inclusion Criteria:

* DSM-IV criteria for pathological gambling
* Eighth grade reading ability
* Reside in the Albany, NY area

Exclusion Criteria:

* Diagnosis of serious psychopathology, including psychosis, bipolar disorder, or alcohol or other substance dependence

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: University at Albany - SUNY
state: New York
Study officials:
References:
Clinical trial NCT00468520: Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial
Official title: A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Induced Labor
Cervical Ripening
Keywords: induction of labor
cervical ripening
Foley catheter
oxytocin
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2007-05-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.

Detailed description: This is a prospective, randomized trial that aims to enroll 200 singleton pregnancies presenting for preinduction ripening. Patients will be randomized to receive either TFC alone (control) or TFC plus low-dose oxytocin (treatment). Providers will not blinded to use of oxytocin and labor was managed according to routine obstetric protocols. This study is powered to detect a 20% difference in the proportion of patients delivered within 24 hours, the primary outcome. Secondary outcomes are related to vaginal delivery rate, duration of induction, complications, and pain management.

Eligibility criteria: Inclusion Criteria:

* singleton gestation
* presenting for induction as determined by their primary obstetrical provider
* with fetuses in cephalic presentation
* gestational age greater than 23 weeks

Exclusion Criteria:

* any condition precluding vaginal delivery
* estimated fetal weight \>4500 grams
* a previous attempt at ripening or induction during the pregnancy
* clinically significant cervical or vaginal infection
* chorioamnionitis
* HIV
* hepatitis B or C
* unexplained vaginal bleeding
* low-lying placenta
* abnormal cervical anatomy or cervical cerclage
* latex allergy

Primary outcomes:
measure: Delivery rate (proportion)
timeFrame: Within 24 hours
Secondary outcomes:
measure: vaginal delivery rate
timeFrame: within 24 hours
measure: use of anesthesia/analgesia
timeFrame: during induction and labor
measure: overall complication rate (composite)
measure: duration of induction and labor
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Patricia C Devine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.
Clinical trial NCT03744520: Sensorial Block Assessment of Erector Spinae Block
Official title: Assessment of Dermatomal Sensorial Block of Erector Spinae Plane Block: Randomized, Prospective, Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia Morbidity
Keywords: regional anesthesia
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Ultrasound-guided erector spinae plane blocks are used as postoperative analgesia method for abdominal, chest and hip surgeries. Regional techniques are well-described methods for postoperative analgesia. However, the sensorial dermatomal spread of regional block varies depending on the multiple variables as the level of the block, local analgesic concentration etc. The aim of this study is to observe dermatomal evaluation of sensorial block.


Eligibility criteria: Inclusion Criteria:

* The patients who received successful erector spinae plane block for postoperative analgesia

Exclusion Criteria:

* Patients under 18 years old
* Patients who are not able to communicate with
* Patients who are on medication which may change the perception of pain.

Primary outcomes:
measure: Spread of sensorial block
timeFrame: in postoperative sixth hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University Medical Faculty
state: Maltepe
Study officials:
References:
Clinical trial NCT01092520: Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children
Official title: Open Label Pilot Study of Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pruritus
Keywords: Gabapentin
Burn Injuries in Children
pruritus
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children with healing burns often suffer from pruritus that may continue for many months. Pruritus can be very distressing to the child and can interfere with sleep, activities of daily living, and rehabilitation therapy. Additionally, constant scratching of skin grafts may result in damage that requires further surgery, thus putting the patient at additional risk and adding to health care costs. Although the size of the burn injury is a risk factor for pruritus, almost 50% of patients with small burn injuries reported moderate or severe pruritus.

Detailed description: Gabapentin has been shown to be effective for the treatment of pruritus in adult patients with brachioradial pruritus, uraemic pruritus and pruritus of unknown origin. Although the specific mechanism is unknown, the end result is the downregulation of excitatory neurotransmitter release and decrease in neuronal hyperexcitability.

The primary objective of this study is evaluating the effectiveness of gabapentin in reducing the severity of pruritus in children with burn injuries.

Eligibility criteria: Inclusion Criteria:

1. Children with partial or deep thickness burn
2. Children receiving triple antihistamines for treatment of pruritus
3. Children with a pruritus score ≥ 2 (Appendix 1) despite triple antihistamine therapy
4. Children who are tolerating liquids by mouth or nasogastric tube

Exclusion Criteria

1. Children with a medical condition for which gabapentin is contraindicated including children who have demonstrated a hypersensitivity to gabapentin or any of the components of the formulation.
2. Children with seizure disorders
3. Children with a pre-existing behavioural or developmental disorder
4. Children with renal impairment
5. Children with severe burns requiring PICU admission

Primary outcomes:
measure: Pruritus score
timeFrame: Daily until discharge
Secondary outcomes:
measure: Quality of Life Score
timeFrame: Daily until discharge
measure: Antihistamine use
timeFrame: Daily until discharge or cessation of antihistamines
measure: Opioid Consumption
timeFrame: Daily until discharge or cessation of opioid intake
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jason Hayes, MD
role: PRINCIPAL_INVESTIGATOR
References: