louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05099016: Joint Effort Study
Official title: Taking Action to Better Manage Cannabis Use Among Young Adults: Preliminary Evaluation of a Digital Tailored Prevention Tool With a Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot randomized controlled trial (RCT) will be conducted to evaluate the acceptability and feasibility of a digital tailored prevention tool (i.e., the Joint Effort mobile application) aimed at supporting university-level students into taking action on their cannabis use. The two main objectives of the proposed study are:

1. To assess the acceptability of the Joint Effort mobile application in terms of uptake, engagement and intervention appreciation.
2. To document the feasibility of the study processes in terms of online recruitment rate, adherence to online data collection methods, and attrition rate.


Eligibility criteria: Inclusion Criteria:

* active cannabis user (i.e., having used cannabis at least once in the past month)
* able to understand French
* own an iPhone (running on iOS 13 or higher).

Primary outcomes:
measure: Uptake of the developed mobile application (acceptability)
timeFrame: 6 months
measure: Subjective engagement with the developed mobile application (acceptability)
timeFrame: 4-weeks post baseline
measure: Objective engagement with the developed mobile application (acceptability)
timeFrame: 6 months
measure: Mobile application appreciation (acceptability)
timeFrame: 2-weeks post baseline
Secondary outcomes:
measure: Online recruitment rate (feasibility of the study processes)
timeFrame: 6 months
measure: Adherence to data collection methods (feasibility of the study processes)
timeFrame: baseline, 4-weeks post baseline, 8-weeks post baseline
measure: Attrition rate (feasibility of the study processes)
timeFrame: 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Université de Montréal
Study officials:
References:
Clinical trial NCT00688116: Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors
Official title: A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumors
Keywords: metastatic cancer
solid tumor
histologically or cytologically confirmed non-hematological malignancy that is metastatic or unresectable
STA-9090
ganetespib
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2008-06-02
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

Detailed description: This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated with STA-9090 (ganetespib) to evaluate for safety, tolerance and efficacy.

Eligibility criteria: Inclusion Criteria:

* Patients must be documented to be refractory or not candidates for current approved therapies. - Must have anECOG status 0-2. - Peripheral neuropathy ?2.
* Must have acceptable organ and marrow function per protocol parameters.
* No clinically significant ventricular arrythmias or ischemia.

Exclusion Criteria:

* Must not be pregnant or breastfeeding. -No chemotherapy or radiation within 3 weeks..
* No previous radiation to \>25% of total bone marrow.
* No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem cell transplantation.
* No primary brain tumors or active brain metastases.
* No use of any investigational agents within 4 weeks.
* No treatment with chronic immunosuppressants.
* No uncontrolled, intercurrent illness.

Primary outcomes:
measure: The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug.
timeFrame: Cycle 1
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC) - Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
Study officials:
References:
Clinical trial NCT00771316: Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated Urinary Tract Infection (0826-054)
Official title: A Phase 3, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK0826 and Meropenem in Patients With Complicated Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urinary Tract Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 6
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 purpose of this study is to demonstrate that MK0826 is comparable to Meropenem in the treatment of complicated Urinary Tract Infections (UTIs) in adults.


Eligibility criteria: Inclusion Criteria:

* Patient has a clinically suspected and /or bacteriologically documented complicated UTI or acute pyelonephritis judged by the investigator to be serious
* Patient has one positive urine culture within 48 hours of enrollment
* Patient has one or more signs or symptoms of either upper or lower UTI
* Patient is male with or without a bladder catheter or urologic abnormalities; OR patient is a female with a history or clinical evidence of one or more urologic abnormalities

Exclusion Criteria:

* Patient has received any amount of effective concomitant antibiotic therapy after obtaining the urine culture for admission to this study (admission urine culture) and prior to the administration of the first dose of study antibiotics
* Patient's infection has been treated with greater than 24 hours of systemic antibiotic therapy known to be effective against the presumed or documented pathogens within the 72 hour period immediately prior to consideration for entry into the study
* Patient has complete obstruction of any portion of the urinary tract. Patient has a history of seizures other than an uncomplicated febrile seizure

Primary outcomes:
measure: Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at the 5 to 9 Day Post Therapy Early Follow-up Visit
timeFrame: 5 to 9 days post therapy
measure: Number of Participants With Serious Urinary Tract Infection With a Clinical Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)
timeFrame: After at least 4 days of IV therapy
measure: Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)
timeFrame: After at least 4 days of IV therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00541216: Ephedrine for the Treatment of Congenital Myasthenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Myasthenic Syndromes, Congenital
Keywords: congenital myasthenia
ephedrine
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-10-10
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Previous research has demonstrated possible efficacy of Ephedrine in the treatment of congenital myasthenia caused by end-plate acetylcholinesterase deficiency.

The aim of the current study is to test the hypothesis that Ephedrine may be beneficial to these patients.

To test this hypothesis we will perform a double blind, placebo-controlled, crossover study clinical efficacy and safety study.

Drug naïve patients who agree to participate will be randomized to two groups. Each group will be treated in a blinded manner for 5 weeks with either placebo or Ephedrine HCl in an escalating dose up to 100 mg per day divided in two doses. After five weeks the groups will cross over and continue treatment or placebo for a further five weeks.

Evaluations of strength and fatiguability will be done at baseline, at the end of each five week period and after a further two weeks.

Safety will be assessed weekly by the investigators using interview and physical examination.

Outcome measures will include Barthel index, Quality of life questionnaire, Timed up and go, spirometry, timed elevation of limbs, and force measurements.

All patients will report to the clinic as per study schedule (See Appendix A). Specifically, the 12 clinic visits will include: baseline (1), safety and efficacy assessments(10) and closeout (1).


Eligibility criteria: Inclusion Criteria:

* Male or female patients , with congenital myasthenia, belonging to a previously reported kindred diagnosed with COLQ deficiency.

Exclusion Criteria:

* History of allergy to Ephedrine or any inactive component.
* Significant abnormalities in screening Cardiovascular parameters (blood pressure, pulse).
* Surgery within 6 weeks of screening.
* Concurrent use of any other medication except steroids.
* Pregnancy.
* Thyrotoxicosis.
* Co-morbid conditions or other neurological disorders that would confound assessment of clinical parameters.
* Participation in another clinical trial within 30 days of study start.
* Patients who are non-cooperative or parents/ legal guardians who are unwilling to sign consent form.

Primary outcomes:
measure: strength and fatiguability: walking, straight arm raising, spirometry.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah Medical Organization
name: Simon Edvardson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00784316: Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
Official title: Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Cardiac Surgery
Keywords: Prevention
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Vaasa Central Hospital, Vaasa, Finland
First posted: 2008-11-02
Enrollment: 316
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to test the efficiency of intravenous administration of metoprolol versus intravenous administration of amiodarone in the prevention of atrial fibrillation after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* elective CABG and aortic valve patients in cardiac surgery,
* previous use of betablocker therapy

Exclusion Criteria:

* previous atrial fibrillation or flutter,
* thyroid disease,
* uncontrolled heart failure,
* II or III degree atrioventricular block

Primary outcomes:
measure: Incidence of atrial fibrillation
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Halonen jari
Study officials:
References:
citation: Halonen J, Loponen P, Jarvinen O, Karjalainen J, Parviainen I, Halonen P, Magga J, Turpeinen A, Hippelainen M, Hartikainen J, Hakala T. Metoprolol versus amiodarone in the prevention of atrial fibrillation after cardiac surgery: a randomized trial. Ann Intern Med. 2010 Dec 7;153(11):703-9. doi: 10.7326/0003-4819-153-11-201012070-00003.
Clinical trial NCT01512316: Exploring Learning and Unlearning of Fear
Official title: The Effect of D-cycloserine on Fear Learning and Extinction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy Individuals
Keywords: Fear
Cycloserine
Conditioning
Functional neuroimaging
Anxiety disorders
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study investigates the effect of d-cycloserine on learning and unlearning of fear in healthy humans and its underlying effect on the amygdala.

As a second objective, the effect of genotype on fear learning will be studied.

Detailed description: A growing body of evidence suggests that the extinction of fear is mediated by the N-methyl-D-aspartate (NMDA) receptor activity in the basolateral amygdala. Intra-amygdala infusions of antagonists of this glutamate receptor in small animals (eg: rats, mice) have demonstrated a blockage of fear acquisition and extinction. Agonists, on the other hand, facilitate conditioned fear extinction.

The animal studies are all based on the simple fear learning paradigm of conditioning. However, it is not clear that human anxiety disorders are based on prior conditioning encounter. Therefore it is important to disentangle the effect of DCS on acquisition and extinction in the context of a simple learning paradigm, particular its effect on the human amygdala.

Eligibility criteria: Inclusion Criteria:

* No axis I diagnosis compatible with the DSM-IV by means of a structured diagnostic interview
* Right-handed

Exclusion Criteria:

* Current psychopharmacological or psychological treatment.
* The presence of a physical/medical condition that may interfere with the study.
* A contraindication for the use of DCS
* Pacemaker, medication pump (such as insulin pump), hearing aid, removable prosthodontics
* Metal in or on body (such as acupuncture needles, artificial limbs, stents, metal splints, clips, implanted electrodes, tattoos, or piercings)

Primary outcomes:
measure: change in BOLD-signal during a fear conditioning task
timeFrame: t0, t+24, t+48
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Catholic University Leuven, Departement of Radiology
Study officials:
References:
Clinical trial NCT06011616: Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy
Official title: Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 44
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 group parallel randomized control trial; both groups will be recruited and provided with interventions in parallel
Primary purpose: TREATMENT

Brief summary: The study aims to determine the effects of upper limb sensorimotor training as compared to task oriented raining in subjects with cerebral palsy. The study will target the upperlimb functions using multiple outcomes and will find the changes in subjects undergoing sensorimotor or task oriented training.

Detailed description: The stduy will include subjects fulfilling the inclusion criteria, will be divided into 2 groups; interventional and control. The interventional group will be recieving sensorimotor training comprising of sensory activities and motor activities. The control group will be having motor activities in the form of task oriented training. The duration of intervention would be 40 minutes in each group, 3 days a week, for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Hemiplegic cerebral palsy Modified Ashworth scale score 2 and 3

Exclusion Criteria:

* Other neurological disorders Previous upper limb surgeries Botox injection in last 1 year

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline
measure: Modified Ashworth Scale (MAS)
timeFrame: After 4 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: After 8 weeks
measure: Finger Joint Position Sense
timeFrame: Baseline
measure: Finger Joint Position Sense
timeFrame: After 4 weeks
measure: Finger Joint Position Sense
timeFrame: After 8 weeks
measure: Manual ability classification system
timeFrame: Baseline
measure: Manual ability classification system
timeFrame: After 4 weeks
measure: Manual ability classification system
timeFrame: After 8 weeks
measure: Manual Muscle Testing
timeFrame: Baseline
measure: Manual Muscle Testing
timeFrame: After 4 weeks
measure: Manual Muscle Testing
timeFrame: After 8 weeks
measure: Abilities of Hand (ABILHAND-KIDS)
timeFrame: Baseline
measure: Abilities of Hand (ABILHAND-KIDS)
timeFrame: After 4 weeks
measure: Abilities of Hand (ABILHAND-KIDS)
timeFrame: After 8 weeks
measure: Pediatric Arm Function Test
timeFrame: Baseline
measure: Pediatric Arm Function Test
timeFrame: After 4 weeks
measure: Pediatric Arm Function Test
timeFrame: After 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Alfarabi Special Education Centre/ Physical Health Centre
state: Islamabad Capital Territory
Study officials:
affiliation: Riphah International University
name: Kiran Khushnood, MSNMPT
role: STUDY_CHAIR
References:
Clinical trial NCT01032616: Uptake and Utilization of Amino Acids by Splanchnic Bed
Official title: Determination of the Difference in Uptake and Utilization of Two Amino Acids by the Splanchnic Bed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Males
Keywords: splanchnic bed
theronine and lysine metabolism uptake
isotopes
metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed by Healthy Males
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Splanchnic uptake and metabolism contributes significantly to the differences in flux seen between the intravenous and intragastric ingestion of certain indispensable amino acids.

This is the third in a series of studies designed to increase the investigators knowledge of the metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed. In the initial two studies the investigators established the neonatal parenteral requirement of threonine and lysine. In the current study, the investigators will be examining the differences in uptake and metabolism of threonine and lysine across the splanchnic bed.

Detailed description: We propose that we will see a smaller amount of enterally fed isotopes reach the plasma as compared to the amount in plasma from the parenterally delivered isotopes. We also believe that the amount of enterally delivered threonine isotope that reaches the plasma will be significantly less than the amount of enterally fed lysine isotope.

Eligibility criteria: Inclusion Criteria:

* Healthy Males

Exclusion Criteria:

* History of inborn error of metabolism
* Presence of a chronic disease
* Have unusual dietary practices
* Has recently lost weight
* Receiving pharmacological therapy or hormonal treatment

Primary outcomes:
measure: Breath VCO2
timeFrame: -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs
measure: Blood CO2
timeFrame: -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Paul Pencharz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02649816: Effectiveness of Resin Sealants: Retrospective Cohort Study
Official title: A Retrospective Cohort Study on Clinical Success of Resin Sealants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: Pit and fissure sealants
Dental Caries
Prevention
Dental undergraduate students
patient's caries risk
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 88
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at Piracicaba Dental School - Brazil

Brief summary: This retrospective cohort study assessed sealant clinical success applied to pit and fissure by dental undergraduate students at Piracicaba Dental School - Brazil.

Detailed description: A population presenting 1st/2nd permanent molars with sealed occlusal surfaces were considered. Dental records were reviewed for: patient's caries risk (High/Low); operator experience (scores 1 to 4, beginners to seniors); number of follow-up visits; isolation procedure; sealant/tooth type; and age at placement. Posteriorly, the patients were called to dental evaluation and the sealed teeth were classified regarding the sealant presence, partial presence or absence, with or without caries, or sealant replacement to a restorative material in Satisfactory or Unsatisfactory, considering the caries presence/absence. Successful outcome was considered in the caries absence.

Eligibility criteria: Inclusion Criteria:

* A population presenting first and second permanent molars with sealed occlusal surfaces by dental undergraduate students at Piracicaba Dental School Brazil.

Exclusion Criteria:

* First and second permanent molars with sealed occlusal surfaces by dentistry.

Primary outcomes:
measure: Probability (%) of the caries development in the treated teeth assessed by Kaplan-Meier survival analysis (Bioestat 5.3).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Piracicaba Dental School - University of Campinas
name: Juliana Camargo
role: PRINCIPAL_INVESTIGATOR
affiliation: Piracicaba Dental School - University of Campinas
name: Kelly Moreira
role: PRINCIPAL_INVESTIGATOR
References: