louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05891366: Single Ascending Dose Study of WAL0921 in Healthy Subjects
Official title: Safety, Pharmacokinetics, and Pharmacodynamics of a Single, Ascending Dose of WAL0921 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Walden Biosciences
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of WAL0921 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing
2. Healthy individuals without known current or chronic medical conditions in the opinion of the Investigator
3. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2

Exclusion Criteria:

1. Clinically significant findings in physical examination, vital signs (blood pressure, heart rate, and body temperature), ECG, and safety laboratory parameters at screening in the opinion of the Investigator
2. Renal function calculated by the CKD-EPI (2021) equation with eGFR \<90 mL/min/1.73 m2 at the time of screening
3. Abnormal levels of proteinuria detected on Urine Protein-Creatinine Ratio (UPCR) test \>0.30 g/g
4. Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: Day 1 to Day 64
Secondary outcomes:
measure: Number of participants with clinically significant changes in hematology lab values
timeFrame: Day 64
measure: Number of participants with clinically significant changes in chemistry lab values
timeFrame: Day 64
measure: AUC
timeFrame: Day 1 to Day 64
measure: Cmax
timeFrame: Day 1 to Day 64
measure: Half-life
timeFrame: Day 1 to Day 64
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Pharmacology Unit
state: Texas
Study officials:
affiliation: Walden Biosciences, Inc.
name: Andrew Blair, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01252966: Cognitive Training for Nicotine Dependence
Official title: Cognitive Training for Nicotine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Nicotine Addiction
Keywords: Tobacco
Smoking
Cognition
Behavioral Training
Relapse
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 213
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: This randomized clinical trial tested the effects of a computerized (web-based) cognitive training intervention on smoking cessation.

All participants received 8 weeks of standard nicotine patch therapy, smoking cessation counseling, and were randomized to 1 of 2 different training programs: cognitive training vs. control training.


Eligibility criteria: Inclusion:

1. Healthy male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months
2. Plan to live in the area for at least the next 8 months
3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form
4. Able to communicate fluently in English (speaking, writing, and reading)
5. Have uninterrupted access to a home computer with sound capabilities, keyboard, mouse, and active Internet connection
6. Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 8 parts per million (ppm) at Intake Visit

Primary outcomes:
measure: Point-prevalence Abstinence at End of Treatment
timeFrame: End of treatment (Week 12)
Secondary outcomes:
measure: Point-prevalence Abstinence at 6-month Follow-up
timeFrame: 6 month follow-up
measure: Cognitive Performance (Working Memory)
timeFrame: Baseline and Week 12 (EOT)
measure: Cognitive Performance (Response Inhibition)
timeFrame: Baseline and Week 12 (EOT)
measure: Cognitive Performance (Attention)
timeFrame: Baseline and Week 12 (EOT)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Interdiscplinary Research on Nicotine Addiction, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Caryn Lerman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kable JW, Caulfield MK, Falcone M, McConnell M, Bernardo L, Parthasarathi T, Cooper N, Ashare R, Audrain-McGovern J, Hornik R, Diefenbach P, Lee FJ, Lerman C. No Effect of Commercial Cognitive Training on Brain Activity, Choice Behavior, or Cognitive Performance. J Neurosci. 2017 Aug 2;37(31):7390-7402. doi: 10.1523/JNEUROSCI.2832-16.2017. Epub 2017 Jul 10.
Clinical trial NCT00823966: Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
Official title: Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A4351010 prescribes the Delavirdine Mesilate(Rescriptor).

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first Rescriptor® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

Patients need to be administered Rescriptor® in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered Rescriptor®.

Primary outcomes:
measure: Number of Participants Who Reported Unlisted Adverse Drug Reaction.
timeFrame: One Year
measure: Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category).
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06716866: Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy
Official title: Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy - Effect of Temporal Interference on Biomarkers of Epilepsy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy
Keywords: temporally-interfering electric fields
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Emory University
name: St. Anne's University Hospital Brno, Czech Republic
name: Semmelweis University
name: HÃ´pital de la Timone (MARSEILLE)
First posted: 2024-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the potential for temporally-interfering electric field stimulation (TIEFS) to treat epilepsy. In this case series within and between subjects design, the impact of TIEFS on epilepsy biomarkers was studied in patients with medial temporal lobe epilepsy.

Secondary analyses examine the underlying physiological effects of TIEF on local brain activity and brain networks.

Detailed description: Participants Patients with drug-resistant focal epilepsy and a clinical diagnosis of medial temporal epilepsy undergoing invasive intracranial electrophysiology studies will be consented in accord with institutional review boards at Emory University, Saint-Anne University Hospital, and the Institute of Neurosurgery and Neurointervention, Semmelweis University. The determination of medial temporal epilepsy is based on clinical semiology, EEG, PET, MRI, and invasive electrophysiology. Across all centers, patients underwent the stimulation protocols 6 to 10 days post-implantation after patient-specific electric field modeling to determine TIEFS electrode placement.

Patients then undergo two sessions of TIEFS on separate days, one sham (aligned carriers), and one active (with an offset in frequency between the carriers to provide a lower-frequency modulation envelope at the anatomical target.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing invasive intracranial EEG studies

Exclusion Criteria:

* None

Primary outcomes:
measure: Reduction of Interictal Biomarkers of Epilepsy
timeFrame: From enrollment until the end of the admission for each patient (the admission is typically 7-14 days in duration).
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Brno
country: Czech Republic
facility: St. Anne Hospital, Masaryk University
Study officials:
References:
Clinical trial NCT00262366: Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula
Official title: Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-12-06
Enrollment: 45
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: Comparison of automatic CPAP with fixed CPAP in patients with OSAS

Detailed description: The polysomnography is divided into two parts, randomly assigned:

* in one part, the patient uses the automatic CPAP device in titration mode
* in the other part, the patient uses the CPAP device, in fixed mode according to the prediction formula

Eligibility criteria: Inclusion Criteria:

* Patients with proven Obstructive Sleep Apnea Syndrome
* Apnea-hypopnea-index \> 20/h
* Awaking index \> 30/h

Exclusion Criteria:

* Severe nasal obstruction
* Hypoventilation
* Excessive sleep fragmentation caused by non-respiratory factors
* COPD (FEV1/FVC \< 65%)
* CPAP compliance \< 3h per night
* Insufficient sleep time (\< 2h TST) during one of both parts of the split night CPAP-titration
* Patients needing \> 16 mbar CPAP pressures

Primary outcomes:
measure: Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring
measure: Arousal index
measure: Pressure profile Auto-CPAP (P50, P95 en Pmax)
measure: All outcomes are measured during polysomnography
Secondary outcomes:
measure: Pressure adaptation during polysomnography according to body position and sleep stage, pressure variability
measure: Measurements of comfort, subjective evaluation by the patient by questionnaires immediately after polysomnography
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Dirk Pevernagie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02437266: Effect of Scapular Mobilization on Patients With Scapular Pain
Official title: Effect of Scapular Mobilization on Patients With Scapular Pain Associated With Myofascial Trigger Point
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Pain Syndrome
Lead sponsor: Mae Fah Luang University Hospital
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of scapular mobilization on pain related parameters including pain intensity, pressure pain threshold, muscle tension, anxiety, Scapular range of motion, patient satisfaction in patients with scapular pain associated with myofascial trigger point:


Eligibility criteria: Inclusion Criteria:

* The participants have experienced spontaneous scapular pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the muscles surrounding the scapula. Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
* The participants will be able to follow instructions.
* Good communication and cooperation.

Exclusion Criteria:

* Shoulder impingement syndrome
* Adhesive capsulitis
* Shoulder instability
* Shoulder arthritides
* Shoulder dislocation and/or bone fracture
* Hypermobility of shoulder joint
* Open wound
* Drug and/or alcohol intoxication
* Contraindications of mobilization

Primary outcomes:
measure: Pain score on Visual analog scale
timeFrame: 5 weeks
Secondary outcomes:
measure: Pressure Pain Threshold as a measure by pressure algometry
timeFrame: 5 weeks
measure: Anxiety on State Anxiety Inventory
timeFrame: 5 weeks
measure: Scapular range of motion
timeFrame: 5 weeks
measure: Patient satisfaction level
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Mueang
country: Thailand
facility: School of Health Science, Mae Fah Luang University
state: Chiang Rai
Study officials:
References:
Clinical trial NCT03297866: Effectiveness of Different Incentive Models in Booster up the Second Follow up Response Rate
Official title: Effectiveness of Different Incentive Models in Booster up the Second Follow up Response Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Test the Effectiveness of Different Incentive Models for Increasing the Follow-up Response Rate in the Current Smoker Subject
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 1246
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All Hong Kong residents

Brief summary: Aim to test the effectiveness of different incentive models for increasing the follow-up response rate in the current smoker subject.

Detailed description: According to the Hong Kong Census and Statistic Department, 10.5% of the Hong Kong population who aged 15 years or above are daily smokers (Thematic Household Survey Report - Report No. 59, 2016). The smoking prevalence was estimated from a thematic household survey that has been conducted every 2 or 3 years. Another population-based survey related to tobacco control is the Tobacco Control Policy-related Survey conducted by the Hong Kong Council on Smoking and Health and the University of Hong Kong. Both surveys were in a cross-sectional design and no follow-up was done. A cohort study with follow-up data could provide more insights for the causal relationship. However, most people are not willing to complete follow-up survey and the response rate is often low (Mellahi, 2016). The low survey response rate could lead to statistically bias in the research funding (Pit, 2014). Therefore, cohort surveys need to provide attractive monetary incentive to the interviewee to increase the response rate (Pit, 2014).

This study aims to assess and compare the 3-month response rate of a follow-up survey due to different financial incentive schemes. The findings will be used for a feasibility assessment of future cohort studies of evaluating tobacco control measures and public opinion, and exploration of appropriate incentive scheme.

Eligibility criteria: Inclusion Criteria:

* Aged 15 or above
* Cantonese or Mandarin speakers

Exclusion Criteria:

* Unable to provide a consent form
* Speak language other than Cantonese and Mandarin

Primary outcomes:
measure: Proportion of respondents who will complete the 3-month follow-up
timeFrame: Finish all telephone survey by Jan 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Public Opinion Programme, the University of Hong Kong
Study officials:
affiliation: Study Principal Investigator
name: Man Ping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheung YTD, Weng X, Wang MP, Ho SY, Kwong ACS, Lai VWY, Lam TH. Effect of prepaid and promised financial incentive on follow-up survey response in cigarette smokers: a randomized controlled trial. BMC Med Res Methodol. 2019 Jul 4;19(1):138. doi: 10.1186/s12874-019-0786-9.
Clinical trial NCT00671866: Neurotoxic Health Hazards of Long-Term Low-Level Exposure to Organophosphate (OP) Compounds in in Hula Valley
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Neuropathy
Keywords: OP
Pesticides
Long-Term Low Level Exposure
Occupational Health
Neurobehavioral Effects
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-05-05
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Kibbutzim

Brief summary: During 1987-1991, WHO supported studies of exposures and short term neurobehavioral effects in a cohort (n=200) with occupational and community exposures to pesticide drift containing organophosphates from orchards and cotton fields in the Hula Valley. We aim (1) to re-examine neurobehavioral outcomes in members of the original cohort and (2) to examine cognitive effects in children with residential exposures. In adults, we will carry out assays of alkyl phosphates, PON1 (paraoxonase-1), NTE (Neuropathy Target Esterase), neurobehavioral tests of cognitive and performance skills, nerve conduction measurements and mood status. We will carry out Psycho-Didactic tests in children. The findings will advance knowledge on delayed term health effects of lengthy everyday exposure to OP pesticides and guide regulatory policy.


Eligibility criteria: Inclusion Criteria:

* Participants of the former study twenty years ago

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Neurology and Toxicology Unit and Service, Shaare Zedek Med Ctr
Study officials:
References:
Clinical trial NCT04850066: Equine-assisted Intervention on Psychosocial Adjustment in Patients With Psychiatric Disorders
Official title: Evaluation of the Efficacy of an Equine-assisted Intervention on the Psychosocial Adjustment of Adult Patients Hospitalized and Monitored in Psychiatry: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Equine-assisted Therapy
Keywords: Psychiatry
Psychosocial adjustment
Lead sponsor: Centre Hospitalier de Dreux
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 98
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 assess the efficacy of a brief equine-assisted intervention on the social adjustment, assertiveness, self-esteem and coping strategies in adult patients with psychosocial dysfunction, hospitalized and followed in psychiatry, as compared to standard care.


Eligibility criteria: Inclusion Criteria:

Patients hospitalized in psychiatry with mental disorders lasting for more than 6 months with an EGF score on the Global Evaluation of Psychosocial Functioning scale of between 31 and 60 at the time of inclusion.

Exclusion Criteria:

* acute psychiatric crisis
* severe comorbidities (such as mental retardation, mental deterioration) which could invalidate informed consent or limit patient compliance with the study protocol.
* medical contraindication to equine-assisted therapy (allergy, immunocompromised patients)
* pregnancy
* no affiliation to a social security scheme
* deprivation of liberty by a judicial decision
* wardship
* horse phobia

Primary outcomes:
measure: Social adjustment (self reported)
timeFrame: Baseline and 6 months
measure: Social adjustment
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Assertiveness
timeFrame: Baseline, 2 and 6 months
measure: Self-esteem
timeFrame: Baseline, 2 and 6 months
measure: Ways of coping
timeFrame: Baseline, 2 and 6 months
Other outcomes:
Locations:
city: Dreux
country: France
facility: Centre Hospitalier Victor Jousselin
Study officials:
affiliation: Pôle Santé Mentale - Centre Hospitalier de Dreux
name: Pierre-Charles PARIS
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité de Recherche Clinique ARC en CIEL - Centre Hospitalier de Dreux
name: Anne HERON
role: STUDY_DIRECTOR
References: