louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04973111: A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose
Official title: A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess Pharmacokinetic and Pharmacodynamic Effects of CT-868 on the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Metabolic Diseases
Body Weight
Lead sponsor: Carmot Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.


Eligibility criteria: Inclusion Criteria:

* Part 1: Obese Otherwise Healthy Males
* Part 2: Males or Females with T2D
* Part 1: BMI 30.0-35.0, inclusive
* Part 2: BMI 27.0-45.0, inclusive
* 18-65 years old, inclusive
* Stable body weight for 2 months

Exclusion Criteria:

* Significant medical history
* Uncontrolled hypertension
* History of malignancy

Primary outcomes:
measure: Change in insulin secretion rate and ambient glucose levels
timeFrame: Baseline up to 4 days
Secondary outcomes:
measure: Change in blood insulin levels at each level of glucose infusion
timeFrame: Baseline up to 4 days
measure: Change in blood glucose levels at each level of glucose infusion
timeFrame: Baseline up to 4 days
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Carmot Clinical Research Unit 101
state: California
Study officials:
affiliation: Carmot Therapeutics, Inc., a member of the Roche Group
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04013711: Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy
Official title: Quantitative Thermal Imaging to Evaluate Skin Toxicity From Radiation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiotherapy Side Effect
Radiodermatitis
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A significant proportion of patients treated with whole-breast or head and neck radiotherapy will experience skin toxicity, i.e. skin dermatitis, which may lead to erythema, dry desquamation and wet desquamation. It is hypothesized that quantitative thermal imaging can be used to measure radiation-induced skin toxicity.

Detailed description: The aim of this study is to use quantitative thermal imaging to evaluate skin toxicity in patients treated with whole-breast or head and neck radiotherapy.

Eligibility criteria: Inclusion Criteria:

1. Biopsy-confirmed diagnosis of breast cancer (Stage 0-III) or head and neck cancer (all subtypes; stage I - IV) according to American Joint Committee on Cancer staging criteria.
2. Subjects must give appropriate written informed consent prior to participation in the study
3. Subjects must be able and willing to comply and understand the instructions associated with the imaging procedure.
4. Both men and women are eligible for participation
5. Subjects must be at least 18 years of age
6. Subjects must be receiving radiotherapy:

   1. adjuvant radiotherapy to the whole breast or chest wall, or;
   2. in the case of head and neck treatment, either as definitive treatment or adjuvantly.
7. definitive radiotherapy of the head and neck

Exclusion Criteria:

1. Subjects with any pre-existing dermatologic abnormalities (open sores, keloids, psoriasis) involving the treated breast or head and neck.
2. Patients with very hairy skin surface (this does not permit measuring the heat output)
3. Subjects with a current or past medical history of connective tissue disease.
4. Subjects who are pregnant or lactating (which usually preclude them from radiotherapy)
5. Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period.

Primary outcomes:
measure: Temperature changes in skin during radiotherapy.
timeFrame: 1 year
Secondary outcomes:
measure: Measure patient-reported toxicity using a validated self-assessment tool (Dermatology Quality of Life Questionnaire)
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Hospital
state: Ontario
Study officials:
affiliation: Clinician Scientist
name: William T Tran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03475511: The Usage of High-resolution Magnetic Resonance Imaging in Patients With Disorders of Consciousness for Early Diagnosis
Official title: The Usage of High-resolution Magnetic Resonance Imaging in Patients With Disorders of Consciousness for Early Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High-resolution Magnetic Resonance Imaging; Disorders of Consciousness
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These patients were admitted to the Department of Rehabilitation at Hangzhou Hospital of Zhejiang CAPR.

Brief summary: In this study, high-resolution brain functional magnetic resonance imaging (MRI) was used to evaluate the differences in brain structure and brain function network between patients with different degrees of disturbance of cognition and healthy controls by means of cohort follow-up and control study. The changes of patients' The dynamic changes of learning, to explore its clinical value as an early diagnosis. Combined with neurobehavioral scales and high-resolution brain structure, functional magnetic resonance imaging data to assess the brain structure, functional characteristics and consciousness of patients with impaired consciousness, and initially establish awareness of patients with recovery of consciousness Predictable imaging signs. Twenty eligible controls, 20 VS patients, and 20 MCS patients will be considered for inclusion in the inclusion / exclusion criteria. Informed consent will be obtained as required before starting any registration process.


Eligibility criteria: Inclusion Criteria:

(1) no use of centrally acting drugs, (2) no use of neuromuscular function blockers and no sedation within the prior 24 h, (3) periods of eye opening indicating a preserved sleep-wake cycle, and (4) a diagnosis of VS or MCS established according to internationally established criteria

Exclusion Criteria:

Magnetic resonance contraindications

Primary outcomes:
measure: Diffusion magnetic resonance imaging analysis
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Hospital of Zhejiang CAPR
state: Zhejiang
Study officials:
affiliation: Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou
name: Benyan F Luo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hangzhou Hospital of Zhejiang CAPR,Hangzhou, Zhejiang, China
name: Jian M Gao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00157911: A Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia (0653-042)
Official title: A Double-Blind, Randomized, Multicenter, Active-Comparative, 12-Week Study to Assess the Efficacy and Safety of the Drug in Conjunction With Another Drug in Korean Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholerolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 136
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: Patients undergo 4-week placebo lead-in and diet period, and 12-week treatment period. Clinical efficacy and safety is evaluated at weeks 4, 8 and 12. This study takes approximately 18 weeks for an individual patient to complete including post-visit at week 14.


Eligibility criteria: Inclusion Criteria:

* Korean males or females at least 18 years of age with hypercholesterolemia

Primary outcomes:
measure: LDL-C
Secondary outcomes:
measure: TC, TG, HDL-C, Apolipoprotein A1, Apolipoprotein B, lipoprotein (a), LDL-C:HDL-C ratio, TC:HDL-C ratio
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bae JW, Kim HS, Lee SC, Han KH, Jeon ES. The safety and efficacy of ezetimibe and simvastatin combination therapy in Korean patients with primary hypercholesterolemia. Korean J Med. 2005;68(5):487-497 [in Korean].
Clinical trial NCT03732911: Developmental Monitoring and Language Promotion
Official title: Developmental Monitoring and Language Promotion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: Child Development
Cognitive Home Environment
Literacy promotion
Text Messages
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this study is to pilot test an intervention developed to enhance parent knowledge regarding child development and encourage parents to engage in activities that promote language acquisition.

Detailed description: Our specific aim for this proposal is to pilot test an intervention developed to enhance parent knowledge regarding child development and the home cognitive environment comprised of distribution of (1) publicly available developmental monitoring materials, (2) age and language appropriate children's books, and (3) text message reminders. Participants in this intervention will receive: (1) educational materials about child development and developmental monitoring checklists; (2) age and language appropriate picture books; and (3) two text messages per week for a 6-month period. Differences in pre- and post-intervention knowledge regarding child development and the home cognitive environment will be assessed.

Eligibility criteria: Inclusion Criteria:

1. Preferred language either English or Spanish,
2. Parent or legal guardian,
3. Age ≥ 18 years,
4. Willing to accept text messages
5. Child ≤ 20 months old

Exclusion Criteria:

1. Individuals unable to provide consent
2. Individuals who do not meet inclusion criteria

Primary outcomes:
measure: Knowledge of child development
timeFrame: Visit 2 (6 months)
Secondary outcomes:
measure: Home cognitive environment:
timeFrame: Visit 2 (6 months)
measure: Frequency Shared Reading:
timeFrame: Visit 2 (6 months)
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
Study officials:
References:
Clinical trial NCT03456011: Battlefield Acupuncture With Sodium Hyaluronate Injections
Official title: Battlefield Acupuncture (BFA), an Adjunct Treatment During Sodium Hyaluronate Injections for Knee Osteoarthritis: A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2018-03-07
Enrollment: 60
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: TREATMENT

Brief summary: The study evaluates pain relief and subsequent range of motion changes combining battlefield acupuncture with sodium hyaluronate vs local anesthetic and sodium hyaluronate

Detailed description: Sodium hyaluronate is FDA approved for knee osteoarthritis. It is a widely used treatment for this condition. This does provide immediate pain relief and is often used in conjunction with lidocaine and ropivacaine to both improve pain relief and treatment tolerance.

battlefield acupuncture has been showing promise as an adjunct pain relief treatment option. If used during intra articular visco supplementation knee injections, this may provide pain relief and positive changes in range of motion without the need of local anesthetic being injected into the joint space.

Eligibility criteria: Inclusion Criteria:

* Patients of the BAMC Orthopaedic clinic
* Active duty, dependent and civilians
* Ages 18-65
* Diagnosed with knee osteoarthritis by their Orthopaedic provider
* Determined to be eligible for Sodium Hyaluronate injections by their Orthopaedic provider

Exclusion Criteria:

* Patient without knee osteoarthritis diagnosis
* Patient requiring immediate surgery for their knee complaints
* Patients younger than 18 or older than 65
* Pregnant patients
* Patients without active pain
* Patients with history of knee arthroplasty
* Patients with auricular deformity which would affect BFA
* Patient with history of vasovagal secondary to needles or injections
* Patients with active infection at BFA treatment sites

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 4 months
Secondary outcomes:
measure: Numerical Rating Scale
timeFrame: 4 months
measure: KOOS
timeFrame: 4 months
measure: KOOS Physical function short form
timeFrame: 4 months
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: BAMC
state: Texas
Study officials:
References:
Clinical trial NCT01398111: Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers
Official title: Open-label, Randomized, Single-dose, Placebo-controlled, 4-way Crossover Study to Investigate the Pharmacokinetic Interaction of Glycopyrrolate and Formoterol in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).


Eligibility criteria: Inclusion Criteria:

* Males and females healthy volunteers aged 18-65 years will be included in the study.

Primary outcomes:
measure: Pharmacokinetics: formoterol and glyco AUC0-t
timeFrame: from pre-dose to 32 hours after administration
measure: Pharmacokinetics: formoterol and glyco Cmax
timeFrame: from pre-dose to 32 hours after administration
Secondary outcomes:
measure: Additional pharmacokinetic variables
timeFrame: from pre-dose to 32 hours post dose
measure: Serum potassium
timeFrame: From pre-dose to 24 hours after administration
measure: Plasma glucose
timeFrame: from pre-dose to 24 hours after administration
measure: Lung function
timeFrame: from pre-dose to 1 hour after administration
measure: Vital signs
timeFrame: from pre-dose to 24 hours after administration
measure: ECG
timeFrame: from pre-dose to 24 hours after administration
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Clinical Pharmacology Unit - SGS Life Science Services
state: Lange Beeldekensstraat 267
Study officials:
affiliation: Clinical Pharmacology Unit at SGS Life Sciences - Antwerpen (Belgium)
name: Lien Gheyle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00033111: A Study of Cabergoline for the Treatment of Cocaine Dependence - 1
Official title: Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of California, Los Angeles
First posted: 2002-04-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 cabergoline for the Treatment of Cocaine Dependence

Detailed description: To assess the efficacy and safety of cabergoline in reducing cocaine use in subjects with cocaine dependence. This is a DB, placebo-controlled, parallel group design study where subjects will receive either .5mg cabergoline or placebo for 12 weeks with a 4 week follow-up.

Eligibility criteria: Inclusion Criteria:

Must have a DSM-4 criteria for cocaine dependence; be seeking treatment for cocaine dependence; have the ability to understand and provide written informed consent; females of child-bearing potential using proper method of birth control.

Exclusion Criteria:

Additional criteria available during screening at the site.

Primary outcomes:
measure: To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence
timeFrame: Week 12
Secondary outcomes:
measure: Reduction in cocaine use
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Torrance Clinic
state: California
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Friends Research Institute, Inc.
name: Steve Shoptaw, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05975411: Telemedicine Anesthesia Consultation, Pilot Study in Obstetrics.
Official title: Telemedicine Anesthesia Consultation, Pilot Study in Obstetrics.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnancy Related
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnancy women

Brief summary: Pilot study in Lower Normandy concerning a total of 90 patients scheduled for a pre-anaesthesia consultation in obstetrics. These parturients who plan to give birth at the maternity hospital of the CHU will be invited to carry out their anesthesia consultation with a view to childbirth either by way of the telemedicine cabin installed in Dozulé, or by way of the telemedicine trolley installed in a center close to their place of residence, or at the CHU de Caen as usual.

The validation of the adequacy of the possibilities of telemedicine with the requirements of the anesthesia consultation worked upstream is the main objective of this work, the appreciation of the parturient at this consultation, the appreciation of the consulting and validating professionals will also be collected with the aim of a maximum optimization of this new offer intended for the region.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman
* over 18 years old
* beneficiary of social security/CMU
* Non-emergency pre-anesthesia consultation
* delivery planned at the maternity ward of the University Hospital of Caen
* living in the vicinity of Dozulé or living near an establishment with a telemedicine cart equipped with the necessary equipment
* Having received clear and honest information about the study, and having given their consent
* Having given their consent for a telemedicine consultation
* patient without comorbidity

Exclusion Criteria:

* Patient refusal
* Patient under guardianship
* Patient with psychomotor disability; hearing impaired; visually impaired
* Difficulties in understanding information, expression; foreign language
* Pathological pregnancy

Primary outcomes:
measure: assessment of the airways via a telemedicine device
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CAEN University Hospital
Study officials:
References:
Clinical trial NCT05074511: Weight Variations Impacts on the Ankle of the Child
Official title: Weight Variations Impacts on the Ankle of the Child
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries
Risk of Falling
Stability
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 250
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two hundred healthy non-athletic children from both sexes will participate in this study.

They will randomly be recruited from primary school stage.

Brief summary: Obesity is a global health problem. It changes the measurement of the human body and makes a big change to move the body. The increased weight and mass change the way the limbs and whole body generate and react to force Excess fat also interferes with joint-muscle interactions that are important for functional capacity and postural balance The tendency to increase the thickness of the abdomen contributes to anterior movement of the COM of the body. The purpose of the study is to investigate the biomechanical effect of weight on foot stability in children.


Eligibility criteria: Inclusion criteria:

* Their age will be ranging from 7 to 9 years.
* All children have normal stature for age percentile according to CDC chart.
* The sample will include both sex and will be divided in to 4 groups according to the CDC (Centers for Disease Control and Prevention) growth charts
* All children are normal \&perform all activities of daily living
* They were able to understand and follow verbal commands and instructions included in the testing procedures.

Exclusion criteria:

* All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
* None of them had any surgical intervention in the lower extremities.
* None of them had any history of musculoskeletal deformities or neuromuscular disorders.
* They had neither visual, auditory defect.

Primary outcomes:
measure: risk of falling in static and dynamic situations for each group
timeFrame: assessed immediately after the procedure
measure: dynamic level of stability for each group
timeFrame: assessed immediately after the procedure
measure: dynamic Postural stability for each group
timeFrame: aassessed immediately after the procedure
measure: ankle muscles peak and angle specific torque, power and work for each group
timeFrame: assessed immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Amira Hussin Mohammed
Study officials:
References: