louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00177476: Enhancing Exercise Participation in Overweight Adults
Official title: Enhancing Exercise Participation in Overweight Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Weight Loss
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-15
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether behavioral strategies implemented during the adoption versus the maintenance periods of weight loss to enhance exercise participation in overweight adults are more effective than a standard behavioral intervention.


Eligibility criteria: Inclusion Criteria:

1. Female or Male
2. 18-55 years of age
3. BMI = 25-39.9 kg/m2
4. Ability to provide informed consent.
5. Ability to provide consent from their personal physician to participate in this study.

Exclusion Criteria:

1. Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
2. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
3. Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 18 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects)
4. Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
5. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
6. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
7. History of myocardial infarction or valvular disease.
8. Weight loss of \>5% of body weight within the previous 12 months.
9. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).

Primary outcomes:
measure: body weight
Secondary outcomes:
measure: Fitness
measure: physical activity
measure: dietary intake
measure: mediators
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: John M. Jakicic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jakicic JM, Rickman AD, Lang W, Davis KK, Gibbs BB, Neiberg R, Marcus MD. Time-based physical activity interventions for weight loss: a randomized trial. Med Sci Sports Exerc. 2015 May;47(5):1061-9. doi: 10.1249/MSS.0000000000000482.
citation: Janney CA, Jakicic JM. The influence of exercise and BMI on injuries and illnesses in overweight and obese individuals: a randomized control trial. Int J Behav Nutr Phys Act. 2010 Jan 6;7:1. doi: 10.1186/1479-5868-7-1.
Clinical trial NCT02145676: OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Muscle Spasticity
Stroke
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.


Eligibility criteria: Inclusion Criteria:

* Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago

Exclusion Criteria:

* Spasticity in the non-study upper limb that requires treatment
* Presence of fixed contractures in of the study muscles in elbow or shoulder
* Profound atrophy of muscles to be injected
* Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months
* Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months
* Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month
* Condition other than stroke contributing to upper limb spasticity
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis

Primary outcomes:
measure: Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale
timeFrame: Baseline, Week 6
measure: Change From Baseline in Pain on an 11-Point Scale
timeFrame: Baseline, Week 6
measure: Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
timeFrame: Baseline, Week 6
measure: Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
timeFrame: Baseline, Week 6
measure: Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02871076: Acupuncture for Post-Traumatic Stress in Combat Veterans
Official title: Acupuncture for Post-Traumatic Stress in Combat Veterans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Acupuncture
Combat
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
First posted: 2016-08-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine if acupuncture is an effective treatment option for treating combat Veterans with PTSD.


Eligibility criteria: Inclusion Criteria:

* Veteran Age 18 to 55
* DSM-5 criteria for chronic PTSD on Clinical Administered PTSD Scale (CAPS-5)
* CAPS-5 score of ≥ 26 and meeting criteria for each of 4 symptoms

Exclusion Criteria:

* Current and past six-months psychosis
* Substance dependence within 6 months (evidence of tolerance and/or withdrawal)
* Thyroid disease
* Decisional incapacity (e.g., dementia)
* Centrally acting medications that have a potential effect on biological expression (e.g., beta-blockers, opiates, and ≥10mg equivalent of diazepam/day)
* Pain levels requiring opiate medications
* Known exposure to chemicals or physical trauma that cause neuropsychiatric sequelae
* Severe depression (Beck Depression Inventory-II score ≥30)
* A diagnosed and untreated sleep breathing disorder (SBD)
* High risk of a SBD as indicated by snoring ≥50 of nights plus one of any

  1. Any witnessed apnea
  2. Feeling non-refreshed in the morning ≥50 of mornings
  3. Daytime sleepiness indicated by falling asleep with routine tasks such as watching TV or reading
* Non-response to ≥2 evidence-based PTSD treatments (adequate medication of 12 weeks or completion to PE, CPT or an intensive program)
* Treatment non-adherence indicated by stopping treatment or \>3 missed appointments in the course of PTSD EBT
* High dissociation as indicated by a score of ≥25 on the Dissociative Experiences Scale - II
* Past chronic PTSD prior to military service
* Current active psychotherapy for PTSD
* Having acupuncture in the past year
* Pregnancy

Primary outcomes:
measure: Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis
timeFrame: 4 months: Baseline CAPS to post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Veterans Affairs Long Beach Healthcare System
state: California
Study officials:
affiliation: Tibor Rubin VA Medical Center
name: Michael Hollifield, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03827876: Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis
Official title: An Open-Label Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Etanercept or Adalimumab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: LEO Pharma
First posted: 2019-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label
Primary purpose: TREATMENT

Brief summary: 4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QOD to patients with 2-10% BSA who are receiving etanercept or adalimumab for at least 24 weeks

Detailed description: 30 subjects treated with etanercept or adalimumab for at least 24 weeks with a body surface area 2-10% and physician global assessment greater than or equal to 2 will receive Enstilar® once daily for 4 weeks followed by QOD for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Male or female adult ≥ 18 years of age;
* Diagnosis of chronic plaque-type
* Patient with 2-10% BSA
* Physician Global Assessment of 2 or greater
* Patient has been treated with etanercept or adalimumab for a minimum of 24 weeks

Exclusion Criteria:

* ˂2 or \>10% BSA
* PGA \<2
* Patient not receiving etanercept or adalimumab, or receiving etanercept or adalimumab \<24weeks

Primary outcomes:
measure: PGA x BSA improvement
timeFrame: 16 weeks
Secondary outcomes:
measure: BSA improvement
timeFrame: 16 weeks
measure: Dermatology Life Quality Index improvement
timeFrame: 16 weeks
measure: Itch Numerical Rating Scale
timeFrame: 16 weeks
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT06659276: Comparison Between Whole Body DWI and FDG PET/CT in Patients with Simptomatic Multiple Myeloma
Official title: Whole Body DWI Sequences As Compared with Standard FDG PET/CT in Patients with Simptomatic Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: multiple myeloma, staging, therapy assessment, DWI, FDG PET CT
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: no additional info

Brief summary: The primary objective is to evaluate the concordance of FDG PET/CT and total body DWI MRI sequences performed during staging and at the completion of therapy. Specifically, we will assess the positivity rates, both patient-based and lesion-based (total and by district), of the two methods during staging and at the completion of therapy. An interim analysis will be conducted comparing the two methods, followed by a final prognostic analysis.


Eligibility criteria: Inclusion Criteria:

* • Patients with symptomatic myeloma in the staging phase or with suspected symptomatic myeloma in the diagnostic phase

  * Patients who have signed the informed consent form

Exclusion Criteria:

* Patients simultaneously affected by other neoplastic diseases or with a history of other neoplasms in the previous 5 years

  * Age \< 18 years
  * Women who are breastfeeding or pregnant
  * Patients with metal implants or devices that constitute an absolute contraindication for MRI
  * Patients with severe claustrophobia
  * Patients with bone pain that prevents prolonged maintenance of the supine position

Primary outcomes:
measure: positivity rate
timeFrame: 33 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi
Study officials:
References:
Clinical trial NCT05026476: Acceptability and Tolerance Study of a Thickener
Official title: Evaluation of the Acceptability (including Gastrointestinal Tolerance, Compliance) of a Thickener
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants and children

Brief summary: This is a prospective, acceptability study to evaluate the gastrointestinal tolerance and compliance of a thickener for the management of reflux, GORD and dysphagia

Detailed description: To evaluate the gastrointestinal tolerance and compliance of a thickener for 7 days for the submission to the Advisory Committee for Borderline Substances (ACBS).

Eligibility criteria: Inclusion Criteria:

I. Infants and children aged 6 months and over who require a thickener for reflux, GORD, dysphagia II. Infants and children already on a thickener for the management of reflux, GORD and dysphagia III. Parents to avoid introducing new weaning/ new foods (for the older infants) whilst on the thickener for 1 week when measuring GI tolerance and thickener intake IV. Willingly given, written, informed consent from patient or parent/guardian

Exclusion Criteria:

I. Inability to comply with the study protocol, in the opinion of the investigator.

II. Contraindications to any feed ingredients (see nutritional table and ingredients list) III. Allergy to milk (thickener is made in a factory that handles milk) IV. Children under the age of 6 months of age V. Emergencies VI. Participation in another interventional study

-

Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: 7 days
Secondary outcomes:
measure: Participant compliance
timeFrame: 7 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital Foundation Trust
Study officials:
affiliation: Chelsea and Westminster
name: Analou Sugar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03368976: PACMAN Ultrasound Recording Data Collection
Official title: Prospective, Multicenter, Single Arm Feasibility Study to Collect Patient and Imaging Data for Avanos Medical Ultrasound Guided Regional Anesthesia System Development
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anesthesia, Local
Lead sponsor: Avanos Medical
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 767
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with planned peripheral nerve block procedures.

Brief summary: Study to collect videos of ultrasound recordings during peripheral nerve block procedures.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years and older with underlying pathologies requiring surgical intervention facilitated by a specific regional nerve block
* Informed consent executed

Exclusion Criteria:

* Patients unable to understand and provide written consent
* Infection at the injection site
* Allergy to local anesthetic agents
* Medical condition obscuring visualization
* Known neuropathy at or around target nerve for the PNB
* Inability to communicate with the investigator or hospital staff

Primary outcomes:
measure: Collection of ultrasound recordings
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Gulf Breeze
country: United States
facility: Andrews Institute
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Troy
country: United States
facility: Universal Medical Resources
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota - Twin Cities
state: Minnesota
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04964076: Clinical Phenotypes of COPD Patients Between in Plateau and Plain
Official title: Clinical and Radiological Phenotypes of Patients With Stable COPD Between in Plateau and Plain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Tibet Autonomous Region People's Hospital
First posted: 2021-07-15
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We consecutively enrolled patients with COPD from January 2018 to December 2021, who visited the outpatient of Department of Respiratory Medicine in Peking University Third Hospital or Tibet Autonomous Region People's Hospital.

Brief summary: We aimed to collect clinical and radiological data of patients with stable COPD in plateau and plain, and compare the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.

Detailed description: The purpose of this study was to investigate the clinical phenotypic characteristics and imaging features of patients with stable chronic obstructive pulmonary disease (COPD) in plateau and plain. We conducted a cross-sectional study, collecting clinical data of stable patients in plateau and plain, and comparing the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.

Eligibility criteria: Inclusion Criteria:

* meeting the diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and had definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC)\<0.7.

Exclusion Criteria:

* age \<40 years;
* subjects with airway diseases other than COPD;
* acute exacerbation of COPD in the past 3 months;
* active tuberculosis;
* cardiovascular or cerebrovascular events in the past 3 months;
* cognitive dysfunction such as vascular dementia or Alzheimer's disease;
* refusal to participate in this study.

Primary outcomes:
measure: Assessment of respiratory symptoms
timeFrame: Data were obtained during the interview.
measure: Exacerbation
timeFrame: Data were obtained during the interview.
measure: Spirometry testing
timeFrame: Data were obtained during the interview.
measure: Emphysema
timeFrame: Within 3 months of the interview.
measure: Airway remodeling -1
timeFrame: Within 3 months of the interview.
measure: Airway remodeling -2
timeFrame: Within 3 months of the interview.
measure: Airway remodeling -3
timeFrame: Within 3 months of the interview.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yongchang Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04377776: Observational Study Concerning COVID-19 Infection in Transplanted Kidney, Pancreas or Pancreatic Islet Patients
Official title: Observational Study to Assess the Health Status of Transplanted Patients (Kidney or Pancreas or Pancreatic Islet Transplantation) at Transplant Medicine Unit (MITRA) During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Pancreas Tranplant
Pancreatic Islet Transplantation
Keywords: COVID-19 infection
Transplanted patients
kidney transplant
pancreas transplant
pancreatic islet transplantation
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 644
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Transplanted Kidney, Pancreas or Pancreatic Islet patients

Brief summary: Collect informations on the health status of transplanted patients (kidney, kidney / pancreas, pancreas or pancreatic islet) during the COVID-19 pandemic. All informations will be collected by short questionnaire via phone.


Eligibility criteria: Inclusion Criteria:

Transplanted Kidney or Kidney/Pancreas or Pancreas or Pancreatic Islet patients at Transplant Medicine Unit - San Raffaele Scientif Institute

Primary outcomes:
measure: Global Prevalence of COVID-19 TX
timeFrame: From 01st February 2020 to 18 May 2020
measure: Hospitalization rate in COVID-19 TX
timeFrame: From 01st February 2020 to 18 May 2020
Secondary outcomes:
measure: Correlation COVID-19 TX and type of transplantation
timeFrame: From 01st February 2020 to 18 May 2020
measure: Prevalence of COVID-19 TX in italian provinces
timeFrame: From 01st February 2020 to 18 May 2020
measure: Symptoms in COVID-19 TX
timeFrame: From 01st February 2020 to 18 May 2020
measure: Correlation COVID-19 TX and comorbidities
timeFrame: From 01st February 2020 to 18 May 2020
measure: COVID-19 TX Therapies
timeFrame: From 01st February 2020 to 18 May 2020
measure: COVID-19 TX in family settings
timeFrame: From 01st February 2020 to 18 May 2020
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Antonio Secchi
role: PRINCIPAL_INVESTIGATOR
References: