louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02886208: Health Outcomes of Teens Participating in Summer Employment Immersion Programs
Official title: Health Outcomes of Teens Participating in Summer Employment Immersion Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Prediabetic State
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 83
Sex: ALL
Minimum age (years): 15
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is a collaboration between investigators and two community partners: a youth employment program and an urban farm. The community partners hire 300+ adolescents for summer jobs at various organizations. Approximately 120 adolescents will be employed with the urban farm site. As one component of their program evaluation plan, investigators will evaluate change in BMI of participants. The investigators hypothesize that there will be a reduction in BMI of those participants working at the urban farm site.

Detailed description: The investigators will measure height/weight/BMI of all participants located at the urban farm site. Investigators will also collect demographic data as well as other social data (example: food security).

Eligibility criteria: Inclusion Criteria:

* employed by summer work program at urban farm

Exclusion Criteria:

* N/A

Primary outcomes:
measure: BMI
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04018508: Massage Therapy for Self-efficacy in LVAD Recipients
Official title: Pilot Study of Massage Therapy to Improve Self-efficacy in Patients With Left-ventricular Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: left ventricular assist device
massage
coping
self efficacy
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study evaluates the role of massage therapy to improve self-efficacy in patients with advanced heart failure who have recently received a left-ventricular assist device. In addition to usual care, half of the volunteer patients will receive a massage at regular clinic visits and half will not receive any massage.

Detailed description: Patients with advanced heart failure who undergo left-ventricular assist device (LVAD) implantation may experience notable physical and/or emotional distress associated with this lifestyle-changing procedure. Furthermore, these patients are faced with the task of coping with the trauma of surgery, creating new self-care routines, and learning to live with a lifesaving mechanical device that must always be connected to a power source.The immediate weeks and months after LVAD implantation are a critical period to lower physical and emotional distress and to influence patient coping and adaptation. In small studies, massage therapy has been increasingly used to improve patient self-efficacy and coping. In this pilot study, we investigate whether regularly scheduled massages delivered in the clinic setting improve self-efficacy and coping in this select patient population.

Eligibility criteria: Inclusion Criteria:

* capacitated, at least 18 years of age, received LVAD implant during last hospital admission

Exclusion Criteria:

* incapacitated, non-English speaking, negative pressure isolation, unstable spine, very low serum platelets (\<10,000/uL), received massage in 30 days prior to enrollment

Primary outcomes:
measure: Change in Self-Efficacy for Managing Chronic Disease 6-item Scale from Baseline to Repeat Visits
timeFrame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
Secondary outcomes:
measure: Change in score on Brief COPE Inventory from baseline to repeat visits
timeFrame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
measure: Change in score on National Comprehensive Cancer Network Distress Thermometer from baseline to repeat visits
timeFrame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
measure: Change in score on McGill Quality of Life Scale (Revised) from baseline to repeat visits
timeFrame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT01105208: Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
Official title: Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef From Bayer (Cephalexin Suspension 250 mg/5 mL and Equivalent Concentration of Keflex Pediatrico From Eli Lilly (Cephalexin Suspension 125 mg/5mL) in Healthy Subjects Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anti-Infective Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Corporación Bonima S.A. de C.V.
First posted: 2010-04-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study
* History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.

Primary outcomes:
measure: Least square estimator of average maximum plasmatic concentration (log transformed)
timeFrame: After two months
measure: Least square estimator of area under the pharmacokinetic curve (log transformed)
timeFrame: After two months
Secondary outcomes:
measure: Time at which maximum concentration is reached
timeFrame: After two months
measure: Area under the pharmacokinetic curve from time=0 to last blood sample
timeFrame: After two months
measure: Clearance constant of plasmatic concentrations of study drug
timeFrame: After two months
measure: Half life of plasmatic concentration of study drug
timeFrame: After two months
measure: Adverse events collection
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Morelia
country: Mexico
state: Michoacán
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03545308: Pharmacokinetics of Rocuronium for Deep Block (DeepRocu)
Official title: Pharmacokinetics of Rocuronium (1 mg/kg) for Deep Block : a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Keywords: Neuromuscular
Deep Anesthesia
Rocuronium
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for surgery under general anesthesia with the need of deep neuromuscular block for surgery

Brief summary: Rocuronium is a non-depolarising neuromuscular blocking agent. The compound has a rapid onset and an intermediate duration of action.

The rapid onset is of importance in patients at risk for pulmonary aspiration, for elective induction of anesthesia. Clinical studies simulating rapid sequence induction in elective patients indicate that rocuronium 0.9 mg kg-1 may be suitable for crash intubation.Also, rocuronium may be an alternative to succinylcholine for rapid sequence induction when high dose is injected (3x Effective Dose 95 %= 1mg/kg). But, pharmacokinetic of rocuronium at 1 mg/kg is not well establish.

The investigator investigate the onset and recovery of a single dose rocuronium (1 mg/kg) in consecutive patients (\>100) using adductor muscle monitoring (Train of Four and Post Tetanic Count)

Detailed description: In this study, pharmacokinetic of rocuronium at 1 mg/kg will be evaluated at each point of Train of Four Response (TOF) and Post Tetanic Count (when TOF=0) troughout the period of anesthesia and surgery.

Time 0 is the time of rocuronium injection, Time 1 is the time when post tetanic count is \> 5-7 and TOF=0, Time 3 when TOF \>0 response, Time 4 when 4 reponses of the TOF and Time 5 when TOF \> 90 %

Eligibility criteria: Inclusion Criteria:

* elective or emergency surgery under general anesthesia with deep block
* approval
* adult

Exclusion Criteria:

* contra indication to neuromuscular blockade (allergy, myopathy, hyperkaliemia)
* refusal
* \< 18 years olds
* Body mass index \> 50
* neuropathy
* regional anesthesia

Primary outcomes:
measure: Onset
timeFrame: 3 hour
Secondary outcomes:
measure: intubation
timeFrame: 1 hour
measure: Post Tetanic Count recovery
timeFrame: 3 hours
measure: Recovery Train of Four
timeFrame: 6 hours
measure: Antagonization
timeFrame: 6 hours
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: jean-yves lefrant, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02439008: Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response
Official title: Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Colorectal Neoplasms
Melanoma
Kidney Neoplasms
Keywords: liver metastases of colorectal cancer
metastases of melanoma or renal cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Institut de Biologie de Lille
First posted: 2015-05-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy and a rationale for adjuvant immunotherapy.

Detailed description: * Patient information and collection of a signed informed consent form
* Clinical data collection
* Blood samples of 35 mL:

  1. after registration, prior to the first fraction of radiotherapy
  2. within 15 minutes after the administration of the 1st, the 2nd and the 3rd radiotherapy sessions
  3. one week, 3 months, 6 months, 9 months and 12 months after the last radiotherapy session
* Storage of the blood samples at ambient temperature
* Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis
* Destruction of the samples at the end of the analysis

Eligibility criteria: Inclusion Criteria:

* Patient requiring a hypofractionated irradiation (≥ 3 fractions, dose ≥ 9 Gy per fraction) either for :
* hepatocellular carcinoma or hepatic lesion of metastatic Colorectal Cancer,
* metastasis from melanoma or renal cancer,
* Age ≥ 18 years old,
* Registered with a social security system,
* Signed written informed consent.

Exclusion Criteria:

* Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,
* Pregnant or breastfeeding woman,
* Patient under guardianship or tutorship.

Primary outcomes:
measure: Analyse of immunological parameters, decription of secreted markers and nanovesicles production
timeFrame: from baseline to 1 year follow up
Secondary outcomes:
measure: Cell viability, determined by number of live/dead cells present
timeFrame: from baseline to 1 year follow up
measure: Progression-free rate
timeFrame: from baseline to 1 year follow up
measure: Number of Participants with Adverse Events related to radiotherapy
timeFrame: from baseline to 1 year follow up
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Xavier Mirabel, MD
role: STUDY_DIRECTOR
affiliation: Institut de Biologie de Lille
name: Nadira Delhem, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03170908: Effective Implementation of Interpersonal Psychotherapy
Official title: Pragmatic Strategies for Assessing and Enhancing High Fidelity Delivery of Interpersonal Psychotherapy (IPT) in Community Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Depressive Symptoms
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-05-31
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-99 seeking psychotherapy for depression in community-based agencies

Brief summary: The study is designed to observe the impact of improved measures of the fidelity on the community delivery of Interpersonal Psychotherapy. Pairs of therapist-patient dyads will be observed, first to develop and test brief measures of fidelity, and then to correlate those measures with symptomatic outcomes.

Detailed description: The study is designed to observe the impact of improved measures of the fidelity on the community delivery of Interpersonal Psychotherapy. In Phase I, 250 pairs of therapist-patient dyads will be observed as IPT Fidelity measures are developed and validated. In Phase II, 175 pairs of therapist-patient dyads will be observed to prospectively validate the IPT Fidelity measures with longitudinal outcomes on the PHQ-9.

Eligibility criteria: Inclusion Criteria:

* age 18-99
* diagnosis of depressive disorder
* being treated with IPT in community settings

Exclusion Criteria:

- none

Primary outcomes:
measure: PHQ-9
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References:
Clinical trial NCT04013308: Iontophoresis With Potassium Iodide and Thyroid Function
Official title: Iontophoresis With Potassium Iodide and the Level of Thyroid Hormones in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Dysfunction
Keywords: Iontophoresis
potassium iodine
thyroid
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study: To assess the influence of iontophoresis treatment with 2% potassium iodide on the level of thyroid hormones (TSH, FT3, FT4) The study group: conducting 10 iontophoresis treatments with Potassium iodide; The control group: conducting 10 placebo treatments with iontophoresis with destilled water; Intervention: 10 iontophoresis treatments with 2% potassium iodide in healthy individuals.

Test the level of thyroid hormones before and after the 10 iontophoresis treatments; The study allows to assess the influence of iodine on the function of thuroid gland.


Eligibility criteria: Inclusion Criteria:

* healthy individuals with normal thyroid function

Exclusion Criteria:

* individuals with thyroid disorders,
* taking thyroid medication,
* using drugs, alcohol, cigaretttes

Primary outcomes:
measure: the level of thyroid gland hormones (TSH, FT3, FT4)
timeFrame: change in the thyroid hormones level from the baseline to 14 days after the last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: Centre for Innovative Research in Medical and Natural Sciences' Medical Faculty of University of Rzeszow
state: Podkarpackie
Study officials:
References:
citation: Zwolinska J, Augustyn B, Baj K, Krukowska J. The effect of galvanization and potassium iodide iontophoresis of the throat and larynx on thyroid parameters: a randomized controlled trial. Sci Rep. 2021 Aug 2;11(1):15590. doi: 10.1038/s41598-021-95145-w.
Clinical trial NCT04909008: Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients
Official title: Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Heart Failure
Pulmonary Hypertension
Keywords: Exercise training
Right ventricle
Exercise capacity
Quality of life
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Florida Heart Research Institute
First posted: 2021-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: OTHER

Brief summary: This research study is being done to find out if exercise therapy can help improve the heart function, overall health, and quality of life of patients with pulmonary hypertension caused by heart failure.

Detailed description: The purpose of this research is to see if taking part in structured exercise training will improve the ability to exercise, the function of the heart, and the function of the blood vessels that supply the lungs in patients with heart failure and pulmonary hypertension. After enrollment all patients will complete exercise testing. Patients will be randomized to either 10 weeks of exercise training (3 times per week) or will continue standard medical care. All patients will undergo detailed exercise testing before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* NYHA functional class I-IIIb.
* LVEF \< 40%.
* Clinically-stable for \> 3 months \[no change in disease status or medication\].
* Willing and able to provide written informed consent and perform cycle-ergometer or treadmill based exercise.

Exclusion Criteria:

* NYHA class IV HF.
* Diagnosis of diastolic HF.
* Comorbidities such as obesity (BMI \>36), uncontrolled systemic hypertension, type 2 diabetes, and COPD (FEV1 \<50%).
* Musculoskeletal or other conditions that would limit exercise participation.
* Pregnant or nursing women

Primary outcomes:
measure: Maximal oxygen uptake (VO2max) measured in mL/kg/min
timeFrame: 10 weeks
Secondary outcomes:
measure: Mean pulmonary arterial pressure (mPAP) measured in mmHg
timeFrame: 10 weeks
measure: Pulmonary vascular resistance (PVR) measured in dynes
timeFrame: 10 weeks
measure: Right ventricular contractile function measured as % fractional area change (RV FAC).
timeFrame: 10 weeks
measure: Left ventricular contractile function measured as % fractional area change (LV FAC).
timeFrame: 10 weeks
measure: Slope of the relationship between mean pulmonary arterial pressure and cardiac output (mPAP-Q slope) measured in mmHg/L/min.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Bryan J Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05885308: Intervening for Increased Quality of Life Among Older People in Sweden
Official title: Intervening for Increased Quality of Life Among Older People in Sweden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Mental Health Issue
Lead sponsor: Karlstad University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the wake of the Covid-19 pandemic, Sweden and other countries have become aware of how life has changed; the world is now a "hybrid world" where many daily activities have moved online. The forced physical isolation has also led to an increase in depression and loneliness, especially among elderly people. Traditional interventions often involve physical contact, and there are valuable lessons to be learned from this situation, where physical isolation is forced, in order to mitigate the consequences both during and after this pandemic.

The overall purpose of this project is to study physical activity as a way to engage in and maintain an active lifestyle and /or increase the quality of life and limit mental health problems for older people and to study how scalability, accessibility, commitment, and adherence can be improved with flexible programs with digital tools. The specific research question is:

Is there a difference between the online exercise program and the onsite exercise program in terms of physical activity, balance, motivation, quality of life and mental health?

The results are expected to give insights into how to increase physical activity using flexible programs with digital options and to maintain quality of life among the elderly. By giving the elderly population different options for being physically active and thereby empowering this group, this project contributes to creating a socially sustainable community in which elderly citizens are included.


Eligibility criteria: Inclusion Criteria:

* Understand Swedish

Exclusion Criteria:

-

Primary outcomes:
measure: Change in physical activity
timeFrame: Time points: 0, 3 and 6 months
measure: Change in leg strength and endurance
timeFrame: Time points: 0, 3 and 6 months
Secondary outcomes:
measure: Change in depression
timeFrame: Time points: 0, 3 and 6 months
measure: Change in Quality Of Life
timeFrame: Time points: 0, 3 and 6 months
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: Karlstad University
state: Varmland
Study officials:
affiliation: Karlstad University
name: Johanna Gustavsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: