louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02471872: Behavioral Research of Environment and Air Pollution Through Education
Official title: Behavioral Research of Environment and Air Pollution Through Education (BREATHE Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attitude to Health
Pollution Related Respiratory Disorder
Health Behavior
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 600
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The BREATHE (Behavioral Research of Environment and Air Pollution Through Education) study is a pilot randomized control trial comparing the efficacy of a classroom-based intervention to no intervention in helping middle-school students understand and make behavioral decisions about air pollution. This study is designed to evaluate the effectiveness of the classroom-based intervention on knowledge of air pollution, understanding of air pollution sources, and behavioral choices made to reduce both contributions to air pollution and personal exposure to air pollution.

It has been well established that pollution is a racial and economic issue. Low-income areas with populations of predominantly people of color tend to be those with the highest rates of pollution and the largest particulate exposure. Creation of and exposure to this pollution is a key issue for the health of inhabitants of these areas, and of those in the broader surrounding areas. By developing, and assessing the effectiveness of, the investigators hope that the BREATHE study will give the investigators insights into how to better combat this higher exposure and reduce the health risks for those in high pollution areas.

The study will take place in 4 visits over a period of 12 months. The hypothesis is that the classroom-based intervention will be effective in leading to behaviors that will reduce exposure to air pollution.


Eligibility criteria: Inclusion Criteria:

* Ability to read, write, and understand English at a middle school level
* Willing to participate in follow up visits

Exclusion Criteria:

* Learning disabilities such as autism
* Moving out of the area in the next 6 months
* Inability to complete the questionnaires

Primary outcomes:
measure: Behavior Change Assessed by Questionnaires
timeFrame: Assessed immediately after intervention, and at 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Improvement in Understanding Assessed by Questionnaires
timeFrame: Assessed immediately after intervention, and at 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
References:
Clinical trial NCT06085872: Testing the REThinkACADEMY Interventions in Prevention of Emotional Disorders in College Students.
Official title: Testing the REThinkACADEMY Interventions in Prevention of Emotional Disorders in First Year College Students.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Stress
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2023-10-17
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Entry in the REThinkACADEMY trial will be based on the high distress range on a psychological validate instrument to assess stress. After participants are enrolled in the REThinkACADEMY trial and randomized, those in the experimental condition ill access a ecological momentary intervention (EMI) app for the prevention of emotional disorders for 4 weeks. In the second stage, for the non-responders to the ecological supportive intervention, the online game will be implemented while the rest of the groups will be monitored for another 4 weeks. At the next step, post-test outcomes assessment will be implemented. Long term assessments will be conducted at 6 months for the college student's naturalistic follow-up phase.


Eligibility criteria: Inclusion Criteria:

* to a first year student enorlled in Babes-Bolyai University of Cluj-Napoca
* internet and PC access to complete the scales and game
* high level of distress based on PDa scores

Exclusion Criteria:

* no internet or PC access

Primary outcomes:
measure: Emotion regulation
timeFrame: baseline, pre-intervention
measure: Changes in emotion regulation
timeFrame: Post-intervention (one week after the intervention)
measure: Levels of emotion regulation
timeFrame: 6 months follow-up
measure: Emotional Distress
timeFrame: Pre-intervention (one week before the intervention)
measure: Changes in emotional distress
timeFrame: Post-intervention (one week after the intervention)
measure: Levels of emotional distress
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Mood disorders
timeFrame: baseline, pre-intervention
measure: Changes in mood disorders
timeFrame: Post-intervention (one week after the intervention)
measure: Trauma
timeFrame: baseline, pre-intervention
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
References:
Clinical trial NCT01431872: Systemic Dickkopf-related Protein 1 (DKK1)During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors
Official title: Systemic DKK1 During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Aromatase Inhibitors
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2011-09-12
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post menopausal breast cancer patients who are planning to be treated with aromatase inhibitors.

Brief summary: The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to peak, then decrease gradually as estrogens reach a new lower, but steady level. The investigators also believe that the peak in DKK1 will initiated a wave of stem cell diversion from the osteoblastogenic pathway to the adipogenic pathway.

The investigators will conduct a longitudinal cohort study of post menopausal women with hormone-responsive breast cancer that will be treated AIs. The study will observe anthromorphic and serum marker changes during the first year of their treatment.


Eligibility criteria: Inclusion Criteria:

* Post Menopausal Breast cancer patients with planned treatment of aromatase inhibitors.
* 18 years or older

Exclusion Criteria:

* BMI \>30 or \<18
* Osteoporosis as defined by protocol.
* Subjects currently on bisphosphonate therapy.
* History of primary or secondary hyperparathyroidism
* History of Hypo-or Hyperthyroidism
* History of Vitamin D levels below LLN
* History of creatinine clearance below the EGFR
* History ofLiver function tests above 1.5 times ULN including LDH, SGOT, SGPT, Alkaline phosphatase, and Bilirubin
* History of documented cirrhosis of the liver
* History of chronic heparin use
* History of chronic glucocorticoid therapy

Primary outcomes:
measure: Estrogen level suppresses DKK1
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Laura Hutchins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06054672: Subthreshold Stimulation on Chronic Low Neck Pain Myofascial Trigger Points
Official title: Effect of Subthreshold Stimulation on Pain and Muscle Activity in Patients With Chronic Low Neck Pain and Myofascial Trigger Points
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Neck Pain
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of subthreshold stimulation on pain and muscle activity in patients with chronic low neck pain and myofascial trigger points.

Detailed description: The study will include 2 groups. One group will receive subthreshold stimulation and other will not receive any treatment. The measurements will include pain and myscle activity.

Eligibility criteria: Inclusion Criteria:

* chronic neck pain
* One or more trigger point

Exclusion Criteria:

* any musculoskeletal or neuromuscular diseases

Primary outcomes:
measure: Electromyographical signals
timeFrame: 2 months
measure: Pressure sensitivity using pressure ergometer
timeFrame: 2 months
Secondary outcomes:
measure: Neck pain and disability
timeFrame: 2 months
measure: Functional ability
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02747472: GIP Receptor Antagonist Studies in Humans
Official title: Involvement of Glucose-dependent Insulinotropic Polypeptide (GIP) in Human Physiology and Pathophysiology - Receptor Antagonist Studies in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism
Keywords: GIP
GIP receptor antagonist
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2016-04-21
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion.

Detailed description: Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour hyperglycaemic clamps with and without concomitant iv infusion of GIP\[1-42\]. The intention is to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling.

The study consists of four experimental days (A-D) with assessment of beta cell function during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP\[1-42\], B) GIP-A, C) GIP\[1-42\] + GIP-A, or D) saline (placebo).

Eligibility criteria: Inclusion Criteria:

* Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria:

* Medication, Diabetes type 1 or 2, BMI \> 25, first degree relatives with Type 2 Diabetes

Primary outcomes:
measure: Insulin levels
timeFrame: 65 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Diabetes Research
state: Gentofte
Study officials:
affiliation: UHGentofte, Center for Diabetes Research
name: Filip K Knop, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Gasbjerg LS, Christensen MB, Hartmann B, Lanng AR, Sparre-Ulrich AH, Gabe MBN, Dela F, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. GIP(3-30)NH2 is an efficacious GIP receptor antagonist in humans: a randomised, double-blinded, placebo-controlled, crossover study. Diabetologia. 2018 Feb;61(2):413-423. doi: 10.1007/s00125-017-4447-4. Epub 2017 Sep 25.
Clinical trial NCT05795972: Inulin Supplementation in Patients With Type 1 Diabetes
Official title: Efficacy Evaluation of Inulin Supplementation on Metabolic Control and Akkermansia Muciniphila Levels in Patients With Type 1 Diabetes: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the glycemic and metabolic control of type 1 diabetic patients in replacement therapy with insulin, comparing those treated with a supplementation of prebiotics (inulin) and those treated with a placebo.

Therefore, the primary objective of the study is represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (HbA1c, lipid profile, C-RP).


Eligibility criteria: Inclusion Criteria:

* Patients with T1D, diagnosed before 35 years of age will be enrolled

Exclusion Criteria:

* advanced complications of T1D (established renal failure, severe retinopathy and diabetic neuropathy)
* BMI\> 30 kg / m2.

Primary outcomes:
measure: glycemic control
timeFrame: 3 months
Secondary outcomes:
measure: akkermania levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
References:
Clinical trial NCT06193304: A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth
Official title: An Open-label Study to Assess the Absorption Through the Mouth After Three Repeated 50 mg Doses of Eliglustat Solution, Separated by 2-hour Intervals, Held in the Mouth for 30 Seconds With Swishing But Without Ingestion, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gaucher's Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: A study to assess the absorption of eliglustat through the mouth in healthy subjects and the safety of any systemic exposure resulting from oral surface absorption of eliglustat in healthy subjects.

Detailed description: Duration of the study for each subject, not including screening, will be 3 days including follow-up.

Eligibility criteria: Inclusion Criteria:

Body weight between 50.0 and 100.0 kg, inclusive, for males, and between 40.0 and 90.0 kg, inclusive, for females, body mass index between 18.0 and 30.0 kg/m2, inclusive.

Having given written informed consent prior to undertaking any study-related procedure.

Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination, laboratory parameters, and ecg).

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.

Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Primary outcomes:
measure: Plasma pharmacokinetic (PK) parameter: Cmax
timeFrame: Multiple timepoints on Day 1
measure: Plasma pharmacokinetic (PK) parameter tmax
timeFrame: Multiple timepoints on Day 1
measure: Plasma pharmacokinetic (PK) parameter AUClast
timeFrame: Multiple timepoints on Day 1
measure: Plasma pharmacokinetic (PK) parameter AUC 0-2h
timeFrame: Multiple timepoints on Day 1
measure: Plasma pharmacokinetic (PK) parameter AUC 2-4h
timeFrame: Multiple timepoints on Day 1
measure: Plasma pharmacokinetic (PK) parameter AUC 4-6h
timeFrame: Multiple timepoints on Day 1
measure: Plasma pharmacokinetic (PK) parameter tlast
timeFrame: Multiple timepoints on Day 1
Secondary outcomes:
measure: Treatment emergent adverse events during the study
timeFrame: Up to Day 3
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Covance Clinical Researsh Unit
state: Indiana
Study officials:
References:
Clinical trial NCT02454504: Quality of Awakening and Impact on Cognitive Function After Administration of Sugammadex in Robotic Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesiology Management
Keywords: Sugammadex
Delayed Emergence from Anesthesia
Curare
Robotic Surgical Procedures
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: With the aim of enhancing the quality of surgery, the robotic cystectomy is often conducted using continuous intravenous infusion of curare, which ensures maximum neuromuscular relaxation until the end of the intervention. Sugammadex, administered for the reversal of deep neuromuscular blocked, enable rapid awakening. Moreover, Sugammadex seems to have a positive effect also on the recovery of cognitive function, psychomotor coordination and mental ability, effects undocumented in Literature.

The aim of the investigators study was to assess whether the reversal with sugammadex after intraoperative continuous infusion of rocuronium, can improve the quality of awakening.


Eligibility criteria: Inclusion Criteria:

* ASA score ≤ III
* Patients underwent robotic cystectomy

Exclusion Criteria:

* Cerebrovascular disease
* BMI ≥ 30

Primary outcomes:
measure: average score obtained on awakening according to specific test
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Regina Elena Cancer Institute
state: RM
Study officials:
References:
Clinical trial NCT00752804: Uremic Toxins in the ICU: Patients After Cardiac Surgery
Official title: Study of the Kinetics of Uremic Toxins in the ICU Patients With Acute Renal Failure, in Order to Optimize the Dialysis Dose: Patients After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: ICU patients with acute renal failure after cardiac surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-09-15
Enrollment: 9
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: Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients after cardiac surgery.The sampling of blood and dialysate will be done during dialyses with different durations (4, 6 and 8h)


Eligibility criteria: Inclusion Criteria:

* ICU patients after cardiac surgery with acute renal failure

Primary outcomes:
measure: Toxin removal
timeFrame: During dialysis
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Raymond Vanholder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06405204: of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve
Official title: The Effect of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve Parameters and Intra-cytoplasmic Sperm Injection Outcomes in Patient With Poor Ovarian Reserve: an Open Label Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: IVF
Keywords: Myo-inositol
Melatonin
Co-enzyme q10
ovarian reserve
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the role of Myo-inositol, melatonin and co-enzyme Q10 on ovarian reserve parameters and ICSI outcome in poor ovarian responder

Detailed description: Each patient will be subjected to:

Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on day 2 to day 3 of menstruation. Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.

Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck- Serono, Italy) from day 2-3 of menstruation, with daily dose of 300-450 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. . For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day. The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection

Eligibility criteria: Inclusion Criteria:

* Infertile women who have one of the criteria of poor ovarian response as follows;

  * Antral follicle count less than 7
  * Anti-Mullerian hormone level Less than 1.2 ng/ml

Exclusion Criteria:

1. Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction
2. Any pelvic pathology such as hydrosalpinx, uterine anomaly.
3. Any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or azoospermia

Primary outcomes:
measure: pregnancy
timeFrame: 1 month of induction for ICSI trial
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
Study officials:
affiliation: Beni-Suef University
name: Sara A Salem, MD
role: PRINCIPAL_INVESTIGATOR
References: