louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00525850: High Fat Diet II on Weight Loss
Official title: Effect of High Saturated Fat No Starch Diet vs. Low Saturated Fat, Low Trans Fat, High Fiber Diet on Weight Loss and Markers of Atherosclerotic Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: cardiovascular disease
weight loss
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2007-09-06
Enrollment: 20
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: To evaluate two different diets and their effects on weight loss and measurements of several risk factors for cardiovascular disease. One diet will be a high saturated fat diet (HSFD) and the other is a low saturated fat diet (LSFD) that limits fat but especially saturated fat as red meat. All participants in this study must eat both diets as this is a randomized cross-over design.


Eligibility criteria: Inclusion Criteria:

In order to qualify, participants must have metabolic syndrome:

* triglycerides greater than 150 mg/dL
* blood pressure greater than 130 mmHg and/or diastolic blood pressure greater than 85 mmHg
* fasting glucose greater than 110 mg/dL
* waist circumference greater than 40 inches in men or 35 inches in women
* reduced HDL less than 40 mg/dL in men and less than 50 mg/dL in women. Participants must be capable of performing symptom-limited maximal exercise capacity study. Blood and urine samples collected at baseline will be analyzed for CBC, serum glucose and electrolytes, hepatic panel and TSH.

Exclusion Criteria:

Participants will be excluded for any significant blood dyscrasia, fasting glucose greater than 200 mg/dL, creatine greater than 2 mg/dL, any significant electrolyte disorder, hepatic functions greater than two times normal or abnormal TSH.

Primary outcomes:
measure: Weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: Brachial artery reactivity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Newark,
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: James Hays, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05784350: Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension
Official title: Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intra-operative Hypotension
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypotension is a common side-effect of general anesthesia induction and is related to adverse outcomes including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury.Half of all the patients were fluid-responsive, pointing to volume status as a significant risk factor. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration, including the maximal diameter of the IVC (dIVCmax) at the end of expiration during spontaneous respiration and the collapsibility index (CI), have been recommended as rapid and noninvasive methods for estimating volume status.

In attempt to prevent hypotension after spinal anesthesia induction, Ondansetron, a serotonin receptor antagonist, has been used effectively .

Research Question Can preoperative IVC-US guided fluid optimization and intravenous ondansetron reduce the incidence of general anesthesia-induced hypotension in adult patients undergoing elective non-cardiac non-obstetric surgery?


Eligibility criteria: Inclusion Criteria:

1. Age \> 18
2. Elective, non-cardiac, non-obstetric surgery under general anesthesia
3. American Society of Anesthesiologists physical status classification I - III

Exclusion Criteria:

1. MAP below 60 mmhg prior to the induction of general anesthesia.
2. Patients treated with angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB) on the day of surgery.
3. Patients with heart failure with ejection fraction (EF) \< 40%.
4. Patients with documented acute or chronic renal failure.
5. Patients with hepatic failure.
6. Patients with neuraxial (spinal/epidural) anesthesia performed before induction of general anesthesia.
7. Patients with suspected difficult airway.
8. Patients with documented allergy to Ondansetron or prolonged QT-syndrome.

   -

Primary outcomes:
measure: Efficacy of preoperative IVC-guided fluid optimization and intravenous ondansetron in reducing the incidence of hypotension after the induction of general anesthesia
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT02180750: Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania
Official title: An Evaluation of a Psychosocial Intervention for Orphans With HIV Infection: a Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: Children
HIV
orphans
Lead sponsor: Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: King's College London
First posted: 2014-07-03
Enrollment: 48
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children living with HIV who are orphaned. This phase 2 trial aims to determine whether attending the intervention improves outcomes compared to standard care. We aim to test the hypothesis that attendance at MWT improves psychological symptoms, self-esteem, emotional and behavioural difficulties, and self-efficacy compared to standard care.


Eligibility criteria: Inclusion Criteria:

* Aged 14-18 years
* HIV positive
* Orphaned
* Naïve to the intervention

Exclusion Criteria:

* Adults
* Children under 14
* HIV negative
* Parent(s) living
* Previously attended the intervention

Primary outcomes:
measure: Change: Brief Symptom Inventory
timeFrame: T0( study entry), T1 (2 weeks), T2 (6 weeks)
Secondary outcomes:
measure: Change: Rosenberg Self-Esteem Scale
timeFrame: T0 (study entry), T1 (2 weeks), T2 (6 weeks)
measure: Change: Goodman's strengths and difficulties questionnaire
timeFrame: T0 (study entry), T1 (2 weeks) T2 (6 weeks)
measure: Change: Self-efficacy questionnaire for children
timeFrame: T0 (study entry), T1 (2 weeks), T2 (6 weeks)
Other outcomes:
Locations:
city: Temeke
country: Tanzania
facility: PASADA
Study officials:
References:
citation: Harding R, Wei G, Gwyther L, Miti E. Improving psychological outcomes for orphans living with HIV in Tanzania through a novel intervention to improve resilience: findings from a pilot RCT. AIDS Care. 2019 Mar;31(3):340-348. doi: 10.1080/09540121.2018.1533630. Epub 2018 Oct 17.
Clinical trial NCT05395650: Cyanocobalamin as Photosensitizing Agent
Official title: Cyanocobalamin as Photosensitizing Agent Using to Make Cross-linking to Cornea Collagen in Treatment of Progressive Keratoconus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keratoconus
Lead sponsor: EL Romany Ophthalmics Factory
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care

Brief summary: is cyanocobalamin active as Photosensitizing Agent instead of riboflavin ? using cyanocobalamin with mix of external collagen to make crosslinking with cornea collagen to make rigid of cornea


Eligibility criteria: Inclusion Criteria:

* - Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing;

Exclusion Criteria:

* Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;

Primary outcomes:
measure: PRESERVATION of presence of red flare by using slit lamb
timeFrame: Base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00607750: Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
Official title: A Phase 2 Randomized, Double-Masked, Study to Evaluate the Safety and Preliminary Efficacy of ATG003 in Patients With Neovascular Age-Related Macular Degeneration (NV-AMD) Receiving Frequent Maintenance Intravitreal Anti-VEGF Antibody Therapy (Ranibizumab or Bevacizumab)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Keywords: Wet AMD, Comentis, ATG003, mecamylamine
Lead sponsor: CoMentis
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be effective in the treatment of neovascular AMD.


Eligibility criteria: Inclusion Criteria:

* \> 55 years of age
* clinical diagnosis of neovascular AMD

Exclusion Criteria:

* confounding ocular condition

Primary outcomes:
measure: To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)
timeFrame: Day 1 - Week 50
Secondary outcomes:
measure: To evaluate the efficacy of ATG003
timeFrame: Day 1 - Week 50
Other outcomes:
Locations:
Study officials:
affiliation: Comentis, Inc.
name: Carl Grove, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04068350: Epidemiological Study of Post-operative Chronic Pediatric Pain.
Official title: Epidemiological Study of Post-operative Chronic Pediatric Pain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Postoperative Pain
Keywords: Pediatrics
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 582
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children between the ages of 6 and 18, who are scheduled for surgery or video-surgery, scheduled or urgent, in the pediatric surgery department of the Bordeaux University Hospital. The main interventions concerned by this protocol are:

* Thoracotomies and thoracoscopies
* Cholécysctectomie
* Laparotomy and appendectomy
* Inguinal surgery (inguinal hernia and testicular ectopia)
* Orthopedic surgery
* Urologic surgery (hypospadias, circumcision and upper urinary tract surgery)

Brief summary: This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.

Detailed description: Chronic pain, defined as continuous or intermittent pain for 3 months or more, postoperative because in the territory of the surgical procedure and does not exist before the operation, is common in adults. Its prevalence varies according to the surgeries between 10 and 50% of the operated adults. The factors potentially responsible for their occurrence are gradually being highlighted in the recent literature, which has made it possible to develop an appropriate analgesic management strategy.

In pediatric surgery, acute pain has long been known and treated as early as possible using multimodal analgesic techniques. On the other hand, there are very few studies evaluating postoperative chronic pain 3 months after infant surgery, as was the case a few years ago in adults.

This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.

Eligibility criteria: Inclusion Criteria:

All children between the ages of 6 and 18, who are scheduled for surgery or video-surgery, scheduled or urgent, in the pediatric surgery department of the Bordeaux University Hospital.

All patients who consented to participate in the research.

Exclusion Criteria:

* All children operated on outpatient surgery.
* Children and parents with difficulties in understanding the questionnaires.
* Refusal of the child or one of the parents.
* Change of home planned during the post-operative follow-up period (3 months).

Primary outcomes:
measure: Chronic postoperative pain
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Hélène BATOZ, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05474950: Minocycline Treatment for Cystoid Macular Edema
Official title: Efficacy and Safety of the Treatment of Minocycline for Cystoid Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Minocycline
Cystoid Macular Edema
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cystoid macular edema (CME) is one of sight-threatening, immune-related ocular diseases. The efficacy of current treatments for CME (anti-VEGF, glucocorticoids and other agents) are limiting. Minocycline, acting as a broad-spectrum antibiotic, is among tetracycline family and recently, its immunomodulatory and anti-apoptosis function has been replied to several immune diseases and degenerative diseases. This study aims to explore the efficacy and safety of minocycline for CME.


Eligibility criteria: Inclusion Criteria:

* Participant diagnosed with CME.
* Participant aged from 18-60 years old.
* Participant that signed the informed consent document and is able to complete the following visits.

Exclusion Criteria:

* Participant is allergy to minocycline or tetracyclines.
* Participant has no contraindications of minocycline or tetracyclines.
* Participant has an abnormal function of liver, heart, kidney and thyroid.
* Female that is pregnant, breast-feeding or planning to become pregnant.
* Participant that is currently using other medications.

Primary outcomes:
measure: Change of cystoid macular edema
timeFrame: At 6 months
Secondary outcomes:
measure: Change of best corrected visual acuity (BCVA)
timeFrame: At 6 months
measure: Change of macular sensitivity
timeFrame: At 6 months
measure: Change of retinal vascular leakage
timeFrame: At 6 months
measure: Change of macular vessel
timeFrame: At 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT05302050: A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus
Official title: A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Type 2
Lead sponsor: Better Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Mass General Brigham
First posted: 2022-03-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study population consists of approximately 500 total participants, ages 18 - 75 years old, inclusive, who have type 2 diabetes. They will be randomized to the treatment or control group at a 3:1 ratio
Primary purpose: TREATMENT

Brief summary: Randomized, controlled, pragmatic trial with open-label extension evaluating BT-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.

Detailed description: The study intervention, BT-001 (the App), will be dispensed at enrollment to the Immediate Intervention App Use arm of the trial. Patients randomized to the Delayed Intervention App Use arm will be provided a "control App" with diabetes control, and then the BT-001 App after 180 days. Each participant is assigned to one 90-day treatment cycle of BT-001. Over the 12-month intervention period, study participants will be able to opt into up to 3 additional treatment cycles of BT-001. Study schema is included at the end of this section

Eligibility criteria: Inclusion Criteria:

* Current (within 3 months prior to enrollment) HbA1c \>=7.01%
* Possession of and ability to use Android or iPhone mobile phone
* Speaks and reads in English
* Willing to measure frequent fasting finger glucose measurements as part of the App utilization

Exclusion Criteria:

* Current use of insulin other than a long-acting insulin analogue or human NPH insulin
* HbA1c \>=11%
* Cognitive impairment or degenerative neuropsychiatric condition (e.g. Alzheimer's, dementia, mixed dementia, other significant memory loss, schizophrenia), or any other condition that in the Investigator's opinion may prevent patient from completing study activities
* Any terminal medical condition with life expectancy of \< 1 year.

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline and Day 180
Secondary outcomes:
measure: Change in HbA1c
timeFrame: Baseline and day 180, 365
measure: Significant change in HbA1c
timeFrame: Baseline and Day 365
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham Hospital and Clinics
state: Massachusetts
Study officials:
References:
Clinical trial NCT02880150: Physiological Characteristics of High Altitude Climbers
Official title: Physiological Characteristics of High Altitude Climbers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Exercise
Sport Performance
Keywords: elite climbers
near infrared spectroscopy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Climbing at high altitude and tolerating hypoxic environment require specific physiological adaptations. Large intersubjects differences exist regarding the ability to adapt to high altitude and hypoxia. The present study aims to characterise the physiological responses to hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised that elite climbers would show better physiological responses to hypoxia and more preserved performances compared to sea level.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 40
* Member of the national high altitude climbing group

Exclusion Criteria:

* Any diseases incompatible with hypoxic exposure, exercise testing
* Pregnancy

Primary outcomes:
measure: Performance reduction in hypoxia versus normoxia
timeFrame: Day one on the evaluation day
Secondary outcomes:
measure: Near infrared signals during exercise
timeFrame: Day one on the evaluation day
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
References:
citation: Verges S, Rupp T, Jubeau M, Wuyam B, Esteve F, Levy P, Perrey S, Millet GY. Cerebral perturbations during exercise in hypoxia. Am J Physiol Regul Integr Comp Physiol. 2012 Apr 15;302(8):R903-16. doi: 10.1152/ajpregu.00555.2011. Epub 2012 Feb 8.
Clinical trial NCT00259350: Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection
Official title: Prevention of Central Venous Catheter Infections : Comparison of the Efficacy of Skin Disinfection With 5% Povidone Iodine in Alcoholic Solution Versus 0.25% Chlorhexidine, 0.025 Benzalkonium and 4% Benzylic Alcohol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ICU Patients Requiring a Central Venous Access
Keywords: Central venous catheter
Skin disinfection
Antisepsis
Nosocomial infection
Catheter infection
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2005-11-29
Enrollment: 520
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 best antiseptic solution for cateheter care remains unknown.High concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. No study has compare alcoholic formulations of low concentration of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central venous catheters.

To compare the incidence of central venous catheter colonization after skin disinfection with either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine, 0.025% Benzalkonium and 4% benzylic alcohol.

To compare the incidence of catheter related bacteremia in the to study groups. To compare the local and general tolerance of the two antiseptic formulations


Eligibility criteria: Inclusion Criteria:

* Patients over 18 yeras of age
* Requiring an internal jugular or sub-clavian central venous catheter for their care during at least 72 h
* Informed consent signed up

Exclusion Criteria:

* Bacteriemic infection not under control
* extensive cutaneous infection
* Women with childbearing potential

Primary outcomes:
measure: Prevention of catheter colonization
Secondary outcomes:
measure: Prevention of catheter related bacteremia
measure: Prevention of a positive culture of the catheter whaterver the threshold
measure: Local and general tolerance
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University hospital
state: Vienne
Study officials:
affiliation: University Hospital of Poitiers, france
name: Olivier MIMOZ, MD, PhD
role: STUDY_CHAIR
References:
citation: Mimoz O, Villeminey S, Ragot S, Dahyot-Fizelier C, Laksiri L, Petitpas F, Debaene B. Chlorhexidine-based antiseptic solution vs alcohol-based povidone-iodine for central venous catheter care. Arch Intern Med. 2007 Oct 22;167(19):2066-72. doi: 10.1001/archinte.167.19.2066.