louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04747886: Inhibitory Control Adult Weight Management
Official title: Supplementing Evidence-based Commercial Weight Management Program With Inhibitory Control Training: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to explore the benefits of supplementing the WW (formerly Weight Watchers) online program with a cognitive training game (PolyRules!) among adults with overweight or obesity.

Detailed description: This two-arm pilot study will be used to estimate the effect size in weight loss of supplementing the WW (formerly Weight Watchers) online program with gamified inhibitory control training (PolyRules!) among adults with overweight or obesity. Participants ages 18 and older (n=30) will be randomly assigned to one of two study arms: (1) WW (formerly Weight Watchers) only or (2) WW + Gamified inhibitory control training (PolyRules!). All participants will complete demographic, medical history questionnaires and cognitive assessment battery at baseline/enrollment and after completing the 3-month intervention protocol. All interactions with PolyRules! and WW will be passively recorded to monitor the frequency of interaction with WW and PolyRules!.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Read, write and speak English with acceptable visual acuity
* BMI between 25-40 kg/m\^2

Exclusion Criteria:

* Currently enrolled in weight loss interventions or undergoing bariatric surgery
* Pregnant women
* Individuals with severe cognitive delays or visual/hearing impairment

Primary outcomes:
measure: BMI at Three Months
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
measure: Change in Visuo-spatial Working Memory Based on Performance on the Corsi Task.
timeFrame: Baseline, 3 months
measure: Change in Performance on the Letter-number Task.
timeFrame: Baseline, 3 months
measure: Change in Performance on the N-back Task.
timeFrame: Baseline, 3 months
measure: Change in Performance on the Cancellation Task.
timeFrame: Baseline, 3 months
measure: To Explore Whether Inhibitory Control Training Confers Any Increases in Self-reported Physical Activity.
timeFrame: Baseline, 3 months
measure: Change in Performance on the Countermanding Task.
timeFrame: Baseline, 3 months
measure: To Explore Whether Inhibitory Control Training Confers Any Benefits in Self-reported Diet
timeFrame: Baseline, 3 months
Locations:
city: West Hollywood
country: United States
facility: Pacific Design Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Sarah-Jeanne Salvy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00372086: Rosiglitazone and Insulin in T1DM Adolescents
Official title: The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Puberty: >Tanner 2 Breast Development or Testis >4ml
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Sydney Children's Hospitals Network
name: National Health and Medical Research Council, Australia
name: Novo Nordisk A/S
First posted: 2006-09-06
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Type 1 Diabetes is the most common life-long disorder with onset in childhood. Patients need insulin injections, blood sugar monitoring several times each day, and adhere to a strict diet. Adequate control of blood glucose is essential to prevent long term kidney and eye complications that result in kidney failure and blindness. Adolescence is a time when diabetes is difficult to control, due in part to high growth hormone levels causing insulin resistance ( a state where the body does not respond as strongly to insulin). This study will test whether treatment with rosiglitazone (an oral medication used frequently in type 2 diabetes) will reduce the insulin resistance of adolescence and improve the control of type 1 diabetes during puberty.


Eligibility criteria: Inclusion Criteria:

* T1DM duration \> 1year
* age 10-18years
* HbA1c \> 8%
* puberty \> Tanner stage 2 breast or testis \>4ml

Exclusion Criteria:

* known non-compliance
* hypo unaware

Primary outcomes:
measure: HbA1c
Secondary outcomes:
measure: insulin dose
measure: frequency of severe hypoglycaemia
measure: insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp
measure: weight
measure: BMI-SDS
measure: skin fold thickness
measure: cholesterol
measure: adiponectin
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
Study officials:
affiliation: Royal North Shore Hospital
name: Monique Stone, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01409486: Screening for Early Detection and Prevention of Pompe Disease in Israel Using Tandem Mass Spectrometry
Official title: Screening for Early Detection and Prevention of Pompe Disease in Israel Using Tandem Mass Spectrometry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pompe Disease
Keywords: Pompe disease
Alpha glucosidase
Newborn screening
Tandem Mass Spectrometry (LC-MS-MS)
The study aims:
To establish the control mean values of alpha glucosidase activity in Dry blood spots of Newborn babies from Israel.
To include the alpha glucosidase assay in the newborn screening program in Israel
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 10000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10000 full-term newborns born in Northern Israel

Brief summary: The aim of the study is:

to develop a comprehensive biochemical assay for detection of Pompe disease (glycogen storage disease type II), to be implemented in the Newborn screening program among the Israeli population.


Eligibility criteria: Inclusion Criteria:

* New born babies born during the study period

Exclusion Criteria:

* Premature babies

Primary outcomes:
measure: Identification of the normal mean control value of Alpha glucosidase activity in Dry blood spots among Newborns in Israel
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
Clinical trial NCT00125086: Platelets for Acute Wound Healing
Official title: Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds
Keywords: wounds
healing
Acute wounds healing by secondary intention
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2005-07-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment.

Detailed description: Platelets contribute to the healing process in soft tissue by providing the initial hemostasis that occurs following injury, a framework for fibrin matrix formation and contribution of growth factors.

According to the US National Institutes of Health, surgical procedures are considered a form of controlled injury, so many of the complications faced by surgery patients are very similar to those faced by trauma patients. Scientists are currently investigating ways to treat wounds caused by trauma, burns or surgical inventions with biological agents (i.e. growth factors) or new drugs. Growth factor priming of acute wound sites pre-activates the cellular and molecular components of tissue repair, prior to tissue injury.

Objectives are aimed at gathering information to establish evidence that autologous platelet gel positively effects the healing of acute wounds.

Eligibility criteria: Inclusion Criteria:

* Normal volunteers
* 18 years old or older

Exclusion Criteria:

* Pregnant or lactating
* Diabetic, keloid former, collagen vascular disease
* Smoker
* Body mass index \>30kg/m2
* Known history of HIV/AIDS; Hepatitis A, B, or C
* Bleeding disorder
* Aspirin, non-steroidal anti-inflammatory drug (NSAID) or anticoagulant user
* Cancer, or treatment for cancer, in past 5 years

Primary outcomes:
measure: Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35
Secondary outcomes:
measure: Measurements of wound depth at each visit
measure: Measurement of residual scarring at 6 months post wounding
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David Hom, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04668586: Laser Lithotripsy During URS - Holmium vs Thulium
Official title: Laser Lithotripsy During Ureteroscopy - Holmium vs Thulium: A Clinical Prospective Randomized Trial of Effectiveness and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Holmium:YAG laser lithotripsy Arm 2: Thulium Fiber laser lithotripsy
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser.

The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.

The outcomes of the URS procedures are compared for the two treatment arms.

Detailed description: The primary aim of the study is to compare the stone free rate (SFR) following URS lithotripsy with Holmium and Thulium lasers. SFRs will be compared both for ureteral stones, renal stones and ureteral and renal stones in total.

Secondary aims are to compare the results of the two lasers in terms of operating times, intraoperative complications, postoperative complications and the rate of post endoscopic JJ-stenting.

The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.

The outcomes of the URS procedures are compared for the two treatment arms.

Eligibility criteria: Inclusion Criteria:

* Patients planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway

Exclusion Criteria:

* Known pathology of the upper urinary tract
* Untreated infection

Primary outcomes:
measure: Stone Free Rate
timeFrame: 3 months after the URS
Secondary outcomes:
measure: Operating Time
timeFrame: Decided immediately after the surgery
measure: Intraoperative Complications
timeFrame: Decided immediately after the surgery
measure: Postoperative Complications
timeFrame: Within 3 months post endoscopically
measure: Postoperative JJ-stenting
timeFrame: Decided immediately after the surgery
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Vestland
Study officials:
affiliation: Helse-Bergen HF, Haukeland University Hospital
name: Øyvind Ulvik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00329186: Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects
Official title: A Randomized, Open-Label, Two-Period, Parallel Group, Crossover Study to Evaluate the Pharmacokinetics of Venlafaxine Extended-Release and DVS SR in Healthy Subjects Who Are Extensive or Poor Cytochrome P450 2D6 Substrate Metabolizers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Healthy Subjects
Major Depressive Disorder
Depression
Cytochrome P-450 CYP2D6
Pharmacokinetics
Health
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 14
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: The purpose of this study is to determine if the relative difference in PK between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women between 18 to 55 years of age
* Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and no clinically significant abnormalities on 12-lead electrocardiogram (ECG)
* History of nonsmoker for at least 1 year

Exclusion Criteria:

* Presence or history of any disorder or significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure), or psychiatric disease that may prevent the completion of the study
* Known or suspected alcohol abuse or consumption of more than 2 standard units per day within past 6 months or known or suspected abuse of prohibited drugs or other substances
* Use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day -1 until the end of the study

Primary outcomes:
measure: The primary objective is to determine if the relative difference in PK between EMs and PMs is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.
Secondary outcomes:
Other outcomes:
Locations:
city: Wichita
country: United States
state: Kansas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Preskorn S, Patroneva A, Silman H, Jiang Q, Isler JA, Burczynski ME, Ahmed S, Paul J, Nichols AI. Comparison of the pharmacokinetics of venlafaxine extended release and desvenlafaxine in extensive and poor cytochrome P450 2D6 metabolizers. J Clin Psychopharmacol. 2009 Feb;29(1):39-43. doi: 10.1097/JCP.0b013e318192e4c1.
Clinical trial NCT00213486: Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
Official title: Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Neoplasms
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the alternative regimen which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival.

Detailed description: Chemotherapy with weekly cisplatin 30 mg/m2 AND Irinotecan 60 mg/m2 was administered at days1,8,22,29 and concurrently with radiotherapy t days 43,50,64,71. Radiotherapy was delivered day 43 to 75 with 50Gy in 25 fractions/5 weeks.

Eligibility criteria: Inclusion Criteria:

* esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed
* performance status \<OR=2 (ECOG)
* caloric intake\>1500 KCal/d
* serum albumin \>32 gr/l
* serum creatinine\<120 microgr/l
* total serum bilirubin \< 1.5 mg/ml
* no prior chemotherapy or radiotherapy or surgery for esophageal neoplasm
* no prior history of malignancy other than cell carcinoma of the skin, in siyu cervical carcinoma, or head and neck carcinoma with complete response since 3 years
* written informed consent

Exclusion Criteria:

* Gilbert's syndrome
* cardiac disease as NYHA class 3 or 4
* myocardial infarction within the previous 6 months
* metastatic disease
* histologically proved invasion of tracheobronchial tree
* metastatic disease

Primary outcomes:
measure: clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan
Secondary outcomes:
measure: toxicity profile
measure: overall survival rate at one and two years
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
affiliation: Federation Francophone de Cancerologie Digestive
name: Pierre MICHEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03649386: Heated Circuit for One-lung Ventilation
Official title: Effect of Heated-humidified Circuit on Arterial Oxygenation in Patients Undergoing One-lung Ventilation for Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: One-lung Ventilation
Oxygenation
Temperature
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: One-lung ventilation interrupts oxygenation. The effect of heated humidifed breathing circuit on arterial oxygenation during one-lung ventilation has not been investigated. The investigators will investigate the effect of the heated humidifed breathing circuit on oxygenation during one-lung ventilation in patients undergoing thoracoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist class I-II
* Patients scheduled for one-lung ventilation for thoracoscopic surgery

Exclusion Criteria:

* Obesity
* Severe obstructive or restrictive lung disease
* Preoperative oxygen supply
* Preoperative intubated state or under mechanical ventilatory support
* Baseline arterial partial pressure of oxygen (PaO2) \< 70 mmHg
* Symptomatic coronary or peripheral arterial disease
* Renal failure
* Preoperative continuous infusion of inotropes or vasopressor
* Pregnancy

Primary outcomes:
measure: Arterial oxygenation
timeFrame: At 30 minutes after one-lung ventilation
Secondary outcomes:
measure: Arterial oxygenation
timeFrame: At 0, 15, 45, and 60 minutes after one-lung ventilation
measure: Mean arterial pressure
timeFrame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
measure: Heart rate
timeFrame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
measure: Temperature
timeFrame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
measure: Central venous pressure
timeFrame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
measure: Cardiac index
timeFrame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
measure: Pressure peak
timeFrame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
measure: Pressure plateau
timeFrame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
measure: Arterial carbon dioxide
timeFrame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
measure: Arterial blood acidosis
timeFrame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
measure: Oxygen saturation of arterial blood
timeFrame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
Other outcomes:
Locations:
Study officials:
affiliation: Keimyung University
name: Hyun-Chang Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289886: Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects
Official title: BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Single Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects Incorporating a Comparison of Fed/Fasted Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Keywords: single-dose
pharmacokinetic
pharmacodynamic
safety
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2011-02-04
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic (PK/PD) of ascending single oral dose of BR-A-657 in healthy male subjects.

Detailed description: BR-A-657 20, 50, 120, 240, 360, 480mg or placebo were administered once to healthy male subjects.

Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects.

PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.

Eligibility criteria: Inclusion Criteria:

* male of 18-55 years old
* Body Mass Index(BMI) 19-29kg/m2
* subjects in good health
* subjects with written informed consent

Exclusion Criteria:

* subjects with multiple drug allergy or allergy to Angiotensin Receptor Blocker(ARB)
* subjects with medication that affect drug absorption or elimination within 30days.
* subjects with orthostatic hypotension of \>20mmHg decrease of Systolic Blood Pressure(SBP)
* subjects with history of neurologic, liver, renal, gastrointestinal, cardiovascular, psychological or other major disorder

Primary outcomes:
measure: No of subjects with Adverse events(AE) from each observations
timeFrame: up to 5~7days post-dose
Secondary outcomes:
measure: Area under the plasma concentration time curve (AUC)
timeFrame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
measure: Time of the maximum observed plasma concentration (Tmax)
timeFrame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
measure: Apparent total plasma clearance (CL/F)
timeFrame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
measure: Apparent plasma terminal elimination half life (t½)
timeFrame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Other outcomes:
Locations:
Study officials:
affiliation: Covance Clinical Research Unit
name: E Engmann, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: