louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04553731: The Effects of mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy
Official title: The Effects of mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obese Pregnant Women
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 92
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: evaluate the health empowerment program with mHealth to promote physical activity for overweight and obese pregnant women.

Detailed description: This two-phase study develops an mhealth application (app) based on social-cognitive theory (SCT) and evaluates its effectiveness for overweight and obese women, which can help to prevent excessive GWG by enhancing optimal weight and healthy behavior during pregnancy.

Eligibility criteria: Inclusion Criteria:

1. pregnant women--who have had, 8-12 weeks
2. pre-pregnancy body mass index \> 25 kg/m2

Exclusion Criteria:

-

Primary outcomes:
measure: Change in body weight and gestational weight gain from pregnancy to 6 months postpartum
timeFrame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks), 6 months postpartum
Secondary outcomes:
measure: Change in physical activity before intervention to childbirth
timeFrame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks); The highest total scores was depend the participants' activities of METs.
measure: self-efficacy related weight gain
timeFrame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks); The highest total scores was 125.
measure: control infant birthweight
timeFrame: The data were collected at childbirth
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Nursing
Study officials:
affiliation: Mackay Medical College
name: Ching-Fang Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03892031: Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer
Official title: Preliminary Study on the Changes of Perioperative Circulatory Function in Patients Undergoing Laparoscopic Radical Cystectomy for Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulatory Function
Laparoscopic Radical Cystectomy for Bladder Cancer
Keywords: brain natriuretic peptide
pneumoperitoneum
Trendelenburg
circulatory function
laparoscopic radical cystectomy for bladder cancer
central venous pressure
stroke volume variation
transthoracic echocardiography
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo laparoscopic radical cystectomy for bladder cancer in Renji Hospital

Brief summary: To optimize the perioperative management of patients undergoing laparoscopic radical cystectomy(LPC) for bladder cancer through observation of perioperative changes of Brain Natriuretic Peptide(BNP), stroke volume variation(SVV), central venous pressure(CVP) and the use of transthoracic echocardiography(TTE).

Detailed description: Long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer influence perioperative circulatory function, resulting in a series of pathophysiological changes. BNP is of high sensitivity and specificity in the evaluation of cardiac function. SVV and CVP are dynamic and static indices to predict fluid responsiveness. TTE is a good indicator of volume and cardiac function.Thus, we conducted the trial to assess the perioperative circulatory function in patients undergoing LPC. We hypothesized that long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer would increase perioperative blood volume and influence cardiac function.

Eligibility criteria: Inclusion Criteria:

* undergoing laparoscopic radical cystectomy for bladder cancer
* ASA I-II

Exclusion Criteria:

* Cardiac insufficiency
* Hepatic insufficiency
* Renal insufficiency

Primary outcomes:
measure: Brain Natriuretic Peptide(BNP)
timeFrame: before induction (T1), at the end of operation(T2), at 12 hours (T3) and 24 hours (T4) postoperatively
measure: Central Venous Pressure(CVP)
timeFrame: before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively
measure: Stroke Volume Variation(SVV)
timeFrame: before induction (T1), at the end of operation (T2)
measure: Transthoracic Echocardiography
timeFrame: before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
name: Jie Chen, MS
role: STUDY_CHAIR
References:
Clinical trial NCT01744431: Can Thrombin Generation Measurement Predict the Risk of Venous Thromboembolism in Acute Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 hospitalized patients

Brief summary: Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill patients

Traditional coagulation tests do not assess the whole coagulation system. Thrombin generation assays measure the ability of plasma sample to generate thrombin following in vitro activation of coagulation. In contrast to the classical clotting assays, thrombin generation reflects and integrates all pro and anticoagulant reactions that regulate the formation and inhibition of thrombin.

The aim of our study is to investigate whether thrombin generation would be able to predict a hypercoagulable state in acute ill patients admitted in the internal medical departments and how it correlates with the Padua prediction score, a score that could assists the risk for venous thromboembolism in hospitalized medical patients.

In total 300 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. We will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT).


Eligibility criteria: Inclusion Criteria:

* signed inform consent

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: venous thromboembolism
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek medical center
Study officials:
affiliation: Emek Medical Center
name: mazen elias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01591031: Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium
Official title: Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium. A Randomized, Prospective, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Injuries
Keywords: laryngeal injuries
vocal cord injuries
hoarseness
sore throat
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anesthesia induction with sevoflurane is not associated with an increased incidence or severity of laryngeal injuries compared with an anesthesia induction with a muscle relaxant.


Eligibility criteria: Inclusion Criteria:

* ear-nose-throat surgery
* orotracheal intubation for surgery of the ear

Exclusion Criteria:

* obesity
* allergy against the study drugs
* patients with a known or suspected difficult airway (Mallampati score 3 or 4 and a mouth opening \< 3.5 cm).
* all patients were examined by stroboscopy one day before surgery and were excluded from the study when preexisting pathologies of the vocal cords were found

Primary outcomes:
measure: incidence of vocal cord injuries
timeFrame: 24 h after tracheal intubation
Secondary outcomes:
measure: incidence of hoarseness
timeFrame: 24h, 48 h, and 72 h after tracheal intubation
measure: incidence of soar throat
timeFrame: 24h, 48h, and 72 h after tracheal intubation
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock
state: Mecklenburg/Vorpommern
Study officials:
References:
citation: Mencke T, Jacobs RM, Machmueller S, Sauer M, Heidecke C, Kallert A, Pau HW, Noeldge-Schomburg G, Ovari A. Intubating conditions and side effects of propofol, remifentanil and sevoflurane compared with propofol, remifentanil and rocuronium: a randomised, prospective, clinical trial. BMC Anesthesiol. 2014 May 22;14:39. doi: 10.1186/1471-2253-14-39. eCollection 2014.
Clinical trial NCT00002031: Evaluation of the Epidermal Langerhans Cell Population in AIDS / ARC Patients by the Topical Application of a Potent Contact Allergen (1-Chloro-2,4-Dinitro-Chlorobenzene) (DNCB)
Official title: Evaluation of the Epidermal Langerhans Cell Population in AIDS / ARC Patients by the Topical Application of a Potent Contact Allergen (1-Chloro-2,4-Dinitro-Chlorobenzene) (DNCB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Langerhans Cells
Dinitrochlorobenzene
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of application of Dinitrochlorobenzene (DNCB) on the number, morphology, and antigen expression of epidermal Langerhans cells in AIDS and AIDS related complex (ARC) patients.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

* Stage III or IV HIV infection.
* Provide informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Kaposi's sarcoma lesions in the proposed treatment sites.
* Liable to require radiation or chemotherapy during the course of the study.
* Not likely to survive the length of the study.
* Obvious ultra-violet-irradiated skin damage in the treatment areas and anyone with recent UV exposure or likely to have such exposure (e.g.:
* holiday tans obtained in Hawaii, members of UV box tanning salons, etc.) Allergy to lidocaine.

Concurrent Medication:

Excluded:

* Other Immunomodulators.

Concurrent Treatment:

Excluded:

* Radiation.

Patients with the following are excluded:

* Kaposi's sarcoma lesions in the proposed treatment sites.
* Liable to require radiation or chemotherapy during the course of the study.
* Not likely to survive the length of the study.
* Obvious ultra-violet-irradiated skin damage in the treatment areas.
* Allergy to lidocaine.

Prior Medication:

Excluded:

* Prior DNCB therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco AIDS Clinic / San Francisco Gen Hosp
state: California
Study officials:
References:
citation: Stricker RB, Elswood BF. Dendritic cells and dinitrochlorobenzene (DNCB): a new treatment approach to AIDS. Immunol Lett. 1991 Aug;29(3):191-6. doi: 10.1016/0165-2478(91)90169-b.
Clinical trial NCT06576531: Exercise and Prediabetes After Renal Transplantation
Official title: Exercise and Prediabetes After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PreDiabetes
Kidney Transplantation
Keywords: Adherence
Post-transplant Diabetes Mellitus
Prediabetes
Renal Transplantation
Therapeutic Exercise
Lead sponsor: University of La Laguna
Sponsor class: OTHER
Collaborators: name: Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias
First posted: 2024-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present clinical trial, EXPRED-II, is the continuation of EXPRED-I (NCT04489043).

Objective: to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation, as a first step to prevent Post-Transplant Diabetes Mellitus (PTDM).

Methodology: a total of 50 patients with prediabetes beyond 12 months after transplantation with capacity to perform exercise will be randomized to standard life-style recommendations as per clinical practice (n=25) or to a stepped ad-hoc designed training intervention (n=25). Prediabetes will be diagnosed based on fasting glucose levels and an Oral Glucose Tolerance Test (OGTT). Patients randomized to exercise will start with aerobic exercise training 5 times/week, 30 min/day for 12 months which may be gradually increased to 60 min/day or combined with strength exercise in the last increment in case of prediabetes persistence. The reversibility/persistence/relapse of prediabetes will be measured with fasting glucose and OGTT every 3 months. The study will last 12 months.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* ≥ 12 months post kidney transplant
* Stable renal function in the last 3-6 months
* Prediabetes (abnormal fasting glucose 100-125 mg/dl and/or glucose intolerance 140-199mg/dl)
* Ability to perform exercise

Exclusion Criteria:

* Infection, cancer, acute cardiovascular disease, advanced kidney disease, pulmonary hypertension and uncontrolled chronic liver disease.
* Inability to understand the protocol
* Severe psychological illness
* PTDM and/or DM prior to transplantation
* Morbid obesity

Primary outcomes:
measure: Reversibility of pre-diabetes in kidney transplant population through therapeutic exercise
timeFrame: Baseline and every 3 months (up to 12 months)
Secondary outcomes:
measure: Compliance
timeFrame: Baseline and every 1.5 months (up to 12 months)
measure: Analytics
timeFrame: Baseline and every 3 months (up to 12 months)
measure: Anthropometric measures
timeFrame: Baseline and every 3 months (up to 12 months)
Other outcomes:
Locations:
city: San Cristobal de La laguna
country: Spain
facility: University of La Laguna
state: Santa Cruz De Tenerife
Study officials:
References:
Clinical trial NCT01219231: Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)
Official title: Exercise in Elderly Individuals With Impaired Glucose Tolerance: Beneficial for Vasculature and Neurons?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impaired Glucose Tolerance
Keywords: Exercise
elderly
cognition
prevention
cognitive decline
Lifestyle
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2010-10-13
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The researchers will investigate whether exercise could provide positive effects on general brain functions in elderly people with impaired glucose tolerance.

Detailed description: The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as Alzheimer's disease are a growing public-health concern with devastating effects.

Referring to animal data, empirical studies, and pilot human trials, exercise should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with impaired glucose tolerance during a short term exercise program.

Eligibility criteria: Inclusion Criteria:

* subjects with impaired glucose tolerance
* 50-65 years old
* moderate to heavy weight (BMI 25-35)
* must be able to do exercise intervention

Exclusion Criteria:

* diabetes
* younger than 50 years
* BMI \< 25
* psychiatric medication
* severe disease
* MMSE \< 26
* severe cardiovascular disorders

Primary outcomes:
measure: Auditory Verbal Learning Task
timeFrame: Prior to intervention and after 6 months of intervention
Secondary outcomes:
measure: Functional/Structural brain changes
timeFrame: Prior to intervention and after 6 months of intervention
measure: Plasma biomarkers
timeFrame: Prior to intervention and after 6 months of intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Neurology, Charité Universitätsmedizin
Study officials:
affiliation: Charité University Berlin
name: Agnes Flöel, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02456831: Soy Formula Feedings in Healthy, Term Infants
Official title: Efficacy of Soy Formula Feedings in Healthy, Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2015-05-29
Enrollment: 115
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.


Eligibility criteria: Inclusion Criteria:

* Healthy infants believed by their parents and/or physicians to be experiencing symptoms of cow's milk formula intolerance and who had not previously consumed a soy-based formula (Intervention subjects).
* Health infants reported to be tolerating a milk-based formula (Cohorts).
* Infants considered full-term, 2 to 9 weeks of age with a birth-weight above the 5th percentile (NCHS).

Primary outcomes:
measure: Stool Characteristics Questionnaire
timeFrame: Change from Baseline (Study Day 1) to Study Day 15
Secondary outcomes:
measure: Formula Intake
timeFrame: Change from Baseline (Study Day 1) to Study Day 15
measure: Gastrointestinal Tolerance Questionnaire
timeFrame: Change from Baseline (Study Day 1) to Study Day 15
measure: Weight
timeFrame: Change from Baseline (Study Day 1) to Study Day 15
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Aurora
country: United States
facility: Dreyer Clinic
state: Illinois
city: Owensboro
country: United States
facility: T&W Research
state: Kentucky
city: Minneapolis
country: United States
facility: Park Nicollet Medical Foundation
state: Minnesota
city: Canton
country: United States
facility: Clinical Studies, Inc
state: Ohio
city: Memphis
country: United States
facility: Research Memphis
state: Tennessee
city: San Antonio
country: United States
facility: Child Care Associates
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: John Lasekan, MBA, PhD, CCRP
role: STUDY_CHAIR
References:
Clinical trial NCT01688531: A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
Official title: A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-09-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Exploratory, international, multi-centre, randomized, investigator blinded study in acne


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 to 35 years inclusive
* Subjects with active, moderate acne

Exclusion Criteria:

* The subject has a secondary acne form (chloracne, drug-induced acne, etc.) (Screening)
* The subject has a severity of acne that is not amenable to treatment with CD0271-CD1579 (Screening)

Primary outcomes:
measure: Description and documentation of acne lesions
timeFrame: over 6 months
Secondary outcomes:
measure: Treatment effect on acne lesions
timeFrame: over 6 months
Other outcomes:
Locations:
city: Windsor
country: Canada
facility: Galderma Investigational site
state: Ontario
city: Montreal
country: Canada
facility: Galderma Investigational site
state: Quebec
city: Nantes
country: France
facility: Galderma Investigational site
Study officials:
References: