louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00761748: Comparison of Two Urostomy Bags (2-piece).
Official title: A Comparative, Randomised, Crossover Study With SenSura Uro 2-piece Versus ConvaTec 2-piece Among 30 Urostomy-operated Persons in Germany
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urostomy Patent
Keywords: Urostomy,
2-piece,
preference,
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.

Detailed description: The 2-piece product is a part of a new product family, under the brand name SenSura. The aim of this investigation is to see how the urology product is perceived and how it performs against another 2-piece product from ConvaTec. The device 'ConvaTec 2-piece combihesive Natura' is selected as the comparative product because of its similarity to SenSura 2-piece product.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old,
* Be able to complete a written consent form
* Be able to fill in the Case Report Form
* Have a urostomy with a diameter of 33 mm. or less.
* Have had the urostomy for 3 months or more.
* Use a 2-piece convex (or convex light) normally.
* Be able to use SenSura URO 2-piece product
* Be able to use ConvaTec, 2-piece product
* Be able to handle the product themselves (application, removal and emptying),

Exclusion Criteria:

* In order to be enrolled in the clinical investigation, the subjects must not:

  * Need to use an ostomy belt
  * Be currently suffering from any dermatological problems, needing special treatment, on the peristomal skin
  * Being treated with chemo- or radiation therapy,
  * Be hospitalized during study enrollment, or have a hospitalization or significant surgery planned during the 4-week study period, or
  * Be pregnant or breast-feeding.

Primary outcomes:
measure: Preference of the Two Urostomy Products
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Visé Mitteldeutschland GmbH
Study officials:
affiliation: Coloplast A/S
name: Daniel Carter, M.Sc
role: STUDY_CHAIR
References:
Clinical trial NCT01407848: Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
Official title: Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transient Tachypnoea of the Newborn
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with Transient Tachypnoea.

Detailed description: In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with transient Tachypnoea. Patients received nebulised Furosemide iv solution 1 mg/kg or nebulised 0,9% saline (4x/d) under blind conditions in random order so long as need a CPAP-treatment but max. 3 days. 20 Patient will be treating.

The benefit will be measured as reduction of dyspnea, respiratory rate, oxygen demand and time on CPAP.

Eligibility criteria: Inclusion Criteria:

* Neonates with 35+0-39+0 GA on the first day of life with the clinical diagnosis of Transient Tachypnoea
* The need for CPAP \>6 h to obtain the oxygen saturation \>92%
* Written informed consent of parent/guardian

Exclusion Criteria:

* Systemic infection
* Intubation and mechanical ventilation before Inclusion in the trail
* Malformation and any other several disease with disturb of respiratory
* Subjects participating in other clinical trials

Primary outcomes:
measure: Reduction of the Silverman-Score
timeFrame: 0-72 h or up to end of CPAP after start of the study
Secondary outcomes:
measure: Oxygen supplementation
timeFrame: 0-72 h or up to end of CPAP after start of the study
measure: A need for secondary intubation and mechanical ventilation
timeFrame: 1-3 day of life
measure: body weight
timeFrame: 1-3 day of life
measure: CPAP-time
timeFrame: 0-72 h or up to end of CPAP after start of the study
measure: blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-)
timeFrame: 0-72 h after start of the study
measure: blood gas (pH, pCO2,pO2)
timeFrame: 0-72 h after start of the study
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Children´s Hospital University of Cologne
state: NRW
Study officials:
affiliation: University Cologne
name: Bernhard Roth, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01332448: Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials
Official title: Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Xenical
Alli
safety
meta-analysis
liver-function test
Roche
orlistat
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All clinical trials found by search procedure:

1. In-house trial repositories at GSK and Roche
2. EMBASE (which includes MEDLINE) using the terms "orlistat", "Xenical" or "Alli", with "placebo" and "clinical trial"
3. Recently published meta-analyses found by the search will also be searched for relevant trials

Brief summary: Roche and GSK will carry out a meta-analysis of liver function data from trials of orlistat to establish whether there is any indication of liver toxicity. The motivation is a cumulative assessment of drug-induced liver injury (DILI) conducted by the FDA following spontaneous reports of liver toxicity in people taking Xenical or Alli.


Eligibility criteria: Inclusion Criteria:

1. The trial must be randomized and placebo-controlled
2. The orlistat dose must be 60mg or 120mg
3. Data on ALT or BIL must be available
4. The nominal treatment period must be 16 weeks or longer

Exclusion Criteria:

1. If cross-over trials are found, data from other than the first period will be excluded.

Primary outcomes:
measure: Odds ratio (Orlistat120:Placebo) for subjects experiencing alanine transaminase (ALT) greater than upper limit of normal (ULN)
timeFrame: within one year of starting treatment
measure: Odds ratio (Orlistat120:Placebo) for subjects experiencing total bilirubin (BIL) > ULN
timeFrame: within one year of starting treatment
measure: Odds ratio (Orlistat120:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart
timeFrame: within one year of starting treatment
measure: Odds ratio (Orlistat120:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart
timeFrame: within one year of starting treatment
Secondary outcomes:
measure: Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN
timeFrame: within one year of starting treatment
measure: Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN
timeFrame: within one year of starting treatment
measure: Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart
timeFrame: within one year of starting treatment
measure: Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart
timeFrame: within one year of starting treatment
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03194048: Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy
Official title: Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastication Disorder
Keywords: drooling
tongue thrust
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and drooling in children with cerebral palsy.

Detailed description: Children were divided into two groups: The FuCT group and control group receiving classical oral motor exercises. Each group received training for 12 weeks. Oral motor assessment was performed. Chewing performance level was determined with the Karaduman Chewing Performance Scale(KCPS). Tongue thrust severity was evaluated with the Tongue Thrust Rating Scale(TTRS). The Drooling Severity and Frequency Scale(DSFS) was used to evaluate drooling severity and frequency. The evaluations were performed before and after treatment.

Eligibility criteria: Inclusion Criteria:

* diagnosed with cerebral palsy
* aged between 4-6 years
* fed by orally
* had tongue thrust

Exclusion Criteria:

* children who were unable the sitting position

Primary outcomes:
measure: Tongue Thrust Rating Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: The Drooling Severity and Frequency Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Özgü İnal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rempel GR, Colwell SO, Nelson RP. Growth in children with cerebral palsy fed via gastrostomy. Pediatrics. 1988;82:857-862. Allen MC, Capute A. The evolution of primitive reflexes in extremely premature infants. Pediatr Res. 1986;20:1284-1289. Blasco PA. Primitive reflexes: their contribution to the early detection of cerebral palsy. Clinical pediatrics. 1994;33:388-397. Singh S, Dua P, Jain S. Habit breaking appliance for tongue thrusting-a modification. Indian J Dent Sci. 2011;3:10.
Clinical trial NCT02343848: Physical Activity and Gestational Complications
Official title: Physical Activity and Gestational Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-01-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The association between physical activity and several complication of pregnancy will be evaluated .

Detailed description: The association between physical activity and several complication of pregnancy will be evaluated. Patients with complications of pregnancy will be recruited. Physical activity will be evaluated using questioner or smart bracelet.

Eligibility criteria: Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* Non pregnant women

Primary outcomes:
measure: Presence of Gestational Complication
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Shalom Mazaki tovi
Study officials:
References:
Clinical trial NCT01487148: POCARED Diagnostics, LTD, Field Study Protocol
Official title: POCARED Diagnostics, LTD, Field Study Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Tract Infections
Lead sponsor: Pocared Diagnostics
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 40000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 70 consecutive leftover and de-identified urine samples arriving in the laboratory each day for culture will be tested.

Brief summary: This study is designed to compare the performance of the P-1000 System, POCARED's Rapid Diagnostic System which uses optical fluorescence analysis, to standard methods of uropathogen quantification and identification.

Detailed description: This study will be conducted at 5 sites, 4 in the United States and 1 site in Israel. 40,000 clinical specimens will be included and assessed by the laboratories using standard reference methods and the P-1000.

Eligibility criteria: Inclusion Criteria:

* Samples arriving in the laboratory for urine culture

Exclusion Criteria:

* Samples \<=2mL
* Specimens stored at room temperature for more than 2 hours (unless a preservative is used)
* Specimens refrigerated for more than 24 hours
* Specimens requesting low count urine culture (\<100,000 CFU/mL \[colony forming units per milliliter\])
* Bloody specimens

Primary outcomes:
measure: Agreement
timeFrame: 6 months
measure: Sensitivity
timeFrame: 6 months
measure: Specificity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: North Hollywood
country: United States
facility: Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Tel Aviv
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: POCARED Diagnostics, Ltd.
name: Jonathan Gurfinkel
role: STUDY_DIRECTOR
References:
Clinical trial NCT01627548: UCLA Couples Counseling for Combat Veterans
Official title: UCLA Welcome Back Veterans Family Resilience Center Couples Counseling for Combat Veterans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Recent Era Combat Veteran
Couples Communication
Keywords: PTSD
Couples
Combat Veteran
Warfighter
OEF
OIF
OND
Structured Approach Therapy
Trauma
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: VA Greater Los Angeles Healthcare System
First posted: 2012-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: A pilot intervention of an existing intervention adapted for the returning warfighter population: a couples treatment for PTSD, Structured Approach Therapy (SAT), which emphasizes reducing the PTSD avoidance/numbing symptoms that are corrosive in families.


Eligibility criteria: Inclusion Criteria:

* OIF/OEF/ OND veteran with at least one deployment
* In a cohabitating relationship for 6 months or longer
* Cohabitating 50% of the time or more
* Diagnosed with PTSD or meets the diagnosis criteria for PTSD as related to deployment experience (CAPS)
* Ability to make weekly appointments
* Willingness to commit to change

Exclusion Criteria:

* Receiving an evidence-based treatment for PTSD within the past 6 months
* Receiving couples therapy within the last 6 months
* Moderate or excessive physical violence within the past 3 months (CTS)
* Alcohol/substance dependence (SCID)
* Known domestic violence/abuse (CTS)
* Symptoms of psychosis within the past 3 months
* Unstable psychiatric medicine usage or on regimen less than 3 months

Primary outcomes:
measure: Improved couples communication as measured by standardized assessments
timeFrame: 4-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Shrley M Glynn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Patricia E Lester, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02220348: A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
Official title: An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Feeding
Constipation
Irritable Bowel Syndrome
Keywords: Linzess
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2014-08-19
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically.


Eligibility criteria: Inclusion Criteria:

* Be a lactating female who has been actively breastfeeding or pumping for at least 4 weeks
* Be already taking linaclotide therapeutically for Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)
* Weaning must not be underway
* Be willing to breastfeed or pump regularly during the study to maintain milk supply and discontinue breastfeeding for the 24-hour period of breast milk collection

Exclusion Criteria:

* Clinically significant disease state in any body system, except for the indication being treated with linaclotide
* Any structural abnormality of the gastrointestinal (GI) tract, or a disease or condition that can affect GI motility
* Participation in any other clinical investigation using an experimental drug within 90 days

Primary outcomes:
measure: Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
timeFrame: From Baseline (Day 1) to Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc (DDSI)
state: Oklahoma
Study officials:
affiliation: Forest Research Institute, an affiliate of Allergan plc.
name: Ramesh Boinpally, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03589248: Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients
Official title: Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients：A Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Dysfunction
Critical Illness
Intestine Ultrasonography
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with severe complications after surgery and severe trauma

Brief summary: It is very important to evaluate the degree of gastrointestinal dysfunction in critical ill patients. Thus the investigators conducted transabdominal intestine ultrasonography(US) in critical ill patients to evaluated the degree of gastrointestinal dysfunction under the acute gastrointestinal injury (AGI)


Eligibility criteria: Inclusion Criteria:

* aged more than 18 years
* Acute Physiology Chronic Health Evaluation II (APACHE II) score \>8

Exclusion Criteria:

* uncontrolled mesenteric vascular disease
* uncontrolled chronic organ dysfunction
* advanced cancer
* any terminal stage disease

Primary outcomes:
measure: predict value of 28-day mortality
timeFrame: one and a half year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gao T, Cheng MH, Xi FC, Chen Y, Cao C, Su T, Li WQ, Yu WK. Predictive value of transabdominal intestinal sonography in critically ill patients: a prospective observational study. Crit Care. 2019 Nov 27;23(1):378. doi: 10.1186/s13054-019-2645-9.
Clinical trial NCT02122848: Exercise Tolerance in Patients With Decompensated Heart Failure
Official title: Effects of Bilevel Positive Airway Pressure on Exercise Tolerance in Patients With Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Exercise tolerance
Noninvasive ventilation
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of airway bilevel positive pressure on the improvement of exercise tolerance in patients with decompensated heart failure.

Detailed description: Heart failure causes limitation of functional capacity and worsening of exercise tolerance. The airway pressure as adjuvant of cardiac rehabilitation has demonstrated improvement of functional capacity, decrease of respiratory work, increase of oxygenation and pulmonary compliance. Objective: to evaluate the effectiveness of the bilevel positive airway pressure (BILEVEL) in the increase of exercise tolerance in patients with decompensated heart failure. Method: this is a cross-over randomized clinical trial, with individuals who will undergo a submaximal progressive exercise test of the lower limbs with a cycle-ergometer using continuous positive airway pressure (CPAP) and BILEVEL in a random order. Patients will also be evaluated using a health related quality of life questionnaire, pulmonary function test, inspiratory muscle and peripheral muscle strength tests. Hypothesis: The increase in exercise tolerance might be greater during the use of BILEVEL.

Eligibility criteria: Inclusion Criteria:

* subjects who has heart failure functional class II or III of New York heart association
* over 18 years
* non-smokers
* without cognitive or motor deficit
* without vasoactive drugs or low doses
* without recent acute myocardial myocardium (\<1 year)
* without recent cardiac surgery (\<1 year)
* without pulmonary disease
* without bronchodilators

Exclusion Criteria:

* unstable angina
* atrial fibrillation and atrioventricular block third degree
* frequent vomiting
* respiratory instability while collecting data

Primary outcomes:
measure: Endurance time of exercise in cycle ergometer.
timeFrame: 4 days
Secondary outcomes:
measure: Dyspnea
timeFrame: 4 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospitalsiriolibanes
Study officials:
affiliation: Hospital Sirio-Libanes
name: Wellington Yamaguti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moraes IG, Kimoto KM, Fernandes MB, Grams ST, Yamaguti WP. Adjunctive Use of Noninvasive Ventilation During Exercise in Patients With Decompensated Heart Failure. Am J Cardiol. 2017 Feb 1;119(3):423-427. doi: 10.1016/j.amjcard.2016.10.025. Epub 2016 Nov 1.