louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00753857: The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction
Official title: The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: risk communication
probability sample by random digit dialing
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-09-17
Enrollment: 260
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE:

The way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug.

PURPOSE:

This randomized trial is studying how well a drug facts page works compared with a short drug summary in helping patients and doctors understand medical information.

Detailed description: This is a randomized study. Participants are contacted by phone via random-digit dialing for initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible participants are then randomized to 1 of 2 intervention arms.

* Compare the effect of a prescription drug summary (one-page summary of drug information that includes a table with data on drug benefit and side effects) vs standard brief summary in direct-to-consumer advertisements on the comparisons of two drugs for the same indication, knowledge of drug efficacy and side effects of each drug, perceptions of drug efficacy and side effects of each drug
* Comprehension of information contained in the drug facts box

Eligibility criteria: Inclusion Criteria:

* Age 35-70 year old in household selected by random digit dialing

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events
timeFrame: Immediate return of patient survey
Secondary outcomes:
measure: Comprehension of information contained in the drug facts box
timeFrame: Immediate return of patient survey
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: VA Medical Center
state: Vermont
Study officials:
affiliation: Dartmouth Medical School; VA Medical Center (WRJ)
name: Steven Woloshin, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth Medical School, VA Medical Center (WRJ)
name: Lisa M Schwartz, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00813657: Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial
Official title: Effects of Resistance Exercise Training Program Performed During the 2nd and 3rd Trimesters of Pregnancy on Maternal and Newborn Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gestational Age
Birth Weight
Anaemia
Gestational Diabetes Mellitus
Type of Delivery
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: The investigators investigated the effects of a supervised maternal exercise training program (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health outcomes in a group of previously sedentary healthy women. A matched control group was assessed over the same time period. Given the fact that most studies in the field have used aerobic exercises, here the investigators largely focused on very light resistance, toning exercises.


Eligibility criteria: Inclusion Criteria:

* sedentary (not exercising \>20 minutes on \>3 days per week)
* with singleton
* not at high risk for preterm delivery (no more than one previous preterm deliveries)
* women planning to give birth in the same obstetrics hospital department (Hospital Severo Ochoa, Madrid, Spain)

Exclusion Criteria:

* not being under medical follow-up throughout the entire pregnancy period were not included in the study
* women having serious medical condition that prevent them from exercising safely

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01587248: Use of Harmonic in Breast Surgery
Official title: Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Modified Radical Mastectomy
Keywords: Breast cancer,
Harmonic scalpel,
Electrocautery,
Modified Radical Mastectomy,
Randomized Controlled Trial
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 152
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL), operating time, drain Volume and drain Days, seroma formation, surgical site infection and postoperative pain in adult females undergoing MRM at a tertiary care hospital. We hypothesized that harmonic yields better outcome than electrocautery dissection.

Detailed description: In this randomized controlled trial, adult females who underwent MRM between April 2010 and July 2011 were randomized to receive either intervention A (harmonic scalpel) or B (electrocautery). The procedure was standardized except elevation of flaps and axillary dissection, that was performed as per randomization. Patients were followed up in clinic for four weeks. The outcomes were estimated blood loss (EBL), operating time, drain Volume and drain Days, complications (seroma, surgical site infection, hematoma and flap necrosis) and postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Adult females with biopsy proven breast cancer underwent MRM

Exclusion Criteria:

* Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)

Primary outcomes:
measure: Duration of drains (days)
timeFrame: 30 days
Secondary outcomes:
measure: Operative time
timeFrame: 3-4 hours
measure: Drain Volume
timeFrame: 30 days
measure: Overall complications
timeFrame: 30 days
measure: Pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sind
Study officials:
affiliation: Aga Khan University
name: Shaista M Khan, FRCS
role: STUDY_CHAIR
References:
citation: Khan S, Khan S, Chawla T, Murtaza G. Harmonic scalpel versus electrocautery dissection in modified radical mastectomy: a randomized controlled trial. Ann Surg Oncol. 2014 Mar;21(3):808-14. doi: 10.1245/s10434-013-3369-8.
Clinical trial NCT01013857: Treating to Target for Patients With Hypertension
Official title: Treating to Target for Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
First posted: 2009-11-16
Enrollment: 240
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with poorly controlled hypertension will have improved hypertensive control with telephone coaching and with telephone coaching combined with home-titration of medications.

Detailed description: Patients with poorly controlled hypertension are randomized to a control arm which receives telephone coaching or an active arm which receives telephone coaching plus intensification of medications via telephone coaching with the coaches using treatment algorithms approved by the patients' physician. These patients' blood pressure control will be compared with usual care patients in a passive arm (chart review only).

Eligibility criteria: Inclusion Criteria:

* 2 blood pressure readings above 145/90.

Exclusion Criteria:

* Cognitive impairment,
* Short life expectancy,
* Creatinine greater than 1.5,
* Inability to check blood pressures at home.

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Diastolic blood pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Bodenheimer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bennett H, Laird K, Margolius D, Ngo V, Thom DH, Bodenheimer T. The effectiveness of health coaching, home blood pressure monitoring, and home-titration in controlling hypertension among low-income patients: protocol for a randomized controlled trial. BMC Public Health. 2009 Dec 10;9:456. doi: 10.1186/1471-2458-9-456.
Clinical trial NCT01305057: Efficacy Test on Skin Hydration and Skin Barrier Function
Official title: Human Use Test on Skin Hydration and Skin Barrier Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Skin
Keywords: dry skin condition
Lead sponsor: Cosmos Technical Center
Sponsor class: INDUSTRY
Collaborators: name: University of Dundee
First posted: 2011-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 33
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined. Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation on the other side twice daily (morning and evening) for 28 days. All subjects gave written informed consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S. ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.

Detailed description: It is expected that the long-term application of P-IP increase skin surface water contents and suppress TEWL.

Eligibility criteria: Inclusion Criteria:

* healthy skin

Exclusion Criteria:

* don't use any moisturizer

Primary outcomes:
measure: Measurement of skin surface water content and Trans-Epidermal Water Loss (TEWL)
timeFrame: Before application, 1 week, 2 week and 4 weeks after application
Secondary outcomes:
Other outcomes:
Locations:
city: Itabashi-ku
country: Japan
facility: Cosmos Technical Center
state: Tokyo
Study officials:
References:
Clinical trial NCT00392548: URINARY VEGF Levels in GBM Patients on Radiation Treatment Protocol
Official title: Urinary VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioblastoma
Keywords: GBM
glioblastoma
urine
VEGF
radiation
Patients must be enrolled to an RTOG GBM study that prescribes 6000 cGy of radiation therapy.
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Radiation Therapy Oncology Group
First posted: 2006-10-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Study of the urinary vascular endothelial growth factor (VEGF) levels in patients with glioblastoma, receiving standard therapy.

Hypothesis: that urinary VEGF levels can serve as a predictor of treatment response and survival.

Detailed description: Measurement of urinary VEGF levels pre treatment,immediately after treatment, and 1 month after treatment

Eligibility criteria: Inclusion Criteria:

* Patient must be enrolled on an RTOG GBM study that prescribes 6000 cGy of radiation therapy.
* Patient must meet the eligibility requirements for the RTOG treatment study. (If the patient is deemed retrospectively ineligible for the RTOG treatment study, the patient will likewise be ineligible for this study.)
* Patient must sign a study-specific informed consent for RTOG 0611 prior to study entry.

Exclusion Criteria:

* Patient not able to receive 6000 cGy of radiation therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Deborah T Blumenthal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02809248: The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX- Stent Study)
Official title: The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX-Stent Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Re-stenosis
Cirrhosis of the Liver
Keywords: LTX Study
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to choose an optimal stent and to get further knowledge about the mechanisms of the engraftment of a stent.

The occurrence of a hyperplasia of neointima can be minimized by application of a coated stent and a concurrent safety four weekly dual thrombocytes therapy


Eligibility criteria: Inclusion Criteria:

* male and female patients with a severe dysfunction of liver
* patient is planned a coronary stent implantation
* adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
* written informed consent prior to study participation

Exclusion Criteria:

* younger than 18 years
* pregnancy and breast-feeding
* acute cardiac syndrome
* contraindication against an intracardiac catheter
* persons in dependence from the sponsor or working with the sponsor
* participation in a parallel interventional clinical trial
* patient has been committed to an institution by legal or regulatory order

Primary outcomes:
measure: the ideal stent (coated stent or uncoated stent)
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uniklinik RWTH Aachen, Med. Klinik I
name: Michael Becker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04577248: The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry
Official title: The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Regurgitation
Mitral Valve Stenosis
Tricuspid Valve Regurgitation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers patient population treated with transcatheter mitral or tricuspid valve therapy

Brief summary: Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.

Detailed description: Long-term mortality after transcatheter mitral or tricuspid valve therapy

Eligibility criteria: Inclusion Criteria:

* Age above 18 years and consentable
* Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation, Tricuspid Stenosis
* Transcatheter mitral or tricuspid valve therapy considered best option by heart-team decision
* Written informed consent

Exclusion Criteria:

* Patient's inability to fully cooperate with the protocol

Primary outcomes:
measure: Long-term mortality
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München
state: Bavaria
Study officials:
affiliation: Dept. of Anesthesiology, Deutsches Herzzentrum München
name: Patrick Mayr, MD
role: STUDY_CHAIR
affiliation: Dept. of Cardiology, Deutsches Herzzentrum München
name: Michael Joner, Prof
role: STUDY_CHAIR
affiliation: Dept. of Cardiology, Deutsches Herzzentrum München
name: Tobias Rheude, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Cardiology, Deutsches Herzzentrum München
name: Costanza Pellegrini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004748: Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
Official title: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Cirrhosis, Biliary
Keywords: cirrhosis
gastrointestinal disorders
primary biliary cirrhosis
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Tufts Medical Center
First posted: 2000-02-25
Enrollment: 90
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC).

II. Determine the optimum dose and duration of MTX treatment.

III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of treatment on FC production.

Detailed description: PROTOCOL OUTLINE:

This is a randomized, double-blind study. Patients are stratified by prior/concurrent medical management.

Patients in the first group are treated with oral methotrexate 3 times a week and a daily oral placebo.

Patients in the second group are treated with daily oral colchicine and an oral placebo 3 times a week.

Therapy continues for 10 years. Beginning year 2, daily oral ursodiol is administered to all patients. Patients with disease progression are crossed to the alternate group or undergo liver transplantation if clinically indicated.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Biopsy proven primary biliary cirrhosis (PBC); Disproportionate increase in alkaline phosphatase; Positive antimitochondrial antibody test OR Symptoms consistent with PBC, e.g.: pruritus, fatigue, malaise, jaundice, elevated bilirubin

No clinically advanced PBC, i.e.: bilirubin greater than 10 mg/dL or albumin less than 2.5 g/dL, determined by 2 analyses 10 weeks apart; bleeding esophageal varices or congestive gastropathy; chronic hepatic encephalopathy; chronic ascites

--Prior/Concurrent Therapy-- No concurrent drugs associated with chronic liver disease

--Patient Characteristics--

Hematopoietic: WBC at least 2500 Platelets at least 100,000 (unless due to hypersplenism); Hematocrit at least 30%

Renal: No renal disease that could cause liver dysfunction

Other: No history of alcohol abuse; No other medical illness that might cause liver dysfunction, e.g., severe cardiac failure; No pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tufts Medical Center
name: Marshall M. Kaplan
role: STUDY_CHAIR
References:
Clinical trial NCT01457248: Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections
Official title: Effect of Endotracheal Tube With Taper-shaped Cuff on Incidence of Postoperative Pneumonia After Aortic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pneumonia
Keywords: after aortic surgery
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
First posted: 2011-10-21
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental lung model, endotracheal tube with taper-shaped cuff has been shown to decrease microaspiration. This effect has never been demonstrated in patients. The investigators hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of postoperative pneumonia in patients after aortic surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 ans
* Elective aortic surgery
* Admission in ICU after aortic surgery

Exclusion Criteria:

* Tracheostomized patients

Primary outcomes:
measure: Incidence of first episode of postoperative pneumonia after aortic surgery
timeFrame: Within the first 28 days after surgery
Secondary outcomes:
measure: Microaspiration
timeFrame: Day 1 and day 2
measure: Length of ICU stay
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 3 weeks
measure: Mortality
timeFrame: Day 28 and day 90
Other outcomes:
Locations:
city: Paris
country: France
facility: Réanimation polyvalente, Département d'Anesthésie-Réanimation, Groupe Hospitalier Pitié-Salpêtrière
Study officials:
References:
citation: Lucangelo U, Zin WA, Antonaglia V, Petrucci L, Viviani M, Buscema G, Borelli M, Berlot G. Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit. Crit Care Med. 2008 Feb;36(2):409-13. doi: 10.1097/01.CCM.0000297888.82492.31.
citation: Nseir S, Zerimech F, Fournier C, Lubret R, Ramon P, Durocher A, Balduyck M. Continuous control of tracheal cuff pressure and microaspiration of gastric contents in critically ill patients. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1041-7. doi: 10.1164/rccm.201104-0630OC.
citation: Dave MH, Frotzler A, Spielmann N, Madjdpour C, Weiss M. Effect of tracheal tube cuff shape on fluid leakage across the cuff: an in vitro study. Br J Anaesth. 2010 Oct;105(4):538-43. doi: 10.1093/bja/aeq202. Epub 2010 Aug 3.
citation: Hortal J, Giannella M, Perez MJ, Barrio JM, Desco M, Bouza E, Munoz P. Incidence and risk factors for ventilator-associated pneumonia after major heart surgery. Intensive Care Med. 2009 Sep;35(9):1518-25. doi: 10.1007/s00134-009-1523-3. Epub 2009 Jun 26.