louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00984685: "Assessment of Risk Factors for Depression Treatment at a Safety Net Clinic"
Official title: "Assessment of Risk Factors for Depression Treatment at a Safety Net Clinic"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Lead sponsor: Scranton-Temple Residency Program
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the diagnosis of depression in theprimary care clinic

Brief summary: The purpose of the study is to identify the barriers for effective treatment of depression, specifically whether modified CHIS Scale is a valid tool for identifying the high risk patients for depression.

Detailed description: Depression is a major illness that affects 10% of the population in a medical setting. It is often under diagnosed and under treated. It is an illness that can challenge a persons ability to perform even routine daily activities. Review of the charts of patients diagnosed with depression showed 80% of the patients do not have follow up appointments. We wondered if modified CHIS scale could identify the risk factors for medication non-adherence.

We hypothesised that modified CHIS Scale an effective tool ,for identifying the compliance of patients with the antidepressant medication.

We are conducting a retrospective cohort study at two of our residency based clinics by interviewing approximately 100 patients with CHIS Scale and PHQ9 Questionnaire on their office visits

Eligibility criteria: Inclusion Criteria:

* Diagnosis of depression before April 15, 2009
* At least one visit since April 15, 2008
* Age 18+

Exclusion Criteria:

* None

Primary outcomes:
measure: proportion of anti-depressant prescriptions filled
timeFrame: August 1, 2008 through July 31, 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Scranton
country: United States
facility: Scranton Temple Residency Program
state: Pennsylvania
Study officials:
affiliation: Scranton-Temple Residency Program
name: John R Guzek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02143856: Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food
Official title: A Randomized, Open-label, Two-way Cross-over Study to Determine the Oral Bioavailability of GLPG1205 After Single-dose Intake in Healthy Male Subjects as a Solid Formulation, With and Without Food
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects.

Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: The amount of GLPG1205 in plasma
timeFrame: From predose up to 504 hours (Day 22) after study drug administration
Secondary outcomes:
measure: The number of subjects with adverse events
timeFrame: From screening up to 28 (+/-2) days after last study drug administration
measure: The number of subjects with abnormal laboratory parameters
timeFrame: From screening up to 28 (+/-2) days after last study drug administration
measure: The number of subjects with abnormal vital signs
timeFrame: From screening up to 28 (+/-2) days after last study drug administration
measure: The number of subjects with abnormal electrocardiogram (ECG)
timeFrame: From screening up to 28 (+/-2) days after last study drug administration
measure: The number of subjects with abnormal physical examination
timeFrame: From screening up to 28 (+/-2) days after last study drug administration
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02949856: E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck
Official title: Endotracheal Tube Intracuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck - Comparison of a Tapered Shaped- and Cylindrical Shaped Cuff
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroidectomy
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.

Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the supine neutral position and is measured after the change to the neck extension.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical classification 1-3, 18-70 year old, thyroidectomy

Exclusion Criteria:

* difficult intubation, history of cervical disease, motion limitation of neck, morbid obesity

Primary outcomes:
measure: Change in intracuff pressure
timeFrame: 1 year
Secondary outcomes:
measure: Change in distance from carina to tip of tube
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Yong-Cheol Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00182156: Cohort Study Comparing Short Daily Hemodialysis (HD) With Conventional HD
Official title: Cohort Study Examining the Effects of Short Daily Hemodialysis As Compared to Conventional Hemodialysis in Outpatients Treated at St Joseph's Healthcare, Hamilton
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: End-stage Renal Disease
Thrombocytopathy
Cardiovascular Diseases
Keywords: hemodialysis
platelet function analyzer
bioimpedance
pulse wave velocity
end stage renal disease
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2005-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Short daily HD v PD v conventional HD

Brief summary: This study is examining the effects of short daily hemodialysis on platelet function, fluid volume control, arterial stiffness and patient quality of life, as compared to conventional hemodialysis.

Detailed description: Bleeding is a common cause of morbidity and mortality in patients with end stage renal disease. A major cause of uremic bleeding is due to platelet dysfunction. It has been theorized that in renal failure, toxins accumulate, some of which inhibit primary hemostasis. All aspects of normal platelet function are affected. Platelet function has previously been difficult to quantify but recently a novel test, the platelet function analyzer (PFA-100) has been determined to be both sensitive and specific in assessing platelet function. Conventional hemodialysis (CHD) has been shown to partially correct thrombocytopathy. Enhanced uremic clearance can now be attained through the use of short daily hemodialysis (SDHD). Cardiovascular disease is the most common cause of mortality in dialysis patients, accounting for 40% of deaths. Volume overload is associated with high blood pressure, left ventricular hypertrophy and elevated markers of inflammation and these factors have been associated with increased cardiovascular mortality. SDHD has been shown to control blood pressure and limit volume expansion. Pulse wave velocity (PWV) has been used to assess arterial compliance and reduction of arterial elasticity of large and small arteries which have been associated with cardiovascular outcomes.

Eligibility criteria: Inclusion Criteria:

* Patient is enrolled in short daily hemodialysis program
* Patient is minimum of 18 years old

Exclusion Criteria:

* Patient is unable to consent due to language barrier
* Patient is unable to consent due to cognitive difficulties
* Patient refuses consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: Clinical Scholar, Medicine
name: Azim Gangji, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, Medicine
name: Catherine M Clase, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04669756: Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary
Official title: Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Adhesion
Surgery
Keywords: endometriosis
ovariopexy
adhesion prevention
laparoscopy
complications
AMH
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 409
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: prospective randomized Trial comparing ovariopexy over 2, 4 or 6 days vs Placebo after surgery because of endometriosis of the pelvic side wall or the ovary or both


Eligibility criteria: Inclusion Criteria:

* premenopausal
* wants to participate
* removal of endometriosis of the pelvic side wall or ovary

Exclusion Criteria:

* postmenopausal
* cannot give informed consent
* no endometriosis during Operation
* no Opening of pelvic side wall or ovary during the Operation
* pregnant
* breast feeding

Primary outcomes:
measure: prevalence of postoperative ovarian adhesions
timeFrame: 3 months after operation
Secondary outcomes:
measure: postoperative pain
timeFrame: daily during postoperative hospitalisation and at follow up visit after 3 months
measure: AMH
timeFrame: at follow up visit after 3 months
measure: postoperative infectious complications
timeFrame: up to 3 months after operation
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Muenster
state: NRW
Study officials:
affiliation: University Hospital Muenster, Germany
name: Sebastian D Schaefer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00677456: Evaluation of Four Reconstructions After Total Gastrectomy
Official title: Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastric Cancer
Nutrition
Keywords: Gastric Cancer
total gastrectomy
reconstruction
life quality
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
First posted: 2008-05-14
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There are four capital reconstructions after total gastrectomy which is widely used in China. Life quality is the only standard to evaluate postoperative results of different reconstructions. In order to determine the best reconstruction after total gastrectomy, we designed this study to compare life qualities of four reconstructions.


Eligibility criteria: Inclusion Criteria:

* Patients should be younger than 80 years old with adequate renal, pulmonary, and heart functions.

Exclusion Criteria:

* death or other reason which cause information discontinue

Primary outcomes:
measure: Patients should live for 6 months at least, and with acceptable life quality
timeFrame: 6 months
Secondary outcomes:
measure: There are significant differences among life qualities of the four reconstructions
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of general surgery,Tangdu hospital
state: Shaanxi
Study officials:
affiliation: Department of general surgery, Tangdu hospital of fourth military medical university
name: XianLi He, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00812656: Serial Measurement of a Plasma Stroke Biomarker Panel in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Official title: Serial Measurement of a Plasma Stroke Biomarker Panel in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Lead sponsor: Klinikum Ludwigshafen
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing cardiac surgery with the use of cardiopulmonary bypass

Brief summary: The purpose of this study is to investigate changes in new plasma stroke biomarker panel in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Elective cardiac surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

* Patients undergoing emergent procedures
* Patients with preoperative mechanical support

Primary outcomes:
measure: Change in stroke index
timeFrame: day before surgery; first and second day postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
state: RLP
Study officials:
affiliation: Klinikum Ludwigshafen
name: Stefan W Suttner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02893956: Conditions of Realization of the Echocardiography in Newborns
Official title: Does Postural Support During Echocardiography Modify Hemodynamic Features and Discomfort Induced by the Examination in Very Premature Neonates?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Newborn
Keywords: Echocardiography
postural support
preterm neonate
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus screening may generate this hemodynamic response and whether postural support would be able to modulate it.

Study design

Prospective, single center, randomized study in less than 29 weeks of gestation neonates, with a post natal age \< 48 hours, and requiring invasive mechanical ventilation.

Crossover design with order of echocardiographies determined by computer randomization: in one group ultrasounds are performed with postural support, than standard conditions, in the other, ultrasounds are performed in standard conditions than with postural support.

The objective of the study is to assess the ratio of the acceleration time/ejection time of pulmonary arterial flow.

The others objectives are to assess echocardiographic-Doppler features (ductus arteriosus shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right and left ventricular functions using tissue Doppler imaging and speckle-tracking echocardiography), pain assessment with a clinical scale and heart rate variability analysis.


Eligibility criteria: Inclusion Criteria:

* Newborn than 30 weeks of gestation neonates,
* Newborn with a post natal age \< 48 hours,
* Newborn requiring invasive mechanical ventilation.
* Signed consent form of parent

Exclusion Criteria:

-

Primary outcomes:
measure: value of the ratio of the acceleration time of pulmonary arterial flow.
timeFrame: up to 1 hour
measure: value of the ejection time of pulmonary arterial flow
timeFrame: up to 1 hour
Secondary outcomes:
measure: pain assessment with a clinical scale
timeFrame: up to 1 hour
measure: number of participant with a Patent ductus arteriosus shunt
timeFrame: up to 2 hours
measure: systolic pulmonary arterial pressure
timeFrame: up to 2 hour
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
References:
Clinical trial NCT01986556: Lesinurad Tablet Relative Bioavailability
Official title: A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Lesinurad Tablets Manufactured at Two Different Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.

Detailed description: A change in manufacturing site of lesinurad tablets has been implemented. This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the two different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.

Eligibility criteria: Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2.
* Subject has a Screening sUA value ≤ 7.0 mg/dL.
* Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
* Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.

Exclusion Criteria:

* Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
* Subject has a history or suspicion of kidney stones.
* Subject has a history of asthma.
* Subject has undergone major surgery within 3 months prior to Day 1.
* Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.

Primary outcomes:
measure: PK profile of lesinurad from plasma
timeFrame: Day 1 and Day 5
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Ardea Biosciences, Inc.
name: J. Hall, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01517256: A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting
Official title: Living Everyday Above-and-beyond Pain Research (LEAP): A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: Chronic pain
Primary care
Multidisciplinary group therapy
Embedded mixed-methods study
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will evaluate the effectiveness of "Living Everyday Above-and-beyond Pain" (LEAP) program in the primary care setting. LEAP is a multidisciplinary chronic pain group therapy developed for the two clinic sites of McMaster Family Health Team: McMaster Family Practice and Stonechurch Family Health Centre. LEAP aims to improve patients'quality of life, interaction with the health care system and their health care utilization. This is a pilot study to evaluate mainly feasibility. The investigators will make use of both experimental and qualitative methods gather evidence of the programs success, strengths and weaknesses.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* diagnosed with chronic pain

Exclusion Criteria:

* chronic pain related to cancer, pelvic pain or headache
* inability to speak or write in English
* patient is unable to attend and participate in group treatment sessions on their own
* substance use or mental health problems of a severity making group treatment participation impossible
* currently participating in another cognitive-behavioral pain management program
* patient is receiving palliative care or has been diagnosed with an illness expecting to cause death within one year

Primary outcomes:
measure: Quality of Life
timeFrame: 8 months
measure: Health care utilization
timeFrame: 8 months
Secondary outcomes:
measure: Qualitative process evaluation (Perceptions of participants regarding the intervention)
timeFrame: 16 months
measure: Pain medication use
timeFrame: 8 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Family Practice Clinic
state: Ontario
Study officials:
References:
citation: Angeles RN, Guenter D, McCarthy L, Bauer M, Wolfson M, Chacon M, Bullock L. Group interprofessional chronic pain management in the primary care setting: a pilot study of feasibility and effectiveness in a family health team in Ontario. Pain Res Manag. 2013 Sep-Oct;18(5):237-42. doi: 10.1155/2013/491279. Epub 2013 Jul 19.