louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00749632: A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence
Official title: An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence, Urge
Keywords: urinary incontinence, urge
urinary urge incontinence
urge incontinence
over active bladder
Lead sponsor: FemmePharma Global Healthcare, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Females 18 to 75 years of age
* Has reported symptoms of urge urinary incontinence/overactive bladder

Exclusion Criteria:

* Is pregnant or lactating
* Has had lower urinary tract surgery within 6 months prior to Screening
* Has a history of urinary retention

Primary outcomes:
measure: Number of micturations and incontinence episodes.
timeFrame: Two weeks pretreatment and three weeks on treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
city: Hackensack
country: United States
facility: Advanced Biomedical Research
state: New Jersey
Study officials:
affiliation: FemmePharma Global Healthcare, Inc.
name: Peter K. Mays, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04497532: Influence of Diet on Pregnancy With Polyhydramnios
Official title: The Influence of a Diet Suited for Gestational Diabetes on Amniotic Fluid Index in Patients Diagnosed With Idiopathic Polyhydramnios - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polyhydramnios
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-08-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic fluid index in women with idiopathic polyhydramnios.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between 24-37 pregnancy weeks, singleton pregnancy, diagnosed with AFI at 95% or more by gestational age
* Express their consent to participate in the study and try to make the recommended dietary change for at least two consecutive weeks from the moment the guidelines are given.
* Without a medical indication for an immediate delivery

Exclusion Criteria:

* Medical recommendation for delivery within two weeks of diagnosis
* Condition of non-idiopathic amniotic fluid: gestational or pre-gestational diabetes, fetal malformation, proof of fetal infection
* Premature rupture or membranes
* Twins pregnancy

Primary outcomes:
measure: Amniotic fluid index (AFI) after 2 weeks
timeFrame: Assess AFI two weeks after diet initiation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wolfson Medical Center
name: Liliya Tamayev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199732: Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a
Official title: Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B
Keywords: Chronic hepatitis B
CCC DNA kinetics
Total HBV DNA kinetics
Adefovir-Dipovixil
Peg interferon alpha 2a
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B infection and treated with adefovir dipivoxil and peg interferon alpha 2a.

Brief summary: Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the liver.

Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment.

The major interest of this marker is that it can be measured by a simple blood test instead of a liver biopsy.

Detailed description: - Studying intra lymphocyte and blood cccDNA: before inclusions, D0 then each month during the first three months each three months during treatment and follow-up.

- Viral kinetics:Before inclusions, at D0, then monthly till the end of treatment and follow-up: Evolution of quantitative viraemia in serum Evolution of quantitative viraemia in circulating lymphocytes Evolution of quantitative viraemia in total blood

- Studying viral genotypes

Eligibility criteria: Inclusion Criteria:

* Male and female patients \>18 years of age and \<70 years of age
* Patients AgHbs+ and AgHbe+ or AgHbe-, and B viral DNA \>104 copies/ml PCR COBAS MONITOR
* Patients treated with adefovir dipivoxil and peg interferon alpha 2a
* Chronic liver disease consistent with chronic hepatitis B infection on a biopsy obtained within the past 24 months
* Naïve patients or patients having a relapse or a therapeutic failure after monotherapy lamivudine or interferon, or bitherapy interferon alpha-lamivudine

Exclusion Criteria:

* Co-infection HIV, HCV

Primary outcomes:
measure: Kinetic cccDNA
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Service d'Hépato-gastroentérologie
city: Limoges
country: France
facility: Service de Médecine Interne
city: Limoges
country: France
facility: Service de Virologie
city: Limoges
country: France
facility: Service des Maladies Infectieuses et Tropicales
Study officials:
affiliation: University Hospital, Limoges
name: Véronique Loustaud-Ratti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03059732: Factors Associated With High Mortality of Gastric Adenocarcinoma in Thailand Versus Japan
Official title: Factors Associated With High Mortality of Gastric Adenocarcinoma in Thailand Versus Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Factor
Keywords: Gastric cancer
Thailand
Japan
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Osaka Medical Center for Cancer and Cardiovascular Diseases
First posted: 2017-02-23
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014 in King Chulalongkorn Memorial Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan.

Brief summary: The differences in patient's clinicopathological characteristic between high and low prevalence of gastric cancer region should be further examined to elucidate factors that associate with poor survival rate of patients with gastric cancer. Therefore, this study aimed to evaluate characteristics of patients with gastric adenocarcinoma and factors associated with different outcome in Thailand and Japan to find a clue to improve patients' survival in low prevalence country such as Thailand.

This is a retrospective cohort study. It was conducted at King Chulalongkorn Memorial Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan. Eligible cases were selected by using standardized search protocols: formal computer searches of all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014.Two physicians, who were informed the definition of each variable, individually reviewed chart of patients.


Eligibility criteria: Inclusion Criteria:

* all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014.

Exclusion Criteria:

* Age \< 18 years
* Incomplete data
* Miss diagnosis of gastric adenocarcinoma
* Died from other causes (not related to gastric adenocarcinoma).

Primary outcomes:
measure: Factors that associated with mortality rate in Thailand compared to Japan
timeFrame: 2010-2014
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Patum Wan
Study officials:
References:
Clinical trial NCT00202332: CABG Without the Use of CPB
Official title: A Prospective Randomised Study od Coronary Artery Bypass Surgery Without the Use of Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Bypass
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Comparison of clinical outcomes in patients undergoing coronary bypass surgery using the heart/lung machine as opposed to using off-pump techniques.


Eligibility criteria: Inclusion Criteria: Eligible for coronary surgery -

Exclusion Criteria: Less than 18 years Emergency and salvage operations

-

Primary outcomes:
measure: Comparison of clinical outcomes for coronary artery bypass graft surgery when performed using cardiopulmonary bypass versus beating heart surgery without cardiopulmonary bypass
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Melbourne Health
name: Stephen Davis, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03341832: Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain
Official title: A Randomized, Double-blind, Active- and Placebo-controlled, Parallel, Multicenter, Phase II an Exploratory Clinical Trial to Evaluate the Efficacy and Safety NVP-1203 in Patients With Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Low Back Pain
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2017-11-14
Enrollment: 91
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with Acute low back pain

Detailed description: This study is a randomized, double-blind, active- and placebo-controlled, parallel, phase II study to evaluate efficacy and safety of NVP-1203 in patients with Acute low back pain

Eligibility criteria: Inclusion Criteria:

* Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing
* 19 Years and older
* A patient has symptom of acute low back pain

Exclusion Criteria:

* Subjects who cannot prohibit anti-inflammatory drug or muscle relaxants during clinical trial
* Inadequate subject for the clinical trial by the investigator's decision

Primary outcomes:
measure: VAS Pain Intensity
timeFrame: 3, 7 days
Secondary outcomes:
measure: Finger to Floor Distance (FFD)
timeFrame: 3, 7 days
measure: Oswestry Disability Index(ODI)
timeFrame: 3, 7 days
measure: Investigator Global Assessment of Response to Therapy(IGART)
timeFrame: 7 days
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Navipharm
state: Gyeonggi-do
Study officials:
affiliation: Severance Hospital
name: Seong-Hwan Moon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Jin Hwan Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Hospital
name: Tae Kyun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06151132: Treatment of Atrial Fibrillation in the Community Settings
Official title: Treatment of Atrial Fibrillation in the Community Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Arrhythmia
Cardiovascular Diseases
Lead sponsor: ITMO University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 430
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People receiving treatment for atrial fibrillation in Tarusa hospital.

Brief summary: Description of treatment of cardiovascular diseases in community settings in Russia

Detailed description: The study will describe different treatment modalities used in management of cardiovascular diseases in community hospital in small town of Tarusa in Russia. This part of the study will focus on atrial fibrillation and its treatment.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing direct current cardioversion for atrial fibrillation or flutter

Exclusion Criteria:

* none

Primary outcomes:
measure: Restoration of sinus rhythm
timeFrame: 1 day
measure: Maintenance in rhythm control strategy
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
measure: Gender
timeFrame: During procedure
measure: Age
timeFrame: During procedure
measure: Body mass index
timeFrame: During procedure
measure: Heart Failure
timeFrame: Before procedure
measure: Arterial hypertension
timeFrame: Before procedure
measure: Coronary heart disease
timeFrame: Before procedure
measure: Diabetes mellitus
timeFrame: Before procedure
measure: Type of arrhythmia
timeFrame: During procedure
measure: Duration of arrhythmia
timeFrame: Before procedure
measure: Settings
timeFrame: During procedure
measure: TEE
timeFrame: Before procedure
measure: First procedure
timeFrame: Before procedure
measure: Echo LVEF
timeFrame: During procedure
measure: Echo LAVI
timeFrame: During procedure
Locations:
Study officials:
References:
Clinical trial NCT06496932: Music for Anxiety Management in Cesarean Delivery
Official title: Management of Anxiety and Vital Signs With Music in Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: cesarean section
music
randomize trial
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized controlled trial will be conducted to determine examine the effects of music played during cesarean delivery on maternal anxiety and vital signs.

Detailed description: It will tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of anxiety and vita lsymptoms.

Eligibility criteria: Inclusion Criteria:

- Aged between 18-35 years,

* Undergoing cesarean section under spinal anesthesia,
* Experiencing spontaneous and singleton pregnancy,
* With a gestational age greater than 37 weeks,
* Pregnant individuals who have had at least 4 routine check-ups during pregnancy conducted by a member of the research team,
* Scheduled for cesarean section (regardless of the number of previous cesarean sections).

Exclusion Criteria:

* Having high-risk pregnancies such as preeclampsia, early membrane rupture, and placental abruption, • Being scheduled for emergency cesarean section for any reason

Primary outcomes:
measure: anxiete level
timeFrame: 37th gestational weeks]
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University
Study officials:
affiliation: AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
name: Tuğba Dündar
role: STUDY_CHAIR
References:
Clinical trial NCT04130932: The Effect of Flooring on Office Workers' Health and Behaviors
Official title: The Effect of Flooring on Office Workers' Health and Behaviors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Researchers are trying to better understand how offices and workspaces influence people's performance, behavior and health during the course of weeks and over long periods of time.


Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent
* Must be adults between the ages of 18 and 60
* Ability to relocate to the Well Living Lab for 9 consecutive weeks
* Full-time Mayo Clinic employees (35+ hours per week)
* Report working a sedentary job (e.g., sit for \>= 50% of their work time).
* Have a working mobile phone that can receive text messages
* Must be present for 80% of the study (minimum of 4 days per week)

Exclusion Criteria:

* Individuals who are shift-workers
* Individuals diagnosed with vascular diseases (i.e., Raynaud's disease, peripheral artery disease, etc.)
* Individuals with diagnosed neurological and psychiatric disorders that may have physical limitations
* Drug (illegal or prescription narcotic), nicotine, or alcohol dependency
* Women who are lactating, pregnant or intend to become pregnant during the duration of the study
* Individuals who are taking medications (either prescribed or over-the-counter) which may affect comfort levels (e.g., opiate based medications)
* Working in occupation requiring standing/stepping \>50% of work time
* Report \< 1 year at current job
* Hospitalization from either a physical or mental disorder in the past six months
* History of cardiovascular, pulmonary, metabolic, neurological, or orthopedic limitations that would prohibit occupational physical activity (e.g., standing, stepping, etc.)

Primary outcomes:
measure: Sickness, absence, presenteeism
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brent Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05250232: One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays
Official title: One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Decay
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of present study is to evaluate clinically the fracture liability , marginal adaptation , and patient satisfaction of conservative versus conventional ceramic Onlays use e-max press to restore defective restored molar with old restoration or caries. with one or more cusp defect


Eligibility criteria: Inclusion Criteria:Inclusion criteria:

All subjects are required to be:

1-From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for onlay restoration:

1. Decayed teeth
2. Teeth restored with defected filling restorations
3. Teeth with occlusal defect 5- Able to return for follow-up examinations and evaluation Exclusion criteria

   1. Patient less than 18 or more than 50 years
   2. Patient with active resistant periodontal diseases
   3. Patients with poor oral hygiene and uncooperative patients
   4. Pregnant women
   5. Patients in the growth stage with partially erupted teeth
   6. Psychiatric problems or unrealistic expectations
   7. Lack of opposing dentition in the area of interest

      -

      -

Primary outcomes:
measure: evaluation of fracture resistance
timeFrame: one year
Secondary outcomes:
measure: evaluation of marginal adaptation
timeFrame: 1 year
measure: evaluation of patient satisfaction to the onlay restoration through questioning the patient about pain during eating , acceptability ,sensitivity
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03412032: Comparison of Two Summative Assessment Methods in Advanced Life Support Courses
Official title: Comparison of Two Summative Assessment Methods in Advanced Life Support Courses - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Assessment
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 428
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Several approaches for summative assessment during Advanced Life Support courses are used. The most commonly used method during European Resuscitation (ERC) Council Life Support Courses is that 1 instructor is miming a whole team, and the candidate has to lead this "team" through a scenario; another variant of the summative assessment (mainly used by American Heart Association (AHA) Courses) is with a group of students, where one student is the team leader to be assessed and the others are his team not being assessed. The second approach might be more realistic; however there is no evidence around with regard to effectiveness (pass/fail rate, ability to test non-technical skills (NTS)) or participant/assessor satisfaction.


Eligibility criteria: Inclusion Criteria:

* All medical students at the University of Bern, study year 2017/2018, 5th and 6th study year

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Team leadership
timeFrame: 1 minute after the assessment is completed
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern, Switzerland
name: Robert Greif
role: STUDY_CHAIR
References: