louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02792244: First Time Mothers and Anal Incontinence Six Years Postpartum
Official title: First Time Mothers and Anal Incontinence Six Years Postpartum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Urinary Incontinence
Quality of Life
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: St.Olavs Hospital, Trondheim University Hospital, Norway
name: Norwegian University of Science and Technology
First posted: 2016-06-07
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parous women participating in two previous studies (1. primiparae delivering their first child between May 2009 and December2010 and 2. women with anal incontinence postpartum)

Brief summary: Previous studies show that incontinence is relatively common during pregnancy and after delivery. Experiencing incontinence during pregnancy or in the first year after delivery increases the risk of long term incontinence. There is scarce documentation of the long term prevalence of anal incontinence (AI) in Norway. This study aims to explore prevalence and risk factors for incontinence approximately six years after delivery among the 1718 who participated in two previous studies exploring the prevalence and predictors of anal incontinence in late pregnancy and during the first year after first delivery, and the effect of pelvic floor muscle exercises as treatment for anal incontinence after delivery. Increased awareness and knowledge about risk factors and long term prevalence of anal incontinence among health professionals as well as pregnant and parous women may give indications about which women to target for preventative measures to reduce the risk of new onset of postpartum AI during pregnancy and after delivery. Further, increased knowledge may aid in planning individualized follow-up during pregnancy and the first year as well as in the long term among women with existing AI symptoms.


Eligibility criteria: Inclusion Criteria:

* Participants in previous studies

Exclusion Criteria:

* Women not participating in previous studies

Primary outcomes:
measure: Anal incontinence
timeFrame: Anal incontinence six years postpartum
Secondary outcomes:
measure: Urinary incontinence
timeFrame: urinary incontinence six years postpartum
Other outcomes:
Locations:
Study officials:
affiliation: Ostfold Hospital Trust
name: Hege H Johannessen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00725244: Trial of Endoscopy Bipolar and Argon of Chronic Rectal Bleeding From Radiation Telangiectasias
Official title: A Randomized Prospective Study of Endoscopy Bipolar Eletrocoagulation and Argon Plasma Coagulation of Chronic Rectal Bleeding From Radiation Telangiectasias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radiation Injuries
Telangiectasis
Keywords: Radiation Injuries
Telangiectasis
Bipolar Eletrocoagulation
Argon Plasma Coagulation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim:

To compare the efficacy, safety and number of sessions of bipolar eletrocoagulation (BEC) and argon plasma coagulation (APC) in the management of the bleeding telangiectasias from chronic radiation coloproctopathy (CRCP).

Methods:

Thirty patients with active bleeding from telangiectasias were enrolled in two groups (15 BEC and 15 APC) and classified according of Saunders score. BEC settings were 50 W and APC settings were 40 W and 1.0 l/min. Colonoscopy was the first exam to rule out synchronous lesions and follow-up was performed with sigmoidoscopies. Clinical cure was defined as cessation of bleeding and endoscopic cure was determined by absence of telangiectasias. Failure was defined whenever more than 7 sessions or other therapy was necessary.

Detailed description: Thirty patients with active and chronic hematochezia from radiation telangiectasias were randomized in two groups :

* fifteen patients in group 1- bipolar eletrocoagulation (BE) and
* fifteen in group 2 - argon plasma coagulation(APC). For inclusion in the study, all patients were required to have active (at least one episode last week) and chronic (persist or appear 6 months after the conclusion of radiotherapy) rectal bleeding. Between May 2005 and April 2008, patients were treated and followed at the Endoscopy Unit in the São Paulo Hospital (UNIFESP).

Eligibility criteria: Inclusion Criteria:

* active (at least one episode last week) and chronic (persist or appear 6 months after the conclusion of radiotherapy) rectal bleeding.
* previous radiotherapy at least 6 months ago
* presence of colonic or rectal telangiectasias
* patients that agreed to participate of the study and signed the Term of Free Consent and Cleared

Exclusion Criteria:

* prior endoscopic treatment
* rectal or colonic surgery
* stenosis rectal
* rectal bleeding before radiotherapy
* severe cardiac disease

Primary outcomes:
measure: Improve of rectal bleeding
timeFrame: 6 months
Secondary outcomes:
measure: Complications of each group
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University Of São Paulo - Gastroenterology
Study officials:
affiliation: Federal University of São Paulo
name: Angelo Ferrari, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06402344: Gestrinone and Endothelial Function in Young Women
Official title: Association of Hormonal Implant With Gestrinone on Endothelial Function in Young Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Hormonal implant
Gestrinone
Endothelial function
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 90
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young women.

Brief summary: The purpose of this study is to assess the association of hormonal implant with gestrinone in cardiovascular health outcomes in young women.

Detailed description: After being informed about the study, volunteers will be screened in accordance with eligibility criteria. Eligible volunteers will be invited to appear to the research institute and participate in the study. All volunteers giving the written informed consent will perform all assessments in the same day at their visit.

Eligibility criteria: Inclusion Criteria:

* Women;
* Between 25 and 45 years age;
* History of ≥ 1 hormonal implant with gestrinone in the last 6 months or never had used any hormonal implants.

Exclusion Criteria:

* Pregnancy;
* Menopause;
* Smoking;
* Moderate-high consumption of alcoholic beverages (above 14 drinks per week);
* Previous cardiovascular event (e.g. myocardial infarction and stroke);
* Uncontrolled psychiatric disease;
* Ventricular arrhythmia;
* Using antibiotics or corticoids;
* Regular contraceptive use (estrogen and progesterone);
* Use of illicit drugs.

Primary outcomes:
measure: Endothelial function
timeFrame: Day 1.
Secondary outcomes:
measure: Arterial stiffness
timeFrame: Day 1.
measure: Heart rate
timeFrame: Day 1.
measure: Blood pressure
timeFrame: Day 1.
measure: Cardiac autonomic modulation
timeFrame: Day 1.
measure: Lipid profile
timeFrame: Day 1.
measure: Glycemia
timeFrame: Day 1.
measure: Ultra-sensitive C-reactive protein (us-CRP)
timeFrame: Day 1.
measure: Hemoglobin
timeFrame: Day 1.
measure: Hematocrit
timeFrame: Day 1.
measure: Progesterone
timeFrame: Day 1.
measure: 17-alpha-hydroxyprogesterone (17-OHP)
timeFrame: Day 1.
measure: Dehydroepiandrosterone (DHEA)
timeFrame: Day 1.
measure: Androstenedione
timeFrame: Day 1.
measure: Free testosterone
timeFrame: Day 1.
measure: Total testosterone
timeFrame: Day 1.
measure: Estradiol
timeFrame: Day 1.
measure: Follicle-stimulating hormone (FSH)
timeFrame: Day 1.
measure: Luteinizing hormone (LH)
timeFrame: Day 1.
measure: Sex hormone-binding globulin (SHBG)
timeFrame: Day 1.
measure: Muscular strength
timeFrame: Day 1.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Medical Referencee - Rehabilitation Center
name: Luciana Diniz Nagem Janot de Matos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04388644: Survey of Satisfaction on Traditional Chinese Medicine Jing-Guan-Fang (JGF) for COVID-19 Prevention
Official title: Department of Chinese Medicine, Branch of Linsen, Chinese Medicine, and Kunming, Taipei City Hospital, Taipei, Taiwan Institute of Traditional Medicine, National Yang-Ming University, Taipei, Taiwan.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corona Virus Infection
Keywords: natural herbal medicine
Chinese medicine
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2020-05-14
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The first-line medical staff who take care of COVID-19 patients in public hospital northern Taiwan., and the self-quarantine who have contacted with history.

Some of the population will take natural herbal medicine to prevent COVID-19 infection.

Brief summary: the retrospective observation study, the first line to care CAVID-19

Detailed description: The satisfaction of using nature herbal medicine for frontline medical staffs to prevent COVID-19: a retrospective clinical study.

The medical frontline staffs have the high risk to be infected during working. The stress and load were acuminated, especially when they got the similar symptoms as COVID-19. NHM has been used to early prevention for thousands of years9-12. It was well accept to take NHM for early prevention in many Asia-Pacific countries. Although many NHM remedies of COVID-19 treatment or prevention were reported, but the related study were lacking. To understand the pressure and the satisfaction of frontline medical staffs after taking JGF for early prevention we conducted this retrospective clinical study to explore the relationship in different groups.

Eligibility criteria: Inclusion Criteria:

* The person first-line medical staff in hospital
* the inspection personnel in airport
* self-quarantine at home.
* self-quarantine at office.

Exclusion Criteria:

* no willing to participate
* allergy to herbal medicine
* severe illness evaluated by physician

Primary outcomes:
measure: the number confirmed COVID-19 cases
timeFrame: 8 weeks
measure: The person with COVID-19 like symptoms
timeFrame: 8 weeks
Secondary outcomes:
measure: The improving rate of COVID-19 like symptoms
timeFrame: 8 weeks
measure: The satisfaction% to taking JGF
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Branch of Chinese Medicine, Taipei City Hospital
city: Taipei
country: Taiwan
facility: Branch of Linsen Chinese Medicine and Kunming, Taipei City Hospital
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
affiliation: Taipei City Hospital
name: Chung-HUa Hsu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005244: Anger Expression, Self-focus and Coronary Heart Disease Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Coronary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To identify behavioral factors underlying the development of cardiovascular risk in young adults.

Detailed description: BACKGROUND:

The continued number of observations relating the Type A behavior pattern to coronary heart disease underscores the importance of developing a careful theoretical basis that may account for the virulent components of a coronary-prone personality.

CARDIA or Coronary Heart Disease Risk Development in Young Adults is a prospective, epidemiological study of coronary heart disease risk factors in cohorts of Black and white men and women, 18 to 30 years of age.

DESIGN NARRATIVE:

From each of the baseline tape-recorded Type A/B structured interviews administered in CARDIA, eighteen questions were scored for self-references, perceived pressure, anger experience, and anger expression. The anger measures were related to other measures of anger-in and hostility in order to establish their validity. The interrelationships of these factors were assessed separately for each of the socioeconomic status (SES) categories. A major focus of the analyses was to describe SES differences in how pressure was perceived and how anger was experienced and expressed. The study also assessed how these factors were related to data already collected on psychosocial risk factors and primary risk factors including blood pressure, serum cholesterol, and cigarette smoking.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California at San Francisco
name: Larry Scherwitz
References:
Clinical trial NCT01112644: Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate Improvement of Symptoms of RLS in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms Who Take OXN PR Compared to Subjects Taking Placebo (PLA).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Idiopathic RLS With Daytime Symptoms
Lead sponsor: Mundipharma Research GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective for the 12-week Titration-/Maintenance Period is:

To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.

Detailed description: A randomised, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate improvement of symptoms of RLS in subjects with moderate to severe idiopathic RLS with daytime symptoms who take oxycodone/naloxone prolonged release (OXN PR) compared to subjects taking placebo (PLA).

Eligibility criteria: Inclusion Criteria:

* Moderate to severe idiopathic RLS with daytime symptoms

Exclusion Criteria:

* Females who are pregnant or lactating.
* Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
* Subjects with evidence of impaired liver/kidney function upon entry into the study

Primary outcomes:
measure: Changes in the IRLS score between the two treatment arms will be compared
timeFrame: 12 weeks and a 6 month extension
Secondary outcomes:
Other outcomes:
Locations:
city: Kassel
country: Germany
facility: Paracelsus Elena Klinik
city: Barcelona
country: Spain
city: Goteborg
country: Sweden
Study officials:
References:
citation: Oertel WH, Hallstrom Y, Saletu-Zyhlarz GM, Hopp M, Bosse B, Trenkwalder C; RELOXYN Study Group. Sleep and Quality of Life Under Prolonged Release Oxycodone/Naloxone for Severe Restless Legs Syndrome: An Analysis of Secondary Efficacy Variables of a Double-Blind, Randomized, Placebo-Controlled Study with an Open-Label Extension. CNS Drugs. 2016 Aug;30(8):749-60. doi: 10.1007/s40263-016-0372-1.
citation: Trenkwalder C, Benes H, Grote L, Garcia-Borreguero D, Hogl B, Hopp M, Bosse B, Oksche A, Reimer K, Winkelmann J, Allen RP, Kohnen R; RELOXYN Study Group. Prolonged release oxycodone-naloxone for treatment of severe restless legs syndrome after failure of previous treatment: a double-blind, randomised, placebo-controlled trial with an open-label extension. Lancet Neurol. 2013 Dec;12(12):1141-50. doi: 10.1016/S1474-4422(13)70239-4. Epub 2013 Oct 18.
Clinical trial NCT06190444: E-health Literacy in Athletes
Official title: A Study of E-health Literacy in Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletic Injuries
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletes

Brief summary: e-health literacy in athletes is very important. The aim of this study was to determine the level of e-health literacy in athletes and to examine the relationship between age, gender, sports branches and injury sites.


Eligibility criteria: Inclusion Criteria:

* volunteering to participate in the training,
* being an athlete for at least 2 years.

Exclusion Criteria:

* having any vision and hearing problems

Primary outcomes:
measure: E-health literacy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
References:
Clinical trial NCT05732844: Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women.
Official title: Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women. Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Stress Urinary Incontinence
Sexual Dysfunction
Keywords: vaginal spheres
physiotherapy
pelvic floor muscle trainning
Lead sponsor: RAPbarcelona
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 64
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: Asess if adding vaginal spheres treatment to the conventional Pelvic Floor Muscle Trainning (PFMT) produces a greater decrease in the severity of the stress urinary incontinence or a greater perceived quality of life related to incontinence.

Detailed description: The intervention group will perform the pelvic floor muscle trainning (PFMT) plus the use of vaginal spheres, while the control group will perform the PFMT treatment only, daily at home. The study will be conducted on women with stress urinary incontinence. The intervention will last four months and will consist of a monthly session with the physiotherapist, doing a total of 4 sessions and the final assessment.

Eligibility criteria: Inclusion Criteria:

* Women aged 18 or over
* Suffer from stress urinary incontinence or mixed urinary incontinence.
* Understand Spanish to be able to self-complete the questionnaires (validated in Spanish).

Exclusion Criteria:

* Not giving informed consent.
* Women with faecal incontinence.
* Women with grade III-IV prolapse.
* Women with pathology that can affect the neuro-muscular response.
* Women with incontinence that is not of functional origin.
* Women who have perineal pain that makes it impossible to apply the spheres.
* Women with an open vagina of more than 2.5 cm opening
* Being pregnant.
* Not being committed to complying with a minimum of 80% of the treatment.
* Having previously started other pelvic physiotherapy treatments

Primary outcomes:
measure: Severity of urinary incontinence using the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire Short form) at Week 16.
timeFrame: Time Frame: Baseline and Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: RAPbarcelona SL
Study officials:
References:
citation: Oblasser C, Christie J, McCourt C. Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women post partum: A quantitative systematic review. Midwifery. 2015 Nov;31(11):1017-25. doi: 10.1016/j.midw.2015.08.011. Epub 2015 Sep 9.
Clinical trial NCT01022840: The Preemptive Analgetic Potency of Low Dose S-Ketamine
Official title: The Opioid Sparing Effect of Minimal Dose S-Ketamine Applied as a Coanalgesic During the Perioperative Period - An Active Placebo-Controlled, Double Blinded, Randomized Clinical Trial (МiniKet)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary hypothesis is improved postoperative analgetic quality using S-Ketamine, particularly in patients suffering from chronic pain.

Detailed description: The investigators are dealing mainly with the finding of the right dosage for the optimal safety and efficacy of S-Ketamine, but also discovering new possible areas of investigation (e.g. anti-depressive effect, anti-neuropathic effect).

Eligibility criteria: Inclusion Criteria:

* Scheduled for major abdominal surgery
* Suitable for PCA
* Cardio-vascular stable
* Age: 18+
* Between 50-120kg BW
* ASA 1-3
* Good Compliance for pain monitoring

Exclusion Criteria:

* Allergy to S-Ketamine
* Severe liver or kidney dysfunction
* Severe coronary disease
* Pregnancy
* Present or past psychotic disorders
* Addiction to alcohol or opioids
* Poor compliance

Primary outcomes:
measure: postoperative opioid consumption
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Med. U Graz
name: Mischa Wejbora, MD
role: PRINCIPAL_INVESTIGATOR
References: