louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01375998: YAZ Post-marketing Surveillance in Japan
Official title: Drug Use Investigation of YAZ
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysmenorrhea
Keywords: YAZ
Dysmenorrhea
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 3273
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is patients who have received a prescription of YAZ on the basis of the decision of the treating gynecologist. The study is expected to collect data of 3,000 patients in about 300 gynecological practices in Japan.

Brief summary: This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea. The objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A total 3,000 patients will be recruited and followed 3 years since starting YAZ administration.


Eligibility criteria: Inclusion Criteria:

* Patients who received YAZ for dysmenorrhea Additional criteria for QOL questionnaire
* Patient informed consent

Exclusion Criteria:

* Patients who are contraindicated based on the product label Additional criteria for QOL questionnaire
* Six months or less after treatment of estrogen or estrogen combination drug

Primary outcomes:
measure: Incidence of adverse drug reactions and sever adverse events
timeFrame: During YAZ administration, up to 3 years
measure: Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)
timeFrame: Baseline and during YAZ administration, up to 3 years
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: During YAZ administration, up to 3 years
measure: Unpleasant physical symptoms collection
timeFrame: Baseline and during YAZ administration, up to 3 years
measure: Unpleasant psychological symptoms collection
timeFrame: Baseline and during YAZ administration, up to 3 years
measure: Analgesic drug for dysmenorrhea
timeFrame: During YAZ administration, up to 3 years
measure: QOL survey using Short-Form 36-Item Health Survey (SF-36)
timeFrame: Baseline and at 6th - 8th cycles (28 datys per cycle)
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Momoeda M, Akiyama S, Tanaka K, Suzukamo Y. Quality of Life in Japanese Patients with Dysmenorrhea Treated with Ethinylestradiol 20 mug/Drospirenone 3 mg in a Real-World Setting: An Observational Study. Int J Womens Health. 2020 May 4;12:327-338. doi: 10.2147/IJWH.S238460. eCollection 2020.
Clinical trial NCT02440698: Experiences With a Genetic Test for Personalized Nutrition Test for Personalized Nutrition
Official title: Experiences With a Healthcare Professional-mediated Genetic Test for Personalized Nutrition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Behavior
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Nutrigenomix Inc.
First posted: 2015-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants (n=80) are employees of a large multi-national food company's R\&D division located in Australia, Switzerland, USA and the UK. They underwent a genetic test for personalized nutrition in March 2015 that was offered at no cost through the company wellness program.

Brief summary: The investigators will use a web-based survey to collect data on individual attitudes and self-reported health behaviour changes following genetic testing for personalized nutrition. Participants (n=80) are employees of a large multi-national food company's R\&D division located in Australia, Switzerland, USA and the UK. They underwent a genetic test for personalized nutrition in March 2015 that was offered at no cost through the company wellness program. A registered dietitian completed a pre-test consultation and disclosed the test results with DNA-based dietary advice. The test provided information on 7 components of diet and additional information on individual risk for gluten intolerance.


Eligibility criteria: Inclusion Criteria:

* Completed a genetic test for personalized nutrition through company wellness program.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Health behaviour change
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Sharing of information
timeFrame: 3 months
measure: Recommendation
timeFrame: 3 months
measure: Satisfaction
timeFrame: 3 months
measure: Interest in future testing
timeFrame: 3 months
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Ahmed El-Sohemy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Daiva Nielsen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03584698: Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage
Official title: The Effect of Adding Vaginal Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Missed Abortion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 144
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Termination of pregnancy is an important subject that has complex and emotional controversies. The most common time of termination of pregnancy is the mid-trimester which has two-thirds of all serious abortion-related complications. There are many indications for mid trimester termination of pregnancy such as missed abortion, serious fetal abnormalities and lastly some women do not wish to continue a pregnancy and will often request termination of pregnancy


Eligibility criteria: Inclusion Criteria:

* Nullipara or previous vaginal delivery only
* Bishop score was ≤ 5
* Women who will accept to participate in the study

Exclusion Criteria:

* Multiple gestations
* Rupture of fetal membranes
* Previous cesarean sections
* Women with heavy bleeding
* Evidence of low implanted placenta by US
* Evidence of intra-uterine infection (either clinical or laboratory)

Primary outcomes:
measure: The induction to fetal expulsion time.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT02130245: Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study
Official title: Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Cholecystitis
Keywords: Laparoscopic cholecystectomy
Acute cholecystitis
Early
Delayed
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The best management of the acute cholecystitis is to do laparoscopic cholecystectomy. The hypothesis is that to do it as an early intervention after patient admission is better than delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.

Detailed description: Doing laparoscopic cholecystectomy for patients with acute cholecystitis as an early intervention after patient admission ( first group) or to do it after a while of treatment and conservation as a delayed cholecystectomy (second group) points of study include the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.

Eligibility criteria: Inclusion Criteria:

* Proved acute cholecystitis clinical, radiologic

Exclusion Criteria:

* Evidence of peritonitis
* ASA III or IV
* Previous upper abdominal surgery
* Pregnancy

Primary outcomes:
measure: Operative time
timeFrame: 1 DAY
Secondary outcomes:
measure: Perioperative complications
timeFrame: 5 weeks
measure: Conversion rate
timeFrame: 1 DAY
measure: hospital stay in days
timeFrame: 2 weeks
measure: Period of giving antibiotics in days
timeFrame: 2 WEEKS
Other outcomes:
Locations:
city: Mansoura,
country: Egypt
facility: mansoura university hospital, EGYPT, central hafr elbatin hospital, Saudia Arabia
Study officials:
References:
Clinical trial NCT05436145: Intern Health Study 2022 and 2023
Official title: Intern Health Study: 2022 and 2023 Cohort Micro-Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Mood
Sleep
Physical Activity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 2562
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

Detailed description: Due to their high stress workloads, medical interns suffer from depression at higher rates than the general population. Interns also tend to have lower sleep and decreased physical activity. The goal of this trial is to evaluate the efficacy of a mobile health intervention intending to help improve the mental health of medical interns. The intervention sends mobile phone notifications which aim to help interns improve their mood, maintain physical activity, and obtain adequate sleep during their internship year.

The primary aim of the study is to evaluate how notifications affect participants' weekly mood, as measured through a daily one question mood survey. The second primary aim of the study is to evaluate how notifications affect participants' long-term mental health, as measured by the Patient Health Questionnaire. The first secondary aim is to evaluate how mood notifications affect participants' weekly mood. The second secondary aim is to evaluate how activity notifications affect participants' weekly step count. The third secondary aim is to evaluate how sleep notifications affect participants' weekly sleep duration. In order to better optimize notification delivery, the final aim (exploratory) is to understand moderators of these effects. Moderators of interest are previous week's mood, previous week's step count, previous week's sleep duration, study week, sex, previous history of depression, and baseline neuroticism.

Eligibility criteria: Inclusion Criteria:

* Medical intern during the 2022-2023 or 2023-2024 internship years
* iPhone or Android phone user
* Logged into the Intern Health Study mobile app, completed consent, and filled out baseline survey by June 30 prior to the start of intern year

Exclusion Criteria:

* None

Primary outcomes:
measure: Average daily mood
timeFrame: Daily, through study completion at the end of intern year (1 year)
measure: Average daily step count
timeFrame: Daily, through study completion at the end of intern year (1 year)
measure: Average nightly sleep duration
timeFrame: Daily, through study completion at the end of intern year (1 year)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Quarterly (every 3 months for 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT02073045: Intensive Education in Increasing Understanding of Lymphedema in Patients With Breast Cancer Undergoing Surgery
Official title: Effect of Intensive Education on Breast Cancer Patient's Understanding of Lymphedema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lymphedema
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies intensive education in increasing understanding of lymphedema in patients with breast cancer undergoing surgery. Lymphedema is the build-up of fluids in the arm (or other extremity) after surgery. Providing written educational handouts and verbal education on the risk factors and symptoms of lymphedema may improve patients' ability to identify symptoms of lymphedema after surgery.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the patient's increased knowledge of lymphedema signs/symptoms after education.

SECONDARY OBJECTIVES:

I. The participant may detect lymphedema signs/symptoms at an early stage by having a pre-surgery comparison of bilateral upper extremities (BUE) circumferential measures to the 3 month post-surgery measures.

OUTLINE:

Participants complete a five question survey, designed by the Occupational Therapy staff, as an instrument to assess a patient's knowledge of lymphedema signs/symptoms before surgery. An Occupational Therapist (OT), Physical Therapist (PT), and/or Certified Lymphedema Therapist (CLT) provide written handouts to participants on the pathophysiology, signs, symptoms, and treatment of lymphedema. Participants repeat the survey at 3 months post-surgery. BUE circumferential measurements are also collected before surgery and at 3 months post-surgery.

Eligibility criteria: Inclusion Criteria:

* Participants will be diagnosed with breast cancer; the participants will be scheduled for a lumpectomy or a mastectomy at UH GMC Seidman Cancer Center
* They must understand written, verbal, and/or recorded survey questioning English

Exclusion Criteria:

* Individuals with previous radiation treatments to the breast or axilla areas
* Prior diagnosis of lymphedema
* Persons that do not speak English
* Those unwilling to participate in the follow-up call 3 months post-surgery

Primary outcomes:
measure: Improvement in participant's knowledge of lymphedema
timeFrame: Baseline to 3 months post-surgery
measure: Total girth differences as assessed by BUE circumferential measurements using the National Lymphedema Network (NLN) guidelines
timeFrame: Baseline to 3 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Dotti Thompson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00806845: Examination of B Cell Responses in Human Blood
Official title: Gewinnung Humaner antikörperproduzierender Zellen Aus Dem Blut
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
B-lymphocyte
Lead sponsor: Regenerative Medicine Network
Sponsor class: NETWORK
Collaborators: name: University of Leipzig
First posted: 2008-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV patients and controls attending specialised clinics, Germany

Brief summary: The aim of this study is the assessment B-cell immune responses in HIV-infected individuals.

Detailed description: Groups of patients with different immune competencies will be examined. The impact of HIV infection on immune response will be assessed.

Eligibility criteria: Inclusion Criteria:

* HIV-infected individuals
* controls

Exclusion Criteria:

- none

Primary outcomes:
measure: Antigen specific B-cell responses
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universität Leipzig
state: Sachsen
Study officials:
affiliation: Universität Leipzig
name: Christian Jassoy, MD
role: STUDY_DIRECTOR
References:
citation: Bussmann BM, Reiche S, Bieniek B, Krznaric I, Ackermann F, Jassoy C. Loss of HIV-specific memory B-cells as a potential mechanism for the dysfunction of the humoral immune response against HIV. Virology. 2010 Feb 5;397(1):7-13. doi: 10.1016/j.virol.2009.11.003. Epub 2009 Dec 4.
citation: Kunz K, Reiche S, Dwai Y, Cordes C, Krznaric I, Bussmann BM, Jassoy C. A broad spectrum of functional HIV-specific memory B cells in the blood of infected individuals with high CD4+ T-cell counts. J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):e56-8. doi: 10.1097/QAI.0b013e31821dd9d1. No abstract available.
citation: Reiche S, Nestler C, Sieg M, Schulz K, Cordes C, Krznaric I, Jassoy C. Hepatitis C virus (HCV)-specific memory B-cell responses in transiently and chronically infected HIV positive individuals. J Clin Virol. 2014 Apr;59(4):218-22. doi: 10.1016/j.jcv.2014.01.023. Epub 2014 Feb 4.
Clinical trial NCT01889745: A Phase I Clinical Study of the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.
Official title: A Phase I Clinical Study, Randomized, Single-blind,Placebo-controlled, Multiple Doses, Dose Escalation Study fo the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Healthy
Lead sponsor: Biotoxtech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2013-06-28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT

Brief summary: This study is designed to multiple dose and dose escalation study

Detailed description: A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Single Dose Escalation Study of the Safety, Tolerabiluty, and Pharmacokinetics of HX-1171 in Healthy Male Subjects

Eligibility criteria: Inclusion Criteria:

* Adult males aged 20 to 40 years at screening.
* Be able to comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or gastrointestinal disorders.
* History of known hypersensitivity to drugs including HX-1171.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Special City of Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01261845: Ecology of Medical Care - Utilisation of Health Care in Austria
Official title: Ecology of Medical Care - Utilisation of Health Care in Austria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Keywords: Delivery of Health Care
Equity in Health Services
Ethnic Groups
Health Services Research
Health Surveys
Immigration
Referral and Consultation
Resource Allocation
Social Justice
Vulnerable Populations
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: National Bank of Austria
First posted: 2010-12-17
Enrollment: 3500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The Austrian population 15 years and older .

Brief summary: BACKGROUND: A proper understanding of the attitudes towards its own health status and concise estimates concerning the health seeking behavior of the different subgroups of a population are highly desirable. The structure of the Austrian population with regard to its age distribution and the proportion of people with immigrant backgrounds have been rapidly changing in recent years. Questions of allocating limited resources and meeting the needs of under-served populations have become increasingly important. However, data that could illuminate these issues are sparse and therefore obtaining them will be important for making sensible policy decisions.

METHODS: A telephone survey of the Austrian population for the assessment of the occurrence of any health complaint and the subsequent help seeking behavior with special emphasize on under-served minority groups - migrant population, elder people, and female gender.

AIMS: Our analysis of the data obtained should help to clarify some hitherto undocumented aspects and should provide the evidence for building a better health care infrastructure with equality of access and efficient coordination. We also hope that this information can help to allocate resources strategically according to needs and cost-efficiency in health care.


Eligibility criteria: Inclusion Criteria:

* 15 years and older

Exclusion Criteria:

* younger than 15 years

Primary outcomes:
measure: Prevalence of health complaints
timeFrame: 1 month
measure: Prevalence of dysphoric disorders
timeFrame: 2 weeks
Secondary outcomes:
measure: Utilization of CAM
timeFrame: 1 month
measure: Utilization of Health Care Resources in Austria
timeFrame: 1 month
measure: Case vignettes for calibration of response measures
timeFrame: 1 month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department for General Practice and Family Medicine, Center for Public Health at the Medical University of Vienna
Study officials:
affiliation: MedUni Vienna
name: Otto Pichlhoefer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pichlhofer O, Maier M. Unregulated access to health-care services is associated with overutilization--lessons from Austria. Eur J Public Health. 2015 Jun;25(3):401-3. doi: 10.1093/eurpub/cku189. Epub 2014 Nov 23.