louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01354275: In Vitro Fertilization Outcomes of Two Treatment Protocols in Women With Polycystic Ovary Syndrome
Official title: IVF/ICSI Outcomes of OCP Plus GnRH Agonist Protocol Versus OCP Plus GnRH Antagonist Fixed Protocol in Women With PCOS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles
Keywords: PCOS
IVF/ICSI
Clinical Pregnancy rates
GnRH Antagonist
GnRH Agonist
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone (GnRH) agonist and GnRH Antagonist fixed protocol.

Detailed description: Women with PCOS undergoing IVF/ICSI cycles will be evaluated by two different protocols. One arm of the study includes oral contraceptive plus GnRH agonist protocol with 150 IU FSH (standard dose) and second arm includes oral contraceptive plus GnRH Antagonist with 150 IU FSH dose and fixed 6th day starting of GnRH Antagonist.

Eligibility criteria: Inclusion Criteria:

* PCOS women undergoing ICSI cycles
* All women will be administered 150 IU rec FSH

Exclusion Criteria:

* Women having other endocrinopathies
* women older than 35
* third IVF/ICSI cycles
* previous and current use of metformin

Primary outcomes:
measure: Ongoing pregnancy rates
timeFrame: March 2009 to June 2011
measure: clinical pregnancy rate
timeFrame: from march 2009 to july 2011
measure: Total gonadotropin use
timeFrame: From march 2009 to June 2011
Secondary outcomes:
measure: OHSS rates
timeFrame: from march 2009 to july 2011
measure: Total ongoing pregnancy rate
timeFrame: from march 2009 to june 2011
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Bulent Haydardedeoglu
Study officials:
affiliation: Baskent University
name: Bulent Haydardedeoglu, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06623175: Effects of Acupuncture in Spontaneous Rapture of Membranes: Applicability and Effectiveness
Official title: Effects of Acupuncture in Spontaneous Rapture of Membranes: Applicability and Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PROM (Pregnancy)
Induced; Birth
Acupuncture
Labour
Cervical Ripening
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effects of acupuncture in women presenting with spontaneous rapture of membranes (PROM) at term and negative swab for Streptococcus Agalactie to promote a spontaneous onset of labour and avoid labour induction after 24 hours, accordingly to our policy. Secondary outcomes were considered the duration of first and second stage of labour, the time elapsed between PROM and delivery.


Eligibility criteria: Inclusion Criteria:

* PROM after 37 weeks of gestation
* absence of maternal and fetal complications
* negative swab of Streptococcus Agalactiae
* limpid amniotic fluid
* absence of uterine contractions after 6 hours of observation
* single pregnancy

Exclusion Criteria:

* PROM before 37 weeks of gestation
* presence of maternal and fetal complications
* positive swab of GBS
* M1 - M3 amniotic fluid
* regular uterine contractions during the first 6 hours of observation
* twin pregnancy

Primary outcomes:
measure: Rate of spontaneous onset of labour and avoidance of labour induction after 24 hours from PROM
timeFrame: Time between PROM and birth/delivery
Secondary outcomes:
measure: Duration of second stage of labour
timeFrame: Time between established labour and delivery
measure: Time elapsed between PROM and delivery
timeFrame: Time elapsed between PROM and delivery
measure: Duration of first stage of labour
timeFrame: Time between PROM and active labour
Other outcomes:
measure: Time elapsed between PROM and full dilation
timeFrame: Time elapsed between PROM and full dilation (10 cm)
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
Study officials:
References:
Clinical trial NCT04966975: Effect and Prognosis of Immunohistochemical Biomarkers Changes in Patients With Bladder Cancer After Neoadjuvant Chemotherapy
Official title: Effect and Prognosis of Immunohistochemical Biomarkers Changes in Patients With Bladder Cancer After Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: bladder cancer
neoadjuvant chemotherapy
immunohistochemical biomarkers
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Shantou Central Hospital
First posted: 2021-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who histologically confirmed bladder cancer treated with neoadjuvant chemotherapy.

Brief summary: Clinical trial to investigate the relationship between the expression of immunohistochemical biomarkers GATA-3, CK20, P53 and Ki67 in bladder cancer and pathological complete response after neoadjuvant chemotherapy.

Detailed description: This is a retrospective study included bladder cancer patients treated with neoadjuvant chemotherapy. We analyzed the changes in the expression of GATA-3, CK20, P53 and Ki67 before and after NAC. Evaluating the sensitivity factor for predicting pathological complete response.

Eligibility criteria: Inclusion Criteria:

1. Any male or female patient aged 18 or older.
2. Histologically confirmed bladder cancer, cystectomy was performed after NAC.
3. Complete clinical data.

Exclusion Criteria:

1. Patients with severe organic disease who can not tolerate chemotherapy or surgery
2. Patients received previous treatment (chemotherapy, radiation, or molecular targeted therapy).
3. Patients with distant metastasis or other cancer history.

Primary outcomes:
measure: Expression of immunohistochemical biomarkers GATA-3, CK20, P53 and Ki67
timeFrame: 1 year
measure: Tumor regression grade
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jian Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00231075: Evaluation of the Safety and Efficacy of Paraplatin in Combination With Taxol in Patients of 70 Years and Older With Ovary Cancer F.I.G.O. Stages III-IV
Official title: National, Phase II Study Designed to Evaluate the Safety and Efficacy of Paraplatin in Combination With Taxol in Patients of 70 Years and Older With Ovary Cancer F.I.G.O. Stages III and IV. FAG-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Epithelial ovary cancer F.I.G.O. stages III or IV
70 years or older
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 75
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV.

Detailed description: The Main objective of this study is to evaluate the faisibility of chemotherapy with Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV and to determine principal predictive factors of this feasibility.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological proven diagnosis of epithelial ovary cancer F.I.G.O stages III or IV (when only cytological proven diagnosis is available: malignant cells and pelvis tumoral mass and increased CA-125 must be diagnosed simultaneously)
* Patient aged \> 70 years
* Neutrophil polynuclears \> 1500/mm3 and Platelets \> 100 000/mm3
* No clinical icterus
* Life expectancy of at least 3 months

Exclusion Criteria:

* Previous diagnosis of malignancy
* Previous chemotherapy treatment
* Previous radiotherapy
* Hypersensitivity to products containing Cremophore EL
* Hepatic values: bilirubine \> 2\*LSN, SGOT-SGPT \> 2\*LSN and/or Alkalin phosphatase \> 3\*LSN
* Myocardiopathy with arrhythmia

Primary outcomes:
measure: Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)
Secondary outcomes:
measure: Toxicity assessment
measure: Overall survival
measure: Progression-free survival
measure: Rate of response
measure: Quality of life
Other outcomes:
Locations:
city: Eaubonne
country: France
facility: Centre Hosptalier Emile Roux
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-sud
Study officials:
affiliation: Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex
name: Gilles Freyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03299075: The Effect of Social Media Use on Eating Behaviours
Official title: The Effect of Social Media Use on Eating Behaviours
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eating Behavior
Keywords: External eating
Technology
Photography
Social media
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals between 18-49 years old who use smartphones

Brief summary: This project aims to explore how social media use, in particular food photography, influences eating behaviours. It will be approached through three methods - a correlational experience sampling method, an experimental experience sampling method, and an experimental laboratory method. This registration describes the correlational experience sampling method.

Detailed description: This project aims to explore how social media use, in particular food photography, influences eating behaviours.

The research question will be approached using a combination of methods. The first is the experience sampling method, where data is gathered from participants as they are going about their day-to-day lives. This method comprises two sub-sections - a correlational study, and an experimental study. This registration describes the correlational experience sampling method.

The study will measure participants' regular phone use and eating behaviours. Participants will be recruited via online platforms and participate in the study for one week. At the beginning of the week, they will be required to fill in some online questionnaires (e.g. demographic information). For the rest of the week, they will be prompted at specific time points in the day via smartphone to answer some questions about their phone use and eating behaviours.

The expected outcome of the project is to collectively evaluate the data from the various methods to conclude how social media use, and in particular the act of food photography, influences the various aspects of eating behaviours.

Eligibility criteria: Exclusion Criteria:

* Symptoms / history of any medical or psychiatric conditions
* Allergies to food products
* History of eating disorders
* Excessive exercise (≥ 5 times a week of self-reported exercise)
* Currently on a special diet or deliberating restricting caloric intake
* Currently on a weight loss program

Primary outcomes:
measure: Enjoyment of food consumed
timeFrame: 15 minutes
Secondary outcomes:
measure: Amount of food consumed
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References:
citation: Yong JYY, Tong EMW, Liu JCJ. Meal-time Smartphone Use in an Obesogenic Environment: Two Longitudinal Observational Studies. JMIR Mhealth Uhealth. 2021 May 6;9(5):e22929. doi: 10.2196/22929.
Clinical trial NCT01415375: Prostate Cancer Education in African American Men
Official title: Prostate Cancer Education in African American Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer Screening Decision
Keywords: prostate-specific antigen (146-154)
prostate-specific antigen (154-163)
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 490
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.

Detailed description: African American and African-Caribbean men have the greatest prostate cancer incidence and mortality rate. Professional organizations provide conflicting recommendations regarding prostate cancer testing but generally agree that men learn about the risks and benefits of testing and share in decisions about testing based on their personal preferences. This study was designed to assess the effects of a decision support intervention on men's knowledge about prostate cancer testing, participation in medical decisions about testing, decision conflict related to testing, and the congruence between prostate cancer testing intentions and behaviors. A randomized controlled trial was conducted. Participants were randomized into one of two conditions: (a) tailored telephone education about prostate cancer testing (intervention group) or (b) tailored telephone education about national guidelines for fruit and vegetable consumption (attention control group).

Eligibility criteria: Inclusion Criteria:

* 45 to 70 year old
* African descent
* accessible by telephone
* have primary care physician

Exclusion Criteria:

* Prostate cancer test in 12 months prior to enrollment
* History of prostate cancer

Primary outcomes:
measure: congruence between prostate cancer testing intention and behavior
timeFrame: 1 and 2 years post randomization
measure: Knowledge about prostate cancer and prostate cancer tests
timeFrame: baseline and 8 months post randomization
measure: Decisional conflict
timeFrame: 8 months post randomization
measure: Verified doctor visit to discuss prostate cancer testing
timeFrame: 2 years post randomization
Secondary outcomes:
measure: State anxiety
timeFrame: baseline and 8 months post-randomization
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Stephen Lepore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lepore SJ, Wolf RL, Basch CE, Godfrey M, McGinty E, Shmukler C, Ullman R, Thomas N, Weinrich S. Informed decision making about prostate cancer testing in predominantly immigrant black men: a randomized controlled trial. Ann Behav Med. 2012 Dec;44(3):320-30. doi: 10.1007/s12160-012-9392-3.
Clinical trial NCT04236375: Eye Movement and Cognitive Dysfunction
Official title: The Development of an Artificial Intelligence Platform for Screening and Referral of Cognitive Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eye Movement Disorder
Cognitive Dysfunction
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 700
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are over 45 years old with or without cognitive dysfunction.

Brief summary: There is association between eye movement disorder and cognitive dysfunction. Therefore, utilizing eye movement and screening for cognitive dysfunction is feasible. In the present study, we will develop an artificial intelligence platform to screening for cognitive dysfunction by inspecting the function of eye movement. Futher more, based on the screening results, the platform will offer referral suggestions.


Eligibility criteria: Inclusion Criteria:

* ①Subjects who are diagnosed as mild cognitive decline, Alzheimer's disease, Vascular dementia, Lewy body dementia, Frontotemporal dementia, other dementia and normal by neurologist.
* ②Subjects who can cooperate with the inspection.
* ③Subjects who agree to participate in the study and sign the consent form

Exclusion Criteria:

* ①Subjects who cannot do the inspection.
* ②Subjects who suffer from diseases that compromise the inspection.

Primary outcomes:
measure: Area under the curve
timeFrame: up to 1 month
Secondary outcomes:
measure: Accuracy, true positive rate, and true negetive rate
timeFrame: up to 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D.,Ph.D
role: STUDY_CHAIR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xun Wang, M.D.,Ph.D
role: STUDY_DIRECTOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Shuyi Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01538875: Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy
Official title: Hydralazine vs. Labetalol for the Management of Hypertensive Crisis in Patients With Hypertensive Disorders of Pregnancy. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension, Pregnancy Induced
Keywords: Hypertension, pregnancy induced
Hydralazine
Labetalol
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 261
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypertensive crisis (defined as a systolic pressure \> 160mmHg or a diastolic pressure \> 110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication with severe and even deadly consequences. The management in this population had been studied, but no consensus has been reached with regards to which treatment is better. Our study will compare two drugs: Hydralazine and Labetalol for the management of hypertensive crisis.


Eligibility criteria: Inclusion Criteria:

* Gestational age \> 24 weeks.
* Hypertensive Crisis (systolic pressure \> 160 mmHg / diastolic pressure \< 110mmHg).

Exclusion Criteria:

* Known allergy to hydralazine.
* Known allergy to labetalol.
* Severe Bradycardia

Primary outcomes:
measure: Control of Hypertensive Crisis
timeFrame: 10 months
Secondary outcomes:
measure: Adverse reactions
timeFrame: 10 months
measure: Number of doses
timeFrame: 10 months
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
References:
Clinical trial NCT02190175: Management of Atrial Fibrillation With Flecainide : the AFFLEC Study
Official title: Multicentre Non Interventional Study in the Management of Atrial Fibrillation With Flecainide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Hellenic Cardiovascular Research Society
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with history of atrial fibrillation who are under treatment with per os flecainide

Brief summary: This is a multicentre non interventional observational study with the objective to follow up patients with atrial fibrillation who based on current indications are treated with per os flecainide , for cardiac pulse maintenance.

Detailed description: the study objectives are

* record safety and efficiency of flecainide as antiarrythmic treatment in atrial fibrillation
* study of flecainide in ST interval

Eligibility criteria: Inclusion Criteria:

* patients with history of atrial fibrillation
* patients able to give informed consent

Exclusion Criteria:

* patients with coronary disease or other cardiopathy with left heart champer affected

Primary outcomes:
measure: ST interval and repolarization measures of myocardia in patients under treatment of flecainide
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Erythros Stavros Hospital
city: Larisa
country: Greece
facility: University Hospital of Larisa
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital
Study officials:
References:
Clinical trial NCT01038375: Tailored Interventions to Improve Hypertension Management After Stroke or Transient Ischemic Attack (TIA)
Official title: Tailored Interventions to Improve Hypertension Management After Stroke or TIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: hypertension
stroke
adherence
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2009-12-23
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clients recruited from Stroke Prevention Clinics in Ontario with diagnosis of Stroke or TIA, Hypertension, and cognitive deficits as indicated by MoCA score \< 26, self-efficacy rating \< 100%, and self-report of missed pills; English speaking; able to give informed consent; older than 18 years of age

Brief summary: The purpose of this study is to determine the effectiveness of interventions to improve adherence to medication and healthier lifestyle choices on blood pressure over a 6 month period in a group of people at high risk for recurrent stroke events. The participants have already had a stroke or TIA, and have uncontrolled blood pressure, as well as problems with memory and problem-solving, or miss taking medications, or who do not believe in the effectiveness of their medications. Interventions focus on motivational interviewing, adherence counseling with memory cuing, and self-monitoring of blood pressure.

Detailed description: * randomized, controlled trial at 4 sites
* measurement of blood pressure, missed pills, self-efficacy rating at baseline and 6 months
* contacting family pharmacists to evaluate prescription renewal patterns at baseline and 6 months

Eligibility criteria: Inclusion Criteria:

* diagnosis of stroke or TIA
* hypertension
* Montreal Cognitive Assessment score less than 26
* self report of missed pills
* self-efficacy rating less than 100%

Exclusion Criteria:

* inability to give informed consent
* 18 years of age or younger

Primary outcomes:
measure: blood pressure
timeFrame: 6 months from baseline testing
Secondary outcomes:
measure: self-efficacy rating
timeFrame: 6 months from baseline
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital, 237 Barton St East
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Centre
state: Ontario
Study officials:
References: