louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00396513: Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.
Official title: Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Statin
Metformin
Testosterone
Menstrual cycle
Lipids
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2006-11-07
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 purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (PCOS).


Eligibility criteria: Inclusion Criteria:

* PCO - ESHRE/ASRM criteria:oligomenorrhea (\<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone \> 70 ng/ml) normal prolactin, TSH, 17-OH progesterone no evidence of androgen producing malignancy, Cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study

Primary outcomes:
measure: Serum testosterone
Secondary outcomes:
measure: regularity of menstrual cycle
measure: serum lutropin
measure: serum follitropin
measure: serum lipids
measure: serum DHEAS
measure: serum SHBG
measure: serum insulin
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics
Study officials:
affiliation: Poznan University of Medical Scienses
name: Leszek Pawelczyk, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Antoni J Duleba, MD
role: STUDY_DIRECTOR
References:
citation: Banaszewska B, Pawelczyk L, Spaczynski RZ, Duleba AJ. Effects of simvastatin and metformin on polycystic ovary syndrome after six months of treatment. J Clin Endocrinol Metab. 2011 Nov;96(11):3493-501. doi: 10.1210/jc.2011-0501. Epub 2011 Aug 24.
citation: Banaszewska B, Pawelczyk L, Spaczynski RZ, Duleba AJ. Comparison of simvastatin and metformin in treatment of polycystic ovary syndrome: prospective randomized trial. J Clin Endocrinol Metab. 2009 Dec;94(12):4938-45. doi: 10.1210/jc.2009-1674. Epub 2009 Nov 4.
Clinical trial NCT01367613: Open-Label Treatment Extension of Protocol MNTX 302
Official title: A Three-Month Open-Label Treatment Extension of Protocol MNTX 302
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Terminal Illness
Keywords: Advanced medical illness
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 to receive SC MNTX.


Eligibility criteria: Inclusion Criteria:

1. Must be enrolled and consented within 28 days of the end of study visit of MNTX 302 and 14 or more days from first dose of study drug in MNTX 302.
2. Negative pregnancy test
3. Stable vital signs

Exclusion Criteria:

1. Women who are pregnant and/or nursing
2. Received any investigational product, other than MNTX, in the past 30 days
3. Evidence of fecal impaction
4. Clinically significant active diverticular disease

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06059313: Premorbid Personality Profile of Patients With Cognitive and Behavioral Disorders
Official title: Relationship Between Premorbid Personality Traits and Cognitive and Behavioral Disorders
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Behavioral Variant of Frontotemporal Disorder (bvFTD)
Phenocopy Frontotemporal Dementia (phFTD)
Frontal Variant of Alzheimer Disease
Bipolar Disorder
Keywords: bvFTD
fvAD
phFTD
bipolar disorder,personality
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted among eligible patients with bvFTD, fvAD, phFTD, followed to Memory Resource and Research Centre at Nantes university Hospital CMRR or referred to the department for a neuropsychological assessment (bipolar disorder). It will prospectively enroll 120 participants.

Brief summary: Damages in frontal area present in neurodegenerative disease (frontotemporal degeneration, frontal variant of Alzheimer disease) and in psychiatric disease (bipolar disorder) can affect behavior and cognition including social cognition. Symptoms vary both quantitatively and qualitatively from disease to another and from person to person. It cannot be completely excluded that in some cases, factors of susceptibility such as premorbid personality traits lead to frontal fragility.

The study will assess the relationship between premorbid profile using NEO-PI 3 inventory and cognitive and behavioral/psychobehavioral manifestations in patients with behavioral variant of frontotemporal disorder (bvFTD), phenocopy frontotemporal dementia (phFTD), frontal variant of Alzheimer disease, bipolar disorder characterized with frontal damages.


Eligibility criteria: Inclusion Criteria :

* Patients with behavioral variant of frontotemporal disorder (bvFTD) according to Rascovsky criteria (2011) or patients with phénocopy frontotemporal dementia (phFTD) who fulfill criteria for possible bvFTD and have no imaging abnormalities or patients with frontal variant of Alzheimer disease according to Ossenkopele criteria (2022), or patient with bipolar disorder according to CIM 10 criteria
* Score for Mini-mental state examination ≥ 18
* Patient with caregiver who has who has known him/her in the 10 years preceding the disease onset.
* Patient and caregiver consents (no opposition)

Exclusion Criteria :

* Patient with no caregiver
* Pregnant or breast feeding women

Primary outcomes:
measure: Premorbid personality traits
timeFrame: Baseline
Secondary outcomes:
measure: Interpersonal Reactivity Index (IRI)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05457413: Impact of Bariatric Surgery on Women Fertility
Official title: Impact of Bariatric Surgery Induced Weight Loss on Women Fertility: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Issues
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 75
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese females undergoing sleeve gastrectomy

Brief summary: Obesity is a multifactorial risk factor for subfertility, in relation to chronic hormonal change induced by adipose tissue. This prospective cohort study aims to evaluate the impact of bariatric surgery induced weight loss on women fertility.

Detailed description: Females undergoing sleeve gastrectomy will be assessed for improvement of fertility indicators

Eligibility criteria: Inclusion Criteria:

* Age from 20-40 years.
* BMI \>35 kg/m2

Exclusion Criteria:

* Women with medical endocrinal disorders as DM, thyroid, hyperprolactinaemia, etc.
* Women using any hormonal treatment or fertility drugs like oral contraceptive pills and/or metformin.
* Women have any surgical complication intra-operatively or post operatively.
* Women refused to participate in the study.

Primary outcomes:
measure: Change in Antimullerian hormone level
timeFrame: 3 months
Secondary outcomes:
measure: Change in serum FSH level
timeFrame: 3 months
measure: Change in serum LH level
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
state: Cairo/القاهرة
Study officials:
affiliation: Associate professor
name: Maii Nawara
role: STUDY_DIRECTOR
References:
Clinical trial NCT00717613: Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting
Official title: Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Localized Prostate Cancer
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2008-07-17
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience sample of men on active surveillance drawn from large academic medical centers, community hospitals, support groups, and the internet.

Brief summary: This study includes an interview with men who have selected "watchful waiting" or "active surveillance" for their localized prostate cancer, in lieu of active treatment (such as surgery or radiation). We hope to understand the educational and support needs of men on surveillance so that we can develop a new intervention that will improve quality of life for such men.

Detailed description: Interviews are conducted over the telephone and require approximately 90 minutes to complete. Men interviewed are compensated for their participation in the study.

Eligibility criteria: Inclusion Criteria:

* 1) male,
* 2) 18 years or older, with biopsy-proven prostate cancer,
* 3) diagnosed with localized disease within the last 24 months,
* 4) have a telephone at the time of enrollment,
* 5) have an address where they can receive study materials by mail (a street address or post office box),
* 6) able to speak and understand English;
* 7) have selected surveillance, rather than active treatment for his prostate cancer.

Exclusion Criteria:

* 1) female
* 2) no diagnosis of localized prostate cancer
* 3) completed or undergoing active treatment (e.g., surgery, radiotherapy, etc.)
* 4) no phone or US mail address
* 5) unwilling or unable to provide informed consent
* 6) unable to speak and understand English

Primary outcomes:
measure: Health-related quality of life, particularly cancer-specific anxiety and general anxiety
timeFrame: One time retrospective interview
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: David M Latini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01472913: Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty With Focus on Blood Loss, Pain, Swelling and Strength
Official title: Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty. A Prospective Randomised Double-blinded Study Focus in on: Blood Loss, Pain, ROM, Swelling and Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss
Keywords: Prospective randomised double-blind study
Fibrin sealant
Bilateral simultaneous total knee arthroplasty
Blood loss
Postoperative pain
Complications
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 48
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 purpose of this study is to measure the effect of fibrin sealant on reducing blood loss, pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on Range Of Movement (ROM) and strength is examined.


Eligibility criteria: Inclusion Criteria:

* Elective bilateral knee arthroplasty
* Must speak and understand Danish
* Musk be able to gave oral and written consent.
* Females must be post-menopausal, and last menstruation must be minimum of one year ago.

Exclusion Criteria:

* Alcohol or medicine abuse
* Treatment with opioids
* Allergy to local anaesthetics
* Allergy to active substances i fibrin sealant
* Age below 18

Primary outcomes:
measure: Blood loss
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Pain
timeFrame: 2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day.
measure: swelling
timeFrame: 2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day
measure: Range of Movement (ROM)
timeFrame: 2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day
measure: Strength
timeFrame: 2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Christian Skovgaard Nielsen, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Henrik Husted, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04780113: Evolution of Perceived Stress in General Practice Residents During COVID-19 Sanitary Crisis
Official title: Evaluation of Evolution of Perceived Stress in General Practice Residents of Rouen and Caen During COVID-19 Sanitary Crisis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Lead sponsor: Centre Hospitalier Eure-Seine
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants being general practice residents in Caen or Rouen

Brief summary: Over the last several years, distress among healthcare professionals is well described, and general practice residents are also affected. Because of COVID-19 sanitary crisis, stress factors are increased, and that may cause anxiety, exhaustion, psychic distress, depression, addictions, or post traumatic stress.

Detailed description: This prospective non-interventional study aims to evaluate via two questionnaires the evolution of perceived stress in general practice residents of two centres in France, Rouen and Caen. The two questionnaires contain the Perceived Stress Scale, as well as items regarding socio-demographic data and stress factors. The first questionnaire is to be distributed during the epidemic COVID-19 wave and the second questionnaire at the end of the epidemic COVID-19 wave.

Eligibility criteria: Inclusion Criteria:

* Being a general practice resident in Rouen or Caen
* Participant informed and non-objection of him/her

Exclusion Criteria:

* Being on maternity leave or not working during the period concerned with the questionnaires

Primary outcomes:
measure: Evolution of perceived stress during the epidemic wave of COVID19 vs. at the end of the epidemic wave of COVID19
timeFrame: maximum 6 months, according to the evolution of the epidemic
Secondary outcomes:
measure: Description of general characteristics of residents and their feelings and experiences with the sanitary crisis
timeFrame: maximum 6 months, according to the evolution of the epidemic
measure: Assessment of residents' profile stress according to their socio-demographic and working characteristics
timeFrame: maximum 6 months, according to the evolution of the epidemic
Other outcomes:
Locations:
city: Évreux
country: France
facility: CH Eure-Seine
Study officials:
affiliation: General Practice Physician
name: Ségolène Guillemette, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02377713: A Single Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: KHK6640
Phase 1
Japanese
single dose
Alzheimer's disease
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 84
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 safety, tolerability and pharmacokinetics of KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's Disease.


Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate Alzheimer's Disease
* Body weight ≥ 40 kg and \< 100 kg
* Clinical Dementia Rating (CDR) score of 1 or 2
* Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26

Exclusion Criteria:

* Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study
* Use of another investigational drug within 4 months prior to the enrollment
* Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
* Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
* Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's Disease
* Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's Disease

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
state: Sumida-ku
Study officials:
References:
Clinical trial NCT01618513: Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target
Official title: Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Keywords: Acromegaly
Somatostatin analogs
Treatment
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Odense University Hospital
name: Herlev Hospital
name: Copenhagen University Hospital, Denmark
name: Aalborg University Hospital
First posted: 2012-06-13
Enrollment: 84
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: Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily used after insufficient surgical intervention, but also as primary medical treatment in selected patients. Evaluation of treatment control is based on monitoring blood levels of growth hormone (GH) and insulin-like growth factor-I (IGF-I). However, evaluation of disease control during SA treatment is not always straightforward. It is usually based on normalization of IGF-I and achievement of a certain GH level. In approximately 40% of patients discordant values of GH and IGF-I levels are seen after treatment with SA, with normalized IGF-I levels, despite elevated GH levels. The mechanism behind this observation is unknown, but it indicates that SA may affect this difference.

The primary objective of this study is to investigate if disease control during SA treatment is best achieved by monitoring either GH or IGF-I.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Capable and of age
* Diagnosed with acromegaly
* Sufficient treated for at least 6 months prior to enrollment

Exclusion Criteria:

* Pregnancy or nursing
* Any disease that may compromise the ability to comply with the protocol, as assessed by the investigator

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline and after 12 months
Secondary outcomes:
measure: SA dosage
timeFrame: After 12 months of treatment
measure: Change in glucose, FFA and insulin
timeFrame: Baseline and after 12 months
measure: Change in discordant GH/IGF-I levels
timeFrame: Baseline and after 12 months
measure: New biomarkers of treatment evaluation
timeFrame: Baseline and after 12 months
measure: New biomarkers of treatment evaluation2
timeFrame: Baseline and after 12 months
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Jens Otto L. Jørgensen, Professor
role: STUDY_CHAIR
References: