linjc16/ctgov huggingface dataset:
The Association of Ferrtin and Homocysteine Etc. With RI and MS in Polycystic Ovary Syndrome (PCOS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the association of serum ferritin and homocysteine levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women with reproductive age. Insulin resistance and metabolic disturbance are well-known long-term consequence of women with PCOS. Recent evidence suggests that increased body iron might be involved in the pathogenesis of insulin-resistance disorders, furthermore, hyperhomocysteinemia is associated with an increased risk of atherosclerotic and thromboembolic disorder. The investigators plan to retrospectively review the medical records of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.

Official Title
-----------------
To Association of Serum Ferrtin and Homocysteine Levels With Insulin Resistence and Metabolic Syndrome in Women With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011. Exclusion Criteria: women who had been diagnosed with disorders of the uterus (e.g., Asherman's Syndrome, Mullerian agenesis), and chromosomal anomalies (e.g., Turner syndrome) women who had menopause women with inadequate clinical/biochemical records women who had had ovarian cysts or ovarian tumors women who took hormone, medicine for Diabetes and/or cardiovascular disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese women<br>BMI>25 | |
| Non obese women<br>BMI<25 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ferritin levels in obese and non-obese women. | The pathogenesis of increased iron stores correlated with insulin resistance and metabolic syndrome among obese and non-obese premenopausal women was different. The hypertriglyceridemia in women with PCOS might be associated with iron metabolism. | the patients have PCOS who visited the Reproductive Endocrinology Clinic at the WanFang Medical Center from Jan 1, 2008 to Nov 30, 2011. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, Ferritin, Homocysteine, Insulin Resistance, Metabolic Syndrome
Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

Study Overview
=================
Brief Summary
-----------------
To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.

Official Title
-----------------
12-month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA

Conditions
-----------------
Sexual Dysfunctions, Psychological

Intervention / Treatment
-----------------
* Drug: Flibanserin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women over 18 and pre-menopausal FSDS-R above 14 Willingness to try to have sexual activity at least monthly Willingness to use an electronic diary daily Stable, monogamous, heterosexual relationship for at least one year Medically acceptable method of contraception Exclusion Criteria: Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial Specified medications Sexual function affected by medication Drug dependence or abuse Sexual partner needing treatment Peri-Menopause or Menopause (surgical or otherwise) Pregnancy Pelvic Inflammatory Disease Major depressive Episode Significant ECG abnormalities Significant Neurologic findings Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings Uncorrected thyroid or endocrine disease Uncontrolled Glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Flibanserin|flibanserin flexible dosing|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of efficacy of flibanserin in Sexually Satisfying Events |  | 24 weeks |
Characterization of the Mechanisms of Resistance to Azacitidine

Study Overview
=================
Brief Summary
-----------------
Myelodysplastic syndromes (MDS) are frequent diseases in elderly patients (median age: 71 years). IPSS classification defines low risk (Low and Intermediate 1), and high risk (Intermediate 2 and High) MDS. High-risk MDS (MDS-HR) have a high risk of transformation into acute leukemia with multilineage dysplasia (AML-DML). The success of Azacitidine has been mainly achieved through a rigorous empirical and clinical research, but the molecular mechanisms by which this molecule exerts its effects remain poorly characterized. The primary mode of action of Azacytidine is through DNA demethylation, and integration in to mRNA that favor traduction inhibition. The impact of this molecule on various cell death programs involved in the elimination of leukemic cells : apoptosis and autophagy is currently poorly known. The research program and clinical studies we proposed focus on two major aspects: - Main objective: Molecular mechanism of action and resistance to Azacitidine: Role of apoptosis versus autophagy. - Secondary Objective: Reversion of Azacytidine resistance using different drugs targeting apoptosis and/or autophagy. Our laboratory has identified new molecules to selectively induce different types of cell death (apoptosis or autophagy).

Official Title
-----------------
Characterization of the Mechanisms of Action of Resistance to Azacitidine in High-risk Myelodysplastic Syndromes and Acute Myeloid Leukemia With Multilineage Dysplasia

Conditions
-----------------
Myelodysplastic Syndromes or Acute Myeloid Leukemia With Multilineage Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years High Risk or Intermediate 2 MDS (IPSS) AML-MD (WHO classification) Treatment with minimum three to six cycles of Azacitidine Informed consent form signed Exclusion Criteria: Treatment with others chemotherapies alone or in association

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematological response | Hematological response evaluated by the International Working Group (IWG) response of Cheson | at 3 months | 
| hematological response | Hematological response evaluated by the International Working Group (IWG) response of Cheson | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival (OS) defined as the time from start of treatment | Day 1 of treatment | 
| Overall survival | Overall survival (OS) defined as the time from start of treatment | at the death |
Comparison Between Calculated Bioavailable Testosterone Level With Radio-immunoassay Result.

Study Overview
=================
Brief Summary
-----------------
Currently, the gold standard to obtain bioavailable testosterone results is radioimmunoassay (RIA). However, this assay requires specific equipment. Giton in 2006 proposed an optimized calculation of the Vermeulen equation, the results of which seem to be well correlated with those obtained by RIA. The aim of this study is to determine if the bioavailable testosterone levels determined by both methods are similar in order to replace the usual RIA assay of bioavailable testosterone by this calculation.

Official Title
-----------------
Comparison Between Calculated Bioavailable Testosterone Level With Radio-immunoassay Result.

Conditions
-----------------
Testosterone, Androgens

Intervention / Treatment
-----------------
* Biological: Blood withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every men and women aged between 18 and 90 can be included Exclusion Criteria: insufficient sample sample not send for RIA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Blood withdrawal|Blood withdrawal in order to perform a bioavailable testosterone RIA (Radio-Immuno Assay).|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between RIA and calculated testosterone level | Concordance between RIA and calculated testosterone level | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
testosterone, androgens, men, women
Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the efficacy of octreotide, a somatostatin octapeptide analog, in decreasing gastrointestinal bleeding in patients with hormone-refractory hereditary hemorrhagic telangiectasia or senile ectasia.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of octreotide twice a day. The dose is adjusted based on response. If there is no requirement for transfusions or intravenous iron for 4 weeks and the hemoglobin is greater than 10 mg/dL, therapy is continued for 1 year. If there is no decrease in bleeding after 10 weeks, the patient is removed from study.

Conditions
-----------------
Hereditary Hemorrhagic Telangiectasia, Ectasia

Intervention / Treatment
-----------------
* Drug: octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Hereditary hemorrhagic telangiectasia or senile ectasia Refractory to or unable to tolerate hormonal therapy, i.e.: Estrogen Progesterone Danazol Gastrointestinal (GI) hemorrhage requiring transfusion within past 3 months Recurrent GI bleeding over more than 1 year At least 4 units packed RBCs transfused within past year OR intravenous iron required more than 4 times within past year No other likely source of hemorrhage determined within past year --Prior/Concurrent Therapy-- Disease hormone-refractory --Patient Characteristics-- No octreotide sensitivity

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: octreotide|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetic diseases and dysmorphic syndromes, hematologic disorders, hereditary hemorrhagic telangiectasia, rare disease, senile ectasia
Impact of Graft Thickness on Visual Gain After Descemet's Stripping Automated Endothelial Keratoplasty

Study Overview
=================
Brief Summary
-----------------
The aim of this study to determinate if there is a correlation between visual acuity gain in patients who underwent a Descemet's stripping automated endothelial keratoplasty (DSAEK) corneal keratoplasty and the central thickness of the graft.

Detailed Description
-----------------
Were included in this study eyes who underwent a DSAEK for endothelial dysfunctions indication (mainly acquired after phacoemulsification or for Fuchs dystrophy) between early 2012 and mid 2015 at CHR Metz-Thionville (Mercy Hospital) Were excluded eyes presenting pathologies (e.g. Age-Related Macular Degeneration, or diabetic macular edema) which are known to induce visual acuity decrease, non-related to the success of the graft and graft failure cases. Central graft thickness was measured in Anterior Segment Optical Coherence Topography (AS-OCT RS-3000 Nidek). Visual acuity gain was defined by the differential between pre-operative visual acuity (VA) and post operative best corrected visual acuity (BCVA) obtained during post-operative visits.

Conditions
-----------------
DSAEK Patient

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with endothelial dysfunctions indication Exclusion Criteria: - eyes presenting pathologies (e.g. Age-Related Macular Degeneration, or diabetic macular edema) which are known to induce visual acuity decrease, non-related to the success of the graft and graft failure cases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity gain after DSAEK lamellar keratoplasty |  | 1 year |
Risk Factors of Porphyria Cutanea Tarda (PCT)

Study Overview
=================
Brief Summary
-----------------
Comparison of patients with documented PCT and HCV infection, documented PCT without HCV, HCV infection without PCT and controls without HCV or PCT. Single blood + urine sample uptake to investigate : mutations in HFE gene, uroporphyrinogen decarboxylase activity, HCV genotye, history of disease.

Official Title
-----------------
Factors Associated With Porphyria Cutanea Tarda in Patients Infected With Hepatitis C Virus

Conditions
-----------------
Porphyria Cutanea Tarda

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Porphyria cutanea tarda /HCV negative Porphyria cutanea tarda/ HCV positive HCV positive HCV negative controls
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Porphyria cutanea tarda, hepatitis C, hemochromatosis
A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Official Title
-----------------
An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis.

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: ibandronate [Bonviva/Boniva]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post-menopausal women with osteoporosis; <=80 years of age; naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for >1 year. Exclusion Criteria: metabolic bone disease other than post-menopausal osteoporosis; treatment with other drugs affecting bone metabolism within last 6 months; previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).

Ages Eligible for Study
-----------------
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ibandronate [Bonviva/Boniva]|3mg iv every 3 months|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).

Official Title
-----------------
Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104

Conditions
-----------------
Progressive Supranuclear Palsy (PSP)

Intervention / Treatment
-----------------
* Drug: ABBV-8E12


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject completed Study C2N-8E12-WW-104 (NCT02494024) Subject was not eligible to enroll in Study M15-562 (NCT02985879) Exclusion Criteria: Subject weighs less than 35 kg at screening Subject has any contraindication or inability to tolerate brain MRI Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBV-8E12<br>ABBV-8E12 administered by intravenous (IV) infusion. | Drug: ABBV-8E12<br>* Solution for infusion<br>* Other names: Tilavonemab;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose. | From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months) |
Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.

Official Title
-----------------
Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie

Conditions
-----------------
Dystonia

Intervention / Treatment
-----------------
* Device: Deep brain stimulation of the internal globus pallidus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of idiopathic multifocal, segmental or generalised dystonia duration of disease > 5 years age between 14 and 75 years relevant disability in activities of daily living despite optimal drug treatment informed consent signed by the patient For adolescents between 14 and 18 years: an additional informed consent signed by a legal guardian is necessary Exclusion Criteria: Mattis-Score < 120 BDI > 25 previous stereotactic brain surgery severe brain atrophy increased bleeding risk immunosuppression and increased risk of infection relevant cerebrovascular disease psychiatric disorders, which might interfere with the cooperation in the study other contraindications for surgery

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Deep brain stimulation of the internal globus pallidus|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep brain stimulation, internal globus pallidus, dystonia
Double-Blind Study of Miglitol in Japanese With type2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of miglitol in Japanese patients with type 2 diabetes that is insufficiently controlled diet alone.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: miglitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type2 diabetic patient on Dietary Therapy Criteria for postprandial plasma glucose and HbA1c are met Exclusion Criteria: Type1 diabetes Patients treated with antidiabetic drugs or Insulin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: miglitol|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alpa-glucosidase inhibitor