linjc16/ctgov huggingface dataset:
Management of Robertsonian Translocation PGT-SR Attempts

Study Overview
=================
Brief Summary
-----------------
to analyze if a probe strategy choice for PGT-SR studies of Robertsonian translocations (RT) influences the fate of embryos? Few studies discussed the importance of probe choices. However, those who did, demonstrated that analysis with locus specific probes improve a diagnosis of dubious results, and addition of a centromeric probe could affect the accuracy of diagnosis

Official Title
-----------------
New Recommendations for Robertsonian Translocation Management After Preimplantation Genetic Testing of Structural Rearrangement (PGT-SR) Attempts: What Should be Done With Mosaic Embryos?

Conditions
-----------------
Robertsonian Translocation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient whom carrying robertsonian translocations in the context of PGT-SR management age > 18 years Exclusion criteria: - age < 18 years

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

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

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 |
| --- | --- | --- |
| Number of Participants with detect all chromosome segments | Number of Participants with detect all chromosome segments | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Several years of miscarriages, Abortions and primary infertility, FISH with 2 probes, FISH with 3 probes
Combination Iron Chelation Therapy

Study Overview
=================
Brief Summary
-----------------
Patients with beta-thalassemia (Cooley's Anemia) continue to suffer from the transfusion-induced iron overload due to the inadequacies of current iron-chelation therapy. Compliance with the use of the only FDA-approved drug for removing excess iron from patients (Desferal) continues to be a major problem despite convincing evidence that it markedly reduces morbidity and prolongs life. The full potential of iron-chelation therapy will not be realized until an orally-effective drug is available. This small trial is testing the premise that a combination of drugs as a new approach to iron chelation therapy may reduce side effects and increase efficacy. If both drugs can be given orally, there may be a better chance of finding a suitable alternative to Desferal. Several combinations of experimental iron chelating drugs are being used in this trial.

Conditions
-----------------
Iron Overload, Thalassemia

Intervention / Treatment
-----------------
* Drug: Combination Iron Chelation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Iron overload Exclusion Criteria: Overt cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Combination Iron Chelation Therapy|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
-----------------
thalassemia, chelation therapy, combination chemotherapy, iron poisoning, chelating agent, deferoxamine, drug screening /evaluation, therapy evaluation
Molecular, Genetic, and Genomic Assessments From Patients Treated With RAD001

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the genetic changes that RAD001 causes in prostate cancer cells and how those changes relate to patients' response to RAD001 treatment.

Detailed Description
-----------------
This correlative science study will be a minimum risk assessment of tumor and plasma samples collected as part of a Phase II clinical trial of RAD001 in patients with HRPC. Prior to enrollment or at the time of signing consent in the Phase II trial, patients will be approached to participate in the correlative science study. Patients who agree to participate will be assigned a separate study number which will be used to identify their molecular, genetic, genomic and biomarker assessments using the tumor and plasma samples. Clinical outcome results from the accompanying Phase II trial will be used for correlative assessments in this study, however, results from this correlative science study will be kept separate from the assessments and reporting of the clinical trial.

Official Title
-----------------
Molecular, Genetic, and Genomic Assessments of MTOR Inhibition in Metastatic Hormone-Refractory Prostate Cancer Tissue From Patients Treated With RAD001

Conditions
-----------------
Metastatic Hormone Refractory Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be enrolled in the clinical study entitled: A Single Arm, Phase II Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer at the time of enrollment onto this study.

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001. |  | pre-treatment, day 29, and monthly blood samples | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine by comparative genomic hybridation (CGH) loss of heterozygosity (LOH) patterns of the 10q23 locus (to assess PTEN status) and other sites of chromosomal alterations associated with pathologic response to mTOR inhibition. |  | pre-treatment, day 19, and monthly blood samples | 
| To identify expression profiles associated with AKT activation and RAD001 treatment effect. |  | pre-treatment, day 29, and monthly blood samples | 
| To identify candidate plasma markers of glycolysis that reflect tumor AKT activity. |  | pre-treatment, day 29, and monthly blood samples |
An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.

Official Title
-----------------
F-ACT Trial: Observational Study on Fatigue and Its Evolution During Treatment With Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis in Daily Clinical Practice

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Moderate to severe active rheumatoid arthritis, defined as DAS28 >/= 3.7 Inadequate clinical response to current treatment with >/= 2 non-biologic DMARDs, 1 of them being methotrexate optimally administered for >/= 3 months, or inadequate clinical response to anti-TNF therapy Eligible for RoActemra/Actemra treatment in daily clinical practice Absence of evolutive tuberculosis (TB) Exclusion Criteria: Hypersensitivity to tocilizumab or any of the excipients Active, severe infections Pregnant or lactating women Participation in any other interventional study Patients with major depression

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16 |  | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue |  | 16 months | 
| Disease Activity Score DAS28 |  | 16 months | 
| Pain: Visual Analogue Scale VAS Pain |  | 16 months | 
| Functional disability: Health Assessment Questionnaire HAQ |  | 16 months | 
| Quality of sleep: VAS |  | 16 months | 
| Anemia: Haemoglobin levels |  | 16 months | 
| Depression: Beck Depression Inventory (BDI) questionnaire |  | 16 months |
Vitreous Detachment and Glaucoma Progression

Study Overview
=================
Brief Summary
-----------------
Posterior vitreous detachment is a common event. With optical coherence tomography, the investigators can precisely follow the stage of posterior vitrous detachment. In this study, the investigators investigate if the loss of contact between the vitreous and the fovea is the start of glaucoma progression.

Official Title
-----------------
Rate of Visual Field Progression Before and After Posterior Vitreous Detachment

Conditions
-----------------
Glaucoma, Posterior Vitreous Detachment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient with glaucoma at least 4 years of follow up at least 6 visual fields at least 4 optical coherence tomographies Exclusion criteria: pars plana vitrectomy others ophtalmological or neurological disease which can modify visual fields

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with posterior vitreous detachment<br>patient with stage 3 or more of posterior vitreous detachment on optical coherence tomography | |
| without posterior vitreous detachment<br>patient with stage 2 or less of posterior vitreous detachment on optical coherence tomography | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glaucoma progression | glaucoma progression based on analysis of visual fields | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RNFL decr | slope of decrease | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Vitreous, Progression
The Effect of Cold Application to the Sacral Area on Labor Comfort:

Study Overview
=================
Brief Summary
-----------------
Purpose: Cold application is considered as an effective alternative treatment for labor comfort because of its low side effects and easy availability. This study aims to determine the effect of cold application to the sacral area in the transition phase of labor on labor comfort. Materials and methods: The study was done as a randomised controlled experimental study. While the women in the experimental group received cold application for 10 minutes every 20 minutes after 8 cm of cervical dilatation, the women in control group received routine care protocol of the unit.

Official Title
-----------------
The Effect of Cold Application to the Sacral Area in the Transition Phase of Labor on Labor Comfort:

Conditions
-----------------
Birth

Intervention / Treatment
-----------------
* Other: cold application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria were having a full-term pregnancy (pregnancies between 37th and 42nd weeks), having a single fetus, having a cephalic presentation, fetal weight of 2,5- 4 kg, pregnant women's having normal body mass index and receiving no antenatal trainings, having an 8 cm cervical dilation. Exclusion Criteria: The women who had any kind of pregnancy complications (placenta previa, preeclampsia, premature rupture of membranes, oligohydramnios and polyhydramnios, presentation disorder, intrauterine growth retardation, intrauterine dead fetus, macrosomia babies, fetal distress, etc.), who had any systemic or neurologic diseases contraction anomalies (hypotonic or hypertonic contractions), who had induced labor, who received narcotic analgesics, who had occiput posterior, who were in the latent and active phases of labor, who had irregular contractions were excluded from the study
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold Application to the Sacral Area<br> | Other: cold application<br>* cold application<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cold Application to the Sacral Area on Labor Comfort | Cold Application to the Sacral Area on Labor Comfort | through study completion, an average of 1 year |
Contrast Sensitivity and Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be modified by different pathologies or by age. The purpose of this study is to identify the changes that could be in relationship with the course of diabetic retinopathy comparing with diabetic patient without retinopathy and in patients with diabetic macular edema so if it is a difference, research for therapeutic strategies to improve it in this patients.

Detailed Description
-----------------
Contrast sensitivity is defined as a subjective measurement, it is the ability to separate the image between figure and background, taking into account the minimum amount of light required; it is evaluated by the contrast threshold, which is the smallest amount of contrast needed to be able to see a target and solve their characteristics, would be his reciprocal value. Medina et al. curve reported in healthy Mexicans SC 5 to 80, where > 51 years have decreased compared to contrast sensitivity studies international; further that contrast sensitivity in older groups of 41 years is decreased high frequency.

Official Title
-----------------
Contrast Sensitivity and Diabetic Macular Edema

Conditions
-----------------
MACULAR EDEMA, DIABETES MELLITUS, DIABETIC RETINOPATHY

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DIABETIC PATIENTS 40-60 YEARS OLD ANY GENDER VISUAL ACUITY >0.25 IN DECIMAL EQUIVALENT, Exclusion Criteria: PATIENTS WITH CATARACTS OR OTHER MACULOPATHY PATIENTS WITH CONTACT LENSES PATIENTS WITH REFRACTIVE ERROR >6.00DP PATIENTS WITH PREVIOUS OCULAR SURGERY

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Contrast Sensitivity<br>Determine changes in contrast sensitivity frequences and visual function (visual acuity) after one month of treatment photocoagulation in macular edema | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast Sensitivity | Diabetic patients who are attended at Ophthalmology service in a general hospital undergo to contrast sensitivity test evaluating all frequency by software with 5 spacial frequency (1.5, 3, 6, 12 and 18 cycle grade, Stereoptical Co 1996) in the Visual Basic program. | up to 8 months |
Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical trial is to compare the efficacy of DMMET-01 versus metformin hydrocloride on metabolic control in mexican type 2 diabetes patients without prior pharmacological treatment.

Official Title
-----------------
Randomized, Double-Blind, Efficacy and Safety, Controlled Study, Between DMMET-01 and Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetics Patients.

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

Intervention / Treatment
-----------------
* Drug: DMMET-01
* Drug: Metformin Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages eligible for study: 40 to 60 years With type 2 diabetes evolution < 5 years without pharmacological treatment 1 month prior to the screening Fasting glucose = 130-200 mg/dL HbA1c of 7% to 9% Blood pressure < 140/80 mmHg Ability to communicate and meet the requirements of the study Signed Written Informed Consent before to conducting any study Body mass index (BMI) of 25 kg/m2 to 35 Kg/m2 Exclusion Criteria: Suspected or confirmed pregnancy Nursing Inability to secure the non-pregnant during the study duration Hypersensitivity to any biguanides Use of an investigational drug within 30 days prior to the screening Liver failure, heart failure, kidney failure or thyroid disease Periods of acute or chronic diarrhea or vomiting Chronic hepatic disease Total Cholesterol >300 mg/dL Triglycerides >400 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Drug<br>DMMET-01 + Diet | Drug: DMMET-01<br>* 90 days: 15 days daily dose 1050.6 mg (before dinner)+75 days dose twice a day 1050.6 mg (before breakfast) 1050.6 mg (before dinner).<br>|
| Active Comparator: Metformin<br>Metformin + Diet | Drug: Metformin Hydrochloride<br>* 90 days: 15 days daily dose 850 mg (before dinner)+ 75 days dose twice a day 850 mg (before breakfast) 850 mg (before dinner)<br>* Other names: Comparator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Control (Fasting glucose, postprandial glucose, HbA1C) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Profile (Total cholesterol, HDL, LDL, triglycerides) |  | 3 months | 
| Adverse Events |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, monotherapy, antidiabetics, metformin
Phenotypic Expressions in a French Pseudoxanthoma-Elasticum Cohort

Study Overview
=================
Brief Summary
-----------------
The cohort is intended to study the phenotypic expressions of the pseudoxanthoma elasticum (PXE) disease in various tissues (eye, skin, arteries, etc).

Detailed Description
-----------------
This national french cohort is intended to improve our knowledge on the PXE disease. The study of phenotypic expression of the diseases is focused on cutaneous, opthalmologic and vascular tissues. All investigations are included in a yearly follow-up for these patients and collected in a database. Plasma are also collected for all patients and stored in our clinical research biological center in Angers, including genetic (DNA) material extracted from diagnostic skin biopsy. French Ministry of Teaching and Research Authorisation number for the PXE collection is AC 2008 871. Declarative number is DC 2008 870.

Official Title
-----------------
Phenotypic Expressions in a French Pseudoxanthoma-Elasticum Cohort

Conditions
-----------------
Pseudoxanthoma Elasticum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PXE disease Informed consent obtained Patient affiliated to Health care system (french social security) Exclusion Criteria: No informed consent No affiliation to a Health care system
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pseudoxanthoma elasticum<br> | |

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

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