linjc16/ctgov huggingface dataset:
Surgical Outcomes for Proliferative Diabetic Retinopathy by Preoperative Glycemic Control and Renal Function

Study Overview
=================
Brief Summary
-----------------
The surgical outcomes of 25-gauge vitrectomy for proliferative diabetic retinopathy has been evaluated by preoperative glycemic control and renal function

Detailed Description
-----------------
The purpose of this study is to evaluate the surgical outcomes of 25-gauge vitrectomy for proliferative diabetic retinopathy by preoperative glycemic control and renal function.

Official Title
-----------------
Evaluation of 25-gauge Vitrectomy Surgical Outcomes for Proliferative Diabetic Retinopathy by Preoperative Glycemic Control and Renal Function

Conditions
-----------------
Proliferative Diabetic Retinopathy

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients had25-gauge vitrectomy for proliferative diabetic retinopathy Exclusion Criteria: The patients had hemodialysis , followed up less than 6 months, had vitrectomy for diabetic macular edema and macular ration but not macular detachment.

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- |
|Procedure: Vitrectomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity measurement | Visual acuity improvement from baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of postoperative vitreous hemorrhage | Incidence of postoperative vitreous hemorrhage | 6 months |
Amphotericin B Treatment in Visceral Leishmaniasis

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.

Detailed Description
-----------------
This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.

Official Title
-----------------
Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis

Conditions
-----------------
Visceral Leishmaniasis

Intervention / Treatment
-----------------
* Drug: Amphotericin B deoxycholate given as daily administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parasitologically proved kala-azar Exclusion Criteria: HIV positive serology

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amphotericin B deoxycholate given as daily administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final cure rate at six months after the end of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
visceral leishmaniasis, amphotericin B, Kala-azar
Splanchnic and Systemic VLDL-TG and FFA Balance

Study Overview
=================
Brief Summary
-----------------
To determine differences between NAFLD and NASH subjects with respect to hepatic FA metabolism (uptake, oxidation, and re-esterification) and hepatic VLDL-TG secretion and peripheral kinetics (oxidation and tissue storage). 8 non-diabetic upper-body obese subjects with NAFLD and 8 with NASH (biopsy proven) will be studied in the overnight fasted state. VLDL-TG stable isotope will be used in combination with hepatic vein catherization to directly measure splanchnic VLDL-TG uptake and secretion. FFA (palmitate) tracers as well as adipose tissue and skeletal muscle biopsies will be used to measure whole-body substrate turnover and flexibility as well as tissue specific substrate handling during fasting and hyperinsulinemic conditions.

Official Title
-----------------
Splanchnic and Systemic VLDL-TG and FFA Balance in Individuals With NAFL and NASH

Conditions
-----------------
NAFLD, NASH - Nonalcoholic Steatohepatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI > 28). 8 obese subject men with NASH (MR spectroskopi, fibro scanner) (BMI > 28). age between 40-70 years. Written consent before the start of the study. Exclusion Criteria: known current disease fixed medical drug consumption except antihypertensive drugs and statins. However, pause statins 3 weeks before the examination date Blood donation within the last 3 months prior to the study Participation in experiments involving radioactive isotopes within the last 3 months Alcohol abuse (over 21 items per week for men and 14 for women) Smoking Weight over 130 kg Cancer patients Large intake of medication

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Splanchnic and systemic VLDL-TG and FFA balance in individuals with biopsy proven NAFL or NASH | splanchnic (liver) VLDL-TG and FFA uptake and secretion, in individuals with biopsy proven NAFL or NASH | 2 years |
Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT

Study Overview
=================
Brief Summary
-----------------
Acute myeloid leukemia (AML) is a genetically heterogeneous disease and allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment option for AML except for AML-M3. Relapse remains the major cause of treatment failure after allo-HSCT. Molecular residual disease has been shown to be a strong risk factor for relapse after HSCT. In this study, the investigators will detect mutations before/after allo-HSCT by using next-generation sequencing (NGS) technique to measure residual disease and evaluate the prognostic impact of molecular residual disease in a cohort of AML participants receiving allo-HSCT.

Official Title
-----------------
A Study of Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or old; Clinical diagnosis of acute myeloid leukemia (AML); Availabe records of MICM and NGS results at diagnosis; Be going to receive allo-HSCT. Exclusion Criteria: Active malignancy; Pregnant or breast feeding women.

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 |
| --- | --- | --- |
| 1-year relapse rate after allo-HSCT | 1-year relapse rate after allo-HSCT | 1 year after allo-HSCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year recurrence-free survival (RFS) | 1-year recurrence-free survival for AML participants | 1 year after allo-HSCT | 
| 1-year overall survival (OS) | 1-year overall survival (OS) for AML participants | 1 year after allo-HSCT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
next generation sequencing, Acute Myeloid Leukemia, Hematopoietic Stem Cell Transplantation
Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

Study Overview
=================
Brief Summary
-----------------
The Purposes of this Study are to determine: The safety of duloxetine and any side effects that might be associated with it. Whether duloxetine can help patients with major depression. It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed. Duloxetine might not have any good effects for you.

Official Title
-----------------
Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You must be at least 18 years old. You must be diagnosed with major depressive disorder You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks. Exclusion Criteria: You are a woman and are pregnant or breastfeeding. You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder. You have a history of alcohol or drug dependence or abuse within the past 6 months. You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once. You have a serious medical illness.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine|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
-----------------
Sad, blue, lack of energy, depressed, hopelessness, guilt
Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients. However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse. Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.

Detailed Description
-----------------
Aims of the study were : to assess the overall efficacy of rituximab in a cohort of unselected patients with hairy-cell leukemia to identify factors associated to treatment response, to duration of treatment response and to patient survival in a cohort of unselected patients with hairy-cell leukemia

Official Title
-----------------
Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

Conditions
-----------------
Hairy-cell Leukemia

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with hairy-cell leukemia diagnosed between July 2002 and September 2012 patients had received at least 3 subsequent injections of rituximab aged > 18 years

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 |
| --- | --- |
| hairy-cell leukemia<br>Patients with hairy-cell leukemia. | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete hematologic response to rituximab therapy | Complete hematologic response was defined as the recovery of normal blood counts (absolute neutrophil count ≥ 1.5x109/L, platelet count ≥ 100x109/L and hemoglobin level ≥ 120g/L for men and ≥ 110g/L for women) the absence of circulating cells of hairy-cell leukemia and clinical signs of hairy-cell leukemia | Month 6 |
Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The Tissue Repository will search for cases, pull slides, Paraffin-embedded tissue (PET) blocks.

Detailed Description
-----------------
This study is done to gather preliminary data for determining the best way to test EGFR expression in patients with cervical cancer who will receive treatment with EGFR inhibitors in the future. This study is designed to obtain preliminary data of genomic and phenotypic alterations of the EGFR pathway in high grade cervical intraepithelial lesions (HG-SIL) and invasive cervical cancers (CC) to be used later for therapeutic guidance and to evaluate genomic (over-expression, amplification, point mutations, etc.) and phenotypic alterations of other transduction pathways interacting with the EGFR pathway.

Official Title
-----------------
Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer

Conditions
-----------------
Cervical Cancer, Cervix

Intervention / Treatment
-----------------
* Genetic: Tissue Repository


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Samples from patients diagnosed with HG-SIL (n=300) and CC (n=300) with a follow-up of at least 24 months, existing at the Department of Pathology will be retrieved by the Tissue Repository, de-identified them and provided with code numbers that will not be linked to patient's data. Exclusion Criteria: None Specified.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Tissue Repository|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
-----------------
Cervical cancer, EGFR, cervical, genomic, DNA, markers, prognostic, gene, epidermal growth factor
Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

Study Overview
=================
Brief Summary
-----------------
The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.

Official Title
-----------------
Double-blind, Parallel, Randomized, (Placebo-controlled) Explorative Study on the Effect of a Mixture of Prebiotic Oligosaccharides on the Composition of Intestinal Microbiota and Selected Health Outcomes in Children 3 to 6 Years of Age

Conditions
-----------------
Infectious Disease, Children, Only, Diet Modification

Intervention / Treatment
-----------------
* Dietary Supplement: prebiotic inulin-type fructan
* Dietary Supplement: Placebo maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is healthy at the time of pre-examination Subject is aged 3-6 years at the time of pre-examination Subject attends a kindergarten at the time of pre-examination Exclusion Criteria: congenital disease or malformation influencing the gastrointestinal System children with congenital or acquired immunodeficiency children with food intolerance, food allergy or metabolic disorder requiring special diet children who regularly (more than 3 times per week) consumed products or food supplements containing prebiotics or probiotics children who consumed antibiotics or laxatives within 14 days children who had any infectious disease within 14 days at the time of pre-examination

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prebiotic inulin-type fructan<br> | Dietary Supplement: prebiotic inulin-type fructan<br> <br> |
| Placebo Comparator: placebo maltodextrin<br> | Dietary Supplement: Placebo maltodextrin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of infectious disease episodes |  | 24 weeks period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiota composition | fecal microbiota composition (qPCR, illumina) | 24 weeks period |
Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.

Study Overview
=================
Brief Summary
-----------------
The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation in the treatment of malignant bone, lung and renal tumors.

Official Title
-----------------
Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.

Conditions
-----------------
Lung Tumor, Bone Tumor, Renal Tumor

Intervention / Treatment
-----------------
* Device: Microwave ablation with Acculis Accu2i pMTA Applicator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women > 18 years old Thermoablation indication of renal neoplasia, bone or lung decided during a multidisciplinary consultation meeting - Generally speaking, the indications are: (i) inoperable primary malignant tumor or secondary malignant tumor, (ii) resectable primary malignant renal and lung tumor with medical contraindication to surgery or general anesthesia Signature of informed consent for participation Affiliation to a social security scheme or French beneficiary of such a regime. Exclusion Criteria: Contraindication to percutaneous thermoablation Renal or lung tumor up to 4 cm Women of childbearing age, premenopausal, non-sterilized surgically, and unwilling to use effective contraception Legal incapacity or legal capacity limited Person unlikely to cooperate in the study and / or low degree of cooperation expected by the investigator Person without health insurance Pregnant women

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal tumor<br>Microwave ablation of renal tumor | Device: Microwave ablation with Acculis Accu2i pMTA Applicator<br> <br> |
| Experimental: Lung tumor<br>Microwave ablation of lung tumor | Device: Microwave ablation with Acculis Accu2i pMTA Applicator<br> <br> |
| Experimental: Bone tumor<br>Microwave ablation of bone tumor | Device: Microwave ablation with Acculis Accu2i pMTA Applicator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor necrosis rate in post-intervention over one month monitoring period. |  | one month |