linjc16/ctgov huggingface dataset:
Vertical Transmission of Hepatitis C Virus

Study Overview
=================
Brief Summary
-----------------
Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). Spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.

Detailed Description
-----------------
Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) has been extensively studied, with a risk around 5% (range: 3 to 10%) from chronically infected pregnant women with a positive HCV RNA during pregnancy. Risk factors include: HCV RNA load level, HIV-HCV co-infection, duration of labour, HCV genotype, child gender, and invasive procedures either during pregnancy or at birth. Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) mainly occurs during the last trimester of pregnancy or at birth or around the birth (El-Shabrawi et al., World Journal of Gastroenterology 2013). Currently, using caesarian section to reduce the risk of Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) is still debated and not recommended in International Guidelines (EASL 2012). Spontaneous viral clearance in infected children during childhood seems to occur in 20% of cases, with predisposing genetic factors (Ruiz-Extremera A et al. Hepatology 2011 ; 53 : 1830-1838) but data about this phenomenon are scarse (Rerksuppaphol S et al. J Gastroenterol Hepatol 2004), justifying the study.

Official Title
-----------------
Mother-To-Child Transmission (MTCT) of Hepatitis C Virus and Spontaneous Viral Clearance in Infected Children: a Retrospective Study.

Conditions
-----------------
Hepatitis C, Transmission

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV chronically infected pregnant women with a positive HCV RNA who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France Exclusion Criteria: negative HCV RNA during pregnancy acute HCV infection during pregnancy (previous negative HCV test during pregnancy) MTCT not to be tested (early child death for instance)

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 15 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 |
| --- | --- |
| HCV pregnant women<br>HCV chronically infected pregnant women, with a positive HCV RNA during pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV status in children born from chronically HCV infected pregnant women |  | up to 10 years (expected average: 5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV RNA in children with positive HCV antibodies (Ab) |  | up to 10 years (expected average: 5 years) |
PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood

Study Overview
=================
Brief Summary
-----------------
Using methods of molecular biology bacteria can be detected in blood. In comparison to conventional blood cultures bacterial DNA is isolated using a new sample preparation system in platelet apheresis concentrates and in the predonation whole blood of donors.

Detailed Description
-----------------
Bacterial contamination of platelet concentrates is discussed worldwide and according to literature occuring in 1:1000 to 1:5000 concentrates. Bacterial contaminated concentrates can in fact cause severe infections in patients. therefore this study initially intends to detect contamination with bacterial DNA in platelet aphereses concentrates. All sample donations are also examined by blood culture for contamination. To exclude already existing infection of the donor one tube of whole blood is taken in addition to the other legally required samples for the production of pharmaceutical medicine. All samples are anonymised before passed on for analysing.

Official Title
-----------------
PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood (First Study)

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy platelet apheresis donor Exclusion Criteria: Missing health clearance for blood donation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood donation, bacterial contamination, platelet concentrates, looxster, pureprove, bacterial genomic DNA, bacterial contamination of platelet concentrates, Preparation of bacterial DNA in blood, comparison of blood culture versus NAT
Evaluation of Fluid Resuscitation in Children With Cancer With Severe Sepsis / Septic Shock

Study Overview
=================
Brief Summary
-----------------
Retrospective study to evaluate the characteristics of patients and of fluid resuscitation during intensive care unit hospitalization of patients under septic chock.

Conditions
-----------------
Cancer, Septic Shock, Other Fluid Overload

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted between Jan/2009 and Dec/2010 patients with septic chock diagnosis Exclusion Criteria: -
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 |
| --- | --- | --- |
Paclitaxel/Cisplatin/Fluorouracil Followed by Paclitaxel/Cisplatin/Radiotherapy and Esophagectomy for Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.

Detailed Description
-----------------
We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.in order to test this hypothesis, we thus propose this phase II clinical study to verify the role of response to one-cycle induction chemotherapyin the prediction of pathologic complete response rate to CCRT and tje outcomes for patients with loco-regional esophageal cancer.

Official Title
-----------------
A Phase II Study With One-cycle Weekly TP-HDFL Followed by Twice Weekly TP-CCRT and Esophagectomy for Locally Advanced Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Procedure: TP-HDFL,TP-CCRT, Esophagectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically proven esophageal cancer Locally advanced diseases T3 N0-1 M0; T1-3 N1 M0; T1-3 or N0-1 M1a Age ≥ 18 years old ECOG ≤ 2 Creatinine < 1.5 mg/dl AST, ALT < 2.5 x upper normal limits Bilirubin < 2.0 mg/dl WBC > 4,000/μl or ANC>2,000/μl Platelet > 100,000//μl Informed consent Exclusion Criteria: Invasion to surrounding organs (T4 disease) Distant mets (except M1a) Prior thoracic irradiation Presence of other squamous cell carcinoma of aerodigestive way Symptomatic co-morbid diseases Previous malignancy

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-cycle induction chemotherapy<br>TP-HDFL, TP-CCRT, Esophagectomy | Procedure: TP-HDFL,TP-CCRT, Esophagectomy<br>* To determine whether clinical response to one cycle of induction chemotherapy (TP-HDFL) could predict the pathologic complete response to preoperative chemoradiotherapy (TP-CCRT) in patients with locally advanced esophageal cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether clinical response to one cycle of induction chemotherapy (TP-HDFL) could predict the pathologic complete response to preoperative chemoradiotherapy (TP-CCRT |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal cancer, Esophagectomy, Paclitaxel, Induction chemotherapy
Analysis of Anti-inflammatory and Antioxidant Pathways in Lung Diseases by Haem Oxygenase-1 (HO-1) in Induced Sputum and Carbon Monoxide (CO) in Exhaled Air

Study Overview
=================
Brief Summary
-----------------
This work will focus on the anti-inflammatory and antioxidant pathways in lung diseases by measuring HO-1 in induced sputum and CO in exhaled air in cases of four respiratory diseases, asthma, chronic obstructive pulmonary disease (COPD), occupational lung diseases (OLD) and interstitial lung disease (ILD).

Conditions
-----------------
Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female Ages >/= 18 years Diagnosed with one or more lung diseases Referred for sputum induction to the Pulmonary Laboratory in the Tel-Aviv Sourasky Medical Center

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exhaled CO levels |  | 2010-2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mucus-stimulated (induced sputum), lung disease (asthma, COPD, ILD and OLD), HO-1 (heme oxigenase-1), oxidative stress, CO (carbon monoxide), The oxidative stress in lung diseases
A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts

Study Overview
=================
Brief Summary
-----------------
This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.

Official Title
-----------------
A Multicenter, Double-Blind, Placebo-Controlled Study With a Modified Allergen Extract for Specific Immunotherapy in Patients With Seasonal Allergic Rhinitis/Rhinoconjunctivitis

Conditions
-----------------
Allergic Rhinitis, Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Biological: modified allergen extract
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis Positive screening skin prick test (wheal diameter > 3 mm) Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication Signed and dated patient´s Informed Consent, Exclusion Criteria: Previous immunotherapy within the last 3 years, Simultaneous participation in other clinical trials, Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), Auto-immune disorders, Severe chronic inflammatory diseases, Malignancy, Alcohol abuse, Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: modified allergen extract<br> | Biological: modified allergen extract<br>* subcutaneous injections<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* subcutaneous injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom and medication score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the treatment |  | 1 year | 
| Documentation of adverse events |  | 1 year | 
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) |  | 1 year | 
| Clinical global improvement |  | 1 year |
Female Sexual Function and Back Pain

Study Overview
=================
Brief Summary
-----------------
Back paın is a common hormonal disorder in women that may affect the phases of female sexual function (FSD). We investigated sexual function in patients with back paın A total of 54 women with back paın and 27 age matched voluntary healthy women who served as the as control group were evaluated with a detailed medical and sexual history, including a female sexual function index (FSFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

Detailed Description
-----------------
A total of 54 women with back paın and 27 age matched voluntary healthy women who served as the as control group were evaluated with a detailed medical and sexual history, including a female sexual function index (FSFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

Conditions
-----------------
Female Sexual Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-45 year old Female Active sexual life Exclusion Criteria: Younger than 20, older than 45 year old. Menopause

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Female sexual function |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Female sexual function
Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers

Study Overview
=================
Brief Summary
-----------------
The combined analysis of microbiome, immunological parameters and host genetics in patients has potential for applying personalized approaches of prevention, diagnostics or therapy in the future. However, the acquisition and analysis of these patient characteristics in a scientifically sound, technically reliable, cost-effective, practicable and future-oriented fashion are a far from trivial task. Therefore the objectives of the study are (i) to optimize a sample and data acquisition and analysis pipeline that fulfills these criteria (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children undergoing stem cell transplantation, yielding information on host immuno-genetics, gut immune function and the human gut microbiome; (iii) deduct the most critical parameters for host-microbiome interplay from this complex dataset.

Official Title
-----------------
Implementation of a Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers for Stratified Clinical Management

Conditions
-----------------
Stem Cell Transplantation

Intervention / Treatment
-----------------
* Other: Stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient (stem cell recipient) with hematological malignancies, age 3-18 Healthy allogeneic stem cell donor (identical or non-identical related donor) Exclusion Criteria: Patients <3 years of age Patient who are unable to provide urine, stool or blood samples due to their medical condition

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stem cell transplant recipient<br> | Other: Stem cell transplantation<br>* Intervention is not conducted as part of the study but patients at Tübingen University Hospital undergoing this intervention as part of their standard care are being monitored in this observational study.<br>|
| Stem cell donor<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively. |  | through study completion, anticipated after 2 years |
A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.

Detailed Description
-----------------
This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.

Official Title
-----------------
A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Amprenavir
* Drug: Lamivudine
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV-positive status. Screening viral load >= 10,000 copies/mm3 14 days prior to entry. CD4+ cell counts >= 200 cells/mm3 14 days prior to entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Clinical diagnosis of AIDS (CDC 1993 Classification C). Concurrent Medication: Excluded: Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens. Patients with the following prior conditions are excluded: Clinically relevant hepatitis in the previous 6 months. Prior Medication: Excluded: Greater than 4 weeks of any nucleoside antiretroviral therapy. Previous therapy with an HIV protease inhibitor. Cytotoxic chemotherapeutic agents within 4 weeks prior to entry. Immunomodulating agents within 3 months prior to entry. Prior Treatment: Excluded: Radiotherapy within 4 weeks prior to entry. Risk Behavior: Excluded: Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.

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: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amprenavir|nan|
|Drug: Lamivudine|nan|
|Drug: Zidovudine|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
-----------------
Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Efficacay of Chloroquine or Hydroxychloroquine in COVID-19 Treatment

Study Overview
=================
Brief Summary
-----------------
Chloroquine or hydroxychloroquine in COVID-19 treatment

Detailed Description
-----------------
Clinical Study Evaluating the Efficacy of Chloroquine or hydroxychloroquine in COVID-19 treatment

Official Title
-----------------
Clinical Study Evaluating the Efficacy of Chloroquine or Hydroxychloroquine in COVID-19 Treatment

Conditions
-----------------
COVID-19, Coronavirus Infection

Intervention / Treatment
-----------------
* Drug: Chloroquine or Hydroxychloroquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Covid 19 patients Exclusion Criteria: Allergy or contraindication to the drug Pregnant or lactating Patients with cardiac problems
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chloroquine or Hydroxychloroquine<br>Chloroquine or Hydroxychloroquine with standard of care treatment. | Drug: Chloroquine or Hydroxychloroquine<br>* Chloroquine or Hydroxychloroquine<br>* Other names: alexoquine, chloroquine, Hydroquine;|
| No Intervention: No intervention<br>standard of care treatment alone. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with cure or death | the number of patients with cure or death | 1 month |