linjc16/ctgov huggingface dataset:
Immunoadsorption in Patients With Severe Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate source data for the survival and the investigation of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.

Official Title
-----------------
Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis

Conditions
-----------------
Systemic Scleroderma

Intervention / Treatment
-----------------
* Device: TheraSorb Ig


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: systemic sclerosis according to the ACE-criteria severe pulmonary manifestation with reduced DLCO signed informed consent Exclusion Criteria: inadequate peripheral venous access participation in another clinical trial heart failure pronounced allergic diathesis, particularly in case of known hypersensitivity to drugs and/or materials used in the extracorporeal circuit

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TheraSorb Ig<br> | Device: TheraSorb Ig<br>* 1,5 plasma volume per treatment venovenous immunoadsorption frequency: three times weekly in week 1 and 2, two times weekly in week 3-6, two times two-weekly in week 7-12 duration: 12 months<br>* Other names: code 330-000-452;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival under immunoadsorption |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival under immunoadsorption |  | 12 months | 
| Number of Serious Adverse Events |  | 12 months | 
| change in modified Rodnan Skin Score |  | 12 months | 
| change in Diffusing Capacity of the Lung for Carbon Monoxide |  | 12 months | 
| change in Scleroderma Health Assenssment Questionnaire |  | 12 months | 
| change of pulmonary arterial pressure |  | 12 months | 
| reoccurrence of finger ulcers |  | 12 months | 
| healing of finger ulcers |  | 12 months |
Applying PET/MR in Rectal Cancer.

Study Overview
=================
Brief Summary
-----------------
The use of the novel recently introduced PET/MR scanner is believed to be promising in RC management, providing great anatomical details and detailed metabolic characterization. Preliminary data indicate it may become a strong imaging modality for staging of RC and has the potential to be used as a predictive tool guiding individualized therapy in patients receiving nT, but confirmation on prospective studies is mandatory. The use of radiomics as analysis approach may assist in achieving a better understanding of the obtained image data, and thus a more accurate disease assessment. Objectives To preliminary assess the potential diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT. To preliminary assess the potential value of PET/MR in predicting pMR to nT. To use radiomics analysis of PET/MR data to develop a quantification clinical tools that allow a more accurate and comprehensive assessment of RC patients.

Official Title
-----------------
Applying PET/MR in Rectal Cancer.

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: PET/MR scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Patients with newly diagnosed RC; histopathological confirmation of adenocarcinoma of colorectal origin. Exclusion Criteria: Patients younger than 18 years; pregnancy; other known active malignancy; previous chemotherapy or radiotherapy; previous pelvic operation; patient that no intent / not suited for neoadjuvant therapy (including metastatic disease at presentation); contraindication to intravenous contrast agents.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rectal Cancer Patients<br> | Diagnostic Test: PET/MR scan<br>* whole-body PET/CT scan and pelvic PET/MR scan (MR protocol will include three plane fast spin echo T2 weighted, DWI and dynamic contrast enhanced imaging). The ad interim assessment will use a pelvic PET/MR scan only (without PET/CT), to avoid the radiation associated with whole body CT. In the staging and post-nT assessment, the addition of PET/MR to the standard use of PET/CT adds no radiation exposure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient that shown the different between diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT |  | 1 year |
Analysis of Human Genomic DNA in Embryo's Culture Media

Study Overview
=================
Brief Summary
-----------------
try to find genomic DNA in culture medium after the embryos develop on Day 3 and Day 5 also in single step culture media. using direct PCR Polymerase Chain Reaction and also WGA Whole Genome Amplification before PCR and sequencing of the samples to find the point mutation

Detailed Description
-----------------
Human fertilized oocytes were individually cultured from Day 1 to Day 3, and from day 3 to days 5/6, in 10 ul medium. A total of 100 samples (50 spent media from Day 3 and 50 from Day 5/6) will be use in the study. Double-stranded DNA (dsDNA) amplifiability will be evaluated in embryos culture media by quantitative PCR on a multicopy gene target (TBC1D3). Quantification will be made with a standard curve constructed with genomic DNA (with culture media -day 3 and day5-, to take into account media inhibitory effects) TSPY1 amplification will be use to assess the presence of Y chromosome WGA followed by PCR on a single copy gene (MTHFR gene) will be performed on a subset of some samples to monitor the C677T polymorphism (genotyping by sequencing) WGA followed by PCR on a single copy gene (MTHFR) will be also performed on blastocoele fluids

Official Title
-----------------
Analysis of Human Genomic DNA in Embryo's Culture Media Targeting on a Single Gene Disease and Point Mutations

Conditions
-----------------
Single-Gene Disease

Intervention / Treatment
-----------------
* Genetic: Polymerase Chain Reaction and Whole Genome Amplification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria all the patients undergoing IVF treatment at Cervesi Hospital Exclusion Criteria: patients with embryos that can't be cultured from day 0 (insemination day) to day 5/6 (blastocyst stage)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| In Vitro Fertilization treatment<br>culture medium discarded after IVF treatment | Genetic: Polymerase Chain Reaction and Whole Genome Amplification<br>* Polymerase Chain Reaction and Whole Genome Amplification<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genomic DNA in culture medium (pg) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amplification of point mutation | amplification of point mutation with PCR (polymerase chain reaction) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
free gDNA, culture media
Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.

Official Title
-----------------
A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.

Conditions
-----------------
Malaria, Falciparum

Intervention / Treatment
-----------------
* Drug: Artemether-lumefantrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female infants and children ≤12 years of age body weight of ≥5 kg and <35 kg, with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite Exclusion Criteria: complicated malaria persistent vomiting malaria due to parasites other than P. falciparum antimalarial treatment received in the past 2 weeks known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease

Ages Eligible for Study
-----------------
Maximum Age: 12 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Artemether-lumefantrine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients free of parasites at day 28. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients free of parasites at 7 days and at 14 days |  |  | 
| Time to clearance from parasites |  |  | 
| Time to clearance of fever |  |  | 
| Hematology and biochemistry parameters |  |  | 
| Electrocardiogram |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Marsh fever, Plasmodium infections, Remittent fever, Paludism, Artemether, Artemisinins, Malaria, Benflumetol, Lumefantrine
Study of the Links Between Suicidal Intentionality and Acute Alcoholism

Study Overview
=================
Brief Summary
-----------------
There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is an increase of the risk of suicide in case of chronic or acute alcohol consumption. However why the alcohol consumption increase the suicidal risk is unknown. The hypothesis of this study is that the alcohol consumption induced disinhibition and facilitates the suicide attempt without premeditation

Detailed Description
-----------------
People hospitalized after a suicide attempt will answer to two questionnaires about the suicide intentionality and the acute alcohol consumption. There is 2 arms: people doing suicide attempt and with positive level of alcohol (up to 0.1g.L) people doing suicide attempt and with negative level of alcohol 110 patients will be included in this study so 55 in each arm.

Official Title
-----------------
Study of the Links Between Suicidal Intentionality and Acute Alcoholism

Conditions
-----------------
Suicide, Attempted

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient hospitalized in emergency department for a suicide attempt by voluntary drug intoxication speaking and understanding french Exclusion Criteria: Patient who has used other psychoactive substances (attested by toxicological analyzes and / or interrogation) Known neurodegenerative pathology

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 |
| --- | --- |
| positive alcoholism<br>positive acute alcoholism had questionnaire about suicidal intentionality | Other: questionnaire<br>* after the inclusion patient will answer to a questionnaire about the suicidal intentionality and a second about the alcool consumption<br>|
| negative alcoholism<br>negative acute alcoholism had questionnaire about suicidal intentionality | Other: questionnaire<br>* after the inclusion patient will answer to a questionnaire about the suicidal intentionality and a second about the alcool consumption<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the score of suicidal intentionality in patient presenting a positive or a negative alcohol level and doing suicide attempt | patient will complete the PIERCE questionnaire about the suicidal intentionality | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute alcoholism
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).

Official Title
-----------------
A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia

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

Intervention / Treatment
-----------------
* Drug: Decitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment. Ineligible to receive intensive chemotherapy for their disease. Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities. Exclusion Criteria: Received previous treatment for AML. Previously received Vidaza. Received any other investigational agents within 30 days of first dose of study drug. Uncontrolled intercurrent illness. Had radiotherapy within 14 days prior to study enrollment.

Ages Eligible for Study
-----------------
Minimum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Decitabine<br>* 20 mg/m^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.<br>* Other names: Dacogen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response = Morphologic Complete Remission (mCR) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myeloid Leukemia, AML, Decitabine, Dacogen, MGI PHARMA, INC.
Effect of Chemotherapy on PD-L1 in NSCLC

Study Overview
=================
Brief Summary
-----------------
PD-L1 is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect PD-L1 in advanced NSCLC patients. The present study aims to evaluate whether PD-L1 will change after receiving chemotherapy in advanced NSCLC patients.

Official Title
-----------------
Effect of Platinum-based Chemotherapy on PD-L1 Expression in Patients With Advanced Non-small Cell Lung Cancer

Conditions
-----------------
Chemotherapy, Immunotherapy, PD-L1

Intervention / Treatment
-----------------
* Other: PD-L1 group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month; Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc) ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min Exclusion Criteria: Patient can not comply with research program requirements or follow-up; Patient will receive immunotherapy;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| PD-L1<br> | Other: PD-L1 group<br>* PD-L1 expression is evaluated using immunohistochemical assay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with PD-L1 positive as assessed by immunohistochemical assay | PD-L1 will be calculated using immunohistochemical assay | through study completion, an average of 1 year |
Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
Weight is a risk factor for knee osteoarthritis Knee osteoarthritis is associated with abnormal gait biomechanics Gait biomechanics are evaluated in gastric bypass patients before and after losing 100 pounds.

Detailed Description
-----------------
Weight is a major risk factor for development of knee osteoarthritis, but not hip or ankle arthritis. One possible mechanism for this is the generation of abnormal gait biomechanics secondary to obesity that are conducive to the development of knee osteoarthritis. We evaluate gait biomechanics, knee symptoms and knee radiographs in 35 obese patients before and after gastric bypass surgery to determine the effect of significant weight loss on gait biomechanics, knee symptoms and knee radiographs.

Official Title
-----------------
Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery

Conditions
-----------------
Obesity, Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: gastric bypass surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing gastric bypass surgery At least 35 years old - Exclusion Criteria: Inability to walk unassisted Pain affecting gait in any lower extremity joint -

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: gastric bypass surgery|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
-----------------
obesity, gait biomechanics, knee osteoarthritis
Bio-Repository of DNA in Stroke: an Epidemiological and Genetic Study

Study Overview
=================
Brief Summary
-----------------
The Bio-Repository of DNA in Stroke (BRAINS) recruits all subtypes of stroke as well as controls from two different continents, Europe and Asia. Subjects recruited from the United Kingdom (UK) will include stroke patients of European ancestry as well as British South Asians. Stroke subjects from South Asia will be recruited from India and Sri Lanka. Subjects are also recruited in Qatar. South Asian cases will also have control subjects recruited.

Official Title
-----------------
Bio-Repository of DNA in Stroke: an Epidemiological and Genetic Study

Conditions
-----------------
Stroke, Stroke, Ischemic, Stroke Hemorrhagic

Participation Criteria
=================
Eligibility Criteria
-----------------
Cases Inclusion Criteria: Patients should be aged > 18 years at the time of enrolment. Diagnosis of haemorrhagic or ischemic stroke using World Health Organization guidelines confirmed by clinical examination and imaging (CT or MRI). All patients with cerebral arteriovascular malformations and aneurysms. South Asian or Caucasian ethnic backgrounds. Patient or relative written informed consent. Exclusion Criteria: Unable to provide consent themselves or through surrogate. Stroke not defined on CT or MRI. Controls Inclusion Criteria: Patients should be aged > 18 years at the time of enrolment. No previous history of stroke. able to provide written consent.

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 |
| --- | --- |
| Stroke<br> | |
| Non-stroke<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA repository of highly phenotyped stroke patients |  | 5 years | 
| Identify novel gene loci associated with different types of stroke |  | 5 years |