linjc16/ctgov huggingface dataset:
Internal Limiting Membrane Peeling on Retinal Displacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate displacement of the retina after idiopathic macular hole surgery with different internal limiting membrane peeling patterns.

Detailed Description
-----------------
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. All patients with idiopathic MH will be randomly allocated into two groups, N-T group or T-N group.

Official Title
-----------------
Displacement of the Retina After Idiopathic Macular Hole Surgery With Different Internal Limiting Membrane Peeling Patterns

Conditions
-----------------
Internal Limiting Membrane Peeling

Intervention / Treatment
-----------------
* Procedure: idiopathic macular hole (MH) surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eyes with idiopathic macular hole Exclusion Criteria: Eyes having re-do macular hole surgery, with high myopia, with proliferative vitreoretinopathy or with a retinal detachment combined with the MH, with other macular diseases, such as age-related macular degeneration.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-T group<br>ILM was peeled off from nasal retina to temporal retina. | Procedure: idiopathic macular hole (MH) surgery<br>* Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns<br>|
| Experimental: T-N group<br>ILM was peeled off from temporal retina to nasal retina | Procedure: idiopathic macular hole (MH) surgery<br>* Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-OD | measurement of temporal vessel to optic disc | preoperation to postoperative 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal displacement, Idiopathic macular hole, Internal limiting membrane peeling
Impact of Previous Treatment of HCV Patients by DAADs on Covid-19 Disease Frequency and Severity

Study Overview
=================
Brief Summary
-----------------
Evaluate effect of DAADs on covid-19 disease.

Detailed Description
-----------------
If Chronic HCV patients who already received DAADs are protected against covid 19 and considered to be immune or not And if DAADS can be used in ttt of covid 19

Official Title
-----------------
Impact of Previous Treatment of HCV Patients by DAADs on Covid-19 Disease Frequency and Severity

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Drug: DAAD Compound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV patient with or without LC. >18 years old. Received DAADs at 2019. Exclusion Criteria: Combined HCV and HIV infected patients. Combined HCV and HBV infected patients. < 18 years old. Pregnant or breast-feeding patients. Patients with autoimmune disease. Patients with multiorgan failure, active cancer, renal insufficiency. Patients received immunosuppressive drugs. Immune compromised patients. Previous confirmed diagnosis of SARS-CoV-2 before starting DAAs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic HCV patients previously treated by DAADs.<br> | Drug: DAAD Compound<br>* Sofosbuvir , Daclatasvir and ribavirin<br>|
| Chronic HCV patients not treated by DAADs yet.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of DAADs on covid -19 | If chronic HCV patients who received DAADs suspected to be infected by covid-19 by having findings suggest covid 19 infection in MSCT chest or clinically symptoms or confirmed by nasopharyngeal swab . And if infected what about severity , if they need hospital admission or oxygen therapy or mechanical ventilation ,if they still alive or died | 12 months (from 1/2/2021 to 1/2/2022) |
Evaluation of Food Insecurity in Adults and Children With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
A survey of adults and parents of children with cystic fibrosis on food insecurity

Detailed Description
-----------------
A survey of adults and parents of children with cystic fibrosis to determine any correlation between food insecurity and BMI or food insecurity and FEV1, and to determine what level of food insecurity is present.

Official Title
-----------------
Evaluation of Food Insecurity in Adults and Children With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have CF and are willing to complete a questionnaire during a routine clinic visit - Exclusion Criteria: NA

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: survey|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate food insecurity incidence in CF patients | Using a survey, determine the number of people who report food insecurity | one time questionnaire administered during a clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if food insecurity leads to worse lung function in CF patients | Using a survey, report the current FEV1 and the number of people who report food insecurity to determine if there is a correlation | one time questionnaire administered during a clinic visit | 
| Determine if food insecurity leads to worse BMI in CF patients | using a survey, report the current BMI and the number of people who report food insecurity to see if there is a correlation | one time questionnaire administered during a clinic visit. |
Routine Application of Ostenil® in Patients With Gonarthrosis

Study Overview
=================
Brief Summary
-----------------
PMCF study to observe the routine application of Ostenil® in the treatment of pain and restricted mobility in degenerative and traumatic changes of the knee joint.

Official Title
-----------------
Routine Application of Ostenil® in Patients With Gonarthrosis

Conditions
-----------------
Gonarthrosis

Intervention / Treatment
-----------------
* Device: Ostenil®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects ≥ 18 years of age and in good general health condition Signed informed consent Existing Ostenil® recommendation for the treatment of gonarthrosis Exclusion Criteria: Known hypersensitivity to one of the Ostenil® components Presence of articular effusion in study-relevant knee joint Known pregnancy or lactating females Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Ostenil®<br>3-5 injections of sodium hyaluronate 1 % (20 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval. | Device: Ostenil®<br>* Ostenil® is a CE-certified viscoelastic solution for injection into the joint cavity, containing 1.0 % sodium hyaluronate from fermentation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain Intensity compared to Baseline (VAS-slider) | Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. 10 cm equals the worst pain. | Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252 | 
| Change of Range of Motion compared to Baseline (Goniometer measurement) | Assessment of the Range of Extension and Flexion of the Knee Joint using a Goniometer. | Day 7, Day 14, Day 21, Day 28, Day 84, Day 168 | 
| Change of Subjective Therapy Evaluation (KOOS Questionnaire) compared to Baseline | Knee injury and Osteoarthritis Outcome Score (KOOS) to assess Stiffness, Pain, Function (daily living) and Quality of Life on a 5-point Likert scale. | Day 84, Day 168 | 
| Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5) | The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse). | Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252 | 
| Incidence of Treatment-Emergent Adverse Events |  | Up to Day 252 |
Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer.

Official Title
-----------------
A PHASE 1, OPEN-LABEL, DOSE-ESCALATION STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 2 DOSING SCHEDULES OF PF-00299804 IN PATIENTS WITH ADVANCED MALIGNANT SOLID TUMORS

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: PF-00299804


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant solid tumor for which there is no currently approved treatment Adequate bone marrow, liver, cardiac, and kidney function Exclusion Criteria: Cardiac disease Anticancer therapy within 4-6 weeks (depending on therapy) Pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>open label single arm trial | Drug: PF-00299804<br>* investigational drug by oral route (escalating doses depending on safety) administered until progression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | 6 months | 
| Pharmacodynamics |  | 6 months | 
| Efficacy |  | 6 months |
Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Life-threatening thrombocytopenia (low platelet count) and neutropenia (low white blood count) remain the major dose-limiting toxicities following chemotherapy treatment for cancer. The only remedy for thrombocytopenia at present is platelet transfusion, which is effective in preventing life-threatening hemorrhage, but may lead to other complications. Preclinical studies and studies in adults have shown recombinant human thrombopoietin (rhTPO) to be effective in stimulating platelet production. The initial phase of this trial will evaluate the safety of rhTPO use immediately after chemotherapy with ifosfamide, carboplatin, and etoposide in children with solid tumors and lymphomas. The second phase of the study will evaluate the effectiveness of rhTPO in decreasing the duration of low platelet count after chemotherapy.

Official Title
-----------------
A Phase I/II Trial of Recombinant Human Thrombopoietin in Children With Malignant Solid Tumors and Lymphoma Receiving Ifosfamide, Carboplatin and Etoposide

Conditions
-----------------
Germ Cell Tumors, Hepatic Cancer, Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma

Intervention / Treatment
-----------------
* Drug: Recombinant Human Thrombopoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of recurrent, refractory, or previously untreated malignant solid tumor or recurrent/refractory lymphoma for which Ifosfamide, Carboplatin, and Etoposide chemotherapy is the most appropriate treatment. Adequate liver and kidney function. Adequate performance status.

Ages Eligible for Study
-----------------
Maximum Age: 21 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

| Intervention/Treatment |
| --- |
|Drug: Recombinant Human Thrombopoietin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of recombinant human thrombopoietin following chemotherapy which includes ifosfamide, carboplatin and etoposide for solid tumors and lymphoma. |  |  | 
| To evaluate whether recombinant human thrombopoietin will reduce the time necessary for platelet counts to recover following chemotherapy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombocytopenia, Platelets, Thrombopoietin
Study of Human Botulism Immunoglobulin in Infants With Botulism

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the safety of human botulism immune globulin (BIG) in patients with infant botulism by monitoring side effects (e.g., rash, fever, hypotension, and anaphylaxis). II. Assess the efficacy of BIG in these patients by monitoring disease severity, incidence of complications (respiratory arrest, aspiration, pneumonia, etc.), and length of hospital stay.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is an open label, multicenter study. Patients should begin therapy within 72 hours of hospital admission, but may receive human botulism immunoglobulin (BIG) in certain circumstances after 72 hours. Patients receive (BIG) IV. Patients are monitored for side effects, disease severity, complications, and length of hospital stay. Patients are followed at 2 weeks after treatment, then every 4 weeks for 6 months. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Botulism, Infant Botulism

Intervention / Treatment
-----------------
* Drug: botulism immune globulin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinical diagnosis of infant botulism in previously healthy infant Bulbar palsies Constipated Lethargy Diminished head control Poor feeding Generalized weakness and hypotonia Weak cry Afebrile (unless secondary infection present) Subacute to acute onset Normal electrolytes Any patient eligible provided no treatment available for life-threatening condition

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: botulism immune globulin|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
-----------------
bacterial infection, clostridium infection, immunologic disorders and infectious disorders, infant botulism, rare disease
The Role of CT-PET-MRI Image Fusion in Determining Radiation Treatment Volumes of Head-and-Neck Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Technical developments in radiation oncology are making it possible to deliver a prescribed radiation dose to radiation target volume with increasing accuracy. Therefore it is becoming even more relevant to accurately define the radiation target volumes. The current standard in defining radiation target volumes in patients with head-and-neck cancer is to combine physical examination data with a CT-scan in the treatment position. The goal of this investigation is to analyse the rol of CT-PET-MRI image fusion in defining radiation target volumes.

Official Title
-----------------
The Value of CT-PET-MRI Image Fusion in Determining Radiation Treatment Volumes in Patients With a Squamous Cell Carcinoma of the Head-and-Neck Region, Who Are to be Treated With Definitive Radiotherapy

Conditions
-----------------
Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Procedure: PET-scan, MRI-scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for definitive radiotherapy with a Head and Neck Neoplasm (squamous cell carcinoma) in one of the following anatomical sites: oral cavity oropharynx hypopharynx larynx Exclusion Criteria: age < 18 years pregnancy

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

| Intervention/Treatment |
| --- |
|Procedure: PET-scan, MRI-scan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.

Official Title
-----------------
A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated written informed consent obtained from the subject Males and females of age 18 years and older at the time of screening Established diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology classification criteria Documented renal biopsy evidence of proliferative glomerulonephritis prior to screening Urine protein-to-creatinine ratio > 0.5 (mg/mg) Exclusion Criteria: Any significant health problem other than lupus or lupus nephritis

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: Open-label Dose-Escalation Arm<br>Conducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product | Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody<br>* Intravenous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality |  | Week 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters | Maximum concentration (Cmax), minimum concentration (Cmin), area under the curve (AUC), half-life (t1/2), clearance (CL) , mean residence time (MRT), volume of distribution at steady state (Vdss) | Week 21 |