linjc16/ctgov huggingface dataset:
A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic radiosurgery has on tumors near the critical structures of the eye (optic apparatus). The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and effectively while sparing the adjacent optic apparatus and normal brain tissues from receiving damaging doses of radiation.

Detailed Description
-----------------
The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

Official Title
-----------------
A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors

Conditions
-----------------
Tumor, Benign, Optic Nerve

Intervention / Treatment
-----------------
* Radiation: CyberKnife Radiosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Perioptic lesion within 2mm of the optic apparatus Age >= 21 KPS >= 50 Planning Target Volume (PTV) <= 6.0 cm in maximal diameter Exclusion Criteria: Malignant histology Age < 21 KPS <= 40 Planning Target Volume (PTV) > 6.0 cm in maximal diameter Prior whole brain XRT Gross total resection

Ages Eligible for Study
-----------------
Minimum Age: 21 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: CyberKnife Radiosurgery<br> | Radiation: CyberKnife Radiosurgery<br>* 25 Gy delivered in 5 fractions of 5 Gy per fraction<br>* Other names: CyberKnife;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor status | To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perioptic, Stereotactic, Radiation, Benign brain tumor, Optic apparatus
RST-001 Phase I/II Trial for Advanced Retinitis Pigmentosa

Study Overview
=================
Brief Summary
-----------------
Currently enrolling a total of 12 patients for Phase 2a of the study: 6 patients must have VA of no-better-than hand motion in the study eye, and 6 patients must have VA in the study eye to range from no-worse-than count fingers to 20/200 vision.

Official Title
-----------------
Phase I/IIa, Open-Label, Dose-Escalation Study of Safety and Tolerability of Intravitreal RST-001 in Patients With Advanced Retinitis Pigmentosa (RP)

Conditions
-----------------
Advanced Retinitis Pigmentosa

Intervention / Treatment
-----------------
* Drug: RST-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Participants must meet all of the following criteria. Age >= 18 years Signed and dated written informed consent obtained from the patient. Ability to comply with testing and all protocol tests. Exclusion criteria: Any one of the following will exclude patients from being enrolled into the study: Unable or unwilling to meet requirements of the study; Participation in a clinical study (ocular or non-ocular) with an investigational drug, agent or therapy in the past six months

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: Group 1<br>Single intravitreal injection of RST-001 | Drug: RST-001<br>* RST-001 is a gene therapeutic delivered by intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Grade 3 or Greater Adverse Event (AE) Considered Related to RST-001. | The U.S. Dept. of Health and Human Services' Common Terminology Criteria for Adverse Events grades AEs from 1 (Mild) to 5 (Death related to AE). Grade 3 is defined as Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Activities of Daily Living (ADL) | Baseline (Day 1) to 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gene therapy, optogenetics, channelrhodopsin, retina, retinitis pigmentosa
COVID-19 STAndard of Care in Sub-Saharan Africa

Study Overview
=================
Brief Summary
-----------------
This study was conducted in three African countries on four COVID-19 care centers (CCCs). The CCCs were set up in collaboration with a medical NGO with long experience in recording and monitoring data for cohorts and clinical trials in emergency contexts. The data were recorded using the WHO COVID-19 rapid core case report form.

Official Title
-----------------
Observational Study of the Clinico-biological Evolution and the Standard of Care Offered to Symptomatic Covid-19 Patients in Sub-Saharan Africa

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SARS-CoV-2 positive at RT-PCR Exclusion Criteria: Asymptomatic patients
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 |
| --- | --- | --- |
| Mortality | In hospital mortality | During hospitalization, with an average of 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical worsening | Combination of an SpO2 <94% at least once during follow-up (including at baseline), use of oxygen therapy at any time during follow-up, or death | Hospitalization, with an average of 11 days |
Comminuted Fractures of the Midshaft of the Tibia; (Interlocking Nail +/- Blocking Screws or Locked Plating With Predicted Distribution of Locking Screws) Choice Based on Finite Element Analysis Correlated With Clinical Outcome and Union.

Study Overview
=================
Brief Summary
-----------------
study is to assess the clinical and radiological results of Comminuted fractures of the midshaft of the tibia; treated with interlocking nail +/- blocking screws or locked plating with predicted distribution of locking screws, choice based on finite element analysis correlated with clinical outcome and union.

Detailed Description
-----------------
FE analyses will be performed using the finite element code COSMOS/M. The three-dimensional lower leg FE model (LL FE model) will be used included the tibia and the fibula. The bony structures will be generated by segmentation of a data set of computed tomographies from the Visible Human Project. Analysis of data regarding clinical outcomes and radiological assessment of healing rate and union

Official Title
-----------------
Finite Element Analysis for Comminuted Fractures of the Midshaft of the Tibia; (Interlocking Nail +/- Blocking Screws or Locked Plating With Predicted Distribution of Locking Screws)

Conditions
-----------------
Comminuted Fracture Tibia

Intervention / Treatment
-----------------
* Other: Finite element analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with closed comminuted fractures of the midshaft of the tibia patients with age ranging from 25 to 45 years old Exclusion Criteria: 1- Simple fractures of the midshaft of the tibia. 2- patients with open comminuted fractures of the midshaft of the tibia. 3- critical and ICU patients. 4- patients with ipsilateral lower limb fractures.

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| locked plating with predicted distribution of loc<br> | Other: Finite element analysis<br>* Biomechanical study to describe micromotion<br>|
| unlocked plating with predicted distribution of loc<br> | Other: Finite element analysis<br>* Biomechanical study to describe micromotion<br>|
| Interlocking nail +/- blocking screws<br> | Other: Finite element analysis<br>* Biomechanical study to describe micromotion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of the fracture | radiographic evaluation of union rate and clinical outcomes | 3 month | 
| Tibia Pain | Visual analogue scale | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comminuted fracture, Finite element analysis, Tibia
Effects of Ischemic Preconditioning After Aortic Clamping

Study Overview
=================
Brief Summary
-----------------
Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.

Official Title
-----------------
Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping

Conditions
-----------------
Vascular Surgery, Ischemia-reperfusion, Ischemia Preconditioning

Intervention / Treatment
-----------------
* Procedure: Ischemic preconditioning during aortic clamping
* Procedure: Procedure/Surgery: usual surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with an aortic aneurysm requiring open surgery (with no possibility of endovascular surgery) Patients who received clear information, with signed consent Patients 18 to 85 years Exclusion criteria: Patients under guardianship No possibility to give the patients clear information (comprehension difficulties, emergency surgery) Pregnancy, lactation Hemodialysis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ischemic preconditioning arm<br>Patients will have the ischemic preconditioning protocol 1 hour before the aortic clamping. | Procedure: Ischemic preconditioning during aortic clamping<br>* Ischemic preconditioning during aortic clamping<br>|
| Other: Control patients<br>Usual surgery assigned to control patients | Procedure: Procedure/Surgery: usual surgery<br>* Procedure/Surgery: usual surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial damage measured by troponin level > 0.4 microgr/L (day 1) | Myocardial damage measured by Troponin I level > 0.4 microg/L | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal damage | Renal damage measured with Post-operative Creatinin clearance < 50% of Pre-operative creatinin clearance | Day 0, day 1, day 3 or day 5. | 
| Muscle weakness | Muscle weakness measured by Creatine phospho Kinase > 200 UI/L | Day 0, day 1, day 3 or day 5 | 
| Myocardial damage measured by troponin level > 0.4 microgr/L |  | Day 0, 3, or 5 |
Comparative Formulation Study of Vabicaserin

Study Overview
=================
Brief Summary
-----------------
This study will compare two different formulations of vabicaserin.

Official Title
-----------------
A Randomized, Open-Label, Single-Dose, 3-Period Crossover, Comparative Study of a Modified Formulation of Vabicaserin (SCA-136) Versus the Reference Formulation in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: vabicaserin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after investigational product administration. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay. Exclusion Criteria: Use of any investigational or prescription drug within 30 days before investigation product administration. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1. Use of any over-the-counter drugs, including herbal supplements within 72 hours before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: vabicaserin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters including plasma concentrations, Cmax, and AUC. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment as measured by evaluating any reported adverse events, scheduled physical examinations, vital sign measurements, ECGs, and clinical laboratory results. |  | 2 months |
Comparison of Th1 Cytokine Levels Between Type 1 and Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Recent reports show increased prevalence of obesity in patients with type 1 diabetes (T1DP)s while some studies stated that patients with type 2 diabetes (T2DPs) have islet cell auto-antibodies. These results raise the question of a common pathway in T1DM and T2DM via an association with T helper cells. In this study investigators aimed to investigate the difference between T helper 1 (Th1) cytokines levels in T1DPs, T2DPs and healthy subjects. The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used oral antidiabetics but insulin before and 31 healthy subjects (CG). Serum interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α) levels were measured using ELISA method. Serum levels of those cytokines in T1DPs were compared with those in T2DPs and controls.

Official Title
-----------------
Comparison of Th1 Cytokine Levels Between Type 1 and Type 2 Diabetes

Conditions
-----------------
Type 1 Diabetes, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being >18 years old Giving consent to participate Exclusion Criteria: Acute and chronic inflammatory diseases significant concomitant disease likely to interfere with glucose metabolism, malignancies, hemoglobinopathies, In addition, glucose intolerance (fasting glucose level and that after glucose load) and HbA1C ≥ 5.7 % were also used exclusion criteria in the control group, group as American Diabetes Association (ADA) defined prediabetes as HbA1C between 5.7-6.4% (Standards of medical care in diabetes -2012. Diabetes care. 2012:35.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Type 1 Diabetes<br>Patients with type 1 diabetes | |
| Type 2 Diabetes<br>Patients with type 2 diabetes | |
| Control<br>Healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in T helper cytokines between groups |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 diabetes, Type 2 diabetes, T helper 1 cytokines
The Rolandic Epilepsy/ESES/Landau-Kleffner Syndrome and Correlation With Language Impairment Study

Study Overview
=================
Brief Summary
-----------------
In clinical practice language impairment is frequently reported in association with nocturnal epileptiform activity. There is a spectrum of epileptic conditions that are characterized by nocturnal epileptiform activity. From mild to severe this spectrum involves: Rolandic epilepsy (RE), nocturnal frontal lobe epilepsy (NFLE), Landau-Kleffner syndrome (LKS) and electrical status epilepticus during slow wave sleep (ESES). The exact characteristic of the relationship between nocturnal epileptiform activity and language impairment is yet to be explored. The investigators suggest that nocturnal epileptiform EEG discharges and nocturnal epileptic seizures during development will cause diseased neuronal networks that involve language. The diseased neuronal networks are less efficient compared with normal neuronal networks. Objective: Identification of a diseased neuronal network characteristic in children with nocturnal epileptiform activity, which can explain language impairment in these children. For this the investigators will use functional magnetic resonance imaging (MRI) to analyse brain activity and diffusion weighted MRI to investigate white matter connectivity.

Conditions
-----------------
Rolandic Epilepsy, Nocturnal Frontal Lobe Epilepsy, Landau-Kleffner Syndrome, Electrical Status Epilepticus During Slow Wave Sleep

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 6-18 diagnosis of Rolandic epilepsy (or other childhood epilepsies as listed in study population description) Exclusion Criteria: structural brain lesions which might influence cognition

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- | --- |
| Mechanism that causes language problems in childhood epilepsy | Morphological, anatomical or functional correlate that can explain the comorbidity of language problems in childhood epilepsy. In Rolandic epilepsy, e.g., the epileptic focus is in the brain motor strip, and from classical anatomy no connection is known from the motor strip to the language areas. Think of deviations in the brain such as cortical thinning in both regions or aberrant functional or anatomical networks linking both regions. | course of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Language problems, childhood epilepsy, bening (rolandic) epilepsy (of childhood) with centro temporal spikes, brain maturation, structral connectivity, functional connectivity
A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.

Official Title
-----------------
A Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Conditions
-----------------
Spinocerebellar Degeneration

Intervention / Treatment
-----------------
* Drug: KPS-0373, High dose
* Drug: KPS-0373, Low dose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese SCD patients with mild to moderate ataxia Exclusion Criteria: Patients with secondary ataxia Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

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

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

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: KPS-0373<br> | Drug: KPS-0373, High dose<br>* 28 weeks<br>Drug: KPS-0373, Low dose<br>* 28 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 28 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARA (Scale for the Assessment and Rating of Ataxia) | The change in the SARA total score at the time of final evaluation | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-8 (QOL) |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH), Spinocerebellar Ataxia (SCA), Cortical Cerebellar Atrophy (CCA)