linjc16/ctgov huggingface dataset:
Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This was a single center, randomized, placebo-controlled study with a sequential i.v. dose escalation cohorts design, to assess safety, tolerability and pharmacokinetics of MOTREM (nangibotide) in healthy volunteers

Official Title
-----------------
A Phase I, Randomised, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Ascending, Single, Intravenous Doses of MOTREM (LR12) in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: nangibotide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male ≥18 to ≤45 years old Body mass index (BMI) between 18-30 kg/m² inclusive Written informed consent to participate. Main Exclusion Criteria: Any clinically relevant acute or chronic diseases Any history of drug or alcohol abuse Any History of clinical significant disease as determined by medical history, physical examination or other evaluations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: MOTREM 1<br> | Drug: nangibotide<br>* Continous i.v. infusion<br>* Other names: MOTREM;|
| Experimental: MOTREM 2<br> | Drug: nangibotide<br>* Continous i.v. infusion<br>* Other names: MOTREM;|
| Experimental: MOTREM 3<br> | Drug: nangibotide<br>* Continous i.v. infusion<br>* Other names: MOTREM;|
| Experimental: MOTREM 4<br> | Drug: nangibotide<br>* Continous i.v. infusion<br>* Other names: MOTREM;|
| Experimental: MOTREM 5<br> | Drug: nangibotide<br>* Continous i.v. infusion<br>* Other names: MOTREM;|
| Experimental: MOTREM 6<br> | Drug: nangibotide<br>* Continous i.v. infusion<br>* Other names: MOTREM;|
| Experimental: MOTREM 7<br> | Drug: nangibotide<br>* Continous i.v. infusion<br>* Other names: MOTREM;|
| Experimental: MOTREM 8<br> | Drug: nangibotide<br>* Continous i.v. infusion<br>* Other names: MOTREM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: Number of subjects with at least one adverse event | Number of subjects with at least one adverse event | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Maximum Plasma Concentration) | Maximum Plasma Concentration [Cmax] | 8 hours |
Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy

Study Overview
=================
Brief Summary
-----------------
This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy.

Detailed Description
-----------------
Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients. Quantification and monitoring of KRAS mutations Using droplet digital PCR in ctDNA extracted from collected patient samples. Correlation analysis of KRAS mutation results with clinical data. Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel. Gene panel composition for pancreatic cancer therapeutic target determination and monitoring. A panel was performed using gDNA and ctDNA of tumor tissue collected from pancreatic cancer patients. Comparative analysis of panel results and quantitative KRAS mutations and evaluation of clinical applicability.

Official Title
-----------------
Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy

Conditions
-----------------
Pancreas Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pathologically confirmed pancreatic adenocarcinoma. Exclusion Criteria: Patients disagree with the study.
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 |
| --- | --- | --- |
| Clinical applicability of KRAS mutations | Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients. | Locally advanced and Resectable patients: Pre Treatment, 1,2,3,6,9,12,15,18,21,24months/ Metastatic patients: Pre Treatment, 1,2,4,6,8,10,12,14,16,18,20,22,24 months | 
| Discovery of biomarkers through ctDNA panel | Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel. | Locally advanced and Resectable patients: Pre Treatment, 1,2,3,6,9,12,15,18,21,24months/ Metastatic patients: Pre Treatment, 1,2,4,6,8,10,12,14,16,18,20,22,24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreas Adenocarcinoma, Circulating-tumor DNA, KRAS mutations, Cancer Panel, Prognostic markers
Possible Predictors of Mortality Based on COVID-19 for Patients Under 50 Years Old: A Multi-Center Experience of Istanbul

Study Overview
=================
Brief Summary
-----------------
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Mortality rates of COVID-19 pandemics vary between countries. It is known that mortality based on COVID-19 is higher in old population. Therefore the aim of this study to analyze the experience of 7 governmental hospitals in terms of patient characteristics, possible risk factors of mortality based on COVID-19.

Detailed Description
-----------------
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Mortality rates of COVID-19 pandemics vary between countries. It is known that mortality based on COVID-19 is higher in old population. Although several factors defined to be effective on this 'age depending factors' regional differences should be assessed deeply to clarify both the etiology and epidemiology. Therefore the aim of this study to analyze the experience of 7 governmental hospitals in terms of patient characteristics, possible risk factors of mortality based on COVID-19.

Official Title
-----------------
Possible Predictors of Mortality Based on COVID-19 for Patients Under 50 Years Old: A Multi-Center Experience of Istanbul

Conditions
-----------------
Covid-19, Risk Factor, Mortality

Intervention / Treatment
-----------------
* Diagnostic Test: PCR for COVID-19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: accepted to participate patients who were proven to have COVID-19 Exclusion Criteria: declined to participate patients whose age under 18 or more than 50 years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PCR for COVID-19|Novel Coronavirus 2019 DNA will be analyzed by PCR in nasopharyngeal swab|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality based on COVID-19 | mortality based on COVID-19 within the patients aged between 18-50 will be evaluated | 3 months |
Investigation of Biomarkers in Susac Syndrome

Study Overview
=================
Brief Summary
-----------------
Susac Syndrome is a rare disease and the establishment of the diagnosis is often difficult. The aim of this investigation is to identify relevant biomarkers and to elucidate the pathogenesis of Susac syndrome

Detailed Description
-----------------
Susac Syndrome is a rare disease characterized by encephalopathy, branch retinal artery occlusion and sensorineural deafness. The pathogenesis is not yet clear, an autoimmune endotheliopathy is discussed. Because of the variable and often incomplete clinical presentation, the establishment of the diagnosis is often delayed or even completely missed. The aim of this study is to identify biomarkers that facilitate the reliable and prompt establishment of the diagnosis. Patients with a definite diagnosis of Susac syndrome and healthy subjects as controls are investigated. Furthermore, the correlation of serological markers with structural retinal and cerebral changes will contribute to clarification of the pathogenesis of Susac syndrome.

Official Title
-----------------
Investigation of Relevant Biomarkers in Patients With Susac Syndrome

Conditions
-----------------
Susac Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult male and female patients with definite Susac syndrome or matching healthy control subjects ability to provide informed consent Exclusion Criteria: pregnancy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Susac syndrome<br> | |
| Matched healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease specific patterns of pathology on cranial MRI | one-time cranial MRI |  | 
| disease specific patterns of pathology in optical coherence tomography | one time optical coherence tomography |  | 
| serological biomarkers |  | not defined, cross-sectional analysis |
Spherical Aberration on the Optical of Two Different Aspherical Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
Purpose: To compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well as tilt and decentration measurements with Visante anterior segment OCT were performed.

Official Title
-----------------
Effect of Spherical Aberration on the Optical Quality After Implantation of Two Different Aspherical Intraocular Lenses

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral age-related cataract Potential postoperative visual acuity of 1.0 Snellen No relevant ocular pathology other than cataract Written informed consent to surgery and participation in the study Exclusion Criteria: Amblyopia, diabetic retinopathy, uveitis or other relevant ophthalmic diseases Optical media disturbances due to: corneal and vitreal opacity, PEX Preceding ocular trauma or ocular surgery within 6 months Inability to cooperate Pregnancy (a pregnancy test will be performed preoperatively in women of reproductive age)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2 different Intraocular lenses<br>2 different intraocular lenses were compared | Device: intraocular lens<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modulation transfer function (MTF) at 3 months after surgery |  | 3 months |
Clinical, Genetic and Epigenetic Characterization of Patients With FSHD Type 1 and FSHD Type 2

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to compare the severity of illness between groups of patients (Facio-Scapulo-Humeral Dystrophy = FHSD1, FSHD2 and patients both FSHD1 and FSHD2). Despite advances in research on the subject, answers are still needed on these diseases. We also aim to determine whether the chromosomal genetic abnormality is involved in other diseases and the frequency of this mutation in the population of patients FSHD. This study will increase our knowledge of the two forms of FSHD who present a common pathophysiological mechanism and may occur together in the same family with a worsening of the clinical phenotype worsening . In addition, epigenetic differences between FSHD type 1 and type 2 seems to have clinical consequences requiring appropriate management

Official Title
-----------------
Clinical, Genetic and Epigenetic Characterization of Patients With FSHD Type 1 and FSHD Type 2

Conditions
-----------------
Muscular Dystrophy, Facioscapulohumeral

Intervention / Treatment
-----------------
* Biological: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years and <75 years FSHD patients 1 or 2 with or without genetic confirmation Exclusion Criteria: - Patient with all conditions considered by the investigator interfering with the proper conduct of the study.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FSHD patient<br> | Biological: Blood test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle damage measure |  | One time at the inclusion | 
| Level of muscle damage |  | One time at the inclusion |
The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker, while the other half will receive routine therapy.

Detailed Description
-----------------
Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the indicators include: respiratory muscle force, diaphragmatic degree of excursion and thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of life, pulmonary function,NT-proBNP,PaO2 and PaCO2.

Official Title
-----------------
The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale

Conditions
-----------------
Chronic Cor Pulmonale

Intervention / Treatment
-----------------
* Device: external diaphragmatic pacemaker group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of chronic cor pulmonale and admit to hospital Exclusion Criteria: pneumothorax or mediastinal emphysema active tuberculosis install a cardiac pacemaker acute cardiocerebrovascular events: acute myocardial infarction, acute myocarditis, severe arrhythmia, severe cerebrovascular accidents. pregnancies end-stage patients (expected survival time less than 6 months)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: external diaphragmatic pacemaker group<br>use the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz | Device: external diaphragmatic pacemaker group<br>* 9 counts per minute, with stimulate frequency 40 Hz<br>|
| No Intervention: control group<br>No inervention, just receive conventional therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiopulmonary function | six miunte walk test | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MIP | MAX INSPIRATORY PRESSURE | 10 DAYS |
Premature Coronary Atherosclerosis in Scleroderma

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the proportion of scleroderma patients who suffer from asymptomatic coronary atherosclerosis compared to healthy controls.

Detailed Description
-----------------
Coronary calcium scores will be obtained from a group of patients with scleroderma and a group of controls. Comparison of the calcium scores will be made.

Official Title
-----------------
Premature Coronary Atherosclerosis in Scleroderma: A Case Control Study

Conditions
-----------------
Scleroderma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years. Fulfillment of the American College of Rheumatology (ACR) criteria for the classification of scleroderma.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scleroderma, sclerosis, atherosclerosis
Validation of a French Version of the PISQ-R

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to perform the linguistic validation of the french version of the PISQ-R questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

Detailed Description
-----------------
Step 1: Establish a French translation of the original questionnaire (English> French. Step 2: Perform a first set of comprehension tests with a panel of 15 patients. Step 3: Establish a revised questionnaire. Step 4: Perform a second series of comprehension tests with a panel of 10 other patients. Step 5: Determine the final questionnaire. Step 6: Perform a back-translation (French> English. Step 7: Send the final version of the questionnaire and the questionnaire back-translated to the specific committee of the IUGA for final approval.

Official Title
-----------------
Validation of a French Version of the PISQ-R: a Tool for Evaluating the Sexuality of Patients With Urinary Incontinence or Pelvic Organ Prolapse

Conditions
-----------------
Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is able to read and understand French The patient must be insured or beneficiary of a health insurance plan Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. Exclusion Criteria: Patient is pregnant The patient is under judicial protection, under tutorship or curatorship The patient does not understand French

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The study population<br>Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. See inclusion/exclusion criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comprehension | These tests assess patient understanding of the original formulation and patient understanding of the various terms used: a list of proposed rewording suggested by patients is made. | Baseline (Day 0; transversal study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
linguistic validation of the PISQ-R questionnaire
Prognosis and Survival Estimates in Palliative Therapy

Study Overview
=================
Brief Summary
-----------------
The accuracy of clinical survival estimates is tested in comparison to objective prognostic scores.

Detailed Description
-----------------
At presentation a clinical survival estimate is obtained in each patient. Survival is also estimated using published prognostic scores in palliative care. Prognostic scores based on blood samples, general symptoms, complaints, and performance status are calculated and validated, respectively Each patient completes questionnaires on psychological distress Survival estimates are limited to 6 months. Each patient is followed for at least 6 months.

Official Title
-----------------
Prognosis in Palliative Therapy - a Prospective Study on Survival Prognostication in Advanced Stage Cancer Patients

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: no specific interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: oncologic disease confirmed incurable locally advanced or metastatic disease palliative treatment intended age > 18 able to understand the study protocol able to complete the forms with assistance if necessary Exclusion Criteria: therapy with curative intent regular clinical follow-up visit without disease progression ongoing therapy

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 |
| --- | --- |
| Palliative Therapy<br>Patients referred to the oncology / radiation oncology departments for palliative therapy. | Other: no specific interventions<br>* There are no specific interventions in this observational study<br>|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative Care, Predictive Value of Tests, Prospective Studies, Survival Analysis, Survival prediction