linjc16/ctgov huggingface dataset:
Behavioural Problems in Huntington Disease : Analysis and Enhancement of Caregiver and Patient Experience

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that caregivers experience allows them to develop a lot of knowledge and know-how about behavioural problems in Huntington Disease and its consequences. The purpose of this study is to collect, describe and analyse caregivers experience in order to find and enhance their knowledge related to the adaptation to behavioural problems of Huntington Disease patients.

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Behavioral: questionnaire qualilty of life
* Behavioral: psychological interview
* Behavioral: psychological tests
* Other: Motor evaluation
* Behavioral: Behavioral evaluation
* Behavioral: cognitive tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For patients: Patients with Huntington Disease declared Huntington Disease diagnosed with abnormal number of CAG repeats: 38 < nucleotide expansion (CAG) Total Functional Capacity ≥ 7 Patients living with a caregiver Aged 18 years and above Subject gave its written consent For caregivers : No risk of caregiver having Huntington disease Aged 18 years and above Subject gave its written consent Exclusion Criteria: For patients: Patient who do not live with a caregiver No national health insurance affiliation Being under guardianship For caregivers : Caregiver at risk for Huntington Disease No national health insurance affiliation Being under guardianship

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients<br> | Behavioral: psychological interview<br> <br> Behavioral: psychological tests<br> <br> Other: Motor evaluation<br> <br> Behavioral: Behavioral evaluation<br> <br> Behavioral: cognitive tests<br> <br> |
| Other: Caregivers<br> | Behavioral: questionnaire qualilty of life<br> <br> Behavioral: psychological interview<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Huntington's Disease health-related Quality of Life questionnaire | The primary outcome is to find a list of caregiver competences necessary to prevent and adapt to behavioural problems of Huntington Disease patients. | Baseline |
Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

Study Overview
=================
Brief Summary
-----------------
Implantable cardioverter defibrillators (ICD) may have the capacity to provoke or worsen ventricular tachyarrhythmias (VT). It has been reported that ICD shocks by itself can increase mortality. This study aimed to determine the role of back-up pacing-induced VT (PIT) to the overall ICD shock burden by avoiding pause-related ventricular back-up pacing by programming the pacing output to a sub-threshold level for ineffective pacing.

Official Title
-----------------
Sub-threshold Ventricular Back-up Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

Conditions
-----------------
Ventricular Tachyarrhythmias, ICD Shock Therapy, ICD Shock Burden

Intervention / Treatment
-----------------
* Other: Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years implanted ICD occurrence of pacemaker-induced VT Exclusion Criteria: documentation of pause-related syncope AV block sick-sinus syndrome younger than 18 years

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 |
| --- | --- |
| Patients with PIT<br>Identification of patients with pacemaker-induced ventricular tachycardias | Other: Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level<br>* Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level to achieve an ineffective pacing output<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of VT requiring ICD shock | Patients were followed-up for the occurrence of ventricular tachycardia requiring ICD shock therapy | 48 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of arrhythmia / Number of arrhythmia | Analysis of the number and the types of recurrent arrhythmias requiring ICD shock termination | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, ventricular tachyarrhythmia, shock, sub-threshold pacing
Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors

Study Overview
=================
Brief Summary
-----------------
A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine Kinase Inhibitors.

Official Title
-----------------
A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients With Non-Small Cell Lung Cancer Who Have Progressive Disease After Treatment With Tyrosine Kinase Inhibitors

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: zalutumumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have documented disease progression after TKI treatment (verified by CT scan and/or MRI according to RECIST). Exclusion Criteria: Estimated life expectancy of less than 3 months. Received the following treatments within 2 weeks prior to Visit 2: Cytotoxic or cytostatic anti-cancer chemotherapy Total resection or irradiation of the target lesion Any investigational agent

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zalutumumab<br> | Drug: zalutumumab<br>* IV infusion, 16mg/kg on weekly basis until DP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months. |  | within 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control defined as CR, PR or Stable Disease (SD) according to the RECIST criteria (revised version 1.1) within 6 months. |  | within 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, Zalutumumab, Efficacy, Safety
Oral Manifestation of COVID 19 Patient: A Cross Sectional Study on Egyptian Population

Study Overview
=================
Brief Summary
-----------------
The oral manifestation of COVID 19 that could help in the diagnosis of patient

Detailed Description
-----------------
Oral ulceration,oral lesion,sensitivity that has been reported by patient tested positive for COVID 19

Official Title
-----------------
Oral Manifestation of COVID19

Conditions
-----------------
Oral Health and COVID 19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tested COVID positive No other chronic disease that has oral manifestation Above 18 Exclusion Criteria: Children Patient with no COVID positive

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral manifestation | The presence or absence or oral manifestation like ulcer burning sensation..will be measured by yes or no using a list of question | 1month |
Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to determine the safety, pharmacokinetics, immunogenicity in humans, the recovery time required from the biologic effects and the optimal biologic dose range of BMS188667 (CTLA4Ig)

Official Title
-----------------
Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: Abatacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women who received adequate counseling and were judged reliabel in their use of contraceptive measures. Diagnosis and documentation of stable psoriasis vulgaris of at least 6 months duration. Psoriasis vulgaris total body surface area involvement between 10% and 49% (Overall Disease Severity Score [ODSS]of 4-7 inclusive). Failure of toxicity or inefficacy of at least one standard antipsoriatic therapy including topical treatment, etretinate, phototherapy, or methotrexate. Exclusion Criteria: Treatment with: a) Retinoids within 2 years, b) cyclosporin A, systemic corticosteroids, methotrexate, or an investigational agent within 16 weeks, c) any phototherapy or photochemotherapy within 4 weeks d) any topical psoriasis treatment other than emollients within 2 weeks prior to enrollment. No clinical response to a prior adequate therapeutic trial of cyclosporin A Prolonged exposure to the sun within 4 weeks prior to the first dose. Guttate, erythrodermic, or pustular psoriasis. Spontaneously improving or rapidly deteriorating psoriasis vulgaris.

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change relative to pretreatment of the Overall Disease Severity Score (ODSS) for psoriasis vulgaris as assess by a blinded observer. Phage-Neutralizing anitbody titer |  | at Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's globas Assessment |  | at Day 36 | 
| Phage-neutralizing antibody titer |  | at Day 16 and Day 29 | 
| Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected |  | at Day 43 |
Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.

Official Title
-----------------
A Randomized, Multicenter, Open-label, Active-controlled, Single-dose, 5-period, Incomplete Block, Cross-over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma

Conditions
-----------------
Stable Asthma

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol
* Drug: formoterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Diagnosis of asthma and baseline lung function tests as determined by the protocol Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol Exclusion Criteria: Severe asthma Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: budesonide/formoterol<br> <br> * Other names: Symbicort;|
| Active Comparator: 2<br> | Drug: formoterol<br> <br> * Other names: Oxis Turbuhaler;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average FEV1 during 12 hours |  | Once a week for 5 weeks during treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine levels of formoterol in 2 different formulations |  | Once a week (12 hour urine collection) for 5 weeks during treatment period | 
| Safety profiles of formoterol in 2 different formulations |  | Once a week for 5 weeks during treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stable asthma, adults, formoterol, Symbicort, Oxis Turbuhaler, bronchodilation
A Phase I Study in Healthy Volunteers to Assess Dosimetry and Safety Following Injection of BMS747158 at Stress

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn the biodistribution of injection of BMS747158 at stress and assess the safety of two doses of BMS747158

Official Title
-----------------
A Phase I Dosimetry, Biodistribution and Safety Study of BMS747158 in Healthy Subjects Undergoing 2-Day Rest/Stress Positron Emission Tomography

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: BMS747158


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-40 BMI 18-30 kg/m2 No active or chronic illnesses If female: not pregnant, use of birth control or not of child-bearing potential Exclusion Criteria: Significant active or chronic illness Any neurological disorder GI disease within 3 months Recent infection Major surgery within 4 weeks Donation of blood within 4 weeks Blood transfusion within 4 weeks Recent history drug/alcohol abuse Head trauma Significant screening ECG, EEG, lab tests, physical exam and vital signs abnormalities Prescription or OTC drugs within 2 weeks Exposure to any other investigational

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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: 1<br> | Drug: BMS747158<br>* 2 IV injection of  11 mCi (total) F-18 labeled compound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetry analysis following whole body imaging after stress injection |  | Imaging takes place approximately 0 - 300 minutes post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety analysis following vital signs, ECGs, EEG, neuro and physical exams, telephone and visit follow up, and blood draws for chemistry and hematology post injection of BMS747158 at rest and stress |  | Screening (14 days prior to dosing) through 14 days post dose administration |
Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders (COVID-19)

Study Overview
=================
Brief Summary
-----------------
Participants are healthcare workers and adult outpatients referred in a COVID-19 screening center. Patients-reported symptoms are collected, then participants underwent a simple olfactory test (CODA for Clinical Olfactory Dysfunction Assessment), prior to swabbing for SARS-CoV-2 diagnosis (RT-PCR). We aimed to evaluate the prevalence of smell and taste disorders, and to calculate the diagnostic value of patient-reported and clinically verified smell disorders in persons with suspected COVID-19.

Official Title
-----------------
Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for COVID-19

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: Reporting of anosmia, ageusia and other clinical symptoms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Symptoms compatible with COVID-19 Close exposure to a confirmed COVID-19 index case Ambulatory (asymptomatic, or if symptomatic, did not require hospitalisation, thus with initial mild disease) Exclusion criteria: known history of smell and taste disorders testing inability (cognitive impairment, non native French speakers, test malingering) testing contraindication (children, pregnancy, breastfeeding, specific allergies).

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 |
| --- | --- |
| COVID-19<br>Healthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France. | Biological: Reporting of anosmia, ageusia and other clinical symptoms<br>* Reporting of anosmia, ageusia and other clinical symptoms related to COVID-19 - CODA test - SARS-CoV2 RT-PCR and ELISA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic values of anosmia and ageusia for COVID-19 | Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic values of CODA | Diagnostic values of CODA (Clinical Olfactory dysfunction Assessment) score for COVID-19 : Simple, fast, semi-objective olfactory test developed for epidemic context | at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, COVID-19, Diagnostic value, Sensitivity, Specificity, Prevalence, Positive predictive value, Negative predictive value, Epidemiology, Diagnostic test, Anosmia, Ageusia, Olfactory disorders, Gustatory disorders, Smell disorders, Taste disorders
EUS-FNA of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique

Study Overview
=================
Brief Summary
-----------------
50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle aspiration using two techniques: negative pressure and slow-pull. Cytological results will be compared.

Detailed Description
-----------------
The study will analyze the cytological results of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic mass using two different techniques of needle suction. Negative pressure and slow-pull. 50 patients with pancreatic mass will be submitted to four passes with both techniques. Each patient will be randomized to decide which technique will be first and subsequently on a alternated fashion until four passes are completed. Smear cytology and cell block preparations for each technique were obtained. The pathologist was blinded for the EUS-FNA technique.

Official Title
-----------------
Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique

Conditions
-----------------
Pancreatic Neoplasm

Intervention / Treatment
-----------------
* Procedure: Endoscopic ultrasound-guided fine needle aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pancreatic solid mass Exclusion Criteria: endoscopic ultrasound non accessible lesions

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: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS- FNA Slow-pull<br>Endoscopic ultrasound-guided fine needle aspiration using a stylet slow-pull technique of solid pancreatic mass | Procedure: Endoscopic ultrasound-guided fine needle aspiration<br>* pancreatic solid mass punctured with a 22G endoscopic ultrasound needle<br>* Other names: EUS-FNA;|
| Active Comparator: EUS-FNA Negative Pressure<br>Endoscopic ultrasound-guided fine needle aspiration using negative pressure technique of solid pancreatic mass | Procedure: Endoscopic ultrasound-guided fine needle aspiration<br>* pancreatic solid mass punctured with a 22G endoscopic ultrasound needle<br>* Other names: EUS-FNA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | cytological results after endoscopic ultrasound fine needle aspiration | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eus-fna, pancreatic neoplasm, slow-pull, negative pressure