linjc16/ctgov huggingface dataset:
Atlas Predicted DBS Settings in Essential Tremor

Study Overview
=================
Brief Summary
-----------------
Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time intensive process. Using an atlas created using functional tremor responses in the operating room to determine the optimal settings would lead to a faster response for the patient and improved quality of life.

Official Title
-----------------
Atlas Predicted DBS Settings in Essential Tremor

Conditions
-----------------
Essential Tremor

Intervention / Treatment
-----------------
* Device: Change DBS programming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seleced for DBS of the VIM nucleus at Vanderbilt Medical center Diagnosis of essential tremor Exclusion Criteria: Unable to use the patient handheld programmer

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DBS programming, standard of care<br>DBS settings determined from the standard Neurologist symptomatic response first then change to settings from Atlas | Device: Change DBS programming<br>* Patient will change their DBS settings to move from one DBS setting to the other, allowed one hour to adjust to the new setting prior to testing<br>|
| Experimental: DBS progamming from Atlas<br>DBS settings determined from the a functional atlas first then change to settings determined by standard of care | Device: Change DBS programming<br>* Patient will change their DBS settings to move from one DBS setting to the other, allowed one hour to adjust to the new setting prior to testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fahn-Tolusa-Marsden Tremor Rating Scale | Tremor quantification | 1 month |
Alpha-1-Antitrypsin-Deficiency in COVID-19

Study Overview
=================
Brief Summary
-----------------
The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored.

Detailed Description
-----------------
The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored. Clinical outcomes, blood inflammatory markers, and virus load are monitored.

Official Title
-----------------
Individual Treatment of COVID-19 by Application of Alpha-1-antitrypsin

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

Intervention / Treatment
-----------------
* Drug: AAT( Alpha 1 Antitrypsin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infection with SARS-COV2 Age over 18 years Exclusion Criteria: Unability to consent Invasive ventilation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AAT( Alpha 1 Antitrypsin)|AAT administration based on clinical indication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical course | Disease course such as death, need for ICU treatment, ventilatory support or deterioration are monitored | 3 months |
Indication for Intraoperative Volume Therapy

Study Overview
=================
Brief Summary
-----------------
This study evaluates which substitution solutions are used in daily clincal practice in various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan Region). Furthermore the indication for usage of these solutions is investigated.

Official Title
-----------------
Indication for Intraoperative Volume Therapy

Conditions
-----------------
Patients Undergoing Any Kind of Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing surgery receiving at least one bag of cristalloid or colloid solution Exclusion Criteria: decline of participation
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 |
| --- | --- | --- |
| Number of Different Substitution Solutions Administered |  | 24h |
The Effect of E-health Video Towards Enhancing Cervical Cancer Screening

Study Overview
=================
Brief Summary
-----------------
The aim of this quasi-experimental study is to evaluate the women's motivation related to cervical cancer screening. The experiment group will receive the e-health video KaSEH and brochure as the intervention. Where as, the control group will receive brochure as the intervention. There is three phase of evaluation which are pre-intervention, intra-intervention and post-intervention. The evaluation will be assess using the self-administered questionnaire based on Protection Motivation Theory. The estimated duration of this quasi-experiment is six month.

Official Title
-----------------
Development and Evaluation of KaSEH Video to Increase Women's Knowledge and Motivation Regarding Cervical Cancer and Its Screening.

Conditions
-----------------
Cervical Cancer Screening

Intervention / Treatment
-----------------
* Other: E-health Video KaSEH
* Other: Brochure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who have never undergone cervical cancer screening. Exclusion Criteria: Women who have been diagnosed or are cervical cancer patients Women who have been diagnosed with any cancer of the gynecological system such as cancer of the vulva, vagina, uterus, fallopian tubes and ovaries.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Receive the e-health video and brochure as the intervention | Other: E-health Video KaSEH<br>* The e-health video KaSEH is produce based on Protection Motivation Theory to enhance women's motivation towards cervical cancer screening.<br>Other: Brochure<br>* The brochure contain the information regarding cervical cancer and its screening<br>|
| Other: Control group<br>Receive brochure as the intervention | Other: Brochure<br>* The brochure contain the information regarding cervical cancer and its screening<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation level | The score of motivation level measured by means (standard deviation) using The Malay-Protection Motivation Theory scale for cervical cancer screening as measurement tool. | 3 month | 
| Practice | Measured by yes (uptake of cervical cancer screening) and no (did not perform screening). | 3 month |
Nexium RESPONSE Trial

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices.

Official Title
-----------------
Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending general practice due to symptoms suggestive of acid related disease and, according to normal routine, the GP would prescribe an acid-inhibiting agent Exclusion Criteria: Alarm symptoms Pregnancy Contraindications to Nexium

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is the patient's key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acid Reflux, Nexium, Esomeprazole
ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to investigate the safety and efficacy of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.

Official Title
-----------------
ONO-4538 Multicenter, Open-label, Single-arm, Phase II Study in Advanced Non-small Cell Lung Cancer

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

Intervention / Treatment
-----------------
* Drug: ONO-4538


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 20 years of age Histologically or cytologically confirmed non-small cell lung cancer Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1) Exclusion Criteria: Current or prior severe hypersensitivity to another antibody product Multiple primary cancers

Ages Eligible for Study
-----------------
Minimum Age: 20 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: ONO-4538<br>ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle | Drug: ONO-4538<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG) |  | Approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (centrally assessed) |  | Approximately 6 months | 
| Response rate (study site assessment by investigator) |  | Approximately 6 months | 
| Overall survival |  | Approximately 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-4538, Advanced non-small cell lung cancer
Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function

Study Overview
=================
Brief Summary
-----------------
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function

Official Title
-----------------
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects With Renal Impairment and Matched Control Subjects With Normal Renal Function

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: HM15912


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject voluntairly agrees to participate in this study and sign an IRB-approved informed consent prior to perfomring any of the Screening visit procedures Males and females ≥ 18 and ≤ 80 years of age at the Screening visit Body mass index of ≥ 17.5 and ≤ 40.0 kg/m2 Meet the following eGFR criteria during the screening period based on the CKD-EPI equation: Severe renal imapriment: eGFR < 30 mL/min/1.73m2 but not requiring hemodialysis. Moderate renal impairment: 30 mL/min/1.73m2 ≤ eGFR < 60 mL/min/1.73m2, Normal renal function (eGFR ≥ 90 mL/min/1.73m2) Exclusion Criteria: Renal transplant recipients or subjects requiring hemodialysis and peritoneal dialysis Subjects with a history or presence of any psychiatric disoerder that, in the opion of the investigator, might confound the results of the study or pose addiitonal risk in administering the IP to the subject Evidence of any viral (including COVID-19), bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to the Screening visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe renal impairment<br> | Drug: HM15912<br>* Drug: HM15912 Active 0.5mg/kg<br>|
| Experimental: Normal renal impairment<br> | Drug: HM15912<br>* Drug: HM15912 Active 0.5mg/kg<br>|
| Experimental: Moderate renal impairment<br> | Drug: HM15912<br>* Drug: HM15912 Active 0.5mg/kg<br>|
| Experimental: Mild renal impairment<br> | Drug: HM15912<br>* Drug: HM15912 Active 0.5mg/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum serum concentration (Cmax) |  | Day 1 to 29 (Total duration: 29 days) | 
| Area under the concentration-time curve from extrapolated to infinity (AUC 0-infinity) |  | Day 1 to 29 (Total duration: 29 days) |
Study to Evaluate the Effects of Psyllium on Blood Glucose

Study Overview
=================
Brief Summary
-----------------
This is an open label, single use, randomized, 4-period cross-over study. In each period, subjects will receive one of 4 test combinations. Blood will be drawn prior to study product consumption and following study product consumption for glucose measures.

Official Title
-----------------
An Open Label, Randomized, 4-Period Cross-over Study to Evaluate the Effects of Psyllium Taken Before a Meal on Postprandial Blood Glucose in Healthy Males

Conditions
-----------------
Healthy Men

Intervention / Treatment
-----------------
* Dietary Supplement: 3.4 g psyllium
* Dietary Supplement: 6.8 g psyllium
* Dietary Supplement: 6.8 g psyllium
* Other: Meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male 18 to 50 years of age general good health Body Mass Index (BMI) in the range of 18.5-29.9 kg/m2 fasting plasma blood glucose <126mg/dL not actively treated for high blood glucose willing and able to have blood drawn at multiple times during each 4 visits Exclusion Criteria: history of allergy or hypersensitivity to inhaled or ingested psyllium or meal ingredients Phenylketonuria (PKU) an eating disorder following special medical or weight-loss dietary restrictions taking dietary supplements or prescription medication for the purpose of weight loss/management

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MM1 - Meal<br>3.4g psyllium served with a meal | Dietary Supplement: 3.4 g psyllium<br>* 3.4 g psyllium served with meal<br>|
| Experimental: MM2 - Meal<br>6.8 g psyllium served with a meal | Dietary Supplement: 6.8 g psyllium<br>* 6.8 g psyllium served with a meal<br>|
| Experimental: MM2 (no Meal)<br>6.8 g psyllium consumed with no meal | Dietary Supplement: 6.8 g psyllium<br>* 6.8 g psyllium<br>|
| Sham Comparator: Meal Only<br>meal only | Other: Meal<br>* meal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone |  | 4 hours |
Hot Flashes and Omega 3

Study Overview
=================
Brief Summary
-----------------
The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.

Official Title
-----------------
Evaluation de l'efficacité Des Acides Gras oméga 3 Hautement concentrés en EPA Sur Les bouffées de Chaleur, Chez Des Femmes en période de péri-ménopause et ménopause : étude Monocentrique, en Groupes parallèles, contrôlée, randomisée vs Placebo

Conditions
-----------------
Hot Flashes, Fatty Acids, Menopause

Intervention / Treatment
-----------------
* Dietary Supplement: omega-3 fatty acids
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: menopause or peri menopause complaining of hot flashes social security affiliation informed consent form signed Exclusion Criteria: primary pathology which can lead to hot flashes allergy to omega-3 fatty acids allergy to sea products High consumption of fat fish or produced by the sea iatrogenic hot flashes actual omega-3 fatty acids consumption or in the 3 last months. consumption of drug or other products for hot flashes in the last month protected persons (L1121-5 to L1121-8 of French Public health code)

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omega-3 fatty acids<br>3 capsules each day during 8 weeks | Dietary Supplement: omega-3 fatty acids<br>* highly dosed in EPA<br>* Other names: groupe actif;|
| Placebo Comparator: placebo<br>3 capsules each day during 8 weeks | Dietary Supplement: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hot flashes frequency | ANOVA by repeated measures | 1 to 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hot flashes frequency difference | difference betwwen week8 and week4 and week0 | 4 week and 8 week | 
| diurnal hot flashes | ANOVA and difference | week 1 to 8 | 
| night hot flashes | ANOVA and difference | week 1 to 8 | 
| vasomotors disorders | ANOVA and differences | week 1 to week 8 | 
| Pittsburgh Sleep Quality Index (PSQI) | sleep quality | week 0 and week 8 | 
| HFRDIS | quality of life | week 0 and week 8 | 
| The Menopause-Specific Quality of Life (MENQOL) | quality of life | week 0 and week 8 | 
| Weight |  | week 0 and week 8 | 
| fatty acids dosage | fatty acids dosage | week 0 and week 8 | 
| number of adverse events |  | week 0 to week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EPA
Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are: A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter Standard drug therapy (antiarrhythmic drugs) To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you. Eligibility Criteria Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include: 18 to 80 years of age Frequent episodes of AF Failed at least 1 drug treatment for AF (beta-blockers or standard AADs) Other criteria

Official Title
-----------------
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Endoscopic Ablation System
* Drug: Standard Anti-arrhythmic Drug (AAD) Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years old Paroxysmal atrial fibrillation (AF) Frequent episodes of AF Failed at least 1 drug treatment Others Exclusion Criteria: Others

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single ablation procedure with Endoscopic Ablation System | Device: Endoscopic Ablation System<br>* Single ablation procedure with Endoscopic Ablation System<br>|
| Active Comparator: 2<br>Medication | Drug: Standard Anti-arrhythmic Drug (AAD) Therapy<br>* Medication as prescribed by physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom for Symptomatic Episode of Atrial Fibrillation at One Year |  | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AF, PAF, paroxysmal atrial fibrillation, ablation, failed drugs