linjc16/ctgov huggingface dataset:
Effect of Different Working Conditions on Risk Factors in Dentists Versus Trainers

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to validate the sanitary consequences of dental studies respectively the longtime executed profession. In comparison to this cohort we will also check a collective of subjects with an optimum of physical activity.

Official Title
-----------------
Effects of Different Working Condition on Risk Factors in Dentists Versus Trainers. A Combined Crosssectional and Longitudinal Trial With Student and Senior Employees.

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Age 19-30 years(longitudinal) 55-60 years (crosssectional) Dentists Trainers Exclusion Criteria: Pregnant CVD Medication; and Diseases affecting body composition

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 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
-----------------
risk factors, metabolic syndrome, dentists, trainers, Healthy subjects, students, seniors
Study of Mental Fatigue in Polio Survivors

Study Overview
=================
Brief Summary
-----------------
Post-Poliomyelitis Syndrome (PPS) is the term describing the new problems affecting polio survivors many years after recovery from paralytic polio. Among the symptoms, fatigue is one of the most frequent and debilitating. In addition to physical incapacitation, the fatigue of PPS also affects mental function. The term brain fatigue is usually used by patients to express problems on the areas of attention, concentration, memory and clear thinking. Unfortunately, little is known about cognitive fatigue of PPS patients. This study is meant to examine if mental impairment is present in PPS patients and, if so, how it interferes on the self-function of patients. Patients will undergo an interview, clinical and neurological evaluation, and a battery of screening laboratory tests to make sure they are eligible for the study. Patients who qualify will undergo neuropsychometric tests in order to assay performance in the main areas of cognitive functioning. Through this organized approach we expect to be able to determine if mental fatigue is a significant problem affecting polio survivors, what areas are most affected, and how it may interfere with daily living.

Conditions
-----------------
Post-Poliomyelitis Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Be a survivor of poliomyelitis Willing to attend two clinic visits for completion of screening procedures and required tests Exclusion Criteria: Suffer from medical conditions that can interfere with cognitive function, including stroke, traumatic brain injury, dementia (progressive memory loss), severe depression, psychosis or other psychiatric disorders, etc.

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candidates for this study are survivors of paralytic poliomyelitis
A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.

Official Title
-----------------
Open-Label Study to Establish the Short Term Efficacy of Intravenous Loading-Doses of Bondronat 6 mg in Patients With Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain, Within 7 Days After Initiation of Treatment

Conditions
-----------------
Pain; Bone Neoplasms; Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: Ibandronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female participants greater than or equal to (>=) 18 years of age Breast cancer with bone metastases Pain score of >=4 on Worst Pain scale of Brief Pain Inventory (BPI) Stable analgesic regimen. Exclusion Criteria: Participants who have received a bisphosphonate within 3 weeks of start of trial Radiotherapy to bone within 4 weeks of enrolment Hypersensitivity to ibandronate Central nervous system (CNS) or meningeal metastases

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

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

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: Ibandronate<br>Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3. | Drug: Ibandronate<br>* Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.<br>* Other names: Bondronat;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with >=25% reduction in mean pain |  | up to Day 6 | 
| Percentage of participants with =<35% increase in mean analgesic consumption |  | up to Days 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in average pain score |  | Baseline (Days 0), 5, and 7 | 
| Analgesic consumption |  | up to Day 7 | 
| Pain response |  | up to Day 7 | 
| Time to pain response |  | up to Day 7 |
Systematic Lymph Node Sampling and Analysis in Patients With Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Prospective investigation of the ratio between malignant and total number of lymph nodes in predefined lymph node stations in patients resected for pancreatic adenocarcinoma. A national Danish project.

Detailed Description
-----------------
Lymph nodes will be sampled from the following stations in patients with adenocarcinomas of the pancreas Group 6: Infrapyloric lymph nodes (IP) Group 8: Lymph nodes around the common hepatic artery (CHA) Group 12: Lymph nodes of the hepatoduodenal ligament (HDL) Group 13: Posterior pancreaticoduodenal lymph nodes Group 14: Lymph nodes around the superior mesenteric artery (SMA) Group 17: Anterior pancreaticoduodenal lymph nodes

Official Title
-----------------
Systematic Lymph Node Sampling and Analysis in Patients Undergoing Radical Resection for Pancreatic Cancer. A National Danish Study

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bioptic verified pancreatic adenocarcinoma or periampullary adenocarcinoma (within 20mm of the papilla) Exclusion Criteria: Patients with non-adenocarcinoma tumors of the pancreas or periampullary region

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of malignant/total number of lymph nodes | Ratio between malignant and total number of lymph nodes in predefined lymph node stations | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of N1 patients | Number of patients with malignant lymph nodes in predefined lymph node stations | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreas adenocarcinoma, lymph node metastases
Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to establish a relationship between the administered activity of the radioiodine and absorbed dose in the tumor sites.

Detailed Description
-----------------
Study Design - the assessment of patients with multiple tumour sites with metastatic thyroid cancer to correlate the administered activity to absorbed dose. Patients will receive the standard therapy dose of 5.5 GBq as per the hospital policy and there will be no change for the protocol purpose.

Official Title
-----------------
Investigating Absorbed Radiation Dose Delivered to Differentiated Thyroid Cancer Metastases Following Administration of Fixed Activity of Radioactive Iodine

Conditions
-----------------
Thyroid Carcinoma, Metastatic Sites Lung Bone Nodal

Intervention / Treatment
-----------------
* Other: SPECT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18 histological confirmation of the differentiated thyroid carcinoma available WHO performance score 0-2 metastatic sites lung and/or bone and/or nodal (radiologically measurable disease > 1 cm) life expectancy > 6 months patient has undergone total/near total thyroidectomy no past history of sensitivity/reaction to 1311 Exclusion Criteria: non iodine concentrating tumours received chemotherapy or radiotherapy in 6 weeks pregnant or breast feeding patients iodine contrast injection in last 3 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: SPECT scan|SPECT scan measures the amount of radio activity that is remaining in patients' body after the consumption of radio iodine for therapeutic purpose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is to correlate the predicted dose from the tracer study with the actual absorbed dose measure on the therapeutic scan |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcomes will be to assess the response at 6 months post therapy in each patient |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radioiodine, differentiated thyroid cancers, dosimetry, metastases
Endovascular Function in Atrial Fibrillation (AF) Patients

Study Overview
=================
Brief Summary
-----------------
recruit 50 patients with atrial fibrillation and 30 controls endovascular function assessment with Peripheral Arterial Tonometry (PAT) follow up the occurence of AF

Official Title
-----------------
Endovascular Function in Patients With Atrial Fibrillation

Conditions
-----------------
PAT Result

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year). Exclusion Criteria: patients with cerebralvascular disease patients with coronary disease patients with peripheric artery disease

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endovascular function results | The method to assess the endovascular function is PAT. The index is Reactive hyperemia index (RHI). RHI between patients and control will be compared. | Up to 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictive effect of endovascular function on recurrence of AF | We will do the multi-logistic analysis of the recurrence of AF. | Up to 1 year |
Treatment Patterns and Outcomes in Participants With Advanced Melanoma in Germany Using a German Database

Study Overview
=================
Brief Summary
-----------------
This study is a non-interventional retrospective observational study performed on secondary data from a German multi-site cohort registry, the German national registry of skin cancer (ADOReg).

Official Title
-----------------
Treatment Patterns and Outcomes in Patients With Advanced Melanoma: A Retrospective Study Using Data From the German ADOREG Registry

Conditions
-----------------
Advanced Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent for inclusion in ADOReg registry must be documented at study site Diagnosis of advanced (nonresectable or metastatic) melanoma in stage III or stage IV Participants received any systemic therapy to treat the advanced melanoma First-line systemic treatment was initiated within the index window (19-Jun-2015 to 30-Jun-2018) Exclusion Criteria: Age <18 years at index date Receipt of clinical trial study drug at any time

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 |
| --- | --- |
| Cohort 1<br>Participants initiating first-line systemic therapy to treat advanced melanoma. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to a maximum of 4 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) |  | Up to a maximum of 4 years of follow-up | 
| Objective Response Rate (ORR) |  | Up to a maximum of 4 years of follow-up | 
| Duration of Response (DOR) |  | Up to a maximum of 4 years of follow-up | 
| Treatment-free Interval (TFI) |  | Up to a maximum of 4 years of follow-up | 
| Treatment-free Survival (TFS) |  | Up to a maximum of 4 years of follow-up | 
| Incidence Rate (IR) of Adverse Drug Responses (ADRs) |  | Up to a maximum of 4 years of follow-up | 
| Resolution Rate (RR) of ADRs |  | Up to a maximum of 4 years of follow-up | 
| Frequency of ADRs |  | Up to a maximum of 4 years of follow-up | 
| Time to Treatment Discontinuation |  | Up to a maximum of 4 years of follow-up |
A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

Study Overview
=================
Brief Summary
-----------------
To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.

Official Title
-----------------
A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: BLI-801
* Drug: BLI-801
* Drug: BLI-801
* Drug: BLI-801


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects at least 18 years of age Constipated according to ROME I criteria Otherwise in good health, as determined by physical exam and medical history If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse) Negative urine pregnancy test at screening, if applicable In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study Exclusion Criteria: Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study Subjects who are pregnant or lactating, or intending to become pregnant during the study Subjects of childbearing potential who refuse a pregnancy test Subjects who are allergic to any BLI-801 component. Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BLI-801 Dose 1 | Drug: BLI-801<br>* Dose 1<br>|
| Experimental: 2<br>BLI-801 Dose 2 | Drug: BLI-801<br>* Dose 2<br>|
| Experimental: 3<br>BLI-801 Dose 3 | Drug: BLI-801<br>* Dose 3<br>|
| Experimental: 4<br>BLI-801 Dose 4 | Drug: BLI-801<br>* Dose 4<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel Movement Count |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, laxative
Safety and Effectiveness Study of the Solysafe Septal Occluder

Study Overview
=================
Brief Summary
-----------------
Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)

Official Title
-----------------
Prospective Mono-center Clinical Study to Evaluate the Safety and Effectiveness of an Intracardiac Septal Closure Device in Patients With Atrial Septum Defect (ASD)

Conditions
-----------------
Atrial Septal Defects

Intervention / Treatment
-----------------
* Device: Device Closure of a Septal Defect


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASD Exclusion Criteria: Criteria that exclude catheterization (e.g. too small size, DIC, high risk of bleeding such as coagulation or clotting disorders)

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- |
|Device: Device Closure of a Septal Defect|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
The venous thromboembolism is one of the first causes of maternal mortality. Until 2003, only a few recommendations were available on the optimal use of antithrombotic therapy as a preventive measure against thromboembolism in pregnant women. In this study, we propose : To gather the experts who took part in the French consensus conference and the local experts to create a score in accordance with the national and international consensus and to give some precise therapeutic strategies. To evaluate the discriminant, feasible and useful character of this new score by a prospective multicentric study including 2000 pregnant women with a risk of thromboembolism or placental vascular pathology who will benefit from therapeutic strategies defined by the new score. .

Detailed Description
-----------------
Purpose : To create a score inspired by our first experience i.e. simple, standardized and quickly usable in day-to-day practice to individualize antithrombotics prescription to women at risk.

Official Title
-----------------
Prospective Multicentric Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women With a Risk of Thromboembolism and/or a Risk of Placental Vascular Complication, Strategy Determined With a Risk Score.

Conditions
-----------------
Placental Vascular Pathologies, Venous Thromboembolism Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multiparous or primiparous parturients followed in one of the participating centers Presenting at least one risk factor of venous thromboembolic pathology and/or placental vascular pathology Exclusion Criteria: parturient that can't be followed unknown familial or personal previous history Parturient with a contraindication to use of the treatment recommended by the therapeutic strategy

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

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

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 |
| --- | --- | --- |
| Occuring of symptomatic thromboembolic events and/or placental vascular pathology, any other pregnancy pathology requiring hospitalization, any complications from the antithrombotic treatment |  | first, second or third trimester during pregnancy or post-partum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venous thromboembolism diseases, placental vascular pathologies, antithrombotic treatment, symptomatic thromboembolic events, pregnant women, score, therapeutic strategies, heparin, aspirin, pregnancy pathology