linjc16/ctgov huggingface dataset:
Factors of Importance for the Subjective and Objective Burden of Informal Caregivers to Patients With Functional Psychoses - a Descriptive and Comparative Study

Study Overview
=================
Brief Summary
-----------------
The objective is to find determinants for the subjective and objective burden of informal caregivers to patients who are requiring continued antipsychotic treatment for functional psychoses among factors related to the patient, the health care and support provision system and the informal caregiver him/her-self.

Detailed Description
-----------------
The study also comprises a descriptive part with the aim: To describe clinical characteristics, symptoms, and functioning in the patient group. To describe patient resource use in terms of support from the health care and social care sector. To describe the socio-economic situation, the general and psychological health, and the coping ability of the informal caregivers.

Official Title
-----------------
Factors of Importance for the Subjective and Objective Burden of Informal Caregivers to Patients With Functional Psychoses - a Descriptive and Comparative Study

Conditions
-----------------
Functional Psychoses, Informal Caregivers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Patients, male or female, aged 18 years or more, suffering or having suffered from a psychotic episode and being in need of continuous antipsychotic medication. The respective patient must have at least one informal caregiver. Subjects (patients and informal caregivers) must be able to read and write. Exclusion Criteria: Diagnosis of dementia and such cognitive impairment which makes self assessments even with assistance unreliable (patients and informal caregivers). Involvement in the planning and conduct of the study (patients and informal caregivers). Other concurrent medical condition interfering with ability to complete study (patients and informal caregivers).

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 |
| --- | --- |
| 1<br>Patients having the following diagnoses are eligible for inclusion into the study: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, delusional disorder, affective psychosis with mood incongruent delusions, psychotic disorder not otherwise specified or patients being actively psychotic. | |
| 2<br>Closest relative(s) /informal caregiver(s) | |

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
-----------------
Caregiver burden
Comparing Aerobic to Resistance Training in Recovery From Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the health outcomes of a 12-week exercise program focused on aerobic training (using a treadmill) to a 12-week exercise program focused on resistance training (using Thera-Bands) in sedentary patients within 6 months of completing treatment for cancer.

Official Title
-----------------
Comparing Aerobic to Resistance Training in Recovery From Cancer

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have a biopsy-proven cancer diagnosis be within six months of having completed chemotherapy or radiation therapy for treatment for cancer as determined by the primary physician be ambulatory but sedentary (i. e., has not followed an exercise regimen of a minimum of 3 times per week for at least 20 minutes each session over the previous six weeks) have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 asymptomatic) or 1 (symptomatic, fully ambulatory) be at least 18 years old be able to read and speak English have a medical statement from either the patient's primary care provider or the primary oncologist indicating that participation in the program is not medically contraindicated Exclusion Criteria: following an exercise regimen a minimum of 3 times per week for at least 20 minutes each session within the previous 6 weeks bone or joint destruction that could be aggravated with exercise severe cognitive impairment identified by either the patient's medical care provider or by the study team neuropathy-sensory common toxicity criteria (CTC) grade 3 (sensory loss or paresthesia interfering with activities of daily living) or grade 4 (permanent sensory loss that interferes with function) peripheral neuropathy

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>aerobic exercise | Behavioral: Exercise<br>* aerobic or resistance training<br>|
| Experimental: 2<br>Resistance Training | Behavioral: Exercise<br>* aerobic or resistance training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise tolerance |  | 12-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Fatigue, Exercise tolerance, Quality of life, Health status
Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to try and identify a more effective treatment plan to improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain tumor that can be removed by brain surgery. The study will record what effects (good and bad) the combination of surgery with chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery and post-operative chemotherapy has on the patient and their survival rate over the next 12 months.

Official Title
-----------------
Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab

Conditions
-----------------
Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Drug: BCNU Wafer
* Drug: Irinotecan
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologically proven diagnosis of GBM in the past with MRI findings compatible with disease recurrence. Multifocal disease is permitted. Must have had prior treatment with standard doses of Temodar KPS >50; ECOG <3 Predicted life expectancy of > 3 months Study entry must be within 5 weeks of surgical resection Exclusion Criteria: Prior exposure to VEGF inhibitors or Irinotecan Intracranial bleed as defined by CT or MRI less than 6 months prior to entry GI bleed less than 6 months prior to entry Uncontrolled concurrent illness that would limit compliance with study requirements

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCNU wafter followed by chemotherapy<br>Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year | Drug: BCNU Wafer<br>* Implantable during surgical resection into the tumor bed<br>* Other names: Gliadel Wafer;Drug: Irinotecan<br>* IV every 2 weeks for up to one year<br>* Other names: CPT-11;Drug: Bevacizumab<br>* IV every 2 weeks for up to one year<br>* Other names: Avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess disease free survival |  | 6 and 12 months |
Drug Use-Results Survey on Picoprep® Combination Powder

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to confirm safety and efficacy with patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.

Official Title
-----------------
Drug Use-Results Survey on Picoprep® Combination Powder

Conditions
-----------------
Bowel Cleansing

Intervention / Treatment
-----------------
* Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.
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 administered Picoprep® for bowel cleansing<br>Patients administered Sodium Picosulfate, Magnesium Oxide and Citric Acid for bowel cleansing | Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid<br>* Combination powder for oral solution<br>* Other names: Picoprep®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel cleansing assessment for colonoscopy | Assessment of each part of large intestine using a bowel cleanliness rating scale | 48 hours after drug administration | 
| Bowel cleansing assessment for colorectal surgery | Assessment of each part of large intestine using a bowel cleanliness rating scale | 48 hours after drug administration |
Circadian, Weekly and Seasonal Variability of Postoperative Mortality and Morbidity (Zirkadianest)

Study Overview
=================
Brief Summary
-----------------
Mortality is subject to cyclic variability: circadian, weekly, and seasonal. This has been shown for different populations, different diseases and in different countries, but not for surgical patients. Aim of this study is therefore to investigate the association between circadian, weekly, and seasonal effects time of surgery postoperative mortality of patients undergoing surgery and general anesthesia.

Official Title
-----------------
The Association Between Circadian, Weekly, and Seasonal Effects and Time of Surgery on Postoperative Morbidity and Mortality of Patients (Zirkadianest)

Conditions
-----------------
Postoperative Mortality and Morbidity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Patients who underwent anesthesia within the study time period. Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult patients<br>All patients undergoing general anesthesia between January 2006 and December 2013 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative mortality | The primary objective of this study is to show associations between postoperative mortality and circadian, weekly and seasonal rhythms. Electronic patient charts are revised for complete hospital length of stay for time of surgery, co-morbidities, intra-operative data and all-cause in-hospital mortality | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | The secondary objective of this is to show associations between hospital length of stay and circadian, weekly and seasonal rhythms. Electronic patient charts are revised for complete hospital length of stay for time of surgery, co-morbidities, intra-operative data and hospital length of stay | One year |
Genes of Hypertension in African Americans

Study Overview
=================
Brief Summary
-----------------
To identify genes contributing to hypertension in African Americans by focusing on the physiological pathways that determine arterial pressure.

Detailed Description
-----------------
BACKGROUND: Since the mid 1990s, the investigators have extensively characterized African Americans for phenotypes related to cardiovascular and renal function. Based on recently completed genome scans, they have identified several chromosomal regions likely to contain genes influencing hypertension-related phenotypes in hypertensive, African American sib pairs. For several phenotypes, overlapping QTLs have also been identified in related studies in a genetically isolated French Canadian population and/or in homologous chromosomal regions in the F2 cross of Dahl-salt sensitive x normotensive Brown Norway rats. DESIGN NARRATIVE: The investigators will extensively phenotype 500 hypertensive and 500 normotensive African American subjects to conduct a genetic association study, using a single nucleotide polymorphism (SNP) genomic scan approach. To achieve a clear separation of blood pressures from hypertensive subjects, normotensive subjects will be selected from the lower third of the population-based blood pressure distribution. Hypertensive (BMI), and age. Inclusion of phenotypes is based on their relevance to the pathophysiology of hypertension and prior evidence of heritability. Candidate genes for SNP analysis will be selected within chromosomal regions of two quantitative trait loci (QTLs) that they have previously demonstrated to be linked to hypertension-related phenotypes--a QTL for body mass index on chromosome 1 and a QTL for microalbuminuria on chromosome 18. SNP analyses will be carried out in 15 percent of the genes within each of these QTLs, and genes will be selected on the basis of their relevance to hypertension, including documented sequence conservation for blood pressure related QTLs with rat or mouse. The final goal of the project is to determine if distinct clusters of blood pressure related phenotypes can be identified that will permit stratification of hypertensive individuals into distinct subgroups to facilitate the analysis of the genetic determinants of hypertension and/or provide mechanistic leads to genes contributing to these traits.

Official Title
-----------------
Genes of Hypertension in African Americans

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
African Americans, age 18-75 years

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genes of hypertension in African Americans | There is no intervention | One time data collection |
Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether low-dose contraceptive pills are effective in the improvement of quality of life in patients in the different phases of menacme.

Official Title
-----------------
Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme

Conditions
-----------------
Quality of Life, Menopause, Contraception

Intervention / Treatment
-----------------
* Drug: gestoden 60 mcg
* Drug: ethinylestradiol 15 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fertile women with indication of use of contraceptive pills Exclusion Criteria: Fertile women with any surgical contraceptive method Women in menopause Diseases the forbidden the use of the drug

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 46 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gestoden and ethinylestradiol<br>Gestoden 60 mcg plus ethinylestradiol 15 mcg, once a day, administered in 24∕4 regimen, for three months. The use of gestoden and ethinylestradiol can do an improvement of the quality of life before and after the use of the drug.Numerous large clinical trials have shown that this combination is as effective in preventing pregnancies as other oral contraceptives presently on the market. Irregular bleeding and spotting rates appear to be at least as good as older formulations. In general, the incidence of side effects associated with the progestin and estrogen components tends to be low, with very little impact on lipid and carbohydrate metabolism. . For this, the regimen can ameliorate the quality of life of the patients. | Drug: gestoden 60 mcg<br>* gestoden 60 mcg, once a day, administered in 24/4 regimen.<br>* Other names: gestodene and ethinyl estradiol;Drug: ethinylestradiol 15 mcg<br>* ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen<br>* Other names: oral contraceptives;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | eleven months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life in differents phases of menacme |  | eleven months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life, Menopause, Contraception
The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice

Study Overview
=================
Brief Summary
-----------------
The study explore the relationship between COVID-19 and the induction of autoimmune diseases.

Detailed Description
-----------------
It has been suggested that the shared pathogenetic mechanisms and clinical-radiological aspects between the hyper-inflammatory diseases and Covid-19 may suggest that SARS-CoV-2 could act as a triggering factor for the development of a rapid autoimmune and/or autoinflammatory dysregulation, leading to the severe interstitial pneumonia, in genetic predisposed individuals.

Official Title
-----------------
The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all gender all age All cases with symptoms or signs suspected to be AI (arthralgia, myalgia, dry eye, dry mouth, generalized pain, ... etc) Exclusion Criteria: Those who refused to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Confirmed COVID19<br>Confirmed COVID19 | |
| Not COVID19<br>Not COVID19 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of autoimmune conditions | incidence of autoimmune conditions | Two-weeks | 
| incidence of autoimmune conditions | incidence of autoimmune conditions | Two-months |
Feasibility of Use of BariCare App in Pre-bariatric Surgery.

Study Overview
=================
Brief Summary
-----------------
This current study aims to evaluate the efficacy of engagement modules in preparing patients for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app (Android and Apple compatible) has been created that will assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged during the lengthy pre-bariatric surgery process.

Official Title
-----------------
Feasibility and Efficacy of Engagement Modules for Pre-Bariatric Surgery Patients.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Use of smartphone app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, who upon completion of an evaluation by Endocrinology, are considered appropriate to pursue a primary, laparoscopic bariatric surgery. Patients who are 18 years of age or greater. Patients who own a smartphone. Exclusion Criteria: Patients with a history of a prior bariatric surgery. Patients with active psychiatric disorder(s). Patients with active tobacco use. Patients with active substance use (alcohol, illicit drugs, etc.)

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Smartphone Arm<br>This is a feasibility trial and thus all participants in the study will be provided a smartphone app to assist them in preparing for bariatric surgery. | Behavioral: Use of smartphone app<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smart phone app feasibility | All subjects will complete a Bariatric Surgery Questionnaire consisting of 30 questions that assess their knowldege in areas of nutrition, physical activity, and bariatric surgery. They will also be given a questionnaire on physical activity (International physical activity questionnaire or IPAQ). The primary objective is to assess improvement on both of these questionnaires with use of app. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use of app | Through a questionnaire provided at the end of study, we will be gathering input from participants regarding ease of use of app, things they would like added or removed, as well as if they found modules helpful. | 3 months |