linjc16/ctgov huggingface dataset:
Atrial Fibrillation Monitoring on Patients With Lymphoma After Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This prospective cohort study is to investigate the incidence of atrial fibrillation after chemotherapy by aplying wearable ECG recoder and the risk factors on patients with newly diagonsed lymphoma

Detailed Description
-----------------
This prospective, single-centre, observational cohort study is disigned to enroll 100 newly diagnosed lymphoma patients who met the inclusion and exclusion criteria to monitor the onset of atrial fibrillation and other arrhythmias during chemotherapy by using wearable ECG recorder, and to evaluate the incidence of atrial fibrillation and related risk factors.

Official Title
-----------------
A Cohort Study of Atrial Fibrillation Monitoring on Patients With Lymphoma After Chemotherapy by Applying Wearable Electrocardiogram

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old; Concurrent chemotherapy on patients with new-onset lymphoma: chemotherapy regimens containing anthracyclines; The subject voluntarily signed the informed consent. Exclusion Criteria: With heart failure, acute stroke or acute coronary syndrome within 3 months before admission With Atrial fibrillation on admission Patient after pacemaker surgery With mental illness or mentally disabled Patients that the investigator considers as unsuitable for this test

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Incidence | Incidence of atrial fibrillation after chemotherapy | 1 year after the first course of chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lymphoma, chemotherapy, atrial fibrillation
Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique

Study Overview
=================
Brief Summary
-----------------
Three complementary activities will be implemented:1) Baseline and repeat census of the catchment population; described in a separate protocol (IVI-ECOVA-03-WS1); 2) Enhanced surveillance for COVID-19 disease, and 3) AEFI-enhanced surveillance. The mass vaccination campaign will be conducted by the Government and is not part of this protocol.

Official Title
-----------------
Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique

Conditions
-----------------
Sars-CoV-2 Infection

Intervention / Treatment
-----------------
* Other: Sinopharm Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They resided in the study area at the time of mass immunization with the Sinopharm vaccine; and They are at least 18 years of age during first round of mass vaccination. Their onset of symptoms was <10 days prior to testing. For each selected PCR test-positive case, we will select up to 3 test-negative controls from generally eligible subjects, matched to each case by age on the date of testing, sex, and calendar date of testing + 3 days. Exclusion Criteria: We will exclude subjects for selection as controls if they have had a positive test result within the following 21 days Any Participant not matching the inclusion criteria mentioned above.

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 |
| --- | --- |
| Case<br> | Other: Sinopharm Vaccine<br>* Sinopharm Vaccine will be administered by the Govt as part of COVID-19vaccination campaign<br>|
| Test Negative Control<br> | Other: Sinopharm Vaccine<br>* Sinopharm Vaccine will be administered by the Govt as part of COVID-19vaccination campaign<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease | Protection conferred by two completed doses of Sinopharm vaccine against RT-PCR-confirmed COVID-19 disease measured as the reduction in risk in adults who received two completed doses of the vaccine compared to those who are not vaccinated. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against severe SARS-CoV-2 infection | Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against RT-PCR confirmed severe SARS-CoV-2 infection | 2 years |
Comprehensive Frailty Assessment

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to describe a patients' fitness before and after treatment (whether that treatment be chemotherapy or a transplant). Fitness is a way of measuring a patient's current quality of health. With surveys, questionnaires and blood tests, we hope to create a tool that will give a good picture of patients' ability to tolerate treatment. In the future, we hope to devise the best treatment for a patient based on their fitness.

Official Title
-----------------
Comprehensive Frailty Assessment

Conditions
-----------------
Myeloma, Multiple, Paraproteinemias, Hematologic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a plasma cell dyscrasia AND/OR any patient receiving a stem cell transplant for a hematologic malignancy at The Ohio State University at least 18 years of age Exclusion Criteria: - Any medical or psychiatric condition that would make it difficult for the patient to comply with study procedures.

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 |
| --- | --- |
| Arm I: Transplant patients<br> | |
| Arm II: Plasma cell dyscrasia patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Comprehensive Frailty Assessment | Responses to the Comprehensive Frailty Assessment will be assessed before and after treatment and changes will be evaluated. In transplant patients, this will be measured one year post transplant and in the non-transplant arm, this will be assessed after the second cycle of treatment. | up to 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | We will assess time to progression for multiple myeloma patients and the relationships of those outcomes to patients' functional, cognitive and psychosocial health. | date of enrollment to date of documented clinical progression up to two years post-enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myeloma, MGUS (monoclonal gammopathy of undetermined significance), amyloidosis, stem cell transplant
Beta-2 Polymorphisms and Beta Receptor Selectivity

Study Overview
=================
Brief Summary
-----------------
We hypothesize that b2 adrenergic polymorphisms affect b-receptor selectivity in patients with heart failure treated with either a b1-selective or a b-nonselective agent. b-2 polymorphisms may contribute to differing responses to drug treatment with beta-blockers in heart failure. Characterizing these polymorphisms may help explain the variability in the degree of selectivity of action of b-blockers at the b receptor, namely if their action is specific for the b-1 or b-2 receptor. Part A was conducted at the University of Utah, and all subjects completed study related activities. Part B (sub-study) consists of genotyping of blood samples collected in part A, which will be completed at the University of Wisconsin. Sub-study (samples and DNA isolation) or Part B entailed analyzing an extra 10 mL of blood that was taken for DNA isolation. Genotyping (i.e. determination of genetic makeup) of beta adrenergic polymorphisms utilized polymerase chain reaction followed by pyrosequencing.

Official Title
-----------------
The Effects of ß2 Polymorphisms on Beta Selectivity After ß-adrenergic Blockade in Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Terbutaline plus Metoprolol or carvedilol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: systolic dysfunction with ejection fraction ≤40% symptomatic heart failure class 2-3 >18 years of age optimal medical therapy of HF excluding the use of any beta-blockers within the previous 30 days of the study Exclusion Criteria: active myocarditis hemodynamically significant valvular heart disease hypertrophic cardiomyopathy contra-indications to beta-blockers concomitant use of beta-agonists beta-antagonist or anti-arrhythmics unstable angina myocardial infarction or bypass surgery within 3 months significant renal insufficiency [creatinine >2.5 mg/dL], liver disease, or anemia

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Terbutaline plus Metoprolol or carvedilol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of beta-2 polymorphisms on potassium changes in response to terbutaline infusions |  |  |
Cognitive Ability Training in Seniors

Study Overview
=================
Brief Summary
-----------------
This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation [tDCS]) during working memory training in seniors with subjective memory impairments.The placebo-controlled double blinded study includes 50 elderly probants which were randomized into verum or sham tDCS.

Official Title
-----------------
Verbesserung Kognitiver Fähigkeiten im Alter

Conditions
-----------------
Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Device: Verum tDCS
* Device: Sham tDCS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: native german speaker between 60-70 years old subjective memory impairment Exclusion Criteria: psychiatric, neurological diseases uncorrected hearing or vision deficits actual psychopharmaca intake metal parts in the head medical electronical implants

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 70 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum tDCS<br>Left frontal anodal stimulation, supraorbital right cathodal stimulation | Device: Verum tDCS<br>* Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anadal, right cathodal<br>|
| Experimental: Sham tDCS<br>sham stimulation, same electrode positions | Device: Sham tDCS<br>* Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological performance in neuropsychological tests | The Investigators are measuring cognitive performance for different executive functions | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activation measured with NIRS | The Investigators are measuring brain activation during executive functions | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subjective Memory Impairment, tDCS, NIRS, Cognitive Training, Working Memory
Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate possible changes in quality of life related to health (HRQL) in locally advanced and metastatic prostate cancer patients, after one year of follow-up.

Official Title
-----------------
Prospective Epidemiological Study to Determine the Variation in the Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer (PROS-PROSQoLI Study)

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men ≥ 18 years old Symptomatic prostate cancer patients who present symptoms due to prostate cancer disease Capacity to comply with the protocol Patient with an expected survival > 12 months Exclusion Criteria: Patients who are also participating in any other clinical study Patient with other malignant diseases, apart from prostate cancer

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

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

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 |
| --- | --- | --- |
| Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socio-demographic characteristics (percentage of patients (a) living married or living with a partner, (b) had completed primary studies, (c) retired or pensioners, (d) patients had a family history of PrCa) |  | 12 months | 
| Anthropometric Characteristics - Body Mass Index |  | Baseline | 
| Prostate-specific Antigen (PSA) |  | Baseline, 12 months | 
| Testosterone level |  | Baseline, 12 months | 
| Digital rectal examination |  | Baseline, 12 months | 
| Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy) |  | 12 months | 
| Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD) |  | 12 months | 
| Change in general health status perception (from either patient or physician perspective) | Assessment of health in relation to Prostate Cancer, the options are: very good, quite good, slightly good, neither good nor bad, slightly bad, quite bad or very bad. | 12 months | 
| Quality of life using EQ-5D questionnaire |  | 12 months |
Epidemiology of Hearing Loss in Diabetic and Non-Diabetic Veterans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if individuals with diabetes are at increased risk of hearing impairment or tinnitus (the perception of ringing or noises in the ears or head). An important goal of this research is also to obtain a better understanding of possible interactions between hearing disorders and other chronic conditions, such as diabetes. Participation in this research will be for a few hours only, to be scheduled at the participant's convenience and according to the testing schedules of the different clinics involved.

Official Title
-----------------
Epidemiology of Hearing Loss in Diabetic and Non-Diabetic Veterans

Conditions
-----------------
Diabetes, Tinnitus, Hearing Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Any participants over 21 years of age and under 80 who do not have an end-stage disease

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
Mebendazole as Adjuvant Treatment for Colon Cancer

Study Overview
=================
Brief Summary
-----------------
mebendazole treating colon cancer

Detailed Description
-----------------
mebendazole as adjuvant treatment for colon cancer

Official Title
-----------------
Clinical Study Evaluating Mebendazole as Adjuvant Therapy in Patients With Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Folfox with avastin
* Drug: Mebendazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal cancer stage 4. Exclusion Criteria: Agranulocytosis Pregnancy Allergy to mebendazole.

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 |
| --- | --- |
| Active Comparator: Folfox with avastin<br>Folfox with avastin only | Drug: Folfox with avastin<br>* Folfox with avastin only<br>* Other names: folfox 4;|
| Experimental: Mebendazole<br>Folfox with avastin with mebendazole | Drug: Mebendazole<br>* Folfox with avastin with mebendazole<br>* Other names: mebendazol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with tumour response | number of patients with response | 6 months |
Oral Antibiotic Prophylaxis in Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators perform a case-control study to compare preparation before elective colorectal surgery. The first group is a prospective patient - registry in all patients with mechanical bowel preparation (MBP) and oral antibiotic prophylaxis the day before colorectal surgery. The second group is a historic collective of patients with MBP only and colorectal surgery. The cases were matches in American Society of Anesthesiologists (ASA) physical status classification system, BMI, operative procedure and risk factors.

Official Title
-----------------
Mechanical Bowel Preparation and Oral Antibiotic Prophylaxis vs. Mechanical Bowel Preparation in Colorectal Surgery With i.v. Antibiotic Prophylaxis

Conditions
-----------------
Surgical Site Infection, Anastomotic Leak

Intervention / Treatment
-----------------
* Drug: Paromomycin Sulfate Powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all colorectal resections Exclusion Criteria: allergy

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 |
| --- | --- |
| Oral Antibiotics<br>The patients get mechanical bowel preparation and oral antibiotic prophylaxis with 4g Paromomycin (Paromomycin Sulfate Powder) and 1 g Metronidazole p.o. and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v. | Drug: Paromomycin Sulfate Powder<br>* The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation<br>* Other names: Metronidazole;|
| iv Antibiotics<br>The patients get mechanical bowel preparation and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infections | Any kind of surgical site infection in the postoperative course. | 30 days (exact 30 days after the Operation date) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic Leak | All with objective methods proven anastomotic leakage (like contrast enema, re-operation or endoscopy) | 30 days (exact 30 days after the Operation date) |
Genetics of Neural Tube Defects

Study Overview
=================
Brief Summary
-----------------
The Genetics of Neural Tube Defects Study at the University of Miami: The University of Miami John P. Hussman Institute for Human Genomics is looking for families to participate in research to identify the genetic and environmental factors that contribute to Neural Tube Defects (NTD). Our research goal is to better understand the genetic and environmental causes of both open NTD, like spina bifida and anencephaly, and closed NTD, like lipomeningocele and tethered cord. This will eventually lead to more accurate genetic counseling and risk assessment, improved treatments, and better prevention methods. Any individual with a diagnosis of NTD and his/her selected family members can participate, if willing. Participation is free. Travel is not required. Participation involves reading and signing a consent form, providing a blood sample, a family and medical history interview, and granting the research staff permission to review the medical records of the individual(s) with NTD. We maintain the highest standards of confidentiality for all families. If interested, please contact Maria Ciliberti, the study coordinator, at 1-877-686-6444 (toll free) or directly at 305-243-4360, or by email Mciliberti@med.miami.edu . Please visit our web site at www.hihg.org for more information.

Official Title
-----------------
Genetics of Neural Tubes Defects

Conditions
-----------------
Neural Tube Defects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any individual with a diagnosis of NTD and his/her selected family members can participate, if willing - Exclusion Criteria: Pregnant children will not be enrolled -
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
-----------------
NTD, open NTD, spina bifida, anencephaly, closed NTD, lipomeningocele, tethered cord.