linjc16/ctgov huggingface dataset:
Study Evaluating a Combined Administration of Lecozotan SR and Citalopram in Young Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to healthy subjects.

Official Title
-----------------
Combined Administration of Lecozotan SR and Citalopram: a Double Blind, Multiple Dose Study in Young Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Lecozotan SR
* Drug: Citalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated IRB/IEC-approved informed consent form before any study-specific screening procedures are performed. Men or women aged 18 to 50 years, inclusive, at screening. Women of nonchildbearing potential, defined as being surgically sterile or postmenopausal for > 1 year, may be included. For women below 50 years of age, at least two years of retrospective amenorrhea and FSH>38 and estrogen <20 are required. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening: BMI = weight (kg)/(height [m])2 Exclusion Criteria: Presence or history of any disorder that may prevent the successful completion of the study. Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. Hypersensitivity to citalopram or any of the inactive ingredients in citalopram.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lecozotan SR|nan|
|Drug: Citalopram|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of 5-HT toxicity (Hunter serotonin toxicity criteria) and CNS questionnaires. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult
A Study of Patients Hospitalized With Acute Heart Failure With Reduced Ejection Fraction (HFrEF)

Study Overview
=================
Brief Summary
-----------------
A study of participants hospitalized with acute heart failure with reduced ejection fraction

Official Title
-----------------
Characterizing Acute Heart Failure With Reduced Ejection Fraction Hospitalization Outcomes

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An average left ventricular ejection fraction (LVEF) < 40% over the entire index hospitalization Age 18 years or older on the index date At least 6 months of activity in the databaseprior to the index date Exclusion Criteria: Any code for myocardial infarction (ICD-9 diagnosis code: 410.xx, ICD-10 diagnosis code: I21.xx) or related terms such as myocardial infarction, mi, infarct or heart attack occurring during the index hospitalization Other protocol defined inclusion/exclusion criteria could apply

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 |
| --- | --- | --- |
| Incidence of 30 day mortality |  | 30 days | 
| Incidence of 30 day readmission |  | 30 days | 
| Incidence of a prolonged length of stay |  | 30 days | 
| Incidence of participants hospitalized with AHF with reduced ejection fraction |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of socio-demographic characteristics in participants hospitalized for acute HFrEF | Socio-demographic characteristics will be summarized using descriptive statistics | 6 years | 
| Distribution of clinical characteristics in participants hospitalized for acute HFrEF | Clinical characteristics will be summarized using descriptive statistics | 6 years |
Red Cell Distribution Width as a Predictor of Mortality in Acute Methanol Poisoning

Study Overview
=================
Brief Summary
-----------------
The study aimed to investigate the association between RDW and in-hospital mortality in methanol poisoning.

Detailed Description
-----------------
RDW values have been found to be an independent predictor of the prognosis among patients with heart diseases, stroke,community-acquired pneumonia (CAP), pulmonary embolism, chronic obstructive pulmonary disease (COPD), septic shock, and acute pancreatitis.

Official Title
-----------------
Red Cell Distribution Width as a Predictor of Mortality in Acute Methanol Poisoning

Conditions
-----------------
Methanol Poisoning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients aged ≥18 years who were admitted to emergency departments from January 2019 to January 2020 on account of acute methanol intoxication. Exclusion Criteria: Incomplete data, Malignancy, Severe anaemia, History of erythrocyte transfusion last 6 weeks -

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 |
| --- | --- | --- |
| Hospital mortality |  | 7 day | 
| Need for mechanical ventilation |  | 7 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol, red blood cell distribution width, methanol poisoning, prognosis
THE FACTORS AFFECTING THE ADHERENCE TO THE PULMONARY REHABILITATION PROGRAM IN COPD

Study Overview
=================
Brief Summary
-----------------
Investigators will compare the factors affecting the adherence to the outpatient pulmonary rehabilitation program in COPD patients

Detailed Description
-----------------
Patients were referred to the Pulmonary Rehabilitation Unit and were recommended to participate in the exercise program by a team of experts included in this study. Demographic and clinical characteristics of patients were recorded before the pulmonary rehabilitation program. All cases were evaluated by pulmonary function test, arterial blood gas analysis, six minute walking test, MMRC Dyspnea Scale. Causes that prevented program adaptation of those who did not participate in the program or who left the program were questioned. Patients completing the eight-week PR program will compare with those who did not complete the program or who did not start the program at the recommended time.

Official Title
-----------------
INVESTIGATION THE FACTORS AFFECTING THE ADHERENCE TO THE OUTPATIENT PULMONARY REHABILITATION PROGRAM IN COPD

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD Patients referred to the outpatient pulmonary rehabilitation unit - Exclusion Criteria: To be unvolunteer -

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 |
| --- | --- | --- |
| Respiratory Function Test | FEV1 (%) FEV1 /FVC TLCO (%) FEV1 (%), FEV1 /FVC, TLCO (%) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Gase Analysis | PAO2, PaCO2, SaO2 | 5 minutes | 
| Six minute walk test | walking distance | 10 minutes | 
| MMRC Dyspnea Scale | 1-5 | 5 minutes | 
| SGRQ Questionnaire | Symptom-Activity-Impact- Total | 20 minutes | 
| HAD Questionnaire | Anxiety- Depression score | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adherence, copd, pulmonary rehabilitation
Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at pharmacoeconomic data for subjects that have received either NicVAX or placebo in the Nabi-4514 or Nabi-4515 studies.

Official Title
-----------------
Health-Related Quality-of-Life and Health-Care Resource Utilization Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Biological: NicVAX vaccine
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are eligible for randomization or have not reached Week 12 in Nabi-4514 or Nabi-4515 studies. Subjects who agree to participate in health-related quality of life study. Exclusion Criteria: Subjects who are unable to complete a HRQoL questionnaire because of inability to understand the language or due to mental impairment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NicVAX<br>Experimental vaccine | Biological: NicVAX vaccine<br>* NicVAX vaccine given 6 times over 6 months<br>|
| Placebo Comparator: Placebo<br>Placebo vaccine | Biological: Placebo<br>* Placebo vaccine given 6 times over 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period. | QoL and health utilization questionnaires will be used to measure this outcome. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate utility scores for use in further health-economic models. | Scores will be computed from QoL questionnaires to measure this outcome. | one year | 
| To evaluate health care resource utilization. | Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacoeconomic, Quality of Life, Health Outcomes, Smoking, NicVAX, Smoking vaccine, Smoking cessation
Sequencing T-cells in Type I Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate CD8 + T-cell receptor (TCR) repertoire differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy controls.

Detailed Description
-----------------
Using a systems biology approach by combining high-throughput sequencing, cytometry, gene expression, transcriptome profiling, HLA typing, single cell analysis, and TCR affinity assays, the investigators will define a set of immune metrics for the prediction or early diagnosis of disease that is superior to the current examination of auto-antibodies, which is a fairly late stage in the disease development. This can also be used to guide therapy in advanced disease.

Official Title
-----------------
Sequencing T-cell Receptor Repertoire of Auto-Antigen Specific T-cells in Type I Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a current or previous diagnosis of Type I Diabetes (Autoimmune-related T1DA as confirmed by a positive test for glutamic acid decarboxylase (GAD) auto-antibodies. When available, idiopathic T1DB patients with a lack of autoantibodies to GAD will be recruited) Patients must be ≥ 18 years old and ≤55 years old Inclusion criteria: patients T2D as controls Patients must have a current or previous diagnosis of T2D Patients must be ≥ 18 years old and ≤55 years old Exclusion Criteria: • <18 years old; > 55 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| Sensitivity and specificity of T cell repertoire analysis to classify Type I Diabetes |  | 3 month intervals for 2 years. Time to assess effectiveness is 1 year. |
Retinal Vascular Changes in Primary Open Angle Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
the study aims to detect ischemic changes in macula using OCT angiography in primary open angle glaucoma patients correlating with glaucoma staging system II by visual field.

Detailed Description
-----------------
Our study will be designed as  prospective non-randomized case - control study The study will include 100 eyes of 100 participants 50 eyes of normal subjects , non-glaucomatous subjects 50 eyes of 50 patients with POAG To detect ischemic changes in macula using OCT angiography correlating with glaucoma staging system II by visual field.

Official Title
-----------------
Retinal Vascular Changes in Primary Open Angle Glaucoma Patients

Conditions
-----------------
Primary Open Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (> 18 years old) Exclusion Criteria: patients with cataract retinal disorders including: AMD , Macular degeneration , retinal detachment , retinitis pigmentosa , etc . corneal opacites any ocular surgeries patients with systemic disease. patient refusal

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POAG patients<br>OCT angiography will be performed | |
| Normal participants<br>OCT angiography will be performed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ischemic changes in macula | Using OCT angiography to detect ischemic changes in macula | Through one year |
Expanded Access Study for Renal Transplant Patients With Envarsus XR ™

Study Overview
=================
Brief Summary
-----------------
Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR (Tacrolimus).

Detailed Description
-----------------
The study is designed to facilitate expanded access of Envarsus XR treatment to renal transplant patients. Patients are identified by the site investigator as a patient who has experienced favorable outcomes while in an Envarsus XR (LCP-Tacro) clinical study and/or the site investigator has identified a renal transplant patient with a medical need for an alternative tacrolimus treatment versus the patient's current tacrolimus treatment.

Official Title
-----------------
Expanded Access Study for Renal Transplant Patients With Envarsus XR™: Envarsus 3007

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients will fulfill all of the following criteria: Patient age ≥18years old Willing to give written informed consent and is able to speak, write and understand English Patient understands potential risks or benefits with treatment of Envarsus XR Patients who have received a primary or secondary kidney transplant Patient who have received prior treatment with Envarsus XR (LCP-Tacro) and who are not currently participating in an Envarsus/LCP-Tacro study OR The treating Investigator has identified the patient as having a medical necessity for switching from their current tacrolimus treatment to Envarsus XR: Investigator is aware the medical necessity for switching is not related to the inability to purchase available tacrolimus. Exclusion Criteria: Patients fulfilling any of the following criteria are NOT eligible for study inclusion: Recipients of organ transplants other than kidney Pregnant or nursing (lactating) women, or planning to become pregnant, where pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive hCG serum or urine laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC method of contraception, UNLESS they are Women whose career, lifestyle, or sexual orientation preclude intercourse with a male partner Women whose partners have been sterilized by vasectomy or other medically approved means

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus|Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
CAre of Patients With PArenteral Nutrition At Home

Study Overview
=================
Brief Summary
-----------------
This research aims to give an overview of a number of aspects related to the quality of care for adult patients on home parenteral nutrition. Concretely this study follows up different aspects on different moments in the care of the patient pathways: process indicators concerning indication, parenteral nutrition, training, team access roads and the succession of complications Outcome indicators the health-related quality of life discrepancies in medication use the role of the different health care providers

Detailed Description
-----------------
Adult patients on HPN will be contacted by phone at three different time moments after their discharge to ask them about indicators, quality of life and discrepancies in medication use. After the follow-up, medical dossiers will be consulted to know which indicators are followed in practice. The role of the different health care providers will be investigated by face-to-face interviews with different healthcare professionals.

Official Title
-----------------
Prospective Non-interventional Non-controlled Multicenter Observational Study to Evaluate the Quality of Care for Adult Patients on Home Parenteral Nutrition (HPN)

Conditions
-----------------
Crohn's Disease, Peritoneal Carcinomatosis With Intestinal Occlusion, Radiation Enteritis, Chronic Diarrhea, Intestinal Lymphomas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in Flanders who speak Dutch, are older then 18 years and are able to give an informed consent. Exclusion Criteria: Patients who are younger then 18 years.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life will be investigated with the HPN-QoL(r) or FACIT-G (r). | 2 years | 
| Number of catheter related infections |  | 2 years |
Improving Person Centered Care for Abortion Clients in India

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the effect of providing pharmacists in UP, India with additional information about medication abortion.

Detailed Description
-----------------
This study evaluates whether providing pharmacists with additional information about medication abortion can improve abortion person-centered care for women accessing MA at these sites.

Official Title
-----------------
Strengthening Patient-Centered Accessibility, Respect, and Quality of Care for Abortion Clients in UP, India

Conditions
-----------------
Reproductive Health

Intervention / Treatment
-----------------
* Behavioral: 2 Page Information Sheet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pharmacist providing medication abortion within Lucknow, Kanpur, Unnao Agreed to participate Exclusion Criteria: Pharmacists not providing medication abortion within Lucknow, Kanpur, Unnao Did not agree to participate
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Pharmacists who received in the intervention. | Behavioral: 2 Page Information Sheet<br>* 2 page information sheet about medication abortion<br>|
| No Intervention: Control<br>Pharmacists who did not received in the intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knowledge about medication abortion | self-reported survey (dose, time, side effects, complications) | baseline compared to 6-months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider behavior when providing medication abortion (MA) to clients | Information provided to mystery clients regarding MA (dose, time, side effects, complications) | 3-months post intervention | 
| Interest and satisfaction with intervention | self-reported survey on interest and satisfaction | 6-months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abortion, person-centered care