linjc16/ctgov huggingface dataset:
Sex or no Sex: That is the Question.

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the impact of sexual intercourse and orgasm in the 72 hrs following embryo transfer of blastocysts on the clinical pregnancy rate. An impact on sexual activity and a decrease in the frequency of intercourse has been observed in infertile couples. In couples who undergo assisted reproductive technology (ART), sexual relations have an additional component that can condition them, such as the fear of influencing the outcome of the cycle. The usual practice in ART cycles has evolved towards a preference for blastocyst-stage embryo transfer, both in fresh in vitro fertilization (IVF) cycles and in frozen embryo transfer (FET) cycles. The investigators consider it important to elucidate whether coital intercourse after embryo transfer (ET) has an impact on the clinical pregnancy rate after the transfer of blastocyst-stage embryos.

Detailed Description
-----------------
It is proposed to carry out an observational, prospective study, in which women with a heterosexual sexual relationship are included, who carry out an embryo transfer, in a FET cycle in the Dexeus Woman Reproduction Medicine Service and who agree to participate in the same.

Official Title
-----------------
Sex or no Sex: That is the Question. Impact of Coital Sexual Intercourse on the Clinical Pregnancy Rate After Embryo Transfer.

Conditions
-----------------
Infertility, Female, Sexual Intercourse

Intervention / Treatment
-----------------
* Other: Sex intercourse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with a heterosexual sexual relationship That they carry out an embryo transfer, in a FET cycle Exclusion Criteria: Exclusion criteria are not foreseen
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sex Intercourse<br>women with a heterosexual sexual relationship after embryo transfer | Other: Sex intercourse<br>* A heterosexual sexual relationship<br>|
| Non sex intercourse<br>women without a heterosexual sexual relationship after embryo transfer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Clinical pregnancy rate measured by ultrasound with the presence of a positive fetal heartbeat | 6-7 weeks after transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage rate | The loss of a pregnancy during the first 13 weeks of pregnancy | Until 13 weeks after embryo transfer procedure | 
| Live birth rate | Number of live birth after embryo transfer | Until 42 weeks after embryo transfer |
Heparin Dose for Radial Angiography

Study Overview
=================
Brief Summary
-----------------
At present, coronary angiogram is usually performed either through an artery in your groin or wrist. An important limitation of the wrist approach is an increase rate of blockage of the wrist artery. It is possible that the dose of blood thinner (i.e. heparin) may decrease the risk of blockage. Early studies seem to suggest that higher dose is required to reduce the risk of this important complication. However, to date there has not been a definitive study to determine the most appropriate heparin dose for the prevention of this complication. The main goal of this study is to determine the appropriate heparin dose to prevent wrist artery blockage and to determine risk factors for developing such a complication.

Official Title
-----------------
Low Versus High Dose Unfractionated Heparin in Patients Undergoing Angiography Via the Radial Artery

Conditions
-----------------
Coronary Angiograph

Intervention / Treatment
-----------------
* Drug: unfractionated heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years of age who were referred for either urgent or elective cardiac catheterization were eligible for the study if a normal Allen's test was demonstrated Exclusion Criteria: myocardial infarction with shock, ST-elevation myocardial infarction, patients undergoing planned percutaneous coronary intervention, and patients in whom transradial approach is contraindicated such as hemodialysis patients

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: low dose heparin<br>30 units per kilogram of unfractionated heparin | Drug: unfractionated heparin<br>* unfractionated heparin<br>|
| Active Comparator: High dose heparin<br>70 units per kilogram of unfractionated heparin (UFH) intravenously | Drug: unfractionated heparin<br>* unfractionated heparin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radial artery occlusion | The primary endpoint was radial artery occlusion defined as absence palpable radial artery with no flow as assessed by Doppler study | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary angiography
Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with brentuximab vedotin in patients with hodgkin's lymphoma.

Official Title
-----------------
A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Brentuximab Vedotin in Combination With TGR-1202, a Novel PI3K Delta Inhibitor, in Patients With Hodgkins Lymphoma

Conditions
-----------------
Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: TGR-1202 + brentuximab vedotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Hodgkin's Lymphoma Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: Any major surgery, chemotherapy or immunotherapy within the last 21 days Known hepatitis B virus, hepatitis C virus or HIV infection Autologous hematologic stem cell transplant within 3 months of study entry. Patients who had prior Allogeneic hematologic stem cell transplant are excluded

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: TGR-1202 + brentuximab vedotin<br>TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin | Drug: TGR-1202 + brentuximab vedotin<br>* TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin<br>* Other names: brentuximab vedotin: Adcetris;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose acceptable for participants | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities | 21 days (1 cycle of therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | To assess the overall response rate (ORR) of TGR-1202 in combination with brentuximab vedotin in patients with Hodgkin's lymphoma | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin's
Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza

Study Overview
=================
Brief Summary
-----------------
With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households. Households with an identified index case of influenza will be randomised into one of three intervention arms: 1. group, where the household will receive general information about transmission of influenza virus and means to prevent it (Controls); 2. group, which will receive surgical masks and be asked to wear them whenever they are in close contact with the index case or other persons of the household that became ill during the observation period; 3. group, which will be given and asked to wear surgical masks as well as to execute intensified hand hygiene. In addition to assessing the secondary attack rate as our primary outcome measure, the investigators will also try to evaluate compliance to those interventions by questionnaires.

Official Title
-----------------
Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Device: Masks
* Device: Masks & hand hygiene
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: influenza like illness symptoms positive rapid test for influenza inclusion within 48h of symptom onset inclusion of at least 3 members of a household (including index case) Exclusion Criteria: severe illness other cases of similar symptoms within 14 days before onset of symptoms in index patient severe asthma or COPD pregnancy of index

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Control | Other: Control<br>* General information about virus transmission in households and basic means to prevent it<br>|
| Other: 2<br>Masks | Device: Masks<br>* Wearing of surgical masks<br>|
| Other: 3<br>Masks and Hygiene | Device: Masks & hand hygiene<br>* Wearing of surgical masks and intensified hand washing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary infection with influenza of the household members who are healthy at the start of the study |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non pharmaceutical measures
HYPONATREMIA IN COVID-19 PATIENTS

Study Overview
=================
Brief Summary
-----------------
SYSTEMIC INFLAMMATION HAS BEEN ASSOCIATED WITH SEVERE COVID-19. HYPONATREMIA CAN RESULT FROM INFLAMMATION DUE TO NON-OSMOTIC STIMULI FOR VASOPRESSIN PRODUCTION. IN THIS PROSPECTIVE COHORT STUDY WE ANALIZED DATA FROM PATIENTS WITH COVID-19 AND THE ASOCIATION WITH HYPONATREMIA AND CLINICAL OUTCOMES.

Official Title
-----------------
HYPONATREMIA AND INFLAMMATION AND CLINICAL OUTCOMES IN HOSPITALIZED COVID-19 PATIENTS

Conditions
-----------------
Covid19, Hyponatremia, Corona Virus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PATIENTS WITH SARS-CoV-2 INFECTION CONFIRMED BY PCR OF NASOPHARYNGEAL SWABS. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 100 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 |
| --- | --- | --- |
| MORTALITY | HYPONATREMIA AND MORTALITY | 30 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU HOSPITALIZATION | HYPONATREMIA AND ICU HOSPITALIZATION | 30 DAYS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
INFLAMMATION, COVID, CORONA
One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.

Official Title
-----------------
A 52 Week, Open Label Extension to the Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: valsartan+amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SUCCESSFUL COMPLETION OF VAA489A2201 CORE TRIAL VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg Exclusion Criteria: PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2201 CORE Other protocol-defined exclusion criteria may 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valsartan+amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough |  |  | 
| Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough |  |  | 
| Sitting and standing pulse |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HYPERTENSION, VALSARTAN, AMLODIPINE,SAFETY
Demographic Characteristics and Psychosocial Health of Transgender People

Study Overview
=================
Brief Summary
-----------------
To study demographic characteristics of subjects referred to endocrine care for gender dysphoria and their psychosocial health

Official Title
-----------------
Demographic Characteristics and Psychosocial Health of Transgender People

Conditions
-----------------
Gender Dysphoria

Intervention / Treatment
-----------------
* Other: Gender dysphoria psychosocial health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria - Person having received complete information on the organization of the research and willing to participate to research Exclusion criteria: - lack of data in the patients' records
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Gender dysphoria psychosocial health|Retrospective analysis of medical records|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective analysis of medical records | Analysis of existing data | 2004-2020 |
Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Trial With Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Amantadine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under antipsychotics with residual symptoms Exclusion Criteria: Pregnancy Lactation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amantadine<br>Amantadine 200mg twice a day | Drug: Amantadine<br>* Amantadine 200mg twice a day over 12 weeks<br>* Other names: Mantidan TM;|
| Placebo Comparator: Placebo<br>Placebo capsules twice a day | Drug: Placebo<br>* Placebo capsules twice a day over 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores in Brief Psychiatric Rating Scale |  | Baseline, 4 weeks, 8 weeks, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Amantadine, Residual symptoms
Alleviating Geriatric Inpatients' Medication-related Iatrogenesis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the MedWise Risk Score™ (MWRS™), a holistic approach to quantifying the risk of a patient's medication regimen. High risk patients will be identified at hospital discharge. Targeted interventions will be made to reduce their MWRS™ with a 30-day follow up. The hypothesis being tested is that a reduction in MWRS™ will lead to reduced 30-day readmission.

Official Title
-----------------
Alleviating Geriatric Inpatients' Medication-related Iatrogenesis

Conditions
-----------------
Iatrogenic Disease, Risk Reduction

Intervention / Treatment
-----------------
* Other: Risk score based intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospital admission for at least 48 hours Prescribed at least 5 medications at hospital discharge Baseline medication risk score of 20 or more Exclusion Criteria: Reside greater than 25 miles from the index facility Discharge to hospice Discharge against medical advice Patient expiration during initial hospitalization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Discharge medication regimen instructions will be provided upon discharge after being assessed using the MWRS, optimized, and assessed by the prescriber. | Other: Risk score based intervention<br>* Targeted interventions based off of risk score software<br>|
| No Intervention: Standard of Care<br>Discharge medication regimen instructions will be provided upon discharge after being assessed by the prescriber. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of individuals with an emergency department visit or hospital readmission | Number of individuals with an emergency department visit or hospital readmission | 30 days after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in score between patients aged older and younger than 65 years | Comparison between age groups | At time of intervention |
Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

Study Overview
=================
Brief Summary
-----------------
Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our hypothesis is that this new method will more accurately predict depth of anaesthesia than the Bispectral Index (BIS) monitor in patients having elective surgery.

Detailed Description
-----------------
Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be recruited. They will be randomised to receive remifentanil effect-site target 0, 2 or 4 ng/ml. Then anaesthesia will be induced with propofol. Loss of the eyelash reflex, response to command and response to electrical stimulation will be measured. The raw EEG will be recorded and analysed off-line using our new method and also for BIS values. Anaesthesia will then proceed according to the needs of the patient and the surgery.

Official Title
-----------------
Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

Conditions
-----------------
Depth of Anaesthesia

Intervention / Treatment
-----------------
* Drug: remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for elective surgery under general anaesthesia Exclusion Criteria: Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability Epilepsy or other EEG abnormality Prescription or illicit drugs known to affect the EEG

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>0 ng/ml target effect site concentration remifentanil | Drug: remifentanil<br>* target effect site concentration during induction<br>* Other names: No other names;|
| Active Comparator: 2<br>2 ng/ml target concentration remifentanil | Drug: remifentanil<br>* target effect site concentration during induction<br>* Other names: No other names;|
| Active Comparator: 3<br>4 ng/ml target effect site concentration remifentanil | Drug: remifentanil<br>* target effect site concentration during induction<br>* Other names: No other names;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction probability for prediction of anaesthetic endpoints |  | During induction of anaesthesia |