linjc16/ctgov huggingface dataset:
The Prevalence of Pulmonary Hypertension in Patients With COVID-19.

Study Overview
=================
Brief Summary
-----------------
The virus infection Covid-19 fills our hospitals and intensive care departments in a very unique way and there is a lack of essential insight into the pathophysiology of the disease. As a result, very specific treatment options are missing. The US Medicines Agency (FDA) has in the last days given a general license for treatment with inhaled nitric oxide (iNO). Inhaled NO in Sweden (and Europe) is approved for the indication of pulmonary hypertension in adults. However, no one has yet described the occurrence of pulmonary hypertension, with or without right ventricular loading, in the Covid-19 patients who become so seriously ill that they need to be treated at an IVA ward. Knowledge of this is, of course, a prerequisite for determining the need for pulmonary artery catheterization (PA catheter, Swan-Ganz catheter) and also to better understand whether iNO treatment or other forms of lung selective vasodilation therapy may be of benefit to this patient group.

Detailed Description
-----------------
Demographics and data from study variables will be documented in paper CRFs at the investigational site. Demography o Age, sex Covid-19 related variables o COVID-19 diagnosis Concomitant diseases o Comorbidity, previous and present Cardiovascular risk factors o Smoking Laboratory values On-site measurements o Evaluation with echocardiography

Official Title
-----------------
The Prevalence of Pulmonary Hypertension, With or Without Right Ventricular Loading, in Patients With COVID-19 Who Are Being Treated With a Respirator in the Intensive Care Unit.

Conditions
-----------------
Hypertension, Pulmonary, Right Ventricular Overload, COVID

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women at least 18 years of age Diagnosed with COVID-19 and is treated at an intensive care unit. Exclusion Criteria: Responsible investigator considers that co-morbidity is so pronounced that it does not allow reasonable interpretation of data. Missing verified diagnosis of COVID-19

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 |
| --- | --- | --- |
| Prevalence | To determine the prevalence of pulmonary hypertension and right ventricular load in patients with COVID-19 treated in intensive care unit evaluated by routine echocardiography. | Day 1 |
Guided Self-Help for Functional Neurological Symptoms

Study Overview
=================
Brief Summary
-----------------
Functional (psychogenic or somatoform) symptoms are commonly observed in neurology clinics. There is no known empirically validated treatment approach to functional symptoms. Cognitive Behavioral Therapy (CBT) can be effective, but there are major obstacles to its provision. The investigators will test the hypothesis that adding a CBT-based guided self-help (GSH) as compared to treatment as usual (TAU) improves patient outcomes.

Official Title
-----------------
Guided Self-Help for Functional Neurological Symptoms: A Randomized Controlled Efficacy Trial

Conditions
-----------------
Functional Neurologic Disease

Intervention / Treatment
-----------------
* Behavioral: Treatment As Usual
* Behavioral: Guided Self-Help


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult neurology outpatient with functional symptoms not largely explained by neurologic disease. Exclusion Criteria: Unable to use the Guided Self-Help intervention, such as due to significant cognitive impairment or unable to comprehend English. Requires specialist psychiatric care. Has headache as the only symptom.

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: TAU+GSH<br>Treatment As Usual plus Guided Self Help. | Behavioral: Treatment As Usual<br>* Communicating the diagnosis to the patient's primary care doctor and neurologist. May include referrals for physical therapy or psychiatric evaluations, or referrals to community therapists or doctors.<br>Behavioral: Guided Self-Help<br>* A self-help workbook based on cognitive behavioral therapy, and four half-hour guidance sessions over a three-month period.<br>|
| Active Comparator: TAU<br>Treatment AS Usual. | Behavioral: Treatment As Usual<br>* Communicating the diagnosis to the patient's primary care doctor and neurologist. May include referrals for physical therapy or psychiatric evaluations, or referrals to community therapists or doctors.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI | Clinical Global Improvement scale score (much worse, worse, same, better, much better) rated by the patient. | 3 months |
Validation of Patient Reported Outcome Measures for Use in Hallux Valgus

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).

Official Title
-----------------
Validation of the Modified Foot Function Index (mFFI) for Use in Hallux Valgus

Conditions
-----------------
Hallux Valgus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, of any race and, aged ≥ 18 years Clinical diagnosis of hallux valgus Fluent in reading/speaking US-English to read and understand informed consent form and to participate in the interview Exclusion Criteria: Participation in another foot-based clinical trial in the last 90 days or in Ipsen's clinical trial D-FR-52120-237 Current chronic drug or alcohol abuse problem

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 |
| --- | --- | --- |
| Concept elicitation (CE) of mFFI | Face-to-face interview (approx. 25 minutes), using semi-structured interview guide to explore the symptoms and impact of HV. | 7 days | 
| Cognitive debriefing (CD) of mFFI | Face-to-face interview (approx. 25 minutes) to explore understanding and relevance of mFFI items. | 7 days | 
| Usability testing of mFFI | Telephone interview (approx. 20 minutes) using a semi-structured interview guide to explore how participants found usability of completing the mFFI daily in electronic format on their own device. | 7 days |
Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine if treatment of post-traumatic stress disorder in combat veterans with paroxetine changes brain responses as measured by functional magnetic resonance imaging and if brain responses can predict who will get better with treatment.

Official Title
-----------------
Neurofunctional Markers of SSRI Treatment Response in PTSD

Conditions
-----------------
Post-traumatic Stress Disorder

Intervention / Treatment
-----------------
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veterans with clinical diagnosis of post-traumatic stress disorder from combat related to deployment to Afghanistan/Iraq (Operation Enduring Freedom/Operation Iraqi Freedom) Exclusion Criteria: Intolerance or sensitivity to paroxetine Major medical or neurologic illness Current psychotropic medication or active psychotherapy treatment Other major psychiatric illness

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Intervention-Paroxetine | Drug: Paroxetine<br>* Paroxetine 20-40mg po QD for 12 weeks<br>* Other names: Paxil (brand name);|
| No Intervention: Arm 2<br>No Intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI) | Mean percent change in brain response in the prefrontal cortex during an emotion reappraisal task in the treatment (paroxetine) group and in the Combat Exposed Control group. Target areas are analyzed from fMRI scans which were completed before participants receive treatment and again after participants received 12 weeks of treatment with paroxetine (20-40mg QD). Combat Exposed Control participants received an fMRI scan after signing initial consent and again 12 weeks later. | Baseline and 12 weeks |
Arthralgia During Anastrozole Therapy for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.

Official Title
-----------------
A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer

Conditions
-----------------
Early Breast Cancer

Intervention / Treatment
-----------------
* Drug: Anastrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole WHO performance status 0, 1 or 2 Provision of written informed consent Exclusion Criteria: Recurrence of breast cancer, inflammatory rheumatism treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin Diabetes treated by insulin Severe renal or hepatic disease Known hypersensitivity to anastrozole

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anastrozole|1mg/Day oral|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With New Events of Arthralgia |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Index of Cochin at 12 Months in Patients Under Anastrozole. | Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values. | 12 months | 
| Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole | Results are based on 97 patients due to missing values | 12 months | 
| Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole | X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values | 12 months | 
| Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole | X ray assessment on hands and wrists based on 99 patients due to missing values | 12 months | 
| Percentage of Participant With Therapeutic Maintenance Under Anastrozole | Treatment compliance. results based on 109 patients due to missing values | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer treatment, joint disorders
Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the interactive effects of acute intravenous (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol.

Official Title
-----------------
Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

Conditions
-----------------
Alcohol Consumption, Tobacco Use

Intervention / Treatment
-----------------
* Drug: Nicotine
* Drug: Ethanol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female, 21 to 50 years old. Exclusion Criteria: Alcohol or Nicotine Naive

Ages Eligible for Study
-----------------
Minimum Age: 21 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

Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Three test days, within-subject design. | Drug: Nicotine<br>* 1.0 microg/kg/min IV x 10 minutes<br>Drug: Ethanol<br>* IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral and Cognitive Measures |  | Baseline and Test Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol, nicotine
Special Investigation of Kaletra in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
This non-interventional, post-marketing observational study was conducted to obtain safety data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women and their children in Japan.

Official Title
-----------------
Special Investigation of Kaletra in Pregnant Women

Conditions
-----------------
Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Drug: Lopinavir/ritonavir (Kaletra)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant women who have received Kaletra for the treatment of HIV infection were eligible for this study Exclusion Criteria: Contraindications according to the Package Insert: Patients with a history of hypersensitivity to any ingredient of Kaletra Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lopinavir/ritonavir group<br>All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection. | Drug: Lopinavir/ritonavir (Kaletra)<br>* Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.<br>* Other names: Kaletra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Drug Reactions (ADRs) | The number of patients (mothers and infants) with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than not related by the investigator (i.e., probable, possible, or unclear). ADRs are reported by preferred term and inclusive of all those reported at any visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term. | During pregnancy and for one year after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human Immunodeficiency Virus
Effect of Tranexamic Acid on Reducing Postoperative Blood Loss in Cervical Laminoplasty

Study Overview
=================
Brief Summary
-----------------
The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the surgical procedure used was identical in all cases.

Detailed Description
-----------------
Tranexamic acid, an inhibitor of fibrinolysis, has proven to be effective in reducing perioperative blood loss in patients undergoing total hip and knee arthroplasty. However, limited numbers of well-controlled trials in spinal surgery have been conducted due to heterogeneity in the performed surgical procedures.

Conditions
-----------------
Cervical Myelopathy

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were scheduled to undergo cervical laminoplasty from C3 to C6 for cervical multilevel compressive myelopathy with a narrow spinal canal for which nonoperative therapy had failed. Exclusion Criteria: Patients with chronic renal failure, cirrhosis of the liver, serious cardiac disease, allergy to TXA, a history of thromboembolic disease, and bleeding disorders, as well as those who were currently receiving antiplatelet and/or anticoagulant drugs, were excluded from this study.
Sexes Eligible for Study
-----------------
All

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo, tranexamic acid<br> | Drug: Tranexamic Acid<br>* Administer 15 mg/kg body weight of tranexamic Acid mixed in 100 mL saline intravenously over 15 min before the skin incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative blood loss |  | during and after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perioperative blood loss, spinal surgery
Role of Parents Concerning Information of Adolescents About Contraception

Study Overview
=================
Brief Summary
-----------------
Adolescence is a period of intensive physical and psychological changes, with notably the start of sexuality. During this period of sexual discovery, a lack or a misuse of contraception may be responsible for unwanted pregnancy. So, sexual education and information about contraception are crucial. Teenagers often consult Internet or discuss with friends to have information but they can be not true or precise. They can also consult health professionals, however shyness and fear can hold them back. Information about contraception may also be given by their parents. The physical closeness and the trust that adolescents have in their parents can promote dialogue.

Detailed Description
-----------------
the aim of the study is to describe information about contraception given by parents to adolescents

Official Title
-----------------
Role of Parents Concerning Information of Adolescents About Contraception

Conditions
-----------------
Parents of Adolescent

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents (father or mother) of adolescents (boy or girl) aged 12 to 18 agreeing to participate to the study Exclusion Criteria: -

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group Parents of adolescents<br>Parents of adolescents aged 12 to 18 | Other: data collection<br>* Information about contraception<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definition of contraception | Parents have explained or not that contraception is all methods aimed at reversibly preventing an unwanted pregnancy | Day 0 | 
| Contraception methods | Parents have explained or not all contraception methods (condom for man, condom for woman, control pills, contraceptive implant, intra-uterine device, contraceptive patch, contraceptive ring, spermicide | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescents, contraception, information