linjc16/ctgov huggingface dataset:
Reporting Usual Physiotherapy Care in Stroke Survivors in Catalonia

Study Overview
=================
Brief Summary
-----------------
Stroke is one of the major leading causes of death and disability globally and presents a high interest of research around all its branches, including rehabilitation. There are published recommendations and clinical guidelines to guide the care of stroke patients with regard to physical therapy. However, the status of current clinical practice is unknown. This study aims to identify and describe the therapeutic approaches most used by physiotherapists in Catalonia in the care of stroke survivors in different phases of evolution. An observational study will be carried out through an anonymous survey of physiotherapists in Catalonia. Through the College of Physiotherapists of Catalonia, all members will be invited to answer a survey on current clinical practice in the care of stroke survivors. The survey will collect data related to the physiotherapist's training and experience, the most frequently used therapeutic approaches, user profiles and institutions. It is intended to collect the data between October 2022 and February 2023. The data will be analyzed by the team of researchers

Official Title
-----------------
Reporting Usual Physiotherapy Care in Stroke Survivors in Catalonia

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physiotherapists who are currently working in Catalonia with patients who have suffered a stroke. Exclusion Criteria: Physiotherapists do not currently work with at least one stroke patient

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Demographic data | Gender, Age, postal code, completion of degree studies, formation in neurology | Day 1 | 
| Specific formation in neurology | CV information | Day 1 | 
| Neurorehabilitation experience | Years of experience, work place, | Day 1 | 
| Multidisciplinary team | Multidisciplinary co-workers such as Physical therapists, occupational therapists, medical doctors, psychologists | Day 1 | 
| Therapeutic intervention | Sessions, doses, type of patients, type of intervention, approaches, | Day 1 | 
| Individual therapy | Doses, time, | Day 1 | 
| Group Therapy | Doses, Time | Day 1 | 
| Therapy | Doses, time | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, Physiotherapy, rehabilitation, catalonia, usual care
Role of Non-invasive Mechanical Ventilation and Diuretics in Improving Weaning Outcome of Patients With High Lung Ultrasound Score

Study Overview
=================
Brief Summary
-----------------
patients who succeeded in SBT with high lung scores by ultrasound, non-invasive ventilation, and diuretic may have a role.

Official Title
-----------------
Role of Non-invasive Mechanical Ventilation and Diuretics in Improving Weaning Outcome of Patients With High Lung Ultrasound Score

Conditions
-----------------
Weaning Failure

Intervention / Treatment
-----------------
* Other: lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 21 years of age mechanical ventilation for more than 48 hrs patients successfully passed according to the traditional weaning criteria lung ultrasound score ≥ 17. Exclusion Criteria: Significant obstructive lung diseases Obstructive sleep apnea Interstitial lung disease Neuromuscular disorders

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: lung ultrasound|non-invasive ventilation and diuretic|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weaning failure ( number of patients) |  | 48 hours |
PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)

Study Overview
=================
Brief Summary
-----------------
The objectives of the study are to describe the quality of life at the beginning of the Preotact® treatment and at the end of the observational period (Qualeffo-41 questionnaire) pain assessment at the beginning of the Preotact® treatment and at the end of the observational period (VAS score) to describe bone mineral density at the beginning of the Preotact® treatment and at the end of the observational period (T-Score) to describe incidence of bone fractures caused by osteoporosis as well as of other pathological findings of the skeleton after the beginning of the Preotact® treatment to describe serum level of calcium and the bone resorption marker desoxypyridinoline (DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the beginning of the Preotact® treatment and at the end of the observational period (only in subgroup of patients, where the physician sees a need to measure these parameters) to document all adverse drug reactions after the beginning of the Preotact® treatment the analysis of subgroups with different risk for bone fractures caused by osteoporosis at the beginning of the Preotact® treatment to assess the manageability and functioning of the Pen system for injection of Preotact® (self administered questionnaire)

Official Title
-----------------
Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis

Conditions
-----------------
Postmenopause, Osteoporosis

Intervention / Treatment
-----------------
* Drug: Parathyroid hormone (PTH) (Preotact)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion requires that Preotact® is prescribed in accordance with the SPC and that the stated contraindications are strictly considered. Caution should be taken by the treating Physician concerning any precautions, warnings and potential drug interactions stated in the SPC. No further inclusion or exclusion parameters are defined. The decision for the individual application of Preotact® will be strictly made by the physicians.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Parathyroid hormone (PTH) (Preotact)|Patients with severe postmenopausal osteoporosis|

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
-----------------
osteoporosis, postmenopausal women, Severe postmenopausal osteoporosis
Omission of Controlled Cord Traction During Active Management of Third Stage of Labor

Study Overview
=================
Brief Summary
-----------------
This is a comparative study which will be conducted in Ain Shams University Maternity hospital to assess the individual and specfic role of controlled cord traction as a part of active management of third stage of labor

Detailed Description
-----------------
300 patients will be randomized into two groups with controlled cord traction and withoout. The primary outcome will be sever postpartum haemorrhage

Official Title
-----------------
Omission of Controlled Cord Traction During Active Management of Third Stage of Labor. A Single Blinded Randomized Controlled Trial

Conditions
-----------------
Labor Stage, Third

Intervention / Treatment
-----------------
* Procedure: Ommited controlled cord traction
* Procedure: controlled cord traction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy term pregnancy Exclusion Criteria: episiotomy operative vaginal delivery known coagulation defect Acute complication during labor e.g. eclampsia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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: omiited controlled cord traction<br>neither controlled cord traction nor fundal pressure will be applied. The placenta will be delivered physiologically and signs of placental separation will be awaited | Procedure: Ommited controlled cord traction<br>* No controlled cord traction and no fundal pressure. placenta will be allowed to deliver physiologically<br>|
| Active Comparator: controlled cord traction<br>the cord will be held in one hand and the other hand will be placed just above the woman's pubic boneto stabilize the uterus during cord traction | Procedure: controlled cord traction<br>* active management of third stage of labor in the form of uterine massage with controlled cord traction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sever post partum haemorrhage | blood loss more than 500 cc | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of third stage of labor | from delivery of the baby to delivery of the placenta | 30 minutes |
Comparing Two Types of Sedation to Gynaecological Patients

Study Overview
=================
Brief Summary
-----------------
The primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.

Detailed Description
-----------------
Investigate the difference between two types of anesthesia.

Official Title
-----------------
Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens

Conditions
-----------------
Transcervical Resection of Endometrium, Transcervical Resection of Fibroids, Transcervical Resection of Polyp

Intervention / Treatment
-----------------
* Drug: Remifentanil, propofol and citanest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years females are having a TCRE, TCRF or TCRP speak and understand Danish no mental problems Exclusion Criteria: <18 years old don´t speak or understand Danish mental problems Lung problems BMI >40 Big fibroma: >3x3 cm abuser Allergy towards i Propofol, Remifentanil and/or Citanest pregnant

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General vs deep sedation<br>General anesthesia: remifentanil and propofol Deep sedation: remifentanil, propofol and citanest | Drug: Remifentanil, propofol and citanest<br>* iv remifentanil iv propofol im citanest<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain on a NRS-scale from 0 to 10 | Measuring postoperative pain in TCRE, TCRF or TCRP patients | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PONV |  | postoperative and 2 weeks after discharge | 
| Time | Operating time Recovery time Discharge time | 1 day | 
| Medicin | The type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin. | 1 day | 
| After discharge outcome measures | Previous anestetics, pain, PONV, fever, bleeding, discharge time. | 2 weeks |
Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with ACE inhibitor plus calcium channel blocker

Official Title
-----------------
An Multicenter Study to Evaluate the Efficacy and Safety of a 5 Week Therapy With the Combination of Valsartan 160 mg Plus Amlodipine 10 mg in Hypertensive Patients Not Adequately Responding to a 5 Week Therapy With Ramipril 5 mg and Felodipine 5 mg

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients (18 years or older) Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives). Patients with moderate essential hypertension (WHO II) Exclusion Criteria: Severe hypertension Pregnant or nursing women Treated hypertensive patients with controlled hypertension under current therapy (MSDBP < 90 mmHg and MSSBP < 140 mmHg) A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV Other protocol-defined exclusion criteria may apply

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

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

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: valsartan + amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate whether 5 weeks of treatment with valsartan 160mg + amlodipine 10mg provide add'l mean sitting systolic BP reduction in patients not adequately responding to 5 weeks of treatment with ramipril + felodipine--i.e., mean systolic BP |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of valsartan 160 mg plus amlodipine 10 mg on mean sitting diastolic BP, normalization and responder rate. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension
Co-Infection of NTM in Patients With Smear Positive Pulmonary TB

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (NTM) co-infection in patients with smear positive pulmonary TB. To detect the NTM co-infection, we will perform duplex PCR targeted for mycobacterial hsp 65 gene using sputa. In addition, the clinical significance of this co-infection will be evaluated.

Official Title
-----------------
Detection of Nontuberculous Mycobacterial co-Infection Using Duplex PCR for Mycobacterial Hsp 65 Gene and Its Clinical Significance in Patients With Smear Positive Pulmonary Tuberculosis

Conditions
-----------------
Tuberculosis, Pulmonary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New patients with pulmonary TB Sputum AFB smear-positivity Exclusion Criteria: Non-applicable
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 |
| --- | --- | --- |
Safety and Efficacy of Seroquel in First Episode Schizophrenia

Study Overview
=================
Brief Summary
-----------------
To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode schizophrenia

Official Title
-----------------
Safety and Efficacy of Seroquel in First Episode Schizophrenia

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

Intervention / Treatment
-----------------
* Drug: Seroquel and Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-35 years Meet ICD-10 criteria for schizophrenia No abnormaility on clinical examination No previous episode of psychosis No previous antipsychotics of any kind in last 3 months Exclusion Criteria: Have received a course of antipsychotics drug treatment prior to entry which may introduce risk factors or interfere with study procedures Have received anticholinergics within 10 days of baseline aseessment Have received mood stabilizers or anti depressants within 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Seroquel and Risperidone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients developing clinically significant EPS at any point between baseline (day 1) and final assessment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI severity of illness |  |  | 
| CGI global improvement |  |  | 
| PANSS total score and subscales) |  |  | 
| Abnormal Involuntary Movement Scale (AIMS) |  |  | 
| Dose of anti cholinergic medication |  |  | 
| Serum prolactin levels |  |  | 
| Proportion of patients discontinuing treatment due to reasons of lack of efficacy or adverse effects |  |  | 
| Proportion of patients experiencing relapse. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when respectively given orally as a single tablet dose and a single dose of a solution.

Official Title
-----------------
A Two Period, 2 Sequence Crossover To Establish The Relative Bioavailability Of A Single Pf-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: PF-04634817
* Drug: PF-04634817


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history and full physical examination.) Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication; Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day; Nursing females; Females of childbearing potential.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single dose PF-04634817 tablet<br>subjects receive a single dose of PF-04634817 as a tablet | Drug: PF-04634817<br>* single dose, 20mg, tablet<br>|
| Active Comparator: single dose PF-04634817 solution<br>subjects receive a single dose of PF-04634817 as a solution | Drug: PF-04634817<br>* single dose, 20mg, solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | 4 days | 
| Plasma Pharmacokinetics for both tablet and solution dosage forms. |  | 4 days | 
| The relative bioavailability (Frel) of PF-04634817 when administered as a tablet compared with a solution. |  | 4 days | 
| lab measurements |  | 4 days | 
| vitals/ECG parameters |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 1, relative bioavailability, healthy volunteers, pharmacokinetics, solution, tablet