linjc16/ctgov huggingface dataset:
Upper Limb Function and Visuospatial Exploration After Stroke

Study Overview
=================
Brief Summary
-----------------
This project is a cross-sectional, observational mono-center study with prospective data collecting. This study aims to further explore quality of upper limb movement in relation to characteristics of visuospatial exploration in stroke subjects and healthy subjects by a applying comprehensive measurements of clinical scales and kinematic data in capacity- and performance-based activities. The results will contribute to assessing and monitoring quality of upper limb movements and visuospatial attention and their relationship.

Official Title
-----------------
Assessing Pathological Synergies of Upper Limb Function and the Relationship to Visuospatial Exploration After Stroke

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

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of 18 years and older with chronic ischemic stroke (> 6 month) restricted to one hemisphere (confirmed by CT/MRI) With impairments in upper limb function and at least partial ability to lift the arm against gravity, flex and extend the fingers Without relevant pre-existing limitations in arm and hand function (orthopaedic, muscular, neurologic) Written informed consent after participants's information Exclusion Criteria: Increased muscle tone in the upper limb with limited rang of motion Severe sensory deficits in the upper limb Clinically significant concomitant disease (affecting the upper limb or impaired vision, e.g. due to glaucoma etc.) Contraindications on ethical grounds (vulnerable persons) Known or suspected non-compliance, drug or alcohol abuse Severe communication or cognitive deficits, that cause inability to follow the procedures

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 |
| --- | --- |
| Stroke subjects<br> | Other: No intervention<br>* No Intervention<br>|
| Healthy subjects<br> | Other: No intervention<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb movement quality | Fugl-Meyer Assessment of the upper extremity (FMA-UE), kinematic data (e.g. joint angles, hand workspace) | One day | 
| Visuospatial exploration | Eye-tracking data (e.g. area of interest, eye movements: saccades, fixations) and to rule out stroke-related deficits of visuospatial attention, clinical tests | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
synergies, upper limb, vision
Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of using a computerized decision program on the adequacy of the perioperative antimicrobial prophylaxis

Detailed Description
-----------------
Adequacy rate of surgical antimicrobial prophylaxis, helped by a computerized decision support system, according to the internal guidelines considering the aspects: drug choice, dosing, timing, and re-dosing

Official Title
-----------------
Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Other: guided antimicrobial prophylaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All elective & emergency surgeries done by neurosurgery, orthopaedics, cardiovascular and digestive specialties made at University Hospitals of Geneva Exclusion Criteria: Patients < 40 kgs
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: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: quasi-experimental study Time-series analysis, with a non-equivalent variable prospective Quality Improvement project
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual antimicrobial prophylaxys<br>standard of care: perioperative antimicrobial prophylaxis without computerized decision support system | |
| Experimental: guided antimicrobial prophylaxis<br>perioperative antimicrobial prophylaxis guided by a computerized decision support system | Other: guided antimicrobial prophylaxis<br>* During the intervention period, antimicrobial prophylaxis decisions will be guided by a computerized program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy rate of surgical antimicrobial prophylaxis | Adequacy rate of surgical antimicrobial prophylaxis according to the internal guidelines | baseline & 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical site infections | Incidence of surgical site infections in subgroups: hip & knee, colon & rectum, lumbar neurosurgeries and heart surgeries | baseline & 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antimicrobial, prophylaxys, CDSS
Efficacy of Near-Assisted Learning (NAL) in Improving Students' Objective Structured Clinical Examination (OSCE) Grades

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the impact of near-assisted learning (NAL) on first-year medical students' objective structured clinical examination (OSCE) grades in a problem-based learning (PBL) environment.

Detailed Description
-----------------
In this randomized controlled trial, 1st year medical students were recruited in the study along with selected highly-performing, trained peer-instructors. The participants were randomly allocated to two groups, an intervention group supervised by the instructors and the control group that had to practice independently. They would attend OSCE sessions and had their performance evaluated, later on, in an exam. In addition to comparing their performance with each other, scores of the previous batch were considered in the comparison.

Official Title
-----------------
Efficacy of Near-Assisted Learning (NAL) in Improving Students' OSCE Grades: A Single-Blinded RCT

Conditions
-----------------
Cost, Problem-based Learning, Peer Group

Intervention / Treatment
-----------------
* Behavioral: Near-assisted learning through trained peers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1st year medical students. Medical students of Sulaiman Alrajhi Colleges. Males. Exclusion Criteria: Students of other academic levels. 1st year medical students of other universities. Females.
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized single blinded trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Near assisted learning group<br>Participants in this arm were supervised by the trained peer-instructors. | Behavioral: Near-assisted learning through trained peers<br>* Students randomly allocated to this group were overseen during sessions by trained peer instructors.<br>|
| No Intervention: Self directed learning group<br>Participants in this arm were practicing independently. They were not supervised by any instructors. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective structured clinical examination (OSCE) Score | After the sessions, the study sample participated in the final osce exam. Their scores were compared. The minimum value was 0 while the maximum value was 100. The higher the score the better students had performed | Less than a month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near-assisted learning, Cost, Education environment, OSCE, Problem-based learning
Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the effects of duloxetine on improvement of brain cortical activity in patients suffering from major depressive disorder using near infrared spectroscopy.

Official Title
-----------------
Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HAMD-17 more than 12 points Participants could understand this study and sign permit Participants could receive NIRS measurements Participants could comply with the protocol of the study Exclusion Criteria: alcohol or substance abuse within 3 months of the study ever participate other clinical study related to duloxetine previous poor treatment effects of duloxetine concomitant use of MAOi within 14 days concomitant use of Linezolid with uncontrolled glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intervention<br>medication: duloxetine 30 to 60 mg tablets by mouth, QD to BID. | Drug: Duloxetine<br>* duloxetine 30 to 60 mg tablets by mouth, QD to BID per day,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression severity | Hamilton Rating Scale for Depression | 0-2-4-8-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brain cortical activity | Using Near Infrared Spectroscopy | 0-2-4-8-12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
near infrared spectroscopy, NIRS, duloxetine
Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas

Study Overview
=================
Brief Summary
-----------------
This is a perspective multicentric study for the treatment of patients aged equal or less than 60 years and submitted to an allogeneic hematopoietic stem cell transplantation from an HLA compatible related or unrelated donor because affected by resistent or refractory or relapsed after autologous stem cell transplantation Ewing Sarcoma or Soft tissues sarcoma who did not benefit from conventional therapy.

Official Title
-----------------
Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas

Conditions
-----------------
Ewing, Soft Tissue Sarcoma

Intervention / Treatment
-----------------
* Procedure: Allogeneic hemopoietic stem cell transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 0-60 years. Performance status according to Karnofsky score > 70% Normal liver function Normal renal function Normal cardiac function Informed consent Availability of an HLA compatible Donor Exclusion Criteria: Absence of at least one of the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cell Transplant<br>All the patient who are affected by refractory or resistant or relapsed Soft tissue sarcoma o Ewing sarcoma who find an HLA compatible allogeneic donor and are submitted to Stem cell transplantation | Procedure: Allogeneic hemopoietic stem cell transplant<br>* administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell<br>* Other names: CE_clin.42_2009_S_sper;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) a 12 months from the enrollment higher than 30% for the patients submitted to allogeneic stem cell transplantation in front of the patients who received conventional chemotherapy. |  | 12 months from the enrollement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant related mortality |  | 12 months after the enrollement of the first patients | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcoma, allogeneic, Hemopoietic stem cell transplant
Orthostatic Tolerance in Mamma Cancer Patients After Anaesthesia

Study Overview
=================
Brief Summary
-----------------
The investigators want to investigate the effect of anaesthesia, on the ability to maintain upright posture immediately after surgery in mamma cancer patients. The investigators hypothesis is, that a standard anaesthesia does not effect the ability to maintain upright posture right after surgery.

Detailed Description
-----------------
It is known, that patients undergoing major surgery have problems maintaining upright posture after major surgery. This can be due to fall in bloodpressure, with symptoms like dizziness, nausea/vomiting and fainting. With this investigation, we want to prove that anaesthesia is not the decisive factor, in patients ability to maintain upright posture after surgery.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having performed elective breast surgery Age between 18 and 70 years Patients who have given written consent to participate in the project after haven completely understood the contents and limitations of the protocol Exclusion Criteria: Patients who do not understand or speak Danish Patients who have not signed the informed consent or the written authority pre-medication, except 1g paracetamol ASA > II Pregnant or breastfeeding Known to have Renal disease Known to have Psychiatric disorder (not considering the use of SSRI antidepressive) Need for crash induction or prone position Oesophageal varicoses Necrosis or cancer in: Mouth, Pharynx, Larynx or Oesophagus Coarctation or aneurism in the proximal Aorta Severe bleeding disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 70 Years

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

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 |
| --- | --- | --- |
| To investigate orthostatic function, measured by Finapress |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the occurrence of postsurgery nausea/vomiting |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mammae cancer patients
Accuracy of Continuous SpO2 Measurement in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.

Detailed Description
-----------------
This study is a single-center blinded study that will enroll up to 15 adult subjects, male or female, of any ethnic background. SpO2 and pulse rate measurements reported by ViSi will be compared with simultaneous measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse oximeter, respectively. The paired measurements will be made in a well-controlled environment under optimal laboratory conditions.

Official Title
-----------------
SpO2 Accuracy Validation of Sotera Wireless Pulse Oximetry Systems During Non-Motion and Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age. Subject is a healthy volunteer capable of undergoing controlled hypoxemia to the level of 70% SaO2 (±3%) with no or minimal medical risk. Subject is willing and able to participate in the measurement period for up to two hours. Exclusion Criteria: Subject has a carboxyhemoglobin level (COHb) ≥3%. Subject has a MetHb level ≥2%. Subject has a ctHb value ≤10g/dl. Subject is in another clinical study that may interfere with the results of this study. Subject is unable or unwilling to have a blood gas and oxygen saturation measurements taken from either wrist/hand. Subject is deemed by the Investigator to be medically unsuitable for participation in this study.

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?
-----------------
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
-----------------
SpO2, Oxygen saturation
DMT210 Topical Gel in the Treatment of Acne Rosacea

Study Overview
=================
Brief Summary
-----------------
The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.

Official Title
-----------------
A Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea

Conditions
-----------------
Acne Rosacea

Intervention / Treatment
-----------------
* Drug: DMT210 Topical Gel 5%
* Other: Vehicle Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is male or non-pregnant female at least 18 years of age. Clinical diagnosis of moderate to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization Patient has at least ten inflammatory lesions of rosacea on the face at Randomization Patient is willing to apply the Investigational Product as directed Patient is willing and able to comply with the protocol Exclusion Criteria: Patient is pregnant or planning to become pregnant Patient is taking a topical therapy which may affect the patient's rosacea

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMT210 Topical Gel<br>DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks | Drug: DMT210 Topical Gel 5%<br> <br> |
| Placebo Comparator: Vehicle Control<br>Topical Gel vehicle applied to the face twice daily for 12 weeks | Other: Vehicle Control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by Inflammatory lesion counts | Inflammatory lesion counts | 12 weeks | 
| Efficacy as measured by Investigator Global Assessment (IGA) | Investigator Global Assessment (IGA) | 12 weeks | 
| Efficacy as measured by 5-point Clinical Erythema Assessment (CEA) | 5-point Clinical Erythema Assessment (CEA) | 12 weeks | 
| Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA) | 5-point Patient Severity Assessment of Erythema (PSA) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events as a measure of safety and tolerability | Incidence of adverse events as a measure of safety and tolerability | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin diseases, rosacea