linjc16/ctgov huggingface dataset:
Derivation and Validation of a Combination of BOSTON Score and DES-OSA Score for Selection of OSA Patients.

Study Overview
=================
Brief Summary
-----------------
Derivation and Validation of a combination of BOSTON score and DES-OSA score to exclude OSA or to confirm OSA in patients.

Detailed Description
-----------------
The aim of this study is to derive and to validate a combination of BOSTON score and DES-OSA score. Firstly, the investigators will use a retrospective cohort of 400 patients to determine this combination. It will allow classifying patients in 3 groups: 1) patients for whom OSA can be excluded with certitude, 2) patients for whom OSA can be diagnosed with certitude, and 3) an intermediate group. Secondly, the 100 patients included in this study will serve to validate the cutoff of the abovementioned combination into a new population.

Official Title
-----------------
Derivation and Validation of a Combination of BOSTON Score and DES-OSA Score for Selection of OSA Patients. A Preliminary Study.

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: Cutoff Validation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted in the Clinique Saint-Luc of Bouge for a polysomnography Exclusion Criteria: Patient's refusal

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 |
| --- | --- |
| All patients<br>Patients in this group will serve to validate the cutoff of the combination of the DES-OSA and BOSTON scores derived in the retrospective group. | Other: Cutoff Validation<br>* We will validate the cutoff of the combination of BOSTON score and DES-OSA scores with the result of a polysomnography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of cutoff values for the combination of BOSTON score and DES-OSA score in order to classify patients following their risk to present an OSA Syndrome. | Validation of cutoff values for the combination of BOSTON score and DES-OSA score derived in the retrospective group in order to validate these cutoff values in order to classify patients following their risk to present an OSA (Obstructive Sleep Apnea) Syndrome. The measurements will serve to validate the classification establish in the retrospective study, namely 1) patients without OSA with certitude, 2) patients with OSA with certitude, 3) an intermediate category. | One month |
Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction

Study Overview
=================
Brief Summary
-----------------
To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction

Detailed Description
-----------------
To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction compared to classical ice bagging

Official Title
-----------------
Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

Conditions
-----------------
Cryotherapy Effect

Intervention / Treatment
-----------------
* Device: Motorized cryotherapy
* Device: Classical cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ACL ruptured patient Exclusion Criteria: Combined meniscal injury requiring surgery Combined ligament injury requiring surgery Combined chondral injury requiring surgery Previous surgery history on corresponding knee Allergic to cold

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motorized cryotherapy<br>Application of motorized cryotherapy after ACL reconstruction for 6 postoperative days | Device: Motorized cryotherapy<br>* application of motorized cryotherapy after ACL reconstruction<br>|
| Active Comparator: Classical cryotherapy<br>Application of ice bags for 6 postoperative days | Device: Classical cryotherapy<br>* application of an ice bag<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after surgery | VAS pain scale (0 to 10 points, higher the worse pain) | postoperative day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effusion after surgery | Effusion by thigh circumference (cm), MRI measurement (cc) | baseline, postoperative day 4, 7, 14, 6 weeks |
Frequency of Prostate-Specific Antigen Screening in African American Men in the San Francisco Area

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to treat. PURPOSE: This research study is looking at whether patients who are being screened for prostate cancer have been previously screened.

Detailed Description
-----------------
OBJECTIVES: Primary To determine the degree to which patients who are being screened for prostate cancer have been previously screened. OUTLINE: Participants complete questions on a survey about prior prostate-specific antigen blood tests done for the purpose of screening for prostate cancer and are asked about their pastor, church, and how they heard about the SELECT study to determine the degree to which African-American men in a church-going population have been previously screened.

Official Title
-----------------
PSA Screening of African-American Men in The San Francisco Area

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: survey administration


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Meets all of the following criteria: African-American male Age 35 years or older Attends church on a regular basis Resides in the San Francisco area PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: survey administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree to which patients who are being screened for prostate cancer have been previously screened |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer
Molar Potency Study of HM12470 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects.

Official Title
-----------------
An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12470 and Regular Human Insulin in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Biological: HM12470


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females must be non-pregnant and non-lactating Males must be surgically sterile or using an acceptable contraceptive method Exclusion Criteria: Participation in an investigational study within 30 days prior to dosing Use of new prescription and non-prescription drugs within 3 weeks preceding the first dosing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>Intravenous (IV) infusion of HM12470 | Biological: HM12470<br>* HM12470 is a long-acting insulin analogue<br>|
| Experimental: Part 2: Sequence 1<br>Intravenous (IV) infusion of HM12470 | Biological: HM12470<br>* HM12470 is a long-acting insulin analogue<br>|
| Experimental: Part 2: Sequence 2<br>Intravenous (IV) infusion of HM12470 | Biological: HM12470<br>* HM12470 is a long-acting insulin analogue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period | - Comparison of HM12470 to RHI based on blood glucose profile generated by intravenous infusion | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of HM12470 | - Maximum concentration of HM12470 over the entire dosing period | 1 month | 
| AUC of HM12470 | - Area Under the Curve of HM12470 over the entire dosing period | 1 month |
Scalp Nerve Block on Emergence Agitation

Study Overview
=================
Brief Summary
-----------------
Emergence agitation is a common problem in children during recovery from sevoflurane anesthesia. Pain is considered as a cause of postoperative emergence agitation and compounding factor of agitation assessment in children. The purpose of this study was to investigate the effect of scalp nerve block on the emergence agitation in children undergoing nevus surgery during sevoflurane anesthesia.

Detailed Description
-----------------
Forty-four children, 1-7 years old, undergoing nevus surgery on head were enrolled. Anesthesia was induced with thiopental sodium and rocuronium, and maintained with sevoflurane. Patients were randomly assigned two groups: the control group received IV remifentanil 1 μg/kg, and the block group received scalp nerve block with 0.25% ropivacaine 2-3 ml. Time to tracheal extubation, recovery time, hemodynamic change, FLACC score, and Watcha behavior scale for emergence agitation were assessed.

Official Title
-----------------
The Effect of Scalp Nerve Block on the Emergence Agitation in Children Undergoing Nevus Surgery During Sevoflurane Anesthesia

Conditions
-----------------
Agitation

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Remifentanil
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II patients undergoing general anesthesia for nevus surgery Exclusion Criteria: developmental disorder neurologic disorder coaguloparthy allergy to local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerve block<br>Scalp nerve block was performed with 0.25% ropivacaine. | Drug: Ropivacaine<br>* 0.25% ropivacaine 2-3 ml was injected around the scalp nerves that are located on the head.<br>Drug: Sevoflurane<br>* Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.<br>|
| Active Comparator: Control<br>Remifentanil was administered intravenously. | Drug: Remifentanil<br>* Remifentanil 1 μg/kg was injected before skin incision.<br>* Other names: Ultiva;Drug: Sevoflurane<br>* Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Watcha behavior scale for emergence agitation (4 point) |  | from immediately after PACU arrival to 10 min, 20 min, and 30 min after arrival |
Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The ProSeal laryngeal mask airway is a relatively new airway device with a modified cuff to increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of gastric insufflation and insertion of a gastric tube. In the following randomized prospective double-blind trial, we test the hypothesis that the postoperative analgesic requirements is higher for the ProSeal laryngeal mask airway than the tracheal tube.

Official Title
-----------------
Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Device: ProSeal LMA
* Device: ProSeal LMA, Tracheal Tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female ASA I-II Age 18-75 Elective laparoscopic surgery Exclusion Criteria: Known or predicted difficult airway Oropharyngeal pathology Mouth opening < 3.0 cm A body mass index > 35 kg m-2 Increased risk of aspiration Inability to communicate or understand the visual analogue scale Analgesics within 24 hours of surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ProSeal LMA|ProSeal LMA vs Tracheal Tube|
|Device: ProSeal LMA, Tracheal Tube|ProSeal LMA vs Tracheal Tube|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesia |  | 24 hrs |
Rapid HIV Testing Program in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the feasibility of a rapid HIV testing program in the Temple University Hospital(TUH)Emergency Department. We hypothesize that a rapid HIV testing program in the TUH Emergency Department is feasible. Patients presenting to the Adult TUH Emergency Department with certain conditions will be offered rapid HIV testing. Testing will be performed by oral swab using the OraQuick Advance test. Patients will receive post-test counseling.

Official Title
-----------------
Pilot Study to Evaluate a Rapid HIV Testing Program in the Emergency Department

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Other: HIV test by oral swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One of the following conditions: Sexually transmitted disease evaluation or prior history of sexually transmitted disease Pregnancy Clinical condition that suggests possible immunodeficiency History of illicit drug use History of chronic viral hepatitis Patients with unexplained pneumonia or recurrent pneumonia Male patients who have a history of sex with men Abdominal pain in a sexually active woman or urethritis in a man Trauma. Age 18 years old or older. Exclusion Criteria: Age less than 18 years. None of the above conditions.

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rapid HIV Tested<br>Subjects have HIV testing by oral swab performed. | Other: HIV test by oral swab<br>* Eligible subjects underwent rapid HIV testing by oral swab.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Rapid HIV Testing in Emergency Department | Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Emergency Department, HIV Seronegativity
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.

Detailed Description
-----------------
The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in healthy elderly volunteers.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Doses of E2609 in Healthy Subjects and an Elderly Cohort

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Drug: E2609
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Healthy males and females Aged 30 to 55 years, inclusive (Cohorts 1 through 5); aged 65 to 85 years, inclusive (Cohort 6) Body mass index (BMI) of 18 to 32kg/m^2 at Screening Additional inclusion criteria for Cohort 6 (healthy elderly subjects) Exclusion Females of child-bearing potential Personal or family history of neurological abnormalities Any clinical abnormality of the electrocardiogram (ECG)at Screening and check-in A family history of cardiac abnormalities Thyroid abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: 1<br> | Drug: Drug: E2609<br>* E2609 orally at varying ascending doses<br>|
| Placebo Comparator: Placebo Comparator: 2<br> | Drug: Placebo<br>* Matching Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as evidenced by the number of subjects with adverse events |  | 38 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses |  | 4 days |
Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity

Study Overview
=================
Brief Summary
-----------------
This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery for obesity.

Detailed Description
-----------------
In patients receiving bariatric surgery, a preoperative liver biopsy will confirm the presence of NASH. Those patients with NASH (histologically defined according the Brunt's criteria) will be randomized to receive metformin (2 times 850 mg orally daily) or placebo for a time period of 1 year. A control liver biopsy will be performed after one year.

Official Title
-----------------
Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving bariatric surgery for obesity Exclusion Criteria: Other causes of liver disease (hepatitis B virus [HBV], hepatitis C virus [HCV], primary biliary cirrhosis [PBC], etc.) Patients with diabetes type I Patients with endocrinological reasons for obesity (eg. Cushing, etc.)
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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NASH<br> | Drug: Metformin<br>* Metformin is used.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with histological amelioration of NASH after a period of 1 year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year |  | 1 year |