linjc16/ctgov huggingface dataset:
A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)

Study Overview
=================
Brief Summary
-----------------
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.

Detailed Description
-----------------
Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.

Official Title
-----------------
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Pimecrolimus cream
* Drug: Betamethasone dipropionate cream
* Drug: Clobetasol propionate cream
* Drug: Glaxal Base cream vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with mild to moderate AD Four comparable TAs TSS of at least 5 on all TAs Difference in TSS not greater than 2 between the TAs Sign score erythema ≥ 2 between the TAs TAs should be at least 2 cm apart Exclusion Criteria: Investigator's opinion Fitzpatrick skin type >5 Topical (i.e. on the TAs) treatment with prohibited medications Systemic treatment with prohibited medications Phototherapy within prohibited timeframe Use of emollients within prohibited timeframe

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pimecrolimus cream<br>Pimecrolimus 1% cream once daily for 14 days | Drug: Pimecrolimus cream<br> <br> * Other names: Elidel;|
| Active Comparator: Betamethasone dipropionate cream<br>Betamethasone dipropionate 0.05% cream once daily for 14 days | Drug: Betamethasone dipropionate cream<br> <br> * Other names: Diprolene;|
| Active Comparator: Clobetasol propionate cream<br>Clobetasol propionate 0.05% cream once daily for 14 days | Drug: Clobetasol propionate cream<br> <br> * Other names: Dermovate;|
| Placebo Comparator: Glaxal Base cream vehicle<br>Glaxal Base cream vehicle once daily for 14 days | Drug: Glaxal Base cream vehicle<br> <br> * Other names: emollient cream;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sign Score (TSS) change | TSS change at end of treatment in relation to baseline | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eczema, AD, Atopic Dermatitis
Molar Potency Study of HM12460A in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in healthy subjects.

Official Title
-----------------
An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12460A and Insulin Glargine in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Biological: HM12460A


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: History of any major surgery within 6 months prior to screening Use of any new prescription or non-prescription drug in the last 30 days

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 | Biological: HM12460A<br>* HM12460A is a long-acting insulin<br>|
| Experimental: Part 2: Cohort A<br>Intravenous (IV) infusion (Dose A) | Biological: HM12460A<br>* HM12460A is a long-acting insulin<br>|
| Experimental: Part 2: Cohort B<br>Intravenous (IV) infusion (Dose B) | Biological: HM12460A<br>* HM12460A is a long-acting insulin<br>|
| Experimental: Part 2: Cohort C<br>Intravenous (IV) infusion (Dose C) | Biological: HM12460A<br>* HM12460A is a long-acting insulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose assessment of HM12460A and insulin glargine over the entire dosing period | - Comparison of HM12460A to insulin glargine based on blood glucose profile generated by intravenous infusion | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of HM12460A | - Maximum concentration of HM12460A over the entire dosing period | 1 month | 
| AUC of HM12460A | - Area Under the Curve of HM12460A over the entire dosing period | 1 month |
Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA

Study Overview
=================
Brief Summary
-----------------
Comparative efficacy of 24 and 48 hours post operative pain control in single total knee replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or 0.5 % bupivacaine for single femoral nerve block

Official Title
-----------------
Comparative Effect of 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for Femoral Nerve Block After Total Knee Replacement

Conditions
-----------------
Post Operative Pain, Total Knee Replacement

Intervention / Treatment
-----------------
* Drug: morphine and bupivacaine
* Drug: spinal morphine and marcaine
* Drug: morphine and bupivacaine
* Drug: morphine and bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single elective total knee replacement in ASA 1-3 without significant cardiovascular limitation Exclusion Criteria: patient at risk in usage COX-2 for post operative pain control

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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: 1<br>Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine | Drug: morphine and bupivacaine<br>* 0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block<br>* Other names: marcaine;|
| Active Comparator: 2<br>Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine | Drug: spinal morphine and marcaine<br>* 0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block<br>* Other names: marcaine;|
| Active Comparator: 3<br>Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine | Drug: morphine and bupivacaine<br>* 0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block<br>* Other names: marcaine;|
| Active Comparator: 4<br>Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine | Drug: morphine and bupivacaine<br>* 0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block<br>* Other names: marcaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment in post operative pain control |  | Begining of first enrollment in december 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS |  | first enrollment in December 2008 |
Accuracy and Reliability of GSA for Remnant Liver Function

Study Overview
=================
Brief Summary
-----------------
Preoperative evaluation of future remnant liver function is critical for patients undergoing hepatic surgery. Overestimation of the remnant liver function can lead to life-threatening postoperative hepatic failure, and its underestimation can lead to a lost opportunity for potentially curative surgery. Conventionally, post-hepatectomy remnant liver function has been estimated preoperatively using computed tomography (CT) volumetry. CT can provide precise anatomical information, and the remnant liver volume, measured by CT volumetry, has been reported to be an effective predictor of hepatic dysfunction after hepatectomy. However, the indirect estimation of liver function by CT volumetry is reliable only when the function is assumed to be homogenous over the whole liver.

Detailed Description
-----------------
99mTc-galactosyl human serum albumin (99mTc-GSA) single-photon emission CT (SPECT) was developed to facilitate investigations of regional hepatic function. A disadvantage of conventional 99mTc-GSA SPECT was poor anatomical resolution, and this newly developed SPECT has a tremendously improved anatomical resolution owing to the fusion of CT and 99mTc-GSA SPECT. Recent reports have indicated that accurate regional function, based on precise anatomical information, could be evaluated using this technique.

Official Title
-----------------
Accuracy and Reliability of GSA for Remnant Liver Function in Scheduled Hepatectomized Patients

Conditions
-----------------
Both Benign and Malignant Liver Mass

Intervention / Treatment
-----------------
* Device: 99mTc-GSA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All eligible patients were those surgically treated for hepato-biliary diseases. Exclusion Criteria: Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 99mTc-GSA|nan|

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
-----------------
liver, surgery, liver function, GSA, ICG
Clinical Evaluation of Cordio Application in Adult COVID-19 Virus Positive Patients

Study Overview
=================
Brief Summary
-----------------
Study on adult patients positive to COVID-19 virus. After signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the Cordio App installed in a smartphone/tablet. The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital admittance (COVID-19 positive) until patient defined as COVID-19 negative and free of relevant clinical symptoms.

Official Title
-----------------
Single-Arm Observational Study Designed to Clinically Evaluate Cordio Application in Adult Patients Positive to COVID-19

Conditions
-----------------
Coronavirus Infection

Intervention / Treatment
-----------------
* Device: Cordio App


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+ years old Diagnosed with COVID-19 positive patients according to medical center guidelines, with symptoms of cough and or dyspnea. Patients that diagnosed with pneumonia, should be confirmed by X-ray and/or CT. Able to understand and provide written informed consent (manually or electronically or giving their consent via the telephone to the study investigator in case of isolated patients). Exclusion Criteria: Subjects, in the Investigator's opinion, unable to comply with the daily use of the application including mental disorders (e.g., depression, dementia). Patients with severe alcohol or drug use. Women who are pregnant or lactating. Participating in another investigation therapy that may interfere with study results (according to investigator discretion)

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cordio App|Adult patients positive to COVID-19 virus will record several predefined sentences via a smartphone / tablet and will answer questions via the app|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice anaysis | patient voice that is recorded during the study will be anylaysis with specific algorithms | 1-2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 positive
Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient

Study Overview
=================
Brief Summary
-----------------
Altered brain networks, including cognitive, motor, and language networks, are investigated by intensive cognitive rehabilitation in subacute stroke patients.

Official Title
-----------------
Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient

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

Intervention / Treatment
-----------------
* Procedure: Cognitive rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 19 to 80 years Patients with subacute stroke within 2 weeks of onset First-ever stroke Supratentorial stroke Less than 8 SAFE (shoulder abduction, finger extension) points Less than 35 FMA Upper scores MEP (motor evoked potential) negative Not more than 24 K-MMSE (Korean Mini-Mental State Examination) score Exclusion Criteria: Difficult to communicate due to severe language impairment. Accompanied by an existing serious neurogenic disease Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder If there are difficulties in conducting the research Any patients who are judged by the investigator to be difficult to participate in this study Patients with contraindicated MRI scans

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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: Intensive cognitive rehabilitation group<br>Participants receive intensive cognitive rehabilitation for 20 hours for 4 weeks. | Procedure: Cognitive rehabilitation<br>* Intensive cognitive rehabilitation by cognitive therapist for 1 hour on every working 20 days (4 weeks) during the subacute stroke phase<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength of connectivity in brain network obtained from MRI neuroimaging data | Participants' MRI neuroimaging data are acquired at pre- and post-intervention. Brain network can be constructed using MRI neuroimaging data, and strength of connectivity can be calculated in the brain network. Strength of connectivity has a value between -1 and 1. | Change in strength of connectivity after intensive cognitive rehabilitation for 4 weeks |
Investigation on the Value of Bilateral Index (BIS) Monitoring for Magnetic Seizure Versus Electroconvulsive Therapy

Study Overview
=================
Brief Summary
-----------------
Electroconvulsive therapy (ECT) has been shown to be an effective treatment for patients suffering from depression, who do not respond to medical treatment. However it is often dismissed by patients, who feel uncomfortably about the application of electric shocks to their heads. In 2000, magnetic seizure therapy (MST) has been introduced which uses magnetism instead of electricity to evoke convulsions. MST seems to be as effective as ECT in terms of its antidepressant potency but may be associated with less severe cognitive side effects. Control of anaesthesia during seizure therapy is demanding since light anesthesia might be associated with awareness, whereas deep anesthesia impedes the antidepressant effect of the convulsion. Therefore, Bispectral index (BIS) monitoring is frequently used to tailor anaesthesia for ECT, however little is known about BIS following MST. The investigators hypothesize that in comparing MST with ECT, (a) patients show a faster increase in BIS and that (b)less left-right differences occur in BIS.

Official Title
-----------------
Bilateral Bispectral Index Monitoring During and After Electroconvulsive Therapy Compared With Magnetic Seizure Therapy for Treatment-resistant Depression

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: depression Exclusion Criteria: age < 18 years old pregnancy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Magnetic Seizure Therapy Group<br>Patients receiving magnetic seizure therapy for depression | |
| Electroconvulsive Therapy Group<br>Patients receiving electroconvulsive therapy for depression | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Time | recovery time from seizure induction to eye opening / restoration of breathing | same day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, bispectral index, electroconvulsive therapy, magnetic seizure therapy
Study to Determine Incidence of Hypoventilation in Patients Who Have Undergone Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if gastric bypass patients experience hypoventilation in the immediate postoperative period, and to what degree.

Detailed Description
-----------------
We propose to determine if patients with clinically significant obesity (body mass index, BMI, between 40 kg/m2 and 85 kg/m2), who have undergone gastric bypass procedures under general anesthesia hypoventilate during the initial twenty-four hour postoperative period, and if so, to what degree. Adequacy of ventilation will be assessed by serial arterial blood analyses. Patients will be monitored for SpO2 in the preoperative holding area, in the operating room, and the post-anesthesia care unit (PACU) by conventional and study pulse oximeters. SpO2 data will be collected continuously and recorded on the study pulse oximeter for the entire study period. Arterial blood samples will be drawn for analysis every four hours by in-dwelling arterial catheter, using standard sterile technique. Hypoventilation is defined as an increase in PaCO2 five or more mm Hg above patient's baseline.

Official Title
-----------------
A Prospective Double Blind Pilot Study to Determine the Incidence of Postoperative Hypoventilation in Patients With Clinically Significant Obesity Who Have Undergone Gastric Bypass Procedures Under General Anesthesia

Conditions
-----------------
Morbid Obesity, Bariatric Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects 18 to 65 years of age Clinically significant obesity with a BMI between 40 and 85 Candidates approved for gastric bypass surgery at Tampa General Hospital (*Please note: authorization for gastric bypass will be completed prior to enrollment in study; this study does not pay for the cost of the operation.) American Society of Anesthesiologists (ASA) Physical Status Classification I-III Able to understand and sign informed consent Exclusion Criteria: Patients not able to understand the informed consent process, or unable to understand the research protocol Patients in which placing an arterial catheter would pose a clinically unacceptable health risk, e.g., bleeding disorders, radial artery malformation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Monitoring and Treatment of Extremity Trauma for Mass Casualties in Difficult Contexts

Study Overview
=================
Brief Summary
-----------------
The prospective cohort study, SuTra2, assesses the functional and socio-economic status of patients who were operated on for a severe limb injury resulting in amputation or limb preservation 1 and 2 years after the 2010 Haiti earthquake.

Official Title
-----------------
Suivi et Traitement du Traumatisme Des Membres en Cas d'Afflux Massif de blessés Dans Les Contextes Difficiles

Conditions
-----------------
Wounds and Injuries, Traumatic Amputation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, with limb injuries due to the earthquake, Who underwent limb surgery, which ended up in limb amputation or limb conservation. Exclusion criteria : Limb injury not related to the earthquake No surgery for the limb injury
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A cohort post amputation<br>Those patients undergoing either traumatic amputation or surgical amputation of limb | |
| A cohort post limb conserving surgery<br>Patients whose surgical management involved conservation of their injured limb | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction with Musculoskeletal functional recovery |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Employment status |  | 2 years |