linjc16/ctgov huggingface dataset:
Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.

Study Overview
=================
Brief Summary
-----------------
The advantages of the celioscopy mini--trocar and monotrocar technical are recognized. There is however no forward-looking or retrospective study comparing the microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section) in gynecological surgery. The objective of this preliminary study is to compare both surgical care in terms of morbidity died operating, in adnexa surgeries.

Official Title
-----------------
Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.

Conditions
-----------------
Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Age > 18 ans OMS = 2 Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy Exclusion Criteria: Contraindication to coelioscopy intervention

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient having an operating indication of adnexa surgery<br>Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate post operative pains | consumption of analgesic for pains in immediate operating comment | Up to 1 month | 
| Court term post operative pains | consumption of analgesic for pains | Up to 2 month | 
| Medium term post operative pains | consumption of analgesic for pains | Up to 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications per operating | Blood loss | During surgery | 
| Complications per operating | Addition of trocar | During surgery | 
| Complications post operating | Duration of hospitalization | Up to 1 month |
Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to investigate the role of the Trasylol in glucagon prevention in degradation using radioimmunoactive method with I125. Additionally different incubation time was introduced in human plasma samples after oral glucose stimulation, also in fasted and hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the techniques for the glucagon measurement are well described nowadays.

Conditions
-----------------
Hyperglucagonemia

Intervention / Treatment
-----------------
* Other: Fasting glycemia
* Other: Hypoglycemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasians 18 years or older with Type 2 diabetes (WHO criteria) Exclusion Criteria: HbA1c >9 % Liver disease (ALAT/ASAT >2 x upper normal limit) Diabetic nephropathy (s-creatinine >130 µM or albuminuria) Proliferative diabetic retinopathy (anamnestic) Severe arteriosclerosis or heart failure (NYHA group III og IV) Anemia treatment with medication not applicable to pause for 12 hours pregnancy or lactation Fasting plasma glucose >15 mM on screening day.

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

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

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

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 |
| --- | --- |
| Experimental: GIP<br> | Other: Fasting glycemia<br>* no intervention<br>Other: Hypoglycemia<br>* Insulin induced hypoglycemia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma glucagon values measured with c-terminal specific micro-protocol RIA4305: 350µl of plasma (duplicate sample). |  | 120 min |
Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery

Study Overview
=================
Brief Summary
-----------------
The objectives of this study were (1) to estimate the incidence of emergency general surgery in a Swiss University Hospital, (2) to describe the characteristics and outcomes of patients undergoing such interventions, and (3) to study the impact of age on the outcomes.

Official Title
-----------------
Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery

Conditions
-----------------
Emergency General Surgery

Intervention / Treatment
-----------------
* Other: Age (young versus older)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - consecutive patients visiting the emergency department Exclusion Criteria: admitted primarily for a psychiatric reason left without consultation

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 |
| --- | --- |
| ED patients<br> | Other: Age (young versus older)<br>* Age<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of emergency general surgery | Emergency general surgery following ED visit | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission to intensive care unit rate | Admission to intensive care unit | During index hospitalization | 
| ICU length of stay | Number of days spent in the ICU during hospital stay | During index hospitalization | 
| 30-day mortality rate | 30-day mortality | 30 days | 
| 90-day mortality rate | 90-day mortality | 90 days | 
| One-year mortality rate | One-year mortality | One year | 
| Hospital length of stay | Hospital length of stay | During index hospitalization | 
| Rate of patient dependent at discharge | Dependent at discharge | Hospital discharge |
NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis

Official Title
-----------------
Relationship of Edoxaban Plamsa Concentration and Blood Coagulation in Healthy Volunteers Using Standard Laboratory Tests and Viscoelastic Analysis

Conditions
-----------------
Blood Coagulation Disorder

Intervention / Treatment
-----------------
* Drug: Edoxaban 60 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: intolerance of the study drug history of bleeding disorder or similar

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rotem<br> | Drug: Edoxaban 60 MG<br>* Viscoelastic analysis and standard laboratory tests after edoxaban ingestion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of edoxaban peak plasma concentrations and viscoelastic analysis | viscoelastic test values and blood coagulation laboratory parameters | 1 day |
Yoga for Pain and Opioid Dependence

Study Overview
=================
Brief Summary
-----------------
This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.

Detailed Description
-----------------
This study aims to develop an adjunctive novel treatment intervention using yoga in opioid agonist maintained patients to effectively treat the co-occurring disorders of non-malignant chronic pain and opioid dependence (POD). Specific Aims: 1) To conduct a pre-pilot phase with 8 patients with POD receiving opioid agonist maintenance treatment.

Official Title
-----------------
Yoga for Pain and Opioid Dependence

Conditions
-----------------
Chronic Pain, Opioid Addiction

Intervention / Treatment
-----------------
* Other: Yoga
* Behavioral: Educational Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Prescription opioid addiction or heroin addiction Moderate to severe chronic pain, Understands English Exclusion Criteria: Current suicide or homicide risk Life threatening or unstable medical condition Medical or psychiatric condition that is judged to be of clinical concern by the PI or admitting clinician Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>Gentle yoga for chronic pain and opioid dependence | Other: Yoga<br>* Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.<br>|
| Active Comparator: Educational Counseling<br>Educational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment. | Behavioral: Educational Counseling<br>* One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Pain reduction will be measured by patient self-report using standard pain rating scales. | 8 weeks | 
| Reduce illicit opioid use | Reduced illicit opioid use will be measured by patient self-report and urinalysis testing. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Addiction, Buprenorphine, Counseling, Methadone, Yoga
Bathing Additives in Pediatric Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The current clinical guidelines for management of atopic dermatitis now recommend bleach baths. This requires simply the addition of regular household bleach to twice-weekly baths. At the Mayo Clinic, dilute acetic acid (vinegar) has been recommended for decades in wet wraps to treat patients hospitalized for their atopic dermatitis. However, this practice has not been widely adopted in the pediatric dermatology community. Will the use of dilute acetic acid (vinegar) in twice weekly baths help manage atopic dermatitis in pediatric patients as well as, or better than, the current accepted guidelines?

Official Title
-----------------
Bathing Additives in Management of Pediatric Atopic Dermatitis

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

Intervention / Treatment
-----------------
* Other: Bathing Additive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients from 6 months to 17 years of age Currently residing in US. Follow up visits at 1 month, 3 months and 6 months after initiation of treatment in study (Figure 1). Last follow-up at 1 year in clinic or via written mailed-out survey. Diagnosis of atopic dermatitis AND Have active signs of bacterial skin infection OR Any documented suspected history of bacterial skin infection (weeping, crusting, and/or pustules on exam), OR Prescription for oral antibiotics for skin infection in the past 6 months from any provider). OR Have been prescribed bleach baths as part of an atopic dermatitis skin care regimen. Exclusion Criteria: Superficial skin infection without diagnosis of atopic dermatitis Lack of in-clinic follow up assessment at 6 months

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 17 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bleach<br>Patients will use bleach added to their baths twice a week. | Other: Bathing Additive<br> <br> |
| Active Comparator: Vinegar<br>Patients will use vinegar (dilute acetic acid) added to their baths twice a week. | Other: Bathing Additive<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EASI score at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Courses of antibiotics required |  | 1 year |
National Tunisian Registry of Hypertension

Study Overview
=================
Brief Summary
-----------------
The Tunisian Society of Cardiology and Cardiovascular Surgery (STCCCV) proposes to coordinate a national, observational, cross-sectional and multicenter survey carried out during one month. The main objective of the survey is to describe the blood pressure and cardiovascular risk profile of the hypertensive patient in Tunisia. This survey will allow us to have a generalized and updated view of the tunisian hypertensive patient in order to optimize treatment and to know the degree of adherence of practitioners to international recommendations in the care of the hypertension in Tunisia.

Official Title
-----------------
National Tunisian Registry of Hypertension

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Informed consent, read and signed Exclusion Criteria: Consent not obtained

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Blood Pressure Level | Mean of Systolic and Diastolic Blood Pressure in mmHg | At inclusion | 
| Cardiovascular Risk Profile | Percentages & Frequencies of cardiovascular risk factors | At inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NATURE-HTN
Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms

Study Overview
=================
Brief Summary
-----------------
The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is the subject of this observational study. 180 patients will be implanted with the Anaconda™ Stent Graft System and will be followed-up annually for 5 years post-implant. The study will satisfy the requirements of the French National Authority for Health (Haute Autorité de santé) and the data collected will be used for reimbursement renewal.

Detailed Description
-----------------
Infrarenal abdominal aortic aneurysms may be treated with the introduction of an abdominal aortic stent graft via the femoral route. This technique is commonly used in high surgical risk patients but can also be suitable under certain conditions for normal risk patients. Abdominal aortic stent grafts, inserted via the femoral artery, are used to treat infrarenal abdominal aortic aneurysms, removing the need for an invasive surgical procedure. The aim of this observational study is to evaluate the long-term (5 year) benefits of the technique by documenting the overall mortality, complications (endoleak, migration), rate of surgical conversion, progression and rupture of the aneurysm in a cohort of patients who are representative of the treated population under real conditions of use.

Official Title
-----------------
Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms

Conditions
-----------------
Abdominal Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient implanted with the Vascutek Anaconda™ Stent Graft System for the treatment of a non-ruptured infrarenal Abdominal Aortic Aneurysm (AAA) Exclusion Criteria: Patients for whom clinical follow-up is impossible and cannot return for check-up visits

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality rate |  | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years | 
| Mortality rate related to rupture of the aneurysm and relationship to the stent |  | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years | 
| Change in diameter of the aneurysm |  | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years | 
| Rate of Type I, II and III endoleaks |  | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years | 
| Surgical conversion rate |  | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years | 
| Rate of endovascular or surgical revisions |  | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years |
Safety and Tolerability of NOVA63035 Corticosteroid in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
Evaluation of safety and tolerability of a single injection of NOVA63035 Corticosteroid administered at one of four doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy

Official Title
-----------------
A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of NOVA63035 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: NOVA63035 Corticosteroid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M & F 18 years and older Diagnosed with diabetes mellitus and presenting diabetic retinopathy Exclusion Criteria: Monocular History of current ocular hypertension or glaucoma in either eye defined Any significant ocular disease (other than diabetic retinopathy)

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cohort 1<br>5 up to 6 patients per arm. Emulsion at 0.8% of drug product. | Drug: NOVA63035 Corticosteroid<br>* Single injection in the study eye<br>|
| Experimental: cohort 2<br>5 up to 6 patients per arm. Emulsion at 0.8% of drug product. | Drug: NOVA63035 Corticosteroid<br>* Single injection in the study eye<br>|
| Experimental: cohort 3<br>5 up to 6 patients per arm. Emulsion at 3.2% of drug product. | Drug: NOVA63035 Corticosteroid<br>* Single injection in the study eye<br>|
| Experimental: cohort 4<br>5 up to 6 patients per arm. Oily solution at 3.4% of drug product. | Drug: NOVA63035 Corticosteroid<br>* Single injection in the study eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular safety |  | Over one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic macular edema, Diabetes, Diabetic retinopathy