linjc16/ctgov huggingface dataset:
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin

Study Overview
=================
Brief Summary
-----------------
The study investigates different adhesive materials on healthy and peristomal skin

Official Title
-----------------
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin

Conditions
-----------------
Skin Abnormalities

Intervention / Treatment
-----------------
* Other: Adhesive material
* Other: Standard adhesive material


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has given written consent Be at least 18 years of age and have full legal capacity Have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) Have suitable peristomal skin area (assessed by investigator) (for stoma patients) Exclusion Criteria: Currently receiving or have within the past 2 months received radio- and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment Are pregnant or breastfeeding Having dermatological problems in the abdominal area (assessed by investigator) Participate in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ostomy Adhesive material<br>Newly designed ostomy adhesive material | Other: Adhesive material<br>* Newly developed adhesive material<br>|
| Other: comparator adhesive material<br>Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product | Other: Standard adhesive material<br>* Standard adhesive material<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherent area | Adherent area (assessed by photos of adhesive materials) | At every material change throughout the study, an average of 1 week |
MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users

Study Overview
=================
Brief Summary
-----------------
This study compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics.

Detailed Description
-----------------
This study compares digital pills, electronic pill bottles, self-report, and dried blood spots, in measuring adherence to antiretroviral medications containing emtricitabine and tenofovir.

Official Title
-----------------
MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users

Conditions
-----------------
HIV-positive Individuals

Intervention / Treatment
-----------------
* Device: MyTPill, a digital pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV+, Viral load >200copies/mL, on single pill containing TDF/FTC, receiving prescription for opioid analgesics Exclusion Criteria: Severe renal or hepatic disease Hypersensitivity to silver, magnesium, or zinc following oral use Pregnancy non-English speaking History of Crohn's disease or Ulcerative Colitis History of bowel surgery, gastric bypass, or bowel stricture History of gastrointestinal malignancy or radiation to the abdomen.

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 |
| --- | --- |
| MyTPill<br>Participants receive digital pills for three months, have a 2-week washout, then switch to Wisepill. | Device: MyTPill, a digital pill<br>* MyTPill is a digital pill containing an approved medication<br>* Other names: Wisepill, a digital pillbox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dried blood spots | Measurement of dried blood spots for TDF/FTC concentrations | six months | 
| Adherence per two different electronic adherence measures | Secondary outcomes are the identification of multi-level factors that are prevalent in the target population most closely linked to ART non-adherence and EAM non-adherence. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pill counts | Count numbers of antiretroviral pills at followup sessions | Six months |
Effects of Omega-3 Fatty Acids on Outcome After Major Liver Resection

Study Overview
=================
Brief Summary
-----------------
To study the efficacy and safety of intravenous Omegaven™ (vs. Placebo) in reducing postoperative morbidity and mortality after major liver resection.

Detailed Description
-----------------
With two single doses of Omegaven (pre- and postoperatively) we aim to reduce postoperative complications measured by the CCI (Comprehensive Complication Index) and the Clavien Dindo classification of surgical complications. The study will include adults (more than 18 years) patients requiring liver resection of at least 1 segment or multiple wedge resections (≥3).

Official Title
-----------------
A Randomized, Double-blind Study of the Effects of Omega-3 Fatty Acids (Omegaven™) on Outcome After Major Liver Resection

Conditions
-----------------
Major Liver Surgery

Intervention / Treatment
-----------------
* Drug: Omegaven™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Requiring liver resection of at least 1 segment or multiple wedge resections (=3) > 18 years of age No coagulopathy (INR < 1.2, platelets >150'000 x10E3/µl) Understands local language Exclusion criteria: Liver resections <1 segment Wedge resections (<3) Liver cirrhosis Coagulopathy (INR > 1.2, platelets < 150'000 x10E3/µl) Hypertriglyceridemia (> 5.0 mmol/l) Hypersensitivity or allergy to Omegaven™ or any fish oil or lipid emulsions Known allergy to egg protein Pregnancy Nursing women Renal failure(estimated GFR < 30 ml/min/1.73m2) Medication impairing platelets aggregation Cannot understand local language

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omegaven™<br>Omegaven™ (approval number:54750 Swissmedic)- 100ml intravenously. The first dose (Omegaven™ or placebo) is administered in the evening before surgery, the second dose at the beginning of anesthesia. The maximum infusion rate must be adjusted to bodyweight (0.5 ml Omegaven™/kg/hour). | Drug: Omegaven™<br> <br> |
| Placebo Comparator: NaCl 0.9%<br>100ml of saline is used as a placebo comparator and administered as described above. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Complications will be assessed using the Comprehensive Complication Index (CCI) and the Clavien-Dindo complication classification. | 1 month after hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
at least 1 segment, multiple wedge resections (≥3)
Bleeding Symptoms of Carriers of Hemophilia A and B

Study Overview
=================
Brief Summary
-----------------
To collect and analyze data on female carriers of severe and moderate hemophilia A and B.

Official Title
-----------------
Bleeding Symptoms of Carriers of Hemophilia A and B

Conditions
-----------------
Hemophilia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female carriers of hemophilia A and B. Exclusion Criteria: Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Bleeding tendency in carriers of severe and moderate haemophilia compared to a control group. |  | Five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carriers of hemophilia
The Research of the Effect of Sevoflurane on Brain-protection of Cardiac Surgery in Infants.

Study Overview
=================
Brief Summary
-----------------
To observe the effect of sevoflurane on the concentration of S100β and regional cerebral oxygen saturation in infants with congenital heart disease undergoing cardiac surgery.

Official Title
-----------------
Effect of Sevoflurane on the Content of S100β in Infants With Congenital Heart Disease Undergo Cardiac Surgery.

Conditions
-----------------
Congenital Heart Disease, Infant, Premature, Diseases

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of congenital heart disease Undergoing heart surgery with cardiopulmonary bypass Exclusion Criteria: Pulmonary arterial hypertension Sevoflurane allergy

Ages Eligible for Study
-----------------
Maximum Age: 3 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
Interventional Model Description: one group is treated with sevoflurane, the other is not.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane<br>Sevoflurane will be used as a narcotic drug in one group during cardiac surgery. | Drug: Sevoflurane<br>* 1.5%-3% Sevoflurane will be given during the cardiac surgery except cardiopulmonary bypass.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of S100β protein | The concentration of S100β protein was performed using the electrochemiluminescence immunoassay.(Blood samples from patients were drawn from central intravenous.) | 5 minutes after tracheal intubation; immediately after cardiopulmonary bypass; immediately after operation; 12 hours, 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of regional cerebral oxygen saturation(rScO2) | The rScO2 was measured by using noninvasive near-infrared spectroscopy during cardiac surgery | 5 minutes after tracheal intubation; immediately after cardiopulmonary bypass; immediately after operation; 12 hours, 24 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sevoflurane, S100β protein, regional cerebral oxygen saturation, infant
IMFINZI Study in Patients With Extensive Stage Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch

Detailed Description
-----------------
To capture the onset (incidence, severity, intervention, outcome, and others) of febrile neutropenia in patients with extensive stage small cell lung cancer who receive durvalumab in combination with platinum agent and etoposide under the actual use.

Official Title
-----------------
IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Extensive Stage Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Small Cell

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with extensive stage small cell lung cancer who are receiving the product in combination with platinum agent and etoposide. Exclusion Criteria: -Patients who have no treatment history with the product (i.e.,durvalumab)
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 |
| --- | --- | --- |
| Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade) |  | 16weeks |
Risk Factors for Post-Operative Nonunion of Tibial Shaft Fractures Based on a Path Analysis Model

Study Overview
=================
Brief Summary
-----------------
Tibial shaft fractures is common long tubular fracture that account for about 13.7% of all fractures. And the incidence of nonunion of tibial shaft fracture varied from 1% to 80%. This study aimed to confirm the risk factors of nonunion of tibial shaft fracture. Moreover, the investigators hope to establish the clinical pathway of various risk factors for fracture nonunion and affirm the importance of different risk factors.

Detailed Description
-----------------
Tibial shaft fractures is common long tubular fracture that account for about 13.7% of all fractures. And the incidence of nonunion of tibial shaft fracture varied from 1% to 80%. The investigators retrospectively analyzed the demographics of these participants in our hospital that occur long tubular fracture. One group is participants that existed fracture nonunion. And the other group is the participants that did not exist fracture nonunion. The investigators recorded twelve variables and confirm the risk factors by uni-variate Logistic regression analysis. Moreover, the investigators hope to establish the clinical pathway of various risk factors for fracture nonunion and affirm the importance of different risk factors.

Official Title
-----------------
Risk Factors for Post-Operative Nonunion of Tibial Shaft Fractures Based on a Path Analysis Model: A Case-Control Study

Conditions
-----------------
Nonunion of Fracture of Tibia (Diagnosis)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The tibial shaft fracture was caused by trauma. Exclusion Criteria: The tibial shaft fracture was caused by tumor, infection and other reasons.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| without fracture nonunion<br>The patients who undergone surgery after tibial shaft fracture did not exist fracture nonunion | |
| with fracture nonunion<br>The patients who undergone surgery after tibial shaft fracture existed fracture nonunion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Gustilo type of the open fracture | the Gustilo type of the open fracture can be divided into three types. And the type I is the open fractures with wounds that is clean and smaller than 1cm. Type II is the the open fractures with wounds that is moderately unclean and bigger than 1cm, which also has a wide soft tissue injury. Type III is the all open fractures that accompany with severe soft tissue injury and pollution. | the outcome of the Gustilo type can acquire within 1 week. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nonunion, tibial shaft fracture, path analysis model
The Effect Evaluation of Laser Acupuncture in Obesity

Study Overview
=================
Brief Summary
-----------------
A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2 groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2 receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds every time, 3 times per week. The measurements of outcomes are performed in the beginning, weekly during treatment, and monthly after treatment for 3 months.

Official Title
-----------------
The Effect Evaluation of Laser Acupuncture in Obesity

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

Intervention / Treatment
-----------------
* Device: Handylaser Trion laser acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index over 25 kg/m2 or Waist girth over 80cm in female, waist girth over 90cm in male Exclusion Criteria: Pathmakers user Epilepsy history Pregnancy Immuno-inhibiting agents user Malignancy Skin contacted disease Weight controlled agents user during trial period Eating disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks | Device: Handylaser Trion laser acupuncture<br>* intervention interval is 3 times per week for 12 weeks<br>* Other names: Handylaser Trion;|
| Sham Comparator: Group 2<br>arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks | Device: Handylaser Trion laser acupuncture<br>* intervention interval is 3 times per week for 12 weeks<br>* Other names: Handylaser Trion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition | body weight | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laser acupuncture, obesity
Treatment of Diabetic Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control diabetic retinopathy.

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate Sterile Suspension (15 mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of patients with diabetic retinopathy. Patients must be at least 18 years of age. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart Exclusion Criteria: Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. Patients who have undergone intraocular surgery within the last 2 months. Patient participating in any other investigational drug study. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access). Patient with significant liver disease or uremia. Patient with known adverse reaction to fluorescein and indocyanine green or iodine. Patient has a history of any medical condition which would preclude scheduled visits or completion of study Patient has had insertion of scleral buckle in the study eye Patient has received radiation treatment Patient is on anticoagulant therapy with the exception of aspirin Patient is pregnant or nursing.

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anecortave Acetate Sterile Suspension (15 mg)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |