linjc16/ctgov huggingface dataset:
Evaluation of the Effect of Output on New Adhesives

Study Overview
=================
Brief Summary
-----------------
The study investigates the impanct real output has on the adhesion of a new adhesive

Official Title
-----------------
A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Other: Adhesive strip A
* Other: Adhesive strip B
* Other: Adhesive strip C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have had a stoma for more than one year Have intact skin on the area used in the evalua-tion Has a stoma with a diameter up to (≤) 35 mm Have a peristomal area accessible for application of adhesive strips (assessed by investigating scientist) Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peristo-mal- or abdominal area (assessed by investigating scientist) Actively participating in other interventional clinical investigations or have previously participated in this investigation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test of three new adhesive strips<br>The subjects test three new adhesive strips adhesive strip A adhesive strip B adhesive strip C | Other: Adhesive strip A<br>* Strip consisting of a newly developed adhesive<br>Other: Adhesive strip B<br>* Strip consisting of a newly developed adhesive<br>Other: Adhesive strip C<br>* Strip consisting of a newly developed adhesive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans epidermal water loss | The trans epidermal water loss is measured on the peristomal skin using a probe. Thrans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin du to natural evaporation. However, when the skin barrier is damaged more water can evaporate. Trans epridermal water loss is used to assess the damage to the skin. | 8 hours |
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy. The hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.

Official Title
-----------------
Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie

Conditions
-----------------
Pain, Postoperative, Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Ropivacaine 0.5 %
* Drug: Isotonic NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eligible for elective vaginal hysterectomy able to speak and understand Danish able to give informed consent Exclusion Criteria: alcohol or medical abuse allergies to local anesthetics age < 18 yrs. intolerance to opioids

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Local infiltration with Ropivacaine | Drug: Ropivacaine 0.5 %<br>* Local Infiltration with Ropivacaine 0.5 %<br>|
| Placebo Comparator: 2<br>Local infiltration with Placebo (NaCl) | Drug: Isotonic NaCl<br>* Local Infiltration with NaCl<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain |  | 32 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PONV |  | 32 h |
Snack Food Reinforcement in Obese and Non-obese Women

Study Overview
=================
Brief Summary
-----------------
Food reinforcement, motivation to obtain food, is associated with energy intake and obesity. Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to diets and weight loss. Our previous study in non-obese adults showed that daily consumption of the same snack food (food typically consumed outside of meals) for 14 days significantly decreased its reinforcing value. The purpose of this study was to replicate and extend these findings to obese individuals as well as to examine effects of different portion sizes of snack foods on food reinforcement. Thirty-one obese (body mass index > 30 kg/m2) and 27 non-obese (BMI < 30 kg/m2) women had food reinforcement and liking tested at baseline and after two weeks of daily consumption of either 0 kcal, 100 kcals, or 300 kcals daily of the same snack food.

Official Title
-----------------
Differential Effects of Daily Snack Food Intake on Reinforcing Value of Food in Obese and Non-obese Women.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women non-smoker not on a diet no restrained eating had to like potential snack foods willing to visit the laboratory 3 times willing to eat snacks provided no medications or medical conditions that affect appetite no food allergies Exclusion Criteria: see above

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Non-obese/0 kcal | |
| 2<br>Non-obese/100 kcal | |
| 3<br>Non-obese/300 kcal | |
| 4<br>Obese/0 kcal | |
| 5<br>Obese/100 kcal | |
| 6<br>Obese/300 kcal | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Responses Made by Clicking a Mouse Button for Food | Participants were asked to click a button on a computer mouse and after a certaion number of responses, participants would receive a point. After 5 points, the participants received a portion of snack food. | During 2nd and 3rd visits | 
| Energy Intake | energy contained in eaten foods and beverages | visits 1, 2, and 3 plus on the phone throughout the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | body weight | visit 1 and visit 3 | 
| Height | height | visits 1 and 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMI, obesity, sensitization, food reinforcement, snack food, Portion size of daily snacks, Weight status
Evaluation of the Effect of Revision Surgery of Lumbar Adjacent Segment Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate postoperative imaging changes and clinical symptom improvement in patients undergoing revision surgery for adjacent segment degeneration.

Official Title
-----------------
Evaluation of the Effect of Revision Surgery of Lumbar Adjacent Segment Degeneration

Conditions
-----------------
Adjacent Segment Disease, Adjacent Segment Degeneration

Intervention / Treatment
-----------------
* Procedure: reversion surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For patients undergoing revision surgery in adjacent segments due to S-ASD, the revision surgery is at least half a year from the first operation; X-ray, CT and MRI examination data of the anterior and lateral extension of the lumbar spine were available within 1 month before surgery and at the last follow-up; Follow-up for at least 2 years after revision; Exclusion Criteria: Patients with history of congenital spinal deformity, spinal tumor, spinal tuberculosis.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: reversion surgery|reversion surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) scores of low back pain and leg pain | Visual Analog Scale (VAS) scores of low back pain and leg pain | 2 years after revision surgery | 
| Japanese Orthopedic Association (JOA) score | Japanese Orthopedic Association (JOA) score | 2 years after revision surgery | 
| Oswestry Disability Index (ODI) | Oswestry Disability Index (ODI) | 2 years after revision surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adjacent Segment Degeneration, reversion surgery
The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.

Conditions
-----------------
Device Success Rate, Device Performance

Intervention / Treatment
-----------------
* Device: i-Gel
* Device: ProSeal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II Age 1.5-6 years Exclusion Criteria: known or predicted difficult airway body mass index > 35 kg m-2 risk of aspiration

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: i-Gel<br> | Device: i-Gel<br>* Oropharyngeal leak pressure Insertion success<br>|
| Experimental: ProSeal<br> | Device: ProSeal<br>* Oropharyngeal leak pressure Insertion success<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure |  | 10 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion success rate |  | 1 Minute |
Internet-based Intervention for Complicated Grief: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
A considerable proportion of bereaved individuals experience chronic and disabling grief (so-called complicated or prolonged grief). Complicated grief is associated with severe mental and physical health problems as well as impaired social and occupational functioning. Interventions based on cognitive-behavioral therapy and applied via the internet have shown to be efficacious for this condition, but have not yet been adapted and evaluated in Norway. The aim of the current study is to adapt an internet-based cognitive-behavioral intervention for complicated grief and evaluate its effectiveness as a pilot study.

Official Title
-----------------
Internet-based Intervention for Complicated Grief: A Pilot Study

Conditions
-----------------
Complicated Grief

Intervention / Treatment
-----------------
* Other: Internet-based cognitive-behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complicated grief Internet access Fluent in Norwegian No concomitant psychological treatment Exclusion Criteria: Severe depression Psychotic symptoms Dissociation Suicidality

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Internet-based cognitive-behavioral therapy for complicated grief | Other: Internet-based cognitive-behavioral therapy<br>* The intervention consists of ten writing assignments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from pretest to posttest in symptoms of complicated grief |  | 6 weeks | 
| Change from pretest to follow-up (1) in symptoms of complicated grief |  | 18 weeks | 
| Change from pretest to follow-up (2) in symptoms of complicated grief |  | 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from pretest to posttest in posttraumatic growth |  | 6 weeks | 
| Change from pretest to follow-up (1) in posttraumatic growth |  | 18 weeks | 
| Change from pretest to follow-up (2) in posttraumatic growth |  | 30 weeks | 
| Change from pretest to posttest in quality of life |  | 6 weeks | 
| Change from pretest to follow-up (1) in quality of life |  | 18 weeks | 
| Change from pretest to follow-up (2) in quality of life |  | 30 weeks | 
| Change from pretest to posttest in depression |  | 6 weeks | 
| Change from pretest to follow-up (1) in depression |  | 18 weeks | 
| Change from pretest to follow-up (2) in depression |  | 30 weeks |
Acceptability and Feasibility of Medical Abortion in Singapore

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70 days LMP will be feasible and acceptable in Singapore.

Official Title
-----------------
Acceptability and Feasibility of Medical Abortion in Singapore: A Study of 800 μg Buccal Misoprostol Following 200 mg Mifepristone for Abortion Through 70 Days Gestation

Conditions
-----------------
Medical Abortion

Intervention / Treatment
-----------------
* Drug: Mifepristone
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an intrauterine pregnancy consistent wit gestational age ≤ 70 days Be 21 years of age or over Be willing and able to sign consent forms Be eligible for abortion according to current hospital guidelines Be able to return to the clinic and able to contact study staff or emergency medical services if needed Be willing to provide an address, email and/or telephone number for purposes of follow-up Agree to comply with the study procedures and visit schedule Exclusion Criteria: confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass chronic renal failure concurrent long-term corticosteroid therapy history of inherited porphyrias IUD in place (must be removed after mifepristone is administered).

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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: All participants<br>All participants in the study will be given the option of home administration of 200 mg oral mifepristone and 800 μg buccal misoprostol for medical abortion. | Drug: Mifepristone<br>* The option of home or clinic administration of 200 mg oral mifepristone<br>Drug: Misoprostol<br>* 800 μg buccal misoprostol through 70 days LMP following administration of mifepristone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful abortion | Proportion of abortions that are complete without surgical intervention | 7-10 days after mifepristone administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the medical abortion method | Proportion of women who are satisfied with the medical abortion method | 7-10 days after mifepristone administration | 
| Preferred location of mifepristone administration | Proportion of women who select home use of mifepristone | The day of enrollment |
A Pilot Study of the Effect of Individualized Clinical Management Among Parent/Child Dyads on Continuity of Care and Interaction

Study Overview
=================
Brief Summary
-----------------
this project aims to collect retrospective data on the conitinuity/disconitnuity rate for child care in the child psychiatry unit of the université hospital of Besançon, France.

Official Title
-----------------
A Pilot Study of the Effect of Individualized Clinical Management Among Parent/Child Dyads on Continuity of Care and Interaction. Phase 1 : Retrospective Evaluation

Conditions
-----------------
Child Psychiatry, Psychodynamic Therapy, Continuity/Discontinuity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family having with a first consultation request submitted from 2015 Children aged < 10 years old at the time of the first consultation

Ages Eligible for Study
-----------------
Maximum Age: 10 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 |
| --- | --- | --- |
| rate of contuinity/discontinuity of child care |  | 3 years |
Intravenous Streptokinase in Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
To determine whether the administration of intravenous streptokinase (SK) early in the course of acute, transmural myocardial infarction would limit myocardial damage.

Detailed Description
-----------------
BACKGROUND: Determination of the potential value of thrombolytic therapy in patients with acute myocardial infarction was an issue of major importance in 1983. An estimated 1.4 million heart attacks occurred each year, of which over 500,000 were fatal. Reduction of mortality required an effective means to reduce infarct size. Studies indicated that reperfusion represented a potent means of achieving salvage of ischemic myocardium. Pilot clinical studies indicated that reperfusion could be achieved in a substantial percentage of patients by lysis of coronary thrombosis with both intracoronary and intravenous streptokinase administration. Intracoronary thrombolysis was receiving widespread clinical applications but had many limitations. The intracoronary route took 90-120 minutes longer to administer than the intravenous route. Because intracoronary therapy required the availability of a catheterization laboratories and highly skilled invasive cardiologists, this treatment was not available to large numbers of patients who were hospitalized in smaller community hospitals. DESIGN NARRATIVE: Randomized design with two groups and fixed sample size. Control patients received routine coronary care. The treatment group received intravenous streptokinase plus conventional care. This was followed with intravenous heparin and warfarin. The primary endpoint was 14 day mortality. Secondary endpoints included angiographic patency of the involved coronary artery at 10 to 14 days, left ventricular function, segmental wall motion analysis, and myocardial infarction size at 30-45 days.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia

Intervention / Treatment
-----------------
* Drug: streptokinase


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women, aged less than 75. Myocardial infarction onset within six hours.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: streptokinase|nan|

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

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