linjc16/ctgov huggingface dataset:
Intraoral Grafting of Ex Vivo Produced Oral Mucosal Composites

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if we can develop a good graft for oral mucosal tissue that is like the top of the mouth in a test tube that could be used successfully in humans. We have already done this successfully mice. The next step is to take a small piece of tissue from a human volunteer and see if we can grow a larger piece of tissue from it outside the human body and graft it back into the same person successfully. We expect that this technique will work. It has already been tried in patients with burns of the skin who have had similar procedures where the skin is grafted back to them. The significance of this research is that oral tissue taken from the top of the mouth or palate is in limited supply and leaves the patient with a painful and uncomfortable post surgery experience. If we are successful with our technique the patient will experience less pain and discomfort from the site that we are using to grow our tissue outside the body than if we had taken it from the top of the mouth or palate. In addition, by waiting longer periods to grow the patient's cells we can make larger pieces of oral tissue than we could have gotten directly from the patient's mouth. Patients who will participate in this study will need to require a soft tissue graft from the mouth to an area that needs additional attached or keratinized mucosa. This will most likely be either in preparation for patients who have or will have dental implants placed. Another subset of patients are those who need scar tissue released or the vestibule of their mouth (area that turns from the gums to the lip) released.

Conditions
-----------------
Mouth Diseases

Intervention / Treatment
-----------------
* Procedure: Oral mucosal graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lack sufficient attached keratinized tissue at recipient surgical site in question

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Oral mucosal graft|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
-----------------
mouth mucosa, transplants
Buprenorphine Detoxification With Two Types of Treatment. BBD IV - 13

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate buprenorphine and behavioral treatment with and without contingent payment on compliance with pro-social activities. In addition, we will examine whether blind naltrexone dosing is effective in indicating naltrexone consumption.

Official Title
-----------------
Buprenorphine Detoxification With Two Types of Treatment. BBD IV

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Weeks abstinent |  |  | 
| Weeks continuous abstinence |  |  | 
| Overall treatment outcome |  |  | 
| Naltrexone consumption |  |  |
The Finnish Diabetes Prevention Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to clarify whether lifestyle intervention provided to people with high type 2 diabetes risk will lower the cumulative incidence of diabetes. Furthermore, the aim is to study the effect of lifestyle intervention on cardiovascular risk.

Official Title
-----------------
The Finnish Diabetes Prevention Study: A Follow-up Study on the Effect of a Dietary and Exercise Intervention in the Prevention of Diabetes and Its Vascular Complications

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Intensive lifestyle counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: impaired glucose tolerance (p-glucose 2 hours after a 75 g oral glucose load between 7.8 and 11.0 mmol/l) body mass index 25 or higher Exclusion Criteria: diabetes (previous gestational diabetes accepted) other chronic disease rendering survival for 6 years condition or medication affecting glucose tolerance recent myocardial infarction

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intensive lifestyle intervention | Behavioral: Intensive lifestyle counselling<br>* Individualized dietary and physical activity counselling aiming at weight reduction dietary fibre 15 g /1000 kcal or more energy proportion of dietary fat less than 30% energy proportion of saturated fat less than 10% moderate physical activity >30 minutes per day or 4 hours per week<br>|
| No Intervention: 2<br>Standard counselling at baseline | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes incidence |  | During the intervention period + after the intervention has been stopped | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CVD incidence |  | During the total follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intervention, impaired glucose tolerance, lifestyle, randomized controlled study, Type 2 diabetes, primary prevention, diet, physical activity
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

Study Overview
=================
Brief Summary
-----------------
The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (DOR 100mg) and islatravir (ISL 0.75mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

Official Title
-----------------
A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study

Conditions
-----------------
HIV-1 Infection

Intervention / Treatment
-----------------
* Drug: MK-8591A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is currently receiving DOR 100 mg/ISL 0.75 mg adult FDC tablet in an MSD-sponsored clinical study and has completed the last treatment visit. Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate. Is male or female and ≥35 kg at the time of signing the informed consent/assent. Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines) Exclusion Criteria: Is taking or is anticipated to require any prohibited therapies.
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: MK-8591A<br>Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks. | Drug: MK-8591A<br>* FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants with serious adverse events (SAEs) | Percentage of participants with serious adverse events (SAEs) | Up to Week 198 | 
| Participants who discontinued due to an adverse event (AE) | Percentage of participants who discontinued study treatment due to an AE. | Up to Week 192 |
Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo

Study Overview
=================
Brief Summary
-----------------
This study is being carried out to see if quetiapine (Seroquel) is effective in preventing patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it compares with non-active treatment.

Official Title
-----------------
A 1-year, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Phase 3 Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Sustained-release Quetiapine Fumarate (SEROQUEL) or Placebo (Abbreviated)

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Seroquel (quetiapine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable schizophrenic patients who have provided written informed consent Patients 18 to 65 years old who remain clinically stable after switching to a stable dose of Seroquel (quetiapine). Exclusion Criteria: Patients with risk of suicide, other disorders or substance abuse that might interfere with the patient's ability to co-operate, Expected non-compliance to treatment Known diabetes mellitus, Contraindications, Intolerance or non-responsiveness to Seroquel or other safety issues.

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Seroquel (quetiapine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse in long-term use in patients with schizophrenia by evaluating the one-year relapse rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
Oxycodone in Serum After Postoperative Oral Oxycodone in Caesarean Sections Under Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
All patients undergoing an elective caesarean section under spinal anesthesia will, according to the hospital routines, receive 10 mg oxycodone slow-release tablet when arriving at our postoperative care unit (PACU). Blood samples will be taken at 0 hour, 1 hour, 2 and 6 hours after administration in order to investigate bioavailability.

Detailed Description
-----------------
After written informed consent, blood samples will be taken before administration, after 1 hour, 2 hours and 6 hours. Need of rescue analgesia (morphine iv) and level of pain, as well as side effects will be registered

Official Title
-----------------
Gastrointestinal Uptake of Oxycodone After Caesarean Section in Spinal Anesthesia

Conditions
-----------------
Analgesic Adverse Reaction, Cesarean Delivery Affecting Newborn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women > 18 years old, with one healthy fetus scheduled for a elective caesarean section in spinal anesthesia, read and signed informed consent - Exclusion Criteria: Known intolerability to oxycodone. Previous use of opioids. Hight < 150 cm, preconceptual BMI > 35. ASA > 2.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- | --- |
| level of oxycodone in serum |  | 1 hour after administration | 
| level of oxycodone in serum |  | 2 hours after administration | 
| level of oxycodone in serum |  | 6 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of pain | NRS scale 0-10 | 0, 1, 2, and 6 hours after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxycodone, caesarean, spinal anesthesia
Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery

Study Overview
=================
Brief Summary
-----------------
This research is being done to determine the resistance across stenosis in the airway.

Detailed Description
-----------------
There is significant utility in objectively measuring airflow as subjects, undergoing endoscopic laryngeal surgery, commonly have difficulties with airflow secondary to their stenosis. Easier and quicker quantification will tailor diagnosis and treatment. In order to obtain an objective measure of airflow in these participants, we will place a 20-gauge angiocatheter needle into the airway. The catheter will be in situ for a short duration during several spontaneous and non-spontaneous breaths. This will be achieved via the existing tracheostomy stoma or percutaneously via the cricothyroid membrane. This technique is commonly used to access the muscles of the larynx, however, the primary purpose will be to measure airflow in this setting.

Official Title
-----------------
Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery

Conditions
-----------------
Laryngotracheal Stenosis

Intervention / Treatment
-----------------
* Diagnostic Test: Measure Airway Resistance Across Stenosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years or older that require outpatient endoscopic laryngeal airway surgery, in the operating room, at a tertiary academic center. Exclusion Criteria: Pregnancy (status will be determined by a urine test as part of standard clinical care in the preoperative setting) Patients that are not cleared for surgery by the preoperative evaluation Patients with severe laryngotracheal stenosis Patients who are morbidly obese (BMI > 40) Patients with lung disease (asthma, COPD)

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 |
| --- | --- |
| Laryngotracheal Stenosis<br>Patients with laryngotracheal stenosis will have pressure sensors placed proximal and distal to the stenosis. Pressure and air flow will be measured | Diagnostic Test: Measure Airway Resistance Across Stenosis<br>* Measure pressure and air flow Across Stenosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure (cm H20) | Using a pressure gauge to measure pressure at locations in the airway | Up to One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Rate (L/min) | using a flow sensor to measure low rate at locations in airway | Up to One Year |
Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care

Study Overview
=================
Brief Summary
-----------------
To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and cognitive functioning in residents living in a community-based adult long-term care facility. Hypothesis 1: Residents who participate in the MiM group will improve in emotional functioning, as compared to residents in the control group. Hypothesis 2: Residents who participate in the MiM group will improve in cognitive functioning, as compared to residents in the control group.

Detailed Description
-----------------
To implement a community-based integrated music, art and imagery, and movement intervention to improve mood and promote cognitive functioning in older adult residents living in a long-term care facility.

Official Title
-----------------
Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care

Conditions
-----------------
Emotion, Impaired Cognition

Intervention / Treatment
-----------------
* Behavioral: Music, Imagery, Movement
* Behavioral: Social Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident in assisted living at long-term care facility with MMSE score above 20 Exclusion Criteria: co-morbid psychiatric diagnosis and/or staff clinical evaluation that determines inappropriateness for study inclusion
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music, Imagery, Movement intervention<br>Music, Imagery, Movement intervention: psychosocial intervention incorporating Music, Imagery and Movement | Behavioral: Music, Imagery, Movement<br>* Implementation of music, art and imagery activation, and movement in group modality<br>|
| Active Comparator: Social Control<br>social control/interaction group | Behavioral: Social Control<br>* social conversational group facilitated by care counselor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emotional functioning |  | pre-post 10 week treatment and 6 week FU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive functioning |  | pre-post 10 week intervention and 6 week FU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
creative arts, older adults, intervention study
Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B

Study Overview
=================
Brief Summary
-----------------
Retrospective, multicenter study in patients with hemophilia B. This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU, and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate. Following informed consent and eligibility, historical patient information including demographics, allergy history, hemophilia history, frequency and severity of allergic reaction(s), number of exposure days with products causing allergic reactions, exposure days to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of event(s), any other adverse event(s) occuring within 48 hours of onset of allergic reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and outcome, current status of patient, and results of any special studies (eg, skin or RAST testing, alloantibody analyses, ect) will be collected.

Official Title
-----------------
A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B

Conditions
-----------------
Hemophilia B, Allergic Reactions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent to release patient information Living or deceased patients with mild to severe hemophilia B who have had at least 1 exposure to replacement factor IX product(s). Living or deceased patients who had their first infusion of any FIX product between 1 January 1991 and 31 December 2003. Exclusion Criteria: There are no exclusion criteria.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia B