linjc16/ctgov huggingface dataset:
Pepsin in Patients With Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
This non-interventional, observational study investigates the course of symptoms in patients with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid hydrochloride over a period of approximately 6 weeks. The change of the Gastrointestinal Symptom Score (GIS©) was the primary parameter for the assessment of efficacy and was performed at baseline, after 3 and 6 weeks of treatment respectively. Safety measures included recording of AEs and physical examination as well as measurement of vital signs. The aim was to observe 100 patients during the course of this non-interventional study.

Official Title
-----------------
A Non-interventional, Observational Study With a Fixed Combination of Pepsin and Amino Acid Hydrochloride in Patients With Functional Dyspepsia

Conditions
-----------------
Abdominal Pain, Functional Gastrointestinal Disorders, Dyspepsia, Nausea, Vomiting, Flatulence

Intervention / Treatment
-----------------
* Drug: Pepsin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with dyspepsia Women and men aged between 18 and 75 Exclusion Criteria: - Unwilling to consent

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 |
| --- |
|Drug: Pepsin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Symptom Score (GIS) | This is a third party assessment form. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability assessed by Adverse Events | Adverse Events | 6 weeks | 
| Subjective assessment of efficacy (4 point Likert scale) | Patient overall assessment (very good, good, moderate, no effect) | 6 weeks | 
| Subjective assessment of feasibility of use (4 point Likert scale) | Patient overall assessment (very good, good, moderate, no effect) | 6 weeks | 
| Symptomatology | Nepean Dyspepsia Index (NDI) modified | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyspepsia, Observational trial, Enzyme therapy, Pepsin
Zinc Supplementation in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of zinc supplementation in the treatment for dysgeusia, progression disease and quality of life in patients with liver cirrhosis.

Detailed Description
-----------------
Taste disorders are symptomatologies in patients with cirrhosis, these have a direct effect in modification of food consumption, increasing weight loss, anorexia and malnutrition, which impacts in decompensation rates and mortality. It has been proposed that zinc deficiency is one of the causes for development of taste disorders. The aim of this study is to describe the presence of taste disorders in patients with cirrhosis and evaluate the effect of zinc supplementation in treatment of taste disorders, and in progression of chronic liver disease.

Official Title
-----------------
Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients

Conditions
-----------------
Dysgeusia, Liver Cirrhosis

Intervention / Treatment
-----------------
* Dietary Supplement: zinc gluconate
* Dietary Supplement: Placebo
* Behavioral: Nutritional education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhotic patients by any etiology, with any dysgeusia Exclusion Criteria: Patients with hepatic encephalopathy at the time of dysgeusia evaluation Patients with any neurological disease Patients with respiratory diseases ath the time of dysgeusia evaluation Patients with active alcohol consumption

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 100 mg placebo<br>100 mg Placebo plus nutritional education | Dietary Supplement: Placebo<br> <br> Behavioral: Nutritional education<br> <br> |
| Experimental: 100 mg zinc supplement<br>Nutritional education plus 100 mg of zinc gluconate | Dietary Supplement: zinc gluconate<br>* Zinc supplementation plus nutritional education<br>Behavioral: Nutritional education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysgeusia | Evaluation of presence of any taste disorder, according to questionnaires and evaluation of perception and recognition thresholds with ascending molar concentrations of basic tastes. | Presence of any taste disorder at 6 months |
Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies

Study Overview
=================
Brief Summary
-----------------
This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants who require pharmacologic therapy. We intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. We plan to also test and generate hypotheses in preparation to apply for funding a larger randomized controlled trial.

Detailed Description
-----------------
Objectives: Primary: To establish feasibility of a protocol for auricular acupuncture in infants suffering from NAS admitted to the NICU receiving pharmacologic therapy. Secondary: In infants suffering from NAS admitted to the Neonatal Intensive Care Unit (NICU) receiving pharmacologic therapy: Determine parent and staff acceptability of auricular acupuncture Determine infant tolerance to auricular acupuncture Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses Evaluate the effect of auricular acupuncture on time to return to birth weight

Official Title
-----------------
Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study

Conditions
-----------------
Neonatal Abstinence Syndrome

Intervention / Treatment
-----------------
* Other: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy Parents give written consent within 72 hours of infant receiving first dose of methadone Exclusion Criteria: Helix or antihelix of ear is deformed and needle is unable to be placed A suspected or confirmed genetic or metabolic syndrome Custody retained by the Department of Children and Families Any skin condition involving the ear(s) Suspected or documented infection at the time of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAS babies<br>Acupuncture for NAS | Other: Acupuncture<br>* Acupuncture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Skin Breakdown and / or Cellulitis |  | up to 57 days | 
| Percentage of Dislodged Needles |  | Within three days of placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture
Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy

Study Overview
=================
Brief Summary
-----------------
This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.

Official Title
-----------------
A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients With Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: lamotrigine


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: 16 years old or older. Have confident diagnosis of epilepsy. Have been on the medication valproate for at least 3 months and is currently on a stable daily dose. Male or female; females of child-bearing potential must have negative pregnancy test at screen and must agree to use an acceptable birth control method. EXCLUSION CRITERIA: A history of hypersensitivity to the drug being studied. Currently being treated with or has been treated in the past with the drug being studied. Undergoing polytherapy treatment with the medication valproate and one or more other antiepileptic drug(s). If undergoing treatment with vagal nerve stimulation, has had device implanted more than 30 days prior to enrollment. Has taken an investigational drug or the medication Felbatol within the previous 30 days. Is abusing alcohol and/or other substances.

Ages Eligible for Study
-----------------
Minimum Age: 16 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug levels of lamotrigine. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study has no secondary outcome measures. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, monotherapy conversion
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients

Study Overview
=================
Brief Summary
-----------------
Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

Detailed Description
-----------------
Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered twice daily is replaced by Prograf as study medication, administered twice daily. Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment. Conversion from Prograf (twice daily, morning & evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1. Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.

Official Title
-----------------
A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Kidney Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen

Conditions
-----------------
Transplantation

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant at least 12 months prior to enrollment. Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL. Exclusion Criteria: Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Tacrolimus<br>* Immunosuppression<br>* Other names: FK506E, MR4;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine clearance |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, HbA1c, acute rejection |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Kidney Transplantation
The Effects of Mindfulness Training on Eating Behaviors and Food Intake

Study Overview
=================
Brief Summary
-----------------
The investigators propose to study the effect of mindfulness training on the eating behaviors and dietary intake of overweight or obese persons. Mindfulness skills training involves bringing non-judgmental attention to thoughts, emotions and bodily sensations - including hunger and satiety cues. It is hypothesized that as subjects advance through the 8-week class series, developing their capacity for mindfulness and in effect learn to pay attention to the sensations, assumptions, cognitions, and beliefs that underlie their eating behaviors, that their eating behaviors will improve. Specifically, the investigators hypothesize that 1) there will be significant improvements in the areas of uncontrolled and emotional eating, 2) there will be significant decreases in total caloric intake and significant increases in fruits and vegetables, and 3) there will be a positive significant relationship between the frequency/consistency of mindfulness practice and improvements from baseline to follow-up measures.

Official Title
-----------------
The Effects of Mindfulness Training on Eating Behaviors and Food Intake

Conditions
-----------------
Obesity, Feeding Behavior

Intervention / Treatment
-----------------
* Behavioral: Mindful Eating and Living Course


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) > 26 Exclusion Criteria: Psychotic disorders Poorly controlled bipolar disorder Borderline or antisocial personality disorder A diagnosed eating disorder

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: MEAL<br>Participation in an 8-week mindful eating course | Behavioral: Mindful Eating and Living Course<br>* An eight week course designed to teach mindfulness skills with an emphasis on mindful eating.<br>* Other names: MEAL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eating behaviors | The TFEQ will be administered. Subscales for emotional eating, uncontrolled eating and cognitive restraint will be assessed | baseline, 2 months, 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nutrition intake | The ASA-24 and the DHQ will be administered to assess nutritional intake | baseline, 2 months, 5 months |
Capnography During ERCP

Study Overview
=================
Brief Summary
-----------------
In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.

Detailed Description
-----------------
In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.

Official Title
-----------------
Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for ERCP

Conditions
-----------------
Hypoxemia, Complications

Intervention / Treatment
-----------------
* Procedure: Capnography
* Procedure: Standard monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>=18 Scheduled for colonoscopy with midazolam and propofol sedation Exclusion Criteria: No informed consent ASA V Pregnancy Prexisting hypotension, bradycardia or hypoxemia

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capnography<br>Arm with capnographic monitoring | Procedure: Capnography<br>* Capnographic monitoring<br>|
| Placebo Comparator: Standard<br>Standard monitoring. | Procedure: Standard monitoring<br>* Standard monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia |  | From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further complications |  | From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Sedation, Gastrointestinal endoscopy, Colonoscopy
Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
Radiostereometric Analysis (RSA) is a new imaging technique used to measure motions in the spine. It provides more accurate measurements that could help in diagnosing problems in the spine earlier than standard xray techniques.

Detailed Description
-----------------
Assessment of segmental spinal motion has been and continues to be a difficult clinical problem. X-ray measurement error of up to 10 degrees for simple measurements for flexion, extension and side bending have been recorded. It is extremely difficult to measure small changes in vertebral alignment that may prove to have clinical significance. The measurement accuracy of the RSA technique far exceeds any manual techniques to date. RSA allows the surgeon to monitor spatial relationships within the spine over time with a much higher accuracy then conventional techniques. This is a non-randomized prospective study design looking at the use of RSA in spinal surgery patients. Subjects in this study will undergo their indicated surgery. Prior to closure, they will be implanted with tantalum beads, which will serve as landmarks when the RSA film pairs are taken post-operatively. The subjects will have standard post-operative x-rays 6 weeks-3 months post-op and again at 12 months post-op. Yearly visits after this are anticipated for 5-10 years with proper funding.

Official Title
-----------------
Use of Radiostereometric Analysis (RSA) for Measuring Spinal Motion Following Lumbar Spinal Surgery

Conditions
-----------------
Spinal Fusion, Lumbar Discectomy

Intervention / Treatment
-----------------
* Procedure: Radiostereometric Analysis beads inserted during surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing Spinal fusion or discectomy Exclusion Criteria: pregnant women

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 |
| --- |
|Procedure: Radiostereometric Analysis beads inserted during surgery|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
-----------------
spinal motion, tantalum beads