linjc16/ctgov huggingface dataset:
An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain. This will then help to make accurate predictions of efficacy and dosing in the future development programme.

Official Title
-----------------
An Open Label Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2516 After Oral Administration to Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD2516


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal MRI scan Healthy male or non-fertile females Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg Exclusion Criteria: History of disease or condition that may interfere with the objectives of the study History of previous or ongoing psychiatric disease/condition Concomitant medication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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 |
| --- | --- |
| Experimental: 1<br>AZD2516 | Drug: AZD2516<br>* Fractionated single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy |  | 1 Month: Baseline and 3 PET examinations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD2516 by adverse events, vitals signs, ECG, body temperature and laboratory variables |  | Assessed at each visit from baseline to follow-up visit | 
| To investigate the Pharmacokinetics of AZD2516 |  | 1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positron Emission Tomography, Phase 1, Healthy volunteers, AZD2516
Effect of Opioids on Experimental Hyperalgesia in Oesophagus, Skin and Muscles

Study Overview
=================
Brief Summary
-----------------
The study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. The study is a randomized cross-over study. The effect of 2 opioids will be compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin and oesophagus, to sensitize these tissues. The pain thresholds before and after opioid administration will be compared. The hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. The study will include an explorative study of the effect of Morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

Detailed Description
-----------------
The study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. The study is a randomized cross-over study. The effect of 2 opioids, Oxycodone and Morphine will be compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin by capsaicin and in oesophagus by a mixture of capsaicin and acid, to sensitize these tissues. The pain thresholds before and after opioid administration will be compared. The hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. The study will include an explorative study of the effect of Morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

Official Title
-----------------
Investigation of the Effect of Opioids on Experimental Hyperalgesia in Oesophagus and Skin, and in an Ischemic Model of Musclepain. Including an Explorative Study of the Effect of Morphine on the Pain Processing in the Brain

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 and 65 years Signed informed concent Healthy Women must use a safe contraceptive method Negative pregnancy test Exclusion Criteria: Pregnancy Allergy to study medication Participating in another medicine study Previous addictive behaviour Need for other treatments Use of strong analgesics Use of any analgesics 24 hours before the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Modulation of Brain Blood Flow Using Dichoptic Visual and Auditory Stimulation

Study Overview
=================
Brief Summary
-----------------
Modulation of brain blood flow using dichoptic Visual and Auditory stimulation using REVIVIEW system will be evaluated.

Detailed Description
-----------------
The participant will undergo baseline MRI to measure blood flow in the brain for comparison later on. After baseline MRI, the participant will observe stimulation using the REVIVIEW system for 20 minutes. The content the participants will see is a nature documentary, after which the participant will undergo additional MRI imaging to assess the change in blood flow in the brain.

Official Title
-----------------
Modulation of Brain Blood Flow Using Dichoptic Visual and Auditory Stimulation

Conditions
-----------------
Cerebral Arterial Diseases

Intervention / Treatment
-----------------
* Device: REVIVIEW dichoptic audio-visual stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - healthy subjects Exclusion Criteria: History of brain diseases Glasses Diagnosed with Diabetes Diagnosed with Degenerative brain diseases Inability to undergo MRI

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation Arm<br>REVIVIEW dichoptic audio-visual stimulation | Device: REVIVIEW dichoptic audio-visual stimulation<br>* REVIVIEW dichoptic audio-visual stimulation using video goggles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood flow in the brain in respond to the stimulation | Evaluate the change in blood flow in different parts of the brain, compared with baseline, after the cessation of stimulation, after 30 minutes and after 60 minutes. | 1 hour |
Acidity Level of Blood From Primary Molar's Pulp While Undergoing Pulpotomy or Pulpectomy Procedure

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the level of acidity of blood samples that are been taken from pulp chambers of primary molars undergoing pulpotomy or pulpectomy procedures. Our hypothesis is that samples from teeth undergoing pulpectomy would be acidic while samples from teeth undergoing pulpotomy would bo neutral.

Detailed Description
-----------------
The samples will be collected by 1 ml syringe that is pre-washed with Heparin.than the samples will be analyzed in an Astrop machine of neonates.

Official Title
-----------------
Characterization of Blood Drawn From the Pulp of Primary Molar Undergoing Pulpotomy or Pulpectomy.

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no systemic disease teeth that are undergoing pulpotomy or pulpectomy Exclusion Criteria: systemic disease pulp necrosis permanent teeth

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 13 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 |
| --- | --- |
| theeth undergoing pulpotomy<br> | |
| teeth undergoing pulpectomy<br> | |

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
-----------------
samples, children, the age group 3-13 years
Randomized Multicenter Study of 5 vs 6 Weekly Fraction of RT in the Treatment of SCC of the Head and Neck

Study Overview
=================
Brief Summary
-----------------
Randomized multicenter study of 5 vs 6 weekly fraction of RT in the treatment of SCC of the head and neck

Conditions
-----------------
Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Radiation: 5 vs 6 weekly fraction of RT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with SCC of the head and neck
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 |
| --- |
|Radiation: 5 vs 6 weekly fraction of RT|Chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomized multicenter study of 5 vs 6 weekly fraction of RT in the treatment of SCC of the head and neck
Duodenal Exclusion for the Treatment of T2DM

Study Overview
=================
Brief Summary
-----------------
Evaluation of duodenal exclusion procedure for the treatment of T2DM

Official Title
-----------------
Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes Mellitus (T2DM)

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Procedure: duodenal exclusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 65 years BMI between 23 and 34 Oral agents or insulin to control T2DM Inadequate control of diabetes as defined as HbA1c >/ 7.5 Understanding of the mechanisms of action of the treatment Exclusion Criteria: More than 10 years of T2DM diagnosis More than 7 years of insulin use Previous abdominal operations Coagulopathy Liver cirrhosis Unable to comply with study requirements, follow-up schedule or give valid consent. Currently pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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 |
| --- |
|Procedure: duodenal exclusion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success based on patients' glycemic control. |  | 2 weeks, 3 months, 6 months, 9 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiologic measurements, Comorbidity improvement, Improvement in QOL. |  | 2 weeks, 3 months, 6 months, 9 months, 12 months |
The Effect of Exposure to an Informative Video on Maternal Anxiety

Study Overview
=================
Brief Summary
-----------------
Stress and anxiety during childbirth have negative consequence on both mother and fetus. Previous studies have learned the effect of several intervention to reduce anxiety during labor- such as music and foot reflexology. Nevertheless, data for informative video before labor for reducing stress and anxiety are sparse. The present study aimed to review and determine the effect of informative video on anxiety, pain and outcomes of the labor in primigravida women.

Detailed Description
-----------------
A randomized control trial studying the effect of exposure to an informative video regarding labor and possible obstetrics emergencies on maternal anxiety and postpartum satisfaction

Official Title
-----------------
The Effect of Exposure to an Informative Video Regarding Possible Obstetric Emergencies on Maternal Anxiety and Peripartum Satisfaction- A Randomized Controlled Trial

Conditions
-----------------
Anxiety, Labor Pain, Patient Satisfaction

Intervention / Treatment
-----------------
* Other: Informative Video group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 18 years of age Nulliparus women Informed consent Reads and understand Hebrew >37 weeks of gestation Exclusion Criteria: Refuse to participate Contraindications for vaginal delivery

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?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Informative video arm<br>Nuliparus women admitted to an induction will be exposed to informative video with data regarding labor and possible obstetric emergencies such as cesarean delivery. All patients will answer the State-Trait Anxiety Inventory (STAI) before and after intervention | Other: Informative Video group<br>* Informative Video group before labor in nulliparous women<br>|
| No Intervention: control arm<br>no intervention. All patients will answer the State-Trait Anxiety Inventory (STAI) before and after delivery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The State-Trait Anxiety Inventory score in delivery room | STAI questionnaire before and after delivery room | 1 hour |
Pediatric Ventilatory Care in Finland 2010

Study Overview
=================
Brief Summary
-----------------
This observational study includes questionnaires send to doctors in all units treating pediatric patients with mechanical ventilation in Finland. Additionally all units treating pediatric patients with mechanical ventilation are invited to perform a quality control-like follow up for 3 months. Patient identity data is not collected, and no interventions to treatment are made.

Official Title
-----------------
Pediatric Ventilatory Care in Finland 2010

Conditions
-----------------
Mechanical Ventilation, Children, Neonates, Pediatric Intensive Care

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age under 16 years Mechanical ventilation during the follow up period

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- |
| Mechanically ventilated children<br>All children under 16 years of age who are needing mechanical ventilation for any reason. | Other: Observation<br>* No interventions are made. The purpose of the study is to find out current practices used in pediatric mechanical ventilation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of mechanical ventilation | Compare the duration of mechanical ventilation in different units in Finland | 1-2000 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator parameters | Comparison of ventilator parameters used during mechanical ventilation of children in pediatric-, neonatal- and adult intensive care units. | 1-2000hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanical ventilation, Children, Neonates, Pediatric intensive care
Fixed Dose NESP Study in Subjects With CRI

Study Overview
=================
Brief Summary
-----------------
Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study, laboratory assessments will be completed and vital signs will be taken. Subjects will enter a 1-week post-treatment observation and evaluation period after the last dose of study drug.

Official Title
-----------------
A Pilot Study Evaluating Once Every Other Week Administration of Fixed Doses of Novel Erythropoiesis Stimulating Protein (NESP) to Subjects With Chronic Renal Insufficiency (CRI)

Conditions
-----------------
Pre-Dialysis

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 18 years of age CRI with a creatinine clearance of less than 40 mL/min Hemoglobin less than 11.0 g/dL Serum vitamin B12 and folate levels above the lower limit of normal and iron replete Exclusion Criteria: Received rHuEPO therapy in the last 12 weeks Expected to initiate renal replacement therapy within 24 weeks or a recipient of a renal transplant Uncontrolled hypertension Seizure activity, CHF, hyperparathyroidism, major surgery, HIV-positive Pregnant or breast-feeding

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: darbepoetin alfa<br>darbepoetin alfa (NESP) | Drug: darbepoetin alfa<br>* 10 mcg NESP administered SC every other week 15 mcg NESP administered SC every other week 20 mcg NESP administered SC every other week 30 mcg NESP administered SC every other week 40 mcg NESP administered SC every other week 50 mcg NESP administered SC every other week 60 mcg NESP administered SC every other week 80 mcg NESP administered SC every other week 100 mcg NESP administered SC every other week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effectiveness of fixed dose(s) of NESP, administered once every other week, in the treatment of anemia in subjects with CRI |  | entire study - 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of chronic NESP therapy |  | entire study - 24 weeks |
Study of the Human Skin Microbiome

Study Overview
=================
Brief Summary
-----------------
Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin.

Detailed Description
-----------------
Subjects age 18 and above may be included in the study. It is the goal of the study to survey multiple skin locations of humans at multiple time points. The subjects' samples will be analyzed using DNA methods in order to identify the types of microbes present on the swabs. Other substances such as proteins, RNA, and other metabolites may also be analyzed. DNA or other molecular components of the sample will be extracted. Alternately, microbes in the sample can be cultured directly. The samples will be explored using molecular analyses. The backbone of the analyses will be shotgun metagenomic sequencing and 16S rDNA amplicon sequencing. The results of these analyses will be used to identify and describe the microbiome of the skin.

Official Title
-----------------
Study of the Human Skin Microbiome

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be 18 years of age or older. Subjects must be able to consent for themselves. Must be willing to participate to a swab of the skin. Exclusion Criteria: Subjects cannot be 17 years of age or younger.

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 |
| --- | --- |
| No Treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin. |  | 2 years |