linjc16/ctgov huggingface dataset:
Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide

Study Overview
=================
Brief Summary
-----------------
One of the most common complaints of admission to the emergency room is gastroenteritis. One of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our study is to investigate whether hyoscine butylbromide used within the indication has an effect on abdominal pain due to acute gastroenteritis. The main purpose of our study is to reduce the pain of the patient at 30th and 60th minutes compared to 0th minute.

Official Title
-----------------
Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial

Conditions
-----------------
Acute Gastroenteritis, Abdominal Pain

Intervention / Treatment
-----------------
* Drug: Hyoscine N Butylbromide
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain Exclusion Criteria: Peritonitis Hemodynamic instability Pregnancy Inability to give consent Medication given in the emergency room before being included in the study Taking pain medication within 4 hours Diabetes Mellitus and other neuropathic diseases

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>In the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds | Other: Placebo<br>* 2 ml of normal saline injection as placebo<br>|
| Active Comparator: Hyoscine N butylbromide<br>In the treatment arm, the patient will be injected intravenously with 1ml 20 mg of Hyoscine butylbromide and 1 ml of normal saline intravenously within 30 seconds. | Drug: Hyoscine N Butylbromide<br>* Hyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Change | Pain change after intervention at 30th and 60th minute. Pain will assesed with Visual Analog Scale (100 mm). 13 mm of change at Visual Analog Scale will assesed as clinically significant. | 30 minute and1 hour |
Ankle Arthrodesis Nail for 2-level Pathologic Tibial Fracture

Study Overview
=================
Brief Summary
-----------------
Tibial pseudarthrosis in 83 year old patient suffering from pathologic fractures

Detailed Description
-----------------
The arthrodesis nail for hind foot problems is used as salvage for tibial fractures after failed plate fixation,

Official Title
-----------------
Ankle Arthrodesis Nail Combined With Locking Compression Plate to Stabilize Two-level Pathologic Tibial Fractures

Conditions
-----------------
Bone Metastases, Fracture Nonunion, Bone Lesion

Intervention / Treatment
-----------------
* Procedure: osteosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - old age, fragility fracture, tibia Exclusion Criteria: active osteomyelitis

Ages Eligible for Study
-----------------
Minimum Age: 80 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Use of an approved implant for expanded application
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Stabilzation of Fracture<br>Arthrodesis nail used for stabilzation of a fracture, single patient | Procedure: osteosynthesis<br>* Closed reduction, internal fixation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight bearing tolerance | Measuring walking distance | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fragility fracture, old age
Carbon-13 Magnetic Resonance Spectroscopy in Glycogen Storage Diseases

Study Overview
=================
Brief Summary
-----------------
The project will use carbon-13 magnetic resonance spectroscopy to assess whether high glycogen levels in skeletal muscle of patients with Glycogen Storage Diseases is a prelude for muscle damage. Patients with Glycogen Storage Diseases will be examined using carbon-13 MR-spectroscopy to quantify the glycogen levels in lumbar, thigh and calf-muscles. The pattern of glycogen concentration will be compared to the pattern of muscle atrophy found in the literature.

Official Title
-----------------
Using Carbon-13 Magnetic Resonance Spectroscopy to Assess Whether High Glycogen Levels in Skeletal Muscle of Patients With Glycogen Storage Diseases is a Prelude for Muscle Damage.

Conditions
-----------------
Glycogen Storage Disease, McArdle Disease, Pompe Disease (Late-onset)

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with genetically verified neuromuscular disease or healthy control Healthy controls needs to be healthy to be included, evaluated by the investigator Exclusion Criteria: Ferrous objects in or around the body Pacemaker or other implanted electronic devices Claustrophobia Inability to understand the purpose of the trial or corporate for the conduction of the experiments. Participation in other trials that may interfere with the results. Competing conditions at risk of compromising the results of the study, evaluated by the investigator. Strenuous exercise in the preceding 2 days before examination Pregnancy or breastfeeding

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 |
| --- | --- |
| McArdle Disease<br> | Other: No intervention<br>* No intervention<br>|
| Pompe disease<br> | Other: No intervention<br>* No intervention<br>|
| Controls<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycogen concentration | The difference in muscle glycogen between patients and controls The difference in muscle glycogen between different muscle groups in patients. | Day 1 |
Exploring the Role of 3T MRI in Gamma Knife Radiosurgery

Study Overview
=================
Brief Summary
-----------------
Gamma Knife radiosurgery is a non-invasive technique for the delivery of a single, high dose of radiation to an intra-cranial target. MRI has an established and central role in the treatment planning process and assessment of response to intracranial radiosurgery. Increasing the field strength of MRI from 1.5T to 3T promises to improve the signal, and in turn the quality of images. However, the technology also introduces new limitations, and the role and safety of 3T MRI in the management of patients receiving radiosurgery has not yet been reported. In this pilot study, we will explore the spatial integrity, and incremental image-guidance utility of 3T MRI in patients receiving radiosurgery. The preliminary data acquired in this study will be instrumental to the judicious design and conduct of subsequent definitive clinical trials. Up to fifty patients will be enrolled in this study.

Official Title
-----------------
Exploring the Role of 3T MRI in Gamma Knife Radiosurgery: A Pilot Study

Conditions
-----------------
Brain Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients planned to receive Gamma Knife radiosurgery will be eligible for enrollment on this study. Exclusion Criteria: Age<18 Contra-indications to 3T MRI, such as implanted metal devices or shrapnel.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
3T MRI, Gamma Knife Radiosurgery
Brief Hospitalization for Schizophrenia: Strategies to Improve Treatment Outcome

Study Overview
=================
Brief Summary
-----------------
The goal of this research program is to implement a series of psychoeducational training classes designed to teach individuals with schizophrenia the importance of medication treatment, how to identify and manage medication side effects, and how to make appointments and emergency plans. The skills taught to the research subjects will lead to demonstrable increases (compared to the control group) in adherence to both the prescribed medication regimen and scheduled outpatient appointments and thereby cause a decrease (again compared to the control group) in rehospitalization rates and bed-days during subsequent twelve months following the intervention. A secondary objective of this work is that if the CREP program is successful and/or illness education is effective, the data will be able to disseminated throughout the VISN 22 via the recently awarded Mental Illness Research Education and Clinical Center (MIRECC) program.

Official Title
-----------------
Brief Hospitalization for Schizophrenia: Strategies to Improve Treatment Outcome

Conditions
-----------------
Schizophrenia, Schizophrenic Disorder

Intervention / Treatment
-----------------
* Behavioral: Community Re-Entry Program: What is Schizophrenia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 years of age. DSM IV diagnosis of schizophrenia or schizoaffective disorder. Competent to give informed consent. Previously participated in Brief Hospitalization for Schizophrenia: Strategies to Improve Treatment Outcome Principal Investigator. Donna Wirshing, M.D. Exclusion Criteria: Physical or cognitive impairment of such severity as to adversely affect the validity of clinical ratings or impair capacity to give informed consent. History of substantial substance dependence 6 months prior to the study. Patients at high risk of suicide or other directed violence.

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

Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Community Re-Entry Program: What is Schizophrenia|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Neuropsycholgy and Neuroimaging in Transient Global Amnesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in assessing three episodic memory's abilities (mental simulation throught the future, and the past, the learning of personnal actions i-e the enactment effect). Secondary goal is to describe the neuronal substrates associated to the alteration of theses abilites in TGA.

Official Title
-----------------
Neuropsycholgy and Neuroimaging in Transient Global Amnesia

Conditions
-----------------
Transient Global Amnesia (TGA)

Intervention / Treatment
-----------------
* Behavioral: Neuropsychological tests
* Device: Cerebral imaging (MRI, PET-FDG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the participants Minimum of 7 years of education French native speaker Healthy subjects : Non pathological Dementia rating scale score Patients : Clinical diagnosis of TGA according to Hodges and Warlow's criterion Exclusion Criteria: Chronic neurological disease Encephalitis Endocrinal disease Hepatic disease Case history of head injury with loss of consciousness of more than one hour Case history of stroke Case history of cancer during the five last years except squamous cell carcinomas Alcoholism or drug addiction Major psychiatric disorders according the Diagnostic and Statistical Manual of -Mental Disorders

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TGA<br> | Behavioral: Neuropsychological tests<br> <br> Device: Cerebral imaging (MRI, PET-FDG)<br> <br> |
| Experimental: Controls<br> | Behavioral: Neuropsychological tests<br> <br> Device: Cerebral imaging (MRI, PET-FDG)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodic memory scores |  | 3 years |
Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment

Study Overview
=================
Brief Summary
-----------------
Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without history of osteoporotic fracture.

Detailed Description
-----------------
One of several studies to develop and clinically validate a novel ultrasonographic device, BUSS, for the assessment of osteoporosis and fracture risk.

Official Title
-----------------
Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1

Conditions
-----------------
Osteoporosis, Fracture, Aging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal women with osteoporotic fracture at spine or wrist postmenopausal women no history of fracture at spine or wrist Exclusion Criteria: women with a history of metabolic disease stroke tibia fracture or surgery BMI ≥ 35 kg/m2 Teriparatide use currently or within the past 6 months, Any skin issues (open wounds or rashes, and/or skin infections) of the tibial area.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With osteoporotic fracture<br>Approximately 100 postmenopausal women that have been enrolled in a population-based case-control study that have experienced a clinically-diagnosed fracture of thoracolumbar spine or distal forearm due to minimal or moderate trauma based on review on their inpatient and outpatient medical records will be enrolled. | |
| Without osteoporotic fracture<br>Approximately 100 control women will have no history of a prior spine, hip, or wrist fracture. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, fracture risk, aging, tibia, sonometer, ultrasound, BMD, bone mineral density, DXA, 3D-HRpQT, waveform profiles
Data Collection on ReCap/Magnum in Total Hip Replacement and Resurfacing

Study Overview
=================
Brief Summary
-----------------
Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.

Detailed Description
-----------------
This observational study intends to collect efficacy and safety data on ReCap/Magnum in Total Hip Replacement and Resurfacing.

Official Title
-----------------
A Prospective, Multicentre Study Evaluating the Clinical Performance of the ReCap/Magnum in Total Hip Replacement and Resurfacing

Conditions
-----------------
Total Hip Resurfacing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Its Respective Indications for Use/Intended Uses

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 |
| --- | --- |
| M2A magnum<br>Consecutive series of patients received Total Hip Resurfacing with ReCap/Magnum | |
| Recap Magnum<br>Consecutive series of patients received Total Hip Replacement with ReCap/Magnum | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postel-Merle d'Aubigné (PMA), Harris Hip Score |  | 1yr and 2yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication |  | Any time | 
| Survival |  | 1yr and 2yr |
Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize software-based fusion/navigation will be accurate to within 3 mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of prostate US/MRI software-based fusion/navigation technology.

Official Title
-----------------
Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for ultrasound-guided gold seeds prostate fiducial placement prior to radiotherapy Exclusion Criteria: eGFR < 45 mL/min/1.73m2 recent (within 4 weeks) kidney or liver transplant contraindication to prostate MRI patient with cardiac pacemaker

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Prostate Volume on Actual MRI | A post-procedure MRI performed within one month after the fiducial placement. | Within one month after the fiducial placement | 
| Prostate Volume on US reconstruction | A US 3-D sweep will be performed during the fiducial placement. | During the fiducial placement | 
| Prostate Volume based on US/EM reconstruction | A 3-D US sweep performed during the fiducial placement and a Electromagnetic tracking data will also be acquired at the same time, and then the two series of data will be used for US/EM reconstruction. | During the fiducial placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiology
AZD5985 Single Ascending Dose Study

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.

Official Title
-----------------
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD5985 in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: AZD5985
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedure Healthy male subjects aged 18 to 45 years (inclusive) Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start Exclusion Criteria: History or presence of any clinically significant disease or disorder in the opinion of the investigator Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator Participation in another investigational drug study within 3 months before Visit 2 or participation in a methodological study (no drug) 1 month prior to Visit 2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD5985 | Drug: AZD5985<br>* Single dose-The starting dose will be 40 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca predefined upper exposure limits<br>|
| Placebo Comparator: B<br>Placebo | Drug: Placebo<br>* Oral suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) |  | Frequent sampling occasions during study days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | Frequent sampling occasions during study days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers