linjc16/ctgov huggingface dataset:
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.

Official Title
-----------------
A Phase I Urodynamic Study of the Opioid Antagonist, Naloxone and Intravenous Methylnaltrexone Reverse Opioid Effects on Bladder Function in Healthy Volunteers

Conditions
-----------------
Healthy Males

Intervention / Treatment
-----------------
* Drug: Naloxone
* Drug: IV Methylnaltrexone (MNTX)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males, 18 to 65 yrs with normal urinary function Body weight less than 150 kg and Body Mass Index between 20-32. Exclusion Criteria: Females History of drug or alcohol abuse History of significant chronic illness (cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, renal, hepatic, etc.) Subjects who received opioids for one week or longer in the last 2 months.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Naloxone<br> <br> |
| Experimental: Arm 2<br> | Drug: IV Methylnaltrexone (MNTX)<br> <br> |
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal force of detrusor contraction (Pdet) after administration of MNTX | To investigate the potential benefit of methylnaltrexone in preventing or treating opioid-induced urinary retention. | 14 days |
Laparoscopic Exploration Versus Abdominal CT Scan

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy and safety of laparoscopy and it's role with blunt abdominal trauma

Detailed Description
-----------------
Evaluate the role of laparoscopy and Abdominal Ct scan in diagnosis and treatment of abdominal trauma and which is more effective and safe laparoscopy or CT

Official Title
-----------------
Laparoscopic Exploration Versus Abdominal CT Scanning in Abdominal Trauma

Conditions
-----------------
Penetrating Abdominal Trauma

Intervention / Treatment
-----------------
* Device: Laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable patients with definite occurrence of intra-abdominal injury patients with equivocal result by clinical and radiological evaluation Exclusion Criteria: patients with penetrating abdominal trauma stable patients not in need for any intervention for conservative management patients with marked haemodynamic instability polyt-traumatized Patients

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopy and CT scan<br>Usage of laparoscopy after inflation of co2 infra umbilical | Device: Laparoscopy<br>* Laparoscopic insertion with carbon dioxide via open technique at the umbilicus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the role of laparoscopy in diagnosis and management of abdominal trauma | Evaluate the efficacy and safety of laparoscopy in diagnosis of abdominal trauma in comparison to abdominal CT scanning in 30 stable patients with with abdominal trauma | Baseline | 
| Evaluate the role of Abdominal CT scanning in diagnosis of abdominal trauma | Evaluate the accuracy of CT scanning in diagnosis of abdominal trauma according to 1- age of the patient 2- amount of dye 3- general conditions of the patient 4- history of medical disease | Baseline |
Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children

Study Overview
=================
Brief Summary
-----------------
Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities, anxiety and depression. The omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could avoid the intake the methylphenidate and its associated adverse side effects.

Official Title
-----------------
A Randomized , Controlled, Doulbe Blind Placebo Trial To Evaluate The Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: Omega 3 caps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 to 15 years and 11 months of age ADHD children with hyperactivity confirmed dy DSM IV criteria Children and parents' consent Exclusion Criteria: Without methylphenidate treatment Fish or other sea products allergic Intake of sea omega 3 fatty acids supplments more one week during 3 months before the trial Children need quickly to take methylphenidate: social, family, or school risk Intake methylphenidate 30 days before the trial or/and intake it during one consecutive week

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo caps<br> | Dietary Supplement: Omega 3 caps<br>* Children between 6 and 8 years must take 2 caps/day Children between 9 and 11 years must take 3 caps/day Children between 12 and 15 years must take 4 caps /day<br>|
| Active Comparator: Omega 3 caps<br> | Dietary Supplement: Omega 3 caps<br>* Children between 6 and 8 years must take 2 caps/day Children between 9 and 11 years must take 3 caps/day Children between 12 and 15 years must take 4 caps /day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD rating scale |  | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity) |  | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
160 children, parallel group
Nutritional Assessment of Children With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Primary outcome is assessment of nutritional status of children with CKD. Secondary outcome is assessment STAMP screening tool for detection of malnutrition of CKD children.

Detailed Description
-----------------
Pediatric Chronic Kidney Disease (CKD) has systemic implication on all aspects of normal development, including nutrition, growth, bone and mineral metabolism and neurocognitive function . Chronic Kidney Disease (CKD) introduces a unique set of nutritional challenges for the growing and developing child .

Official Title
-----------------
Nutritional Assessment of Children With Chronic Kidney Disease Attending Assuit University Children Hospital

Conditions
-----------------
Nutrition Disorders, Child

Intervention / Treatment
-----------------
* Dietary Supplement: dietary supplements for CKD patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of both sexes. Diagnosed as chronic kidney disease. Age: 2 years up to 15 Years Children. Exclusion Criteria: • Age: less than 2 years old child and more than 15 years old child. Previously diagnosed to have any co- morbid or systemic disease other than CKD. Irregular dialysis. Renal transplant.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: dietary supplements for CKD patients|follow up and assessment of nutritional status of CKD patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of nutritional status of children with CKD. | by measuring body mass index in kg/m2. | from January 2021 to June 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess STAMP screening tool | Five steps STAMP assessment for detection of malnutrition in children with CKD. | from January 2021 to June 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic kidney disease
Comparison of Intrathecal Fentanyl or Sufentanil in 1 mg Bupivacaine Spinal Anesthesia for TURP in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Adequate sensory block for surgical procedure without side effects and immediate mobilization after surgery are desirable anesthetic technique in various surgeries. Considering the sensory innervations to the prostate, a sensory block up to L1 - T12 is adequate to the TURP. Low-dose intrathecal local anesthetics may meet these criteria, but occasional lack of sufficient sensory block could be troublesome. In this randomized study, the investigators evaluated the spinal anesthetic characteristics following intrathecal administration of bupivacaine 1 mg with fentanyl or sufentanil in elderly patients undergoing TURP.

Conditions
-----------------
Adequate Anesthesia With Unimpaired Motor Strength

Intervention / Treatment
-----------------
* Drug: Fentanyl
* Drug: Sufentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 65   under 85yrears old male elderly patients undergoing TURP only spinal anesthesia patients consent about this study Exclusion Criteria: spine surgery History coagulopathy impaired communication impaired orientation DM complication neuropathy BMI > 30 -> overweight patients.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>Fentanyl | Drug: Fentanyl<br>* 1mg 0.5% bupivacaine + fentanyl 20 mcg + 1.8 ml glucose ( total 2.4-ml) VS 1mg 0.5% bupivacaine + sufentanil 5 mcg + 2.1ml glucose (total 2.4-ml) intrathecally.<br>|
| Active Comparator: Group B<br>Sufentanil | Drug: Sufentanil<br>* 1mg 0.5% bupivacaine + fentanyl 20 mcg + 1.8 ml glucose ( total 2.4-ml) VS 1mg 0.5% bupivacaine + sufentanil 5 mcg + 2.1ml glucose (total 2.4-ml) intrathecally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to achieve peak sensory block without unimpaired motor strength | peak sensory & sympathetic block level, time to peak sensory & sympathetic block level, motor block level at peak sensory & sympathetic block level, lowest BP and HR during spinal anestheisa, frequency of painkiller | 2 minites after injection intrathecally start |
The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to obtain blood or saliva samples to define genes for migraine and pain diseases.

Detailed Description
-----------------
It is estimated that over one-third of the world's population suffers from persistent or recurrent pain. Migraine is highly heritable and the majority of juveniles who suffer from the disorder have a mother or father who also have the disease. The blood or saliva samples will go through DNA analysis and be sequenced for candidate genes or subjected to whole-genome sequencing. By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases.

Official Title
-----------------
The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)

Conditions
-----------------
Migraine Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family members (genetic duo or trio), consisting of an adolescent 10 to 18 years of age and at least one of their biologic parents willing to be participate in trial Adolescent and at least 1 biologic parent with Migraine diagnosis confirmed by Dr. Christy Jackson Is reliable, cooperative and willing to comply with all protocol-specified procedures and/or sub-study if consented Able to understand and grant informed consent Exclusion Criteria: Patient has been previously enrolled in the MAP GeneBank at Scripps Clinic Registry Has a significant chronic medical condition (i.e.chronic meningitis or a secondary origin/cause of headache) which, in the investigator's option, may interfere with the patient's optimal participation in the study Treatment with any investigational agents or devices within 30 days preceding enrollment in the study Has undergone ECT within 90 days preceding enrollment in the study

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| Migraine Disease<br>Patients 10 to 18 years of age with the diagnosis of Migraine disease and at least one of their biologic parents will be included in this study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene identification | By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases. | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome Characterization, Treatment and Examining the Connection to Developmental and Molecular Factors

Official Title
-----------------
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome Characterization, Treatment and Examining the Connection to Developmental and Molecular Factors

Conditions
-----------------
Velocardiofacial Syndrome, Williams Syndrome, Fragile X Syndrome

Intervention / Treatment
-----------------
* Drug: methylphenidate, fluoxetin, risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chromosomal deletion proven by FISH examination Exclusion Criteria:
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: methylphenidate, fluoxetin, risperidone<br>* first cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Velocardiofacial syndrome, Williams syndrome, fragile X syndrome, cognitive phenotype, psychiatric phenotype
TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

Study Overview
=================
Brief Summary
-----------------
TransitionCHF aims to recruit a unique cohort of patients with asymptomatic left ventricular dysfunction (NYHA I) to study the progression to symptomatic (>NYHA I) HF and to identify parameters/ biomarkers promoting and predicting the individual risk of transition. Results from TransitionCHF Cohort Study will inform and refine current treatment guidelines. The implementation of common patient data sets and biobanking standards will enable data and biomaterial sharing with other study groups of the German Center for Cardiovascular Research (DZHK). This study will set the standard for a unique DZHK heart failure database and Biobank for innovative preclinical and clinical trials.

Official Title
-----------------
Systolic Dysfunction to Congestive Heart Failure Cohort Study

Conditions
-----------------
Systolic Dysfunction, Transition, Heart Failure, Biobank

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic systolic dysfunction (defined as: ejection fraction < 40% by echocardiography or MRI; documented within the last 3 months prior to baseline visit) A maximum of one hospitalization for heart failure (defined as hospitalization with signs and symptoms of heart failure requiring intravenous loop diuretic therapy within 48 hours after hospital admission) at least 2 years prior to the baseline visit No heart failure symptoms (NYHA II, III or IV) upon inclusion 6MWD ≥ 80% of reference values Written informed consent Age ≥ 18 years Exclusion Criteria: Symptomatic heart failure (NYHA>I) at baseline visit Any significant valvular disease (> 2nd degree) Severe pulmonary disease (e.g. FEV1/FVC <0.7 and FEV1<50%) Severe renal disease (GFR < 15 ml/min) ejection fraction at baseline visit ≥ 50% by echocardiography or MRI Life expectancy < 1 year Pericardial disease Hypertrophic cardiomyopathy Myocardial infarction within the last 3 months Planned cardiac surgical intervention within 3 months after inclusion Geographical reasons (e. g. patients living outside Germany or planning to move abroad) Inability to give informed consent (e. g. mental disorders) Therapy with loop diuretics (e.g. torasemide, furosemide, piretanide) within 4 weeks prior to inclusion/baseline visit

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 |
| --- | --- | --- |
| Composite endpoint of hospitalization for heart failure and cardiovascular death |  | 0.5 - 13 years |
Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination. The objective of the study is to assess the safety pattern of everolimus in a real world setting.

Official Title
-----------------
Observational Study of Everolimus in Combination With Exemestane in Postmenopausal Patients With Hormone Receptor-positive, HER 2-negative Advanced Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Everolimus and exemestane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with HR-positive, HER2-negative advanced breast cancer who are treated with everolimus and exemestane according to the approved Summary of Product Characteristics (SmPC). Patients who started treatment after approval of this indication but before the initiation of this study can be retrospectively included, provided that they have systematically been assessed for adverse events. The decision to treat the patient with everolimus and exemestane must be independent of the patient's participation in the study. The patient must provide signed Informed Consent before any data can be captured. Exclusion Criteria: - No formal exclusion criteria

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br>Everolimus and exemestane | Drug: Everolimus and exemestane<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Up to 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | Up to 2.5 years | 
| Overall response rate |  | Up to 2.5 years | 
| Clinical benefit rate |  | Up to 2.5 years | 
| Overall survival |  | Up to 2.5 years | 
| Time on treatment with everolimus |  | Up to 2.5 years | 
| Reason for stopping treatment with everolimus |  | Up to 2.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced breast cancer, Everolimus