linjc16/ctgov huggingface dataset:
Quality of Friendships in Children With Neurofibromatosis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine if children with a higher disease severity have lower quality friendships than children who are less severely affected and children who are unaffected. Researchers will test the hypothesis that the quality of friendships is inversely related to their disease severity. Specific Aims: To use the FQQ to determine if the quality of friendships in children with NF1 is lower than the quality of friendships in unaffected children. To use a disease severity scale and the FQQ to determine if children who are less severely affected have higher friendship qualities than children who are more severely affected.

Detailed Description
-----------------
You (your) child will be asked to complete a short questionnaire (40 questions) about their relationship with their best friend. Doctors will review your (child's) medical chart to find out how severe the disease is, so that this may be compared to the answers you have (your child has) given on the friendship questionnaire. This is an Investigational Study. About 90-100 children and adolescents with NF-1 will be asked to take part in this study. All will be enrolled at M.D. Anderson.

Official Title
-----------------
Quality of Friendships in Children With Neurofibromatosis: Relationship to Disease Severity

Conditions
-----------------
Neurofibromatosis

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Patients with a clinical diagnosis of neurofibromatosis, type 1 (NF-1) who are between the ages of 8 and 18 years will be eligible. Patients must be English or Spanish speaking (test instrument will be translated into Spanish), and be able to read. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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 |
| --- | --- |
| Quality of Friendships<br>Patients with Neurofibromatosis, type 1 (NF-1) between the ages of 8 and 18 years old. | Behavioral: Questionnaire<br>* Questionnaire about the patient's relationship with their best friend.<br>* Other names: Survey;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease severity scale and Friendship Quality Questionnaire (FQQ) |  | Questionnaire completion by patient and chart review by doctor for disease severity scoring. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurofibromatosis, Quality of Friendships, Disease Severity, Questionnaire, NF-1
The EU Hyprotect Registry

Study Overview
=================
Brief Summary
-----------------
European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery

Official Title
-----------------
European Hypotension Prediction Index Real World Experience Using AcumenTM Hypotension Prediction Index Software to Prevent Intraoperative Hypotension: the Multicentre Prospective Observational Registry

Conditions
-----------------
Hemodynamic Monitoring

Intervention / Treatment
-----------------
* Device: AcumenTM Hypotension Prediction Index software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting adult patients (≥18 years) Patient is scheduled for elective major non-cardiac surgery under general anesthesia that is expected to last at least 120 minutes and in whom blood pressure is monitored using an arterial catheter Patients in whom the AcumenTM Hypotension Prediction Index software with the Acumen IQ sensor on the Hemosphere platform is used intraoperatively Exclusion Criteria: Patients undergoing emergency surgery OR nephrectomy, liver and/or kidney transplantation Patients suffering from atrial fibrillation and/or sepsis (according to current Sepsis-3 definition) American Society of Anesthesiology (ASA) physical status classification V or VI Disability and/or other circumstances under which the patient is not able to understand the nature, significance and scope of the investigation Pregnancy at the time of surgery Patients without signed informed consent / data protection statement Patient participating in other interventional trials

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AcumenTM Hypotension Prediction Index software|The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software | To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software | Duration of the procedure through 30 days after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraoperative hypotension, Preventive Therapy, Blood pressure monitoring
Development and Validation of a Comorbidity Index in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). Like other chronic diseases, patients with CD may be affected by other diseases called comorbidities. The prevalence of comorbidities in IBD patients ranges from 30 to 70 %. Unlike other chronic diseases, there is currently no CD-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. Several clinical indexes have been developed for the study of comorbidities, including the Charlson index and the Groll index, which are widely used. The disadvantage of these indexes is that they are not adapted to patients with CD. The primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.

Official Title
-----------------
Development and Validation of a Comorbidity Index in Crohn's Disease

Conditions
-----------------
Crohn Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 and 59 years old Established diagnosis of CD with a minimum disease duration of 3 months Disease considered by the treating gastroenterologist to have been stable for at least 3 months Exclusion Criteria: Subject unable to comply with study procedures Surgery for CD 3 months prior to inclusion visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 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 |
| --- | --- | --- |
| To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD. | Probability of having an IBD disability index ≥ 35 (i.e. moderate and severe disability). | Through study completion, an average of 3 years |
An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.

Official Title
-----------------
PHASE 1B OPEN-LABEL STUDY OF THE SAFETY AND CLINICAL ACTIVITY OF CRIZOTINIB (PF-02341066) IN TUMORS WITH GENETIC EVENTS INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK ) GENE LOCUS

Conditions
-----------------
Neoplasms Malignant

Intervention / Treatment
-----------------
* Drug: Crizotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically or cytologically proven diagnosis of malignancy other than NSCLC positive for translocation or inversion event involving the ALK gene locus positive for ALK amplification events positive for ALK activating point mutations Exclusion Criteria: mutations of amplifications involving the c-Met gene but not the ALK gene concurrent treatment on another therapeutic clinical trial prior therapy specifically directed against ALK

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Crizotinib<br> | Drug: Crizotinib<br>* Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule<br>* Other names: PF-02341066;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities |  | 36 Months | 
| Overall Response Rate |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response |  | 36 months | 
| Plasma concentrations of crizotinib |  | 30 Months | 
| Overall Survival |  | 36 Months | 
| Proportion of patients with each of the ALK genetic events |  | 36 Months | 
| Progression-Free Survival (PFS) |  | 36 Months | 
| Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crizotinib, neoplasm malignant, lymphoma, neuroblastoma, anaplastic lymphoma kinase, ALK
The Effect of Antiemetics on Bowel Preparation Before Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Polyethylene glycol (PEG) is one of the most common laxatives used in colonoscopy. However, 5 - 15% of patients can not complete the preparation due to its poor taste and large volume. So this study is aimed to explore the effect of antiemetics on abdominal discomforts associated with PEG.

Official Title
-----------------
The Effect of Antiemetics on Bowel Preparation Before Colonoscopy

Conditions
-----------------
Bowel Preparation

Intervention / Treatment
-----------------
* Drug: Domperidone
* Drug: sulpiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years patients scheduled for colonoscopy Exclusion Criteria: intestinal obstruction or hemorrhage; allergy to domperidone, sulpiride or PEG; pregnancy or breastfeeding; previous use of prokinetics within 1 month.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Domperidone group<br>Patients in Domperidone group took 10mg of domperidone 30min before PEG. | Drug: Domperidone<br>* Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.<br>|
| Experimental: Sulpiride group<br>Patients in Sulpiride group took 100mg of sulpiride 30min before PEG. | Drug: sulpiride<br>* Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.<br>|
| No Intervention: Control group<br>Patients in Control group followed the regular routine of 3L split-dose of PEG. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the discomforts during bowel preparation | The primary endpoint of this study was the discomforts during bowel preparation such as nausea, vomit, abdominal fullness and pain. These symptoms were assessed as none, mild, moderate and severe. Patients with mild to severe symptoms were classified as presence of discomforts. | before colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of bowel preparation assessed by Boston Bowel Preparation Scale | The secondary endpoint was the quality of bowel preparation assessed by the Boston Bowel Preparation Scale (BBPS) during the withdrawal phase of colonoscopy. The BBPS uses a 0-3 points scale assessing the bowel preparation quality in 3 segments of the colon (the right, transverse and left colons). BBPS score ≥ 6 were defined as adequate bowel preparation. | during colonoscopy |
Comparison of Low Fat and Low Carbohydrate Diets With Respect to Weight Loss and Metabolic Effects

Study Overview
=================
Brief Summary
-----------------
The investigators will test the hypothesis that a LOW CARB hypocaloric diet will reduce body weight over six months more than a LOW FAT hypocaloric diet. In addition to body weight, the investigators will measure cardiovascular and metabolic variables and will take blood samples in order to determine whether certain metabolites may predict the diet success.

Official Title
-----------------
Randomized Parallel Group Comparison on the Influence of a Low Carbohydrate and a Low Fat Hypocaloric 6 Months Diet on Body Weight Reduction, Metabolic and Cardiovascular Variables in Obese Healthy Women and Men.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index > 27 kg/m2 No chronic medication (except oral contraceptives and L-Thyroxine) or possibility to stop medication for study duration Able to give written informed consent Exclusion Criteria: Pregnancy and nursing Severe cardiovascular, liver, kidney, hepatic or orthopedic disease that need treatment Metabolic or endocrine disease that need treatment Hypertension blood pressure > 160/95 mmHg or need of > 2 drugs Previous stroke or cerebral ischemia Significant neurologic or psychiatric disease Any kind of eating disorder Bariatric surgery in the past Drug or alcohol abuse Any cancer in the past Acute and chronic infections Metallic implants (e.g. pace makers) or conditions that do not allow MRI scans Body weight > 130 kg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low fat hypocaloric diet<br> | Behavioral: dietary intervention<br>* dietary counseling, group teaching<br>|
| Active Comparator: Low carbohydrate hypocaloric diet<br> | Behavioral: dietary intervention<br>* dietary counseling, group teaching<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight reduction |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight maintenance | follow up assesement after 6 months diet | Month 12 - 36 | 
| Reduction of visceral adipose tissue mass |  | Month 6 | 
| Reduction of left ventricular mass |  | Month 6 | 
| Influence on energy expenditure and fat oxidation rates |  | Month 6 |
Effect of Tourniquet on Sensory Nerve Conduction Threshold (sNCT) and OxyNeuroGram (ONG) Index- A Volunteer Study

Study Overview
=================
Brief Summary
-----------------
There are a number of risk factors for development of chronic pain that have been evaluated including age, gender, type and duration of surgery, duration of pain prior to surgery and tourniquet application. There is some scientific evidence from animal studies demonstrating that prolonged tourniquet application can result in lack of oxygen supply to nerves, and subsequent nerve damage resulting in chronic pain. This theory has not been proven in humans. In this study the investigators will indirectly assess the evidence for abnormalities caused by tourniquet application on subjects' nerves using well established devices to determine the function of these nerves.

Official Title
-----------------
Effect of Tourniquet on Sensory Nerve Conduction Threshold (sNCT) and OxyNeuroGram (ONG) Index- A Volunteer Study

Conditions
-----------------
Sensory Nerve Conduction, Oxyneurogram Index

Intervention / Treatment
-----------------
* Device: tourniquet, sensory nerve conduction abnormality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Over 18 years of age Exclusion Criteria: Neurological disease Diabetes mellitus History of nerve injury Chronic pain Alcoholism Blood pressure measurements greater than 140/80 and infection in the monitored area

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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 |
| --- | --- |
| Other: Tourniquet, pain, nerve injury, sensory nerve function<br> | Device: tourniquet, sensory nerve conduction abnormality<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sensory nerve conduction |  | baseline, 5 minutes | 
| Changes in oxyneurogram index |  | baseline, 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourniquet, Endoneural, Ischemia
The Evaluation of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy

Study Overview
=================
Brief Summary
-----------------
The study aims to compare pre- and postoperative 3D renal function results of patients who underwent on-clamp and off-clamp partial nephrectomy.

Official Title
-----------------
3D Assessment of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: On-clamp partial nephrectomy
* Procedure: Off-clamp partial nephrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Men and women >18 years; 2. Diagnosis of unilateral renal cell carcinoma (stage T1-T3aN0M0); 3. Planned surgery: retroperitoneoscopic/laparoscopic/robotic partial nephrectomy; 4. Patients with CT of the kidneys with contrast enhancement performed according to the required protocol. - Exclusion Criteria: Age < 18 years old or ASA> 3; Solitary kidney; Bilateral kidney The presence of concomitant systemic pathology (DM, AH), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma; Obstructive nephropathy Systemic intake of nephrotoxic drugs; Pregnancy. -

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: On-clamp partial nephrectomy<br>Patients who are assigned to on-clamp partial nephrectomy. | Procedure: On-clamp partial nephrectomy<br>* Partial nephrectomy will performed with renal artery clamping (less than or equal to 25 minutes)<br>|
| Other: Off-clamp partial nephrectomy<br>Patients who are assigned to off-clamp partial nephrectomy. | Procedure: Off-clamp partial nephrectomy<br>* Partial nephrectomy will performed without renal artery clamping<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR after the surgery |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate (Clavien-Dindo) |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney cancer, partial nephrectomy, split renal function