linjc16/ctgov huggingface dataset:
Infusion Laboratory: Protocol 3 (Risperidone) - 4

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate clinical safety issues pertaining to risperidone, to cocaine and to its interaction, and to determine how pretreatment with risperidone modifies the subjective as well as physiological effects of cocaine.

Official Title
-----------------
Infusion Laboratory: Protocol 3 (Risperidone)

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of change in neurotoxicity based on chore |  |  | 
| Degree of drug craving |  |  | 
| History, incidence and amount of drug use |  |  | 
| Type and severity of stimulant withdrawal symptoms |  |  | 
| Characterization of study population |  |  | 
| Population incidence of symptoms of depression, po |  |  | 
| Frequency and intensity of drug use and sexual beh |  |  | 
| Evidence of change in subjective responses to coca |  |  | 
| Clinical physiological response to cocaine challen |  |  | 
| Degree to which study medication influences change |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Genetic Disorders of Obesity Program Database

Study Overview
=================
Brief Summary
-----------------
This study collects data on children with severe, early-onset obesity.

Detailed Description
-----------------
Children and adolescents who have suffered from severe weight gain prior to 5 years of age and who are seen in the Genetic Disorders of Obesity Program at Texas Children are asked to participate in a prospective, observational study. The investigators collect demographic information, body measurements, medical/family history, as well as other questionnaires. Additionally, genetic information, medical lab results, and responses to treatment options are collected. The goal of the study is to determine if the investigators can better understand which children would benefit from testing and further workup as well as to understand how obesity develops in these children and adolescents.

Official Title
-----------------
Genetic Disorders of Obesity Program Database

Conditions
-----------------
Obesity, Childhood, Genetic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For individuals 2 years and older, BMI > 97 percentile For individuals < 2 years old, weight-to-length ratio > 95th percentile Exclusion Criteria: No other exclusion criteria
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 |
| --- | --- | --- |
| Prevalence of genetic causes of severe, early-onset obesity | We will measure the number of genetic variants identified in clinical testing | through study completion, an average of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI over time | BMI in kg/m2 will be documented over time. BMI is calculated using weight and height | through participant completion, an average of 2 years |
Methylene Blue and Ozone in Early Sepsis

Study Overview
=================
Brief Summary
-----------------
effects of methylene blue and ozone O3 therapy effects in early sepsis management , and their implications upon outcome

Detailed Description
-----------------
effects of methylene blue on inducible nitric oxide messenger RNA transcription and protein expression are well evident in vasoplegia ,and septic shock . In the same time , ozone O3 therapy is also valuable in immune-modulation in multiple pathologies . our study collaborate both methylene blue and Ozone in early sepsis management , and we will evaluate the global medical progress , ICU stay , Morbidity and mortality

Official Title
-----------------
Methylene Blue and Ozone in Early Sepsis , a Randomized Double Blind Trial

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: methylene blue
* Drug: ozone
* Other: saline infusion
* Other: oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: early sepsis Adults patients Exclusion Criteria: cardiac problems Glucose-6-Phosphate-Dehydrogenase Insufficiency Ozone Allergy Recent Myocardial Infarction Active Hyperthyroidism Thrombocytopenia Pregnancy Contraindications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: M methylene blue and ozone<br>intravenous methylene blue and blood mixed with ozone ozone injection in early sepsis patients | Drug: methylene blue<br> <br> Drug: ozone<br> <br> |
| Placebo Comparator: P Placebo<br>saline and oxygen mixed blood injection in early sepsis patients | Other: saline infusion<br> <br> Other: oxygen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APACHE score |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay |  | 30 days |
CT Residual Gastric Fluid Volume

Study Overview
=================
Brief Summary
-----------------
Hypothesis: The investigators hypothesize that more than 50% of the patients receiving enteric contrast material (ECM) < 2 hours of anesthesia/sedation would have residual gastric fluid volume (GFV) > 0.4 ml/kg. The investigators also hypothesize that measuring GFV by using region of interest in the CT technique is accurate compared to blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.

Detailed Description
-----------------
The purpose of our study is to examine the residual gastric fluid volume when oral contrast is administered within 2 hours of anesthesia /sedation and to validate the accuracy of measuring the residual gastric volume by using region of interest in the CT image by using blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.

Official Title
-----------------
Residual Gastric Fluid With Administering Clear Liquids Within Two Hours of Anesthesia in Children

Conditions
-----------------
Clinical CT Abdomen/Pelvic With Oral Contrast and Sedation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for CT abdomen with contrast and require anesthesia/sedation Subjects must be 1 month to 10 years of age (inclusive) The subject's legally authorized representative has given written informed consent to participate in the study Exclusion Criteria: Subjects violate the institution fasting guideline before anesthesia /sedation with the exception of the oral contrast

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 10 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 |
| --- | --- | --- |
| Residual gastric fluid volume (GFV) < 0.4ml/kg or > 0.4 ml/kg | Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study. | Approximately 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual gastric fluid volume (GFV) < 0.8 ml/kg or > 0.8 ml/kg | Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study. | Approximate 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT, sedation, oral contrast
The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
The present study is designed to test the hypothesis that acupuncture, before and after embryo transfer, significantly improves pregnancy rates, compared to embryo transfer with sham acupuncture and no acupuncture at all.

Official Title
-----------------
The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer After in Vitro Fertilization: A Prospective Randomized Sham-controlled Trial

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Procedure: Active acupuncture
* Procedure: Sham acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient is undergoing embryo transfer after IVF or ICSI patient has given informed consent to participate Exclusion Criteria: frozen embryo transfer previous enrollment in study
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Experimental: 1<br>Active acupuncture | Procedure: Active acupuncture<br>* Acupuncture 25 minutes before and after embryo transfer<br>|
| Sham Comparator: 2<br>Sham Acupuncture- acupuncture at neutral points | Procedure: Sham acupuncture<br>* Acupuncture at neutral points, 25 minutes before and after embryo transfer<br>|
| No Intervention: 3<br>Embryo transfer with no acupuncture | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy |  | 4-5 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth |  | 9 months after treatment | 
| Implantation rate |  | 4-5 weeks after treatment | 
| Side effects with acupuncture treatment |  | 2 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, Infertility, Acupuncture
Non Randomized Humerusshaft Fracture

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to radiologically compare the fracture healing as well as the functional treatment outcome of conservative and operative treatment of defined humerusshaft fractures after 6w./12w./and 12 month based on the modified constant score.

Detailed Description
-----------------
Radiologically compare the fracture healing as well as the functional treatment outcome of conservative and operative treatment of defined humerusshaft fractures after 6w./12w./and 12 month based on the modified constant score.

Official Title
-----------------
Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures

Conditions
-----------------
Humerusshaft Fractures

Intervention / Treatment
-----------------
* Device: Humerus Nail or LC Plate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over age 16 fracture according to AO classifications 12A2, 12A3, 12B2 have to be available for the FU's Exclusion Criteria: open fractures polytraumatized patients multiple sclerosis, paraplegic, or other conditions having a direct impact on the healing pseudoarthrosis pathological and refractures

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Humerus Nail or LC Plate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Radiological comparison of fracture healing between the conservative versus operative treatment | Radiological comparison of fracture healing between the conservative versus operative treatment | 3 months to 12 months post OP | 
| - Comparison of functional outcome | Comparison of functional outcome | 3 months to 12 months post OP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Collection of possible complication of the treatment | Collection of possible complication of the treatment | 3 months to 12 months post OP | 
| - Subject satisfaction | Subject satisfaction | 3 months to 12 months post OP | 
| - Financial impact of the compared treatments | Financial impact of the compared treatments | 3 months to 12 months post OP | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fractures, Humerus, Conservative treatment, Operative treatment
Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin

Study Overview
=================
Brief Summary
-----------------
In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based chemotherapy, germinal gene polymorphisms will be analyzed.

Detailed Description
-----------------
To investigate the impact of single nucleotide (SNP) polymorphism on the toxicity profile in colorectal cancer patients treated with FOLFOX chemotherapy, 10 cc of blood will be drawn in EDTA tube for extraction. DNA will be extracted from peripheral blood samples using DNA isolation kit, and SNP polymorphisms will be evaluated.

Official Title
-----------------
Pharmacogenomic Study to Predict Toxicity and Response in Colorectal Cancer Patients Treated With Oxaliplatin-based Chemotherapy

Conditions
-----------------
Curatively Resected Stage III Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 or older curatively resected colon adenocarcinoma pathologically staged III adequate performance status adequate major organ functions to be treated with adjuvant FOLFOX chemotherapy written informed consent Exclusion Criteria: those who disagree the study

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 |
| --- | --- |
| FOLFOX<br>Stage III colorectal cancer patients who are treated with adjuvant FOLFOX chemotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropathy |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxaliplatin, neuropathy, SNPs
Spinal Cord Stimulation Research Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.

Official Title
-----------------
Posture Responsive Spinal Cord Stimulation Research Study

Conditions
-----------------
Chronic Low Back and Leg Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be ambulatory Be 18 years of age or older Have chronic low back pain and/or leg pain due to neuropathic causes Be implanted with the Restore or Restore Advanced system for greater than or equal to 3 months Be implanted with percutaneous thoracic leads Have stable pain control Adjust stimulation parameters manually on a regular basis Be willing and able to complete protocol requirements Be willing and able to provide written informed consent Be male or nonpregnant female Exclusion Criteria: Plan to enroll in another clinical study during participation in this study, or currently enrolled in another clinical study Be morbidly obese Had pain-related surgery in the previous 12 weeks of enrollment or intend to undergo surgery during the period of the study

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
-----------------
Subject's, response, changes, in spinal, cord, stimulation, during, postural
Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to create a repository of blood samples from patients diagnosed with primary and metastatic brain tumors who are being seen in the Department of Radiation Oncology at Duke Cancer Center.

Detailed Description
-----------------
Repository blood samples will be used to study the association of circulating biomarkers with radiation therapy outcomes.

Official Title
-----------------
Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors

Conditions
-----------------
Brain Tumor, Primary, Brain Metastases, Adult

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a confirmed diagnosis of primary or metastatic brain tumor (histology or imaging as appropriate) Exclusion Criteria: Participation in other blood repository research protocols at Duke

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 |
| --- | --- | --- |
| Number of circulating immune cells in peripheral blood | reported as mean +/- standard deviation | 6 weeks post radiation therapy |
The Roles of Cytokines in the Mechanism of Insulin Resistance and Energy Balance

Study Overview
=================
Brief Summary
-----------------
Insulin resistance and disturbances in energy homeostasis are associated with body weight changes, such as diabetes, hypertension, hyperlipidemia, obesity, cancer cachexia, aging, and acute or chronic infectious diseases. Cytokines secreted by adipose tissue and inflammatory cells play important roles in the pathological conditions. Several novel cytokines were disclosed recently, but their functions have not been well known. Further investigation of these cytokines, resulting in insulin resistance and energy homeostasis, is very important to elucidate the mechanisms and develop new therapeutic strategies.

Detailed Description
-----------------
We are studying patients with body weight change, increased or decreased. Healthy people are the control group. We are recording body weight, body height, and physical exam results. In addition, we are drawing peripheral blood for further biochemical and cytokine assays.

Conditions
-----------------
Metabolic Syndrome X, Cachexia, Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insulin resistance condition

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic syndrome