linjc16/ctgov huggingface dataset:
Uterine Artery Ligation to Decrease Blood Loss With Central Placenta Previa

Study Overview
=================
Brief Summary
-----------------
This trial will address the effect of uterine artery ligation during Cesarean section in cases with placenta previa to decrease blood loss.

Detailed Description
-----------------
This Study will address the effect of uterine artery ligation prior to fetal delivery during Cesarean section in cases with central placenta previa to guard against postpartum hemorrhage and to minimize blood loss.

Official Title
-----------------
Uterine Artery Ligation to Minimize Blood Loss in Patients With Central Placenta Previa

Conditions
-----------------
Placenta Previa Without Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Uterine artery ligation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasound Symptomatic Placenta previa with at least one episode of bleeding Estimated gestational age within 28 to 40 weeks Maternal age > 18 years Informed consent Social affiliation Exclusion Criteria: Premature rupture of membranes Severe bleeding. Abnormal fetal heart rates. Pre-eclampsia, chorioamnionitis, severe chronic renal disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ligation group<br>Uterine artery ligation will be done for patients in this group | Procedure: Uterine artery ligation<br>* Uterine artery ligation during cesarean section before delivery of the baby<br>|
| Placebo Comparator: Control group<br>Conventional CS | Procedure: Uterine artery ligation<br>* Uterine artery ligation during cesarean section before delivery of the baby<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hemoglobin level | Changes in hemoglobin level before and after CS will reflect the amount of blood loss during operation | hemoglobin level will be done baseline and will be repeated 24 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of uterine contractility. |  | During CS and within 3 hours after CS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
placenta previa, uterine artery ligation
Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Development

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the relationship between growth hormones, and recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with the body's ability to produce growth hormones. These hormones may be needed by the body for growth, mental development and sexual maturation.

Official Title
-----------------
Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Recovery

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Drug: Growth Hormone Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This is Phase II trial-subjects have already completed Phase I. Traumatic brain injury (TBI). Results of the blood work from Phase I shows that your growth hormone levels are low. Exclusion Criteria: Have not completed Phase I of the study.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth Hormone<br> | Drug: Growth Hormone Replacement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive changes following moderate/severe TBI |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth Hormone replacement, subject 8 to 21, moderate to severe traumatic brain injury, growth hormone deficient
Validation of MMS Test for Cancer Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the validation of MMS test to detect active tumor growth in different cancer types before and after therapy, as well as in the course of therapy and for subsequent relapse control compared to standard methods (clinical examination, imaging, tumor markers). It should be consider whether the MMS test has comparable diagnostic accuracy, and thus can replace more expensive or invasive procedures in future.

Official Title
-----------------
Validation of MMS Test to Detect Active Tumor Growth of Different Cancer Types Before and After Therapy, as Well as for Subsequent Relapse Control in Comparison to Conventional Methods

Conditions
-----------------
Colo-rectal Cancer, Stomach Cancer, Melanoma, Sarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of colo-rectal cancer Clinical diagnosis of stomach cancer Suspected diagnosis of melanoma Exclusion Criteria: Colitis ulcerosa Morbus Crohn Cancer in time period two years before Cancer therapy in time period two years before

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 |
| --- | --- |
| MMS test<br>therapy monitoring of patients with colo-rectal or stomach disease or with melanoma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| active tumor growth before and after cancer therapy |  | up to 36 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colo-rectal cancer, stomach cancer, melanoma, MMS test, therapy monitoring, Sarcoma
Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of morning versus evening intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change.

Official Title
-----------------
Efficacy and Safety of Morning Versus Evening Intake of Simvast CR Tablet in Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 3 Trial

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Simvastatin CR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 19 and 75 Defined as a fasting 100mg/dl≤ LDL cholesterol <220mg/dl and triglyceride level<400 mg/dl Need drug therapy by NCEP ATP III guideline Signed informed consent Exclusion Criteria: Has a hypersensitivity to HMG-CoA reductase inhibitor or simvastatin Has a presence or history of alcohol abuse or drug abuse Active gallbladder disease within 12 months Pancreatitis or Hepatic dysfunction (ALT or AST levels > 2XUNL) HbA1c≥ 9% in type 2 diabetes mellitus patients SBP < 90mmHg or > 160mmHg DBP < 50mmHg or > 100mmHg Myocardial infarction or revascularization procedure within 6 months Has significant cardiovascular disease Malignant tumor within 5years Has fibromyalgia, myopathy, rhabdomyolysis or acute myalgia Uric acid level > 9 mg/dl Thyroid stimulating hormone ≥ 2XUNL Active peptic ulcer disease CPK levels > 3XUNL creatinine level > 2 mg/dl Negative pregnancy test for women of childbearing age and agreement to use contraception while on study Had participated other clinical trial within 4 weeks Need systemic administration of corticosteroids intermittently

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin CR 20mg- morning administration<br> | Drug: Simvastatin CR<br> <br> |
| Active Comparator: Simvastatin CR 20mg- evening administration<br> | Drug: Simvastatin CR<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percent change from baseline in LDL cholesterol |  | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a) |  | week 8 |
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Lyme Disease

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Lyme Disease

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease

Conditions
-----------------
Lyme Disease, Lyme Disease, Chronic

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study Male or female patients of any age (interest is given to children to compare with mothers) Diagnosis of Lyme Disease Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who have been diagnosed with Lyme Disease | Other: No intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Lyme Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific disease types. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | One year |
Progenitor Cells in Human Esophagus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand how esophageal cells change with age.

Detailed Description
-----------------
The researchers will collect information from the patient's medical record and collect esophageal tissue at the time of the patient's surgery in excess of clinical diagnosis (i.e. tissue that would otherwise be discarded). There will be no patient contact after the patient's surgery. The researchers will analyze sections of adult esophagus tissue for the presence of CD34+ sox2+ progenitor cells to determine the number of progenitors present at a particular age. The researchers will also examine sections of different portions of the esophagus, to determine whether certain sections contain more progenitors, and thus perhaps a greater ability to regenerate, than others. This study involves testing DNA and patients will not be notified of the genetic test results and the results will not be put into their medical record. Patients will be asked to give consent to have any remaining esophageal tissue used for future studies of esophageal disease at Mayo Clinic, learn about, prevent, or treat any other health problems and give their sample and related information to researchers at other institutions.

Official Title
-----------------
Progenitor Cells in Human Esophagus

Conditions
-----------------
Progenitor Cells, Aging, Cells, Esophagus Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old Esophagus surgery at Mayo Clinic Exclusion Criteria: <18 years old

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 |
| --- | --- | --- |
| Amount of Progenitor Cells | We will examine sections of different portions of the esophagus, to determine whether certain sections contain more progenitors, and thus perhaps a greater ability to regenerate, than others. | 1 year |
Chiropractic Care, Medication, and Self-Care for Neck Pain

Study Overview
=================
Brief Summary
-----------------
This study will compare the effectiveness of chiropractic care, medications, and self-care on neck pain, a very common condition. The broad, long-term objective of this study is to identify effective therapies for neck pain sufferers and to increase understanding of neck pain conditions.

Detailed Description
-----------------
Neck pain is very common, with considerable socioeconomic consequences. Although some therapies appear promising, there are too few randomized clinical trials of sufficient quality to support the use of one therapy over another. This is especially true for acute/subacute neck pain. Although commonly treated with prescription medications, neck pain sufferers are increasingly seeking relief through complementary and alternative medicine therapies, such as chiropractic spinal manipulation. Little is known, however about the short- and long-term relative efficacy of these therapies and how they compare to giving patients simple advice on self-care. The broad, long-term objective of this research is to identify effective therapies for neck pain sufferers and to increase our understanding of neck pain conditions. This randomized, observer-blinded clinical trial is a unique collaborative effort by experienced chiropractic and medical researchers and will focus on patients with acute/subacute neck pain (<12 weeks duration). The study will determine the relative efficacy of chiropractic spinal manipulation, prescription medication, and self-care advice for neck pain in both the short term (after 6 weeks) and long term (after 52 weeks), using patient-rated neck pain as the main indicator of success.

Official Title
-----------------
Chiropractic Care, Medication, and Self-Care for Neck Pain

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Procedure: Chiropractic spinal manipulation
* Drug: Acetaminophen
* Behavioral: Self-care
* Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS)
* Drug: Tylenol with codeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Pregnant women, due to use of diagnostic procedures (x-rays) and study treatments (NSAIDs and narcotic medications)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Chiropractic spinal manipulation|nan|
|Drug: Acetaminophen|nan|
|Behavioral: Self-care|nan|
|Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS)|nan|
|Drug: Tylenol with codeine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Phase 1b Study of the Safety of REN001 in Patients With Fatty Acid Oxidation Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase 1b study is to assess REN001 safety in subjects with fatty acid oxidation disorders.

Detailed Description
-----------------
This is a Phase 1b, open-label, multiple-dose study of the safety and tolerability of 2 dose levels of REN001 in subjects with fatty acid oxidation disorders (FAODs) with confirmed mutations in the Carnitine palmitoyltransferase II deficiency (CPT2), Very long-chain Acyl-CoA dehydrogenase deficiency (VLCAD), Long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency (LCHAD) or Trifunctional Protein Deficiency (TFP). All subjects will provide written consent prior to commencing any study related activities or assessments. Potential subjects will be screened for study participation up to 8 weeks prior to the start of dosing.The study is divided into two parts, Part A and Part B. Part A has finished enrollment and further eligible patients will participate in Part B only.

Official Title
-----------------
An Open Label Study to Determine the Safety and Tolerability of 12 Weeks Treatment With Oral REN001 in Subjects With Fatty Acid Oxidation Disorders (FAOD)

Conditions
-----------------
Fatty Acid Oxidation Disorders

Intervention / Treatment
-----------------
* Drug: Low Dose REN001
* Drug: High Dose REN001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must give written, signed and dated informed consent Confirmed diagnosis of FAOD A diagnostic acylcarnitine profile, in blood or cultured fibroblasts A stable treatment regimen for at least 30 days prior to enrollment Exclusion Criteria: Unstable or poorly controlled disease Treatment with an investigational drug within 1 month or within 5 half-lives, whichever is longer Have been hospitalized within 3 months prior to screening for any major medical event Pregnant or nursing females

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Part A<br>REN001 Low Dose oral once daily x 12 weeks | Drug: Low Dose REN001<br>* Oral<br>|
| Experimental: Group 2 - Part A<br>REN001 High Dose oral once daily x 12 weeks | Drug: High Dose REN001<br>* Oral<br>|
| Experimental: Group 3 - Part B<br>REN001 High Dose oral once daily x 12 weeks | Drug: High Dose REN001<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants with Adverse Events (AEs) as a measure of safety and tolerability | Continous to Week 12 |
Oxaliplatin and 5-FU Based Preoperative Chemoradiation

Study Overview
=================
Brief Summary
-----------------
Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Detailed Description
-----------------
Effect of treatment, safety profile and quality of life scorings.

Official Title
-----------------
Oxaliplatin and 5-FU Based Preoperative Chemoradiation

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: Chemoradiation
* Drug: 5-FU
* Radiation: Preoperative chemoradiation
* Procedure: Pelvic surgery
* Drug: Neoadjuvant oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Rectal cancer

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemoradiation<br>Neoadjuvant chemotherapy and chemoradiation | Drug: Oxaliplatin<br> <br> Drug: Chemoradiation<br> <br> Drug: 5-FU<br> <br> Radiation: Preoperative chemoradiation<br> <br> Procedure: Pelvic surgery<br> <br> Drug: Neoadjuvant oxaliplatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile |  | 5 years | 
| Number of patients obtaining pCR |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical, radiological and molecular response to treatment |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxaliplatin, radiation