linjc16/ctgov huggingface dataset:
National Marrow Donor Program (NMDP)

Study Overview
=================
Brief Summary
-----------------
To serve as a focal point for bone-marrow research.

Detailed Description
-----------------
BACKGROUND: In 1986, the Department of the Navy initiated the National Bone Marrow Donor Registry. Because the support of a National Bone Marrow Donor Registry was not very closely related to the Navy's primary missions, in 1989 the management of the contract for the program was transferred by the Congress from the Navy to the NHLBI. By 1989, bone marrow transplantation had become an effective and accepted treatment for an increasing number of diseases of the bone marrow and the immune system. Until only a few years prior to 1989, most marrow donors were siblings, carefully matched for HLA (tissue) antigens. Since only a small proportion of candidates for a bone marrow transplant have matched brothers or sisters, additional family members were tried as donors. These included parents, children, slightly mismatched siblings, and other relatives. Even with the broadening of the bone marrow donor source, no more than 30-40 percent of patients with diseases amenable to marrow transplant therapy had available donors. Improved results with these selectively mismatched relatives and a distinct need to provide appropriate treatment for more patients led to trials with unrelated, HLA-matched community volunteers as bone marrow donors. By 1989, research had progressed to the point where transplants from such unrelated donors were nearly as successful as those from matched siblings, when stratified by disease status and risk parameters. In 1989, 20 to 25 percent of patients for whom a formal donor search was initiated received a transplant. This was expected to increase substantially. DESIGN NARRATIVE: The program was established by the Department of the Navy in 1986 and transferred to the NHLBI in 1989. The purpose was to develop and maintain a registry of individuals willing to donate bone marrow for patients in need of transplants, to facilitate marrow transplants by serving as a coordinating and communications center for a network of donor, collection and transplant centers in the United States and internationally, and to facilitate research into the efficacy of unrelated donor marrow transplants. In 1992, the program was enlarged to support a limited number of demonstration projects to develop, implement, and evaluate innovative models for minority marrow donor recruitment. In 1995, the NMDP was transferred to the Health Resources and Services Administration (HRSA), although NHLBI provided funds in this year.

Conditions
-----------------
Bone Marrow Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
Sexes Eligible for Study
-----------------
Male

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Precise Treatment System of Biliary Malignancies Based on Special Disease Database

Study Overview
=================
Brief Summary
-----------------
Malignant tumors of biliary system lack standard treatment and precise prognosis assessment methods. This study including 12 hospitals, collecting clinical and follow-up data of patients with biliary malignant tumors including cholangiocarcinoma and gallbladder carcinoma in recent 10 years, aim to build a special disease database, then use Bayesian networks and importance theory to establish a mathematical model to assess treatment strategies and prognosis accurately. At the same time, data on biliary malignant tumors newly treated by multicenters from 2018 to 2020 will be included to validate, adjust and refine the models to guide clinical individualized precise treatment.

Official Title
-----------------
A Multi-center Study：Surgical Optimization and Prognosis Auxiliary System of Biliary Malignancies Based on Special Disease Database

Conditions
-----------------
Biliary System Disorder, Cholangiocarcinoma, Gall Bladder Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria： Clinical diagnosis of biliary malignancy including gallbladder carcinoma or cholangiocarcinoma verified by pathological results Must be able to undergo surgery Undergoing radical surgery for biliary malignancy (R0 or R1 resection) Not complicated with other malignancy No other treatments before and during surgery, such as radiotherapy and chemotherapy. Exclusion Criteria: Non-primary gallbladder or cholangiocarcinoma With distant metastasis (M1 phase) Incomplete follow-up data Died within 30 days after surgery.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from biliary tract carcinoma | Death from cholangiocarcinoma or gallbladder carcinoma | Every three months, up to five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognosis, Surgery options, Bayesian networks
The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of study is to test whether perioperative sodium bicarbonate infusion can prevent acute kidney injury following open heart surgery in infective endocarditis patients.

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: sodium bicarbonate
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients over the age of 20 scheduled for open heart surgery for infective endocarditis Exclusion Criteria: end stage renal disease (serum creatinine concentration > 300 μmol/L) on dialysis chronic moderate to high dose corticosteroid therapy (> 10 mg/day prednisolon or equivalent) preoperative severe hypernatremia (Na+ > 150 mmol/L), alkalemia (PH > 7.50), or pulmonary edema neurocognitive dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium bicarbonate group<br>Sodium bicarbonate group | Drug: sodium bicarbonate<br>* 0.5 mmol/kg for 1 hr, and then 0.15 mmol/kg/h for 23 hrs The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery<br>|
| Placebo Comparator: Saline group<br>Saline group | Drug: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups. | We would investigate if the peak creatinine level during the postoperative 48h would differ by more than 0.3 mg/dL between two groups. The primary outcome was decided based on the AKIN criteria which defines acute kidney injury if serum creatinine increases more than 0.3 mg/dL during the postoperative 48 h. ; increase in serum creatinine of 0.3 mg/dL or >50 percent developing over <48 hours | postoperative 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sodium bicarbonate, renal function, infective endocarditis, open heart surgery
Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.

Detailed Description
-----------------
Study population: 30 patients will be included who meet all the following criteria: ALT > 2 times normal range; liver histology revealing NASH (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the NCEP, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake < 40 g/week. All patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or Mallory bodies) but without cirrhosis will be included. Patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. Patients who will develop overt type 2 DM with HbAic > 7% during study will be withdrawn. Intervention: All patients will have dietary intervention by a dietician and will be encouraged to increase physical activity. Patients will be receiving metformin 850 mg tid for 12 months. Outcome: Improvement of liver enzymes (ALT, AST, GGT) Improvement of metabolic profile: lipid profile, fasting and post-load glucose and insulin levels, HOMA. Liver histology (repeated liver biopsy after 1 year). Soluble TNF receptors- TNF-receptor P55 and P75.

Official Title
-----------------
Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALT > 2 times normal range. Liver histology revealing non-alcoholic steatohepatitis [NASH] (type 2-4), without cirrhosis. Clinical characteristics of the metabolic syndrome as defined by the National Cholesterol Education Program (NCEP), but no overt diabetes. Negative work-up for other causes of liver diseases including alcohol intake < 40 g/week. Exclusion Criteria: Diabetes mellitus. Alcohol intake > 40 g per week.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histological and biochemical changes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-alcoholic fatty liver disease, insulin resistance, metformin
Inpatient Mortality Prediction Algorithm Clinical Trial (IMPACT)

Study Overview
=================
Brief Summary
-----------------
Through the mapping of retrospective patient data into a discrete multidimensional space, a novel algorithm for homeostatic analysis, was built to make outcome predictions. In this prospective study, the ability of the algorithm to predict patient mortality and influence clinical outcomes, will be investigated.

Official Title
-----------------
A Randomized Clinical Trial of a Mortality Prediction Algorithm

Conditions
-----------------
Death, Decompensation, Heart, Decompensation; Heart, Congestive

Intervention / Treatment
-----------------
* Other: Patient mortality prediction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients admitted to the participating units will be eligible. Exclusion Criteria: All patients younger than 18 years of age will be excluded.

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prediction Algorithm<br> | Other: Patient mortality prediction<br>* Healthcare provider is notified of patient mortality prediction.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality |  | Through study completion, an average of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay |  | Through study completion, an average of 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dascena, patient mortality, machine learning, algorithm, diagnostic
Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This is a prospective study to demonstrate the safety and efficacy of differentiated neurons-derived from adult CNS progenitors cells transplanted in selected patients with Parkinson's disease.

Official Title
-----------------
Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Biological: Intracerebral microinjections


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to give informed consent prior to study Male or Female with Diagnostic Criteria of Parkinson's disease Age 35 to 85 years old Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease Hoehn and Yahr Stage III or IV Parkinson's disease observed in the absence of: Oculomotor palsy Cerebellar sign Orthostatic hypotension (drop greater than 20mmHg in mean pressure) Pyramidal sign Amyotrophy Good general health or stable medical condition well controlled, without contraindications to anesthesia Exclusion Criteria: Patients with severe dementia and brain atrophy on MRI Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV Patients older than 85 or younger than 35 Patients who withhold informed consent Patients with a history of alcohol or drug abuse Sexually active women of childbearing potential without adequate form of birth control Evidence of abnormal coagulation or anticoagulant therapy Pregnancy or lactation History of seizure disorders or current use of antiepileptic medication Severe cognitive impairment Clinically significant laboratory abnormality

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 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: Treatment<br> | Biological: Intracerebral microinjections<br>* Stereotactic delivery of cell suspension into basal ganglia structures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor UPDRS | UPDRS Motor scale | 6 months |
A Study of Lobucavir in Patients With AIDS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS.

Detailed Description
-----------------
Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.

Official Title
-----------------
Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients

Conditions
-----------------
Cytomegalovirus Infections, HIV Infections

Intervention / Treatment
-----------------
* Drug: Lobucavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Aerosolized pentamidine. TMP / SMX. Isoniazid. Dapsone. Fluconazole. Ketoconazole. Rifabutin. Fluoxetine HCl. Acetaminophen. Antacids. Metamucil. Multivitamins. Other drugs with approval from sponsor. Patients must have: AIDS. CD4 count < 200 cells/mm3. Cytomegalovirus ( CMV ) viruria and virosemenia. No evidence of intraocular CMV. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Acute or chronic cardiovascular, pulmonary, renal, hepatic, pancreatic, hematologic, endocrine, neurological, or other unstable illness. Inability to take oral medication. Allergy to nucleoside analogs. Diarrheal illness. Poor venous access. Positive test for drugs of abuse. Any other condition that would render patient unsuitable for study. Patients with the following prior conditions are excluded: History of pancreatitis. Recent diarrheal illness. History of weight loss. Acute serious illness within 4 weeks prior to study entry. Prior Medication: Excluded within 4 weeks prior to study entry: Erythropoietin. Any agent with anti-CMV activity. Other investigational agents. Prior Treatment: Excluded within 4 weeks prior to study entry: Surgery. Blood transfusion. Drug abuse.

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


Arms and Interventions

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

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
-----------------
Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents
Overuse Injuries in Road Cyclists, Prevalence and Prevention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the prevalence of overload injuries to road cyclists in Sweden, and if it 's possible to prevent low back pain by a simple exercise program for two months of training .

Official Title
-----------------
Overuse Injuries in Road Cyclists, Prevalence and Prevention

Conditions
-----------------
Overuse Injuries

Intervention / Treatment
-----------------
* Other: Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planning to ride Vätternrundan 2014 in a subgroup . Cycled Vätternrundan at least twice in the past or bicycled for exercise at least 800 mil ( the equivalent of two seasons) . Age 18-55 years . Training cycle at least three hours a week or three days a week . Exclusion Criteria: Do not have access to a computer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Training<br>Two exercises for training of core stability and mobility. | Other: Training<br>* Two exercises for training of core stability and mobility.<br>|
| No Intervention: Control<br>Control group without training | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and type of overuse injuries |  | Four months follow-up |
Effects of Talampanel on Patients With Advanced Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to test the safety and effectiveness of the study drug, Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a result of treatment to Parkinson's disease. It is not clear why people with Parkinson's disease develop involuntary movements (dyskinesias) but studies show that blocking receptors in the brain for a chemical called glutamate decreases these movements. Talampanel is a drug which blocks these receptors.

Official Title
-----------------
Effects of Talampanel on Patients With Advanced Parkinson's Disease Who Have Been on Sinemet for More Than 5 Years and Have Dyskinesia (Abnormal Involuntary Movements)

Conditions
-----------------
Dyskinesias, Parkinson Disease, Movement Disorders

Intervention / Treatment
-----------------
* Drug: talampanel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Troublesome on-period dyskinesias as defined by a Unified Parkinson's Disease Rating Scale (UPDRS) dyskinesia sub-score >25% of Duration of dyskinesia during waking hours and 33 must have moderate disability Lang-Fahn dyskinesia rating score more than 2 for at least two of the 5 tasks Must have Dyskinesia on average 25% of waking hours/day based on Patient Diaries Have been diagnosed with Parkinson's disease > 5 years at Screening Exclusion Criteria: Previous surgical therapies for PD Isolated or predominantly diphasic dyskinesias Moderate Dementia On disallowed concomitant medications including CYP3A4 inhibitors and inducers, amantadine, etc.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>75mg per day (in 3 doses) Talampanel for 22 days | Drug: talampanel<br>* 75mg per day divided into 3 doses for 22 days<br>|
| Placebo Comparator: 2<br>3 doses a day for 22 days | Drug: talampanel<br>* 75mg per day divided into 3 doses for 22 days<br>|

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
-----------------
Involuntary Movements, Abnormal Movements, Advanced Parkinson's disease, Levodopa induced dyskinesia