linjc16/ctgov huggingface dataset:
Physical CAM Therapies for Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This is a pilot randomized trial intended to evaluate the effectiveness of acupuncture, chiropractic and massage for chronic back pain in older and younger adults.

Official Title
-----------------
Physical CAM Therapies for Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Procedure: massage therapy
* Procedure: chiropractic
* Procedure: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Low back pain duration of at least 3 months; Low back pain occurring in the past week; No numbness or tingling in the lower extremities; No pain that radiates to below the knee; No use of massage, chiropractic or acupuncture for any reason in the past year; Able to attend scheduled appointments; Able to hear, read, and understand English; No low back pain surgery in the past 3 years; No unexplained weight loss; No previous vertebral or spinal fractures; No previous non-traumatic bone fractures; No other spinal pathology, including scoliosis, spinal stenosis, osteoporosis, or ankylosing spondylitis; No cancer (except simple skin cancers) in the past 5 years; No pacemakers; No bleeding problems or anticoagulant use; No major organ transplants; No oral corticosteroid use for more than 4 consecutive weeks during the past year; Cannot be pregnant; Must be able to get down to and up from the floor by yourself; Able to walk 2 flat city blocks unassisted; Willing to participate in periodic telephone interviews.

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Intervention/Treatment |
| --- |
|Procedure: massage therapy|nan|
|Procedure: chiropractic|nan|
|Procedure: acupuncture|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
-----------------
chronic low back pain, acupuncture, chiropractic, massage therapy, CAM therapies
Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

Study Overview
=================
Brief Summary
-----------------
Probiotic administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotic consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009). Changes in energy metabolism might be involved in the effects of probiotics on weight control. The objective of this study was to assess the efficacy of the consumption of a probiotic formulation on energy balance in overweight subjects.

Official Title
-----------------
Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic formulation
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Masss Index (BMI) 25 - 30 kg/m2 Healthy (determined by medical questionnaire) Able to commit to the duration of the study Providing consent for participation Exclusion Criteria: History of cardiovascular disease (CVD), diabetes, cancer, renal, thyroid or hepatic disease History of gastrointestinal surgery History of sleep disorders Recent bacterial infection (< 2 weeks) Weight loss > 5 kg in the last 3 months Under antibiotics or treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy Excessive consumption of products enriched in probiotics (> 4 servings per week) within the last 4 weeks before the start of the study History of drug or alcohol abuse (> 2 drinks daily) Regular smokers (more than 5 cigarettes a day) Not eating breakfast regularly or eating breakfast before 6h00. Not willing to eat any of the foods to be served in the study for any reason Physical activity level > 150 min of moderate or intense exercise per week Concurrent or recent intervention study (within 60 days)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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: Probiotic<br> | Dietary Supplement: Probiotic formulation<br>* Twice a day for 24 days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Twice a day for 24 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake |  | Lunch | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Energy balance
Post Market Clinical Follow-Up of Plasmafit® Cup

Study Overview
=================
Brief Summary
-----------------
Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Device: Plasmafit® Total Hip Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age 18 years Indication for cementless total hip arthroplasty Patient consent for study participation Physical and mental willingness to participate at clinical and radiological follow-up Exclusion Criteria: Patient not available for follow-up Increased anesthetics risks according to the American Society of Anesthesiology: ASA IV Tumor Alcohol or drug abuse Permanent cortisone therapy Clinically relevant infection Pregnancy or planned pregnancy Prior interventions like osteotomy, fracture treatment or prior THA at the concerned hip Acute fracture at the concerned hip Patients needing a cemented hip arthroplasty

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 |
| --- | --- |
| Plasmafit® Total Hip Arthroplasty<br> | Device: Plasmafit® Total Hip Arthroplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival Rates | Implant survival is analysed at follow-up examinations at 3 months, 12 months, 5 years and 10 years | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteolysis | Radiological Outcome | 3 months, 12 months, 5 years, 10 years | 
| Ossifications | Radiological Outcome | 3 months, 12 months, 5 years, 10 years | 
| Implant Position | Radiological Outcome | 3 months, 12 months, 5 years, 10 years | 
| Migration of Plasmafit® | Radiological Outcome | 3 months, 12 months, 5 years, 10 years | 
| Clinical Outcome | Harris Hip Score | 3 months, 12 months, 5 years, 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
THA, Plasmafit®
Risk of Hepatitis B Virus Reactivation in Patients Undergoing Allografting

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the risk of hepatitis B reactivation in patients undergoing allografting.

Official Title
-----------------
Risk of Hepatitis B Virus Reactivation in Patients Undergoing Allografting

Conditions
-----------------
Hepatitis B Virus, Allograft, Hematological Malignancies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing an allograft for hematological malignancies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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
-----------------
Incidence of hepatitis B after allografting, Risk of hepatitis B reactivation, Lamivudine prophylaxis
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.

Official Title
-----------------
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Multiple-center Study With Additional Open-label Single-blind and Placebo-controlled 24-Week Histology Cohorts to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for Up to 24 Weeks in Patients With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

Conditions
-----------------
Nonalcoholic Steatohepatitis (NASH)

Intervention / Treatment
-----------------
* Biological: NGM282
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females, between 18 and 75 years of age, inclusive Histologically confirmed NASH diagnosis Exclusion Criteria: Clinically significant acute or chronic liver disease Prior liver transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Placebo Comparator: Cohort 1 - Placebo<br>Cohort 1 - Placebo | Other: Placebo<br> <br> |
| Experimental: Cohort 1 - NGM282 3mg<br>Cohort 1 - NGM282 3mg | Biological: NGM282<br> <br> |
| Experimental: Cohort 1 - NGM282 6mg<br>Cohort 1 - NGM282 6mg | Biological: NGM282<br> <br> |
| Experimental: Cohort 2 - NGM282 0.3mg<br>Cohort 2 - NGM282 0.3mg | Biological: NGM282<br> <br> |
| Placebo Comparator: Cohort 2 - NGM282 1mg<br>Cohort 2 - NGM282 1mg | Biological: NGM282<br> <br> |
| Experimental: Cohort 2 - NGM282 3mg<br>Cohort 2 - NGM282 3mg | Biological: NGM282<br> <br> |
| Experimental: Cohort 3 - NGM282 1mg<br>Cohort 3 - NGM282 1mg | Biological: NGM282<br> <br> |
| Placebo Comparator: Cohort 4 - Placebo<br>Cohort 4 - Placebo | Other: Placebo<br> <br> |
| Experimental: Cohort 4 - NGM282 1mg<br>Cohort 4 - NGM282 1mg | Biological: NGM282<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in absolute liver fat content as measured by MRI from Baseline to Week 24 |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percentage liver fat content as measure by MRI from Baseline to Week 24 |  | 24 weeks |
A Randomized, Double-Blind, Trial Comparing Epinephrine Versus Phenylephrine as a Vasoconstrictor in Regional Anesthesia for Upper Extremity Surgery

Study Overview
=================
Brief Summary
-----------------
The study involves research, the purpose of which is to compare three different drug mixtures (Epinephrine, Phenylephrine 25 µg, or Phenylephrine 50 µg). Specifically, how long each medicine lasts will be studied.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Epinephrine/phenylephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Shoulder surgery with regional anesthesia Exclusion Criteria: Shoulder surgery with general anesthesia unhealthy

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epinephrine/phenylephrine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL was investigated. Secondary objective of this study was to evaluate the response rates of this new regimen.

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Caelyx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 18 years of age recurrent ovarian, peritoneal, or tubal cancer and prior treatment with platinum- and paclitaxel were eligible to this trial. Eastern Cooperative Oncology Group (ECOG) performance status less than 3. renal function (serum creatinine 1.25 times the upper limit of normal, glomerular filtration rate greater than 60 ml/min) liver function (AST/ ALT three times the upper limit of normal, bilirubin concentrations 1.25 the upper limit of normal) bone marrow function (neutrophil count greater than 1.5 x 109/l, and a platelet count greater than 100 x 109/l). Exclusion Criteria: patients with more than 4 chemotherapies in medical history severe cardiac disease

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

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

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: Caelyx<br> | Drug: Caelyx<br>* Caelyx 40 mg/ m2biweekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | Toxicity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Overall survival | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biweekly schedule of PLD - Ovarian cancer - pegylated liposomal doxorubicin -quality of life - Toxic skin reactions
RNA Sequencing of Solid and Cystic Lesions of the Pancreas

Study Overview
=================
Brief Summary
-----------------
The nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may be benign, precancerous, or cancer. Current tests such as cytology (looking under a microscope) and tumor markers do not always give us the answer. The investigators are looking for genetic markers on biopsy specimens from the pancreas that will give us a better test for diagnosis. This study is only for diagnosing these lesions. The investigators are not treating any patients.

Official Title
-----------------
RNA Sequencing of Solid and Cystic Lesions of the Pancreas

Conditions
-----------------
Pancreas Cyst, Pancreas Mass

Intervention / Treatment
-----------------
* Procedure: pancreas biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greater than 18 years old, not pregnant, referred for endoscopic ultrasound, have a cyst or mass of the pancreas needing diagnosis. Exclusion Criteria: pregnant, less than age 18, no mass or cyst found.

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 |
| --- | --- |
| pancreas cysts and solid masses<br>patents referred for solid and cystic lesions of the pancreas who will have a biopsy for usual medical care. | Procedure: pancreas biopsy<br>* patients who are already having a pancreas biopsy will be invited to enroll. After obtaining enough tissue for usual medical care, we will divert some tissue for the study.<br>* Other names: RNA sequencing of pancreas tissue;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene classifier that will classify lesions as benign or malignant with 95% certainty |  | 2 years |
Ziprasidone Pharmacokinetics Using a Reduced Food Effect Formulation Compared to Pharmacokinetics From Commercial Capsules

Study Overview
=================
Brief Summary
-----------------
Commercial ziprasidone capsules show a large increase in bioavailability with food. The formulation tested in this study aims to reduce or eliminate that increase.

Official Title
-----------------
Phase 1 Study Of Ziprasidone Pharmacokinetics Of Reduced Food Effect Formulation B16 Under Fed And Fasting Conditions Compared To Commercial Geodon Capsules Under Fed Conditions In Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ziprasidone
* Drug: B16 Fasted
* Drug: B16 Fed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Signed informed consent document Exclusion Criteria: Any significant physical or psychological disease Concomitant administration of other pharmaceuticals

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Geodon fed<br>Commercial Geodon (ziprasidone) capsules given with food | Drug: ziprasidone<br>* 40 mg capsule, single dose x 3<br>* Other names: Geodon, Zeldox;|
| Experimental: B16 Fasted<br>Experimental reduced food effect formulation given without food | Drug: B16 Fasted<br>* 40 mg tablet, single dose X 3<br>|
| Experimental: B16 Fed<br>Experimental reduced food effect formulation given with food | Drug: B16 Fed<br>* 40 mg tablet, single dose X 3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability measured as geometric mean ratios of AUCinf and Cmax and the associated 90% confidence intervals calculated for various pairs of study treatments. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events reported, laboratory test results, vital signs observed with each study treatment |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, pharmacokinetics, bioavailability, food effect
The Effect of Gallstone Characteristics for the Severity of Gallstone Pancreatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the effect of gallstone characteristics for the severity of acute gallstone pancreatitis (GSP)

Detailed Description
-----------------
The timing of cholecystectomy is closely related to the severity of acute gallstone pancreatitis (GSP). The effect of gallstone characteristics (including stone size, number, etc.) for the severity of GSP are currently unknown.

Official Title
-----------------
The Effect of Gallstone Characteristics for the Severity of Acute Gallstone Pancreatitis

Conditions
-----------------
Acute Gallstone Pancreatitis

Intervention / Treatment
-----------------
* Other: Gallstone characteristics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute gallstone pancreatitis (GSP) patients. Exclusion Criteria: Pancreatitis with bile duct stones, trauma, drugs, and surgery; Recurrent gallstone pancreatitis; Combined with other malignant tumors, such as liver cancer, cholangiocarcinoma, pancreatic cancer, gastric cancer, Hematologic tumor, and lymphoma; Previous hepatobiliary and pancreatic surgery, Organ transplantation; Intestinal obstruction or other obstructive diseases; Chronic pancreatitis or pancreatic duct stones; Thrombotic disease; Alcoholic pancreatitis and hyperlipidemia pancreatitis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Gallstone characteristics|stone size, number, the thickness|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severity of GSP patients | Based on the 2012 Atlanta International Consensus, Mild acute pancreatitis (MAP) is defined as no organ failure and no local or systemic complications. Moderate to severe acute pancreatitis (MSAP) refers to patients with organ failure, local complications, or aggravated complications. Severe acute pancreatitis (SAP) is defined as persistent organ failure for more than 48 hours. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified computed tomography severity index (MCTSI) score | Without knowing the prognosis, two radiologists with eight and ten years of experience independently scored the severity of GSP through the MCTSI score and reached an agreement through discussion when there was disagreement. | 1 month | 
| Gallstone size | The diameter of the stones | 1 month | 
| Number of stones | The number of gallstones | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatitis, Gallstone, Severity