linjc16/ctgov huggingface dataset:
Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety of sodium phenylbutyrate (NaPB) treatment in subjects with amyotrophic lateral sclerosis (ALS) and the ability to take this medication without major side effects.

Detailed Description
-----------------
Although it is known that nerve cells die in the brains and spinal cords of patients who have ALS, the cause of the cell death is unknown. There is evidence that this cell death may be caused by changes in DNA, the body's genetic material. Drugs such as sodium phenylbutyrate (NaPB) can increase the expression of genes, block how the motor nerve cells in ALS die, and may prove to be an effective therapy for ALS. NaPB has shown an improvement in survival in mice with conditions similar to ALS. STUDY DESIGN: All research participants will take sodium phenylbutyrate for a total of 20 weeks. The dose of medication will be increased every 2 to 4 weeks until a maximum, easily tolerated dose is achieved (study maximum is 21 g/day).

Official Title
-----------------
Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: sodium phenylbutyrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with ALS At least 18 years of age Women, who can become pregnant, must actively use effective birth control measures Exclusion Criteria: Must not have any other neurological (nervous system) disease Veterans only are eligible to participate at VA sites.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>ALS patient | Drug: sodium phenylbutyrate<br>* histone deacteylase inhibitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of side effects at each dosage, including abnormalities in vital signs, physical examination, blood tests and EKGs, change in vital capacity (breathing function) and ALS functional rating scale |  |  | 
| Relationship between blood levels and sodium phenylbutyrate dosage |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALS, histone deacetylase inhibition, open label, safety study, sodium phenylbutyrate
Anti-osteoporosis Medication Monitoring and Management Service

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent years, efforts have been made to change the delivery of these medications from oral form to injection form every, 3, 6 or 12 months to increase adherence. However, both patients and providers are sometimes confused about the multiple choices. Also, patients may receive extra medications if providers did not keep tract of their previous AOM uses or patients may changes providers. There were urgent needs to provide AOM monitoring and management services to improve cares. OBJECTIVES: To establish a anti-osteoporosis medication management service at National Taiwan University Hospital and its BeiHu Branch. METHODS: Participating physicians will select those eligible for services and refer to study coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture, sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic visit, telephone reminder and follow up for patients, and communicate with providers on regular bases. the investigators plan to enroll 500 patients with 18-month follow up for each.

Official Title
-----------------
Anti-osteoporosis Medication Monitoring and Management Service

Conditions
-----------------
Osteoporosis, Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=50 and one of the below Newly prescribed with AOMs Recent change of AOMs Poor adherence to AOMs Participating physicians feel that the service will benefit the patient in overall osteoporosis and medication managements. Exclusion Criteria: Life expectancy less than 2 years or can't be assessed for communication problems patient in our fracture liaison service or other medication clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| medication adherence | Medication adherence will be assessed at 4, 8, 12, 18 months after enrollments. Final results will be reported at 18 month. If the patient changes medication, all AOMs adherence will be combined. Specific formula is as below: for oral medications, adherence is defined as # medication taken/ #medication prescribed within past 3 months for injection medications, adherence is defined as # of injection/ # of due injection since baseline or last follow up phone call. Statistics: Simple counts of adherence % among all participants. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Education, Medication Monitoring, Adherence, Management
Mental Health Consequences of COVID19 Infection in the French RMD Cohort

Study Overview
=================
Brief Summary
-----------------
this observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. The objective of the study is to compare RMD patients with COVID 19 infection (cases) to RMD patients who have not had COVID 19 infection (controls) on their mental health.

Official Title
-----------------
Mental Health Consequences of COVID19 Infection in the French Rheumatic Musculoskeletal Diseases (RMD) Cohort

Conditions
-----------------
Covid19, Systemic Autoimmune Disease, Inflammatory Rheumatism, Auto Inflammatory Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient case: Patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease With confirmed COVID-19 infection (at least one month prior to study inclusion) Study information given to the patient Patient affiliated to social security Patient control: Patient with inflammatory rheumatism, systemic autoimmune disease or autoimmune disease. Not having had a confirmed COVID-19 infection Study information given to the patient Patient affiliated to social security Exclusion Criteria: Opposition to participation in the study by the patient and/or his legal representative Adult patient not able to understand the implications and rules of the study Protected adults under guardianship or curatorship

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 |
| --- | --- |
| case group<br>RMD patients with COVID 19 infection | |
| control group<br>RMD patients without COVID 19 infection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID |  | at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of PTSD depending on whether or not autoimmune patients have experienced COVID |  | at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection |
Prospective Controlled Study of Posttransplant Diabetes

Study Overview
=================
Brief Summary
-----------------
Research participants will be asked to undergo complete medical history, physical examination and blood tests. The purpose of these tests is to determine whether persons are predisposed to develop diabetes mellitus after kidney transplantation and also to make an early diagnosis if a patient develops diabetes mellitus. Medical information collected as part of the standard transplant evaluation and posttransplant medical care may be incorporated into this study. It is important to realize that research subjects will not be given an experimental drug as part of this study. After kidney transplantation, research subjects will be followed in the posttransplant clinic visits. The study will last up to 6 months. During this time the subjects may be asked to participate in clinical assessment visits (medical history and physical examination), and also during the third or fourth month after transplant will be asked to do a repeat glucose tolerance test.

Conditions
-----------------
Diabetes Mellitus, Kidney Failure

Intervention / Treatment
-----------------
* Procedure: renal transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting Plasma Glucose (FPG) <126mg/dl. No history of diabetes mellitus or treatment with oral antidiabetic agent or insulin. ESRD or chronic renal failure with CrCl <= 20cc/min per 1.73m2. Waiting list registration for cadaveric or set date for living donor renal transplantation. Willingness and ability to understand and give informed consent.

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

| Intervention/Treatment |
| --- |
|Procedure: renal transplant|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
-----------------
Kidney transplantation, Immunology
Recessive Dystrophic Epidermolysis Bullosa Screening for Possible Gene Transfer

Study Overview
=================
Brief Summary
-----------------
Recessive Dystrophic Epidermolysis Bullosa (RDEB) is a severe inherited blistering skin disease caused by absence of type VII collagen. Patients with RDEB develop large, severly painful blisters and open wounds from minor trauma to their skin. In the future, we hope to start a gene transfer study on a specific group of RDEB subjects and we are screening subjects for that potential trial now.

Detailed Description
-----------------
This study is a preparation for a gene transfer trial. In the gene transfer trial, we will transfect autologous RDEB keratinocytes with a type VII collagen containing retrovirus vector. We then plan to graft the genetically engineered and corrected autologous keratinocytes back on to wounds of the RDEB subject. We expect the grafts to attach as normal keratinocytes and replace the damaged skin with skin that is able to make type VII collagen and anchor normally to the dermis. We are trying to define the number of subjects 18 or older who meet the criteria for the gene transfer trial. We are offering the subjects the opportunity to be evaluated for the potential trial.

Official Title
-----------------
Recessive Dystrophic Epidermolysis Bullosa Screening for Possible Gene Transfer

Conditions
-----------------
Epidermolysis Bullosa Dystrophica

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Clinical diagnosis of RDEB by local dermatologist 2. 18 years of age or more and willing to give consent 3. Estimated to have at least 100 to 200 sq. cm. areas of open erosions on the trunk or extremities suitable for skin grafting 4. Ability to undergo adequate anesthesia to allow grafting procedures to take place 5. Parents are alive, do not have EB, and they are willing to give consent for genetic testing Exclusion Criteria:1. Medical instability limiting ability to travel to Stanford University Medical Center 2. Participation in another clinical trial without prior approval 3. The presence of medical illness expected to complicate participation and/or compromise the safety of this technique

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 |
| --- | --- | --- |
| Disease documentation | Documentation of disease | 1 year | 
| documentation of disease | documentation of disease | 1 year |
Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.

Official Title
-----------------
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin degludec
* Drug: insulin degludec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDeg 100 U/mL<br> | Drug: insulin degludec<br>* 0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.<br>|
| Experimental: IDeg 200 U/mL<br> | Drug: insulin degludec<br>* 0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve during one dosing interval at steady-date |  | After 8 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum Insulin Degludec concentration-time curve |  | During one dosing interval at steady state | 
| Area under the serum Insulin Degludec concentration-time curve |  | From 0 to 24 hours after single dose |
Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.

Official Title
-----------------
The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy: a Double Blinded Randomized Placebo Controlled Trial

Conditions
-----------------
Renal Calculus, Kidney Stones

Intervention / Treatment
-----------------
* Drug: Ketorolac
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing percutaneous nephrolithotomy for kidney stone disease Exclusion Criteria: History of nonsteroidal antiinflammatory drug allergy Asthma History of long-term opioid use Intraoperative blood loss greater than 300 mL Postoperative hemodynamic instability Active peptic ulcer disease Advanced renal impairment (Creatinine > 2.0 mg/dL) Bleeding diathesis Current use of probenecid Pregnancy

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac<br>90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. | Drug: Ketorolac<br>* 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.<br>* Other names: Acular;|
| Placebo Comparator: Placebo<br>1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. | Drug: Placebo<br>* 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 'Right Now' | Visual analog scale score for pain on a scale from 0 = None to 10 = Worst. | 24 hours after the end of surgery | 
| Morphine Equivalents of Concomitant Pain Medication | The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient. | 24 hours after the end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous, Nephrolithotomy, Kidney stones
A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial assessing duloxetine and comparator to placebo in patients who have generalized anxiety disorder.

Official Title
-----------------
A Comparison of Duloxetine Hydrochloride, Venlafaxine Extended Release, and Placebo in the Treatment of Generalized Anxiety Disorder

Conditions
-----------------
Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Duloxetine
* Drug: venlafaxine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female outpatients at least 18 years of age, presenting with generalized anxiety disorder (GAD). Exclusion Criteria: Any current and primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I diagnosis other than GAD. Patients diagnosed with major depressive disorder within the past 6 months -or- patients diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year -or- obsessive-compulsive disorder, bipolar affective disorder, psychosis factitious disorder, or somatoform disorders during their lifetime The presence of an Axis II disorder or history of antisocial behavior, which in the judgement of the investigator would interfere with compliance with study protocol Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine History of alcohol or any psychoactive substance abuse or dependence (as defined in the DSM-IV-TR) within the past 6 months

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine|nan|
|Drug: venlafaxine|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess whether duloxetine hydrochloride 60 to 120 mg QD is superior to placebo in the treatment of GAD, defined as statistically greater reduction in anxiety symptoms as measured by the HAMA |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported anxiety symptomatology |  |  | 
| Quality of Life |  |  | 
| Clinical Global Improvement |  |  | 
| HAMA factor scores |  |  |