linjc16/ctgov huggingface dataset:
Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition

Study Overview
=================
Brief Summary
-----------------
The investigators are doing this research study to discover factors, such as job, hobbies, or race that are associated with arthrosis at the base of your thumb on X-rays. Thumb arthrosis is one of the most common kinds of arthritis. About 116 people will take part in this research study at Massachusetts General Hospital (MGH).

Official Title
-----------------
Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition

Conditions
-----------------
Trapeziometacarpal Arthrosis

Intervention / Treatment
-----------------
* Radiation: X-Ray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 55 years and older Not seeking care for TMC arthrosis from hand surgeon at the time of visit english fluency and literacy Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Patients with Trapeziometacarpal (TMC) Arthrosis<br>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis | Radiation: X-Ray<br>* X-ray as part of standard care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age | Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years. | Baseline at Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint | Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no) | Day 1, baseline | 
| QuickDASH (Disability of the Arm, Shoulder, and Hand) |  | Day 1, baseline |
Pharmacokinetics of Antiepileptics in Patients on CRRT

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to measure levels of any of the following AEDs (levetiracetam, phenobarbital, phenytoin, ketamine, valproic acid, lacosamide) in blood and effluent on critically ill patients receiving CRRT in order to characterize drug pharmacokinetics and optimize dosing strategies in patients on CRRT.

Official Title
-----------------
Pharmacokinetics of Antiepileptic Drugs in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy

Conditions
-----------------
Acute Kidney Injury, Renal Insufficiency, Renal Failure, Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Levetiracetam
* Drug: Lacosamide
* Drug: Phenytoin
* Drug: Phenobarbital
* Drug: Ketamine
* Drug: Valproic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Expected to be on CRRT and receive any of the following for more than 24 hrs Expected to survive for more than 24 hrs Achievement of steady state drug concentrations prior to study enrollment Exclusion Criteria: Pregnancy Age < 18 Prisoner

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No study intervention<br>No study intervention | Drug: Levetiracetam<br>* Standard of care<br>Drug: Lacosamide<br>* Standard of care<br>Drug: Phenytoin<br>* Standard of care<br>Drug: Phenobarbital<br>* Standard of care<br>Drug: Ketamine<br>* Standard of care<br>Drug: Valproic Acid<br>* Standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of renal replacement therapy on drug exposure (AUC of plasma concentration levels) | Simultaneous samples will be taken from pre-filter, post-filter, and effluent sampling ports before dose administration, after the completion of the infusion or 1 hours post oral dose, and 6 additional time points post-infusion or post oral administration. | Single Dosing Interval - 12 hours | 
| Influence of renal replacement therapy on drug clearance | Simultaneous samples will be taken from pre-filter, post-filter, and effluent sampling ports before dose administration, after the completion of the infusion or 1 hours post oral dose, and 6 additional time points post-infusion or post oral administration. | Single Dosing Interval - 12 hours | 
| Determination of drug specific sieving coefficient (SC) | SC is a measure of a filter efficiency in clearing drugs and solute. SC will be calculated using pre-filter and effluent concentrations | Single Dosing Interval - 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antiepileptics, Continuous Renal Replacement Therapy
Besponsa Post Marketing Surveillance Study

Study Overview
=================
Brief Summary
-----------------
Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of besponsa will be observed.

Detailed Description
-----------------
Before the approval of BESPONSA® in Korea, this non-interventional study is designated as a Post-Marketing Surveillance (PMS) Study and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP) which is required by MFDS. The safety and effectiveness information of BESPONSA® will be gathered in the setting of routine practice in Korea during the initial 6 years after the approval.

Official Title
-----------------
Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)

Conditions
-----------------
Hematologic Maligmancy

Intervention / Treatment
-----------------
* Drug: Inotuzumab ozogamicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL). Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion criteria Patients meeting any of the following criteria will not be included in the study: Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information. Patients to whom BESPONSA® is contraindicated as per the local labeling. -

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| R/R ALL<br>Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL) | Drug: Inotuzumab ozogamicin<br>* R/R ALL who treated with Inotuzumab ozogamicin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events categorized according to physical organ and disease/symptom |  | 28 days following the last administration of BESPONSA®. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractory and relapsed B-cell ALL
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.

Official Title
-----------------
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: fluticasone furoate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females between 18 and 45 years of age. History of grass and/or ragweed allergic rhinitis. Positive skin test to grass and/or ragweed antigen. Positive response to screening nasal challenge. Exclusion Criteria: Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. Pregnant or lactating women. Upper respiratory infection within 14 days of study start.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Veramyst, then Placebo<br>fluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week | Drug: fluticasone furoate<br>* 2 puffs in each nostril once daily for 1 week<br>* Other names: Veramyst;Drug: Placebo<br>* 2 puffs in each nostril once daily for 1 week<br>|
| Active Comparator: Placebo, then Veramyst<br>placebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week | Drug: fluticasone furoate<br>* 2 puffs in each nostril once daily for 1 week<br>* Other names: Veramyst;Drug: Placebo<br>* 2 puffs in each nostril once daily for 1 week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tryptase Level From Baseline to Post-antigen Challenge | Tryptase levels (mcg/L) were measured from nasal lavages | After one week of treatment wtih veramyst or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Eye Symptom Scores After Antigen Challenge | Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe | After one week of treatment wtih veramyst or placebo |
The Benefits of Early Initiation of Continual Renal Replacement Therapy in Patients With Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the benefit of early initiation of CRRT in the initial phase of severe sepsis in patients admitted to the ICU. Primary evaluated end-point is 28-day mortality. Secondarily evaluated end-point is length of ICU-stay, length of stay in hospital, duration of mechanical ventilation. There are two groups. One group of participants with early CRRT initiation and another group with late CRRT initiation. Reference group no CRRT.

Detailed Description
-----------------
The aim is to determine the optimal timing of initiation of CRRT with respect to the degree and duration of acute kidney injury (AKI) in ICU patients. The CRRT parameters and the duration of therapy will be monitored, depending on initial biochemical and clinical values of the patient. Part of the study is the follow-up of patients with a 3-month delay.

Official Title
-----------------
The Benefits of Early Initiation of Continuous Renal Replacement Therapy (CRRT) in Patients With Severe Sepsis

Conditions
-----------------
Severe Sepsis

Intervention / Treatment
-----------------
* Procedure: renal replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: reaching criteria of severe sepsis, ICU admission Exclusion Criteria: pregnant women, younger than 18 years, reaching contraindications for initiation of renal replacement therapy

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 |
| --- | --- |
| early CRRT initiation<br>Patients in ICU with severe sepsis, both gender, adult, over 18 years od age. Initiation of renal replacement therapy up to 48 hours after reaching criteria of severe sepsis. | Procedure: renal replacement therapy<br> <br> |
| late CRRT initiation<br>Patients in ICU with severe sepsis, both gender, adult, over 18 years od age. Initiation of renal replacement therapy after 48 hours after reaching criteria of severe sepsis. | Procedure: renal replacement therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | yes/no | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of mechanical ventilation | days of mechanical ventilation including weening | 28 days |
Association Between Response to Treatment of C. Diff Colitis and Anti-C.Diff Toxin Antibody

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is three fold: 1)To collect serum from patients with documented Clostridium difficile infection and test for the presence of antibody to C. difficile toxin at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To collect stool samples for test of C. difficile toxin at similar time intervals. 3)To assay random serum samples from the VA lab in order to determine the rate of antibody to C. difficile toxin in our patient population.

Detailed Description
-----------------
Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and mortality that may be around 2-3%. Current recommended therapy for this condition is metronidazole, given orally. Our observations suggest that about 10-20% of patients fail to respond to initial therapy with metronidazole, and 20% relapse after treatment. The reason why some persons are cured whereas others relapse is, at present, unknown. There is a suggestion in the medical literature that recurrent infection is associated with the failure to generate antibody to C. difficile toxin. It is also possible that those patients who become infected lack antibody, whereas others in the population tend to have such antibody. The investigators propose to study our patients at VAMC Houston in order to relate occurrence and/or the failure to respond to therapy or the appearance of recurrent disease to the presence of anti-toxin antibody. The investigators also propose to study sera obtained at random from VAMC patients in order to determine the prevalence of antibody in our patient population.

Official Title
-----------------
Association Between Clinical Response of Clostridium Difficile Colitis to Treatment and Emergence of Anti-C.Difficile Toxin Antibody

Conditions
-----------------
Clostridium Enterocolitis, Pseudomembranous Colitis, Antibiotic-Associated Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients at the Houston VA with documented C. difficile infection Exclusion Criteria: None
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
-----------------
Clostridium difficile
A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy of intravenous micafungin for the empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy patients with invasive fungal infections caused by Candida sp. or Aspergillus sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.

Official Title
-----------------
A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections

Conditions
-----------------
Invasive Fungal Infections

Intervention / Treatment
-----------------
* Drug: Micafungin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received Micafungin as empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy Patients received Micafungin treatment at least 1 dose Exclusion Criteria: Patients received Micafungin treatment combined with other antifungal drugs at the same time Neither efficacy or safety can be evaluated because of missing data, confused record

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 |
| --- | --- |
| Micafungin group<br> | Drug: Micafungin<br>* Intravenous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall success rate | Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall incidence and severity of adverse events |  | Up to 12 months | 
| Overall incidence and severity of adverse drug reactions |  | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Micafungin, Candida, Aspergillosis, Antifungal
Lippia Alba for Migraine Prophylaxis and Treatment

Study Overview
=================
Brief Summary
-----------------
Abstract Background: There is no universally accepted and effective prophylaxis of migraine headache episodes. Thus the investigators aimed to investigate the effects of Lippia alba (Mill.) N. E. Brown, an herb with many effects on central nervous system, on pain frequency and intensity of migraine patients. Methods: Patients were enrolled in a prospective, phase 2, non-controlled cohort study to orally receive ethanolic extract of L. alba leaves (1-2 drips/kg/day). Headache intensity and frequency of episodes were recorded before and after 30-60 days of treatment. The investigators also studied the chemical composition of its essential oil by gas chromatography-mass spectrometry. Results: The investigators described for the first time a particular L. alba chemotype with geranial and carvenone as major compounds. With treatment, both frequency and intensity of pain episodes significantly decreased from baseline to first reassessment date. More than 80% of patients experienced a minimum 50% reduction on pain intensity and frequency. No side effects were reported. Conclusions: Treatment with a geranial plus carvenone chemotype of L. alba ethanolic extract is a cheap, widely available, highly effective therapy to reduce both the intensity and the frequency of headache episodes of migraine patients with no side effects. Keywords: headache, migraine, medicinal plant, essential oil, phytotherapy

Official Title
-----------------
Chemical Composition and Therapeutic Effects of Lippia Alba (Mill.) N. E. Brown Leaves Ethanolic Extract in Patients With Migraine

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Drug: Lippia alba (Mill.) N. E. Brown ethanolic extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migraine diagnostic Exclusion Criteria: Patient's request

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: Lippia alba<br> | Drug: Lippia alba (Mill.) N. E. Brown ethanolic extract<br>* 1-2 drops per kilogram per day, PO, twice a day<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
-----------------
headache, migraine, medicinal plant, essential oil, phytotherapy