linjc16/ctgov huggingface dataset:
Clinical, Biological and NMR Outcome Measures Study for Hereditary Inclusion Body Myopathy Due to Mutation of UDP-N-acetylglucosamine 2-epimerase/N-acetylmannosamine Kinase Gene (GNE)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to identify the best clinical and biological outcome measures for further therapeutics approaches.

Conditions
-----------------
HIBM

Intervention / Treatment
-----------------
* Other: motor function and strength assessment
* Other: NMR assessment
* Other: 24h urine and serum collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be at least 18 years of age. Must be willing and able to provide consent. Must have a genetic diagnosis of HIBM, GNE myopathy, Quadriceps Sparing Myopathy (QSM), Inclusion Body Myopathy Type 2, distal myopathy with rimmed vacuoles (DMRV), or Nonaka disease. Must be willing and able to comply with all study requirements. Affiliated to or a beneficiary of a social security category Must take part in the HIBM-PMP UX001-CL401 study Exclusion Criteria: Received ManNAc therapy or other similar substance Any unrelated, comorbid disease or condition that, in the view of the investigator, would interfere with study participation or would affect safety. Patients with specific contraindication to MRI (i.e. metallic foreign body, claustrophobia…) will be allowed to participate, but MRI will not be performed. Pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIBM patient<br>motor function, muscle strength, NMR, 24h urine and serum collections at baseline, then annually | Other: motor function and strength assessment<br> <br> Other: NMR assessment<br> <br> Other: 24h urine and serum collection<br> <br> |
| Active Comparator: Controls<br>motor function, muscle strength, 24h urine and serum collections at baseline only | Other: motor function and strength assessment<br> <br> Other: 24h urine and serum collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of changes in motor function and muscle strength assessment between 2 time points |  | baseline, 1 year, 2 years, 3 years | 
| Measure of changes in NMR upper and lower limbs assessment between 2 timepoints(not for controls) |  | baseline, 1 year, 2 years, 3 years | 
| 24h urine and serum collection, measures at different time points |  | baseline, 1 year, 2 years, 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIBM, GNE
The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin

Study Overview
=================
Brief Summary
-----------------
The study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who are requiring a loading dose of phenytoin.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: fosphenytoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female, hospitalized patients 2 years of age or older Adult patients or guardian for pediatric patients to provide written informed consent Exclusion Criteria: patient with a history of hypersensitivity to hydantoins patient with hypotension, sinus bradycardia, sino-atrial block, second or third degree A-V block, or Adams-Stokes syndrome pregnant or nursing female patients

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| Experimental: 15mg/kg of loading dose<br> | Drug: fosphenytoin<br>* 15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin<br>|
| Experimental: 18mg/kg of loading dose<br> | Drug: fosphenytoin<br>* 15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin<br>|
| Experimental: 22.5mg/kg of loading dose<br> | Drug: fosphenytoin<br>* 15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 8 to 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency and nature of seizures |  | 8 to 12 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NPC-06, fosphenytoin, phenytoin, pharmacokinetics, safety
Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of gemcitabine given as a continuous infusion in treating patients who have advanced metastatic cancer.

Detailed Description
-----------------
OBJECTIVES: Determine the maximum tolerated dose of continuous infusion gemcitabine in patients with metastatic malignancies. Determine the toxicity profile of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients on dose levels 1-5 receive gemcitabine IV continuously over 72 hours on week 1. Patients on dose levels 6 and 7 receive gemcitabine IV continuously over 72 hours on weeks 1-3. Courses repeat every 2 weeks (for patients on dose levels 1-5) and every 4 weeks (for patients on dose levels 6 and 7) in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Official Title
-----------------
Phase I Study of Continuous Infusion Gemcitabine

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Drug: gemcitabine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of an advanced metastatic malignancy for which no curative therapy exists PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Pulmonary: Corrected DLCO at least 60% expected Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Prior short-infusion gemcitabine allowed Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

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: gemcitabine hydrochloride|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
-----------------
unspecified adult solid tumor, protocol specific
Neuropeptides in the Humane Intra- og Extracerebral Circulation.

Study Overview
=================
Brief Summary
-----------------
The study aim at examining whether Sumatriptan changes the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.

Detailed Description
-----------------
The study is meant to give a better understanding of the basic mechanisms behind migraine, and a better understanding of the effects of sumatriptan on the trigemino vascular system. The endpoints are changes in the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.

Official Title
-----------------
Neuropeptides in the Humane Intra- og Extracerebral Circulation - in Relation to Sumatriptan in Healthy Volunteers.

Conditions
-----------------
Healthy, Migraine

Intervention / Treatment
-----------------
* Drug: sumatriptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers 18-50 years, 50-100 kg. Fertile women must use birth control. Exclusion Criteria: All primary types of headache Daily intake of medicine except birth control Pregnancy Hypertension Hypotension other chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentration of vasoactive intestinal polypeptide (VIP), |  |  | 
| calcitonin gene-related protein (CGRP), pituitary adenylate cyclase |  |  | 
| activating peptide (PACAP,) and the prostanoids |  |  | 
| 6-keto-PGF1α, PGE2, PGD2 and PGF2α, sampled from different |  |  | 
| venous catheters. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VIP, PACAP, CGRP, Prostanoids
Role of Antibodies Against Glutamate Receptors and Double Stranded DNA in Epilepsy Patients

Study Overview
=================
Brief Summary
-----------------
The investigators will check the serum of epilepsy patients for antibodies against glutamate receptors and double stranded DNA. They will characterise the patients (by the kind of epilepsy, autoimmune disease comorbidity, and cognitive profile).

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 120 epilepsy patients from the epilepsy clinic and Emergency Room (ER) Controls: 100 patients with other neurological diseases and no epilepsy; and 30 healthy volunteers.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Return to Work and QOL Following TBI. Impact of Rehabilitation Service.

Study Overview
=================
Brief Summary
-----------------
The proportion of patients who return to work after surviving severe traumatic brain injury (TBI) has been estimated in number of studies but results do not agree.This may be due to complex interaction between many factors, including available rehabilitation services. In Denmark rehabilitation services vary been regions and municipalities. Hospital based rehabilitation is organized by the regions. Rehabilitation outside the hospitals is organized by the municipalities The first purpose of this study is to investigate a possible link between centralized hospital based rehabilitation and better return to work / quality of life. The second purpose is to investigate whether municipality size affects quality of life and return to work after severe TBI. Data on return to work are derived from a national register on labor market attachment. Data on quality of life are derived from a questionnaire. The study population is identified from the Danish Head Trauma Database. The completeness and accuracy of the database will be investigated as the first part of the project.

Official Title
-----------------
Return to Work and QOL Following TBI. Impact of Rehabilitation Service.

Conditions
-----------------
Brain Injuries, Return to Work, Quality of Life

Intervention / Treatment
-----------------
* Other: Rehabilitation service


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-64 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Rehabilitation service<br>Centralized or Decentralized rehabilitation Size of municipality | Other: Rehabilitation service<br>* Centralized/ decentralized hospital based rehabilitation defined as hospital based rehabilitation in a single or in multiple locations, respectively. Size of the municipality responsible for providing rehabilitation services after discharge from hospital<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to return to work | Data Source: Register (DREAM) | up to 11 years post-injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Data Source: Questionnaire (QUOLIBRI) | 1-10 years post-injury | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain injuries, Rehabilitation services, Return to Work, Quality of life
Follow-up of Patients After Knee Arthrodesis With an Intramedullary Nail

Study Overview
=================
Brief Summary
-----------------
Follow-up of patients who underwent a knee arthrodesis with different types of intramedullary nails.

Official Title
-----------------
Follow-up of Patients After Knee Arthrodesis With an Intramedullary Nail

Conditions
-----------------
Knee Arthrodesis With Intramedullary Nail

Intervention / Treatment
-----------------
* Procedure: History taken and clinical examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent a knee arthrodesis with an intramedullary nail between 1994 and 2005 Exclusion Criteria: -

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 |
| --- | --- |
| Experimental: knee arthrodesis<br> | Procedure: History taken and clinical examination<br>* History is taken and clinical examination is followed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up of patients who underwent a knee arthrodesis with different types of intramedullary nails |  | t0 |
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fed Conditions

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: letrozole
* Drug: letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to letrozole or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: letrozole<br>2.5 mg tablet | Drug: letrozole<br>* 2.5 mg tablet<br>* Other names: Femara;|
| Active Comparator: Fermara<br>2.5 mg tablet | Drug: letrozole<br>* 2.5 mg tablet<br>* Other names: Femara;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 31 days |
STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients.

Detailed Description
-----------------
STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.

Official Title
-----------------
A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: STA-4783
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M or F 18 or older with histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin ECOG performance status of greater than or equal to 2 Measurable disease per RECIST criteria Received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy regimens are allowed) At least 4 weeks have passed since last chemotherapy or immunotherapy At least 2 weeks have passed since last radiotherapy. Life expectancy of greater than 12 weeks Clinical lab values within protocol parameters Exclusion Criteria: Female patients pregnant or lactating Female patients of childbearing potential not using or not willing to use effective contraception Presence of a second malignancy other than nonmelanoma skin cancer Presence of a clinically significant and uncontrolled infection Presence of clinically significant arrythmias Presence of serious concurrent illness or other conditions that do not permit adequate follow-up and compliance with protocol History of severe hypersensitivity reactions to taxanes Use of any investigational agents within 4 weeks prior to the first dose of study drug

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: STA-4783|nan|
|Drug: Paclitaxel|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
-----------------
metastatic, increased antitumor effect