linjc16/ctgov huggingface dataset:
A Phase II Study of Anlotinib in MTC Patients

Study Overview
=================
Brief Summary
-----------------
Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The trial is to explore ALTN for the effectiveness of advanced medullary thyroid carcinoma and security.

Official Title
-----------------
Phase 2 Study of Anlotinib in Advanced Medullary Thyroid Carcinoma

Conditions
-----------------
Tumor

Intervention / Treatment
-----------------
* Drug: Anlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.late medullary thyroid carcinoma; 2.18-70years, ECOG:0-2,Expected survival period >3 months; 3.Calcitonic≥500pg/ml, thyroid function normal; 4.HB≥100g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT 80×109/L ,BIL/Cr in normal range,ALT/AST(aspartate aminotransferase )≤1.5*ULN(for hepatic metastases,ALT/AST(aspartate aminotransferase )≤5*ULN) ;TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF LLN. 5.Username contraceptive during the study and after 6 months; 6.Volunteer. Exclusion Criteria: 1.Received vascular endothelial growth inhibitor type of targeted therapy; 2.Subject was diagnosed with The second cancer; 3.Participated in other clinical trials in four weeks; 4.Received in other radiotherapy or chemotherapy treatment in four weeks; 5.With AE> 1; 6.Has influence of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis, or the brain/soft meningeal disease patient; 8.Any serious or failed to control the disease 9.Artery/venous thrombotic; 10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.History of psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history; 14.Concomitant diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Anlotinib<br> | Drug: Anlotinib<br> <br> * Other names: ALTN;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enhanced CT scan |  | each 42 days up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | each 21 days up to up to 48 months |
Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease

Study Overview
=================
Brief Summary
-----------------
Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good compliance and clinical response to gluten-free diet. These patients are usually premenopausal women in whom the cyclic menstrual bleeding and the oral iron intake are not balanced. The aim of the study is to compare the efficacy of a pharmacological therapy, frequently not tolerated, and a dietary approach through a iron-rich diet in this subset of patients.

Official Title
-----------------
Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease

Conditions
-----------------
Celiac Disease, Iron Deficiency (Without Anemia)

Intervention / Treatment
-----------------
* Drug: Iron sulfate 105 mg
* Dietary Supplement: Iron-rich diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Celiac patients on gluten free diet since 1 year iron deficiency (ferritin <15 ng/L or ferritin 15-20 + transferrin saturation <15%) Exclusion Criteria: allergy to iron supplementation anemia pregnancy or breastfeeding menopause organic or psychiatric diseases

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iron sulfate 105 mg<br>Iron sulfate 105 mg: 1 pill/day is administered | Drug: Iron sulfate 105 mg<br>* Daily supplementation with iron sulfate 105 mg 1 pill/day<br>|
| Experimental: Iron-rich diet<br>Iron-rich diet recommendations are given | Dietary Supplement: Iron-rich diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritin levels (ng/mL) increase > 95% compared to basal levels |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin levels (g/dL), compared to basal levels |  | 12 weeks | 
| Iron levels (mcd/dl), compared to basal levels |  | 12 weeks | 
| Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels |  | 12 weeks |
Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.

Official Title
-----------------
A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach

Conditions
-----------------
Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: HEALOS and Leopard Cage
* Device: Leopard Cage and Autograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistent back and/or leg pain refractory to 6 months of non-surgical therapy Male or female 18 to 70 years of age (inclusive) Objective evidence of significant disc degeneration at one or two adjacent lumbar level(s) from L2/L3 to L5/S1 Exclusion Criteria: Significant disc degeneration at more than two adjacent levels Greater than Grade II spondylolisthesis Prior fusion surgery of the lumbar spine (prior discectomies and intradiscal electrothermal therapy [IDET] are allowed) Insulin-dependent diabetes mellitus Pregnant or lactating, or wishes to become pregnant within the 24 month duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: HEALOS and Leopard Cage<br>* Placement in interbody space<br>|
| Active Comparator: 2<br> | Device: Leopard Cage and Autograft<br>* Placement in the interbody space<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled) | Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties). | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
One or Two Level Degenerative Disc Disease
Pre and Per-operative Electrophysiological Cartography of Speech Area With Cortical Electrode Matrices

Study Overview
=================
Brief Summary
-----------------
New method for speech area cartography in patient individual cortical anatomy in view of improving functional area limit preservation during surgery.

Conditions
-----------------
Tumoral or Epileptical Cortectomy

Intervention / Treatment
-----------------
* Device: ECoG and intracortical electrodes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients needing cortectomy Male or female aged over 18 years Registered in the French social security scheme Signed informed consent Exclusion Criteria: •All categories of protected persons

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: BRAINSPEAK<br>Electrocorticographical (ECoG) and intracortical electrodes | Device: ECoG and intracortical electrodes<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electrophysiological recording | Electrophysiological recording of brain Speech Area, using Cortical Electrode Matrices, in order to improve functional area limit preservation during surgery | 2 hours |
MRI Assessment of Patient Suitability for Cardiac Resynchronization Therapy (CRT)

Study Overview
=================
Brief Summary
-----------------
The goals of this project are to: 1) explore the potential use of magnetic resonance imaging (MRI) data for improved prediction of response to cardiac resynchronization (CRT), and 2) use the MRI-derived data together with a computer model of the cardiovascular system to study the relative roles of different factors in the mechanical effects of dyssynchrony in failure, and in the response (or lack thereof) to CRT.

Official Title
-----------------
MRI Assessment of Patient Suitability for Cardiac Resynchronization Therapy (CRT)

Conditions
-----------------
Cardiac Resynchronization Therapy, Magnetic Resonance Imaging (MRI)

Intervention / Treatment
-----------------
* Procedure: Cardiac MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients ages 18 and over scheduled by conventional criteria (symptomatic impairment of cardiac function with broadened QRS) for clinical CRT procedures at NYULMC. Normal kidney function as determined by GFR levels. Inclusion Criteria for Controls Normal kidney function as determined by GFR levels No significant cardiovascular disease or risk factors. Exclusion Criteria: electrical implants such as cardiac pacemakers or perfusion pumps ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing (which will be removed) pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.

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

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heart Failure Patients<br>patients who are scheduled to undergo clinically ordered CRT for heart failure complicated by dyssynchrony | Procedure: Cardiac MRI<br> <br> |
| Active Comparator: Control<br>20 matched control subjects | Procedure: Cardiac MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Derivation of score of patient suitability for CRT | Binary logistic regression and receiver operating characteristic curve (ROC) analyses will be used to assess the utility of baseline (pre-CRT) MRI-derived measures, alone and in combination, for the prediction of response to CRT. | 4 Years |
Fast Titration in the Treatment of Schizophrenia, Taiwan

Study Overview
=================
Brief Summary
-----------------
Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
Fast Titration of Quetiapine Versus Conventional Titration in the Treatment of Schizophrenia/Schizoaffective Disorder: a Randomised, Parallel Group Open Trial

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, at least 18 years old, inpatients with relapse Schizophrenia all subtypes, and with a CGI (Clinical Global Impression) score >=4. Exclusion Criteria: Pregnancy or breast-feeding, patients treated with Clozapine within 28 days of randomization, patients with a known arrhythmia, any psychotic disorders not defined in the inclusion 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the safety and tolerability of a fast titration of quetiapine to the current titration approved by the regulatory authorities. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
A Pharmacokinetic Evaluation Study in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.

Official Title
-----------------
Pilot Single-Dose Intravenous Pharmacokinetic Evaluation of INS37217 Solution in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: denufosol tetrasodium (INS37217)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: are nonsmokers or those subjects whom have not smoked within 6 months are within 20% of their ideal body weight are healthy on the basis of a pre-trial physical examination Exclusion Criteria: history or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening history of cardiac arrhythmias, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, Parkinsonism, or drug allergy use of concomitant medication other than hormonal contraceptives and multi-vitamins donation of blood in the 60 days preceding the screening visit have been diagnosed with HIV, hepatitis B or hepatitis C

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: denufosol tetrasodium (INS37217)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection and characterization of plasma concentrations of INS37217 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot study - not specified |  |  |
LC-MS/MS 25(OH)D Status in a Large Cohort

Study Overview
=================
Brief Summary
-----------------
The present study assessed serum 25(OH)D in a cohort of 74235 outpatients by liquid-chromatography-tandem-mass-spectrometry (LC-MS/MS). The investigators studied the distribution of serum 25(OH)D concentrations in males and females of different age groups, the prevalence of measurable amounts of 25(OH)D2 and seasonal variability.

Detailed Description
-----------------
Measurements were performed under routine circumstances. Samples were collected in serum tubes with clot-activator. As per routine procedure, samples were centrifuged upon arrival in the lab and stored at 4° C until measurement. 25(OH)D3 and 25(OH)D2 were quantitated separately. Results from subjects <18 years were excluded from the analysis. The study was approved by the local Ethics Committee.

Official Title
-----------------
LC-MS/MS Based 25(OH)D Status in a Large Central European Outpatient Cohort- Gender and Age Specific Differences

Conditions
-----------------
25(OH)D Measurement and 25(OH)D Deficiency

Intervention / Treatment
-----------------
* Diagnostic Test: 25(OH)D measurement, PTH measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years, outpatients; Exclusion Criteria: <18 years, inpatients;

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 |
| --- |
|Diagnostic Test: 25(OH)D measurement, PTH measurement|25(OH)D analyses by LC-MS/MS were performed as part of our routine clinical work with a commercial kit from Recipe (Munich, Germany) ; PTH was measured in lithium-heparin plasma using the PTH STAT assay from Roche Diagnostics (Mannheim, Germany) on a Cobas 8000 auto-analyzer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25(OH)D measurement | Describe the 25(OH)D status in South-Tyrol,a region in central Europe, by a rigorously controlled, NIST 972a aligned LC-MS/MS method. | 2015-2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
25(OH)D, PTH, mass spectrometry, data mining
Prospective Evaluation in Older Premature, Untreated Breast Milk and Milk Processed by the Breast-milk Bank

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution of the total content and plasma profile of essential fatty acids (EFA) in a population of premature infants.

Official Title
-----------------
Directed Donation of Untreated Milk or Milk Processed by the Breast-milk : Prospective Evaluation in Older Premature

Conditions
-----------------
Infant, Premature, Diseases, Fatty Acid Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent's written informed consent Gestational age less than 33 weeks of amenorrhea Hospitalisation in an NICU at the time of inclusion Intended enteral nutrition with breast milk Exclusion Criteria: Persons not covered by the French social security system Major congenital malformation Participation in other biomedical study protocols Babies that are likely to be transferred to another hospital during the study period

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 12 Hours

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| breast-milk bank<br>breast milk collected and processed by the breast-milk bank before being used | |
| breast milk<br>breast milk used without any treatment, directly by children | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the effects of the milk-treatment process at the milk bank on the composition of the milk in terms of FA | Level of total FA and composition of FA on samples of untreated breast milk immediately after the milk has been expressed Level of total FA and composition of FA on samples of breast milk provided by the milk bank just before being given to the infant | 3 weeks after the establishment of enteral nutrition | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast milk, breast-milk bank, plasma profile, essential fatty acids