linjc16/ctgov huggingface dataset:
Study on the Rehabilitation Treatment of Knee Osteoarthritis Based on ICF

Study Overview
=================
Brief Summary
-----------------
To solve the existing Knee osteoarthritis;KOA) clinical norms and guidelines have low operability, Disconnection between treatment plan and specific evaluation results, difficulty in achieving individualized intervention and other problems, on the one hand, we need to develop Chinese expert consensus or clinical path based on evidence-based medicine to adapt to China's national conditions, on the other hand, is more important in The KOA clinical process introduces a set of tools to translate evidence-based medicine evidence into specific, actionable treatments, Thus, a more flexible, more comprehensive and three-dimensional, adaptable, targeted, more conducive to the promotion of the individual integration KOA rehabilitation intervention program.

Official Title
-----------------
Study on the Rehabilitation Treatment of Knee Osteoarthritis Based on ICF

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Diagnostic Test: ICF core set


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neither knee had undergone knee replacement, and no knee replacement had been performed in recent half a year planning to have a knee replacement; Volunteered to participate in the study and signed the informed consent. Exclusion Criteria: People with consciousness disorder, cognitive disorder, severe mental illness, unable to accurately express their own will, or unable to cooperate with the completion of various assessments and treatment

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 |
| --- | --- |
| ICF<br> | Diagnostic Test: ICF core set<br>* KOA rehabilitation regimen based on the complete core combination of ICF was accepted<br>|
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment compliance | treatment compliance of rehabilitation treatment | 1month | 
| treatment compliance | treatment compliance of rehabilitation treatment | 3month | 
| treatment compliance | treatment compliance of rehabilitation treatment | 6month |
Donating Oral Mucosal Cells for the Study of ex Vivo Culture of Cells Sheets

Study Overview
=================
Brief Summary
-----------------
Cultivated oral mucosal epithelial sheets on amniotic membrane have been reported to have good clinical results in treating patients with ocular surface disorders in both human and animal studies. However, such technique has not been well established in this hospital. The main purpose of this study is to obtain the discarded oral mucosal tissue from healthy donors who volunteer to donate their oral mucosa from buccal area. The obtained oral mucosal tissue will be cultured under different types (co-culture with or without 3T3 cells)。Inverted light microscopy, electron microscopy and immunostaining with K3/K12, K14, Ki67, P63, connexin 43, and involucrin will be preformed to test the effects of foreskin cell line co-culture system on cell condition. The investigators plan to start the study from Jan. 1st, 2011 to Dec. 31th, 2015. Thirty patients will be enrolled.

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

Intervention / Treatment
-----------------
* Procedure: Donating oral mucosal cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age 20 to 55 year-old healthy contributor. does not have disease of the oral cavity. Exclusion Criteria: In the past had the oral mucosa disease, wound cicatrization bad, or hemoglutination condition not good medical history. Sickness must stop using above any anti-hemoglutination medicine one week.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health people.<br> | Procedure: Donating oral mucosal cells<br>* Donating oral mucosal cells<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
-----------------
obtain the oral mucosal tissue from healthy donors
Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the efficacy of the regimen in patients with relapsed ALL.

Detailed Description
-----------------
Patients will receive standard dose CLAG-M (cladribine, cytarabine, mitoxantrone, filgrastim). Standard support care will be given. Efficacy will be assessed through bone marrow examinations and blood tests.

Official Title
-----------------
Phase II Trial of CLAG-M in Relapsed ALL

Conditions
-----------------
Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitts Leukemia/Lymphoma, Chronic Myelogenous Leukemia

Intervention / Treatment
-----------------
* Drug: CLAG-M
* Drug: CLAG-M


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory acute lymphoblastic leukemia, Burkitts leukemia/lymphoma, Lymphoid blastic CML, Lymphoblastic lymphoma.
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: CLAG-M<br> | Drug: CLAG-M<br>* IV times 5 days<br>* Other names: Novantrone;Drug: CLAG-M<br>* Chemotherapy<br>* Other names: Mitoxantrone (Novantrone);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission percentage |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 2 years |
Clofarabine in Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias. Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less toxic than similar drugs.

Detailed Description
-----------------
The first group of patients will be treated at the starting dose level of 2 mg/m2 over 1 hour daily for 5 days. Dosage escalation will be permitted in individual patients if no toxicity occurred during the preceding course. Subsequent dose escalations will be by 50% until Grade 2 toxicity, then by 35% until the maximum tolerated dose. Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies

Conditions
-----------------
Hematologic Neoplasms, Lymphoproliferative Disorders, Leukemia, Leukemia, Lymphocytic, Chronic

Intervention / Treatment
-----------------
* Drug: Clofarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of chronic lymphocytic leukemia Diagnosis of other acute leukemia At least 2 weeks since prior chemotherapy, immunotherapy, and/or radiotherapy Recovered from toxic effects of prior therapy Bilirubin no greater than 2 mg/dL Creatinine no greater than 1.5 mg/dL Exclusion criteria: Candidate for treatment of higher efficacy or priority Pregnant or nursing

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clofarabine|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
-----------------
Acute Leukemia, Chronic Lymphocytic Leukemia, Antineoplastic Agents, Nucleosides, Dose-Response Relationship, Drug, Cladribine, Fludarabine
AAV Gene Therapy Study for Subjects With PKU

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1/2, open-label, dose escalation study to evaluate the safety, efficacy and tolerability of BMN 307 in adult PKU subjects with PAH deficiency. Participants will receive a single administration of BMN 307 and will be followed for safety and efficacy.

Official Title
-----------------
A Phase 1/2 Open-Label, Dose Escalation Study to Determine the Safety and Efficacy of BMN 307, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Phenylalanine Hydroxylase in Subjects With Phenylketonuria

Conditions
-----------------
Phenylketonuria (PKU)

Intervention / Treatment
-----------------
* Drug: BMN 307


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with diagnosis of PKU which is a condition characterized by PAH deficiency Ability and willingness to maintain dietary protein intake consistent with baseline intake Willingness to abstain from hepatotoxic substances post-BMN 307 administration Willingness and capable per investigator opinion to comply with study procedures and requirements Willingness to use effective methods of contraception Plasma Phe levels > 600 µmol/L Exclusion Criteria: Subjects with primary BH4 deficiency or other forms of BH4 metabolism deficiency Clinically significant liver dysfunction or disease Prior treatment with gene therapy Any condition that, in the opinion of the investigator or Sponsor, would prevent the subject from fully complying with the requirements of the study History of malignancy

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 of BMN 307<br> | Drug: BMN 307<br>* AAV Gene Therapy Infusion<br>|
| Experimental: Dose 2 of BMN 307<br> | Drug: BMN 307<br>* AAV Gene Therapy Infusion<br>|
| Experimental: Dose 3 of BMN 307<br> | Drug: BMN 307<br>* AAV Gene Therapy Infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean Plasma Phe levels |  | baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean Plasma Phe levels |  | baseline, week 96 | 
| Change from baseline in dietary protein intake from intact food |  | baseline, week 96 | 
| Number of participants with treatment-emergent adverse event |  | At 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PKU, PAH Deficiency
Bone Flap Fixation Systems For Craniotomy Procedures

Study Overview
=================
Brief Summary
-----------------
Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.

Official Title
-----------------
Bone Flap Fixation Systems For Craniotomy Procedures

Conditions
-----------------
Craniotomy

Intervention / Treatment
-----------------
* Device: Clamp-like system
* Device: Plates and screws


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is 18 years or older. The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use. At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed. Life expectancy higher than 6 months. The subject is willing to give his/her informed consent and to comply with the required follow-up. Exclusion Criteria: The subject presents any of the contraindications of the assigned craniotomy closure system. Orbitozygomatic or mastoid craniotomies. Posterior fossa (skull base) surgeries. Combined used of craniotomy systems (plates and clamps). The subject is currently participating in an investigational drug or device study.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clamp-like system<br> | Device: Clamp-like system<br>* Craniotomy closure<br>* Other names: Cranial LOOP;|
| Active Comparator: Plates and screws<br> | Device: Plates and screws<br>* Craniotomy closure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone flap alignment score | 1-4 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse effects and device deficiencies (device safety) | Frequency and type of Device related Adverse effects (AE and SAE) and device deficiencies | 6 months | 
| Bone-flap alignment score | 1-4 | 0-7 days after surgery (before discharge) | 
| Surgeon usability questionnaire | Likert scale [1-7], where 1 is very difficult and 7 very easy | 0 days after surgery | 
| Device related artefacts in neuroimaging | frequency | 6 months | 
| Device-related bulges or visible offsets | frequency | 6 months | 
| Post-craniotomy headache | Incidence | 6 months |
Transcranial Doppler in Mild and Moderate Traumatic Brain Injury (TBI)

Study Overview
=================
Brief Summary
-----------------
Utility of transcranial Doppler as an Early Predictor of Neurological deterioration in Mild and Moderate Traumatic Brain Injury

Detailed Description
-----------------
Transcranial Doppler done to TBI patients on admission and follow up was done and Secondary Neurological deterioration was documented

Official Title
-----------------
Transcranial Doppler as an Early Predictor of Neurological Outcome in Mild and Moderate Traumatic Brain Injury

Conditions
-----------------
Trauma, Brain

Intervention / Treatment
-----------------
* Diagnostic Test: Transcranial Doppler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with traumatic brain injury and glasgow coma scale 9_15 Exclusion Criteria: Unstable or patient on Mechanical ventilation, Sever brain injury , patient receive anticoagulant

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 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 |
| --- | --- |
| (glasgow coma scale) 9 _15<br>No Secondary Neurological deterioration | Diagnostic Test: Transcranial Doppler<br>* Transcranial Doppler on middle cerebral arteries<br>* Other names: CT of the brain;|
| (glasgow coma scale) 9_15<br>Secondary Neurological deterioration | Diagnostic Test: Transcranial Doppler<br>* Transcranial Doppler on middle cerebral arteries<br>* Other names: CT of the brain;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Neurological deterioration | Decrease in glasgow coma scale and /or deterioration need to surgical intervention | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trans , cranial, TBI
Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Study Overview
=================
Brief Summary
-----------------
This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.

Official Title
-----------------
A Pilot, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Conditions
-----------------
Systemic Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Drug: rilonacept (IL-1 Trap)
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria include, but are not limited to, the following: Patients aged 4 to less than 21 years who meet the criteria for active SJIA Must have been on a stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks prior to the screening visit Exclusion Criteria include, but are not limited to, the following: Use of certain medications prior to the baseline visit History of recurrent infections

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Dose 1 | Drug: rilonacept (IL-1 Trap)<br> <br> Other: Placebo<br> <br> |
| Experimental: Cohort 2<br>Dose 2 | Drug: rilonacept (IL-1 Trap)<br> <br> Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of treatment emergent adverse events (TEAEs) |  | Baseline to Week 123 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SJIA
An Analysis of Dental Treatments Rendered by Undergraduates at Ajman University to Patients From Fujairah, Uae

Study Overview
=================
Brief Summary
-----------------
A total of 650 dental records were selected from 6000 dental records of patients who had received dental treatment in the Dental Clinic, College of Dentistry, Ajman University(AU)-Fujairah Campus, between academic year,2015/2016 and 2016/2017

Detailed Description
-----------------
A total of 650 dental records was randomly selected from 6000 dental records of patients who had received dental treatment in the Dental Clinic, College of Dentistry, Ajman Universi-ty(AU),Fujairah Campus, between the academic years 2015/2016 and 2016/2017. The size of study sample was determined using, Cochran' formula at 95% confidence. Using the random table generated by Microsoft Excel, the records for 650 patients were then randomly selected. After all the dental records to be included in this study were chosen and retrieved from the achieves. The following types of dental treatments: Composite restorations, amalgam restorations, glass ionomer restorations, fixed prosthetic treatments, removable prosthetic treatment, endodontic treatments, extractions treatments, fluoride treatments, fissure sealants treatment, pulp therapy treatments and stainless steel crowns treatments were extracted from the patient's dental records, coded and recorded in Microsoft excel sheet.

Official Title
-----------------
Dental Treatments Analysis Rendered by Undergraduates at Ajman University, Fujairah, Uae

Conditions
-----------------
Treatment

Intervention / Treatment
-----------------
* Other: retrospective


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dental treatment performed in the time frame Exclusion Criteria: Dental treatment not performed
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: retrospective|Retrospective study to assess treatment done by dental students|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of student performed dental treatment | Previous Dental case records used as measurement | From baseline to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
students, dental treatment, gender, age