linjc16/ctgov huggingface dataset:
A Gene Transfer Study for Late-Onset Pompe Disease (RESOLUTE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT). Participants will be treated in sequential, dose-level cohorts.

Official Title
-----------------
Phase 1/2, Dose-escalation Study to Evaluate the Safety, Tolerability and Efficacy of a Single Intravenous Infusion of SPK-3006 in Adults With Late-onset Pompe Disease

Conditions
-----------------
Pompe Disease, Pompe Disease (Late-onset), Glycogen Storage Disease Type 2, Glycogen Storage Disease Type II, LOPD, Lysosomal Storage Diseases, Acid Maltase Deficiency

Intervention / Treatment
-----------------
* Genetic: SPK-3006


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent; Males and Females ≥18 years of age with late-onset Pompe disease; Received ERT for at least the previous 24 months Have clinically moderate, late-onset Pompe disease characteristics; Agree to use reliable contraception. Exclusion Criteria: Active hepatitis B and/or C; Significant underlying liver disease; Human immunodeficiency virus (HIV) infection; Prior hypersensitivity to rhGAA; Pre-existing anti-AAV neutralizing antibody titers; High titer antibody responses to rhGAA; Requires any invasive ventilation or requires noninvasive ventilation while awake and upright; Received any prior vector or gene transfer agent; Active malignancy (except non-melanoma skin cancer); History of liver cancer; Pregnant or nursing women; Any evidence of active infection at the time of SPK-3006 infusion.

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPK-3006<br>All participants who meet the eligibility criteria will receive a single intravenous (i.v.) administration of SPK-3006. | Genetic: SPK-3006<br>* adeno-associated viral (AAV) vector<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse and serious adverse events (AEs/SAEs), including clinically significant abnormal laboratory values. | Adverse events. | Up to 5 years | 
| Occurrence of immune response against AAV capsid |  | Up to 5 years | 
| Occurrence of immune response against GAA transgene |  | Up to 5 years |
Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly controlled Type 2 diabetes patients. This study is designed to understand the pharmacological effects and genetic variation of incretin based therapy on type 2 diabetes.

Detailed Description
-----------------
Background: Since GLP-1 receptor is encoded by GLP1R ( glucagon-like peptide-1 receptor) gene, individuals may veritably respond to incretion based treatment, depending on the presence or absence of minor alleles characterized by single nucleotide polymorphisms. The genotyping of patients will be performed to compare the genetic factors and the pharmacological effects. Expected Results: How to select a anti-diabetic drug tailored to the individual becomes more and more important because the enormously increasing classes of treatment modality. This study could be of great help in recommending the best possible agent for an individual, improving the possibility of treatment success, and justifying if the need of expensive drugs in a given patient.

Official Title
-----------------
Clinical and Genetic Variations Study of Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients

Conditions
-----------------
Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: i) Age > 20 years old ii)DM (diabetes mellitus) diagnosed > 2 years iii)HbA1c level of 8% to 12% iv) Receiving incretin based therapy at least one month (including either GLP-1 agonist or DPP(dipeptidyl peptidase)-IV inhibitor Exclusion Criteria: Type 1 Diabetes Mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| mean amplitude of glycaemic excursions (MAGE) |  | 3 months |
The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the effect of a dental water jet on initial peri-implant disease resolution.

Detailed Description
-----------------
Peri-implant disease is becoming more frequent during the last decade. Till today, there is no effective evidence-based treatment. The use of water-jet might improve those situations and reduce morbidity and implant loss.

Official Title
-----------------
The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease

Conditions
-----------------
Peri-implantitis

Intervention / Treatment
-----------------
* Device: Water jet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated Informed Consent Form. Patient suffer from peri- implant disease Age Eligible for study: 18 year old and older Genders Eligible for study: Both Exclusion Criteria: Patient substantially fails to comply with the study schedule, or treatment program as described in this Protocol.

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: water-Jet<br>use of water jet for 1 month | Device: Water jet<br>* use of water jet for a month<br>* Other names: silonit water jet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Probing depth around the implant | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing | Bleeding on probing (BOP) around the implant | one month |
24-Week Open Label Extension to a Randomized, 6-Week Double Blind, Placebo Controlled Study, to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this open-label study was to evaluate the safety and tolerability of flexible doses of Extended Release OROS® Paliperidone in the treatment of geriatric subjects with schizophrenia after completion of the initial double blind study

Detailed Description
-----------------
The primary objective of the open-label extension phase was the long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia, and the secondary objective was the assessment of long-term efficacy. Paliperidone ER OROS® tablet formulation (3 to 12 mg/day) to be taken orally

Official Title
-----------------
R076477-SCH-702: a 24 Week Open-Label Extension to R076477-SCH-302

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

Intervention / Treatment
-----------------
* Drug: Paliperidone ER OROS®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, and who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open label phase Exclusion Criteria: Significant and/or unstable systemic illnesses Allergy or hypersensitivity to risperidone or paliperidone Significant risk of suicidal or violent behavior Biochemistry, hematology, or urinalysis results that are not within the laboratory's reference range, and that are deemed by the investigator to be clinically significant

Ages Eligible for Study
-----------------
Minimum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paliperidone ER OROS®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of long-term efficacy of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia, . |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia: paliperidone
Retinopathy of Prematurity:Summary of a Decade

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity screening.

Conditions
-----------------
Retinopathy of Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates either with a BW of less than 1501 gram (g) or born at a GA of 34 weeks (wk) or less selected infants with an unstable clinical course were included
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| neonates with retinopathy of prematurity<br>all neonates meet the criteria: a BW of less than 1501 gram (g) born at a GA of 34 weeks (wk) or less and selected infants with an unstable clinical course were included | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of neonates developed retinopathy of prematurity |  | ten years | 
| risk factors contributing to ROP development | mechanic ventilation. oxygen therapy, respiratory distress syndrome, sepsis, intraventricular, hemorrhage, blood transfusion v.s | ten years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incidence, neonatal care, retinopathy of prematurity, risk factors
Assessment of Eyelid Topology and Kinetics Based on Deep Learning Method

Study Overview
=================
Brief Summary
-----------------
This study plans to assess eyelid topology (such as margin reflex distance, eyelid contour, and corneal exposure area) and blinking (such as frequency, velocity, and duration), using deep learning method to automatically extract eyelid topological features, and to predict subtypes of levator function, using deep learning method to extract blinking features, in order to provide new ideas and means to assess eyelid topology and kinetics.

Official Title
-----------------
Department of Ophthalmology

Conditions
-----------------
Eyelid Diseases

Intervention / Treatment
-----------------
* Other: Photography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal volunteers without eyelid diseases patients with blepharoptosis patients with blepharospasm patients with dry eye disease patients with Graves' disease Exclusion Criteria: variable ptosis (e.g., myasthenia gravis), entropion, ectropion, enophthalmos, exophthalmos, strabismus, and abnormalities of pupil
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 |
| --- | --- |
| Normal participants<br> | Other: Photography<br>* Facial photographs and blinking videos are taken<br>|
| Patients with blepharoptosis<br> | Other: Photography<br>* Facial photographs and blinking videos are taken<br>|
| Patients with blepharospasm<br> | Other: Photography<br>* Facial photographs and blinking videos are taken<br>|
| Patients with dry eye disease<br> | Other: Photography<br>* Facial photographs and blinking videos are taken<br>|
| Patients with Graves' disease<br> | Other: Photography<br>* Facial photographs and blinking videos are taken<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one-dimensional parameters of eyelid topology | Palpebral fissure length [Margin reflex distance 1, Margin reflex distance 2], Lid length [Upper lid length, Lower lid length], Multiple mid-pupil lid distances | through study completion, 5 years | 
| two-dimensional parameters of eyelid topology | Palpebral fissure area [Medial area, Corneal area, Lateral area] | through study completion, 5 years | 
| subtypes of levator function | Levator function is classified into three categories: good, fair and poor | through study completion, 5 years |
SENTINEL LYMPH NODE BIOPSY AFTER NEOADJUVANT CHEMOTHERAPY

Study Overview
=================
Brief Summary
-----------------
Omitting axilary lymph node dissection (ALND) following SLNB with residual cancer in patients with locally advanced disease after neoadjuvan chemotherapy (NAC) is still controversial. In this study, the investigators evaluated factors affecting local recurrence and outcome in patients with locally advanced breast cancer (LABC), who underwent sentinel lymph node (SLN) with or without ALND after NAC.

Detailed Description
-----------------
All patients with clinically positive axilla will undergo neoadjuvant chemotherapy. Axillary fine needle aspiration biopsy or Trucut biopsy is mandatory. All patients with clinically node negativity (physical exam, USG, and/or MRI, PET-CT) after Neoadjuvant Chemotherapy (NAC) will be considered for SLNB with any technique (blue dye alone, radionuclide alone or both combined) and any breast surgery (mastectomy or breast conservation). PET-CT and MRI are not mandatory. PE and USG and/or MRI are preferred. At least, 2 sentinel lymph nodes will be obtained. Intraoperative evaluation of SLNs is recommended. All patients with clinally-negative axilla and underwent SLNB will be included into the study: SLNB (-) & RT SLNB (+) & RT SLNB (+) & ALND & RT Radiotherapy details will be announced as supplementary

Official Title
-----------------
IS SENTINEL LYMPH NODE BIOPSY WITH RADIOTHERAPY ALONE WITHOUT AXILLARY LYMPH NODE DISSECTION SAFE FOLLOWING NEOADJUVANT CHEMOTHERAPY IN INITIALLY CLINICALLY AXILLA POSITIVE PATIENTS: NEOSENTITURK-TRIAL/MF-18-03

Conditions
-----------------
Sentinel Lymph Node

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T0-4, N1-3, M0 Exclusion Criteria: Inflammatory breast cancer, pregnant patients Patients with metastatic disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SLNB (-)&level 1-3 RT<br>SLNB (-)&level 1-3 RT | |
| SLNB (+)&level 1-3 RT<br>SLNB (+)&level 1-3 RT | |
| SLNB(+)&ALND&level 3 RT (+/-level 1-2)<br>SLNB(+)&ALND&level 3 RT (+/-level 1-2) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence free survival | Breast and axillary recurrence rates | January 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Local recurrence and distant metastasis rates | January 2023 | 
| Overall survival | Overall survival | January 2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sentinel lymph node biopsy, Neoadjuvan chemotherapy
Effects of Gait Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of robot-assisted gait training on active walking in the patients with stroke.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: Robot-assisted gait training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1st-ever-stroke hemiplegic patient after stroke who can stand independently, but cannot walk more than 10 meters independently whose muscle powers of hip and knee are more than poor on manual muscle test Exclusion Criteria: previous gait difficulty before stroke onset arthralgia on lower extremity uncontrolled hypertension or hypotension severe medical illness

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Robot-assisted gait training|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
-----------------
Robot, Gait, Stroke
Revisiting Omental Transposition in Locally Advance and Locally Recurrent Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Locally advance breast cancer and extensive locoregional recurrence are still considered as complexity of reconstruction. Although previous studies concluded that omental transposition was considerably indicated in poor vascularity in irradiated tissue, secondary infection and large defect become the obstacles of local tissue flaps. While some centres showed the excellent healing of omental transposition. Meanwhile, many studies showed the preferable outcome in escalating radiotherapy in term of locoregional control. In the investigators' institute, omental transposition in breast cancer has been developed for twenty years. The only institute in Thailand enhanced using this procedure in order to closure of large primary breast cancer and chest wall recurrence. This procedure is undertaken by single surgeon (Dr. K.J.). The investigators' protocol of omental transposition is including preoperative chemotherapy, preoperative accelerated radiation up to 80 Gy, approval of breast cancer centre committee, and meticulous wound care including vacuum assisted wound dressing, non-adhesive dressing. As a result, survival time could be improved.

Official Title
-----------------
Revisiting Omental Transposition in Locally Advance and Locally Recurrent Breast Cancer

Conditions
-----------------
Survival Rate

Intervention / Treatment
-----------------
* Procedure: Omental transposition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with omental transposition operation within King Chulalongkorn Memorial Hospital More than 18 years of age Exclusion Criteria: The patients with refusal

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Curative group<br>Locally advance breast cancer and locally recurrent breast cancer without metastasis underwent omental transposition | Procedure: Omental transposition<br>* Harvesting the omentum to cover irradiated defects of breast cancer<br>* Other names: Omental graft;|
| Palliative group<br>Locally advance breast cancer and locally recurrent breast cancer with metastasis underwent omental transposition | Procedure: Omental transposition<br>* Harvesting the omentum to cover irradiated defects of breast cancer<br>* Other names: Omental graft;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time |  | 22 years |