linjc16/ctgov huggingface dataset:
A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of NT 201 injections in the treatment of enlarged pores and excessive sebum production in the face.

Detailed Description
-----------------
Eligible subjects will be randomized to one of the two treatment groups: NT 201 group and placebo in order to receive one session of injections with either NT 201 or placebo in the upper face (forehead and cheek area) on Day 1 and followed for about 90 days after treatment.

Official Title
-----------------
A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Exploratory Study to Investigate NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face

Conditions
-----------------
Enlarged Pores, Sebum Production

Intervention / Treatment
-----------------
* Drug: NT 201
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cheek pore size assessed as large by the investigator Oily skin on the forehead Exclusion Criteria: Treatment with Botulinum toxin (BoNT) of any serotype in the face within the last 12 months Facial cosmetic procedure (e.g., chemical peel, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, ultrasound treatment, tattooing of eyebrows) within the last 12 months Treatment with any dermal filler in the face within the last 12 months Any previous insertion of permanent material in the face, including permanent dermal fillers (e.g., silicone, polymethyl methacrylate) Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NT 201<br>Single NT 201 injection treatment. | Drug: NT 201<br>* Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl).<br>* Other names: Xeomeen;|
| Placebo Comparator: Placebo<br>Single placebo injection treatment. | Drug: Placebo<br>* Solution for injection prepared by reconstitution of powder with 0.9% NaCl.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 4 in Pore Volume in the Cheek Area | Antera 3D will be used as an assessment tool. | Baseline (Day 1), Week 4 | 
| Change from Baseline to Week 4 in Sebum Level in the Forehead Area | Sebumeter will be used as an assessment tool. | Baseline (Day 1), Week 4 |
IReC-Bio Protocol for The International Centre for Recurrent Head and Neck Cancer (IReC) Clinical and Biological Tissue Bank

Study Overview
=================
Brief Summary
-----------------
IReC is the world's first centre for recurrent head and neck cancers. We have the ambitious aim to create a centre of international excellence and set international standards in the curative treatment of recurrent head and neck cancers. One of IReC's key objectives is to develop a national research tissue bank to support laboratory and translational research. The cornerstone of translational research is a well-annotated biobank of cancer samples to explore and validate key research findings. The purpose of IReC-Bio is to support research into recurrent head and neck cancers. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes.

Official Title
-----------------
Protocol for The International Centre for Recurrent Head and Neck Cancer (IReC) Clinical and Biological Tissue Bank

Conditions
-----------------
Head Cancer Neck

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proven or suspected of recurrent cancers of the head and neck FFPE blocks(s) or fresh frozen tumour tissue available for collection Details of clinical follow-up available Two or more tumour-containing blocks available from the same specimen Exclusion Criteria: FFPE tumour samples contain insufficient tumour sample for analysis Insufficient clinical details available
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of a national research tissue bank | Development of a national research tissue bank - collection of samples collected from patients with H&N cancer to be used in future approved research. Outcome will be measured by collection of samples from eligible participants for use in future research. Samples collected will be stored within the Royal Marsden Biobank. | Up to 50 years |
Baduanjin Program Effect on Geriatric Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
functional dyspepsia is very common between geriatric population

Detailed Description
-----------------
Forty Egyptian geriatrics with functional dyspepsia, after randomization, will be divided to 2 groups; the first 20-geriatric group will receive 5-session per-week 40-minute baduinjuin for 8 weeks plus the daily dose of pantoprazole (40 mg orally administered tablet drug. in the other 20-geriatric group, the daily dose of drug will be administered only for 8 weeks .

Official Title
-----------------
Baduanjin Program Effect on Geriatric Functional Dyspepsia

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Behavioral: baduinjuin activities
* Other: pantoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: functional dyspepsia complaints geriatric population Exclusion Criteria: cardiac complaints respiratory complaints articular complaints

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>the 20-geriatric group will receive 5-session per-week 40-minute baduinjuin for 8 weeks plus the daily dose of pantoprazole (40 mg orally administered tablet drug) | Behavioral: baduinjuin activities<br>* in this 20-geriatric group will receive 5-session per-week 40-minute baduinjuin for 8 weeks plus the daily dose of pantoprazole (40 mg orally administered tablet drug)<br>|
| Other: group B<br>this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks . | Other: pantoprazole<br>* in this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cortisol | it is a serum stress marker | It will be measured after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression sub component of Hospital anxiety and depression scale | It will be measure depression | It will be measured after 8 weeks | 
| anxiety sub component of Hospital anxiety and depression scale | It will be measure anxiety | It will be measured after 8 weeks | 
| Glasgow dyspepsia severity score | It will be used to assess functional dyspepsia | It will be measured after 8 weeks | 
| visual analogue scale | It will be used to assess abdominal symptoms of geriatric patients regarding functional dyspepsia | It will be measured after 8 weeks |
FSHD Molecular Characterization

Study Overview
=================
Brief Summary
-----------------
To characterize the clinical and molecular phenotype of FSHD.

Detailed Description
-----------------
The purpose of this study is to validate alterations in therapeutically relevant biomarkers in muscle tissue from FSHD patients. These biomarkers are responsive to the upregulation of the DUX4 gene and protein, which is the fundamental molecular defect in FSHD. In anticipation of a future clinical trial, the Investigators intend to assess the correlation between the expression of these relevant biomarkers and clinical functional measures. The Investigators will also explore the utility of muscle MRI in identifying regions of muscle suitable for sampling for relevant biomarkers, as MRI-related signal changes have been proposed as an anatomic marker of early FSHD pathology.

Official Title
-----------------
Clinical and Molecular Characterization of Facioscapulohumeral Muscular Dystrophy (FSHD)

Conditions
-----------------
Facio-Scapulo-Humeral Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 13 years or older Genetically proven FSHD1 or FSHD2 as determined by the investigators Exclusion Criteria: Inability to complete an MRI scan (Adults only). Other medical or cognitive issues that, in the opinion of the examiner, preclude accurate functional assessment.

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- | --- |
| Validation of Biomarkers | To validate alterations in therapeutically relevant biomarkers in muscle tissue from FSHD participants. Each participant will provide data at a single timepoint. The data in totality will be reviewed upon study completion. | Through study completed, anticipated to be 4 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FSHD
Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Oro-antral Fistula

Study Overview
=================
Brief Summary
-----------------
Oroantral fistula (OAF) is a pathological communication between the oral cavity and the maxillary sinus. A variety of surgical techniques have been developed, with recurrence rates of up to 33%7, mainly due to wound contraction and postoperative infection. To increase the success rates of OAF closure procedures, the use of double-layered closure techniques has developed, but most of these techniques alter the original oral anatomy and may result in significant postoperative morbidity.

Official Title
-----------------
Double Layer of Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Large Oro-antral Fistula

Conditions
-----------------
Oro-Antral Communication

Intervention / Treatment
-----------------
* Procedure: Double layer of buccal myomucosal Flap and buccal pad of fat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Large Oro-antral Fistula Recent or previously failed closure of oro-antral Fistula Exclusion Criteria: Immuno-supressed patients fistulae smaller than 5 mm in size
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 large Oro-antral Fistula<br>closure of oro-antral fistula by myomucosal flap and buccal pad of fat | Procedure: Double layer of buccal myomucosal Flap and buccal pad of fat<br>* The buccal myomucosal flap will be harvested from cheek below stenson papilla and will be sutured over buccal pad of fat which will be sutured at palatal mucosa after complete curettage of infected fistulous tract.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing | The size of fistula will be clinically measured by digital caliper in centimeter for preoperative and postoperative for uneventful wound healing and disappearance of fistula . | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection | fluid level will be measured in cubic centimeter in computed tomography | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oro-Antral Fistula, Buccal pad of fat, Myomucosal Flap
A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.

Study Overview
=================
Brief Summary
-----------------
Orthopedic anaesthesia and acute postoperative pain management, two anesthesiology subspecialties,are getting more credit for reducing hospital stays, promoting functional recovery and improving patient satisfaction.

Official Title
-----------------
A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.

Conditions
-----------------
Bone Fracture

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -The study will include 100 adult patients (18 to 50 years old) with ASA physical status class I and class II undergoing orthopedic lower limb surgeries under itrathecal anathesia . Exclusion Criteria: Patient refusal. Drug abuse. Patient with neurological, psychiatric or neuromuscular disease. Chronic pain on medicine. Known allergy to the study medications. Patients e contraindications to intrathecal anesthesia .

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group D<br>(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg dexametomidine. | Drug: Dexmedetomidine<br>* (50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg Dexametomidine.<br>|
| Active Comparator: Group K<br>(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine. | Drug: Ketamine<br>* (50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery | comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery. | 1 year |
Clinical Study of 18F-FAPI-RGD PET/CT in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about 18F-FAPI-RGD PET/CT imaging in assessing rheumatoid arthritis disease activity. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

Detailed Description
-----------------
Patients with rheumatoid arthritis who met the 2010 American College of Rheumatology/European League against Rheumatism Rheumatoid arthritis classification criteria will be included. All patients will be assessed for disease activity and the clinical disease activity Index (cDAI) was calculated. Blood sedimentation rate and CRP assay results will be collected. All patients will undergo 18F-FAPI-RGD PET/CT examination. The correlation of cDAI, ESR and CRP levels with PET joint count and PET joint index as measured by 18F-FAPI-RGD PET/CT will be statistically analyzed.

Official Title
-----------------
Clinical Study of 18F-labeled Probes Targeting Fibroblast Activating Protein and Integrin avβ3 (FAPI-RGD) to Assess Disease Activity in Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria. Exclusion Criteria: A. Patients with malignant tumors and other rheumatic immune diseases; B. clinical and conventional radiographic inspection of materials; C. researchers think not suitable for other information to participate in this study.
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 |
| --- | --- | --- |
| Correlation between clinical indicators and PET/CT results | Correlation of clinical disease activity Index (cDAI), erythrocyte sedimentation rate (ESR), and CRP levels with 18F-FAPI-RGD PET/CT results | 1 month |
The Effect of Peripartum Magnesium Sulfate Use on the Occurrence of Postpartum Depression

Study Overview
=================
Brief Summary
-----------------
This is an observational study that will be conducted on pregnant women under vaginal delivery or cesarean section. The magnesium sulfate will be given to appropriate participants with a protocol that obstetrician are already using in our hospital. After delivery, participants are asked to answer sequential questionnaires to assess postpartum depression.

Official Title
-----------------
The Effect of Peripartum Magnesium Sulfate Use on the Occurrence of Postpartum Depression

Conditions
-----------------
Postpartum Depression

Intervention / Treatment
-----------------
* Drug: Magnesium sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who will do delivery. Gestational week >= 30 week Singleton Exclusion Criteria: History of depression

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 |
| --- | --- |
| Control<br>Control group with participants who do not get magnesium sulfate administration. | |
| Magnesium group<br>Intervention group with participants who get magnesium sulfate administration. | Drug: Magnesium sulfate<br>* Magnesium sulfate will be administered following a protocol that obstetricians already use in our hospital.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postpartum depression | depression diagnosis using K-EPDS(Korean version of Edinburgh Postnatal Depression Scale) on a scale of 7 to 30 points. | 6 week after discharge | 
| postpartum depression severity | depression severity using K-EPDS; mild (7 13 points), moderate (14 19 points), severe (20 30 points) | 6 week after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postpartum depression | depression diagnosis using K-EPDS(Korean version of Edinburgh Postnatal Depression Scale) on a scale of 7 to 30 points. | 2week after discharge | 
| postpartum depression severity | depression severity using K-EPDS; mild (7 13 points), moderate (14 19 points), severe (20 30 points) | 2 week after discharge |