linjc16/ctgov huggingface dataset:
Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)

Study Overview
=================
Brief Summary
-----------------
This is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks), run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24 weeks).

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: TCH346


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: clinical diagnosis of laboratory-supported probable, probable, or definite ALS; sporadic or familial ALS; ALS symptom onset for no more than 3 yrs at study entry; FVC equal to or more than 70%; patients who are either riluzole naive or patients who are receiving concomitant treatment with riluzole at a stable dose of riluzole (50 mg bid) at study start. Exclusion criteria: Known or suspected chronic infectious disease including HIV, hepatitis B, or hepatitis C. Clinically significant ECG abnormalities. Known hypersensitivity to study drug or related drugs (e.g. selegiline, MAO-A and B inhibitors, or tricyclic antidepressants). Patients treated with potent inhibitors of CYP1A2 or CYP3A4 (a list of such inhibitors will be provided to the investigator). Treatment with MAO-A and B inhibitors (including selegiline) within the past 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 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: TCH346|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of functional decline as defined by the ALS Functional Rating Scale-Revised |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time |  |  | 
| Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening) |  |  | 
| Neurocognitive evaluation in a subset of patients(every visit except screening) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALS, Lou Gehrig's disease
Effects of Oral Salmon Calcitonin in Human Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis

Detailed Description
-----------------
Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability. Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA. Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.

Official Title
-----------------
Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: oral salmon calcitonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: radiographic OA according to the criteria of the American College of Rheumatology; morning joint stiffness between 15 and 30 minutes; pain on weight bearing and motion reported greater than 40 mm on a 0-100 mm visual analogue scale; normal liver and kidney function tests; serum CRP levels < 10 mg/l Exclusion Criteria: previous or ongoing treatment with anti-resorptive drugs such as bisphosphonates, estrogen or raloxifene crystal deposition diseases known hereditary or congenital defects clinically significant hepatic, renal, cardiovascular, psychiatric, endocrine and/or hematological diseases intra-articular injections of either corticosteroids (previous 3 months) or hyaluronan (previous 6 months)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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: oral salmon calcitonin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lequesne's algofunctional index |  |  | 
| Biomarkers of joint metabolism |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lequesne's algo-functional score, Biomarkers of joint metabolism
Optimization and Clinical Study of Early Prediction Model for Neonatal Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about neonatal acute respiratory distress syndrome in describe participant population. The main question it aims to answer is: using perinatal factors to predict early neonatal acute respiratory distress syndrome and reduce its mortality. Participants' umbilical cord blood will be collected for testing, but will not receive any intervention.

Official Title
-----------------
Optimization and Clinical Study of Early Prediction Model for Neonatal Acute Respiratory Distress Syndrome

Conditions
-----------------
Neonatology

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A newborn born alive Exclusion Criteria: Stillborn newborn Respiratory distress syndrome(RDS), transient tachypnoea of the neonate (TTN), or congenital anomalies as a primary current acute respiratory condition Hereditary endocrine and metabolic diseases Incomplete records

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute

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 |
| --- | --- |
| Baseline characteristics of all patients<br> | Other: No intervention<br>* No intervention<br>|
| General characteristics of the patients.<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General characteristics of the patients |  | 2023.1-2025.12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal acute respiratory distress syndrome, Model of prediction, Perinatal factors
Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy

Study Overview
=================
Brief Summary
-----------------
To explore the correlation between gastric ultrasound evaluation and gastroscopic direct vision evaluation of gastric contents, so as to more accurately use gastric ultrasound to evaluate the gastric contents of patients undergoing painless electronic gastroscopy in the outpatient department, so as to develop an individual painless diagnosis and treatment strategy to reduce the risk of lung aspiration.

Official Title
-----------------
Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy

Conditions
-----------------
Ultrasound Evaluation of Gastric Contents

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18years Patients undergoing painless electronic gastroscopy. Voluntarily participate and sign informed consent. Exclusion Criteria: Patients undergoing general electronic gastroscopy. Patients who refused to undergo gastric ultrasound. Patients with postural difficulties during gastric ultrasonography. with fresh wounds or infections at the site of Gastric ultrasound Patients whose ultrsound image quality is too poor to properly display the relevant anatomical structures.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cross-sectional area of the antrum (CSA) | The maximum anteroposterior diameter (recorded as D1) and maximum craniocaudal diameter (recorded as D2) between the gastric antrum serosal surfaces were measured perpendicularly to each other.CSA(cm2) = (π × D1 × D2) / 4 | Before the painless electronic gastroscopy | 
| Predicted volume | Predicted volume calculated by CSA | Before the painless electronic gastroscopy | 
| Observed volume | All gastric fluid was thoroughly suctioned through an endoscope side port, measured to the nearest mL and recorded | Before the painless electronic gastroscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric ultrasound, gastric contents, painless electronic gastroscope
Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the effect of lidocaine patch on the shoulder pain score after end of surgery. The secondary purpose of this study is to investigate the effect of lidocaine patch on the total number of analgesic request on ward.

Official Title
-----------------
Ajou University School of Medicine

Conditions
-----------------
Gallbladder Diseases

Intervention / Treatment
-----------------
* Drug: Lidocaine patch and hypafix
* Drug: hypafix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic cholecystectomy under general anesthesia Exclusion Criteria: Infection, trauma, or bleeding on shoulder Allergy to lidocaine Chronic pain Renal dysfunction Liver dysfunction Seizure History of shoulder surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patch group<br>Lidocaine patch and Hypafix | Drug: Lidocaine patch and hypafix<br>* Appliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction<br>|
| Placebo Comparator: Control group<br>Just Hypafix | Drug: hypafix<br>* Appliance of hypafix on both shoulder tip after anesthetic induction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder pain score |  | Change from baseline shoulder pain score up to 24 hr after end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of analgesics request on ward |  | Up to postoperative day 3 |
Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

Study Overview
=================
Brief Summary
-----------------
Prior studies have suggested that topical furosemide may reduce the recurrence of sinonasal polyposis following sinus surgery. This project aims to further investigate that claim through a blinded randomized controlled clinical trial following patients who undergo functional sinus surgery for chronic rhinosinusitis with sinonasal polyposis by randomly assigning participants to receive topical furosemide versus placebo nasal spray for 2 months post operatively. Outcomes would be compared at 6 months through endoscopic grading scores using Lund Kennedy and Meltzer scores as well as Sino-Nasal Outcome Test (SNOT-22) scores to measure the rate and degree of recurrence and impact on symptoms in the treatment group versus placebo.

Official Title
-----------------
Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

Conditions
-----------------
Nasal Polyps

Intervention / Treatment
-----------------
* Drug: Furosemide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic rhinosinusitis and sinonasal polyposis who are candidates for functional endoscopic sinus surgery Exclusion Criteria: Hypersensitivity to furosemide or sulfonamides pregnancy history of tinnitus history of sensorineural hearing loss poorly controlled diabetes current diuretic therapy known electrolyte disorder currently taking aminoglycosides BUN and creatinine levels out of the normal range history of renal disease allergy to sulfonamides

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furosemide<br> | Drug: Furosemide<br>* furosemide<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp Recurrence | Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence. | 6 months | 
| Polyp Recurrence | Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence. | 6 months | 
| Polyp Recurrence | Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms. | 6 months |
Neonatal Brain Waves After Electrocoagulation

Study Overview
=================
Brief Summary
-----------------
Electrocoagulation effect of neonatal brain waves after cesarean section

Detailed Description
-----------------
Electrocoagulation is used for bleeding control on usual basis in cesarean sections and other surgical procedures . We are planning to test the effect of electrocoagulation unipolar on neonatal brain waves compared with neonates that were exposed to bipolar electrocoagulation .Bipolar electrocoagulation should have les of an effect because of it coagulates in a close ,closed electrical cycle .

Official Title
-----------------
Neonatal Brain Waves After Electrocoagulation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: term normal newborn after normal pregnancy after elective cesarean section Exclusion Criteria: any fetal or neonatal disease or condition that may affect brain waves

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 30 Days

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electrocoagulation,pregnancy,brian waves
Nation-wide Hepatitis C Virus (HCV) Registry in Taiwan

Study Overview
=================
Brief Summary
-----------------
To determine the treatment efficacy, safety and long-term outcomes of chronic hepatitis C patients receiving directly acting antivirals in Taiwan

Detailed Description
-----------------
The National Health Insurance Administration (NHIA) in Taiwan supports the use of antivirals against CHC. Recently, the introduction of directly acting antivirals (DAA) has markedly improved the treatment adherence, efficacy and safety issues in well-designed clinical trials. However, the real world community effectiveness and long-term benefits of DAA for HCV treatments remain to be determined. Since the NHIA in Taiwan has reimbursed the DAA in the treatment of chronic hepatitis C (CHC) patients in the near future, establishment of a well prospectively designed registry policy is demanded in the national level to explore the unmet needs of HCV control in Taiwan. The primary purpose of the study is to establish a nationwide registry of patients undergoing antiviral treatment with DAA regimens for CHC at both academic and community practices. Based on this database, the clinical gaps regarding to treatment guidelines and management of adverse events will be identified. The registry system will be established as a research network and provide sufficient high-quality clinical information for investigators in Taiwan.

Official Title
-----------------
Nation-wide Hepatitis C Virus (HCV) Registry in Taiwan

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Other: directly acting antivirals (DAAs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients who are treated with DAA and have willingness to participate in this registry. Exclusion Criteria: Chronic hepatitis C patients who are unwilling to participate in the study and do not provide written informed consent for participation.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: directly acting antivirals (DAAs)|Eligible subjects would be those CHC patients who receive approved DAA in the daily practice in Taiwan. No clinical developing medications will be allocated patients.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients who have successfully eradicated HCV by DAAs | To determine the treatment efficacy, defined as undetectable HCV RNA 12 weeks after end of therapy (sustained virological response 12 weeks after treatment, SVR12) of chronic hepatitis C patients receiving directly acting antivirals | 12 months |
Investigational Multi-purpose Contact Lens Care Solution.

Study Overview
=================
Brief Summary
-----------------
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.

Conditions
-----------------
Contact Lens Wear

Intervention / Treatment
-----------------
* Device: Vistakon Investigational Multi-Purpose Solution I
* Device: ReNu MultiPlus Multi-Purpose Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be an adapted contact lens wearer best corrected distance visual acuity must be 20/25 or better in each eye must be wearing their habitual lenses on a daily wear basis must be willing to refrain from swimming during the study Exclusion Criteria: any systemic diseases that may interfere with contact lens wear any clinically significant ocular disease any ocular infection use of certain medications any grade 2 or greater slit lamp findings any know sensitivity to marketed contact lens care solutions currently pregnant or lactating monovision corrected

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental multi-purpose solution<br>Multi-purpose contact lens care solution. | Device: Vistakon Investigational Multi-Purpose Solution I<br>* Multi-purpose contact lens care solution.<br>|
| Active Comparator: ReNu MultiPlus Multi-Purpose Solution<br>Multi-purpose contact lens care solution. | Device: ReNu MultiPlus Multi-Purpose Solution<br>* Multi-purpose contact lens care solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings | Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment. | 3 months | 
| Distance Visual Acuity (LogMAR) | Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported. | Up to 3 Months |