linjc16/ctgov huggingface dataset:
The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis

Detailed Description
-----------------
This is a double-blind and randomized study. Subjects are informed to consume the samples before meals in the morning every day. The clinical and radiological diagnosis of osteoarthritis of the knee is evaluated by the doctor. The blood samples and questionnaires are collected at every visit of the trial.

Official Title
-----------------
The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis

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

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: TCI633
* Drug: Type 2 collagen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Osteoarthritis patients with joint pain or discomfort (diagnosed by the physician for severe classification of the Kellgren-Lawrence Grade 1-3) Without heart, liver, kidney, endocrine and other major organic diseases (patient return) Exclusion criteria With heart, liver (GOT and GPT values are 3-fold higher than the standard maximum), kidney (estimated creatinine clearance less than 25 mL/min), endocrine and other major organic diseases (patient return) People with mental illness
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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Blank<br>|
| Experimental: TCI633<br>Testing product | Dietary Supplement: TCI633<br>* Probiotics<br>|
| Active Comparator: Type 2 collagen<br>Known drug for OA | Drug: Type 2 collagen<br>* Positive control group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KL Grade (evaluated by doctor) | Pain relief and functional improvement in osteoarthritis | Change from baseline at 6 months | 
| WOMAC™ Osteoarthritis Index | The questionnaire includes three-part: i) join pain (five questions); ii) joint stiffness (two questions); and, iii) physical functions of joints (seventeen questions). Each question is scored 0-4. Low to high WOMAC scores represent slight to severe OA symptoms. The lower scores mean a better outcome. | Change from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood C-terminal telopeptide of collagen type II (CTX-II) level | To measure the level of CTX-II in blood | Change from baseline at 6 months | 
| Blood C-reactive protein (CRP) level | To measure the level of CRP in blood | Change from baseline at 6 months |
Efficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy and safety of topical application of NP000888 ointment compared to vehicle in plaque and fingernail psoriasis subjects. Duration of administration: 24 weeks

Official Title
-----------------
Multi-center, Randomized, Vehicle-controlled, Investigator-blinded, Parallel Groups Study to Evaluate the Efficacy and Safety of NP000888 in Subjects With Plaque and Nail Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: NP000888
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with a clinical diagnosis of plaque psoriasis defined as an IGA score at least 2 (mild) at Screening and Baseline visits Subject with a plaque psoriasis total Body Surface Area (BSA) involvement of at least equal to 3% but less than 20% at Screening and Baseline visits Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a fingernail PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits Exclusion Criteria: Subject with guttata, erythrodermic, exfoliative, inverse, pustular or palmo plantar, infected or ulcerated psoriasis or psoriasis involvement >=20% BSA or an unstable form of psoriasis, defined as at least one flare in the previous month before Screening visit Subject with chronic plaque psoriasis who are candidates for systemic therapy at Screening and Baseline visits Subject with clinical signs of psoriatic arthritis at Screening and Baseline visits Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a nail-PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits.

Ages Eligible for Study
-----------------
Minimum 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NP000888<br>Pharmaceutical form: Ointment | Drug: NP000888<br>* 270 µg/g topical (BID) for 24 weeks<br>|
| Placebo Comparator: Vehicle<br>Pharmaceutical form: Ointment | Drug: Vehicle<br>* Topical (BID) for 24 weeks<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate in IGA score (clear or almost clear) | Success rate in IGA score (clear or almost clear) | Baseline - Week 12 | 
| Percent change from baseline in total mtNAPSI scores | Mean percent change from baseline in total mtNAPSI scores | Baseline - Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis
Impact of MK-0954A on Uric Acid in the Management of Hypertension (MK-0954A-366)

Study Overview
=================
Brief Summary
-----------------
This was a retrospective, chart review, observational study to assess the effect of MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period of at least three months on serum uric acid levels.

Official Title
-----------------
A Retrospective Survey to Evaluate the Impact of Hyzaar on Uric Acid in the Management of Hypertensive Patients in Normal Practice

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Participant was >20 years and <75 years of age on the index date (i.e., the date of initiating MK-0954A therapy) Diagnosed with hypertension and had received MK-0954A 50/12.5 mg for at least 3 months Had at least one serum uric acid measurements at baseline and one at 3 months after using MK-0954A 50/12.5 mg Had the following records documented in the chart during the data collection period: medical history and co-morbidities (if available) sitting blood pressure, serum uric acid, lipid profile test results before and after using MK-0954A 50/12.5 mg serum electrolytes, serum creatinine, and pre-meal sugar (if available) prescription information of all antihypertensive regimens Exclusion criteria: Had been treated with diuretic or angiotensin-receptor blockers (ARBs) 2 weeks before initiated treatment with MK-0954A 50/12.5 mg Serum creatinine >2 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| All Participants<br>Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Uric Acid (SUA) Level | SUA at baseline and Month 3. | Baseline and Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients With Hyperuricemia | Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males. | Baseline and Month 3 | 
| Diastolic Blood Pressure (DBP) | DBP at baseline and month 3. | Baseline and Month 3 | 
| Systolic Blood Pressure (SBP) | SBP at baseline and month 3. | Baseline and Month 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential hypertension Uric acid Retrospective Hyzaar
A Study of the Effect on Oro-dental Complications of Intensity Modulated Radiotherapy (IMRT) Versus Conventional Radiotherapy in Patients With Cancer of the Head or Neck

Study Overview
=================
Brief Summary
-----------------
Study to investigate the effect of two types of radiotherapy on saliva: IMRT versus conventional radiotherapy. In each group, one part will receive normal dental preventive treatment. The other part will use products for treatment of dry mouth (Biotene gamma). Both anorganic and organic components of the saliva will be studied at different time points, combined with bacterial swabs.

Official Title
-----------------
A Study of the Effect on Oro-dental Complications of Intensity Modulated Radiotherapy (IMRT) Versus Conventional Radiotherapy in Patients With Cancer of the Head or Neck

Conditions
-----------------
Cancer: Head or Neck

Intervention / Treatment
-----------------
* Procedure: IMRT versus conventional radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old Cancer of head or neck Exclusion 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT<br> | Procedure: IMRT versus conventional radiotherapy<br>* Comparing MRT versus conventional radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of saliva |  | Before, during (week 4) and after radiation (week 2, 3, 6 and 12) | 
| Quality of saliva |  | Before, during (week 4) and after radiation (week 2, 3, 6 and 12) | 
| Oral flora |  | Before, during (week 4) and after radiation (week 2, 3, 6 and 12) |
Postoperative Pain Control After Kidney Surgery : a Comparison of Intrathecal Morphine Plus PCA and PCA Only

Study Overview
=================
Brief Summary
-----------------
postoperative pain after kidney surgery is very high. We always use PCA for postopertive pain. But almost patients still had severe pain. We try to use spinal morphine before operation aims to reduce pain.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: spinal morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: kidney surgery who less than 60 years old. no underlying disease ASA less than 3 Exclusion Criteria: refuse spinal morphine history of morphine allery

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Drug: spinal morphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption in PCA |  | 48 hours | 
| side effect |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient who recieve kidney surgery and Patient controlled anesthesia with spinal morphine, intrathecal
Anosmia and / or Ageusia and Early Corticosteroid Use

Study Overview
=================
Brief Summary
-----------------
Time to recover of Anosmia and / or ageusia and early corticosteroid use

Detailed Description
-----------------
In a study of dexamethasone kinetics in two groups of 15 patients with community-acquired pneumonia, one group was treated with dexamethasone 6 mg/day by mouth and the other with 4 mg/day intravenously. The apparent volume of distribution was 1 L/kg in both groups, but the half-life after oral administration was approximately 7 hours, and after intravenous administration 9 hours. The bioavailability of oral dexamethasone was 81% (95% CI = 54-121%). However, the biological half-life of dexamethasone is much longer, of the order of 36-54 h compared with 18-36 h for prednisolone. Time to recover of Anosmia and / or ageusia and early corticosteroid use

Official Title
-----------------
Anosmia and / or Ageusia in COVID-19: Timeline, Treatment With Early Corticosteroid and Recovery

Conditions
-----------------
Covid19, Anosmia

Intervention / Treatment
-----------------
* Drug: Early-Dexamethasone
* Drug: Late dexamethazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any case with COVID-19 Age more than or equal to 18 years Mild to moderate severity Exclusion Criteria: Diabetes Any contra-indication for the interventional drug Mentally disabled cases

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early CS<br>early use of dexamethasone as early as the laboratory confirmation of inflammation. | Drug: Early-Dexamethasone<br>* early use of dexamethasone as early as laboratory evidence of high inflammatory markers<br>* Other names: Dexamethasone;|
| Active Comparator: Late CS<br>Dexamethasone is to be used lately upon the deterioration of cases | Drug: Late dexamethazone<br>* Use of dexamethasone on deterioration of the cases with increased severity<br>* Other names: Dexamethasone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery | Time to recovery from anosmia and / or agusia | one to 6 weeks |
The Effect of Obstructive Sleep Apnea on Medical Outcomes After Gastric Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea (OSA) is a syndrome characterized by repetitive episodes of airway obstruction during sleep, which result in low oxygen level in the blood and bad sleep quality. Both of these effects are implicated in medical, neurological and cognitive disorders in subjects with OSA. The purpose of this study is to examine how OSA affects medical and neurobehavioral outcomes after gastric bypass surgery for weight loss in morbidly obese patients.

Official Title
-----------------
The Effect of Obstructive Sleep Apnea on Medical and Neurobehavioral Outcomes After Gastric Bypass Surgery - An Exploratory Investigation

Conditions
-----------------
Obesity, Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Procedure: Neurocognitive Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for Laparoscopic roux-en-Y gastric bypass (RYGB) surgery Presence or absence of OSA confirmed by polysomnography Comprehension of spoken and written English Exclusion Criteria: Major psychiatric, neurological, or neuromuscular disorder History of untreated thyroid disease Known diabetes mellitus History of stroke with or without apparent neurological deficits Alcohol consumption which exceeds 2 drinks per day or drug abuse. Undergone a sleep study in the past

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Neurocognitive Testing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of preoperative OSA on the long term neurocognitive function after Roux-en-Y gastric bypass (RYGB) surgery for weight loss in morbidly obese patients |  | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of preoperative neurocognitive impairment on the long term neurocognitive function after RYGB |  | 1 year after surgery | 
| The effect of preoperative neurocognitive impairment on the weight loss function after RYGB and how this relates to the presence of OSA |  | 1 year after surgery |
Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis

Official Title
-----------------
A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase II/III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Active Ankylosing Spondylitis

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: SHR-1314
* Drug: SHR-1314
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs Exclusion Criteria: - pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br> | Drug: SHR-1314<br>* SHR-1314 high dose<br>|
| Experimental: Treatment group B<br> | Drug: SHR-1314<br>* SHR-1314 low-dose<br>|
| Placebo Comparator: Treatment group C<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks |  | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Responded for ASAS 20 Response at 32 Weeks |  | 32 Weeks | 
| Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks |  | 16 and 32 Weeks | 
| Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks |  | 16 and 32 Weeks | 
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks |  | 16 and 32 Weeks | 
| Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks |  | 16 and 32 Weeks |
Regulation of Immunological Cytokines by Qiliqiangxin Capsule in Dilated Cardiomyopathy Patients

Study Overview
=================
Brief Summary
-----------------
Purpose :Research into the impact of Qiliqiangxin capsule on IFN-γ，IL-4，NT-proBNP in dilated cardiomyopathy patients with heart failure. Methods :Data were collected from the patients with idiopathic dilated cardiomyopathy ( cardiac function NYHA Ⅱ-Ⅳ) in the first affiliated hospital of Harbin Medical University from May 2012 to April 2014. These 30 cases were treated under the recommendations of normal diagnosis and treatment in cardiomyopathy. This experiment was randomized double-blinded，the experimental interferences were avoided and patients were divided into the experimental group and the placebo group. The patients in experimental group received the relevant tests and inspections before the beginning of experiment，signed the informed consent. Then the investigators get the venous blood centrifugalization and cryopreservation. The patients take the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，the investigators evaluated the symptoms，the function of heart，blood pressure，heart rate and keep blood specimens. Three and six month later，electrocardiogram and echocardiography were taken and the determination of the NT - proBNP was done. The placebo group was followed up in the same way.

Official Title
-----------------
Regulation of Immunological Cytokines by Qiliqiangxin Capsule in Dilated Cardiomyopathy patients--a Randomized Double Blind Clinical Trial

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: Qiliqiangxin Capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congetive heart failure Exclusion Criteria: Valvular heart 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the experimental group<br>The patients in experimental group received the relevant tests and inspections before the beginning of experiment，signed the informed consent. Then we get the venous blood centrifugalization and cryopreservation. The patients take the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，we evaluated the symptoms，the function of heart，blood pressure，heart rate and keep blood specimens. Three and six month later，electrocardiogram and echocardiography were taken and the determination of the NT - proBNP was done. | Drug: Qiliqiangxin Capsule<br> <br> |
| the placebo group<br>The placebo group was followed up in the same way. | Drug: Qiliqiangxin Capsule<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine level at 3 months |  | 3 months |