linjc16/ctgov huggingface dataset:
Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis

Study Overview
=================
Brief Summary
-----------------
General Objective : To evaluate the outcome of non surgical periodontal therapy with local drug delivery adjunct to scaling and root planning Specific Objective : To determine the effect of intra-pocket application of hyaluronic acid /chlorohexidine gel in non surgical periodontal treatment on clinical periodontal parameters and microbiological level .

Official Title
-----------------
Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis: A Split Mouth Randomized Controlled Trial

Conditions
-----------------
Periodontitis, Hyaluronic Acid, Chlorhexidine

Intervention / Treatment
-----------------
* Procedure: Non surgical periodontal therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : 20-60 years old At least 20 remaining teeth Periodontitis stage III and IV ,Grade A, B and C Exclusion Criteria: Patients taking specific medications: antibiotic , anticoagulants or anti-inflammatory Previous periodontal therapy in the past 3-6 months. Immunocompromised patients Systemically diseased patients: Diabetes ,osteoporosis etc History of allergies or hypersensitivity reactions to chlorohexidine or Hyaluronic acid Pregnant or lactating women. Heavy Smokers (more than 20/day)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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
Interventional Model Description: Split mouth RCT
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>NS therapy + Chlorhexidine/Hyaluronic acid subgingival gel application | Procedure: Non surgical periodontal therapy<br>* Subgingival ultrasonic debridement + manual root planning<br>|
| Placebo Comparator: Control<br>NS therapy + Placebo gel subgingival application | Procedure: Non surgical periodontal therapy<br>* Subgingival ultrasonic debridement + manual root planning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pocket depth |  | 2 months | 
| Bleeding on Probing |  | 2 months | 
| Clinical attachment level |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index |  | 2 months |
Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone

Study Overview
=================
Brief Summary
-----------------
Extracorporeal shock wave lithotripsy (ESWL) of pancreatic stones has been described as an effective approach for stone drainage and pain relief, and general or epidural anesthesia has been reported for such procedure. Single infusion of remifentanil has been described in ESWL of urinary stones, but it has never been described in ESWL of pancreatic stones. Moreover, single infusion of remifentanil might induce several complications, such as postoperative nausea and vomiting. The investigators attended to investigated whether combination of flurbiprofen with remifentanil reduced remifentanil dose and attenuated the complications.

Conditions
-----------------
Pancreatic Stone Disease

Intervention / Treatment
-----------------
* Drug: Remifentanil
* Drug: Flurbiprofen and remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-65 years ASA I-II ESWL indication was met Exclusion Criteria: patients with hypertension patients compromised in cardiopulmonary function patients undergoing ESWL for the second or more times

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rem group<br>Patients in this group receive single infusion of remifentanil with target concentration infusion. | Drug: Remifentanil<br>* Patients in Rem group receive sedation and analgesia with remifentanil, dose of which will be determined by the up-and-down method.<br>|
| Experimental: Flur group<br>Patients in this group receive both infusion of flurbiprofen and remifentanil | Drug: Flurbiprofen and remifentanil<br>* Patients in this group receive sedation and analgesia with flurbiprofen and remifentanil, dose of which was determined by the up-and-down method.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue score of pain |  | During ESWL procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular responses including blood pressure and heart rate |  | During ESWL procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extracorporeal shock wave lithotripsy, remifentanil, flurbiprofen, pancreatic stone
The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients.

Detailed Description
-----------------
The prevalence of type 2 diabetes is increasing dramatically in the last decade in China. Hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health outcomes. Flax lignans, a phytoestrogen found in flaxseed is thought to be the compound responsible for cholesterol-lowering effect of flaxseed. Our purpose is to improving the lipid profile in type 2 diabetic patients with supplementation of flax lignans.

Official Title
-----------------
The Effects of Flax Lignans on Lipid Profile and Glucose Management in Type 2 Diabetes: a Randomized Double-Blind Cross-Over Study

Conditions
-----------------
Type 2 Diabetes, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: flax lignans


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed type 2 diabetes Age: 50-79 years old LDL-cholesterol more than 2.9 mmol/l Exclusion Criteria: Current or previous (within 6 months) use of estrogen therapy Cancer Chronic gastrointestinal diseases Current use of antibiotics Any severe liver or renal diseases Systolic blood pressure more than 180 mmHg or phase 3 hypertension Any severe mental diseases Severe cardio- or cerebro-vascular diseases

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 79 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: flax lignans|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol at 3 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lignans, type 2 diabetes, flaxseed, cholesterol
NeoCart Phase 2 Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee.

Official Title
-----------------
A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee

Conditions
-----------------
Articular Cartilage Damage

Intervention / Treatment
-----------------
* Biological: NeoCart
* Procedure: microfracture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with symptomatic knee pain indicative of an articular cartilage injury and able and willing to give informed consent. Exclusion Criteria: Patients with any previous surgical treatment other than debridement or microfracture of the study cartilage defect.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: NeoCart<br> | Biological: NeoCart<br>* autologous tissue implant<br>|
| Active Comparator: microfracture<br> | Procedure: microfracture<br>* microfracture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study will extend the experience derived from our Phase 1 study. |  | One year |
ROX Index in Acute Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
evaluation of ROX index among ICU patients to evaluate the success of non invasive ventilation or the need for intubation

Official Title
-----------------
Role of ROX Index as an Indicator for Non-invasive Ventilation in Acute Respiratory Failure

Conditions
-----------------
Rox Index

Intervention / Treatment
-----------------
* Other: ROX index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants admitted to RICU with type I and type II respiratory failure requiring NIV support with one or more of the following : PaO2/FiO2 less than or equal to 300 mmHg despite supplying oxygen at a flow rate ≥ to 10 l/min for ≥ 15 min Patients requiring ventilatory support due to increased respiratory rate ≥ 25 breaths/min or using accessory muscles of respiration Exclusion Criteria: 1. Absolute indication for intubation like coma, hemodynamic instability, or life-threatening arrhythmia. 2. Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy,or active upper gastrointestinal bleeding. 3. Resusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ROX index|observation of ROX index to evaluate the efficacy of non invasive ventilation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success vs failure of non invasive ventilation | by ROX index calculation | within 6 months |
Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis

Official Title
-----------------
A 24-Week, Randomized, Multicenter, Parallel-Group, Double-Blind, Vehicle-Controlled Study on Pimecrolimus Cream 1% Assessing the Steroid-Sparing Effect in the Long Term Management of Pediatric Patients With Severe Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients aged 2 to < 18 years with severe AD (score 8 or 9 according to Rajka and Langeland) responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase Exclusion Criteria: Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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: 1<br>Pimecrolimus | Drug: Pimecrolimus<br>* Pimecroliums cream 1 % bid.<br>* Other names: Elidel;|
| Placebo Comparator: 2<br>Vehicle | Drug: Placebo<br>* Vehicle control (placebo) bid.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corticoid-sparing effect of pimecrolimus cream 1% |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atopic dermatitis control |  |  | 
| safety of pimecrolimus cream 1% |  |  | 
| quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric
Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free Clinics - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the utilization of incentive values (considerably lower than those typically used in research clinics) to motivate clients to attend treatment and initiate and sustain abstinence.

Detailed Description
-----------------
The purpose of the proposed research is to implement and systematically evaluate, in community treatment settings, motivational incentive procedures that have been well researched and have proven efficacious in a variety of treatment research clinics.

Official Title
-----------------
Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free Clinics

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criterea: New intake to a drug-free CTP Evidence of cocaine or methamphetamine use, any reported use in past 2 weeks or positive urine screen at study intake. For those exiting a controlled environment, any stimulant use within two weeks of entering the controlled environment Exclusion Criteria: Unable to give informed consent (fails simple consent quiz) Answers yes to question: Are you in recovery from gambling? That is, have you stopped gambling because of previous problems with gambling?

Ages Eligible for Study
-----------------
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASI |  |  | 
| Cocaine use |  |  | 
| AIDS risk behavior |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
substance use disorders
Treatment of the Hypertensive Leg Ulcers by PRF Application

Study Overview
=================
Brief Summary
-----------------
Hypertensive leg ulcers are very painful and difficult to treat ulcers. Their treatment is not well established. We want to study the efficacy of PRF applications on the pains related to those ulcers. PRF (Platelet-Rich Fibrin) is an autologous fibrin clot, obtained extemporaneously from patient's blood, without any additive nor complex manipulation. It contains blood platelets and white blood cells, trapped in fibrin during clot formation. PRF (Platelet-Rich Fibrin) is form immediately after blood punction in a dry tube, that does not contain any anticoagulant. Coagulation naturally occurs within few minutes, and tubes are placed in a centrifuge: red blood cells are separated from the fibrin clot thanks to difference of density, and blood platelets and white blood cells are trapped in the fibrin clot. The fibrin clot is then rapidly applicated on the ulcer surface for four days. Our hypothesis is that platelet growth factors and cytokines, liberated during platelet activation, could help to treat hypertensive leg ulcers, that are caused by a vascular spasm.

Detailed Description
-----------------
2 to 8 PRF (depending on the ulcer surface), applied on painful hypertensive leg ulcer, and covered by a dressing for 4 days. Afterwards, dressings are made in a classical way. If needed (persistence of important pain), the PRF application can be repeated after 7 days.

Official Title
-----------------
Treatment of the Hypertensive Leg Ulcers by PRF Application

Conditions
-----------------
Hypertensive Leg Ulcer

Intervention / Treatment
-----------------
* Procedure: PRF (Platelet-Rich Fibrin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertensive leg ulcer important pain (>= 5/10) Exclusion Criteria: significant venous deficiency significant arterial deficiency other leg ulcers any active diseases such as infection, neoplasia, auto-immune disease

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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF application<br> | Procedure: PRF (Platelet-Rich Fibrin)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain auto evaluation (spontaneous and caused by local care) | - Pain experienced during the last ulcer care. Ulcers are described using the: Size Presence or absence of necrosis on the bottom and banks Presence or absence of purplish banks | Pain was assessed by self-assessment Single Digital Scale - Pain felt in the past 24 hours; |
What the Body Does to Foliglurax in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.

Detailed Description
-----------------
Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of radioactive tracer. Blood, urine and faeces will be collected to measure how much of the radioactivity gets into the blood stream and ends up in the urine and faeces. It is also measured how the body gets rid of the radioactivity and how quickly.

Official Title
-----------------
Interventional, Open-label, Single-dose Study Investigating the Absorption, Metabolism and Excretion (AME) of Foliglurax (Lu AF99757) Following Oral Dosing of 14C-foliglurax to Healthy Men

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

Intervention / Treatment
-----------------
* Drug: Foliglurax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Healthy men with a body mass index (BMI) of 19-30 kg/m2 (inclusive), and with a body weight of minimum 60 kg at the Screening Visit. Exclusion Criteria: - The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

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

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: Foliglurax<br> | Drug: Foliglurax<br>* Single oral dose of 80 mg [14C]-foliglurax(93µCi/3.44 MBq), 1mg/mL oral solution (prepared from [14C]-foliglurax powder for oral solution)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of radioactivity excreted | Cumulative amount of radioactivity excreted in urine and faeces | Before dosing until day 11 | 
| AUC(0-inf) foliglurax | Area under the plasma concentration time curve from zero to infinity | From day 1 until day 11 | 
| Cmax foliglurax | Maximum observed plasma concentration | From day 1 until day 11 | 
| CL/F foliglurax | Oral clearance for foliglurax in plasma | From Day 1 until Day 11 | 
| Total recovery of the administered dose | % of dose in urine and faeces | Before dosing until day 11 |