linjc16/ctgov huggingface dataset:
The Use of Antibiotic Sinonasal Rinse After Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
Double blind placebo controlled trial to evaluate whether the routine use of nasal irrigation with mupirocin is more effective than saline irrigations alone in reducing symptoms of chronic rhinosinusitis in the early postoperative period.

Official Title
-----------------
The Use of Antibiotic Sinonasal Rinse After Sinus Surgery: A Randomized Double-Blind Control Trial

Conditions
-----------------
Chronic Rhinosinusitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Rhinosinusitis Undergoing endoscopic sinus surgery Exclusion Criteria: Age under 18 Documented adverse reaction to mupirocin

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mupirocin<br>topical antibiotic | Drug: Mupirocin<br> <br> |
| Placebo Comparator: Placebo<br>Placebo control for mupirocin | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in Chronic Rhinosinusitis Patients | Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named SNOT 20 ( 20 questions for Sino-Nasal Outcome Test) Snot20: Scale 1 to 5 for 20 symptoms numbered below where 5 is the worst symptom. Total SNOT is scale from 0-100 where 100 is the worst. The following are the elements: 1. need to blow 2. sneezing 3. runny nose 4. cough 5. postnasal drip 6. Thick nasal discharge 7. Ear fullness 8. Dizziness 9. Ear pain 10. facial pain/pressure 11. difficulty falling asleep 12. wake up at night 13. lack of a good night's sleep 14. wake up tired 15. Fatigue 16. Reduced productivity 17. Reduced concentration 18. frustrated/ restless/irritable 19. sad 20. Embarrassed | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in Chronic Rhinosinusitis Patients | Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named Visual Analog Scale for Nasal Obstruction/Congestion. VAS for nasal obstruction is scale from 0 to 100 where 100 mean worse. | 3 months |
Lower Limb Flexibility in Duchenne Muscular Dystrophy: Effects on Functional Performance

Study Overview
=================
Brief Summary
-----------------
The investigator investigated the effect of lower limb flexibility on functional performance of children with Duchenne Muscular Dystrophy.

Detailed Description
-----------------
Thirty children whose functional levels were in 1 or 2 according to the Brooke Lower Extremity Functional Classification Scale were included in the study. Flexibilities of hamstrings, hip flexors, tensor fascia latae, and gastrocnemius muscles were evaluated in dominant lower limb. Popliteal angle test, hip flexor flexibility test, tensor fascia latae flexibility test and gastrocnemius flexibility test were used for flexibility asssessments. Functional performance was assessed with 6 Minute Walk Test (6 MWT) and Timed Performance Tests. The correlation between the flexibility of lower limb muscles' and performance tests were examined.

Official Title
-----------------
Lower Limb Flexibility in Duchenne Muscular Dystrophy: Effects on Functional Performance

Conditions
-----------------
Duchenne Muscular Dystrophy, Performance, Flexibility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a Duchenne Muscular Dystrophy diagnosis, Being in the ambulatory period and climbing four steps independently, To be able to cooperate the physiotherapist's directions, Not having any severe contracture in the lower limbs which may prevent assessments, Not having any injury or surgery involving the lower limbs during the last 6 months. Exclusion Criteria: Children who did not provide these criteria and did not will to participate the study were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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 |
| --- | --- | --- |
| 6 Minute Walk Test | The 6 Minute Walk Test (6MWT) is a standard test recently used to evaluate functional capacity in neuromuscular diseases, and found to be a safe and valid test that can be performed in Duchenne Muscular Dystrophy | 6 Minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Performance Test | Timed performance tests such as 10 m walk, Gower's (from supine position to stand up), ascending/descending 4 steps were also performed. During these tests, the child's performance was recorded in seconds. | 3 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Duchenne Muscular Dystrophy, lower limb flexibility, performance
Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

Study Overview
=================
Brief Summary
-----------------
Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from 0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable SEP response rates. Study part 2 will consist of a series of consecutive SEP measurements in patients with LUT symptoms during low bladder volume and maximum cystometric capacity to assess reliability of measurements and influence of potential concomitant LUTS treatments.

Conditions
-----------------
Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Procedure: EEG and EP measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers: Written informed consent, good mental and physical health, age >18y, Patients with LUTS and Patients with LUTS and treatment: Written informed consent, age >18y, prior urodynamic investigation, LUTS since >6months with or without detrusor overactivity Exclusion Criteria: healthy volunteers: any neurological or urological pathology, current pregnancy or lactation, urinary tract infection, hematuria, any previous pelvic or spine or craniocerebral surgery, any anatomical anomaly of the LUT or genitalia, any metabolic disease, any LUT malignancy, bladder capacity <150mL, SDV at 60mL; Patients with LUTS and Patients with LUTS and treatment: current pregnancy or lactation, urinary tract infection, gross hematuria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br>Healthy volunteers | Procedure: EEG and EP measurement<br> <br> |
| Experimental: Patients with LUTS<br>Patients with LUTS | Procedure: EEG and EP measurement<br> <br> |
| Experimental: Patients with LUTS and treatment<br>Patients with LUTS and treatment | Procedure: EEG and EP measurement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N1latency of LUT SEPs |  | 2-3 measurements within 4-16 weeks from first exam |
Stopping Cavities Study: Diammine Silver Fluoride

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.

Detailed Description
-----------------
Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.

Official Title
-----------------
Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Drug: 38% diammine silver fluoride
* Other: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nyvad criteria 3 Active carious lesion Exclusion Criteria: Allergy to silver Stomatitis or oral ulcerative condition Weight less than 15 kg

Ages Eligible for Study
-----------------
Minimum Age: 24 Months
Maximum Age: 60 Months

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 38% diamine silver fluoride<br>Topical application of 38% diammine silver fluoride to active cavity | Drug: 38% diammine silver fluoride<br>* treatment of cavity with study agent<br>* Other names: silver diamine fluoride;|
| Placebo Comparator: Water<br>Topical application of fluoride free water to active cavity | Other: Water<br>* Fluoride free, distilled water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Caries Activity | Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change | 14-21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
silver diamine fluoride, diammine silver fluoride, children
Single Dose Phase I Study of FYU-981

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered. The effect of food on PK/PD of FYU-981 is also investigated.

Official Title
-----------------
Single Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).

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

Intervention / Treatment
-----------------
* Drug: FYU-981, (Oral single dosing)
* Drug: Placebo, (Oral single dosing)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese healthy adult subjects Body mass index: >=18.5 and <25.0 Exclusion Criteria: Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FYU-981<br> | Drug: FYU-981, (Oral single dosing)<br>* Subjects randomized to the FYU-981 arm receive active drug, FYU-981.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo, (Oral single dosing)<br>* Subjects randomized to the placebo arm receive placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Cmax: Maximum plasma concentration) |  | 48 hours | 
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) |  | 48 hours | 
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) |  | 48 hours | 
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) |  | 48 hours | 
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) |  | 48 hours | 
| Pharmacokinetics (kel: Elimination rate constant) |  | 48 hours | 
| Pharmacokinetics (MRT: Mean residence time) |  | 48 hours | 
| Pharmacokinetics (Ae: Amount of drug excreted in urine) |  | 48 hours | 
| Pharmacokinetics (fe: Fraction of dose excreted in urine) |  | 48 hours | 
| Pharmacokinetics (CLr: Renal clearance) |  | 48 hours |
Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

Study Overview
=================
Brief Summary
-----------------
Prospective, monocentric, observationnal study. The primary objective of this study is to identify if presurgical child or/and parental anxiety is predictive of chronic postsurgical pain in abdominal or urologic ambulatory surgery.

Detailed Description
-----------------
The post surgical pain guidelines recommend to identify predictive factors, especially for vulnerable subjects. For children, there is few data about predictive factors of postoperative pain after ambulatory surgery. The objective of this study is to collect preoperative data (preoperative children's anxiety and parental anxiety) and postoperative data (postoperative pain measure: the day of surgery and 3 months after surgery) for children undergoing abdominal ou urologic ambulatory surgery, and to determine if there is a relationship between these data (Odds Ratio)

Official Title
-----------------
Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

Conditions
-----------------
Ambulatory Surgery, Children, Only, Inguinal Hernia, Umbilical Hernia, Urologic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: child from 3 to 18 years old undergoing scheduled urology or abdominal ambulatory surgery child and parents speaking French affiliation to national health insurance Exclusion Criteria: emergency surgery lack of parents consent no parental support on surgery day

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 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 |
| --- | --- | --- |
| Children's preoperative anxiety | - For children younger than 12 : mYPAS (the Modified Yale Preoperative Anxiety Scale). If the score is less than 24 : quiet child. If the score is greater than 24 : anxious child - For children older than 12 : anxiety visual analog scale (VAS) From 0 (better) to 10 (worse) | Preoperative : day of surgery | 
| Parents' preoperative anxiety | anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means anxious | Preoperative: day of surgery | 
| children's pain | for children younger than 6: Evendol scale. From 0 (better) to 15 (worse) for children older than 6: anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). | postoperative: day of surgery | 
| Chronic postsurgical pain in children | For all children, score PPMP (Postoperative Pain Measure for Parents) From 0 (better) to 10 (worse) | 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric department, children, chronic postsurgical pain, perioperative anxiety
SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).

Detailed Description
-----------------
Patients are given SU5416 via twice-weekly intravenous infusions in 4-week treatment cycles. Any patient who has not experienced unacceptable toxicity and who is deemed to be responding to the study drug (no evidence of disease progression) is permitted to continue receiving SU5416 in 4-week treatment cycles (up to a maximum of 1 year of therapy) until that patient experiences either unacceptable toxicity or tumor progression, as defined in the protocol.

Official Title
-----------------
A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory Cutaneous AIDS-Related Kaposi's Sarcoma

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
-----------------
* Drug: SU5416


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are at least 18 years old. Have KS. Have taken paclitaxel, DaunoXome, or Doxil for KS and they have either not gotten better or could not tolerate treatment therapy. Have 1 of the following symptoms for KS: 5 lesions (sores), generalized KS-related edema (swelling) without sores, or KS-related edema of the arms and legs. Agree to use an effective method of birth control during the study. Exclusion Criteria Patients will not be eligible for this study if they: Are pregnant or breast-feeding. Are allergic to Cremophor.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SU5416|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Enzyme Inhibitors, SU 5416, Protein-Tyrosine Kinase
Efficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma

Detailed Description
-----------------
In this study, approximately 18 to 47 patients who have previously received sorafenib, lenvatinib, or oxaliplatin-containing chemotherapy . After determining the dose of IBI310, the study will enter the expansion phase

Official Title
-----------------
An Open-label, Single-arm, Phase Ib Study of the Efficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma

Conditions
-----------------
Advanced Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: IBI308 200mg


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria： Locally advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology. Disease progression after surgery and / or local treatment. Previous standard systemic treatments for advanced hepatocellular carcinoma have failed or developed intolerable toxicity. exclusion criteria： Histology contains fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components. Have a history of hepatic encephalopathy, or have a history of liver transplantation. Diffuse liver cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI310<br>An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma | Drug: IBI308 200mg<br>* Received IBI310 combined with sintilizumab 200mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event |  | 21-42days | 
| Evaluation of the objective response rate of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma |  | 21-42days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the ORR of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma (researched by the investigator according to RECIST V1.1). |  | 1years |