linjc16/ctgov huggingface dataset:
Efficacy of Fibrin Sealant in Hypospadias Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate if application of a fibrin sealant over the urethroplasty suture line for waterproofing instead of a dartos vascularized pedicled flap to reduce complications and improve the outcome in hypospadias repair.

Detailed Description
-----------------
Many procedures have been tried for the sake of proper management of hypospadias and reducing the complications. Of them, tabularized incised plate (TIP) is one of the most convenient technique, which became the most common procedure for hypospadias repair (Elsayem et al., 2022). Although many surgical modifications and techniques have been prescribed to minimize post-operative complications and improve outcomes, a high percentage of complications still occurs. Urethrocutaneous fistulae are the most common post-operative complication (10%-40%) after hypospadias surgery; other complications being skin flap related complications such as flap necrosis, suture line breakdown, ascent of the testis and penile torsion (Shenoy et al.,2021). In this thesis a secondary preputial dartos flap will be performed in all cases and we will evaluate the value of usage of fibrin glue on the 1ry suture line .

Official Title
-----------------
Efficacy of Fibrin Sealant in Hypospadias Surgery

Conditions
-----------------
Hypospadias

Intervention / Treatment
-----------------
* Procedure: fibrin sealant in hypospadias


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria All treatment naïve children with hypospadias. Exclusion Criteria: Adult hypospadias. Recurrent cases. Prio pelvic trauma or radiation.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 18 Years

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

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: Fibrin group<br>Fibrin sealant covered with 2ry dartos flap. | Procedure: fibrin sealant in hypospadias<br>* fibrin sealant will be used over the suture line<br>|
| Active Comparator: Standard TIP technique<br>standard TIP technique with second dartos flap and no use of fibrin sealant | Procedure: fibrin sealant in hypospadias<br>* fibrin sealant will be used over the suture line<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of surgery | Number of patients with good stream, normal looking meatus and no need for auxiliary maneuvers. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications of hypospadias surgery | Number of patients with fistula, chordee, rotation, .... | 3 months |
Delirium Assessment in the Pediatric Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to show the efficacy of non-pharmacological interventions on preventing pediatric delirium in pediatric intensive care unit

Detailed Description
-----------------
The aim of this study was to show the efficacy of non-pharmacological interventions on preventing pediatric delirium in pediatric intensive care unit. Patients who is followed up for at least 48 hours in pediatric intensive care unit will be included in the study. Parents of patients will be allowed to stay with the patient as long as the conditions of service is appropriate. Parents will provide oral treatments to the patients. Patients will be allowed to spend time with their phone, tablet or toy in accordance with their age. Fellow resident will screen for pediatric delirium each child using the Cornell Assessment of Pediatric Delirium twice a day.

Official Title
-----------------
Assessment of Delirium Frequency and Risk Factors in Pediatric Intensive Care Unit

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric Cerebral Performance Category < 5 points Patients who stay in PICU >48 hours Exclusion Criteria: Pediatric Cerebral Performance Category > 4 points Patients who stay in PICU <48 hours

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
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 |
| --- | --- | --- |
| Pediatric delirium frequency | The effect of non-pharmacological interventions on the prevalence of pediatric delirium | Up to a month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium, Pediatric intensive care
A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 3+3 design, evaluating MM-141 at varying dose levels and frequencies.

Official Title
-----------------
A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

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

Intervention / Treatment
-----------------
* Drug: MM-141


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy Eighteen years of age or above Able to understand and sign an informed consent (or have a legal representative who is able to do so) Measurable disease according to RECIST v1.1 ECOG Performance Score of 0 or 1 Adequate bone marrow, hepatic, renal and cardiac function Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141 Exclusion Criteria: Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing Symptomatic CNS disease Received other recent antitumor therapy Pregnant or breast feeding

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>MM-141 monotherapy | Drug: MM-141<br> <br> |
| Experimental: Arm B<br>MM-141 and Everolimus | Drug: MM-141<br> <br> |
| Experimental: Arm C<br>MM-141 and Abraxane and Gemcitabine | Drug: MM-141<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity and number of adverse events related to escalating doses of MM-141 | Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Hepatocellular Carcinoma, Oncology, Phase I, ErbB3, IGF-1R, Everolimus, Gemcitabine, Abraxane
EMONO for the Treatment of Peripheral Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
To assess the effect of 3 consecutive days of one-hour administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical air), in add-on therapy to chronic analgesic treatments, on average pain intensity in patients with chronic peripheral neuropathic pain. A total of 250 randomised patients to be included in all the participating centres, i.e., 125 randomised patients in each of the 2 study groups treatments

Official Title
-----------------
Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) for the Treatment of Peripheral Neuropathic Pain: A Randomises, International, Multicentre, Placebo-Controlled, Phenotype-stratified Phase IIa Study

Conditions
-----------------
Neuralgia

Intervention / Treatment
-----------------
* Drug: Medical Air
* Drug: EMONO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a mean pain intensity from 4 to 9 as assessed daily with a Numerating Rating Scale during the 7 day period preceding inclusion in spite of administration of usual pain treatments. Neuropathic pain lasting for more than 3 months but less than 10 years Definite or probable peripheral neuropathy Exclusion Criteria: legal incapacity patient with another concomitant chronic pain ongoing major depression Chemotherapy-induced peripheral neuropathic pain

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Oxygen/Nitrogen (22%/78%)<br>Medical Air | Drug: Medical Air<br> <br> * Other names: Oxygen/Nitrogen;|
| Active Comparator: Nitrous Oxide/Oxygen (50%/50%)<br>EMONO | Drug: EMONO<br> <br> * Other names: Nitrous Oxide/Oxygen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Numeric Rating Scale (NRS) | 7 days after the last administration of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Numeric Rating Scale (NRS) | 28 days after the last administration of treatment | 
| Pain characteristic | Neuropathic Pain Symptom Inventory (NPSI) | 28 days after the last administration of treatment | 
| Quality of life questionnaire | Medical Outcome Study Short Form (SF-12) | 28 days after the last administration of treatment | 
| Number of patients with adverse events |  | through study duration, up to 31 days |
Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial (a type of research study) designed to describe the efficacy (effectiveness) and toxicity (safety) of a new medical treatment, NESP (Novel Erythropoiesis Stimulating Protein). This study will be offered to patients with cervical cancer undergoing a combination of chemotherapy and radiation. This treatment may lower your red blood cells. The use of NESP may stimulate the body to produce more red blood cells. Our hypothesis is that higher red blood cells will be beneficial to the patient during treatment for cervical cancer.

Official Title
-----------------
Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.

Conditions
-----------------
Anemia, Cervix Neoplasms

Intervention / Treatment
-----------------
* Drug: NESP - Novel Erythropoiesis Stimulating Protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Consent form completed and signed Hemoglobin between 9-13 g/dL Life expectancy of at least 4 months Karnofsky Performance Status =/> 70 No evidence of hemolysis, GI bleeding, or bleeding due to recent surgery Adequate renal and liver function

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NESP - Novel Erythropoiesis Stimulating Protein|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
-----------------
Cervical cancer
Knowledge, Attitude, And Practice In A Group Of Egyptian Dentists Towards Preventive Measures In Pediatric Dentistry: A Cross-Sectional Study

Study Overview
=================
Brief Summary
-----------------
The study will include general dental practitioners or dental specialists from Police Academy Hospital and pediatric dentists from Pediatric dentistry department at Faculty of Dentistry Cairo University. A self-administered questionnaire will be given to dentists by direct interviewing and they will be allowed to complete the questionnaire in Faculty of Dentistry, Cairo University or Police Academy Hospital. The data will be based on a collection of responses to the 38 items in the questionnaire.

Official Title
-----------------
Knowledge, Attitude, And Practice In A Group Of Egyptian Dentists Towards Preventive Measures In Pediatric Dentistry: A Cross-Sectional Study

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

Intervention / Treatment
-----------------
* Other: A self administered questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Egyptian dentists working in either Faculty of Dentistry Cairo University or Police Academy Hospital. Postgraduate students. Exclusion Criteria: Refusal to participate in the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: A self administered questionnaire|The questionnaire is in English language, it contains binary questions related to KAP on different preventive measures in pediatric dentistry and consists of 38 items divided into 4 sections as follows: I) Socio-demographic data: (7 items). It includes gender, total years in practice, nature of primary practice, school of graduation, scientific degree and specialty II) Assessment of Knowledge towards preventive measures in pediatric dentistry. (16 items) III) Assessment of Attitude towards preventive measures in pediatric dentistry. (10 items) IV) Assessment of Practice towards preventive measures in pediatric dentistry. (5items) One score is given for each response to items.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge,attitude and practice towards preventive measures in pediatric dentistry. | Measuring device is a KAP questionnaire and measuring unit id binary questions | 3 months |
Exploring Stress and Coping Behaviors of the Major Carer Whose Children With Prader-Willi Syndrome

Study Overview
=================
Brief Summary
-----------------
Ask the 4 carers of children with Prader-willi syndrome to disclose their experiences and difficulties for searching better management and intervention

Conditions
-----------------
Prader-Willi Syndrome

Intervention / Treatment
-----------------
* Other: counseling, emotional support
* Other: emotional support
* Other: emotional support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a person who care and live with children with Prader-Willi syndrome Exclusion Criteria: siblings or less-contact family teachers

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- |
| Lifestyle counseling<br> | Other: counseling, emotional support<br> <br> Other: emotional support<br>* emotional support during the interview<br>Other: emotional support<br>* emotional supporting during the interview<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| experience |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress, carer's experiences, Prader-willi syndrome, personal experiences
Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

Detailed Description
-----------------
Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking. - Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

Official Title
-----------------
Cyclobenzaprine Treatment for Muscle Cramps in Cirrhotic Patients

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Cyclobenzaprine
* Drug: Calcium Carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis and has frequent muscle cramps Exclusion Criteria: Allergy to cyclobenzaprine Encephalopathy. Receiving antidepressant drugs

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?
-----------------

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: Cyclobenzaprine<br>Cyclobenzaprine administration for 2 weeks | Drug: Cyclobenzaprine<br>* cyclobenzaprine administration for 2 weeks<br>* Other names: cyclosed;|
| Placebo Comparator: PLacebo<br>Calcium carbonate for 2 weeks | Drug: Calcium Carbonate<br>* Calcium carbonate for 2 weeks<br>* Other names: Calcitron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of muscle cramps | The number of muscle cramps | 3 months |
An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy

Study Overview
=================
Brief Summary
-----------------
Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents.

Official Title
-----------------
An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy

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

Intervention / Treatment
-----------------
* Drug: Abatacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA for at least 1 year Clear clinical signs of active RA in 1 knee joint Meet ARA (1987) criteria for diagnosis of RA and ACR (1991) criteria for RA functional classes I, II, or III Inadequate clinical response to a minimum of 3 months of therapy with anti-TNF-blocking agents Taking background DMARDs for a minimum of 3 months and at stable doses for at least 28 days Exclusion Criteria: Serious bacterial infection in last 3 months History of TB History of cancer within 5 years Evidence of latent or active bacterial or viral infection Intra-articular corticosteroids within 3 months Exposure to live vaccines Exposure to CTLA4Ig or BMS-188667 Treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, D-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Abatacept<br>* Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 & < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.<br>* Other names: Orencia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of each subject's synovial tissue markers |  | at baseline and after 4 months of treatment with abatacept | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum |  | after 4 months of treatment | 
| assess safety & tolerability of abatacept |  | administered for 4 months |