linjc16/ctgov huggingface dataset:
Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant

Study Overview
=================
Brief Summary
-----------------
CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to evaluate the safety and efficacy of CG53135-05 when administered as a single dose to patients at risk for developing oral mucositis.

Official Title
-----------------
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of CG53135-05 Administered Intravenously as a Single Dose for the Prevention of Oral Mucositis in Patients Receiving Autologous Hematopoietic Stem Cell Transplant

Conditions
-----------------
Stomatitis

Intervention / Treatment
-----------------
* Drug: CG53135-05, velafermin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients ages > 18 yrs Patients undergoing high dose chemotherapy with or without radiation therapy treatment as conditioning for autologous hematopoietic stem cell transplantation. The conditioning regimens include at least one of the following: high dose melphalan (Mel 200), busulfan, or etoposide, with or without total body irradiation. Patients with Karnofsky performance scores > or = 70% Informed consent for participation in study Exclusion Criteria: Patients who weigh < 33 kg Premenopausal female patients who are pregnant, lactating or are likely to become pregnant Patients with active medical conditions that preclude autologous hematopoietic stem cell transplantation Patients diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C Patients with known hypersensitivity to recombinant protein therapeutics Patients who have taken CG53135-05, palifermin or other investigational drugs in the past 30 days Patients who have untreated symptomatic dental infection Patients with a history of sensitivity or allergy to E. coli-derived products Patients with WHO Grade 3 or 4 oral mucositis (OM)

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CG53135-05, velafermin|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
-----------------
oral mucositis, oncology - supportive care, mouth diseases
Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.

Official Title
-----------------
A Phase 2, Single-Dose, Randomized, Active and Placebo Controlled, Four-Period, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 or Albuterol in Subjects With Persistent Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: ARS-1
* Drug: Albuterol MDI
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Is a male or female subject between the ages of 12 and 65 years, inclusive. 2. Asthma that has been stable for at least four weeks prior to screening as defined by clinical history. 3. Reversible bronchoconstriction. 4. Has body weight more than 30 kilogram (kg) and body mass index between 18 and 34 kg/m², inclusive. 5. Has no medical history of hypertension and cardiovascular disease in the last 10 years. 6. At screening, has stable vital signs. Exclusion Criteria: 1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition. 2. Patients receiving beta blocker. 3. Has any clinically significant medical condition or physical exam finding as deemed inappropriate by the Investigator. 4. Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram. 5. Has mucosal inflammatory disorders. 6. Has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 mg/100 µL dose of ARS-1<br> | Drug: ARS-1<br>* ARS-1<br>|
| Active Comparator: 2 mg/100 µL dose of ARS-1<br> | Drug: ARS-1<br>* ARS-1<br>|
| Active Comparator: albuterol MDI (180 mcg)<br> | Drug: Albuterol MDI<br>* 180 mcg<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of ARS-1 versus Albuterol and placebo | Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC) | From baseline (timepoints 0) to 1 hour |
Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence

Study Overview
=================
Brief Summary
-----------------
As many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly respond to these problems by adding adjunctive medications, despite the absence of systematic studies that support such practices. It is possible, however, that in many of these cases, the unstable course and/or unsatisfactory treatment response reflects incomplete adherence with the originally prescribed oral antipsychotic, rather than a need for adjunctive medications. This study will examine whether switching patients who demonstrate an unstable course and/or an unsatisfactory clinical response to a long-acting injectable preparation as the primary antipsychotic may enhance medication adherence and improve outcomes.

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: Depot Risperidone Microsphere (Consta)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients will be male or female Between 18-65 years of age and will meet DSM-IV criteria for schizophrenia or schizoaffective disorder. The subject must have, in their physicians opinion, an unstable course and must have been treated with an oral antipsychotic. Exclusion Criteria: Pregnant and breast feeding females will be excluded. Because fluoxetine is known to change the plasma level of CONSTA, subjects taking fluoxetine within two weeks of starting the study will be excluded. Patients who are known to have a hypersensitivity to oral Risperdal will be excluded.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Depot Risperidone Microsphere (Consta)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the value of the LNR as a prognostic indicator in patients with rectal cancer who offered total mesorectal excision.

Detailed Description
-----------------
Patients and methods Study design and setting This is a retrospective review of prospectively collected and maintained database of patients with CRC admitted in the Oncology Center of Mansoura University (OCMU), the Colorectal Surgery Unit of Mansoura University Hospitals, and the Department of General Surgery of Alexandria University. Selection criteria Patients of either gender aged 18 years or above who presented with rectal cancer of any stage will be included in the study. We will exclude patients with patients younger than 18 years; patients with synchronous colon cancer; synchronous liver, pulmonary or bones metastasis; or synchronous gastrointestinal cancer; or patients who were lost to follow-up. Study endpoints The primary endpoint of the study is to assess the value of lymph node ratio (LNR) on the oncological outcomes.

Official Title
-----------------
Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer: a Retrospective Cohort

Conditions
-----------------
Recurrence

Intervention / Treatment
-----------------
* Procedure: Lymph node harvesting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rectal cancer of TNM stage I-III underwent radical resection with curative intent Exclusion Criteria: synchronous colon cancer synchronous gastrointestinal cancer underwent palliative resection presented with intestinal obstruction those lost to follow-up.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Lymph node harvesting|Lymph node harvesting after radical resection for rectal cancer with curative intent|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph node value | Value in prediction of oncological outcomes | one year |
ReSure Sealant Pivotal Study

Study Overview
=================
Brief Summary
-----------------
This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.

Official Title
-----------------
ReSure Sealant Pivotal Study

Conditions
-----------------
Cataract Surgery Incision Leak

Intervention / Treatment
-----------------
* Device: ReSure Sealant
* Procedure: Sutures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a cataract and is expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens Subject must be 22 years of age or older Exclusion Criteria: Any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment Previous corneal or retinal surgery or planned multiple procedures during cataract surgery.

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Active Comparator: Suture<br>Suture application | Procedure: Sutures<br> <br> |
| Experimental: ReSure Sealant<br>Sealant application | Device: ReSure Sealant<br>* Comparison of ReSure Sealant to suture(s)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery. |  | Days 1-28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foreign Body Sensation |  | Days 1-28 | 
| Best corrected visual acuity | Best corrected visual acuity worse than 20/40 at day 1 | Day 1 | 
| Best corrected visual acuity | Best corrected visual acuity worse than 20/40 at 28 days | Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract surgery
Validation of a Short Questionnaire (SSI) for Sleep Disorders in Patients With Alcohol

Study Overview
=================
Brief Summary
-----------------
Sleep disorders are very common in alcohol patients (40-90% according to studies) These sleep disorders may persist after withdrawal and represent a major factor in relapse. In a previous study, the investigators validated a simple sleep questionnaire (the Short Sleep Index = SSI) from a multicentre series of 602 American patients (Perney et al., Alcohol Alcohol 2012) The SSI is obtained from the Hamilton score (baseline score for anxiety and depression)

Detailed Description
-----------------
to compare the SSI with a reference sleep questionnaire (Pittsburg Quality Sleep Index) in alcohol patients in different situations: Ambulatory or hospitalization

Official Title
-----------------
Validation of a Short Questionnaire (SSI) for Sleep Disorders in Patients With Alcohol

Conditions
-----------------
Alcohol Dependence, Sleep Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Sick people with alcohol abuse or dependence Inpatient or outpatient follow-up (Nîmes University Hospital, Grau du Roi Hospital, Montpellier, Centre de Soins d'Accompagnement et de Prévention en Addictologie (CSAPA of Nîmes University Hospital) Agreeing to answer the questionnaire Not having a cognitive deficit or psychiatric pathology that makes interrogation unreliable Exclusion criteria : NA

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| to compare the SSI with a reference sleep questionnaire (Pittsburg Quality Sleep Index | PQSI and SSI scores. PQSI : The overall score is obtained by summing the seven components. It goes from 0: no difficulty to 21: major difficulties. A PSQI greater than 5 indicates sleep disturbances and ranks subjects as good and bad sleepers. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the duration of these 2 tests | duration (minutes, seconds) | Day 1 |
Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa

Study Overview
=================
Brief Summary
-----------------
The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.

Official Title
-----------------
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Ropinirole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson's disease Modified Hoehn and Yahr Scale Stages II - IV Stable dose of L-dopa for at least 4 weeks prior to screening. Lack of control with L-dopa therapy. Women of child-bearing potential must use a clinically accepted form of birth control. Exclusion Criteria: Significant and/or uncontrolled medical conditions (excluding Parkinson's disease) within 3 months of screening. Any abnormality, at screening, that is considered clinically relevant by the Investigator. Dementia Use of dopamine agonists within 4 weeks of screening visit. Participation in other investigational drug studies.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in awake time off at Week 24 LOCF (last observation carried forward). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in: |  |  | 
| amount and percent of awake time spent on |  |  | 
| percent awake time spent off |  |  | 
| Unified Parkinson's Disease Rating Scale (UPDRS) total motor score |  |  | 
| UPDRS Activities of Daily Living score |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease, Dyskinesia, Adjunctive Therapy with L-dopa
Continuous Glucose Monitoring Technology in the Perioperative Period During Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This is an observational study of continuous glucose monitoring technology during cardiac surgery. The investigators would like to develop data for descriptive analysis of a comparison of continuous glucose monitoring with a gold standard under the conditions of cardiac surgery.

Official Title
-----------------
A Prospective Observational Trial of Continuous Glucose Monitoring Technology in the Perioperative Period During Cardiac Surgery

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Device: Use of continuous glucose monitor during surgery. ( Medtronic Minimed Guardian REALTime Continuous Glucose Monitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Competent adults scheduled for elective cardiac surgery. Exclusion Criteria: Inability to consent, emergency surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Cardiac Surgery Patients<br>Competent Adult Patients going for elective cardiac surgery. | Device: Use of continuous glucose monitor during surgery. ( Medtronic Minimed Guardian REALTime Continuous Glucose Monitor)<br>* Use of continuous glucose monitor during surgery.<br>* Other names: Medtronic Minimed Guardian REALTime Continuous Glucose Monitor;|

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
-----------------
Cardiac Surgery, Perioperative Glucose Control
Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
Purpose Primary endpoint To evaluate the 3-year disease free survival Second endpoints To evaluate the 3-year & 5-year overall survival To analyze the toxicity and the quality of life

Official Title
-----------------
A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Drug: paclitaxel
* Drug: Cisplatin 50mg/m2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical cancer stage Ia2-IIa histology; squamous, adeno, adenosquamous subtype age; 20∼70 years performance status; GOG 0∼2 no medical illness hematologic, renal, hepatic function; normal grossly no residual disease histologically confirmed lymph nodes metastases no parametrial extension and negative resection margin number of retrieved lymph nodes; ≥ 20 Exclusion Criteria: patients with grade 2 peripheral neuropathy patients with uncontrolled infection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: paclitaxel|Paclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks * 6 cycles|
|Drug: Cisplatin 50mg/m2|Cisplatin 50mg/m2 Repeat every 3 weeks * 6 cycles|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| log-rank test Cox regression analysis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical cancer