linjc16/ctgov huggingface dataset:
Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders

Study Overview
=================
Brief Summary
-----------------
To evaluate topical A-007 in patients with advanced malignancies including Kaposi's sarcoma and lymphoproliferative disorders.

Official Title
-----------------
Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections, Lymphoproliferative Disorders

Intervention / Treatment
-----------------
* Drug: A-007


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Maintenance antihormones, hormones, and glucocorticoids. Patients must have: Histologically proven metastatic cancer including Kaposi's sarcoma and lymphoproliferative disorders to the skin or cutaneous sites. NOTE: Primary basal or squamous cell cancer of the skin is allowed. Failed both primary and secondary chemotherapy and/or immunotherapy protocols. Measurable skin or cutaneous lesions. 4 Life expectancy of at least 20 weeks. Prior Medication: Required: Prior therapy for cutaneous lesions from Kaposi's sarcoma or lymphoproliferative disorders. Allowed: Prior maintenance steroids and hormone/antihormone therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active infections other than medically stable HIV infection. Active congestive heart failure, any persistent arrhythmia or transient serious arrhythmia (ventricular tachycardia, sinoatrial arrest, etc.), or progressive cardiomyopathy. Unstable blood pressure. Seizures or other CNS disorders. Severe unstable diabetes mellitus. Coagulopathies. Thrombotic disease. Any other medical conditions that would prevent completion of study or produce significant risk to patient. Concurrent Medication: Excluded: Concomitant chemotherapy or immunotherapy. Ongoing corticosteroid therapy (unless maintenance). Patients with the following prior conditions are excluded: History of active cardiopulmonary or respiratory disease. History of sun hypersensitivity and photosensitive dermatoses. History of allergy or hypersensitivity to cosmetics, toiletries, or other dermatological products.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: A-007|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
Lufwanyama Neonatal Survival Project

Study Overview
=================
Brief Summary
-----------------
We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.

Detailed Description
-----------------
This is a cluster randomized trial of the impact of providing additional training and supplies to traditional birth attendants in a rural setting in Zambia. 120 TBAs are randomized into intervention/control. Intervention TBAs receive NRP training, supplies for neonatal resuscitation, receiving blankets for thermoregulation, and amoxicillin tablets. Control TBAs continue according to prior standard of care. Primary outcome is mortality at 28 days life as a proportion of births attended by TBAs in each study arm.

Official Title
-----------------
Lufwanyama Neonatal Survival Project

Conditions
-----------------
Mortality

Intervention / Treatment
-----------------
* Other: Neonatal resuscitation protocol
* Other: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TBA trained in safe delivery; willing to sign informed consent; willing to be randomized; willing to adhere to study procedures Exclusion Criteria: TBA living outside of Lufwanyama district
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>TBAs who receive training and supplies for the intervention | Other: Neonatal resuscitation protocol<br>* training in neonatal resuscitation and sepsis identification early treatment<br>|
| Active Comparator: control<br>TBAs continuing with current standard of practice | Other: Standard of care<br>* continued with current standard of care for birth attendants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perinatal mortality |  | day zero | 
| sepsis mortality |  | deaths between days 1-28 | 
| cost effectiveness |  | days 0-28 | 
| successful delivery of nevirapine prophylaxis to HIV exposed deliveries |  | day zero umbilical cord dried blood spot | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
birth asphyxia, neonatal sepsis, maternal to child transmission of HIV
Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients

Study Overview
=================
Brief Summary
-----------------
To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To compare the effectiveness of two different amphotericin B doses in the treatment of biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and pharmacodynamic parameters of the two different dosing regimens.

Official Title
-----------------
Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients

Conditions
-----------------
Candidiasis, Esophageal, HIV Infections

Intervention / Treatment
-----------------
* Drug: Amphotericin B


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis are excluded. Concurrent Medication: Excluded: Systemic administration of amphotericin B for a proven or suspected systemic fungal infection. Patients with the following are excluded: Documented Candida fungemia. Histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis. Systemic administration of amphotericin B for a proven or suspected systemic fungal infection. Patient refusal to enter study. Patient must be an immunosuppressed host, with biopsy-proven Candida esophagitis. Patients with polymicrobial esophagitis will be included as long as Candida esophagitis is documented by esophageal biopsy. Informed consent must be signed and obtained.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Amphotericin B|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
-----------------
AIDS-Related Opportunistic Infections, Esophagitis, Acquired Immunodeficiency Syndrome, Amphotericin B, Candidiasis, Oral
Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital

Study Overview
=================
Brief Summary
-----------------
Holter Monitoring is a way to continuously check the electrical activity of the heart . Continuous ECG recording show to be one of the most effective noninvasive clinical tools in the diagnosis of cardiac symptoms prognostic assessment and in the evaluation of many cardiac therapeutic intervention. The clinical utility of ambulatory ECG lies in its ability to examine continuously a patient over an extended period of time, permitting patient ambulatory activity and facilitating the diurnal electrocardiographic examination of a patient in a changing environmental conditions (both physical and psychological) .

Official Title
-----------------
Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital

Conditions
-----------------
Critically Ill Childern in PICU

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1- children admitted to pediatric department as in : Pediatric intensive care unit (PICU). Pediatric critical care unit (PCCU). Emergency room (ER). 2- Age from 1 month- 12 years. 3- Critical ill child fulfill these criteria: Persistent convulsions. Abnormal GCS Haemodynamic instability Foreign body inhalation Sever cardiac problem Irregular breathing DKA Others Exclusion Criteria:1-Neonates 2-End-stage or those with end-organ failure . 3-Whom GCS is below 6. 4-Whom done cardiac catheterization for any purpose . 5-Previously done Holter. 6-Multiple traumatized patient.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
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 |
| --- | --- |
| critically-ill childern<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormalities detecred in Holter monitoring of critically-ill childern | the relation between abnormalities detected in Holter and prognosis of critically-ill childern | one year | 
| The relation between heart rate variability and outcome ,prognosis of illness | Increased illness severity and poor outcomes ,the most common method of objectively assesing autonomic nervous system dysregulation is through measurement of heart rate variability ,which reflect the normal ,physiologic alternation in the intervals in the time between consecutive heart beats that occur when there is balance of sympathetic and parasympathetic inputs on the electrical conduction system of the heart. | one year | 
| Arrhythmia detected in critically-ill childern | arrhythmia detected in Holter of critically ill childern whom have any critical illness | one year |
Medina Embolization Device In Neurovascular Aneurysm Study

Study Overview
=================
Brief Summary
-----------------
A global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study conducted to assess the performance of the Medina Embolization Device when used in unruptured and ruptured intracranial aneurysms.

Official Title
-----------------
The MEDINA Study: Medina Embolization Device In Neurovascular Aneurysms Study - A Post Market Clinical Follow-up Study

Conditions
-----------------
Intracranial Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has provided written informed consent using the Ethics Committee-approved consent form and agrees to comply with protocol requirements Subject is 18- 85 years old Subject has a ruptured or unruptured saccular intra-cranial aneurysm amenable to be treated with the Medina Embolization Device Exclusion Criteria: Aneurysm is partially thrombosed Aneurysm has been previously treated with surgery or endovascular therapy Subject has had major brain surgery including endovascular procedures within the past 30 days Vessel characteristics (tortuosity, stenosis, morphology) preclude safe endovascular access to the aneurysm Subject is pregnant or breast-feeding or wishes to become pregnant during the length of the study participation The Investigator determines that the validity of the study outcomes may be compromised by the subject's enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embolization Device, Medina, Rupture Intracranial Aneurysm, Unrupture Intracranial Aneurysm
The Effects of Hesperidin and Flaxseed in Prediabetes

Study Overview
=================
Brief Summary
-----------------
To study the effects of Hesperidin and flaxseed supplement in patients with prediabetes, 50 patients will be randomly allocated to control group or 2 capsules Hesperidin and 30 gram flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, blood pressure, blood sugar, inflammatory and anthropometric factors will be assessed and compared between groups.

Official Title
-----------------
Evaluation of the Effects of Hesperidin and Flaxseed Supplementation in Patients With Prediabetes

Conditions
-----------------
PreDiabetes

Intervention / Treatment
-----------------
* Dietary Supplement: hesperidin and flaxseed
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 to 70 years prediabetes: impaired fasting glucose (>100 mg/dL) and/or HbA1C 5.7% to 6.5%, and overweight or obese with body mass index range of 25 to 40 kg/m2 Exclusion Criteria: pregnancy or lactation A history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis Following program to lose weight in recent 3 mo

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

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: hesperidin and flaxseed<br> | Dietary Supplement: hesperidin and flaxseed<br>* 2 capsuls hesperidin and 30 g flaxseed<br>|
| Placebo Comparator: control<br> | Other: control<br>* no supplementation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prediabetes | number of participants with normal plasma glucose | 12 weeks |
Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
To validate the morphine-sparing effect and safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.

Official Title
-----------------
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Of Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain Following Orthopedic Or Gynecological Surgery

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

Intervention / Treatment
-----------------
* Drug: Parecoxib and placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergo gynecological or orthopedic surgery under epidural anesthesia Exclusion Criteria: A previous history of intolerance or hypersensitivity to any NSAID, cyclooxygenase-2 selective inhibitors, sulphonamides, or any of the excipients of parecoxib.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Parecoxib and placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the morphine-sparing effect of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery. |  |  |
Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome

Study Overview
=================
Brief Summary
-----------------
Assessment of long-term effectiveness of ZOMACTON in treatment of Growth Hormone Deficiency or growth retardation due to Ullrich-Turner Syndrome and assessment of compliance and adherence, optionally with the aid of an electronic app or patient diary.

Official Title
-----------------
A Prospective Non-Interventional Study to Assess Long-term Effectiveness of Zomacton® and Factors Affecting Adherence in Patients With Growth Hormone Deficiency or Growth Retardation Due to Ullrich-Turner Syndrome

Conditions
-----------------
Growth Disorders

Intervention / Treatment
-----------------
* Drug: Zomacton


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients (< 18 years) with growth hormone deficiency or growth retardation due to Ullrich-Turner-Syndrome Patients already receiving or who have been prescribed Zomacton® de novo according to its German label; the decision to prescribe Zomacton® was made independently from participation and prior to enrollment in this study. Patient and their parents (or legal representatives) who are willing and able to provide signed informed consent for use of their personal data. Exclusion Criteria: Participation in an interventional clinical study within the last 30 days prior to baseline visit or during the follow-up period

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Zomacton<br> | Drug: Zomacton<br>* Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear growth (change in height) | Change in height defined as the change of the standard deviation score of body height vs. baseline | Over the first 12 months (month 0, 3, 6, 9 and 12) |
Effects of Training Intensity on the CHD Risk Factors in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to find out whether training at different exercise intensities reduces the risk of developing cardiovascular disease (CVD) to a different extent. Heart attacks and stroke are the leading cause of death in older women. Reduced variability of the heart rate and increased dips and swings in blood pressure are risks factors that predict the chance of developing CVD as are increased levels of clotting protein fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol (>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat level before you start training and after 15 and 30 weeks of training in the form of walking. At the present time the effects of exercise intensity on these factors are not well understood. This study will add to the basic understanding of these issues and allow us to recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce the risk of developing CVD.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal and preferably on hormone replacement therapy In good general health Have a body mass index (BMI, weight in kg/height in m2) of between 25 and 40 Exercise less than 20 min/day two days a week

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Exercise|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
-----------------
exercise