linjc16/ctgov huggingface dataset:
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction

Study Overview
=================
Brief Summary
-----------------
Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of rubitecan in this patient population.

Official Title
-----------------
Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: Rubitecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is at least 18 years of age. The patient has histologically or cytologically proven malignancy recurrent or refractory to standard treatment or for which there is no standard therapy. The patient has measurable disease. The patient has sufficiently recovered from the acute toxic effects of previous chemotherapy, radiotherapy (no less than 3 weeks prior to randomization), and/or immunotherapy. The patient's estimated life expectancy is at least 8 weeks. The patient has a National Cancer Institute Common Toxicity Criteria (NCI CTC) Performance Status between 0 and 2. The patient has adequate bone marrow function. The patient must not have active central nervous system (CNS) metastases. Exclusion Criteria: The patient has any serious, uncontrolled intercurrent illness or infection. The patient is receiving anti-retroviral therapy (HAART) for HIV infection. The patient is pregnant or nursing.

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

| Intervention/Treatment |
| --- |
|Drug: Rubitecan|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
-----------------
rubitecan, Orathecin, 9-nitrocamptothecin, solid tumors, organ dysfunction, renal dysfunction, hepatic dysfunction, RFS 2000
Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment

Study Overview
=================
Brief Summary
-----------------
In Northern India, skewed sex ratios, female feticide and higher child mortality rates for girls have become serious concern. The female child mortality as a result of son preference have increased during the last several decades. Since families cannot know the sex of the fetus due to Indian government policies, they now 'neglect' girl child to ensure there are few survivors. Survival chances of second and third daughters are plunging neglecting healthcare and nutrition has become tool for death as 'good riddance'.

Official Title
-----------------
Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment: Randomized Controlled Trial

Conditions
-----------------
Abuse Neglect Social, Deprivation, Maltreatment Syndrome (Infant or Child)

Intervention / Treatment
-----------------
* Behavioral: Family Counselling and safeguarding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Families having girl child before High risk families with high expectation of having son Exclusion Criteria: Families having son before Relocation and moving out of town during study period Not ready to consent for intervention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Nurses delivered the supportive intervention along with family counselling from last term of pregnancy through three months and then were followed till the first birthday of the child. | Behavioral: Family Counselling and safeguarding<br> <br> |
| No Intervention: Control Group<br>Control group families were followed in usual care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mother-infant interaction (Parent/Caregiver Involvement Scale) |  | Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abuse and neglect outcomes (reported incidences of abuse and maltreatment) |  | Upto six weeks reported incidences of abuse and maltreatment |
Treatment of Anal Fissure by Activated Human Macrophages

Study Overview
=================
Brief Summary
-----------------
Chronic anal fissure is a linear tear in the distal anal canal. Most chronic fissures require intervention to heal. Surgical sphincterotomy is currently performed. However, the procedure permanently weakens the internal sphincter and may be associated with permanent complications such as incontinence. Current topical treatment or  chemical sphincterotomy is effective in the short term for about 70% of the patient more than 50% of them will suffer from recurrence. Number of studies support the hypothesis that local ischemia is the reason for failure to heal in anal fissure. Treatment of refractory wounds by macrophage suspension is an innovative method since 1995, macrophage suspensions have been used successfully in more than 1400 patients in several hospitals in Israel without any side effect.Macrophages have key function in almost every stage of wound healing. They help in the digestion of bacteria, in a later stage, they secret IL-6, which influences endothelial cell proliferation and the initiation of angiogenesis. The study hypothesis is that local injection of activated human macrophages into chronic anal fissure may induce fissure healing.

Official Title
-----------------
Treatment of Anal Fissure by Activated Human Macrophages

Conditions
-----------------
Biological Therapy for Chronic Anal Fissure, Treatment by Biological Factors - Activated Macrophages, Interventional Study

Intervention / Treatment
-----------------
* Drug: Local injection of activated macrophages to anal fissure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive symptomatic adults with chronic idiopathic anal fissure Exclusion Criteria: Pregnant women Acute fissures Anal fissures of various causes ( i.e.,hemorrhoids, fistula in ano, inflammatory bowel disease) Immunosuppressed patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Intervention/Treatment |
| --- |
|Drug: Local injection of activated macrophages to anal fissure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMPLETE FISSURE HEALING |  |  |
Ultrasonographic Predictors of Hypotension After Induction

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the predictive value of the inferior vena cava collapsibility index and caval aorta index for detecting hypotension after induction of general anesthesia.

Detailed Description
-----------------
Since cardiovascular depressant and vasodilatory effects of anesthetic agents, patients may be at risk of hypotension after induction of general anesthesia. Previous studies reported that, for evaluating volume status, some ultrasonographic measurements such as inferior vena cava collapsibility index (IVCCI) could be used. Also some studies stated that measurement of aorta diameter index (IVC : Ao index) is reliable to predict hypotension after induction of spinal anesthesia. At the study, the investigators aimed to investigate the predictive values of the inferior vena cava collapsibility index and caval aorta index under ultrasound guidance in predicting post-induction hypotension in patients under general anesthesia.

Official Title
-----------------
Pre-operative Ultrasonographic Evaluation of Inferior Vena Cava Collapsibility Index and Caval Aorta Index to Predict Hypotension After Induction of General Anesthesia

Conditions
-----------------
General Anesthesia, Hypotension on Induction

Intervention / Treatment
-----------------
* Other: Inferior vena cava-Aorta diameter index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients more than 18 years of age American Society of Anesthesiologists' (ASA) physical status 1 or 2 Exclusion Criteria: BMI more than 30 kg/m² Use of angiotensin converting enzyme inhibitors pregnancy, emergency operations baseline arterial systolic blood pressure less than 90 mmHg mean arterial blood pressure less than 70 mmHg

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Inferior vena cava-Aorta diameter index|Before the induction of general anesthesia, inferior vena cava-Aorta diameter index and inferior vena cava collapsibility index will be measured.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value of IVCCI to detect post-induction hypotension assessed by Receiver operating characteristic (ROC) curve analysis. | Measurement of inferior vena cava collapsibility index. | 20 minutes | 
| Diagnostic value of IVC : Ao index to detect post-induction hypotension assessed by ROC curve analysis. | Measurement of inferior vena cava-Aorta diameter index. | 20 minutes |
Stepwise Screening for Silent Atrial Fibrillation After Stroke

Study Overview
=================
Brief Summary
-----------------
The main hypothesis of this work is that an approach combining clinical parameters and biomarker assays could improve the understanding and prediction of the occurrence of silent atrial fibrillation (AF) in the acute phase after stroke. In this prospective work, the investigators will rely on the Dijon Stroke Registry, which collects extensive clinical data for each patient hospitalized for a stroke. As part of this registry, patients are seen 6 months after stroke to assess their clinical status. This clinical follow-up will allow us to judge the evolution of the AF diagnosed during the acute episode at a distance.

Official Title
-----------------
Stepwise Screening for Silent Atrial Fibrillation After Stroke

Conditions
-----------------
Ischemic Cerebrovascular Accident

Intervention / Treatment
-----------------
* Biological: Blood sample
* Procedure: Long term ECG monitor
* Procedure: Monitoring ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who had an ischemic stroke defined according to WHO criteria and hospitalized in the Stroke Unit at the Dijon University Hospital. Patient 18 years of age and older Patient who has given oral consent Exclusion Criteria: Person not affiliated to a national health insurance scheme Protected adult Pregnant or breastfeeding woman Patient refusing to participate in the study Transfer planned after the stay in the Stroke Unit to a department outside the Dijon University Hospital, not allowing for the long term screening with an external ECG monitor History of atrial fibrillation or atrial flutter Patient wearing a pacemaker or defibrillator with an atrial lead

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

| Intervention/Treatment |
| --- |
|Biological: Blood sample|2 ml of blood for testing for serum biomarkers (IL-6, GDF-15, soluble ST-2 soluble, osteoprotegerin, galectin 3)|
|Procedure: Long term ECG monitor|Fitting and removal of a long term ECG monitor (SpiderFlash, LivaNova)|
|Procedure: Monitoring ECG|Recording of automatic ECG monitor results (CSM Philips IntelliVue MP50 system)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of atrial fibrillation during continuous monitoring in a Stroke unit within six months of stroke. |  | 6 months |
RATE Registry - Registry of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) Episodes in the Cardiac Rhythm Management (CRM) Device Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to produce a prospective, outcome-oriented registry to document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF Diagnostics in select SJM devices.

Official Title
-----------------
Registry of AT/AF Episodes in the CRM Device Population: RATE Registry

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: CRM Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is implanted with a CRM device Patient has no documented history of AF (3 months prior to enrollment) Patient is >18 years of age Patient has life expectancy of >24 months

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 |
| --- | --- |
| No history of AF<br>Patient should not have had a documented history of AF for a period of 3 months prior to enrollment. | Device: CRM Device<br>* Pacemaker, ICD, or CRT device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of atrial tachycardia and atrial fibrillation in a cardiac rhythm management population |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development or exacerbation of HF |  | 2 years | 
| Development of AF |  | 2 years | 
| AT/AF burden |  | 2 years |
Osteochondritis Dissecans of the Knee

Study Overview
=================
Brief Summary
-----------------
Osteochondritis dissecans is a relatively common...

Official Title
-----------------
Outcome of the Knee Osteochonditis Dissecans Patiets in Kuopio University Hospital (1990-2009): A Retropective Analysis

Conditions
-----------------
Osteochondritis Dissecans, Juvenile Osteochondritis Dissecans

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteochondritis dissecans diagnosis code (ICD-8 to -10) in the medical records of KUH Knee OCD verified from the medical records Exclusion Criteria: -Any other medical condition
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 |
| --- | --- | --- |
| Knee pain measured by NRS (numeric rating scale, 0-10) | 0=no pain 10=maximal pain | At the time of recruiting, which is an avarage calculated from all participiants enrolled for this study (estimated avarage follow-up 12-16 years). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm Knee Score and Knee Injury and Osteoarthritis Outcome Score (KOOS) | Lysholm Knee Score and KOOS are validated subjective questionares assessing outcome after knee surgery/injury. | At the time of recruiting, which is an avarage calculated from all participiants enrolled for this study (estimated avarage follow-up 12-16 years). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteochondritis dissecans, Juvenile osteochondritis dissecans, Knee, Osteochondral, Outcome
Academic Performance and Refractive Error

Study Overview
=================
Brief Summary
-----------------
Refractive errors constitute the leading cause of visual disability worldwide and that myopia progresses dramatically when students reach school age. Studies from different countries have reported inconsistent associations between educational outcomes and refractive errors. Therefore, our study aimed to assess the associations of high academic performance with ametropia prevalence and myopia progression in Chinese schoolchildren base on a multicohort observational design.

Official Title
-----------------
The Associations of High Academic Performance With Childhood Ametropia Prevalence and Myopia Progression

Conditions
-----------------
Refractive Errors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schoolchildren in the 1st to 9th grades Exclusion Criteria: schoolchildren unwilling to participate had a history of wearing rigid contact lenses, medical treatment or diseases that could cause poor vision or negatively affect the academic outcomes with unreliable auto-refraction values

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of spherical equivalent refractive (RSE) | A multi-linear regression was used. | up to 3 years |
Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin

Study Overview
=================
Brief Summary
-----------------
The clinical performance of a restorative glass ionomer and bulk-fill resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a restorative glass ionomer [Equia Forte HT, GC, Tokyo, Japan (EHT)] and bulk-fill composite resin [SonicFill2, Orange, CA, USA (SBF)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

Official Title
-----------------
Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin

Conditions
-----------------
Tooth Disease

Intervention / Treatment
-----------------
* Device: Glass ionomer
* Device: Bulk-fill composite


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age range will be 18 to 65 patients should have at least 2 approximal caries lesions require restoration healthy periodontal status a good likelihood of recall availability Exclusion Criteria: poor gingival health adverse medical history potential behavioral problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glass-ionomer<br>Equia Forte HT, GC, Tokyo, Japan (EHT) | Device: Glass ionomer<br>* Equia Forte HT, GC, Tokyo, Japan<br>|
| Experimental: Bulk-Fill<br>SonicFill2, Orange, CA, USA (SBF) | Device: Bulk-fill composite<br>* SonicFill2, Orange, CA, USA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performances of different restorative systems according to USPHS criteria | Two year results according to USPHS criteria | two years |
The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to identify how the body responds to increased dietary protein (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes in blood glucose, hormones, appetite, and energy expenditure will be examined.

Conditions
-----------------
Low Protein Dietary Intake, High Protein Dietary Intake

Intervention / Treatment
-----------------
* Other: Meal Patterning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 21 and older, BMI between 25.0-34.6, Weight Stable for at least 6 mths, body >25%, non smoking, clinically normal blood profiles, non-diabetic. Exclusion Criteria: intermittently been involved in a diet and/or exercise program within the last 3 months, Have no allergies to eggs.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dietary Protein Intake<br>LP intake 3 meals and 6 meals HP intake 3 meals and 6 meals | Other: Meal Patterning<br>* LP intake 3 meals and 6 meals HP intake 3 meals and 6 meals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, protein intake, satiety, eating, meal patterns