linjc16/ctgov huggingface dataset:
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation. Gain of weight, length and head circumference, date of the beginning of enteral feedings, length of time to recover birth weight and age of hospital discharge will be recorded and compared between both groups.

Detailed Description
-----------------
Preterm infants birth weight equal or less than 1500 grams and gestational age equal or less than 32 weeks will be randomized in two groups: standard care that will receive the usual treatment applied to all infants admitted to our unit and a second groups that will receive standard care plus maternal tactile and kinesthetic stimuli that will be taught to the mothers. Randomization will be performed among those that accept to participate in the study. Growth (birth, length and head circumference), age of life to start receiving enteral feedings, length of hospital stay, time to recover birth weight will be recorded and compared between both groups.

Official Title
-----------------
Effect of Maternal Tactile and Kinesthetic Stimulation on Length of Hospital Stay of Very Low Birth Weight Infants

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Behavioral: Tactile stimulus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm newborns with birth weight equal to or less than 1500 grams and gestational age equal to or less than 32 weeks. Mother willing to participate in study. Exclusion Criteria: Major congenital malformations Congenital infectious diseases Mother not willing to participate in study

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 3 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Experimental: 2<br>tactile stimulus | Behavioral: Tactile stimulus<br>* four times a day<br>* Other names: massage therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on beginning of enteral feedings |  |  | 
| growth during hospitalization |  |  |
Colonic Duplication; Two Cases Report and Review of Literature

Study Overview
=================
Brief Summary
-----------------
Duplicated colon appendix are infrequent detected during surgical exploration. For Diagnosed cases, excision of the duplicated part is indispensable, due to risk of malignancy.

Detailed Description
-----------------
Alimentary tract duplication represents(ATD) 0.2% of all pediatric congenital malformations Which affect all gastrointestinal tracts (GIT) from the mouth to the anus. ATD more common in with no familial or racial predilection. The ileum is the most common site (30%-35%) and the colon is the least common site (7%-20%). The transverse colon is the most common site for colonic duplication. The duplicated part of GIT maybe in the mesenteric or anti-mesenteric side. It may has same vascular supply and mesentry or not(reported only in small bowel).. Communication between the anomalous and actual enteric lumens may or may not be present. Here in, two cases of colonic and anal duplication add to the knowledge with review of literature of duplicated colon in children.

Official Title
-----------------
Colonic Duplication; Two Cases Report and Review of Literature

Conditions
-----------------
Colonic Diseases

Intervention / Treatment
-----------------
* Other: colonic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients till age of 18 years old All patients diagnosed with duplicated colon with or without symptoms Patients with duplicated colon and other associated colorectal anomalies Exclusion Criteria: Patients > 18 years with duplicated colon All patients with duplication cyst

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: colonic surgery|resection of duplicated colon|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post duplicated colon resection constipation by Bristol stool scale | Bristol stool form scale it range from type 1 (separate hard lumps,like hard nuts) to type 7 stool (Watery, no solid pieces ENTIRELY LIQUID) | 6 months |
The Feasibility Study of the Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period

Study Overview
=================
Brief Summary
-----------------
Investigators aim to collect endometrial sampling with Li Brush among target population who have risks for endometrial neoplasm, then Fractional curettage should performed with these participants, investigators intend to compare the pathological diagnosis results of cytology and fractional curettage to evaluate the sensitivity of Li Brush and investigators expect that the brush can be used for screening of endometrial cancer in the postmenopausal period in the clinic.

Detailed Description
-----------------
Investigators screen the suitable participants according to the inclusion and exclusion standards, and then collect their endometrial sampling with Li Brush. Pathologists will help to decide the cytology obtained by Li Brush and histology diagnosis of the endometrial sampling. Comparing the pathological diagnosis results of cytology and histology, investigators want to prove the feasibility of cytology diagnosis of endometrial cancer in the postmenopausal period, as the same time, investigators intend to evaluate the possible factors that affecting the precision of Li Brush for endometrial cancer in the postmenopausal period.

Official Title
-----------------
The Feasibility Study of Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period

Conditions
-----------------
Endometrial Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal abnormal uterine bleeding; Ultrasound of the pelvic showed thickened endometrial ( usually more than 5mm) ; Family history of endometrial cancers; Other participants with risks for endometrial cancer (such as fat, Lynch Syndrome and so on) Exclusion Criteria: Cervical cancer; Fever (body's temperature is higher than 37.5 degrees ); Vaginitis (excluding atrophic vaginitis); Patients who cannot bear the operation; Coagulation disorders; Pregnancy and suspected pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| endometrial neoplasms<br>patients with risk of endometrial cancer in the postmenopausal period | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the new diagnosis method with gold standard via Kappa statistic | Kappa statistic will be used to access the agreement of the two diagnosis results. The diagnosis result is dichotomous data: having endometrial cancer or not. The safety risk is the same as it of the gold standard. | one week within the enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postmenopause, endometrial sampling, vaginal bleeding
Novel Association of Cholesterol Ester Storage Disease Due to Lysosomal Acid Lipase Deficiency and Non-Alcoholic Fatty Liver Disease: A Prospective Clinical Study

Study Overview
=================
Brief Summary
-----------------
Non-alcoholic fatty liver disease (NAFLD) is a world-wide problem with a global prevalence estimated at 1.5 billion people. It is characterised by significant diversity and phenotypic heterogeneity. Morbidity rates are estimated at 20% to 30% in Western adults, increasing to 90% in patients who are morbidly obese or diabetic. Risk factors in non-obese NAFLD patients are of especial practical and theoretical importance. Cholesterol Ester Storage Disease (CESD) is an autosomal recessive chronic disease of variable phenotype, caused by a deficiency in lysosomal acid lipase (LAL) and characterized by accumulation of fat in tissues and organs. Hepatic accumulation of fat in this disorder can cause hepatomegaly with varying degrees of damage varying from steatosis to fibrosis, elevated aminotransaminases, and isolated splenomegaly. Since the contribution of LAL deficiency to non-obese NAFLD is poorly understood, the investigators propose to evaluating the association between NAFLD and LAL deficiency in a prospective study in our population.

Conditions
-----------------
Non-alcoholic Fatty Liver Disease, Cholesterol Ester Storage Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18-80 years; BMI 25-40; Fatty liver disease (bright liver, hepatomegaly by ultrasound (Liver span > 15 cm mid clavicle line), splenomegaly (>13 cm) or both. Exclusion Criteria: Alcohol abuse>30 gm/day, or > 70 gram per week; Soft drink abuse; Drugs known to cause fatty liver; Chronic hepatitis (B and C); Biliary liver disease; Autoimmune hepatitis; HIV; Genetic/Metabolic liver disease (Wilson, alpha-1 antitrypsin, CF); Failure to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| NAFLD<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver ultrasound, ultrasound Doppler of the common carotid artery, hepatic Fibroscan evaluation (transient elastography) for assessment of steatosis and fibrosis |  | year |
Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients

Study Overview
=================
Brief Summary
-----------------
Prospective single arm, single center observational study to assess the nutritional status and the nutrient supply during hospitalization for elective gastrointestinal surgery.

Official Title
-----------------
Assessing Nutritional Status and Nutrient Supply in Hospitalised Patients Undergoing Major Abdominal Surgery of the Gastrointestinal Tract

Conditions
-----------------
Colorectal Cancer, Esophageal Cancer, Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective surgery of the upper or lower gastrointestinal tract mental and verbal ability to understand, read and write in German language written informed consent for study participation Exclusion Criteria: age <18 years inadequate ability to be compliant with the study protocol or to complete documentation for the Food frequency questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Change in nutritional status | Controlling Nutritional Status (CONUT) score will be assessed at baseline and on postoperative day 7 | 24 hours pre-surgery and 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake | Dietary intakes are collected by Food Frequency questionnaires and the data are expressed as the kilocalories (kcal) consumed per day | 1 day before surgery, the day of surgery and up to 7 days after surgery | 
| Change in plasma amino acid levels | Blood sample analysis | 24 hours pre-surgery up to 7 days after surgery | 
| Change in beta-hydroxybutyrate levels | Blood sample analysis | 24 hours pre-surgery up to 7 days after surgery | 
| Change in free fatty acid levels | Blood sample analysis | 24 hours pre-surgery up to 7 days after surgery | 
| Change in triacylglycerides levels | Blood sample analysis | 24 hours pre-surgery up to 7 days after surgery | 
| Change in low density lipoprotein levels | Blood sample analysis | 24 hours pre-surgery up to 7 days after surgery | 
| length of hospital stay |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutrition, Surgery
Safety and Efficacy of Lastacaft® for the Prevention of Itching Associated With Allergic Conjunctivitis in Korea

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study will assess the safety and efficacy of Lastacaft® Opthalmic Solution 0.25% (Alcaftadine) for the prevention of itching associated with Allergic Conjunctivitis as prescribed as standard of care in clinical practice in Korea.

Official Title
-----------------
Evaluation of the Safety and Effectiveness of Lastacaft® Ophthalmic Solution 0.25% (Alcaftadine) for the Prevention of Itching Associated With Allergic Conjunctivitis: A Postmarketing Surveillance Study in Korea

Conditions
-----------------
Conjunctivitis, Allergic

Intervention / Treatment
-----------------
* Drug: Alcaftadine Ophthalmic Solution 0.25%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with itching associated with allergic conjunctivitis. Exclusion Criteria: -Patients with hypersensitivity to Lastacaft® or its components.

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| Lastacaft®<br>One drop of Lastacaft® Ophthalmic Solution 0.25% (Alcaftadine) in each eye daily as prescribed as standard of care in clinical practice. | Drug: Alcaftadine Ophthalmic Solution 0.25%<br>* Alcaftadine Ophthalmic Solution 0.25% (Lastacaft®) as prescribed as standard of care in clinical practice.<br>* Other names: Lastacaft®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | 2 Weeks |
Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study

Study Overview
=================
Brief Summary
-----------------
This study was conducted to develop and validate integrated eye tracking and EEG measures for assessment of mild traumatic brain injury.

Official Title
-----------------
Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study

Conditions
-----------------
Mild Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 -55, ability to use left and right hands and right foot to complete cognitive and motor tasks without adaptive equipment, and fluent in English Exclusion Criteria: history of severe TBI, history of neurological illness unrelated to TBI, vision problems that are uncorrected by contacts or glasses, history of psychotic disorder, or current homicidal or suicidal ideation or intent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Individuals without traumatic brain injury | |
| Mild TBI<br>Individuals with mild traumatic brain injury | |
| Moderate to Severe TBI<br>Individual with moderate to severe traumatic brain injury | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saccadic RT | Saccadic Response Time | 1 day (single time point) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic brain injury, concussion, eye tracking, EEG, fMRI, DTI, Neurocognition
Dermacyd Silver Frutal (Lactic Acid) - Compatibility.

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd Silver Frutal (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: LACTIC ACID(ND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Phototype Skin I,II, III e IV Integral skin test in the region Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion Exclusion criteria: Lactation or pregnancy Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection Diseases which can cause immunosuppresion, such as diabetes, HIV Personal history of atopy History of sensitivity or irritation for topic products Cutaneous active disease (local and/or general) which can modify the study results Use of new drugs and/or cosmetics during the study Cutaneous reaction Previous participation in studies using the same product in test Volunteer which has immunodeficiency congenital or acquired Relevant history or confirmation of alcohol or other drugs abuse Intolerance detected or suspected for some component of the sample tested Medecin or sponsor employees or their close family. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd Silver Frutal (Lactic Acid)<br>Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample. | Drug: LACTIC ACID(ND)<br>* Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 21 consecutive days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale. |  | from the treatment start to the end of the study (treatment period 6 weeks) |
Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).

Official Title
-----------------
2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin NPH
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Currently on basal-bolus regimen BMI = 35.0 kg/m2 HbA1c =11.0% Exclusion Criteria: Proliferative retinopathy or maculopathy Recurrent major hypoglycaemia Cardial problems Uncontrolled hypertension Impaired hepatic or renal function

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|
|Drug: insulin NPH|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after a two-year trial period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Body weight |  |  | 
| Antibodies |  |  | 
| Body composition |  |  | 
| Blood glucose |  |  | 
| Hypoglycaemia |  |  |