linjc16/ctgov huggingface dataset:
HEAD-Study Optimizing the Treatment of Children With BECTS

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that Levetiracetam is as effective as Sulthiame in the treatment of children with BECTS. Patients entering the HEAD-Studie are either treated with Leveitracetam or Sulthiame over a 6 months period. Patients are equally randomised to one of the two treatment regimens. Administration of medication as blinded capsules.

Official Title
-----------------
HEAD-TO-HEAD Evaluation of the Antiepileptic Drugs Levetiracetam (LEV) vs. Sulthiame (STM) in a German Multi-Centre, Doubleblind Controlled Trial in Children With Benign Epilepsy With Centro-Temporal Spikes

Conditions
-----------------
Epilepsy, Rolandic

Intervention / Treatment
-----------------
* Drug: Treatment with levetiracetam or sulthiame over a six-month period.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 6 and 12 years Weight between 15 kg and 60 kg At least two preceding seizures within the last six months before study start Typical electroencephalogram (EEG) with Rolando focus (centrotemporal spike or sharp-wave-focus) Diagnosis of BECTS Written informed consent from parents and child Exclusion Criteria: Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep [CSWS], Landau-Kleffner-syndrome) Preceding treatment with antiepileptic drugs Mental Retardation (intelligence quotient [IQ] <85) Focal neurological deficit Relevant major internistic disease (e.g. hepatopathy, nephropathy, endocrinopathy) Participation in another clinical trial within the last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Treatment with levetiracetam or sulthiame over a six-month period.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 6 months | 
| Cognitive effects |  | 6 months | 
| Efficacy on EEG pattern |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
benign epilepsy, pediatrics, children, rolandic epilepsy, levetiracetam, sulthiame
Predictors Favoring the Role of Exclusive Enteral Nutrition in Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
To idetify the factors favoring the use of enteral nutrition would be helpful to select preferred patients suitable for enteral nutrition.

Detailed Description
-----------------
Crohn's disease (CD) is a chronic, transmural inflammatory disorder affecting the whole alimentary tract from mouth to anus. Over the past decades, the incidence of CD is either high and stable or low but rising in the worldwide. Although the precise etiopathogenesis of CD remains unknown, a number of lines of evidence showed that inappropriate diet was one of the reasons responsible for the onset of CD, and diet therapy has been gaining increasing attention in the therapeutic work-up of CD. Due to reduced intake and high intestinal losses, over three quarters of CD patients would suffer weight loss. Involvement of small bowel in CD patients made their nutrition status much poorer than ulcerative colitis (UC) patients. Therefore, nutrition support is of great value in the management of CD. It is widely accepted that enteral nutrition could help pediatric CD patients to reach clinical and endoscopic remission, with similar efficacy but less side effects than corticosteroids. However, the value of enteral nutrition in adult active CD is still controversial, with an unstable remission rates ranging from 8% to 100%. Varied characteristics and compliance of enrolled patients might explain this wide range. Considering this, idetification of factors favoring the use of enteral nutrition would be helpful to select preferred patients suitable for enteral nutrition. In this study, we will observe the role of enteral nutrition in active adult CD. The age, gender, serum CRP, albumin, fecal calprotectin, nutritional risk screening 2002 (NRS2002), involved intestinal segments and other items will be correlated with the changes of Crohn's disease activity index (Best CDAI) and CRP in order to idetify the factors favoring the use of enteral nutrition.

Conditions
-----------------
Crohn's Disease, Enteral Nutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as active CD based on clinical presentation, endoscopic and pathology results Has the willing to receive enteral nutrition Exclusion Criteria: No exposure to Glucosteroids or immunosuppressions Complete intestinal obstruction

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- | --- |
| Changes of Best CDAI |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of serum CRP |  | 2 months |
Phase I Study in RAD 001 Patients With Relapse AML

Study Overview
=================
Brief Summary
-----------------
A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse

Detailed Description
-----------------
The primary objective of the study is to determinate the maximal tolerate dose and evaluate the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I study.

Official Title
-----------------
Multicentric Study of GOELAMS Phase I Evaluation of RAD001 in Association With Aracytine and Daunorubicine in AML Treatment in Patients Less Than 65 Years in Relapse More Than One Year After First Complete Remission

Conditions
-----------------
AML

Intervention / Treatment
-----------------
* Drug: RAD 001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients from 18 to 65 years old AML in relapse more than 1 year after CR inform consent signed Exclusion Criteria: age more than 65 cardiac insufficiency renal insufficiency hepatic disease other type of AML blastic MCL HIV positive serology other malignancy pulmonary infection

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
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAD 001<br>RAD 001 in day 1 and day 7 from 10 mg to 50 mg | Drug: RAD 001<br>* RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg<br>* Other names: everolimus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal dose tolerated | 5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step | 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological study | biological study of PI3K/AKT an mTORC1 activation in blast cells | Day 1 and day 7 | 
| Biological study | concentration mesures of RAD 001 in total blood | Day 1 and Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RAD 001 in relapsed AML
The Efficacy of Laser Assisted Hair Removal in the Treatment of Acne Keloidalis Nuchae; a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Laser causes elimination and miniaturization of hair shafts that are the principal contributor to inflammation in Acne Keloidalis Nuchae (AKN).

Conditions
-----------------
Acne Keloidalis Nuchae

Intervention / Treatment
-----------------
* Device: Nd-YAG laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from AKN
Sexes Eligible for Study
-----------------
All

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 |
| --- |
|Device: Nd-YAG laser|All patients received 5 sessions (4 weeks apart) of long pulsed nd-YAG laser assisted hair removal on the affected area, emitting 1064 nm, with a fluence of 35-45 J/cm2 and pulse duration 10-30 msec adjusted to skin type and hair thickness. Laser was applied to all papules and plaques.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global response to treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  | 6 months |
Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

Study Overview
=================
Brief Summary
-----------------
To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori

Official Title
-----------------
Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

Conditions
-----------------
Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive

Intervention / Treatment
-----------------
* Drug: Rabeprazole Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: gastric low-grade mucosa-associated lymphoid tissue (MALT) lymphoma with Helicobacter pylori positive The stages of MALT lymphoma are Lugano International Conference classification Stage I or II 1 and Wotherspoon grade 4 or 5 Exclusion criteria: With diffuse large B-cell lymphoma Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma Corresponding to contraindication of each drug
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Arm 1 Rabeprazole Sodium<br> | Drug: Rabeprazole Sodium<br>* The following 3 drugs are taken orally at the same time twice daily for 7 days: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and clarithromycin 200 mg. The dose of clarithromycin may be properly increased as needed, although the upper limit is 400 mg twice daily. If Helicobacter pylori eradication with proton pump inhibitor, amoxicillin, and clarithromycin fails, the following 3 drugs will be taken at the same time twice daily for 7 days as an alternative treatment for adults: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and metronidazole 250 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of gastric low-grade MALT lymphoma by eradication of Helicobacter pylori |  | Every 3 months within the 1st year and every 6 months | 
| Transition rate to secondary therapy for eradication of Helicobacter pylori |  | Every 6 months within the 1st year and every 12 months as needed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rabeprazole Sodium, Helicobacter pylori, stomach neoplasms
Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability

Study Overview
=================
Brief Summary
-----------------
To compare the accuracy of four lens diameter measurement methods and to study the influencing factors of intraocular lens deviation after operation

Official Title
-----------------
Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability

Conditions
-----------------
Subluxation of Lens

Intervention / Treatment
-----------------
* Procedure: Phacoemulsification and intraocular lens implantation for cataract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Subluxation of the lens is less than 180 degrees; (2) Part of the edge of the lens can be seen in the pupil area after the pupil is dilated Exclusion Criteria: (1) Total dislocation of the lens to the vitreous cavity (2) Patients with small eyeballs and small eyelid fissures (3) Patients younger than 18 years old (4) Congenital cataracts in both eyes (5) Corneal dystrophy or endothelial cell insufficiency (6) Chronic uvea Inflammation (7) Progressive fundus disease (8) Fragile capsular bag (9) Retinitis pigmentosa or pseudocapsular exfoliation syndrome

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 88 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Phacoemulsification and intraocular lens implantation for cataract|Phacoemulsification and intraocular lens implantation for cataract|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens diameter | Measured by related instruments before surgery and calculated by the circumference of the tension ring in the surgical video screenshot | through study completion, an average of 1 year | 
| The eccentric distance of the intraocular lens | The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens. | 1 week postoperation | 
| The eccentric distance of the intraocular lens | The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens. | 1 month postoperation | 
| The eccentric distance of the intraocular lens | The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens. | 3 month postoperation | 
| The tilt angle of the intraocular lens | The angle between the plane of the lens and the plane of the pupil is the inclination of the lens | 1 week postoperation | 
| The tilt angle of the intraocular lens | The angle between the plane of the lens and the plane of the pupil is the inclination of the lens | 1 month postoperation | 
| The tilt angle of the intraocular lens | The angle between the plane of the lens and the plane of the pupil is the inclination of the lens | 3 month postoperation |
Study Of Perennial Allergic Rhinitis In Pediatrics

Study Overview
=================
Brief Summary
-----------------
To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period

Official Title
-----------------
Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis-

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: Cetirizine Dry Syrup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with perennial allergic rhinitis. Giving informed consent. Children with a positive response to specific IgE antibody test. Children assessed as positive in the nasal eosinophil count. Children whose severity score of nasal symptom is 4 or higher. Exclusion criteria: have spastic disease such as epilepsy have a history of drug hypersensitivity are pregnant, lactating or possibly pregnant female Children are sensitive to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods have vasomotor rhinitis and eosinophilic rhinitis have asthma that requires the treatment with corticosteroid have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation have started specific desensitization treatment or nonspecific modulation treatment but who have not reached the maintenance level of treatment have received surgical treatment for reduction and modulation of nasal mucosa redintegration therapy of nasal cavity to improve the degree of nasal airway surgical operation to improve rhinorrhea.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 14 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: Cetirizine Dry Syrup|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the total nasal symptom score (TNSS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic, pediatric, Rhinitis, Perennial
Biomarkers for Therapy Response in Drug-resistant Tuberculosis

Study Overview
=================
Brief Summary
-----------------
Multi-center, observational, prospective cohort study including patients with multidrug-resistant tuberculosis at different sites in Germany. The aim the study is the identification of biomarkers for therapy response.

Detailed Description
-----------------
The increasing rates of multidrug-resistant (MDR) tuberculosis (TB) are causing great concern. The current study that will be conducted at different centers in Germany. Biomarkers for treatment response during the course of the tuberculosis therapy will be evaluated. The study will be conducted with funding of the German Center for Infection Research (DZIF).

Official Title
-----------------
Biomarkers for Therapy Response in Drug-resistant Tuberculosis

Conditions
-----------------
Tuberculosis, Multidrug-resistant

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with confirmed pulmonary MDR-TB Subject able and willing to give informed consent Exclusion Criteria: HIV infection physical or mental inability preventing study participation at the discretion of the investigator member of a vulnerable or special population (prisoner, soldier, mentally ill, under guardianship) age <18 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| M/XDR<br>The M/XDR-cohort will consist of patients with a suspected infection with an M/XDR-TB strain.The suspicion will be held on behalf of molecular biological methods (i.e. GeneXpert, detection of rifampicin resistance with high probability of simultaneous isoniazid resistance). The suspected cases will be confirmed by culture (n= 20). Empirically, less than 10% of the cases have an XDR-TB | Other: no intervention<br>* no intervention<br>|
| Susceptible<br>The non M/XDR-TB cohort will consist of patients with no suspected infection with an M/XDRTB strain. The suspicion will be out ruled on behalf of molecular biological methods (i.e.GeneXpert, detection of rifampicin resistance with high probability of simultaneous isoniazid resistance). The non M/XDR-TB cases will be confirmed by culture (n= 20). Empirically, about 90% of these patients have no drug resistance against first line drugs. | Other: no intervention<br>* no intervention<br>|
| Healthy Controls<br>Healthy controls. | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of biomarkers for therapy response |  | 3 years |
Monochromatic Digital-Pupillometry With Two Automated Devices in Comparison to Manual Measurements on Digital Photographs

Study Overview
=================
Brief Summary
-----------------
Retrospective, analysis of three different methods to measure patients' pupil diameters

Conditions
-----------------
Pupil Examination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: usable measurement values from three different examinations Exclusion Criteria: bad image quality
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 |
| --- | --- | --- |
| Pupils' diameter | Measurement of patients pupil diameter with several methods | September 2016 |