linjc16/ctgov huggingface dataset:
Psychosocial Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to research psychosocial and socioeconomic factors among families that might affect glycemic control in children and adolescent with type 1 diabetes mellitus. These factors might be: living conditions, structure of the family, socioeconomic status, divorces and parent's own glycemic control status (if parent's type 1 diabetes mellitus is present in the family).

Detailed Description
-----------------
This study is going to clarify if there are some socioeconomical or psychosocial factors that might influence child's type 1 diabetes mellitus glycemic control. Study population consists of 300-350 diabetic children aged 1-16 years who have diabetic controls at Tampere University Hospital and their families. Required information is going to be collected with 2 questionnaires, wich families are kindly asked to fill in.

Official Title
-----------------
Psychosocial and Socioeconomic Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetic children aged 1-16 years and their parents. Patient's and parents' willingness to participate Exclusion Criteria: Type 1 diabetes duration under 1 year. Difficulties to understand written finnish. -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 16 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 |
| --- | --- |
| Diabetic children aged 1-16 years and their families<br>Diabetic children aged 1-16 years and their families. A child's disease duration must be over 1 year so that possible remission period is over. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's type 1 diabetes glycemic control | Socioeconomic and psychosocial factors affecting in type 1 diabetes glycemic status in children | Through study completion, an average 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents' divorce rate | Frequency of parent's divorces in a family with a child with type 1 diabetes | Through study completion, an average 5 years | 
| Parent's type 1 diabetes glycemic status | Possible parent's own type 1 diabetes glycemic status correlation with a child's type 1 diabetes glycemic control | Through study completion, an average 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycemic control, Children, Psychosocial and socioeconomic factors
Haufen Diagnostic Biomarkers of BK Renal Disease

Study Overview
=================
Brief Summary
-----------------
To prospectively test whether the detection of three-dimensional, cast-like polyomavirus aggregates, termed Haufen, in voided urine samples can serve as an accurate biomarker of intra-renal disease, i.e. polyoma-BK-virus nephropathy (PVN). We want to correlate the detection of 'Haufen' with histologic findings made in renal biopsies as well as signs of polyomavirus activation, i.e. viremia and viruria. The prospective study is designed to further validate our retrospective findings (manuscript in press, J Am Soc Nephrology) and more specifically to correlate 'Haufen' shedding with the histologically confirmed course of PVN.

Official Title
-----------------
Polyomavirus Aggregates, Haufen, in Voided Urine Samples as Diagnostic Biomarkers of Intra Renal BK-virus Disease: a Prospective Proof-of-concept Study

Conditions
-----------------
Polyoma Virus Nephropathy

Intervention / Treatment
-----------------
* Procedure: Renal Allograft Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Recipient of renal transplant Positive for polyoma virus Haufen cells present in urine Positive for polyoma virus nephropathy Exclusion Criteria: anyone who does not meet the inclusion criteria

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Allograft Biopsy<br>Urine left over from clinic visits is analyzed for 'Haufen' by negative staining electron microscopy as a marker of intra-renal polyomavirus nephropathy. Correlate Haufen, urine, and plasma data with the clinical presentation and with renal biopsy findings. Patients with PVN will be approached for study participation in which their routine samples will be monitored until urine is negative for 'Haufen', and a study protocol biopsy will be obtained for confirmation. | Procedure: Renal Allograft Biopsy<br>* A renal allograft biopsy will be performed when the urine is determined to be Haufen negative.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate Haufen, urine and plasma data with the clinical presentation and - in selected cases - with renal biopsy findings. |  | The biopsy will be performed when urine is determined to be Haufen negative |
Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems

Study Overview
=================
Brief Summary
-----------------
To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction.

Official Title
-----------------
Comparison of the Infiniti Vision and the Series 20000 Legacy Systems

Conditions
-----------------
Cataract Extraction

Intervention / Treatment
-----------------
* Device: Legacy 20000
* Device: Infinit system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract Eligible for cataract extraction with primary implantation of a posterior chamber IOL 2 to 3+ cataract density Exclusion Criteria: Preoperative ocular pathology that can affect visual acuity Corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities. Previous intraocular or corneal surgery. Other ocular surgery at the time of the cataract extraction. Surgical Exclusion Criteria: Significant intraoperative intraocular bleeding Detached Descemet's membrane Implantation of the intraocular lens in the anterior chamber or sulcus

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- |
|Device: Legacy 20000|nan|
|Device: Infinit system|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound time |  |  | 
| Amount of fluid used |  |  | 
| Post operative visual acuity. |  |  |
Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether mesalamine is effective vs. placebo in the prevention of diverticulitis flares in a 24-months follow-up. The primary end-point of the study is the incidence of diverticulitis flares. Will be made a clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and altered intestinal motility.

Conditions
-----------------
Diverticular Disease

Intervention / Treatment
-----------------
* Drug: mesalamine
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years both males and females patients positive history of acute diverticulitis flare during the last year. The patients will be recruited only after the complete clinical remission of diverticulitis flare. patients who have given their free and informed consent Exclusion Criteria: complicated diverticulitis(fistulas, stenosis, abscesses and/or bleeding) ascertained hypersensitivity to the salicylates any severe pathology that can interfere with the treatment or the clinical or instrumental test of the trial clinically significant renal or hepatic impairment esophageal, gastric or duodenal ulcer within 30 days prior to randomisation patients with active malignancy of any type, or history of a malignancy (patients with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable) treatment with any investigational drug within the previous 30 days treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety from the tablets recent history or suspicion of alcohol abuse or drug addiction patients who become unable to conform to protocol patients with ascertained pregnancy previous participation in this study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mesalamine<br>Posology: mesalamine: 1,6 g/die for ten days every month for 24 months | Drug: mesalamine<br>* mesalamine: 1.6 g/die for ten days/month until 24 months<br>|
| Placebo Comparator: placebo<br> | Other: placebo<br>* 2 pills/day for ten days/month until 24 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diverticulitis relapse |  | 24 months |
ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.

Official Title
-----------------
A Phase 2b Randomized, Double-blind, Placebo-controlled, 12-week Study to Evaluate the Safety and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation

Conditions
-----------------
OIC

Intervention / Treatment
-----------------
* Drug: ALKS 37
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are at least 18 years of age at time of consent Have a body mass index (BMI)of 19 to 35 kg/m2 at screening Are receiving prescribed opioid medication for the management of chronic, non-cancer pain Meet the criteria of OIC Agree to use an acceptable method of contraception for the duration of the study Exclusion Criteria: Pregnancy and/or currently breastfeeding Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed) Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction Any gastrointestinal (GI) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction Use of naloxone, Subutex or Suboxone, Revia, Vivitrol, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study Participation in a clinical trial of a pharmacological agent within 30 days before screening

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Capsules for oral administration | Drug: Placebo<br>* Capsules for oral administration<br>|
| Experimental: ALKS 37<br>Capsules for oral administration | Drug: ALKS 37<br>* Capsules for oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the weekly average of complete spontaneous bowel movements during treatment |  | Weeks 1 through 4 of treatment |
Explore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI)

Study Overview
=================
Brief Summary
-----------------
The investigators would remind the guardians of observation after immunization via sending short message and collect the information of AEFI by two ways, short message/telephone and website questionnaire.

Detailed Description
-----------------
The investigators will compare the rate between active and inactive surveillance of AEFI

Official Title
-----------------
Phase 4 Study of MR and APDT Vaccine

Conditions
-----------------
Adverse Reaction to Drug

Intervention / Treatment
-----------------
* Other: sending message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According with the regular vaccination Immunization the acellular pertussis diphtheria tetanus vaccine and Measles and rubella combined vaccine Exclusion Criteria: Disapproval the AEFI information
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sending message<br>The investigators would send the tip to the children's guardian | Other: sending message<br>* Sending the suggestive short message<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence about AEFI | Incidence about AEFI comes from the rate between number of adverse event and the all quantity for immunization about MR and APDT | 1.5years |
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets

Official Title
-----------------
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: esterified estrogens 1.25 mg and methyltestosterone 2.5 mg
* Drug: Esterified estrogens 1.25 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-hysterectomized, menopausal women between the ages of 35 and 65 years (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: esterified estrogens 1.25 mg and methyltestosterone 2.5 mg<br>* ESTRATEST® administered orally QD<br>|
| Active Comparator: 2<br> | Drug: Esterified estrogens 1.25 mg<br>* Esterified estrogens 1.25 mg administered orally QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the total score of the Menopause Rating Scale (MRS) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the domain and individual item scores of the MRS |  | 12 weeks | 
| Change from baseline in the domain scores of the MENQOL |  | monthly for 3 months | 
| Comparison of changes in hormone levels and correlation with changes in the MRS |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause; Postmenopause; Estrogen; Hormone Therapy
Health Impact Study of Aquatabs in Tamale, Ghana

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to determine whether Aquatabs, a water treatment tablet, reduces diarrheal diseases in a peri-urban population of Tamale, Ghana.

Official Title
-----------------
Health Impact Study of a Water Treatment Tablet, Aquatabs, in Tamale, Ghana

Conditions
-----------------
Diarrhea

Intervention / Treatment
-----------------
* Other: Sodium dichloroisocyanurate (NaDCC) tablets
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Households with at least one child under 5 years old Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Placebo group does not receive Aquatabs. | Other: Placebo<br>* Placebo<br>|
| Experimental: B<br>Intervention arms receives Aquatabs. | Other: Sodium dichloroisocyanurate (NaDCC) tablets<br>* Intervention arm receives NaDCC tablets to use for to disinfect their household water for use for 20L of water. Ideally, disinfection occurs every day.<br>* Other names: Aquatabs;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the impact of Aquatabs on diarrhea among persons in households in Tamale, Ghana. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the microbiological quality of household water among persons living in Tamale, Ghana. |  | 12 weeks | 
| Determine the acceptability of Aquatabs. |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sodium dichloroisocyanurate, water purification, disinfection, Ghana
Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

Study Overview
=================
Brief Summary
-----------------
This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.

Official Title
-----------------
Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Study on Trichuris Trichiura.

Conditions
-----------------
Parasitic Diseases

Intervention / Treatment
-----------------
* Drug: albendazole
* Drug: mebendazole
* Drug: ivermectin
* Drug: albendazole + ivermectin
* Drug: mebendazole + ivermectin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who are enrolled in class one to six Are infected with T. trichiura Whose parent consent and who are willing to participate Exclusion Criteria: Those with acute and chronic diseases other than T. trichiura Those with a history of any serious adverse drug reactions

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>albendazole treatment | Drug: albendazole<br>* albendazole (400 mg on dose)<br>|
| Active Comparator: 2<br>mebendazole treatment | Drug: mebendazole<br>* mebendazole (500 mg one dose)<br>|
| Active Comparator: 3<br>ivermectin treatment | Drug: ivermectin<br>* ivermectin (200 microgram/kg body weight)<br>|
| Active Comparator: 4<br>albendazole + ivermectin treatment | Drug: albendazole + ivermectin<br>* albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight)<br>|
| Active Comparator: 5<br>mebendazole + ivermectin treatment | Drug: mebendazole + ivermectin<br>* mebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record adverse reactions |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment |  | 6 weeks |