linjc16/ctgov huggingface dataset:
Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate an impact of preoperative bladder underactivity on treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to compare it between the two types of surgery for benign prostatic hyperplasia.

Official Title
-----------------
Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)

Conditions
-----------------
Prostatic Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in whom 12-month follow-up data were available Exclusion Criteria: a previous diagnosis of urethral stricture prostate or bladder carcinoma neurogenic bladder disease a previous history of urological surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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 |
| --- | --- | --- |
| Change from baseline bladder voiding efficiency at 12 months after surgery | bladder voiding efficiency = voided volume x 100 / (voided volume + post-void residual urine volume) | 12-months postoperatively |
Management of Patients With Type 2 Diabetes and Hypertension Using Mobile Health Care System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether cellular phone based health care system is effective in the treatment of diabetes and hypertension.

Detailed Description
-----------------
Diabetes care is facilitated by a patient's being engaged in a self-management program with the advice and counsel of physicians, but many diabetic patients can not receive the continous monitoing and advice from his physician in their every day life. It is very difficult to keep up life style modification in their real life. Few studies have examined the effects of cellular phone based intervention that provide an interactive component daily. Our goal is to test the hypothesis that diabetes and hypertension management using cellular phone based health care system would result in significant improvement of blood glucose and blood pressure level.

Official Title
-----------------
Efficacy of Mobile Health Care System in Patients With Type 2 Diabets and Hypertension

Conditions
-----------------
Diabetes, Hypertension, Obesity

Intervention / Treatment
-----------------
* Device: Mobile Health Care System (DrUB)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type II diabetes using only oral hypoglycemic agents 7% < HbA1c < 10% systolic blood pressure > 130 or diastolic blood pressure > 80 BMI > 23 20 < age < 75 Exclusion Criteria: type I diabetes or type II diabtes using insulin treatment liver, renal or heart disease recent change (within 1 month) in the type or dosage of anti-diabetic agent, anti-hypertensive medication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mobile Health Care System (DrUB)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c, fasting blood glucose level, Weight change, Blood pressure level in the morning, lipid profiles |  | baseline, 3months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise time during one week, self reported change in dietary habit, fat consumption ratio |  | baseline, 3months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mobile Health Units, Chronic Disease
Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.

Conditions
-----------------
Visual Acuity

Intervention / Treatment
-----------------
* Device: Trifocal Intraocular Lens
* Device: Bifocal Intraocular Lens
* Device: Low Addition Bifocal Intraocular Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any gender, aged 50 to 80 years Signed informed consent form Healthy eyes besides cataract Assured follow-up examinations Stable corneal conditions within the last 12 months Corneal astigmatism less than 1D Implantation into the capsular bag by injector Exclusion Criteria: Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders) Pseudophakia Cornea guttata; keratoplasty Irregular astigmatism (e.g. Keratoconus) Corneal scarring Diabetic retinopathy Aniridia Amblyopia Amotio operation; anamnesis with vitreous surgery Pseudoexfoliation Syndrome; Uveitis Previous intraocular and corneal surgery Intraocular tumours; endotamponade Glaucoma or IOP higher than 24mmHg Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR Need for a dioptre out of the range of +16.0D to +26.0D Inability to achieve secure lens placement in the capsular bag Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis Pregnancy or lactation period for female patients

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 809M<br>bifocal intraocular lens (IOL) | Device: Bifocal Intraocular Lens<br>* trifocal intraocular lens (IOL)<br>|
| Active Comparator: 839MP<br>trifocal intraocular lens (IOL) | Device: Trifocal Intraocular Lens<br>* bifocal intraocular lens (IOL)<br>|
| Active Comparator: SN6AD1<br>bifocal intraocular lens (IOL) | Device: Low Addition Bifocal Intraocular Lens<br>* low near addition intraocular lens (IOL)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermediate visual acuity |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance visual acuity |  | 12 months | 
| Near visual acuity |  | 12 months |
Breast Cancer in Young Women: Is it Different?

Study Overview
=================
Brief Summary
-----------------
Breast cancer is the leading cancer among women in Saudi Arabia representing almost the third of cancer diagnosed in Saudi women. Breast cancer in Saudi women is more frequently observed at young age. The data on this observation is either lacking or scares. Furthermore, the pathological and molecular features of breast cancer in young women are not clear. The study will provide important information to the national health care planner about this disease in young women including shedding light on possible genetic risk factors

Detailed Description
-----------------
The study is a prospective longitudinal cohort study of young women with breast cancer. Over a 3-year period, we aim to identify a total of 600 women with newly diagnosed breast cancer, of those 300 women age 40 and younger and 300 older women from academic and community health care institutions across the Riyadh area. It is anticipated at least 400 of these women will agree to participate in the study. The comparable control group of older patients with breast cancer will be used for study comparison. Patient surveys, medical record review, and blood and tissue collection will be utilized. Women will be surveyed every 6 months after diagnosis. The study will investigate short and long-term disease and treatment issues, and psychosocial concerns. We will also collect tumor and blood samples to characterize the pathological and molecular aspects of tumors, and establish tumor bank for future studies.

Official Title
-----------------
Breast Cancer in Young Women: Is it Different?

Conditions
-----------------
Female Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Diagnosis of breast cancer Age 40 or younger at diagnosis for study group and older women for control group Informed consent obtained from patient Exclusion Criteria: Absence of informed consent

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

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

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 |
| --- | --- | --- |
| experience of breast cancer in young women | To identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer in King Abdulaziz Medical City and other collaborating hospitals to assess a broad range of variables at baseline and over the course. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer
A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop taste profiles of iberdomide and mezigdomide drug substances and oral formulation prototypes in order to develop a pediatric oral form of iberdomide and mezigdomide.

Official Title
-----------------
An Open-label Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants

Conditions
-----------------
Healthy Participants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is qualified based on training and experience. Participants must be trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations. Training is initially accomplished by tasting model compounds and learning to recognize and describe these accurately. These abilities are then honed and refined through additional experience in performing taste profiling. Participant is qualified based on training and experience. Senopsys LLC will provide all participants. Participants must be trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations. Training is initially accomplished by tasting model compounds and learning to recognize and describe these accurately. These abilities are then honed and refined through additional experience in performing taste profiling. Exclusion Criteria: Participant has any history of any illness, medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might confound the results of the study or places the participant at unacceptable risk if he or she were to participate in the study. Participant has a known hypersensitivity to mezigdomide, iberdomide, thalidomide, lenalidomide, or pomalidomide. Participant is a female that is pregnant, breastfeeding, or is a women of childbearing potential (WOCBP).

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 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 |
| --- | --- |
| Healthy participants who perform taste evaluations<br>A maximum of 10 healthy adult participants will complete a maximum of 30 taste assessment days, to evaluate the taste characteristics of iberdomide or mezigdomide on each taste assessment day. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste Evaluation - Aromatic Identity |  | Up to 3 Months | 
| Taste Evaluation - Amplitude |  | Up to 3 Months | 
| Taste Evaluation - Mouthfeel |  | Up to 3 Months | 
| Taste Evaluation - Off-notes |  | Up to 3 Months | 
| Taste Evaluation - Aftertaste |  | Up to 3 Months |
Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and effective add-on therapy for resistent depression in adolescent patients. A group of adolescents suffering from non psychotic major depression that was resistant to at least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent procedure for both parents and patients, patients will go through a clinical and cognitive evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30 sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.

Official Title
-----------------
The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study

Conditions
-----------------
Adolescent Depression

Intervention / Treatment
-----------------
* Device: repetitive transcranial Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 15-18 years old Right hand dominant Suffering from major depression CDRS > 60 At least 3 months of current depressive episode Failed 2 drug trials (or 3 drug trials if trial terminated prematurely due to side effects) and at least 1 course of psychotherapy No contraindication for rtms (safety questionnaire) No change in pharmacotherapy in the last month Exclusion Criteria: Schizophrenia or psychotic symptoms Hypertension Epilepsy History of major head trauma Metal implements in the head History of neurosurgery History of severe head migraine History of hearing loss or sp cochlear transplantation Pregnancy Current drug abuse Unstable medical condition History of manic episode Current treatment with lithium or tricyclic or tetracyclic antidepressants

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 18 Years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS<br> | Device: repetitive transcranial Stimulation<br>* rTMS using the figure of 8 magstim for 4 weeks or 20 work days, using 100% threshold to the LDPFC 42 trains per day 4 sec pretrain inter train interval of 30 sec.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Depression Rating Scale (CDRS) comparison before after therapy |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescent resistant depression, repetitive transcranial magnetic stimulation, treatment of resistant adolescent depression
Dental and Oral Finding in Israeli Children With Past Intrauterine Growth Retardation (IUGR)

Study Overview
=================
Brief Summary
-----------------
oral status and early childhood caries (ecc) in israeli children with past IUGR

Official Title
-----------------
Dental and Oral Findings in Israeli Children With Past IUGR - a Comprehensive Study

Conditions
-----------------
Dental Caries

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children who were born and diagnosed with IUGR Exclusion Criteria: children whos mothers have been diagnosed with diabetes or high blood pressure children with genetic disorders multiple babies pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 4 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| past IUGR<br>3-4 y old children with past IUGR | Other: no intervention<br>* no intervention<br>* Other names: past IUGR;|
| control<br>3-4 y old healthy children | Other: no intervention<br>* no intervention<br>* Other names: past IUGR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral status of children with past IUGR |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
past IUGR, ECC, oral findings in children with past IUGR
Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers

Study Overview
=================
Brief Summary
-----------------
Sensory coverage in the finger continues to be a challenging problem. This study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.The main evaluated outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, fingertip pain and joint motion.

Detailed Description
-----------------
Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Tinel's sign was rated as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma.

Conditions
-----------------
Soft Tissue Injuries

Intervention / Treatment
-----------------
* Procedure: Flap including bilateral nerve branches


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a soft-tissue defect in the areas where sensory return was considered important ●a defect with exposed bone or tendon in one finger the defect associated with the transected digital nerves in both sides a defect greater than 1.5 cm a patient aged 15 to 60 years Exclusion Criteria: injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor injuries to the dorsal branches of the digital nerves that precluded its use as donor nerves attached with the flap a defect less than or equal to 1.5 cm patient age < 15 years or > 60 years

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bilaterally innervated flap<br>Two nerve branches attached with the flap for sensory reconstruction. | Procedure: Flap including bilateral nerve branches<br>* Two nerve branches are attached with the flap for sensory coverage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static 2PD test | We use a Disk-Criminator to test two nearby points when touching the flap | 18 months to 24 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Soft tissue defect, dorsal branch of the digital nerve, dorsal branch of the digital artery, dorsal digital flap
Ulinastatin in Inhalation Lung Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.

Official Title
-----------------
Multicenter,Randomized,Parallel Assignment,Blank Control Study of Ulinastatin in Inhalation Lung Injury

Conditions
-----------------
Inhalation Injury

Intervention / Treatment
-----------------
* Drug: ulinastatin
* Drug: blank group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe inhalation lung injury Within 48hours after inhalation injury Age 18 to 70 years old Burned area not more than 70% TBSA Signed the informed consent form Exclusion Criteria: Pregnancy or lactation Allergy for ulinastatin Received an investigational drug or device within 90 days prior to entering study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: blank control group<br> | Drug: blank group<br>* standard treatment<br>|
| Experimental: ulinastatin group<br>ulinastatin is a multivalent kunitz-type serine protease inhibitor refined from human urine | Drug: ulinastatin<br>* Resolved 4 vials of drugs in 100ml physiological saline solution,intravenously infused for 1-2h,tid,for continuous 10days<br>* Other names: brand name: noan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | until death or discharge from hospital, data reviewed every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of mechanical ventilation |  | from admission to 90 days | 
| length of ICU stay |  | until death or discharge from hospital, data reviewed every 3 months | 
| length of hospital stays |  | until death or discharge from hospital, data reviewed every 3 months | 
| blood inflammatory mediator |  | 0days,5days and 10days | 
| Bronchoscopy morphological evaluation |  | 0days,5days and 10days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ulinastatin, inhalation injury