linjc16/ctgov huggingface dataset:
RCT Between UPP and Controls in Adult OSA

Study Overview
=================
Brief Summary
-----------------
To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.

Detailed Description
-----------------
Two arms: the intervention group undergo uvulopalatoplasty one month after baseline polysomnography (PSG1) and a PSG2 6 months after surgery . The control group perform PSG 1 and are then waiting 6 months, thereafter undergo PSG2, then surgery and PSG3 6 months after surgery. All patients are followed for four years with PSG. Patients fill in questionnaires at PSG sessions, and blood pressure control the morning after.

Official Title
-----------------
Randomized Control Trial Between Uvulopalatoplasty and Delayed Surgery (Controls)

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: UPP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AHI of 15 or more Friedmans stage I+II Tonsil size 0-1 BMI<34 ESS värde >7 Failed treatment with CPAP and mandibular device Exclusion Criteria: Severe cardiovascular or neurological disease ASA IV Not interested in surgical treatment

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Uvulopalatoplasty<br>Surgery with cold steel, single sutures of palate and tonsillar pillars including palatopharyngeal muscle | Procedure: UPP<br>* surgery with cold steel in general anesthesia<br>* Other names: Uvulopalatoplasty;|
| No Intervention: Controls<br>Only waiting 6 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography: group differences in changes of apnea-hypopnea index (AHI) | compare the two groups of changes in number of apneas and hypopneas per sleep hour measured with inlab polysomnography, between baseline and follow-up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire: group differences in changes of daytime sleepiness | using validated questionnaire Epworth sleepiness scale measure changes between baseline and follow-up and compare the differences between groups | 6 months | 
| Questionnaire: group differences in changes of general health | using validated question | 6 months | 
| Blood pressure: group differences in changes of blood pressure |  | 6 months |
A Multicenter Registry to Study the Characteristics and Outcomes of Jordanian Heart Failure Patients.

Study Overview
=================
Brief Summary
-----------------
Heart Failure research registry is a collection of computerized information about individuals with heart failure. The database in this registry is obtained from several Jordanian medical centers which will represent an extremely valuable resource for epidemiological research on heart failure patients.

Detailed Description
-----------------
Understanding the cause of Heart Failure (HF) and how the body will respond to it, is critical for an effective treatment. HF is a global problem with significant morbidity and mortality, despite improved understanding of the pathophysiology and a growing range of therapeutic options. Jordanian Heart Failure Registry (JoHFR) will be the first research project of heart failure prevalence in Jordan. It is undertaken by primary healthcare professionals with main aim to improve knowledge about the care of patients with HF. The investigators responsible for conducting this research are physicians and their teams who deal with heart failure patients in their outpatient and inpatient clinic centers including the public and private medical sectors in Jordan's medical community. Standards in the Hashemite kingdom of Jordan complies with the recognized good guideline directed medical practices internationally

Official Title
-----------------
The Jordanian Heart Failure Registry (JoHFR)

Conditions
-----------------
Heart Failure, Chronic Heart Failure, Acute Heart Failure

Intervention / Treatment
-----------------
* Other: observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 18 years or older with Heart Failure diagnosis as defined by internationally recognized guidelines. Current residents of the Hashemite Kingdom of Jordan Exclusion Criteria: Patients who refuse or unable to sign a consent form. Patient inability to follow up with provider

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observational|Heart failure, non interventional|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death | The main objective of the JoHFR is to obtain reliable estimate of rates of cardiovascular death and or hospitalization for decompensated heart failure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| worsening kidney function | as compared to baseline eGFR | 12 months |
Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.

Official Title
-----------------
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of a Single Oral Dose Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

Conditions
-----------------
Typhoid Fever

Intervention / Treatment
-----------------
* Biological: Ty800 (Salmonella typhi) Oral Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Males or Females aged 18 to 55 years, inclusive Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol Exclusion Criteria: History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame. People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Ty800 (Salmonella typhi) Oral Vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity |  | Baseline through Day 14 | 
| Reactogenicity |  | Baseline through Month 1 follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longterm safety and immunogenicity |  | Month 1 to 6 post-dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of Typhoid Fever in Adult Travelers
Inflammation in Children With Attention-Deficit/Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the inflammatory response in children with this disorder.

Detailed Description
-----------------
Attention deficit-hyperactivity disorder (ADHD) is a prevalent childhood neuropsychiatric disorder, characterized by age-inappropriate and impairing levels of inattention, hyperactivity and impulsiveness. Approximately 5-10% of school-age children are affected by ADHD, and in many cases, symptoms persist into adolescence and adulthood. Cytokines are key mediators of immune function and can be either pro-inflammatory or anti-inflammatory. Recently few studies have suggested involvement of cytokine pathways in subjects with ADHD. Polymorphism of IL-1 receptors antagonists' alleles have been suggested in families and subjects suffering from ADHD. Moreover, a new variant of inflammatory bowel disease, another immunological based disease, was recently suggested in children with ADHD and other developmental disorders. There are no other published reports on cytokine production in children who suffer from ADHD.

Official Title
-----------------
Inflammation in Children With Attention-Deficit/Hyperactivity Disorder

Conditions
-----------------
Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
-----------------
* Procedure: Blood drawing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A defined condition of ADHD according to TOVA test (TOVA score > (-1.8), Connor's questionnaire (Connor's score > 15 points) and Achenbach's questionnaire; A consent form signed by parents or legal guardianships; Exclusion Criteria: A history of any other neurological or major psychiatric disorder or other significant medical problems; No current medications;

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 13 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood drawing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, Cytokines, CR-P
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: suvorexant
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peri- or postmenopausal women DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes Some awakenings co-occur with a hot flash Score on the Insomnia Severity Index (ISI) measure ≥15 Hot flashes present, including at night Exclusion Criteria: Diagnosis of other primary sleep disorders Shift workers Current or expected use of hypnotic medications Current major depressive episode Lifetime history of bipolar disorder, psychosis, or other serious mental health problem Current alcohol/substance use disorder Obesity Renal or hepatic disease Pregnancy or breastfeeding Recent malignancy Recent surgery Neurological disorder or cardiovascular disease raising safety concerns Medical instability considered to interfere with study procedures Concomitant medications with drug interaction or co-administration concerns Contraindications or allergic responses to suvorexant Recent or planned travel across time zones Excessive coffee or cigarette use

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: suvorexant<br>suvorexant 10-20 mg taken at bedtime for four weeks | Drug: suvorexant<br>* 10-20 mg taken at bedtime for four weeks<br>* Other names: Belsomra;|
| Placebo Comparator: placebo<br>placebo taken at bedtime for four weeks | Drug: placebo<br>* placebo taken at bedtime for four weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-person Change in ISI Score | The Insomnia Severity Index (ISI) is a scale comprising seven questions scored 0-3. The total ISI score is the sum of all questions, with a total range from 0-21 with higher values indicating worse insomnia. Within-person change in ISI score from baseline to 4 weeks was calculated. | baseline and 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insomnia, hot flashes, menopause, suvorexant, belsomra
Determination of the ED50 and ED95 of Prophylactic Norepinephrine Infusion for Preventing Post-induction Hypotension in Elderly Patients Undergoing Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to determine the ED50 and ED95 of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients undergoing major abdominal surgery using up-and-down sequential method . The main question it aims to answer is: What is the effective concentration of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients. Participants will receive different concentrations of norepinephrine infusion at the beginning of anesthesia induction until 15 minutes after intubation.

Official Title
-----------------
Second Affiliated Hosptial， School of Medicine, ZheJiang University

Conditions
-----------------
Norepinephrine, Post-induction Hypotension

Intervention / Treatment
-----------------
* Drug: norepinephrine bitartrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 65 to 80 years Undergoing major abdominal surgery American Society of Anesthesiologists (ASA) physical status of I/II/III Exclusion Criteria: Patient refusal Severe untreated or uncontrolled hypertension despite medications Bradycardia (heart rate < 50 beat per minute) Cardiac morbidities, heart block greater than the first degree Severe hepatic and renal dysfunction hyperthyroidism vascular diseases BMI>30 Monoamine oxidase inhibitors were used 2 weeks before surgery

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

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: Norepinephrine<br> | Drug: norepinephrine bitartrate<br>* The treatment group will receive a continuous infusion of norepinephrine at the beginning of anesthesia induction until 15 minutes after intubation. The dosage of norepinephrine was decided by the up-and-down sequential allocation method with an initial dose of 0.05 µg/kg/min and a 0.005 µg/kg/min gradient.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypotension | less than 80% baseline blood pressure less than 80% baseline blood pressure less than 80% baseline blood pressure | 15 minutes after intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of bradycardia | heart rate less than 50 beat per minute | 15 minutes after intubation | 
| incidence of reactive hypertension | increased mean arterial pressure by > 20% of the baseline reading | 15 minutes after intubation |
Application and Clinical Effectiveness of Pelvic Reconstruction in Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder in the Male

Study Overview
=================
Brief Summary
-----------------
To study the effect of pelvic reconstruction on early return of continence after robot-assisted radical cystectomy-orthotopic ileal neobladder in the male.

Detailed Description
-----------------
This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy-orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to whether received pelvic reconstruction or not. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Official Title
-----------------
Application and Clinical Effectiveness of Pelvic Reconstruction in Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder in the Male

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: pelvic reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients aged 18 or older. Patients those who are diagnosed with urothelial carcinoma. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder. Patients those who are able to cooperate and complete the follow-up. Patients those who volunteer to participate in this study and sign the informed consens. Exclusion Criteria: Patients thsoe who are diagnosed distant metastasis before surgery. Patients those who are diagnosed with other malignancies. Patients those who had received pelvic radiotherapy or major pelvic operation.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| reconstruction group<br>Patients will receive pelvic reconstruction following radical cystectomy during the operation. | Procedure: pelvic reconstruction<br>* After radical cystectomy, the pelvic reconstruction including the ligation of dorsal vascular complex and posterior reconstruction will be performed on patients.<br>|
| non-reconstruction group<br>Patients will not receive pelvic reconstruction following radical cystectomy during the operation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| day-time and night-time continence rate | Patients were considered continent when they required 0 or 1 safety pad during the day or at night. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative complication rate |  | 3 months | 
| operative time |  | 24 hours | 
| estimated blood loss |  | 24 hours | 
| overall survival |  | 1 year | 
| recurrence-free survival |  | 1 year |
Tracheobronchial Secretion Removal

Study Overview
=================
Brief Summary
-----------------
Patients undergoing intubation and mechanical ventilation require removal of secretion by means of trachoebronchial suctioning. Timing of the procedure is mainly based on clinical parameters. TBA Care® is a new commercially available device designed to generate a signal when secretions are present in the respiratory tract of intubated patients, thus indicating the need for endotracheal suctioning only when necessary and prior to clinical deterioration. In a prospective randomized trial in intubated and mechanically ventilated patients of a general ICU the researchers investigated the efficacy of TBA Care® in detecting the presence of retained secretions compared to the standard indicators.

Conditions
-----------------
Respiration, Artificial, Respiratory Insufficiency

Intervention / Treatment
-----------------
* Device: TBA care device
* Device: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age greater than 18 years presence of an endotracheal tube to provide mechanical ventilation expected duration of mechanical ventilation greater than 48 hours. Exclusion Criteria: age < 18 years, pregnancy presence of active bronchial bleeding

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TBA<br> | Device: TBA care device<br>* Tracheal suction maneuvers are performed according to the indications provided by the TBA care device or to clinical parameters whichever occurs first.<br>|
| Active Comparator: Control<br> | Device: Control<br>* In this group suction maneuvers are performed according to clinical indications or on a fixed schedule whichever comes first.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |