linjc16/ctgov huggingface dataset:
Feeding Premature Infants During Non-invasive Respiratory Support

Study Overview
=================
Brief Summary
-----------------
A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support

Official Title
-----------------
Feeding Very-low-birth-weight (VLBW) Premature Infants (<1500g) During Non-invasive Respiratory Support- Continuous Drip Vs. Bolus Gavage Feeding

Conditions
-----------------
Premature Infant, Non-invasive Respiratory Support

Intervention / Treatment
-----------------
* Other: Length of feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants <1500gr, on non-invasive respiratory support Feeding>20 ml/kg/day Exclusion Criteria: Major congenital malformations Unstable infants because of sepsis, central nervous system, cardiac or other significant morbidities Gastrointestinal morbidity such as spontaneous intestinal perforation (SIP) and necrotising enterocolitis (NEC).
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolus gavage feeds<br>Bolus gavage feeds over 15-30 minutes | Other: Length of feeding<br>* Feeds will be given via nasogastric tube over 15-30 min versus 2 hr<br>|
| Experimental: Continuous feeds<br>Continuous feeds over 2.0 hrs | Other: Length of feeding<br>* Feeds will be given via nasogastric tube over 15-30 min versus 2 hr<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation instability as documented by oxygen saturation histograms |  | before dischatge home at an average of 40 weeks gestation | 
| Time to full feeds (TFF) defined as full enteral gavage feeding of 150 cc/Kg/day |  | before dischatge home at an average of 40 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory-length of respiratory support |  | before dischatge home at an average of 40 weeks gestation | 
| Incidence of Necrotising enterocolitis (NEC) as defined by the medical team |  | before dischatge home at an average of 40 weeks gestation |
Translation, Cultural Adaptation and Validation of Urdu Version of VISA-A Questionnaire

Study Overview
=================
Brief Summary
-----------------
This study is designed to translate and validate the VISA-A questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.

Official Title
-----------------
Translation, Cultural Adaptation, and Validation of Urdu Version of Victorian Institute of Sports Assessment - Achilles (VISA-A) Questionnaire for Athletes With Achilles Tendinopathy

Conditions
-----------------
Achilles Tendinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals aged over 18 years and both genders. Athletic population with the diagnosis of unilateral mid-portion or insertional Achilles tendinopathy, paratendinosis, partial tendon rupture with or without retrocalcaneal bursitis. With positive Painful arc sign and Royal London Hospital Test. Healthy individuals. Exclusion Criteria: Complete rupture of Achilles tendon, Pregnant women and those with any history of radicular pain or lower extremity injury Previous surgery

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change being assessed in interpretation of Severity of Achilles tendinopathy.among participants using translated version of VISA-A questionnaire. | VISA-A is consisted of eight questions that measured the domains of pain, function in daily living, and sporting activity. Results range from 0 to 100, where 100 represents the perfect score | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achilles tendinopathy, Validity, Reliability, Translation, VISA-A
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room

Study Overview
=================
Brief Summary
-----------------
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress

Detailed Description
-----------------
In this study, it is aimed to search the efficacy and comfort of the four different non-invasive ventilation modes in the delivery room. HHFNC, NCPAP, NIPPV and NHFO modes are used for the respiratory distress of the late preterm and term babies.

Official Title
-----------------
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress

Conditions
-----------------
Respiratory Disease, Respiratory Insufficiency

Intervention / Treatment
-----------------
* Device: HHHFNC
* Device: NCPAP
* Device: NIPPV
* Device: NHFO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: late preterm and term infants with respiratory distress Exclusion Criteria: intubation for the respiratory distres. major abnormalities

Ages Eligible for Study
-----------------
Maximum Age: 2 Hours

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HHFNC<br>In this group patients will receive respiratory support by high flow nasal cannula. | Device: HHHFNC<br>* noninvasive ventilation modality<br>|
| Active Comparator: nCPAP<br>In this group patients will receive respiratory support by nasal CPAP. | Device: NCPAP<br>* noninvasive ventilation modality<br>|
| Active Comparator: nIPPV<br>In this group patients will receive respiratory support by nasal IPPV. | Device: NIPPV<br>* noninvasive ventilation modality<br>|
| Active Comparator: nHFO<br>In this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation. | Device: NHFO<br>* noninvasive ventilation modality<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Silverman Score | The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N-PASS score | evaluation of the comfort of the four different noninvasive ventilation modes | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory distress, newborn, noninvasive ventilation
The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial

Study Overview
=================
Brief Summary
-----------------
It is well established that uncomplicated distal ureteroscopy can be safely performed without leaving a ureteral stent. However, many urologists continue to leave ureteral stents following uncomplicated ureteroscopy, regardless of stone location, due to concerns for post-operative complications, patient symptoms and to reduce unplanned medical visits. There is a paucity of data regarding the utility of stent placement for proximal ureteral or renal stones following ureteroscopy. We have designed a prospective, randomized controlled trial to evaluate the role of ureteral stent placement following ureteroscopy and pyeloscopy in proximal and renal stones.

Official Title
-----------------
The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial

Conditions
-----------------
Ureteroscopy

Intervention / Treatment
-----------------
* Device: Placement of ureteral stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients age ranges 18-89 with solitary or multiple proximal ureteral or renal stones 1.5cm or smaller measured in the longest dimension on preoperative imaging (CT or xray). Proximal ureteral stones are those proximal to the pelvic brim in the ureter. Exclusion Criteria: Stone size greater than 1.5 cm on preoperative imaging Pregnancy Stent placement prior to ureteroscopy (pre-stented patients) Patients with solitary kidney

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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: Stent<br> | Device: Placement of ureteral stent<br>* will randomize groups to either receive a postoperative ureteral stent or not.<br>|
| Experimental: No stent<br> | Device: Placement of ureteral stent<br>* will randomize groups to either receive a postoperative ureteral stent or not.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | ED returns, Unplanned OR returns, admissions, UTIs | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective patient symptom scores | symptom questionnaires | 6 weeks |
Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants

Detailed Description
-----------------
Rapid feeding advancement achieves full enteral volume of feedings earlier than the slower advancement.They received significantly fewer days of parenteral nutrition, exhibited a shorter time to regain birth weight and shorter duration of hospital stay. The incidence of NEC and the number of episodes of feeding intolerance were not significantly different between rapid and slow advancement. while the incidence of culture-proven late onset sepsis was significantly less in infants receiving a rapid feeding advancement

Official Title
-----------------
Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants

Conditions
-----------------
Preterm Infant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All preterm neonates admitted to NICU with gestational age less than 36 weeks, and haemodynamically stable Exclusion Criteria: gastrointestinal tract anomalies, haemodynamically unstable infants, gestatinal age equal or more than 36 weeks, preterms who develop NEC, preterms on mechanical ventilation.

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 15 Weeks

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 |
| --- | --- | --- |
| effect of entral feeding on preterm | -Length of hospital stay. | six months |
A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together

Official Title
-----------------
A Randomized, Repeat Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Solabegron (GW427353) in Combination With Oxybutynin in Healthy Adult Subjects.

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: solabegron and oxybutynin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males & females ages 18-65; Body weight >50kg; BMI between 19-32; Signed and dated informed consent; QTc Interval <450 msec; Exclusion Criteria: Resting blood pressure >140/90 mmHg or HR >100 at screening; History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation; Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing; Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study; history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions; history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing; clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: solabegron and oxybutynin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absorption rate of solabegron and oxybutynin |  | as measured by multiple blood draws after repeat dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess bladder function |  | prior to dosing Session 1 and post dose for each session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solabegron,, oxybutynin,, healthy adults,, drug interaction
An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients. Data from eligible patients will be collected for the 6 months following transplantation.

Official Title
-----------------
Retrospective Review of Valganciclovir Efficacy in Preventing CMV Disease in D+/R- Liver Transplant Recipients - A Non-Interventional Program

Conditions
-----------------
Cytomegalovirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver transplant recipients, >/= 16 years of age Transplantation between January 2004 and June 2009 CMV seronegative recipient (R-) who received a liver transplant from a seropositive donor (D+) Valganciclovir therapy for at least 70 days beginning within 10 days post transplantation Assessment of CMV disease status within the first 6 months post transplantation Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis | Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. | 6 months |
Upper Airway Collapse in Patients With Obstructive Sleep Apnea Syndrome by Drug Induced Sleep Endoscopy

Study Overview
=================
Brief Summary
-----------------
This is a prospective, interventional cohort study of drug-induced sleep endoscopy (DISE). The goal is to evaluate the upper airway in a cohort of patients with obstructive sleep apnea hypopnea syndrome (OSAHS) diagnosed in a prior polysomnography. This study correlates the sedation level measured by entropy during DISE using propofol via a TCI pump with the local obstruction patterns of the upper airway according to the VOTE classification. As OSAHS is a widespread disease and the DISE procedure has become a common tool for diagnosis and evaluation of further treatment, a growing number of research articles deal with this topic. These articles are available through pubmed.

Official Title
-----------------
Evaluation of the Upper Airway Collapse in Patients With Obstructive Sleep Apnea Syndrome by Drug Induced Sleep Endoscopy According to the Munich Sleep Video Protocol

Conditions
-----------------
Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Procedure: Drug induced sleep endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented sleep apnea Syndrome with an AHI > 5 diagnosed by polysomnography Exclusion Criteria: active infection performed oral, head or neck surgery, pregnancy, ASA classification III or higher, chronic use of alcohol, sedatives or illicit drugs and chronic obstructive pulmonary disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug induced sleep endoscopy<br>Patients upper airway is assessed by drug induced sleep endoscopy | Procedure: Drug induced sleep endoscopy<br>* Titration of propofol using a target controlled Infusion pump and description of the upper airway according to the VOTE classification<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collapse of the upper airway according to the VOTE classification |  | 30 minutes |
Investigating the Physiological Effects of Weight Loss on Male Fertility

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the physiological effects of weight loss on seminal parameters in male participants with reduced reproductive capacity. Learning more about the physiological role of weight loss on reproductive function and metabolic profile of overweight and obese men may give us a better understanding of male fertility and improve the management of patients with reduced fertility. The effects of weight loss on seminal quality are not well understood.

Detailed Description
-----------------
Participants will receive dietary supplements or National Health Service (NHS) advice on healthy eating to achieve weight loss.

Official Title
-----------------
Investigating the Physiological Effects of Weight Loss on Male Fertility

Conditions
-----------------
Male Infertility, Obesity, Weight Loss

Intervention / Treatment
-----------------
* Dietary Supplement: Low Energy Diet
* Other: NHS advice on healthy eating


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) ≥ 30 kg/m^2 [Part: 1, 2& 3] Evidence of reduced reproductive capacity (e.g. reduced sperm concentration or motility) [Part 3 only] Exclusion Criteria: History of undescended testes, testicular surgery or mumps infection Hormonal therapy such as testosterone or selective oestrogen receptor modulators History of systemic cytotoxic therapy or pelvic radiotherapy Chronic systemic disease, such as cardiac, renal or liver failure At least one of the following: Alcohol intake >30 units per week Smoking daily Recreational drug use at a frequency not less than weekly Acute illness likely to affect the result of study Impaired ability to provide full consent to take part in the study An occupation requiring strenuous physical exercise that may require a high energy diet

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low Energy Diet<br>Commercially available diet products | Dietary Supplement: Low Energy Diet<br>* Caloric restriction to achieve weight loss<br>|
| Other: NHS advice on healthy eating<br>Dietary / lifestyle advice programme | Other: NHS advice on healthy eating<br>* Advice on energy requirements as per the British Dietetic Association<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm concentration | Sperm per ml | 8 to 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male Infertility, Obesity