louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01762007: The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypospadias
Keywords: hypospadias, bladder outlet obstruction, ultrasonography
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 0
Sex: MALE
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: 13 patients with 6Mo-2Yr old penile hypospadias patients before operation Group 2: 13 patients with 6Mo-2Yr old male patients without hypospadias Group 3: 15 patients with penile hypospadias patients under the age of 5 Yr who got tubularized incised plate operation at out institution at the age between 6Mo and 2Yr old and more than 1 Yr have passed Group 4: 15 patients with 2Yr-5Yr old male patients without hypospadias

Brief summary: Even successfully managed hypospadias without any complication, voiding problem could be developed due to the increased urethral resistance. The investigators are trying to analyze the effect of hypospadias operation on voiding function by checking the detrusor thickness and urinary nerve growth factor.


Eligibility criteria: Inclusion Criteria:

\<Group 1\>

1. 6Mo-2Yr old penile hypospadias patients before operation \<Group 2\>
2. 6Mo-2Yr old male patients without hypospadias \<Group 3\>
3. penile hypospadias patients under the age of 5 Yr who got tubularized incised plate operation at out institution at the age between 6Mo and 2Yr old and more than 1 Yr have passed \<Group 4\>
4. 2Yr-5Yr old male patients without hypospadias1. 0-3 year old children without any abnormality of urinary tract

Exclusion Criteria:

\<Group 1, 2, 4\>

1. patients with history of urethral operation, febrile urinary tract infection, neurogenic abnormality om operation \<Group 3\>

1. patients with history of urethral operation other than hypospadias repair, febrile urinary tract infection, neurogenic abnormality
2. patients with development urethra-cutaneous fistula

Primary outcomes:
measure: Detrusor thickness
timeFrame: immediate analysis of detrusor thickness at the enrollment time of this study
Secondary outcomes:
measure: urinary nerve growth factor level
timeFrame: immediate analysis of urinary nerve growth factor level at the enrollment time of this study
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sang Won
Study officials:
References:
Clinical trial NCT04456907: Systemic Effects After Local Injection of Platelet-rich Plasma
Official title: Systemic Effects After Local Injection of Platelet-rich Plasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Rich Plasma (PRP)
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 24
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective Platelet-rich plasma (PRP) is widely utilized in the treatment of sports injuries with favorable outcomes. However, potential systemic effects after localized PRP injection are unclear at present.

Design: prospective randomized study Methods Twenty-four Taiwanese male athletes with tendinopathy were randomized into a PRP group (n = 13) or a saline group (n = 11).


Eligibility criteria: Inclusion Criteria

- Adult male athletes were diagnosed with tendinitis

Exclusion Criteria:

* Receive local injections and surgery within three months
* Systemic disease
* Diagnosis of anemia

Primary outcomes:
measure: Urinary excretion of endogenous AAS metabolites
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Hosptial
Study officials:
References:
Clinical trial NCT06185907: In-hospital Outcomes of Older Patients With Gastric Cancer and Their Risk Factors
Official title: In-hospital Outcomes of Older Patients With Gastric Cancer and Their Risk Factors: Large Comprehensive Institution-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 3238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males takes up 74% of the entire population, whose median age is 70 years.

Brief summary: The investigators plan to analyze the data of patients with gastric cancer (GC) consecutively hospitalized in Ruijin Hospital, a large tertiary center in China, comprehensively describe the characteristics of GC patients ≥65 years, and assesse their in-hospital outcomes regarding duration, fee, and death. Factors associated with the in-hospital outcomes will be further comprehensively explored.


Eligibility criteria: Inclusion Criteria:

* Older gastric cancer (GC) patients
* With primary malignancies of the stomach (International Classification of Diseases for Oncology, Third Edition \[ICD-O-3\] topology code: C16)
* ≥65 years

Exclusion Criteria:

* With benign, premalignant, or in situ tumors
* With cancers originating from non-stomach sites

Primary outcomes:
measure: Mortality
timeFrame: Up to 1 month
measure: Cost
timeFrame: Up to 1 month
measure: Duration of stay
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
References:
Clinical trial NCT05636007: Early Detection of noctUrnal hypoglyCemiA in TypE 2 Diabetes Using Pulse Rate Variability Measured by a Smartwatch(EDUCATED-Smartwatch)
Official title: Early Detection of noctUrnal hypoglyCemiA in TypE 2 Diabetes Using Pulse Rate Variability Measured by a Smartwatch(EDUCATED-Smartwatch)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypodlycemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 2 diabetes patients with continuous glucose monitoring

Brief summary: In patients with type 2 diabetes, it is necessary to identify and manage nocturnal hypoglycemia as early as possible, so as to reduce the damage caused by nocturnal hypoglycemia.We explore whether smartwatches can provide early warning of nocturnal hypoglycemic events in patients with type 2 diabetes by detecting changes in pulse variability.


Eligibility criteria: Inclusion Criteria:

* 1. ≥18 years old 2.continuous glucose monitoring in patients with type 2 diabetes 3.Agreed to research into the group, and be able to sign the informed consent

Exclusion Criteria:

* 1.Arrhythmia, such as sinus arrest, sick sinus syndrome, atrial fibrillation, atrial flutter 2.Such as acute or chronic infectious diseases,hyperthyroidism and thyroid function did not return to normal pregnancy 3.nursing mothers

Primary outcomes:
measure: nocturnal hypoglycemia
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02149407: Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants
Official title: Efficacy and Safety of Glycerin Suppositories for Treatment of Feeding Intolerance in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Feeding Intolerance
Lead sponsor: King Saud Medical City
Sponsor class: OTHER_GOV
Collaborators: name: Sulaiman Al Habib Medical Group- Arrayan Hospital
First posted: 2014-05-29
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Feeding intolerance is a common problem in preterm infants.


Eligibility criteria: Inclusion Criteria:

* Preterm infants with birth weight equal or less than 1500 g

Exclusion Criteria:

* Significant congenital malformations
* Severity of illness such that death is likely in the first few days after birth

Primary outcomes:
measure: Time to full feeding (days)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
measure: Incidence of feeding intolerance
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Incidence of necrotizing enterocolitis (NEC)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
measure: Incidence of proven late onset infection
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
measure: Incidence of hyperbilirubinemia
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
measure: Length of hospital stay (days)
timeFrame: At discharge from hospital, an expected average of 8 weeks
Other outcomes:
measure: Growth at discharge from hospital
timeFrame: At discharge from hospital, an expected average of 8 weeks
measure: Retinopathy of prematurity (ROP)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
measure: Bronchopulmonary dysplasia (BPD)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
measure: Patent ductus arteriosus (PDA)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
measure: Side effects
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud Medical City
city: Riyadh
country: Saudi Arabia
facility: Sulaiman Al Habib Medical Group
Study officials:
affiliation: KSMC
name: Latifa Almahmoud, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00980707: Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarkers of Asthma
Official title: Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarker of Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Asthma
Keywords: versican
hyaluronan
sputum
Lead sponsor: Associated Scientists to Help Minimize Allergies
Sponsor class: OTHER
Collaborators: name: Benaroya Research Institute
name: GlaxoSmithKline
First posted: 2009-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the role of versican and hyaluronan measurements in induced sputum as biomarkers of asthma. Enroll 10 subjects with mild persistent asthma who are not receiving treatment with a controller therapy.

Detailed description: We will compare spirometry, eNO and sputum measurements of versican and hyaluronan before and after treatment with fluticasone 220 ug/bid.

Eligibility criteria: Inclusion Criteria:

* Allergic asthma defined as a positive methacholine challenge

Exclusion Criteria:

* Non-atopic patients

Primary outcomes:
measure: Compare hyaluronan and versican in asthmatics versus atopic non-asthmatics.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Associated Scientists to Help Minimize Allergies
state: Washington
Study officials:
affiliation: Associated Scientists to Help Minimize Allergies
name: Leonard C Altman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05521607: Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
Official title: Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice in Newborns with High Melanin Content (Chicago)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Jaundice
Lead sponsor: Picterus AS
Sponsor class: INDUSTRY
Collaborators: name: University of Chicago
First posted: 2022-08-30
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.

Detailed description: A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) will be conducted to include a total of 250 newborns with a desired distribution of skin color according to Neomar's scale : skin color 1 and 2: 20%, skin color 3: 30% and skin color 4: 50%. Skin color may also be quantitatively assessed using a handheld spectrophotometer (CM-700d, Konica Minolta).

The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's chest. A validated smartphone with Picterus JP will be used to collect digital images, which are analysed to calculate a Picterus bilirubin value.

Eligibility criteria: Inclusion Criteria:

* Infants born with gestational age \&amp;gt; 35 weeks.
* Birth weight ≥ 1800 grams
* Age 1 - 14 days
* Infants requiring a TSB blood sample for clinically suspected jaundice as part of standard care

Exclusion Criteria:

* Infants showing signs of inborn disease.
* Infants with skin rash or other skin disease that affects the skin where measurements are performed.
* Infants transferred to the pediatric ward for medical treatment.
* Infants that have received phototherapy in the last 24 hours

Primary outcomes:
measure: Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
timeFrame: 3-6 months
Secondary outcomes:
measure: Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.
timeFrame: 3-6months
measure: Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin.
timeFrame: 3-6 months
measure: Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jeanmarie Schied, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03359707: Access to Healthcare and the Right to Health of People Living in Disadvantaged Neighborhoods Around Cayenne in French Guiana
Official title: Access to Healthcare and the Right to Health of People Living in Disadvantaged Neighborhoods Around Cayenne in French Guiana
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Care Acceptability
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: poor populations living in the surroundings of cayenne

Brief summary: ACSES aims to describe the health behaviours and vulnerabilities of poor urban communities living in the greater Cayenne area. It was a questionnaire based study conducted around a red cross truck providing testing.


Eligibility criteria: Inclusion Criteria:

* living in poor neighborhoods around cayenne

Exclusion Criteria:

* minors
* refusal to participate

Primary outcomes:
measure: Healthcare Acceptability - Questionnaire survey
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02824107: Psychosocial Risk Factors in Stroke and Myocardial Infarction
Official title: INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Stroke
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 294
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to identify groups of subjects at risk of recurrence in secondary prevention based on Psychosocial Factors.

The aim is also to propose novel levers to reduce health inequalities in this population so as to develop new prevention strategies for neuro- and cardio-vascular health This study is based on data from questionnaires (Quality of life at work, perceived stress, perceived disease severity) and on behavior indicators (factors related to lifestyle: alcohol, smoking, obesity, sedentarity).

Biomarkers of endothelial function (ADMA) will also be assayed. It's an interventional study because of blood sample


Eligibility criteria: Inclusion Criteria:

* Patients who have provided oral consent to participate
* Patients over 18 years
* Patients hospitalized for type 1 MI or ischemic stroke/TIA \< 24H after symptom onset
* Age \< 65 years
* With a professional activity (INSEE definition) at the time of the neuro or cardiovascular event
* At least one of the following risk factors: current smoking, obesity (waist circumference \> 88 cm (W)/102 cm (M) or a waist/hip ratio 0.85(W)/0.9(M), sedentarity (physical activity \< 150 min / week), alcohol consumption (\> 3 standard glasses per day for men, \> 2 standard glasses/d for women)

Exclusion Criteria:

* Adult under guardianship
* Patients without national health insurance cover
* Pregnant or breast-feeding women
* Clinical state making it impossible to use questionnaires or to measure risk factors
* Stroke or TIA not related to atheroma or cardioembolism (dissection, hemopathy...)
* type \> 1 MI

Primary outcomes:
measure: number of psychosocial factors (PSF) on the level of risk for neuro-cardiovascular disease.
timeFrame: through the completion study an average of 6 month
Secondary outcomes:
measure: study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF
timeFrame: 1st day
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT01179607: Study of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic Subjects With Hypo- or Normonatraemia
Official title: A Randomized, Double Blind, Placebo Controlled, Phase II, Dose-titration Trial to Explore the Safety, Tolerability, Pharmacokinetic Profile and Efficacy of M0002 in Cirrhotic Subjects With Ascites and Hypo- or Normonatraemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cirrhotic Ascites
Lead sponsor: Movetis
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: M0002, an orally active, selective non-peptidergic antagonist of the vasopressin V2 receptor inhibits vasopressin-induced water reabsorption from the kidney. Therefore the aquaretic effect of M0002 has a potential clinical benefit in the treatment of ascites and hyponatreamia in cirrhotic patients.


Eligibility criteria: Main Inclusion Criteria:

1. Subjects with any form of cirrhosis with ascites and who had at least 1 paracentesis of at least 4 liter in the last 6 months.
2. Dose of diuretics of spironolactone and furosemide was to be stable for at least one week prior to the screening visit or subject was refractory to diuretics.
3. Subjects had to have been on a salt restricted diet (\< 5.2 grams sodium/day, 90 mmol) during the screening period prior to the trial drug administration.
4. Other treatment for the management of cirrhosis and ascites should be stable for at least 2 weeks prior to trial drug administration.
5. Child-Pugh B and C liver cirrhosis score lower than 12.
6. Subjects with hyponatraemia with sodium level between 120 and 132 mmol/l or normonatraemia with sodium level between 133 and 145 mmol/l measured at screening visit and day 1.

Main Exclusion Criteria:

1. Women of child bearing potential (WOCBP)
2. Functional transjugular intrahepatic portasystemic stent shunt (TIPS), peritoneovenous shunt
3. Liver transplantation
4. Budd-Chiari syndrome
5. Unstable hepatic disease (acute hepatitis, AST or ALT \> 5 x upper limit of normal, bilirubin \> 10 mg/dL)

Primary outcomes:
measure: Plasma sodium levels, weight, number of paracentesis
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04031807: Risk Factors for Failure After Single-incision Sling Procedure in Women With Stress Urinary Incontinence
Official title: Risk Factors for Failure After Single-incision Sling Procedure. Retrospective Analysis of 132 Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: Single-Incision Sling
Stress Urinary Incontinence
Failure
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 132
Sex: FEMALE
Minimum age (years): 37
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From September 2009 to September 2017, the medical records of the patients who underwentsingle-incision sling procedure for stress urinary incontinence without concomitant pelvic prolapse surgery were analyzed.

Brief summary: The main risk factors for failure after single-incision slings are reduced urethral mobility and stress urinary incontinence severity in long-term follow-up.

Detailed description: The medical records of the 132 patients were retrospectively analyzed. Preoperative assessment included medical history and urogynecological examination. Patients were asked to answer validated questionnaires such as Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). Objective cure of SUI was defined as the absence of demonstrable leakage of urine on the cough stress test. Subjective cure was based on negative response to UDI-6, question 3. Patients were divided according to objective cure rate into two groups: cured (Group A) and failed patients (Group B).

Eligibility criteria: Inclusion Criteria:

Women who underwent single-incision sling procedure for stress urinary incontinence

Exclusion Criteria:

Urodinamically proven detrusor overactivity

Neurogenic bladder

Previous anti-incontinence surgery including midurethral slings

Postvoidal residual volume (PVR) \>100mL

Previous radical pelvic surgery

Anterior pelvic organ prolapse greater than stage I

Primary outcomes:
measure: objective cure
timeFrame: September 2009 to September 2017
Secondary outcomes:
measure: subjective cure
timeFrame: September 2009 to September 2017
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Maltepe University Faculty of Medicine
Study officials:
affiliation: MALTEPE UNIVERSITY FACULTY OF MEDICINE DEPARTMENT OF OB&GYN
name: BERNA HALILOGLU PEKER, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References: