louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02813109: Urine Biomarkers for Renal Function Monitoring in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Infant
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
Collaborators: name: Hallym University Medical Center
First posted: 2016-06-24
Enrollment: 83
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: below gestational age 37 weeks

Brief summary: The true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr) levels in infants are unreliable as a detector of renal function in the first few days of life because they may continue to reflect maternal levels. Although few candidates appear to be a useful biomarker for kidney injury, scant reference data on these biomarker in preterm infants exist, and studies have yielded conflicting results. Therefore, we aimed to determine the reliable urinary biomarkers to detect kidney injuries in preterm infants.


Eligibility criteria: Inclusion Criteria:

* premature infants born before 37 weeks of gestational age

Exclusion Criteria:

* cardiac or renal anomalies
* transferred in 2 days after birth from other hospitals

Primary outcomes:
measure: correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
timeFrame: postnatal 1day
measure: correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
timeFrame: postnatal 3day
measure: correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
timeFrame: postnatal 5day
measure: correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
timeFrame: postnatal 7day
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center - Kangnam
Study officials:
References:
Clinical trial NCT01158209: An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt
Official title: An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 18 Years of Age, in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-08
Enrollment: 490
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women \>= 18 attending out-patient departments of primary, secondary or tertiary care centres for gynaecological examination and agreeing to provide a cervical sample for human papillomavirus testing.

Brief summary: The purpose of the study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women aged \>= 18 years, attending out-patient health services for gynaecological examination and who agree to HPV testing in Egypt .


Eligibility criteria: Inclusion Criteria:

* Women \>= 18 years of age attending a clinic for gynaecological examination.
* Women who agree to provide a cervical sample for human papillomavirus testing.
* Written informed consent obtained from the subject.

Exclusion Criteria:

* Referral for abnormal cervical sample at the current visit.
* Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed.
* History of hysterectomy.
* Known diagnosis of immunosuppression, or patient on immunosuppressives.
* Pregnant women.
* Having received one or more doses of HPV vaccine prior to participating in the study.

Primary outcomes:
measure: Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing.
timeFrame: Average timeframe: 12 months
Secondary outcomes:
measure: Occurrence of HPV DNA and of any of the HPV types among women of different age-strata undergoing cervical sample testing
timeFrame: Average timeframe: 12 months
measure: Behavioural risk factors assessed by behavioral questionnaire
timeFrame: At the single study visit (Day 0)
measure: Assessing the awareness of HPV in relation to transmission and cause of cervical cancer
timeFrame: At the single study visit (Day 0)
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: GSK Investigational Site
city: Cairo
country: Egypt
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Shaltout MF, Sallam HN, AbouSeeda M, Moiety F, Hemeda H, Ibrahim A, Sherbini ME, Rady H, Gopala K, DeAntonio R. Prevalence and type distribution of human papillomavirus among women older than 18 years in Egypt: a multicenter, observational study. Int J Infect Dis. 2014 Dec;29:226-31. doi: 10.1016/j.ijid.2014.07.029. Epub 2014 Nov 1.
Clinical trial NCT02494609: Oral Contraceptive DDI Study
Official title: A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin (LX4211) and Ortho-Cyclen®, an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy Premenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-07-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin (LX4211) and an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy Premenopausal Women.


Eligibility criteria: Inclusion Criteria:

* Premenopausal females with a body mass index (BMI) between 18 and 32 kg/m2 (inclusive)
* Have not received any oral contraceptives during the Screening period or for at least 15 days prior to the first dose of Period 1

Exclusion Criteria:

* History of any contraindications to the combined oral contraceptive tablet including thrombosis and the history of any thromboembolic disease, recurrent jaundice, acute or chronic liver disease, hormonally-induced migraines, undiagnosed vaginal bleeding, significant hyperlipidemia, and mammary, endometrial, or hepatic carcinoma (known or suspected)
* Prior exposure to sotagliflozin (LX4211)
* History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
* Concurrent conditions that could interfere with safety and/or tolerability measurements
* Women who are breastfeeding or are planning to become pregnant during the study
* Positive serum pregnancy test
* Have taken injectable contraceptives or hormonal intrauterine devices within 12 months prior to the first dose of Period 1 or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of Period 1

Primary outcomes:
measure: Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
timeFrame: Day 6 to Day 8, Day 55 to Day 57, Day 62 to Day 64
measure: Plasma concentration of norgestimate/ethinyl estradiol to evaluate protocol specified PK parameters
timeFrame: Day 55 to Day 57, Day 62 to Day 64
Secondary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: Day 1 to Day 70
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Lexicon Investigational Site
state: Indiana
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Suman Wason, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06363409: The Acute and Accumulative Effects of Snack Foods on Exercise Recovery
Official title: The Acute and Accumulative Effects of Almonds on Exercise Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Strength
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the research is two-fold. One goal is to determine if post-exercise almond or cereal bar consumption can promote muscle gain as well as increasing muscular strength throughout an eight-week weight training program. The other goal is to assess the short-term effects of almonds or cereal bar on recovery that may explain the overall long-term adaptations.


Eligibility criteria: Inclusion Criteria:

* BMIs of 18.5-30 kg/m2
* participate in no more than 3 hours of structured exercise per week

Exclusion Criteria:

* weight training more than 30 min/week,
* smoking,
* use of medications known to impact inflammation,
* musculoskeletal limitations,
* use of supplements within 1 month of participation that are known to impact body composition, antioxidant or inflammatory status,
* regular consumption of more than 2 servings of nuts per week,
* unwillingness to refrain from recovery treatments during the study such as hydrotherapy, massage, stretching, compression garments, anti-inflammatory medications and topical applications.

Primary outcomes:
measure: delayed onset of muscle soreness
timeFrame: baseline, 24 hour, 48 hour, and 72 hour after baseline
measure: markers of muscle damage
timeFrame: Baseline, 24 hour, 48 hour and 72 hour after baseline
measure: changes in strength
timeFrame: Baseline and 8 weeks
measure: changes in body composition
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Mark Kern, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03461809: A Retrospective Study of the Effects of Ocular Acupuncture on Ocular Motor Nerve Palsy
Official title: A Retrospective Study to Investigate the Efficacy and Relative Factors of Ocular Acupuncture in Ocular Motor Nerve Palsy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oculomotor Nerve Palsy
Trochlear Nerve Palsy
Abducens Nerve Paralysis
Keywords: diplopia; ocular motor nerve palsy; acupuncture
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with ocular motor nerve palsy who received ocular acupuncture.

Brief summary: This retrospective observational study is designed to assess the response to treatment with ocular acupuncture and its relative factors, in terms of diplopia status, ocular motility differences, and clinical features, in ocular motor nerve palsy patients. During this study, a retrospective data collection will be carried out using the information contained in the medical record of aimed patients, provided that the treatment with ocular acupuncture.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Patient who received at lease 1 times of ocular acupuncture treatment
* Patient who received full set of ophthalmology \& neurology assessment pre- and post-treatment.

Exclusion Criteria:

* patient who combined with extraocular muscles diseases, eg.thyroid eye disease
* patient who underwent periocular surgery
* patient who combined with congenital ocular motor nerve palsy, eg. Brown syndrome.
* patient who had untreated condition which may lead to ocular motor nerve palsy such as intracranial aneurysm and brain tumor.

Primary outcomes:
measure: Clinical efficacy rate (Cure, Effective and Invalid)
timeFrame: Through study completion, an average of 1 month.
Secondary outcomes:
measure: Diplopia angle
timeFrame: Through study completion, an average of 2 weeks.
measure: Eyeball movement distance
timeFrame: Through study completion, an average of 2 weeks.
measure: Distance between upper and lower eyelid.
timeFrame: Through study completion, an average of 2 weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03725709: Metabolomic Profiling of in Patients With type2 Diabetes
Official title: Metabolomic Profiling of Cerebrospinal Fluid and Plasma in Patients With type2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnoses Disease
Diabetes Mellitus, Type 2
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with received spinal anesthesia and had written informed consent

Brief summary: To exam the metabolomic profiling of CSF and plasma in diabetes and establish the human CSF Metabolome Database of Type 2 DM.

Detailed description: Human cerebral spinal fluid (CSF) is known to be a rich source of small molecule biomarkers for central neurological and neurodegenerative diseases. However, the metaboloic bases of CSF in diabetes patient have not been studied. In this plan, the investigators will use analytical platforms, including nuclear magnetic resonance (NMR), liquid chromatography-mass spectrometry (LC-MS), to perform quantitative metabolomics on human CSF and blood samples and further establish the human CSF Metabolome Database of DM. This work will can supply important CSF metabolic profit information and help to facilitate a wide range of metabolomic studies on central nervous system diseases and their associations disease.

Eligibility criteria: Inclusion Criteria:

Diabetes group

1. .20-75 years of age
2. .Type 2 diabetes patient by clinical diagnosis
3. .American Association of Anesthesiologists (ASA)≦III

Control group (non-diabetic group):

1. .20-75 years of age
2. .No history of DM and other systemic illness
3. .American Association of Anesthesiologists (ASA)≦ II

Exclusion Criteria:

1. patient refuses to sign informed consent
2. patients with coagulopathy, systemic infective disease and severe liver and renal function impairment.
3. patients with spine or brain tumor and severe CNS disease.
4. the presence of severe and/or uncontrolled and/or unstable medical disease within 12 months prior to study other than DM which could compromise participation in the study (e.g. acute pancreatitis, stroke, liver cirrhosis, congestive heart failure, and systemic immune disorder etc.
5. Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)

   -

Primary outcomes:
measure: Find the reliable biomarkers, using metabolomic analysis [NMR, LC-MS]
timeFrame: Through study completion, an average of 1 year
measure: Exam metabolic profiles of CSF and plasma in diabetes. (Metabolites analysis of CSF and plasma)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT02200809: MR-guided Focal Laser Ablation of the Prostate
Official title: MR-guided Focal Laser Ablation of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
MRI
Focal Laser Ablation
Keywords: MR-guided therapy
Focal laser ablation
Prostate cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Canisius-Wilhelmina Hospital
name: Ziekenhuisgroep Twente
First posted: 2014-07-25
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed and biopsy proven prostate cancer
* Intermediate risk patients (PSA \<= 20 ng/mL, Gleason ≤ 7, T2b)
* No previous treatment for prostate cancer
* Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images
* Signed informed consent by patient
* Age 18 years or older
* Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia)

Exclusion Criteria:

* Impossibility to obtain a valid informed consent
* Patients unable to undergo MR imaging, including those with contra-indications
* Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection)
* Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
* Patients with evidence for nodal or metastatic disease
* Patients with an estimated Glomerular Filtration Ratio (eGFR) \< 40 mL/min/1.73 m2

Primary outcomes:
measure: Disease free survival
timeFrame: 36 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
state: Gelderland
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente
state: Overijssel
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Jurgen Futterer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05979909: Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma
Official title: Preventing Intravesical Recurrence in Patients With Urothelial Carcinoma of the Upper Urinary Tract: a Pilot Randomized Trial of a Single Prophylactic Bladder Instillation of Mitomycin C After Diagnostic Ureteroscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Urothelial Carcinoma Ureter
Urothelial Cancer of Renal Pelvis
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In the current study, 40 patients will be randomized to receive MMC or no intervention and will be followed for two years to determine the incidence of adverse events and IVR.


Eligibility criteria: Inclusion Criteria:

* Suspected upper tract urothelial carcinoma (UTUC)
* Diagnostic ureteroscopy required
* Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy

Exclusion Criteria:

* Prior or concomitant urothelial carcinoma of the bladder
* History of UTUC
* Ureteroscopy within the preceding six months
* Untreated urinary tract infection
* Suspected or confirmed perforation of the upper or lower urinary tract
* Lower urinary tract fistula
* Leukopenia or thrombocytopenia
* ECOG performance status 2 or greater
* Known hypersensitivity to mitomycin C
* Pregnancy or breastfeeding
* Lack of capacity to consent

Primary outcomes:
measure: Recruitment rate
timeFrame: 30 days
measure: Randomization rate
timeFrame: 30 days
measure: Retention rate
timeFrame: 2 years
Secondary outcomes:
measure: Adverse events (any)
timeFrame: 30 days
measure: Adverse events (severe)
timeFrame: 30 days
measure: Intravesical recurrence
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05324709: Yoga on Stress Management in Adolescents
Official title: Yoga on Stress Management in Adolescents: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Adolescent Problem Behavior
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The World Health Organization (WHO, 2013) defined the 10-19 age group as "adolescent" and the 15-24 age group as "youth". Adolescence period; It is a period of rapid growth, development and maturation in terms of physical, mental, biochemical and social aspects.10-20% of children and adolescents living in the world have mental health diseases such as generalized anxiety disorders, depression, eating disorders, and post-traumatic stress disorders.In adolescents, yoga is practiced as a relaxing tool to reduce stress, especially for exam anxiety.In Turkey, there are no yoga-based experimental studies to prevent anxiety, stress and depression in adolescents.

Detailed description: The aim of the study is to examine the effect of the Yoga-Based Stress Management Program on the ability to cope with stress in adolescents.Stress management sessions of the Adolescent Health Promotion-Physical Activity, Nutrition, Stress Management (COPE HEALTH-TEEN) program will be used in the stress management training to be explained in the program. There will also be yin yoga exercises.

The general population of the research will be high school senior students in Safranbolu district of Karabük province in the 2021-2022 academic year. First of all, the stress, anxiety and depression levels of the adolescents will be calculated. The research will be carried out in a total of 14 high schools. Each school will be determined as a "cluster" and 7 experimental and 7 control schools will be randomly selected. Simple random draw method will be applied in the selection of experimental and control schools. Adolescents who meet the inclusion criteria will be included in the study.

Eligibility criteria: Inclusion Criteria:

* High school senior student

  * Those who volunteered to participate in the research and
  * Students who are allowed to participate in the research by their parents

Exclusion Criteria:

* Students with any physical or mental disability • Low levels of perceived stress, anxiety, depression

Primary outcomes:
measure: Change in stress level compared to baseline at 3 months.
timeFrame: Basaline, week 1, month 3
measure: Change in anxiety level compared to baseline at 3 months.
timeFrame: Basaline, week 1, month 3
measure: Change in depression level compared to baseline at 3 months.
timeFrame: Basaline, week 1, month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Karabuk
country: Turkey
facility: Karabuk University
Study officials:
References: