louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002022: Treatment Program for Anemia in AIDS Patients
Official title: Treatment Program for Anemia in AIDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Cytopenias
Keywords: Recombinant Proteins
Drugs, Investigational
Erythropoietin
Acquired Immunodeficiency Syndrome
Anemia
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The objective of the Eprex (erythropoietin) Treatment Program is to provide erythropoietin for the treatment of anemia in AIDS patients.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Life expectancy \< 3 months.
* = or \< grade 4 performance score.
* AIDS-related dementia.
* Uncontrolled hypertension.
* Acute symptomatic opportunistic infection or other AIDS-defining illness.

Patients with the following are excluded:

* Life expectancy \< 3 months.
* = or \< grade 4 performance score.
* AIDS-related dementia.
* Uncontrolled hypertension.
* Acute symptomatic opportunistic infection or other AIDS-defining illness.

Patients must have:

* A clinical diagnosis of AIDS.
* Hematocrit \< 30 percent.
* Endogenous serum erythropoietin level = or \< 500 U/ml.
* A life expectancy = or \> 3 months.
* \> Grade 4 performance score.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Raritan
country: United States
facility: R W Johnson Pharmaceutical Research Institute
state: New Jersey
Study officials:
References:
Clinical trial NCT04024722: Improving in Vitro Fertilization in Women With Poor Ovarian Response
Official title: Improving the Results of in Vitro Fertilization in Women With Poor Ovarian Response and Early Ovarian Insufficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Poor Ovarian Response
Ovarian Insufficiency
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Improving the results of in vitro fertilization in women with poor ovarian response and early ovarian insufficiency

Detailed description: BACKGROUND: Mechanical disruption of the Hippo signaling pathway in the ovaries can increase the likelihood of pregnancy and childbirth in women with early ovarian insufficiency. The method may also "work" in women with poor ovarian reserve and poor response to routine fertility treatments.

OBJECTIVE: To examine whether mechanical stimulation of ovaries by cutting the ovarian cortex treatment can increase eggs number aspirated during In Vitro Fertilization (IVF).

METHODS: Patients eligible for the study with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of IVF success and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a pelvic ultrasound (US) and blood tests for the hormonal profile at the IVF clinic.

Eligibility criteria: Inclusion Criteria:

* Volunteers with poor ovarian response to standard fertility treatments according to the criteria of the European Fertility Association (ESHRE).
* Diagnosis of early ovarian insufficiency or symptoms that predict early ovarian insufficiency (imminent) seeking to become pregnant.

Exclusion Criteria:

Volunteers with

* Severe endometriosis diagnosed with laparoscopy.
* Previous major surgery involving ovaries.
* Ovarian cancer.
* Female reproductive malformations.
* Contraindications for laparoscopic surgery.

Primary outcomes:
measure: Number of oocytes
timeFrame: up to 1 year
measure: Fertilization rate
timeFrame: up to 1 year
measure: Embryos number
timeFrame: up to 1 year
measure: Pregnancies rate
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilay University Medical Center
Study officials:
References:
Clinical trial NCT04982822: Novel Senhance Robotic System in Urologic Surgery: Its Clinical Application and Implication
Official title: Novel Senhance Robotic System in Urologic Surgery: Its Clinical Application and Implication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urologic Diseases
Surgery
Keywords: Urology
Senhance
Robotic surgical system
Laparoscopic surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study populations consisted of aged from 18 years old to 90 years old and had will to receive laparoscopic surgeries using the Senhance robotic system.

The were excluded if there's major severe cardio-pulmonary condition or had received extensive abdominal surgeries.

Brief summary: An observational study to collect data from the participants who received urologic surgeries using the Senhance Robotic system.

Detailed description: This is an observational study and investigators will collect peri-operative demographic data, and short-term outcomes (3-6 months) from the participants who received minimal invasive surgeries using Senhance robotic system in the National Taiwan University Hospital Yunlin Branch, Urology Department. The investigators want to demonstrate if the robotic system is safe and feasible in urologic laparoscopic surgeries.

The operation included TEP, radical prostatectomy, radical nephrectomy (nephroureterectomy) , adrenalectomy, radical cystectomy, and ureter surgery et al.

up to 2022/12, we had recruited 127 TEP, 83 radical prostatectomies, 17 adrenalectomies, 40 nephrectomies, 29 partial nephrectomies, 13 radical cystectomies and 18 other surgeries, such as ureter surgery

Eligibility criteria: Patients undergo laparoscopic urologic surgeries

Primary outcomes:
measure: Peri-operative complications
timeFrame: postoperative 30 days
measure: short-term outcome
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Outside U.S./Canada
Study officials:
affiliation: National Taiwan University Hospital Yunlin Branch
name: LunHsiang Yuan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02180022: Effects of Onion Peel Extract on Endothelial Function
Official title: Effect of Onion Peel Extract on Endothelial Function and Endothelial Progenitor Cells in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Overweight
Obese
Keywords: Quercetin
Endothelial function
Onion peel extract
volunteers
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Kyunghee University
First posted: 2014-07-02
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Acute or chronic intake of polyphenol-rich foods has been reported to improve endothelial function. Quercetin, found abundantly in onion, is a potent antioxidant flavonoid. This study was designed to investigate whether consumption of onion peel extract (OPE) improves endothelial function in healthy overweight and obese subjects.

Detailed description: Epidemiological studies have shown a rapid increase in the prevalence of overweight and obesity, not only in adults but also in children and adolescents, thus increasing the risk of early development of cardiovascular disease (CVD). Quercetin, found abundantly in onion, prevents the induction of endothelial dysfunction, superoxide production, and overexpression by angiotensin II in the rat aorta. Furthermore, in our previous study we showed that supplementation with quercetin-rich onion peel extract (OPE) influenced adipokine expression, thus addressing its modulatory effect on obesity-induced inflammation, and improved insulin resistance by alleviating the metabolic dysregulation of free fatty acids, suppressing oxidative stress, upregulating glucose uptake, and downregulating inflammatory gene expression. But there are limited studies on the relationship between quercetin supplementation and endothelial dysfunction in humans.

Eligibility criteria: Inclusion Criteria:

* age 20 to 60 years
* BMI \>23 kg/m2
* abdominal circumference \> 90 cm in males or \>85 cm in females

Exclusion Criteria:

* hypertension (\>140/90 mmHg),
* diabetes
* any cardiovascular disease,
* kidney disease,
* thyroid disease
* cerebrovascular disease
* liver disease (bilirubin level \>2 mg/dl)
* pregnancy

Primary outcomes:
measure: The difference of endothelial function
timeFrame: 12 weeks after study drug treatment
Secondary outcomes:
measure: The difference of EPC (endothelial progenitor cell) counts
timeFrame: 12 weeks after study drugs treatment
Other outcomes:
measure: The composite measure of change of blood pressure, heart rate, body weight and blood chemistry
timeFrame: up to 12 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Kyung Hee University Hospital
name: Weon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01784822: Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair
Official title: Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernias
Keywords: Ventral hernia
Graft repair
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2013-02-06
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from University of Tennessee, Duke University and Cleveland Clinic

Brief summary: The objective this study is to collect post-market data on the performance of the Zenapro™ Hybrid Hernia Repair Device when used to reinforce or bridge the abdominal wall for the repair of ventral hernias.


Eligibility criteria: Inclusion Criteria:

* Primary or recurrent ventral hernia
* Need for abdominal wall repair with reinforcement or bridging material to obtain the desired surgical result

Exclusion Criteria:

* Age \< 21 (i.e., infants, children)
* Device intended to be used in an infected wound
* Known sensitivity to porcine material
* Pregnant or planning pregnancy in the future
* Life expectancy of less than 12 months from the date of the index procedure
* Hernia too large to be covered with a single device with at least 4-5 cm of tissue overlap on all sides

Primary outcomes:
measure: Rate of hernia recurrence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References:
Clinical trial NCT06403722: Perinatal Outcomes in Patients With Elevated sFlt-1/PlGF Ratio
Official title: Perinatal Outcomes in Patients With Suspicion of Preeclampsia and Elevated sFlt-1/PlGF Before Term: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension in Pregnancy
Keywords: Hypertension, pregnancy induced
Angiogenic factors
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 190
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects admitted with suspicion of preeclampsia, between 24 and 36 6/7 weeks with result of sFlt-1/PlGF before delivery.

Brief summary: Retrospective cohort study that evaluated 190 subjects admitted with diagnosis of hypertensive disorder of pregnancy, between 24 and 36 6/7 weeks, with an sFlt-1/PlGF index greater than or equal to 110. Data were collected on their clinical course prior to termination of pregnancy, using the last reported sFlt-1/PlGF ratio value to classify the population into four cohorts: values between 110-205, between 206 and 654, between 655 and 999 and greater than 1000.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of hypertensive disorder of pregnancy
* Gestational age between 24 - 36 6/7
* sFlt-1/PlGF \> 110

Exclusion Criteria:

* Gestational age below 23 6/7 weeks and above 37 weeks at the moment of admission.
* Absence of sFLt-1/PlGF ratio result.

Primary outcomes:
measure: Kidney injury
timeFrame: From the moment of admission up until discharge after delivery, average 5 to 10 days
measure: Hepatic enzyme abnormalities
timeFrame: From the moment of admission up until discharge after delivery, average 5 to 10 days
measure: HELLP Syndrome
timeFrame: From the moment of admission up until discharge after delivery, average 5 to 10 days
measure: Growth restricted fetus
timeFrame: From the moment of admission up until delivery, average 5 to 10 days
measure: Stillbirth
timeFrame: From the moment of admission up until discharge after delivery, average 5 to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
Study officials:
References:
Clinical trial NCT01862822: Position of Children During Urine Collection: Evaluation Study
Official title: Position of Children During Urine Collection: Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Infection
Keywords: Paediatrics
Urinary tract infection
Urine collection
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 803
Sex: ALL
Minimum age (years): 2
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Urinary tract infection (UTI) is a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Even though official guidelines recommend clean catch method, catheterization or suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators have noticed that the rate of contaminated urine cultures was lower when children were kept in an upright position at the time of urine collection. The upright position could explain this decrease, perineum being less in contact with urine. These results are borderline significant, the investigators would like to confirm them with a specific study.


Eligibility criteria: Inclusion Criteria:

* Children aged 2 - 36 months
* Non-toilet-trained children
* Indication to bag urine collection with the following criteria :
* fever ≥ 38.5 °C
* unexplained fever
* and at least 1 of the following criteria for girls and uncircumcised boys, at least 2 criteria for circumcised boys :
* age ≤ 12 months
* fever ≥ 48 hours
* poorly tolerated fever (chills ± cyanosis ± pronounced weakness...)
* preceding episode of tract urine infection

Exclusion Criteria:

* Parents opposed to the participation of their children in the study
* Diarrhea
* Current antibiotic treatment or during the 8 preceding days of the urine collection
* Genitals / perineal anomaly

Primary outcomes:
measure: Proportion of polybacterial urine analysis in each group
timeFrame: 1 hour
Secondary outcomes:
measure: The failure rate in upright position in private practice
timeFrame: 1 hour.
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital, Limoges
Study officials:
References:
Clinical trial NCT03901222: 3D Analysis of the Effects of tDCS (Transcranial Direct Current Stimulation) on a Functional Task in High Level Athletes
Official title: 3D Analysis of the Effects of tDCS on a Functional Task in High Level Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Athlete
Keywords: tDCS
Athlete
Endurance
Fatigue
3D
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, triple-blind, sham-controlled, crossover
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Relatively high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of bi-anodal tDCS (transcranial direct current stimulation) or sham tDCS The primary outcome is a 3D evaluation coupled with EMG (Electromyography) of their primary lower limb muscles after each session

Detailed description: Recruitment :

Relatively high level athletes will be recruited through social media and advertisements.

Each subject came twice to the Liege University Hospitals' Human Movement Analysis Laboratory.

After placing the different infrared emitters and placing and calibrating the surface EMG electrodes, subjects underwent 3 maximal squat jumps (without upper limb implication). They were then familiarized with the fatigue protocol (8 jumps at a 33 jumps per minute pace).

Then each subject received either bi-anodal tDCS of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, subjects underwent another warmup 3 maximal squat jumps, and then the fatigue protocol (comprised of 30 maximal jumps at a rate of 33 per minute).

Eligibility criteria: Inclusion Criteria:

* At least 10 hours of sport a week
* Right handed and footed

Exclusion Criteria:

* One on the TSST (in high and relatively high risk sections)
* Previous neurological or orthopedic pathologies affecting limbs

Primary outcomes:
measure: Peak Height
timeFrame: Changes between Prior and Immediately Following tDCS and Sham
measure: Gluteal EMG (Electromyography) recordings (% of maximal EMG value)
timeFrame: Changes between Prior and Immediately Following tDCS and Sham
measure: Quadriceps EMG (Electromyography) recordings (% of maximal EMG value)
timeFrame: Changes between Prior and Immediately Following tDCS and Sham
measure: Triceps EMG (Electromyography) recordings (% of maximal EMG value)
timeFrame: Changes between Prior and Immediately Following tDCS and Sham
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Liege Univeristy Hospital
Study officials:
affiliation: Liege University Hospital
name: Stephen Bornheim, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00202722: Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour
Official title: Remifentanil as Analgesia for Labour Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labour Pain
Satisfaction
Adverse Effects
Keywords: Remifentanil, parenteral opioids, obstetric analgesia, IVPCA
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2005-09-20
Enrollment: 41
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour. Intravenous patient controlled analgesia (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate, SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives also recorded their impression of the parturients pain. The parturients level of sedation were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and concentration of remifentanil were performed. After delivery, both mother and midwife evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were sufficient, nausea, vomiting, level of sedation and dizziness.

Detailed description: Primary and secondary outcome measures presented under "results"

Eligibility criteria: Inclusion Criteria:

Healthy women (ASA I-II), in active labour, one fetus with no suspected pathology, expecting normal childbirth, informed consent.

Exclusion Criteria:

Failure to obtain informed consent, received opioids within last 8 hours before study start, serious side-effects mother and abnormal fetal heart rate.

Primary outcomes:
measure: Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)
timeFrame: From start with remifentanil treatment until delivery, up to 8 hours.
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: From start of remifentanil treatment until delivery
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet sykehus HF
state: Vest-Agder
Study officials:
affiliation: part time
name: Jan H. Rosland, Professor
role: STUDY_CHAIR
References:
citation: Blair JM, Hill DA, Fee JP. Patient-controlled analgesia for labour using remifentanil: a feasibility study. Br J Anaesth. 2001 Sep;87(3):415-20. doi: 10.1093/bja/87.3.415.