louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05381376: Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion
Official title: Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Database for Intrauterine Adhesion
Risk Factors for Intrauterine Adhesion
Risk Stratification and Prognostic Assessment
Intrauterine Adhesion
Lead sponsor: Beijing Obstetrics and Gynecology Hospital
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 2200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Taking α=0.05 and β=0.1, the overall time incidence (pregnancy rate) was taken as the lowest value of P=0.25, the risk factor (uterine adhesion fraction) coefficient was -0.18, and the decision coefficient for the risk factor (uterine adhesion fraction) was 0.8. The PASS software calculated 1622, taking into account the shedding factor (20%) and the randomization requirement of n=2028, based on each center's outpatient volume, the total number of cases to be included in this study database is at least 2200.

Brief summary: 1. To establish a follow-up database for uterine adhesions and a library of biological specimens for Intrauterine Adhesion. 2. using epidemiological surveys and biological analyses to screen risk factors for the development and prognosis of Intrauterine Adhesion. 3. Predictive models based on clinical and biochemical indicators, specimen testing and hysteroscopic images are also combined with statistical analysis and machine learning algorithms to enable patients' risk stratification and prognostic assessment.


Eligibility criteria: Inclusion Criteria:

* Previously diagnostic hysteroscopy confirmed adhesions combined with infertility or recurrent pregnancy loss (early pregnancy loss \>2)
* Desiring to conceive
* Ages between 20-45 years;
* Patients without gynecological endocrine disorders (e.g. PCOS) and AMH\>1ng/ml;
* Signing informed consent.

Exclusion Criteria:

* Hysteroscopy contraindications;
* Hormone therapy contraindications;
* Pregnancy contraindications;
* History of malignant pelvic tumor and radiotherapy;
* Severe hepatic or renal dysfunction;
* Complicated with hematological disorders (eg.platelet dysfunction, severe anemia, blood-borne infections);
* Male factor infertility(eg.seminal abnormalities).

Primary outcomes:
measure: Rate of pregnancy
timeFrame: 2 years
Secondary outcomes:
measure: Recurrence rate of IUA
timeFrame: 3 month
measure: Menstrual blood volume
timeFrame: 3 month
measure: CSGE
timeFrame: 3 month
measure: AFS
timeFrame: 3 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Yishaofu Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT04585776: A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
Official title: An Exploratory Study Assessing Time in Target Glucose Range Using a New Titration Scheme of LY900014 and Insulin Degludec in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and insulin degludec. The reason for this study is to evaluate the amount of time with glucose values within target range.


Eligibility criteria: Inclusion Criteria:

* Participants must have type 1 diabetes and have been treated with insulin therapy for at least 1 year
* Participants must be using Continuous Glucose Monitoring (CGM) with total CGM use ≥ 2 months in the prior 6 months
* Participants must have been on the same type of short acting insulin (Humalog U-100, Novolog, Admelog, or Apidra) for at least 30 days prior to screening
* Participants must have been treated with long-acting insulin degludec U-100 for at least 30 days prior to screening

Exclusion Criteria:

* Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months before screening
* Participants must not have had more than 1 episode of severe hypoglycemia within the last 90 days prior to screening
* Participants must not be taking certain diabetes medications that are not allowed for study participation

Primary outcomes:
measure: Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)
timeFrame: Day 46
Secondary outcomes:
measure: Insulin to Carbohydrate Ratio (ICR)
timeFrame: Day 46
measure: Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin
timeFrame: Day 46
measure: Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
timeFrame: Day 46
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Minneapolis
country: United States
facility: HealthPartners Institute dba International Diabetes Center
state: Minnesota
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03586076: A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects
Official title: A Double-Blind Randomised 2-Arm, 2-Period Crossover Study to Access the Similarity of Safety and Pharmacokinetics of JHL1922 and Pulmozyme® After Single and Repeated Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: JHL Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomised, 2 single-doses and then repeated-dose (5 days), 2-arm, 2-period crossover phase 1 study in 24 healthy male or female subjects. Subjects will be randomised to one of two treatment sequences in 2 treatment periods: JHL1922 (test treatment) first and then Pulmozyme (reference treatment) or Pulmozyme (reference treatment) first and then JHL1922 (test treatment).

Detailed description: All 24 subjects will receive either JHL1922 or Pulmozyme as single doses of 2.5 mg and then 10 mg per eRapid nebulizer, followed after a washout by a 5-period of daily dosing of 10 mg of either JHL1922 or Pulmozyme per eRapid nebulizer.

The primary objective is to assess the similarity of safety and tolerability of test products, and the exploratory objective is to assess the similarity, if possible, of the systemic levels and sputum levels of dornase alfa after administration of test products.

Eligibility criteria: Inclusion Criteria:

* 18-70 years, inclusive
* Body Mass Index: 18.0-30.0 kg/m2, inclusive
* Weight: between 55 and 105 kg
* Condition: healthy; normal pulmonary function by spirometry

Exclusion Criteria:

- Any medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, incl. active, or history of, pulmonary disorders incl. asthma or chronic obstructive pulmonary disease (COPD)

Primary outcomes:
measure: Cmax
timeFrame: up to 21 days
measure: AUC0-t,
timeFrame: up to 21 days
measure: AUC0-tau
timeFrame: up to 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: JHL Biotech Investigational Site
Study officials:
affiliation: PRA Group B.V., a PRA Health Sciences company
name: Sjoerd Van Marle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01924676: Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers
Official title: An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to PF-003454390 Formulation X in the Fasted State in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: food effect
pharmacokinetics
bioavailability
oxycodone
management of moderate to severe pain
Lead sponsor: PainT
Sponsor class: UNKNOWN
First posted: 2013-08-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers

Detailed description: This study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulation K in healthy volunteers.

Additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test PF-00345439 Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between 18 and 55 years of age (inclusive).

Exclusion Criteria:

* Evidence or history of clinically significant disease
* Positive urine drug test

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose
measure: Concentration at time 24 hours (C24) of oxycodone, as data permit.
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00870376: Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms
Official title: Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lower Urinary Tract Symptoms
Keywords: lower urinary tract symptoms
biomarkers
urodynamic studies
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female patients with LUTS

Brief summary: Urodynamic study is an objective method to evaluate female patients with lower urinary tract symptoms (LUTS). However, this method includes place a urinary catheter, thus prevents it as a routine method to evaluate and follow up patients with LUTS. Therefore, it is necessary to find a simple and objective method to help in evaluating female patients with LUTS. Several kinds of biomarker had been reported in diagnosing patients with overactive bladder; however, the sensitivity remained poor. The aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with LUTS.


Eligibility criteria: Inclusion Criteria:

* All female patients (\> 20 years) with Lower urinary tract syndrome.

Exclusion Criteria:

* Female patients with tumor and stone were excluded.

Primary outcomes:
measure: The aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with LUTS.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Banciao, Taipei
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT02218476: Beneficial Effects of Coenzyme Q10 Treatment on the Mitochondrial Dysfunction and Oxidative Stress Associated to Atherothrombosis Developement in Antiphospholipidid Syndrome Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coenzyme Q10 on Athero-thrombosis in APS Patients
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will be performed on 50 APS (antiphospholipid Syndrome) patients, which will be randomized to receive either CoQ10 (200mg/day) or placebo for one month. Blood will be drawn at time 0 and at the end of the treatment. Studies will be conducted in plasma and purified leukocytes from APS. Design: 1) Study of endothelial function: 2) Analysis of changes operated on various prothrombotic/proinflammatory parameters and their associated intracellular signalling. 3) Analysis of mitochondrial ultra structure and activity; mitochondrial antioxidant system characterization; Expression levels and activity of transcription factors/proteins involved in oxidative stress (Foxo 3, NFkB, Nrf2), Quantification of CoQ10 (Coenzyme Q10). 4) Biomarkers of oxidative stress. 5) miRNAs microarrays, RT-PCR validation and correlation/association studies. 6) Induction of over-expression of miRNAs of interest; luciferase constructs. 7)Studies of methylation.


Eligibility criteria: Inclusion Criteria:

1. Patients who fulfilled Sidney criteria for APS (antiphospholipid Syndrome) (Miyakis S et al., J Thromb Haemost 2006; 4:295-306)
2. Age over 18 years
3. Written informed consent

Exclusion Criteria:

1. Acute Liver Disease.
2. Severe renal impairment
3. Acute arterial or venous thrombosis episode in the last 3 months
4. Pregnancy and breastfeeding

Primary outcomes:
measure: Change in endothelial function in vivo
timeFrame: 0 weeks, 4 weeks, 8weeks, 12weeks
Secondary outcomes:
measure: Change in Tissue factor
timeFrame: 0 weeks, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía de Córdoba
state: Andalucía
Study officials:
name: Rosario Lopez Pedrera, Biology
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perez-Sanchez C, Aguirre MA, Ruiz-Limon P, Abalos-Aguilera MC, Jimenez-Gomez Y, Arias-de la Rosa I, Rodriguez-Ariza A, Fernandez-Del Rio L, Gonzalez-Reyes JA, Segui P, Collantes-Estevez E, Barbarroja N, Velasco F, Sciascia S, Cecchi I, Cuadrado MJ, Villalba JM, Lopez-Pedrera C. Ubiquinol Effects on Antiphospholipid Syndrome Prothrombotic Profile: A Randomized, Placebo-Controlled Trial. Arterioscler Thromb Vasc Biol. 2017 Oct;37(10):1923-1932. doi: 10.1161/ATVBAHA.117.309225. Epub 2017 Jul 6.
Clinical trial NCT03185676: Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance
Official title: The Long Term Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance as Compared to a Control.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose and insulin have already been study in the past. The aim of the current study is to evaluate the long term effect of the probiotic bilberry drink on glucose tolerance and insulin resistance in healthy adults and in comparison to a control drink.


Eligibility criteria: Inclusion Criteria:

Healthy adults with a BMI between 20-30

Exclusion Criteria:

-

Primary outcomes:
measure: The long term effect of a bilberry-based probiotic beverage on postprandial levels of serum insulin
timeFrame: Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Klinisk Prövningsenhet, Kliniska Studier Sverige - Forum Söder
Study officials:
References:
Clinical trial NCT02488876: Database of Tissue Samples to Understand the Inflammatory Response After Cardiac Surgery
Official title: Non-individual Related Ongoing Collection of Blood Samples for the Compilation of a Unique Database of Tissue Samples to Understand the Inflammatory Response After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Diseases
Keywords: Cardiac surgery
Tissue sample database
Inflammatory responds
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for cardiac surgery

Brief summary: The aim of this study is to collect non-individual related blood samples for the compelling of a unique database of tissue samples to understand the inflammatory responds after cardiac surgery on an on-going basis. This includes especially protein analyses and genetic testing for certain neurotransmitters in the blood and tissues to understand disease markers related to heart disease. The study is designed as an openly recruiting biobank with the purpose to later serve multiple study purposes. Outcomes refer to protein analyses and genetic testing for neurotransmitters in the blood and tissues.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery

Exclusion Criteria:

* None.

Primary outcomes:
measure: Inflammatory Cytokines
timeFrame: Perioperatively until 7 days after cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen, Department of Thoracic and Cardiovascular Surgery
state: NRW
Study officials:
affiliation: Department of Cardiothoracic Surgery
name: Andreas Goetzenich, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ney J, Heyland DK, Amrein K, Marx G, Grottke O, Choudrakis M, Autschbach T, Hill A, Meybohm P, Benstoem C, Goetzenich A, Fitzner C, Stoppe C. The relevance of 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D concentration for postoperative infections and postoperative organ dysfunctions in cardiac surgery patients: The eVIDenCe study. Clin Nutr. 2019 Dec;38(6):2756-2762. doi: 10.1016/j.clnu.2018.11.033. Epub 2018 Dec 13.
Clinical trial NCT01255176: Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC)
Official title: Evaluation of the Effects of Physical Therapy Method of Restoring Cardiac Thoracic Abdominal Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infants With Heart Disease
Respiratory Therapy
Techniques
Keywords: Infant
Physical Therapy
Lead sponsor: University of the State of Santa Catarina
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It gave a clinical trial which will be included in the 60 infants, aged up to 24 months, diagnosed with congenital's population will be divided by simple randomization into three groups: 20 infants in the intervention group, 20 infants in the control group, not receive the RTA technique and another 20 infants in a placebo group, we just get the support manual therapist for 5 minutes. Initially the data will be collected cardio heart rate, respiratory rate and oxygen saturation. Then the researcher will apply three specific rating scales, based on clinical presentation and behavior of infants. Hypothesis: The RTA improves cardiorespiratory parameters and reduces signs of discomfort and pain of infants with congenital heart acyanogenic.


Eligibility criteria: Inclusion Criteria:

* Newborns admitted to the nursery without ventilatory support or oxygen therapy, and whose parents agree with the child's participation in the study. Will be excluded newborns who have some problems during any of the study procedures and those whose condition will change after the intervention, with shift in ventilatory support or oxygen therapy.

Exclusion Criteria:

* In case of inability to collect some of the parameters evaluated at the appropriate time, the RN also will no longer part of the sample, as well as those who show no contraindication to therapy.

Primary outcomes:
measure: Changes in cardiorespiratory parameters
timeFrame: 15 minutes after the end of the intervention
measure: Pain Scales (NIPS, PIPP, NFCS)
timeFrame: Immediately after intervention and 15 minutes after the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Joana de Gusmão Children's Hospital
state: Santa Catarina
Study officials:
affiliation: Professor of Universidade do Estado de Santa Catarina
name: Camila Schivinski, Doctor
role: PRINCIPAL_INVESTIGATOR
References: