louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02341339: Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology
Official title: Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective Feasibility Study:

Fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during their surgical evaluation of infertility. Of note, these patients are already scheduled to undergo surgery as part of their standard of care.

Detailed description: The surgical technique will involve laparoscopic brush and tissue biopsies of the fallopian tube lumen. A small piece of the fallopian tube lining will be removed during the surgery.The biopsy is a minimally invasive and relatively pain free procedure. Co culture blood serum will be drawn at least one day prior to the biopsy and during the IVF cycle. The fallopian tube sample is sent to the Center for Reproductive Medicine (CRM) lab where it is treated, purified and frozen. The next month or whenever the physician deems appropriate, the patient will then undergo a typical IVF cycle and will be given standard medication protocol determined by her physician to stimulate egg growth in her ovaries. The patient's eggs will be retrieved and mixed with sperm. At this time, the lab will begin to thaw and grow the fallopian tube cells. Once fertilization is confirmed, the patient's embryos will be placed on top of her own (now thawed) fallopian tube cells and allowed to grow. Subsequently, the embryos will be placed on top of her uterus for implantation and pregnancy.

Eligibility criteria: Inclusion Criteria:

* Women undergoing assisted reproductive technology at Weill Cornell Medical College (WCMC) and are scheduled to undergo surgery as part of their standard of care
* Women who had a prior failed IVF cycle
* Women with normal Hysterosalpingogram (HSG) or a prior laparoscopy confirming normal tubal status
* Both the patient (potential subject) and her partner must sign the consent form

Exclusion Criteria:

* Pregnancy
* Undiagnosed vaginal bleeding
* Fallopian tube disease

Primary outcomes:
measure: Number of participants with good embryo quality as a measure of efficacy
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of participants with Adverse Events as a measure of Safety and Tolerability
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Weill Medical College of Cornell University
name: Rony Elias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06613139: Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers
Official title: An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2- Period, Crossover Study to Evaluate Bioequivalence Between YHP2305 and YHR2404 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Bioequivalence
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2024-09-25
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment two-way crossover
Primary purpose: TREATMENT

Brief summary: An open-label, randomized, single-dose, oral administration, 2-sequence, 2- period, crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects

Detailed description: Subjects in group A will be administered comparator and YHP2305 by crossover design on day 1, 8.

Subjects in group B will be administered YHP2305 and comparator by crossover design on day 1, 8.

Eligibility criteria: Inclusion Criteria:

* Those who are 19 years old or older at the screening visit
* Those whose weight is over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
* Those who express their voluntary consent to participate in the trial by signing a written consent
* Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
* Others who are judged ineligible to participate in the trial by the principal investigator.

Primary outcomes:
measure: Area under the plasma drug concentration-time curve [AUCt]
timeFrame: 0-36 hours
measure: Maximum plasma concentration [Cmax]
timeFrame: 0-36 hours
Secondary outcomes:
measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
timeFrame: 0-36 hours
measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
timeFrame: 0-36 hours
measure: Time of peak concentration [Tmax]
timeFrame: 0-36 hours
measure: Terminal phase of half-life [t1/2]
timeFrame: 0-36 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bumin Hospital
Study officials:
affiliation: Locations
name: Taegon Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03152539: Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Healthy Volunteers
Official title: Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Resonance Imaging
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 733
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Methodological development of new MRI approaches
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of the studies that will be carried out on volunteer patients who have given their consent will be the development and optimization of the sequence parameters or the design of the stimulation paradigms in order to optimize the quality and Relevance of the images realized taking into account anatomical, functional or metabolic parameters. These adjustments will be carried out without interfering with the management of voluntary patients

Detailed description: The pathologies that interest us in these refinements concern mainly the chronic (or sequellar) brain disorders which can be degenerative, developmental or vascular. The patients who will be recruited will be known patients of our Service (University Clinic of Neuroradiology and MRI) that we follow during checks. The type of examination that will be applied to them, between MRI, EEG and NIRS, will be specified in the consent form. These examinations will not be invoiced either to the patient or to the social security, and the related costs will be borne by our Federative Research Structure or sometimes, when these explorations are upstream of a defined research protocol and funded, They will be financed under this protocol.

Eligibility criteria: Inclusion Criteria:

* major
* socially insured persons
* given their consent.
* absence of contraindication to the MRI examination

Exclusion Criteria:

* Subjects under the age of 18
* pregnant women
* all other persons referred to in articles L1121-5 to L1121-8 of the CSP

Primary outcomes:
measure: Spatial resolution of new MRI imaging sequences MRI scanning.
timeFrame: Two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
Study officials:
References:
Clinical trial NCT02614339: Effect of Adjunctive Metformin on Recurrence of Non-DM Colorectal Cancer Stage II High-risk/ III Colorectal Cancer
Official title: Effect of Adjunctive Metformin on Recurrence of Non-DM Colorectal Cancer Stage II High-risk/ III Colorectal Cancer: Open-label Randomized Controlled
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-DM Stage II High-risk Colorectal Cancer
Non-DM Stage III Colorectal Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 593
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to identify the effect of adjunctive metformin on recurrence of non-DM Stage II High-risk/ III colorectal cancer. This study is open-label randomized controlled study.

The primary endpoint is to compare the 3-year disease free survival between metformin group and non-metformin group. The secondary endpoint is to compare the 5-year overall survival and disease specific survival between two group, to identify the safety of metformin, and to compare the recurrence rate of polyps after polypectomy between two groups.


Eligibility criteria: Inclusion Criteria:

1. patients with stage II high-risk/ III colorectal cancer who were taken an operation for cure, or patients with stage III rectal cancer who were taken an chemoradiation therapy and subsequently operation
2. age 20 - 80 years
3. patients without DM
4. patients who have well performance status for chemotherapy
5. patients who are agreed the study protocol

Exclusion Criteria:

1. patients with DM
2. patients who were diagnosed other cancers (≥ stage II) within 5 years
3. patients who have familial adenomatous polyposis, hereditary non-polyposis colorectal cancer, or inflammatory bowel disease
4. patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)
5. patients who have risk factors to increase lactic acidosis which are renal disease, lung disease, liver disease, or infectious disease
6. Creatinine ≥ 1.5mg/dL (for male), ≥ 1.4mg/dL (for female)
7. patients with congestive heart failure which is needed to treat
8. patients who have allergic history of metformin
9. pregnancy

Primary outcomes:
measure: Disease free survival
timeFrame: after 3 years
Secondary outcomes:
measure: 5-year overall survival
timeFrame: after 5 years
measure: recurrence rate of polyps after polypectomy
timeFrame: after 1 year, and then according to the findings in 1 year colonoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02256839: Evaluation of the QuantiFERON-TB Test.
Official title: Evaluation of the 4th Generation QuantiFERON-TB Gold Test (CST001) for the Detection of Tuberculosis Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Tuberculosis
TB
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have either low-exposure rist to tuberculosis or have non-tuberculous mycobacterial infections

Brief summary: To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

Detailed description: To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.

Eligibility criteria: Low-exposure Risk Group

Inclusion Criteria:

* No identified risk factors for TB infection

Exclusion Criteria:

* Age less than 18 years or greater than 80 years
* Identified Risk Factors For TB Infection

Non-tuberculous mycobacterial infection Group

Inclusion Criteria:

* history of nontuberculous mycobacterial disease (pulmonary or extrapulmonary) in accordance with the 2007 ATS/IDSA criteria

Exclusion Criteria:

* Age less than 18 years or greater than 80 years
* Identified Risk Factors For TB Infection

Primary outcomes:
measure: Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives
timeFrame: 1 day (At time of enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kevin Winthrop, MD, M.P.H
role: PRINCIPAL_INVESTIGATOR
References:
citation: QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.
Clinical trial NCT06307639: Seminal Levels of PGK2 and ACRV1 as Predictors of Micro-TESE Results in NOA
Official title: Seminal Levels of PGK2 and ACRV1 as Predictors of Micro-TESE Results in NOA
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Male Infertility Due to Azoospermia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile males with normal volume, functional (non-obstructive) azoospermia.

Brief summary: * Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).
* Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples.


Eligibility criteria: Inclusion Criteria:

* Infertile males with normal volume, functional (non-obstructive) azoospermia.
* Age: 18-45 years

Exclusion Criteria:

* Patients with proven obstructive azoospermia.
* Cryptorchidism.
* Testicular Agenesis and testicular atrophy.
* Patient with exposure to gonadal toxins like chemotherapy, radiotherapy, and alkylating agents.

Primary outcomes:
measure: Know more about the functional role of PGK2 and ACRV1 in the process of spermatogenesis.
timeFrame: 2 years
measure: Detect if PGK2 and/or AVRV1 level can used as predictor for spermatogenesis in infertile men with non-obstructive azoospermia undergoing Testicular Sperm Extraction.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04889339: Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
Official title: Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scoliosis
Adolescent Idiopathic Scoliosis
Keywords: Scoliosis
Spine deformity
Brace
Growth modulation
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 58
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be separated into two stages. Each patient will initially try a control brace and a test brace in a crossover study model to evaluate the immediate correction. Each patient will then use one brace from either the control arm or test arm to evaluate the long-term correction of the brace.
Primary purpose: TREATMENT

Brief summary: Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. Our team has developed an innovative conception method for brace design by simulating the growth modulation using numerical models. Those models are customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and validate its clinical application.


Eligibility criteria: Inclusion Criteria:

* AIS diagnosis
* Risser 0-2
* Primary curve angles 20 degrees - 40 degrees
* If female, either premenarchal or less than 18 months postmenarchal.

Exclusion Criteria:

* Patients with a pre-existing cardiovascular condition
* Patients with a symptom of a neurological disorder
* Patients with any other disorder of the musculoskeletal system affecting the lower limbs

Primary outcomes:
measure: Change in Cobb angle
timeFrame: Baseline - 2 years
Secondary outcomes:
measure: Treatment failure rate
timeFrame: Baseline, 2 years
measure: Quality of Life (QoL)
timeFrame: Baseline, 2 years
measure: Immediate in-brace Cobb angle
timeFrame: 5 minutes after brace fitting
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
Clinical trial NCT01534039: A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers
Official title: Phase 4-A Clinical Comparison of a Marketed Moldable Skin Barrier Versus a Marketed Stretch-to-Fit Skin Barrier in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peristomal Skin Complication
Lead sponsor: Independent Nurse Consultants LLC
Sponsor class: OTHER
Collaborators: name: ConvaTec Inc.
First posted: 2012-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or urostomy.

Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin protection, wear-time, ease of use, ease of teaching, and comfort.

Detailed description: Study to include 60 subjects, three centers, total of 4 weeks, 2 weeks in each product. Subjects recruited from a population of persons who have had an existing fecal or urinary stoma for a duration of at least three months. There is no restriction on primary diagnosis for ostomy surgery. Subjects must be of legal consenting age, must currently be managing their own stoma with a two piece pouching system, either a pre-cut, cut to fit, moldable or stretch-to-fit, any manufacturer. Subjects may not require convexity and be willing to not to use any accessory products during the study.

Eligibility criteria: Inclusion Criteria:

* Existing fecal or urinary ostomy for at least three months,consenting age, able to perform independent ostomy care, willing to not use accessory products, currently wearing a 2 piece marketed product.
* Able to participate for four weeks.

Exclusion Criteria:

* Needing convexity.

Primary outcomes:
measure: Ability to maintain secure (snug) fit around stoma
timeFrame: Two weeks
Secondary outcomes:
measure: Skin Protection
timeFrame: Two weeks
measure: Wear Time
timeFrame: Two weeks
measure: Ease of use
timeFrame: Two weeks
measure: Ease of teaching
timeFrame: Two weeks
measure: Comfort
timeFrame: Two weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Independent Nurse Consultants LLC
state: Arizona
Study officials:
affiliation: Independent Nurse Consultants LLC
name: Ann M Durnal, RN BSN WOCN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05642039: Mindfulness Training Hidradenitis Suppurativa (HS)
Official title: Effectiveness of Mindfulness Training on the Quality of Life of Hidradenitis Suppurativa Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hidradenitis Suppurativa
Quality of Life
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to investigate the effectiveness of mindfulness training on the quality of life of Hidradenitis Suppurativa (HS) patients. HS can have a profound impact on quality of life.


Eligibility criteria: Inclusion Criteria:

* Hidradenitis Suppurativa patients registered in the University of Miami Hospital dermatology system. Patients can have lesions present at the time of study participation

Exclusion Criteria:

* Individuals with any of the following: active drug addictions, untreated Post Traumatic Stress Disorder (PTSD), psychosis or suicidal ideations
* Adults unable to consent
* Pregnant women
* Prisoners
* Individuals below the age of 18 years old
* Individuals who do not speak English

Primary outcomes:
measure: HS Quality of Life Measure (HiSQOL) Scores
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI) Scores
timeFrame: Up to 10 weeks
measure: Number of participants at each Refined Hurley Classification
timeFrame: Up to 10 weeks
measure: Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores
timeFrame: Up to 10 weeks
measure: Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores
timeFrame: Up to 10 weeks
measure: Pain Visual Analog Scale (VAS) Scores
timeFrame: Up to 10 weeks
measure: Sleep Quality Scale (SQS) Scores
timeFrame: Up to 10 weeks
measure: Number of Pain medication Usage
timeFrame: Up to 10 weeks
measure: Number of work/school days missed
timeFrame: Up to 10 weeks
measure: Number of visits to the emergency room
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hadar Lev-Tov, MD
role: PRINCIPAL_INVESTIGATOR
References: