louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04323683: The Effect of Progesterone on Human Endometrium
Official title: The Effect of Progesterone Levels on Human Endometrial Transcriptomics During the Implantation Window
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fertile women

Brief summary: This study evaluates the relationship between progesterone levels and endometrial gene expression


Eligibility criteria: Inclusion Criteria:

* Ages 18-35, regular menstrual cycles, the cycle length between 25 and 35 days, body mass index (BMI) between 18 - 25

Exclusion Criteria:

* History of infertility, history of pelvic pain or/and endometriosis, history of pelvic mass, history of hormonal therapy in the last 3 months

Primary outcomes:
measure: Differentially expressed genes between women with low and normal progesterone
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queen's medical center
Study officials:
References:
Clinical trial NCT00298883: Desensitization of Renal Transplant Candidates
Official title: Desensitization of Renal Transplant Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End Stage Renal Disease
Kidney Transplantation
Keywords: Renal
Transplant
PRA
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2006-03-03
Enrollment: 9
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: Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal transplantation.

Detailed description: Pre-formed HLA antibodies prevent renal transplantation because of the risk of hyperacute rejection. We propose a prospective study evaluating the efficacy of Enteric Coated Mycophenolate Sodium (Myfortic) in decreasing the titers of anti-HLA alloantibodies in patients awaiting kidney transplantation. Myfortic is an immunosuppressant that inhibits the proliferation of B and T cells by blocking the enzyme inosine monophosphate dehydrogenase. We will attempt to determine whether a 6-week course of Myfortic adequately decreases the antibody reactivity to a level compatible with transplantation.

Eligibility criteria: Inclusion Criteria:

* Patients on the deceased donor kidney transplant waiting list with panel reactive antibodies \>50% and living donor waiting list patients who have a history of a positive crossmatch (donor-specific antibodies) will be eligible for the study.

Exclusion Criteria:

* Any subjects not meeting the Inclusion Criteria
* Subjects unable to attend weekly clinic visits for six weeks
* Inability to tolerate Myfortic

Primary outcomes:
measure: decrease in antibody reactivity
timeFrame: six weeks
Secondary outcomes:
measure: CBC and CMP values </> 2 times normal
timeFrame: six weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Shiro Fujita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01821183: Strength and Strength-ratio of Hip Rotator Muscles at Soccer Players
Official title: Strength and Strength-ratio of Hip Rotator Muscles at Soccer Players Compared to Non-soccer Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Injuries
Muscular Atrophy
Dysfunction
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: soccer club of Sarnen, Switzerland Residents of Sarnen and Basel, Switzerland

Brief summary: At this investigation we want to find out whether there is a difference in muscle strength of the internal and external rotation hip muscles between soccer players and non-soccer players caused by typical movement patterns seen in soccer sport.

Detailed description: Nontraumatic hip injuries are a problem often seen in Soccer Players. A biomechanical formation mechanism is probably. Little research has focused on the measurement of hip external and internal rotation strength at soccer players. The purpose of this study is to investigate the influence of soccer sports at the isometric force and force ratio of the hip rotator muscle system. Two samples of Athletes will be compared: Soccer Players (N15) and Non-soccer players (N15) matched in sex, age and level of physical activity to investigate hip rotator force in 3 different angles of hip flexion (0°/45°/90°). The measurement will be made with a handheld dynamometer.

Eligibility criteria: Inclusion criteria:

Study group:

Amateur footballers (N15) in the age between 18 and 35 At least five years of active footballer's career Football training twice weekly Active participation in play No pain or limitations in the area of the hip or the lower extremity

Control group:

Athletes (N15), non-soccer players with now asymmetric leg activities In the age between 18 and 35 At least twice weekly sports activity for at least 30 minutes No pain or limitations in the area of the hip or the lower extremity

Exclusion criteria:

Professions with asymmetric leg activities Pain or limitations in the area of the hip or the lower extremity Surgery on the hip in the prehistory

Primary outcomes:
measure: Strength of the internal and external rotators of the hip
timeFrame: "up to 10 months"
Secondary outcomes:
Other outcomes:
Locations:
city: Sarnen
country: Switzerland
facility: Physiotherapy Burch&Keiser
state: OW
Study officials:
affiliation: Head of degree program: Master of Functional Kinetic Science, University of Basel, Switzerland
name: Niklaus F. Friederich, MD Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01815983: Video-Assisted Laryngoscopy Education
Official title: Does Video-Assisted Self Review Help Students Learn a New Skill Faster?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Surgery
Keywords: Laryngoscopy
Tracheal Intubation
Video Laryngoscopy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to evaluate the impact of a video recording review on the acquisition of a new technical skill (laryngoscopy and tracheal intubation).


Eligibility criteria: Inclusion Criteria:

* Medical students on elective rotation in anesthesiology.

Exclusion Criteria:

* None

Primary outcomes:
measure: Impact of videolaryngoscopy on skill acquisition.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Neal Fleming, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06138483: A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse
Official title: A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropharyngeal Squamous Cell Carcinoma
Keywords: Oropharyngeal Squamous Cell Carcinoma
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasian patients, with newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC

Brief summary: Inclusion of new biomarkers to improve the personalized treatment approach for HPV-positive and -negative oropharyngeal squamous cell carcinoma (OPSCC) patients is urgently needed. Emerging evidences suggest that mutations in epigenetic regulators, as well as epigenetic changes, deeply influence the biology of OPSCC, thus representing attractive targets for the definition of novel molecular markers for this malignancy. Based on these considerations, our project aims to retrospectively identify a new mutational and epigenetic signature to identify OPSCC patients at high risk of early relapse, and to set up a new multicenter prospective study in order to validate it


Eligibility criteria: Inclusion Criteria:

* newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC, according to AJCC 7th Edition,
* managed with definitive treatment modality (either radical surgery plus adjuvant radiotherapy ± chemotherapy or definitive chemo-radiotherapy)
* minimum follow up of 2 years or who had disease recurrence within 2 years after the end of treatment.
* neoplastic lesion contains ≥ 70% neoplastic cells

Exclusion Criteria:

Patients:

* with distant metastases at diagnosis,
* who have been managed with palliative intent;
* with previous history of head and neck cancer are not eligible

Primary outcomes:
measure: risk of recurrence
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO), IRCCS
city: Belluno
country: Italy
facility: Ospedale San Martino di Belluno - ULSS 1 Dolomiti
city: Mestre
country: Italy
facility: Ospedale dell'Angelo - Mestre - Ulss 3 Serenissima
city: Pordenone
country: Italy
facility: Ospedale Santa Maria degli Angeli - ASFO
city: Treviso
country: Italy
facility: Ospedale di Treviso - ULSS 2 Marca Trevigiana
Study officials:
affiliation: Centro di Riferimento Oncologico (CRO), IRCCS
name: Elisabetta Fratta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00554983: Efficacy and Safety From a Recombinant Folding Variant of Bet v 1
Official title: A Multicentre Randomised Placebo-controlled Double-blind Pivotal Clinical Trial for the Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, rBet v 1-FV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Recombinant birch pollen allergy
IgE-mediated allergic disease attributed to birch pollen
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2007-11-07
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety from a recombinant folding variant of Bet v 1


Eligibility criteria: Inclusion Criteria:

* Allergic rhinoconjunctivitis attributable to birch pollen
* Positive SPT
* Positive EAST
* Positive specific provocation test

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies

Primary outcomes:
measure: Symptom-Medication-Score
timeFrame: during pollen season
Secondary outcomes:
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
name: Ludger Klimek, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01639183: Power Toothbrush Use in Nursing Homes to Eliminate Mouth and Body Inflammation
Official title: The Effects of Daily Power Toothbrushing on Caregiver Compliance and on Oral and Systemic Inflammation in a Nursing Home Population: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Keywords: oral inflammation
systemic inflammation
compliance
power toothbrushing
nursing home residents
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Foundation for Dental Hygiene Research and Education
First posted: 2012-07-12
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate whether brushing the teeth of nursing home residents with a power toothbrush as compared with standard care typically provided in nursing homes, will increase caregiver compliance with the provision of daily oral care as well as lower oral and systemic inflammation.

Detailed description: It is well recognized worldwide that residents of nursing homes have poor oral health primarily due to caregiver resistance in the provision of daily oral hygiene care. Fear of being bitten or assaulted by the resident as well as lack of time and discomfort with working in the mouth, are reasons cited for this resistance. It is also now recognized that inflammation in the mouth can raise overall inflammation within the body potentially leading to serious health consequences. Numerous studies involving periodic professional interventions as well as education and training of caregivers in oral care provision have not met with a great deal of success. Caregivers in some studies have indicated preference to power toothbrushes as they are bulkier and longer eliminating the need for insertion of fingers into the mouth and subsequently alleviating fears of being bitten. This study hypothesizes that caregiver utilization of a power toothbrush may increase their compliance with daily oral care provision and could potentially result in elimination of oral and systemic inflammation.

Eligibility criteria: Inclusion Criteria:

* Residents of Nursing Home
* Presence of any natural teeth
* Non-aggressive behavior
* Presence of Periodontal inflammation

Exclusion Criteria:

* Smoking
* Comatose
* On a ventilator
* Aggressive behavior
* Presence of communicable disease
* On antibiotics

Primary outcomes:
measure: Caregiver Compliance
timeFrame: 6 weeks
measure: Systemic Inflammation
timeFrame: 6 weeks
measure: Oral Inflammation
timeFrame: 6 weeks
Secondary outcomes:
measure: Oral Plaque on Teeth
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Deer Lodge Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Salme E Lavigne, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06004583: C-Reactive Protein/Albumin Ratio and Acne Vulgaris
Official title: Relationships Between Disease Severity and The C-Reactive Protein/Albumin Ratio and Various Hematological Parameters in Patients With Acne Vulgaris
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Keywords: acne vulgaris
CRP albumin ratio
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acne vulgaris patients and control healthy individuals

Brief summary: Objective: Acne vulgaris, an inflammatory disease, was investigated in this study with the claim that C-reactive protein (CRP) / albumin ratio and some hematological parameter ratios have the potential to be used as inflammatory markers to monitor disease severity and prognosis.

Methods: A descriptive cross-sectional study was conducted with two groups of patients aged 18-65 years, 61 patients diagnosed with acne vulgaris and 35 healthy control patients, and routine hemogram and biochemical parameters were compared. The Global Acne Severity Index was used to determine the severity of acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Acne vulgaris patients diagnosed by a dermatologist
* Healthy participants without acne
* 18-40 years of age
* Voluntary participation

Exclusion Criteria:

* Aged below18 or above 40 years
* Not voluntarily participated patents
* Pregnants, breast milked mothers, emergency situations

Primary outcomes:
measure: CRP/albumin ratio
timeFrame: 3 months
Secondary outcomes:
measure: Usage of CRP/albumin ratio as a Biomarker
timeFrame: 3 months
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: AtaturkU
Study officials:
References:
Clinical trial NCT02150083: Trial of Two Techniques to Assess Postoperative Voiding Function
Official title: Diagnostic Accuracy of Two Techniques for Assessing Postoperative Voiding Function - A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Keywords: midurethral sling
voiding study
voiding trial
retrograde voiding trial
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women. Many surgical procedures have been developed to treat SUI, and midurethral slings have gradually become the first line treatment. Voiding dysfunction, or inability for a patient to empty her bladder, immediately after surgery is common. A bladder test is often performed in the recovery area to see if the patient is able to empty her bladder. This typically consists of filling the bladder with 300 mL of saline through the foley catheter. The catheter is then removed and the patient is asked to void. The investigators then measure the voided volume and the residual left inside the bladder to determine if she is able to empty her bladder sufficiently or not. A successful voiding trial is defined as voiding 2/3 of the total volume in the bladder and having less than 100 mL left inside the bladder as residual. Our goal of this study was to evaluate efficiency and effectiveness of a retrograde postoperative voiding trial that is initiated in the operating room. Our hypothesis was that a retrograde postoperative voiding trial initiated in the operating room would be as effective as a standard retrograde postoperative voiding trial to predict postoperative voiding dysfunction while allowing for patients to spend less time in the recovery unit.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Women over the age of 18
* Patients with stress urinary incontinence planning to undergo midurethral sling placement

Exclusion Criteria:

* Prior incontinence surgery
* Concomitant surgery for pelvic organ prolapse except for anterior repair
* Intraoperative cystotomy
* Patients taking anticholinergic medication

Primary outcomes:
measure: Comparison of the proportion of subjects who passed the voiding trial between the two groups
timeFrame: Close of incision until discharge, approximately 3 hours.
Secondary outcomes:
measure: Comparison of length of stay in post-anesthesia care unit between the two groups
timeFrame: Close of incision until discharge, approximately 3 hours
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Catherine Matthews, MD
role: STUDY_DIRECTOR
affiliation: University of North Carolina
name: Erinn Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00479583: Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX
Official title: A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Cancer (solid tumors)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer


Eligibility criteria: Inclusion Criteria:

* Patients eligible for FOLFIRI or FOLFOX therapy
* ECOG performance status score 0-1
* At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
* At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva)
* No maximum age for Study Arm A (FOLFOX)
* 18-65 years of age for Study Arm B (FOLFIRI)

Exclusion Criteria:

* Treatment with other TKIs within the past 4 weeks
* Active inflammatory bowel disease
* Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks
* History of thromboembolism
* Severe unmanageable diarrhea
* Uncontrolled or significant cardiovascular disease

Primary outcomes:
measure: Safety assessment
timeFrame: throughout the study
measure: dose-limiting toxicity (DLT)
timeFrame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
measure: determination of maximum tolerated dose (MTD)
timeFrame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
Secondary outcomes:
measure: Describe anti-tumor of combination therapy
timeFrame: Every 8 weeks throughout the study
measure: Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples
timeFrame: throughtout the study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Saint-Herblain Cedex
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: