louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00817388: Correlating Ic/Pbs Symptoms With Urine Biomarkers
Official title: Correlating Ic/Pbs Symptoms With Urine Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Cystitis
Pelvic Pain
Keywords: Interstitial cystitis
pelvic pain
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with and without intersitial cystitis/painful pelvic pain will be asked to provide an urine specimen and complete a brief questionnaire.

Brief summary: Completion of a brief survey tool and providing an urine specimen. The study purpose is to improve our understanding of interstitial cystitis and painful pelvic syndrome.

Detailed description: The purpose of the study is to improve our understanding of the IC/PBS and develop new treatments. Participation in the study will allow us to compare clinical information, obtained by completion of a brief survey, with substances found in the a urine specimen that is donated to the Beaumont Biobank.

Eligibility criteria: Inclusion:

1. Men and women with interstitial cystitis/painful bladder syndrome greater than 18 years old
2. Male and female controls without a history of IC/PBS diagnosis

Exclusion:

1. Unable to complete questionnaires and/or give informed consent

Primary outcomes:
measure: To correlate IC/PBS symptoms with urine biomarkers
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Michael Chancellor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02879188: Ambulation Versus Standing on Postoperative Day 0
Official title: Ambulation Versus Standing on Postoperative Day 0: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: degenerative joint disease
total knee arthroplasty
physical therapy
arthroplasty, replacement, knee
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the impact of the timing of physical therapy (PT) initiation on postoperative length of stay and the time to physical therapy clearance following total knee replacement.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* scheduled for primary TKA (Total Knee Arthroplasty) for any degenerative condition
* Anesthesia for TKA is Spinal + Regional block (Adductor Canal Block)

Exclusion Criteria:

* require assistive devices (walker, wheelchair) for ambulation preoperatively
* planning to go to a subacute nursing facility or acute rehab facility following surgery
* \< 18 yrs of age
* not willing to participate or unable to consent

Primary outcomes:
measure: Length of Hospitalization Stay
timeFrame: 5 days
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 1 week
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Craig Della Valle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06602388: Human Internal BIOASTER's Samples Collection
Official title: Non-interventional, Monocentric Study Aimed at Building up a Collection of Biological Samples Collected From Bioaster Collaborators for Scientific Purposes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Biological Samples
Keywords: Biological
samples
collection
Lead sponsor: Bioaster
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
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: Healthy volunteers (Bioaster employees)

Brief summary: BIOASTER is a Technological Research Institute dedicated to microbiology and infectious diseases. BIAOSTER s areas of expertise are organized around four research programs: 1/ Antimicrobials; 2/ Vaccines; 3/ Microbiota; 4/ Diagnostics.

Hibiscus is a non-interventional, monocentric study aimed at building up a a collection of biological samples (stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair) collected from BIOASTER employees. These samples to be used for scientific purposes including the technological development of Bioaster s collaborative and in-house research projects.


Eligibility criteria: Inclusion Criteria:

Some inclusion criteria can be defined according to the needs of the scientific objective. For example, it is up to volunteers to decide whether or not to participate if they meet the following criteria:

* Age criteria (e.g.: specific, non-identifying range sought: 30-40 years)
* BMI criteria (for example: BMI between 18.5 and 29 kg/m2)
* Gender criteria (e.g.: women only)

Exclusion Criteria:

Some of the following non-inclusion criteria may be defined according to the needs of the project:

* Minor subject
* Health criteria (e.g. presence or absence illness/infection/vaccination/allergy/anti-infective treatment in the last 3 months prior to the date of sampling)
* Smoker status
* Severe chronic illness (active cancer, HIV, severe renal failure, ongoing severe heart, liver or biliary disorders, arthritis)
* Diagnosed acute or chronic gastrointestinal disease or complication (e.g. celiac disease, gastroesophageal reflux, gastric or duodenal ulcer, Crohn\&#39;s disease, hemorrhoids, irritable bowel syndrome),

In all cases, it will be requested that volunteers with the following criteria do not participate in the study:

* Pregnant or breast-feeding women
* Subjects under curatorship or guardianship
* Subjects under legal protection.

Primary outcomes:
measure: The number of analyzable samples collected for scientific purposes.
timeFrame: 3 years after the first inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bioaster
name: Cyril GUYARD, Study Director
role: STUDY_DIRECTOR
affiliation: Bioaster
name: Dr Xavier MORGE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03871088: N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
Official title: N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression, omega-3 fatty acids, nutritional intervention
Lead sponsor: National Science and Technology Council, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-03-12
Enrollment: 400
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: BASIC_SCIENCE

Brief summary: Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.

Detailed description: In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.

Eligibility criteria: Inclusion Criteria:

* the diagnostic criteria of DSM-IV for MDD
* 18 to 65 years old
* pre-study ratings of 18 or greater on the 21-item Hamilton Rating Scale for Depression (HAMD)
* physically healthy under comprehensive evaluations in medical history, physical examination, and laboratory parameters tests
* have not received any psychiatric treatment in 2 weeks
* competent to receive a full explanation of this study and give written informed consent.

Exclusion Criteria:

* a recent or past history of other DSM-IV AxisI diagnoses besides unipolar major depression, including psychotic disorders, organic mental disorders, impulse control disorders, substance use disorder or substance abuse (last 6 months prior to the study), and bipolar disorders
* AxisII diagnoses, including borderline and antisocial personality disorder
* a notable medical comorbidity
* acutely suicidal ideation and attempt were noted that close monitoring such as hospitalization is necessary
* regular consumption of omega-3 PUFAs supplements or a habit of eating ﬁsh equal or more than 4 times per week

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAMD) Changes
timeFrame: From Week 0 to Week 12
Secondary outcomes:
measure: Response rate
timeFrame: at Week 12
measure: Remission rate
timeFrame: at Week 12
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT01069588: Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw
Official title: ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rupture of Anterior Cruciate Ligament
Keywords: bioabsorbable screw
acl reconstruction
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2010-02-17
Enrollment: 67
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 2-4 years post ACL reconstruction performed by Dr. Kurt Spindler, under age 35, injured in sport, unilateral primary ACL.

Brief summary: To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL reconstruction.

Detailed description: This study will combine the use of survey response, MRI, and x-rays of the knees in Dr. Spindler's ACL reconstructed patients in order to examine long term healing of two types of bioabsorbable screw. We will use a 2-4 yr time point to look at patient reported symptoms of pain and swelling from the surveys and use the x-rays and MRIs to look at absorption of the screw, healing of the graft, and body reactions to the screw.

Eligibility criteria: Inclusion Criteria:

* Age range: 12-35 years of age at the time of follow-up.
* Gender: Both.
* Minorities: All.
* Involved in sports at the time of injury.
* Participants must be at least two years past the date of ACL reconstruction surgery and not more than four years past the date of surgery
* Bioabsorbable Screws used during ACL reconstruction surgery

Exclusion Criteria:

* Age: \<12 or \>35 years of age
* Non-active or unable to participate for health reasons
* Simultaneous bilateral ACL reconstruction surgeries.
* If any of the following conditions exist in the ipsilateral knee:

  * Revision ACL reconstruction
  * Complex knee injury
* If any of the following conditions exist in the contralateral knee:

  * ACL deficient
  * Prior ACL reconstruction
  * Prior surgery of any type
* Insufficient initial documentation
* Cannot be contacted by phone
* Neither Calaxo nor Milagro screw used at the time of ACL reconstruction

Primary outcomes:
measure: Screw integrity
timeFrame: 2-4 yrs
measure: Tunnel enlargement
timeFrame: 2-4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kurt P Spindler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox CL, Spindler KP, Leonard JP, Morris BJ, Dunn WR, Reinke EK. Do newer-generation bioabsorbable screws become incorporated into bone at two years after ACL reconstruction with patellar tendon graft?: A cohort study. J Bone Joint Surg Am. 2014 Feb 5;96(3):244-50. doi: 10.2106/JBJS.L.01652.
Clinical trial NCT00702988: Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)
Official title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Neonates
Keywords: Neonatal outcome
Congenital malformations
In-Vitro Fertilization
Controlled ovarian stimulation
Follow-up
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with an ongoing pregnancy at least 10 weeks after embryo transfer in Trial 38826 were enrolled in this trial.

Brief summary: The objective of this trial was to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects and their offspring.

Detailed description: This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during Trial 38826. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Eligibility criteria: Inclusion Criteria:

* Subjects who participated in Trial 38826 and became pregnant (as confirmed by USS at or beyond 10 weeks after ET) after having received at least one dose of either Org 36286 or Puregon®; and
* Able and willing to give written informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Pregnancy status at 20 weeks of gestation
timeFrame: one pregnancy period
measure: Take-home baby rate
timeFrame: one pregnancy period
Secondary outcomes:
measure: Pregnancy follow-up
timeFrame: one pregnancy period
measure: Delivery follow-up
timeFrame: one pregnancy period
measure: Neonatal outcome
timeFrame: one pregnancy period
measure: Infant follow-up
timeFrame: one pregnancy period
measure: Congenital malformations and chromosomal abnormalities
timeFrame: one pregnancy period
Other outcomes:
Locations:
Study officials:
References:
citation: Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.
Clinical trial NCT03352388: Effects of Dairy- and Berry-based Snacks on Nutritional and Functional Status and Quality of Life in Older People
Official title: Tailored Food Solutions for Improving Nutrition and Well-being in Older People. Effects on Nutritional and Functional Status and Quality of Life in Older People at Home Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorders in Old Age
Keywords: Older people
Nutrition
Snack
Dairy
Protein
Berries
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 85
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Malnutrition or its risk is common among older people, especially among those receiving home care services. It impairs the quality of life of the older people and results in significant costs to society. To maintain adequate nutrition, increased meal frequency is important. In addition to main meals, regular consumption of tasty, convenient, nutrient- and energy-dense snacks is recommended. The purpose of this study is to investigate the effects of dairy- and berry-based snack consumption on nutritional and functional status and quality of life among vulnerable older people at home care.


Eligibility criteria: Inclusion Criteria:

* Home care clients of the City of Kuopio

Exclusion Criteria:

* Advanced dementia

Primary outcomes:
measure: Nutritional status
timeFrame: Baseline and 3 months
measure: Albumin
timeFrame: Baseline and 3 months
measure: Prealbumin
timeFrame: Baseline and 3 months
measure: Hand grip strength
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: Baseline and 3 months
measure: Mid-arm muscular area (MMA)
timeFrame: Baseline and 3 months
measure: Hemoglobin
timeFrame: Baseline and 3 months
measure: C-reactive protein (CRP)
timeFrame: Baseline and 3 months
measure: Activity and sleep assessed by ActiGraph monitoring
timeFrame: Baseline and 3 months
measure: Health-related quality of life
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
affiliation: Senior Researcher
name: Riitta Törrönen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Senior Researcher
name: Irma Nykänen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor
name: Ursula Schwab, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Senior Researcher
name: Mika Tarvainen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nykanen I, Torronen R, Schwab U. Dairy-Based and Energy-Enriched Berry-Based Snacks Improve or Maintain Nutritional and Functional Status in Older People in Home Care. J Nutr Health Aging. 2018;22(10):1205-1210. doi: 10.1007/s12603-018-1076-7.
Clinical trial NCT03642288: The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction
Official title: The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction：A Retrospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CRE-induced SBO
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic radiation enteropathy (CRE) is a major issue for long-term cancer survivors. The aim of this study was to clarify the diagnostic and therapeutic effect of the Gastrografin (GG) challenge for patients with CRE induced small bowel obstruction SBO.


Eligibility criteria: Inclusion Criteria:

* with a first diagnosis of CRE combined with SBO and ASBO that was determined by clinical history, computed tomography (CT) manifestation, and conﬁrmed by intraoperative and histologic ﬁndings.
* radiation therapy completed at least 6 months before enrolment.

Exclusion Criteria:

* a colostomy or ileostomy;
* large bowel obstruction;
* with a known history of either allergy or hypersensitivity to iodinated contrast agents;
* with signs of strangulation;
* metastatic disease;
* obstruction within 4 weeks after a recent operation or serious comorbidity.

Primary outcomes:
measure: The rate of successful conservative treatment
timeFrame: 5 days
Secondary outcomes:
measure: The time to resolution
timeFrame: 2 weeks
measure: The length of hospital stays
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00172588: Evaluation of Endometrial Stromal Cell Apoptosis in Adenomyosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Keywords: adenomyosis
apoptosis
flowcytometry
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Our previous results revealed that the expression of killer inhibitory receptors (KIRs) on NK cells was decreased in eutopic endometrium in women with adenomyosis. It implies that the formation of adenomyosis might be due to abnormal endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. In addition, in vitro coculture of macrophages and endometrial stromal cells (ESC) increase the expression of IL-6 mRNA in ESC, which might further enhance the proliferation of ESC and subsequently result in the formation of ectopic endometrial implants in adenomyosis. Besides, another possible mechanism is the abnormal apoptosis of ESC in adenomyosis. In endometriosis, apoptotic endometrial cells were found to be decreased, which possibly accounts for the formation of endometriosis. However, there have not been reports investigating the apoptosis of ESC in adenomyosis.

In this study, we try to investigate apoptotic ESC with flow cytometry in women with and without adenomyosis. Annexin V, bcl-2, and caspase-3 were measured to represent the degree of apoptosis in ESC.

Detailed description: Eutopic endometrium was obtained and separated into single endometrial stromal cell (ESC) in women with adenomyosis (study group) and without adenomyosis (control group).

Annexin V-PE, bcl-2-PE, and caspase-3-PE are stained, and flow cytometry is done to measure the degree of apoptosis in ESC. On the other hand, another half of ESC are cultured for 24h, and also Annexin V-PE, bcl-2-PE, and caspase-3-PE are stained, and flow cytometry is done.

Eligibility criteria: Inclusion Criteria:

* women with adenomyosis
* at early- to mid-secretory phases

Exclusion Criteria:

* postmenopausal
* malignancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, National Taiwan University Hospital
name: Jehn-Hsiahn Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: