louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06263985: Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.
Official title: Prospective Analysis of Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Lead sponsor: Michigan Institution of Women's Health PC
Sponsor class: OTHER
Collaborators: name: Coloplast A/S
First posted: 2024-02-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects undergoing the treatment for pelvic organ prolapse with Axis Dermis biologic mesh.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are:

* Is the leading edge of the prolapse above the hymen
* Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure.

Detailed description: This is a prospective single-arm study of 50 subjects undergoing pelvic organ prolapse repair using the Axis™ Dermis biologic mesh. They will be followed for a period of 3 years. A subgroup analysis is for patients with uterine prolapse and vaginal mesh hysteropexy.

Clinical examination including vaginal wall retraction with or without pelvic ultrasound, POP-Q, and also specific validated questionnaires at baseline, 1 month, 6 month, 12 month, 24 month and 36 month visits will be assessed.

Eligibility criteria: Inclusion Criteria:

* Subjects with preoperative stage II or greater prolapse on the Pelvic Organ Prolapse Quantification System Assessment (POP-Q)
* Subjects who have bothersome vaginal bulge based upon symptoms.
* Subjects who undergo any type of Axis Dermis surgery (anterior, posterior, total, with or without a uterus).

Exclusion Criteria:

* Subjects who are unable to follow-up.
* Subjects who cannot complete the validated questionnaires.
* Subjects that lack competency of the English language.
* Subjects who decline to be part of the clinical trial.
* Subjects who do not sign an informed consent.

Primary outcomes:
measure: Improvement in function
timeFrame: Preoperative to 3 years postoperative.
measure: Improvement in Anatomy
timeFrame: Preoperative to 3 years postoperative.
Secondary outcomes:
measure: Assess complications or untoward side effects.
timeFrame: intraoperative to 3 years postoperative
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Advanced Urogynecology of Michigan
state: Michigan
Study officials:
affiliation: Michigan Institution of Women's Health PC
name: Salil Khandwala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04974385: Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty
Official title: Comparison of Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty: a Prospective, Double-blinded, Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Analgesia
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age or older
* Undergoing total shoulder arthroplasty
* Willing and able to sign consent form to participate in study

Exclusion Criteria:

* \< 18 years of age
* Unwilling or unable to sign consent form to participate in study
* Allergy to local anesthetic
* Medical contraindication to interscalene nerve block
* Chronic opioid use

Primary outcomes:
measure: Opioid Consumption
timeFrame: 72 hours postoperative
Secondary outcomes:
measure: Numeric Rating Scale Reported Pain Scores
timeFrame: 72 hours postoperative
measure: Nerve Block Related Adverse Events
timeFrame: 72 hours postoperative
measure: Patients with Additional, Unanticipated Pain Related Medical Encounters
timeFrame: 72 hours postoperative
measure: Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale
timeFrame: 72 hours postoperative
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: Donald A Elmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730985: From the Gut to the Strut: Reducing Inflammation for Healthy Muscles
Official title: Effectiveness of the Intake of a Food Supplement Based on Hydroxymethylbutyrate, Carnosine, Lactoferrin and Magnesium on Reduction of Inflammation and on the Improvement of the Health of the Muscle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammation
Sarcopenia
Gut Permeability
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aims to evaluate the effectiveness of a dietary supplement on reducing inflammation and improving muscle health. The product is a food supplement notified to the Ministry of Health consisting of: hydroxymethylbutyrate, carnosine, lactoferrin and magnesium, which help reduce inflammation and intestinal permeability and to improve muscle health.


Eligibility criteria: Inclusion Criteria:

* sarcopenic patients aged 55-85. Sarcopenia will be diagnosed according to the European Working Group on Sarcopenia in Older People (EWSGOP-2) criteria by muscle strength or chair stand test.

Exclusion Criteria:

* severe kidney disease (glomerular filtration rate \<30 mL/min),
* moderate-to-severe hepatic failure (Child-Pugh Class of B or C),
* endocrine diseases associated with disorders of calcium metabolism (with the exception of osteoporosis),
* psychiatric disorders,
* cancer (in the previous 5 years),
* hypersensitivity to any investigational food component
* subjects taking protein/amino acid supplements (up to 3 months prior to the study).
* patients not capable of taking oral therapy and those receiving or having indication for artificial nutrition or included in another clinical nutrition trial

Primary outcomes:
measure: Inflammation status
timeFrame: At the beginning of the treatment
measure: Inflammation status
timeFrame: After 4 months of treatment
measure: Muscle strength evaluation
timeFrame: At the beginning of the treatment
measure: Muscle strength evaluation
timeFrame: After 4 months of treatment
measure: body composition assessment
timeFrame: At the beginning of the treatment
measure: body composition assessment
timeFrame: After 4 months of treatment
measure: Physical performance assessment
timeFrame: At the beginning of the treatment
measure: Physical performance assessment
timeFrame: After 4 months of treatment
measure: Gut permeability.
timeFrame: At the beginning of the treatment
measure: Gut permeability.
timeFrame: After 4 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).
Study officials:
References:
Clinical trial NCT01538485: Vitamin D Supplementation and Regulatory FoxP3+ T Cells in the GUT
Official title: Pilot Study to Assess the Effects of Vitamin D Supplementation on the Number of Regulatory FoxP3+ T Cells in the Gastrointestinal Mucosa in Healthy Women and Men: Step 3 in the Austrian Diabetes Prevention Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immune Tolerance
Keywords: Vitamin D
regulatory T cells
GUT
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In this pilot study the investigators aim to investigate the effects of vitamin D supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.

Detailed description: This is a monocentric, open pilot study, with the aim to evaluate the effect of vitamin d supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.

The primary goal is to evaluate the influence of vitamin D supplementation on the regulatory FoxP3+ T cells in the gastrointestinal mucosa under controlled conditions within 2 months.

The secondary study goals are to evaluate the effect of vitamin D supplementation on peripheral induced tregs and on other important immune cells in the tissue (NK, NKT cells and LPCD) and in the blood (NK, NKT cells, Th17, Th1, Th2 cells) within 2 months.

Eligibility criteria: Inclusion Criteria:

* 18-40 years
* non smoker
* BMI: 20-30 kg/m²
* Healthy

Exclusion Criteria:

* hypercalcemia \> 2,65 mmol/L
* pregnancy
* chronic diseases

Primary outcomes:
measure: Increase of regulatory FOXP3+ T cells
timeFrame: 2 months
Secondary outcomes:
measure: other immune cells in the gastrointestinal mucosa
timeFrame: 2 months
measure: serum calcium level
timeFrame: 2 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical university Graz
Study officials:
affiliation: Medical University of Graz
name: Thomas R. Pieber, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02983656: Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicocele
Keywords: Vaccine Safety
Lead sponsor: Zhejiang Provincial Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
Collaborators: name: Changchun Keygen Biological Products Co., Ltd.
First posted: 2016-12-06
Enrollment: 394
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant preventive inoculation of varicella vaccine in 2014-2015

Brief summary: The purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine.


Eligibility criteria: Inclusion Criteria:

* The registered permanent residence or resident place are local (reside more than 3 months);
* Participant preventive inoculation of varicella vaccine in 2014-2015;
* Adverse reactions occurred and should be reported in the AEFI monitoring system.

Exclusion Criteria:

* Subjects with a known allergy to any ingredient of the vaccine, and with any allergy history to any vaccine;
* Subjects with any acute diseases, severe chronic diseases, acute bout of chronic diseases, and catching cold and fever;
* Subjects with uncontrolled seizures and other progressive neurological diseases, with a history of Guillain-Barré syndrome.

Primary outcomes:
measure: incidence of adverse reactions
timeFrame: 1 year after the first and second doses
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang Provincial Center for Disease Control and Prevention
name: Qian Li, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02723656: Proactive Care Coordination for Cancer Survivors Who Smoke
Official title: Using Cancer Registry Data to Promote Proactive Tobacco Cessation Among Adult Cancer Survivors U48
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: smoking
cancer
cancer registry
smoking cessation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 581
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: This is a population-based randomized controlled trial of 600 patients with a diagnosis of cancer in the past 2 years and registry indicating smoking at the time of diagnosis, that will inform critical questions regarding the relative efficacy of care coordination options, the reliability of Electronic Health Record (EHR) tobacco use data, and how patients will react to proactive tobacco related communications. Investigators will compare the reach and efficacy of two proactive approaches to enrolling cancer survivors in tobacco treatment (Arm 1: mailed care coordination vs. Arm 2: telephone care coordination) using a two-arm randomized design at two urban cancer centers, and will explore cancer survivor attitudes and preferences about proactive tobacco treatment.


Eligibility criteria: Inclusion Criteria:

* ICD 9 cancer diagnosis seen at each site in the past two years
* Documentation of current smoking in the cancer registry.

Exclusion Criteria:

* Dementia
* Stage IV or Stage IIIB cancer

Primary outcomes:
measure: Proportion of patients in the study's original proactive outreach cohort of N=600 who complete at least one call with the Quitline
timeFrame: 12 Months
Secondary outcomes:
measure: biochemically validated 7-day abstinence
timeFrame: 6 Months, 12 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Paul Krebs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06511856: FH ORTHO Shoulder Observatory
Official title: Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma
Arthropathy Shoulder
Lead sponsor: FH ORTHO
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient considered for implantation or use of medical devices for shoulder arthroplasty and traumatology distributed by FH ORTHO SAS.

Brief summary: This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma.

In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.

This study meets the requirement for post-market clinical follow-up (PMCF) as defined in the European Medical Device Regulation (MDR 2017/745).

It therefore involves collecting in real life, i.e. under the usual conditions of surgery and short and long-term patient follow-up, minimal clinical data that will make it possible to document the continued benefit/risk of the medical devices concerned.

This study is designed as a permanent long-term observatory, of a non-interventional nature, with the objective of having long-term follow-up data (5 to 10 years depending on the devices concerned) for a maximum number of patients included.


Eligibility criteria: Inclusion criteria:

1. Any patient undergoing implantation of medical devices distributed by FH ORTHO SAS for shoulder arthroplasty and traumatology, used in accordance with their approved labelling, in one of the centres participating in the Observatory (retrospectively or prospectively)
2. Patient is at least 18 years of age
3. Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally) In some countries, such as France, the patient will have to be socially insured to be included in the study.

Exclusion criteria:

1. Patient unable to participate in the study and/or complete the questionnaires 2. Refusal of patient participation

-

Primary outcomes:
measure: Performance of the medical devices over long term follow-up (maximum10 years)
timeFrame: maximum 10 years
Secondary outcomes:
measure: revision rate medical devices over long term follow-up (maximum10 years)
timeFrame: maximum 10 years
Other outcomes:
Locations:
city: Lunel
country: France
facility: Clinique VIA DOMITIA
city: Paris
country: France
facility: Clinique Bizet
city: Saint-Jean
country: France
facility: Clinique de l'Union
Study officials:
References:
Clinical trial NCT00668356: Bioequivalence Study of Didanosine in Children Treated for HIV
Official title: PKPOP Study of Didanosine in HIV Treated Children, at Fasting Period and During the Meal
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV disease in children
HIV
children
didanosine
bioequivalence
pharmacokinetics
treatment experienced
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-04-29
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to show that the administration of 400/mg/m2/day of didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of didanosine during fasting, in HIV infected children treated by a ARV combination including ddI

Detailed description: The didanosine is one of the reverse transcriptase inhibitors. This drug is efficient against the viral replication of the HIV. Licensing for the children was obtained in June, 1992. The main problem of the didanosine is its poor bioavailability: although gastro-resistant capsules were developed, its bioavailability remains dependent on alimentation. Taking a meal 1-2 hours before the administration of ddI leads to a reduction of 50% of its bioavailability as well for the child as for the adult. It is therefore recommended to take ddI during fasting period. This regimen in some cases can decrease therapeutic observance. A pharmacokinetic study of ddI will be conducted during the meal with 240 mg/m2/day during fasting period compare to 400 mg/m2/day during the meal. 26 patients, aged more than 6 years old, will be included and randomised in 2 groups. The first group will take the standard dose of ddI during 28 days during fasting period (phase A), then the high dose during the meal during 28 days (phase B). The second group will take first the phase B and secondly the phase A. Patients will be sequentially evaluated both after the first and the second period of treatment for pharmacokinetics and biological analysis.

Eligibility criteria: Inclusion Criteria:

* Children treated by the didanosine capsules more than 3 months
* viral load \< 50 copies/ml
* written informed consent
* Normal renal function

Exclusion Criteria:

* Lack of observance
* Any treatments which can interact with ddI
* No written informed consent
* Weight \> 60 kg

Primary outcomes:
measure: PK parameters
timeFrame: 28 days
Secondary outcomes:
measure: Biological analysis
timeFrame: 28 days
measure: Quality of life
timeFrame: 28 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Stephane Blanche, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05556356: Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
Official title: Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Carpometacarpal Osteoarthritis
Lead sponsor: Indiana Hand to Shoulder Center
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Basilar thumb arthritis is a common problem that affects 7% of men and 15% of women. It is regarded as one of the more painful procedures commonly performed by hand surgeons. Opioid overuse and diversion are significant problems in the country that contribute to opioid addiction as well as deaths from opioid overdose. Prior studies have examined the effect of different nerve block compositions on perioperative and postoperative analgesia, but none have looked at perioperative loading analgesia. We will attempt to address this problem by exploring alternative analgesia regimens to decrease opioid prescribing after 1st carpometacarpal (CMC) joint arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years of age or older)
* Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis
* Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays
* Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study
* Bilateral thumbs included

Exclusion Criteria:

* \<18 years age
* Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb CMC joints
* Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy
* History of opioid dependency or current chronic opioid use
* Contraindication to acetaminophen use
* Contraindication to NSAID use
* Contraindication or known allergy to peripheral nerve blockade, including coagulopathy
* Contraindication to supraclavicular block due to anatomic variability or inability to tolerate phrenic nerve blockade.
* Contraindication to multivitamin use
* Liver dysfunction

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 2 weeks
measure: Number of Narcotic Pills Used
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
Study officials:
References: