louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05851157: A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548
Official title: A Phase 1, Randomized, Open-label, Crossover Study Evaluating the Effects of Food on the Pharmacokinetics of VX-548 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 in healthy participants.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (Kg/m\^2)
* A total body weight greater than (\>) 50 kilogram (kg)

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Participants of childbearing potential

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
timeFrame: Pre-dose up to Day 35 Post-dose
measure: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-548 and its Metabolite
timeFrame: Pre-dose up to Day 35 Post-dose
measure: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
timeFrame: Pre-dose up to Day 35 Post-dose
Secondary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 44
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON Salt Lake City
state: Utah
Study officials:
References:
Clinical trial NCT00333957: Capsule Endoscopy in Cystic Fibrosis
Official title: Capsule Endoscopy in Cystic Fibrosis-Screening for Small Bowel Disease in Cystic Fibrosis Patient.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: capsule endoscopy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-06-06
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Cystic Fibrosis patients continue to have bowel problems even after adequate pancreatic enzyme supplementation. There may be pathology of the lining of the bowel. Capsule endoscopy will be used to photograph the entire bowel.

Detailed description: The capsule endoscope system (Given Imaging, Ltd.) consists of 3 elements: a disposable capsule (PillCamTM SB) that acquires video images during natural propulsion through the digestive system.

The video-capsule PillCamTM SB has been cleared by the FDA for use in patients over 10 years of age for the detection of small intestinal disorders. It has been used in patients under age 10 and has been placed with the use of a gastroscope in patients unable to swallow the capsule. In fact, a new delivery device has been introduced recently that facilitates placement of the video-capsule in pediatric patients.For the purposes of this study, only patients over age 10 years who are able to swallow the capsule would be enrolled.

There are approximately 450 CF patients in the registry in Israel, with about 300 above the age of 10. Study subjects would be enrolled from this registry population and would be screened for the presence of the contraindications noted above. Patients would be assessed for symptoms of possible small bowel lesions at the time of enrollment including gastrointestinal bleeding, palpable abdominal mass, weight loss, diarrhea, and abdominal pain. Markers of inflammation including stool calprotectin will be assessed in all patients. These data would be recorded for further analysis.

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Eligibility criteria: Inclusion Criteria:

Inclusion criteria would include those subjects with known CF who are able to give informed consent to undergo capsule endoscopy and whose guardians provide consent as well, if applicable. -

Exclusion Criteria

Subjects would be excluded if they were felt to be poor surgical candidates as patients may need to undergo surgery in the rare event of retention of the capsule. Patients genotype and lung function will be noted; patients will be excluded if FEV1 \< 40%.

-

Primary outcomes:
measure: We will examine the entire small bowel
measure: of CF opatients
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Michael Wilschanski, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01727557: Anesthetic Technique for AV Fistulae Creation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Keywords: Hemodialysis and AV fistula
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done. In this case, the numbing medication will be injected directly into the area where your fistula will be made. In regional anesthesia, the numbing medication will be injected around the nerve (part of the body that gives sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare the three month success rates of AV fistulae created by the two anesthesia techniques.

Detailed description: The primary objectives of the study are:

1. To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.
2. To evaluate the immediate (within 3 days) and long-term complications three months after AV fistula construction under regional anesthesia or local anesthesia.

The secondary objective of the study is to use a short questionnaire survey To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).

Eligibility criteria: Inclusion Criteria:

* Age 21-70 years old
* Able to give informed consent
* Creation of first time AV fistula
* Possible 3 month follow up visit
* ASA-I-IV

Exclusion Criteria:

* BMI ≥40
* Repeated AV fistula creation,
* ASA -V,
* Allergic to local anesthetic agents,
* Significant lung and cardiac disease,
* Infection at the site of regional anesthesia,
* Pre-existing peripheral nerve damage,
* Significant bleeding disorders,

Primary outcomes:
measure: AV fistula success rate
timeFrame: Three months from the day of creation
Secondary outcomes:
measure: Short term comfort level
timeFrame: Within three days of procedure
measure: Short term safety, number of post operative complications
timeFrame: Three days after the creation
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
Clinical trial NCT03440957: Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed
Official title: Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patient Confined in the Bed
Keywords: advanced cancer
osteopathy
pain
bedridden
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Staying confined in the bed is frequent at the end of life. The cancer patients can also experiment this situation, and consequences are painful, with pain increasing with the time. This pain are related to the joints stiffing , muscles mass decreasing, and tendons retractions . The non pharmacological approach associated with the conventional treatments can be interesting to assess in this frails patients.


Eligibility criteria: Inclusion Criteria:

* Man or woman
* Aged 18 years or older
* Having signed informed consent to participate in the study
* Patient affiliated to a social security scheme
* Patient with pain affecting the musculoskeletal system following prolonged bed rest
* Capable to understand French
* Capable of completing self-assessment scales

Exclusion Criteria:

* Patients with bone metastases at risk for the use of osteopathy
* Patients under legal protection measures
* Patients with cognitive impairment preventing self-evaluation
* Patient who is considered too fragile or with a clinical condition too unstable by the doctor refer to be included in the study
* Patients in the pre-agonic or agonic phase

Primary outcomes:
measure: Decreased pain intensity of 2 points measured by Analog Visual Scale (AVS) before and after the session
timeFrame: 15 days
Secondary outcomes:
measure: Decrease in analgesic consumption for pain related to immobilization
timeFrame: 15 days
measure: Decreased 2 points of intensity of other symptoms associated before and after session measured with Edmonton Symptom Assessment System (ESAS).
timeFrame: 15 days
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Marilène FILBET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06516757: A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health.
Official title: A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Health
Bacterial Vaginosis
Keywords: Vaginal pH Balance
Vaginal Flora
Women's Health
Lead sponsor: Love Wellness
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-07-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Participants will complete a questionnaire before using the product and on Days 3 and 7 of using the product. They will also complete a vaginal swab pH test before using the product and after 7 days of using the product (Day 8).


Eligibility criteria: Inclusion Criteria:

* Female at birth
* Aged 18+
* Interested in maintaining a calm, soothed, and healthy vaginal environment and balanced vaginal pH levels
* Regularly experience atypical vaginal smell, discharge, itching, swelling, irritation, pain or - burning during sex, and/or a burning sensation while urinating
* Willing to avoid introducing any products or new forms of prescription medication or supplements targeting vaginal health during the study period
* Has used a boric acid suppository before
* Willing to avoid the use of any intra-vaginal products during the study product use
* Willing and able to follow the study protocol

Exclusion Criteria:

* Surgeries or invasive treatments in the last six months or planned during the study period
* Introduced any products or forms of prescription medication or supplements targeting vaginal health in the last 12 weeks
* Known allergies to the product ingredients
* Diagnosed with chronic health conditions impacting participation
* Pregnant, breastfeeding, or trying to conceive
* History of substance abuse
* Current or former smoker within the past six months
* Unwilling to follow the study protocol
* Currently participating in any other clinical trial or perception study

Primary outcomes:
measure: Vaginal Health and Balance
timeFrame: Baseline, Day 3, Day 7, and Day 8
measure: Vaginal Health and Balance
timeFrame: Baseline, and Day 8
Secondary outcomes:
measure: Participant Perception of Product Convenience
timeFrame: Day 3 and Day 7
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT00214357: The Effects of Mindfulness Training on School Staff
Official title: The Effects of Mindfulness Training on School Staff Emotions, Attention, and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teachers
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary research objective is to investigate psychological, behavioral, and physiological changes in school staff as a result of undergoing meditation and stress reduction training. Specifically, we hypothesize that school staff undergoing meditation and stress reduction training will show decreased emotional distress on self-report measures, increased sustained attention on a behavioral task, and decreased stress levels as indexed by salivary cortisol.


Eligibility criteria: Inclusion Criteria:

* Staff from Madison, WI area elementary school

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Self-report; behavioral task; diurnal cortisol
Secondary outcomes:
measure: Self-report measures
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Donal G MacCoon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04946266: Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers
Official title: Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Cancer
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with localized kidney tumors

Brief summary: An exploratory analysis of the expression of MFI2-AS1 will be performed at the plasma level with the objective of comparing this expression with tumor tissue. The objective would be to be able to use long non-coding RNA as a biomarker for diagnosis before tissue analysis and for patient follow-up. In addition, correlations will be made between tumor expression of MFI2-AS1 and genetic and immune alterations in tumors in order to better clarify the link between the expression of this long non-coding RNA and the characteristics of the tumor and of the tumor. tumor microenvironment.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Localized kidney tumors\> T1a
* Patient having signed an informed consent
* Patient affiliated to a health insurance plan
* Subject having signed a consent form to participate in research and the constitution of a collection and genetic analyzes

Exclusion Criteria:

* Metastatic carcinoma from the outset
* Contraindication to performing a TAP CT with injection of contrast product
* Inability to provide informed information about the subject (subject in an emergency situation, difficulties in understanding, etc.)
* Subject under legal protection
* Subject under tutorship or curatorship
* Pregnancy
* Feeding with milk

Primary outcomes:
measure: Expression of MFI2-AS1
timeFrame: 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: les Hôpitaux Universitaires de Strasbourg
name: TRICARD Thibault
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06898866: Functional and Occupational Rehabilitation of Troops
Official title: An Effectiveness-Implementation Trial of Functional Restoration for Chronic Pain Management in Active Duty Military Personnel
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Musculoskeletal Pain
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: University of Washington
First posted: 2025-03-27
Enrollment: 480
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active duty military personnel diagnosed with chronic musculoskeletal pain.

Brief summary: The proposed implementation science project will evaluate the factors that support or hinder the successful implementation of the FORT Functional Restoration Program at six Military Treatment Facilities (MTF) across the Military Health System. It will also evaluate the associated effectiveness outcomes related to chronic musculoskeletal pain management in active-duty military personnel.

Detailed description: This project will be an effectiveness-implementation hybrid type 2 study design using a stepped-wedge randomized clinical trial research design. The study will simultaneously evaluate clinical and implementation outcomes related to the establishment of functional restoration programs. The study investigators have collaborated with the Defense Health Agency (DHA) Pain Management Clinical Support Services to identify chronic pain management programs at six MTFs interested in systematically improving and assessing the outcomes of their program. The MTFs will be randomized in pairs to initiate the Implementation Facilitation strategy to improve the implementation of their program over three 6-month intervals, after an initial 6-month baseline. This hybrid design will allow for the evaluation of both implementation and clinical effectiveness research aims and support rapid translation of research outcomes. Each site will participate in a minimum 6-month baseline period prior to the intervention period to serve as its own treatment as usual.

Eligibility criteria: Inclusion Criteria:

"patient referred to functional restoration program by provider"

Exclusion Criteria:

"patient not referred to functional restoration program by provider"

Primary outcomes:
measure: Pain Impact Score (PIS)
timeFrame: Baseline to 13 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02569866: Antibiotics After Breast Reduction:Clinical Trial With Randomization
Official title: Antibiotics After Breast Reduction:Clinical Trial With Randomization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgical Site Infection
Keywords: plastic surgery
mammaplasty
wound infection
prophylaxis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Universidade do Vale do Sapucai
First posted: 2015-10-07
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates.

Detailed description: Prevention of SSI is important due to its morbidity, longer hospital stays and higher costs. In many surgical procedures where the risk of infection is relatively low and the postoperative infection can be treated properly, the role of antibiotics is not clear.

Despite the lack of evidence from prospective randomized controlled trials of evaluation, the use of antibiotics in plastic surgery is widespread in order to offer the highest safety standards patients.

The breast reduction is defined as "clean surgery" with a lower infection rate to 3.4%. Thus, the antibiotic is not recommended. However, studies have shown a real rate of infection associated with procedures ranging from 4-36%.

Thus, this trial was designed to verify the role of antibiotics in reduction mammaplasty.

Eligibility criteria: Inclusion Criteria:

* Breast hypertrophy
* Body mass index between 19 to 30 kg/m2

Exclusion Criteria:

* Patients undergoing a surgical procedure in the breast
* Diagnosis of breast pathology
* Smoking
* Childbirth or lactation less than a year
* Uncontrolled comorbidities
* Use of immunosuppressive drugs
* Misuse of capsules supplied
* Absence during the weekly follow-up

Primary outcomes:
measure: Surgical site infection in the postoperative of reduction mammaplasty.
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Hospital das Clínicas Samuel Libanio
state: Minas Gerais
Study officials:
affiliation: Federal University of São Paulo
name: Lydia M Ferreira, PhD
role: STUDY_CHAIR
References:
citation: Veiga-Filho J, Veiga DF, Sabino-Neto M, Amorim MC, Novo NF, Ferreira LM. The role of antibiotics in reduction mammaplasty. Ann Plast Surg. 2010 Aug;65(2):144-6. doi: 10.1097/SAP.0b013e3181c47d88.
citation: Garcia ES, Veiga DF, Veiga-Filho J, Cabral IV, Pinto NL, Novo NF, Sabino Neto M, Ferreira LM. Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial. Trials. 2016 Nov 30;17(1):567. doi: 10.1186/s13063-016-1700-y.