louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05527834: Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants
Official title: VNRX-7145-104: an Open-label, Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Healthy Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-09-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.


Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-65 years
* Males or non-pregnant, non-lactating females
* Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
* Laboratory values meeting defined entry criteria

Exclusion Criteria:

* History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug
* Conditions that potentially alter absorption and/or excretion of orally administered drugs
* Congenital or acquired immunodeficiency syndrome
* Positive alcohol, drug, or tobacco use/test

Primary outcomes:
measure: Cmax
timeFrame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
measure: AUC0-t
timeFrame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
measure: AUC0-inf
timeFrame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON Plc.
state: Kansas
Study officials:
References:
Clinical trial NCT01830634: Lower-limb Strength and Flexibility Program on Prevention of Falls in the Community-dwelling Elderly
Official title: Effect of Strength and Flexibility Training With Elastic Band on Gait Pattern and Functional Ability in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Community-dwelling elderly
Rehabilitation
Theraband
Strengthening and stretching exercise
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 107
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Accidental falls result in major physical and psychological morbidity in the elderly. The aim of this study was to evaluate the effects of lower-limb strength and flexibility program, which is analyzed under the control of other risk factors, on preventing falls and fall-related injuries in the community-dwelling elderly.

Detailed description: To estimate the effect of strength and flexibility training with elastic band on community-dwelling elderly gait, balance, and functional performance. All subjects received a home exercise program with low resistance elastic band training. All subjects were assessed for functional assessment, balance and gait analysis at initial and after training.

Eligibility criteria: Inclusion Criteria:

* elder living in community
* age \> 65 years old

Exclusion Criteria:

* no walking ability before fall
* conscious change or disease induce fall
* impaired cognition

Primary outcomes:
measure: Computerized balance evaluation
timeFrame: after 3 months intervention
Secondary outcomes:
measure: improve in functional activity
timeFrame: after 3 months intervention
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital Taiwan
Study officials:
affiliation: Changhua Christian Hospital
name: TaSen Wei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01348334: Synthetic Mesh Materials In Sling Surgery
Official title: Use Of Three Types Of Synthetic Mesh Materials In Sling Surgery: A Prospective Randomized Clinical Trial Evaluating Effectiveness And Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence
Keywords: Sling surgery
synthetic meshes
ultrapromesh®
mix mesh
incontinence
The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2011-05-05
Enrollment: 144
Sex: FEMALE
Minimum age (years): 31
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the clinical results contributions to surgical success,and complications of mixed type of mesh materials as well as prolen mesh materials in sling surgery in a 3 year follow-up the first time in literature.

Detailed description: Broad based double forced sling operations were performed in 144 patients by using 3 different types of mesh materials between 2004 and 2007. Group I consisted of 48 patients in whom Vypromesh® (Ethicon,USA) was used; Group II consisted of 48 patients in whom Ultrapromesh®( Ethicon,USA) and Group III consisted of 48 patients in whom Prolene light mesh® (Johnson\&Johnson,USA) was used. The data of the patients and the success of the operation were evaluated based on 24hr pad test, ICIQ-SF scoring, and Korman questionnaire analysis.

Main outcome measures:The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.

Eligibility criteria: Inclusion Criteria:

* Stress urinary incontinence
* Mix urinary incontinence
* Previous failed anti-incontinence surgery
* Previous gynecologic surgery

Exclusion Criteria:

* Urodynamical detrusor overactivity or impaired bladder activity
* Prolaps of pelvic organ
* Urge incontinence
* Neurogenic bladder
* Bladder outlet obstruction
* Urinary fistula, Pregnancy
* Active urinary or vaginal enfection
* Contraindication to anesthesia
* \> 100ml PVR urine volume

Primary outcomes:
measure: continence rates at three years after surgery
timeFrame: three years after surgery
Secondary outcomes:
measure: urethral erosion at three years after surgery
timeFrame: three years after surgery
measure: vaginal erosion at three years after surgery
timeFrame: three years after surgery
measure: Denovo urgency at three years after surgery
timeFrame: three years after surgery
measure: urine retantion at three years after surgery
timeFrame: three years after surgery
measure: sutur granuloma at three years after surgery
timeFrame: three years after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04656834: Hand Incision Study
Official title: Hand Surgical Incision Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hand Surgery
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are 18 years old or older who are having surgery for either a trigger finger release or carpal tunnel release by one of Rothman Orthopaedics Hand \& Wrist Surgeons

Brief summary: The cosmetic outcome of a patient's surgical scar is important for patient satisfaction, especially in more visibly exposed areas of the body such as the hand. A patient's surgical scar often serves as a long-term reminder of their surgery experience, so optimizing final scar appearance should be of high importance. Surgical incision closure techniques and suture materials may vary by individual hand surgeons, even with common hand procedures.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old
* Able to provide consent
* Undergoing either trigger finger release or carpal tunnel release

Exclusion Criteria:

* Patients \< 18 years old
* Unable to provide consent
* Unable to comply with follow up requirements

Primary outcomes:
measure: Participant Satisfaction with Scar Appearance (Questionnaire #1)
timeFrame: 12 weeks
measure: Participant Satisfaction with Scar Appearance (Questionnaire #2)
timeFrame: 12 weeks
measure: Participant Satisfaction with Scar Appearance (Questionnaire #3)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04028934: Study of the Quality of Life of Patients Treated by Heavy Surgery as Part of an Enhanced Recovery at Beau Soleil Clinic- QUALICHIR
Official title: Study of the Quality of Life of Patients Treated by Heavy Surgery as Part of an Enhanced Recovery at Beau Soleil Clinic- QUALICHIR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enhanced Recovery After Surgery
Cystectomy
Lead sponsor: Clinique Beau Soleil
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an indication of cystectomy validated by the surgical team and if there is an oncological indication by the multidisciplinary meeting of onco-urology, and having accepted the principle of ERAS

Brief summary: Heavy and oncological surgery is undergoing a major evolution. Some surgical dogmas are falling and care is better rationalized. The interactions between the patient and the caregivers on the other hand, and from the caregiver to the caregiver are favored. Thus was born, about 10 years ago, the principle of enhanced recovery after surgery (ERAS).

But recovery has improved in the patient in the best possible shape in the operating room, and, during the gesture, minimize the negative effects of surgery and anesthesia. Finally, postoperatively, to re-empower the patient as quickly as possible.

The interest of this study is the benefit of the quality of life of the patient being treated for cystectomy as part of an enhanced recovery program. This is to argue the diffusion of this program and the care teams for its realization.


Eligibility criteria: Inclusion Criteria:

* Patients with an indication of cystectomy validated by the surgical team and if there is an oncological indication by the multidisciplinary meeting of onco-urology.
* Patient affiliated to a social security scheme
* Patient classified ASA from 1 to 3
* Patient informed and having accepted the principle of enhanced recovery after surgery

Exclusion Criteria:

* Patients classified ASA ≥4
* Patients with severe or poorly balanced associated conditions (diabetes, long-term corticosteroid therapy, severe undernutrition, cirrhosis, immunosuppression, cardiac disease), contraindications to enhanced recovery after surgery (ERAS) may be temporary if they are corrected.
* Patients who can not comply with the ERAS protocol because they do not understand the language or cognitive disorder.
* Vulnerable people (Article L 1121-6 of the CSP)
* Majors subject to legal protection or unable to express their consent (Article 1121-8 of the CSP)

Primary outcomes:
measure: Estimation of the percentage of patients who will have a "good or very good" quality of life, when they were included in an enhanced recovery program in urology following a cystectomy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Lacombe Sandy
Study officials:
References:
Clinical trial NCT00920634: Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)
Official title: Protocol for Drug Use Investigation of Follistim Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anovulation
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 384
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese 300 patients

Brief summary: The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent IVF

Exclusion Criteria:

* Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
* Pregnant or possible pregnant women, or lactating women
* Patients with undiagnosed atypical vaginal bleeding
* Patients with a history of hypersensitivity to any of the ingredients of this product
* Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease

Primary outcomes:
measure: Occurrence of ovulation
timeFrame: 3 months, from initiation of treatment to confirmation of pregnancy.
Secondary outcomes:
measure: Pregnancy outcome
timeFrame: 3 months, from initiation of treatment to confirmation of pregnancy.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00694434: Graduated Embryo Score (GES) in the Fresh Cycle Predicts Outcome From Frozen Embryo Transfer
Official title: Graduated Embryo Score (GES) Int he Fresh Cycle Predicts Outcome From Frozen Embryo Transfer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Cryopreservation
Frozen embryo transfer
Graduated Embryo Score
Lead sponsor: Sher Institute for Reproductive Medicine, Las Vegas
Sponsor class: OTHER
First posted: 2008-06-10
Enrollment: 183
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All IVF patients at our center between 2002 and 2007 with at least 2 frozen blastocysts undergoing frozen embryo transfer.

Brief summary: Evaluation of embryo quality in the fresh cycle as a predictor of outcome from frozen embryo transfer.

Detailed description: Outcomes from frozen embryo transfer reviewed based on the quality of the embryos in the ftresh cycle as assessed by the Graduatede embryo score.

Eligibility criteria: Inclusion Criteria:

* 2 frozen blastocysts

Primary outcomes:
measure: On-going gestation (beyond 8 wks)
timeFrame: Fetal heart activity at 8 weeks of gestation
Secondary outcomes:
measure: Implantation rate (gestational sacs/ embryos transferred)
timeFrame: 8 weeks of gestation
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Sher Institute for Reproductive Medicine
state: Nevada
Study officials:
affiliation: Sher Institute
name: Jeffrey D Fisch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06448234: Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Lowering LDL Cholesterol in Hypercholesterolemic Patients
Official title: Evaluating the Efficacy of AI-Guided vs. Standard Physician-Guided Dietary Supplement Prescriptions for Lowering LDL Cholesterol in Hypercholesterolemic Patients: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: LDL cholesterol reduction
AI-guided prescriptions
Dietary supplements
Personalized nutrition
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center of New Medical Technologies
First posted: 2024-06-07
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial compared AI-guided and standard physician-guided dietary supplement (DS) prescriptions for lowering LDL cholesterol (LDL-C) in hypercholesterolemic patients. The AI system used genetic, metabolic, and clinical data to personalize DS regimens, hypothesizing superior efficacy over traditional methods. This 3-month randomized, controlled trial involved adults aged 40-75 with specific LDL-C levels, excluding those with significant health risks. Participants were divided into a control group with physician-guided DS and an AI-guided group. The AI system from Triangel Scientific provided dynamic, personalized recommendations. Baseline and follow-up measurements included lipid profiles and adherence assessments. The AI-guided group showed significantly greater LDL-C reduction and improvement in other lipid markers. The study concluded that AI-guided DS prescriptions are more effective, suggesting a promising future for AI in personalized cholesterol management.


Eligibility criteria: Inclusion Criteria:

* Age between 40 and 75 years.
* LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.

Exclusion Criteria:

* Personal history of cardiovascular disease or high risk (≥ 20%).

  * Triglycerides (TG) ≥ 400 mg/dL.
  * Body Mass Index (BMI) ≥ 35 kg/m²
  * Use of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months.
  * Diabetes mellitus.
  * Known severe or uncontrolled thyroid, liver, renal, or muscle diseases.

Primary outcomes:
measure: change in LDL-C
timeFrame: 180 days
Secondary outcomes:
measure: Percent change in high-sensitivity C-reactive protein (
timeFrame: 180 days
measure: Percent change in high-density lipoprotein cholesterol
timeFrame: 180 days
measure: Percent change in total cholesterol.
timeFrame: 180 days
measure: Percent change in serum triglycerides between the groups.
timeFrame: 180 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References:
Clinical trial NCT00164034: Trauma Reception and Resuscitation Project
Official title: Trauma Reception and Resuscitation Project - 'Time for a New Approach'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: Trauma
Wounds
Injuries
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Victorian Trauma Foundation
name: National Trauma Research Institute
First posted: 2005-09-14
Enrollment: 1171
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Test the hypothesis that the implementation of real-time, computer-prompted algorithms in the first half hour of trauma management will result in a measurable reduction in management errors associated with the reception and resuscitation of major trauma patients.

Demonstrate that a reduction in management errors will translate into a reduction in morbidity and mortality.


Eligibility criteria: Inclusion Criteria: All injured patients \> 15 years old who are brought or present to the The Alfred Trauma Centre during the study period.

Exclusion Criteria: Stable Trauma patients (ie Pulse rate \<100/minute, MAP \>70mmHg, Hb \>70, temperature \>35 and \<37.5, Spo2 \>92%, GCS \>13) undergoing secondary transfer from another hospital, where trauma occurred \>6hrs prior to arrival.

Primary outcomes:
measure: Error rate per patient treated demonstrated by deviation from the algorithms
Secondary outcomes:
measure: Missed injuries
measure: Time to decision
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital, Emergency and Trauma Centre, .
state: Victoria
Study officials:
affiliation: The Alfred Hospital, Bayside Health, Melbourne, Australia
name: Mark Fitzgerald, MBBS, FACEM, MRCMA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fitzgerald M, Cameron P, Mackenzie C, Farrow N, Scicluna P, Gocentas R, Bystrzycki A, Lee G, O'Reilly G, Andrianopoulos N, Dziukas L, Cooper DJ, Silvers A, Mori A, Murray A, Smith S, Xiao Y, Stub D, McDermott FT, Rosenfeld JV. Trauma resuscitation errors and computer-assisted decision support. Arch Surg. 2011 Feb;146(2):218-25. doi: 10.1001/archsurg.2010.333.
Clinical trial NCT02982434: The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation
Official title: Injection of the New Pharmaceutical Composition Containing Botulinum Toxin Into Epicardial Fat Pads to Treat Atrial Fibrillation After Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atrial Fibrillation
Ischemic Heart Disease
Keywords: atrial fibrillation
botulinum toxin
ischemic heart disease
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-12-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.


Eligibility criteria: Inclusion Criteria:

* Patients with paroxysmal AF (recurrent episodes for at least 2 years, with ≥ 6 episodes over the last 6 months)
* At least one failed antiarrhythmic drug
* Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery

Exclusion Criteria:

Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation or atrial fibrillation at the time of screening Planned maze procedure or pulmonary vein isolation Unwillingness to participate

Primary outcomes:
measure: Freedom from any atrial tachyarrhythmias
timeFrame: 12 months
Secondary outcomes:
measure: number of deaths
timeFrame: 12 month
measure: time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU
timeFrame: 1 month
measure: incidence of congestive heart failure
timeFrame: 12 month
measure: incidence of sustained ventricular arrhythmias
timeFrame: 12 month
measure: stroke or transient ischemic attack
timeFrame: 12 month
measure: incidence of myocardial infarction
timeFrame: 12 month
measure: rehospitalization
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
city: Tomsk
country: Russian Federation
facility: Cardiology Research Institute
Study officials:
References: