louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01286337: Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique
Official title: Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Axilla Node Dissection
Keywords: axilla
surgery
technique
bipolar vessel sealing
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection compared to the traditional surgical technique


Eligibility criteria: Inclusion Criteria:

* Women with documented breast cancer (by histology or cytology) and candidate to elective axillary lymphadenectomy

Exclusion Criteria:

* Age less than 18 years
* Denied written informed content
* Previous axillary operations (except for sentinel node biopsy)
* Preoperative radio-chemotherapy
* Scheduled reconstructive breast operation

Primary outcomes:
measure: reduction of lymphorrhea rate
timeFrame: forth postoperative day
Secondary outcomes:
measure: reduction of lymph output from the axillary drain
timeFrame: forth postoperative days
Other outcomes:
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
Study officials:
affiliation: milano-bicocca university
name: angelo nespoli, md
role: STUDY_DIRECTOR
affiliation: milano-bicocca university
name: luca gianotti, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nespoli L, Antolini L, Stucchi C, Nespoli A, Valsecchi MG, Gianotti L. Axillary lymphadenectomy for breast cancer. A randomized controlled trial comparing a bipolar vessel sealing system to the conventional technique. Breast. 2012 Dec;21(6):739-45. doi: 10.1016/j.breast.2012.08.003. Epub 2012 Sep 7.
Clinical trial NCT01366937: Assessment of Vitamin B12 Bioavailability From Egg
Official title: Assessment of Vitamin B12 Bioavailability From Egg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bioavailability of Vitamin B12 From Chicken Eggs
Keywords: vitamin B12
egg
14C
fecal excretion
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
First posted: 2011-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults, 18 y or older

Brief summary: The hypothesis of this study is that chicken eggs can be enriched in vivo with 14C-B12 and fed to healthy human subjects to determine B12 bioavailability from eggs.

The goal of this research is to enrich eggs in vivo with radioactively labeled vitamin B12 to a level that allows us to feed the enriched eggs to humans and determine how much of the vitamin B12 is digested and absorbed into the body. This will tell us if eggs are a good dietary source of vitamin B12. Importantly, sensitive technology available at the Lawrence Livermore National Laboratories allows us to measure very low amounts of radioactive vitamin B12. This allows us to do this experiment with a level of radioactive B12 that is not harmful to animals or humans. The results of the investigators first experiment indicate that the investigators can inject radioactively labeled vitamin B12 into a laying hen and detect the radioactive vitamin B12 in the eggs at a level sufficient for feeding to humans in a bioavailability study.


Eligibility criteria: Inclusion Criteria:

* normal healthy subjects, adequate B12 status and absorptive capacity and the availability to complete the protocol.

Exclusion Criteria:

* any chronic health disorder, anemia of any kind, renal insufficiency, and pregnancy or lactation.

Primary outcomes:
measure: Fecal enrichment of 14C
timeFrame: Over the course of 8 days after dosing with 14C labeled egg
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: Usda, Ars, Whnrc
state: California
Study officials:
affiliation: ARS, USDA, WHNRC
name: Linday H Allen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ARS, USDA, WHNRC
name: Marjorie G Garrod, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01641237: Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions
Official title: The Effect of Fluoride in an Experimental Dentifrice on Remineralization of Erosive Lesions In-Situ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Enamel Erosion
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-07-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.


Eligibility criteria: Inclusion Criteria:

* intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.

Primary outcomes:
measure: Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship
timeFrame: Baseline to 4 hours
Secondary outcomes:
measure: %SMHR
timeFrame: Baseline to 4 hours
measure: Percentage Relative Erosion Resistance
timeFrame: Baseline to 4 hours
measure: Enamel Fluoride Uptake (Corrected Data)
timeFrame: Baseline to 4 hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03362437: Evaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy Participants
Official title: A Study to Evaluate the Pharmacokinetics of BMS-986177 From Form A and Form B in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-12-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B


Eligibility criteria: Inclusion Criteria:

* Body mass index 18.0 to 32.0 kg/m2, inclusive
* Women must not be of childbearing potential (cannot become pregnant)

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Head injury in the last 2 years
* History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc.

Other protocol defined inclusion / exclusion criteria could apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 3 days
measure: AUC from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to 3 days
measure: AUC from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to 3 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 12 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 30 days
measure: Number of participants with electrocardiogram abnormalities
timeFrame: Up to 12 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 12 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 12 days
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Clinical
state: Nottingham
Study officials:
affiliation: Briston-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00100737: Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin's Lymphoma (NHL)
Official title: A Phase 2 Randomized, Open-Label, Controlled Trial of the Addition of 8 Weeks SC Administration of Aldesleukin (Rh-Interleukin-2 [IL-2]) to 4 Weeks of IV Administration of Rituximab in the Treatment of Rituximab Naïve Subjects With Follicular Non-Hodgkin's Lymphoma, Refractory or Relapsed After Previous Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Hodgkin Lymphoma
Keywords: non-hodgkins lymphoma
interleukin-2
rituximab
CD20+ follicular B-cell non-hodgkins lymphoma (grade I, II,III)
Lead sponsor: Chiron Corporation
Sponsor class: INDUSTRY
First posted: 2005-01-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8 weeks in combination with rituximab is effective and safe when compared to rituximab given alone in the treatment of follicular NHL subjects that have never received rituximab as a treatment and are refractory or relapsed after previous chemotherapy.


Eligibility criteria: Inclusion Criteria:

* CD20+ follicular B-cell non-hodgkin's lymphoma with at least 1 site of measurable disease.
* Previous treatment with 1 to 4 prior chemotherapy regimens
* ECOG performance status of greater than or equal to 2
* Life expectancy of greater than 18 weeks
* Meet safety lab requirements and organ function tests

Exclusion Criteria:

* Prior treatment with rituximab or IL-2
* Prior radioimmunotherapy including Zevalin or Bexxar
* 5 or more prior chemotherapy regimens
* Clinically significant cardiac disease, lung dysfunction, autoimmune disease, thyroid disease, active infection, unstable psychiatric condition, or HIV infection.
* History of allogenic bone marrow transplant
* Female subjects that are pregnant or breast feeding
* Immunosuppressive therapy including corticosteroids or investigational agents within 4 weeks prior to the planned start of study treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
References:
Clinical trial NCT03133637: Ceftriaxone and Jaundice in Neonates
Official title: Effect of Ceftriaxone on Neonatal Jaundice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jaundice and Sepsis in Neonates
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 27
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term neonates

Brief summary: Ceftriaxone is an antibiotic often used for the management of sepsis. Neonates commonly have jaundice during the first postnatal week. Ceftriaxone will be given as standard of care for sepsis and investigators will observe the effect on jaundice.


Eligibility criteria: Inclusion Criteria:

* Term infants with sepsis requiring IV antibiotics for more than 3 days and who has total serum bilirubin 6-12 mg/dL and resolving by day 4 of life.

Exclusion Criteria:

* Infants with asphyxia (Apgar score \<3 at 5 minutes), chromosomal disorder, failed hearing test at baseline, family history of hearing loss, unconjugated hyperbilirubinemia requiring phototherapy, TORCH infection, craniofacial malformations, listeria monocytogenes infection, and any clinical conditions which will preclude discharge to home.

Primary outcomes:
measure: change in bilirubin binding assays
timeFrame: baseline and through study completion, an average of 1 hour
Secondary outcomes:
measure: Automated brain stem evoke response test
timeFrame: through study completion, an average of 1 hour
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05517837: A Phase 1, First-in-Human Study of BMS-986421 in Healthy Participants
Official title: A Phase 1, Randomized, Multi-Part, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986421 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Healthy Participants
Keywords: BMS-986421
Safety
Tolerability
Dose Escalation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of BMS-986421 in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Participants are required to remain in the clinical facility from Day -1 (Part 1) or Day -2 (Part 2) until clinic discharge.
* A negative test for COVID-19, which will be performed in the manner mandated by the clinical site where this study is being conducted, at screening and admission.
* All female participants, Women of Childbearing Potential (WOCBP) and women not of childbearing potential, must have a negative highly sensitive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) at screening and on Day -1 (or Day -2 for Part 2).

Exclusion Criteria:

* Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
* Vaccination or plans for vaccination with non-live vaccines within 30 days before Day -1 (for Day -2 for Part 2) until the follow-up phone call.
* Donation of blood or blood transfusion within 8 weeks of first study intervention administration.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 8 Weeks
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 8 Weeks
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 8 Weeks
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 8 Weeks
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 8 Weeks
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 192 hours after each dose
measure: Area under the plasma concentration-time curve from time zero to time last quantifiable concentration (AUC[0-T])
timeFrame: Up to 192 hours after each dose
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 192 hours after each dose
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Local Institution - 0001
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05485337: Effectiveness of Therapeutic Tactics of Analgesia in Patients With Gunshot and Mine-explosive Wounds at the Stages of Treatment
Official title: Effectiveness of Therapeutic Tactics of Analgesia in Patients With Gunshot and Mine-explosive Wounds at the Stages of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: pain treatment, analgesia, wounds, stages of treatment.
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 2215
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: all patients were injured during hostilities

Brief summary: In 82.1% of patients with gunshot and mine-explosive wounds, pain becomes chronic, therefore, the study of the effectiveness of therapeutic tactics for pain relief in this category of patients at the stages of treatment will be important for improving the results of pain treatment.

Detailed description: The effectiveness of the therapeutic tactics of analgesia in patients with gunshot and mine-explosive wounds at the stages of treatment needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Given that in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Eligibility criteria: Inclusion Criteria:

* the presence of gunshot wounds

Exclusion Criteria:

* no gunshot wounds

Primary outcomes:
measure: visual analog scale
timeFrame: 12 months
measure: Didier Bouhassiraa DN4
timeFrame: 12 months
measure: The Hospital Anxiety and Depression Scale
timeFrame: 12 months
measure: Chaban Quality of Life Scale
timeFrame: 12 months
measure: Mississippi PTSD scale (military version)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Bogomolets National Medical University, Ministry of Health of Ukraine
Study officials:
References:
Clinical trial NCT06063837: Live Instruction and Fitness Tracking*: A 12-week Combined Aerobic and Resistance Training Intervention
Official title: The Implementation of a Community-health Focused Intervention Using Combined Aerobic and Resistance Training Protocols in a Group Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Health Risk Behaviors
Lead sponsor: University of Maryland Eastern Shore
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This project was a 12-week aerobic and resistance training intervention that included participants meeting at a pre-determined location from 1-2 times per week for 12 weeks. Aerobic activity was walking. Resistance training included traditional and non-traditional implements.

Detailed description: The 12-week program included a 60-minute session. Participants filled out a Physical Activity Readiness Questionnaire and completed pre-exercise fitness tests. The fitness tests included the curl up, pushup, and a 1.5 mile walk test. The session involved a warmup which included stretching followed by a 5-min walk for a total of 10 minutes. Functional bodyweight and resistance training exercises were implemented and supervised by the principal investigator (PI) who specializes in program design and implementation. The exercises targets major muscle groups such as legs, chest, back, and shoulders. The resistance training portion took 30-35 minutes. Steady-state aerobic activity which included walking took place at the end of the session for 10-15 minutes. The intensity was monitored using self-rated RPE scores which participants would report to the PI following each session.

Eligibility criteria: Inclusion Criteria:

* Somerset county resident
* Pass American College of Sports Medicine (ACSM) screening algorithm 2022 and the Physical activity readiness questionnaire

Exclusion Criteria:

* signs/symptoms of cardiovascular, metabolic or renal disease without medical clearance

Primary outcomes:
measure: Bodyweight as assessed by InBody H20N
timeFrame: 12 weeks
measure: Waist circumference as assessed by tape measure 1-in above umbilicus
timeFrame: 12 weeks
measure: Body Composition as assessed by Bod Pod
timeFrame: 12 weeks
measure: Body Mass Index as assessed by InBody H20N
timeFrame: 12 weeks
Secondary outcomes:
measure: Cardiorespiratory endurance for time and heart rate as assessed by the Rockport 1-mile Fitness Walking Test equation for estimating cardiorespiratory fitness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Princess Anne
country: United States
facility: University of Maryland Eastern Shore
state: Maryland
Study officials:
affiliation: University of Maryland Eastern Shore
name: LaShawn Nastvogel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06123637: Analgesia Nociception Index-guided Anesthesia and Standard Anesthesia
Official title: Comparison of Analgesia Nociception Index-guided Anesthesia and Standard Anesthesia on Remifentanil Requirement in Desflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to compare the analgesia nociception index-guided anesthesia and standard anesthesia on remifentanil requirement in desflurane anesthesia.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of gastric cancer

Exclusion Criteria:

* Conversion to open laparotomy
* Prior opioid abuse
* Prior infection
* Cardiac arrythmia

Primary outcomes:
measure: Remifentanil requirement
timeFrame: at time of the end of skin suture (up to 4 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: