louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06875349: Foot Reflexology and Abdominal Massage
Official title: The Effects of Foot Reflexology and Abdominal Massage in Elderly on Constipation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: constipation
reflexology
abdominal massage
randomised
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: to determine and compare the effects of foot reflexology and abdominal massage applied to elderly individuals on constipation

Detailed description: This randomized controlled study examined the effects of foot reflexology and abdominal massage on constipation in 90 elderly individuals from three nursing homes. Participants were divided into three groups: reflexology, abdominal massage, and control. The intervention groups received eight sessions over three weeks, while the control group received no treatment.

Eligibility criteria: Inclusion Criteria:

Being 65 years or older Having no movement restrictions Not using pharmacological laxatives Being diagnosed with constipation according to the ROMA IV criteria Voluntarily agreeing to participate in the study

Exclusion Criteria:

Individuals having a condition that prevents cognitive, affective and verbal communication Having a disorder related to the nervous system and circulatory system Having an injection applied to the abdominal region during the application process Having a systematic disorder related to the GIS (diarrhea, irritable bowel syndrome, fecal impaction, incontinence, etc.) Having physiological and structural disorders that may prevent evacuation in the anus region (rectal fissure, etc.) Having any negativity in the sensory function examination test performed with a sharp-blunt hard object on the sole of the foot and abdomen Having any physiological and structural disorders related to the foot/sole of the foot

Primary outcomes:
measure: Constipation Severity Scale
timeFrame: Day 1 and Day 13 and Day 25
measure: Constipation Severity Scale
timeFrame: Day 1 and Day 13 and Day 25
measure: Constipation Severity Scale
timeFrame: Day 1 and Day 13 and Day 25
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
References:
Clinical trial NCT02169349: Molecular Diagnosis on Circulating Tumor DNA of Non-Small Cell Lung Cancer
Official title: Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage IIIb and IV Non Small Cell Lung Cancer
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2014-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from patients receiving treatment for NSCLC at the Rennes Hospital

Brief summary: The purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of Non-Small Cell Lung Cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Male or female aged \>= 18 years
* Stage IIIb and IV Non Small Cell Lung Cancer histologically confirmed

Exclusion Criteria:

* Tissue and plasma samples can not be provided for mutation analysis
* Unwilling or unable to provide informed consent
* Any serious medical condition that would interfere with the subject's safety

Primary outcomes:
measure: Mutation profiling of circulating tumor DNA from plasma samples.
timeFrame: 1 year
Secondary outcomes:
measure: Quantity of circulating tumor DNA in serially collected plasma specimens.
timeFrame: 1 year
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU
Study officials:
affiliation: Rennes University Hospital
name: Jean Mosser, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03760549: Study of the Safety and Immunogenicity of NasoVAX Extension
Official title: Extension Study for Study ALT-103-201: One-year Follow-up for the 1×10(11th) vp NasoVAX Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects who were previously randomized to the 1×10(11th) vp NasoVAX group in Study ALT-103-201

Brief summary: This study is an extension to Study ALT-103-201, a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age.

Detailed description: This study is an extension to Study ALT-103-201 to evaluate immunogenicity of NasoVAX administered by intranasal spray at a single dose of 1×1011 vp at Day 366 (± 60 days). Up to 15 subjects who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 will be screened, and a serum sample will be collected from each eligible subject for evaluation of influenza HAI assay against influenza A/California/07/2009(H1N1), a strain homologous to the one used for NasoVAX (monovalent AdcoCA09.HA). Ad5 antibody neutralization assay may also be performed.

Eligibility criteria: Inclusion:

1. Receipt of NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201
2. Adequate venous access for phlebotomy
3. Provision of written informed consent

Exclusion:

1. Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with the subject providing an adequate blood sample or the subject's ability to give informed consent

Primary outcomes:
measure: Immune response to NasoVAX when administered by intranasal spray at a single dose of 1×10(11th) vp after approximately 1year
timeFrame: Day 366
Secondary outcomes:
measure: Persistence of antivector immune response following NasoVAX administered by intranasal spray at a single 1×10(11th) vp dose after approximately 1year
timeFrame: Day 366
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Optimal Health Research
state: Maryland
Study officials:
affiliation: Study Principal Investigator
name: Peta-Gay Jackson-Booth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406549: Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus
Official title: Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus Aureus Nasal Colonization: Comparative Analysis to Culture Screening Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcus Aureus
Keywords: Staphylococcus aureus
Nasal colonization
pre-surgical patients
Sensitivity
Specificity
Nasal Staphylococcus aureus in pre-surgical patients
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2006-12-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture methods.


Eligibility criteria: Inclusion Criteria:

1. Subjects 18 years of age or older, male or female and from any race or culture.
2. Subjects who are ambulatory (able to walk unaided or with a cane, walker, wheelchair) on the day of their pre-operative visit for non-emergent surgery.

Exclusion Criteria:

1. Subjects who are on the nasal topical antibiotic Mupirocin (Bactroban® Nasal Ointment) within the last 4 weeks.
2. Subjects who are present at the preoperative visit with prescribed nasal medical devices (e.g. CPAP = Continuous Positive Airway Pressure or Nasal Cannula), nasal prosthetics, the wearing of nasal jewelry or trauma to the nose or anything that may inhibit sampling of the anterior nares.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Decatur
country: United States
facility: Atlanta Institute for Medical Research
state: Georgia
city: Chicago
country: United States
facility: Northwestern Univesity
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Paris
country: France
facility: Hospital Bichat
city: Muenster
country: Germany
facility: University of Muenster Hospital and Clinics
city: Breda
country: Netherlands
facility: Amphia Hospital
Study officials:
affiliation: The Cleveland Clinic
name: Steve Gordon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01263249: Effects of Catheter Tip Location Relative to the Femoral Nerve on Sensory and Motor Function
Official title: Continuous Femoral Nerve Blocks: Effects of Catheter Tip Location Relative to the Femoral Nerve on Sensory and Motor Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Continuous Femoral Nerve Blocks in Healthy Volunteers
Keywords: Femoral
Nerve Block
Anterior
Posterior
Continuous Infusion
Perineural Catheter
Volunteer
Lower Extremity Nerve Blocks
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-12-20
Enrollment: 19
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: To determine if the way local anesthetic, or numbing medication, is delivered through a tiny tube next to the nerves that go to the thigh affects the strength and sensation in the thigh.

Detailed description: Specific Aim: Research study to test the hypothesis that differing the location of the perineural catheter tip during a continuous femoral nerve block (anterior vs. posterior) impacts quadriceps muscle strength. These results will help define the optimal perineural catheter tip location relative to the femoral nerve used for continuous peripheral nerve blocks and help guide both clinical care and future research in this clinically-relevant area.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or over
* Willing to have bilateral femoral perineural catheters placed with a subsequent ropivacaine infusion and motor/sensory testing for 6 hours, requiring an overnight stay in the UCSD GCRC/CTRI to allow dissipation of local anesthetic infusion effects by the following morning

Exclusion Criteria:

* current daily analgesic use
* opioid use within the previous 4 weeks
* any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
* body mass index \> 30 kg/m2
* pregnancy
* incarceration

Primary outcomes:
measure: Quadriceps femoris muscle strength
timeFrame: percentage of baseline muscle strength six hours after infusion initiation
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center, Hillcrest
state: California
Study officials:
affiliation: University of California, San Diego
name: Brian M Ilfeld, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05154149: Assessing the Level of Disability and Fear Avoidance Beliefs in Bankers of Karachi
Official title: Assessing the Level of Disability and Fear Avoidance Beliefs in Bankers of Karachi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Keywords: Fear Avoidance Belief
musculoskeletal Disorders
neck pain
Lead sponsor: Al- Shifa Physiotherapy Institute /Clinic
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bankers with neck pain working in the bank for past two years

Brief summary: An observational study will be conducted to determine the level of pain and disability among bankers working in different banking setups for past 2 years by using Neck Disablity Pain Index and Fear Avoidance Belief Questionnaire. the participant will be recruted fromdifferent private and public banking sectors of Karachi, including Habib bank limited, Silk bank,JS bank and other.

Detailed description: A cross-sectional study with a total sample size of 100 participants will be recruited for the purpose of the survey. The participants will be given Neck Disability Pain Index Questionnaire and Fair avoidance belief Questionnaire in order to determine the level of pain and disability among bankers who are performing their duties in bank from atleast two years.

Eligibility criteria: Inclusion Criteria:

* bankers with neck pain

Exclusion Criteria:

* neck surgery

Primary outcomes:
measure: Neck Disability Pain Index
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: Pakistan
facility: Al-Shifa Institute
state: Sindh
Study officials:
References:
Clinical trial NCT01702506: Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)
Official title: Phase 1 Three Period Crossover Study To Evaluate The Effect Of Food And Antacids On The Pharmacokinetics, Safety & Tolerability Of PF-299,804 In Healthy Volunteers Who Have Received PF-299,804
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Dacomitinib
PF-00299804
fed
fasted
antacid
relative Bioavailability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication


Eligibility criteria: Inclusion Criteria:

* Healthy subjects including males between the ages of 18 and 55 years. Females of non childbearing potential .
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or the appropriate time based on the elimination characteristics of the study medication.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 2 weeks
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 2 weeks
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: 2 weeks
measure: Area under the Concentration-Time Curve (AUC)
timeFrame: 3 days
measure: Apparent Oral Clearance (CL/F)
timeFrame: 2 weeks
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 2 weeks
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 2 weeks
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ruiz-Garcia A, Masters JC, Mendes da Costa L, LaBadie RR, Liang Y, Ni G, Ellery CA, Boutros T, Goldberg Z, Bello CL. Effect of food or proton pump inhibitor treatment on the bioavailability of dacomitinib in healthy volunteers. J Clin Pharmacol. 2016 Feb;56(2):223-30. doi: 10.1002/jcph.588. Epub 2015 Oct 9.
Clinical trial NCT01910506: RDEA3170 AME Study
Official title: A Phase 1 Absorption, Metabolism and Excretion Study of [14C]RDEA3170 Orally Administered to Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-29
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will determine the characteristics of absorption, metabolism, and excretion (AME) of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries (µCi) of \[14 C\]RDEA3170 in healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

* Body weight ≥ 50 kg (110 lbs.) and body mass index ≥ 18 and ≤ 30 kg/m2.
* No clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values.
* Screening serum urate level ≤ 7.0 mg/dL.
* Subject has a minimum of 1 bowel movement a day.

Exclusion Criteria:

* History or suspicion of kidney stones.
* History of gastrointestinal ulcers, Helicobacter pylori infection, or other disorders of gastric pH.
* History of previous surgery on the stomach or small intestine (appendectomy is acceptable). Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or has given a plasma donation within 6 weeks prior to Day 1.
* Inadequate venous access or unsuitable veins for repeated venipuncture.

Primary outcomes:
measure: Characteristics of AME in terms of pharmacokinetics (PK), metabolism, and excretion
timeFrame: Day 1 predose, 15, 30, 45 mins, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36, 48, 54, 60, 72 hrs postdose (blood and plasma only); Day 1, -12 to 0, 0-6, 6-12, 12-24 hrs postdose (urine and feces only)
Secondary outcomes:
measure: Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Ardea Biosciences, Inc.
name: S. Baumgartner
role: STUDY_DIRECTOR
References:
Clinical trial NCT03911206: A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma
Official title: The Duke Healthy Breathing Study Stage 2 (DHBS): A Randomized Controlled Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 11
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the safety and tolerability of a 6-week Inspiratory Muscle Training and cardiovascular exercise training program in children and adolescents with asthma.

To also determine the efficacy of inspiratory muscle training and exercise in increasing respiratory muscle strength and endurance, and to explore relationships between fitness interventions (inspiratory muscle training and exercise), exercise tolerance, airway closure and dyspnea scores.


Eligibility criteria: Inclusion Criteria:

* 10-17 years of age
* Clinician-diagnosed asthma
* Sedentary activity defined as having not participated in a sports team or formal activity (dance classes, gym membership, active hobby requiring physical activity) in the past 12 months or have a
* Body mass index (BMI) ≥85th percentile (adjusted for sex and age)
* Child must have a designated caregiver who expresses a commitment to encourage the participant to attend weekly clinic-based exercise and also complete additional home exercise.

Exclusion Criteria:

* Previous intubation for asthma,
* Forced expiratory volume in 1 second (FEV1) \< 50% of predicted at enrollment;
* Any major chronic illness that in the opinion of the PI would interfere with participation in the intervention or completion of the study procedures;
* Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI
* Currently active in sports, vigorous play or planned exercise more than 1 time per week on average over the past month
* Current Pregnancy as determined by urine pregnancy test.
* Parent/Caregiver unable to consent in English

Primary outcomes:
measure: Percentage of Participant's with asthma and not participating in any physical activity
timeFrame: 6 weeks
measure: Number of Adverse events reported by participants.
timeFrame: 6 weeks
measure: Number of participants that complete respiratory muscle training (IMT) and exercise.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References: