louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01214330: Clinician-Collected Versus Patient-Collected Cervical Pap Smears
Official title: A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2010-10-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.

Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.

Detailed description: The SoloPap "kit" provides to subjects who would not otherwise have a Pap smear done a convenient and private way to collect samples and ship them to a laboratory for processing. The current study is pilot/pre-cursor study for a larger subsequent study that aims to determine whether SoloPap is truly noninferior to clinician-collected Pap smears in detecting cervical pathology. It will also determine user preference and willingness to perform a self- test.

Eligibility criteria: Inclusion Criteria:

* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
* All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding

Exclusion Criteria:

* Age \<18 years (not recommended for Pap Smear)
* Known pregnancy
* Women who have had a total hysterectomy (cervix removed)
* Women with vaginal bleeding
* Persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands

Primary outcomes:
measure: Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
timeFrame: 1 hour
Secondary outcomes:
measure: Patient Opinions
timeFrame: Directly after interventions (Solo Pap and physician-collected pap smear samples)
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Mike O'Callaghan Federal Hospital/Nellis Air Force Base
state: Nevada
Study officials:
affiliation: Mke O'Callaghan Federal Hospital
name: Paul Crawford, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03108430: Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation
Official title: Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inhalation Pneumonia
Risk Factor
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Observation of inhalations in medicine and resuscitation and collection of data likely to influence the emergence of an IP.

Brief summary: Inhalation pneumonia (PI) is common in clinical practice but is rarely studied. For example, there are no data on the incidence of pneumonia after inhalation and risk factors or protective factors to develop one since it is known that anyone who inhaled does not necessarily develop an IP. There is no data on the benefit of treating inhalation by antibiotic therapy pre-emptively although this practice is common. In this context, this observational study wishes to take stock of the situation on the subject in order to determine what actions to implement to prevent IP.


Eligibility criteria: Inclusion Criteria:

* In intensive care: Any intubated patient who presented:
* It is a coma with GCS ≤ 12 without VAS protection, whatever the duration
* Either a proven inhalation, defined by the presence in the VAS of gastric fluid or food
* Either a suspected inhalation, defined by the extrahospital anamnesis
* In medicine :
* Any wrong way (defined by a reflex cough when taking food)
* Coma without intubation, regardless of duration or depth

Exclusion Criteria:

* Patients with VAP

Primary outcomes:
measure: Calculate the annual incidence of PI, the incidence of PI in inhaled patients (in each subgroup), and analyze the risk factors by logistic regression, based on the number of patients hospitalized during the study period.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT03404830: High Intensity Training to Reduce the Risk of Falls in Older People
Official title: Effects of a Program of High Intensity Exercise by Intervals on the Risk of Falls the Physical Condition and the State of Health in People Over 60 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk of Falls
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Due to the high incidence of falls in the elderly population, this study is presented as a method to reduce the risk of falls through a specific type of training in people over 60 years of age.

Detailed description: A 16-week high intensity interval training (HIIT) program, compared to a continuous exercise program and one that does not perform any training program, decreases the risk of falls and improves the state of health, physical condition and quality of life to a greater extent than a group that does not perform any type of exercise in people over 60 years.

Eligibility criteria: Inclusion Criteria:

* To participate in the study, participants will be required to be 60 years of age or older.

Exclusion Criteria:

* All participants with diseases that may alter balance and functional activity (such as auditory or vestibular alterations), central or peripheral neurological disorders, other rheumatological diseases, or serious psychiatric or somatic diseases will be excluded.

Primary outcomes:
measure: Opto-electric measuring system.
timeFrame: Up to twelve weeks.
measure: CT10P
timeFrame: Up to twelve weeks.
measure: UPDATE AND PERFORM THE TEST
timeFrame: Up to twelve weeks.
measure: Sensor Medica
timeFrame: Up to twelve weeks.
measure: Opto-electric measurement system
timeFrame: Up to twelve weeks.
measure: Dynamometer
timeFrame: Up to twelve weeks.
measure: Confidence Scale of the specific balance of activities (ABC)
timeFrame: Up to twelve weeks.
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Up to twelve weeks.
measure: Pulsometer
timeFrame: Up to twelve weeks.
measure: UKK walk test of 2 km
timeFrame: Up to twelve weeks.
measure: InBody 720
timeFrame: Up to twelve weeks.
measure: SF-36 (The Short Form-36 Health Survey)
timeFrame: Up to twelve weeks.
measure: HADS (Hospital Anxiety And Depression Scale)
timeFrame: Up to twelve weeks.
measure: Accelerometer
timeFrame: Up to twelve weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Pizarra
country: Spain
facility: AQUASPORT PIZARRA pool
state: Málaga
Study officials:
References:
citation: Jimenez-Garcia JD, Hita-Contreras F, de la Torre-Cruz MJ, Aibar-Almazan A, Achalandabaso-Ochoa A, Fabrega-Cuadros R, Martinez-Amat A. Effects of HIIT and MIIT Suspension Training Programs on Sleep Quality and Fatigue in Older Adults: Randomized Controlled Clinical Trial. Int J Environ Res Public Health. 2021 Jan 29;18(3):1211. doi: 10.3390/ijerph18031211.
Clinical trial NCT04179630: Study of Aldafermin (NGM282) in Participants With Impaired Renal Function
Official title: A Phase 1, Single-center, Open Label, Parallel Group Study to Evaluate the Pharmacokinetics, Safety & Tolerability of a Single Dose of Aldafermin (NGM282) in Subjects With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Impaired Renal Function
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2019-11-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Renal Function.


Eligibility criteria: Inclusion Criteria:

* Current diagnosis of stable chronic kidney disease and eGFR, as assessed by the Modification of Diet in Renal Disease (MDRD) estimate:

  1. Mild renal impairment: eGFR 60-89 mL/min/1.73m²
  2. Moderate renal impairment: eGFR 30-59 mL/min/1.73m²
  3. Severe renal impairment: eGFR \< 30 mL/min/1.73m²
* Healthy control subjects with normal renal function will be matched (age ± 10 years; sex, race, BMI ± 15%) to their respective subject in the impaired renal function groups and have eGFR ≥90 mL/min/1.73m . Healthy control subjects should have no systemic chronic disease.
* Males and Females age 18-75
* Body mass index (BMI) 25-40 kg/m²

Exclusion Criteria:

* Renal allograft recipients
* History of renal cell carcinoma or any history of metastatic disease involving the kidney
* End Stage Renal disease, requiring or not requiring dialysis
* Subject requiring or anticipated requirement of dialysis within 3 months of study entry
* Diagnosis of acute kidney injury/acute renal failure, or hospitalization for kidney related issue within 3 months of Screening
* Any renal disease or related condition actively being treated other than chronic kidney disease
* Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact renal function within 2 weeks of Screening
* History of treatment for a chronic condition with a medication that is known to have nephrotoxic potential, and after treatment, renal function/status has not been fully evaluated
* Uncontrolled hypertension
* Uncontrolled diabetes

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
timeFrame: 12 Days
measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUC 0-infinity) of aldafermin (Day 1 through Day 4)
timeFrame: 12 Days
Secondary outcomes:
measure: Type and frequency of Adverse Events (Day 1 through Day 11)
timeFrame: 12 Days
Other outcomes:
Locations:
city: Miami
country: United States
facility: NGM Clinical Study Site
state: Florida
Study officials:
affiliation: NGM Biopharmaceuticals
name: NGM Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02984930: Effect of Proton Pump Inhibitor and Mosapride on Acid Pocket in Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 30
Sex: ALL
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: The gastric acid pocket is believed to be the reservoir from which acid reflux events originate. The risk for acidic reflux is mainly determined by the position of the gastric acid pocket. Little is known about how changes in position and size of the acid pocket contribute to the therapeutic effect of proton pump inhibitors(PPI) plus mosapride in patients with gastroesophageal reflux disease. Investigators will conduct a prospective randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing the acid pocket position and size.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed GERD(gastro-esophageal reflux disease), defined by the presence of oesophagitis obtained during a previous upper endoscopy or typical GERD symptoms(heartburn, acid reflux).

Exclusion Criteria:

* who had organic gastrointestinal disease including inflammatory bowel disease, cancer and ulcer
* who took drugs which could affect evaluation of the treatment; other PPIs, H2RAs(H2 receptor antagonists), prokinetics,mucosal protective agents, antacids, cholinergic and anticholinergic agents, and antidepressants for at least 4 weeks prior to study start
* who had severe systemic diseases including hepatic and nephrotic disease
* who had previous gastrectomy history
* who was in state of pregnancy

Primary outcomes:
measure: Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group
timeFrame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
measure: Location(cm) of the acid pocket between PPI+placebo group and PPI+mosapride group
timeFrame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
Secondary outcomes:
measure: Improvement of reflux symptom
timeFrame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00351130: Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy
Official title: An 8 Week Extension to a Randomized, Double-blind, Parallel Group, Active-controlled, Multi-center, 14 Week Study to Evaluate the Effectiveness of a Valsartan Versus and Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension,
stage 1 hypertension,
stage 2 hypertension,
valsartan,
amlodipine,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-07-12
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.


Eligibility criteria: Inclusion criteria

* MSSBP\> 140 mm Hg, and/or MSDBP\> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study

Exclusion criteria

* Premature discontinuation in the core study or failure to comply with the core study protocol
* Any patient that the investigator decides should not participate in the extension

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 weeks
Secondary outcomes:
measure: Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 14 and 22 weeks
measure: Adverse events after 22 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novatis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00293930: A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Treatment Outcome
Tacrolimus
Safety
Psoriasis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2006-02-20
Enrollment: 645
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of plaque psoriasis

Exclusion Criteria:

* Skin disorder other than plaque psoriasis in the areas to be treated.
* Disease on only elbows, knees, and scalp

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: San Diego
country: United States
state: California
city: San Fransisco
country: United States
state: California
city: Longmont
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Miami
country: United States
state: Florida
city: Newnan
country: United States
state: Georgia
city: Evansville
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: St. Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Winston Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Bryan
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Lynchburg
country: United States
state: Virginia
city: Dayton
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Winnipeg
country: Canada
state: Manitoba
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: North Bay
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Astellas Pharma US, Inc.
name: J Rico, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00362830: A Study of the Alternative Administration of Ixabepilone and Vinflunine
Official title: A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test how vinflunine interacts with ixabepilone in the human body.


Eligibility criteria: Inclusion Criteria:

* ECOG status of 0-1

Exclusion Criteria:

* Inability to tolerate venous access
* Brain mets
* Severe nerve damage
* ANC \<2,000/mm3
* Platelets \<100K
* Bilirubin \>= 1.5 times the IULN
* ALT/AST \>= 2.5 times the IULN
* Creatinine \<50 mL/min
* Prior treatment with vinflunine and/or ixabepilone
* Strong use of CYPP450 drugs

Primary outcomes:
measure: Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.
timeFrame: upon occurrence
Secondary outcomes:
measure: Determine the overall safety profile, efficacy and rate and extent to which ixabepilone and vinflunine are absorbed or otherwise available to the treatment site in the body.
timeFrame: upon occurrence
Other outcomes:
Locations:
city: Miami
country: United States
facility: University Of Miami Miller School Of Medicine
state: Florida
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04231630: Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease
Official title: A Single Patient Observational Trial of an Exclusive Human Milk Diet to Provide and Evaluate Growth in a Single Infant at Home With Complex Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Growth Delay
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Prolacta Bioscience
First posted: 2020-01-18
Enrollment: 1
Sex: MALE
Minimum age (years): 6
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single patient observational trial to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet including a human milk based human milk fortifier formulated for term infants fluid restricted due to surgically correctable congenital conditions.

Detailed description: A single patient observational study to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier.

The study hypothesis is that this infant if fed an exclusive human milk diet will have improved growth in part due to data greater tolerability of the diet.

It is estimated that the study will require 90 days to complete. Growth in safety observations will be collected only during the time the patient is receiving the diet.

The primary objective is to evaluate growth velocity (weight velocity \[g/kg/day\] of a single infant receiving a 100% human milk diet including a human milk based human milk fortifier formulated for term infants who are fluid restricted due to surgically correctable congenital conditions. This will be compared to the infant's growth velocity prior to the initiation of said diet.

Eligibility criteria: Inclusion Criteria:

* Complex congenital heart disease in presence of poor linear and head circumference growth and unable to tolerate cow's milk protein

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Growth
timeFrame: through study completion, approximately 6 months
Secondary outcomes:
measure: Linear growth
timeFrame: through study completion, approximately 6 months
measure: Head circumference growth
timeFrame: through study completion, approximately 6 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Medical School
state: Texas
Study officials:
References: