louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03317470: Addressing Unmet Basic Needs to Improve Adherence Among Women With an Abnormal Pap
Official title: Addressing Unmet Basic Needs to Improve Adherence Among Women With an Abnormal Pap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Abnormal Pap Smear
Colposcopy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The investigators aim to improve adherence to follow-up recommendations for an abnormal Pap and effectively reduce disparities in cervical cancer risk and disease among rural and low-income urban women.


Eligibility criteria: Inclusion Criteria:

* Newly referred patients to colposcopy clinic at SIUM and WUSM
* Aged 18 years or older
* English speaking
* Able to provide verbal consent
* Diagnosis of abnormal pap will be confirmed by pathology report
* Member of all races and ethnic groups

Exclusion Criteria:

* Male
* Established colposcopy clinic patients
* Known diagnosis of cancer
* Pregnancy
* Incarcerated
* Unable to consent
* No access to a working contact phone number

Primary outcomes:
measure: Participant adherence to initial colposcopy visit
timeFrame: At the time of initial colposcopy visit
Secondary outcomes:
measure: Number of unmet basic needs
timeFrame: -2 weeks prior to initial colposcopy visits
measure: Type of unmet basic needs
timeFrame: -2 weeks prior to initial colposcopy visits
measure: Participant adherence to recommended follow-up after initial colposcopy visit
timeFrame: At the time of initial colposcopy visit
measure: Participant acceptability of the unmet basic needs survey
timeFrame: At the time of initial colposcopy visit
measure: Participant perception of effectiveness of life navigator to assist with their unmet basic needs
timeFrame: At the time of initial colposcopy visit
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Lindsay M Kuroki, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuroki L, Massad LS, Martin A, Liu J, Brown D, Leon A, Groesch K, Wilson T, Zeino Y, Diaz-Sylvester P, Delfino K, Hyon K, Kreuter M. Addressing Unmet Basic Needs to Improve Colposcopy Adherence Among Women With Abnormal Cervical Cancer Screening. J Low Genit Tract Dis. 2021 Apr 1;25(2):106-112. doi: 10.1097/LGT.0000000000000593.
Clinical trial NCT02913170: Nattokinase Supplementation and Hemostatic Factors
Official title: Nattokinase Supplementation and Hemostatic Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effects of nattokinase supplementation on hemostatic factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time, prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid profiles were measured at baseline and at 8-week follow-up.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 69 years
* Hypercholesterolemia (200mg/dL ≤ serum cholesterol ≤ 280mg/dL)
* Nondiabetic (fasting blood glucose \< 126mg/dL and 2-hour blood glucose \< 200mg/dL)

Exclusion Criteria:

* Use of any medication or supplements
* Diagnosis of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, cardiovascular disease, pancreatitis, cancer, or any life-threatening illness that required regular medical treatment
* Women who were pregnant, breastfeeding or intending to become pregnant during the study period
* Drug or alcohol abuse

Primary outcomes:
measure: Collagen-epinephrine closure time at baseline
timeFrame: baseline
measure: Collagen-epinephrine closure time at 8-week follow-up
timeFrame: 8-week follow-up
Secondary outcomes:
measure: Prothrombin time at baseline
timeFrame: baseline
measure: Prothrombin time at 8-week follow-up
timeFrame: 8-week follow-up
measure: Activated partial thromboplastin time at baseline
timeFrame: baseline
measure: Activated partial thromboplastin time at 8-week follow-up
timeFrame: 8-week follow-up
measure: Fibrinogen concentration at baseline
timeFrame: baseline
measure: Fibrinogen concentration at 8-week follow-up
timeFrame: 8-week follow-up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03797170: Design of New Personalized Therapeutic Approaches for Diffuse Large B-cell Lymphoma
Official title: Design of New Personalized Therapeutic Approaches for Diffuse Large B-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffuse Large B Cell Lymphoma
Keywords: RCHOP
first line
microbiota
response
disease control
therapy toxicity
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by diffuse large B-cell lymphoma (DLBCL) undergoing therapy with front-line R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone).

Brief summary: In Europe diffuse large B-cell lymphoma (DLBCL) is a rare disease whereas in Italy it is not. Approximately 40% of DLBCL patients has refractory disease or will relapse after initial response. In onco-hematology, a role for gut microbiota (GM) in mediating immune activation in response to chemotherapy, has been suggested. In this scenario, the Investigators hypothesized that GM could play an important role in DLBCL prognosis and response to treatment, establishing a connection between lifestyle and clinical response. The project is aimed to the study of the functional GM layout in association with specific patterns of treatment response in de novo DLBCL undergoing standard first line chemo-immunotherapy. Results may build the scientific basis to design new and personalized intervention strategies (both in treatment approach and in life-style recommendations), to enhance clinical response and reduction of disease refractoriness through modulation of the gut microbial ecosystem.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Patients affected by histologically confirmed diffuse large B-cell lymphoma
3. Patients amenable for therapy with RCHOP (RCHOP is the standard first line therapy for DLBCL and it scheduled regardless of participation in present study).
4. Patients must provide written informed consent.

Exclusion Criteria:

1. Concomitant second malignancy, other than lymphoma.
2. Previous anti-lymphoma therapy.
3. Pregnancy or breastfeeding.
4. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.

Primary outcomes:
measure: GM dysbiosis assessment (bacterial DNA of gut microbiota in all patients)
timeFrame: 18 months
Secondary outcomes:
measure: Response to therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
state: FC
city: Bologna
country: Italy
facility: Institute Of Hematology "Seràgnoli"
Study officials:
affiliation: Institute of Hematology "L. e A. Seràgnoli", University of Bologna
name: Pier Luigi L Zinzani, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01906970: Clinical Experimental Study to Investigate Specific Features of ClampArt®
Official title: Clinical Experimental Study 2, to Further Investigate the Measurement Accuracy, Glucose Control Quality, Safety, Handling and Functionality of ClampArt® and Its Influence on Pharmacodynamic Parameters in Glucose Clamps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Profil Institut für Stoffwechselforschung GmbH
Sponsor class: INDUSTRY
First posted: 2013-07-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A single centre, clinical experimental study. Every subject will undergo clamp experiments, where a clamp device (ClampArt®) measures and controls the blood glucose concentration after administration of marketed insulin products.


Eligibility criteria: Inclusion Criteria:

* Healthy, TD1, TD2

Exclusion Criteria:

* Participation in a Trial within the last weeks

Primary outcomes:
measure: Measurement accuracy, glucose control quality, safety, handling and functionality of ClampArt®
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
state: NRW
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH
name: Tim Heise, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01571375: The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury - a Prospective Study
Official title: The Differences Between Out-of-hospital Severe Traumatic Brain Injury (TBI) Treatment in a Physician-staffed Versus Paramedic-staffed Emergency Medical Service (EMS) Unit and Its Effect on Patient Prognosis
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
HEMS
Out-of-hospital
Finland
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The Aim of the Study is to Measure the Effect of Finnish Physician-staffed EMS Unit Treatment Methods on Traumatic Brain Injury (TBI) Patient Prognosis.

Physician-staffed HEMS unit was implemented to the EMS 2011. The aim of this study is to compare the results against a historical database to see if the implementation of a HEMS unit will improve the prognosis of TBI patients.

Detailed description: A Secondary Aim is to Identify Out-of-hospital Treatment Factors That Can be Influenced by Education and Protocols.

Eligibility criteria: Inclusion Criteria:

* TBI with CGS \< 9 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital.

Exclusion Criteria:

* Multiple trauma

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Glasgow Outcome Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, professor
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Tom Silfvast, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Tarja Randell, PhD
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Ilkka Virkkunen, PhD
role: STUDY_CHAIR
affiliation: Tampere University
name: Toni Pakkanen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05449275: Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop
Official title: The Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop Due To Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Drop
Keywords: Stroke
Faradic Current
Ankle-Foot Orthosis
Foot Drop
Randomized Control Trial
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aims to compare changes in gait quality and function between faradic current \& Ankle foot orthosis with stroke related foot drop

Detailed description: Randomized control trial study will be carried out at different health care units when synopsis will be approved. Enrollment of patients will be done by using purposive sampling technique. The selection of the patients will be done on the basis of exclusion criteria and inclusion criteria. The patients enrolled will be divided into 2 groups. Group A patients will be given faradic current on the other hand group B patients will be provided with ankle foot orthosis. The assessment of the patient will be done after 6 months and the outcome tools used will be 10-meter walk test, stroke impact scale, 6-meter walk test, Berg balance scale, Time up and go test. The data of the patient will be noted before giving treatment and after treatment and will be compared after 6 months. Consent will be taken from each patient. Statistical Package of Social Sciences Version 20 will be used for the entry and analysis of data

Eligibility criteria: Inclusion Criteria:

* Patients who had been affected by stroke
* Good communication skills so the patient can follow the instructions
* Patients of both genders with any age group

Exclusion Criteria:

* Impairment in lower limb other that foot drop
* Patient suffering with any cardiovascular disease

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 12th Week
measure: Stroke impact scale
timeFrame: 12th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT06229275: Study to Evaluate the Effectiveness of the Personal Pap Smear Device™ for Collection of Cervical Cells
Official title: A Phase III Cross-Over Comparative Study to Evaluate the Effectiveness of the Rover Cervex-Brush Device vs. the Personal Pap Smear Device™ for Collection of Cervical Cells for Detecting Cervical Dysplasia or Neoplasia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Cervical Cancer Screening
Keywords: pap smear collection
Lead sponsor: Morehouse School of Medicine
Sponsor class: OTHER
Collaborators: name: GyneConcepts, Inc.
First posted: 2024-01-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: This purpose of this research study is to determine the effectiveness of the Personal Pap Smear TM Device to collect adequate cervical cell samples for cytology examination when compared with the Rover Cervex-Brush (Cervix-Examination Brush).

Detailed description: To determine the effectiveness of the Personal Pap Smear TM Device to collect adequate (as defined by Bethesda Guidelines 2014) cervical cell samples for cytology examination as compared with the Rover Cervex-Brush (Cervix-Examination Brush).

Eligibility criteria: Inclusion Criteria:

* Adult women, aged 21-65 years old.
* Do not have any medical or psychiatric condition affecting the ability to give voluntary informed consent.
* Be able to read and understand English

Exclusion Criteria:

* Participants currently on menses
* Inability to provide Informed Consent
* Previous total hysterectomy
* History of radiation treatment for cervical cancer
* Pregnancy
* Medical condition that interferes with conduct of study, in investigator's opinion
* Evidence of active cervical infection requiring treatment
* Known bleeding diathesis

Primary outcomes:
measure: Comparison of the samples for the Predicate Device versus PPS device
timeFrame: Baseline
Secondary outcomes:
measure: The Comparison of Cell Types of the PPS Device versus the Predicate Device
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Morehouse School of Medicine
name: Regina K Leonis, MD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00036075: Study Using CP-461 to Treat Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
prostate
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Cell Pathways
name: OSI Pharmaceuticals
First posted: 2002-05-08
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether an investigational drug, CP-461, is safe and effective for the treatment of patients with prostate cancer and who have measurable disease.


Eligibility criteria: Eligibility Criteria:

* Male 18 years of age.
* Histologically confirmed adenocarcinoma of the prostate, stage D1 or D2.
* Failure of androgen ablation (orchiectomy or LHRH, flutamide).
* Patients must have PSA progression and progression in measurable disease.
* No prior history of systemic chemotherapy.
* No investigational drugs within 4 weeks of study entry.
* No radiation therapy or hormonal therapy within 4 weeks of study entry.
* No isotope therapy within 6 weeks of study entry.
* No antiandrogens within 4 weeks of study entry. Patients must continue LHRH.
* If patients had prior surgery, it must be at least 21 days prior to study entry, and the patient must have recovered from all side effects.
* Patients must have stopped bisphosphonates 28 days prior to study entry.
* No prior malignancy allowed except for adequately treated basal cell or squamous cell skin cancer, or adequately treated stage I or II cancer from which the patient is currently in remission, and has been disease free for at least 5 years.
* Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator not have significant active concurrent medical illness, such as a history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude protocol treatment or survival.
* All patients must be informed of the investigational nature of the study and must sign and give written informed consent in accordance with institutional and federal guidelines.
* No other chemotherapeutic, biological response modifiers, radiation therapy, corticosteroid therapy, or hormonal concomitant therapy (except continuation of LHRH) may be given during treatment. Patients should not be planning on receiving concomitant bisphosphonates.
* ECOG Performance Status = 0-3.
* WBC \> or = 3500/ul or ANC \> or = 1500/ul.
* Bilirubin \< or = ULN.
* Creatinine \< or = 2.0 mg/dl.
* Platelets \> or = 100,000/ul.
* ALT or AST \< 2.5 X ULN.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT05060575: Hypertension Patients on Drug Medication Adherence and Rational Medication Use
Official title: The Effect of Education and Telephone Counseling Given to Hypertension Patients on Drug Medıcation Adherence and Rational Medication Use: Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension Patients
Keywords: Hypertension
Tele nursing
Education
Rational medication use
Drug medication adherence
Nursing
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will be conducted to determine the effects of education and telephone counseling given to hypertension patients on drug treatment compliance and rational drug use.

Detailed description: This research will be conducted to determine the effects of education and telephone counseling given to hypertension patients on drug treatment compliance and rational drug use.

Research Hypotheses H0: Education and telephone counseling given to hypertension patients do not affect drug treatment compliance.

H1: Education and telephone counseling given to hypertension patients increase drug treatment compliance.

H0: Education and telephone counseling given to hypertension patients do not affect rational drug use.

H1: Education and telephone counseling given to hypertension patients increase rational drug use.

This study was planned as a single-blind randomized controlled experimental study.

Eligibility criteria: Inclusion Criteria:

* - Diagnosed with hypertension,
* Hypertension disease duration of at least 6 months,
* Using at least one drug due to hypertension,
* 18 years old and over
* Literate,
* Living in the town centre,
* Owns a phone
* Open to communication and cooperation,
* Patients willing to participate in the study will be included in the study.

Exclusion Criteria:

* Having a psychiatric illness
* Hearing loss,
* Can't understand or speak Turkish and
* Patients who do not wish to continue the study will be excluded from the study.

Primary outcomes:
measure: Adherence to Medication Self-Efficacy Scale
timeFrame: 12 weeks
measure: Rational Drug Use Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Diastolic/Systolic blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Hacer GÖK UĞUR
state: Cumhuriyet Campus Cumhuriyet District
Study officials:
affiliation: Ordu Ünivercity
name: Hacer GÖK UĞUR, Assoc.
role: PRINCIPAL_INVESTIGATOR
References: