louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02995902: FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer
Official title: FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Cell Lung Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine the value of FLT-PET early after initiated chemotherapy in patients with small cell lung cancer, and to determine whether MRI of the brain should be performed routinely in these patients.


Eligibility criteria: Inclusion Criteria:

* biopsy proven small cell lung cancer
* referred for standard chemotherapy
* oral and written informed consent

Exclusion Criteria:

* metal or electronical devices in the body not compatible with MRI of brain or thorax
* pregnancy or lactation
* communication difficulties

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Disease free survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Study officials:
affiliation: Dept of Clinical Physiology, Nuclear medicine and PET, Rigshospitalet, Denmark
name: Andreas Kjær, MD phD MDSci
role: STUDY_CHAIR
References:
citation: Christensen TN, Langer SW, Villumsen KE, Johannesen HH, Lofgren J, Keller SH, Hansen AE, Kjaer A, Fischer BM. 18F-fluorothymidine (FLT)-PET and diffusion-weighted MRI for early response evaluation in patients with small cell lung cancer: a pilot study. Eur J Hybrid Imaging. 2020 Jan 27;4(1):2. doi: 10.1186/s41824-019-0071-5.
Clinical trial NCT04951102: An Electronic Shared Decision-Making Application to Improve Asthma Outcomes
Official title: An Electronic Shared Decision-Making Application to Improve Asthma Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Shared Decision Making
SDM
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects will be clustered in 2 groups of patients and physicians based on participating health care provider and clinic location. Group A will be the intervention group and Group B will be the control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will increase knowledge about the feasibility and effect on patient satisfaction and clinical outcomes of using an electronic Shared Decision Making (SDM) application (app) for patients with asthma in the allergy/immunology clinic visit setting. SDM is defined as an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options and make informed choices.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Diagnosis of persistent asthma
* Have an in-person visit or telehealth encounter at the allergy/clinical immunology clinics participating in this study

Exclusion Criteria:

* Diagnosis of intermittent asthma
* Any other lung disease
* Smoking greater than 20 pack years or current smoking
* Mental impairment such that participation would not be possible

Primary outcomes:
measure: Patient satisfaction
timeFrame: Within 1 week of completing asthma shared decision making app worksheet and their asthma clinic visit
Secondary outcomes:
measure: Physician satisfaction
timeFrame: Within 1 week of patient visit
measure: Change in level of asthma control will be determined
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine, University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alan Baptist, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06381102: Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1
Official title: How Does the Length of Pulse Trains and Pulse Intervals Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.


Eligibility criteria: Inclusion Criteria:

1. between the ages of 18-80 years
2. English speaking (must be able to consent and complete the interviews in English)

Exclusion Criteria:

1. chronic pain (average intensity \&gt;2/10 on 0-10 scale, for longer than 3 months)
2. acute pain of intensity greater than 3/10
3. chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
4. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
5. pregnancy
6. currently taking Buprenorphine or recently stopped taking (within 1 month)
7. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
8. implants in the head or neck, cochlear implants, or pacemaker
9. head or neck metastasis or recent ear trauma
10. history of epilepsy
11. history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).

Primary outcomes:
measure: Tolerability measured by tolerability questionnaire
timeFrame: Up to 3 hours.
measure: Tolerability measured by self-report
timeFrame: Up to 3 hours.
Secondary outcomes:
measure: Change in heart rate variability (HRV)
timeFrame: Baseline and up to 3 hours.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Marlon Wong, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00423202: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.
Official title: Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Current diagnosis of either PPH or PAH secondary to the scleroderma spectrum of disease, systemic lupus erythematosus, anorexigen use, or HIV infection at the Screening Visit
* Right heart catheterization, completed prior to Screening Visit must meet pre-specified hemodynamic criteria
* Female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit
* Male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking this study drug and queried regarding his understanding of the potential risks as described in the Informed Consent Form

Exclusion Criteria:

* PAH due to or associated with congenital heart disease, coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea
* Portopulmonary hypertension
* Bosentan within four weeks prior to Screening
* Phosphodiesterase type V inhibitor or chronic prostanoid therapy within four weeks prior to Screening
* IV inotrope use within two weeks prior to Screening
* ALT or AST lab value that is greater than 1.5 times the upper limit of normal
* Pulmonary function tests not meeting pre-specified criteria
* Contraindication to treatment with an ERA
* History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years
* Females who are pregnant or breastfeeding

Primary outcomes:
measure: Change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy compared to placebo.
Secondary outcomes:
measure: Change from baseline measured after 12 weeks of treatment compared to placebo in the Borg Dyspnea Index immediately following exercise, WHO functional class and SF-36 Health Survey.
measure: Clinical worsening of PAH.
measure: Assessment of the safety and tolerability of the study drug.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01321502: Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Famciclovir Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes
Keywords: treatment of herpes
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-03-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to famciclovir, penciclovir or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Advanced Biomedical Research
state: New Jersey
Study officials:
References:
Clinical trial NCT06054802: Perioperative Sleep Quality and Postoperative Pain Outcomes
Official title: The Influence of Perioperative Sleep Quality on Postoperative Pain Outcomes in Pediatric Patients Undergoing Knee Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Surgery
ACL Injury
Pain
Sleep
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 166
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric/adolescent patients undergoing anterior cruciate ligament (ACL) repair or reconstruction at Nationwide Children's Hospital.

Brief summary: This is a prospective, observational cohort study that will examine how sleep quality impacts postoperative pain and opioid consumption for pediatric patients. The investigators will administer a questionnaire preoperatively to determine which patients have poor or good sleep quality. They will then compare postoperative pain and opioid use between groups for two weeks following surgery. For a secondary aim, investigators will use electronic medication vials (eCAP) to monitor participants' medication use at home and compare to self-reporting.


Eligibility criteria: Inclusion Criteria:

* able to read, understand, and speak English
* are undergoing ACL repair or reconstruction
* have availability of a mobile device/computer to receive text messages

Exclusion Criteria:

* \< 10 or \> 18 years of age
* have a history of sleep-disordered breathing including sleep apnea
* have a history of chronic pain or current opioid use
* have a history of developmental delay that would preclude study participation

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Difference in opioid consumption between self-report and eCap
timeFrame: Days 1-14 post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT01344902: An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Colon Cancer
Lead sponsor: Photocure
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology.

Detailed description: Carcinoma of the lower GI-tract is among the leading malignancies in the western world causing a substantial morbidity, mortality and consequently a large burden to the health care system in the diagnosis, treatment and follow-up of these patients.

The primary objectives of this study is to determine carcinoma- and adenoma lesion true detection rate of HAL fluorescence colonoscopy in patients with known or strong suspicion of neoplasia in the colon. The secondary objective and endpoints are to determine carcinoma- and adenoma lesion false detection rate of HAL fluorescence colonoscopy, to compare carcinoma- and adenoma lesion true detection rates and the false detection rates of fluorescence with standard colonoscopy and to characterize the safety profile of HAL fluorescence colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Female and Male subjects with known or strong suspicion iof adenoma or carcinoma of the colon after screening of follow-up colonoscopy
* Female and male patients with verified neoplastic lesions

Exclusion Criteria:

* Known or strong suspected porphyria
* Contraindications to colonoscopy

Primary outcomes:
measure: Determine the carcinoma- and adenoma lesion true detection rate
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum München Pasing
Study officials:
References:
citation: Mayinger B, Neumann F, Kastner C, Degitz K, Hahn EG, Schwab D. Early detection of premalignant conditions in the colon by fluorescence endoscopy using local sensitization with hexaminolevulinate. Endoscopy. 2008 Feb;40(2):106-9. doi: 10.1055/s-2007-967019. Epub 2008 Jan 16.
Clinical trial NCT01396902: Text Reminders for Immunization Compliance in Kids (TRICKS) Pilot Study
Official title: Text Reminders for Immunization Compliance in Kids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Immunizations
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: As a participant in these research program you will be a parent of a child born at Wesley Medical Center who plan to use Carriage Park Pediatric Clinic for your child's care. Mobile phone text messages will be sent to remind you of your child's immunizations.

The long term research goal is to increase childhood immunization rates by improving parental health literacy through an innovative text messaging system regarding immunization schedules for children under the age of six.


Eligibility criteria: Inclusion Criteria:

* parent or caregiver of a well child born at Wesley Medical Center;
* planning to utilize the Carriage Park Pediatric Clinic for his/her child's medical home; (
* adult (\> 18 years of age);
* present use of a mobile phone for sending and receiving text messages;
* English or Spanish speaking;
* able to provide informed consent.

Exclusion criteria include:

* personal or religious beliefs against immunizations;
* inability to complete enrollment information.

Primary outcomes:
measure: the first aim is to assess our ability to enroll at least 70% (N=90) of eligible parents in a text messaging program
timeFrame: up to 1 year
Secondary outcomes:
measure: the second aim is to implement the TRICKs intervention with parents of newborns.
timeFrame: up to 1 year
measure: the third aim is to collect immunization information on participant's children.
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Kansas University School of Medicine-Wichita
state: Kansas
Study officials:
References:
citation: Ahlers-Schmidt CR, Chesser AK, Nguyen T, Brannon J, Hart TA, Williams KS, Wittler RR. Feasibility of a randomized controlled trial to evaluate Text Reminders for Immunization Compliance in Kids (TRICKs). Vaccine. 2012 Aug 3;30(36):5305-9. doi: 10.1016/j.vaccine.2012.06.058. Epub 2012 Jun 29.
Clinical trial NCT00398502: Comparisons Of The Bioavailability And Pharmacodynamics Of Various Formulations Of MOA-728 In Subjects On Methadone
Official title: A Randomized, Open-label, 3-period Crossover Study to Determine the Relative Bioavailability of Two Oral Formulations of MOA-728 and to Compare the Pharmacodynamics of the Two Oral Formulations of MOA-728 and the Subcutaneous Formulation in Subjects on Stable Methadone Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metahdone-maintenance Subjects
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary: To determine the relative bioavailability of MOA-728, an investigational drug, administered orally in both the capsule and tablet formulations to methadone maintenance subjects.Secondary: To assess the pharmacodynamic effect of MOA-728 administered both orally and subcutaneously to methadone maintenance subjects using the oral-cecal transit time.


Eligibility criteria: * Men or nonlactating and nonpregnant women, aged 18 to 65 years, inclusive. Women of nonchildbearing potential must be surgically sterile (hysterectomy, oophorectomy, and/or tubal ligation) or postmenopausal for ³1 year. Women of childbearing potential must be using an acceptable nonhormonal method of contraception (intrauterine device \[IUD\], diaphragm, or condom with spermicidal jelly or foam, or abstinence) for a period of at least 1 month before and after dose administration. All women must have negative pregnancy test results within 48 hours before the start of the first test article administration.
* Body mass index in the range of 18 to 35 kg/m² and body weight ≥50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
* Subjects with positive results for HBsAg, and/or HCV antibodies may be enrolled if their bilirubin and serum albumin values are within normal limits and their liver function tests are within 1.2 times the upper limit of the normal range.
* A history of methadone treatment for at least 1 month before day -1 and have a positive drug test for methadone.
* No concomitant medication with the exception of stable doses of anxiolytic agents, antidepressants, Seroquel, occasional sleep medications, and drugs or supplements required to enhance or maintain regulation of bowel movements (must be stopped for the 72 hours before the first dose of test article administration in each period).
* Must have a high probability for compliance with and completion of the study.

Primary outcomes:
measure: Pharmacokinetics and Pharmacodynamics
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
state: Florida
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References:
Clinical trial NCT00126802: The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer
Official title: The Role of Tomotherapy (Dynamic IMRT and Megavoltage CT Scanning) in Hypofractionated/Dose Escalated Conformal Radiation Treatment Using Magnetic Resonance Spectroscopy (MRS) Scans to Predict and Document the Pattern of Local Failure for High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: tomotherapy
MRSZ
high risk prostate cancer
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2005-08-05
Enrollment: 60
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Helical tomotherapy is being used to treat the prostate gland, local rates of spread and regional lymph nodes whilst sparing gross structures. The radiation to the gross disease in the prostate is hypofractionated and dose escalated. Magnetic resonance spectroscopic imaging (MRSI) is incorporated into pre- and post-treatment evaluation.


Eligibility criteria: Inclusion Criteria:

* High risk localized prostate cancer

Exclusion Criteria:

* Low/intermediate risk, metastatic cancer
* Patient refusal

Primary outcomes:
measure: Rectal Toxicity
timeFrame: 5 weeks
Secondary outcomes:
measure: prostate-specific antigen (PSA) and MRSI disease control
timeFrame: 3 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Robert Pearcey, MD
role: PRINCIPAL_INVESTIGATOR
References: