louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04671108: Comparative Clinical Performance of 59% Hioxifilcon A Contact Lenses vs. Marketed Hydrogel Contact Lenses
Official title: Comparative Clinical Performance of 59% Hioxifilcon A Daily Disposable Contact Lenses vs. Marketed Daily Disposable Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error - Myopia Bilateral
Lead sponsor: Vision Service Plan
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over with 1 week of lens wear with each contact lens type.
Primary purpose: TREATMENT

Brief summary: The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens.

Detailed description: This randomized clinical trial will compare the short-term clinical performance, and wearer acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against marketed DD lenses in a short cross-over clinical trial.

The primary outcome variable for this study is overall subjective comfort.

Eligibility criteria: Inclusion Criteria:

* Currently wearing spherical DD contact lenses at least 5 days/week
* Vision correctable to 20/30 acuity in each eye with spherical DD contact lenses
* No ocular or systemic disease that contra-indicates soft contact lens wear

Exclusion Criteria:

* Participating in another clinical trial
* Vision not correctable to 20/30

Primary outcomes:
measure: Overall subjective comfort
timeFrame: 1 week after contact lens wear
measure: Overall subjective comfort
timeFrame: 2 weeks after contact lens wear
Secondary outcomes:
measure: End of day subjective comfort
timeFrame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
measure: Subjective vision
timeFrame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
measure: Overall subjective lens preference
timeFrame: Visit 3 - After approximately 2 weeks of contact lens wear
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Ross Eyecare
state: Georgia
city: Westerville
country: United States
facility: Professional VisionCare
state: Ohio
city: Brentwood
country: United States
facility: Primary Eyecare Group
state: Tennessee
Study officials:
References:
Clinical trial NCT04337008: Renin Angiotensin System - CoronaVirus
Official title: Renin Angiotensin System - CoronaVirus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID 19
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to demonstrate overactivation of Renin Angiotensine System (RAS) in positives COVID-19 patient, especially in those with the most serious clinical forms where the mortality of patients in intensive care is on average 50%.

We are expecting two groups: a group of 25 positive COVID 19 patients in intensive care and a group of 25 positive COVID 19 hospitalized patients in conventional hospitalisation. We will measure RAS, serum potassium and collect data on the treatment of these patients (especially antihypertensive therapy) one week apart (at the patient'entry into hospital and 7 days later).

This is a preliminary study that could possibly allow the start of a therapeutic trial in order to test the effectiveness of RAS blocker treatments in this condition.


Eligibility criteria: Inclusion Criteria:

* Positive COVID 19 patients hospitalized in conventionnal hospitalisation
* Patients hospitalized in intensive care secondary to COVID-19 : Patient under invasive mechanical ventilation (PaO2 / FiO2 ratio \<300; PEEP\> = 5 cmH20; PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample; PaO2 / FiO2 ratio\> 300)

Exclusion Criteria:

* Minor patient
* Patient deprived of liberty
* Patient's refusal to participate in the study
* Patient for whom therapeutic limitation measures such as non-admission to intensive care have been issued

Primary outcomes:
measure: overactivity of the renin / aldosterone system
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: ASSISTANCE PUBLIQUE HÖPITAUX de MARSEILLE
Study officials:
affiliation: ASSISTANCE PUBLIQUE HÔPITAUX de MARSEILLE
name: Emilie Garrido-Pradalie
role: STUDY_DIRECTOR
References:
Clinical trial NCT03343743: Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers
Official title: Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with recurrent calcium oxalate stones undergoing endourological procedures for renal stones at our institution from June 2013 to June 2014 were considered eligible for enrolment. Enrolled patients underwent a baseline unenhanced CT scan before the urological procedure; after endoscopic removal of their stones, the patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C \<200 mg/L) for at least 12 months. Finally, the patients underwent a follow-up unenhanced CT scan during hydration regimen.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing endourological procedures for renal stones
* Recurrent stone disease
* Calcium oxalate stones (\>50% of the stone made of calcium oxalate)

Exclusion Criteria:

* Systemic conditions causing stones (hyperparathyroidism, intestinal malabsorption, renal tubular acidosis)
* Non-calcium oxalate stones

Primary outcomes:
measure: Changes in renal papillary density
timeFrame: At baseline and after 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ferraro PM, Vittori M, Macis G, D'Addessi A, Lombardi G, Palmisano C, Gervasoni J, Primiano A, Bassi PF, Gambaro G. Changes in renal papillary density after hydration therapy in calcium stone formers. BMC Urol. 2018 Nov 12;18(1):101. doi: 10.1186/s12894-018-0415-7.
Clinical trial NCT00414843: Storage of Bile From Routine Procedures to Study Risk Factors
Official title: A Prospective Study of Human Bile and Molecular Predictors of Biliary Malignancy Risk
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gallbladder Cancer
Cholangiocarcinoma
Biliary Tract Cancer
Keywords: Storage
Bile
Biomarkers
biliary malignancies
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2006-12-22
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects presenting to Indiana University for treatment of biliary tract disease.

Brief summary: The purpose of the study is to establish a repository of human bile as a resource for studies evaluating molecular predictors of biliary cancer risk.

Detailed description: The specific aim of this study is to establish a repository of human bile to serve as a resource for studies looking at molecular predictors of biliary tract cancer. The development of fluid based biomarkers will enable early diagnosis in at-risk individuals with a recognized risk factor for cholangiocarcinoma, as well as provide surveillance mechanisms for screening populations where biliary tract cancer has a high incidence.

Eligibility criteria: Inclusion Criteria:

* Presenting to IU for treatment of biliary tract disease; Age greater than or equal to 18

Exclusion Criteria:

* Problems other than biliary tract disease

Primary outcomes:
measure: Establish Repository of Human Bile
timeFrame: 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Mary Maluccio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199043: Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma
Official title: Randomised Phase III Trial of Effectivity and Safety of Rasburicase Compared With Allopurinol for Treatment of Hyperuricemia in Patients With Acute Lymphoblastic Leukemia or High-Grade NHL With High Risk of Tumorlysis Syndrome (> 15 Yrs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adult Acute Lymphocytic Leukemia
High-grade Lymphoma
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the efficacy and tolerability of two approaches to treat and prevent hyperuricemia is tested in patients with acute lymphoblastic leukemia or high-grade lymphoma with high risk of tumor lysis syndrome. Both arms are compared by randomisation. In one arm patients receive during pre-phase chemotherapy conventional prophylaxis with allopurinol whereas in the other arm Rasburicase is used.


Eligibility criteria: Inclusion Criteria:

* patients of the GMALL B-ALL/NHL-Study 2002
* patients of the GMALL-Study 07/2003
* patients of the GMALL-Study Elderly 1/2003 which fulfill the following criteria:
* bulky disease (\> 7.5 cm)
* high LDH (\> 2 x UNL)
* uric acid \>8 mg/dl/ \>475µmol/L at diagnosis
* leukocytes \> 30 000/µl

Exclusion Criteria:

* exclusion Criteria of the GMALL B-ALL/NHL Study 2002 or the GMALL-Study 07/2003 or GMALL-Elderly 1/2003 and:
* asthma or severe, live-threatening atopic allergy in history
* hypersensitivity against Uric acid
* Glucose-6-Phosphate-Dehydrogenase deficiency
* pretreatment with Rasburicase or Urikozyme™

Primary outcomes:
measure: renal function, uric acid, electrolytes, adverse events and mortality in pre-phase and the two following cycles of chemotherapy, time and dose compliance of chemotherapy
timeFrame: 3 weeks
Secondary outcomes:
measure: response rate, incidence of tumor lysis syndrome
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital, Medical Dept. II
Study officials:
affiliation: University Hospital of Frankfurt, Medical Dept. II
name: Dieter Hoelzer, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04769843: Impact of Swallowing Impairment on Individuals With Parkinson Disease
Official title: Incorporating the Psychological Consequences of Dysphagia Into Swallowing Care: A Preliminary Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Dysphagia
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from 1) local Parkinson Disease support groups, 2) through referrals from local speech-language pathologists, and 3) through the Fox Trial Finder on the Michael J. Fox Foundation website.

Brief summary: In this online study, investigators will explore the psychosocial burdens of swallowing difficulties in people with Parkinson's Disease. This study is completely virtual, so you can participate from wherever you live in the United States. Participation requires you to complete a one-hour Zoom interview and a brief questionnaire. You will be compensated with a $25 Walmart gift card. To learn more, please use the "send email" feature. Thank you!

Detailed description: This is a mixed methods study. The investigators will collect qualitative data from participants by conducting 1-2 hour semi-structured interviews on Zoom. The interview questions are designed to systemically inquire about patient experiences, affective reactions, coping strategies, social support, self-identity issues, and treatment experiences. The investigators will collect quantitative data by asking participants to complete The Brief Illness Perception Questionnaire. The data will be analyzed using a comprehensive stress and coping model, which has not been done previously in the field. The investigators hope to discover themes about psychosocial burdens and related coping mechanisms.

Eligibility criteria: Inclusion Criteria:

* Participants must currently have oropharyngeal dysphagia and Parkinson Disease
* Participants must be at least 18 years of age
* Participants must speak English.

Exclusion Criteria:

* Participants whose receptive and expressive language skills will not allow them to participate in one-on-one interviews

Primary outcomes:
measure: Identification of the Impact of Swallowing Impairment on Individuals with Parkinson Disease as Expressed During Interviews
timeFrame: To be assessed from the participant interviews through study completion, an average of 1 year.
Secondary outcomes:
measure: Overall Score on Brief Illness Perception Questionnaire (Brief IPQ) as Self-Reported by Participants
timeFrame: The Brief IPQ will be mailed to participants after their interview and asked to complete it and return it to us within one week.
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona University
state: Arizona
Study officials:
affiliation: Northern Arizona University
name: Rebecca S Bartlett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03254043: Evaluating a Novel Medication Device for Methadone Dosing
Official title: Evaluating a Novel Medication Device for Methadone Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-08-18
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate whether a commercially available, secure, electronic pill box is a feasible, acceptable, and satisfactory method to manage take-home dosing of methadone for both methadone clinic patients and staff members.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Receiving methadone for the treatment of opioid use disorder for at least 90 days and having been on the same methadone dose for at least 30 days
* Have previously received a take-home dose of methadone as part of routine care
* Be willing to comply with the study schedule
* Be a methadone patient in the clinic within which this study is being conducted

Exclusion Criteria:

* Pregnancy
* Presence of an acute medical problems that requires immediate or intense medical management
* Presence of serious or unstable mental illness that interferes with study procedures
* Planning to leave methadone treatment within the next 12 weeks
* Being maintained on a dose of methadone that is less than 10mg or more than 100mg
* Currently receiving split doses of methadone as part of routine care

Primary outcomes:
measure: Participant willingness to use the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone
timeFrame: Week 12
measure: Participant acceptance of the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone
timeFrame: Week 9
measure: Change in participant satisfaction
timeFrame: Week 4
measure: Change in participant satisfaction
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Addiction Treatment Services (ATS)
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kelly Dunn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00295243: Phase I Study of GW572016 With Topotecan to Treat Advanced Solid Malignancies
Official title: A Phase I Trial of the Dual Kinase Inhibitor GW572016 in Combination With Topotecan in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignancies
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-02-23
Enrollment: 25
Sex: ALL
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: Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will be given Topotecan intravenously on Days 1, 8 and 15.

Detailed description: Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will be given Topotecan intravenously on Days 1, 8 and 15. During Cycle 1 participants will be required to spend the evening before Day 1 in the General Clinical Research Center and frequent blood samples will be drawn on Day 1; this schedule will be repeated the evening of Day 6 with the blood samples drawn on Day 7. Participants will have weekly CBCs.

Eligibility criteria: Age 18 and older Histologic proof of cancer that is unresectable ANC greater than 1500 u/L PLC greater than 100,000 u/L Total bilirubin less then or equal to ULN AST less than 3 x ULN or AST less than 5 x ULN if liver involvement Creatinine less than 1.5 x ULN Hemoglobin greater than 9 g/dL Echocardiogram with ejection fraction great than 40% Life expectancy of more than 12 weeks

Primary outcomes:
measure: find the highest dose of GW572016 and Topotecan that can be safely given together
measure: Learn the side effects of GW572016 and Topotecan when given together
measure: Learn whether GW572016 changes how the body handles or processesTopotecan
measure: Learn whether Topotecan changes how the body handles or processes GW572016
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Charles Erlichman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03124043: Get In Touch Phase 2
Official title: Get In Touch Phase 2 - Evaluating a Diabetes Care Support Program Facilitated by Cellular-enabled Glucose Meters, a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Livongo Health
First posted: 2017-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the Get In Touch - Phase 2 (GIT-2) study was to evaluate a diabetes care support intervention facilitated by cellular-enabled glucose meters in adults with persistent poor control of type 2 diabetes.

Detailed description: A 2-group randomized crossover trial comparing usual care to a diabetes care support intervention among patients with repeated HbA1c recordings greater than 8.0 percent during the previous 12 months. The intervention included 6 months of enrollment in Livongo for Diabetes, a Certified Diabetes Educator (CDE) based remote diabetes monitoring program facilitated by cellular-enabled glucose meters, with additional remote monitoring by their usual care team. HbA1c levels were recorded at enrollment and 3, 6, 9, and 12 months post enrollment. Questionnaire data were collected at baseline, 6 months, and 12 months post enrollment. Primary outcomes evaluated were change in HbA1c and treatment satisfaction at the 6 month endpoint with secondary outcomes of change in HbA1c and treatment satisfaction at the 12 month endpoint.

Eligibility criteria: Inclusion Criteria:

* speak English, having type 2 diabetes with two consecutive HbA1c recordings greater than 8.0% over the previous 12 months at the time of recruitment

Exclusion Criteria:

* excluded if they were cognitively impaired, pregnant, or prisoners.

Primary outcomes:
measure: Change in HbA1c
timeFrame: During 6-month enrollment in Intervention
Secondary outcomes:
measure: Change in Treatment Satisfaction
timeFrame: During 6-month enrollment in intervention
Other outcomes:
Locations:
Study officials:
affiliation: UMass Medical School
name: Michael Thompson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amante DJ, Harlan DM, Lemon SC, McManus DD, Olaitan OO, Pagoto SL, Gerber BS, Thompson MJ. Evaluation of a Diabetes Remote Monitoring Program Facilitated by Connected Glucose Meters for Patients With Poorly Controlled Type 2 Diabetes: Randomized Crossover Trial. JMIR Diabetes. 2021 Mar 11;6(1):e25574. doi: 10.2196/25574.
Clinical trial NCT00959543: MRI Findings in Throwing Shoulders of Waterpolo Players
Official title: MRI Findings in Throwing Shoulders of Waterpolo Players Abnormalities in Professional Waterpolo Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Waterpolo Players
Non Throwing Shoulders
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: MRI examination of 60 shoulders of waterpolo players (30 throwing shoulders as well as the opposite side) and 15 healthy probands as control group (30 shoulders of non waterpolo players. The correlation of MRI alteration and clinical symptomatic findings in both groups will be investigated. The clinical examination is performed by 2 board certified orthopedic surgeons and based on the Constant Murley Score.


Eligibility criteria: Inclusion Criteria:

* Study shoulders of elite waterpolo players
* Study shoulders of healthy non throwing persons
* Age between 18-35 years
* Male
* Given informed consent

Exclusion Criteria:

* Previous shoulder surgery
* Goal keeper
* Metallic implants
* Pacemaker
* Tattoos with metallic colors

Primary outcomes:
measure: Correlation between alterations of SSP-tendon in MRI and clinical symptoms
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of Orthopedic Surgery
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Michael A. Badulescu, MD
role: PRINCIPAL_INVESTIGATOR
References: