louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04772560: Toric Contact Lens Digital Performance and Comfort Study
Official title: Toric Contact Lens Digital Performance and Comfort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

Detailed description: This study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. Primary Hypotheses: Subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. As such, the following hypotheses will be tested: H01: There is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections Ha1: There is a statistically significant difference in visual acuity or vision performance between contact lenses corrections

Eligibility criteria: Inclusion Criteria:

* 18 to 39 years of age (inclusive)
* pl to -6.00D vertexed sphere power and -0.75 to -1.50D vertexed refractive cylinder OD and OS
* Current/established full time (\>6 days week, \>8 hours/day) soft contact lens wearer
* Best corrected acuity of 20/25 or better in each eye
* Self-report of at least 4 hrs/day using digital devices
* Willing to wear lenses at least 8 hours each day during the study period
* Able to speak and read English at a high school level / have at least a high school diploma or equivalent (by self-report)

Enclusion Criteria:

* History of ocular pathology or surgery
* Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency)
* Gas permeable lens wear for at least 3 months
* Symptomatic soft contact lens wearer (CLDEQ-8 score \<12 at baseline)

Primary outcomes:
measure: Near Visual LogMAR Acuity
timeFrame: 10 +/- 2 days
measure: Dynamic Visual Acuity
timeFrame: 10 +/- 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
Study officials:
affiliation: University of Houston College of Optometry
name: Kathryn Richdale
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00468260: The Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
Official title: An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies-extension Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Malignancies
Keywords: Cancer
EPO906
Patupilone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-02
Enrollment: 12
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: To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.


Eligibility criteria: Inclusion criteria Participation in study EPO906A2120E1

* Age ≥ 18 years of age
* Life expectancy ≥ 3 months
* Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist
* Completed all PK sampling in the core study

Exclusion criteria

* Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis
* Female patients who are pregnant or breast feeding
* Patients with a severe and/or uncontrolled medical disease

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Safety
measure: Tolerability
measure: Potential activity of patupilone once every 21 days in patients that completed the core study
Secondary outcomes:
measure: Objective response and tumor evaluation assessed by response evaluation criteria in solid tumors (RECIST)
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT05144360: Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension
Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hypertension Associated
Type II Diabetes Mellitus
Keywords: Hypertension
Type II Diabetes Mellitus
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2021-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Atenas association in the treatment of type 2 diabetes mellitus and hypertension


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;
* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;
* Participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to any of the formula compounds;
* Type 1 diabetes mellitus;
* Known or suspected secondary hypertension.

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 120 days
measure: Systolic blood pressure (SBP)
timeFrame: 120 days
Secondary outcomes:
measure: Adverse events
timeFrame: 150 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05365360: Sham LaserCap vs. LaserCap SD vs. LaserCap HD+
Official title: Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia, a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Androgenetic Alopecia
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Transdermal Cap, Inc.
First posted: 2022-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Androgenetic alopecia (AGA) is a prevalent disease, occurring in 80% of Caucasian men and 50% of Caucasian women by age 701. Treatments for AGA are limited, and presently the only FDA-approved medications for AGA are topical minoxidil and oral finasteride1.

In addition to medical therapies, FDA-cleared medical devices are now utilized for the treatment of AGA as of 20072. These devices, termed low level laser therapy (LLLT), come in multiple forms including combs, helmets and sports cap wearable devices2. These home-use, wearable devices utilize the \~650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair growth, a process termed "photobiomodulation"3.

Recent meta-analyses investigating photobiomodulation and LLLT for AGA have noted an increase in fluence or energy delivered per cm is associated with increased hair density3. However, randomized control trials (RCT) with direct comparison of LLLT devices of different fluences has yet to be performed. Accordingly, in the present study we aim to investigate if increasing fluence in LLLT devices is associated with increased hair density by comparing sham LaserCap to LaserCap SD (1.15 J/cm2, low fluence) and LaserCap HD+ (3.93 J/cm2, high fluence) in RCT.


Eligibility criteria: Inclusion criteria:

* 25 years and older
* Men and women with AGA, untreated or with 6-month washout of previous treatments
* Men: Norwood stage IIa - V
* Women: Ludwig I-1 - II-2, or frontal pattern
* All patients: Fitzpatrick skin types I to IV

Exclusion criteria:

* Men: Norwood stage Va, VI, VII
* Women: Ludwig stage III, advanced
* All patients: Fitzpatrick skin types V, VI
* Current use or within the past six month of other treatment for AGA, including topical and oral minoxidil, topical and oral finasteride and dutasteride
* Age 0-25 years

Primary outcomes:
measure: Target area total hair count at 26 weeks via phototrichogram
timeFrame: 26 weeks
Secondary outcomes:
measure: Target area vellus hair count at 26 weeks via phototrichogram
timeFrame: 26 weeks
measure: Target area terminal hair count at 26 weeks via phototrichogram
timeFrame: 26 weeks
measure: Physician assessed improvement via global photography at 26 weeks
timeFrame: 26 weeks
measure: Hair growth rate at 26 weeks via phototrichogram
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Dermatology
state: Arizona
Study officials:
References:
Clinical trial NCT01729676: Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation
Official title: Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation: FACT STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 315
Sex: MALE
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: Men never previously treated with hormononal therapy for prostate cancer

Brief summary: French epidemiological data have shown a heterogeneous distribution of the risk of mortality from prostate cancer according to region. The main objective is to describe the distribution of prostate cancer stages when first line hormonal therapy is introduced (overall and by region).


Eligibility criteria: Inclusion Criteria:

* Patients with histologically demonstrated prostatic adenocarcinoma.
* Patients never previously treated with hormonal therapy for prostate cancer.
* Patients eligible for hormonal therapy after initial consultation (alone or in combination with curative treatment).
* Patients agreeing to the collection of personal health data for the purposes of the study.
* Patients with locally advanced or metastatic prostatic cancer tumours or a biological recurrence after curative treatment.

Exclusion Criteria:

* Patients participating in a clinical study involving prostate cancer at the time of inclusion in the investigation.
* Patients having received or currently receiving hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor antagonists, antiandrogens, oestrogens, 5 alpha reductase inhibitors).

Primary outcomes:
measure: Estimated percentage of different prostate cancer stages (overall and by region)
timeFrame: During a single consultation when first-line prostate cancer hormone therapy is started
Secondary outcomes:
measure: The characteristics of the patients with prostate cancer by region
timeFrame: During a single consultation when first-line prostate cancer hormone therapy is started
measure: The influence of regional factors on staging of prostate cancer
timeFrame: During a single consultation when first-line prostate cancer hormone therapy is started
Other outcomes:
Locations:
city: Libourne
country: France
facility: Hôpital Robert Boulin
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT05567276: Responding to Children and Adolescents With Tyrannical Behaviour
Official title: Non-Violent Resistance Parental Training Versus Treatment as Usual for Children and Adolescents With Severe Tyrannical Behaviour: a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oppositional Defiant Disorder
Keywords: Child-To-Parent Violence
Severe tyrannical behaviour
NVR
parental training program
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 82
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children with STB aged 6-20 years old

Brief summary: This was a randomized controlled trial that compared the NVR intervention group with a TAU group during a four-months period in reducing stress in parents of children aged 6-20 years and displaying severe tyrannical behaviour (STB).


Eligibility criteria: Inclusion criteria:

1. being the parent of a child aged 6 - 20 years who endorses the DSM-5 criteria of IODD. In fact, ODD is considered a necessary but not a sufficient condition for tyranny behavior
2. two or more positive answers to the custom quetions routinely used to identify STB in children/adolescents at the University Hospital of Montpellier), related to a 12 month period :

   * Are you afraid of your child?
   * Is your child physically or psychologically violent toward you?
   * Do you think that your child is the decision maker in the family?
   * Do you feel ashamed by your situation at home?
3. being able to attend half of the sessions.

Exclusion criteria:

1. predicted absence from at least half of the sessions
2. subject deprived of liberty
3. subject under guardianship or curatorship.

Primary outcomes:
measure: Parenting Stress Index/Short Form(PSI-SF)
timeFrame: 4 months from baseline
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 4 months from baseline
measure: Child Behaviour Checklist (CBCL)
timeFrame: 4 months from baseline
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: 4 months from baseline
measure: Kiddie Schedule for Affective Disorders and Schizophrenia Present/Lifetime version
timeFrame: at baseline
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Diane Purper-Ouakil, M.D., Ph. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00950976: Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients
Official title: Clinical Trial of Enteral Citrulline in Volunteers With Surgical Repair of Ventral Hernias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Deficiency
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2009-08-03
Enrollment: 14
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: To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline.


Eligibility criteria: Inclusion Criteria:

* adults, male \& female, non-pregnant
* BMI 18.5-29.9

Exclusion Criteria:

* cancer
* HIV positive

Primary outcomes:
measure: Plasma amino acid levels
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Associate Professor of Surgery and Critical Care, University of Pittsburgh Physicians
name: Juan B. Ochoa, MD Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02299076: Pro-Change Smoking Cessation Intervention
Official title: Software to Translate Behavioral Economics Insights to Improve Health (Phase 2b)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking Cessation
Motivation
Keywords: Tobacco smoking cessation
Motivation
Lead sponsor: VAL Health, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
name: Rhode Island Primary Care Physicians Corporation
name: Pro-Change Behavior Systems
First posted: 2014-11-24
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a behavioral economics solution impacts smoking cessation program engagement and quit rates.

Detailed description: The behavioral economics solution is a weekly regret contest in which participants can win or miss out on money based on their behavior.

Eligibility criteria: Inclusion Criteria:

* Be current tobacco users (specifically smokers)
* Be 18 years old or over

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Average Number of Completed Sessions Per Participant
timeFrame: Every 30 days for up to 6 months post-enrollment
measure: Outcome of Smoking Cessation Intervention
timeFrame: Every 30 days for up to 6 months post-enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Old Greenwich
country: United States
facility: VAL Health
state: Connecticut
Study officials:
affiliation: President
name: Karen Horgan, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific Advisory Board
name: Kevin Volpp, MD, PhD
role: STUDY_DIRECTOR
affiliation: Scientific Advisory Board
name: David Asch, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00255476: The IRESSA Novel Head and Neck Chemotherapy Evaluation Study
Official title: A Randomised Phase II Study to Investigate the Feasibility and Benefits of Combining ZD1839 and Cisplatin/5FU, as Induction Therapy, in Patients With Locally and Advanced Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Cancer
Cancer of Head and Neck
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Patients with histologically proven primary SCCHN
* Aged 18 or over

Exclusion Criteria:

* Patients eligible for surgery with curative intent
* Other co-existing malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Exclude UCNT

Primary outcomes:
measure: To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
Secondary outcomes:
measure: To compare safety and tolerability in these patients
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Iressa Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02622776: Advanced Methods for Cancer Detection by Vaginal Screening
Official title: Advanced Methods for Cancer Detection by Vaginal Screening (ADVISE): A Pilot Study of Using Vaginal Cell Sampling for Ovarian or Endometrial Cancer Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Endometrial Cancer
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 122
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This pilot study is the first step in the development of an new assay that may be further tested as a screening method for ovarian and endometrial cancers.

Detailed description: Most high grade ovarian cancers originate in the fallopian tubes. Since the lining of the fallopian tube opens into the uterine cavity cancer cells from ovarian/fallopian tube cancers can travel through the uterus to the cervix and vagina. Likewise, endometrial cancer cells shed through the cervix into the vagina. It may be possible to develop a screening test for ovarian and endometrial cancers by collecting vaginal cells.

Eligibility criteria: Inclusion Criteria:

Ovarian Cancer and Endometrial Cancer cases:

1. Women age 19 or older.
2. Histologically confirmed high grade serous cancer (had a pre-operative core biopsy) of ovarian/fallopian tube/peritoneal origin or histo-cytologically confirmed endometrial cancer, not yet treated by surgery or chemotherapy.
3. Give consent to access primary tumour tissue following surgery or biopsy.

Healthy participants:

1) Healthy women between the ages of 19 and 60.

Exclusion Criteria:

Ovarian Cancer and Endometrial Cancer cases:

1. Women with self-reported, known pregnancy.

   Healthy participants:
2. Women with a prior diagnosis of gynecologic malignancy (ovarian, endometrial, cervical, or vulvar cancer) will be excluded.
3. Women who report irregular bleeding (spotting between menstrual cycles, or post-menopausal bleeding), or who have self-reported gynecologic concerns (e.g. pelvic pain, pelvic masses, dyspareunia) or have had a recent evaluation for gynecologic concerns (consultation with a gynecologist, pelvic ultrasound, endometrial biopsy) are ineligible.
4. Women with known Lynch Syndrome and/or BRCA1 or BRCA2 germline mutations will not be eligible to participate as healthy volunteers for this study.
5. Women with self-reported, known pregnancy.

Primary outcomes:
measure: Assay sensitivity and specificity as assessed by the mutation detection rate in tumour and vaginal DNA
timeFrame: 24 months
measure: Patient Acceptance of the methods of DNA collection (Vaginal self-swab and tampon collection)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Anna Tinker, MD
role: PRINCIPAL_INVESTIGATOR
References: