louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01547598: Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 135
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: This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.


Eligibility criteria: Inclusion Criteria:

* Open angle glaucoma or ocular hypertension
* Best corrected visual acuity of 20/100 or better in both eyes

Exclusion Criteria:

* Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks
* Previous treatment with LUMIGAN® RC or DuoTrav®
* History of LASIK, LASEK, RK or PRK in the study eye(s)
* Active ocular inflammation

Primary outcomes:
measure: Mean Diurnal Intraocular Pressure (IOP)
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Mean IOP at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
timeFrame: Week 12
measure: Change From Baseline in Mean IOP at Week 6
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Vancouver
country: Canada
state: British Columbia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03873298: Inhaled NO in IPF and COPD During 6 Minute Walk Test
Official title: The Influence of Inhaled Nitric Oxide on Oxygen Saturation of Patients With COPD and IPF During Six Minute Walk Test.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COPD
IPF
Inhaled Nitric Oxide
Six Minute Walk Test
Oxygen Saturation
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Bellerophon
First posted: 2019-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT, placebo controlled
Primary purpose: TREATMENT

Brief summary: Our objective is to evaluate the influence of inhaled NO on the saturation and exercise capacity of patients with COPD and IPF. each participant will undergo two six minute walk tests, one with inhaled NO and the other with placebo.

Detailed description: This is a randomiized, placebo controlled trail that will evaluate the influence of inhaled NO (INO) on the saturation and exercise capacity of patients with COPD and IPF. All patients will sign a consent form before enrolment. Each patient will undergo two six-minute walk tests. Whether the INO will be used in the first or the second trial will be determined by computer generated randomization with random numbers sealed in opaque envelops. For the placebo 6-minute test we will use placebo cartridges in the INO generator, for INO 6-minute test we will use NO cartridges. The treatment with INO or placebo will start 20 minutes before the 6-minute walk test and will end at the end of the 6-minute walk test. Between tests a time interval of at least 60 minutes will be kept. During the test, the patients' pulse and saturation level will be monitored with a pulse oximetry. The data will be recorded continuously from baseline to 5 minutes after the test is over. The distance the patient walked will also be recorded. Patients that require supplemental oxygen will perform the tests with oxygen supplementation.

Dosing The NO dosing will be fixed. The first 10 patients will be treated with INO at a dose of 45 parts per million (ppm) per kilogram (kg). from patient 10 to 20 a dose of 75 ppm per kg will be given and from patient 20-100 a dose of 115 ppm per kg will be given.

Eligibility criteria: Inclusion Criteria:

1. Patients with COPD with disease severity of GOLD stage 3-4
2. Patients with IPF with a Forced vital capacity under 80% and a diffusion capacity under 60%
3. Ambulatory patients that can perform a 6-minute walk test

Exclusion Criteria:

1. Patients with moderate to severe heart failure - EF \< 40%
2. Patients with severe PVD or scleroderma

Primary outcomes:
measure: Saturation level during the test
timeFrame: 26 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Mordechai Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00166998: The Study of Infrared Imaging on Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Keywords: Breast neoplasms
diagnosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Breast cancer can cause focal temperature increase on the breast skin due to vasodilatation mediated by NO secretion from cancer cells. Our study is to evaluate this situation and to assess the diagnostic efficacy of infrared imaging (thermography)on breast cancer.

Detailed description: Malignant breast neoplasms can secrete NO to induce focal vasodilatation and increased blood flow and angiogenesis to the tumor, thus increase the focal temperature, which can be evaluated by breast thermography (infrared imaging). We will evaluate the efficacy of infrared imaging for detection and diagnosis of breast cancer, and if infrared imaging can effectively differentiate malignant from benign breast dieases and the sensitivity, specificity, false-negative rate will also be estimated.

Eligibility criteria: Inclusion Criteria:

* normal group: women who has normal mammograms or ultrasound in 6 months abnormal group: women who has suspicious findings on mammograms or ultrasound in recent 6 months

Exclusion Criteria:

* women who don't fit the above inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jane Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parisky YR, Sardi A, Hamm R, Hughes K, Esserman L, Rust S, Callahan K. Efficacy of computerized infrared imaging analysis to evaluate mammographically suspicious lesions. AJR Am J Roentgenol. 2003 Jan;180(1):263-9. doi: 10.2214/ajr.180.1.1800263.
citation: Wu LA, Kuo WH, Chen CY, Tsai YS, Wang J. The association of infrared imaging findings of the breast with prognosis in breast cancer patients: an observational cohort study. BMC Cancer. 2016 Jul 27;16:541. doi: 10.1186/s12885-016-2602-9.
citation: Wang J, Chang KJ, Chen CY, Chien KL, Tsai YS, Wu YM, Teng YC, Shih TT. Evaluation of the diagnostic performance of infrared imaging of the breast: a preliminary study. Biomed Eng Online. 2010 Jan 7;9:3. doi: 10.1186/1475-925X-9-3.
Clinical trial NCT04066998: Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab
Official title: Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Conjunctival Diseases
Atopic Dermatitis
Side Effect
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with Dupilumab


Eligibility criteria: Inclusion Criteria:

* patients with severe atopic dermatitis resistant to main immunosuppressive drugs
* treated with Dupilumab
* with or without conjunctivitis
* postmenopausal women (since minimum 24 months), surgically sterilized women or women on contraception

Exclusion Criteria:

- pregnant or breastfeeding women

Primary outcomes:
measure: Increase of lacrimal inflammatory cytokines
timeFrame: Month 8
Secondary outcomes:
measure: Comparison of the increase of lacrimal inflammatory cytokines between the 2 groups
timeFrame: Month 8
measure: Absence/Presence of demodex
timeFrame: Day 0
measure: Increase of lacrimal eosinophiles
timeFrame: Month 8
measure: Improvement of quality of life
timeFrame: Month 8
Other outcomes:
Locations:
Study officials:
affiliation: CHU de Besançon
name: Camille FEBVAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00634998: Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy
Official title: Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Neuropathies
Keywords: Vitamin C
Ascorbic Acid
Diabetic Neuropathies
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to determine whether vitamin C supplementation is beneficial in treating and/or preventing diabetic peripheral neuropathy in people with type 2 diabetes.

Detailed description: Painful diabetic peripheral neuropathy (DPN), a condition characterized by pain affecting the feet, legs and hands that is often characterized as burning or a "pins and needles" sensation, is estimated to affect up to 66% of the U.S. diabetic population. This pilot study will examine the effect of a daily dose of ascorbic acid, a known aldose reductase inhibitor, versus placebo, and the effect that it can have on intracellular erythrocyte (red blood cell) sorbitol levels, aldose reductase activity and aldose reductase enzyme levels utilizing benchtop methods, and effects on clinical DPN-associated pain reporting and changes in quantitative sensory testing in the lower extremities via touch discrimination and vibratory sensory testing in patients with Type 2 Diabetes Mellitus (T2DM) over the course of 90 days of treatment.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* diabetic peripheral neuropathy
* A1C of 6.0-10.0%

Exclusion Criteria:

* Terminal diagnosis
* Dementia
* Anemia
* Significant renal dysfunction
* History of B-12 deficiency
* Peripheral vascular disease
* Current smoker
* History of kidney stones
* Current ascorbic acid use
* Presence or foot infection and/or ulcer

Primary outcomes:
measure: Changes in intracellular erythrocyte sorbitol levels
timeFrame: Changes at 90 days compared to baseline
measure: Changes in aldose reductase enzyme activity
timeFrame: Activity at 90 days compared to baseline
measure: Changes in aldose reductase enzyme levels
timeFrame: Levels at 90 days compared to baseline
Secondary outcomes:
measure: Changes in Neuropathic Pain Scale (NPS) measurement and quantitative sensory testing in the lower extremities via touch discrimination with Semmes-Weinstein monofilaments and vibratory sensation testing
timeFrame: Changes at 90 days compared to baseline
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University, College of Pharmacy, Department of Pharmacotherapy
state: Washington
Study officials:
affiliation: Washington State University
name: Joshua J Neumiller, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04648098: Effect of Post-stroke Discharge Training
Official title: The Effect of Post-stroke Discharge Training and Telephone Counseling Service on Patients' Functional Status and Caregiver Burden: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Caregiver Burnout
Lead sponsor: Kırklareli University
Sponsor class: OTHER
Collaborators: name: Trakya University
First posted: 2020-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional (Clinical Trial)
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of post-stroke discharge training and telephone counseling service on patients' functional status and caregiver burden. The study was conducted with 69 stroke patients (34 in the intervention group and 35 in the control group) and their caregivers. In the study, data were collected before discharge and three months after discharge. Discharge training and telephone counseling (one week after discharge and once a month for three months) were given to the caregivers of the patients in the intervention group.

Detailed description: This study, which was planned as a randomised controlled study, was conducted university hospital neurology clinic in Turkey. A total of 80 participants who met the inclusion criteria were randomised to either the intervention and control groups.

In this study, Patient Information Form, Modified Rankin Scale and Barthel Index were used to collect data about patients, while Caregiver Information Form and Caregiver Burden Scale were used to collect data about caregivers Pre-tests were applied to patients and caregivers in the intervention and control groups before discharge. After the pre-tests were applied to the caregivers in the intervention group, discharge training was given.

Eligibility criteria: Inclusion Criteria:

* the age of 18 and over (for patients and caregivers)
* having undergone a hemorrhagic or ischemic stroke (for patients)
* being literate (for caregivers)
* being primarily responsible for the care of the stroke patient during the hospital stay and at home after discharge (for caregivers)
* using a mobile or home phone (for caregivers)
* being open to communication and collaboration (for caregivers)

Exclusion Criteria:

* Rankin Scale score of 4 above (for patients)
* Having problem in terms of hearing and understanding (for caregivers)

Primary outcomes:
measure: Caregiver Burden Scale
timeFrame: Change from baseline score at the end of the third month
measure: The Barthel Index
timeFrame: Change from baseline score at the end of the third month
measure: Modified Rankin Scale
timeFrame: Change from baseline score at the end of the third month
Secondary outcomes:
Other outcomes:
Locations:
city: Kırklareli
country: Turkey
facility: Kırklareli University
Study officials:
affiliation: Trakya University
name: Özgül EROL
role: STUDY_DIRECTOR
References:
Clinical trial NCT02506998: Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts
Official title: Evaluation of Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts as an Adjuvant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinoconjunctivitis
Keywords: Allergic rhinoconjunctivitis
Dialyzable Leukocyte Extracts
Lead sponsor: National Polytechnic Institute, Mexico
Sponsor class: OTHER
Collaborators: name: Instituto de Oftalmología Fundación Conde de Valenciana
First posted: 2015-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the changes of quality of life of patients with allergic rhinoconjunctivitis treated with standard medications plus Dialyzable Leukocyte Extracts (DLE). All patients will receive DLE in combination with current guide lines-suggested standard medication.

Detailed description: DLE are heterogenous mixtures of peptides under 10 kilo Daltons (kDa) obtained after disruption of peripheral blood leukocytes from healthy human donors. DLE have been reported to improve clinical response in allergies, such as asthma and atopic dermatitis.

The therapeutic effect of DLE is related to an immune modulatory effect that changes innate signaling pathways, such as Toll Like Receptors, and Nuclear Factor -kappa B; production of cytokines might also be modified with the use of DLE, including Tumor Necrosis Factor a, Interleukin (IL)-6, and induction of Interferon-g secretion, driving immune response to a T-helper Th1 immune-regulatory response, and thus helping to reduce allergy symptoms.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of symptomatic seasonal or perennial allergic rhinitis
* Active rhinoconjunctivitis
* Six week standard treatment before inclusion
* Confirmation of an Immunoglobulin E-mediated response through previous positive skin or in vitro allergen testing

Exclusion Criteria:

* Other immunological immune-mediated diseases such as autoimmune diseases and cancer.
* Unstable chronic disease, such as diabetes, cardiac diseases, chronic kidney failure, chronic hepatic disease.

Primary outcomes:
measure: Quality of Life
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Polytechnic Institute
name: Toni Homberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03782298: Safety and Performance of PEEK Anchors in Extremities
Official title: Safety and Performance of PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL) in Extremities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medial or Lateral Instability Repairs/Reconstructions
Hallux Valgus Repairs
Achilles Tendon Repairs/Reconstructions
Midfoot Reconstructions
Metatarsal Ligament/Tendon Repairs/Reconstructions
Bunionectomy
Scapholunate Ligament Reconstructions
Ulnar
Lateral Epicondylitis Repair
Bicep Tendon Reattachments
Keywords: Dynomite
Spyromite
Raptormite
Foot
Ankle
Wrist
Hand
Elbow
Footprint
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have undergone extremity joint repair using the study devices, PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL)

Brief summary: Safety and performance of the study devices in extremities up to 12 months post-surgery


Eligibility criteria: Inclusion Criteria:

* Subjects who have undergone extremity joint repair using the study devices.
* Subjects aged 18 years and older at the time of surgery.

Exclusion Criteria:

* Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
* Subjects who are \< 3 months post-operative

Primary outcomes:
measure: Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention
timeFrame: 12 months
Other outcomes:
measure: Visual Analog Scale (VAS) - Pain
timeFrame: 6 and 12 months
measure: Count of Participants With Range of Motion (ROM) Full Functional Arc
timeFrame: 6 and 12 months
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Chardon
country: United States
facility: Precision Orthopaedic Specialties, Inc.
state: Ohio
city: Grapevine
country: United States
facility: Foot and Ankle Associates of North Texas-Grapevine
state: Texas
city: London
country: Canada
facility: Fowler Kennedy Sport Medicine Clinic
state: Ontario
Study officials:
affiliation: Smith & Nephew, Inc.
name: Judth Horner
role: STUDY_CHAIR
References:
Clinical trial NCT03455998: Chronic Abdominal Pain After Gastric Bypass
Official title: Chronic Abdominal Pain After Gastric Bypass for Morbid Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Pain
Keywords: morbid obesity
gastric bypass
pain
symptoms
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned for bariatric surgery (gastric bypass) at a single center

Brief summary: The study aims to explore patients perception of chronic abdominal pain after Roux en Y gastric bypass surgery for morbid obesity. The investigators aim to describe characteristics of symptoms of pain. Potential risk factors for developing abdominal pain post gastric bypass will be explored.

Detailed description: This is a single-center, prospective, longitudinal, cohort study performed at the Department of Morbid Obesity and Bariatric Surgery, Oslo University Hospital. Patients undergoing gastric bypass are eligible for inclusion. The study is approved by the Regional Committee for Medical and Health Research Ethics (no.2013/1263), South-East health region. All participants provide written consent for study paennrollment.

The participants are asked to fill inn a set of questionnaires before and during follow-up after gastric bypass surgery. Symptom characteristics are explored and evaluated. Quality of life is included in the analyses. The main outcome is findings at 2 years post surgery, but the patients will be followed for 5 years.

The investigators also aim to evaluate by objective measures the patients perception of pain by temperature and skin pressure stimulants before and after surgery (2 years).

Eligibility criteria: Inclusion Criteria:

• Indication for gastric bypass surgery i.e. BMI \> 40 kg/m2 or BMI \> 35 kg/m2 and obesity related comorbidity following failed attempts of sustained weight loss

Exclusion Criteria:

* Other indications for gastric bypass surgery than obesity
* Previous bariatric surgery
* Other concomitant surgical procedures for abdominal pain such as cholecystectomy

Primary outcomes:
measure: Chronic abdominal pain 2 years post gastric bypass surgery
timeFrame: Patient follow up complete 2020
Secondary outcomes:
measure: Quality of life
timeFrame: patient follow up complete 2020
measure: Objective evaluation of pain perception
timeFrame: baseline and 2 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university Hopsital
Study officials:
affiliation: Oslo University Hospital
name: Tom Mala, MD.phd
role: PRINCIPAL_INVESTIGATOR
References: