louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00595101: A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
Official title: A Phase 2, 28-Day Parallel-Group, Double-Masked, Dose Finding Study Comparing The Safety And Efficacy Of PF-03187207 To Latanoprost In Patients With Primary Open Angle Glaucoma Or Ocular Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 117
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Man or woman at least 20 years of age
* Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.

Exclusion Criteria:

* Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
* Contraindications to latanoprost and nitric oxide treatment
* Known latanoprost non-responders

Primary outcomes:
measure: Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28
timeFrame: Baseline, 28 days
Secondary outcomes:
measure: Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28
timeFrame: Baseline, Day 14, Day 28
measure: Target IOP
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Narashino
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Shimachi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Kawasaki
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Kasukabe
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Fuji
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Mishima
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Susono
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Hachioji
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Hamura
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Minato
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Musashino
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shizuoka
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Ken Harper
role: STUDY_DIRECTOR
References:
Clinical trial NCT01416701: Vitamin D and Chronic Obstructive Lung Disease
Official title: Vitamin D and COPD. A Randomised, Double-blind, Placebo-controlled Trial of the Effect of Vitamin D on Withdrawal From Pulmonary Rehabilitation and Exercise Endurance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Obstructive Lung Disease
Keywords: COPD
Vitamin D
Pulmonary rehabilitation
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2011-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 50
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 examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years
* Diagnosed COPD with forced expiratory volume in 1 second (FEV1) \< 50 % of predicted
* Breathlessness relative to MRC dyspnoea grade 3 or more

Exclusion Criteria:

* Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease
* Patients with hyper- or hypocalcemia at inclusion
* Patients with cardiovascular or musculoskeletal disease that impacts significantly on walking based on the investigator's judgement
* Patients with dementia or other mental conditions rendering them unable to understand the study information and thus provide informed consent
* Patients with terminal disease or known cancer with bone metastases, increasing their risk of hypercalcemia
* Patients taking more than 20 mcg vitamin D on a daily basis. If a patient takes vitamin D below this limit, dose should have been stable 6 months prior to inclusion in order to achieve steady-state.
* Pregnancy

Primary outcomes:
measure: Withdrawal from rehabilitation.
timeFrame: 24 weeks
measure: Improvement in walking distance
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in vitamin D status.
timeFrame: 52 weeks
measure: Change in calcium metabolic status.
timeFrame: 52 weeks
measure: Change in quality of life.
timeFrame: 52 weeks
measure: Change in status of bone metabolism.
timeFrame: 52 weeks
measure: Change in walking distance.
timeFrame: 52 weeks
measure: Change in fat mass and fat free mass.
timeFrame: 52 weeks
measure: Change in physical activity.
timeFrame: 24 weeks
measure: COPD exacerbations.
timeFrame: 52 weeks
measure: All cause hospital admissions.
timeFrame: 52 weeks
measure: All cause mortality.
timeFrame: 52 weeks.
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital, Department of Respiratory Medicine
city: Hvidovre
country: Denmark
facility: Medical Unit, Hvidovre University Hospital
Study officials:
affiliation: Hvidovre Universityl Hospital
name: Jørgen Vestbo, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03057301: Assessment of Home Tonometry in Glaucoma
Official title: Assessment of Home Tonometry in Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Intraocular Pressure
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2017-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with glaucoma attending a university hospital glaucoma clinic.

Brief summary: Worldwide, glaucoma is the most common cause of irreversible blindness. The major risk factor is raised pressure within the eye (intraocular pressure, IOP). IOP is typically measured using Goldman applanation tonometry (GAT). This involves instilling anaesthetic eye drops and using a probe to contact the cornea and obtain a pressure measurement. A major disadvantage of GAT is that only limited numbers of pressure measurements can be obtained, whereas IOP is known to vary throughout the day and in ¾ of people is highest during the night. The result is that clinicians have poor understanding of patient's 24 hour IOPs and the effect that this might have on their glaucoma. This is a serious limitation as the treatment of glaucoma depends on lowering IOP.

Recently a new device has become available, designed specifically for home IOP monitoring. The iCare HOME tonometer is a CE marked commercial device (http://www.icaretonometer.com/products/icare-home-tonometer/) that can be used to gain insight into 24-hour IOP fluctuations. The investigators wish to determine the feasibility of home IOP monitoring using this device. The iCare HOME tonometer depends on the patient performing self-tonometry. Testing one's own IOP may be technically difficult and it is likely that large numbers of patients will struggle with this.


Eligibility criteria: Inclusion Criteria:

* Glaucoma
* At least 4 previous visual field tests (to enable rate of change to be calculated).
* Age 16 years and above
* Age less than 100

Exclusion Criteria:

* Corneal disease (potentially affects pressure measurements)
* Neovascular glaucoma
* Uveitis
* Secondary glaucomas
* Inability to give informed consent.
* Less than 16 years of age.
* Pregnancy.
* Unable to hold iCare HOME® tonometer due to upper limb weakness or disability.

Primary outcomes:
measure: Whether or not the subject is deemed successful in using the home tonometer
timeFrame: On baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Princess Alexandra Eye Pavilion
state: Midlothian
Study officials:
affiliation: NHS Lothian
name: Andrew J Tatham, FRCOphth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05061667: Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
Official title: Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Thoracic surgery
Postoperative pain
Rhomboid block
Paravertebral block
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to compare thoracic paravertebral block and rhomboid block for postoperative analgesia and analgesic usage in thoracic surgeries.

Detailed description: Patients with scheduled thoracic surgery are going to be enrolled for this study. Patients will be randomized and separated in two groups. Group I will receive thoracic paravertebral block, group II will receive rhomboid block. Each group will receive patient controlled analgesia with intravenous fentanyl. Patients will be monitored at postoperative 1st, 3rd, 6th, 12th, 24th hours and their VAS scores, adverse reactions like nausea and vomiting, total analgesic usage, additional analgesic need and time of the first report of pain will be filed. Then the two groups will be compared and evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for general thoracic surgery
* ASA I-III

Exclusion Criteria:

* Patients without consent
* Emergency surgeries
* Pregnancy
* Coagulopathies and bleeding diathesis
* Allergy to local anesthetics
* Local skin infection at the puncture site

Primary outcomes:
measure: Difference in Visual Analogue Scale (VAS) scores between two groups
timeFrame: 24 hours
measure: Difference in additional analgesic usage between two groups
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence of nausea and vomiting
timeFrame: 24 hours
measure: Patient satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University
Study officials:
References:
citation: Ciftci B, Ekinci M, Atalay YO. Ultrasound-guided rhomboid intercostal block provides effective pain control after video-assisted thoracoscopic surgery: a brief report of three cases. Korean J Anesthesiol. 2021 Aug;74(4):355-357. doi: 10.4097/kja.20538. Epub 2020 Nov 17. No abstract available.
citation: Longo F, Piliego C, Martuscelli M, Tomaselli E, Crucitti P, Longo F, Agro FE. Rhomboid intercostal and subserratus plane block for intubated uniportal video-assisted thoracoscopic surgery lobectomy. J Clin Anesth. 2020 Oct;65:109881. doi: 10.1016/j.jclinane.2020.109881. Epub 2020 May 26. No abstract available.
citation: Longo F, Piliego C. Rhomboid intercostal and subserratus plane block for non-intubated video-assisted thoracoscopic surgery. J Clin Anesth. 2020 May;61:109612. doi: 10.1016/j.jclinane.2019.09.006. Epub 2019 Oct 24. No abstract available.
Clinical trial NCT01244204: Role of Vitamin D in Innate Immunity to Tuberculosis
Official title: Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Tuberculosis
Keywords: vitamin D deficiency
tuberculin sin test
immunity
tuberculosis
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators proposed a pilot study preparatory to developing a randomized trial of vitamin D for the prevention of TB infection. The specific aims are presented below:

1. To recruit subjects, obtain consent, distribute vitamin D supplements to the children in the schools, obtain blood samples and transport them to the United States.
2. To test the hypothesis that daily vitamin D supplementation will increase plasma levels of 25(OH)D, and restore TLR-induced antimicrobial activity in monocytes/macrophages tested in vitro.


Eligibility criteria: Inclusion Criteria:

* Eligible subjects will be children age 12 to 15 years inclusive in public school, located in Songino-Khairhan district, who are residents of Ulaanbaatar, and whose parents have given informed consent and who accent to participate in the study.

Exclusion Criteria:

* Individuals with pre-existing calcium, parathyroid conditions, or type I diabetes, sarcoidosis, or who require chronic diuretic therapy including calcium channel blockers, or who are cognitively impaired.

Primary outcomes:
measure: Serum vitamin D levels
timeFrame: 6 months
measure: Tuberculin Skin Test conversion
timeFrame: 6 monhs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yegorov S, Bromage S, Boldbaatar N, Ganmaa D. Effects of Vitamin D Supplementation and Seasonality on Circulating Cytokines in Adolescents: Analysis of Data From a Feasibility Trial in Mongolia. Front Nutr. 2019 Oct 23;6:166. doi: 10.3389/fnut.2019.00166. eCollection 2019.
citation: Ganmaa D, Giovannucci E, Bloom BR, Fawzi W, Burr W, Batbaatar D, Sumberzul N, Holick MF, Willett WC. Vitamin D, tuberculin skin test conversion, and latent tuberculosis in Mongolian school-age children: a randomized, double-blind, placebo-controlled feasibility trial. Am J Clin Nutr. 2012 Aug;96(2):391-6. doi: 10.3945/ajcn.112.034967. Epub 2012 Jul 3.
Clinical trial NCT06916104: Impact of Respiratory Allergy on Response to Initiation of Biotherapy in Severe Asthma in Adult Severe Asthmatic Patients Followed at Poitiers University Hospital on Biotherapy
Official title: Impact of Respiratory Allergy on Response to Initiation of Biotherapy in Severe Asthma in Adult Severe Asthmatic Patients Followed at Poitiers University Hospital on Biotherapy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Severe Asthma
Biotherapy
Respiratory Allergy
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: severe asthma patients on dual therapy at POITIERS University Hospital

Brief summary: The aim of this study is to take stock of the situation of adult patients with severe asthma on biotherapy, followed up at Poitiers University Hospital, and in particular to increase our knowledge of factors predictive of response to biotherapy. The main aim is to improve the management of adult severe asthma patients treated with biotherapy, according to their allergic status.


Eligibility criteria: Inclusion Criteria:

* Severe asthma patient on biotherapy
* Age \> or = 18 years
* Follow-up at Poitiers University Hospital

Exclusion Criteria:

* Absence of allergological assessment
* Patient's refusal to participate in study

Primary outcomes:
measure: Find out whether a positive respiratory allergy test influences the efficacy of one or more biotherapies
timeFrame: 1 year
Secondary outcomes:
measure: analyze the allergological workup, particularly with regard to common pneumallergens
timeFrame: 1 year
measure: look at the response to the biotherapy used
timeFrame: 1 year
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu Poitiers
Study officials:
References:
Clinical trial NCT01265472: Comparison of Translocator Protein Expression and Binding Activity in Normal Tissue Versus Non Melanotic Malignancy
Official title: Comparison of the Expression Level of Translocator Protein (TSPO) and Binding Activity in Normal Cutaneous Tissue Versus Non Melanotic Cutaneous Malignancy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Squamous Cell Carcinoma
Basal Cell Carcinoma
Keywords: Translocator Protein
Basal Cell Carcinoma
Squamous Cell Carcinoma
Malignancy
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Not an observational study.

Brief summary: Translocator protein (TSPO) is a intracellular protein that is found primarily in the outer membrane of the mitochondria that is encoded by the TSPO gene. It has been found that TSPO expression in the skin correlates with cell proliferation and differentiation. Many studies have shown that TSPO overexpression in solid malignancies such as in ovarian cancer, colon cancer, and others, was also found to correlate with more aggressive cancer behavior. Working Hypothesis and Aims: Previous studies described an aberrant expression of TSPO levels in solid malignancies as compared to normal tissues. It is assumed that this aberration can be found in cuntaneous malignancies as well. The occurrence of this aberration may lead to the understanding of the mechanism of TSPO involment in the cutaneous malignancy, and in malignancies in general. Methods: The study will be carried out on surgically resected skin lesions suspected to SCC or BCC, which will be removed as part of the surgical routine treatment. The excision will be made in elliptic shape including the lesion and a part of normal skin surrounding it. A sample will be taken from the central part of the lesion and from the external extremity of the normal tissue. Western Blot will be conducted to detect the expression of TSPO. Binding activity with the TSPO specific ligandwill also be determined. Expected Results: We expect to observe either (a) a higher level of TSPO expression and a lower binding activity in malignant tissue compared with healthy control tissue or (b) a higher level of TSPO expression and a lower binding activity in malignant tissue compared with healthy control tissue. Importance: Until today, only a very small number of studies have examined TSPO in cutaneous malignancies, and these only examined TSPO expression. Our study will also measure the binding activity of TSPO in cutaneous malignant tissues compared to normal tissues


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Basal Cell Carcinoma or Squamous Cell Carcinoma

Exclusion Criteria:

* Non-compliance with inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05487404: A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels
Official title: A Double-Blind Clinical Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ethanol Intoxication
Keywords: Aldeyra
ADX-629
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Double-Blind Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects between the ages of 21 and 65 years, inclusive, at Screening;
2. Subjects with the ability to obtain transportation to and from the study site;
3. Subjects who agree to abstain from consumption of non-study alcohol during the study.

Exclusion Criteria:

1. Subjects with abnormal laboratory values of clinical significance, at the discretion of the Investigator, at Screening;
2. Subjects with nicotine product use within 14 days prior to Screening until the end of the study;
3. Subjects with any history of or current alcohol or other substance use disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition;
4. Subjects with a positive urine drug screen or breath alcohol test at Screening or Check-In (both treatment periods).

Primary outcomes:
measure: Number of Subjects With Serious Adverse Events
timeFrame: The safety assessment period was approximately two days for each treatment period.
Secondary outcomes:
measure: Change From Baseline of Dermal Flushing
timeFrame: The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.
measure: Change From Baseline for Romberg Test
timeFrame: The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology
state: Ohio
Study officials:
References:
Clinical trial NCT04395404: Structural Orbital Changes in Anophthalmic Socket Syndrome
Official title: Structural Orbital Changes in Anophthalmic Socket Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anophthalmos; Acquired
Anophthalmic Socket Syndrome
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Unilateral anophthalmic socket syndrome (superior sulcus grading 0 till 4)
* Enucleation/evisceration with primary implant more than 5 years ago
* After informed consent

Exclusion Criteria:

* MRI absolute and relative contraindications such as metallic fragments or metallic containing devices,
* history of orbital trauma, previous anophthalmic socket and eyelid surgery, inflammation, infection, buphthalmos, congenital anophthalmos and radiation

Primary outcomes:
measure: Displacement of orbital structures
timeFrame: At least 5 years after enucleation or evisceration
measure: Volumetric orbital difference
timeFrame: At least 5 years after enucleation or evisceration
measure: Surface comparisson of bony orbits
timeFrame: At least 5 years after enucleation or evisceration
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: