louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02070133: Efficacy of Simvastatin for the Treatment of COPD
Official title: Pilot Study on the Efficacy of Statins for the Treatment of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Bronchitis
Statins
Endothelial dysfunction
Systemic inflammation
BODE index
Uric acid
Vascular growth factors
Lead sponsor: Hospital Universitari Son Dureta
Sponsor class: OTHER
Collaborators: name: Fundació d'investigació Sanitària de les Illes Balears
name: Cimera
First posted: 2014-02-25
Enrollment: 18
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate in patients with stable Chronic Obstructive Pulmonary Disease (COPD) the efficacy of statins (simvastatin) on: (1) endothelial function; (2) systemic inflammation; (3)BODE (B: body mass , O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index; (4) Uric acid; and, (5)vascular growth factors. Design: a 12 weeks randomized (1:1), double-blind, placebo control study. Population: 18 males with stable COPD between 40-80 years of age, exsmokers, with Forced expiratory volume in one second (FEV1) between 30 and 80% predicted post-bronchodilation.


Eligibility criteria: Inclusion Criteria:

* Stable COPD between 40-80 years of age, exsmokers, with FEV1 lower that 80% predicted post-bronchodilation.

Exclusion Criteria:

* Severe co-morbidity (advanced-stage cancer, tuberculosis affecting more than a third of the total lung parenchyma, pneumonectomy, pneumoconiosis, left cardiac failure previously reported, known cardiopathy with ventricular dysfunction (ejection fraction \< 45%) or any cardiovascular disease, Diabetes Mellitus treated with insulin, Hypercholesterolemia, Chronic inflammatory diseases (asthma, rheumatoid arthritis, lung fibrosis, autoimmune diseases), Treatment with systemic steroid, non steroidal anti-inflammatory drugs or stains within 3 months prior to inclusion.

Primary outcomes:
measure: Endothelial Dysfunction (Arterial Stiffness)
timeFrame: Day 1 and day 84 (end of of week 12)
Secondary outcomes:
measure: Systemic inflammation
timeFrame: Day 1 and day 84 (end of of week 12)
measure: BODE index
timeFrame: Day 1 and day 84 (end of of week 12)
measure: Uric acid
timeFrame: Day 1 and day 84 (end of of week 12)
measure: Vascular growth factors
timeFrame: Day 1 and day 84 (end of of week 12)
Other outcomes:
Locations:
city: Bunyola
country: Spain
facility: Fundacio Caubet-CIMERA
state: Illes Balears
city: Palma Mallorca
country: Spain
facility: Hospital Son Espases
state: Illes Balears
Study officials:
affiliation: Hospital Son Espases, Palma Mallorca
name: Ernest Sala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01022333: The Potential for Oral Diindolylmethane (DIM) Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers
Official title: The Potential for Oral DIM Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Cancer
Keywords: BRCA1
breast cancer
3,3'-di-indolylmethane
dietary intervention
estrogen metabolites
mRNA expression
BRCA1 protein
Estrogen
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: BioResponse
First posted: 2009-12-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Women with a BRCA1 mutation face a lifetime risk of breast cancer of approximately 70% and a lifetime risk of ovarian cancer of approximately 40%. A number of potential anti-cancer nutrients have been proposed, however, it is important that diet supplements be evaluated prior to general recommendation.

The risk of breast and ovarian cancer in carriers of a BRCA1 mutation might be lowered by some nutritional supplements. For example, green tea, broccoli and vitamin D are of potential interest. One dietary supplement that is thought to have potential for BRCA1 carriers is diindolylmethane (DIM), which is an active ingredient in broccoli and other green vegetables. DIM - is found in vegetables like broccoli and is available as a supplement in health food stores. The investigators think that DIM may increase the production of the normal copy of BRCA1 and offset the effect of the mutation.

The purpose of this study is to determine that there is a potential for oral DIM supplementation to result in the increased production of the BRCA1 protein in BRCA1 mutation carriers. The results of the study will also serve as an evaluation of the current use and success of preventive strategies for BRCA1 mutation carriers.


Eligibility criteria: Inclusion Criteria:

* Carriers of a mutation in the BRCA1 gene
* Non-carriers of a mutation in the BRCA1 gene who come from a family with a BRCA1 mutation (a family in which at least one individual has tested positive for a BRCA1 mutation)
* Can participate after being free of DIM supplementation for one month

Exclusion Criteria:

* Have a personal history of cancer
* Currently pregnant or breast-feeding

Primary outcomes:
measure: Oral DIM supplementation increases BRCA1 mRNA expression and hence BRCA1 protein in women with a BRCA1 mutation
timeFrame: 6 months
Secondary outcomes:
measure: Oral DIM supplementation causes favorable estrogen metabolism in women with a BRCA1 mutation
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Familial Breast Cancer Research Unit, Women's College Research Institute
state: Ontario
Study officials:
affiliation: Women's College Research Institute
name: Steven A Narod, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05547633: Detection and Management of Sinusitis in a Single-center Prospective Cohort of Patients with Exudative AMD (SINE)
Official title: Detection and Management of Sinusitis in a Single-center Prospective Cohort of Patients with Exudative AMD (SINE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AMD
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2022-09-21
Enrollment: 200
Sex: ALL
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: Patients followed at The Rothschild Hospital Foundation hospital for neovascular AMD receiving at least 6 intravitreal injections/year in at least one eye over the past 2 years.

Brief summary: An inflammatory component associated with AMD has been highlighted by genetic associations of predisposition to AMD, as well as by the recently demonstrated link between AMD and periodontitis.

Some patients followed at the Fondation Adolphe de Rothschild Hospital for wet AMD seemed to show an improvement of neovascular activity (less need for intravitreal injections of anti-VEGF) after treatment of their sinusitis.

The investigators would therefore like to assess the link between AMD and sinusitis, an infection close to the site of AMD.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient followed and treated for at least 2 years for bilateral neovascular form of age-related macular degeneration (AMD)
* At least one eye treated with ≥ 6 intravitreal injections during the year preceding preinclusion
* Express consent to participate in the study
* Affiliated with or beneficiary of a social security plan

Exclusion Criteria:

* Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, minors, and persons under legal protection: guardianship or curatorship).
* Severe myopia (\> 6 diopters)
* Patient already being treated for acute or chronic sinusitis
* History of central serous chorioretinopathy or diffuse retinal epitheliopathy

Primary outcomes:
measure: Estimate the prevalence of sinusitis in patients with bilateral multi-injected neovascular AMD (≥ 6 intravitreal injections per year in at least one eye)
timeFrame: Day 0
Secondary outcomes:
measure: To compare, between patients screened and managed for sinusitis and those not requiring treatment for sinusitis, the evolution of the number of intravitreal injections
timeFrame: Month 15
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschild
Study officials:
References:
Clinical trial NCT01430533: Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
Official title: A Randomized, Double-blind, Vehicle Controlled Phase 1 Dermal Safety Study to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: dermal sensitization potential
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2011-09-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.

Detailed description: In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* male or female subjects
* aged 18 - 65 years
* ability to understand and fulfill the study requirements

Exclusion Criteria:

* affected skin in designated test area
* pregnancy or lactation
* not willing to comply with study requirements

Primary outcomes:
measure: skin sensitization reaction
timeFrame: day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Robert I. Cooper, MD
state: North Dakota
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00199433: A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients
Official title: A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Movement Disorder Syndrome
Keywords: Parkinson's Disease
Movement Disorder
Neurology,
Clinical Trial
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin Co., Ltd.
First posted: 2005-09-20
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.

Detailed description: Parkinson's disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures. Current therapeutic approaches include dopamine replacement and the use of dopamine receptor agonist drugs. These therapies are effective but may be associated with unwanted complications like wearing off phenomena and involuntary abnormal movements (dyskinesia). Istradefylline may provide a nondopaminergic approach to the treatment of Parkinson's disease.

This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinson's disease with placebo.

Eligibility criteria: Inclusion Criteria:

1. Early PD by UKPDS criteria
2. Mild to moderate difficulty daily activities
3. Females: Either postmenopausal or willing to use adequate contraception

Exclusion Criteria:

1. Unable to discontinue current PD medication
2. Exposure to Levodopa for more than 1 month
3. Symptoms that may suggest a diagnosis other than Parkinson's disease
4. Medical conditions and/or abnormal laboratory findings which preclude participation including cancer in the last 5 years, a history of drug abuse/dependence, abnormal cognitive status, a history of seizures, neuroleptic malignant syndrome, psychosis, or abnormal liver function tests

Primary outcomes:
measure: Change from baseline in the UPDRS subscale III at endpoint.
Secondary outcomes:
measure: Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.
measure: Safety:
measure: Exam
measure: vitals
measure: weight
measure: ECG
measure: laboratory tests and adverse events
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Kyowa Pharmaceutical Inc.
state: New Jersey
Study officials:
affiliation: Kyowa Kirin, Inc.
name: Neil Sussman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05092633: Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement
Official title: Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance
Keywords: Miniscrew
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT

Detailed description: Miniscrews can achieve good anchorage for different types of tooth movements, as intrusion, retraction, and protraction. However, obtaining primary stability is a challenge in their clinical application.Low Level Laser Therapy is suggested to prevent miniscrew displacement. Also previous studies concluded that Low Level Laser Therapy has an effect in stabilizing miniscrew after direct application.

So the aim of this study is to assess the effect of Low Level Laser Therapy on displacement of miniscrews during canine retraction.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 22 years old.
* Permanent dentition.
* Class I Bimaxillary protrusion and class II devision 1 patients.
* Good oral hygiene.

Exclusion Criteria:

* Medically compromised patients.
* Chronic renal failure and hormonal disorders as thyroid and parathyroid.
* Regular use of steroids, barbiturates, anticonvulsants drugs, and thyroid hormone replacements.
* Tobacco smoking.
* Any disease or metabolic disorder that can affect bone physiology

Primary outcomes:
measure: effect of low level laser therapy on displacement of miniscrews
timeFrame: 4 months
Secondary outcomes:
measure: effect of LLL application on gingival condition around the miniscrew.
timeFrame: 4 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
city: Alexandria
country: Egypt
facility: AlexandriaU
Study officials:
affiliation: Alexandria University
name: Mohamed A Elzoheiry
role: STUDY_DIRECTOR
References:
Clinical trial NCT05711433: Risk Factors for Postoperative Pancreatic Fistula Following Non-traumatic Pancreatic Surgery. Retrospective Observational Study.
Official title: Risk Factors for Postoperative Pancreatic Fistula Following Non-traumatic Pancreatic Surgery. Retrospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Neoplasm
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-02-03
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective observational study was conducted in the surgical unit of Zagazig university hospital from July 2014 to July 2019. Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.

Brief summary: Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.

Detailed description: Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. POPF incidence and risk factors vary.

A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.

Eligibility criteria: Inclusion Criteria:

* \> 18 years,
* both sexes,
* respectablee pancreaticoduodenal tumors, or chronic pancreatitis

Exclusion Criteria:

* \<18 years,
* Patients who underwent total pancreatectomies,
* Patients discovered intraoperatively to be fixed to portal vein or superior mesenteric artery, traumatic pancreatic surgeries, postoperative associated gastric or biliary leak, pancreaticoduodenal cancers infiltrating the colon, stomach or liver.

Primary outcomes:
measure: incidence of postoperative pancreatic fistula
timeFrame: 3.5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03268733: The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome
Official title: The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Polycystic Ovary Syndrome
Keywords: Folic acid
PCOS
Insulin resistance
Infertility
Lead sponsor: University of Khartoum
Sponsor class: OTHER
Collaborators: name: Awad, Mohamed Ibrahim, M.D.
name: Duria abdulwahab Elrrayes
First posted: 2017-08-31
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open trial
Primary purpose: TREATMENT

Brief summary: An open clinical trial

Detailed description: The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number will receive no folic acid

Eligibility criteria: Inclusion Criteria:

* Patients who will visit this centre suffering from PCOS-related subfertility will be invited to be enrolled to this study if met the Rotterdam criteria for the diagnosis of PCOS

Exclusion Criteria:

* The patients whom will be excluded from the study are those comorbid with hyperprolactinemia, congenital adrenal hyperplasia, diabetes mellitus, significant cardiovascular problems, thyroid dysfunctions, unresolved medical conditions, or using medications suspected to affect reproductive or metabolic functions within two months of the study entry.

Primary outcomes:
measure: pregnancy rates
timeFrame: 3 months
measure: Ovulatory pattern improvements
timeFrame: 3 months
measure: Clinical signs of hyperandrogenemia
timeFrame: 3 months
Secondary outcomes:
measure: Plasma level of testosterone
timeFrame: 3 months
measure: Plasma level of insulin
timeFrame: 3 months
measure: Plasma level of follicle-stimulating hormone (FSH)
timeFrame: 3 months
measure: Plasma level of luteinizing hormone (LH)
timeFrame: 3 months
Other outcomes:
measure: Lipid profile
timeFrame: 3 months
measure: Plasma level of random glucose
timeFrame: 3 months
measure: Plasma level of folate
timeFrame: 3 months
measure: Plasma level of homocysteine (Hcy)
timeFrame: 3 months
measure: Plasma level of hemoglobin (Hb)
timeFrame: 3 months
measure: Plasma level of C-reactive protein (CRP)
timeFrame: 3 months
Locations:
city: Khartoum
country: Sudan
facility: Saad Abul ella fertility Centre
Study officials:
affiliation: University of Khartoum
name: Mohammed Hassan Alnazeer
role: STUDY_CHAIR
References:
Clinical trial NCT02025933: Project Healthy Eating in Children. A Study on the Health Effects of Fish Intake in Overweight Children
Official title: Title in Norwegian: Ung og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Barn.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
Keywords: Children
Age 9-12 years
Overweight (iso-BMI > 25)
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: The Fisheries and Aquaculture Industry Research Fund
First posted: 2014-01-01
Enrollment: 25
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cildren aged 9-12 years are invited to participate in the study. The children must be healthy and not use prescription medications that affects lipid metabolism, glucose regulation or the immunesystem.

Brief summary: It has previously been seen that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. In this project the investigators will investigate whether increased intake of fish or meat improve metabolic health in children aged 9-12 years as well when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in children as measured by glucose tolerance, lipid metabolism and inflammatory markers.


Eligibility criteria: Inclusion Criteria:

* overweight (iso-BMI \> 25)
* 9-12 years
* healthy

Exclusion Criteria:

* diagnosed diseases such as diabetes, CVD, intestinal diseases, arthritis
* prescription medications affecting the metabolism of glucose, lipids or the immune system
* use of supplements containing long chain n-3 fatty acids
* high intake of fish
* food allergy

Primary outcomes:
measure: Changes in metabolic status (glucose, lipids, inflammation)
timeFrame: Baseline and end of intervention period (12 weeks)
Secondary outcomes:
measure: Body composition
timeFrame: Baseline and end of intervention (12 weeks)
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
Study officials:
affiliation: University of Bergen
name: Oddrun A Gudbrandsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: