louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01785147: Efficacy and Safety of BP1.4979 in Smoking Cessation
Official title: Randomized Placebo Controlled Trial Assessing the Efficacy and Safety of BP1.4979 in Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Addiction
Keywords: Tobacco addition
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled CO (abstinent \< 10 ppm).

Detailed description: BP1.4979 is a novel compound with promising efficacy on smoker which have been assessed on phase I studies.

This is a multicenter,randomized, double blind, placebo controlled, phase IIb trial with parallel group to assess safety and efficacy of BP1.4979 in smoker.

Eligibility criteria: Main inclusion Criteria:

* a smoking history of at least 10 years
* subject smoking at least 15 cigarettes per day at the time being and for at least 30 days before selection.
* having already made at least 2 attempts to stop
* with no period of abstinence \> 3 months in the previous year
* FTND ≥ 7

Main exclusion Criteria:

* any significant psychiatric illness or mood disorder, assessed by the BDI
* HAD scale (A + D ≥ 19, the day of the selection and inclusion)
* AUDIT ≥ 8
* subject smoking cigars or pipes exclusively
* subject taking any antismoking medication and/ or Nicotine Replacement Therapy (NRT) in the previous month.

Primary outcomes:
measure: 4-week prolonged abstinence from smoking cigarettes
timeFrame: 4 weeks
Secondary outcomes:
measure: 7-day tobacco Point Prevalence Abstinence (PPA)
timeFrame: 7 days
measure: Number of adverse events
timeFrame: 26 weeks
measure: Vital signs measures
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Hôpital Paul Brousse
state: Ile de France
Study officials:
affiliation: Hôpital Paul Brousse
name: Henri-Jean AUBIN, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06080347: Effect of Anti-inflammatory Diet in Osteoarthritis
Official title: An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with Osteoarthritis, and the role of microbiome and circulating metabolites.


Eligibility criteria: Inclusion Criteria:

* Unilateral radiographic symptomatic KOA
* No changes in therapy during the previous 3 months
* Interested in dietary intervention and able to provide consent and attend follow-up visits

Exclusion Criteria:

* Previous knee surgery
* Severe radiographic disease (KL grade 4)
* Rheumatoid Arthritis
* Any Abnormal blood values in the comprehensive metabolic panel test at screen (Abnormality will be defined based on standard reference ranges)
* Use of corticosteroids and/or intra-articular injections during the preceding 3 months
* Use of fish oils and glucosamine
* Participation in a weight loss program in the preceding 6 months
* Recent changes in physical activity levels
* Regular smoking
* Patients with food allergies
* Patient with other medical conditions that will impair the ability to participate in a nutritional study
* Plan to change systemic therapy
* Patients unwilling to change dietary habits

Primary outcomes:
measure: Change in Knee Osteoarthritis Pain
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California
state: California
Study officials:
References:
Clinical trial NCT01978847: Retrospective Review of Anterior and Posterior Cervical, Thoracic, and Lumbar Instrumented Arthrodesis Surgeries
Official title: Proposal for Retrospective Review of Anterior&Posterior Cervical, Thoracic, and Lumbar Instrumented Arthrodesis Surgeries Performed at OSU.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Condition
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spinal arthrodesis can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions.

Brief summary: Retrospective review will allow for an evaluation of potential patient- or procedure-related factors that are associated with the development of either radiologic or clinical adjacent-segment pathology.

Detailed description: Spinal arthrodesis can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions. In recent years, the development of more sophisticated segmental instrumentation techniques and hardware has allowed for incorporation of multiple spinal levels in single settings. The long-term consequences for spinal motion segments adjacent to such fusions remain unknown.

The investigators propose to undertake a retrospective case study analysis evaluating both radiologic and clinical parameters indicative of adjacent-segment pathology in patients who have undergone instrumented arthrodesis procedures at Ohio State University, performed by either Dr. Francis Farhadi, James B. Elder, or Gary Rea.

Eligibility criteria: Inclusion Criteria:

* Must have had a Spinal arthrodesis procedure at Ohio State University

Exclusion Criteria:

* NA

Primary outcomes:
measure: The number of patients with radiologic evidence of fusion
timeFrame: 5 years
Secondary outcomes:
measure: The number of patient with clinical evidences of fusions
timeFrame: 5 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State Unviersity
state: Ohio
Study officials:
affiliation: Ohio State University
name: Francis Farhadi, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00368147: Access Creation for Hemodialysis: Association With Structural Changes of the Heart
Official title: Access Creation for Hemodialysis: Potential Contribution to Left Ventricular Remodelling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arteriovenous Fistula
Arteriovenous Graft
Left Ventricular Hypertrophy
Brain Natriuretic Peptide
Keywords: Hemodialysis
Arteriovenous Fistula
Arteriovenous Graft
Left Ventricular Hypertrophy
Brain Natriuretic Peptide
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Kidney Foundation of Canada
First posted: 2006-08-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine if the creation of a fistula or a graft plays a role in the development of heart disease for patients undergoing hemodialysis

Detailed description: Patients with end stage renal disease are at 18-20 times greater risk of dying from cardiovascular disease as the general population. Both traditional and non-traditional cardiovascular risk factors are thought to be important. Of the non-tradtional cardiovascular risk factors, creation of an arteriovenous fistula or graft for the purposes of a blood access for hemodialysis may contribute to an elevation in BNP and left ventricular hypertrophy - both factors that have been associated with an increased risk of mortality Prior to access creation and at one month and one year post access creation - samples for BNP will be collected Prior to access creation and at one year post access creation - echocardiography will be performed

Eligibility criteria: Inclusion Criteria: 1)Hemodialysis 2)high risk for heart failure (DM, age\&gt;50, and/or systolic dysfunction) 3) first arteriovenous fistula/graft 4) informed consent 5) technically adequate echocardiogram 6) stable hgb(\&gt;100) 7) stable mineral metabolism (normal calcium, phosphate \&lt;2.1mmol/L, PTH\&gt;50pmol/L)

Exclusion Criteria: 1)Expected survival \&lt;1 year 2) Expected to get a living donor transplant in one year 3)primary access failure 4) ARF

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Heatlh Network
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Deborah Zimmerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00795847: Morning Hypertension and Preminent Therapy Study
Official title: The Efficacy and Safety of Losartan/Hydrochlorothiazide Combination Drug (Preminent) in Patients With Morning Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertensive patients with morning hypertension
Lead sponsor: Kurume University
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 216
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: It is difficult to control morning hypertension in practical clinical situation. Angiotensin receptor blocker (ARB) and thiazide are suggested to be effective to maintain the antihypertensive effects for 24 hours. However, monotherapy sometimes is not enough to control blood pressure level in the next morning and there are little evidence of the combination therapy for morning hypertension. The investigators hypothesized that a losartan 50 mg/hydrochlorothiazide 12.5 mg combination drug, Preminent, is effective and safe for controling morning hypertension, compared with high-dose of losartan 100 mg, in Japanese. Patients with morning hypertension were randomized to preminent treatment group or high-dose losartan treatment group. The efficacy and safety were compared after 3-month treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of outpatients with morning hypertension (135/85 mmHg)
* Under treatment with any antihypertensive agents

Exclusion Criteria:

* Poorly controlled hypertension (DBP\>120 mmHg)
* Poorly controlled diabetes (HbA1c\>9.0%
* Gout or hyperuricemia (UA\>8.0 mg/dL)
* Serum Cr\>2.0 mg/dL
* Serum K\>5.5 mmol/L
* Liver dysfunction (ALT\>90 IU/L and/or g-GTP\>14o IU/L)
* Secondary hypertension
* Patients who have contraindication for losartan and/or thiazide diuretics

Primary outcomes:
measure: Blood pressure level in the morning by blood pressure self-measurement
timeFrame: 3 months
Secondary outcomes:
measure: Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide
timeFrame: 3 months
Other outcomes:
Locations:
city: Kurume
country: Japan
facility: Cardio-vascular Medicine, Kurume University
state: Fukuoka
Study officials:
affiliation: Kurume University
name: Tsutomu Imaizumi, MD, PhD
role: STUDY_CHAIR
affiliation: Kurume University
name: Hisashi Kai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01200147: Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation
Official title: Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dysphagia
Schatzki Ring
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dysphagia is a common reason for referal to the investigators Gastoenterology service. As many as 14% of patients undergoing radiological studies for dysphagia are found to have schatzki rings. Current recommendations for treatment of patients with symptomatic Schatzki rings are based on ancedotal experience and uncontrolled studies. The only randomized study on comparison of techniques the investigators were able to locate was published in 2000 and included only 26 patients. This study demonstrated that the biopsy techinque was as effective as and better tolerated than the standard dilation technique. Considering that the cost and time required for dilatation is greater than the basic biopsy technique, significant cost savings could be achieved using the biopsy technique. As well, patient satisfaction is an important factor considering that Schatzki rings can recur and repeated endoscopy is often required. Therefore, a study that shows a technique to be as or better than the current standard in effectiveness, cost, time, and patient comfort could lead to shift in current practice.

Detailed description: None available, study was withdrawn

Eligibility criteria: Inclusion Criteria:

* Presenting to endoscopy unit with symptoms of dysphagia or known history of schatzki ring

Exclusion Criteria:

* Prior esophageal or gastric surgery, severe esophagitis, coagulopathy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: VG Hospital-Capital District Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Mark McMillan, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00417547: Comparison of Body Dissatisfaction Among Islamic Veil Practicing (IVP), Non-Complete IVP, and Inconsiderate to IVP Women
Official title: Comparison of Body Dissatisfaction Among Islamic Veil Practicing (IVP), Non-Complete IVP, and Inconsiderate to IVP Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Body Dissatisfaction
Obesity
Eating Disorders
Keywords: Self Concept
Eating Disorder
Body Mass Index
Dressing
Islamic Veil
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institutes of Health (NIH)
First posted: 2007-01-01
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes

Brief summary: The aim of this research is to examine the social, psychological and Islamic veil practicing (IVP), non-complete IVP and Inconsiderate to IVP correlates of body mass index (BMI) status in a women population. It is hypothesized that women who are IVP would differ on depression, and social variables compared with their non-practicing peers.

Detailed description: In this cross-sectional study, a population-based sample of 1774 female responded anonymously to an aerobic health club administered questionnaire. Body mass index was calculated from height and weight and categorized into four classes of underweight, normal, overweight, and obese. The questionnaire also included questions about social experiences, body dissatisfaction as Body Shape Questionnaire (BSQ), future goals and Islamic Veil Practicing (IVP). Persian version of Beck Depression Inventory (BDI-II Persian) and Rosenberg Self Esteem Scale was also distributed among six groups of women having IVP/regular exercise (RE), IVP/non-RE, Non-complete IVP/RE, Non-complete IVP/non-RE, Inconsiderate to IVP/RE, and Inconsiderate to IVP/non-RE. Correlations of BMI with social, psychological, future goals and IVP were explored

Eligibility criteria: Inclusion Criteria:

* Open for all women practicing Islamic veil, Non-complete IV, or Inconsiderate to IV

Exclusion Criteria:

* Overt signs of Anorexia Nervosa, Bulimia Nervosa

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Aerobic Health Clubs
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: REZA RASTMANESH, Ph.D.
role: STUDY_CHAIR
References:
citation: Rastmanesh R, Gluck ME, Shadman Z. Comparison of body dissatisfaction and cosmetic rhinoplasty with levels of veil practicing in Islamic women. Int J Eat Disord. 2009 May;42(4):339-45. doi: 10.1002/eat.20613.
Clinical trial NCT00292747: Drotaverine in Dysmenorrhoea Treatment
Official title: Comparison of the Efficacy and Tolerability of Drotaverine 80 mg, Ibuprofen 400 mg and Their Combination in a Calendar Packaging for the Treatment of Primary and Secondary Dysmenorrhoea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Dysmenorrhea
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-16
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered alone, in the treatment of primary and secondary dysmenorrhoea.


Eligibility criteria: Inclusion Criteria:

* History of at least 6 months of dysmenorrhea, with presence of moderate to severe pain in each of the last 3 cycles
* With regular menstrual cycles (25-35 days)
* Using an adequate barrier contraception method (except for virgins)

Exclusion Criteria:

* Evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
* Proven hypersensitivity to drotaverine hydrochloride or ibuprofen or proven intolerance to lactose
* Any described contraindication to either drotaverine hydrochloride or ibuprofen (see Summary of Product Characteristics)
* Oestro-progestative contraception within the last 2 months
* Regular use of sedative, hypnotics, tranquillizers or any other addictive agents
* History or evidence of acute or chronic alcohol abuse
* Heavy smoking (\> 10 cigarettes/day)
* Need of a permanent treatment with other antispasmodics and/or analgesic agents during the trial
* Lactation
* Pregnancy
* Participation in another clinical trial in the last 3 months prior to the start of this study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi-aventis, Hungary
name: László Erős, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04898647: Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
Official title: Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperviscosity Syndrome
Waldenstrom Macroglobulinemia
Keywords: Hyperviscosity Syndrome
Waldenstrom Macroglobulinemia
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Saint Vincent
name: Centre Henri Becquerel
name: University Hospital, Caen
name: University Hospital, Lille
name: Centre Hospitalier de Lens
First posted: 2021-05-24
Enrollment: 100
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: Walsdenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. Clinical manifestations of the hyperviscosity syndrome (HVS) are related to the large amount of IgM in circulating blood or to some physicochemical characteristics such as the presence of a cryoglobulin property. Although HVS is one of the most frequent criteria for initiating therapy in WM, few studies focused on its description and no diagnostic criteria are available.

The present study aims to identify a diagnostic system for HVS, taking into account objective symptoms such as bleedings, fundoscopic findings and also subjective symptoms such as fatigue and comorbidities that may influence the severity of symptoms.


Eligibility criteria: Inclusion Criteria:

* Patient with WM
* Patients that may require a first-line or subsequent-line therapy
* patients who will require treatment initiation
* patients with serum monoclonal component concentration greater than 15 g/L and who will underwent hyperviscosity assessment, even if hyperviscosity is not found and in the absence of other treatment criteria, no treatment is finally initiated.
* Patients agreeing to give informed consent.

Exclusion Criteria:

* Patients with another chronic B-cell malignancy
* patients with lymphoplasmacytic proliferations
* patients with marginal zone lymphoma.
* patients with WM and histologic transformation
* Absence of informed consent.

Primary outcomes:
measure: Correlation between items collected in questionnaires and HVS detection
timeFrame: 3 years
measure: Correlation between fundoscopic findings and HVS detection
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: