louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01300754: Effectiveness of Dextrose Injection for Osgood-Schlatter Disease
Official title: Phase 2 Study of Dextrose Injection for Sport-Limiting Osgood Schlatter Disease in Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osgood-Schlatter Disease
Keywords: Osgood-Schlatter
Tendinosis
Apophysitis
Enthesopathy
Dextrose.
Lead sponsor: Universidad Nacional de Rosario
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 54
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To examine the potential of dextrose injection versus lidocaine injection versus supervised usual care to change pain/function/activity levels in adolescent athletes with Osgood-Schlatter Disease (OSD).

Detailed description: Patients and methods: Girls ages 9-15 years old and boys ages 10-17 years old will be assigned to either therapist-supervised usual care, or to double-blind injection of 1% lidocaine solution with or without 12.5% dextrose. Injections will be administered monthly for three months. All subjects will then be offered dextrose injections monthly as needed. Change in the Nirschl Pain Phase Scale (NPPS) will serve as the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

* Age:9-15 year old girls and 10-17 year old boys
* Pain Location: Anterior knee.
* Sport Type: Jumping or kicking sport.
* Team Member with Coach: Member of and organized team with a coach.
* Imitation of exact pain and precise location to the tibial tuberosity with a single leg squat.
* At least 2 months of formal and gently progressive hamstring stretching, quads strengthening, and gradual sports reintroduction.
* Pain with sport at least 3 months.

Exclusion Criteria:

* Patellofemoral crepitus
* Patellar origin tenderness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Hospital Provincial de Rosario
state: Santa Fe
Study officials:
affiliation: Hospital Provincial de Rosario
name: Gaston A Topol, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Topol GA, Podesta LA, Reeves KD, Raya MF, Fullerton BD, Yeh HW. Hyperosmolar dextrose injection for recalcitrant Osgood-Schlatter disease. Pediatrics. 2011 Nov;128(5):e1121-8. doi: 10.1542/peds.2010-1931. Epub 2011 Oct 3.
Clinical trial NCT00450554: Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac
Official title: EVALUATION DE LA REPONSE IMMUNITAIRE CONTRE LA SOUCHE DE NEISSERIA MENINGITIDIS B:14,P1.7,16
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccination
Keywords: Neisseria meningitidis B:14, P1-7, 16
Serum bactericidal activity
Menbvac
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 236
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville

Brief summary: The main objective of the study is to estimate the proportion of children, born between the 01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (\>= 4), before and after the third MenBvac vaccination.


Eligibility criteria: Inclusion Criteria:

* children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated twice by MenBVac
* parental authority(ies)assent

Exclusion Criteria:

* no parental authority(ies)assent
* no blood sample during the third vaccination
* impossibility of third vaccination

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: UH-rouen
state: Seine Maritime
Study officials:
affiliation: Service des Maladies Intectieuses et Tropicales
name: CARON François, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01586754: Subclinical Organ Damage in Overweight and Obese Patients: Does Presence of Metabolic Syndrome Matter?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Subclinical Organ Damage
Overweight
Obese
Keywords: metabolic syndrome
obesity
endothelial damage
homocysteine
microalbumin
carotis intima-media thickness
Lead sponsor: Goztepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese or overweight patients, aged between 18-80 who are non-smokers, with a GFR \> 60 ml/min and without any history of diabetes (insulin dependent or non-insulin dependent), coronary artery disease or peripheral arterial disease, attending to hyperlipidemia and obesity outpatient clinic.

Brief summary: Microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic and randomized clinical trials. Carotis intima-media thickness is also found to be elevated in early stages of atherosclerosis. Recent studies have shown correlations between homocysteine, microalbumin levels and carotis intima-media thickness in type 2 diabetics but no data exists for obese or overweight patients who also have metabolic syndrome, in terms of markers of subclinical organ damage. Since obesity is a risk factor for cardiovascular disease and since it is known that patients with metabolic syndrome are at higher risk of cardiovascular events, the investigators wanted to examine whether there is an association between homocysteine, microalbumin levels and carotid intima-media thickness in patients with or without metabolic syndrome, who are either overweight or obese.


Eligibility criteria: Inclusion Criteria:

1. 18-80 years
2. BMI \>= 25
3. Ex or non-smokers (must have quit smoking at least 5 years ago)

Exclusion Criteria:

1. NIDDM or IDDDM
2. Nephropathy (GFR \< 60 ml/min), previous history of coronary artery disease or peripheral arterial disease
3. Current smokers
4. Active infection or other acute illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Goztepe Training and Research Hospital
Study officials:
affiliation: Istanbul Medeniyet University Goztepe Training and Research Hospital
name: ESRA EKIZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06299254: Placebo Effect About Fatigue in Obesity
Official title: The Modulation of Individual Level of Fatigue Through Placebo Effect in Obesity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: placebo effect
fatigue
motivation
physical abilities
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: University of Turin, Italy
First posted: 2024-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital

Brief summary: Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels.


Eligibility criteria: Inclusion criteria:

• Right-handed diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).

Exclusion criteria:

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders

Primary outcomes:
measure: Behavioural outcome of fatigue
timeFrame: baseline
Secondary outcomes:
measure: The individual level of perceived fatigue
timeFrame: baseline
Other outcomes:
Locations:
city: Piancavallo
country: Italy
facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
state: VCO
Study officials:
References:
Clinical trial NCT00219154: A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazidebased Treatment Regimen With Optional Addition of Amlodipine
Official title: A Twenty Six-week, Randomized, Double-blind, Parallel Group, Multicenter, Active Controlled, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 1125
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 study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension.


Eligibility criteria: Inclusion Criteria:

-Patients with essential hypertension

Exclusion Criteria:

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of myocardial infarction. Other protocol-defined inclusion exclusion criteria also apply

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after 26 weeks
Secondary outcomes:
measure: Change from baseline systolic blood pressure after 26 weeks
measure: Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 26 weeks
measure: Achieve blood pressure of < 140/90 mmHg after 26 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Schmieder RE, Philipp T, Guerediaga J, Gorostidi M, Smith B, Weissbach N, Maboudian M, Botha J, van Ingen H. Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide. Circulation. 2009 Jan 27;119(3):417-25. doi: 10.1161/CIRCULATIONAHA.107.750745. Epub 2009 Jan 12.
Clinical trial NCT00440154: A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,Ezetimibe-Calibrated, Multicenter Study Evaluating the Safety and Efficacy of Four Doses and Two Dose-Regimens of AVE5530 Over 4 Weeks in Patients With Mild to Moderate Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-02-26
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma levels and the safety and tolerability of AVE5530.


Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate primary hypercholesterolemia with stabilized LDL-C baseline ≥130 mg/dL and ≤ 250 mg/dL (≥ 3.36 mmol/L and ≤ 6.46 mmol/L)
* Male aged ≥ 18 years or postmenopausal women at screening

Exclusion Criteria:

* Presence of any clinically significant endocrine disease known to influence serum lipids or lipoproteins
* Patients with type 1 diabetes
* Presence or history of cancer within the past five years
* Triglycerides ≥ 300 mg/dL (3.39 mmol/L)
* Fasting plasma glucose \> 160 mg/dL (8.9 mmol/L)
* Impaired kidney function and active liver disease
* Within one month prior to screening visit and/or at the time or after the screening visit, administration of any lipid lowering treatment
* Creatine Kinase \> 2xUpper Limit of Normal range

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

Primary outcomes:
measure: Percent change in LDL-C from baseline
timeFrame: 4 weeks
Secondary outcomes:
measure: Absolute change from in LDL-C levels
timeFrame: 4 weeks
measure: Percent change in other lipids and lipoprotein fractions from baseline
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-Aventis Administrative Office
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04307654: Lactate and Complications in Cytoreduction Surgery for Peritoneal Carcinomatosis
Official title: Evaluation of the Relationship Between Lactacidemia and Postoperative Complications After Cytoreduction Surgery for Peritoneal Carcinomatosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactacidemia and Complications
Keywords: lactic acid
Cytoreductive surgery
postoperative complications
Lead sponsor: Hospital General Universitario de Castellón
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with peritoneal carcinomatosis who underwent cytoreduction surgery in the Multidisciplinary Unit of Abdomino-Pelvic Oncology Surgery (MUAPOS) of the University General Hospital of Castellón

Brief summary: Serum lactate is a risk factor for postoperative complications in patients undergoing cytoreduction surgery in peritoneal carcinomatosis

Detailed description: Background. Cytoreduction surgery has been developed as a treatment of peritoneal carcinomatosis. However, this surgery is associated with important complications. The present study attempts to assess the relationship between lactacidemia levels and the rate of associated complications in patients undergoing cytoreduction surgery during the immediate postoperative period in a critical unit.

Methods. Retrospective observational study. 57 patients underwent cytoreduction surgery during the years 2014 and 2015 at the General University Hospital of Castellón. All patients were admitted to the critical unit immediately after surgery. Lactacidemia levels at the time of admission and discharge from the critical unit were collected. Post-surgical complications that appeared during the stay in the critical unit were recorded and classified according to the Clavien-Dindo classification.

Lactacidemia levels were still significantly higher in this group at the time of discharge.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with peritoneal carcinomatosis who underwent cytoreduction surgery in the Multidisciplinary Unit of Abdomino-Pelvic Oncology Surgery (MUAPOS) of the University General Hospital of Castellón.

Exclusion Criteria:

* patients without lactic acid levels in the register.

Primary outcomes:
measure: Postoperative complications
timeFrame: 2014-2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00405054: A Phase II Study of MK0457 in Patients With T315I Mutant CML and Ph+All (0457-008)
Official title: A Phase II Study of MK0457 in Patients With T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leukemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate MK0457 in patients with chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Efficacy and safety will be evaluated.


Eligibility criteria: Inclusion Criteria:

* This study will evaluate MK0457 in patients with CML (chronic myelogenous leukemia) and Ph+ALL (Philadelphia chromosome-positive acute lymphoblastic leukemia)
* Patients must have adequate organ function
* Patients must have documented T315I mutation

Exclusion Criteria:

* Patients within 3 months of allogeneic bone marrow transplant or not fully recovered from previous anti-leukemia therapy
* Patients with uncontrolled congestive heart failure
* Patients with active or uncontrolled infection or active Hepatitis B or C
* Patients with known HIV positivity or AIDS related illness
* Patients with currently active second malignancy, other than non-melanoma skin cancer.

Primary outcomes:
measure: efficacy
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Seymour JF, Kim DW, Rubin E, Haregewoin A, Clark J, Watson P, Hughes T, Dufva I, Jimenez JL, Mahon FX, Rousselot P, Cortes J, Martinelli G, Papayannidis C, Nagler A, Giles FJ. A phase 2 study of MK-0457 in patients with BCR-ABL T315I mutant chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia. Blood Cancer J. 2014 Aug 15;4(8):e238. doi: 10.1038/bcj.2014.60.
Clinical trial NCT00776854: Bioburden Reduction of Diabetic Foot Ulcer
Official title: Noveon Laser Treatment to Effect Bioburden Reduction or Elimination in Diabetic Foot Ulcer: A Davice Performance Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetic Foot Ulcer
Lead sponsor: Nomir Medical Technologies
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer


Eligibility criteria: Inclusion Criteria:

* 18 and older
* Diabetic foot ulcer
* MRSA positive

Exclusion Criteria:osteomylelitis pregnancy allery to e mycin

-

Primary outcomes:
measure: Decrease of Bioburden Effect In diabetic Foot Ulcer
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Nomir Medical
state: Massachusetts
Study officials:
References:
Clinical trial NCT04713254: Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men
Official title: Interventional, Open-label, One-sequence Study to Investigate the Effects of Lu AG06466 on the Pharmacokinetics of the Cytochrome P450 Substrates Midazolam (CYP3A4), Bupropion (CYP2B6), and Metoprolol (CYP2D6) in Healthy Young Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of repeated doses of the drug Lu AG06466 on the exposure of metoprolol, midazolam and bupropion

Detailed description: On Day 1, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK sampling will be performed for 48 hours.

On Day 3, bupropion will be dosed as a single oral dose and PK sampling will be performed for 48 hours.

On Days 5-18, subjects will be dosed with Lu AG06466 once daily.

On Day 15, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK sampling will be performed for 48 hours.

On Day 17, bupropion will be dosed as a single oral dose and PK sampling will be performed for 48 hours.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of 18.5 to 30 kg/m2 (inclusive) at the Screening and Baseline Visits

Exclusion Criteria:

* The subject has any concurrent disorder that may affect the pharmacological target or absorption, distribution, or elimination of the investigational medicinal product.

Other in- and exclusion criteria may apply

Primary outcomes:
measure: AUC 0-inf for midazolam
timeFrame: Day 1 and Day 15
measure: AUC 0-inf for metoprolol
timeFrame: Day 1 and Day 15
measure: AUC 0-inf for bupropion
timeFrame: Day 3 and Day 17
measure: Cmax for midazolam
timeFrame: Day 1 and Day 15
measure: Cmax for metoprolol
timeFrame: Day 1 and Day 15
measure: Cmax for bupropion
timeFrame: Day 3 and Day 17
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Dallas CRU
state: Texas
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: