louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06317675: Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease
Official title: Osteopathic Manipulative Treatment for Patients Affected by Symptoms Related to Gastro-oesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastro-oesophageal Reflux Disease
Keywords: GERD
Osteopathic manipulative treatment
OMT
Manual therapy
Lead sponsor: Studio Osteopatico Busto Arsizio
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)


Eligibility criteria: Inclusion Criteria:

* Retrosternal burning sensation and/or regurgitation
* Diagnosis of reflux with any methodology
* Duration of symptoms for more than 3 months
* Taking short or long-term proton pump inhibitors (as needed, treatment start date and expected end date, mg, drug name)
* With or without esophagitis
* With or without hiatal hernia
* With or without helicobacter pylori
* GERDQ questionnaire \> 8 points

Exclusion Criteria:

* neoplastic pathologies
* patients who have undergone surgery for GERD
* systemic pathologies (rheumatic, infectious conditions, feverish state, vascular alterations, endocrine diseases including diabetes, metabolic and neoplastic syndromes),
* patients already undergoing manipulative therapy for reflux
* patients with active gastric ulcers
* congenital or acquired immune diseases
* allergic state of any kind
* pregnancy
* use of intrauterine device
* patients undergoing corticosteroid therapy
* patients already subjected to manual/respiratory therapy in the last 3 months

Primary outcomes:
measure: Mean change in GERD-HRQL
timeFrame: At week 2, 4 an 8.
measure: Adverse effects
timeFrame: At week 2, 4 and through study completion (8 weeks)
Secondary outcomes:
measure: Exercise adherence
timeFrame: through study completion (8 weeks)
measure: Change in drugs use
timeFrame: At week 2, 4 and 8.
Other outcomes:
Locations:
city: Saronno
country: Italy
facility: CTFO
state: Varese
Study officials:
References:
Clinical trial NCT00080275: Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
Official title: An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: Niacin
Statin
Zocor
Simvastatin
Coronary Heart Disease
Dyslipidemia
Atherosclerosis
Hypercholesterolemia
Stroke
High-Density Lipoprotein Cholesterol
Low-Density Lipoprotein Cholesterol
Lipoprotein
Lipid
Niacin ER/simvastatin
Total Cholesterol
Triglycerides
Lead sponsor: Kos Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-03-29
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this 24 week study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS) in subjects with elevated fat levels in their blood (dyslipidemia).

At least 600 subjects with a similar medical condition will take part in this study.

Detailed description: Objectives:

To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS.

Eligibility criteria: Inclusion Criteria:

* Patient has primary Type II hyperlipidemia or mixed dyslipidemia.
* If the patient is currently taking a lipid modifying medication other than Zocor \& he/she is willing to discontinue this medication
* LDL-C levels and/or non HDL-C levels above normal.
* Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.

Exclusion Criteria:

* Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives.
* HbA1c ≥ 9% in diabetic patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Karas RH, Kashyap ML, Knopp RH, Keller LH, Bajorunas DR, Davidson MH. Long-term safety and efficacy of a combination of niacin extended release and simvastatin in patients with dyslipidemia: the OCEANS study. Am J Cardiovasc Drugs. 2008;8(2):69-81. doi: 10.2165/00129784-200808020-00001.
Clinical trial NCT01276275: Extended Drug Utilization Study Among Patients Exposed to Ticagrelor, Clopidogrel and Prasugrel
Official title: A Pharmacoepidemiological Study to Examine Patient Characteristics, Drug Utilization Pattern and Crude Incidence Rates of Selected Outcomes in New Users of Ticagrelor, Clopidogrel and Prasugrel in National Swedish Registries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding ,Arrhythmias, Heart Failure, Acute Renal Failure, Acute Liver Failure, Dyspnoea, Gout
Keywords: Acute coronary syndrome, thienopyridine, epidemiology
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 7200
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: All patients aged 20 to 84 years before their first study drug dispension (start date) will be included in the study. The study period will start the first month after ticagrelor market introduction in Sweden (the first of June 2011),

Brief summary: The purpose of the study is to describe patient characteristics and drug usage among patients that are prescribed ticagrelor for the first time and to compare them with patients who are prescribed clopidogrel and prasugrel for the first time.

A further purpose is to ascertain and estimate the crude incidence rate of bleeding, arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout among new users in the three cohorts of ticagrelor, clopidogrel and prasugrel.


Eligibility criteria: Inclusion Criteria:

* First time users of ticagrelor, clopidogrel and prasugrel, respectively

Exclusion Criteria:

* Individuals with more than one of above three antiplatelet drugs dispensed the same day

Primary outcomes:
measure: Drug utilization: Description of patient characteristics and drug usage
timeFrame: Up to one year after entry into study cohort
Secondary outcomes:
measure: Follow-up of safety outcomes: First occurrence of bleeding, arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout
timeFrame: Up to one year after entry into study cohort.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: Centre for Pharmacoepidemiology, Karolinska Institute, Stockholm
name: Helle Kieler, MD, PhD, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01463475: University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol
Official title: University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft Versus Host Disease (GVHD)
Acute Myocardial Infarction (AMI)
Keywords: MSC
Allogeneic
Bone marrow cells
Healthy subject donors
Collection of MSC from bone marrow aspirate
Bronchiolitis obliterans syndrome (BOS)
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-11-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. After the cell banks are created, these cell products will be used in future translational or clinical research.

Detailed description: Cell banks will be manufactured and cellular products used for future translational or clinical research.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 35 years
* Willingness to provide written informed consent

Exclusion Criteria:

* Presence of risk factors for or clinical evidence of Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), Human transmissible spongiform encephalopathy (including Creutzfeldt-Jakob disease) treponema pallidum,
* Presence of communicable disease risk associated with xenotransplantation.
* Test positive for Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), cytomegalovirus (CVM), West Nile Virus, treponema pallidum.
* Use of investigational drug within 30 days or 5 half lives which ever is longer. Use of investigational implanted device.
* History of malignancy.
* Pregnancy
* In the opinion of the hematologist or the investigator, a condition that compromises the ability of the donor to safely provide BM donation.

Primary outcomes:
measure: Culture and expand mesenchymal stromal cells (MSC)
timeFrame: Day 1- cells are counted within 24 hours of bone marrow aspirate collection
Secondary outcomes:
measure: Characterization profile of MSC during and after expansion will be assessed
timeFrame: Examine the cell surface marker profile of MSC using standard flow cytometry
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Peiman Hematti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: John M Centanni, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04144075: Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial.
Official title: Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: Psychosis
Quality of life
Mindfulness
Compassion
Self-compassion
Schizophrenia
Lead sponsor: Complejo Hospitalario Universitario Insular Materno Infantil
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 150
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: This is a randomized clinical trial to check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme.

Detailed description: MAIN AIM To check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme, compared with those participating in an active control programme or those following usual treatment.

DESIGN

Randomized clinical trial, three parallel groups:

1. Experimental, which will receive the MSC together with the usual treatment (TAU).
2. Active control, which will receive an alternative programme with cognitive, behavioural and psychoeducational components (CBTG) together with the TAU.
3. Passive control, which will receive the TAU. STUDY DISORDER

Schizophrenia. DATA FROM THE INTERVENTION UNDER STUDY Program developed by Kristin Neff and Christopher Germer, after observing in diverse investigations the inverse correlation between levels of self-pity and diverse pathological clinical variables.

POPULATION UNDER STUDY Patients from Telde's Mental Health Unit who have been diagnosed with schizophrenia.

TOTAL NUMBER OF SUBJECTS 150

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizohrenia

Exclusion Criteria:

* Drug addict

Primary outcomes:
measure: World Health Organization Quality of Life Instument. WHOQOL-BREF
timeFrame: 15 minutes
Secondary outcomes:
measure: Self-compassion scale (SCS)
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Las Palmas de Gran Canaria
name: Alicia Díaz Megolla
role: STUDY_DIRECTOR
References:
Clinical trial NCT00289575: MBCP Safety and Performance in the Osteonecrosis of Femur Head
Official title: Evaluation of Safety and Performance of Macroporous Biphasic Calcium Phosphate Granules Combined With Cellulosic-Derived Gel, in Filling Bones Gap After Aseptic Osteonecrosis Biopsy of Femur Head.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteonecrosis
Keywords: Femur head aseptic osteonecrosis
Bone reconstruction
Macroporous biphasic calcium phosphate granules
Lead sponsor: Biomatlante
Sponsor class: INDUSTRY
Collaborators: name: CIC Bordeaux
First posted: 2006-02-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this pilot study is to evaluate MBCP performance in bone regeneration after osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone weakness following the healthy area drilling, thanks to a bone reconstruction at the expense of the biomaterial.

Detailed description: Twelve patients will be enrolled in this study and evaluation of infection and inflammation of the drilled area, pain and hip function will be assessed during a one year follow up. Bone reconstruction will be evaluated with scanner and radiography.

Eligibility criteria: Inclusion Criteria:

* femur head osteonecrosis (1 to 2 level in ARCO scale)
* signed informed consent

Exclusion Criteria:

* primary bone infection
* femur head sphericity loss
* cancer, diabetes, tuberculosis previous history
* HIV, Hepatitis B, Hepatitis C infection
* drepanocytosis
* current corticotherapy
* current immunosuppressive therapy
* innate or acquired immune deficience
* pregnancy or lack of efficient contraception
* current participation in an other study

Primary outcomes:
measure: Infection and inflammation of the drilled area (blood and clinical assessment).
measure: Adverse events.
Secondary outcomes:
measure: Pain (Analogic Visual Scale)
measure: Hip function
measure: Bone reconstruction evaluation through scanner and radiography
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux
name: Thierry FABRE, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Center INSERM/Bordeaux University Hospital
name: Jacques DEMOTES-MAINARD, Pr
role: STUDY_CHAIR
References:
Clinical trial NCT00943475: Assessment of Hemodynamic Response in Surgery of Circumcision in Children
Official title: Assessment of Hemodynamic Response and Pos-operatory Pain in Surgery of Circumcision in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Children Who Need Circumcision
Keywords: DPNB, pain, hemodynamics effects, circumcision
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 40
Sex: MALE
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The surgery stress relives systemic inflammatory response by hormones and adrenergic receptors. When the pro-inflammatory mediator is higher than anti-inflammatory response, the physiologic status is impaired and the patient is more susceptible an infection and cardiovascular collapse. The anesthesia can abolish or minimize the surgery stress, improved more safety to the patient.

This study is a double blind controlled trial with 40 patients divided in two groups (EMLA and Dorsal Penile Nerve Block - DPNB) submitted a standard inhalator anesthesia and postectomy surgery by Plastbell®. The investigators will be observe heart rate, respiratory rate, arterial pressure, involuntary movements during the surgery and pain in the pos-operatory.

With this study, the investigators can define what tactic (EMLA or DPNB) associated a general anesthesia is more effective to relive the pain when children are submitted a postectomy by Plastbell®.


Eligibility criteria: Inclusion Criteria:

ASA status physical 1 children between 3 and 13 years old

Exclusion Criteria:

* parents don't accept the study classic circumcision

Primary outcomes:
measure: local anesthesia relieve the circumcision pain
timeFrame: per-operatory; 1h and 24h pos-operatory
Secondary outcomes:
measure: local anesthesia relieve the circumcision pos-operatory pain
timeFrame: 1h and 24h pos-operatory
Other outcomes:
Locations:
city: Juiz de Fora
country: Brazil
facility: federal University of Juiz de Fora
state: Minas gerais
Study officials:
affiliation: Federal University of Juiz de Fora
name: Jose murillo B Netto, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serour F, Mori J, Barr J. Optimal regional anesthesia for circumcision. Anesth Analg. 1994 Jul;79(1):129-31. doi: 10.1213/00000539-199407000-00024.
citation: Choi WY, Irwin MG, Hui TW, Lim HH, Chan KL. EMLA cream versus dorsal penile nerve block for postcircumcision analgesia in children. Anesth Analg. 2003 Feb;96(2):396-9, table of contents. doi: 10.1097/00000539-200302000-00018.
Clinical trial NCT00284375: Systematic Registration of All Big Toe Prostheses Placed in Ghent University Hospital
Official title: Systematic Registration of All Big Toe Prostheses Placed in Ghent University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Big Toe Prosthesis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 500 patients will be included.

Brief summary: Systematic registration of all big toe prostheses placed in Ghent University Hospital for analyses of global results, comparison between different types of prostheses, ...


Eligibility criteria: Inclusion Criteria:

* Big toe prosthesis

Exclusion Criteria:

-

Primary outcomes:
measure: Frequency of big toe prostheses.
timeFrame: ongoing basis
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wim Bongaerts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Jeroen De Vil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06036875: CARE: Cancer Risk Perception and Women of Color
Official title: CARE: Cancer Risk Perception and Women of Color
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 550
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diverse women between 18 and 50 years of age

Brief summary: This study examines patient understanding of current and lifetime risk for breast cancer in women of color from diverse racial and ethnic backgrounds.

Detailed description: PRIMARY OBJECTIVES:

I. Examine the association between BC risk factors and BC risk perceptions among younger Black and Hispanic women and explore differences in associations by race and ethnicity (Black Hispanic, Black, Hispanic).

II. Explore how younger Black and Hispanic women conceptualize and formulate their risk for BC and to explore the relationship between risk perceptions and risk-reduction strategies.

OUTLINE: This is an observational study.

Patients complete a survey and may participate in an interview on study.

Eligibility criteria: Inclusion Criteria:

* Self-identify as female
* Between the ages of 18 and 50
* No medical history of breast cancer

Exclusion Criteria:

* Unable to understand or comprehend English or Spanish

Primary outcomes:
measure: Perception of risk
timeFrame: Baseline (at enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Jessica D. Austin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02573675: An Assessment on Current Outcomes of Peritoneal Dialysis in Korea
Official title: An Assessment on Current Outcomes of Peritoneal Dialysis in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Failure, Chronic
Keywords: hemodialysis
peritoneal dialysis
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 30000
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: All incident dialysis patients who started chronic dialysis therapy between January 1, 2009 and December 31, 2014 in Korea

Brief summary: In this study, the recent trends in outcomes according to the dialysis modality in Korea since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic burden according to the dialysis modality will be investigated retrospectively using the Korean Health Insurance Review and Assessment Service (HIRA) database.

Detailed description: This study is designed as an observational and retrospective cohort study, thus there will be no intervention or specified prescription.

For the comparison of outcomes according to dialysis modality, we will adopt an intention-to-treat analysis, and consider the dialysis modality at day 90 to be the initial dialysis modality. However, the investigators will also regard the dialysis modality at day 30 as the initial dialysis modality in order to evaluate and compare earlier mortality.

Eligibility criteria: Inclusion Criteria:

* Patients who started dialysis during the study period and remained on the dialysis therapy for at least 90 days

Exclusion Criteria:

* Patients who were younger than 18 years of age
* Patients who survived for less than 90 days from the date of dialysis initiation

Primary outcomes:
measure: Survival rate according to dialysis modality
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kim H, Kim KH, Park K, Kang SW, Yoo TH, Ahn SV, Ahn HS, Hann HJ, Lee S, Ryu JH, Kim SJ, Kang DH, Choi KB, Ryu DR. A population-based approach indicates an overall higher patient mortality with peritoneal dialysis compared to hemodialysis in Korea. Kidney Int. 2014 Nov;86(5):991-1000. doi: 10.1038/ki.2014.163. Epub 2014 May 7.