louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00442559: Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)
Official title: Korean Study of "Real-World" Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 191
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Between 2 and 14 years old
* Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA)
* Diagnosed with comorbid allergic rhinitis

Exclusion Criteria:

* Patients with suspected sinus infection
* Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases

Primary outcomes:
measure: Change From Baseline for Daytime Asthma Symptom Score
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline for Daily Allergic Rhinitis Symptom Score
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04280159: Modern Hybrid Imaging in Patients With OSCC
Official title: Modern Hybrid Imaging for Staging and Monitoring Patients With Oral Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm
Keywords: Head and Neck
SCC
PET/CT
Staging
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with squamous cell carcinoma of the oral cavity,

Brief summary: Prospective diagnostic study to determine the diagnostic accuracy of preoperative 18F--fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) in detecting local tumor extent, cervical lymph node metastases and distant metastases/secondary primary tumor.


Eligibility criteria: Inclusion Criteria:

* Histopathological proven head and neck carcinoma
* Written inform consent
* 18 years of age

Exclusion Criteria:

* Cancer of unknown primary
* En-bloc resection of lymph node levels
* Uncertainties regarding the removed lymph node levels

Primary outcomes:
measure: Diagnostic accuracy of FGD-PET/CT to detect the primary tumor
timeFrame: 2013-2018
measure: Diagnostic accuracy of FGD-PET/CT to detect lymph nodes metastases
timeFrame: 2013-2018
measure: Diagnostic accuracy of FGD-PET/CT to detect distant lymph node metastases.
timeFrame: 2013-2018
Secondary outcomes:
measure: Diagnostic accuracy of MRI to detect the primary tumor
timeFrame: 2013-2018
measure: Diagnostic accuracy of MRI to detect lymph nodes metastases
timeFrame: 2013-2018
measure: Diagnostic accuracy of CT to detect the primary tumor
timeFrame: 2013-2018
measure: Diagnostic accuracy of CT to detect lymph nodes metastases
timeFrame: 2013-2018
measure: Diagnostic accuracy of CT to detect distant lymph node metastases.
timeFrame: 2013-2018
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Department of Cranio- and Maxillofacial Surgery
Study officials:
affiliation: Dpt. of CMF, University Hospital Wuerzburg
name: Urs Müller-Richter, MD, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002259: Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
Official title: Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Mitoxantrone
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To study the toxicity and efficacy of IV mitoxantrone hydrochloride (Novantrone) in AIDS-related Kaposi's sarcoma.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

* Biopsy proven Kaposi's sarcoma in advanced stages.
* Positive HIV antibody, HIV culture or antigen capture or T4 cells \< 500 in a patient with AIDS risk factor.
* Informed consent and availability for follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Uncontrolled opportunistic infection.
* Any medical, surgical or psychiatric condition which would constitute a contraindication to the use of mitoxantrone.

Concurrent Medication:

Excluded:

* Zidovudine (AZT).

Patients with the following are excluded:

* Uncontrolled opportunistic infection.
* Unable to give informed consent.
* Any medical, surgical or psychiatric condition which would constitute a contraindication to the use of mitoxantrone.

Prior Medication:

Excluded:

* More than one form of chemotherapy regimen.
* Doxorubicin therapy \> 300 mg/m2.

Prior Treatment:

Excluded:

* Previous therapy consisting of more than one modality of therapy (e.g., chemotherapy plus radiotherapy or more than one form of chemotherapy regimen.)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
Study officials:
References:
Clinical trial NCT00140959: Losartan and HCTZ and Amlodipine vs Atenolol and Amlodipine (0954A-309)(COMPLETED)
Official title: Antihypertensive Effects of a Fixed-dose Combination of Losartan and Hydrochlorothiazide Plus Amlodipine Versus a Hydrochlorothiazide and Atenolol Combination Plus Amlodipine in Subjects With Ambulatory Systolic Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the effects of combination losartan versus combination atenolol in patients with ambulatory systolic hypertension.


Eligibility criteria: Inclusion Criteria:

* Males or females at least 18 years of age who have ambulatory systolic hypertension.

Primary outcomes:
measure: Mean daytime ambulatory systolic blood pressure
Secondary outcomes:
measure: Ambulatory BP
measure: Pulse pressure
measure: Trough sitting BP
measure: Percentage of patients who reach goal ambulatory systolic BP
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lacourciere Y, Poirier L, Lefebvre J. Expedited blood pressure control with initial angiotensin II antagonist/diuretic therapy compared with stepped-care therapy in patients with ambulatory systolic hypertension. Can J Cardiol. 2007 Apr;23(5):377-82. doi: 10.1016/s0828-282x(07)70771-7.
Clinical trial NCT05118659: Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo
Official title: Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo. A Randomized And Controlled Clinic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertigo
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This analysis aims to evaluate the immediate effect that cervical sustained natural apophyseal glides (SNAGs) have on a group of individuals with induced vertigo by a caloric vestibular stimulation.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects,
* Age 18-44 years.

Exclusion Criteria:

* Consume of antipsychotics, antidepressants, antiarrythmics and/or anticonvulsivants
* Hippoacusia
* Auditory diseases
* Peripheral or central vestibulopathies
* Cerviogenic dizziness
* Balance disorders
* Nistagmus
* Oculomotor nerve dysfunctions
* Migraine
* Cervical osteoporosis, lashing or fracture
* Discal cervical hernia
* Cervical neuropathy
* Psychriatic disorders
* Epilepsy
* Pregnancy

Primary outcomes:
measure: vHIT (Video Head Impulse Test)
timeFrame: 15 minutes
Secondary outcomes:
measure: Anxiety
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
city: Madrid
country: Spain
facility: Jose V Leon Hernandez
Study officials:
References:
Clinical trial NCT05909059: CAR T-cell Therapy in Patients With Renal Dysfunction
Official title: Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-hodgkin Lymphoma,B Cell
Multiple Myeloma
Acute Lymphoblastic Leukemia, Adult
Lead sponsor: Northside Hospital, Inc.
Sponsor class: OTHER
Collaborators: name: Blood and Marrow Transplant Group of Georgia
First posted: 2023-06-18
Enrollment: 20
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 is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma
* Adequate bone marrow function to receive lymphodepleting chemotherapy
* Renal function \</= 60mL/min/1.73m2
* ECOG 0-2

Exclusion Criteria:

* Relative CNS disorders
* Active uncontrolled infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator
* Use of therapeutic dose systemic corticosteroids (defined as \>20mg/day prednisone or equivalent) within 72 hours of CAR-T administration

Primary outcomes:
measure: Occurrence of CRS
timeFrame: 90 days
measure: Occurrence of ICANS
timeFrame: 90 days
measure: Occurrence of Cytopenias
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Caitlin Guzowski
state: Georgia
Study officials:
References:
Clinical trial NCT06596759: Diaphragmatic Breathing for the Treatment of Bloating and Distension
Official title: Diaphragmatic Breathing for the Treatment of Bloating and Distension: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bloating
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of diaphragmatic breathing using the validated Mayo Bloating Questionnaire.


Eligibility criteria: Inclusion Criteria:

* Referred for breath testing for the indication of bloating.

Exclusion Criteria:

* Not referred for breath testing for the indication of bloating.

Primary outcomes:
measure: Change in Mayo Bloating Questionnaire (MBQ) score
timeFrame: Baseline, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Brian E Lacy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03153059: Gut Microbiota and Stool Frequency
Official title: The Association Between Gut Microbiota and Stool Frequency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gut Microbiota
Keywords: gut microbiota
stool frequency
Lead sponsor: Kosin University Gospel Hospital
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: We hypothesized that some difference in the composition and distribution of gut microbiota in people with a large number of defecation (two or three times a day or more), people with normal defecation (one time a day or two days), and people with a small number of defecation (two times a week or less).

And we investigate the association between gut microbiota and stool frequency.

Detailed description: We divided three groups. (total number = 60 subjects)

1. a large number of defecation group (≥ 2-3 times/day) - 20 subjects
2. normal defecation group (1 time/day or 1 time/2 days) - 20 subjects
3. a small number of defecation group (≤ 2 times/week) - 20 subjects

After collection of stools, we will analyze the composition and distribution of gut microbiota, and compared the results of three groups.

Eligibility criteria: Inclusion Criteria:

* adults between the age of 20 and 50

Exclusion Criteria:

* subjects with cancer or IBD (inflammatory bowel disease)
* subjects with history of abdominal surgery
* subjects who take medication related to gastrointestinal motility within 3 months
* subjects who take antibiotics within 3 months

Primary outcomes:
measure: stool frequency and gut microbiota
timeFrame: six months
Secondary outcomes:
measure: stool consistency and gut microbiota
timeFrame: six months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
Study officials:
References:
Clinical trial NCT03567759: Transpulmonary Pressure in One Lung Ventilation and Open Pneumothorax
Official title: Effect 0ne Lung Ventilation and Open Pneumothorax on Respiratory Mechanics and Transpulmonary Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumothorax
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of age 18-85 years scheduled for VATS requiring one lung ventilation

Brief summary: Esophageal Pressure During one lung ventilation

Detailed description: Esophageal pressure comparison during positive pressure ventilation, one lung ventilation, lateral position and open pneumothorax

Eligibility criteria: Inclusion Criteria:

* patients scheduled for VATS requiring one lung ventilation
* Body mass index below 35 kg/m\^2

Exclusion Criteria:

* esophageal pathology preventing insertion of orogatric tube
* scoliosys

Primary outcomes:
measure: Changes in esophageal pressure
timeFrame: from tracheal intubation untill fiveminutes after induction of open pneumothorax
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Amit Lehavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00724659: Pre and Post Arthrogram Ultrasound Images of Joints
Official title: An Evaluation of Pre and Post Arthrogram Ultrasound Images of Joints: Does Arthrography Have a Role in Ultrasonography?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Abnormalities
Keywords: Arthrogram
Contrast
Joint
Ultrasound
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the usefulness of contrast in ultrasonography of the joints.

Detailed description: To determine if using intra-articular contrast (contrast injected into a joint) will provide clearer, more precise ultrasound images of the joints then an ultrasound done without the use of a contrast agent.

Eligibility criteria: Inclusion Criteria:

* clinically ordered arthrogram

Exclusion Criteria:

* pregnant women
* children under the age of 18

Primary outcomes:
measure: To add to the general knowledge of the researchers and to possibly benefit future patients in the diagnosis and treatment of joint abnormalities.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT05722600: Effects of Hardaliye, a Fermented Grape Drink, on Oxidative Stress, Lipid Profile and Blood Pressure in Young Footballers
Official title: Effects of Hardaliye, a Fermented Grape Drink, on Oxidative Stress, Lipid Profile and Blood Pressure in Young Footballers: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Antioxidative Stress
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 36
Sex: MALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the present study, the authors aimed to investigate the effects of hardaliye (grape juice) consumption on oxidative stress parameters, lipid profile and blood pressure in young football players.


Eligibility criteria: Inclusion Criteria:

* Being a male football player playing in a team in the Elite Development League,
* Participating in training with the team at least 5 days a week for 3 months,
* Not consuming red wine, grape juice, and/or hardaliye regularly before the study was started,
* Those who stayed in the sports facility where catering service was provided for breakfast, lunch and dinner were included in the study.

Exclusion Criteria:

* With chronic disease,
* Smoker,
* Those taking antioxidant supplements,
* Non-cooperative subjects or unwilling to sign an informed consent and participate in the study.

Primary outcomes:
measure: Change in total antioxidant capacity
timeFrame: 28 days
measure: Change in total oxidation status
timeFrame: 28 days
measure: Change in oxidative stress index
timeFrame: 28 days
measure: Change in lipid parameters
timeFrame: 28 days
measure: Change in blood pressure
timeFrame: 28 days
Secondary outcomes:
measure: Change in perceived exercise-induced pain
timeFrame: 28 days
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
Clinical trial NCT01160900: FIT (Fast Infarction Treatment): Complete Revascularization During Primary Percutaneous Coronary Intervention (PCI) Can be Achieved Safely With an Improved Clinical Outcome During the Indexed Hospitalization.
Official title: Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myocardial Infarction
Ischemia
Heart Failure
Necrosis
Stents
Keywords: cardiovascular diseases
heart disease
hemorrhage
coronary angioplasty
drug eluting stents
Lead sponsor: Azienda Ospedaliera San Camillo Forlanini
Sponsor class: OTHER
First posted: 2010-07-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Few reports described outcomes of complete compared with infarct related artery (IRA) only revascularization in patients with ST elevation myocardial infarction (STEMI) and multivessel coronary disease (CAD).

The purpose of this study is to determine outcome (death, myocardial infarction, target vessel failure) of 180 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty.

Before the first angioplasty patients are randomized to 2 different strategies: 1) culprit vessel angioplasty only, 2) staged revascularization.


Eligibility criteria: Inclusion Criteria:

* myocardial acute infarction
* prolonged chest pain (\>20 minute) started less \<12 hours before arrive in hospital
* ST segment elevation of \>1mm in \>2 contiguous leads
* new left bundle branch block
* diameter of the coronary suitable of angioplasty \>2mm
* the patients agrees to the study protocol and provides a written consensus
* two or more coronary suitable for angioplasty

Exclusion Criteria:

* refused written consensus
* hypersensitivity or contraindication to any of the following medications: heparin bivalirudin aspirin prasugrel stainless steel
* history of bleeding
* cardiogenic shock (PA \< 90mmHg)
* chronic total occlusion in the second lesion
* TIMI Flow \< II in the culprit lesion
* recent pregnancy
* history of intra-cerebral major hemorrhagic stroke
* an elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment life expectancy \<1 year

Primary outcomes:
measure: death at 30 days
timeFrame: 1 month
measure: stent thrombosis
timeFrame: 1 year
measure: target vessel failure
timeFrame: 1 year
measure: re-acute myocardial infarction
timeFrame: 1 month
Secondary outcomes:
measure: bleeding
timeFrame: 1 month
measure: timi frame count
timeFrame: 1 day
measure: vascular site access complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
Study officials:
References: