louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01620307: Rapamune Improves Outcomes of Severe H1N1 Pneumonia
Official title: Adjuvant Treatment With a mTOR Inhibitor, Rapamune Improves Outcomes of Severe H1N1 Pneumonia With Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: H1N1 Pneumonia
Hypoxemia
Keywords: H1N1 patients with severe hypoxemia requiring ventilator support
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Severe H1N1 pneumonia with acute respiratory failure shows hyperactive immune cells infiltration of lung. Rapamune, a mTOR inhibitor, modulates the immune response by blocking activation of T- and B-cells. To investigate the clinical efficiency of rapamune in severe H1N1 pneumonia with respiratory failure, this study was conducted.

Detailed description: From 2009 winter to 2011 spring, patients with flu-like symptoms in Chang Gung Memorial Hospital were screened by rapid antigen test and influenza subtype was confirmed by polymerization chain reaction (PCR). 38 H1N1 patients with severe hypoxemia \[alveolar-arterial oxygen gradient, (A-a) O2 gradient, \> 200 mmHg\] requiring ventilator support were randomized to receive Rapamune (2mg/day) or not. Patients were then randomized to receive either Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days. The outcome variables include liberation of ventilator, ICU mortality, necessity of ECMO, Sequential Organ Failure Assessment (SOFA) score and complications after admission to ICU were recorded. SOFA score composed of scores from six organ systems, graded from 0 to 4 according to the degree of dysfunction/failure.

Eligibility criteria: Inclusion Criteria:

* H1N1 patients with severe hypoxemia \[alveolar-arterial oxygen gradient, (A-a) O2 gradient, \> 200 mmHg\] requiring ventilator support were included to randomization.

Exclusion Criteria:

* severity of illness and multiple organ dysfunction (MOD) were assessed within 24 hours of ICU admission.

Primary outcomes:
measure: liberation of ventilator
timeFrame: 28 days
Secondary outcomes:
measure: necessity of Extracorporeal membrane oxygenation(ECMO)
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Tsang-Tang Hsieh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04553107: Reducing Costs by Deprescribing Medications
Official title: Reducing Healthcare Costs in Older Adults by Deprescribing Unnecessary, Harmful, and Costly Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Deprescribing
Adverse Drug Reaction
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield
First posted: 2020-09-17
Enrollment: 419
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to implement a pharmacist-led deprescribing intervention for adults 65 and older taking 10 or more medications at University of Texas (UT) Physicians clinics and to assess the effect of the pharmacist intervention on the incidence of adverse drug reactions, emergency room visits, and hospitalizations as well as costs to the patient and to the healthcare system in adults 65 and older taking 10 or more medications treated at UT Physicians.


Eligibility criteria: Inclusion Criteria:

- taking 10 or more regular medications

Exclusion Criteria:

* not receiving primary care at UT Physicians

Primary outcomes:
measure: Adverse Drug Reactions (ADR)
timeFrame: 3 months post enrollment
measure: Adverse Drug Reactions
timeFrame: 6 months post enrollment
measure: Adverse Drug Reactions
timeFrame: 12 months post enrollment
measure: Healthcare Cost
timeFrame: 3 months post enrollment
measure: Healthcare Cost
timeFrame: 6 months post enrollment
measure: Healthcare Cost
timeFrame: 12 months post enrollment
Secondary outcomes:
measure: Medication use
timeFrame: At enrollment
measure: Medication cost
timeFrame: 3 months post enrollment
measure: Medication cost
timeFrame: 6 months post enrollment
measure: Medication cost
timeFrame: 12 months post enrollment
measure: QOL
timeFrame: Baseline
measure: QOL
timeFrame: 12 months post enrollment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Holly M Holmes, MD,MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03229707: Impact Of Digital Photography & Conventional Method On The Accuracy Of Dental Shade Matching In The Esthetic Zone
Official title: Impact Of Digital Photography & Conventional Method On The Accuracy Of Shade Matching In The Esthetic Zone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accuracy of Dental Shade Selection in the Aesthetic Zone
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study:

Is to evaluate the accuracy of digital photography in optimizing shade matching when compared to conventional method of shade selection.

Detailed description: Randomized control trial, 2 groups will be included. Group 1: Color matching using Vita 3D master, using modified (USPHS) criteria Group 2: Color matching using digital photography using (Photoshop adopt) the assessment will be through a questionnaire for the patient satisfaction outcome using Visual analogue scale

Eligibility criteria: Inclusion Criteria:

1. Patients between 18-70 years old, able to read and sign the informed consent document.
2. Patients requiring restorations in the esthetic zone.
3. Patients don't have active periodontal or pulpal diseases
4. Patients willing to return for follow-up examination and evaluation.

Exclusion Criteria:

1. Patients in the growth stage.
2. Patients with poor oral hygiene and lack of motivation.
3. Psychiatric problems or unrealistic expectations.

Primary outcomes:
measure: Patient satisfaction
timeFrame: 1 year
Secondary outcomes:
measure: Color Matching
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: MSc Student of Fixed Prosthodontics, Division of Fixed Prosthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt
name: Rawan Ferroukhi, Masters in FixedProsthodontics
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844207: A Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine
Official title: A Phase 1, Open Label, Randomized, Single Dose, Parallel Group Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malaria
Keywords: Bioavailability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective is to estimate the relative bioavailability of fixed azithromycin / chloroquine combination tablets relative to co-administered individual tablets of azithromycin and chloroquine.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* History of febrile illness within 5 days prior to first dose.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.

Primary outcomes:
measure: AUClast and Cmax of azithromycin and chloroquine for each treatment.
timeFrame: up to 96 hours post dose on Day 5
Secondary outcomes:
measure: Tmax of azithromycin and chloroquine for each treatment cohort.
timeFrame: up to 96 hours post dose on Day 5
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02610907: A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Primary outcomes:
measure: Remaining adhesive area of adhesive
timeFrame: 30 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: R&D Principal Scientist
name: Lene F Nielsen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06249607: Impact Of Mindfulness Breathing Versus Storytelling On Non- Specific Insomnia In Elderly
Official title: Impact Of Mindfulness Breathing Versus Storytelling On Non- Specific Insomnia In Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep Disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 93
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare between effects of mindfulness breathing and storytelling on insomnia in the elderly.

Detailed description: Sufficient sleep is essential for optimum health just a few of the numerous processes occurring during sleep include memory consolidation, clearance of brain metabolites, and restoration of nervous, immune, skeletal, and muscular systems. Despite the significance of adequate sleep, insufficient or disturbed sleep is extremely common. For instance, thirty percent of employed adults report obtaining 6 or fewer hours of sleep per night, approximately one-third of all adults report significant sleep complaints, and the two most common sleep disorders, insomnia and sleep-disordered breathing (SDB), each have prevalence rates exceeding 10% in the adult population. Unfortunately, current approaches to treatment are limited .

Story telling is another common soothing bedtime routine for children that uses pictures and writing. It is also a nursing intervention that can be implemented to comfort hospitalized children with acute illness and increase enthusiasm. Story telling is a recommended activity that enhances sleep duration in children. Furthermore, it is considered a positive bedtime routine, in addition to praying and brushing teeth, compared to maladaptive bedtime routine, such as watching television, playing with gadgets, and playing games with high-level activities .

Eligibility criteria: Inclusion Criteria:

* Patients who have non-specific insomnia for one month at least.
* Their ages \> 65 years.
* Medically stable patients.
* Current complaint of poor SQ (score \> 5 of the SQ scale)
* Body mass index ≤ 35 kg/m2.

Exclusion Criteria:

* Patients having a well-structured diagnosis of relevant brain illness or
* any disease directly affects sleep.
* Any patient with unstable medical condition
* History of chronic insomnia
* Indication of receiving treatments for depression and anxiety
* Hearing problem

Primary outcomes:
measure: The Pittsburgh Sleep Quality Index
timeFrame: baseline
measure: Actigraphy
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Naser specialized hospital
Study officials:
affiliation: physical therapy
name: mohamed abubakr rabiee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03236207: Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
Official title: Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow Milk Allergy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 67
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.


Eligibility criteria: Inclusion Criteria:

* Born at term (\>36 weeks gestation)
* 2 months to \<4 years of age at enrollment
* Documented CMA within 6 months prior to enrollment
* Otherwise healthy
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Children consuming mother's milk at the time of inclusion and during the trial
* Any chromosomal or major congenital anomalies
* Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
* Immunodeficiency
* Anaphylaxis to any food
* Receiving free amino acid formula
* Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
* Currently participating in another clinical trial

Primary outcomes:
measure: allergic reaction post DBPCFC
timeFrame: 2 hours
Secondary outcomes:
measure: stool characteristics
timeFrame: 1 week
measure: formula intake
timeFrame: 1 week
measure: adverse events
timeFrame: 1 week
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Hoag Medical Group
state: California
city: Mountain View
country: United States
facility: Stanford University
state: California
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Saint Louis
country: United States
facility: Midwest Clinical Research
state: Missouri
city: Albuquerque
country: United States
facility: Breathe America
state: New Mexico
city: Great Neck
country: United States
facility: Northwell Health System
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center
state: Oklahoma
city: Orangeburg
country: United States
facility: Carolina ENT
state: South Carolina
city: Memphis
country: United States
facility: Memphis & Shelby County Pediatrics
state: Tennessee
city: Houston
country: United States
facility: Houston Clinical Research Associates
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
Study officials:
affiliation: Mt Sinai
name: Anna Nowak-Wegrzyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04021888: The Effects of Exercise Program in Alzheimer's Patients With Mild to Moderate Stage Alzheimer's Disease
Official title: The Effects of Exercise Program in Alzheimer's Patients With Mild to Moderate Stage Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Aerobic Exercise
Breathing Exercise
Resistance Training
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Sevgi Ozalevli
name: Gorsev Yener
First posted: 2019-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this trial is to investigate the feasibility of an exercise program consisting of respiratory exercises, aerobic exercises and strengthening exercises in mild to moderate Alzheimer's disease. The trial also aims to investigate the effectiveness of the exercise program on respiratory symptoms, exercise capacity, cognition, physical performance, depression, sleepiness, activities of daily living and quality of life.

Patients will be divided into exercise (intervention) and control group by randomization method. The study is planned to be performed with a total of 60 patients, 30 in each group. The patients in the exercise group will be given breathing exercises aerobic exercises and strengthening exercises for 2 days a week for 12 weeks, about 30-40 minutes while the patients in the control group will be provided with suggestions, home exercise program and daily life activities

Detailed description: Exercise group was trained 3 times a week under the supervision of a physiotherapist and encouraged to exercise at home on other days

Eligibility criteria: Inclusion Criteria:

* aged over 65 years
* can walk independent

Exclusion Criteria:

* can't see
* have done any exercise in the last 6 months
* have a major and uncontrolled orthopedic, neurological or cardiopulmonary problem that restricts functioning
* having non Alzheimer's disease dementia

Primary outcomes:
measure: Change in cognition
timeFrame: Baseline, 12th week
Secondary outcomes:
measure: Change in pulmonary functions
timeFrame: Baseline, 12th week
measure: Change in respiratory muscle strength
timeFrame: Baseline, 12th week
measure: Change in functional capacity
timeFrame: Baseline, 12th week
measure: Change in physical performance
timeFrame: Baseline, 12th week
measure: Change in sleepiness
timeFrame: Baseline, 12th week
measure: Change in quality of life
timeFrame: Baseline, 12th week
measure: Change in activities of daily living
timeFrame: Baseline, 12th week
measure: Change in depression
timeFrame: Baseline, 12th week
measure: Change in muscle strength
timeFrame: Baseline, 12th week
Other outcomes:
Locations:
city: İzmi̇r
country: Turkey
facility: Elvan Keleş
Study officials:
affiliation: İzmir Katip Çelebi Üniversitesi
name: Elvan Keleş, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00259688: Prevalence Study of Sleep Apnea in Women With Preeclampsia
Official title: Sleep Disordered Breathing and Preeclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preeclampsia
Keywords: Preeclampsia
Sleep Apnea
CPAP
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
First posted: 2005-11-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hypothesis: The prevalence of sleep apnea is greater in pregnant women with preeclampsia than in pregnant women without preeclampsia.The presence of sleep apnea will be associated with poor blood pressure control, worsening blood pressure during sleep and evidence of fetal distress. The usual treatment for sleep apnea is to have the patient breathe pressurized air through a mask. This is called continuous positive airway pressure (CPAP). In preeclamptic women with sleep apnea, use of CPAP will result in improved blood pressure control and reduced fetal distress.

Detailed description: Sleep apnea is common in the adult population. In middle aged men, the presence of sleep apnea has been correlated with hypertension, cardiovascular disease and mood disorders. Sleep apnea is not as well studied in women and even less is known about sleep apnea in pregnant women. However, preliminary evidence suggests that the incidence is quite high, particularly in women with severe preeclampsia. We propose to perform sleep studies on 30 women with preeclampsia and 30 healthy pregnant controls. In addition to the usual sleep study monitoring, we will also measure beat-to-beat blood pressure through non-invasive monitoring and we will do continuous electronic fetal monitoring. Women found to have sleep apnea will have a repeat study in which CPAP therapy is applied, and be provided CPAP therapy for nightly use at home.

Eligibility criteria: Inclusion Criteria:

* Pregnant women \>18 years of age

Exclusion Criteria:

* significant medical conditions that would be expected to affect maternal- fetal outcomes
* need for admission to hospital, so that it transfer to the sleep would compromise maternal-fetal safety

Primary outcomes:
measure: Determine the prevalence of sleep apnea in preeclampsia and pregnancy.
timeFrame: Time of delivery for each woman
Secondary outcomes:
measure: For those subjects diagnoses with sleep apnea: Improvement in blood pressure and electronic fetal monitoring during with use of CPAP.
timeFrame: Time of delivery for each woman
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital Sleep Disorders Centre
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: John K Reid, MD, BSc
role: PRINCIPAL_INVESTIGATOR
References: