louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04307693: Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
Official title: Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 65
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, open labelled, randomized clinical trial
Primary purpose: TREATMENT

Brief summary: In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.

Detailed description: This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of lopinavir/ritonavir, hydroxychloroquine, or control arm.

Eligibility criteria: Inclusion Criteria:

* confirmed mild COVID-19 (NEWS scoring system 0-4)

Exclusion Criteria:

* unable to take oral medication
* pregnancy or breast feeding
* immunocompromised patients
* creatinine clearance (CCL) \< 30 mL/min
* aspartate transaminase (AST) or alanine transaminase (ALT) \> 5 times Upper limit of normal (ULN)

Primary outcomes:
measure: Viral load
timeFrame: hospital day 3, 5, 7, 10, 14, 18
Secondary outcomes:
measure: Viral load change
timeFrame: hospital day 3, 5, 7, 10, 14, 18
measure: Time to clinical improvement (TTCI)
timeFrame: up to 28 days
measure: Percentage of progression to supplemental oxygen requirement by day 7
timeFrame: hospital day 7
measure: Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
timeFrame: hospital day 7
measure: Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
timeFrame: up to 28 days
measure: Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
timeFrame: hospital day 7
measure: adverse effects
timeFrame: up to 28 days
measure: Concentration of Lopinavir/ritonavir and hydroxychloroquine
timeFrame: 1, 2, 4, 5, 12 hours after taking intervention medicine
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
Study officials:
References:
citation: Lipsitch M, Perlman S, Waldor MK. Testing COVID-19 therapies to prevent progression of mild disease. Lancet Infect Dis. 2020 Dec;20(12):1367. doi: 10.1016/S1473-3099(20)30372-8. Epub 2020 May 6. No abstract available.
Clinical trial NCT03561493: The Effect of Zumba Dance on Primary Dysmenorrhea
Official title: Effect of Zumba Exercise on Menstrual Pain in Women With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the objective of this study is to investigate the effect of practising Zumba exercise in decreasing menstrual pain in young women with primary dysmenorrhea.

Detailed description: primary dysmenorrhea or painful menstruation without pelvic pathology is one of the most common complaints in women's medicine. The pain begins with the onset of menstrual bleeding and lasts for 72-12 h. Pain is usually in the middle line of the highest severity. Dysmenorrhea pain is often described as cramped and intermittent. Zumba is a dance-based fitness class that originated in Colombia in the 1990s and is now extremely popular worldwide. the aim of this study is to investigate the effect of 8 weeks of regular Zumba exercise on the severity of primary dysmenorrhea.

Eligibility criteria: Inclusion Criteria:

* having regular menstrual cycles (30-35 days) and bleeding time of 3-10 days.
* history of primary dysmenorrhea(PD) which had affected daily activities in at least 50% of their cycles through the past 6 months; and pain intensity over 4 cm, based on the 10-cm visual analog scale score.
* having a pain score for PD on the visual analog scale (VAS) of 4-7 cm
* Age: 18-25 years.

Exclusion Criteria:

* Pregnancy
* known diseases of the genitourinary system (e.g., pelvic inflammatory disease and urinary tract infections) or secondary dysmenorrhea and chronic diseases (heart disease, respiratory, kidney, blood pressure, asthma, diabetes, epilepsy, migraine, thyroid, anemia, nervous disorders).
* Previous Zumba fitness practice.
* irregular menstrual cycles; the use of intra-uterine devices and oral contraceptive pills.
* musculoskeletal injuries and metabolic/cardiorespiratory contraindications to physical exercise

Primary outcomes:
measure: Intensity of pain
timeFrame: duration of menses(5-7 days) 1st menstrual cycle.
measure: Intensity of pain
timeFrame: duration of menses(5-7 days) 2nd menstrual cycle.
Secondary outcomes:
measure: menstrual pain duration
timeFrame: 7 days from 1st day of menstruation).
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03408093: Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b
Official title: Cross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1b
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Interferon beta-1b (INFb-1b)
Multiple Sclerosis (MS)
Relapsing-remitting MS (RRMS)
Secondary progressive MS (SPMS)
Clinically isolated syndrome (CIS)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included patients who had been on interferon beta-1b for more than 6 months and who agreed to participate in this study.

Brief summary: The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or patients with a first outbreak or clinically isolated syndrome (CIS) that carry more than 6 months in treatment with interferon beta-1b

Exclusion Criteria:

-

Primary outcomes:
measure: Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test
timeFrame: Four weeks just before baseline visit
Secondary outcomes:
measure: Demographic data
timeFrame: At baseline
measure: Number of patients with MS diagnosis
timeFrame: At baseline
measure: Age at first episode and at diagnosis
timeFrame: At baseline
measure: Time since last relapse
timeFrame: At baseline
measure: Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team
timeFrame: At baseline
measure: Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS
timeFrame: At baseline
measure: Number of patients with adverse events during the last month
timeFrame: Four weeks just before baseline visit
measure: Clinical setting characteristics like existence of MS unit
timeFrame: At baseline
measure: Time on INFb-1b therapy
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Fernandez O, Aguera E, Izquierdo G, Millan-Pascual J, Ramio I Torrenta L, Oliva P, Argente J, Berdei Y, Soler JM, Carmona O, Errea JM, Farres J; Group on Adherence to IFNb-1b in Spain. Adherence to interferon beta-1b treatment in patients with multiple sclerosis in Spain. PLoS One. 2012;7(5):e35600. doi: 10.1371/journal.pone.0035600. Epub 2012 May 16.
Clinical trial NCT00845793: The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study
Official title: The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Nutrition
Lifestyle modifications
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This protocol is intended to test whether a focused nutritional intervention in hospitalized patients with type 2 diabetes can have an impact on long term eating habits, physical activity and anthropometric parameters.

The rational is to use the food tray as a means of conveying simple and practical nutritonal and behavioral messages.

Detailed description: Patients hospitalized at Hadassah Medical Center who have type 2 diabetes will relieve a focused nutritional intervention using mainly the food tray during the hospitalization. The intervention will be administered by the hospital nutrition team.

At baseline (upon admission) - medical data will be collected as well as nutritional and behavioral questionnaires will be administered. The intervention will take place during the hospitalization period. Follow up using the same tools will be performed at 3 and 12 month.

We believe that the hospitalization period, even for reasons non related to diabetes, is a window of opportunity to implement lifestyle changes.

Eligibility criteria: Inclusion Criteria:

* Age 20-80 years
* Diagnosis of type 2 diabetes
* Speaking and reading Hebrew

Exclusion Criteria:

* Chronic medical condition requiring a specific diet
* Non Hebrew speaking
* Pregnant women

Primary outcomes:
measure: Changes in the results of the nutrition quality questionnaire
timeFrame: 3 and 12 months
Secondary outcomes:
measure: Changes in anthropometric measures Changes in physical activity levels
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT03519893: Bariatric Surgery and Pharmacokinetics of Losartan
Official title: Bariatric Surgery and Pharmacokinetics of Losartan: BAR-MEDS Losartan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Losartan
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-05-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on losartan are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Losartan concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01636193: Drug Use Investigation for ROTARIX®
Official title: Drug Use Investigation for ROTARIX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Rotavirus
Rotarix
Drug Use Investigation
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 1607
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis as part of routine immunisation programme.

Brief summary: This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.

Detailed description: This is non-interventional study conducted in one group received Oral Rotarix®. This surveillance is abbreviated as SMILER (Surveillance and Monitoring In Living clinical Experience for Rotarix).

Eligibility criteria: Inclusion Criteria:

• Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.

Exclusion Criteria:

• All infants included in the special drug use investigation of Oral Rotarix will be excluded.

Primary outcomes:
measure: Occurrence of Adverse events under clinical practice.
timeFrame: During the 31-day observation period after each vaccination.
measure: Occurrence of typical symptoms of intussusceptions and bloody stool.
timeFrame: During the 31-day observation period after each vaccination.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00285493: Low Back Pain and Antibiotic Treatment
Official title: Phase 1 Study of Antibiotic Treatment for Low Back Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Low Back Pain
Keywords: low back pain
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2006-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical trial using antibiotic treatment, namely Rulid, after onset of low back pain.

Detailed description: Clinical trial using antibiotic treatment, namely Rulid, after onset of low back pain.

Eligibility criteria: Inclusion Criteria:

- Must be able to swallow tablets

Exclusion Criteria:

- Allergy to antibiotics

Primary outcomes:
measure: protocol designed to assess or examine persons or groups in a systematic way to identify specific markers for eligibility for further evaluation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loewenstein Hospital
name: Bambi Alyagon, MSc
role: STUDY_DIRECTOR
affiliation: Loewenstein Hospital
name: Shoshana Weiler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04571593: Remote Yoga Nidra for Anxiety and Sleep
Official title: Digital Delivery of Yoga Nidra for Anxiety and Sleep: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Due to Anxiety and Fear
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this application is to collect survey data indicating the effects of a digital Yoga Nidra practice on anxiety and sleep during COVID-19. We will explore effects on momentary anxiousness, as well as on sleep. Participants will be consented through REDCap during the Yoga Nidra class, then asked to complete an intake form, a sleep questionnaire (composed of questions from the Post Sleep Questionnaire (PSQ)) and a pre/post State Trait Anxiety (STAI) Index, surrounding the practice. Participants will receive an email the next morning, inquiring about their sleep (\~2 min survey), and again the following week, the morning of the Yoga Nidra class, in order to remind them about the weekly class offering and also to collect sleep data for a night that did not include pre-bed Yoga Nidra. We will additionally report feasibility measures including enrollment, retention, qualitative feedback, and challenges of using the digital platform. Using this data, we will gain valuable feasibility data for implementation of this type of mind-body practice using digital platforms. We will also gain important data on the effects of this practice on anxiety and sleep.


Eligibility criteria: Inclusion Criteria:

* Adults
* Can understand a recording in English while resting comfortably

Exclusion Criteria: NA

Primary outcomes:
measure: Change in Momentary Anxiety
timeFrame: Pre-intervention and immediately after the intervention
measure: Change in Sleep Quality
timeFrame: Baseline (pre-intervention), 1 day (morning after intervention), and 2-6 days later (survey sent each Tuesday, to capture a night without Yoga Nidra)
Secondary outcomes:
measure: Incidence of Intervention-Emergent Challenges as assessed by a Feedback Survey
timeFrame: Post-intervention (survey sent at 16 weeks)
measure: Satisfaction as assessed by a Feedback Survey
timeFrame: Post-intervention (survey sent at 16-weeks)
Other outcomes:
Locations:
city: Portland
country: United States
facility: National University of Natural Medicine, Helfgott Research Institute
state: Oregon
Study officials:
affiliation: National University of Natural Medicine
name: Erica M Sharpe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02165293: A Single Center Study to Evaluate the Penetration of RO7033877 Into the Lung in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-06-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This single-center, open-label study will investigate RO7033877 concentrations in plasma and in various lung compartments, including epithelial lining fluid (ELF), and alveolar macrophages (AM) in healthy volunteers after multiple intravenous (IV) administration. Bronchoscopy will be performed after the start of the last infusion on Day 3 at different timepoints. Blood, urine and brochoalveolar lavage samples will be collected to determine RO7033877 concentrations. The anticipated time on study treatment is 3 days.


Eligibility criteria: Inclusion Criteria:

* Male or female healthy volunteers, 18 to 55 years of age, inclusive. A female participant is eligible to participate if she is of non-childbearing potential defined as postmenopausal or surgically sterile
* Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive
* Nonsmokers
* Healthy male volunteers with female partners of childbearing potential must use adequate contraception methods

Exclusion Criteria:

* Evidence of active chronic disease
* Regular consumption of drugs of abuse
* Infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV)
* History of clinically significant hypersensitivity or allergic drug reactions
* Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
* Abnormal blood pressure or vital signs
* Contraindications to bronchoalveolar lavage (BAL)

Primary outcomes:
measure: Multiple-dose pharmacokinetics of RO7033877 for plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM): Cmax and AUC
timeFrame: 5 days (in-clinic period)
measure: ELF and AM/Plasma Ratios of Cmax and AUC
timeFrame: 5 days (in-clinic period)
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 12 days
measure: Changes in clinical laboratory safety tests, vital signs, and ECGs
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00346593: Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Clinical Vision Research Australia
name: Cooper Companies
First posted: 2006-06-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens during continuous wear (up to 30 nights) over a period of 24 months.


Eligibility criteria: Inclusion Criteria:

* Has had an oculo-visual examination in the last 2 years.
* Is correctable to at least 6/7.5 distance visual acuity in each eye with spherical contact lenses.
* Is a current soft contact lens wearer.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease.

Exclusion Criteria:

* Has any systemic disease that might interfere with contact lens wear
* Is using any systemic or topical medications that will affect ocular health.
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: Clinical Vision Research Australia
state: Victoria
Study officials:
affiliation: Clinical Vision Research Australia
name: Carol Lakkis, BScOptom PhD
role: PRINCIPAL_INVESTIGATOR
References: