louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00929487: Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers
Official title: Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lens wear
contact lens solution
corneal staining
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-06-29
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.

Detailed description: This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.

Eligibility criteria: Inclusion Criteria:

* Have read, understood, signed, and dated the written Informed Consent.
* Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
* Vision correctable to at least 20/30 Snellen.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Topical ocular medication use.
* History of hypersensitivity to any component of the study contact lens care systems.
* Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
* Pregnant, lactating, or planning a pregnancy.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Corneal Staining
timeFrame: 2 hours
Secondary outcomes:
measure: Subjective Comfort
timeFrame: 2 hours
Other outcomes:
Locations:
city: Farnham
country: United Kingdom
facility: Visioncare Research, Ltd.
state: Surrey
Study officials:
References:
citation: Malet F. An acute clinical comparison of corneal staining and comfort associated with contact lens care solutions. Cont Lens Anterior Eye. 2014 Oct;37(5):351-7. doi: 10.1016/j.clae.2014.05.007. Epub 2014 Jul 26.
Clinical trial NCT02351687: Package of Interventions After Recovering From Moderate Acute Malnutrition
Official title: Randomized Controlled Trial of the Impact of Offering a Nutrition and Health Intervention to Children Recovered From Moderate Acute Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Moderate Acute Malnutrition
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Malawi
First posted: 2015-01-30
Enrollment: 1499
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children who recover from moderate acute malnutrition in Malawi remain at high risk for relapse or death in the year following recovery. This cluster-randomized trial will evaluate a package of affordable, safe, proven interventions specifically targeted to this population of children in an attempt to decrease their risk of relapse or death following recovery from moderate acute malnutrition. These children will be followed for a year following recovery to assess rates of relapse and mortality.


Eligibility criteria: Inclusion Criteria:

* recovered from moderate acute malnutrition, as defined by mid-upper arm circumference (MUAC) of 11.5-12.4 cm

Exclusion Criteria:

* not permanent resident in vicinity of site
* severe chronic illness
* receiving other supplementary food or participating in other research

Primary outcomes:
measure: Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: St. Louis Nutrition Project
Study officials:
affiliation: Washington University School of Medicine
name: Mark J Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stobaugh HC, Rogers BL, Rosenberg IH, Webb P, Maleta KM, Manary MJ, Trehan I. Children with Poor Linear Growth Are at Risk for Repeated Relapse to Wasting after Recovery from Moderate Acute Malnutrition. J Nutr. 2018 Jun 1;148(6):974-979. doi: 10.1093/jn/nxy033.
citation: Stobaugh HC, Bollinger LB, Adams SE, Crocker AH, Grise JB, Kennedy JA, Thakwalakwa C, Maleta KM, Dietzen DJ, Manary MJ, Trehan I. Effect of a package of health and nutrition services on sustained recovery in children after moderate acute malnutrition and factors related to sustaining recovery: a cluster-randomized trial. Am J Clin Nutr. 2017 Aug;106(2):657-666. doi: 10.3945/ajcn.116.149799. Epub 2017 Jun 14.
Clinical trial NCT00913887: To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Official title: A Relative Bioavailability Study of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Keywords: Anti-Inflammatory
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets under non-fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 32 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Red River Clinical
name: Paul D. Larsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00109187: An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g
Official title: Open-Label Extension Study II of Xolair (Omalizumab) in Moderate to Severe, Persistent Asthma Subjects Who Completed Study Q2143g (ALTO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Moderate Persistent Asthma
Severe Persistent Asthma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2005-04-26
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects in the New Treatment Group may require additional visits for study drug injections (as frequently as every 2 weeks). Data collection during these additional visits will be limited to the assessment of adverse events. The study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.


Eligibility criteria: Inclusion Criteria:

* Successful completion of the 24-week study period in Study Q2143g
* Signed informed consent (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
* For subjects who have never received Xolair, a serum IgE level \>=30 IU/mL and \<=1300 IU/mL and have a body weight \>=20 kg and \<=150 kg
* Females of childbearing potential must, in the opinion of the investigator, be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.

Exclusion Criteria:

* Thrombocytopenia as evidenced by a platelet count of \<100,000/uL
* Pregnant or breastfeeding
* Significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrine or gastrointestinal disease) within the previous 3 months
* History of neoplasia
* Any systemic condition requiring regular administration of an immunoglobulin
* Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
* History of noncompliance with medical regimens
* Current participation in a study using an investigational new drug other than Xolair
* Participation in Study Q2195g

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06288087: Comparing Machine Guided VR Based Training With Educator Guided Training in Metaverse
Official title: Comparing Machine Guided VR Based Training With Educator Guided Training in Metaverse Environment: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Cardiac Life Support
Virtual Reality
Serious Game
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: OTHER

Brief summary: The main aim of this study is to compare the learning outcomes of machine guided VR based training for adult advanced life support with educator guided training in metaverse environment.

Detailed description: Online education stands as one of the metaverse's potential application areas. The metaverse's ability to offer shared social connections differs it from existing online educational platforms such as Simulation, AR, and VR, which primarily focus on presenting virtual content and environments without fostering communal interaction. This facilitates interaction between learners and educators during metaverse-based training sessions allowing educators to guide the learners and provide feedback. The educators' presence fosters communication and collaboration during training sessions, thereby enhancing learners' motivation and engagement.

In our university, a VR-based multiplayer training module within the metaverse environment specifically designed for ALS (Adult Advanced Life Support) training has been developed. This module serves as an additional training tool to simulation-based training, enabling learners to receive guidance either from machine algorithms or educators within the metaverse. The objective of this study is to reveal the benefits of educator presence in the metaverse during VR-based training sessions.

Eligibility criteria: Inclusion Criteria:

* Volunteering for the study

Exclusion Criteria:

* Previously experienced VR-induced motion sickness
* Previous Advanced Life Support training
* Other medical conditions like vertigo attacks
* Being under medication, which may cause vertigo like symptoms.

Primary outcomes:
measure: Comparing Learning outcome of the Advanced Cardiac Life Support Training of the two interventions used in this study
timeFrame: The participants will complete the exam mode for final evaluation right after the completion of training on the same day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University CASE (Center of Advanced Simulation and Education)
state: Non-US/Canada
city: Istanbul
country: Turkey
facility: Acibadem University CASE (Center of Advanced Simulation and Education)
state: Non-US/Canada
Study officials:
References:
Clinical trial NCT00142987: Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
Official title: Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IBS-C and IBS With Mixed Bowel Habits
Keywords: Tegaserod, IBS-C, women, mixed bowel habit
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 664
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent literature has demonstrated that the group of IBS sufferers who experience mixed bowel habits may be more similar to IBS-C patients than IBS-D patients. This study will evaluate the efficacy and safety of tegaserod 6 mg b.i.d. in women with IBS and mixed bowel habits, excluding those with predominant diarrhea.


Eligibility criteria: Inclusion Criteria:

* women, outpatients, 18-65 years of age with IBS-C or IBS with mixed bowel habits
* In the 12 months preceding study entry, they had to have at least 12 weeks (not necessarily consecutive) of abdominal discomfort/pain with 2 out of 3 features: 1) relieved with defecation; 2) onset associated with a change in stool frequency; 3) onset associated with a change in form (appearance) of stool.
* Had to fulfill the following criteria (IBS questionnaire) during the last 3 months prior to study entry: abdominal discomfort or pain present during at least 3 weeks in the last 3 months, and at least two of the following: abdominal discomfort or pain gets better or stops after a bowel movement; change in bowel movement frequency when the abdominal discomfort or pain starts; change in bowel movement consistency when the abdominal discomfort or pain starts

Exclusion Criteria:

* IBS-D
* not reporting any constipation and diarrhea criteria
* evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit
* history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
* evidence of cathartic colon or history of laxative abuse

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
Secondary outcomes:
measure: Weekly assessment of patient's overall satisfaction relief.
measure: Over 4 weeks of treatment and during each week improvment of abdominal discomfort pain, bloating, stool frequency, stool consitency, straining urgency.
measure: During 4 week treatment period efficacy assessment in IBS-C subgroup and mixed IBS.
measure: Assessment of safety and tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: East Hanover NJ
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT06117787: Blood Pressure Monitor Clinical Test (Cuff Range: 13.5cm-19.5cm）
Official title: Blood Pressure Monitor#Model#KD-7920#Clinical Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal blood pressure and hypertensive patients over 12 years old.

Brief summary: The purpose of this study is to verify the accuracy of the blood pressure cuffs with blood pressure monitor device.

Cuff circumference is 13.5cm-19.5cm.


Eligibility criteria: Inclusion Criteria:

* Normal blood pressure and hypertensive patients over 12 years old.

Exclusion Criteria:

* Patients with serious arrhythmias or a high frequency of arrhythmias
* Pregnant woman
* Other investigators believe that it is not suitable to participate in this clinical trial

Primary outcomes:
measure: blood pressure monitor accuracy
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Study officials:
References:
Clinical trial NCT03793387: Intra-op vs Pre-op Transbronchial Localization for Small Lung Nodule
Official title: Preoperative Versus Intraoperative Transbronchial Dye Localization for Small Pulmonary Nodule : A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 40
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: Comparing pre-operative transbronchial localization under augmented fluoroscopy and intra-operative transbronchial localization using electromagnetic navigation bronchoscopy system for small lung nodules.

Detailed description: Using electromagnetic navigation bronchoscopy (ENB), transbronchial localization can be performed in the operating room (OR) under general anesthesia without extra radiation exposure, which is expected to reduce the discomfort for the patient during localization. This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 40 patients with pulmonary nodules will be randomly assigned into two groups. One group will receive bronchoscopic dye localization in the hybrid examination room equipped with cone-beam computed tomography, and the other group will receive ENB-guided dye localization in OR. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.

Eligibility criteria: Inclusion Criteria:

A. One of each: lung nodule size less than 1 cm; depth more than 2 cm; GGO lesion B. 20\~90 years old C. sign permit

Exclusion Criteria:

A. Previous emphysema, TB, COPD B. Previous ipsilateral thoracic surgery C. Bleeding tendency D. Heart failure, cirrhosis, CKD E. Pregnancy or breast feeding F. Immunocompromised G. Severe infection H. Unable to sign permit

Primary outcomes:
measure: Successful localization
timeFrame: 2 days
measure: Successful resection
timeFrame: 2 days
Secondary outcomes:
measure: Localization duration
timeFrame: 1 day
measure: Total radiation exposure
timeFrame: 2 days
measure: Complication
timeFrame: 14 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Hsin-Chu Branch
state: Hsin-Chu County
Study officials:
References:
Clinical trial NCT03127787: Clinical Performance Evaluation of DxN CMV Assay
Official title: Clinical Performance Evaluation of DxN CMV Assay
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cytomegalovirus
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult kidney transplant recipients undergoing CMV therapy

Brief summary: The DxN Cytomegalovirus (CMV) assay is an in vitro diagnostic assay intended as an aid in the management of CMV-infected individuals undergoing antiviral therapy. the purpose of the study is to establish the clinical performance of the DxN CMV Assay for plasma samples in the intended use population.

Detailed description: same as brief summary

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Must have had a kidney transplant and be evaluated for post-transplantation care
* Must have demonstrated post-transplant CMV DNAemia
* Must be eligible for and treated with anti-CMV drugs

Exclusion Criteria:

* HIV positive
* Proven ganciclovir or valganciclovir resistance

Primary outcomes:
measure: virological response to therapy
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Chicago
country: United States
facility: NWU
state: Illinois
city: Indianapolis
country: United States
facility: IU
state: Indiana
city: Rochester
country: United States
facility: Mayo
state: Minnesota
Study officials:
References:
Clinical trial NCT00212277: Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.
Official title: Phase3,Open-label,Long-term,NSAID-Add-on,Clinical Trial of Mono-phase Low-dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysmenorrhea
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2005-09-21
Sex: FEMALE
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: The purpose of this long-term study is to determine whether combination oral contraceptive pill of Norethindrone \& Ethinyl estradiol is effective in the treatmentof dysmenorrhea associated with endometriosis.


Eligibility criteria: Inclusion Criteria:

* dysmenorrhea associated with endometriosis

Exclusion Criteria:

* severe hepatopathy
* pregnant woman

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tottori University,Tottori,Japan
name: Naoki Terakawa, M.D.,Ph.D.
role: STUDY_DIRECTOR
References: