louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02365376: Collection and Storage of Human Biospecimens for Research Into Rare Diseases and Medical Conditions
Official title: Collection and Storage of Human Biospecimens for Research Into Rare Diseases and Medical Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rare Genetic Disorders
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-02-18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with rare genetic diseases or medical conditions actively being investigated by BioMarin.

Brief summary: The objective of this protocol is to enable collection of biospecimens to facilitate current and future multidisciplinary research in rare genetic disorders and medical conditions.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written, signed informed consent
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Use of any investigational product or investigational medical device within 30 days prior to screening, except as part of a BioMarin-sponsored study
* Concurrent disease or condition that would interfere with study participation or safety.

Primary outcomes:
measure: continuous collection of donated study subject samples
timeFrame: unknown, continuous sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT01538576: Paediatric Subjects - Special Survey
Official title: Special Survey for Paediatric Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-24
Enrollment: 71
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under 15 years of age with diabetes requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)

Brief summary: This study is conducted in Japan. The aim of this study is to collect safety and efficacy data when using insulin aspart in children with diabetes under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Subjects with diabetes requiring insulin therapy

Exclusion Criteria:

* Subjects who had treatment history of insulin aspart

Primary outcomes:
measure: Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control
timeFrame: Year 1
measure: HbA1c (glycosylated haemoglobin)
timeFrame: Year 1
Secondary outcomes:
measure: Hypoglycaemic events
timeFrame: Year 1
measure: Adverse Events
timeFrame: Year 1
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01119976: Association Between the Menstrual Cycle and Weight Loss
Official title: Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Sierra Neuropharmaceuticals
First posted: 2010-05-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study to look at the association between weight loss and the menstrual cycle in healthy, overweight, premenopausal women. Participants will be asked to follow a reduced-calorie diet and exercise plan for 3 months.

Detailed description: Two different reduced calorie diet and exercise plans will be compared. One plan changes diet and exercise prescription with the phases of the menstrual cycle, while the other is a standard reduced calorie diet and exercise plan based on MyPyramid.gov website.

Eligibility criteria: Inclusion Criteria:

* Healthy females between the ages of 18-40 (inclusive)
* BMI between 26.5-35.4 kg/m² (inclusive)
* Regular menstrual cycle (28 ± 3 days)
* Weight stable (within ± 3-kg) 2 months prior to study inclusion
* Must use barrier contraception (e.g. male/female condom) for the study's duration
* Must be willing to follow the prescribed diet/exercise plan for the study's duration

Exclusion Criteria:

* On hormonal contraceptives or any other daily use of medications which can make the subject unsuitable for inclusion in the study.
* Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.)
* Restrictions against participating in cardiovascular exercise and strength training
* Any condition, which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
* Women who are pregnant, lactating, or planning to become pregnant during the study period

Primary outcomes:
measure: Body weight
timeFrame: 3 months
Secondary outcomes:
measure: Waist Circumference
timeFrame: 3 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Center for Human Nutrition
state: Colorado
Study officials:
affiliation: University of Colorado Denver and Health Sciences Center
name: James O Hill, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00980876: A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
Official title: Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Externa
Lead sponsor: Farmoquimica S.A.
Sponsor class: INDUSTRY
Collaborators: name: Pharmagenix Projetos em Medicina Farmacêutica Ltda.
First posted: 2009-09-21
Enrollment: 224
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.

Detailed description: Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study.

Population: 224 patients with external otitis , men and women aged between 1 - 70 years.

Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure).

Secondary endpoint: The endpoint will be the identification of the side effects of medication use.

Eligibility criteria: Inclusion Criteria:

* Informed of the nature of the study and given written informed consent;
* Patients with acute otitis externa;
* Intact tympanic membrane.

Exclusion Criteria:

* Known allergy or sensitivity to Ciprofloxacin Hydrochloride and Hydrocortisone;
* Patient has the tympanic membrane not intact;
* Diabetes
* Bilateral Acute Otitis Externa;
* Pregnant or lactating patients;
* Overt fungal Acute Otitis Externa;
* Other diseases of the ear
* Current Infection requiring systemic antimicrobial therapy.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.

Primary outcomes:
measure: Cure (reduced pain, swelling and otorrhea)
timeFrame: 7 days
Secondary outcomes:
measure: Identification of possible side effects
timeFrame: 7 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Clínica Quiron
state: São Paulo
Study officials:
affiliation: Clínica Quiron
name: Agricio N. Crespo, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00768976: Study of Patient Satisfaction With the Cancer Clinical Trial Experience
Official title: Study of Patient Satisfaction With the Cancer Clinical Trial Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Participant must have participated in a clinical trial conducted by the Summa Health System Hospitals Cancer Research Program.
Participant should have been registered for clinical trial participation three months prior to receiving the satisfaction survey.
Lead sponsor: Summa Health System
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant must have participated in a clinical trial conducted by the Summa Health System Hospitals Cancer Research Program.

Brief summary: The primary objective of this study is to evaluate the quality of the clinical trial experience of cancer patients participating in cancer research studies through Summa Health System Hospitals Cancer Research Program by evaluating patient satisfaction regarding reasons for participating, facility, consent and treatment, personal issues and overall assessment.

The secondary objective of this study is to determine areas for improvement to make the patient's clinical trial experience a satisfying and positive journey.


Eligibility criteria: Inclusion Criteria:

* Participant must have participated in a clinical trial conducted by the Summa Health System Hospitals Cancer Research Program.
* Participant should have been registered for clinical trial participation three months prior to receiving the satisfaction survey.

Exclusion Criteria:

* Participant has withdrawn consent for clinical trial participation and/or follow up.
* Participant has a major medical illness that would prevent completion of the survey.

Primary outcomes:
measure: Evaluation of surveys to determine if there are opportunities for performance and/or quality improvement projects.patient satisfaction regarding reasons for participating, facility, consent and treatment, personal issues and overall assessment.
timeFrame: Survey will be sent to subject 3 months after study registration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Summa Health System
name: Joyce Neading, RHIT, CTR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04029376: Study to Learn More About the Stomach and Intestine Complaints of Children Aged From 3 to 14 Years
Official title: Non-Interventional Study of Children Aged From 3 to 14 Years Suffering From Functional Gastrointestinal Complaints Classified According to the Rome Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 1032
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female children aged between 3 and up to 14 years with Functional Gastrointestinal Complaints

Brief summary: In this observational study, researchers want to gain more information on children suffering from abnormal stomach and intestine function (based on the Rome criteria) and treated Iberogast. The Rome criteria have been developed by experts to support doctors to diagnose stomach and intestine disorders. This study will focus on children aged from 3 to 14 years in age treated by their doctor with the herbal drug Iberogast for their stomach and intestine complaints for one week. Researcher want to learn more about the efficacy of Iberogast by observing the changes of symptoms related to the stomach and intestine disorders. In addition information on the safety of the drug and how well the drug is tolerated by the patients will be collected.


Eligibility criteria: The selection of the children to be documented was the sole responsibility of the physician whereby the information of the Rome III criteria on functional gastrointestinal diseases in children as well as the prescribing information on Iberogast could be consulted as guideline. Only the therapeutic necessity was determining for the use of all medicines. The treating physicians received standardised information regarding the ailment picture (Rome III criteria) before the beginning of the study and during the investigator meetings.

Primary outcomes:
measure: Gastrointestinal Symptoms Profile (GIS) Score
timeFrame: Up to 1 week
measure: Global Assessment of the Efficacy by the Physicians
timeFrame: Up to 1 week
measure: Global Assessment of the Efficacy by the Children or Their Parents
timeFrame: Up to 1 week
measure: Lost Attendance days
timeFrame: Up to 1 week
Secondary outcomes:
measure: Global Assessment of the Tolerability by the Physician
timeFrame: Up to 1 week
measure: The number of subjects with adverse events
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
References:
Clinical trial NCT02936076: Exercise as a Buffer Against Stress-induced Overeating
Official title: Exercise as a Buffer Against Stress-induced Overeating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-10-18
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the psychological benefits of chronic exercise as well as the effects of exercise training on eating behaviors and stress-induced overeating in overweight and obese women. Participants will be randomized to an 12-week exercise condition or a delayed exercise condition. Assessments will occur at baseline, 6 weeks, and 12 weeks and will include answering surveys in real-time using smartphones, several assessments of eating behaviors and dietary intake, and questionnaire measures of factors which could mediate the relationship between exercise and eating. Participants will be compensated for completing assessments and for adherence to the exercise protocol.


Eligibility criteria: Inclusion Criteria:

* Female
* 18-60 years of age
* BMI 25 to \<40 kg/m2
* Physically inactive (\<60 min/week of physical activity)
* Must own a smartphone
* Must be willing to receive and respond to text message prompts for 14 days at baseline, 6 and 12 weeks

Exclusion Criteria:

* Shift workers
* Individuals who do not endorse stress-eating
* Recent weight loss or current enrollment in a weight loss program
* Women who are pregnant or plan on becoming pregnant in the next 6 months
* Any medical condition that would limit participation in physical activity
* Diabetes
* Inability to walk without an assisted device
* Inability to meet exercise recommendations
* Failure to adequately complete all baseline assessment measures

Primary outcomes:
measure: Stress-induced Overeating Measured Via Smartphone Surveys
timeFrame: 12 weeks
measure: Percentage of Overeating Episodes Characterized as 'Overeating'
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Body Weight (% Initial Weight)
timeFrame: baseline and 12 weeks
measure: Stress as Measured Via Questionnaire
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References:
citation: Unick JL, Dunsiger SI, Leblond T, Hahn K, Thomas JG, Abrantes AM, Stroud LR, Wing RR. Randomized Trial Examining the Effect of a 12-wk Exercise Program on Hedonic Eating. Med Sci Sports Exerc. 2021 Aug 1;53(8):1638-1647. doi: 10.1249/MSS.0000000000002619.
Clinical trial NCT03960476: Decision Making and Implementation of Aging-in-Place/Long Term Care Plans Among Older Adults
Official title: Decision Making and Implementation of Aging-in-Place/Long Term Care Plans Among Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-05-23
Enrollment: 293
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study participants receive access to the web-based study intervention, PlanYourLifespan.org.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study seeks to better understand how older adult aging-in-place/long term care decision making and implementation is impacted by age-related changes (e.g. cognition, health literacy, chronic conditions), social influences (e.g. caregivers/supporters), and environmental factors.

Detailed description: Subjects who are part of the National Institute on Aging (NIA)-funded LitCog study will be given access to PlanYourLifespan.org, a web-based decision-making and planning tool. Participants will be followed for up to 42 months to examine the mediating/moderating factors involved in decision-making, timing of decision implementation, and goal concordance. Findings have the potential to inform healthcare providers, caregivers, health/long term care insurers, area agencies on aging, and older adults nationally in supporting aging-in-place decisions and services use.

Eligibility criteria: Inclusion Criteria:

* Current participant in the LitCog Trial \[R01AG03611\]
* English-speaking
* Community-dwelling
* Currently use a computer or tablet with internet

Exclusion Criteria:

* Previous participation in the Advanced Planning for Home Services study \[IH-12-11-4259\]

Primary outcomes:
measure: Change in long-term care plan decision-making
timeFrame: Change from baseline decision-making at 36 months. Will also be measured every six months, up to 42 months.
Secondary outcomes:
measure: Participant utilization of long-term care services
timeFrame: Baseline and every six months, up to 42 months
measure: Number of participants that implement any of their long-term care plans
timeFrame: Baseline and every six months, up to 42 months
measure: Participant long-term care goal concordance
timeFrame: Baseline and every six months, up to 42 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT01021176: Evaluate a Medication on How Hunger and Appetite Are Influenced by Smell
Official title: A Single Dose Pilot Study to Evaluate the Safety and Dose-Response of Smell to Intranasal Diltiazem
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Food Intake
Keywords: Food Intake
Hunger
Lidocaine
Nose
smell
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Compellis Pharmaceuticals
First posted: 2009-11-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray which will then reduce food intake.

Detailed description: You will fast on your first visit. Complete questionnaire about taste and smell to insure you don't have a cold or anything that would interfere with sense of smell. Your nose will be checked. Blood pressure taken, and administer to you a spray with diltiazem 2, 4, 8 mg or a placebo. Your sense of smell will be tested at different time points.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 25 and 40 kg
* Blood pressure in within normal range

Exclusion Criteria:

* Used tobacco products in the past month
* Used a calcium channel blocker medication in the last month
* used nasal sprays in the last month
* have an abnormal sense of smell or abnormalities of the lining in your nose
* female and have irregular menstrual periods
* female and are nursing a baby or pregnant
* female and have had a partial hysterectomy (still have ovaries)

Primary outcomes:
measure: Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray.
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank L. Greenway, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00811460: A Study of Taspoglutide in Type 2 Diabetic Patients
Official title: A Double-blind, Crossover, Randomized, Placebo-controlled Study to Investigate the Effect of Two Different Doses of Taspoglutide IRF Administered as Continuous Subcutaneous Infusion on First- and Second-phase Insulin Secretion in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-65 years of age;
* type 2 diabetes mellitus;
* treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* type 2 diabetes duration of \<3 months;
* treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
* treatment with insulin for \>7 days within 6 months prior to screening.

Primary outcomes:
measure: Incremental area under insulin concentration time curve relative to basal insulin concentration
timeFrame: First 10 minutes after glucose bolus
Secondary outcomes:
measure: Incremental area under insulin concentration time curve relative to basal insulin concentration
timeFrame: 10-120 minutes after glucose bolus
measure: Adverse events, laboratory parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: