louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00437619: A Study of Sequential Treatment With Daivobet (Betamethasone Dipropionate Plus Calcipotriol) and Daivonex (Calcipotriol) in Patients With Psoriasis.
Official title: An Open Label Study to Evaluate the Clinical Response to Sequential Treatment With Daivobet and Daivonex in Patients With Mild to Moderate Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-02-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the efficacy and safety of sequential treatment with Diavobet (betamethasone propionate 0.5mg/g plus calcipotriol hydrate 50 micrograms/g) once daily for 4 weeks followed by Daivonex (calcipotriol hydrate 50 micrograms/g) twice daily for 4 weeks, in the control of signs and symptoms in patients with mild to moderate psoriasis. Only patients showing a \>50% response to Daivobet will progress to the Daivonex maintenance phase. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* clinical diagnosis of psoriasis vulgaris;
* PASI score 1-12 in \>=1 body area.

Exclusion Criteria:

* clinical presentation of erythrodermic pustular psoriasis, expressed in plates and localized lesions on face and/or scalp;
* viral, fungal or bacterial skin infections;
* use of any topical treatment for psoriasis within previous 15 days;
* use of any systemic therapy and phototherapy for psoriasis within previous 30 days.

Primary outcomes:
measure: PASI reduction
timeFrame: Weeks 4 and 8
Secondary outcomes:
measure: AEs.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Belem
country: Brazil
city: Belo Horizonte
country: Brazil
city: Botucatu
country: Brazil
city: Brasilia
country: Brazil
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04228341: The Effect of Degree of Rice-polishing on Glycaemic Response
Official title: The Effect of Degree of Rice-polishing on Glycaemic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Obesity
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2020-01-14
Enrollment: 14
Sex: MALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover design
Primary purpose: OTHER

Brief summary: To investigate the effects of rice polishing on glycaemic and insulinaemic response in healthy Chinese male volunteers.

Detailed description: There will be a total of 8 test session. Each session will last for 3.5 hours. At each test session, volunteers will be served with test meal and blood will be collected. After an overnight fast, subjects will visit the research center. Two fasting capillary blood samples will be collected via fingerprick. Following the fasting samples, subject will consume the test meals. Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal. These samples will be used to analyses for whole capillary blood glucose. At every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.

Eligibility criteria: Inclusion Criteria:

* Male
* Chinese ethnicity
* Age ≥21 and ≤ 60 years
* Body mass index between 18.5 to 25 kg/m2
* Normal blood pressure =\<140/90 mmHg
* Fasting blood glucose \<6.0 mmol/L
* In general good health

Exclusion Criteria:

* Current smoker
* Have any metabolic diseases (such as diabetes, hypertension etc)
* Do not have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* Have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
* Have intolerances or allergies to any foods
* Currently partake in sports at the competitive and/or endurance levels
* Intentionally restrict food intake

Primary outcomes:
measure: Glucose
timeFrame: Up to 180 minutes
Secondary outcomes:
measure: Insulin
timeFrame: Up to 180 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References:
Clinical trial NCT00837941: A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)
Official title: Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Painful Diabetic Neuropathy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.


Eligibility criteria: Inclusion Criteria:

* Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin
* Patient has pain in both feet that occurred after onset of diabetes
* Patient agrees to maintain a consistent activity level throughout the study
* Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy
* Female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study
* Patients taking a pain medication must be on a stable dose at least 1 month prior to participating in study

Exclusion Criteria:

* Patient has a history of congestive heart failure
* Patient has/had a seizure disorder
* Patient has tried and failed 3 or more drugs to treat neuropathic pain
* Patient is currently taking pregabalin or duloxetine hydrochloride
* Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma)
* Patient has history of hepatitis B or C or HIV infection
* Patient has skin-condition that may decrease sensitivity in area of neuropathic pain

Primary outcomes:
measure: analgesic efficacy measured by patients self reported pain level after single dose administration
timeFrame: 5-11 hours after single dose is administered
Secondary outcomes:
measure: The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo
timeFrame: 24 hours after single dose is administered
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00128141: Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
Official title: Effect of Maternal Tactile and Kinesthetic Stimulation on Length of Hospital Stay of Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Lead sponsor: National Bioethics Commission of Brazil
Sponsor class: OTHER
First posted: 2005-08-09
Enrollment: 104
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation. Gain of weight, length and head circumference, date of the beginning of enteral feedings, length of time to recover birth weight and age of hospital discharge will be recorded and compared between both groups.

Detailed description: Preterm infants birth weight equal or less than 1500 grams and gestational age equal or less than 32 weeks will be randomized in two groups: standard care that will receive the usual treatment applied to all infants admitted to our unit and a second groups that will receive standard care plus maternal tactile and kinesthetic stimuli that will be taught to the mothers. Randomization will be performed among those that accept to participate in the study. Growth (birth, length and head circumference), age of life to start receiving enteral feedings, length of hospital stay, time to recover birth weight will be recorded and compared between both groups.

Eligibility criteria: Inclusion Criteria:

* Preterm newborns with birth weight equal to or less than 1500 grams and gestational age equal to or less than 32 weeks.
* Mother willing to participate in study.

Exclusion Criteria:

* Major congenital malformations
* Congenital infectious diseases
* Mother not willing to participate in study

Primary outcomes:
measure: length of hospital stay
Secondary outcomes:
measure: effect on beginning of enteral feedings
measure: growth during hospitalization
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Universidade Federal do Rio Grande do Sul-Hospital de Clínicas de Porto Alegre
name: Renato S Procianoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00525941: An Exploratory Study of NBI-34060 Capsules and Next Day Functioning
Official title: An Exploratory Phase IIIb, Single-Blind, Outpatient Study to Assess Next-Day Functioning in Adult Primary Insomnia Patients Following the Administration of NBI-34060 Capsules During the Night
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Insomnia
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2007-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel during the next day after dosing with NBI-34060. The study will also examine the pattern and extent of nighttime awakenings as reported by the patients, as well as and the patient's sleep experience during treatment.


Eligibility criteria: Inclusion Criteria:

* insomnia (DSM-IV diagnosed; at least one month)
* Nocturnal awakenings
* Usual bedtimes between 9:00PM and Midnight.
* Bedtimes that do not vary by more than 2 hours on 5 or more nights per week.
* A usual time in bed of 7 to 9 hours.

Exclusion Criteria:

* no serious concomitant illness
* no other condition that could interfere with sleep

Primary outcomes:
measure: Assessments of Next-Day Function
timeFrame: daily/six weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: biweekly/six weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: New York
country: United States
facility: Clinilabs, Inc.
state: New York
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cincinnati
country: United States
facility: Tri-State Sleep Disorders Center
state: Ohio
Study officials:
affiliation: Clinilabs, Inc.
name: Gary K. Zammit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03144141: Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
Official title: Association Between Holter Electro Hysterogram (EHG) and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Preterm delivery accounts for about 10% of deliveries in France. Prematurity is the leading cause of perinatal morbidity and mortality in economically developed countries. Despite the development of therapeutics and paraclinic examinations, this rate of preterm delivery remains stable or even increases. The use of medically assisted procreation techniques alone can not explain this rate.

The analysis of the electrical activity of the uterus (electrohysterograms) is a promising technique for early diagnosis of the risk of premature delivery, allowing better management of the patients. This study is part of a European theme to study risk factors for the prevention of prematurity.


Eligibility criteria: Inclusion Criteria:

* Patients arriving at maternity emergency for threat of premature birth between 26 SA and 35 SA defined by uterine contractions and a cervical modification
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patient minor,
* Associated Obstetric Pathology: Pre-Eclampsia, Premature Rupture of Membranes (RPM)
* Patient under tutelage or curatorship or deprived of public law

Primary outcomes:
measure: Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT04073641: Survey of People With Diabetes, Caregivers of People With Diabetes Parents of Children and Young People With Diabetes
Official title: Danish Diabetes Barometer Survey 2019
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Diabetes Association
First posted: 2019-08-29
Enrollment: 10500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with type 1 and type 2 diabetes, caregivers of people with diabetes and parents of children and young people with diabetes. Primary survey population are members of the national diabetes association.

Brief summary: A survey of people with diabetes and caregivers of people with diabetes and parents of children and young people with diabetes in Denmark in order to assess perceived diabetes related health and wellbeing and perceived access to and gaps in medical care, support and other financial and support services.

Detailed description: A questionnaire survey was designed for online completion by people with diabetes and caregivers of people with diabetes and parents of children and young people with diabetes in Denmark in order to assess their perceived diabetes related health and wellbeing and perceived access to and gaps in medical care, support and other financial and support services. The aim is for the survey to provide a cross-sectional assessment of present access to health, wellbeing and care for people with diabetes and caregivers in Denmark and to establish a survey tool suitable for ongoing long-term monitoring of well-being, care and support to people with diabetes and caregivers in Denmark.

Eligibility criteria: Inclusion Criteria:

* Age over 18

Exclusion Criteria:

* Not able to complete online questionnaire

Primary outcomes:
measure: Diabetes membership survey of health, access to care, support and services
timeFrame: The survey was administered from April 11 to 29th 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Niels Ejskjaer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Soren E Skovlund, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT04598841: Nutrition Support for Hirschsprung Disease
Official title: A Multicentric Study on Pre-operative Nutritional Support for Hirschsprung's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Supporting
Hirschsprung Disease
Infants
Prospective Study
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 110
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A multi-center, prospective,randomized, non-blind, controlled study was conducted to investigate the effects of different pre-operative nutritional support modes on perioperative nutritional status, surgical treatment success rate, and rehabilitation process in children with Hirschsprung disease.


Eligibility criteria: Inclusion Criteria:

1. Children aged 0-5 years.
2. Clinical diagnosis with Hirschsprung's disease who requires surgery;

Exclusion Criteria:

1. Complicated with severe complications such as enterocolitis associated with Hirschsprung disease;
2. History of diseases associated with various organ systems that may be life-threatening;
3. Other severe digestive tract malformations or other diseases that may interfere with the treatment or compliance of the child;
4. Patients who have participated in other clinical trials within the last 1 month;
5. Any other conditions in which the investigator considers it inappropriate to participate in the trial.

Primary outcomes:
measure: rate of postoperative HAEC
timeFrame: 3 months
Secondary outcomes:
measure: Z score
timeFrame: 3 months
measure: LOS
timeFrame: 1 months
measure: reoperation
timeFrame: 3 months
measure: readmission
timeFrame: 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT04739241: Premixed vs Basal Bolus Insulin Therapy in Older Patients With Type 2 Diabetes
Official title: Is Premixed Insulin Therapy an Alternative to Basal Bolus Therapy in Type 2 Diabetes Mellitus People Older Than 65 Years Old: A Pilot Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: premixed insulin therapy
basal-bolus insulin therapy
type 2 diabetes
elderly
Lead sponsor: Consorci Sanitari Integral
Sponsor class: OTHER
First posted: 2021-02-04
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 purpose of this study is to compare efficacy and security of premixed insulin treatment vs basal bolus insulin treatment in older patients with poorly controlled type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Outpatients
* Age ≥ 65 years old
* Type 2 diabetes mellitus
* HbA1c ≥9% (74 mmol/mol)
* Previously treated with one or two doses of basal insulin and oral hypoglycaemic agents

Exclusion Criteria:

* Severe insulin-resistance
* High doses of corticosteroids
* Chemotherapy treatment
* High comorbidity
* Bad compliance of the treatment
* Frequent severe hypoglycaemia

Primary outcomes:
measure: Change in HbA1c levels
timeFrame: 12 months after recruitment
Secondary outcomes:
measure: Incidence of hypoglycaemia as an adverse effect of the treatment
timeFrame: every month during the 12-month follow-up
measure: Incidence of dosing errors as a measure of the safety of the treatment
timeFrame: every month during the 12-month follow-up
measure: Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12.
timeFrame: 12-month follow-up
measure: Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12.
timeFrame: 12-month follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04983641: Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit
Official title: Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit: A Prospective, Randomized, Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Keywords: PROMIS
Patient Reported Outcomes Measurement Information System
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patient-Reported Outcomes Measurement Information System (PROMIS) forms will be administered remotely to consecutive Orthopaedic patients presenting for new physician clinic visits. These patients will be sent either reminder e-mails, reminder digital patient portal ("MyChart") messages, or no reminder messages at all concerning PROMIS form completion at timepoints prior to their respective clinic visits and PROMIS form completion rates will consequently be assessed. The primary objective of this study is to develop an understanding of whether pre-visit reminder messages influence PROMIS form completion in Orthopaedic patients.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* English speaking
* No previous PROM form completion at the healthcare system
* Seeing a respective orthopedic provider for the first time
* Active registration with the electronic medical record (EMR; Epic, Verona, WI) patient portal ("MyChart")
* Valid e-mail address.

Exclusion Criteria:

* Under 18 years old
* Non-English speaking
* Previous PROM form completion at the healthcare system
* Seeing a respective orthopedic provider for follow-up
* No active registration with the electronic medical record (EMR; Epic, Verona, WI) patient portal ("MyChart")
* No valid e-mail address.

Primary outcomes:
measure: Pre-visit PROMIS completion rates in orthopaedic patients receiving reminder e-mails, digital patient portal ("MyChart") message reminders, or no messages prior to scheduled clinic visit
timeFrame: 1 week
measure: At-visit PROMIS completion rates in orthopaedic patients receiving reminder e-mails, digital patient portal ("MyChart") message reminders, or no messages prior to scheduled clinic visit
timeFrame: 1 week
measure: Overall (Pre-visit and at-visit) PROMIS completion rates in orthopaedic patients receiving reminder e-mails, digital patient portal ("MyChart") message reminders, or no messages prior to scheduled clinic visit
timeFrame: 1 week
Secondary outcomes:
measure: Time to pre-visit PROMIS form completion
timeFrame: 1 week
measure: PROMIS form completion rates according to patient demographics
timeFrame: 1 week
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References: