louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01947842: Effect of a Smartphone Application on Oral Contraceptive Adherence in College Females
Official title: Effect of a Smartphone Application on Oral Contraceptive Adherence in College Females: a Randomized-controlled Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adherence to Oral Contraceptive Therapy
Keywords: Smartphone
adherence
contraceptives
college
females
Lead sponsor: Belmont University
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is to see if smartphone applications help college women remember to take birth control better than pharmacist consultation alone. Patients will participate in this study for 6 (six) months. The study will have two groups. Patients will be randomly assigned to one group or the other. The control group will be counseled by the pharmacist on the importance of taking birth control as prescribed. The study group will get the same counseling, but will also be set up to receive reminders to take medication on a smartphone application called Dosecast.


Eligibility criteria: Inclusion Criteria:

* female gender
* 18-29 years of age
* current prescription for an OCP
* currently enrolled as a student at the institution associated with the pharmacy
* possession of a compatible smartphone.

Exclusion Criteria:

* Pregnant patients
* Patients who become pregnant during the study will discontinue, but their data up until time of discontinuation will be used
* Patients using other forms of contraception (patch, injection, IUD, intra-vaginal ring, implant).

Primary outcomes:
measure: Doses Missed
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
city: Oxford
country: United States
facility: University of Mississippi
state: Mississippi
city: Nashville
country: United States
facility: Belmont University
state: Tennessee
Study officials:
References:
Clinical trial NCT01863342: Influence of Central Sensitization on Efficacy of Patient-controlled Epidural Analgesia in Osteoarthritis Patients Undergoing Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Keywords: central sensitization; osteoarthritis; epidural analgesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: osteoarthritis patients undergoing total knee replacement

Brief summary: Nociceptor inputs can trigger a prolonged but reversible increase in the excitability and synaptic efficacy of neurons in central nociceptive pathways, the phenomenon of central sensitization. The degenerative joint disease, osteoarthritis, with characteristic destruction of cartilage and alteration in bone is a very common cause of chronic pain. The degree of pain does not always correlate with the extent of joint damage or presence of active inflammation raising the possibility that there may be a central component to the pain. The central sensitization inventory (CSI) is a new self-report screening instrument to measure the degree of central sensitization, and to help identify patients with central sensitivity syndromes. The aim of this investigation is to evaluate the influence of preoperative central sensitization, which represented by CSI score, on postoperative pain score in osteoarthritis patients undergoing total knee replacement who receiving patient-controlled epidural analgesia.


Eligibility criteria: Inclusion Criteria:

* Aged 20 to 80 years osteoarthritis patients undergoing total knee replacement under spinal anesthesia, and who receiving postoperative epidural PCA

Exclusion Criteria:

* refusal
* coagulopathy
* neurologic deficit
* preoperative opioids medication
* recent analgesics change

Primary outcomes:
measure: Peak pain score
timeFrame: at the point of Epidural PCA to postoperative 1-48 h
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04510142: Questionnaire Follow=up Study Sonia 2
Official title: Questionnaire Follow=up Study Sonia 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alkaptonuria
Homogentisic Acid
Homogentisate Dioxygenase
Alkaptonuria Severity Score Index
Keywords: Royal Liverpool University Hospital
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-08-12
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cross-sectional cohort who completed SONIA 2 Study

Brief summary: Survey of health of patients completing SONIA 2 study: A cross-sectional analysis by questionnaire

Detailed description: The Liverpool site will post the once only, short questionnaire (in the correct language using translated documents as appropriate) to the address of those patients who completed SONIA 2. Hospital approved translation services will be used. A return-addressed stamped envelope for ease of return will also be provided. Those who received nitisinone will be sent the nitisinone-administration questionnaire and those who did not receive nitisinone will be sent a no-nitisinone questionnaire

Eligibility criteria: Inclusion Criteria:

- Documented diagnosis of AKU. Age ≥16 years.

Exclusion Criteria:

- Not completed SONIA 2 study for the full 4-year duration.

Primary outcomes:
measure: to collect information on their health status since completing participation in SONIA 2
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Royal Hospitals NHS Foundation Trust
Study officials:
References:
Clinical trial NCT03934242: Impact of Information Campaign's Alongside Maternity Staff About Bedding Infant
Official title: Impact of Information Campaign's Alongside Maternity Staff About Bedding Infant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Death in Children
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 300
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: every newborn

Brief summary: It is now well established that infants should be placed on the back only in a SleepSack without coverage or plush or pillow on a firm mattress in a bedroom. Despite these old recommendations of good practice, deviations are observed and some infants are most always lying according to the recommended position. The goal is to assess the impact of an information campaign of staffs maternity of the CHU of Reims on the practices of the sleeping of infants to motherhood, and then at the home of the parents.

Detailed description: Proposal for participation to the holders of parental authority of newborns eligible within 72 hours after the birth of the child. If acceptance of participation, the newborn will be included in the study. Participation in the study will not affect the medical care of the child. Participation in the study will consist of: a collection of data including the child sleeping mode, complete a questionnaire covering the child sleeping habits to motherhood and home during the 1st month of life. Information on the habits of sleeping in the home of the child will be collected via a phone call by an investigator. Inclusions will be held over 2 periods: one before and one after the completion of training of health care personnel regarding the sleeping of infants nursing staff training will consist of oral information by the investigative team and written information...

Eligibility criteria: Inclusion Criteria:

* born in reims CHU
* parents are 18 years old or more
* parents accept their participation in the study

Exclusion criteria :

* hospitalization in URIP / kangourou / neonatalogy
* needed baby warmer

Primary outcomes:
measure: correct new born's bedding
timeFrame: Day 0
measure: correct new born's bedding
timeFrame: month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT01110642: Novel Treatment for Syndromic Ichthyoses
Official title: Open-label, Pilot Study to Assess Cholesterol-Lovastatin Solution in the Treatment of Syndromic Ichthyoses
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Syndromic Ichthyoses
CHILD Syndrome
Smith Lemli Opitz Syndrome
Conradi Syndrome
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-04-26
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label-pilot study to assess the efficacy and safety of a novel cholesterol-lovastatin topical solution in children with rare syndromic ichthyoses. Often times, these children have difficulty in finding easily applied treatments to make their psoriasiform and ichthyotic plaques more manageable. We propose the use of a cholesterol-lovastatin topical solution as a treatment option with the hypothesis that it will lead to regression of involved areas and decreased erythema and warty-like appearance of the plaques. We plan to enroll children with syndromic ichthyoses over the age of 1 year for a 12 month study with a total of 5 visits and 5 phone calls.


Eligibility criteria: Inclusion Criteria:

* Informed Consent form signed by the subject or subject's legal representative; also, if the subject is under the age of majority but capable of providing assent, signed assent from the subject.
* Diagnosis of a syndromic ichthyoses (verified by Dr Amy S. Paller).
* Children and adults 12 months of age and above

Exclusion Criteria:

* Use of any investigational drug within the 30 days before enrollment.
* Current malignancy.
* Pregnancy or breastfeeding during the study. (All female subjects of childbearing potential will be assessed for pregnancy at all visits.)

Primary outcomes:
measure: Physician global assessment of severity (PGAS)
timeFrame: 12 months
Secondary outcomes:
measure: Total body surface area (TBSA)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Amy S Paller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00809042: Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia
Official title: The Effect of Combination Therapy of Hydroxyurea With L- Carnitine and Magnesium Chloride on he-Matologic Parameters and Cardiac Function of β-Thalassemia Intermedia Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: β-Thalassemia Intermedia
Keywords: Hydroxyurea
magnesium chloride
L-carnitine
β-thalassemia intermedia
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-12-16
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is determination of the efficacy of combination of hydroxyurea with L-carnitine or magnesium in improving hematologic parameters and cardiac status in patients with β-thalassemia intermedia in comparison with hydroxyurea alone .


Eligibility criteria: Inclusion Criteria:

* Beta thalassemia intermedia patients with mean hemoglobin level \>= 7gr/dl, need to blood transfusion with more than 6 months interval or no need to blood transfusion

Exclusion Criteria:

* Hypothyroidism
* Hypoparathyroidism
* Diabetes mellitus
* Hepatitis B and C
* Positive tests for human immunodeficiency virus
* Any cardiac symptoms or receiving drug for cardiac disease
* Presence of other hemoglobinopathies except thalassemia intermedia and pregnant or lactating womens

Primary outcomes:
measure: Hematologic Parameters
timeFrame: monthly
Secondary outcomes:
measure: echocardiographic parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Hematology Research Center of Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Hematology Research Center of Shiraz University of Medical Sciences
name: Mehran Karimi, Full Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02246842: A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.
Official title: A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam® 1500IU to Rhophylac® 1500IUin Rh-D-negative Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-23
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Females
* Ages of 18 and 55 years
* Bodyweight of 50-85kg.

Exclusion Criteria:

* Clinically relevant abnormalities at physical examination, ECG or laboratory tests.

Primary outcomes:
measure: Cmax for anti-D
timeFrame: Pre-dose, 1, 8, 24, 32, 48, 72 & 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 & 14 weeks post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Unit 34, Surrey Technology Centre, Surrey Research Park
country: United Kingdom
facility: Guildford Clinical Pharmacology Unit
state: Occam Road, Guildford, Surrey
Study officials:
affiliation: Guildford Clinical Pharmacology Unit
name: Dr A Sutton, MB BS, FFARCSI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04356742: Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-22
Enrollment: 198
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.


Eligibility criteria: Inclusion Criteria:

1. Patients with type II diabetes mellitus aged 19 years or older
2. Patients who had taken metformin(≥1000mg/day) and DPP(dipeptidyl peptidase)-4 inhibitor combination therapy(or complex is allowed) at the same dose for at least 8 weeks prior to the screening visit
3. Patients with fasting plasma glucose≤250mg/dL at the screening visit
4. Patients with 18.5kg/m\^2≤BMI≤40kg/m\^2 at the screening visit
5. Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion Criteria:

1. Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
2. Patients with a medical history of New York Heart Association(NYHA) class III\~IV heart failure or with congestive heart failure, acute and unstable heart failure
3. Patients with severe infectious disease or severe traumatic systemic disorders
4. Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
5. Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
6. Patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit

Primary outcomes:
measure: Change from the baseline in HbA1c (%) after 24 weeks
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks
timeFrame: Baseline, 24 weeks
measure: Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks
timeFrame: Baseline, 24 weeks
measure: Change from the baseline in weight after 24 weeks
timeFrame: Baseline, 24 weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon St. Mary's Hospital
Study officials:
References:
Clinical trial NCT00767442: Least Invasive Nonlinear Light Microscopy
Official title: Least Invasive Nonlinear Light Microscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Leukoplakia
Oral Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2008-10-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinics

Brief summary: Evaluate the ability to image oral mucosa in healthy volunteer by nonlinear microscopy


Eligibility criteria: Inclusion Criteria:

* Health volunteer
* Patient with suspected oral mucosa lesion

Exclusion Criteria:

* Active infectious disease
* Inability to cooperate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: TW
Study officials:
affiliation: NTUH
name: Wen-Jeng Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00370942: GW823093C For The Treatment Of Type 2 Diabetes Mellitus
Official title: GW823093 Japan Phase IIa Mono
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: GW823093C
diabetes
type 2 diabetes mellitus
DPP-IV inhibitor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-01
Enrollment: 159
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to find dose response and as extension in treatment of GW823093C.


Eligibility criteria: Inclusion criteria:

* Type 2 diabetes mellitus.
* Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))

Exclusion criteria:

* Patients who have metabolic disease judged by investigator as a clinically significance
* Serious cardiovascular disease or serious hepatic disease

Primary outcomes:
measure: Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group
timeFrame: 12 weeks
Secondary outcomes:
measure: Long term safety variables
timeFrame: 64 weeks
Other outcomes:
Locations:
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Miyagi
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05821842: Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion
Official title: Sonu Nasal COngestion RElief Study (SCORE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Congestion and Inflammations
Lead sponsor: Third Wave Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion.

Detailed description: Sonu consists of and acoustic vibrational headband worn circumferentially at the level of the forehead. A smart phone App, paired to the headband, delivers acoustic resonant frequencies of the subject's nasal cavity through the headband and provides relief. Sonu is intended to be used for the treatment of moderate to severe nasal congestion due to rhinitis.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Present with symptoms of nasal congestion for 1 month or more prior to treatment
* Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening

Exclusion Criteria:

* Head, nasal or sinus surgery within 3 months
* Sinus infection diagnosed within the last month, or rhinitis medicamentosa
* Documented history of nasal polyposis or mass

Primary outcomes:
measure: Primary Effectiveness
timeFrame: 2 weeks
Secondary outcomes:
measure: Secondary Effectiveness
timeFrame: 2 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Otolaryngology Medical Group
state: California
Study officials:
affiliation: San Francisco Otolaryngology Medical Group
name: Jacob Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: