louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00329134: Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
Official title: Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2006-05-24
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: No pediatric formulations of quinine exist. Therefore, quinine tablets are broken into 2 or 4 parts, according to the body weight. Based on the body weight, 1/2 or 1/4 a tablet is administered to the child.

At this moment, quinine sulphate pellets are developed. These pellets enable an adequate dosing according to the body weight.

56 children with malaria will be dosed every 8 hours during 7 days with 10-15mg/kg body weight.


Eligibility criteria: Inclusion Criteria:

* Malaria (falciparium malaria, uncomplicated)
* Informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Clocktime when child has had no fever for minimal 48h (< 37,5°C)
measure: Parasitemy
Secondary outcomes:
measure: Plasma concentration of quinine at day 4 between first and second administration
Other outcomes:
Locations:
city: Butare
country: Rwanda
facility: Centre Hospitalier De Butare
Study officials:
affiliation: University Hospital, Ghent
name: Luc Van Bortel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00786734: Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)
Official title: A Randomized, Open Label, Comparative Study to Evaluate Effect of Pitavastatin for Reduction of Myocardial Damage in Patient Are Scheduled Elective PCI for Stable Angina Pectoris
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Percutaneous Coronary Intervention
Keywords: pitavastatin
PCI
stable angina
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients who is scheduled elective PCI are randomized to pitavastatin 4mg daily or without pitavastatin for 5 -7days before the procedure. Creatine kinase-MB, troponin I, and myoglobin levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation). After PCI, pitavastatin will be administered for additional 4 weeks(2nd evaluation).

Detailed description: Procedural ischemic myocardial injury remains the most frequent complication after coronary angioplasty. Recently it was reported that pretreatment with atorvastatin reduce the myocardial damage compared to placebo. Thus, we will evaluate the difference of pretreatment of pitavastatin compared to standard therapy on the reduction of myocardial damage in patient who is scheduled elective PCI for stable angina pectoris.

Eligibility criteria: Inclusion Criteria:

* Patients with LDL ≥ 100mg/dL
* Patients who are scheduled an elective PCI for stable angina

Exclusion Criteria:

* Acute myocardial infarction (\<3 months)
* Unstable angina
* Previous treatment with statins (\<6 months)
* Increase in CK-MB above upper normal limit
* Increase in liver enzymes (AST/ALT) above 2 times of upper normal limit
* Increase in serum creatinine above 2 times of upper normal limit
* Left ventricular ejection fraction \<30%
* Previous treatment with glycoprotein Ⅱb/Ⅲa receptor inhibitor (\<4 weeks)

Primary outcomes:
measure: Proportion of patients whose CK-MB > 2 times above UNL
timeFrame: First evaulation time (before PCI)
Secondary outcomes:
measure: Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL
timeFrame: First evaluation time
measure: Mean peak values of CK-MB, troponin I and myoglobin after intervention
timeFrame: After PCI (<24hrs)
measure: Change of hs-CRP, wall motion score
timeFrame: Second evaluation time
measure: Occurence of all major adverse cardiac events
timeFrame: Second evaluation time
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea Kangnam St. Mary's Hospital
Study officials:
affiliation: Professor, Catholic University of Korea Kangnam St. Mary's Hospital located
name: Ki Bae Seung, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01076634: Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 33
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 trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the glucose infusion rate curve during one dosing interval at steady-date"
timeFrame: After 8 days of treatment
Secondary outcomes:
measure: Area under the serum Insulin Degludec concentration-time curve
timeFrame: During one dosing interval at steady state
measure: Area under the serum Insulin Degludec concentration-time curve
timeFrame: From 0 to 24 hours after single dose
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Korsatko S, Deller S, Koehler G, Mader JK, Neubauer K, Adrian CL, Thomsen H, Haahr H, Pieber TR. A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200 U/mL formulations of ultra-long-acting insulin degludec. Clin Drug Investig. 2013 Jul;33(7):515-21. doi: 10.1007/s40261-013-0096-7.
Clinical trial NCT04342234: Neural Network to Calculate Morphology of the Cleft Palate to Reduce Cleft Lip and Palate Treatment Burden.
Official title: Neural Network to Calculate Morphology of the Cleft Palate to Reduce Cleft Lip and Palate Treatment Burden.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cleft Palate
Orofacial Cleft
Keywords: Cleft Lip
Neural Network
palatal plate therapy
palatal 3D geometry
palatal shape reconstruction
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Botnar Research Centre for Child Health (BRCCH)
name: sciCORE Basel
name: Department of Computer Science, Computer Graphics Laboratory, ETH Zurich
First posted: 2020-04-10
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cleft lip and palate malformation with available routinely performed plaster cast model from palatal impressions and/or intraoral scans of palate, and corresponding images of the cleft palate treated in the past as well as future patients treated at University hospital Basel (USB) for the last 50 years will be included (1970 till 2025). Models were (until 2020) and intraoral scans are (since 2020) taken routinely in newborns and for follow-up (age 1-20 years) according to WHO Guidelines.

Brief summary: This study is to develop a neural network to compute palatal three dimensional (3D) geometry by using routinely taken intraoral/palatal photographs and palatal casts of infants with cleft lip and palate deformity for reducing cleft lip and palate treatment burden. Data of palatal casts and palatal images of cleft patients routinely treated at the University Hospital Basel will be analyzed.The collection of large data helps in developing a neural network that will allow the computation of the 3D geometry from single photographs.


Eligibility criteria: Inclusion Criteria:

* Patients with cleft lip and palate malformation with available routinely performed plaster cast model from palatal impressions, intraoral scans from the palate and corresponding images of the cleft palate (1970 till 2025)

Exclusion Criteria:

* Existence of a documented rejection

Primary outcomes:
measure: 3D palatal geometry
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Mund-, Kiefer- und Gesichtschirurgie, Universitätsspital Basel
Study officials:
affiliation: Mund-, Kiefer- und Gesichtschirurgie, Universitätsspital Basel
name: Andreas Müller, PD Dr. med. Dr. med. dent. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02580734: Efficacy of Melatonin in Burning Mouth Syndrome (BMS)
Official title: Melatonin to Treat Burning Mouth Syndrome (BMS): A Randomized, Cross-over, Placebo-controlled, Triple-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burning Mouth Syndrome
Keywords: burning mouth syndrome
treatment
oral chronic pain
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether melatonin is effective in the treatment of burning mouth syndrome (BMS).

Detailed description: This is a crossover trial involving a total of 20 patients with Burning Mouth Syndrome, considered a chronic neuropathic pain. In two consecutive treatment periods, both 8 week long, each patient receives externally indistinguishable capsules (placebo or melatonin). A 4 weeks wash-out period is applied, between these two periods.

The capsules contain either placebo or 3 mg-melatonin (4 time/day for a total of 12 mg/day of melatonin). The primary endpoint is the change in pain intensity at the end of each treatment period, measured using VAS, verbal intensity score and NRS, as well as number of oral sites affected by the burning sensation. Furthermore, data from quality of life, anxiety and sleep questionnaires are collected (sf-36, HAM-A, ESS, MOS).

Adverse effects are carefully recorded as well as blood samples, in order to measure serum melatonin levels during the trial.

Eligibility criteria: Inclusion Criteria:

* patients over 18 yrs suffering from burning mouth syndrome

Exclusion Criteria:

* epilepsy
* pregnancy
* concomitant treatment with melatonin
* concomitant anticoagulants
* night time working persons

Primary outcomes:
measure: Reduction/resolution of symptoms in BMS
timeFrame: within the first 60 days
Secondary outcomes:
measure: improvement in quality of life
timeFrame: within the first 60 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04606134: Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring
Official title: A Single Center, Prospective, Blinded Study to Evaluate the Efficacy and Safety of a Tripeptide/Hexapeptide Topical When Used With Er:YAG Hybrid Laser for the Treatment of Acne Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 10
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 evaluate the efficacy of a tripeptide/hexapeptide topical (Alastin Regenerating Skin Nectar with TriHex Technology®) in wound healing and scar reduction following Erbium:YAG hybrid resurfacing laser for acne scarring compared to the standard of post-procedure care consisting of a bland moisturizer.


Eligibility criteria: Inclusion Criteria:

* male or females
* age 18 and older
* with evidence of grade II-III acne scars on the face (mild to moderate) as determined by the Goodman \& Baron qualitative global acne scar grading system

Exclusion Criteria:

* treatment to face with any energy device within 6 months
* tanning within 7 days
* dermabrasion or chemical peel within 3 months
* current use of systemic retinoids
* keloidal scaring in the treatment area
* use of systemic steroids within 6 months
* use of topical products with retinoid, alpha-hydroxyacid, salicylic acid, vitamin C or E within 14 days

Primary outcomes:
measure: Mean Change From Baseline in Erythema
timeFrame: baseline to day 34
measure: Mean Change From Baseline in Erythema
timeFrame: baseline to day 4
Secondary outcomes:
measure: Mean Change in Skin Barrier Function
timeFrame: baseline to day 34
measure: Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale
timeFrame: baseline to day 90
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01621334: The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use
Official title: Stage 1B Study Motivating Substance Abusing Batterers to Seek Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Domestic Violence
Substance Abuse
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-06-18
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is a stage 1b developmental trial evaluating an intervention called "The Men's Domestic Abuse Check-Up" with adult men abusing their intimate partners and also struggling with alcohol or drug use.

Detailed description: One hundred and forty adult men concerned about their substance use and behaviors toward intimate partners, recruited in Washington State, will be enrolled in the trial. Participants are recruited through print and radio ads. Following a baseline assessment, participants are then randomly assigned to receive one of two interventions:

* The experimental intervention is a two-session motivational enhancement treatment. A personalized feedback report, containing information from the participant's assessment as well as normative comparison data, is reviewed, with the counselor employing motivational interviewing strategies intended to impact study outcomes.
* The comparison condition involves an educational brochure focusing on the legal, health and behavioral effects of intimate partner violence, substance abuse, and HIV risky behaviors.

Following the two interventions, participants are reassessed at 1 week, 1 month, and 4 months following either intervention.

Eligibility criteria: Inclusion Criteria:

* age (18 years and older)
* gender (male)
* self-reported abusive behaviors
* concerned about alcohol or drug use

Exclusion Criteria:

* not fluent in English
* they have a thought disorder that precludes full participation
* they refuse to accept randomization to condition

Primary outcomes:
measure: treatment seeking
timeFrame: 4 months
Secondary outcomes:
measure: self-report of intimate partner violence and substance use
timeFrame: 4 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Innovative Programs Research Group, School of Social Work, University of Washington
state: Washington
Study officials:
affiliation: University of Washington School of Social Work
name: Lyungai F Mbilinyi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03884634: Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery
Official title: Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcer
Pressure Injury
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 6627
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be all adult patients undergoing cardiac surgery at Cleveland Clinic main campus during the study period.

Brief summary: This is a systematic random sampling study of the effects of the Dabir Micropressure Overlay on perioperative pressure injuries during cardiac surgery.

Detailed description: This is a simple pragmatic systematic quality improvement study aimed at real-world evaluation of a device claimed to reduce pressure ulcers in patients undergoing cardiac surgery.

Data acquisition will be based on systematic sampling of cardiac surgery operations based on odd and even calendar dates. On odd dates the Dabir micropressure overlay will be functional on the operating room tables. On even dates the Dabir micropressure overlay will not be functional on the operating room tables. Data on baseline characteristics, operative parameters, and primary and secondary endpoints will be gathered from STS and wound care sources, which are routinely collected for all patients. There will be no additional patient information and data collected specifically for this study.

Eligibility criteria: Inclusion Criteria:

* All cases scheduled in the cardiac surgery OR suites at the CCF main campus.

Exclusion Criteria:

* Patients who have had previous surgery within 5 days of enrollment in the study will excluded from analysis.

Primary outcomes:
measure: Number of patient developing new perioperative pressure ulcers
timeFrame: 5 days from operation
Secondary outcomes:
measure: Pressure ulcer stage
timeFrame: 5 day from operation
measure: Number of wound care consultations
timeFrame: From date of surgery until 30 days or the date of hospital discharge or the date of death from any cause, whichever came first, assessed up to 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Eric Roselli, M. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04191434: Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma
Official title: Multicenter, Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2019-12-09
Enrollment: 134
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: The purpose of this study is to evaluate the efficacy and safety of Flamboyant 125/12 association in adults with asthma.


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants aged 18 years or more;
* Diagnosis of uncontrolled moderate asthma;
* Participants with Forced expiratory volume in 1 second (FEV1) \> 60% of predicted;

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 12 months prior to Screening Visit.
* Current smoking or smoking history equivalent to "10 pack years"
* Participants with untreated oral candidiasis;
* Pulmonary disease history (e.g., chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis, tuberculosis);
* Participants with a history of acute asthma exacerbation, respiratory tract infection or hospitalization for asthma in the last 4 weeks;
* Known HIV-positive status or active hepatitis B or C virus test result
* Participants with current evidence or history of uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac arrhythmia;
* Participants with current medical history of cancer and/or cancer treatment in the last 5 years;
* Participants using medications that would have an effect on bronchospasm and / or lung function.

Primary outcomes:
measure: Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry.
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Insight Pesquisa Clínica
state: Rio Grande Do Sul
city: Tatuí
country: Brazil
facility: IMC Tatuí
state: São Paulo
city: São Paulo
country: Brazil
facility: CPCLin
Study officials:
References:
Clinical trial NCT03510234: Self-confidence Study in Patients With Argus II Artificial Retina
Official title: Self-confidence Study in Patients With Argus II Artificial Retina
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pigmentary Retinopathy
Keywords: Pigmentary retinopathy
Argus II retinal prosthesis
Self-confidence
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 18
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: Patient already operated in France with artificial retina and having 1 year of follow-up

Brief summary: To evaluate whether the use of the Argus II retinal prosthesis improves the confidence and self-esteem of patients with advanced retinopathy pigmentosa


Eligibility criteria: Inclusion Criteria:

* Major patient (≥18 years old)
* Patient already operated in France with artificial retina and having 1 year of follow-up
* Patient who has agreed to use his medical data for research purposes

Exclusion Criteria:

- Refusal to participate in the study

Primary outcomes:
measure: Self-confidence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service D'Ophtalmologie
Study officials:
affiliation: University Hospital, Strasbourg, France
name: David GAUCHER, MD, PhD
role: STUDY_DIRECTOR
References: