louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06179537: Evaluation of the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects
Official title: A Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects Following Single and Multiple Oral Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2023-12-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects Following Single and Multiple Oral Doses


Eligibility criteria: Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females

Exclusion Criteria:

* History of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.

Primary outcomes:
measure: Assessment of ECG QTcF interval (ms) change
timeFrame: Pre-dose up to 48 hours post-dose for both single and multiple administration
measure: Assessment of diastolic and systolic blood pressure (mmHg) change
timeFrame: Pre-dose up to 48 hours post-dose for both single and multiple administration
measure: Assessment of heart rate (BPM) change
timeFrame: Pre-dose up to 48 hours post-dose for both single and multiple administration
measure: Number of participants with clinically significant changes in Clinical laboratory tests
timeFrame: Pre-dose up to 48 hours post-dose for both single and multiple administration
measure: Number of participants with clinically significant changes in Physical Examination
timeFrame: Pre-dose up to 48 hours post-dose for both single and multiple administration
measure: Adverse Event and Adverse Event of medical interest monitoring
timeFrame: Pre-dose up to 48 hours post-dose for both single and multiple administration and again at follow-up call (1 week after discharge)
measure: Measurement of the area under the plasma concentration by time curve (AUC)
timeFrame: Pre-dose up to 48 hours post-dose for both single and multiple administration
measure: Measurement of the maximum observed plasma drug concentration (Cmax)
timeFrame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Pharmacology Ltd.
Study officials:
References:
Clinical trial NCT01512537: Alternative Treatments of Vitamin D Deficiency
Official title: Comparison of UVB and Vitamin D Supplementation in Treatment of Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
UVB
Vitamin D supplementation
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in treatment of vitamin D deficiency.

Detailed description: Patients with vitamin D deficiency were recruited and randomized into two groups, one exposed to UVB and the other receiving oral treatment with vitamin D supplementation.

Eligibility criteria: Inclusion Criteria:

* Vitamin D deficiency (\< 25 nmol/l)
* Age 15 or above

Exclusion Criteria:

* Travel south of 45 degrees latitude during the trial.
* Ongoing treatment with vitamin D supplementation.
* Intake of light sensitive medicine, such as tetracyclins.
* Skin light eruptions

Primary outcomes:
measure: Vitamin D (nmol/l).
timeFrame: Week 0
measure: Vitamin D (nmol/l)
timeFrame: Week 3
measure: Vitamin D
timeFrame: Week 6
Secondary outcomes:
measure: Parathyroid hormone (pmol/l).
timeFrame: Week 0, 3 and 6.
measure: Albumin (g/l).
timeFrame: Week 0, 3 and 6.
measure: Calcium (mmol/l)
timeFrame: Week 0, 3 and 6.
measure: Hemoglobin A 1c (percentage HbA1c of total hemoglobin).
timeFrame: Week 0, 3 and 6.
Other outcomes:
Locations:
city: Malmoe
country: Sweden
facility: Department of Dermatology, Lund University Malmoe
Study officials:
affiliation: Department of Dermatology, Lund University, Malmoe
name: Åke Svensson, Assoc. Prof., MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05069337: Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia
Official title: Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Children Aged 6 Months to 10 Years Old Under General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 100
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children aged 6 months to 10 years old under general anesthesia

Brief summary: For children aged 6 months to 10 years old under general anesthesia, intraoperative lung ultrasound pictures are acquired, grades are evaluated for each pictures and machine learning is used to learn and apply it.

Detailed description: 1. routine general anesthesia is performed in the selected children.
2. After mechanical ventilation, the degree of lung atelectasis is evaluated using transthoracic lung ultrasonography in the anterior, lateral, posterior regions of the upper and lower points of both lungs(a total of 12 regions).
3. Atelectasis is checked by the presence of B-line and juxta pleural consolidation.
4. Machine learning is used to educate the photos of 70 people and grading system, and process is checked whether it applies well to the photos of the remaining 30 people.

Eligibility criteria: Inclusion Criteria:

1. children aged 6 months to 10 years old under general anesthesia
2. ASA I-III

Exclusion Criteria:

1. If the parents of the patient cannot communicate in Korean
2. If mechanical ventilation is not planned (for example, A1 pulley)
3. emergency operation
4. a child whose ultrasound image quality is expected to deteriorate due to diseases such as thoracic deformity, scoliosis, or rib fractures
5. If lateral position was not available

Primary outcomes:
measure: consolidation score
timeFrame: After intubation and before the surgery start or after the surgery complete and before the extubation
Secondary outcomes:
measure: B-line score
timeFrame: After intubation and before the surgery start or after the surgery complete and before the extubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
name: Hyo Jin Byon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00755937: Remicade® Crohn's Disease Registry Across Canada (Study P02793)
Official title: Remicade® Treatment Registry Across Canada in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 556
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primarily from community centers and some academic centers.

Brief summary: This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects with Crohn's disease being treated with Remicade® as per approved product monograph in Canada. In contrast to a controlled clinical trial, there is no imposed experimental intervention and treatment with Remicade® is determined solely by the subject's physicians. Thus, the data captured and reported in this registry will reflect a "real world" approach to the treatment of Crohn's disease with Remicade®.

Detailed description: Subjects will be selected for this registry using a non-probability sampling method.

Eligibility criteria: Inclusion Criteria:

* Patient was given the Patient Information Brochure; AND,
* Patient has never been treated with Remicade® (patient is naïve to Remicade® at the time of registration); AND,
* Patient is a good candidate to receive Remicade® as per the product monograph; AND,
* Patient has agreed to complete the Patient Diary for one week prior to each visit in the registry; AND,
* Patient has signed the approved consent form.

Exclusion Criteria:

* Per product monograph

Primary outcomes:
measure: Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).
timeFrame: 12 months after baseline
measure: Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).
timeFrame: 24 months after baseline
measure: Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).
timeFrame: 36 months after baseline
measure: Clinical Remission at 12 Months (CDAI <= 150 Points).
timeFrame: 12 months after baseline
measure: Clinical Remission at 24 Months (CDAI <= 150 Points).
timeFrame: 24 months after baseline
measure: Clinical Remission at 36 Months (CDAI <= 150 Points).
timeFrame: 36 months after baseline
Secondary outcomes:
measure: Number of Serious Adverse Events
timeFrame: Throughout study (up to 36 months)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01356537: Home Therapy With VPRIV in Gaucher's Disease
Official title: Non Interventional Study of VPRIV® (Velaglucerase Alfa) Home Therapy in Patients With Gaucher's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gaucher Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 34
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with proven Gaucher's Disease foreseen for home treatment with VPRIV (Velaglucerase alfa) at German Gaucher centers

Brief summary: The purpose of this study is to proof increasing patient satisfaction and preservation of quality of life in patients with Gaucher's Disease receiving their enzyme replacement therapy with VPRIV (Velaglucerase alfa)at their home setting compared to receiving the infusions at the clinic or at doctor's practice.


Eligibility criteria: Inclusion Criteria:

* Male or female patients with a confirmed diagnosis of Gaucher disease type 1
* Age\> 2 years
* patients who have at least 3 infusions (6 weeks) at least 5-year or 5-6 infusions (10-12 weeks) at 2 - to 4-year patients have received VPRIV ® and tolerate well
* The patient is compliant, the previous VPRIV ® infusions were / performed approximately every 2 weeks in the center during office visits
* The patient was already before inclusion in this study for a home infusion therapy and has consented to (or their legal representative)
* The patient / be lawful. Representative has consented in writing to participate in this study.

Exclusion criteria:

• The patient is participating in a clinical trial with a medicinal product

Primary outcomes:
measure: Patient satisfaction estimated on a 10-ary Likert scale, quality of life estimated by SF-36 questionnaire
timeFrame: comparison of baseline to 12 months value
Secondary outcomes:
measure: Number (per infusion) and severity of infusion-related side effects
timeFrame: baseline compared to 12 months
Other outcomes:
Locations:
city: Bregenz
country: Austria
facility: Landeskrankenhaus Bregenz
city: Salzburg
country: Austria
facility: Paracelsus Medizinische Privatuniversität Salzburg
city: Wien
country: Austria
facility: AKH, Allgemeines Krankenhaus der Stadt Wien
city: Wien
country: Austria
facility: Medical University of Vienna
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Köln
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
city: München
country: Germany
facility: Klinikum rechts der Isar
city: Rostock
country: Germany
facility: Albrecht-Kossel-Institut für Neuroregeneration (AKos)
city: Schwerin
country: Germany
facility: Helios Klinikum Schwerin
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01156337: Sodium Management in Acute and Chronic Heart Failure
Official title: Sodium Management in Acute and Chronic Phases in Patients With New York Heart Association Class III (Class C) Heart Failure. Short and Long Term Findings.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure III NYHA class
Furosemide
Sodium
water restriction
decompensated heart failure
Hypertonic saline solution
Moderate sodium restriction
Lead sponsor: Ospedale G. F. Ingrassia
Sponsor class: OTHER
Collaborators: name: University of Palermo
name: University of Naples
name: Buccheri La Ferla Hospital, Palermo
First posted: 2010-07-02
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: Patients in III NYHA class HF

Brief summary: The study was aimed to verify the effects of Hypertonic saline solution (HSS) and a moderate sodium (Na) restriction plus high furosemide dose in the short term (hospitalization time) and a moderate Na restriction in the long term on readmissions and mortality in patients in III NYHA class.


Eligibility criteria: Inclusion Criteria:

* Decompensated HF due to ischemic or nonischemic cardiomyopathy,
* \>18 years of age,
* HF according to Framingham criteria
* NYHA functional class III
* EF \<40%,
* Serum creatinine \<2,5 mg/dL
* BUN \<60 mg/dL,

Exclusion criteria:

* NYHA class \> III or \< III,
* Cerebral vascular disease,
* Dementia,
* Cancer,
* Uncompensated diabetes,
* Severe hepatic disease
* Patients requiring pacemaker
* Previous RCT implantation
* Alcoholic habit

Primary outcomes:
measure: readmission for HF worsening
Secondary outcomes:
measure: mortality
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: GF Ingrassia Hospital
Study officials:
References:
Clinical trial NCT01561937: Use of Activated Recombinant Human Factor VII to Reduce Bleeding Caused by Warfarin Treatment
Official title: Use of Recombinant FVIIa to Mitigate Warfarin Anticoagulation Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Haemostasis
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 127
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 trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Ratio).


Eligibility criteria: Inclusion Criteria:

* INR below or equal to 1.2

Exclusion Criteria:

* The receipt of any investigational drug within 1 month prior to this trial
* Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or NSAIDs (Non-Steroidal Anti-Inflammatory Drug) within 14 days prior to trial
* African-American race
* Weight above 160 kg
* Supplemental Vitamin K use

Primary outcomes:
measure: Bleeding duration measured in minutes after biopsies in trial part A
timeFrame: From onset of bleeding till the end of the bleeding
measure: Bleeding duration measured in minutes after biopsy B1 in trial part B
timeFrame: From onset of bleeding till the end of the bleeding
Secondary outcomes:
measure: Blood volume reported in millilitres after biopsies in trial part A
timeFrame: From onset of bleeding till the end of the bleeding
measure: Blood volume reported in millilitres after biopsy B1 in trial part B
timeFrame: From onset of bleeding till the end of the bleeding
measure: Adverse events, including thrombotic events
timeFrame: From day 0 to days 14-28
measure: Change in coagulation-related parameters after biopsy B1
timeFrame: From baseline to 3 hours after B1
measure: Change in coagulation-related parameters after biopsy B2
timeFrame: From baseline to 3 hours after B2
measure: Change in coagulation-related parameters after biopsy B3
timeFrame: From baseline to 3 hours after B3
measure: Clot dynamics: R in minutes (trial part B)
timeFrame: Time to onset of clot formation
measure: Clot dynamics: K in minutes (trial part B)
timeFrame: Time to achieve 20mm clot strength
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03891537: Neural Therapy Effect and Bilateral Tubal Ligation
Official title: Evaluation Of The Neural Therapy Effect On Long Term Postoperative Discomforts İn Patients Who Undergo Bilateral Tubal Ligation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tubal Obstruction
Dysmenorrhea
Keywords: Bilateral Tubal Ligation
Postoperative Discomforts
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had bilateral tubal ligation with modified Pomeroy technique and had complaints such as dysmenorrhea dyspareunia in the first postoperative year

Brief summary: The aim of this study is to evaluate the effect of nebulisation in patients with bilateral tubal ligation in the first postoperative year, the amount of dysmenorrhea, dyspareunia and menstrual bleeding, recurrent vaginitis and cystitis.

A retrospective analysis of bilateral tubal ligation with optional modified Pomeroy technique in the family planning unit and evaluation of the results of patients who underwent Neural Therapy during and postoperatively will be evaluated.


Eligibility criteria: Inclusion Criteria:

* patients who underwent bilateral tubal ligation with modified Pomeroy technique,
* Patients with dysmenore, dyspareunia and menstrual bleeding,

Exclusion Criteria:

* postoperative asymptomatic
* Additional treatments for pain and complaints

Primary outcomes:
measure: postoperative dysmenorrhea
timeFrame: 1st year postoperative
measure: postoperative dyspareunia
timeFrame: 1st year postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT00700037: Change in Plaque Characteristics With Atorvastatin
Official title: Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Atherosclerosis
Dyslipidemia
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary syndrome.

Detailed description: Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI and have at least one atherosclerotic lesion of \>25% stenosis other than culprit lesions of current ACS are enrolled. Fibrous cap thickness of a target coronary plaque is evaluated by optical coherence tomography.

Eligibility criteria: Inclusion Criteria:

* Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI.
* plasma LDL cholesterol levels : \>=100mg/dL and ≤160mg/dL
* at least one atherosclerotic lesion of \>25% stenosis other than culprit lesions of current ACS

Exclusion Criteria:

* Patients who will undergo coronary bypass surgery.
* Patients with major complications during treatment of culprit coronary lesions.
* Patients with an atherosclerotic lesion with \>50% stenosis at a left main trunk.

Primary outcomes:
measure: Fibrous cap thickness by OCT
timeFrame: 12 months
Secondary outcomes:
measure: macrophage number
timeFrame: 12 months
Other outcomes:
Locations:
city: Wakayama
country: Japan
facility: Wakayama Medical University
Study officials:
affiliation: Wakayama Medical University
name: Takashi Akasaka
role: PRINCIPAL_INVESTIGATOR
References:
citation: Komukai K, Kubo T, Kitabata H, Matsuo Y, Ozaki Y, Takarada S, Okumoto Y, Shiono Y, Orii M, Shimamura K, Ueno S, Yamano T, Tanimoto T, Ino Y, Yamaguchi T, Kumiko H, Tanaka A, Imanishi T, Akagi H, Akasaka T. Effect of atorvastatin therapy on fibrous cap thickness in coronary atherosclerotic plaque as assessed by optical coherence tomography: the EASY-FIT study. J Am Coll Cardiol. 2014 Dec 2;64(21):2207-17. doi: 10.1016/j.jacc.2014.08.045. Epub 2014 Nov 24.