louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02341313: Point of Care Ketone Measurement in the Newborn
Official title: Feasibility of the Use of Point of Care Technology to Measure Ketone and Lactate Levels in the Newborn at Risk From Hypoglycaemia Due to Impaired Perinatal Counter Regulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoglycaemia
Keywords: Hypoglycaemia
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 50
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants at risk of hypoglycaemia

Brief summary: Low blood sugar levels are common in babies after birth. This may be normal as babies can use other sources of energy. However if a baby does not produce these fuels the brain can be starved of energy and be damaged. Measurement of these fuels is not done as part of clinical practice in the newborn. The investigators aim to see whether at the same time as taking the blood sugar level from a heel prick these fuels can be measured in a small drop of blood. At the same time as blood needs to be taken for clinical reasons the study team will to take a drop of blood from 50 babies to see how good the point of care (POC) meters are compared to the laboratory at measuring these fuels. If accurate these POC meters could identifying those at risk from brain damage as well as prevent separation of mothers and babies who are establishing breast feeding.


Eligibility criteria: Inclusion Criteria:

* Infants having blood samples taken for clinical management of glucose control

Exclusion Criteria:

-

Primary outcomes:
measure: Measure of ketone levels between Point of care and laboratory assessment
timeFrame: Neonatal period up to 28 days of age
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: addenbrookes Hospital
Study officials:
affiliation: Cambridge University
name: Kathryn Beardsall, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232219: Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion
Official title: Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether fish oil supplements may be beneficial in preventing the recurrence of atrial fibrillation after cardioversion.

Atrial fibrillation is a heart condition which can sometimes be successfully treated by a cardioversion.

Cardioversion involves resetting the heart back to normal with the use of electric current.

There is a tendency for the atrial fibrillation to recur , days weeks or even months after the cardioversion.

Fish oil supplements may be of benefit to patients with heart problems Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.


Eligibility criteria: Inclusion Criteria:

* Patients with persistent Atrial Fibrillation on Warfarin.

Exclusion Criteria:

* paroxysmal atrial fibrillation with self terminating episodes.
* left atrial size\>6.0cm
* myocardial infarction in the previous 6 months.
* contraindications to amiodarone use .
* cardiac surgery in the previous 3 months .
* an acute reversible illness contributing to the development of af
* a QTc interval \> 480ms.
* pregnancy

Primary outcomes:
measure: Recurrence of atrial fibrillation followed cardioversion
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Safety and tolerability
timeFrame: 1 year
Locations:
city: Melbourne
country: Australia
facility: Royal Melbourne hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Paul Sparks, MBBS, PhD. FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00682019: Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-05-21
Enrollment: 383
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.


Eligibility criteria: Inclusion Criteria:

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
* History of unresponsiveness to sildenafil
* Stable sexual relationship for \> 6 month.

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy.

Primary outcomes:
measure: Per-patient success rates based on Sexual Encounter Profile, Question 3
timeFrame: 10 weeks
Secondary outcomes:
measure: Per-subject success rates based on Sexual Encounter Profile, Question 2
timeFrame: 10 weeks
measure: International Index of Erectile Function- Erectile Function domain score
timeFrame: 10 weeks
measure: Global Assessment Question (GAQ)
timeFrame: 10 weeks
measure: Safety and tolerability
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00238719: Study Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of Venlafaxine ER In Children and Adolescent Outpatients With Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety
Children Disorders
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-13
Enrollment: 293
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the anxiolytic efficacy, safety, and tolerability of a flexible-dose of venlafaxine extended release (ER) administered for 16 weeks in the treatment of children and adolescent outpatients with social anxiety disorder (generalized) in a placebo-controlled study.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatient
* 8-17 year old
* diagnosis of Social Anxiety Disorder

Exclusion Criteria:

* concomitant psychiatric or medical disorders which interfere with safety or assessment

Primary outcomes:
measure: Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.
Secondary outcomes:
measure: Response, defined as a score of 1 (very much improved) or (very improved), on the Clinical Global Impressions-Improvement (CGI-I) scale; Final on therapy Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-AC) total score.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02196519: Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Reversal Procedure
Lead sponsor: Cohera Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age
* Be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications
* Be scheduled for an ileostomy reversal procedure
* Be willing to follow instructions for incision care
* Agree to return for all follow-up evaluations specified in this protocol
* Sign informed consent

Exclusion Criteria:

* Anesthesia risk judged to be higher than ASA2
* Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
* Any condition involving compromised immune system
* Any condition known to effect wound healing, such as collagen vascular disease
* Known blood clotting disorder
* Be receiving antibiotic therapy for pre-existing condition or infection
* Concurrent use of fibrin sealants or other anastomosis care devices
* Be currently taking systemic steroids or immunosuppressive agents
* Have known or suspected allergy or sensitivity to any test materials or reagents
* Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: W Bemelman
role: PRINCIPAL_INVESTIGATOR
affiliation: Meander Medical Center- Amersfoort
name: E Consten
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02216019: Diagnostic Interest of Leukocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry in Heart Surgery
Official title: Diagnostic Interest of Leukocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry in Heart Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Keywords: cardiac surgery
infectious complication
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 60
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 undergoing planned heart surgery with cardiopulmonary bypass

Brief summary: In septic patients, Septiflux1 study identified immature granulocytes which may have a diagnostic and prognostic interest. However, with these preliminary results it is not possible to make a difference between what is linked to the infection and what is a consequence of the inflammation which goes along with the septic process. Using flow cytometry, the study of leukocytes in a pure inflammatory model such as cardiopulmonary bypass in heart surgery could make possible to test the diagnostic interest of the immature granulocytes but also to attribute a prognostic value for the occurrence of post-operative infections.

Detailed description: Expression of CD10, CD16, CD24, CD64 on granulocytes, of CD14 and CD16 on monocytes and of CD3 on T lymphocytes.

Flow cytometers will all be calibrated the same way using common reagents (known fluorescent calibration beads). Moreover, CD45 and CD3 level of expression on lymphocytes will help to check that the collection of data is standardized between the different centers.

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* Patient undergoing planned heart surgery with cardiopulmonary bypass

Exclusion Criteria:

* Pregnancy,
* progressive solid cancer,
* HIV infection,
* history of blood or inflammatory disease,
* long-term immunosuppressive treatment,
* urgent surgical intervention,
* documented preoperative infection

Primary outcomes:
measure: Expression of the marker CD64, CD10 and CD16
timeFrame: 1 hour
Secondary outcomes:
measure: Early onset of infectious complications
timeFrame: 7 days
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges - Service de réanimation polyvalente
Study officials:
affiliation: CHU LIMOGES
name: Bruno FRANCOIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750919: Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)
Official title: A Twenty-six Weeks, Open-label Extension Trial to Evaluate Safety and Efficacy of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 21106
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-11
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).


Eligibility criteria: Inclusion Criteria:

* Sign written informed consent
* Completed clinical trial 21106/P05701/MK-8265-002

Exclusion Criteria:

* Any (serious) adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106/P05071/MK-8265-002 as judged by the investigator
* Were significantly non compliant with protocol criteria and procedures of trial 21106/P05701/MK-8265-002, as judged by the investigator
* Pregnancy

Primary outcomes:
measure: Change From Baseline in Total Sleep Time (TST)
timeFrame: Baseline and Week 26
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to 30 weeks
measure: Number of Participants Discontinuing Due to AEs
timeFrame: Up to 26 weeks
Secondary outcomes:
measure: Change From Baseline in Sleep Latency (SL)
timeFrame: Baseline and Week 26
measure: Change From Baseline in Wake Time After Sleep Onset (WASO)
timeFrame: Baseline and Week 26
Other outcomes:
Locations:
Study officials:
References:
citation: Ivgy-May N, Hajak G, van Osta G, Braat S, Chang Q, Roth T. Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension. J Clin Sleep Med. 2020 Sep 15;16(9):1455-1467. doi: 10.5664/jcsm.8526.
Clinical trial NCT00254319: Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: Phase II Trial of Bevacizumab (Avastin) Plus Pemetrexed (Alimta) and Carboplatin in Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Untreated Advanced Non-Small Cell Lung Cancer
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2005-11-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Avastin is a novel antiangiogenic agent that has recently been shown to improve response rates and survival of patients with advanced nonsquamous non-small cell lung cancer when added to front-line carboplatin/paclitaxel chemotherapy, and is now being routinely incorporated into the treatment of these patients. Alimta is a recently approved chemotherapeutic that has shown activity against non-small cell lung cancer when given alone and in combination with carboplatin, has a favorable toxicity profile andrequires only a brief (10 minute) infusion time. Therefore we propose to study the combination of Avasin, Alimta, and Carboplatin administered as front-line therapy to patients with advanced nonsquamous non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

I am 18 years of age or older. I have advanced non-small lung cancer. I have not had any major surgical procedures within 28 days prior to my starting treatment.

I have high blood pressure that is controlled. I am not on heparin, coumadin or lovonox for treatment of medical conditions. I do not have serious wound healing problems. I have not received any previous treatment, except radiation therapy for my disease.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Voorhees
country: United States
facility: The CINJ at Cooper University Hospital
state: New Jersey
Study officials:
affiliation: The Cooper Health System
name: James Stevenson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06738719: A Phase 3 Study to Evaluate Efficacy & Safety of Subcutaneous CT-P13 in Patients With Moderate to Severe Active Rheumatoid Arthritis
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients With Moderately to Severely Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Moderately to Severely Active Rheumatoid Arthritis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis


Eligibility criteria: \[Main Inclusion Criteria\]

1. Patient who is male or female aged 18 to 75 years old (both inclusive).
2. Patient who has a diagnosis of RA at least 24 weeks prior to the first administration of the study drug (Day 1) and fulfill the 2010 ACR/EULAR classification criteria for RA.
3. Patient who has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed), 6 or more tender joints (of 68 assessed), and either a high-sensitivity C-reactive protein (hsCRP) ≥1.0 mg/dL (≥10 mg/L) or an erythrocyte sedimentation rate (ESR) ≥28 mm/hour at Screening.
4. Patient who has been receiving the treatment of oral or parenteral dosing with MTX for at least 12 weeks and has been on stable dosing with MTX between 10 to 25 mg/week for at least 4 weeks prior to the first administration of the study drug (Day 1).
5. Patient who has adequate renal and hepatic function at Screening

\[Main Exclusion Criteria\]

1. Patient who has previously received investigational or licensed product; biological agents or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or a tumor necrosis factor (TNF) α inhibitors for the any purpose.
2. Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product.
3. Patient who has received or has plan to receive any of prohibited medications or treatments as defined in the protocol.

Primary outcomes:
measure: Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12
timeFrame: Week 0 ~ Week 12
Secondary outcomes:
measure: Change from baseline in HAQ-DI at Week 12
timeFrame: Week 0 ~ Week 12
measure: Evaluate Pharmacokinetics of CT-P13 SC
timeFrame: Up to 52 Weeks
measure: Evaluate Safety of CT-P13 SC
timeFrame: Up to 52 Weeks
Other outcomes:
Locations:
city: Warsawa
country: Poland
facility: Klinika Reuma Park Sp. z.o.o
Study officials:
References:
Clinical trial NCT05267119: Comparison of Scalp Microbiome of Healthy Women Wearing Hijab and Those Who do Not Wear Hijab
Official title: Comparison of Scalp Microbiome of Healthy Women Wearing Hijab and Those Who do Not Wear Hijab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbial Colonization
Scalp--Diseases
Keywords: scalp
microbiome
hijab
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women aged 18 years old or older who had not undergone menopause

Brief summary: An observational study was performed on 48 women wearing hijab and 48 women not wearing hijab to compare the scalp microbiome.

Detailed description: The scalp sample of all subjects was taken to be analyzed for its microbial diversity. The samples were processed with Next-Generation Sequencer and analyzed with bioinformatics analysis.

The primary outcome was the characteristics of scalp microbiome

Eligibility criteria: Inclusion Criteria:

* Healthy women
* Aged 18 years old or older who had not undergone menopause
* Consenting to the study

Exclusion Criteria:

* Scalp and hair diseases (e.g. alopecia, trichotillomania, scalp infection, malignancy)
* Systemic diseases (diabetes mellitus, liver diseases, renal diseases, autoimmune diseases)
* Use of topical and oral antifungal agents
* Use of cytostatic agents
* Use of topical and oral antibiotics
* Use of topical and oral vitamin D
* Use of chemical products on hair (e.g. bleaching, permanent blow, hair coloring, hair straightener)
* Pregnancy
* Lactating
* Hypersensitivity towards basic ingredients of shampoo (e.g. synthetic detergent, conditioner, thickening agent).

Primary outcomes:
measure: Alpha diversity and beta diversity of scalp microbiome
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia
Study officials:
References: