louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04206527: Improving Person-Centered Care for Family Planning in India
Official title: Strengthening People-centered Accessibility, Respect, and Quality for Family Planning Services in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Planning
Keywords: Person-Centered Care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Population Services International
First posted: 2019-12-20
Enrollment: 1104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the impact of a training to ASHAs on person-centered care (PCC) for family planning (FP).

Detailed description: ASHAs will be provided with a training on family planning (FP) counseling and method options. Half of the group will receive additional trainings on person-centered care (PCC) principles and respectful care while the other half of the group will not receive this additional training. Women working with both the control ASHAs (FP trained) and Interventions ASHAs (FP+PCC trained) will be surveyed following their interactions with the ASHA to understand the quality of their experience with the ASHA and whether the woman has taken up a FP method of her choice following interaction with the ASHA.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-49
* Consented/agreed to participate
* Has met with a control or intervention ASHA at least once in the previous three months

Exclusion Criteria:

* Not a women aged 18-49
* Did not consent/agree to participate
* Has not met with a control or intervention ASHA at least once in the previous three months

Primary outcomes:
measure: Person-centered Family Planning Scale Score
timeFrame: 3-months after first FP counseling with ASHA
measure: Experience of providing FP counseling
timeFrame: at least 3-months after FP training
Secondary outcomes:
measure: Uptake of Family Planning
timeFrame: 3-months after first FP counseling with ASHA
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Population Services International
state: Uttar Pradesh
Study officials:
affiliation: University of California, San Francisco
name: Nadia Diamond-Smith, PhD
role: STUDY_DIRECTOR
References:
citation: Diamond-Smith N, McDonell C, Sahu AB, Roy KP, Giessler K. A mixed-methods evaluation of the impact of a person-centered family planning intervention for community health workers on family planning outcomes in India. BMC Health Serv Res. 2020 Dec 11;20(1):1139. doi: 10.1186/s12913-020-05995-9.
Clinical trial NCT02707627: Laser Therapy for Pediatric Burn Scars
Official title: A Controlled Trial Investigating the Use of Laser Therapy to Improve Pediatric Burn Scars.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cicatrix, Hypertrophic
Burns
Keywords: Pediatric
Laser
Burn
Scar
Photothermolysis
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be pediatric patients with hypertrophic scars requiring treatment.

Brief summary: A new era of outcomes for pediatric burn patients has begun as burn care continues to improve. Unfortunately, complete restoration of burn-injured skin may be limited by the development of hypertrophic scarring. Treatment with laser therapy is one of the newest forms of scar therapy available. Although laser therapy has only been adopted by burn clinicians within the last several years, early evidence suggests that it may offer significant benefits. Thus the aim of this study is to investigate the effectiveness of using laser therapy to treat hypertrophic burn scars in pediatric patients by using a comprehensive set of subjective and objective scar assessment tools.


Eligibility criteria: Inclusion Criteria:

1. Age 1-18 years at presentation
2. Patients with a hypertrophic burn scar that has been clinically diagnosed by a burn care specialist
3. Hypertrophic burn scar resulting from any etiology
4. Hypertrophic burn scar is ≥ 2 months post healing
5. Ability to complete English- language questionnaires

Exclusion Criteria:

1. Patients with concomitant skin disease (i.e. chronic skin conditions, herpes infection)
2. Patients with a history of keloid scarring
3. Patients who cannot tolerate the intravenous (IV) sedation used to perform laser therapy procedures
4. Patients who have had previous laser therapy procedures

Primary outcomes:
measure: Vancouver Scar Scale Score
timeFrame: Baseline (month 0) to month 12
Secondary outcomes:
measure: Patient and Observer Scar Assessment Scale Score
timeFrame: Baseline (month 0) to month 12
measure: Scar thickness
timeFrame: Baseline(month 0) to month 12
measure: Scar stiffness measured by the DermaLab Combo® skin analysis device
timeFrame: Baseline(month 0) to month 12
measure: Scar stiffness measured by ultrasound elastographgy
timeFrame: Baseline(month 0) to month 12
measure: Scar colour
timeFrame: Baseline(month 0) to month 12
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT01548027: Surgical Transversus Abdominis Plane Block in Pediatric Patients
Official title: Efficacy of Surgical Transversus Abdominis Plane Block for Postoperative Pain Relief Following Abdominal Surgery in Pediatric Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Keywords: TAP block
postoperative analgesia
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 54
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study to determine the effect of surgical transversus abdominis plane block and local infiltration for postoperative pain control in major abdominal surgery compare with control group.

Detailed description: Most children experience postoperative pain after major abdominal surgery. They may have ineffective ventilation, following atelectasis and pneumonia if receive inadequate pain management. There are several methods used for pain relief such as epidural block, intravenous analgesia with local infiltration, transversus abdominis plane (TAP) block by ultrasound guided and surgical TAP block. Therefore, the investigators would like to compare the effectiveness of postoperative pain control with TAP block. However, TAP block in children need experience and ultrasound. The investigators decided to do surgical TAP block performing by inject from peritoneum point to skin instead.

Eligibility criteria: Inclusion Criteria:

1. Age \< 15 year
2. ASA I-III
3. Abdominal surgery : all upper abdomen and lower abdomen which would have midline incision
4. Elective surgery

Exclusion Criteria:

1. Allergic to Lidocaine or bupivacaine
2. Delayed development
3. Major abdominal surgery within 2 year

Primary outcomes:
measure: opioids consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Time to first analgesic
timeFrame: 24 hr
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Saowaphak Lapmahapaisan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01802827: Ventilator Associated Tracheobronchitis in the First 14 Days in ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Colonization
Tracheobronchitis and Pneumonia Associated With Ventilator
Keywords: airway colonization
tracheobronchitis
pneumonia
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients ventilated \> 48hours

Brief summary: To investigate the clinical course and risk factors for VAT and the impact of VAT on Intensive Care Unit (ICU) morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* \> 48 hours mechanical ventilation

Exclusion Criteria:

* immunodeficiency
* pregnancy
* severe COPD, chronic bronchitis, bronchiectasis
* recent pneumonia

Primary outcomes:
measure: mortality
timeFrame: mortality at 4 weeks
Secondary outcomes:
measure: ICU length of stay
timeFrame: expected average length of stay 15 days
measure: mortality at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02402127: Lubricity Post-Wear - Competitive Lenses Pilot
Official title: Evaluation of the Lubricity of Daily Disposable Silicone Hydrogel Contact Lenses After Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: Contact lenses
Lubricity
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of wear.

Detailed description: In this 3-treatment, 3-period, 6-sequence crossover study, each participant will wear all 3 products in randomized order, 1 product at a time, with a washout period of up to 7 days between treatment periods. Lenses will be collected for ex-vivo lubricity analysis. The ex-vivo lubricity analysis will be conducted under a separate non-clinical protocol.

Eligibility criteria: Inclusion Criteria:

* Must sign an informed consent form.
* Soft contact lens wearer (both eyes).
* Willing to wear study lenses at least 16 waking hours and attend all study visits.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Use of systemic or ocular medications for which contact lens wear could be contraindicated.
* Use of artificial tears and rewetting drops during the study.
* Monocular (only 1 eye with functional vision) or fit with only 1 lens.
* History of herpetic keratitis, ocular surgery, or irregular cornea.
* Pregnant.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Average Coefficient of Friction of Worn Lenses at 16 Hours
timeFrame: Day 1, Hour 16, each product
Secondary outcomes:
measure: Average Coefficient of Friction of Unworn Lenses
timeFrame: Day 1 (each product)
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, Vision Care, Global Medical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT02284373: Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
Official title: Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lymphedema
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This investigation is a randomized clinical trial of a prospective cohort of subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of pneumatic compression in improving symptoms, quality of life and wound healing in patients with venous ulcers and/or lymphedema.

Detailed description: This investigation is a randomized clinical trial of a prospective cohort of an estimated 140 subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms:

Randomization Arm 1: 70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.

Randomization Arm 2: 70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.

Observational Arm 3: 50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.

Eligibility criteria: Inclusion Criteria:

* Presence of a venous ulcer on the lower extremity for at least 12 weeks14 days
* Presence of lymphedema in the lower extremity for at least 14 days

Exclusion Criteria:

* Pregnant women or women of childbearing potential not on contraception
* Previous use of the pneumatic compression device
* Class IV congestive heart failure

Primary outcomes:
measure: To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00894673: Efficacy and Safety of Sodium Heparin (Hipolabor) in Patients
Official title: Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Surgery
Keywords: heparin cardiac surgery
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients aged above 18 years;
* Patients with cardiac surgery and requiring movement; AND
* Extracorporeal.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical changes (eg myeloproliferative syndromes, anemia Hb \<11.0 g / dL,
* Platelets \< 150,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (rTTPA\> 1.40);
* Patients with renal dysfunction (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with history of heparin-induced thrombocytopenia;
* Tables infection (eg endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
* Use of acetylsalicylic acid is less than 5 days;
* Use of low molecular weight heparin for less than 24 hours; OR
* Use of non-fractioned heparin for less than 12 hours.

Primary outcomes:
measure: Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery
timeFrame: 48 hours after surgery.
Secondary outcomes:
measure: Evaluation of the average dose and and safety of porcine heparin.
timeFrame: 48 hours after surgery.
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Lal Clinica Pesquisa e Desenvolvimento Ltda
state: SP
city: Valinhos
country: Brazil
facility: LAL Clinica
state: SP
Study officials:
References:
Clinical trial NCT04780373: Prognostic Score in Covid-19
Official title: Identification of a Clinical Score to Support the Clinician in Phase 2 of Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19 Prognostic Parameters
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Italian Caucasian Patients ≥ 18 years old SARS-CoV-2 infection confirmed by PCR

Brief summary: The aim of the study is to define the clinical and biochemical parameters that characterize COVID-19 patients with a negative prognostic evolution. Our clinical score will be capable to recognize patient with favorable prognosis or patient with poor prognosis by statistical data analysis.


Eligibility criteria: Inclusion Criteria:

* patients over 18 and symptomatic and positive for COVID-19 by polymerase chain reaction assay for rhino-pharingeal swab

Exclusion Criteria:

* Under 18

Primary outcomes:
measure: Data collection of clinical and demographical parameters of patients affected by COVID-19
timeFrame: 8 months
Secondary outcomes:
measure: Application of statistical analysis on data of patients affected by COVID-19
timeFrame: 2 months
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: University of L'Aquila
Study officials:
References:
citation: Sinatti G, Santini SJ, Tarantino G, Picchi G, Cosimini B, Ranfone F, Casano N, Zingaropoli MA, Iapadre N, Bianconi S, Armiento A, Carducci P, Ciardi MR, Mastroianni CM, Grimaldi A, Balsano C. PaO2/FiO2 ratio forecasts COVID-19 patients' outcome regardless of age: a cross-sectional, monocentric study. Intern Emerg Med. 2022 Apr;17(3):665-673. doi: 10.1007/s11739-021-02840-7. Epub 2021 Oct 12.
Clinical trial NCT03024073: Assessment of Near Vision Capacity in Different Light Intensities
Official title: Assessment of Near Vision Capacity in Different Light Intensities and Temperatures in Patients Who Underwent Pseudophakic Presbyopic Correction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Presbyopic patients that underwent pseudophakic presbyopic correction with bilateral bifocal intraocular lenses implantation

Brief summary: Patients who underwent presbyopic correction with bilateral bifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample oa patients who underwent presbyopic correction with bilateral bifocal intraocular lenses implantation


Eligibility criteria: Inclusion Criteria:

* Presbyopia

Exclusion Criteria:

* Glaucoma
* Corneal pathology
* Fundus pathology
* Severe neurological/mental diseases that interfere with visual acuity

Primary outcomes:
measure: Uncorrected Near Vision Acuity (UnVA)
timeFrame: 6 months
Secondary outcomes:
measure: Near Vision Capacity (NVC)
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Democritus University of Thrace
state: Evros
Study officials:
affiliation: Democritus University of Thrace
name: Georgios Labiris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00521573: Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Transplantation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-08-28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in heart transplanted patients.

Detailed description: Dark chocolate contains a high amount of flavonoids. Flavonoids hold the possibilities to improve oxidative stress and hence the possibility to improve endothelium-dependent coronary vasomotion, which is a powerful surrogate for clinical prognosis. Coronary atherosclerosis is promoted by impaired endothelial function and increased platelet activation. High oxidative stress and reduced antioxidant defenses play a crucial role in the pathogenesis of atherosclerosis, in particular in transplanted hearts. The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in heart transplanted patients.

Eligibility criteria: Inclusion Criteria:

1. Patients after heart transplantation not requiring immediate coronary intervention
2. Age 20 - 80
3. Written obtained informed consent

Exclusion Criteria:

1. Heart failure (acute or chronic \>NYHA II)
2. Ventricular tachy-arrythmias or AV-Block \>I°
3. Renal insufficiency (\>200 μmol/l) or liver disease (ALT or AST \>150 IU)
4. Symptomatic hypotension, hypertension \>160/100mmHg
5. Known allergy to compounds dark chocolate
6. Acute infectious disease
7. Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
8. Participation in another study within the last month
9. Concomitant vitamin supplements

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Zurich
name: Roberto Corti, MD
role: PRINCIPAL_INVESTIGATOR
References: