louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04403542: Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
Official title: Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Myopia
Hyperopia
Keywords: Extended Wear
Contact Lens
Overnight Wear
Vision Correction
Contralateral Wear
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-05-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

Detailed description: Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an IRB/IEC approved Informed Consent form.
* Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
* Best corrected visual acuity of 20/25 or better in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
* Any habitual wear of Biofinity contact lenses.
* Pregnant or breast-feeding.
* Other protocol specified exclusion criteria may apply.

Primary outcomes:
measure: Distance Visual Acuity (VA) With Study Lenses
timeFrame: Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit
Secondary outcomes:
Other outcomes:
Locations:
city: Medina
country: United States
facility: Alcon Investigator 6402
state: Minnesota
city: Granville
country: United States
facility: Alcon Investigator 8046
state: Ohio
city: Memphis
country: United States
facility: Alcon Investigator 2786
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT00913042: Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia
Official title: Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile
Neutropenia
Post-chemotherapy
Keywords: Febrile neutropenia
Blood culture
Bacteremia
Bacterial DNA testing
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Febrile neutropenia post-chemotherapy

Brief summary: Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost exclusively by blood cultures. The reasons for this low documentation are likely multiple: (1) some of these fevers are of non-infectious origin. (2) The bacterial inoculum present in the blood may be low and consequently undetectable by conventional blood cultures.

The primary objective of the study is to assess new blood culture procedures and technics, in order to improve the diagnostic yield of blood cultures during febrile neutropenic episodes.

Detailed description: Evaluation criteria are 1) proportion of microbiologically documented infections 2) time elapsed from bed side sampling to microbiological diagnostic, in case of positive sample.

The assessed procedures included a large volume of blood, an early incubation made possible by the availability of a culture device in the hematology department, an early warning in case of positive blood culture, bacterial DNA detection in blood, and an early identification of the positive strains and their resistance profile.

We hypothesize that the combination of these different procedures will improve the proportion of microbiologically blood culture from 30 to 45%. One hundred and 20 episodes of febrile neutropenia are necessary to achieve this goal.

Eligibility criteria: Inclusion Criteria:

* age \> 18 y
* first episode of febrile neutropenia during a given neutropenic phase
* PMN \< 500/mm3, chemotherapy-induced
* fever \> 38°C twice, or \< 38°3C once
* signed informed consent

Exclusion Criteria:

- patient already receiving empirical or therapeutic antibacterial after their first episode of febrile neutropenia

Primary outcomes:
measure: proportion of microbiologically documented infections
timeFrame: Day 14 from inclusion
Secondary outcomes:
measure: clinical status at the end of hospitalisation
timeFrame: Day 30 from inclusion
Other outcomes:
Locations:
city: Creteil
country: France
facility: Hematology Department, Paris 12 University Hospital Henri Mondor
Study officials:
affiliation: Henri Mondor University Hospital
name: Cécile Pautas, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00829842: Oral Hygiene With Chlorhexidine and Incidence of Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery
Official title: Evaluation of Oral Hygiene With 0.12% Chlorhexidine Antiseptic Solution on the Incidence of Nosocomial Pneumonia and Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ventilator Associated Pneumonia
Nosocomial Pneumonia
Heart Surgery
Keywords: chlorexidine
ventilator-associated pneumonia
nosocomial pneumonia
heart surgery
oral hygiene
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-01-27
Enrollment: 160
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hospital infections play an important role in the increase of patients' morbimortality and hospitalization costs, especially in the case of individuals admitted to intensive care units (ICU) during postoperative heart surgery. Analysis of the epidemiological profile of the hospital infections in the pediatric-ICU (P-ICU) of Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, University of São Paulo (HCFMRP-USP) demonstrated a 31.1% incidence of pneumonia (PNM) and a rate of ventilator-associated pneumonia (VAP) of 23.81 per 1000 ventilators-day between March 2004 and February 2005 in the group submitted to cardiac surgery. Knowledge of the pathophysiology and risk factors associated with this infection allows for measures aiming at reducing its incidence. The objective of the present study is to evaluate the effect of oral hygiene with a 0.12% chlorhexidine solution on the incidence of PNM and PAV in children submitted to cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* age 0 to 18 years submitted to heart surgery
* parent approval

Exclusion Criteria:

* previous oral intubation
* previous or present pneumonia
* parent refusal
* death during surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Jacomo AD, Carmona F, Matsuno AK, Manso PH, Carlotti AP. Effect of oral hygiene with 0.12% chlorhexidine gluconate on the incidence of nosocomial pneumonia in children undergoing cardiac surgery. Infect Control Hosp Epidemiol. 2011 Jun;32(6):591-6. doi: 10.1086/660018.
Clinical trial NCT01682642: The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
Official title: IVF Outcome in Patients With Peritoneal Endometriosis. The Impact of a Hormonal Treatment of the Endometriosis Prior to the IVF on the Pregnancy Rates.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Endometriosis
Keywords: endometriosis
pregnancy
In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI)
peritoneal implants
embryo quality
Lead sponsor: AZ Jan Palfijn Gent
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouw Hospital
First posted: 2012-09-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study of endometriosis patients we compare a common treatment of surgical therapy and medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In both cases they immediately start In Vitro Fertilization (IVF) treatment.


Eligibility criteria: Inclusion Criteria:

* laparoscopical vaporization of endometriosis
* 1,2, 3e IVF cycle
* endometriosis stage I and II
* younger than 38 years

Exclusion Criteria:

* endometriosis cysts
* uterine pathology
* endocrinological diseases and problems

Primary outcomes:
measure: Number of Metaphase II Cells (MII)
timeFrame: 3 weeks
Secondary outcomes:
measure: Pregnancy Rate
timeFrame: 12 weeks
measure: Good Embryo Quality
timeFrame: 3 days after oocyte retrieval
measure: Number of Pro Nuclear Cell (2PN)
timeFrame: 1 day after oocyte retrieval
measure: Number of Cryopreserved Embryos
timeFrame: 1 week after oocyte retrieval
measure: Total Follicle Stimulating Hormone (FSH) Dose
timeFrame: 3 weeks
Other outcomes:
measure: Number of Days of Stimulation
timeFrame: 3 weeks
Locations:
city: Gent
country: Belgium
facility: AZ Jan Palfijn
state: Oost-vlaanderen
Study officials:
affiliation: Fertility Center AZ Jan Palfijn Gent
name: Wim Decleer, gynecologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Fertility Center AZ Jan Palfijn Gent
name: Paul Devroey, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05353842: Scale Up of Project Workout on Wheels Internet Intervention (WOWii)
Official title: Scale Up Trial of Project WOWii to Increase Exercise Among People With Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Craig Hospital
Sponsor class: OTHER
Collaborators: name: Kessler Institute for Rehabilitation
name: Shepherd Center, Atlanta GA
First posted: 2022-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed is to test the feasibility, fidelity, and effectiveness of scaling up an evidence- and theory-based virtually delivered physical activity intervention (WOWii) for individuals living with chronic SCI for delivery through other rehabilitation settings. The study outcomes address (1) feasibility based on participant enrollment, retention, and program engagement; (2) fidelity of intervention delivery; and (3) program effectiveness based on subjective and objective exercise data, and participant exercise perceptions regarding self-efficacy and barriers.


Eligibility criteria: Inclusion Criteria:

* more than 12 months post SCI
* requires use of wheelchair due to SCI
* receive signed approval from medical provider to initiate moderate-intensity exercise program
* have internet access via computer, tablet, or smartphone
* provide informed consent

Exclusion Criteria:

* already engaged in engaged in sufficient physical activity to meet CDCP guidelines
* cognitive of language impairments that would affect ability to participate
* presence of medical issue for which exercise is contraindicated
* pregnancy

Primary outcomes:
measure: Enrollment of Participants in WOWii Program (feasibility)
timeFrame: One time at end of study recruitment
measure: Retention of Participants Enrolled in WOWii Program (feasibility)
timeFrame: One time at end of 16 week intervention
measure: Engagement of Participants Enrolled in WOWii Program (feasibilty)
timeFrame: One time at end of 16 week intervention
measure: Percentage of behavior skills covered by peer facilitators during WOWii Program (fidelity)
timeFrame: One time at end of 16 week intervention
measure: % of WOWii sessions in which peer facilitators generate group-based conversation (fidelity)
timeFrame: One time at end of 16 week intervention
measure: Change in number of minutes spent in aerobic exercise (effectiveness)
timeFrame: Baseline, end of intervention (Week 16), end of follow up (Week 24)
measure: Change in score on International Physical Activity Questionnaire Scores (effectiveness)
timeFrame: Baseline, end of intervention (Week 16), end of follow up (Week 24)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT02983942: Ketogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma
Official title: Ketogenic Diet Adjunctive to High Dose Methotrexate Chemotherapy for Primary Central Nervous System Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Primary Central Nervous System Lymphoma
Keywords: ketogenic diet
Primary Central Nervous System Lymphoma
chemotherapy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ketogenic diet has shown auxiliary effect on treatment of malignant tumors require high glucose consumption. This study is designed to evaluate the safety and efficacy of ketogenic diet adjunctive to high dose methotrexate(HD-MTX) chemotherapy for primary central nervous system lymphoma (PCNSL).

Detailed description: In a pilot study of primary central nervous system(CNS) lymphoma patients, ketogenic diet was given in adjunction with standard HD-MTX chemotherapy as interventional group; standard HD-MTX is given with routine diet as control group. The primary endpoint is the safety of ketogenic diet in PCNSL patients receiving chemotherapy, secondary endpoints include rate of complete remission, remission time, rate of tumor relapse and overall survival.

Eligibility criteria: Inclusion Criteria:

1. Age 18-70
2. Histopathologically confirmed PCNSL
3. No systemic involvement
4. Ability and willingness to sign informed consent
5. Normal liver and kidney function
6. Karnofsky Performance Score of 60 or more

Exclusion Criteria:

1. Any systemic involvement of the tumor
2. Systemic illness or medical condition may pose additional risk, including cardiac, metabolic or endocrine disorders; incompensated renal or liver disfunction; history of renal calculi, hyperuricemia, hyper calcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
3. Uncontrolled hyperlipidemia or hyperglycemia
4. Human immunodeficiency virus positive, or hepatitis C positive
5. Pregnancy of breastfeeding
6. Inability or unwillingness to give written informed consent.

Primary outcomes:
measure: Number of participants with treatment related adverse events as assessed by CTCAE v4.0
timeFrame: Two years
Secondary outcomes:
measure: The chemosensitivity of tumor
timeFrame: Two years
measure: Long term effect of chemotherapy
timeFrame: Two years
measure: overall survival
timeFrame: Three years
measure: Quality of life
timeFrame: Two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Song Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01897142: A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers
Official title: A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects.
* Healthy non-child bearing female subjects.
* 18 to 35 years of age.

Exclusion Criteria:

* Heart disease.
* Clotting disorders.
* Use of nicotine products.
* Diabetes.

Primary outcomes:
measure: Incidence of dose limiting treatment related adverse events
timeFrame: Through Day 43
measure: Incidence, severity and causal relationship of treatment emergent adverse events, treatment emergent serious adverse events, and withdrawals due to treatment emergent adverse events
timeFrame: Through Day 43
measure: Incidence and magnitude of treatment emergent abnormal laboratory findings
timeFrame: Through Day 43
measure: Change from baseline in vital sign measurements, ECG parameters, and physical examinations
timeFrame: Through Day 43
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Through 4 hour post dose Day 1
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Through 4 hour post dose Day 1
measure: Pharmacodynamic activity as measured by prothrombin time/internationalize normalized ration (PT/INR)
timeFrame: Through post dose Day3
measure: Pharmacodynamic activity as measured by activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT)
timeFrame: Through post dose Day3
measure: Pharmacodynamic activity as measured by thrombin-antithrombin (TAT) complexes
timeFrame: Through post dose Day 2
measure: Pharmacodynamic activity as measured by prothrombin fragments 1+2 (PF1+2)
timeFrame: Through post dose Day 2
measure: Pharmacodynamic activity as measured by D-dimer
timeFrame: Through post dose Day 7
measure: Pharmacodynamic activity as measured by protein C activity
timeFrame: Through post dose Day 2
measure: Pharmacodynamic activity as measured by Factor V activity
timeFrame: Through post dose Day 3
measure: Incidence of antibody immune response
timeFrame: Through post dose Day 43
measure: Factor X activity
timeFrame: Through post dose Day 43
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05002842: Implementation of Mind-Body Practices in an Online Community of Caring (CaringBridge)
Official title: Implementation of Mind-Body Practices in an Online Community of Caring (CaringBridge)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Stress
Keywords: Cancer
Gratitude
Social Support
Online
Perceived Stress
CaringBridge
Social Connectedness
Social Assurance
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 979
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: CaringBridge (CB) is an online health community for people undergoing challenging health journeys. This platform provides an opportunity for individuals and their caregivers to rally support for a loved-one during a health journey. CaringBridge offers the opportunity for expressive writing through journal entries, wellbeing resources, participant health journey stories, and practical scheduling and communication tools to support community, healing, and wellbeing. Loving Kindness Meditation (LKM) is a systemized mind-body approach developed to increase loving acceptance and has been shown to increase resilience in the face of adversity. The aim of this study is to better understand how mind-body practices, like LKM, impact adult CB users


Eligibility criteria: Inclusion Criteria:

* English literacy
* CaringBridge user with an active email address
* Visitor/Caregiver/Patient on a Cancer Journey (for Phase 2 only)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in Perceived Stress: The Perceived Stress Scale
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in Self-Compassion: The Self-Compassion Scale
timeFrame: 3 weeks
measure: Change in Compassionate Love: The Compassionate Love for Humanity Scale
timeFrame: 3 weeks
measure: Change in Social Support: The Social Connectedness Scale
timeFrame: 3 weeks
measure: Change in Social Support: The Social Assurance Scale
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota Earl E. Bakken Center for Spirituality &amp; Healing
name: Mary Jo Kreitzer, PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Telke S, Leininger B, Hanson L, Kreitzer MJ. A Randomized Trial of 21 Days of Loving Kindness Meditation for Stress Reduction and Emotional Well-being Within an Online Health Community for Patients, Family, and Friends Experiencing a Cancer Health Journey. J Integr Complement Med. 2022 Feb;28(2):158-167. doi: 10.1089/jicm.2020.0512. Epub 2022 Jan 11.