louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01082900: Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
Official title: Prophylactic CPAP/PEEP in Delivery Room (DR) Resuscitation, Effects on Natriuretic Peptide in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transient Tachypnea
Keywords: Transient Tachypnea of the Newborn
Elective Cesarean section
Late preterm
CPAP
Delivery Room
Lead sponsor: New York Hospital Queens
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 138
Sex: ALL
Minimum age (years): 2
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid and a common cause of admission of full term infants and late pre term infants (34 to 36 weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at delivery, and mode of delivery are considered risk factors for TTN. The investigators hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot study to evaluate the prophylactic administration of CPAP in the Delivery Room towards prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a randomized control trial after obtaining informed consents from the parents of eligible infants. Infants will be randomized to receive either experimental treatment (prophylactic CPAP) or standardized care.


Eligibility criteria: Inclusion Criteria:

* Babies born to mothers via elective CS: elective CS defined as planned CS in the absence of Labor.
* Late preterm infants (34 1/7 to 36 6/7 weeks gestational age)

Exclusion Criteria:

* Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥18 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization
* Need for use of PPV for perinatal depression or other indications
* Presence of any of the following

  * congenital malformations (diagnosed prenatally)
  * chromosomal anomalies (diagnosed prenatally)
  * congenital heart disease diagnosed by fetal echocardiography.

Primary outcomes:
measure: Measure of incidence of TTN
timeFrame: 24 hours
measure: Need for admissions to NICU secondary to TTN
timeFrame: 24 hours
Secondary outcomes:
measure: levels of plasma brain natriuretic peptide compared
timeFrame: 24 hours
Other outcomes:
Locations:
city: Flushing
country: United States
facility: New York Hospital Queens
state: New York
Study officials:
affiliation: New York Hospital Queens
name: Pinchi Srinivasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00250900: Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
Official title: Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Keywords: Otitis
Antibiotic
Prescription
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2005-11-08
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription

Detailed description: We conducted a randomized, controlled trial evaluating a consecutive series of children diagnosed with AOM during a one year period in an urban pediatric emergency department, utilizing diagnostic recommendations from contemporary evidence-based guidelines. The objectives of the study were to determine whether treatment of AOM using a "Wait and See Prescription" (WASP) significantly reduces use of antimicrobials compared with a "Standard Prescription" (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media

Exclusion Criteria:

* clinician suspicion or diagnosis of a concurrent bacterial infection
* patient appeared "toxic" as determined by the PEM clinician
* patient was hospitalized
* history of compromised immunity
* patient was treated with antimicrobials in the preceding seven days
* either tympanic membrane was perforated
* myringotomy tubes were present
* uncertain access to medical care
* primary language of the parent or guardian was neither English nor Spanish
* prior enrollment in the study

Primary outcomes:
measure: Proportion of each group that filled the antibiotic prescription
Secondary outcomes:
measure: Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: David M Spiro, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spiro DM, Tay KY, Arnold DH, Dziura JD, Baker MD, Shapiro ED. Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial. JAMA. 2006 Sep 13;296(10):1235-41. doi: 10.1001/jama.296.10.1235.
Clinical trial NCT00807300: Computed Tomography (CT) - Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma
Official title: Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: percutaneous treatment
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Percutaneous, image-guided tumor ablation has evolved as a genuine alternative for the treatment of unresectable hepatocellular carcinoma. Published data exploring stereotactic or proton beam percutaneous irradiation have revealed,that hepatocellular carcinoma (HCC) is radiosensitive to certain protocols. In Phase I and II studies, the investigators investigated the potential role of local irradiation in primary and secondary liver tumors employing a Iridium192 source. The promising results of previous studies indicate that CT-guided brachytherapy might play a role in the treatment of unresectable HCC.

Therefore, the investigators started a randomized, controlled, clinical Phase-II study to evaluate the efficacy and survival-benefits of brachytherapy versus transarterial chemoembolization in patients with unresectable HCC.


Eligibility criteria: Inclusion Criteria:

* diagnosis of HCC by histopathology or according to the criteria of the Consensus Conference of the European Association for the Study of Liver Disease
* unresectable HCC
* Karnofsky-Index \> 70
* estimated life expectancy \> 16 weeks
* adequate bone marrow function
* adequate contraception for female patients
* informed consent

Exclusion Criteria:

* portal vein thrombosis on the tumor side
* extrahepatic spread
* Child C
* other untreated malignant disease
* general contraindication for chemotherapy
* active infectious disease
* neuropathy, platin-allergy
* pregnancy

Primary outcomes:
measure: Time to untreatable progression
timeFrame: the follow up period
Secondary outcomes:
measure: Time to progression
timeFrame: the follow up period
measure: Overall survival
timeFrame: the follow up period
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg
state: Saxony-anhalt
Study officials:
affiliation: Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg
name: Jens Ricke, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04254900: Energy Availability in Male and Female Elite Wheelchair Athletes Over Seven Consecutive Training Days
Official title: Energy Availability in Wheelchair Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Energy Supply; Deficiency
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2020-02-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elite wheelchair athletes from national team in different wheelchair sports

Brief summary: Low energy availability (LEA) is a major problem in sports as athletes ingest often a lower amount of energy compared to their actual needs. The availability of energy is calculated based on their daily energy intake and the energy cost of the daily training sessions in relation to their fat-free mass. Based on this calculation, it is known how much energy will available for the body (beside the fuel for training) to keep it in optimal physiological functioning. It has been shown, that LEA occurs very often in female athletes, in endurance athletes as well as athletes in weight-sensitive sports (i.e. jockeys, combat sports, gymnastics, ballet). The purpose of this study was to investigate, whether LEA is a problem in wheelchair athletes as well.

Detailed description: Energy availability will be assessed over 7 consecutive training days using a dietary and training record as well as the Leisure Time PHysical Activity Questionnaire for spinal cord injury. Resting Energy expenditure will be measured as well as body composition (by a DXA) before the start of data collection.

Eligibility criteria: Inclusion Criteria:

* athletes from a national team in wheelchair sports

Exclusion Criteria:

* unable to follow normal training routine
* unable to record diet or training

Primary outcomes:
measure: energy availability
timeFrame: 7 consecutive days during pre-season
Secondary outcomes:
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Lucerne
Study officials:
affiliation: Swiss Paraplegic Centre
name: Joelle Flueck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00864500: Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
Official title: Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bio-Equivalence
Vasoconstriction
Clobetasol
Healthy adult females
Lead sponsor: Actavis Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.

Detailed description: Study Type: Interventional Study Design: An open label, one period, randomized, vasoconstrictor assay study.

Official Title: Bioequivalence of two Clobetasol Propionate 0.05% Topical Lotions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

· Vasoconstrictor Response

Eligibility criteria: Inclusion Criteria:

* Non-tobacco-using female subjects, 18 to 50 years of age, inclusive.
* A demonstrated blanching response to Clobex TM (clobetasol propionate) Lotion, 0.05 %.
* A body mass index (BMI) 30 kg/m2 or less as calculated according to Novum Standard Operating Procedures.
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
* Signed and dated informed consent form which meets all criteria of current FDA regulations.

Exclusion Criteria:

* History of allergy to any systemic or topical corticosteroid (including clobetasol) or to any cream, lotion, ointment, gel, cotton, soap, cosmetic, rubber, or tape, which in the opinion of the Investigator would compromise the safety of the subject or the study.
* Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of skin blanching.
* Significant history or current evidence of chronic infectious disease, system disorder (especially hypertension or circulatory disease), or organ dysfunction.
* Presence of a medical condition requiring regular treatment with prescription drugs.
* Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
* Use of any topical dermatological drug therapy (including topical corticosteroids) on the flexor surface of the ventral forearms in the 30 days prior to dosing.
* Use of any tobacco products in the 30 days prior to dosing.
* Receipt of any drug as part of a research study within 30 days prior to initial study dosing.
* Pregnant or lactating.

Primary outcomes:
measure: Vasoconstrictor Response
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Soran Hong,, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05040100: Utilizing a 3D Printed Model of the Mediastinum to Teach Thoracic Anatomy to Medical Trainees
Official title: Utilizing a 3D Printed Model of the Mediastinum to Teach Thoracic Anatomy to Medical Trainees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anatomy Teaching Methods
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Three-dimensional (3D) printed anatomic models are increasingly being developed for medical education. The investigators sought to compare the efficacy of a 3D printed model of the mediastinum as a study tool with standard textbooks for teaching medical trainees thoracic anatomy.

Participants were randomly assigned to either a lecture using a standard anatomy textbook or the same lecture along with a 3D printed model of the mediastinum. Participants took a timed pre-test and post-test, identifying 12 mediastinal structures on a prosected human cadaver. Independent and dependent t-tests were used to compare individual and group improvements respectively. A subjective assessment was also performed.


Eligibility criteria: Inclusion Criteria:

* Medical trainee

Exclusion Criteria:

* none

Primary outcomes:
measure: Improvement from pre-test to post-test
timeFrame: Up to 1 year
Secondary outcomes:
measure: Subjective Evaluation
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Natalie Lui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00375700: Effect of an Oral Supplement on the Total Energy and Protein Intake of Head and Neck Cancer Patients in the Last 2 Weeks of Radiation Therapy
Official title: Efficacy of an Oral Nutrition Supplement on the Total Caloric and Protein Intake of Head and Neck Cancer Patients During the Last 2 Weeks of Radiation Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Cancer
Keywords: food
diet
oral supplement
head and neck cancer
radiation
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2006-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, an oral nutrition supplement has been developed that take into consideration: the nutritional requirements, treatment side-effects and taste preferences of head and neck cancer patients; the acceptance of a supplement when experiencing radiation therapy side-effects; and the taste preferences of head and neck cancer patients which may affect the supplement intake. We hope to increase dietary intake during the last 2 weeks of radiation therapy.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx and thyroid.
* all histologic types of cancer
* all tumour stages according to American Joint Committee for Cancer (AJCC) Staging
* all forms of RT including standard or investigational for head and neck cancers
* alert and mentally competent
* English speaking

Exclusion Criteria:

* an allergy or intolerance to any of the substances used in the nutrition supplement
* Type I or II diabetes mellitus
* renal insufficiency
* unable to swallow
* additional criteria of all forms of chemotherapy standard or investigational or combination of radiation/chemotherapy standard or investigational for head and neck cancers

Primary outcomes:
measure: total energy and protein intake
timeFrame: Study completion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alberta
name: Cathy Kubrak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04730700: Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.
Official title: Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 50
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 better understand how people feel after a radiofrequency ablation standard of care surgery using a different type of needle (multi-tined expandable electrode/MEE) in comparison to receiving conventional medical management (CMM) techniques.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old.
* Patients with pain lasting at least 6 months.
* Patients with history of non-radiating low back pain.
* Patient who had two diagnostic medial branch blocks (MBB) with significant (\>50%) improvement on both injections.
* Patient has signed study-specific informed consent.
* Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.

Exclusion Criteria:

* Patient with low back pain with radiation or involvement of pain going into their legs below their knees.
* Patient did not receive satisfactory relief from diagnostic MBB (\<50% relief).
* Patient is unable to receive radiation exposure.
* Patient is currently pregnant.
* Patient has a current local overlying low back or systemic infection.
* Patient currently receiving or seeking workers compensation, disability remuneration, and/or involved in injury litigation.
* Known or suspected drug or alcohol abuse.
* Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
* Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation.
* Patient has an implanted intrathecal pump or spinal neuromodulation device.
* Patient currently on daily oral morphine equivalent (OME) of 50.

Primary outcomes:
measure: The mean visual analog scale (VAS) between the two group
timeFrame: 12 months
Secondary outcomes:
measure: Observe the incidence of complications associated with MEE while utilizing this device
timeFrame: 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Dawood Sayed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01924000: Minoxidil 1% for Eyebrow Enhancement
Official title: Minoxidil 1% for Eyebrow Enhancement: A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eyebrow Hypotrichosis
Thin Eyebrow
Lead sponsor: Mae Fah Luang University Hospital
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in enhancement of eyebrows.


Eligibility criteria: Inclusion Criteria:

* male or female aged 18-60 years
* hypotrichosis of eyebrows
* healthy
* informed consent obtained

Exclusion Criteria:

* underlying diseases
* alopecia areata or trichotillomania
* thyroid diseases
* pregnancy or breast feeding
* previous eyebrow tattoo, trauma or accident.
* history of eyebrow or hair medications in 6 months
* history of minoxidil or its ingredient allergy
* history of eyebrow surgery.

Primary outcomes:
measure: The change of global photographic assessment after 16 weeks from baseline
timeFrame: baseline and 16 weeks
Secondary outcomes:
measure: The change of hair diameter after 16 weeks from baseline
timeFrame: baseline and 16 weeks
Other outcomes:
measure: The change in number of hairs after 16 weeks from baseline
timeFrame: baseline and 16 weeks
measure: Number of participants with adverse events. Adverse events include any skin rashes or symptoms.
timeFrame: 16 weeks
measure: Patient satisfaction by self-assessment questionnaires
timeFrame: baseline and 16 weeks
Locations:
city: Bangkok
country: Thailand
facility: Mae Fah Luang University Hospital (Bangkok)
Study officials:
affiliation: Mae Fah Luang University Hospital (Bangkok)
name: Chuchai Tanglertsampan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suwanchatchai W, Tanglertsampan C, Pengsalae N, Makornwattana M. Efficacy and safety of bimatoprost 0.03% versus minoxidil 3% in enhancement of eyebrows: a randomized, double-blind, split-face comparative study. J Dermatol. 2012 Oct;39(10):865-6. doi: 10.1111/j.1346-8138.2012.01579.x. Epub 2012 May 17. No abstract available.