louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01869582: Safer Births - Reducing Perinatal Mortality
Official title: Safer Births - New Knowledge and Innovations to Decrease Perinatal Mortality and Morbidity Worldwide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Heart Rate Abnormalities
Respiratory Depression
Birth Asphyxia
Neonatal Resuscitation
Keywords: Fetal hypoxia
Birth asphyxia
Neonatal resuscitation
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Muhimbili National Hospital, Tanzania
name: Haydom Lutheran Hospital
name: Stavanger Acute medicine Foundation for Education and Research, Norway
name: Weill Cornell Medical Collage, USA
name: Laerdal Global Health
First posted: 2013-06-05
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Safer Births is a research and development collaboration to establish new knowledge and new innovative products to better equip and increase competence of health workers for safer births and increased newborn survival worldwide.

The main objectives are:

To randomize different devices for fetal heart rate assessments. To assess if a novel Newborn Resuscitation Monitor will facilitate newborn resuscitation in a low-resource setting. To determine bag mask ventilation treatment and devices beneficial for neonatal outcome.


Eligibility criteria: Inclusion Criteria:

* Randomizing fetal heart rate assessment: Singleton delivery, Term gestation age, Cephalic presentation, Fetal heart rate normal, Cervical dilatation ≤7cm, Consent to participate
* Randomizing bag mask ventilation: infants in need of positive pressure ventilation, Consent to participate

Exclusion Criteria:

* Randomizing fetal heart rate assessment: Placenta abruption/praevia, Ruptured uterus, Morbid Obesity

Primary outcomes:
measure: Perinatal Mortality
timeFrame: From start of labour to 7 days postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Haydom
country: Tanzania
facility: Haydom Lutheran Hospital, Research Institute
state: Manyara
city: Dar es Salaam
country: Tanzania
facility: Muhimbili National Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Hege L Ersdal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili National Hospital
name: Hussein L Kidanto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haydom Lutheran Hospital
name: Estomih R Mduma, Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mdoe PF, Ersdal HL, Mduma ER, Perlman JM, Moshiro R, Wangwe PT, Kidanto H. Intermittent fetal heart rate monitoring using a fetoscope or hand held Doppler in rural Tanzania: a randomized controlled trial. BMC Pregnancy Childbirth. 2018 May 4;18(1):134. doi: 10.1186/s12884-018-1746-9.
citation: Thallinger M, Ersdal HL, Francis F, Yeconia A, Mduma E, Kidanto H, Linde JE, Eilevstjonn J, Gunnes N, Stordal K. Born not breathing: A randomised trial comparing two self-inflating bag-masks during newborn resuscitation in Tanzania. Resuscitation. 2017 Jul;116:66-72. doi: 10.1016/j.resuscitation.2017.04.012. Epub 2017 Apr 17.
Clinical trial NCT01120782: Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.


Eligibility criteria: Inclusion Criteria:

1. The subject must be between 18 and 40 years old.
2. The subject must have normal eyes.
3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
4. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
5. The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye.
6. The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
7. The subject's refractive cylinder axis must be 180 +/- 30 in each eye.
8. The subject must be an adapted wearer of soft toric contact lenses in both eyes.
9. The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
10. Subjects must already possess a wearable pair of spectacles. -

Exclusion Criteria:

1. Ocular or systemic allergies or disease that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
3. Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
4. Clinically significant tarsal abnormalities that might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Pregnancy or lactation
8. Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
9. Diabetes
10. Strabismus -

Primary outcomes:
measure: Prescription Equivalence
timeFrame: after 15 minutes of lens wear
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
state: Florida
city: New York
country: United States
state: New York
Study officials:
References:
Clinical trial NCT00498082: Determinants of Efficacy of EsophyX Treatment in Gastro-Esophageal Reflux Disease
Official title: Determinants of Efficacy of EsophyX Treatment in Gastro-Esophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2007-07-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: EsophyX is a promising endoscopic treatment for gastro-esophageal reflux disease. It is not known whether there are some pre- or per-operative anatomic or pathophysiological findings which may influence outcome.

The aim of this trial is to study a series of parameters acquired during the pre-therapeutic work-up or during the procedure and their influence on the outcome of the procedure.


Eligibility criteria: Inclusion Criteria:

* Patients being considered for EsophyX treatment of GERD

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires St-Luc
Study officials:
affiliation: Cliniques universitaires St-Luc
name: Hubert Piessevaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05860582: A Study of [14C]GB491 in Male Healthy Subjects
Official title: A Study of [14C]GB491 on Mass Balance and Biotransformation in Chinese Male Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Nonsmall Cell Lung Cancer
Lead sponsor: Genor Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491. This study will help understand how the drug appears in the blood, urine, and feces after it is administered.

In addition, this study will also evaluate the safety of a single dose of \[14C\]GB491 when given to healthy subjects.


Eligibility criteria: Inclusion Criteria:

* A healthy male volunteer between 18 and 50 years of age inclusive
* A total body weight \>=50kg, and a BMI of 19.0-26.0 kg/m2
* A signed informed consent document

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Subjects with HBsAg-positive, or HCV-Ab-positive, or TPPA-positive, or HIV infection
* Subjects with a history of habitual constipation/diarrhea, irritable bowel syndrome, or inflammatory bowel disease

Primary outcomes:
measure: Total radioactivity in plasma PK
timeFrame: Up to 168 hours post dose
measure: Total radioactivity in urine and fecal samples
timeFrame: Up to 360 hours post dose
measure: Metabolite G1T30 and other major matabolites (if applicable)
timeFrame: Up to 168 hours post dose
Secondary outcomes:
measure: Quantitative analysis of drug concentrations of GB491, metabolite G1T30 and other major metabolites (if applicable) in plasma
timeFrame: Up to 168 hours post dose
measure: Adverse events
timeFrame: Up to 360 hours post dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing GoBroad Boren Hospital
state: Beijing
Study officials:
affiliation: Beijing GoBroad Boren Hospital
name: Fang HOU, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04431882: The Role of Optic Nerve Sheath Fenestration in Leukemic Patients Having Increased Intracranial Pressure
Official title: The Role of Optic Nerve Sheath Fenestration in Leukemic Patients Having Increased Intracranial Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Leukemic Patients With Increased Intracranial Pressure
Optic Nerve Sheath Fenestration
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single arm clinical trial for patients presenting with severe sight threatening papilledema due increased intracranial pressure following leukemia treatment meeting the criteria of idiopathic intracranial hypertension not responding to maximal medical treatment.
Primary purpose: TREATMENT

Brief summary: Optic nerve sheath fenestration (ONSF) first described by De Wecker in 1872 for the treatment of neuroretinitis. Since then, optic nerve sheath fenestration has become well established procedure for treatment of papilledema in medically uncontrolled patients of idiopathic intracranial hypertension.

Detailed description: Optic nerve sheath fenestration (ONSF) first described by De Wecker in 1872 for the treatment of neuroretinitis. Since then optic nerve sheath fenestration has become well established procedure for treatment of papilledema in medically uncontrolled patients of idiopathic intracranial hypertension. Indications for ONSF in cancer patients are not well established, but a few case reports have shown success of ONSF in patients with perineural metastasis of breast cancer, increased intracranial pressure with papilledema due to a brain tumor, leukemia and optic nerve sheath meningioma. This study is conducted to establish the role of optic nerve sheath Fenestration in leukemic patients mainly those suffering from acute lymphoblastic leukemia.

Eligibility criteria: Inclusion Criteria:

* Evidence of progressive visual loss and papilledema did not improve despite the maximal medical therapy prescribed.
* Informed written consent was obtained from the parents/care providers of the study participants.

Exclusion Criteria:

* Can not get the informed consent

Primary outcomes:
measure: Visual acuity using LOGMAR
timeFrame: Three months
measure: Papilledema grading using frisén scale
timeFrame: Three months
Secondary outcomes:
measure: Visual acuity using LOGMAR
timeFrame: 2 weeks
measure: Papilledema grading using frisén scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Medicine
Study officials:
affiliation: Alexandria Faculty of Medicine
name: Mai ElBahwash
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03676582: AspiRATE: Novel Intervention to Acoustically Detect Silent Aspiration in Acquired Dysphagia.
Official title: The AspiRATE Study: a Proof-of-concept Assessment of a Novel Intervention to Acoustically Detect Silent Aspiration in Patients With Acquired Dysphagia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia, Oropharyngeal
Keywords: swallowing disorders
instrumental swallow assessment
acoustic analysis
respiratory changes
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2018-09-18
Enrollment: 25
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: Adults over the age of 18 years with acquired dysphagia

Brief summary: This study will investigate whether silent aspiration during swallowing can reliably be detected using acoustic signal processing plus pulse oximetry.

Detailed description: This proof of concept trial, involving original research from a multicentre, multidisciplinary team, aims to establish whether silent aspiration can be detected in patients with dysphagia (swallowing difficulties), using a microphone array attached to the neck (to capture acoustic respiratory changes), pulse oximetry (to detect reduction in blood oxygen levels) and respiratory rate analysis, with data combined and analysed via post-capture signal processing techniques.

The project aims to develop equipment and signal processing algorithms to a point where a novel intervention has been established that allows semi-automated detection of safe versus unsafe (aspiration) swallows. The intervention will be trialled in patients with dysphagia within standard videofluoroscopy clinics under clinical supervision. There will be on-going development of the intervention and signal processing algorithms during this process. Public and patient involvement work will feed back into the design process.

If the intervention performs successfully in this proof-of-concept study, the investigators aim to proceed to a larger clinical trial to determine its sensitivity and specificity as a screening tool for aspiration, before final development into a commercial product.

Eligibility criteria: Inclusion Criteria:

* Dysphagia ± aspiration,
* age 18 and above

Exclusion Criteria:

* Not competent for consent,
* previous neck surgery (not including thyroid surgery)
* cervical skin infection or defect
* pregnant (or unknown pregnancy status).

Primary outcomes:
measure: Presence or Absence of Aspiration
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS FT
state: Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS FT
name: Sue Pownall, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03966482: Semi-occluded Vocal Tract Exercise in Velopharyngeal Dysfunction in Patients With Cleft Palate
Official title: Exercise Of Semi-Occluded Vocal Tract In Velopharyngeal Dysfunction In Patients With Cleft Palate : Effects Of Short-Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Palate
Keywords: cleft palate
velopharyngeal sphincter
velopharyngeal insufficiency
speech therapy
rehabilitation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncompared before-after clinical trial
Primary purpose: TREATMENT

Brief summary: Analyze the effect of SOVTE (Semi-occluded Vocal Tract Exercise), with high resistance tube, on the velopharyngeal mechanism, for speech rehabilitation of twelve patients with cleft palate with vocal alterations, after four weeks. The study was developed in the city of Porto Alegre, southern Brazil. The hypothesis of the study is that after four weeks of exclusive therapy with exercise it will be improvement in the voice of patients with cleft palate.

Detailed description: The study is an uncompared before-after clinical trial. All patients were submitted to videonasoendoscopy and had their vocal emissions recorded before and after the four weeks of speech therapy. These individuals were submitted to multidimensional evaluation comprised of analysis of images generated by specialized videonasoendoscopy software, analysis of speech emissions by perceptual-auditory evaluation and acoustic analysis, and vocal self-assessment.

Eligibility criteria: Inclusion Criteria:

* Individuals with surgically repaired CLP (Cleft lip and palate), regardless of gender and regardless of the type of clef palate.
* The sample only included patients aged 6+ because this is the ideal age to be submitted to videonasoendoscopy.
* These patients attended four speech therapy sessions.
* All individuals agreed to participate in this research voluntarily.

Exclusion Criteria:

* Individuals with cleft lip and palate associated with genetic syndromes or other congenital malformation
* Individuals who proved unable to do SOVTE (Semi-occluded Vocal Tract Exercise),
* No condition to be submitted to videonasoendoscopy examination,
* Patients who did not attend the four sessions of therapy or who did not do exercise at home were excluded from the sample.

Primary outcomes:
measure: Analyze the effect of semi-occluded vocal tract exercise, with high resistance tube, on the velopharyngeal mechanism
timeFrame: one month
Secondary outcomes:
measure: Changes on speech after semi-occluded vocal tract exercise in cleft palate.
timeFrame: one month
Other outcomes:
Locations:
Study officials:
affiliation: Chief of plastic surgery of Clinicas Hospital of Porto Alegre's
name: Marcus Vinicius M Collares, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00238082: The Effect of QVAR on Lung Functioning in Chronic Obstructive Pulmonary Disease
Official title: The Effect of HFA-beclomethasone Dipropionate on Static Lung Volumes in COPD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD
Keywords: COPD
Chronic Obstructive Pulmonary Disease
Emphysema
Chronic Bronchitis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2005-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an investigator-sponsored research study to evaluate if treatment with HFA-134a beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway "remodeling" or scarring in subjects with COPD. Approximately 20 subjects with COPD will participate for approximately 7 weeks, with 10 receiving an active (BDP) inhaler with HFA-134a and 10 receiving a placebo.


Eligibility criteria: Inclusion Criteria:

* COPD diagnosis
* FEV1/FVC\<70%
* FEV1 50-80% predicted
* Albuterol response of \<12% and \<200mL or methacholine PC20 \> 8mg/mL
* RV \> 120% predicted
* DLCO \< 80%
* smokers and nonsmokers
* Lower age limit 45 years

Exclusion Criteria:

* Asthma
* Other chronic airway or parenchymal lung disease
* Other comorbid illness (including but not limited to DM, MI or CAD-related intervention in 6 months, neurologic disease, syncope)
* Use of any steroid (oral, IV, nasal, pulmonary) within 12 weeks
* Use of theophylline, leukotriene modifiers within 12 weeks
* Use of long-acting beta-agonists (formoterol, salmeterol) or anticholinergic (tiotropium)

Primary outcomes:
measure: Spirometric response (FEV1)
measure: Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
Study officials:
affiliation: National Jewish Medical and Research Center faculty
name: Richard Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04799782: Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
Official title: Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injuries
Sleep Disordered Breathing
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to look at the effect of using Mirtazapine to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (SCI) and non-injured persons during sleep. During this part of the study participants will be asked to take Mirtazapine (15mg per day) and a placebo in a random fashion, each for a one week period (drug period) of time followed by one week without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for one weeks followed by a night study to look at the effect the Mirtazapine/placebo pill has on the way the body responds during sleep.

Detailed description: Randomized placebo controlled cross-over study. Each subject will be studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; the participants will be blinded to whether they are taking Mirtazapine or placebo. After the one week treatment a sleep study will be repeated. Mirtazapine will be given at 15 mg dose before bed-time. (2) Cross over medication for one week will be followed by a second sleep study.

Eligibility criteria: Inclusion Criteria:

* Adults with SCI (\>6months after spinal cord injury) at the T6 level/above
* Non-injured adults

Exclusion Criteria:

* Pregnant and lactating females
* Heart failure, vascular disease, or stroke
* Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease
* BMI \>38 kg/m2
* Mechanical ventilation dependence

Primary outcomes:
measure: CO2 Reserve (Delta-PETCO2-AT)
timeFrame: One Week
Secondary outcomes:
measure: AHI (Apnea/Hypopnea Index)
timeFrame: One Week
Other outcomes:
Locations:
Study officials:
References: