louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04416880: Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency
Official title: Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation; Insufficient, Partial
Hypogalactia, Without Mention of Attachment Difficulty
Keywords: acupuncture
exclusive breastfeeding
breastmilk
press tack needle
lactation insufficiency
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was meant to see the effectiveness of press tack needle acupuncture in improving lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1 Shaoze. Press Tack Needles were placed in these acupuncture points for 7 days in hope that it will give continuous acupuncture stimulation that might help in improving lactation insufficiency with minimal side effect, less time consuming, and more efficient for the patient.


Eligibility criteria: Inclusion Criteria:

* Breastfeeding mother who suffers from lactation insufficiency
* Breastfeeding mother from 2 weeks to 5 months post-partum
* Breastfeeding mother with healthy baby

Exclusion Criteria:

* Subject consumes drugs that are known to decrease breastmilk production
* Subject with infection or inflammation in the intended acupuncture points
* Subject with bleeding disorder
* Subject consumes anticoagulant
* Subject with known diabetic history
* Subject with body temperature \> 38 degree celcius

Primary outcomes:
measure: Breastmilk Volume
timeFrame: Day 7 of acupuncture or sham treatment
measure: Breastmilk Volume
timeFrame: Day 10 of acupuncture or sham treatment (Day 3 after press tack needles were removed)
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Puskesmas Kecamatan Menteng
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Poliklinik Akupunktur Medik RSCM
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Puskesmas Kelurahan Pegangsaan
state: DKI Jakarta
Study officials:
affiliation: Faculty of Medicine University of Indonesia
name: Diana Oei, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03337880: Neonatal Outcomes in Instrumental Delivery
Official title: Neonatal Outcomes in Instrumental Delivery: Newborn Head Mark and Comfort.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Instrumental Delivery; Nec, Affecting Fetus or Newborn
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mature newborns who profit an instrumental delivery or not.

Brief summary: The aim of this study is to compare the impact of instrumental delivery on newborn head mark and newborn comfort over the impact of non-instrumental delivery. It is also to evaluate how mothers age, Body Mass Index, instrumental extraction indication, extractor type, variety and height of the fetal presentation, operator, time of birth (day or night) and birth weight impact on head mark existence and newborn comfort.


Eligibility criteria: Inclusion Criteria:

* term infant
* non-opposition of the newborn parent

Exclusion Criteria:

* outborn child
* premature newborn
* newborn transferred

Primary outcomes:
measure: Head mark or injury
timeFrame: 12 to 72 hours of age
measure: Newborn comfort
timeFrame: 12 to 72 hours of age
Secondary outcomes:
measure: Analgesic use
timeFrame: 0 to 72 hours of age
measure: Length of hospitalisation after childbirth
timeFrame: First month of life
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital
Study officials:
References:
Clinical trial NCT02147262: Laboratory Characteristics in Chronic Atrophic Acrodermatitis
Official title: Inflammatory Proteins,Gene Polymorphisms, and Transcriptome Profiles in Patients With Chronic Atrophic Acrodermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Atrophic Acrodermatitis
Keywords: chronic atrophic acrodermatitis
Lyme borreliosis
molecular characteristics
outcome
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
name: Medical University of Vienna
name: Harvard University
First posted: 2014-05-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with chronic atrophic dermatitis to gain better insight into pathogenesis of chronic infection with Borrelia burgdorferi sensu lato.


Eligibility criteria: Inclusion Criteria:

* chronic atrophic dermatitis in patients \>18 years

Exclusion Criteria:

* none

Primary outcomes:
measure: inflammatory proteins in patients with chronic atrophic dermatitis
timeFrame: up to 24 months
Secondary outcomes:
measure: clinical characteristics of patients with chronic atrophic dermatitis treated with doxycycline for 14 or 28 days
timeFrame: at enrollment, at 2, 6 12 and 24 months follow-up
Other outcomes:
measure: gene polymorphisms in patients with chronic atrophic dermatitis
timeFrame: at enrollment, at 6 months follow-up
measure: transcriptome profiles in patients with chronic atrophic dermatitis
timeFrame: at enrollment
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana, Department of Infectious Diseases
Study officials:
affiliation: UMC Ljubljana
name: Franc Strle, MD, PhD
role: STUDY_CHAIR
affiliation: UMC Ljubljana
name: Dasa Stupica, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06055062: Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 5.5-years-old
Official title: Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 5.5-years-old: EPIPAGE2 and EPIRMEX Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Preterm Birth
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 39
Sex: ALL
Minimum age (years): 66
Maximum age (years): 66
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A French cohort preterm population from the EPIPAGE-2 study.

Brief summary: Background: Compared to term-born peers, very preterm children generally perform poorly in executive functions, with a significant impact on learning at school and quality of life. These EF deficits are related to microstructural abnormalities in white matter and subcortical brain structure.

Objective: To investigate if an alteration of cerebral metabolism in very premature at term corrected-age correlates to executive dysfunctions at school age.

Design, setting, patients: Very preterm patients eligible for Epirmex underwent cerebral Magnetic Resonance Imaging at term-equivalent age and 1H-MRS using a monovoxel technique. The volumes of interest were the posterior periventricular white matter zone and the basal ganglia and thalamus The ratios of N Acetyl Aspartate (NAA) to Choline (cho), NAA to Creatine(Cre), Cho to Cr, and Lac (Lactate) to Cr were calculated.

Main outcome measures: Survival at 5 ½ years with or without neurodevelopmental disabilities (composed of cerebral palsy, visual, hearing, cognitive deficiency, behavioral difficulties, or developmental coordination disorders) were described. The executive functions were assessed using two indices from the Wechsler Intelligence Scale measured in the EPIPAGE 2 cohort at age five-and one-half years: the Working Memory Index (WMI) and the Fluid Reasoning Index (FRI).


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria form EPIPAGE2 and EPIRMEX
* Children who underwent spectroscopy with regions of interest analyzed: periventricular zone, gray nuclei, brainstem.
* Children who received a complete cognitive assessment in EPIRMEX (integrated assessment identical to that planned in EPIPAGE2) at age 5 ½.

Non-inclusion Criteria:

* Children with severe karyotype abnormalities.
* Children with central nervous system malformations diagnosed antenatally or on neonatal tests
* Children with severe cerebral palsy or major neurosensory (blindness, profound deafness...) not allowing children to take the tests scheduled at age 5 ½.

Primary outcomes:
measure: neurodevelopmental development
timeFrame: 1 month
Secondary outcomes:
measure: Explored disabilities
timeFrame: 1 month
measure: Schooling
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00587262: Scalar Localization Cochlear Electrode Array Using 64 Slice CT
Official title: Scalar Localization of Cochlear Implant Electrode Array in Hearing Preservation Patients Using 64 Slice CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Keywords: Cochlear
Hearing
High frequency hearing loss
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 5
Sex: ALL
Minimum age (years): 8
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Either part of the existing Cochlear Implant data base, or those persons who have had a Cochlear implant with either short or long electrode array who have had a high frequency hear loss.

Brief summary: Insertion of electrode array in scala vestibuli, rather than the preferred location within scala tympani, leads to loss of native hearing in those patients with isolated high-frequency hearing loss undergoing cochlear implantation.

Detailed description: We aim to determine the surgical placement in patients with high frequency who had long electrode array insertions because they did not meet audiometric criteria for short array devices.

From this basis we will be able to determine if suboptimal insertion (e.g., in the scala vestibuli) leads to loss of low-frequency hearing in these patients. We also will look at the possibilities of using this data in predicting outcomes, modifying implant design, and perfecting surgical technique.

Eligibility criteria: Inclusion Criteria:

* Registered in the Cochlear Implant Database.
* Patient has short or long electrode cochlear implant for high frequency hearing loss.

Exclusion Criteria:

* Inability to provide consent.
* Patients with underlying otospongiosis, extensive labyrinthitis ossificans or cochlear dysplasia. (These patients would have been identified with pre-operative imaging prior to cochlear implantation).

Primary outcomes:
measure: The aim of our study is to determine surgical placement of the short electrode of cochlear implants in patients with high frequency loss.
timeFrame: Two years
Secondary outcomes:
measure: Determine the surgical placement in patients with high frequency who had long electrode array insertions because they did not meet audiometric criteria for short array devices.
timeFrame: Two Years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John (Jack) I. Lane, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lane JI, Witte RJ, Driscoll CL, Shallop JK, Beatty CW, Primak AN. Scalar localization of the electrode array after cochlear implantation: clinical experience using 64-slice multidetector computed tomography. Otol Neurotol. 2007 Aug;28(5):658-62. doi: 10.1097/MAO.0b013e3180686e26.
Clinical trial NCT00970762: Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)
Official title: Comparative Study of Org 9426 With Vecuronium Bromide (Phase III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-02
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to determine and compare the safety and effectiveness of two neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are undergoing general elective surgery with sevoflurane anesthesia.

Study participants received an intubating dose of a neuromuscular blocker (to enable insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed, to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular blocker (onset time) after the intubating dose was measured and compared as the primary outcome.

Detailed description: The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular blocking action.

Eligibility criteria: Inclusion criteria:

* at least 20 but under 65 years of age
* American Society of Anesthesiologists (ASA) Class 1, 2 or 3 for general elective surgery
* not considered to be pregnant
* scheduled for elective surgery under sevoflurane or propofol anesthesia with an anticipated duration of about 1.5-3 hours
* normal laboratory values

Exclusion Criteria:

* certain medical conditions or medical histories
* receiving certain medications or treatments

Primary outcomes:
measure: Onset time of intubating dose. DESCRIPTION: The time interval between the completion of injection of the study drug (rocuronium or vecuronium) and the maximal depression of first twitch--measured via TOF Watch Sx(R)-- was defined as the onset time.
timeFrame: Day of Surgery, after injection of study drug until maximal depression of first twitch achieved
Secondary outcomes:
measure: Number of subjects who achieved maximal block >=90% after the intubating dose. DESCRIPTION: Reaching a 90% depression of first twitch--measured via TOF Watch Sx(R)--was defined as achieving 90% block
timeFrame: Day of Surgery, after injection of study drug until maximal depression of first twice achieved
measure: Clinical duration after first maintenance dose. DESCRIPTION: The time interval between the completion of injection of study drug and return of first twitch to 25%(as measured by TOF Watch Sx(R)) was defined as the clinical duration.
timeFrame: Day of Surgery, after injection of study drug until return of first twitch to 25%
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03422562: Probiotics and Intestinal Microbiome in Preterm Infants
Official title: Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Microbial Colonization
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 62
Sex: ALL
Minimum age (years): 23
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: BASIC_SCIENCE

Brief summary: The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is associated with increased feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial populations and decrease intestinal disease in preterm infants. There is limited data linking clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW preterm infants.

Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the other no) of infants less than 1000 grams birth weight and \< 29 weeks gestation. A comparison of stool microbiome analysis and the incidence of feeding intolerance and time to reach full feeds in the two groups will be made.


Eligibility criteria: Inclusion Criteria:

* Infants born less than 29 weeks gestation and \<1000 g birth weight admitted to the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre in Calgary.

Exclusion Criteria:

* Infants with major congenital anomalies, hypoxic-ischemic injury, NEC or bowel perforation before 72 hours of life.

Primary outcomes:
measure: Stool Microbiome
timeFrame: 4 weeks
Secondary outcomes:
measure: Stool Microbiome
timeFrame: 2 weeks
measure: Feeding intolerance
timeFrame: 4-6 weeks
measure: Full Feeds
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Belal Alshaikh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Physician
name: Belal Alshaikh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alshaikh B, Samara J, Moossavi S, Ferdous T, Soraisham A, Dersch-Mills D, Arrieta MC, Amin H. Multi-strain probiotics for extremely preterm infants: a randomized controlled trial. Pediatr Res. 2022 Dec;92(6):1663-1670. doi: 10.1038/s41390-022-02004-z. Epub 2022 Mar 21.
Clinical trial NCT00741962: A Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress in Healthy Adults
Official title: A Pilot Double-Blind Crossover Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress and Their Biomarkers in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the safety and efficacy of VR-3 Herbal Blend and its effects on acute and chronic stress responses.


Eligibility criteria: Inclusion Criteria:

1. Men and women between the ages of 35-45
2. No health concerns as determined by study physicians
3. Women must not be pregnant or become pregnant for the duration of the study.

Exclusion Criteria:

1. The subject has a history of hypersensitivity to any of the compounds used in the study
2. The subject is pregnant or a lactating female. Note: If the potential subject is a post-menarcheal female, a pregnancy test (urine or serum) must be performed within 24 hours of study drug administration and confirmed negative in order for the potential subject to be enrolled).
3. History of Psychiatric Illness or Chronic Stress or Anxiety
4. Hypertension, cardiovascular disease, or other health concerns that may confound study results
5. Allergy or sensitivity to test product or ingredients
6. Individuals who are cognitively impaired or who are not able to give informed consent
7. Clinically significant or abnormal laboratory result that can confound the study
8. Medication or nutraceutical intake that can interact with the adaptogens or the biomarkers used in the study (to be determined by study physician)
9. Previous participation in a clinical research trial within 30 days prior to randomization
10. The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
11. The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda

Primary outcomes:
measure: Change in salivary alpha-amylase and cortisol as stress biomarkers for the acute and chronic stress response following VR-3 Herbal Blend use
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in acute psychological stress
timeFrame: 10 weeks
measure: Change in chronic stress
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Naples
country: United States
facility: NEMA Research
state: Florida
Study officials:
References:
Clinical trial NCT03145662: High Pressure Balloon vs Cutting Balloon
Official title: Cutting Balloon vs. High Pressure Balloon for the Treatment of AV Graft Stenosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization to either high pressure balloon or cutting balloon
Primary purpose: TREATMENT

Brief summary: Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). Angiograms will then be performed before and after intervention.

Detailed description: Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). Angiograms will then be performed before and after intervention.

Data will be collected from standard of care visit, including physician visits and ultrasounds. Follow up will be based on the function of the AV access, dialysis center criteria and/or standard of care ultrasound results: including venous pressure of the AV access, difficult cannulation, urea recirculation, and change in character and sound of the AV access (thrill/bruit), which are standard of care assessment at a dialysis center. All patient data sheets will be kept in a study binder and locked in the research room. Randomization will be performed with a computer program.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years of age
2. AV fistula or graft
3. Undergoing weekly hemodialysis
4. Patients must agree to the terms of the study and sign an informed Consent

Exclusion Criteria:

1. Pregnant women

Primary outcomes:
measure: Stenosis Rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: UTMC
state: Ohio
Study officials:
References: