louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01932502: Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy
Official title: Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy: Efficacy, Tolerability, Dosing Equivalence, and Retention Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Refractory Epilepsy
Keywords: epilepsy
Onfi
clonazepam
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2013-08-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the clinical safety, tolerability, and efficacy of clobazam (Onfi) when it replaces the pre-existing clonazepam therapy in patients with refractory epilepsy.

Detailed description: The study is designed to answer frequently asked questions when clinicians replace existing 1,4-benzodiazepine to Onfi, as follows:

1. What should be the optimal equivalent doses for conversion?
2. How quickly should it be converted?
3. Would there be significant improvement of seizure control?
4. Should we expect difference in tolerability? If so, what are common adverse events?
5. Would the tolerance to the therapeutic effect differ with Onfi after conversion?

Eligibility criteria: Inclusion Criteria:

* Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to the initial study visit.
* Currently taking stable dosing regimen of clonazepam (0.5-4mg daily) for seizure control.
* Takes at least one additional Anti-epileptic drug besides benzodiazepine.
* Age 18-70 years, inclusive.
* In opinion of investigator, can be safely treated with Onfi.
* Minimum of 2 seizures, but no more than 24 complex partial or generalized seizures, during the 8-week baseline period prior to study entry.
* Able to communicate effectively with study personnel and considered reliable, able, willing, and cooperative with regard to complying with protocol-defined requirements, including completion of study diary.

Exclusion Criteria:

* Clinically relevant current illness or history of that may interfere with the subject's ability to complete the study as determined by the investigator.
* History of status epilepticus within 6 months prior to the initial study visit.
* History of suicidal attempts or suicidal ideation within 12 months of initial visit.

Primary outcomes:
measure: Efficacy
timeFrame: 28 days
Secondary outcomes:
measure: Tolerability
timeFrame: Weeks 6 - 52 after medication conversion
measure: Retention
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Health
state: Arizona
Study officials:
affiliation: Banner Health Systems
name: Steve Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03240302: A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI Sperm Selection Method
Official title: A Comparative Study of Sibling Oocytes, Which Examines Two Sperm Selection Methods for Top Quality of Spermatozoa , Prior Intracytoplasmic Sperm Injection (ICSI) Performance, and Their Effect on Embryo Quality and IVF Outcome: A Common Selection Method Based on Morphology (ICSI) vs. a Selection Method for Mature Spermatozoa With CD44 Receptors for Hyaluronic Acid (PICSI - Physiological Selected Intracytoplasmic Sperm Injection)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.


Eligibility criteria: Inclusion Criteria:

* Males aged 18-60
* Females aged 18-35
* Males with mild OTA (oligo terato astheno zoospermia) and at least one failed IVF cycle
* Males with normozoospermia with at least 2 unexplained failed IVF cycles
* Females with normal FSH and normal AMH values
* Females who have retrieved in previous cycles at least 6 oocytes

Exclusion Criteria:

* Couples who have been exposed to heavy smoking, drugs and chronic diseases
* Males who have undergone testicular surgery (TESE) or defined as severe OTA
* Females with egg factor infertility

Primary outcomes:
measure: Comparison of fertilization rate
timeFrame: Three years
measure: Comparison of embryo quality
timeFrame: Three years
Secondary outcomes:
measure: Implantation rate
timeFrame: Three years
measure: Pregnancy rate
timeFrame: Three years
measure: Miscarriage rate
timeFrame: Three years
measure: Live birth rate
timeFrame: Three years
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Einat Shalom Paz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hillel Yaffe Medical Center
name: Medeia Michaeli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01814202: Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trial (Pilot Phase) to Evaluate the Efficacy of a Medical Nutrition Product, PTM202, in Children With Acute Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Diarrhea
Lead sponsor: PanTheryx, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a medical nutrition product, PTM202, along with standard of care, enhances recovery and reduces diarrhea morbidity in young children


Eligibility criteria: Inclusion Criteria:

* males or females between 6 months and 5 years of age
* acute diarrhea (\<48 hours) without interfering co-morbidities
* guardian willing to have child admitted to hospital as an inpatient for 96 hours and to return to the clinic with the child on Day 7 for a final evaluation
* Guardian is willing and able to report to the Investigator information on stool frequency, stool consistency and food and water intakes during the follow up phase.
* Written informed consent must be obtained prior to admission to this study.
* The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea.

Exclusion Criteria:

* Suspected or confirmed cholera
* Suspected dysentery
* Symptom duration \>48 hours at screening
* Vomiting severity that is like to make administration and retention of test article impossible
* Severe malnutrition (defined as weight for height of less than -3 SD below median, per WHO Standards (6).
* Child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening.
* History of hypersensitivity or allergy to milk or egg

Primary outcomes:
measure: diarrhea duration
timeFrame: 7 days
Secondary outcomes:
measure: food intake
timeFrame: 7 days
measure: stool frequency
timeFrame: 7 days
measure: stool consistency
timeFrame: 7 days
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Shafiqul A Sarker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05952102: Nigella Sativa as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia
Official title: Role of Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pneumonia
Keywords: Nigella Sativa Oil
Pneumonia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 104
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nigella sativa is the world's oldest immunomodulator. The main active component in Nigella sativa is thymoquinone. Research shows thymoquinone has antioxidant, anti-inflammatory, and antimicrobial effects. Based on these observations on the pharmacological activities of Nigella sativa, the potential therapeutic efficacy of N. Sativa was proposed in CAP.

Detailed description: The aim of this work is to assess the benefit of oral Nigella Sativa oil supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with pneumonia admitted to the Pulmonology Unit, Pediatric Department.

Primary outcome:

1- The duration of clinical manifestations of pneumonia including time taken for normalization of respiratory rate, temperature, and oxygen.

saturation, chest in drawing, hypoxia, lethargy, and inability to feed 2- The duration of hospital stay.

Secondary outcome:

1. Discharge or death of the patient.
2. Occurrence of pneumonia complications.

Eligibility criteria: Inclusion Criteria:

* Signs and symptoms of lower respiratory tract infections (LRTI) (LRTI was defined as ≥ 1 of the following: new or different cough or sputum production, chest pain, dyspnea, tachypnea, or abnormal auscultatory findings).
* Focal findings on chest x-ray indicating pneumonia.

Exclusion Criteria:

* Children with immunodeficiency, chronic lung disease, malignancy, congenital lung anomalies, underlying disorder impacting respiration i.e. genetic, metabolic, neuromuscular disorders....etc, children with CHD affecting the pulmonary blood flow

Primary outcomes:
measure: Respiratory rate
timeFrame: 3 days
measure: Temperature
timeFrame: 3 days
measure: Oxygen saturation
timeFrame: 3 days
measure: Feeding
timeFrame: 3 days
measure: Respiratory distress
timeFrame: 7 days
measure: Hospital stays
timeFrame: 14 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Pneumonia complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine
state: Gharbia
Study officials:
affiliation: Tanta University
name: Asmaa E. Fayed, MBBS
role: STUDY_CHAIR
References:
Clinical trial NCT05012202: Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
Official title: Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss
Keywords: Vaginal delivery
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes pregnant women admitted to the Labor \& Delivery unit for delivery.

Brief summary: Postpartum hemorrhage is a well-known complication of delivery and the leading cause of maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly collected as a means to assess or base treatment for blood loss. The Hemi device is a point-of-care device designed to provide hematocrit, followed by the stage of hemorrhagic shock using artificial intelligence algorithms. The ultimate goal of the product is to provide an accurate hematocrit from easily attainable samples such as vaginal blood during hemorrhage to remove yet another barrier to access for actively bleeding women. The purpose of this study is to compare the hematocrit of vaginal blood using the Hemi device with standard venipuncture.

Detailed description: This will be a prospective cohort study. The investigators will recruit 41 pregnant women admitted for delivery. Following delivery, a sample of vaginal blood will be collected and the Hemi device will be used to obtain hematocrit. These results will be masked to the clinical team until the time of data collection. A CBC will also be collected via venipuncture at this time. This study will be comparing hematocrit levels by standard clinical laboratory versus results from the device.

Eligibility criteria: Inclusion Criteria:

* Pregnant women between the ages of 18-50
* Admission for vaginal delivery
* Singleton pregnancy
* Term gestation (\>=37 weeks)

Exclusion Criteria:

* Pregnant women \< 18 years or \> 50 years
* Incarcerated patients
* Patient unwilling or unable to provide consent
* Enrolled in another trial that may affect outcome

Primary outcomes:
measure: Hematocrit
timeFrame: During delivery
Secondary outcomes:
measure: Time to obtain results
timeFrame: During delivery
Other outcomes:
Locations:
city: Galveston
country: United States
facility: UTMB
state: Texas
Study officials:
References:
Clinical trial NCT03227302: Associations of the Grades of Doctor and Neonatal Outcomes
Official title: Associations of the Grades of Doctor and Neonatal Outcomes: An Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Standardized Training System for Residents
Neonatal Outcomes
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 20000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All neonates with gestational age are from 26 weeks to 42 weeks

Brief summary: In China, the standardized training system for residents was built last year, and the associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.

Detailed description: In China, the grades of doctors and accoucheurs are divided into four levels, and different levels may induce differences of neonatal asphyxia and death. The standardized training system for residents was built last year,the associations of the grades of doctors and accoucheurs and neonatal asphyxia,neonatal death before and after the training systems need to be assess.

Eligibility criteria: Inclusion Criteria:

* Gestational age (GA) is from 26 to 42 weeks

Exclusion Criteria:

* major congenital malformations or complex congenital heart disease

Primary outcomes:
measure: neonatal asphyxia
timeFrame: within 28 days
measure: death
timeFrame: within 28 days
Secondary outcomes:
measure: Bayley Scales of Infant Development
timeFrame: at 2 months and 2 years old
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics, Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Shi Yuan, PhD,MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06411002: Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines
Official title: A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Frown Lines
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL).

Approximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent.

The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.


Eligibility criteria: Inclusion Criteria:

1. Be outpatient, male or female subjects, in good general health, 18 years of age or older
2. Have a score of moderate (2) or severe (3) GL during maximum contraction as assessed by the IGA-FWS
3. Have a score of moderate (2) or severe (3) FHL during maximum contraction as assessed by the IGA-FHWS

Exclusion Criteria:

1. Previous treatment with botulinum toxin type A in the face, or treatment with \>200 U of any botulinum toxin anywhere else in the body, in the past 6 months prior to screening
2. Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of contraception
3. Allergy or sensitivity to any botulinum toxin preparations or to any component of the investigational product

Primary outcomes:
measure: IGA-FWS
timeFrame: Week 4
measure: IGA-FHWS
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Revance
state: Tennessee
Study officials:
References:
Clinical trial NCT02117102: Effect of Use of a New Technique for Pediatric Urine Collection in ER
Official title: Effect of Use of a New Technique for Pediatric Urine Collection on the Length of Stay in the Emergency Department: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Infection
Unspecified Fever
Lead sponsor: Jeju National University Hospital
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 170
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Urinary tract infection is most common serious bacterial infection in children who admit into the emergency department (ED). However the collection of urine from young children is time consuming process. So many children and their family guardian waste time until medical disposition established.

In 2013, Maria Luisa Herreros Fernandez etc have suggested a new urine collection technique for newborn, that bladder and lumbar stimulation technique is fast and safe.

The aim of this study is to determine clinical efficacy of bladder and lumbar stimulation technique (BLST) for pediatric patient in ED.

Detailed description: Bladder and lumbar stimulation technic

Step 1

- Oral or IV hydration : Aprropriate to the weight of the children

Step 2 - Bladder stimulation : Gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 sec

Step 3

- Lumbar stimulation : Lumbar paravertebral zone in the lower back with a light circular massage for 30 sec

Both stimulation manoeuvres are repeated until micturition starts and a midstream urine sample can be caught in a sterile collector

Eligibility criteria: Inclusion Criteria:

* Children have unspecific fever and requiring and urine test

Exclusion Criteria:

* Initial shock state
* History of congenial urinary tract abnormality
* Parents who have declined taking part in the research

Primary outcomes:
measure: Success rate of bladder and lumbar stimulation techninc
timeFrame: 10 min
Secondary outcomes:
measure: Urine collection time
timeFrame: 3 hour
Other outcomes:
Locations:
city: Jeju City
country: Korea, Republic of
facility: Jeju national university hospital
state: Jeju special governing province
Study officials:
affiliation: Emergency department of Jeju national university hospital
name: Sung wook Song
role: STUDY_CHAIR
References:
citation: Herreros Fernandez ML, Gonzalez Merino N, Tagarro Garcia A, Perez Seoane B, de la Serna Martinez M, Contreras Abad MT, Garcia-Pose A. A new technique for fast and safe collection of urine in newborns. Arch Dis Child. 2013 Jan;98(1):27-9. doi: 10.1136/archdischild-2012-301872. Epub 2012 Nov 21.
Clinical trial NCT04730102: Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells
Official title: Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Rectal washout
transanal total mesorectal excision
rectal cancer
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
Collaborators: name: Skane University Hospital
name: Lund University
First posted: 2021-01-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing transanal mesorectal excision at Slagelse Hospital, Denmark

Brief summary: The study aims to assess the existence of intraluminal malignant cells and the appropriate fluid volume needed to perform rectal washout during transanal total mesorectal excision (taTME) for rectal cancer.

Detailed description: Twenty patients undergoing taTME for rectal cancer is included. Following the closure of the rectal lumen by a purse string suture, rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity. Each sample is cytologically examined by a pathologist and labelled either malignant or non-malignant.

Eligibility criteria: Inclusion Criteria:

* Surgery at Slagelse Hospital for rectal cancer with transanal mesorectal excision
* Consent to participate in the study

Exclusion Criteria:

* No consent to participate
* No surgery

Primary outcomes:
measure: Existence of intraluminal malignant cells in fluid samples from rectal washout
timeFrame: Intraoperatively
Secondary outcomes:
measure: Fluid volume needed to perform rectal washout during transanal total mesorectal excision to eliminate intraluminal malignant cells
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Slagelse Hospital
state: Zealand
Study officials:
affiliation: Skåne University Hospital, Malmö, Region Skåne, Sweden
name: Pamela Buchwald
role: PRINCIPAL_INVESTIGATOR
References: