louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01736501: Surveying Parents About Genome Screening of Newborns
Official title: Surveying Parents About Genome Screening of Newborns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parents of Healthy Newborns
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 1101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A 10 minute baseline survey will be administered to parents of healthy newborn infants while in the hospital after delivery at Brigham and Women's Hospital, to be followed by a 25 minute survey 3-24 months later. We will measure parents' attitudes and preferences related to genome screening of newborns. The specific aims of this study are:

1. To investigate whether parents' opinions regarding genome screening of newborns change between the first 48 hours post-partum and 3-24 months post-partum.

   a. We hypothesize that there will not be significant differences between interest in genome screening results in the 48 hours post-partum compared to 3-24 months post-partum.
2. To determine whether seeing hypothetical genome screening results affects parents' decisions regarding whether they would want genome screening for their newborn.

   1. We expect many parents to state initially (in the 48 hours post-partum) that they would elect to have genome screening for their newborn if it were available. In the follow-up survey, half of study participants will receive hypothetical scenarios in which they will need to struggle with the probabilistic and ambiguous nature of the information that could be derived from genome sequencing. We will examine whether this alters their preferences. We will also explore whether parents who receive hypothetical genome screening results scenarios are more likely to alter their preferences than parents who do not receive hypothetical scenarios.


Eligibility criteria: Inclusion Criteria:

* Parent of a healthy newborn in the BWH Department of Obstetrics
* English-speaking

Exclusion Criteria:

* Impaired decision-making capacity
* Newborn with life-threatening health concerns in the 48 hours post-partum

Primary outcomes:
measure: Interest in genome screening for newborn if this service were available through a research study
timeFrame: Change between baseline and 3-24 month follow-up
Secondary outcomes:
measure: Rate of refusal of newborn screening
timeFrame: baseline
Other outcomes:
measure: Parental Stress
timeFrame: 3-28 month follow-up
measure: Postpartum bonding
timeFrame: 3-28 month follow-up
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Robert C. Green, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waisbren SE, Back DK, Liu C, Kalia SS, Ringer SA, Holm IA, Green RC. Parents are interested in newborn genomic testing during the early postpartum period. Genet Med. 2015 Jun;17(6):501-4. doi: 10.1038/gim.2014.139. Epub 2014 Dec 4.
Clinical trial NCT06303401: Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises in Post Partum Low Back Pain
Official title: Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises on Pain and Disability Among Patients With Post-Partum Low Back Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Post Partum
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain.

Detailed description: Patients fulfilling the inclusion criteria will be divided into 2 groups i.e. Group A and Group B. Patients in Group A will receive thrust manipulation technique and Group B will receive pelvic stabilization exercises, heating pad will be given to both groups. Patients will be treated 3 times per week for 4 consecutive weeks. Patient will be evaluated at baseline, midline and at end of 4th week. Pain, functional status and disability will be evaluated after every 3 sessions.

Eligibility criteria: Inclusion Criteria:

* age 20-40 years
* Postpartum women (after 6 weeks)(3, 12)
* Postpartum LBP patient
* Patient pain increased by provocation test i.e. Faber test, High thrust test and Gaenslen test

Exclusion Criteria:

* C-section
* inflammatory or malignant type of pain
* Neurological deficit
* Severe trauma
* Pelvic fracture
* Osteoporosis, spinal stenosis, spondylolysis, spondoloesthesisi

Primary outcomes:
measure: Numeric pain rating scale (NPRS)
timeFrame: 4th week
measure: Modified Oswestry Disability Index (ODI)
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital and Shahab Orthopedic & General Hospital
state: KPK
Study officials:
affiliation: Riphah International University
name: Asmar Fatima, MS OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05121701: Covid-19 Pandemic and Use of Video Laryngoscopy
Official title: Airway Management During the Covid-19 Pandemic: A Comparison of Direct Laryngoscopy Versus Video Laryngoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
Lead sponsor: Van Bölge Eğitim ve Araştırma Hastanesi
Sponsor class: OTHER_GOV
First posted: 2021-11-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a highly contagious infection with the highest viral load in the upper respiratory secretions. Despite using personal protective equipment, SARS-CoV-2 contamination to the healthcare personnel is possible during the airway management of infected patients. Direct laryngoscopy remains as the most common method for endotracheal intubation. Our study aimed to compare the use of video laryngoscopy with direct laryngoscopy for tracheal intubation in adult patients receiving general anesthesia for elective surgery during the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Elective surgery

Exclusion Criteria:

* Intraoral or neck surgery
* gastroesophageal reflux
* delayed gastric emptying
* pregnancy
* scoliosis

Primary outcomes:
measure: Intubation time
timeFrame: First 5 minutes of the operation
Secondary outcomes:
measure: Intubation Comfort
timeFrame: First 5 minutes of the operation
measure: Cormack-Lehane Scoring
timeFrame: First 5 minutes of the operation
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum City Hospital
Study officials:
References:
citation: Piepho T, Fortmueller K, Heid FM, Schmidtmann I, Werner C, Noppens RR. Performance of the C-MAC video laryngoscope in patients after a limited glottic view using Macintosh laryngoscopy. Anaesthesia. 2011 Dec;66(12):1101-5. doi: 10.1111/j.1365-2044.2011.06872.x. Epub 2011 Aug 25.
Clinical trial NCT02226601: Aprepitant to Mitigate Opioids' Cognitive Side Effects
Official title: Aprepitant to Mitigate Opioids' Cognitive Side Effects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Dysfunction
Keywords: drowsiness
loopiness
nausea
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Morphine and similar substances (called opioids) are often prescribed for moderate to severe pain, such as after a surgery, thus allowing for minimal pain and a better recovery. Unfortunately various, non-dangerous side effects from opioids occur often that limit the way patients feel and can take of themselves, despite otherwise good pain control and minimal limitations from the surgery itself.

Detailed description: In this proposed study the investigators want to examine if the drug aprepitant can decrease the so called "cognitive impairments" opioids may cause, such as drowsiness, loopiness and feeling "high".

This would allow for a better recovery period, in which patients can be more "themselves", participate in activities around them and move forward.

Subjects scheduled for elective surgeries with expected opioid medication for moderate to severe pain and good functional status shortly after surgery will be randomized to receive either aprepitant or placebo shortly before their surgery and for two more days thereafter.

A telephone interview for cognitive status and several specific questions will be used to assess the effect of aprepitant on the subjects' cognitive and functional status.

Eligibility criteria: Inclusion Criteria:

* healthy English speaking, opioid-naive consenting adults

Exclusion Criteria:

* current or very recent (\< 3 months) opioid therapy
* morbid obesity
* liver disease
* therapy with pimozide, terfenadine, astemizole, cisapride, vitamin K antagonists (warfarin), hormonal contraceptives
* acute or chronic infections
* immunocompromised status
* hemodynamically unstable, hemorrhage (bleeding)
* recent surgery
* pregnancy, nursing
* younger than 18 years old
* not proficient of the English language

Primary outcomes:
measure: cognitive function
timeFrame: 3 days post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Kai Schoenhage, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walsh SL, Heilig M, Nuzzo PA, Henderson P, Lofwall MR. Effects of the NK1 antagonist, aprepitant, on response to oral and intranasal oxycodone in prescription opioid abusers. Addict Biol. 2013 Mar;18(2):332-43. doi: 10.1111/j.1369-1600.2011.00419.x. Epub 2012 Jan 19.
Clinical trial NCT01788501: Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease
Official title: Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease in Paediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Graft vs Host Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare efficacy and safety of tacrolimus/methotrexate with cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic hematopoietic stem cell transplantation patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of hematological malignancy
* Age under 18 years old
* Serum bilirubin less than 1.5 X upper limit of normal
* Aspartate transaminase, Alanine transaminase less than 2.5 X upper limit of normal
* Alkaline phosphatase less than 2.5 X upper limit of normal
* Serum creatinine less than 1.5 X upper limit of normal
* Agrees to participate, and informed consent signed

Exclusion Criteria:

* Evidence of HIV infection
* Documented uncontrolled disease (infections)
* Prior transplantation (hematopoietic stem cell or solid organs)

Primary outcomes:
measure: incidence of grade II-IV acute graft versus host disease
timeFrame: day 100 post transplantation
Secondary outcomes:
measure: incidence of infection
timeFrame: day 100 post transplantation
measure: incidence of adverse drug reactions
timeFrame: day 100 post transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Pharmacy
name: JungMi Oh, Pharm.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01739101: The Reproductive Life Plan in Midwifery Counseling
Official title: The Reproductive Life Plan in Midwifery Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Childbearing
Pregnancy
Health Behavior
Lifestyle
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 299
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many women and men are at risk for sexual transmitted infections and unwanted pregnancies and have unrealistic family planning intentions and insufficient knowledge of health promoting lifestyle prior to conception. Without sufficient support from the health care system this can lead to negative consequences. The aim of our study was to investigate if the usage of the Reproductive Life Plan in midwifery counselling increases women's knowledge of reproduction and particularly knowledge of folic acid intake prior to pregnancy. Secondary aims were to evaluate the influence on women's family planning and to further explore how women experienced the Reproductive Life Plan-based counselling.


Eligibility criteria: Inclusion Criteria:

* Visitor at the Student Health Clinic

Exclusion Criteria:

* Not speaking Swedish
* Male

Primary outcomes:
measure: Knowledge of reproduction
timeFrame: 2 months after the intervention
Secondary outcomes:
measure: Family Planning Intentions
timeFrame: 2 months after the intervention
Other outcomes:
measure: Experience of the intervention
timeFrame: 2 months after the intervention
Locations:
city: Uppsala
country: Sweden
facility: The Student Health Centre
Study officials:
affiliation: Uppsala University
name: Jenny Stern
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Tanja Tydén, PhD
role: STUDY_DIRECTOR
affiliation: Uppsala University
name: Margareta Larsson, PhD
role: STUDY_DIRECTOR
References:
citation: Moos MK. Unintended pregnancies: a call for nursing action. MCN Am J Matern Child Nurs. 2003 Jan-Feb;28(1):24-30; quiz 31.
citation: Sanders LB. Reproductive life plans: initiating the dialogue with women. MCN Am J Matern Child Nurs. 2009 Nov-Dec;34(6):342-7; quiz 348-9. doi: 10.1097/01.NMC.0000363681.97443.c4.
citation: Johnson K, Posner SF, Biermann J, Cordero JF, Atrash HK, Parker CS, Boulet S, Curtis MG; CDC/ATSDR Preconception Care Work Group; Select Panel on Preconception Care. Recommendations to improve preconception health and health care--United States. A report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR Recomm Rep. 2006 Apr 21;55(RR-6):1-23.
citation: Stern J, Larsson M, Kristiansson P, Tyden T. Introducing reproductive life plan-based information in contraceptive counselling: an RCT. Hum Reprod. 2013 Sep;28(9):2450-61. doi: 10.1093/humrep/det279. Epub 2013 Jul 10.
Clinical trial NCT00557401: An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD
Official title: A Multi-Center Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Study of XP19986 in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux
Lead sponsor: XenoPort, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD


Eligibility criteria: Inclusion Criteria:

* History and documentation of GERD diagnosed by a gastroenterologist, with symptoms (heartburn and/or regurgitation) on ≥ 3 days during the week prior to screening and prior to randomization

Exclusion Criteria:

* Current or historical endoscopic evidence of erosive esophagitis LA Classification Grade B, C, or D

Primary outcomes:
measure: Number of heartburn events over the treatment period
timeFrame: 4-weeks
Secondary outcomes:
measure: Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: MDS Pharma Services
state: California
Study officials:
affiliation: XenoPort, Inc.
name: Jay Huff, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05197101: To Evaluate the Efficacy and Safety of Balloon Catheter Combined With Oxytocin Induction in Nulliparous Women With Estimated Fetal Weight ≥3500g at 39-40 Weeks of Gestation
Official title: To Evaluate the Efficacy and Safety of Balloon Catheter Combined With Oxytocin Induction in Nulliparous Women With Estimated Fetal Weight ≥3500g at 39-40 Weeks of Gestation: a Randomized, Controlled, Observational Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macrosomia, Fetal
Keywords: balloon catheter
oxytocin
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is a randomized, controlled, observational study. 150 nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation will be enrolled as subjects in the two groups is 1:1. In the experimental group, vaginal examination will be performed at 39 to 40 weeks to assess cervical conditions. If the bishop score \<6, the balloon catheter combined with oxytocin induction will be planned at 40 weeks ±3 days. In the control group, one week to 41 weeks ±3 days will be expected. Vaginal examination will be performed again to evaluate cervical conditions. If the bishop score \<6 points, and balloon catheter combined with oxytocin induction will be performed. After 96h, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.


Eligibility criteria: Inclusion Criteria: singleton head position pregnancy, negative Down's screening and /or NIPT screening, no malformation was found, with slight/without pregnancy complications -

Exclusion Criteria:twin or multiple pregnancy, scar uterus, with contraindications to vaginal delivery, estimated fetal weight \>4500g

-

Primary outcomes:
measure: vaginal birth rate
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01637701: Plasmakinetic Enucleation of the Prostate to Treat Benign Prostatic Hypertrophy Patients With Large Prostate
Official title: Comparison of Pasmakinetic Enucleation of the Prostate With Bipolar Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH With Large Prostate
Keywords: benign prostatic hypertrophy
bipolar transurethral resection of the prostate
plasmakinetic enucleation of the prostate
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 80
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the perioperative and postoperative characters of plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients with large prostate.

Detailed description: Despite the availability of numerous minimally invasive alternatives, monopolar transurethral resection of the prostate (TURP) remains the most frequently performed operation for benign prostatic hypertrophy (BPH) with small to moderate size prostates. Nevertheless, TURP for large prostates is associated with various complications and unsatisfactory long-term results. B-TURP and PkEP have both been proved to have more favorable postoperative outcomes than monopolar TURP. But whether B-TURP or PkEP is better remain controversial. We aim to compare the perioperative and postoperative characters of PkEP with B-TURP for BPH patients with large prostate. Moreover, we evaluate the long-term results of both approaches.

Eligibility criteria: Inclusion Criteria:

* Qmax \< 10 mL/s, IPSS \>19
* Age between 50 and 70 years
* Prostate volume between 70 and 200 mL, as determined by TRUS, and medical therapy failure.

Exclusion Criteria:

* Patients with neurogenic bladder
* Urethral stricture
* Bladder tumor
* Prostate cancer and previous prostate bladder neck
* Urethral surgery
* PSA\>4ng/ml, or receiving prostate biopsy within 3 months

Primary outcomes:
measure: time of catheterization
Secondary outcomes:
measure: Operation time
measure: resected adenoma weight as a measure of treatment efficacy
measure: changes in serum haemoglobin as a measure of one of the complications
measure: postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability
timeFrame: 5 years
measure: postoperative Qmax as a masure of treatment efficacy and durability
timeFrame: 5 years
measure: re-operation rate as a measure of durability
timeFrame: 5 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou General Hospital
state: Fujian
Study officials:
affiliation: Fuzhou General Hospital
name: Jianming Tan, M.D. & Ph.D.
role: STUDY_DIRECTOR
References: