louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02950974: Change in Serum Chloride Level After Loading Dose of Sterofundin Solution Compared With Normal Saline Solution
Official title: Change in Serum Chloride Level After Loading Dose of Sterofundin Solution Compared With Normal Saline Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Change in Serum Chloride Level
Keywords: sterofundin
resuscitation
normal saline
chloride
fluid
SID
pH
osmolality
urine
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Prospective, crossover, randomized trial to evaluate plasma compositions after loading dose of sterofundin solution given to healthy volunteer in the resuscitation manner compared with normal saline solution.

Detailed description: 10 healthy volunteers were randomly assigned to receive either normal saline or sterofundin for the first solution in dose of 30 mL/kg (max 2 L) over 1 hour. Blood was collected at baseline (T0), at 60 minutes (T1), 120 minutes (T2), and 240 minutes (T4) from baseline. Time to fist void after initiation of fluid and urine volume were also recorded. After wash-out period of at least 1 week, crossover studies were performed with another fluid.

Eligibility criteria: Inclusion Criteria:

* No underlying disease
* LVEF \> 0.5
* No current medication usage

Exclusion Criteria:

* Pregnancy or lactation
* BMI \<18 or \>25
* Fever presented in the past 2 weeks

Primary outcomes:
measure: Change in serum chloride
timeFrame: 4 hours
Secondary outcomes:
measure: Change in serum pH
timeFrame: 4 hours
measure: Change in serum osmolality
timeFrame: 4 hours
measure: Change in serum SID
timeFrame: 4 hours
measure: Time to first void
timeFrame: Within 24 hours
measure: Urine volume
timeFrame: Within 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Ramathibodi Hospital
name: Sunthiti Morakul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Awad S, Allison SP, Lobo DN. The history of 0.9% saline. Clin Nutr. 2008 Apr;27(2):179-88. doi: 10.1016/j.clnu.2008.01.008. Epub 2008 Mar 3.
citation: Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72.
citation: Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
citation: Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during acute normovolaemic haemodilution. Intensive Care Med. 2004 Jul;30(7):1432-7. doi: 10.1007/s00134-004-2176-x. Epub 2004 Feb 28.
Clinical trial NCT00956774: Comparison of Three Cannulas for Hysterosalpingography
Official title: Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: HSG
Cannula
HSG procedure
infertility evaluation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the three commonly used hysterosalpingography (HSG) injection devices on the basis of patient pain perception, total fluoroscopic and procedural time, and side effects in a prospective, randomized study. An important and novel secondary outcome is the comparison of the quality of images obtained with these three devices. The investigators hypothesize that the balloon catheter and cervical vacuum cup will be less painful than the acorn tipped cannula and that there will be no difference in image quality between the three groups.

Detailed description: This study is a prospective, randomized trial of women undergoing HSG as part of their infertility evaluation. At the time of scheduling, the patient will be randomized to either the cervical vacuum cup, balloon catheter (H/S catheter set, UA Medical, Biotech America), or the acorn-tipped cannula using stratified blocked randomization. 100 subjects will be randomized to one of the three cannulas. Patients will be stratified into 4 groups representative of the four reproductive endocrinologists in order to overcome any potential interoperator bias.

Four reproductive endocrinologists will perform the HSG procedures in a standardized fashion. Fluoroscopy will ensure proper location of the cannula and check for uterine filling of contrast. Digital images will document tubal filling and spilling of contrast. The patient will be rolled to right and left side to confirm free spillage of contrast in the peritoneal cavity. The last image will be taken after the balloon tip is deflated or the cannulas are removed to best evaluate the lower uterine segment.

Eligibility criteria: Inclusion Criteria:

* Women undergoing HSG at an academic medical center

Exclusion Criteria:

* Contrast media allergy
* Prior LEEP (Loop Electrosurgical Excision Procedure) or other cervical procedure
* Contraindication to NSAID use
* Known active pelvic infection
* Active vaginal bleeding

Primary outcomes:
measure: pain scores
timeFrame: 15 minutes
Secondary outcomes:
measure: the total duration of the procedure
timeFrame: 15 minutes
measure: direct fluoroscopic time
timeFrame: 15 minutes
measure: rates of vasovagal reaction
timeFrame: 15 minutes
measure: diagnostic quality of images obtained
timeFrame: 1 month
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: Sara Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05124574: Transplacental Transmission of COVID-19
Official title: Prospective Evaluation of Transplacental Transmission of SARS-COV-2 (COVID-19) in a Cohort of 10 Mother/Child Dyads
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: SARS-COV-2 Infection
Keywords: immune response
SARS-COV-2
ACE2 receptors
MPRSS2
cathepsin L
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 10
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: Pregnant woman with proven SARS-COV-2 infection during full-term delivery

Brief summary: SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. .

The case described by J. Vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.

Detailed description: In 2021, it becomes essential to clarify if and how SARS-COV-2 reaches the fetus, in order to prevent neonatal infection, optimize pregnancy management and better understand the pathogenesis of COVID-19.

SARS-COV-2, ACE2 and TMPRSS2 co-receptors are highly expressed in placental tissues and may be actively involved in transplacental transmission of the virus. From a case of materno-fetal transmission described by our team (publication in progress), we observed placental expression of the Spike SARS-COV-2 protein, but also of the ACE2 receptors, TMPRSS2 and cathepsin L. Cytotrophoblast and syncytiotrophoblast cell stains were positive within the placental villi. Maternal leukocytes were also labeled for these proteins.

Eligibility criteria: Inclusion Criteria:

* Social security affiliation
* Signed informed consent
* Pregnant woman with proven SARS-COV-2 infection during full-term delivery

Exclusion Criteria:

* Patient vaccinated within 15 days prior to inclusion

Primary outcomes:
measure: Spike SARS-COV-2 protein in placental tissues
timeFrame: Baseline : childbirth
Secondary outcomes:
measure: ACE2 receptors in placental tissues
timeFrame: Baseline : childbirth
measure: TMPRSS2 in placental tissues
timeFrame: Baseline : childbirth
measure: cathepsin L in placental tissues
timeFrame: Baseline : childbirth
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hugues PATURAL, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01827774: Soft Tissue Graft for Repair of Pelvic Organ Prolapse
Official title: A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Graft repair
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2013-04-10
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women.


Eligibility criteria: Inclusion Criteria:

* Patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse.
* POPQ = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse)
* At least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia)

Exclusion Criteria:

* Age \< 18 years
* BMI \> 40
* Not medically fit for transvaginal surgery under general or spinal anesthesia
* Active UTI at the time of the index procedure as determined by urine culture
* Vaginal atrophy (Note: Patient may be included after vaginal atrophy has been effectively treated.)
* Prior placement of synthetic mesh or biologic graft for pelvic organ prolapse
* A history of cervical, ovarian, uterine, endometrial, vaginal, vulval, colon, rectal or bladder cancer
* Currently planned obliterative surgical repair for pelvic organ prolapse
* Systemic infection at the time of surgery
* Requires chronic immunosuppressive therapy, including steroids or cytotoxic agents
* Pregnant, breastfeeding or planning pregnancy during the study period
* Previous diagnosis of collagen disorder (i.e., Marfan's, Ehlers-Danlos)
* Physical allergies or cultural objections to the receipt of porcine products
* Life expectancy of less than 12 months
* Ongoing participation in an investigational device or drug trial
* Currently undergoing evaluation or treatment for chronic pelvic pain (e.g., pain as a result of interstitial cystitis, endometriosis, vulvodynia, pelvic congestion syndrome)
* Active vaginal infection at the time of the index procedure
* History of pelvic inflammatory disease

Primary outcomes:
measure: Rate of recurrence of pelvic organ prolapse
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References:
Clinical trial NCT02320474: Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)
Official title: Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 3 Choroidal Neovascularization
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.


Eligibility criteria: Inclusion Criteria:

* Males or females aged more than 50 years
* Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
* Exudation on SD-OCT scans defined by intraretinal cysts or subretinal fluid.
* Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS)
* Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality

Exclusion Criteria:

* Any contraindications as reported in the labelling of Aflibercept (Eylea®): Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity.
* Any previous history of intravitreal injections in the study eye for exudative AMD
* Any secondary chorioretinal anastomosis due to retinal scar or fibrosis
* Any history of vitrectomy
* Media opacities preventing accurate imaging of the retina (cataract)
* Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole)
* Confirmed intraocular pressure ≥25 mmHg or non-stable glaucoma.

Primary outcomes:
measure: Mean change from baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Poitiers
country: France
facility: Polyclinic of POITIERS
Study officials:
affiliation: CHU Poitiers
name: Nicolas LEVEZIEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06347874: Cryo Rib Fracture Study
Official title: Comparison of Cryoablation of Intercostal Nerves to Erector Spinae Plane Catheters in Patients With Rib Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rib Fractures
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized prospective controlled trial. This will be single blinded trial. The individual doing the outcome assessments will be blinded. Randomization will be 1:1.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter.


Eligibility criteria: Inclusion Criteria:

* Patients who are over 18 who have more than one ribs fractured.

Exclusion Criteria:

* Patients who have an exclusion to regional anesthesia.
* Patients who are pregnant via self-report or pregnancy test if they take one.
* Non-English speakers
* Patients who have cold urticaria
* Patients with bilateral fractures
* Patients currently intubated

Primary outcomes:
measure: Maximum pain score on POD (Post Operative Day) 7
timeFrame: 7 days post procedure
measure: Opioid Use
timeFrame: 30 days post procedure
measure: Functional Pain Scores
timeFrame: 30 days post procedure
measure: Number of Patients using opioids at POD 30
timeFrame: 30 days post procedure
measure: Length of hospital stay
timeFrame: 30 days post procedure
measure: Number of patients returned home by POD 30
timeFrame: 30 days post procedure
measure: time to first ambulation
timeFrame: 30 days post procedure
measure: number of patients admitted to ICU
timeFrame: 30 days post procedure
measure: number of patients that required mechanical ventilation
timeFrame: 30 days post procedure
measure: Pulmonary Function Testing.
timeFrame: 30 days post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Neil Hanson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02709174: Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models
Official title: Diagnosing Pulmonary Embolism in Pregnancy: Are Biomarkers and Clinical Prediction Models Useful?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Pregnancy
D-Dimer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 59
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: pregnant women who presented to the Emergency Department or Labor and Delivery unit with signs and symptoms suspicious for PE

Brief summary: Objective: To evaluate whether trimester specific d-dimer levels and brain natriuretic protein (BNP), along with the modified Wells score (MWS), is a useful risk stratification tool to exclude pregnant women at low-risk of pulmonary embolism (PE) from diagnostic imaging with radiation exposure.

Detailed description: To account for all women meeting the study eligibility criteria, this study utilized a combined prospective and retrospective arm. Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution were prospectively enrolled from February 2014 to August 2015. Both d-dimer and BNP serum levels were drawn, and a MWS was assigned. All pregnant women diagnosed with a PE that underwent diagnostic imaging and had a d-dimer level drawn from January 2009 to June 2014 were retrospectively enrolled. Patient electronic records were used to apply the MWS and analyze their risk.

Eligibility criteria: Inclusion criteria:

* adult pregnant women \>= 18 years old
* d-dimer obtained and if the patient was pregnant at the time of PE diagnosis
* patient presented to the Emergency Department or Labor and Delivery unit
* patient presented with signs and symptoms suspicious for PE

Exclusion criteria:

* non-pregnant patients
* patients \< 18 years old

Primary outcomes:
measure: Serum D-dimer levels (ug/ml)
timeFrame: 18 months
Secondary outcomes:
measure: Modified Well's Criteria- a risk scoring system for likelihood of pulmonary embolism
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Advocate Health
name: Barbara Parilla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03888274: ClearUP Longitudinal Pilot Study
Official title: ClearUP Longitudinal Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Pain
Congestion
Lead sponsor: Tivic Health Systems
Sponsor class: INDUSTRY
First posted: 2019-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.


Eligibility criteria: Inclusion Criteria:

* 18-71 years of age (inclusive)
* Present with symptoms of sinus pain or facial pain in the forehead, periorbital, facial, or nasal region
* Current pain score ≥ 5 (Numeric Rating Scale 0-10)
* Frequency of sinus/facial pain at least twice weekly for 1 month
* Able to read and understand English
* Agree to participate in the study
* Able and willing to provide Informed Consent

Exclusion Criteria:

* Do not meet Inclusion Criteria
* Currently taking or recently taken any oral steroid medications in the last 90 days
* Sinus surgery in previous 90 days
* History of Chronic Migraine (≥ 15 headache days per month)
* Pain location in the vertex, occiput, or temporal region of the skull or in mandibular region
* Purulent rhinorrhea

Primary outcomes:
measure: Numeric Rating Scale for Pain
timeFrame: 4 weeks
Secondary outcomes:
measure: Congestion Quantifier 7
timeFrame: 4 Weeks
measure: Numeric Rating Scale for Pain
timeFrame: 6 hours
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Allergy and Asthma Associates of Santa Clara Valley Research Center
state: California
Study officials:
References:
citation: Goldsobel AB, Prabhakar N, Gurfein BT. Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion. Bioelectron Med. 2019 Nov 20;5:18. doi: 10.1186/s42234-019-0035-x. eCollection 2019.