louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04904744: Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
Official title: Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Utilization
Vaccine Preventable Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 1235
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our objective is to determine the effectiveness of varied outreach methods to children age 12-17 years old who are due for a well child check visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the COVID-19 vaccination.


Eligibility criteria: Inclusion Criteria:

* age 12-17 years
* has not had a well child check in past 365 days
* no future well child check visit scheduled
* parent preferred language = English or Spanish

Exclusion Criteria:

* phone number not available in electronic health record

Primary outcomes:
measure: Number of Participants Who Completed an Adolescent Well-care Visit
timeFrame: Within 8 weeks of the date of intervention or the date of randomization for the control group
Secondary outcomes:
measure: Number of Participants Who Scheduled an Adolescent Well-care Appointment
timeFrame: Within 2 weeks of the date of intervention or the date of randomization for the control group
measure: Participant Receipt of COVID-19 Vaccine
timeFrame: Within 8 weeks of the date of intervention or the date of randomization for the control group
measure: Family Member Receipt of COVID-19 Vaccine
timeFrame: Within 8 weeks of the date of intervention or the date of randomization for the control group
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's
name: William Brinkman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burkhardt MC, Berset AE, Xu Y, Mescher A, Brinkman WB. Effect of Outreach Messages on Adolescent Well-Child Visits and Coronavirus Disease 2019 Vaccine Rates: A Randomized, Controlled Trial. J Pediatr. 2023 Feb;253:158-164.e1. doi: 10.1016/j.jpeds.2022.09.035. Epub 2022 Oct 4.
Clinical trial NCT03433144: The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
Official title: The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Tranexamic Acid
Orthognathic Surgery
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, patients will be randomized into two groups: and intervention group and placebo. The intervention group will receive a single pre-operative dose of TXA IV (10mg/kg) and the placebo group will receive the same volume of fluid intravenously.
Primary purpose: TREATMENT

Brief summary: This study seeks to answer the question: Does a single pre-operative dose of tranexamic acid have a statistically significant reduction in blood loss during orthognathic surgery?

If it does, this drug may begin to be used routinely during orthognathic surgery to reduce blood loss in our patients.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing either

  * Bilateral saggital split osteotomy (lower jaw surgery)
  * Lefort 1 osteotomy (upper jaw surgery)
  * Combination of BSSO and Lefort
* Patients between with ages of 16-65
* No cardiac comorbidities (hypertension, congenital heart malformation)
* No known coagulopathy
* No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
* ASA I and II patients

Exclusion Criteria:

* Patients younger than 16 and older than 40
* Patients with known coagulopathy
* Patients with cardiac comorbidities
* Patients with a family history of bleeding disorders
* Patients who have undergone previous orthognathic surgery
* ASA III patients or higher

Primary outcomes:
measure: blood loss during surgery
timeFrame: intra-operative only
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Nick Emanuele, DDS, BBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01474044: To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)
Official title: A Phase IV Study to Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Atrophic Gastritis (CAG)
Lead sponsor: Xinjiang Biochemical Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 851
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG).

Detailed description: Till now, there is no ideal treatment to chronic atrophic gastritis(CAG). This study is try to find a possible treatment to CAG with Gastropyloric Complex Capsules.

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years, male or female
* Histologically diagnosed CAG
* HP negative confirmed by gastric mucosal staining
* Signed an written informed consent

Exclusion Criteria:

* CAG with high-grade intraepithelial neoplasia
* Severe gastric mucosal erosion or bleeding needing treatment
* Active peptic ulcer, GERD, or esophageal stricture
* History of upper GI tract surgery
* History of malignant diseases
* With depression, anxiety neuroses, or hysteria
* Heart failure (NYHA class lll or lV), liver disease (ALT ≥ 80 IU/L, AST ≥ 80 IU/L) or renal disease(Cr ≥ 150 ummol/L)
* Uncontrolled hypertension
* Uncontrolled diabetes
* Alcohol abuse
* Drug allergy
* Participated in another investigational study within 4 weeks prior to Visit 0
* Pregnancy, be a nursing mother or without conception control
* There is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason; the investigator considers the participant inappropriate for participation in the study

Primary outcomes:
measure: Effective rate confirmed by histology
timeFrame: within 180 days after treatment
Secondary outcomes:
measure: clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching
timeFrame: within 180 days after treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases
name: Kaichun WU, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02044640: Identifiable Factors That May Lead to Postoperative Nausea and Vomiting After Simple Laparoscopic Appendectomy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Appendicitis
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a laparoscopic appendectomy

Brief summary: This is a retrospective chart review meant to identify any factors that are correlated with and may possibly lead to postoperative nausea and vomiting in order to predict need for longer hospital stays and potentially decrease postoperative nausea and vomiting.


Eligibility criteria: Inclusion Criteria:

* Laparoscopic Simple Appendectomy
* Uncomplicated surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: During 1st 24 hours post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00389740: A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)
Official title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Raloxifene on Bone Mineral Density in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-10-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare how well alendronate and raloxifene increase the bone density in women who have osteoporosis and have experienced menopause.


Eligibility criteria: Inclusion Criteria:

* Patient is postmenopausal (or surgically menopausal) for at least 6 months
* Patient must be diagnosed with osteoporosis
* Patient has spinal anatomy suitable for DEXA of the lumbar spine

Exclusion Criteria:

* Patient is receiving or has received treatment prior to randomization which might influence bone turnover
* Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss)
* Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism

Primary outcomes:
measure: Bone Mineral Density (BMD) in PA lumbar spine at 12 months
Secondary outcomes:
measure: Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Luckey M, Kagan R, Greenspan S, Bone H, Kiel RD, Simon J, Sackarowitz J, Palmisano J, Chen E, Petruschke RA, de Papp AE. Once-weekly alendronate 70 mg and raloxifene 60 mg daily in the treatment of postmenopausal osteoporosis. Menopause. 2004 Jul-Aug;11(4):405-15. doi: 10.1097/01.gme.0000119981.77837.1f.
Clinical trial NCT04093440: Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes
Official title: CardiOmetabolic SyndroME Response to Therapeutic lIfestyle Changes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
ASCVD
Lifestyle Risk Reduction
Keywords: cardiometabolic clinic
Lead sponsor: Holy Cross Hospital, Florida
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Intensive lifestyle intervention has shown to be effective in high risk patient populations and has gathered support from leaders-as outlined in the 2015 consensus paper by the Cardiometabolic Health Alliance. Thus there has been a call to establish new care models that assist Metabolic Syndrome patients in reducing there risk. The investigators aim to evaluate the impact of a lifestyle intervention program on metabolic syndrome patients.


Eligibility criteria: Inclusion Criteria:

* Metabolic syndrome patients meeting 3 of 5 criteria:

  1. waist circumference (37 in) in white and AA men, (35 in) in Asian men, and (31.5 in) in women;
  2. triglycerides ≥150 mg/dl;
  3. high-density lipoprotein cholesterol (HDL-C) \<40 mg/dl in men and \<50 mg/dl in women;
  4. blood pressure ≥130/85 mm Hg
  5. fasting glucose ≥100 mg/d or HgbA1c ≥ 5.71 (includes diabetics)
* Patients requiring secondary ASCD prevention

Exclusion Criteria:

* Patients with less than 5 year survival
* Patients with cancer undergoing therapy or on palliative treatment
* Patients with end stage heart failure

Primary outcomes:
measure: Reversal of metabolic syndrome
timeFrame: At the end of 12 months
Secondary outcomes:
measure: Mortality
timeFrame: within three to five years of intervention
measure: hemoglobin A1c
timeFrame: At the end of 12 months
measure: waist circumference
timeFrame: At the end of 12 months
measure: blood pressure
timeFrame: At the end of 12 months
measure: total cholesterol
timeFrame: At the end of 12 months
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Internal Medicine Residency Clinic at Holy Cross Hospital
state: Florida
Study officials:
affiliation: Jim Moran Heart and Vascular Research Center at Holy Cross Hospital
name: Charles Russo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jim Moran Heart and Vascular Research Center at Holy Cross Hospital
name: Paul Papagni, JD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03695640: Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty
Official title: The Effect of Magnesium Sulfate Added to Levobupivacaine in Continous Femoral Block on Analgesic Requirements Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Arthroplasty, Total
Postoperative Pain
Keywords: total knee arthroplasty
postoperative pain
continuous femoral nerve block
magnesium sulphate
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled, prospective
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block following total knee arthroplasty.

Detailed description: Pain after knee arthroplasty is a serious concern. This study was designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block on analgesic requirements following total knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* scheduled for elective unilateral primary total knee arthroplasty

Exclusion Criteria:

* Patient refusal to enroll in the study
* Patient refusal of neuraxial anesthesia
* Existence of contraindications for neuraxial anesthesia
* Known history of allergy to any of the study drugs

Primary outcomes:
measure: Visual Analogue Score
timeFrame: T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours
Secondary outcomes:
measure: Analgesic consumption
timeFrame: T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University Faculty of Medicine Hospital
state: Balgat
Study officials:
affiliation: Ufuk University
name: Baturay K Kazbek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albrecht E, Morfey D, Chan V, Gandhi R, Koshkin A, Chin KJ, Robinson S, Frascarolo P, Brull R. Single-injection or continuous femoral nerve block for total knee arthroplasty? Clin Orthop Relat Res. 2014 May;472(5):1384-93. doi: 10.1007/s11999-013-3192-3.
Clinical trial NCT03810040: Effect of Degranulation Needle With Different Diameters on the Rate Good Embryo in IVF
Official title: Effect of Degranulation Needle on the Rate Good Embryo in IVF
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embryo
Keywords: Embryos quality
In vitro fertilization
Denuding pipette
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 400
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.

Detailed description: Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. The participants were divided into two group. Odd-numbered days the zygotes were degranulated with the 140 microns needles. Even-numbered days the zygotes were degranulated with the 150 microns needles. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.

Eligibility criteria: Inclusion Criteria:

* first cyele of IVF treatment

Exclusion Criteria:

* oocyte number less than 4
* oocyte number over than 25

Primary outcomes:
measure: quality of embryo
timeFrame: one year
Secondary outcomes:
measure: clinical outcome - clinical prengancy rate
timeFrame: three years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: jin ni
role: STUDY_DIRECTOR
References:
Clinical trial NCT01835340: Breath Gas Measurement of Propofol During Anesthesia in Patients With Endourological Procedures
Official title: Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urological Disease
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Draeger
First posted: 2013-04-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Propofol can be measured continuously in breath gas during anesthesia. This study compares propofol concentration in plasma and breath gas and processed electroencephalographic monitoring (bispectral index) under clinical conditions with patients and total intravenous anesthesia. Target controlled infusion technique is used to deliver adequate propofol concentration in plasma.


Eligibility criteria: Inclusion Criteria:

• 18 years of age

* Written informed consent
* Ability and willingness to give written informed consent
* American Society of Anesthesiologists (ASA) risk score I-II

Exclusion Criteria:

* Denial of the patient
* Patients ASA physical status III- IV
* Pregnancy
* Volunteers with history of neurological disease or stroke
* Volunteers with a history of recreational drug abuse
* Volunteers with a history of alcohol abuse
* Known drug allergies
* History of adverse events during general anesthesia
* Total intravenous anesthesia not practicable

Primary outcomes:
measure: Exhaled propofol (parts per billion)
timeFrame: Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Dept. of Anesthesiology and Intensive Care
state: Schleswig-Holstein
Study officials:
affiliation: University of Luebeck
name: Hartmut Gehring, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grossherr M, Hengstenberg A, Meier T, Dibbelt L, Igl BW, Ziegler A, Schmucker P, Gehring H. Propofol concentration in exhaled air and arterial plasma in mechanically ventilated patients undergoing cardiac surgery. Br J Anaesth. 2009 May;102(5):608-13. doi: 10.1093/bja/aep053. Epub 2009 Mar 31.
Clinical trial NCT04831840: Recurrent Urinary Tract Infections and the Microbiome
Official title: Is PCR Amplification More Sensitive Than Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Recurrent Bladder Infections?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Recurrent Urinary Tract Infection
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with RUTIs and controls will be enrolled from University of Miami's or Holy Cross Hospital's female pelvic medicine and reconstructive surgery clinics.

Brief summary: The primary objective is to determine if polymerase chain reaction (PCR) (UTIP™) is more sensitive in identifying urinary tract infections (UTI's) than standard urine cultures.


Eligibility criteria: Inclusion Criteria:

* 18 y/o-90 y/o
* Able to consent
* Female
* Group A only: Recurrent UTI (2 UTIs in 6 months)
* Group B only: No history of recurrent UTIs

Exclusion Criteria:

* Pregnant
* Pelvic radiation
* Urinary retention (\>200 ml residual)
* Greater than Stage 2 prolapse
* Renal calculi
* Immunosuppressed
* Neurologic disorder with significant bladder impairment
* No current UTI via dip stick

Primary outcomes:
measure: Proportion of uropathogens
timeFrame: Day 1
measure: Proportion of patients negative for repeat testing
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Laura Martin, DO
role: PRINCIPAL_INVESTIGATOR
References: