louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04482205: Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures
Official title: Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures in Musculoskeletal Service Line of a Tertiary Care Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Economic Burden
Keywords: economic burden, covid-19 pandemic
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 840
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted for operative intervention of fractures management and elective procedures for tumour, degenerative disease, sport related injuries

Brief summary: Covid-19 has adversely impacted the health care organizations by over burdening with Covid patients and suspending the elective surgeries and clinics A single center retrospective study was conducted to quantify losses due to postponement of elective surgeries and extra cost for procurement of PPEs. The secondary objective was to see the effect of Covid -19 on the total costs of inpatient care during Covid era.

Detailed description: Covid-19 has impacted adversely the economy of Pakistan that has already poor and challenged socioeconomic conditions This is a single hospital retrospective cross sectional study conducted to quantify losses due postponement of elective surgeries and procurement of PPEs and see the effect of Covid -19 on the total costs of inpatient care during Covid era.

We included all the patients admitted in orthopedic section for operative intervention of fractures and elective procedures from January 1, 2020 to May 31, 2020. We divided this period into two halves; the first half was from January first to March 15 named as PreCovid Era and second half was from March 16, to May 31, 2020, termed as Covid Era. The total number of trauma procedures and elective procedures were compared in both eras. We compared six procedures each from upper and lower limit for cost analysis and length of stay. We also analyzed the extra cost for procurement of PPEs.

Eligibility criteria: Inclusion Criteria:

* All the patients admitted in orthopedic section for operative intervention of fractures and elective procedures from January 1, 2020 to May 31, 2020.

Exclusion Criteria:

* Patients presenting with other bone morbidities that did not require surgical interventions including rickets, osteomalacia, osteogenesis imperfecta, marble bone disease (osteopetrosis), Paget disease of bone, and fibrous dysplasia, patients with incomplete medical records were excluded from the study.

Primary outcomes:
measure: the effect of Covid -19 on the total costs of inpatient care
timeFrame: 5 months
Secondary outcomes:
measure: drop in the collective revenue generated in covid era
timeFrame: 5 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Pervaiz Hashmi, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00742105: Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan
Official title: A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer
Solid Tumor
Advanced Solid Tumor
Keywords: PI3K
mTOR
Advanced solid tumor
Adult
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-27
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.


Eligibility criteria: Inclusion Criteria:

* World Health Organization (WHO) Performance Status of ≤ 2
* Histologically-confirmed, advanced solid tumors
* Progressive, recurrent unresectable disease
* Age ≥ 20

Exclusion Criteria:

* Hematopoietic:
* No diabetes mellitus or history of gestational diabetes mellitus
* No acute or chronic renal disease
* No acute or chronic liver disease
* No acute or chronic pancreatitis
* No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
* No acute myocardial infarction or unstable angina pectoris within the past 3 months
* Not pregnant or nursing and fertile patients must use barrier contraceptives

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Incidence of dose limiting toxicity (DLT) at each dose level
timeFrame: 22-28 days
Secondary outcomes:
measure: Safety measured by type, frequency and severity of adverse drug reactions
timeFrame: Every 4 weeks
measure: Preliminary Efficacy od BGT226
timeFrame: Every 8 weeks
measure: Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling
timeFrame: Baseline, every 3 weeks
measure: Biomarkers: Percentage of change, pre- versus post-treatment
timeFrame: Every month
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kobe-shi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02308605: SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke
Official title: A Field Deployable Blood Test for Stroke, Capable of Detecting Brain Ischaemia From the Earliest Stages of Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: SMARTCap
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 217
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 320

Brief summary: The hypothesis is that a stroke causes release of purines from brain into blood and that this is a very early biomarker of brain ischaemia. The investigators propose a simple blood test of substances (the purines) that result from cellular metabolism and are produced in excess when brain cells are starved of oxygen and glucose (as occurs during a stroke).

Detailed description: In this study, the investigators propose to use newly developed biosensor technology (SMARTCap) to directly address whether purines are indicators of real strokes, and can distinguish strokes from other conditions with similar symptoms, more rapidly.

Eligibility criteria: Inclusion Criteria:

1. Stroke patients: Admitted to the Hyperacute Stroke Unit having a suspected stroke within 1 hour of admission. Important to note that not all these patients will have suffered a stroke
2. Control participants: Relatives of patients admitted to the stroke treatment pathway, who are healthy and have no signs of cardiovascular illness
3. Healthy volunteers

Exclusion Criteria:

1. Stroke patients: Delay in admission exceeds the time window of 4 hours between stroke symptoms and admission
2. Control participants: Obvious signs or history of cerebrovascular disease
3. Unhealthy volunteers

Primary outcomes:
measure: To measure the levels of purine in the blood in Stroke patients compared to non-stroke patients (Healthy controls)
timeFrame: 30 minutes down to 5 minutes
Secondary outcomes:
measure: To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans
timeFrame: 24 hours to 7 days
Other outcomes:
measure: To measure the change in purines and their variability in control patients from baseline to day 7
timeFrame: 24 hours - 7 days
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire NHS Trust
city: Stoke-on-Trent
country: United Kingdom
facility: University of Keele
Study officials:
affiliation: University Hospitals Coventry & Warwickshire NHS Trust
name: Christopher HE Imray, MB BS FRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dale N, Tian F, Sagoo R, Phillips N, Imray C, Roffe C. Point-of-care measurements reveal release of purines into venous blood of stroke patients. Purinergic Signal. 2019 Jun;15(2):237-246. doi: 10.1007/s11302-019-09647-4. Epub 2019 Mar 12.
Clinical trial NCT00500305: The Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indomethacin Therapy
Patent Ductus Arteriosus
Keywords: indomethacin therapy
patent ductus arteriosus
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2007-07-12
Enrollment: 60
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants. Standard indomethacin treatment is associated with intestinal and renal morbidity. B-type natriuretic peptide is elevated in significant PDAs. This study will determine whether BNP guided therapy could reduce doses of indomethacin.


Eligibility criteria: Inclusion Criteria:

* Infants with echocardiographically confirmed PDA
* Infants determined by attending physician to require PDA closure

Exclusion Criteria:

* infants with congenital hearts disease
* infants with creatinine value \> 2.0

Primary outcomes:
measure: Number of indomethacin doses given on study
timeFrame: 2 days
Secondary outcomes:
measure: rate of PDA ligation
timeFrame: Discharge from NICU
measure: Rate of Chronic lung disease
timeFrame: 36 weeks corrected gestational age
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: D Sc Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01019005: Pain Relief After Forefoot Surgery
Official title: Pain Relief After Forefoot Surgery: Tibial Perineural Catheter vs. Wound Catheter Infusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Surgery
Keywords: post-operative analgesia
opioid
catheter
tibial nerve block
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim to test whether continues local anaesthetic infusion via tibial catheter or wound catheter will improve pain relief following forefoot surgery

In this sequential prospective randomised, controlled clinical trial,75 Patients undergoing forefoot surgery will be randomized into three groups (tibial, wound, control). All groups will receive ankle block ± general anesthetic (standard technique). The tibial group will have a tibial catheter inserted through which local anaesthetic will be infused. The wound group will have a catheter inserted directly into the wound immediately after surgery. The control group will have a sham catheter (covered by a bandage across foot) attached to a pump which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/ vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively. All groups will be then followed by telephone calls 48 hours. Patients will be instructed to come to the clinic on the 4th postoperative day where the catheter will be removed.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older (ASA I \& II)
* Able to give written consent
* Patients having elective forefoot surgery with a planned ankle block.
* Expected postoperative pain to be at least moderate in severity the day following surgery

Exclusion Criteria:

* Refusal
* Inability to communicate
* History of alcohol or opioid abuse (also chronic opioid user)
* Mental or medical conditions which may affect quantifying pain scores (VAS)

Primary outcomes:
measure: Post-operative pain
timeFrame: 2,8,12,24,48 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT05853705: Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease (Strong Hearts App)
Official title: Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Child
Adult
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2023-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall goal of this program is to create a remote, mobile application enabled exercise program for patients with Congenital Heart Disease (CHD). Pilot trials will consist of a remote exercise program with app-embedded exercise modules designed to promote and encourage safe and healthy exercise habits across a range of CHD anatomies. This app-enabled program will allow for real time data collection integrating wearable devices, as well as compliance and safety monitoring to enhance research capabilities. The app-enabled program will be versatile and may be applied in the future to patients with non-cardiac conditions.


Eligibility criteria: Inclusion Criteria:

* Repaired or unrepaired Congenital Heart Disease (CHD)
* Between ages 10 and 50, inclusive, at time of consent
* Android or Apple smartphone that meets the operating systems below with the ability to download applications from either Google Play or the Apple store

  * Android: 6.0 or higher
  * Apple: iPhone Operating System (iOS) 13 or higher

Exclusion Criteria:

* Physical or mental disabilities preventing exercise participation
* Uncontrolled systemic hypertension (symptomatic or greater than Stage 2 hypertension while on therapy)
* Poorly controlled arrhythmia
* Clinically unstable heart failure
* Known pregnancy at the time of enrollment

Primary outcomes:
measure: Change in peak rate of oxygen volume consumption (VO2) on Cardiopulmonary Exercise Testing
timeFrame: Baseline, up to 12 weeks
Secondary outcomes:
measure: Change in Pediatric Cardiac Quality of Life Inventory
timeFrame: 1 year
measure: Change in Short Form 36 (SF-36) Health Survey
timeFrame: 1 year
measure: Change in sit-to-stand test
timeFrame: Baseline, up to 12 weeks
measure: Change in secondary Cardiopulmonary Exercise Testing outcome measures
timeFrame: Baseline, up to 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke UMC
name: Reid C Chamberlain, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03093805: Topical Vitamin D in Acute Graft Versus Host Disease of the Skin
Official title: Clinical Effectiveness of Calcipotriene in Acute Graft Versus Host Disease of the Skin: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft Vs Host Disease
Keywords: Hematopoietic Stem Cell Transplant
Graft Versus Host Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of Calcipotriene cream. This is a synthetic vitamin D3 derivative for topical use. It is used to treat grade 1-3 acute skin graft versus host disease (GVHD) in hematopoietic stem cell transplant (HSCT) recipients. Calcipotriene will be used as the exclusive topical therapy in addition to standard of care GVHD treatment prescribed for the study subject by the primary physician.

Detailed description: Acute skin GVHD affects about one third of pediatric and adult transplant recipients. Chronic GVHD (cGVHD) affects 40-60% of adult patients who have undergone allogeneic HSCT. It is a major cause of non-relapse mortality and morbidity. Systemic prednisone is the first-line treatment for cGVHD; however, about one-half of all patients do not respond to this initial therapy, and there is no standard second-line therapy. Immunosuppressive therapy used for treatment of GVHD brings significant risk of infection, poorly affecting clinical outcomes.

Vitamin D affects immunoregulation, fibroblast proliferation, collagen synthesis and endothelial cell function, and the investigators hypothesize that topical vitamin D application will have a positive effect on acute and chronic skin GVHD. The investigators hypothesize that topical vitamin D cream may restore normal cell function and decrease the use of steroid creams in acute GVHD of the skin.

Eligibility criteria: Inclusion Criteria:

* HSCT recipients with acute Grade I through III GVHD based on Glucksberg criteria. Recipients of multiple transplants are still eligible to participate in this research study.
* Each study subject is to have calcium and vitamin D level prior to starting study, if not obtained within 30 days of beginning treatment.

Exclusion Criteria:

* Patient with active cellulitis at the start of the treatment.
* Patients with hypercalcemia or vitamin D levels above 100 μg/L.
* Patients with known allergy to any of the topical therapy components.
* Patients who have received previous treatment with topical vitamin D cream.

Primary outcomes:
measure: GVHD Grade
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Gregory Wallace, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01298505: A Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects
Official title: A Phase 1 Double-blind (3rd Party Open), Randomized, Placebo-controlled Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of Pf-03654764 In Combination With Fexofenadine In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1 multiple dose safety toleration fexofenadine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given by mouth together with fexofenadine.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability.
timeFrame: 30 days
Secondary outcomes:
measure: Plasma concentrations of PF-03654764 will be measured.
timeFrame: 7 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01880905: The Length of Uteroovarian Ligament and the Risk of Ovarian Torsion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Torsion
Keywords: the length of uterine ovarian ligament
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Ovarian torsion is one of the gynecological emergency. This complication requires high clinical suspicion and early detection, to prevent permanent loss of ovarian function. The long uterine ovarian ligament could be a risk factor for ovarian torsion. We want to measure the uterine ovarian ligament length during routine laparoscopy/laparotomy and to compare the length between the torsion group and other non torsion patients

Detailed description: Female patient who are going to undergo laparoscopy/laparotomy for any gynecological reason will ask to participate. During the operation the uteroovarian ligament length will be measure by sterile ruler (calibrated plastic device 1 mm in diameter).

The length of uteroovarian ligament will compared between the patient who will diagnose with ovarian torsion (study group) and the other women (control group)

Eligibility criteria: Inclusion Criteria:

* Indication for gynecological operation
* hemodynamically stable

Exclusion Criteria:

* Ovarian torsion in the past
* History of pelvic inflammatory disease (PID)

Primary outcomes:
measure: uteroovarian ligament length
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Sava
country: Israel
facility: Meir Medical Center
Study officials:
References: