louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03657368: Ventilation Strategy During General Anesthesia for Orthopedic Surgery
Official title: Ventilation Strategy During General Anesthesia for Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Surgery
Ventilation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 2887
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The objective is to determine the optimal intraoperative ventilation strategy among the chosen tidal volume and positive end-expiratory pressure (PEEP) levels, and standardize it in an enhanced recovery pathway for orthopedic surgical patients. In particular, we propose to determine which combination of intraoperative tidal volume and positive end-expiratory pressure is best for patients having elective orthopedic surgery.

Detailed description: This is a non-randomized alternating intervention cohort study in which all orthopedic surgery operating rooms will alternate amongst four designated ventilation settings which include two tidal volumes and two PEEP levels. At the end of the four-week sequence, the entire sequence will be repeated 26 times over a 2-year period. Thus, ventilator settings will not be randomized on a per-patient basis, or even among study weeks.

Ventilation parameters will be designated at the beginning of each study week. However, clinicians will be free to adjust to whatever ventilation settings they believe is optimal in individual patients to ensure oxygenation and patient safety.

Eligibility criteria: Inclusion Criteria:

* Surgery in orthopedic operating rooms 32-37
* General anesthesia with endotracheal intubation.

Exclusion Criteria:

* Non-orthopedic procedures;
* Intubation before induction of anesthesia.

Primary outcomes:
measure: Time-weighted average SaO2/FiO2 ratio in the postanesthesia care unit (PACU)
timeFrame: After surgery until discharged from PACU or up to 90 minutes
Secondary outcomes:
measure: Composite of serious postoperative pulmonary complications
timeFrame: After surgery from 2 to 5 days
measure: Oxygenation in ward, defined as SaO2/FIO2 ratio
timeFrame: After surgery from 2 to 5 days
measure: Length of postoperative hospital stay
timeFrame: from 2 to 5 days
Other outcomes:
measure: Exploratory outcome:
timeFrame: After surgery until discharged from the hospital
measure: Exploratory objective:
timeFrame: from 2 to 5 days
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Alparslan Turan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02755168: External Pop-Out Technique Versus Classic Head Extraction During Cesarean Section
Official title: Feasibility and Outcomes of External Pop-out Versus Classic Fetal Head Extract During Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caesarean Section
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Caesarean section is one the most common operations worldwide, its rates are globally increasing. A multitude of efforts had been done aiming at reduction of Caesarean section related maternal morbidities; most of them are related to technical modifications of how to open and how to close the abdominal and uterine incisions . The comparative studies of blunt versus sharp extension of the uterine incision showed a reduction of the incidence of unintended extension from 8.8% to 4.8% .

The vulnerability of the lower uterine segment for tears are related to stage of labor. The frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in first and second stages of labor respectively.

The original techniques of fetal head extraction entail the introduction of the obstetricians hand or other instruments into the lower uterine segment . This puts the lower uterine segment at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time, infection adhesions and blood transfusion. Adherence to the available the generated good quality evidence bases practice in Caesarean section is anticipated to decease such morbidities.

The idea of the present technique was derived from the fact that during vaginal delivery the main task of obstetrician is to support the perineum while the fetal head extends to get out through birth canal.


Eligibility criteria: Inclusion Criteria:

* single fetus
* more than 37 weeks of gestation
* elective Caesarean section

Exclusion Criteria:

* non-cephalic presentation
* placenta previa
* hydrocephalus
* Multiple pregnancy

Primary outcomes:
measure: The success rate of External POP out technique
timeFrame: 20 minutes
Secondary outcomes:
measure: Number of women will need blood transfusion
timeFrame: 24 hours
measure: Time of head extraction
timeFrame: 5 minutes
measure: Easiness score:
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT02302768: Effect of Semet (80 and 160 mcg) Versus Placebo in Euthyroid Patients With AIT
Official title: Effect of Supplementation of Two Doses of L-selenomethionine (Semet; 80 and 160 mcg) Versus Placebo in Patients With Chronic Autoimmune Thyroiditis (AIT) With Normal Thyroid Function.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thyroiditis Autoimmune
Lead sponsor: University of Siena
Sponsor class: OTHER
Collaborators: name: IBSA Institut Biochimique SA
First posted: 2014-11-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over the past 10 years, several clinical studies have suggested that selenium supplementation may influence the natural history of AIT. Recently, Interferon gamma (IFNγ)-inducible chemokines (CXCL-9, -10 and -11) were shown to be elevated in the AIT patients. The aim of this prospective, randomized, controlled study is to evaluate the effect of two different doses of selenomethionine (80 or 160 mcg) versus placebo in euthyroid women with AIT, in terms of reduction of anti-thyroid antibodies and improvement of thyroid hypoechogenicity, over 24 months. Serum levels of selenium, CXCL-9, -10 and -11 and their regulators, Tumor necrosis factor alpha (TNFα) and INFγ, thyroid function and volume and the quality of life of AIT patients are also evaluated.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic autoimmune thyroiditis defined by positivity of anti thyroperoxidase and/or anti thyroglobulin antibodies (\> or = 100 U/l) and thyroid hypoechogenicity

Exclusion Criteria:

* Presence of other thyroid disease but micronodules
* History of the malignancy in the past 5 years
* Drugs affecting immune system and/or thyroid function
* Pregnancy detected during screening or follow-up.

Primary outcomes:
measure: Reduction of anti-thyroid antibodies
timeFrame: 12 months
measure: Improvement of thyroid echogenicity
timeFrame: 12 months
Secondary outcomes:
measure: Prevention or reduction of the incidence of hypothyroidism
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Siena
name: Furio Pacini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rayman MP. Selenium and human health. Lancet. 2012 Mar 31;379(9822):1256-68. doi: 10.1016/S0140-6736(11)61452-9. Epub 2012 Feb 29.
citation: Nacamulli D, Petricca D, Mian C. Selenium and autoimmune thyroiditis. J Endocrinol Invest. 2013 Nov;36(10 Suppl):8-14.
citation: Rotondi M, Chiovato L. The chemokine system as a therapeutic target in autoimmune thyroid diseases: a focus on the interferon-gamma inducible chemokines and their receptor. Curr Pharm Des. 2011;17(29):3202-16. doi: 10.2174/138161211798157559.
Clinical trial NCT04998968: Quality in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy
Official title: Quality of Life in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy in a Swedish Population Based Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Permanent Hypoparathyroidism
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients are identified through the national quality registry for endocrine surgery, SQRTPA and the Swedish National Patient Register

Brief summary: Quality of life study. The study with include all patients operated with total thyroidectomy between 2005-2015 in Uppsala-Örebro healthcare region, Sweden. The study population has been identified in a previous study and includes close to 1700 patients, of which about 200 developed permanent hypoparathyroidism after surgery.

Quality of Life will be assessed using SF-36 Health Surgery and the outcome for patients with and without permanent hypoparathyroidism will be compared.


Eligibility criteria: Inclusion Criteria:

* Total thyroidectomy between 2005-2015 in Uppsala-Orebro healthcare region.

Exclusion Criteria:

* Malignancy
* Sternotomy
* Previous thyroid surgery
* Previous or concurrent parathyroidectomy

Primary outcomes:
measure: Quality of Life using SF-36 short form
timeFrame: 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University
name: Olov Norlén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00549068: POWER Point of Care Effect on Satisfaction of Treatment
Official title: Impact of NTx Point of Care (POC) Device on Patient Satisfication With Actonel 35mg Once a Seek Treatment a Multicenter Prospective Open Label Randomized Controlled Community Practice-based Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2007-10-25
Enrollment: 2433
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare the subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel 35mg Once-a-Week for 24 weeks, and receiving feedback information, after 12 weeks of treatment, based on bone resorption marker results using the NTx Point-Of-Care (POC) device, to similar women treated as per regular clinical practice


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with postmenopausal osteoporosis using community practice standards
* Women previously non-treated for osteoporosis, OR treated for osteoporosis with biphosphonates (alendronate, etidronate), hormone replacement therapy estrogen, estrogen-related drugs, progesterone, subcutaneous estrogen implant), raloxifene, fluoride, or calcitonin within the past 2 years but discontinued prior to enrolment into the study either due to:lack of effect or intolerance

Exclusion Criteria:

* Subjects treated with Actonelr 5 mg daily,
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* Known/Suspected hypersensitivity to any component of Actonelr 35 mg Once-a-Week
* Known/Suspected hypocalcaemia
* Known/Suspected severe renal impairment (creatinine clearance \< 30ml/min)
* Known/Suspected hyperparathyroidism
* Known/Suspected hyperthyroidism
* Known/Suspected active urinary tract infection
* Known high urine levels of calcium (3 4mg/ml)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Compare subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel® 35 mg Once-a-Week for 24 weeks, and receiving feedback information after 12 weeks of treatment to similar women monitored as per regular clinical practice
Secondary outcomes:
measure: Compare subject satisfaction with Actonel® 35 mg Once-a-Week in subject subgroups: previously treated with biphosphonates, HRT, raloxifene, fluoride, or calcitonin within past 2 years vs. those previously non treated
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Mary Tzortzis
role: STUDY_DIRECTOR
References:
Clinical trial NCT03987568: Characterize Tumor Hypoxia by Magnetic Resonance Imaging
Official title: To Characterize Tumor Hypoxia by Magnetic Resonance Imaging in African American and Caucasian Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Prostate Tumor
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-17
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to measure the hypoxia (low oxygen condition) in prostate cancers and its effect in survival. In this study, investigators will assess hypoxia by magnetic resonance imaging (MRI) and create a hypoxia score. Investigators will study the hypoxia score and how it correlates (if any) to the disease aggressiveness as well as its effect on the treatment outcomes.

Detailed description: Primary Objective(s):

* To assess hypoxia in primary prostate tumors by magnetic resonance imaging.
* To correlate hypoxic score with disease aggressiveness (proliferation biomarkers' expression).

Secondary Objective(s):

* To correlate hypoxic score with ExoHypoxic concentration in plasma of same patient.
* To correlate hypoxic score with fatty acid synthase (FASN) expression.

Eligibility criteria: Inclusion Criteria:

* The minimum age for this study is men 40 years and older. Prostate cancer mainly affects men over the age of 40.
* Patients with Caucasian and African American race
* Patients with pathology-proven prostate cancer (Gleason 6 or higher)
* Patients who have not yet undergone therapy (systemic drugs, radiation, or prostatectomy)
* Patients who will have a radical prostatectomy as standard of care.
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria:

* Patients who have already received some form of treatment or are not planning to undergo radical prostatectomy for treatment.
* Patients with any other cancer along with prostate cancer.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: Differences in Tumor Hypoxia Scores Between Subgroups
timeFrame: 30 days
measure: Number of Biomarkers Expressed
timeFrame: 30 days
Secondary outcomes:
measure: ExoHypoxic Concentrations in Plasma
timeFrame: 30 days
measure: Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gagan Deep, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01501968: Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity
Official title: Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Drug Safety
Keywords: Colistin
ascorbic acid
renal toxicity
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2011-12-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.

Detailed description: Renal toxicity due to colistin therapy is common. Ascorbic acid (vitamin C) has been shown to prevent colistin associated renal toxicity in animals. This study is conducted to determine if acorbic acid can prevent Colistin-Associated Nephrotoxicity.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years hospitalized patient who needs colistin for therapy of nosocomial infection

Exclusion Criteria:

* pregnant woman
* lactating mother
* allergy to ascorbic acid
* receiving non-steroidal antiinflammatory drugs (NSAID), aminoglycosides, vancomycin, cisplatin, amphotericin-B
* received radiocontrast media within 1 week
* renal stone
* G-6-PD deficiency

Primary outcomes:
measure: number of patients with Renal toxicity associated with colistin
timeFrame: up to 28 days
Secondary outcomes:
measure: number of subjects with cure or improvement
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Visanu Thamlikitkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sirijatuphat R, Limmahakhun S, Sirivatanauksorn V, Nation RL, Li J, Thamlikitkul V. Preliminary clinical study of the effect of ascorbic acid on colistin-associated nephrotoxicity. Antimicrob Agents Chemother. 2015;59(6):3224-32. doi: 10.1128/AAC.00280-15. Epub 2015 Mar 23.
Clinical trial NCT05316168: Post Operative Pain Management for ACL Reconstruction
Official title: Isolated Adductor Canal Block vs Adductor Canal Block With IPACK in ACL Reconstruction: A Randomized, Prospective Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Health care providers are seeking methods to limit post-operative pain and opioid prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block (ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery. Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR) patients who received isolated ACB versus ACB with IPACK.

The primary aim of this study is to investigate the role of IPACK in combination with ACB in reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim is to determine any effect of IPACK on post-operative functional outcomes.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing primary ACLR for ACL tear, including patients with concomitant meniscectomy or meniscal repair.

Exclusion Criteria:

* Revision ACLR, worker's compensation, pregnancy, age\<18 years

Primary outcomes:
measure: Post operative pain management
timeFrame: 14 days
measure: Post operative pain management 2
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05778968: Etco2 Levels on the End-tidal Concentration of Sevoflurane
Official title: The Effect of Different Etco2 Levels on the End-tidal Concentration of Sevoflurane in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-tidal Sevoflurane
End-tidal Carbon Dioxide
Minimum Alveolar Concentration
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: he assessment of adequate levels of anaesthesia traditionally relies not only on a patient's movement but also on the hemodynamic response (or both) to a surgical stimulus

Detailed description: Currently a derivative of MAC namely, end tidal partial pressure (FET) displayed on the work station as concentration , maybe an alternative useful measure of the anaesthetic effect of an inhaled anaesthetic agent

. Many pharmacological factors have been associated with alterations in MAC and Mac derivatives such as nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, and anesthetics.

However, few studies have focused on physiological factors, such as hypercarbia or hypocarbia. A correlation has been found between Paco2 and Etco2 in ventilated patients with healthy lungs. Some authors have suggested that Etco2 could be considered appropriate for estimating Paco2 even in critical patients. Knowledge of the effects of Paco2 on end tidal concentration of sevoflurane among patients undergoing laparoscopic cholecystectomy may help anaesthesiologists titrate sevoflurane carefully and precisely during different mechanical ventilation settings to avoid dose-dependent hypotension, impaired cardiac contractility, and hypothermia caused by excessive anaesthetic depth of sevoflurane.

Eligibility criteria: Inclusion Criteria:

* American Society of anaesthesiologist ASA physical status I, II
* admitted for laparoscopic cholecystectomy

Exclusion Criteria:

* Refusal of patients.

  * Patients with renal or liver dysfunction.
  * Patients with chronic pain other than cholelithiasis.
  * Cardiac disorders as uncontrolled hypertension, arrhythmia, Ischaemic heart disease, valvular heart disease and pulmonary hypertension.
  * Patient with haematological disorder as Sickle cell disease.
  * Chest patient as asthma, COPD.
  * Combined surgery .
  * History of allergy to any of the study drugs.
  * Patients with communication problems, cognitive dysfunction, or psychological disorders.
  * Patients who received analgesics or sedatives 24 h before a scheduled surgery.
  * Alcohol or drug abuse.

Primary outcomes:
measure: end tidal concentration of sevoflurane
timeFrame: Total time of operation
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: tarek Abdelhay Mostafa
state: El Gharbyia
Study officials:
affiliation: tanta university, faculty of medicine
name: thanaa elnomany, MD
role: STUDY_DIRECTOR
References: