louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00980590: Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground
Official title: Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Keywords: supine emergency intubations
emergency intubations
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pre-hospital intubation is often required in sub-optimal conditions, such as in patients lying on the ground. Direct laryngoscopy and intubation of a patient lying supine on the ground is difficult because the intubator's head is far above the head of the patient. It is thus tricky to align the intubator's visual axis with the patient's tracheal axis. The Airway Scope is a new laryngoscope designed to facilitate intubation without requiring alignment of the oral, pharyngeal, and tracheal axes. We thus tested the hypothesis that the intubation with the Airway Scope is faster than the Macintosh laryngoscope in subjects lying on the ground.

Detailed description: Adult surgical patients were enrolled. Following anesthesia induction and muscle relaxation, direct laryngoscopy was performed as usual and airway characteristics noted. Patients were randomly assigned to tracheal intubation by either the Airway Scope (n=50) or the Macintosh laryngoscope (n=50). Intubation was performed from a table positioned at the height as the operating table, thus simulating intubating on the ground. Overall intubation success rate, time required for intubation, the number of attempts required for successful intubation, and airway complications related to intubation were recorded.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for various surgeries requiring tracheal intubation as part of anesthesia and designated as American Society of Anesthesiologists (ASA) physical status I, II, or III.

Exclusion Criteria:

* Patients with an increased risk of pulmonary aspiration, cervical spine pathology, anticipated airway difficulties (i.e., Mallampati grade IV or thyromental distance \<6 cm), and American Society of Anesthesiologists physical status \>III.

Primary outcomes:
measure: Intubation Time
timeFrame: The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography.
Secondary outcomes:
measure: Overall Intubation Success Rate
timeFrame: Intubation period
measure: Number of Intubation Attempts
timeFrame: Intubation period
measure: Incidence of Intubation Complications
timeFrame: Intubation period
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Kosei Hospital,.
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
affiliation: Kosei Hospital, Tokyo, Japan.
name: Ryu Komatsu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02337790: Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals
Official title: Necklace-Shaped Sensor for Non-Invasive Monitoring of Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate in Patients With a Pacemaker, Implanted Cardioverter-Defibrillator, or Ventricular Assist Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Hypertension
Keywords: Hypertension
Heart Failure
Fluids
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be from the Imperial Cardiac Clinic

Brief summary: This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.

Detailed description: The study had the following objectives:

1. Verify that the CoVa Monitoring System does not interfere with implanted devices.
2. Verify that implanted devices do not interfere with the functions of the CoVa Monitoring System.
3. Verify that the CoVa Monitoring System fits on a wide variety of body types.

Eligibility criteria: Inclusion Criteria:

* Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening.
* Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
* Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
* Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.

Exclusion Criteria:

* Subject is participating in another clinical study that may affect the results of either study.
* Subject is unable or not willing to wear electrode patches as required.
* Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
* Subject is considered by the PI to be medically unsuitable for study participation.

Primary outcomes:
measure: Number of Patients with Interference between implanted devices and CoVa Monitoring System
timeFrame: One time for up to 15 minutes during a clinic visit for device interrogation
Secondary outcomes:
Other outcomes:
Locations:
city: Imperial
country: United States
facility: Imperial Cardiac Center
state: California
Study officials:
affiliation: Baxter Healthcare Corporation
name: Matthew J Banet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03438890: Laparoscopic Lens Defogging Using Anti-fog Solution, waRm Saline, and Chlorhexidine Solution
Official title: Randomized Comparison of Laparoscopic LEns Defogging Using Anti-fog Solution, waRm Saline, and Chlorhexidine Solution (CLEAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 96
Sex: FEMALE
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: The aim of this study is to compare three popular methods of minimizing or reducing laparoscopic lens fogging (LLF) by heating lens using warm saline, applying anti-fog agent to lens, and rubbing lens with chlorhexidine in laparoscopic gynecologic surgery.

Detailed description: The physiology behind laparoscopic lens fogging (LLF) is well understood based on meticulous experiments outlining the role of temperature and humidity. Despite many efforts, including uses of warm saline, various anti-fog agents, chlorhexidine, betadine, and rubbing the lens on serosal surfaces, to reduce LLF, there remains no consensus as to which method is superior to prevent LLF. Furthermore, most previous studies were experimental trials conducted in a simulation model or a non-human in vivo model or an expert's commentary based on their clinical experiences , and there was no randomized controlled trial focusing LLF in human model. Therefore, this randomized trial aimed to compare three popular methods of minimizing or reducing LLF by heating lens using warm saline, applying anti-fog agent to lens, and rubbing lens with chlorhexidine in laparoscopic gynecologic surgery.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 65 years
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* the absence of pregnancy at the time of surgery

Exclusion Criteria:

* allergy to chlorhexidine or anti-fog solution
* anticipating cases of abrupt change in intra-abdominal humidity such as hemoperitoneum and profuse ascites
* extremely short or long operative time (\<20 min or \> 180 min) affecting the frequency of LLF
* unavailability of the surgical recording equipment for laparoscopic procedure.

Primary outcomes:
measure: the severity of LLF during the first 3-min operation
timeFrame: At the time of surgery
Secondary outcomes:
measure: the severity of LLF occurred during the remaining operative time except the first 3-min
timeFrame: At the time of surgery
measure: the number of lens cleansing
timeFrame: At the time of surgery
measure: total time to spend for lens cleaning
timeFrame: At the time of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital, Seoul, Republic of Korea
name: Taejong Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00170690: Preference Study With Elderly Patients Recurrent Ovarian Cancer
Official title: Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: North Eastern German Society of Gynaecological Oncology
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 123
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)

Detailed description: Approximately 60% of all cancer diseases appear to people aged 65 years and older. Ovarian cancer is the most frequent cause of death among gynaecological malignant tumours. Since the highest carcinoma incidence is between the 60th and 70th year more women will come down with ovarian cancer because of increased life expectancy. At least 65% of patients with FIGO stage III/IV will exhibit a relapse or progress after first-line therapy. In most studies the age of the patients is limited to 65 years. It could be shown that especially elder patients often receive an inadequate operative and cytostatic therapy resulting in a worse prognosis.

Patients aged 70 years or elder who will be treated with treosulfan, given oral or intravenous, shall be compared regarding the patient compliance, toxicity especially hematological and gastrointestinal toxicity grade 3-4 (CTC NCI), overall survival, progression free survival, quality of life.

Eligibility criteria: Inclusion Criteria:

* patient with relapsed ovarian cancer
* study therapy of third regime
* measurable or evaluable tumor lesions or progression defined as CA-125 more than \>= 100 U/ ml.
* Age \>= 70 years
* ECOG 0-2
* written informed consent

Exclusion Criteria:

* Pretreatment with treosulfan
* patient without measurable or evaluable tumor lesions or CA-125 more than \>= 100 U/ ml.
* no adequate bone marrow function (leukocyte \<= 2,9 x 109/l, platelets \<= 100 x 109/ l
* creatinin and bilirubin within \>= 1,25 x fold of the reference laboratory´s normal range
* simultaneous radiotherapy

Primary outcomes:
measure: Comparison of patient´s compliance in both arms defined as therapy break-offs
timeFrame: during study treatment
Secondary outcomes:
measure: Toxicity, overall survival, progression-free survival
timeFrame: during study treatment and follow-up
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jalid Sehouli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03091790: Mesh Type in Ventral Hernia Repair
Official title: Mesh Type in Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Keywords: ventral hernia
mesh
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for open ventral hernia repair at LBJ General Hospital

Exclusion Criteria:

* Active infection
* Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis)
* Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown)
* Patient unlikely to follow-up (i.e. no phone)

Primary outcomes:
measure: Complication free at 1 year post-operative
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Complication free at 3 years post-operative
timeFrame: 3 years after surgery
measure: Dindo-clavien complications
timeFrame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
measure: Patient centered outcomes
timeFrame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
measure: Cost
timeFrame: 1 year and 3 years after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT Health at Lyndon B. Johnson General Hospital
state: Texas
Study officials:
affiliation: UT Health
name: Julie L Holihan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01487590: Cephalic Version by Acupuncture-Moxibustion for Breech Presentation
Official title: A Simple Blind Controlled Randomized Trial: Cephalic Version by Acupuncture-moxibustion vs Placebo for Breech Presentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breech Presentation
Keywords: pregnancy
breech
acupuncture
moxibustion
version
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 328
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: For breech presentation, the cesarean section rate is decreased by external cephalic version. This is a painful operation, with some rare but serious complications. The aim of this trial is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive technique, to correct breech presentation before 37 weeks of gestation.

Detailed description: Monocentric controlled randomized trial in a simple blind fashion, comparing acupuncture-moxibustion versus a placebo in singleton pregnancies with breech presentation between 33+5 to 35+5 weeks of gestation. The intervention arm consists of acupuncture-moxibustion at the BL67 acupuncture point, for six seances of twenty minutes two days apart. In the placebo group, the cold light of an inactivated laser is to be applied in the same point during the same time. When cephalic version fail, a manual external cephalic version is to be proposed. The main outcome measure is cephalic presentation at 37+2 weeks of gestation.

Eligibility criteria: Inclusion Criteria:

* breech presentation,
* SINGLETON

Exclusion Criteria:

* maternal age between 18 ans 45,
* multiple gestation,
* fetal or uterine malformation,
* premature rupture of membranes

Primary outcomes:
measure: Cephalic presentation
timeFrame: at 37+2 weeks of gestation
Secondary outcomes:
measure: Successful manual external cephalic version after intervention
timeFrame: Before 41 weeks of gestation
measure: Cephalic presentation at delivery
timeFrame: Date of delivery
measure: Cesarean section rate
timeFrame: Date of delivery
measure: Premature rupture of membranes
timeFrame: Before delivery
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Jeanne de Flandre, CHRU de Lille
Study officials:
affiliation: CHRU de Lille, France
name: Damien SUBTIL, PhD-MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU de Lille, France
name: Capucine COULON, MD
role: STUDY_CHAIR
References:
citation: Coulon C, Poleszczuk M, Paty-Montaigne MH, Gascard C, Gay C, Houfflin-Debarge V, Subtil D. Version of breech fetuses by moxibustion with acupuncture: a randomized controlled trial. Obstet Gynecol. 2014 Jul;124(1):32-39. doi: 10.1097/AOG.0000000000000303.
Clinical trial NCT05699590: Galectin-3 in Papillary Thyroid Carcinoma
Official title: Galectin-3 Immunoreactivity in Papillary Thyroid Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Galactin 3-thyroid Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Formalin fixed and paraffin embedded prostatic tissue blocks from 70 patients

Brief summary: Thyroid cancer is a common head and neck malignancy. It is the most common endocrine tumor in the body accounting for 1% of all cancers worldwide. The incidence of thyroid cancer varies worldwide. Most countries have reported an upward trend in its incidence.

Thyroid cancer encompass the most common well-differentiated papillary carcinoma (80% of all thyroid cancers) and follicular carcinoma (15%), as well as poorly differentiated carcinoma (\< 1%) and anaplastic carcinoma (\< 2%).

Papillary thyroid carcinomas (PTCs) are the most commonly encountered thyroid malignancies. The diagnosis of PTC is based on the special nuclear features such as overlapping of nuclei, intranuclear inclusions, optical clearing, anisonucleosis and nuclear grooves. However, it is often difficult to differentiate PTC from benign papillary thyroid hyperplasia . As differentiation between benign or malignant thyroid lesions has clinical, therapeutic, and prognostic significance, it is necessary to make accurate diagnosis by using biomarkers.

Recently, a large number of immunohistochemical (IHC) markers have been studied to assist in differentiating non-neoplastic lesions from malignant thyroid lesions. CK19, galectin-3, TG, Ki67, BRAF, calcitonin, HBME-1, TTF-1, and RET are some of the examples of these IHC markers.

Galectin-3 is a 31-kDa β-galactoside binding lectin. It has been shown to be expressed by several types of non-neoplastic and neoplastic cells, and it is involved in cell-cell adhesion and in cell-matrix interactions.


Eligibility criteria: Inclusion Criteria:

1. Thyroidectomy specimens both hemithyroidectomy and total thyroidectomy.
2. All the studied cases include sufficient materials for the immunohistochemical study.
3. Complete clinical data

Exclusion Criteria:

1. Patients with recurrence of the primary tumor.
2. Patients with a history of preoperative chemotherapy and/or radiotherapy.
3. Insufficient or tiny tissue biopsies

Primary outcomes:
measure: Diagnosis and prognosis of papillary thyroid carcinoma both classic variant and follicular variant
timeFrame: Two or three days after staining tissue sections with Galactin 3 antibody
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pathology department, Faculty of medicine ,Sohag university
name: Amira Ahmed Abdelnaby, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01422590: Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin
Official title: Pharmacodynamics After Concomitant Administration With Mitiglinide and Sitagliptin Compared to Mitiglinide, Sitagliptin Single Administration in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: sitagliptin
mitiglinide
type 2 diabetes mellitus
Pharmacodynamics
Safety
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: JW Pharmaceutical
First posted: 2011-08-24
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 1. Explore pharmacodynamics

   * glucose
   * insulin
   * C-peptide
   * glucagon
   * intact GLP-1
   * DPP-4 activity
   * CGMS (continuous glucose monitoring system)
2. Assess Safety

   * adverse events
   * clinical laboratory test
   * physical examination

Detailed description: Pharmacodynamic assessment

* CGMS data is obtained from day 1 to day 3 (48 hours)
* PD is measured before (day 1) and after drug administration (day 2)

  1. AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity
  2. MAGE (mean amplitude of glycemic excursion) from CGMS data

Eligibility criteria: Inclusion Criteria:

* Male or female patients with type 2 diabetes mellitus
* 6.5% ≤ HbA1c \< 9.0%
* Stopped treatment of sulfonylurea and biguanide for more than 8 weeks
* Stopped treatment of other anti-diabetic agents for more than 12 weeks
* 16 kg/m2 ≤ body mass index \< 30 kg/m2

Exclusion Criteria:

* Fasting glucose ≥ 200 mg/dL
* Required insulin therapy
* Patients with neuropathy, retinopathy or renopathy
* Contraindicated for mitiglinide or sitagliptin

Primary outcomes:
measure: AUC (area under the curve) of plasma glucose
timeFrame: day 1 and day 2 of each period
measure: AUC of insulin
timeFrame: day 1 and day 2 of each period
measure: AUC of intact GLP-1
timeFrame: day 1 and day 2 of each period
measure: AUC of C-peptide
timeFrame: day 1 and day 2 of each period
measure: AUC of glucagon
timeFrame: day 1 and day 2 of each period
measure: MAGE
timeFrame: day 1 and day 2 of each period
measure: AUC of DPP-4 activity
timeFrame: day 1 and day 2 of each period
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Wooseong Hur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung JA, Kaku K, Kim JH, Kim JR, Ko JW, Lee SY, Huh W. Additive postprandial glucose-lowering effects of mitiglinide and sitagliptin in patients with type 2 diabetes mellitus. Adv Ther. 2013 Nov;30(11):1018-29. doi: 10.1007/s12325-013-0072-x. Epub 2013 Nov 19.