louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03251677: Total Laparoscopic Hysterectomy vs Minilap Hysterectomy
Official title: A Prospective Randomized Study Comparing Total Laparoscopic Hysterectomy (Lap Hysterectomy) vs Minilaparotomy (Mini-lap Hysterectomy) for Benign Uterine Lesions: Peri-operative Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysteromyoma
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the perioperative outcomes between mini-lap hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.

Detailed description: A prospective randomized open-label study was conducted. Women \>18 years of age undergoing TLH because of benign indications were recruited. Patients were randomized for either TLH (Group I, 40 cases) or minilap hysterectomy (Group II, 40 cases) through 4-5cm abdominal Pfannenstiel incision.

Inclusion criteria were mobile uterus with benign lesion and with a size up to 12 weeks gestation. Exclusion criteria adopted were patients with enlarged uterus \< 12 weeks, suspected malignancy and large adnexal masses (\>5cm). Peri-operative outcomes were compared.

Written informed consent was obtained from all the patients and the Departmental Ethical Committee approved the study. Patients from OB/GYN Mansoura University Hospital were enrolled. All the operations were performed by at least one of the consultants included as authors in this study.

Eligibility criteria: Inclusion Criteria:

* Mobile uterus.
* Uterine size up to 12 weeks gestation.
* Benign lesions.

Exclusion Criteria:

* Enlarged uterus \> 12 weeks gestation.
* Suspected malignancy.
* Large adnexal masses.

Primary outcomes:
measure: Operative Time (min)
timeFrame: Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)
measure: Estimated blood loss (mL)
timeFrame: Through surgical intervention completion
Secondary outcomes:
measure: Early postoperative complications
timeFrame: Within 30 days after operation
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Tarek Shokeir
Study officials:
affiliation: Mansoura University
name: Tarek Shokeir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05964777: rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder
Official title: Efficacy and Safety of rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder: a Randomized, Double-blind, Sham Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder in Remission
Keywords: repetitive transcranial magnetic stimulation，Transcranial alternating current stimulation，diffusion tensor imaging，bipolar disorder
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 54
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on the individualized positioning technology of diffusion tensor imaging (DTI), the purpose of this study is to explore a new stimulation target and protocol for the treatment of bipolar disorder in remission through the repetitive transcranial magnetic stimulation(rTMS) and transcranial alternating current stimulation（tACS）under neuronavigation，verify whether there is abnormal functional connectivity and structural connections between the dorsolateral prefrontal cortex (dlpfc) and the dorsal anterior cingulate gyrus (dacc) related to cognitive impairment in bipolar disorder in remission, which will contribute to further understand the relevant neural pathway and mechanism.


Eligibility criteria: Inclusion Criteria:

* 1. Age 14-45 years old, regardless of gender\] 2.Meet DSM-V diagnostic criteria for bipolar depressive in remission 3.Young Mania Rating Scale (YMRS) ≤ 6 points; 4.Hamilton Depression Scale(HAMD-17)≤7 points; 5.Cognitive deficit questionnaire PDQ≥17 points; 6.Han nationality, right-handed; 7.More than 9 years of education.

Exclusion Criteria:

1. History of severe somatic or brain organic diseases and craniocerebral trauma;
2. Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
3. Those who do not cooperate or cannot effectively complete the experiment;
4. Drug, alcohol or other psychoactive substance abusers;
5. Pregnant, lactating or planned pregnancy;
6. ECT or rTMS or tACS treatment was performed within six months.

Primary outcomes:
measure: thinc-it
timeFrame: 0,3week
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Psychiatry, First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: ShaoHua Hu, MD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Zhejiang University [Recruiting] Hangzhou, Zhejiang, China, 310000 Contact: ShaoHua Hu, MD 13957162903 dorhushaoh
name: China Zhejiang
role: STUDY_DIRECTOR
References:
Clinical trial NCT01231477: Cytokines and Sevoflurane During Surgery
Official title: Effects of Inhalation Anaesthesia With Sevoflurane on Cytokine Response in Patients Submitted to Otorhinolaryngological Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytokines
Inflammatory
Sevoflurane
Keywords: anaesthetic techniques, inhalation
sevoflurane
Cytokines
Immune response
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Thirty adult patients ASA I physical status were allocated in 2 grups: 15 volunteers, not submitted to anesthesia and surgery, and 15 patients scheduled for tympanoplasty or septoplasty anesthetized with sevoflurane at 2,5%. Blood samples were drawn at 4 moments: before induction of anaesthesia, before surgery, at 120 minutes after anaesthesia induction, and on the postoperative first day. Blood samples from volunteers were drawn only once.

Brief summary: The aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and surgery on cytokines response.


Eligibility criteria: Inclusion Criteria:

* both gender, ASA I physical status, 18-50 years old, tympanoplasty and septoplasty.

Exclusion Criteria:

* Malignant or genetical diseases; diabetes; smoking; elicit drugs, recent RX radiation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Botucatu Medical School
state: São Paulo
Study officials:
affiliation: Botucatu Medical School
name: Jose EB Orosz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03995277: Effect of Biotin on Routine Laboratory Values
Official title: Investigator-Initiated Study to Evaluate the Effect of Biotin Ingestion On Routine Laboratory Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Biotin Ingestion
Interference With Routine Analyical Tests
Keywords: Biotin
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants take 10 mg/d of biotin at the same time each morning for 10 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), and 10 days after participants stopped taking biotin (day 20).
Primary purpose: DIAGNOSTIC

Brief summary: Inaccuracy of laboratory medicine diagnostic tests may be associated with ingestion of over-the-counter biotin supplements.

Detailed description: Study group 1) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in over-the-counter supplements (10 mg/d) in healthy adults and subjects with thyroid hormone supplementation. Therefore, this study was designed to assess the association of short-term biotin ingestion for 10 days with performance of various analytes based on Roche, Abbott and Siemens assays.

Study group 2) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in multivitamin supplements (biotin = 50 µg/d) in healthy adults. Therefore, this study was designed to assess the association of short-term biotin ingestion for 20 days with performance of various analytes based on Roche, Abbott and Siemens assays.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Apparently healthy

Exclusion Criteria:

* Pre-existing condition other than hypothyroidism
* Intake of dietary supplements containing biotin

Primary outcomes:
measure: Variance of routine analyte concentrations
timeFrame: 20 days (high-dose groups) and 30 days (low-dose group)
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University of Augsburg
city: Hamburg
country: Germany
facility: University Heart Center Hamburg
city: Hamburg
country: Germany
facility: University of Hamburg
city: Mainz
country: Germany
facility: University of Mainz
Study officials:
affiliation: University Heart Center Hamburg
name: Mahir Karakas, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02687477: PADN to Treat Severe Obstructive Sleep Apnea
Official title: Pulmonary Artery Denervation to Treat Severe Obstructive Sleep Apnea: a Single-center, Prospective, First-in-man Study（PADN-OSA）
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 1
Sex: ALL
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: This project is focused on the treatment of severe obstructive sleep apnea with pulmonary artery denervation (PADN). Although it has now been proved that continuous positive airway pressure (CPAP) is the primary treatment for obstructive sleep apnea, on the other hand, there is evidence that 25 to 50% of patients can not tolerate CPAP.

The investigators previously reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of pulmonary hypertension. Excessive sympathetic activation play an important role in the occurrence and development of OSA and cause cardiovascular events. It is worth evaluating the feasibility and tolerance of introducing PADN at the severe stage of obstructive sleep apnea. Therefore, the purpose of our study is to evaluate the safety and feasibility of PADN in the treatment of severe OSA.


Eligibility criteria: Inclusion Criteria:

* Apnea hypopnea index more than 30, not tolerated or refused continuous positive airway pressure;

Exclusion Criteria:

* Acute coronary syndrome;
* Pregnant;
* Expected life less than 12 months;

Primary outcomes:
measure: the change from baseline to month 6 in apnea-hypopnea index
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: the absolute change in Epworth Sleepiness Scale from baseline to follow-up
timeFrame: Baseline and 6 months
Other outcomes:
measure: the change in obstruction of the upper airway by MRI scan
timeFrame: Baseline and 6 months
measure: the change in interleukin-6 (IL-6) at 6-month follow-up
timeFrame: Baseline and 6 months
measure: the change in C-reactive protein at 6-month follow-up
timeFrame: Baseline and 6 months
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shao-Liang Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00182377: Pentastarch Use in Cardiac Surgery
Official title: A Randomized, Prospective, Blinded Clinical Trial to Evaluate the Efficacy and Safety of Pentastarch Use in Patients Undergoing Coronary Artery Bypass Surgery or Valve Replacement Surgery Using Cardiopulmonary Bypass Circuits
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Keywords: patients undergoing cardiac surgery requiring cardiopulmonary bypass
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2005-09-16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid administration. Fluids are used routinely to replace blood lost during and after surgery. Significant amounts of fluid are also used to prime the tubing and components of the cardiopulmonary bypass pump before and during its use. The use of Pentaspan - a synthetic pentastarch - was started because of the restriction of use for blood and blood products, particularly albumin. Pentaspan is usually used after surgery in the Intensive Care Unit (ICU). The impact of the use of pentastarch on coagulation, fluid balance and bleeding are very limited. This study will methodically evaluate the impact of using increasingly greater amounts of pentastarch during surgery on an open heart surgery patient's recovery in particular - is there more bleeding, does his/her blood clot as well, and how much fluid overall is used and excreted?


Eligibility criteria: Inclusion Criteria:

* All patients undergoing either coronary artery bypass surgery or valve surgery requiring the use of cardiopulmonary bypass circuit

Exclusion Criteria:

* Emergency surgery
* Regurgitant valve pathology
* Redo surgery
* Significant left ventricular (LV) dysfunction
* Significant renal insufficiency
* Anticipation of associated procedure - eg carotid endarterectomy
* Ongoing sepsis or endocarditis
* Received aspirin (ASA) or Plavix within 96 hours of surgery

Primary outcomes:
measure: transfusion requirements
measure: fluid balance
Secondary outcomes:
measure: postoperative bleeding
measure: mediastinal drainage
measure: coagulation parameters
measure: respiratory status
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - General Division
state: Ontario
Study officials:
affiliation: McMaster University
name: Irene Cybulsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02596477: Evaluation of Vepoloxamer in Chronic Heart Failure
Official title: A Phase 2 Randomized, Double-Blind, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vepoloxamer Injection, 22.5% (Sodium-Free) in Ambulatory Subjects With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Heart Failure
Keywords: Heart failure
Lead sponsor: Mast Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate whether vepoloxamer can provide a blood chemical marker and functional benefit to damaged heart muscle cells. This will be evaluated by measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Age 18 through 74
* Duration of documented heart failure \>3 months
* On stable concomitant medication regimen ≥4 weeks
* Left ventricular ejection fraction ≤35%
* Systolic blood pressure ≥90 mmHg

Exclusion Criteria:

* Severe valvular stenosis or primary valvular regurgitation as the cause of heart failure
* History of myocardial infarction, coronary artery bypass graft surgery, or percutaneous intervention within the prior 3 months
* Estimated glomerular filtration rate ≤45 mL/min/1.73 m2
* Acutely decompensated heart failure within 1 month prior to the screening visit

Primary outcomes:
measure: Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP
timeFrame: Study Day 1 through Study Day 30
measure: Number of subjects with a change in Six Minute Walk test
timeFrame: Study Day 1 to Study Day 30
measure: Number of subjects with a change in Borg dyspnea index
timeFrame: Study Day 1 to Study Day 30
measure: Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire®
timeFrame: Study Day 1 to Study Day 30
measure: Number of subjects with a change in left ventricular end diastolic volume index
timeFrame: Study Day 1 to Study Day 30
measure: Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03
timeFrame: Study Day 1 to Study Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Research Center
state: Michigan
city: Tupelo
country: United States
facility: Research Center
state: Mississippi
city: Cardiff
country: Australia
facility: Research Center
state: New South Wales
city: Melbourne
country: Australia
facility: Research Center
state: Victoria
Study officials:
affiliation: Mast Therapeutics, Inc.
name: Edwin L. Parsley, D.O.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06721377: Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.
Official title: Clinical and Radiographic Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Edentulism in Lower Jaw
Edentulism
Keywords: overdenture
implant placemnent
Novaloc attachment.
Equator attachment
edentulism
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Maximum age (years): 69
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be selected from the outpatient clinic of Removable Prosthodontic Department. Faculty of Dental Medicine for Girls, Al-Azhar University..

Each patient will be assessed for eligibility and Informed consent will be obtained from patient after explanation of the treatment protocols and expected outcomes or alternative management.

Detailed description: All 10 patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two groups, one group will be loaded by Novaloc attachment. While the other group will be loaded by Equator attachment. Implants will be functionally loaded after three months of insertion.

Eligibility criteria: Inclusion Criteria:

* All patients' ridges should be covered with firm mucosa which is free from any signs of inflammation or ulceration.
* Patients should be free from any bone disorder and exhibit adequate height and width of the residual alveolar ridge.
* All patients must have sufficient inter arch space.

Exclusion Criteria:

* Patients with oral or systemic diseases.
* Patients with xerostomia or excessive salivation.
* Patients with parafunctional habits (bruxism or clenching).
* Heavy smoker or alcoholic patients.
* Patients with history of temporo-mandibular dysfunction.
* Patients with brain disorders or psychiatric disorders.

Primary outcomes:
measure: Radiographic evaluation of bone height
timeFrame: at baseline, 6 and 12 months
measure: Radiographic evaluation of bone density
timeFrame: at baseline, 6 and 12 months
Secondary outcomes:
measure: Pocket depth
timeFrame: at baseline, 6 and 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine , Al Azhar Univeristy For Girls
state: Nasr city - Cairo
Study officials:
name: sara H kadry, masters
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05209477: Effects of Body Position and Recruiting Maneuver on Lung Aeration Assessed Through Ultrasound in Patients Intubated for Acute Respiratory Failure Related to Novel Coronavirus 19 Disease
Official title: Effects of Body Position and Recruiting Maneuver on Lung Aeration Assessed Through Ultrasound in Patients Intubated for Acute Respiratory Failure Related to Novel Coronavirus 19 Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Lead sponsor: Azienda Ospedaliera di Perugia
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Second analysis of data prospectively collected during an investigation assessing the clinical characteristics of patients admitted for hypoxemic acute respiratory failure (hARF) related to novel coronavirus 19 disease (COVID-19). In particular, the primary aim of the present analysis is to assess the effects of recruiting maneuver and prone positioning on lung aeration evaluated through lung ultrasound in patients undergoing invasive mechanical ventilation


Eligibility criteria: Inclusion Criteria: Patients intubated for COVID-19 hARF -

Exclusion Criteria: Any contraindication to recruitment and lung ultrasound, pregnancy

-

Primary outcomes:
measure: lung ultrasound score
timeFrame: after 20 minutes following study entry, in volume controll ventilation and supine position
measure: lung ultrasound score recruitment
timeFrame: 2 minutes
measure: lung ultrasound score prone positioning
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Università degli Studi di Perugia
state: Umbria, Italy
Study officials:
References: