louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01216488: Comparison Between Two Different Volumes of Anesthesia Drug in Forearm Surgery
Official title: Comparison of Axillary Block Under Ultrasound With 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Forearm and Arm Surgery
Keywords: Forearm surgery
Hand surgery
Anesthesia
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 72
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: Hospitalized patients for superior member surgery have different types of anesthesia.Forearm and/or arm surgery could be done under general anesthesia, but in the most of the cases, this surgery was done under locoregional anesthesia.Several injections of local anesthesia at the nerves axilla are used with the used of ultrasonography.

The purpose of this study is to show that the anesthesia efficiency is the same with 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.

Detailed description: Inclusion criteria :

* age \> 18 years old
* patient who must have a non emergency surgery of the forearm or the hand
* ASA I or ASA II
* informed consent
* Ensured patient

Exclusion criteria :

* pregnancy
* respiratory insufficiency
* cardiac insufficiency
* hepatic insufficiency
* renal insufficiency
* ASA III or IV
* contraindications to the locoregional anesthesia
* contraindications to the xylocaine used
* patient participate to an another clinical study
* guardianship patient

Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* patient who must have a non emergency surgery of the forearm or the hand
* ASA I or ASA II
* informed consent
* Ensured patient

Exclusion Criteria:

* pregnancy
* respiratory insufficiency
* cardiac insufficiency
* hepatic insufficiency
* renal insufficiency
* ASA III or IV
* contraindications to the locoregional anesthesia
* contraindications to the xylocaine used
* patient participate to an another clinical study
* guardianship patient

Primary outcomes:
measure: Axillary block efficiency conducted by ultrasound
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Department of Anesthesia CHRU Brest
state: Brittany
Study officials:
affiliation: CHRU Brest
name: François PICART, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02057588: Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms
Official title: Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrythmia
Keywords: ablation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-02-07
Enrollment: 16
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: The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various electrical conduction patterns. Electroanatomic mapping data and 12 Lead ECG will also be collected to characterize electrical conduction patterns during standard electrophysiology exam.


Eligibility criteria: Inclusion Criteria:

* Patient with SJM CRM device implanted for more than 90 days

Exclusion Criteria:

* Suspicion of lead dislodgment

Primary outcomes:
measure: Correlation of ventricular activation patterns determined by 12-lead ECG and device IEGMs-based method
timeFrame: Acute, intraoperative
Secondary outcomes:
measure: Ventricular activation origin location determined by IEGMs based method vs. by detailed mapping
timeFrame: Acute, intraoperative
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU haut leveque
Study officials:
affiliation: University Hospital, Bordeaux
name: Frederic Sacher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01455688: Early Antiviral Therapy for Critically Ill HIV Infected Patients
Official title: Early Antiretroviral Therapy for Critically Ill HIV Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Keywords: critically ill patients
HIV infection
HAART
mortality
Lead sponsor: Hospital Nossa Senhora da Conceicao
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 115
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: The aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. The investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the ICU. The investigators just have retrospective studies in this scenario. After admission to ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission) or conventional therapy (initiation of HAART after ICU discharge). The following data will be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be followed to determine ICU mortality, hospital mortality and 6-month mortality.


Eligibility criteria: Inclusion Criteria:

* HIV infection
* CD4 cell count less than 350 cells/mm3 within 3 months prior to study entry OR CD4 cell count between 350 cells/mm3 and 500 cells/mm3 if age \> 55 years, coinfection with HBV or HCV, neoplasia, viral load \> 100,000 copies/ml or elevated cardiovascular risk OR AIDS-defining illness

Exclusion Criteria:

* Regular use of HAART
* Pregnant

Primary outcomes:
measure: Hospital mortality
timeFrame: 4 weeks
Secondary outcomes:
measure: 6-month mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
Study officials:
References:
citation: Boniatti MM, Pellegrini JAS, Marques LS, John JF, Marin LG, Maito LRDM, Lisboa TC, Damiani LP, Falci DR. Early antiretroviral therapy for HIV-infected patients admitted to an intensive care unit (EARTH-ICU): A randomized clinical trial. PLoS One. 2020 Sep 21;15(9):e0239452. doi: 10.1371/journal.pone.0239452. eCollection 2020.
Clinical trial NCT01844388: A Study to Compare a New Eye Drop Formulation With Refresh Contacts®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contact Lens Lubrication
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.


Eligibility criteria: Inclusion Criteria:

-Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week.

Exclusion Criteria:

* Wearing monovision lenses
* Have had refractive surgery within the previous 12 months
* Have infection of the eye, eyelids or eye structures.

Primary outcomes:
measure: Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
timeFrame: Baseline, Day 90
Secondary outcomes:
Other outcomes:
measure: Average Daily Contact Wearing Time
timeFrame: Day 90
measure: Reason for Contact Lens Replacement
timeFrame: Day 90
Locations:
city: Bloomington
country: United States
state: Illinois
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Nichols JJ, Lievens CW, Bloomenstein MR, Liu H, Simmons P, Vehige J. Dual-Polymer Drops, Contact Lens Comfort, and Lid Wiper Epitheliopathy. Optom Vis Sci. 2016 Aug;93(8):979-86. doi: 10.1097/OPX.0000000000000878.
Clinical trial NCT05022888: Near-Infrared Spectroscopy in Myofascial Pain Syndrome
Official title: Investigation of the Diagnostic Effect of Muscle Tissue Oxygenation Values in Patients With Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Pain Syndrome
Regional Tissue Oxygen Saturation
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective
Primary purpose: DIAGNOSTIC

Brief summary: Myofascial pain syndrome is a regional pain syndrome accompanied by sensorial, motor and autonomic symptoms . myofascial trigger points are most frequently detected in the upper trapezius, levator scapula, and axial postural muscles such as rhomboid major. Myofascial pain syndrome is characterized by active myofascial trigger points in the form of focal hyperirritable nodules palpated in the tight band of the muscle .

Alteration of tissue vascularization could limit or prevent th may cause adhesions, contractures and pain. As a result of decreased blood flow, tissue oxygenation may decrease.

Detailed description: In this study, it will be tried to determine the role of muscle tissue oxygenation in the activity and diagnosis of the disease in myofascial pain syndrome.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* myofascial pain syndrome

Exclusion Criteria:

* Cervical radiculopathy
* Fibromyalgia
* Shoulder joint disease,
* Peripheral and central nervous system disease
* Polyneuropathy,
* Inflammatory rheumatic disease,
* Malignancy

Primary outcomes:
measure: regional tissue saturation
timeFrame: 15 minute
Secondary outcomes:
measure: peripheral oxygen saturation
timeFrame: 15 minute
measure: Visual Analogue Scale (VAS)
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Burcu M.D Metin ÖKMEN, Assoc. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Korgün MD Ökmen, Assoc. PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT01941888: Propofol TCI Administered by Gastroenterologists During Endoscopy: a Randomized Double Blind Controlled Study
Official title: Phase IV Study of Propofol TCI (Target Controlled Infusion)Administered by Gastroenterologists During Endoscopy in Moderate Sedation: a Randomized Double Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Propofol
Target Controlled Infusion
Moderate Sedation
Gastrointestinal Endoscopy
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 140
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: Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation.

This randomized double blind controlled study compares standard moderate sedation level of sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS (group P).

Detailed description: 70 CS and 70 EGD ASA I-II patients were studied. In group S (n=70) we administered fentanyl (1μg/kg) + midazolam (0.04-0.03 mg/kg) for CS and midazolam (0.04-0.03 mg/kg) for EGDS and in group P (n=70) fentanyl 1µg/Kg + propofol TCI 1.2-1.6 μg/ml for CS and propofol TCI 1.2-1.6 μg/ml for EGD. Vital parameters and Observer's Assessment of Alertness and Sedation Scale (OAA/S) were monitored throughout the study. Endoscopist's and patient's satisfactions were measured after procedure and 24-72 h later by visual analog scale (VAS).

Eligibility criteria: Inclusion Criteria:

* age \>18 yrs
* ASA (American Society of Anesthesiologists risk class III-IV)I-II
* patients undergoing to gastroscopy or colonoscopy

Exclusion Criteria:

* significant systemic disease (American Society of Anesthesiologists risk class III-IV)
* history of allergic reactions to any of the study drugs
* chronic use of opioid analgesics
* psychiatric disorder
* pregnancy
* difficult airways (Mallampati score \>2)
* age \<18 yrs

Primary outcomes:
measure: Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation
timeFrame: one day
measure: Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation
timeFrame: one day
Secondary outcomes:
measure: Safety (number of partecipants with adverse events) of propofol TCI moderate sedation
timeFrame: one day
measure: Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients
timeFrame: one day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
affiliation: San Raffele Hospital
name: Massimo Agostoni, MD
role: STUDY_DIRECTOR
affiliation: San Raffaele Hospital
name: Lorella Fanti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Raffaele Hospital
name: Marco Gemma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06467188: Turkish Validity and Reliability of the Haptotherapeutic Well-Being Scale
Official title: Turkish Validity and Reliability of the Haptotherapeutic Well-Being Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Therapeutic Agalactia
Keywords: Haptonomy
Validity
Reliability
Scale
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women over 18 age, living in Turkiye, using social media (Facebook, Instagram), and agreeing to participate in the study

Brief summary: Objectives: Haptotherapy fosters a sense of unity between the body, mind, and emotions. In addition, it contributes to expanding the woman's perception of her pregnancy and developing a more positive attitude towards pregnancy and childbirth. The study aims to examine the Turkish validity and reliability of the Haptotherapeutic Well-Being Scale, which will be used to evaluate the well-being levels of haptonomy and haptotherapy practices in women.

Design: The study was methodological type. Methods: The study conducted between October 20 and December 20, 2023, with 242 women who volunteered to participate by sharing forum pages on social media (Facebook, Instagram) via the web. Data were collected using a personal information form, including sociodemographic and obstetric characteristics and the Haptotherapeutic Well-Being Scale.


Eligibility criteria: Inclusion Criteria:

* Women over 18 age, living in Turkiye, using social media (Facebook, Instagram), and agreeing to participate in the study.

Exclusion Criteria:

* Women who were illiterate in Turkish, had hearing-vision problems or mental disabilities, did not have social media (Facebook, Instagram), and did not volunteer to participate.

Primary outcomes:
measure: Haptotherapeutic Well-Being Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
References:
Clinical trial NCT00909688: Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses
Official title: Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine the safety, tolerability, and drug absorption profile of multiple IV doses of BLI 489 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Men or women of non-childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening;
* Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg.;
* Healthy as determined by the investigator on the basis of screening evaluations;
* Calculated creatinine clearance within normal limits using the Cockcroft-Gault formula;
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history, and if a smoker must be able to abstain from smoking during the inpatient stay;
* Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study;
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease;
* Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the investigational product;
* Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1;
* History of drug abuse within 1 year before study day 1;
* Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.

Primary outcomes:
measure: Assess safety of drug given to healthy subjects by evaluating any reported adverse events (AEs), scheduled physical examinations, vital sign measurements, 12-lead ECGs, and clinical laboratory test results.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02379988: Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy
Official title: Pilot Study For Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receive for patients being treated for left sided breast cancer.

Detailed description: Subjects have a standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient.

Eligibility criteria: Inclusion Criteria:

* Patients of Dr. Gonzalez
* ≥18 years of age
* Node-negative left breast cancer
* Invasive or DCIS breast cancer
* Prior lumpectomy
* Deemed appropriate for treatment in the prone position by the treating physician
* Able to tolerate prone position and breath hold during CT simulation

Exclusion Criteria:

* \<18 years of age
* Patients requiring treatment in supine position

Primary outcomes:
measure: The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques.
timeFrame: Treatment Day 1 (both pFB and pDIBH scans were done on the same day)
Secondary outcomes:
measure: Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added.
timeFrame: Treatment Day 1
measure: Heart Mean Dose Based on Breast Volume
timeFrame: Treatment Day 1
measure: Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added.
timeFrame: Treatment Day 1
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Radiation Oncology Department at the University of Arizona Heath Network
state: Arizona
Study officials:
affiliation: University of Arizona Radiation Oncology
name: Victor J Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona Radiation Oncology
name: Uma Goyal, MD
role: PRINCIPAL_INVESTIGATOR
References: