louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04790292: Impact of Dexamethasone Added to Intra-articular Morphine and Bupivacaine for Post-operative Analgesia After Knee Arthroscopy
Official title: Impact of Dexamethasone Added to Intra-articular Morphine and Bupivacaine for Post-operative Analgesia After Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Dexamethasone
Bupivacaine
Morphine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 40
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: A randomized double-blinded clinical trial was carried out on 40 patients undergoing knee arthroscopy. Patients were divided randomly into two equal groups. All drugs used were injected intra-articularly at the end of arthroscopy. In the control group, patients were administered 10mg morphine added to bupivacaine 25mg. In the study group, patients were administered 10mg morphine and 8mg dexamethasone added to bupivacaine 25mg. Visual analog score for pain at rest and movement, time to first analgesic request, total analgesic consumption, duration of analgesia and adverse effects were recorded.


Eligibility criteria: Minimum Age: 18 years Maximum Age: 65 years Sex: Both Gender Based: No Accepts Healthy Volunteers: No

Criteria:

Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II
* Scheduled for minor arthroscopic knee surgeries (meniscectomy, chondroplasty, minor ligament repair and diagnostic arthroscopy)

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status above (II)
* Undergoing major knee surgeries
* History of allergies to any of the used drugs
* History of diabetes mellitus
* Contraindications of morphine use (e.g. asthmatic patient, chronic obstructive pulmonary disease, and addiction)

Primary outcomes:
measure: visual analogue score(VAS) at rest and movement
timeFrame: first 24 hours post operative
Secondary outcomes:
measure: Rescue analgesia time
timeFrame: first 24 hours post operative
measure: Total analgesic consumption
timeFrame: first 24 hours post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
affiliation: Ain Shams University
name: Heba F Abd El-Aziz Toulan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04025892: Pregnancy Tracking Pilot
Official title: A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gestational Weight Gain
Keywords: pregnancy
digital health
daily weighing
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study will examine perceptions about daily weighing for pregnant women with overweight or obesity by testing the feasibility, acceptability, and preliminary efficacy of daily weighing for reducing excess gestational weight gain (GWG) within the context of a low intensity, digital-health based intervention delivered remotely with electronic feedback to participants.


Eligibility criteria: Inclusion Criteria:

* women ages 18-34
* first pregnancy and at 13-20 weeks' gestation
* low-risk uncomplicated pregnancy
* overweight or obese at the time they became pregnant
* willing to receive emails.

Exclusion Criteria:

* Individuals who are not pregnant
* not willing to receive emails
* pregnant women expecting more than a single birth,
* outside the window of 13-20 weeks' gestation
* high-risk or complicated pregnancy for which participation would be contraindicated
* advanced maternal age according to obstetric guidelines (i.e., age 35 or older)
* diabetes
* history of eating disorders
* pre-pregnancy weight less than 25 kg/m2or greater than 36 kg/m2 (either not overweight or with extreme obesity)

Primary outcomes:
measure: Frequency of scale use
timeFrame: Approximately 6 weeks
Secondary outcomes:
measure: Weight change trajectories during scale use
timeFrame: Approximately 6 weeks
measure: Knowledge of gestational weight gain guidelines
timeFrame: During baseline visit (~ 1 hour)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Global Digital Health Science Center
state: North Carolina
Study officials:
affiliation: DUSON
name: Dori Steinberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06213792: Visuo-Vestibular Adaptation in Virtual Reality
Official title: Visuo-Vestibular Adaptation in Virtual Reality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Person
Keywords: Vestibulo-Ocular Reflex
Adaptation
Head Impulse Test
Virtual Reality
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy subjects

Brief summary: The vestibulo-ocular reflex (VOR) stabilizes the gaze during rapid head movements by inducing an eye rotation of equivalent amplitude but in the opposite direction to the head rotation. Normally, the ratio of eye rotation amplitude to head rotation, or VOR gain, is 1. Under some conditions such as growth or the use of corrective glasses, this gain is adapted to the new visuo-vestibular conditions. This well-known sensorimotor adaptation phenomenon can be achieved through the experimental creation of a conflict between vestibular and visual information.

Incremental velocity error (IVE) allows for a rapid adaption of the VOR at high speed by synchronously projecting a laser target that moves to create a progressively increasing visuo-vestibular conflict. However, this method does not correspond to the ecological conditions of VOR use, as the training is conducted in darkness and the visuo-vestibular conflict does not involve the entire visual scene.

Recreating this type of adaptation in a virtual reality environment could allow for adaptation with a visual stimulus involving the entire visual scene, thus more closely resembling the physiological conditions of VOR use. We hypothesize that a visual simulation of the entire scene would be more effective than an isolated target in VOR adaptation during high velocity head rotation.


Eligibility criteria: Inclusion Criteria:

* Age from 18 to 60
* Understanding of the experimental instructions
* Informed Consent

Exclusion Criteria:

* Underlying ENT or neurological disorders
* Corrected Visual Acuity lower than 5/10
* Other conditions leading to oscillopsia or ataxia
* Oculomotor palsy, ocular instability in primary position
* Treatment that may affect ocular motility (psychotropes)
* Cervical rachis pathology with instability
* Cochlear Implants
* Non-stabilized medical disease
* Subject suffering from debilitating motion sickness or Virtual Reality sickness
* Pregnant women
* Patients under tutelage
* Patient without social security

Primary outcomes:
measure: VOR gain
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Neurologique
Study officials:
References:
Clinical trial NCT03378492: Utilizing Ultrasound for Residents as an Aid in Epidural Placement
Official title: Utilizing Ultrasound for Residents as an Aid in Epidural Placement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epidural Placement
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural placement in residents performing all epidural techniques under direct staff anesthesiologist supervision.

Detailed description: The purpose of this study is to assess the abilities of the "Accuro" to assist in lumbar epidural placement in patients. It is hypothesized that the use of the Accuro will result in an increase of first-attempt success rates, defined as successful epidural needle placement on the first needle insertion attempt.

Eligibility criteria: Inclusion Criteria:

* Patients presenting for vaginal delivery
* ASA-1, ASA-2, and ASA-3
* Patients with no known back deformities
* Ability to sit upright for epidural placement
* No prior lumbar surgery
* No allergies to ultrasound gel
* Pre-pregnancy BMI \>= 30

Exclusion Criteria:

* Patients \< 18 years of age

Primary outcomes:
measure: Success Rate
timeFrame: Baseline (at time of procedure)
Secondary outcomes:
measure: Needle passes
timeFrame: Baseline (at time of procedure)
measure: Needle insertion attempts
timeFrame: Baseline (at time of procedure)
measure: Accuracy of needle insertion
timeFrame: Baseline (at time of procedure)
measure: Vertebral level of epidural placement
timeFrame: Baseline (at time of procedure)
measure: Time to landmark identification
timeFrame: Baseline (at time of procedure)
measure: Time to loss of resistance
timeFrame: Baseline (at time of procedure)
measure: Time to complete epidural analgesia administration
timeFrame: Baseline (at time of procedure)
measure: Total technical procedure time
timeFrame: Baseline (at time of procedure)
measure: Epidural space depth
timeFrame: Baseline (at time of procedure)
measure: Pain
timeFrame: Baseline (at time of procedure)
measure: Analgesia efficacy rate
timeFrame: Baseline (at time of procedure)
measure: Time to comfort
timeFrame: Baseline (at time of procedure)
measure: Patient satisfaction
timeFrame: Follow Up (Up to 1 day)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05960292: Laparoscopic Versus Vaginal Approach Closure Complications
Official title: Laparoscopic Versus Vaginal Approach Closure Complications of Vaginal Vault in Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaginal Vault Prolapse
Keywords: Laparoscopic hysterectomy
Vaginal hysterectomy
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2023-07-25
Enrollment: 56
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.

Detailed description: Laparoscopic hysterectomy (LH) is a minimally invasive operation that could be made when vaginal hysterectomy is not accessible due to anatomical problems.

Vaginal cuff dehiscence (VCD) is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (TLH) compared with abdominal and vaginal hysterectomy.

The study shows effects of the laparoscopic approach versus the vaginal route for the management of vaginal cuff closure during total laparoscopic hysterectomy on female sexual function.

Eligibility criteria: Inclusion Criteria:

1. Patients who undergo laparoscopic hysterectomy
2. Age ranged from 40 to 80 years.
3. Patients suffering from chronic pelvic inflammatory disease (PID)
4. Dysfunctional uterine bleeding
5. Adenomyosis
6. Endometriosis
7. Fibroid
8. Endometrial hyperplasia
9. Benign ovarian cyst

Exclusion Criteria:

* Patients with known malignancy

Primary outcomes:
measure: Post operative bleeding (defined as blood loss ≥500 cc)
timeFrame: First 24 hours after The Operations
measure: Postoperative pain
timeFrame: First 24 hours after The Operations
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University hospitals
Study officials:
affiliation: Al-Azhar University, Faculty of medicine for boys
name: ElSayed ElDesouky, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06103292: Calcium Levels in Major Trauma
Official title: Ionized Calcium Level Abnormalities In Major Trauma Patients Pre And Post Receiving Blood Transfusion And Its Relation To Mortality Rate
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Major Trauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study all consecutive adult multiple trauma patients presenting to the emergency department with the inclusion criteria until the sample size is satisfied.

Brief summary: To assess and treat The calcium level abnormalities in major trauma pre and post receiving blood transfusions .

Detailed description: Primary objective:

* to evaluate the level of ionized calcium in multiple trauma patients with massive hemorrhage

Secondary objective:

* to build a relation between the level of ionized calcium and the degree of hemorrhagic shock

Eligibility criteria: Inclusion Criteria:

1. \>18 years old - \< 70 years
2. Major trauma patients.
3. Admission and Ionized calcium measurement before blood transfusions

Exclusion Criteria:

1. patients below 18 years or \> 70 years of age.
2. Pregnant women
3. Arrested patients
4. Patients managed outside the hospital and had received blood transfusions

Primary outcomes:
measure: follow up ionized calcium level
timeFrame: 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sauaia A, Moore FA, Moore EE, Moser KS, Brennan R, Read RA, Pons PT. Epidemiology of trauma deaths: a reassessment. J Trauma. 1995 Feb;38(2):185-93. doi: 10.1097/00005373-199502000-00006.
citation: Heckbert SR, Vedder NB, Hoffman W, Winn RK, Hudson LD, Jurkovich GJ, Copass MK, Harlan JM, Rice CL, Maier RV. Outcome after hemorrhagic shock in trauma patients. J Trauma. 1998 Sep;45(3):545-9. doi: 10.1097/00005373-199809000-00022.
citation: Zink KA, Sambasivan CN, Holcomb JB, Chisholm G, Schreiber MA. A high ratio of plasma and platelets to packed red blood cells in the first 6 hours of massive transfusion improves outcomes in a large multicenter study. Am J Surg. 2009 May;197(5):565-70; discussion 570. doi: 10.1016/j.amjsurg.2008.12.014.
citation: Barry GD. Plasma calcium concentration changes in hemorrhagic shock. Am J Physiol. 1971 Apr;220(4):874-9. doi: 10.1152/ajplegacy.1971.220.4.874. No abstract available.
Clinical trial NCT03739489: Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability
Official title: Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Rate Variability
Keywords: healthy subjects
repetitive transcranial magnetic stimulation
heart rate variability
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The participant will be received three different sessions of rtms, with wash out 30 days between sessions.
Primary purpose: TREATMENT

Brief summary: Repetitive transcranial magnetic stimulation is a non-invasive neuromodulation technique used to treat different neuropsychiatric disorders, such as, depression, neuropathic pain, fibromyalgia and obsessive-compulsive disorder. It is known that the heart rate variability is altered in these conditions. Therefore the focus of this research is to show the influence of rTMS on the Heart Rate Variability.


Eligibility criteria: Inclusion Criteria:

* Agreed participate the protocol
* Signing the consent form
* Do not present any cardiac problems or disease

Exclusion Criteria:

* Trauma of Skull, epilepsy don't treated,
* Use of medications decrease the seizure threshold
* Patients in use of drugs, how cocaine and alcohol
* Neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
* Pregnant or breastfeeding women

Primary outcomes:
measure: Heart rate variability changes
timeFrame: Three times during the entire study. Following the scheme, Until 1 hour before each session, 15 minutes along the each session and until 1 hour after the end of session
Secondary outcomes:
measure: Conditioned Pain Modulation
timeFrame: 48 hours before the first session of stimulation
measure: Volume in
timeFrame: 1 week before the first session of stimulation
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
state: SP
Study officials:
References:
Clinical trial NCT00824889: Exploratory Study of Natural Killer Cells in Human Skin
Official title: Exploratory Study of Natural Killer Cells in Human Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Contact Dermatitis
Psoriasis
Lichen Planus
Graft Versus Host Disease
Melanoma
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Natural Killer (NK) cells play a unique role during innate immune responses as they are able to recognize and eliminate, without specific sensitization, tumors, microbe-infected cells as well as allogeneic cells.In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin.

Detailed description: Then, we will define whether these parameters are qualitatively/ quantitatively modified in the following skin pathologies: a) atopic dermatitis; b) contact dermatitis; c) psoriasis ; d) lichen planus ; e) GVH (graft versus host disease) ; (f) melanoma.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Consent obtained after healthy donor or patient information.
* Patients suffering from one of the following diseases: a) atopic dermatitis ; b) contact dermatitis; c) psoriasis ; d) lichen planus ; e) GVH ; f) melanoma.

Exclusion Criteria:

* Age below 18,
* pregnant or breastfeeding women,
* persons under guardianship, persons without social security, prisoners, persons hospitalized without consent on the basis of French laws L. 3212-1 et L. 3213-1. Patients affected by HIV infection, AIDS, Hepatitis A, B or C infection.
* Neutropenia \<1000/mm3.
* Thrombopenia \<50 000/mm3.

Primary outcomes:
measure: In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin.
timeFrame: 12 months
Secondary outcomes:
measure: To determine whether the eventual modifications detected in skin pathologies are correlated to qualitative/ quantitative alterations of NK cell subsets present in the peripheral blood.
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service de Dermatologie- Hopital Sainte Marguerite
Study officials:
affiliation: Assistance Publique des Hopitaux de Marseille
name: Caroline Gaudy-Marqueste, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01888289: Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition
Official title: An Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANE® Capsules 40 mg of Roche Laboratories Inc., Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions

Detailed description: An open label, randomized, two-treatment, single dose, oral bioequivalence study of Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fasting conditions

Eligibility criteria: Inclusion Criteria:

1. Healthy males between 18 and 45 years of age inclusive.
2. Informed of the nature of the study and given written informed consent.
3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).

Exclusion Criteria

1. Hypersensitivity to isotretinoin or related compounds.
2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
3. Recent history of mental illness, drug addiction, drug abuse or alcoholism.
4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
5. Received an investigational drug within the 4 weeks prior to study dosing.
6. Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
7. Regular tobacco use in the 3 months prior to study dosing.

Primary outcomes:
measure: Area under curve (AUC)
timeFrame: Pre-dose (0) and 0.5, 1,2,3,4,5,6,8,10,16,24,36,48,72 and 96hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Quadrangle Drive, Chapel Hill,
country: United States
facility: AAI
state: North Carolina
Study officials:
affiliation: AAI
name: Dr. Ralph Scallion, MD
role: PRINCIPAL_INVESTIGATOR
References: