louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05363566: Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i
Official title: Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Baska Mask
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Baska mask (proact Medical Ltd, Northants, UK) is the latest addition to an era of supraglottic airway devices in clinical use. It is made of medical grade silicone; it has many advantages in its constructions over other LMA, a cuff less membranous bowl in which the saliva secretion collected. An inbuilt "tab" that allows to extend its angulation for straightforward negotiation of the oropharyngeal curve during placement


Eligibility criteria: * Inclusion criteria

  1. Adult patients from 18 to 60 years of age.
  2. American Society of Anesthesiologists (ASA) physical status I and II
  3. Both genders
  4. Patients scheduled for elective surgeries lasting less than 2 hours under general anesthesia on spontaneous ventilation.
  5. El Ganzouri index Score ≥ 4
  6. Patients with BMI \< 35 kg/m2
* Exclusion criteria

  1. The patients who will be refusal or inability to give informed consent,
  2. ASA class III or IV
  3. El Ganzouri index Score \< 4,
  4. Oropharyngeal pathology making a proper SAD fit unlikely as weak dentation, neck pathology
  5. Respiratory illness including upper respiratory infection or pneumonia within the six weeks preceding surgery
  6. Risk for gastric aspiration (e.g., hiatus hernia, gastro-oesophageal reflux disease or non-fasting status), expected duration of surgery longer than 2 h
  7. Contraindication to SGA use including morbid obesity (body mass index 35 kg m-1, history of obstructive sleep apnea)
  8. Any condition for which the primary anesthesia team deemed intubation with a tracheal tube to be necessary.

Primary outcomes:
measure: insertion time
timeFrame: 1 hour
Secondary outcomes:
measure: Ease of device insertion
timeFrame: 1 hours
measure: Oropharyngeal leak pressures
timeFrame: 1 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT05041166: A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers
Official title: Optimized In-Human [13C]Pyruvate MRI For Assessment Of Physiologic Reference Data In Different Organs
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: MRI
Hyperpolarized (HP) [13C] pyruvate
21-309
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2021-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This in-human study of HP \[13C\]pyruvate MRI at MSKCC will be an open-label study.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to learn about the use of \[13C\]pyruvate as an imaging agent for MRI scans. In past studies, researchers have seen that \[13C\]pyruvate can improve imaging with MRI scans. However, they would like to know more about how the imaging agent is distributed in healthy organs and tissues. This study will provide additional information about the use of \[13C\]pyruvate as an imaging agent for MRI scans, and it will show us how the substance is metabolized (changed into energy) in the organs and tissues of healthy volunteers. For (n=5) volunteers undergoing brain imaging we will compare the standard injection at 5mL/second with a slower infusion (0.1-1mL/second) to achieve a 60 second infusion time, to approach quasi steady-state metabolism and improve SNR.


Eligibility criteria: Inclusion Criteria:

Fifty healthy volunteers will be included.

* Age between 18-80
* Negative serum or urine pregnancy test for female volunteers of childbearing age and potential (as defined by MSKCC Standards \& Guidelines), from assays obtained \<2 weeks prior to study enrollment. Urine pregnancy tests are only valid for the day of test.

Exclusion Criteria:

* Breast-feeding
* History of metabolic (e.g. diabetes) and renal functional disorders.
* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
* Acute major illness (e.g., unstable cardiovascular condition, systemic malignant diseases, etc.).
* Standard MRI safety screening will be applied (MRI screening questionnaire); volunteers with MR unsafe devices, or conditional devices where research mode is not allowed, will be excluded.

Primary outcomes:
measure: Signal-to-noise ratios
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Vesselin Miloushev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02103166: Role of Hyoscine Bromide in Latent and Active Labor
Official title: Randomized, Masked, Placebo-controlled Clinical Trial to Evaluate the Effects of a Single Intravenous Dose of Hyoscine Bromide on the Duration and Pain in Latent and Active Labor
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Labor, First Stage
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether hyoscine bromide decreases the duration of the active phase of labor.


Eligibility criteria: Inclusion Criteria:

* Age: 18 or more.
* Term pregnancy.
* Cephalic presentation.
* Oxytocin perfusion not present at the time of inclusion.
* Uterine dynamic established.
* Abscence of high risk factors or very high risk factors for pregnancy.
* Written informed consent

Exclusion Criteria:

* Induction of labor.
* Presence of risk factors.
* Patients with hypersensitivity to the active substance or to any of the excipients or any contraindication reflected in technical report.

Primary outcomes:
measure: Time to complete dilation
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Montse Palacio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Mariona Rius, MD
role: STUDY_CHAIR
affiliation: Hospital Clinic of Barcelona
name: Ana Sandra Hernandez, MD
role: STUDY_CHAIR
affiliation: Hospital Clinic of Barcelona
name: Irene Teixido, MD
role: STUDY_CHAIR
affiliation: Hospital Clinic of Barcelona
name: Irene Vives, MD
role: STUDY_CHAIR
affiliation: Hospital Clínic
name: Midwives Collaborative Group HCP
role: STUDY_CHAIR
References:
Clinical trial NCT01499966: Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains
Official title: Assessment of Tubigrip Versus Plaster of Paris in the Treatment of Grade 1 and 2 Lateral Ankle Sprains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injuries
Keywords: Lateral Ankle Sprain
Plaster of Paris
Tubigrip
Lead sponsor: Liaquat National Hospital & Medical College
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Until now very few studies have been done to compare the efficacy of tubigrips or plaster of paris in the treatment of lateral ankle sprains, the investigators aim to compare the tubigrip against plaster of paris in the treatment of lateral ankle sprains.

Detailed description: 200 patients were enrolled after meeting inclusion criteria.All patients gave the verbal as well as written consent for inclusion in the study. The hospital committee ethical review board gave the permission for this study. Only 126 patients agreed to participate in the study. After informed consent was obtained the patients were randomized such that each patient was allocated to use either a Tubigrip (Group A) or Plaster of Paris (Group B)using the Block randomization. The patients in TG group receive the Tubigrip treatment and the patients in POP group were given a below knee plaster cast. Patients were instructed to follow up at 2 weeks and then at 6 weeks. The functional score and pain were used as outcomes of the study

Eligibility criteria: Inclusion Criteria:

* age 18-40 years
* grade 1 and 2 ankle sprains
* permanent residents in place of study
* no concomitant bone pathology
* have not been recruited in other trial simultaneously

Exclusion Criteria:

* Patients with age \<18 years
* injury \>48 hours, fractures
* multiple injuries
* any neurological or musculoskeletal illness
* any co-morbid associated with long term disabilities
* grade 3 lateral ankle sprains

Primary outcomes:
measure: pain, karlsson score
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Liaquat National Hospital
state: Sindh
Study officials:
affiliation: Liaquat National Hospital
name: Zaki Idrees, FRCS
role: STUDY_CHAIR
References:
citation: Naeem M, Rahimnajjad MK, Rahimnajjad NA, Idrees Z, Shah GA, Abbas G. Assessment of functional treatment versus plaster of Paris in the treatment of grade 1 and 2 lateral ankle sprains. J Orthop Traumatol. 2015 Mar;16(1):41-6. doi: 10.1007/s10195-014-0289-8. Epub 2014 Mar 27.
Clinical trial NCT00327366: Effect of Bright Light on Sex Hormones and Ovulation in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anovulation
Keywords: Menstrual Cycle
Light Therapy
Sex Hormones
Ovulation
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2006-05-18
Enrollment: 27
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigated whether bright artificial light may influence menstrual cycle and ovulation conclusively, and what underlying hormonal changes for this effect are.

Detailed description: Several studies have shown a shortening of the menstrual cycle following light therapy in women with abnormally long menstrual cycles or with winter depression, which suggests that bright light may influence sex hormones and ovulation. The study was designed to investigate this possibility. Twenty-two women with slightly lengthened menstrual cycles and without clinically evident endocrine abnormalities completed a study lasting for two menstrual cycles separated by an off-protocol episode of at least 1 menstrual cycle. Bright light therapy was administered for a week at home during one experimental cycle, and dim light during another cycle (placebo-controlled, crossover, counter-balanced order). Daytime blood sampling and ultrasound scan were performed before and after a week of light therapy, on the \~7th and 14th days after menstruation onset. Ultrasound examination was repeated further to document ovulation. Serum was assayed for thyroid-stimulating hormone, prolactin, luteinizing hormone, follicle-stimulating hormone, and estradiol. The preliminary results were reported at the SLTBR meeting in June, 2005.

Eligibility criteria: Inclusion Criteria:

* Age 19-40 years
* Mean menstrual cycle 28-38 days
* Good general health
* Generally normal sleep-wake regimen
* Motivated for free participation

Exclusion Criteria:

* Low cooperation
* Medications known to interfere with hormone release
* Clinically evident endocrine abnormalities including the signs of
* Hyperandrogenism
* Travel over several time zones during two months prior the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Internal Medicine SB RAMS
name: Konstantin V. Danilenko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02398266: Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid
Official title: Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral Artery Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The measurement of limb skeletal muscle perfusion and perfusion reserve during exercise is an approach that can assess the total impact of the complex pathophysiologic processes in patients with limb ischemia, particularly in those with diabetes in whom distal arterial disease and abnormal microvascular functional responses are common. This trial is designed to: (a) optimize methods for assessment of limb perfusion at rest and during stress using contrast-enhanced ultrasound (normal subjects) and a microbubble contrast agent that is able to provide non-linear signal without destruction at medium acoustic pressures, and (b) to test whether perfusion imaging provides incremental information on the severity of disease in patients with peripheral artery disease.


Eligibility criteria: Inclusion Criteria:

* For Healthy controls: no active major medical problems or vasoactive medications
* For PAD: Known diagnosis with PAD an ABI of 0.4-0.6

Exclusion Criteria:

* Rutherford class 6 or greater
* Allergy to ultrasound contrast agents
* Previous limb amputation
* Pregnancy
* Known congenital or acquired right to left shunt

Primary outcomes:
measure: Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT05701566: Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy
Official title: Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Satisfaction
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot randomized controled study
Primary purpose: OTHER

Brief summary: A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.

Detailed description: VR is an attention-distracting technology via visual and auditory signals by a computer-generated virtual engulfing environment. This technology has already been used in a variety of medical conditions and previous studies have demonstrated the benefit of using it as an additional tool for pain relief and as a substitute to sedation in invasive procedure. In this study we examined the use of VR as a substitute for sedation in colonoscopy. In this randomized control study, 60 patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure. The primary outcome was the overall satisfaction of patients who underwent unsedated colonoscopy with VR headset compared with patients who underwent standard sedation colonoscopy. Pain during the procedure, PDR, colonoscopy duration, post colonoscopy adverse events, post colonoscopy recovery and time-to-return to daily functions and turnaround time at the endoscopy unit were secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* adult patients (≥18) with any elective indication for colonoscopy.

Exclusion Criteria:

* known seizures' disorders, cognitive, visual or auditory impairment.
* patients who were unable or unwilling to sign an informed consent.
* Pregnant women.

Primary outcomes:
measure: Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.
timeFrame: 1 day
Secondary outcomes:
measure: Pain during the procedure
timeFrame: 1 day
measure: polyp detection rate (PDR)
timeFrame: during colonoscopy procedure
measure: Colonoscopy duration
timeFrame: during colonoscopy procedure
measure: Post colonoscopy adverse events
timeFrame: 1 day
measure: Time-to-return to daily activities (work, driving)
timeFrame: 1 day
measure: Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit)
timeFrame: 1 day
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: Gastroenterology department, Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Ido Veisman, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01854866: Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion
Official title: Phase II Study of Tumor Cell-derived Microparticles Used as Vectors of Chemotherapeutic Drugs to Treat Malignant Ascites and Pleural Effusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Pleural Effusion,
Malignant Ascites
Keywords: Pleural Effusion
ascites
Malignant
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Malignant ascites and pleural effusion are common symptoms in patients with advanced cancer. Currently, the management of malignant ascites and pleural effusion is a considerable clinical challenge. The investigator hypothesized that tumor cell-derived microparticles packaging chemotherapeutic drugs might be a useful means to treat malignant ascites and pleural effusion. Thirty malignant ascites or pleural effusion patients will be recruited for Phase II clinical trials.

Detailed description: Ascites or pleural effusion were first removed from patients. The patients were then locally injected with microparticles packaging chemotherapeutic drugs 4 times a week. The therapeutic effects and side effects were recorded.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of malignant ascites or malignant pleural effusion

Exclusion Criteria:

* Non-malignant ascites or pleural effusion

Primary outcomes:
measure: Volume of Ascites or Pleural Effusion
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Provincial Traditional Chinese Medical Hospital
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Bo Huang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang K, Zhang Y, Zhang H, Xu P, Liu J, Ma J, Lv M, Li D, Katirai F, Shen GX, Zhang G, Feng ZH, Ye D, Huang B. Delivery of chemotherapeutic drugs in tumour cell-derived microparticles. Nat Commun. 2012;3:1282. doi: 10.1038/ncomms2282.
Clinical trial NCT05437666: Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence
Official title: Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 40
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 investigate the effects of pelvic floor health education program on urinary incontinence symptoms, knowledge level and quality of life in women with stress urinary incontinence.

Detailed description: Stress urinary incontinence (SUI) is the involuntary urinary incontinence that develops in parallel with the increase in intra-abdominal pressure and is seen in the absence of detrusor contraction. Studies have shown that SUI, leading to a decrease in the quality of life and worsening of social and health conditions, is more common in women than men.

Knowledge of pelvic floor health or urinary incontinence is generally low. Low level of knowledge or wrong information limits patients' access to treatment. Pelvic floor muscle exercise and lifestyle recommendations are also the first treatment options for SUI.

The information and awareness related to the pelvic floor and SUI can be increase and unhealthy behavioral strategies can be modifiable through education programs. Therefore the education programs related to the pelvic floor health would have positive effects on urinary incontinence symptoms, knowledge level and quality of life. Studies about this issue are needed.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Women with stress urinary incontinence
* Those who volunteered to participate in the study
* Being literate

Exclusion Criteria:

* Having advanced pelvic organ prolapse
* Having a malignancy
* Having a urinary tract infection
* Those who have a problem that interferes with cooperation and understanding

Primary outcomes:
measure: Presence of urinary incontinence symptoms
timeFrame: change from baseline at 6 weeks
Secondary outcomes:
measure: Pelvic floor health knowledge level
timeFrame: change from baseline at 6 weeks
measure: Urinary incontinence konwledge level
timeFrame: change from baseline at 6 weeks
measure: Life quality
timeFrame: change from baseline at 6 weeks
measure: Compliance with the program
timeFrame: after program (6th week)
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References: