louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01645267: Calcaneal Neck Lengthening Osteotomy With Artificial Bone Graft
Official title: Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyappatite / β- Tricalcium Phosphate Bone Substitute
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flatfoot
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this foot deformity (plano valgus) surgery may be indicated. The deformity is corrected with an osteotomy at the heelbone. In most cases bone graft material has to be obtained from the iliac crest to support the osteotomy. In the planned study a group of children will be operated with an artificial bone graft material and thus avoiding the need harvesting of bone graft at the iliac crest.

Detailed description: Planovalgus or flatfoot deformity is observed in children with different neuromuscular disorders and is associated with pain and gait disorders due to non-reducible talonavicular joint subluxation. Surgical treatment is aimed at correcting foot malalignement and achieving sufficient plantar flexion in the ankle joint. With a calcaneal lengthening osteotomy procedure the planovalgus deformity can be corrected but it requires the use of graft material to be inserted as a bone wedge at the osteotomy site. In this way the talonavicular joint is indirectly reduced. Obtaining autograft material from the iliac crest in growing children carries a risk of growth arrest and iliac wing deformity which has led to widespread use of allograft bone when performing the operation.

New materials are being developed as substitutes for bone graft material with biphasic calcium phosphate ceramic (BCP) being the most commonly used. BCP is a mixture of porous hydroxyapatite (HA) and β-tricalcium phosphate (β -TCP). Calcium phosphate ceramics have excellent biocompatibility and are thought to be able to facilitate and guide new bone growth. This has been demonstrated in experimental studies. In retrospective clinical studies on patients having filled large bone defects with hydroxyapatite graft material radiological healing is seen at follow ups after average 7.9 years. It has also previously been demonstrated that BCP can be used as artificial bone graft in osteotomies with a good result and complete healing of the osteotomi.

Eligibility criteria: Inclusion Criteria:

* Flatfoot condition needing surgery

Exclusion Criteria:

* Traumatic conditions

Primary outcomes:
measure: Healing of osteotomy
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Martin Gottliebsen, PhD-student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04766567: Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy
Official title: Long Term Obstetric, Perinatal and Surgical Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Keywords: Cesarean section
Cesarean myomectomy
Lead sponsor: Bilge Hospital
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aims to investigate whether there is a difference in short- and long-term complications in patients undergoing cesarean myomectomy (endometrial or serosal myomectomy) during cesarean section.

Detailed description: Myomectomy is frequently performed during cesarean section. Infertility, myoma recurrence, adhesions , uterine rupture (complete/incomplete), impaired uterine healing (partial or complete dehiscence/poor/good), placental abnormalities, and perinatal complications in subsequent pregnancy are may be associated with cesarean myomectomy. In this study, patients who underwent cesarean myomectomy during cesarean section in our institute were analyzed in a retrospective manner. Patients were divided into three groups as those receiving serosal myomectomy, endometrial myomectomy and those who only underwent cesarean section. The groups were compared with respect to the presence of adhesion formation, time to achieve pregnancy (fertility), morphology of the myomectomy scar, presence of uterine rupture and placental abnormalities.

Eligibility criteria: Inclusion Criteria:

* Participants should have singleton pregnancy delivered by cesarean section
* Cesarean section technique should include: Transverse hysterotomy to enter the uterine cavity, single layer closure of the uterine wall, non-sutured visceral and parietal peritoneum
* Myomectomy during cesarean section should include: only patients, who have undergone a single myomectomy and have been applied a single layer suture technique with the preservation of the pseudocapsule-for all cesarean myomectomy cases

Exclusion Criteria:

* Patients having history of any malignancy
* Patients with coagulation disorders
* Patients with a history of previous intraabdominal surgery on reproductive organs
* Patients with a history of endometriosis

Primary outcomes:
measure: Complications of cesarean myomectomy
timeFrame: Post-cesarean 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Medicana Samsun Hospital
Study officials:
affiliation: Bilge Hospital
name: Oguz Guler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844467: A Retrospective Epidemiological Study on Pneumococcal Infection in Children in Ministry of Health Hospital at EHSA Region in the Eastern Province
Official title: Serotyping of Pneumococci
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumococcal Infection
Keywords: Risk factors
Case fatality
disease burden
Resistance
Benefits of pneumococcal vaccination
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children under 5 years with invasive pneumococccal dis.

Brief summary: The purpose of this study is to establish retrospectively the incidence rates of invasive pneumococcal disease in children aged less than 5 years. The investigators allocate the El Hasa region for the study because it has higher incidence of sickle cell anemia. The study will include data from 2003 to 2007(before introduction of the vaccine) and then for 2008 and 2009 (after introduction of the vaccine).

Detailed description: Data will be collected from patents files or records for 5 years before the introduction of the vaccine and for 2 years after the introduction of the vaccine. We assigned 4 doctors in each hospital to carry and supervise the work.

Eligibility criteria: Inclusion Criteria:

* Invasive pneumococcal disease
* Children under 5 years
* Children lived in Elhasa region

Exclusion Criteria:

* Children above 5 years
* No invasive pneumococcal disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01452867: Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
Official title: Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Arrest
Keywords: Airway
Bag-Valve -Mask- Ventilation
Laryngeal Mask - Ventilation
Laryngeal Tube - Ventilation
Lead sponsor: Krankenhaus Bruneck
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
First posted: 2011-10-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Gaining evidence which ventilation technique may be most efficient and safe is of utmost importance to potentially improve outcome during cardiopulmonary resuscitation.

Detailed description: During cardiopulmonary resuscitation (CPR) ventilation has to be efficient to provide oxygen to the body and safe to avoid potentially fatal regurgitation and aspiration pneumonia and excessive stomach inflation. Basically trained rescuers have severe problems to ventilate a patient during cardiopulmonary resuscitation. This study intends to compare three commonly employed ventilation techniques. First, the traditionally bag-valve mask ventilation is commonly taught during CPR course, despite recent evidence suggesting low efficiency rates. Second, the laryngeal mask and the laryngeal tube supraglottic airways have shown high efficiency and safety in previous studies in the hand of experienced clinicians. Until now it is unclear if basically trained rescuers are better in ventilation with bag valve mask ventilation or the supraglottic airway devices, the laryngeal mask and the laryngeal tube. The purpose of this study is to compare in anesthetised patients airway management and ventilation with bag-valve mask, laryngeal mask and laryngeal tube.

Eligibility criteria: Inclusion Criteria:

* ASA I-II

  -\> 18 years old
* elective surgery in general anesthesia

Exclusion Criteria:

* Patient not sober
* BMI \> 35kg/m2
* Pathologies of cerebral spine or peripheral neurological deficit
* Hiatus hernia, history of gastric reflux
* Stomach or Esophagus -Operation in the medical history
* Acute respiratory infection or obstructive lung disease
* Non elective surgery
* facial deformity

Primary outcomes:
measure: Airway Management time until first effective Ventilation
timeFrame: 90 sec
Secondary outcomes:
measure: Stomach inflation
timeFrame: 60 sec
Other outcomes:
Locations:
city: Bruneck
country: Italy
facility: Krankenhaus Bruneck
state: Bolzano
Study officials:
References:
Clinical trial NCT04537767: The Effect of Esmolol on Patients With Sepsis
Official title: The Effect of Esmolol on Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Keywords: sepsis
septic shock
esmolol
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 120
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 investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

Detailed description: Severe sepsis, septic shock, and their complications have become the major healthcare problem that affects millions of people each year, resulting in high mortality rates. Septic responses have an extremely complex chain of events including inflammatory and anti-inflammatory processes, humoral and cellular reactions, and cardiocirculatory abnormalities. Esmolol may have some potential in treating septic shock and sepsis. The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

Eligibility criteria: Inclusion Criteria:

* sepsis patients
* HR\>100bpm 6h after admission
* with CVC and ScvO2\>65%

Exclusion Criteria:

* age \<18 years,
* used β-blocker before,
* cardiac dysrhythmias,
* need for an inotropic agent,
* valvular heart disease,
* hemoglobin\>6g/L
* pregnancy.

Primary outcomes:
measure: REE
timeFrame: Day 7 after enrollment
Secondary outcomes:
measure: 28-day mortality rate
timeFrame: Day 28 after enrollment
measure: HR control rate
timeFrame: 24 hours after enrollment
measure: Vasoactive drug administration dose
timeFrame: Day 1/3/7 after enrollment
measure: Concentration of Lac
timeFrame: Day 1/3/7 after enrollment
measure: O2ER
timeFrame: Day 1/3/7 after enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06153667: Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
Official title: Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Fibroid
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women ≥ 18 years with symptomatic uterine fibroid(s).

Brief summary: This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult women ≥ 18 years old at the time of enrollment.
* Subject has symptomatic uterine fibroid(s), suitable to embolization.
* Subject provides written informed consent.

Exclusion Criteria:

* Subject is pregnant.
* Subject has suspected pelvic inflammatory disease or any other pelvic infection.
* Subject has any malignancy of the pelvic region, (e.g., endometrial neoplasia).

Primary outcomes:
measure: Primary Safety
timeFrame: 30 days
measure: Primary Effectiveness
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The Alfred Health
Study officials:
References:
Clinical trial NCT05209867: Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV
Official title: CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Inflammation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Consortium for Medical Marijuana Clinical Outcomes Research
First posted: 2022-01-27
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related to chronic inflammation, a condition characterizing PLWH.

The investigators propose to study the effects of CBD on inflammation in PLWH, and establish the molecular role of different immune cells in this process. The investigators plan to use single cell RNA-sequencing (scRNAseq) to isolate CBD-specific cellular phenotypes from five persons with HIV who will provide blood samples before and after taking CBD.


Eligibility criteria: Inclusion Criteria:

* Willingness to take CBD and to participate in follow up for two months
* Older than 21 and younger than 60
* Under antiretroviral therapy for 5+ years and suppressed viral load (CD4 count \<350cells/ml)

Exclusion Criteria:

* Conditions/medications that may impair the immune response, e.g., rheumatoid arthritis, cancer, diabetes, chronic infections, CAD (Cold agglutinin disease), cellulitis, autoimmune diseases such as lupus, sarcoidosis
* All medications that may affect inflammation such as aspirin, steroids, statins; CD4 count \<350cells/ml), pregnancy, and current marijuana or CBD use (urine drug screen)
* UF(University of Florida)/Shands staff and students will not be considered for enrollment

Primary outcomes:
measure: Number of Differentially Expressed Genes
timeFrame: Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Simone Marini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02967367: Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome
Official title: Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: During last years, numerous sleep trackers have been commercialized. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep.

For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA).

The purpose of the present study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.

Detailed description: During last years, numerous sleep trackers have been commercialized. They are working on accelerometer-based technology. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep..

For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA).

The purpose of our study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.

Eligibility criteria: Inclusion Criteria:

* high clinical suspicion of obstructive sleep apnea syndrome

Exclusion Criteria:

* other associated sleep disorder
* inability to sign informed consent

Primary outcomes:
measure: Time in Bed
timeFrame: one night (up to 600 minutes)
measure: Sleep Efficiency
timeFrame: one night (up to 600 minutes)
measure: Total Sleep Time
timeFrame: one night (up to 600 minutes)
Secondary outcomes:
measure: Deep Sleep
timeFrame: one night (up to 600 minutes)
measure: Light Sleep
timeFrame: one night (up to 600 minutes)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHu Saint Pierre
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Marie Bruyneel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02642367: Stylet Use for McGrath Videolaryngoscope
Official title: Comparison of With or Without Use of Stylet for Endotracheal Intubation With McGrath Videolaryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Orotracheal Intubation
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious complications. We compared the intubation time and success rate whether or not use of stylet for endotracheal intubation with McGrath videolaryngoscope.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I or II undergoing orotracheal intubation for elective surgery

Exclusion Criteria:

* cervical spine injury
* rapid sequence induction
* body mass index\> 35 kg/m2
* airway pathology

Primary outcomes:
measure: intubation time
timeFrame: 2 min after rocuronium injection
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeongki-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Yeop Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT00003467: Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
Official title: Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent adult brain tumor
adult brain stem glioma
adult mixed glioma
adult anaplastic astrocytoma
adult pilocytic astrocytoma
adult oligodendroglioma
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.

Detailed description: OBJECTIVES:

* Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma.
* Assess the toxicity of this therapy in these patients.

OUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma).

Patients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: This study will accrue a maximum of 68 patients within 18-24 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed recurrent primary low grade glioma including:

  * Fibrillary astrocytoma
  * Oligodendroglioma
  * Mixed glioma
* Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* Hematocrit greater than 29%
* Absolute neutrophil count greater than 1500/mm\^3
* Platelet count greater than 125,000/mm\^3

Hepatic:

* SGOT less than 1.5 times upper limit of normal (ULN)
* Bilirubin less than 1.5 times ULN

Renal:

* Creatinine less than 1.5 mg/dL
* BUN less than 25 mg/dL

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy unless disease progression

Endocrine therapy:

* Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study)
* No concurrent immunosuppressive agents

Radiotherapy:

* At least 4 weeks since prior radiotherapy unless disease progression

Surgery:

* Not specified

Other:

* No other concurrent medication that may interfere with study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Henry S. Friedman, MD
role: STUDY_CHAIR
References: