louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04108507: Prevention of Residual Low Back Pain After Percutaneous Kyphosis(PKP) Using Posterior Branch Block of Spinal Nerve
Official title: Prevention of Residual Low Back Pain After Percutaneous Kyphosis(PKP) Using Posterior Branch Block of Spinal Nerve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporotic Fracture
Keywords: Percutaneous kyphoplasty（PKP）
nerve block
posterior branch of spinal nerve
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 198
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to block the posterior branch of lumbar spinal nerve during PKP operation and compare it with the patients without spinal nerve block, so as to verify the effect of posterior branch block of spinal nerve in relieving short-term and long-term residual low back pain after operation.

Detailed description: Patients older than 60 years old who underwent Percutaneous kyphosis(PKP) surgery for osteoporotic fractures were randomly divided into two groups. The lumbar spinal nerve branch was blocked with betamethasone and ropivacaine in the experimental group during PKP operation, while the lumbar spinal nerve branch block was not performed in the control group during PKP operation. The low back pain was evaluated at 1 week, 2 weeks, 1 month, 3 months and 6 months after operation using Visual analogue pain score(VAS)scale.So as to compare the effect of lumbar spinal nerve block on residual pain after PKP.

Eligibility criteria: Inclusion Criteria:

* osteoporotic fracture
* acute vertebral compression fracture (within 2 weeks)
* fracture level lower thanT6

Exclusion Criteria:

* other types of fractures
* patients younger than 60 years of age,
* with other disease (metabolic bone disease, metastasis, uncor- rectable coagulopathy, spinal infection, severe cardiopulmonary comorbidity, cognitive disorders etc)

Primary outcomes:
measure: Residual low back pain after operation
timeFrame: 6 months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The 2nd Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
citation: Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, Venmans A, van Rooij WJ, Schoemaker MC, Juttmann JR, Lo TH, Verhaar HJ, van der Graaf Y, van Everdingen KJ, Muller AF, Elgersma OE, Halkema DR, Fransen H, Janssens X, Buskens E, Mali WP. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010 Sep 25;376(9746):1085-92. doi: 10.1016/S0140-6736(10)60954-3. Epub 2010 Aug 9.
Clinical trial NCT01504607: Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation
Official title: Corneal Endothelial Morphologic Assessment in Pediatric Cataract Surgery With IOL Implantation: Comparison of Preoperative and Early Postoperative Specular Microscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Cataract Surgery
IOL Implantation
Change in Corneal Endothelial Cell Morphology
Keywords: corneal endothelium
congenital cataract surgery
IOL implantation
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 106
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children older than 4 years undergoing cataract surgery with IOL implantation were included.

Brief summary: Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs following cataract surgery. However, no data is available regarding endothelial changes after cataract surgery with IOL implantation in pediatric eyes.

The aim of this study is to prospectively observe changes in endothelial cell density, coefficient of variation and hexagonality following cataract surgery with IOL implantation in pediatric eyes.


Eligibility criteria: Inclusion Criteria:

* Eyes undergoing pediatric cataract surgery with IOL implantation at Iladevi Cataract \& IOL Research Center, Ahmedabad, India.
* Children older than 4 years undergoing cataract surgery with IOL implantation were included.

Exclusion Criteria:

* Exclusion criteria were as follows: eyes with traumatic or subluxated cataract and inability to get preoperative specular. Intraoperatively, sulcus fixated IOLs, and eyes with no IOL implantation were excluded.

Primary outcomes:
measure: Corneal endothelial morphology
timeFrame: preoperatively to 3 months postoperatively
Secondary outcomes:
measure: Change in central corneal thickness
timeFrame: preoperatively to 3 months postoperatively
Other outcomes:
Locations:
Study officials:
References:
citation: Vasavada AR, Praveen MR, Vasavada VA, Shah SK, Vasavada V, Trivedi RH. Corneal endothelial morphologic assessment in pediatric cataract surgery with intraocular lens implantation: a comparison of preoperative and early postoperative specular microscopy. Am J Ophthalmol. 2012 Aug;154(2):259-265.e1. doi: 10.1016/j.ajo.2012.02.018. Epub 2012 Apr 27.
Clinical trial NCT04395807: Helmet CPAP Versus HFNC in COVID-19
Official title: Helmet Continuous Positive Airway Pressure Versus High-Flow Nasal Cannula in COVID-19: A Pragmatic Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID
Acute Hypoxemic Respiratory Failure
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Region Skane
First posted: 2020-05-20
Enrollment: 2
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: We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure.

Detailed description: A detailed description can be found in the study protocol published in Trials in Dec 2020:

Tverring, J., Åkesson, A. \& Nielsen, N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials 21, 994 (2020). https://doi.org/10.1186/s13063-020-04863-5

Eligibility criteria: Inclusion Criteria (all of the following):

1. Age ≥ 18 years
2. Sars-Cov-2 found in the upper or lower respiratory tract by PCR during the current disease episode
3. Peripheral oxygen saturation (SpO2) \< 92 % despite conventional low-flow oxygen therapy of at least 6 L /min for at least 15 min
4. A decision to initiate HFNC or Helmet CPAP by the attending ward physician
5. The patient has given written informed consent to participate.

Exclusion Criteria (any of the following):

1. Need for direct admission to the intensive care unit for mechanical ventilation
2. Unconsciousness or drowsiness
3. Pneumothorax
4. Carbon dioxide pressure (pCO2) \> 6 kPa in venous blood gas (VBG)
5. Underlying chronic obstructive pulmonary disease stage III-IV
6. A decision not to participate
7. Inability to comprehend the study content and give informed consent

Primary outcomes:
measure: Ventilator-Free Days (VFD)
timeFrame: 28 days
Secondary outcomes:
measure: SpO2/FiO2-ratio
timeFrame: 1 hour after randomisation
measure: Patient comfort
timeFrame: 24 hours after randomisation
measure: Frequency of endotracheal intubation
timeFrame: 28 days
measure: Frequency of carbon dioxide rebreathing
timeFrame: 28 days
measure: Days alive within
timeFrame: 28 days and 180 days
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg's Hospital
state: Region Skane
Study officials:
affiliation: Lund University
name: Jonas Tverring, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tverring J, Akesson A, Nielsen N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials. 2020 Dec 3;21(1):994. doi: 10.1186/s13063-020-04863-5.
Clinical trial NCT02393807: The Bioavailability of a Spray Dried Dispersion Solid Dose Formulation of PF-06260414 Relative to a Suspension Formulation
Official title: A Phase 1 Single-dose Open Label 3-way Crossover Study To Evaluate The Bioavailability Of A Spray Dried Dispersion Solid Dose Formulation Of Pf-06260414 Relative To A Suspension Formulation Under Fasted Conditions And The Effect Of Food On The Bioavailability Of The Pf-06260414 Spray Dried Dispersion Solid Formulation In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: Chronic Obstructive Pulmonary Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The current study will investigate the relative bioavailability of a spray dried dispersion solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF 06260414 relative to a single oral dose of 30 mg of PF 06260414 administered as a nanosuspension under fasted or fed conditions in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Any condition possibly affecting drug absorption (eg, gastrectomy)

Primary outcomes:
measure: Single dose pharmacokinetics under fasted condition: Cmax of PF- 06260414 formulations
timeFrame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
measure: Single dose pharmacokinetics under fasted condition: AUClast of PF- 06260414 formulations
timeFrame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
measure: Single dose pharmacokinetics under fed condition: Cmax of PF- 06260414 formulations
timeFrame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
measure: Single dose pharmacokinetics under fed condition: AUClast of PF- 06260414 formulations
timeFrame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Secondary outcomes:
measure: AUCinf of PF-06260414
timeFrame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
measure: t½ of PF-06260414
timeFrame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
measure: Tmax of PF-06260414
timeFrame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05350007: Evaluation of Rumination, Frailty and Tanatophobia in Cancer Patients Over 65 Years of Age
Official title: Evaluation of Rumination, Frailty and Tanatophobia in Cancer Patients Over 65 Years of Age
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Death
Rumination
Frailty
Keywords: cancer
tanatophobia
rumination
fraility
elderly
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients aged 65 and over receiving chemotherapy

Brief summary: The aim of this study is to evaluate tanatophobia and rumination in individuals over 65 years of age receiving cancer chemotherapy and to determine the related factors.

Detailed description: No studies were found in the literature evaluating the relationship between frailty and lack of social support with tanatophobia and rumination. The aim of this study is to evaluate tanatophobia and rumination in individuals over 65 years of age receiving cancer chemotherapy and to determine the related factors.

Eligibility criteria: Inclusion Criteria:

* 65 years or older
* Conscious and no communication problems
* Being literate
* Willing to participate in our study voluntarily
* Cancer patient receiving active chemotherapy treatment

Exclusion Criteria:

* Not being willing to participate in the research
* Serious life-threatening condition (critical illness, intensive care unit stay, acute complication)
* Dementia, Alzheimer's, cognitive dysfunction
* Major psychiatric illness

Primary outcomes:
measure: Rumination
timeFrame: 1 week
measure: Tanatophobia
timeFrame: 1 week
Secondary outcomes:
measure: fraility
timeFrame: 1 month
measure: lack of social support
timeFrame: 1 month
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: Sultan Abdülhamid Training and Research Hospital
state: İstanbul
Study officials:
affiliation: Sultan Abdülhamid Training And Research Hospital
name: Elif Yıldırım Ayaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06724107: Photofunctionalization With UVC
Official title: Effect of Photofunctionalization With on Titanium Dental Implants. A Pilot Sutdy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implant Site Reaction
Keywords: ISQ (implant stability quotient)
inmediate loading
UVC
dental implants
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Summary:

Objective: The general objective is to compare the placement of standard implants with a surface photofunctionalization technique based on ultraviolet C radiation (UVC), having as working hypothesis that this photofunctionalization will accelerate the bone apposition on the implant surface and increase the amount of bone that binds to the implant, making it possible to load these photofunctionalized implants in less time.

Design: Pilot, clinical, randomized, prospective, controlled, single-center, prospective study.

Scope of the study: Master's Degree in Oral Surgery and Implantology. Faculty of Dentistry. Complutense University of Madrid.

Subjects of the study: patients attending the Master's Degree in Oral Surgery and Implantology for rehabilitation with dental implants, regardless of the sector in which they have missing teeth.

Key words: ISQ (implant stability quotient), inmediate loading, UVC, dental implants.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age.
* Patients requiring dental implant surgery with or without bone or soft tissue regeneration surgery.
* Acceptance of the informed consent document.

Exclusion Criteria:

* Subjects with systemic diseases leading to untreated or uncontrolled haemostasis or coagulation disturbances.
* Subjects with active infectious diseases (tuberculosis, HIV, syphilis, hepatitis, etc).
* Patients under pharmacological treatment with monoclonal antibodies, bisphosphonates, chemotherapy or prolonged treatment with corticoids.
* Patients with alcoholism or drug addiction.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Bone regeneration
timeFrame: 3 months
Secondary outcomes:
measure: ISQ and marginal bone loss
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Jesus Torres
Study officials:
affiliation: UCM
name: isabel leco, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02621307: Effect of Salba & Flax on Postprandial Glycemia and Subjective Satiety
Official title: The Effect of Salba (Salvia Hispanica L) Versus Flax on Postprandial Blood Glucose Response and Subjective Appetite in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperglycemia, Postprandial
Keywords: postprandial glycemia
subjective appetite
Salba
Flax
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether drinks containing Salvia hispanica L (Salba) or Flax lower postprandial blood glucose levels and improve appetite in healthy individuals.

Detailed description: Dietary fibre has been implicated in improving many risk factors associated with Type 2 Diabetes and Cardiovascular Disease (CVD). However, on average, Norther Americans consume less than half of the recommended amount set by health agencies. It has been proposed that the health benefits of dietary fibre may be attritbuted to rheological characteristics such as viscosity. Salvia hispanica L (Salba) and Flax are nutritionally similar. The primary objective of this research trial is to study the effects of Salba and Flax on postprandial glycemia and appetite in healthy individuals.

Eligibility criteria: Inclusion Criteria:

* BMI less than 35 kg/m\^2

Exclusion Criteria:

* known history of liver or kidney disease, diabetes, hypertension, stroke, or myocardial infarctions, thyroid disease, gastrointestinal disease, or AIDS
* subjects using medications or Natural Health Products

Primary outcomes:
measure: Change in Postprandial Blood Glucose
timeFrame: 2 Hours
Secondary outcomes:
measure: Change in Subjective Satiety
timeFrame: 2 Hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT00385307: Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
Official title: An Eight-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Paroxetine (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of Two Fixed Doses of SR58611A (175 mg q12/ 350 mg q12) in Outpatients With MDD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Clinical Trials
Major Depressive Disorder
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-09
Enrollment: 680
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: To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
* Patient meets criteria for a recurrent Major Depressive Episode (MDE)
* Patient meets severity assessments of depression specified by the study

Exclusion Criteria:

* Patient is at immediate risk for suicidal behavior
* Patient is with a unstable medical condition
* Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
* Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
* Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
* Patient has been treated with paroxetine (Paxil) within the previous 6 months
* Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study

Primary outcomes:
measure: Change from baseline in total score of a depression rating scale at 8 weeks
Secondary outcomes:
measure: Safety assessments
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00741507: Unhealthy Alcohol Drinking and Anesthetic Requirement in Women
Official title: Unhealthy Alcohol Drinking and Anesthetic Requirement in General Anesthesia in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: Anesthetics
Sedatives
Analgesics
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2008-08-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Unhealthy alcohol drinking is negatively influencing health of people and costing a large number of annual finance via "secondhand" effects. Additionally, unhealthy alcohol use covers a spectrum that is associated with varying degrees of risk to health. The investigators hypothesized that unhealthy alcohol drinking resulted in significant increase in anesthetic requirement during general anesthesia. This investigation would clarify the association between unhealthy alcohol use and the intraoperative consumption of anesthetics, and provide clinical evidence for preoperative assessment with respect to the alcohol drinking habit.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* Chinese
* 19-45yr
* Undergoing general anesthesia

Exclusion Criteria:

* A history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
* Participants younger than 18yr，older than 45yr or pregnancy was eliminated.
* Those who were not willing to or could not finish the whole study at any time.

Primary outcomes:
measure: Anesthetic requirements
timeFrame: 10 min after completion of operation
Secondary outcomes:
measure: Economic assessment
timeFrame: 1 day after operation
measure: Odds Ratio of alcohol use and the consumption of anesthetics
timeFrame: 1 day after completion of study
measure: Side effects
timeFrame: 30 min after completion of the study
measure: Bispectral Index (BIS) value
timeFrame: 0, 5, 10, 20, 30, 45, 60, 90 min after anesthesia
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_CHAIR
References: