louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04245670: 5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:
Official title: 5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Prostate Cure Foundation
First posted: 2020-01-29
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.


Eligibility criteria: Inclusion Criteria

* Histologically confirmed prostate adenocarcinoma (centrally reviewed)
* High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml,
* High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA \> 20 ng/mL
* Willing to give informed consent to participate in this clinical trial
* Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires

Exclusion Criteria

* Prior pelvic radiotherapy
* Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
* Anticoagulation medication (if unsafe to discontinue for fiducial insertion)
* Diagnosis of bleeding diathesis
* Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20
* Evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
* Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
* Hip prosthesis

Primary outcomes:
measure: Acute Toxicity
timeFrame: Baseline to 3 months post completion of treatment
measure: Acute Toxicity
timeFrame: Baseline to 3 months post completion of treatment
Secondary outcomes:
measure: Quality of Life outcome
timeFrame: Baseline to end of 5 year follow up
measure: Biochemical disease-free survival
timeFrame: Baseline to end of 5 year follow up
measure: Quality of life outcome
timeFrame: Baseline to end of 5 year follow up
measure: Quality of life outcome
timeFrame: Baseline to end of 5 year follow up
measure: Economic analysis
timeFrame: Baseline to end of 5 year follow up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontairo
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Andrew Loblaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01405170: A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions
Official title: Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Therapeutic Equivalency
Keywords: bioequivalence study
methylprednisolone
suspension
tablets
fed
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fed conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \> 45 kg (99 lbs).

Exclusion Criteria:

* Any condition possible affecting drug absorption (eg, gastectomy).
* A positive urine drug screen.

Primary outcomes:
measure: AUCinf (area under the concentration time curve to infinity)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
measure: Cmax (maximum concentration)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Secondary outcomes:
measure: AUClast (area under the concentration time curve to last time point)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
measure: Tmax (time at maximum concentration)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
measure: Half-life
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02889770: Dead Space Monitoring With Volumetric Capnography in ARDS Patients
Official title: Dead Space Monitoring During PEEP Titration in Patients With Hypoxemia Secondary to Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Capnography
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 10
Sex: ALL
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: ARDS patients

Brief summary: This studies´ objective is to describe how different PEEP levels affect dead space measured by Bohr´s formula.

Detailed description: In ARDS patients PEEP has contradictory effects on ∆P (driving pressure of the airway) hat depends on the balance between lung recruitment and overdistension. Some authors showed that incremental levels of PEEP did not much affect dead space in ARDS patients. These studies used different methods for the assessment of dead space.

Such technique also overestimates the dead space. We believe that the right way to measure dead space is applying the original Bohr's equation using the mean PACO2 value. Therefore, the aim of this observational study was to describe the effect that PEEP has on Bohr's dead space and its sub-components in mechanically ventilated patients with ARDS.

This observational study was performed in the Intensive Care Unit of a University Hospital.

Protocol design The protocol started recording the data during baseline protective ventilation. After 15 minutes of data recording, we studied four levels of PEEP - 0, 6, 10 and 16 cmH2O - which were randomly assigned by a randomization table.

Respiratory, hemodynamic, arterial blood gas analysis and volumetric capnographic parameters were recorded. We analyzed the last 2 minutes of each protocol steps consisting in more than 30 breaths or data-points.

Eligibility criteria: Inclusion Criteria:

* age older than 18 years
* requirement of invasive mechanical ventilation for more than 4 hours and less than 12 hours
* severe hypoxemia (PAFI \< 200) secondary to ARDS or post-operatory atelectasis

Exclusion Criteria:

-requirement of invasive mechanical ventilation prior to enrollment in this study

Primary outcomes:
measure: Dead space variation
timeFrame: 60 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Emiliano Gogniat, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04725370: Characterization of Cleft Lip and Palate Conditions in Guatemala
Official title: Comparison of Cleft Lip and Palate Between a United States Tertiary Care Center and a Guatemalan Surgical Mission: A Cohort Study of 629 Pediatric Patients and a Survey of Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip
Cleft Palate
Cleft Lip and Palate
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 629
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with isolated cleft lip and/or palate scheduled for cleft-related surgery at either the Children's Hospital of Philadelphia or Smiles for Guatemala during the previously described time frames

Brief summary: The purpose of this study is to compare types of and risk factors for cleft lip and palate in a Guatemalan population to a United States population.

Detailed description: Demographic, surgical, and cleft type data from US patients were gathered via chart review of the electronic medical record. Data from Guatemalan patients was gathered orally from patient caregivers in their native language. Consent was also given orally in the caregivers native language. All data was de-identified prior to analysis.

Eligibility criteria: Inclusion Criteria:

* diagnosis of isolated cleft lip and/or palate
* scheduled for cleft-related surgery at either the Children's Hospital of Philadelphia or Smiles for Guatemala during the previously described time frames

Exclusion Criteria:

* diagnosis of a recognized medical syndrome
* medically complex defined as having major medical problems in three or more organ systems
* diagnosis of isolated midline cleft lip
* diagnosis of Tessier facial cleft
* greater than 18 years of age

Primary outcomes:
measure: Cleft phenotype
timeFrame: pre-surgery
Secondary outcomes:
measure: Cleft risk factors
timeFrame: during the surgery
measure: Surgical care
timeFrame: pre-surgery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Oksana A Jackson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Michelle Scott, DDS, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04926870: PACS System in the Training of Ophthalmologists
Official title: Application of CBL Teaching Based on PACS System in Training of Ophthalmologists
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Case Based Learning
Keywords: teaching effect
teaching method
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate teaching effect of CBL (case based learning) teaching method based on PACS (picture archiving and communication systems).

Detailed description: In this randomized controlled clinical trial, we aim to explore the teaching effect of CBL (case based learning) teaching method based on PACS (picture archiving and communication systems) for doctors to master the specialized knowledge of orbital tumor.

Eligibility criteria: Inclusion Criteria:

* Orbital diseases standardized training of doctors
* Willing to receive training

Exclusion Criteria:

* Refuse to attend the assessment

Primary outcomes:
measure: Examination score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Huijing Huijing
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02485470: Benefits of MPACT in Locally Advanced Head and Neck Cancer Patients Undergoing Chemoradiotherapy
Official title: Benefits of MPACT in Locally Advanced Head and Neck Cancer Patients Undergoing Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to test, in a randomized controlled trial among head and neck cancer patients, the short and longer term effects of the MPACT (Maintaining Physical Activity during Cancer Treatment) program (infused with motivational interviewing and self-determination theory-based strategies) initiated at the time of concurrent chemotherapy with radiation (CCRT), on key outcomes such as functional mobility and quality of life, and ultimately physical activity. The central hypotheses is that in head and neck cancer patients undergoing CCRT, the MPACT program, as compared to usual care controls, will result in less acute decline, faster recovery, and better maintenance of these key outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients greater than or equal to 40 years old with AJCC (American Joint Committee on Cancer) stage II-IV head and neck squamous cell carcinoma who are beginning first-line non-surgical treatment with concurrent chemoradiotherapy (CCRT) and who are capable of understanding and adhering to the protocol requirements
* Patients must be willing to comply with the study procedures and visits.

Exclusion Criteria:

* Active or symptomatic cardiopulmonary disease
* Substantial dementia
* Acute medical conditions, such as acute flare-up of joint condition or infection
* Participants must not be actively receiving physical therapy in a relevant area, at the time of enrollment, or participating in intensive (30 min per day) aerobic program three times per week.
* Patients are actively being treated for another cancer at the time of enrollment
* Active or unstable metabolic conditions such as brittle diabetes or severe anemia
* Alcohol intake less than 3 ounces per day
* Hemiplegia or lower limb amputation
* Significant orthopedic or musculoskeletal condition that does not allow weight bearing
* Unable to maintain safe stance and walk, either with or without an assistive device

Primary outcomes:
measure: Mean change in 6 minute walk distance (6MWD)
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Michelle Mierzwa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04776070: Establishing Malnutrition Diagnosis System by Using Artificial-intelligence Technology
Official title: Establishing Malnutrition Diagnosis System by Using Artificial-intelligence Technology to Improve the Application of Clinical Pathway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disease-related Malnutrition
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan Academy of Medical Sciences
name: Peking Union Medical College
First posted: 2021-03-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients in Peking Union Medical College

Brief summary: The prevalence of malnutrition is estimated at 30-50% of hospitalized patients in China. Disease-related malnutrition increases the risk of infection, mortality, length of hospitalization as well as the economic burden. National Nutrition Plan proposed to reduce malnutrition, but a clear, effective roadmap and protocol has not existed yet. Several factors impede to resolve the above challenges. They include :1) the low efficiency of current malnutrition diagnosis methods; 2) the lack of dynamic, standard method that can evaluate nutritional status in quantitative way. To this end, the investigators aim to establish an artificial-intelligence malnutrition diagnosis system to improve the application of malnutrition Clinical Pathway. Firstly, the investigators will establish a multidimensional malnutrition large data set, based on our previously built national hospital nutrition screening data set.

It will contain deep 3D facial images, semi-structured and structured electronic medical record. Then, the investigators will use ensemble learning algorithm to establish a fully automatic, artificial-intelligence malnutrition diagnosis model that includes both etiological and phenotypic diagnosis.


Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years old);
* Within 48 hours of admission;
* Inpatients at high risk of malnutrition, such as malignant tumors, chronic obstructive pulmonary disease, etc;
* Han nationality;
* Able to given informed consent.

Exclusion Criteria:

* Patients with artificial facial changes (such as plastic surgery , head and neck radiotherapy , head and neck trauma);
* Diseases with special facial changes (such as acromegaly);
* High dose glucocorticoid users;
* Patients with facial edema;
* Emergency admission with an expected length of stay of less than 3 days;
* Other conditions researchers thought could not be included

Primary outcomes:
measure: malnutrition diagnosis
timeFrame: Within 48 hours of admission
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongcheng district，Peking union medical college hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01429675: Safety and Pharmacokinetic Characteristics of DP-R206 in Healthy Adult Volunteers
Official title: Randomized, Open-label Crossover Study to Evaluate Comparative Pharmacokinetics of Ibandronate Between DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 Complex Tablet) and a 150mg Ibandronate Tablet in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is compare the pharmacokinetic characteristics of DP-R206 (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Bonviva (150mg Ibandronate, qd) after oral administration in healthy adult volunteers.

Detailed description: The number of patient is eighty-four. Patients were randomly assigned either a Bonviva tablet(150mg Ibandronate, qd) first, DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) Second or DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) first, Bonviva tablet(150mg Ibandronate, qd) second.

Eligibility criteria: Inclusion Criteria:

* 20 to 55 years of healthy volunteers

Exclusion Criteria:

* Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)

Primary outcomes:
measure: Composite of pharmacokinetics
timeFrame: predose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 32, 48, 72, 120 hours post-dose
Secondary outcomes:
measure: Composite of pharmacokinetics
timeFrame: predose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 32, 48, 72, 120 hours post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun seop Bae, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04248075: Effect of Sedatives on Perioperative Electroencephalogram in Elderly Patients Undergoing Spinal Anesthesia
Official title: Effect of Sedatives on Perioperative Electroencephalogram in Elderly Patients Undergoing Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Effect of Sedatives
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients scheduled to undergo total knee arthroplasty under spinal anesthesia

Brief summary: In the present study, we observe perioperative findings of electroencephalogram in sedated and non-sedated elderly patients undergoing total knee arthroplasty under spinal anesthesia.

Detailed description: In the present study, we observe perioperative findings of electroencephalogram in sedated and non-sedated elderly patients undergoing total knee arthroplasty under spinal anesthesia. Electroencephalogram is performed before, during, and 1 day after surgery.

After the induction of anesthesia, sedation is performed according to the patient's request. If a patient want to be sedated during surgery, one of the three sedatives (dexmedetomidine, propofol, and midazolam) is administered.

Eligibility criteria: Inclusion Criteria:

* Eldery patients scheduled for spinal anesthesia

Exclusion Criteria:

* MMSE ≤ 23
* Hemodynamic unstability
* Liver disease
* Renal disease

Primary outcomes:
measure: EEG frequency bands (alpha, beta, theta, delta, and gamma waves) during spinal anesthesia
timeFrame: 30 min after the induction of spinal anesthesia
Secondary outcomes:
measure: EEG frequency bands (alpha, beta, theta, delta, and gamma waves) 1 day after surgery
timeFrame: 1 day after surgery
measure: Incidence of delirium
timeFrame: For 7 days after surgery.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06407375: Assessment of Renal Function by Multiparametric MRI
Official title: Assessment of Renal Function by Multiparametric MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Renal Impairment
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Metabolic syndrome is a collection of conditions that affect at least three of the following five criteria: abdominal obesity, high blood pressure, high fasting glucose levels, high triglyceride levels, and low levels of high-density lipoprotein (HDL) cholesterol. Chronic kidney disease (CKD) is a common complication of metabolic syndrome, with an estimated prevalence of 13-40%. Early diagnosis of progressive conditions before the onset of reduced glomerular filtration rate (GFR) or albuminuria may be of clinical benefit but is not possible at present. Furthermore, the diagnosis and quantification of CKD in the context of metabolic syndrome is challenging due to the lack of reliable diagnostic biomarkers, and the current methods may not accurately reflect kidney function in patients with metabolic syndrome. Magnetic resonance imaging (MRI) has been sparsely explored as a potential tool to assess renal perfusion, oxygenation, and fibrosis. Multiparametric MRI (mpMRI) combines several different imaging techniques to provide a more comprehensive evaluation of tissue structure and function. These techniques hold promise for non-invasive assessment of kidney function, but their clinical utility is still largely experimental. Therefore, we aim to conduct an exploratory study to investigate the reliability, reproducibility as well as the validity of parameters for kidney function of multiparametric MRI as well as compare these parameters in between healthy patients and patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Diagnosed metabolic syndrome

Exclusion Criteria:

* MRI exclusion criteria

Primary outcomes:
measure: Glomerula Filtration Rate
timeFrame: 05/2025
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
state: ZH
Study officials:
References: