louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02177526: Imaging of High Grade Prostate Cancer
Official title: Detection of Malignant Calcifications in High Grade Prostate Cancer With Comedo-type Necrosis Using Thin Section Computed Tomography and Susceptibility Weighted Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostatic Carcinoma
Keywords: CT
MRI
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Management of prostatic carcinoma varies according to stage of disease. Trans-rectal ultrasound guided biopsy is known to underestimate the degree of tumor due to undersampling and random non-targeted technique. Methods to improve pre-operative tumor localization and grading, including multi-parametric (MP) magnetic resonance imaging (MRI) is an active area of research but requires further validation.

High grade tumors can undergo comedo-type necrosis with malignant calcifications which only occurs in Gleason pattern 5 tumors and which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI.

Detection of malignant calcification within tumor foci will improve the accuracy of localization and grading in prostatic carcinoma.

Detailed description: High grade (Gleason pattern 5) tumors can undergo comedo-type necrosis producing malignant calcifications which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI. Detection of malignant calcifications in areas of Gleason pattern 5 tumor will improve the accuracy of pre-operative localization and grading in prostatic carcinoma.

Eligibility criteria: Inclusion Criteria:

* Patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies
* Patients with biopsy proven Gleason pattern 5 tumor and without comedo-type necrosis associated calcification

Exclusion Criteria:

* Patients who do not have malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies

Primary outcomes:
measure: The number of prostate patients with comedo-type necrosis.
timeFrame: up to 4 weeks
Secondary outcomes:
measure: The number of other features measured on MRI.
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital (Civic Campus)
state: Ontario
Study officials:
affiliation: OHRI
name: Nick Schieda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592826: HMP (Home Macular Perimeter) -Usability Trial
Official title: Phase III Study of the Usability of the HMP Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: PHP
HMP
HPHP
AMD
CNV
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-14
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited in community centers and clinics and will include up to 25 people aged \>50 years (Age-related Macular Degeneration age group). The group will be heterogeneous in terms of education, age, ethnic background, and gender. The subjects will be enrolled in one site in the USA In order to get 20 completed subjects, and based of assumption of 25% attrition- 25 subjects will be recruited to the study

Brief summary: The study is divided in two stages. The purpose of the first stage is to evaluate the percentage of subjects that can unpack the device, install it, learn the task and calibrate it according to their personal capabilities. The purpose of the second stage is to assess the ability of the subjects to perform reliable tests .

Detailed description: Stage I:

* Receive a packed HMP device.
* Unpack the device and install it, using a set-up guide
* Use an interactive tutorial to learn the task
* Calibrate the sensitivity of the test

This stage will be completed within 1 to 5 visits, depending on personal progress rate.

Subjects who have successfully completed stage I will be recruited to stage II.

Those subjects will:

• Perform 3 tests , each test in a different day

Eligibility criteria: Inclusion Criteria:

* Age \>50 years
* Familiar with computer usage
* Capable and willing to sign a consent form and participate in the study
* Ability to speak, read and understand instructions in English

Exclusion Criteria:

* Subject already participating in another study.

Primary outcomes:
measure: Proportion of subjects who successfully set up the device
timeFrame: 1 month
measure: Proportion of subjects who successfully pass the training program (successful calibration module)
timeFrame: 1 month
Secondary outcomes:
measure: Proportion of subjects with reliable tests results
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Kidney Health Center of Maryland
name: Adam Mr Weinstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04399226: Dexmedetomidine-Propofol and Ketamine-Propofol During Upper Gastrointestinal System Sedation
Official title: Efficacy and Safety of Deksmedetomidine-propofol or Ketamine-propofol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia; Reaction
Keywords: Dexmedetomidine, Ketamine, Propofol, Sedation
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II groups were included. Patients that had severe organ disease, allergies to study drugs, refused to participate in the study were excluded. Cases were randomized into the dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30).

Brief summary: Sedation with dexmedetomidine-propofol or ketamine-propofol was planned in patients with upper gastrointestinal endoscopy.

Detailed description: Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II groups were included. Patients that had severe organ disease, allergies to study drugs, refused to participate in the study were excluded. Cases were randomized into the dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30). Cardiac monitoring, peripheral oxygen saturation, bispectral index (BIS) monitoring were performed. Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine). Patients were followed up with a Ramsay Sedation Scale (RSS) of≥4. Mean, standard deviation, mean, lowest-highest frequency and ratio values were used in descriptive statistics of the data, SPSS 22.0 program was used for the analyses.

Eligibility criteria: Inclusion Criteria:

* ASA I-II group
* 60 patients
* between the ages of 18 and 60
* planned to have upper gastrointestinal system (UGIS) endoscopy with sedation,

Exclusion Criteria:

* severe heart, lung, liver disease
* kidney failure,
* bleeding diathesis
* fever,
* infection,
* electrolyte disorder such as hypokalemia, hypocalcaemia, acid-base disorder, hypothermia, allergy to drugs to be used, and study those who refused to be included were excluded

Primary outcomes:
measure: Demographic data
timeFrame: 2 minutes
Secondary outcomes:
measure: adverse events
timeFrame: 2 minutes
Other outcomes:
measure: sedation depth
timeFrame: 2 minutes
Locations:
city: VAN
country: Turkey
facility: Van Yuzuncu Yil University
state: Tuşba
Study officials:
affiliation: Yuzuncu Yıl University
name: Arzu Esen TEKELİ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05162326: BC-101 in Treatment of Nasolabial Fold Wrinkles
Official title: A Phase 1/2 Study of the Safety and Efficacy of BC-101 in Treatment of Nasolabial Fold Wrinkles Via Subcutaneous/Intradermal Injection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Nasolabial Fold Wrinkles
Lead sponsor: Bright Cell, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is an open-label, single-arm, dose-escalating study to evaluate the safety and tolerability of BC-101 administered via subcutaneous/intradermal injection in the treatment of moderate to severe nasolabial folds.


Eligibility criteria: Inclusion Criteria:

1. Subjects who are in general good health condition.
2. Subjects who have moderate to extremely deep bilateral nasolabial fold wrinkles, as documented by a score of 3 or greater on the six-point Evaluator Wrinkle Severity Assessment scale (0-5).
3. Subjects who are dissatisfied with both nasolabial fold wrinkles based on a score of -1 or -2 on the Subject Wrinkle Assessment Scale (-2 to +2).
4. Subjects who voluntarily adhere to the research procedures and ensure good compliance during the research period.
5. Subjects who fully understand the research nature of this study and sign the informed consent.

Exclusion Criteria:

1. Subjects who have an active cutaneous infection on the face.
2. Subjects with existing malignant neoplasm.
3. Subjects with persistent pre-cancerous lesions (e.g., actinic keratosis).
4. Subjects who have active dermal diseases, inflammation, or any related disease.
5. Subjects who have cosmetic or surgical treatment on nasolabial fold area in 3 months before the study (including laser, chemical peels, fillers, botulinum toxin).
6. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.
7. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.

Primary outcomes:
measure: Incidence of any treatment-emergent adverse events
timeFrame: 12 weeks after injection
Secondary outcomes:
measure: Changes in wrinkle severity assessment from baseline
timeFrame: 6 weeks, 12 weeks and 26 weeks after injection
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00698126: Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes
Official title: A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Aspart (NovoRapid® ) or Soluble Human Insulin for the Treatment of Diabetes Mellitus the UPGRADE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 4099
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any subject with type 2 diabetes who is already in treatment with insulin aspart or soluble human insulin will be included in the study

Brief summary: This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes
* Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years

Exclusion Criteria:

* Patients with an end-stage renal failure
* Patients with a serious liver disease
* Patients with concomitant malignant disease

Primary outcomes:
measure: Number of major hypoglycaemic events reported as serious adverse drug reactions
timeFrame: after 26 weeks
Secondary outcomes:
measure: Number of serious and non serious drug reactions
timeFrame: during 26 weeks
measure: Number of serious adverse event
timeFrame: during 26 weeks
measure: Number of all major (daytime and nocturnal) hypoglycaemic events
timeFrame: during 26 weeks
measure: Number of major hypoglycaemic events related to omission of a meal after injection
timeFrame: during 26 weeks
measure: Number of major hypoglycaemic events related to physical exercise of at least 30 min duration
timeFrame: during 26 weeks
measure: Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit
timeFrame: after 26 weeks
measure: Weight and waist circumference change
timeFrame: during 26 weeks
measure: Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level
timeFrame: after 26 weeks
measure: Quality of Life (QoL)
timeFrame: after 26 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00881426: To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb (Cefzil) 500 mg Cefprozil Tablets In Healthy Adults Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antibiotic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Cefzil 500 mg Cefprozil tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 16 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02775526: TOT, TVT And Burch Colpo-Suspension for Treatment of Female Mixed Urinary Incontinence
Official title: Trans-Obturator Tape, Tension-Free Vaginal Tape and Burch Colposuspension for Treatment of Female Mixed Urinary Incontinence: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment
Keywords: Mixed urinary incontinence
Transobturator tape (TOT)
Tension-Free Vaginal Tape (TVT)
Burch colposuspension
Urinary incontinence
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 220
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective interventional randomized controlled trial will recruit women with MUI scheduled for surgical treatment where patients will be randomized to either Burch colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2 years. The primary outcome measures will be the objective and subjective cure rates.


Eligibility criteria: Inclusion Criteria:

* Women with mixed urinary incontinence.

Exclusion Criteria:

* Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study.
* Women who improved on medical treatment with persistence of stress element only were also excluded.

Primary outcomes:
measure: objective cure rate
timeFrame: 2 years
measure: subjective cure rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References:
Clinical trial NCT03368326: Use of Critical-Care Pain Observation Tool and Bispectral Index for Detection of Pain in Brain Injured Patients
Official title: Use of Critical-Care Pain Observation Tool and Bispectral Index for Detection of Pain in Brain Injured Patients：A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care
Brain Injuries
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with brain injury and artificial airway

Brief summary: Brain injured patients are at high risk of pain due to the illness itself and a variety of nociceptive procedures in intensive care unit. Since the disorder of consciousness, speech, and movement, it is usually difficult for them to self-report the presence of pain reliably. The Critical-Care Pain observation Tool (CPOT) has been recommended for clinical use in the critically ill patients when self-report pain is unavailable. Besides, it seems that the bispectral index (BIS), a quantified electroencephalogram instrument, can be used for pain assessment along with the CPOT tool in some nonverbal critical ill patients (e.g., intubated and deep sedation). However, the validity and reliability of CPOT and BIS for pain assessment in brain injured patients are still uncertain so far. So the aim of this research is to investigate the value of CPOT and BIS for pain evaluation in this specific patient group.


Eligibility criteria: Inclusion Criteria:

* patients with brain injury and artificial airway

Exclusion Criteria:

* age under 18 years,
* quadriplegia,
* administration of paralytic medications within 24 hours,
* if the patient failed the quality test of BIS signal,
* impending death,
* be included in any other research.

Primary outcomes:
measure: Changes of the Critical-Care Pain Observation Tool (CPOT) scores
timeFrame: 1.Before nociceptive/non-nociceptive procedure; 2.Within the first 5 minutes after nociceptive/non-nociceptive procedure.
measure: Changes of the bispectral Index (BIS) value
timeFrame: 1.Before nociceptive/non-nociceptive procedure; 2.Within the first 5 minutes after nociceptive/non-nociceptive procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Intensive care unit, Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Intensive care unit, Beijing Tiantan Hospital, Capital Medical University
name: Jian-Xin Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01578226: Procalcitonin in Cirrhotic Patients at High Risk for Sepsis
Official title: Role of Procalcitonin (PCT) for the Diagnosis of Sepsis in Ascitic Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Ascites
Sepsis
Keywords: Cirrhosis
Ascites
Decompensation
Bacterial infection
Sepsis
Procalcitonin
PCT
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All ascitic cirrhotic patients admitted to our third level Liver Unit.

Brief summary: Infections are frequent life-threatening events in patients with cirrhosis, occurring at least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no clear-cut clinical and biochemical features are helpful in diagnosing and prognostically stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker presenting high sensibility and specificity in diagnosing bacterial infections in different clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.


Eligibility criteria: Inclusion Criteria:

* liver cirrhosis regardless of aetiology
* clinically relevant ascitic decompensation at time of hospital admission

Exclusion Criteria:

* high haematic ascites
* ongoing antimicrobial therapy or stopped less than 7 days before admission
* last hospital discharge within 7 days
* surgery or trauma within 30 days from enrolment
* hepatocellular carcinoma out of Milan criteria
* extra hepatic malignancies
* immunodeficiency syndrome
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Gastroenterology Unit - University Hospital of Modena
Study officials:
affiliation: University of Modena and Reggio Emilia
name: Filippo Schepis, MD
role: PRINCIPAL_INVESTIGATOR
References: