louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02402699: Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
Official title: Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Melanoma
Hepatitis B
Hepatitis C
Keywords: HBV
HBC
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult unresectable, recurrent, or Metastatic Melanoma patients with HBV or HCV treated with at least 1 dose of Ipilimumab therapy in Taiwan

Brief summary: This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) Melanoma.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Age of 18 years or older on date of first dose of Ipilimumab
* Patients who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or Metastatic Melanoma in Taiwan
* Patients with advanced Melanoma and HBV or HCV who are initiating Ipilimumab under the discretion of their physician

Exclusion Criteria:

* Patients who received Ipilimumab as part of a clinical trial
* Patients who are receiving Ipilimumab for any indication other than local approval (ie, unresectable or Metastatic Melanoma)
* Patients who are not infected with HBV or HCV

Primary outcomes:
measure: Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load
timeFrame: During 6months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei 105
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01990599: Airway Management for Trigeminal Thermal Coagulation
Official title: Airway Management in Patients Undergoing Thermal Ganglion Gasseri Coagulation, a New Method - Preliminary Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: nasopharyngeal tube
airway management
thermal coagulation of the Gasserian ganglion
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Airway management of patients undergoing thermal coagulation of the Gasserian ganglion is very delicate. This is because of the specific operation site and moreover patients should recover quickly from anesthesia to follow verbal intraoperative commands of the surgeon. Endotracheal intubation or laryngeal mask of course hinders the patient from speaking. An obvious alternative airway management, as performed in this preliminary study, is a nasopharyngeal placed tube.

The purpose of the present study is to objectify the gas exchange in patients during this new ventilation technique.


Eligibility criteria: Inclusion Criteria:

- Patients undergoing thermal coagulation of the Gasserian ganglion

Exclusion Criteria:

* Body weight over 100 kg
* Recurrent nasal bleeding
* Patients suffering from reflux disease
* Additional risk of aspiration (e.g. hernia diaphragmalis)

Primary outcomes:
measure: Blood gas exchange
timeFrame: Before and during the neurosurgical intervention
Secondary outcomes:
measure: SpO2 oxygen saturation (pulse oximeter)
timeFrame: Before and during the neurosurgical intervention
measure: Hemodynamic parameters
timeFrame: Before and during the neurosurgical intervention
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT04216199: Role of Point of Care Ultrasound in Endotracheal Tube Placement
Official title: Role of Point of Care Ultrasound in Confirmation of Endotracheal Tube Placement in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Role of point of care ultrasound in endotracheal tube placement in children

Detailed description: Role of point of care ultrasound in confirmation of endotracheal tube placement in children

Eligibility criteria: Inclusion Criteria:

* Children below 18 years needing endotracheal intubation.

Exclusion Criteria:

* Age more than 18 years.
* Patients with significant neck or lung pathology.
* Patients with elective intubation

Primary outcomes:
measure: Number of patients with correct placement of endotracheal tube
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Emergency medicine department - Alazhar University
name: Fekry khater, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Anasthesia and Pain department - Alazhar University
name: Mohamed S Sharaf, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiodiagnosis Department - Tanta University
name: Mohamed H Elshafey, Prof
role: STUDY_DIRECTOR
affiliation: Emergency medicine department - Tanta University
name: Mohamed G Elbahnasawy, Lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT06163599: Reducing Mental Health Disparities Among Latinxs With a Telenovela Intervention
Official title: Reducing Mental Health Disparities Among Latinxs With a Telenovela Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Keywords: anxiety disorder
transdiagnostic Treatment
United Protocol
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary aim of our study is to determine the effectiveness of an transdiagnostic telenovela video intervention in reducing anxiety and depressive symptoms using a pre/post-test design with Spanish-speaking Latinxs.

Detailed description: Telenovela video interventions are a low-resource, low-cost methodology developed to diminish the treatment-provider gap (Heilemann et al., 2017). Research shows that telenovela interventions represent an acceptable (Heilemann et al., 2018) and potent (Heilemann et al., 2017) intervention option for disseminating information to the Latinx population. Prior research utilizing transmedia telenovela interventions that include a telenovela component have demonstrated some effectiveness at reducing symptoms of anxiety and depression among Latinxs (Heilemann et al., 2017; Kajiyama et al., 2018) as have fotonovelas (Sanchez et al., 2019). To date researchers have not investigated how the telenovela approach combined with a transdiagnostic treatment paradigm might help reduce behavioral health disparities among Spanish-speaking Latinxs given that such an intervention would be easily disseminable and target the two most common disorders observed among this population. The primary aim of this study is to determine the effectiveness of an transdiagnostic telenovela video intervention in reducing anxiety and depressive symptoms using a pre/post-test design with Spanish-speaking Latinxs.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Identify as Latinx
3. Prefer behavioral health services in Spanish
4. Meet the DSM criteria for any mild to moderate anxiety disorder
5. Ownership of a smartphone

Exclusion Criteria:

1. Suicidality
2. Psychosis
3. Bipolar disorder
4. Severe anxiety disorders
5. Severe depressive disorders
6. Homicidality

Primary outcomes:
measure: Generalized Anxiety Disorder-7
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Reno
country: United States
facility: La Clinica @ the UNR Psychological Services Center
state: Nevada
Study officials:
References:
Clinical trial NCT04019899: Myo-inositol and Vitamin D3 During IVF
Official title: Effects of Supplementation With Myo-inositol, Vitamin D3, Folic Acid and Melatonin on IVF Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Infertility
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2019-07-15
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Administration of a multicomponent dietary supplement (myo-inositol, vitamin D3, folic acid and melatonin) to women undergoing IVF procedures.

The aim of the study is to monitor the effects on the pregnancy, implantation and abortion rates.


Eligibility criteria: Inclusion Criteria:

* BMI (kg/m2): 18.5 - 24.9
* basal FSH on day 3 \<15 mIU/ml

Exclusion Criteria:

* presence of insulin resistance (IR)
* hyperglycaemia, hyperprolactinemia, hypothyroidism or androgen excess
* diagnosis of PCOS (according to Rotterdam ESHRE-ASRM Sponsored PCOS consensus workshop group)
* intake of hormones or drugs that can potentially influence the ovulation
* FSH\>15 on day 3

Primary outcomes:
measure: Implantation rate
timeFrame: Single time-point: at 6 weeks of pregnancy
measure: oocyte and embryo quality
timeFrame: Single time-point: respectively, 12 days and 15 days after the beginning of Controlled Ovarian Hyperstimulation
measure: clinical pregnancy
timeFrame: Single time-point: at 14 days from embryo transfer
Secondary outcomes:
measure: Gemellarity
timeFrame: Single time-point: at 6 weeks of pregnancy
measure: Abortion rate
timeFrame: Single time-point: at 6 weeks of pregnancy
measure: Number of FSH IU used for controlled ovarian hyperstimulation
timeFrame: Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Clinica Alma Res
state: RM
Study officials:
References:
Clinical trial NCT01807299: The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children
Official title: The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Physical Training
ADHD-Attention deficit hyperactivity disorder
Omega 3
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 68
Sex: MALE
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life.

Detailed description: The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life. The treatment of this disease is expensive and difficult. Moreover, physical exercise and omegas consumption may improve the cognitive functions and behavior, so it could be an interesting strategy to improve this disorder. The aim of the present study is to verify the effects of multiple components physical training and the consumption of omega 3 on behavior, cognitive functions and the serum levels of BDNF and IGF-1 in ADHD children. Thus, 68 ADHD children, between seven and fourteen years old will be selected. The volunteers will be randomly divided into four groups: Physical Training Group (PTG), Omega Group (OG), Omega and Physical Training Group (OPTG) and Control Group (CG). The protocol of the experiment will last three months in which the OPTG will make physical training and receive fish oil capsules, and the PTG will make only the physical training and receive a placebo of fish oil. The others groups will be oriented not to make any type of physical training, but the OG will receive fish oil capsule, and the CG will receive a placebo of fish oil. Behavioral and cognitive functions evaluations and blood analysis will be made at the beginning and at the end of the protocol.

Eligibility criteria: Inclusion Criteria:

* Children with ADHD: male, between seven and fourteen years old, sedentary, studing in a regular school.

Exclusion Criteria:

* Taking psychoactive medications, taking omega supplement.

Primary outcomes:
measure: Conners Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Departamento de Psicobiologia
Study officials:
affiliation: Universidade Federal de São Paulo (UNIFESP)
name: José Carlos F Galduróz, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05468099: Aerosol Generation in Dental Clinics
Official title: Mitigating Effect of Bioaerosols During Orthodontic Procedures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction
Occupational Exposure
Dentist-Patient Transmission
Keywords: aerosol
bioaerosol
dentistry
orthodontics
saliva
nose
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study examines 4 different methods to reduce dental bioaerosol spread in orthodontic procedures.

Detailed description: We aim to examine 4 different methods to reduce dental aerosol spread during orthodontic procedures. These methods are: 1) high-volume evacuator, 2) high-volume evacuator and saliva ejector 3) Local Exhaust System 4) disinfection with povidone-iodine nasal swabs and chlorhexidine mouthwash.

Eligibility criteria: Inclusion Criteria:

* Orthodontic debonding being performed
* Acceptance to participate in the study and provide required saliva and nasal samples

Exclusion Criteria:

* Refusal to participate
* Refusal to provide saliva/nasal swab samples
* Allergy to Chlorhexidine gluconate
* Allergy to Povidone-Iodine

Primary outcomes:
measure: Particle concentration measurements across the 4 different types of interventions
timeFrame: During procedure
measure: Mass concentration measurements across the 4 different types of interventions
timeFrame: During procedure
measure: Bioaerosol measurement from the tracked sources
timeFrame: During procedure
Secondary outcomes:
measure: Bacterial contamination on the inside surface of the mask of operators and assistants
timeFrame: During procedure
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Khaled Altabtbaei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04720599: Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
Official title: Clinical Evaluation of ExoDx™ Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urologic Cancer
Keywords: exosome
ExoDx Prostate
Lead sponsor: Exosome Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 120
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Men, aged 50yrs or older with an elevated PSA between 2-10ng/ml scheduled for an initial biopsy

Brief summary: The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.


Eligibility criteria: Inclusion Criteria:

* Clinical suspicion for prostate cancer
* Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
* Scheduled for a initial prostate biopsy

Exclusion Criteria:

* Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
* History of prostate cancer.
* History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
* Known hepatitis status (all types) and/or HIV documented in patient's medical record.
* Patients with history of concurrent renal/bladder tumors.
* Prior MRI used in the decision to biopsy

Primary outcomes:
measure: Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Voorhees
country: United States
facility: New Jersey Urology
state: New Jersey
city: München
country: Germany
facility: Klinikum der Universität München
Study officials:
affiliation: Exosome Diagnostics, Inc.
name: Mikkel Noerholm
role: STUDY_DIRECTOR
References:
citation: Kretschmer A, Kajau H, Margolis E, Tutrone R, Grimm T, Trottmann M, Stief C, Stoll G, Fischer CA, Flinspach C, Albrecht A, Meyer L, Priewasser T, Enderle D, Muller R, Torkler P, Alter J, Skog J, Noerholm M. Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy. Sci Rep. 2022 Mar 21;12(1):4777. doi: 10.1038/s41598-022-08608-z.
citation: Kretschmer A, Tutrone R, Alter J, Berg E, Fischer C, Kumar S, Torkler P, Tadigotla V, Donovan M, Sant G, Skog J, Noerholm M. Pre-diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post-prostatectomy pathology outcome. World J Urol. 2022 Apr;40(4):983-989. doi: 10.1007/s00345-022-03937-0. Epub 2022 Jan 27.
Clinical trial NCT01002599: Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery
Official title: Does BoussignacTM CPAP Compared to Venturi Mask Improve Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Keywords: bariatric surgery
morbidly obese
BMI >35
CPAP
Venturi
Boussignac
Ventilation
Pulmonary function
Morbidly Obese Patients undergoing bariatric surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 54
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: This is a randomized controlled study in which morbidly obese patients undergoing bariatric surgery will be recruited in the preoperative clinic. Patients will be randomized into 2 groups to receive oxygen with Boussignac TM continuous positive airway pressure (CPAP) or conventional Venturi mask postoperatively immediately after extubation. The objective of the study is to examine if Boussignac TM CPAP results in improved oxygenation versus Venturi face mask when it is applied immediately after extubation in morbidly obese patients post bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Patient aged between 18 to 75 years of age
* American Society of Anesthesiologists' (ASA) class I to III
* Morbidly obese with a body mass index \> 35 kg/m2
* Patients undergoing bariatric surgery

Exclusion Criteria:

* Patient refusal
* Pre-existing cardiac failure, asthma, chronic obstructive pulmonary disease or interstitial pulmonary disease
* Systolic blood pressure less than 90 mmHg despite pharmacotherapy
* Hb \< 70 g/L
* Impaired gastric emptying
* Severe psychiatric disorder
* Language barrier

Primary outcomes:
measure: PaO2/FiO2 ratio (PF ratio) immediately on arrival to postanesthesia care unit, 1 hour, 2 hours, and 24 hours post-extubation.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
Clinical trial NCT01987999: Eradication of Prostate Cancer Using F-989
Official title: Phase II Eradication of Prostate Cancer Using F-989
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Optimal Health Research
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the findings of an early study with prostate cancer and to expand our knowledge of treating prostate cancer using F-989.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of prostate cancer
* Referred to the study by their treating physician

Exclusion Criteria:

- Any type of treatment before starting study

Primary outcomes:
measure: Gleason Score
timeFrame: 1 year
Secondary outcomes:
measure: Prostate Specific Antigens (PSA)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Optimal Health Research
name: Steven Osguthorpe, ND
role: PRINCIPAL_INVESTIGATOR
References: