louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05175937: REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology
Official title: REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrhythmias
Sudden Cardiac Death
Heart Failure
Keywords: Connectivity
Remote monitoring
Cardiac Implantable Electronic Device
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 1104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample size will be about 1104 patients; 736 patients implanted with Bluetooth technology devices and 368 patients followed with traditional remote control.

Brief summary: The objective of this observational study is to assess clinical benefits of innovative features (e.g. Bluetooth technology and smartphone patient applications) in a patient population that is implanted with standard indication for implantable cardiac defibrillator.

Detailed description: REACTION is an observational study in which patients will be followed as for clinical practice and no specific study tests/procedures will be perfprmed. After implanting a device, the patient will be assigned to an arm or to the other based on the technology of the device (bluetooth or RF) he/she wears, if he/she gives the consent to partecipate. It is not a randomized study. Patients will be enrolled consecutively until reaching the sample defined for both the arms.

Eligibility criteria: Inclusion Criteria:

* All patients implanted with an ICD as for standard indications
* Over 18 years of age
* Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

Exclusion Criteria:

* Subject who is, or is expected to be inaccessible for follow-up
* pregnancy

Primary outcomes:
measure: Adherence
timeFrame: 12 months
measure: Effectiveness
timeFrame: 12 months
Secondary outcomes:
measure: Clinical benefits in CRT area:
timeFrame: 12 Months
measure: Clinical benefits in ICD therapies
timeFrame: 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Prof Antonio Rapacciuolo,MD, PhD
Study officials:
References:
Clinical trial NCT00730652: Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
Official title: A Phase I, Open-Label, Multicenter, Dose-escalation, Multidose Study of MDX-1411 Administered Every 7 Days in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.
Keywords: Medarex Inc.
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle cell lymphoma.

Detailed description: Dose-escalation, multidose study of MDX-1411, a fully human nonfucosylated monoclonal antibody (mAb) targeting the CD70 transmembrane cell-surface protein, which is highly expressed in B-cell malignancies such as CLL and MCL.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of relapsed/refractory MCL or hematologically/bone marrow confirmed relapsed/refractory CLL that is not amenable to cure by surgery or other means and has failed at least 1 prior systemic therapy;
* Subjects may have been treated with up to 6 prior systemic therapies for relapsed/refractory disease or have become intolerant to a systemic therapy
* For MCL, must have measurable disease
* At least 4 weeks since the last systemic therapy, including RT, for the treatment of MCL/CLL;
* At least 4 weeks since taking any corticosteroids prior to the first dose of MDX-1411
* ECOG Performance Status 0 to 2;
* No known positivity for human immunodeficiency virus (HIV) and no active infection with Hepatitis B or Hepatitis C;

Exclusion Criteria:

* History of severe hypersensitivity reactions to other monoclonal antibodies;
* Use of other investigational drugs within 30 days before study drug administration
* Prior treatment with any other anti-CD70 antibody;
* Active infection requiring i.v. systemic therapy within 4 weeks of receiving the first dose of MDX-1411;
* Evidence of bleeding diathesis or coagulopathy;
* Active autoimmune disease requiring immunosuppressive therapy;
* Known current drug or alcohol abuse;
* Underlying medical conditions that will make the administration of MDX-1411 hazardous

Primary outcomes:
measure: Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)
timeFrame: Day 1-40
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medarex
name: Medarex Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04426552: Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation
Official title: Dexmedetomidine Versus Sevoflurane Inhalation for Fibreoptic Nasotracheal Intubation in Children With Anticipated Difficult Intubation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Craniofacial Abnormalities
Mandibular Hypoplasia
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: difficult problem in the paediatric age group because of their small mouth opening and un-cooperativeness.Currently used methods of sedation for fibreoptic intubation such as benzodiazepines, propofol or opioids may cause respiratory depression, especially when used in high doses

Detailed description: Dexmedetomidine, an a2-agonist, has none-to-minimal respiratory depressant effects, which is clearly a great advantage in handling a critical (unstable, difficult) airway while inducing sedation in both adult and infants. The aim is to compare intubation conditions between dexmedetomidine and sevoflurane inhalation during fibreoptic intubation in pediatric patients with an anticipated difficult intubation

Eligibility criteria: Inclusion Criteria:

* ASA physical status I and II
* aged 1 year to 3 years
* require general anaesthesia with tracheal intubation for surgical correction of the congenital or acquired pathology that created the difficult airway

Exclusion Criteria:

* parents refusal
* Allergy to drugs

Primary outcomes:
measure: Assessment of intubation
timeFrame: At intubation time
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Rehab Abd Elraof Abd Elaziz
state: Smouha
Study officials:
affiliation: Alexandria University
name: Rehab A. Abd Elaziz, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01145352: Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]
Official title: Enbrel-JIA Use Results Survey [All-Case Surveillance]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis
Keywords: Enbrel-JIA
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 113
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).

Brief summary: This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA.

1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events
2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.

Detailed description: All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).

Eligibility criteria: Inclusion Criteria:

* Patients in active polyarticular JIA (restricted to the case of lack of effect by other treatment) during enrollment period (2.5years).
* Patients receiving Enbrel for JIA as diagnosed by a qualified physician.
* Age 5 - 16 years

Exclusion Criteria:

* Patients not administered ENBREL

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events of Etanercept
timeFrame: 24 weeks
measure: Number of Participants With Serious Treatment-Related Adverse Events of Etanercept
timeFrame: 24 weeks
measure: Number of Unlisted Treatment-Related Adverse Events of Etanercept
timeFrame: 24 weeks
measure: Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Overall Improvement On Physician's Assessment.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Yokohama City University School of
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00152152: Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery
Official title: Use of Radiostereometric Analysis (RSA) for Measuring Spinal Motion Following Lumbar Spinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Fusion
Lumbar Discectomy
Keywords: spinal motion
tantalum beads
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: DePuy-Acromed, Inc.
First posted: 2005-09-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Radiostereometric Analysis (RSA) is a new imaging technique used to measure motions in the spine. It provides more accurate measurements that could help in diagnosing problems in the spine earlier than standard xray techniques.

Detailed description: Assessment of segmental spinal motion has been and continues to be a difficult clinical problem. X-ray measurement error of up to 10 degrees for simple measurements for flexion, extension and side bending have been recorded. It is extremely difficult to measure small changes in vertebral alignment that may prove to have clinical significance. The measurement accuracy of the RSA technique far exceeds any manual techniques to date. RSA allows the surgeon to monitor spatial relationships within the spine over time with a much higher accuracy then conventional techniques.

This is a non-randomized prospective study design looking at the use of RSA in spinal surgery patients. Subjects in this study will undergo their indicated surgery. Prior to closure, they will be implanted with tantalum beads, which will serve as landmarks when the RSA film pairs are taken post-operatively. The subjects will have standard post-operative x-rays 6 weeks-3 months post-op and again at 12 months post-op. Yearly visits after this are anticipated for 5-10 years with proper funding.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing Spinal fusion or discectomy

Exclusion Criteria:

* pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Bruce E. Fredrickson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01023152: Effect of Remote Ischemic Preconditioning on Acute Kidney Injury in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study the effect of remote ischemic preconditioning on acute kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary bypass.

Detailed description: Hypothesis : RIPC using tourniquet might be a simple technique with the benefit to provide renal protection without disturbing operating procedure and prolongation of total operating time.

Eligibility criteria: Inclusion Criteria:

* patients undergoing complex valve surgery.

Exclusion Criteria:

* older than 80 years
* those with left main disease \>50%, or hepatic or pulmonary disease
* active infective endocarditis
* left ventricular ejection fraction \<30%
* myocardial infarction (MI) within 3 weeks
* pre-existing renal dysfunction (serum creatinine (Cr) level \>1.4 mg/dl), and those with peripheral vascular disease affecting the lower limbs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05110352: Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome
Official title: Pilot Epidemiological Study to Determine the Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Reflux, Laryngopharyngeal
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to find, using validated and efficient tools, a laryngopharyngeal reflux in patients receiving polysomnography for suspected obstructive sleep apnea syndrome.

It is proposed to carry out simultaneously, at the Sleep Center of the Polyclinique of Poitiers (CSPP), a polysomnography, a 24-hour Restech pharyngeal pH-metry (day and night), a Peptest (in the evening and in the morning of the polysomnography), with the RSS-12 questionnaire and the RSA score.


Eligibility criteria: Inclusion Criteria:

* Adults (\> 18 ans)
* Polysomnography planned for OSA assessment
* RPL known or not, suspected or not
* Affiliation to a social security scheme or beneficiary of such a scheme
* Patient having signed the free and informed consent

Exclusion Criteria:

* Minors
* Smoking, alcoholism, chronic or serious disabling pathology
* Medical history of upper aerodigestive tract cancer, radiotherapy
* Recent infection of upper aerodigestive tract, chronic rhinosinusitis
* Permanent nasal obstruction
* Active allergy
* Non-obstructive SAS (central)
* Patient under anti-secretory treatment (IPP) during the 8 days preceding the Restech associated with the PSG
* Refusal to participate in the study
* Protected patients: Adults under guardianship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient
* Hospitalized without consent

Primary outcomes:
measure: Proportion of patients with Obstructive Sleep Apnea Syndrome diagnosed with pharyngolaryngeal reflux.
timeFrame: 3 months
Secondary outcomes:
measure: RSS-12 score
timeFrame: 3 months
measure: RSA score
timeFrame: 3 months
measure: Peptest
timeFrame: 3 months
Other outcomes:
Locations:
city: Potiers
country: France
facility: Centre du Sommeil de la Polyclinique de Poitiers
Study officials:
References:
Clinical trial NCT04126252: Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction
Official title: A Comparison of Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: International Islamic University, Islamabad
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 116
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with four arms involving a control group.


Eligibility criteria: Inclusion Criteria:

* Men diagnosed with erectile dysfunction
* Must be in the age range of 18 to 40 years
* Must be in a stable heterosexual relationship
* Must not be suffering from any medical or psychiatric illness

Exclusion Criteria:

* Men not meeting criteria of diagnosis of erectile dysfunction
* Men not in a heterosexual relationship
* Men above the age of 40 years
* Men diagnosed with any medical or psychiatric illness

Primary outcomes:
measure: International Index of Erectile Functioning-5
timeFrame: 3 months maximum
Secondary outcomes:
Other outcomes:
Locations:
city: Bahāwalpur
country: Pakistan
facility: Ahmad Bilal Private Practice
state: Punjab
Study officials:
affiliation: International Islamic University, Islamabad, Pakistan
name: Ahmad Bilal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bilal A, Abbasi NUH. Development of an indigenous manual of cognitive behavior sex therapy for young men. J Family Med Prim Care. 2022 Aug;11(8):4127-4130. doi: 10.4103/jfmpc.jfmpc_1892_21. Epub 2022 Aug 30.
Clinical trial NCT05198752: A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors
Official title: A Phase 1 Clinical Study to Evaluate the Tolerability, Safety,Immunogenicity and Efficacy of the Neoantigen mRNA Personalised Cancer Vaccine SW1115C3 in Patients With Advanced Malignant Solid Tumours
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Stemirna Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 30 participants in Cohort (C)1:50 mcg of SW1115C3 ; C2: 100 mcg of SW1115C3; C3: 150 mcg of SW1115C3.
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 open label study to evaluate the tolerability, safety, immunogenicity, and efficacy of SW1115C3, a neoantigen mRNA personalised cancer vaccine, in patients with advanced malignant solid tumours.


Eligibility criteria: Inclusion Criteria:

* Are 18 to 80 years old (including boundary values), without limitation of sex at time of consent.
* Based on the RECIST 1.1 criteria for disease progression, (a maximum increase in tumour diameter of 20%) for participants undergoing prescreening who are receiving standard treatment, these participants may reach the defined disease progression criteria at the time of tumour vaccine administration.

Exclusion Criteria:

* Have used a live attenuated vaccine within 4 weeks before the first use of SW1115C3 with the following exceptions:
* Adverse reactions induced by previous anti-tumour treatments have not yet recovered to Grade ≤ 1 (except for toxicity evaluated to have no risk of safety by the PI \[or designee\], such as hair loss, Grade 2 peripheral neurotoxicity and hypothyroidism stabilised by hormone-replacement therapy) based on NCI CTCAE version 5.0.

Primary outcomes:
measure: ，Dose-limiting toxicity incidence (participants who experience DLT)
timeFrame: 21 day
Secondary outcomes:
measure: Objective response rate(ORR) assessment per RECIST Version 1.1
timeFrame: 1 year
Other outcomes:
Locations:
city: Benowa
country: Australia
facility: Pindara Private Hospital
state: Queensland
city: Frankston
country: Australia
facility: Peninsula & South Eastern Haematology and Oncology Group
state: Victoria
city: Nedlands
country: Austria
facility: One Clinical Research
state: Western Australia
Study officials:
References:
Clinical trial NCT06559852: The Impact of Yoga on Endometriosis-Related Pain
Official title: The Impact of Yoga on Endometriosis-Related Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: Pelvic Pain
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The central hypothesis of the investigators is that the practice of yoga will result in an improvement of endometriosis related pain symptoms for women with endometriosis.

Detailed description: Yoga has been demonstrated to improve menstrual pain associated with primary dysmenorrhea through use of physical exercises, mental meditation, and breathing techniques. Still, there has been limited studies assessing potential benefits of yoga on pain symptoms of endometriosis. It is important to further assess yoga as a complementary therapy for women with endometriosis.

Eligibility criteria: Inclusion Criteria:

1. Reproductive aged women 18-45
2. Self-reported prior surgery with pathology confirming a diagnosis of endometriosis
3. No current use of yoga
4. Baseline moderate pain, score greater than or equal to 5 on VAS scoring
5. Access to internet with wifi capability for zoom platform and completion of weekly surveys
6. Access to items required for yoga session participation (2 blankets or towels, firm pillow, stable chair, wall space, comfortable clothing, water)
7. Ability to commit to duration of 12-week yoga course

Exclusion Criteria:

1. Pregnant patients
2. Established yoga participation or moderate exercise regimen
3. Physical trauma or disability
4. Planned surgery or hormonal medication change during study
5. Non-English speaking patients

Primary outcomes:
measure: Change in Endometriosis Health Profile-30 Pain Score
timeFrame: Baseline to completion at 12-weeks
Secondary outcomes:
measure: Change in Visual Analog Scale scores
timeFrame: Baseline to completion at 12-weeks
Other outcomes:
Locations:
Study officials:
References: