louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05108519: Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies
Official title: A Prospective Study Evaluating Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving any anti-VEGF-related regimen

Brief summary: This study collects information about complications and clinical response in cancer patients treated with anti-VEGF-related therapies. This study aims to observe side effects that may happen to patients with advanced cancer who are treated with anti-VEGF related therapy. This may help doctors learn if there are any relationships between these side effects and how the disease may respond to treatment.

Detailed description: PRIMARY OBJECTIVE:

I. To explore the incidence of clinical complications associated with anti-VEGF-related therapies in cancer patients treated at Emory University and the University of Texas M.D. Anderson Cancer Center (MDACC).

SECONDARY OBJECTIVES:

I. To explore the correlation of clinical response rates to a novel blood pressure scoring system in cancer patients treated with anti-VEGF-related therapies.

II. To explore the correlation of objective response to each toxicity grade 3 or higher in cancer patients treated with anti-VEGF-related therapies.

III. To investigate the validity of a novel multi-parameter-based blood pressure scoring system and to determine if the new scoring method is concordant with the current Common Terminology Criteria for Adverse Events (CTCAE) method.

OUTLINE:

Patients' medical records are reviewed.

Eligibility criteria: Inclusion Criteria:

* Patients must be able to understand and be willing to sign a written informed consent document
* Patients must be receiving any anti-VEGF-related regimen in monotherapy or combination therapy

Primary outcomes:
measure: Incidence of grade 3+ adverse events (AE) at least possibly related to anti-VEGF-related treatment (overall and each type separately)
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Nicolas L Palaskas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02734719: Increasing Bone Density by Application of Surface Electrical Stimulation
Official title: Increasing Bone Density by Application of Surface Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoporosis
Electrical Stimulation
Posture
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bonestim system for osteoporosis treatment uses surface electrical stimulation of neuromuscular and skeletal tissue by multipad stimulation electrodes for inducing contractions of the spinal column muscles. The primary aim of this clinical study is to determine if the Bonestim therapy can improve bone density. A secondary aim is to determine whether the applied treatment increases postural stability and facilitation of daily life activities.

Inducing of contractions of the spinal column muscles in this manner could be new treatment options for the patients with reduced mobility and the patients with serious contraindications for drugs.


Eligibility criteria: Inclusion Criteria:

* T score at least 1,5 (ideal 2,-2,5)
* Stable bone turn over (lab.analyses.)

Exclusion Criteria:

* fracture,pace maker, malignancy and gastrointestinal problems
* chronic corticosteroid therapy
* spinal surgery in previous year

Primary outcomes:
measure: density of bone measured by central Dxa measurement
timeFrame: 6 months
Secondary outcomes:
measure: sagittal flexibility measured by Schober measurement
timeFrame: 6 months
measure: daily activities measured by Oswestry disability index
timeFrame: 6 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Study officials:
References:
Clinical trial NCT03664219: Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization
Official title: Evaluation of the Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization With and Without Isolation of the Simultaneously Placed Implants Using Collagen Membrane
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant Site Reaction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Atrophied posterior mandible
Primary purpose: TREATMENT

Brief summary: Evaluation of the neurosensory disturbances after inferior alveolar nerve lateralization with and without isolation of the simultaneously placed implants using collagen membrane And measuring the stability of implants after placement .


Eligibility criteria: Inclusion Criteria:

* Adult patients with with atrophied posterior mandibular ridge
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence pathological lesions
* Heavy smokers more than 20 cigarettes per day .(24)
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Primary outcomes:
measure: Neurosensory disturbances - sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area
timeFrame: Year
Secondary outcomes:
measure: Stability - Osstell device to assess the primary stability of placed dental implant
timeFrame: Year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01542619: A Safety and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor VIIa With Albumin (rVIIa-FP) in Healthy Male Volunteers
Official title: A Randomized, Placebo-controlled, Single Center, 5 Cohort Dose Escalation Trial to Investigate Safety and Pharmacokinetics of rVIIa-FP (CSL689) in Comparison to Placebo in Healthy Male Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in comparison to placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between 18 and 35 years of age, both inclusive.
* Body weight between 50.0 and 100.0 kg, both inclusive.
* Body mass index (BMI) between 18.0 and 29.9 kg/m2, both inclusive.
* Written informed consent for study participation obtained before undergoing any study specific procedures.

Exclusion Criteria:

* Subjects at increased cardiovascular risk.
* Any clinical sign or known history of atherosclerosis or thromboembolic events.
* A subject considered at high risk of thromboembolic events confirmed either from history or by thrombophilia screening test.
* Subjects with significant elevation of cholesterol level.
* Renal dysfunction.
* Overt bleeding.
* Smokers with positive cotinine test at screening.
* Participation in any other trial investigating a procoagulant within the last six months prior to screening.
* Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
* Contraindications to Warfarin (Coumadin®).

Primary outcomes:
measure: The frequency of related Adverse Events (AEs) to rVIIa-FP.
timeFrame: 28 days
measure: Number of subjects who develop inhibitors against Factor VII (FVII).
timeFrame: 28 days
measure: Number of subjects who develop antibodies against rVIIa-FP.
timeFrame: 28 days
Secondary outcomes:
measure: Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP
timeFrame: 120 hours
measure: Half- life (t1/2) of a single dose of rVIIa-FP
timeFrame: 120 hours
measure: Incremental recovery (IR) of rVIIa-FP
timeFrame: 120 hours
measure: Clearance (Cl) of a single dose of rVIIa-FP
timeFrame: 120 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Phase I Unit
Study officials:
affiliation: CSL Behring
name: Alex Veldman, M.D.
role: STUDY_DIRECTOR
References:
citation: Golor G, Bensen-Kennedy D, Haffner S, Easton R, Jung K, Moises T, Lawo JP, Joch C, Veldman A. Safety and pharmacokinetics of a recombinant fusion protein linking coagulation factor VIIa with albumin in healthy volunteers. J Thromb Haemost. 2013 Nov;11(11):1977-85. doi: 10.1111/jth.12409.
Clinical trial NCT03011619: Brief CBT for the Treatment of Depression During Inpatient Hospitalization
Official title: Brief CBT for the Treatment of Depression During Inpatient Hospitalization
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Keywords: Depression
Cognitive Behavioral Therapy (CBT)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 0
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: Moderately to severely depressed subjects will be randomized to the "Control Group," who will receive care as usual, or the "CBT Group," who will receive care as usual in addition to the manualized course of Cognitive Behavioral Therapy (CBT).

Detailed description: Participants assigned to the CBT condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy. If a patient is randomly assigned to the enhanced CBT group, manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.The training M.D., who is a treating physician on HCC-10, will also intermittently and randomly observe the CBT sessions to ensure the manual properly is being followed. Although the control condition may contain elements of CBT as per the clinician completing the therapy, it is not manualized, does not include specific exercises to be completed between sessions, and is not a course that builds upon skills from the previous day, as in the CBT condition. Participants assigned to the control condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria on initial assessment on the unit.
* Demonstrates at least moderate degree of depressive symptoms on MADRS, HAM-D, and CGI-S.
* Provides written informed consent.

Exclusion Criteria:

* A mental illness other than depression that is the primary cause of treatment, as determined by the Principal Investigator.
* A cognitive or neurologic disorder that inhibits ability to engage in CBT.

Primary outcomes:
measure: Montgomery-Ashberg Depression Scale (MADRS)
timeFrame: 15 Minutes
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: 20 Minutes
measure: Clinical Global Impression Severity Scale (CGI-S)
timeFrame: 20 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Jacqueline Sergie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00899119: Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia
Official title: Autologous Stem Cell Harvesting for Waldenstrom's Macroglobulinemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma
Keywords: Waldenström macroglobulinemia
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Collecting and storing stem cells to study in the laboratory may help doctors learn more about collecting stem cells from patients who have undergone treatment for Waldenstrom's macroglobulinemia.

PURPOSE: This laboratory study is collecting stem cells from patients with Waldenstrom's macroglobulinemia.

Detailed description: OBJECTIVES:

* Harvest and store adequate CD34+ stem cells from patients with Waldenstrom's macroglobulinemia (WM) for potential future use in transplantation strategies.
* Evaluate the ability to harvest stem cells after therapy for WM (e.g., fludarabine-based chemotherapy) by evaluating the number of days to adequate harvest.
* Collect aliquots of stem cells for future research analysis as part of a WM database project.

OUTLINE: Patients undergo collection of autologous stem cells beginning on day 4 or 5 and continuing until an adequate number of stem cells are collected. Cells are then cryopreserved.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of Waldenstrom's macroglobulinemia (WM)
* Less than 30% lymphoplasmacytoid cells in bone marrow by histopathology
* Received prior chemotherapy for WM

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* WBC \> 2,000/mm³
* Platelet count \> 50,000/mm³
* LVEF ≥ 50%
* No organ dysfunction that would preclude future transplantation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Number of days to adequate stem cell harvest
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
state: New York
Study officials:
affiliation: Herbert Irving Comprehensive Cancer Center
name: Gwen L. Nichols, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01192919: Tumour Registry Lung Cancer (TLK)
Official title: Clinical Registry Describing Treatment Reality and Therapy Modalities of Patients With Lung Cancer (NSCLC, SCLC and Neuroendocrine Tumors) Requiring Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: bronchial carcinoma
registry
real life treatment
cohort study
NSCLC
SCLC
Germany
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 2500
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: patients with lung cancer requiring therapy

Brief summary: Overview of treatment reality in patients with bronchial carcinoma requiring systemic treatment and being treated by office-based oncologists in Germany.

Detailed description: The TLK is a prospective, longitudinal, nation wide cohort study that collects data on the treatment reality of patients with NSCLC and SCLC. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Patients are followed until death or for a maximum of 3 years.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed Small Cell Lung Cancer (SCLC), Non Small Lung Cancer (NSCLC) or neuroendocrine tumors receiving therapy
* written informed consent
* start of neoadjuvant, adjuvant or first-line therapy no longer than 4 weeks before informed consent

Exclusion Criteria:

* patients not receiving any systemic therapy

Primary outcomes:
measure: Documentation of actually used therapy forms in bronchial carcinoma requiring treatment
timeFrame: 3 years per patient
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Hans-Werner Tessen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Verschuer U, Schnell R, Tessen HW, Eggert J, Binninger A, Spring L, Janicke M, Marschner N; TLK-Group (Tumour Registry Lung Cancer). Treatment, outcome and quality of life of 1239 patients with advanced non-small cell lung cancer - final results from the prospective German TLK cohort study. Lung Cancer. 2017 Oct;112:216-224. doi: 10.1016/j.lungcan.2017.07.031. Epub 2017 Sep 12.
citation: Steffens CC, Elender C, Hutzschenreuter U, Dille S, Binninger A, Spring L, Janicke M, Marschner N; TLK-Group (Tumour Registry Lung Cancer). Treatment and outcome of 432 patients with extensive-stage small cell lung cancer in first, second and third line - Results from the prospective German TLK cohort study. Lung Cancer. 2019 Apr;130:216-225. doi: 10.1016/j.lungcan.2019.02.026. Epub 2019 Feb 25.
Clinical trial NCT06756919: EFFECTS OF MUSIC THERAPY DURING ENDOSCOPY ON PAIN, ANXIETY AND VITAL SIGNS
Official title: EFFECTS OF MUSIC THERAPY DURING ENDOSCOPY ON PAIN, ANXIETY AND VITAL SIGNS: A RANDOMIZED CONTROLLED STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Therapy
Keywords: music
endoscopy
nursing
pain
vital signs
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was conducted to evaluate the effect of music therapy on the vital signs, anxiety and pain of the patients during endoscopy procedure

Detailed description: The aim of this study was to the effects of music during the endoscopy procedure on anxiety, pain and vital signs.This study was conducted as a randomized, controlled, double-blind trial. The study population consisted of patients in the endoscopy unit of a university hospital between June and December 2023. The patients were randomly divided into the experimental group, who listened to music during endoscopy, and the control group, which did not receive any intervention other than routine nursing care. This study, data were collected via a patient information form, the State-Trait Anxiety Inventory (STAI-State), the visual analogue scale (VAS), and a vital signs monitoring form.

Eligibility criteria: Inclusion Criteria:

* Patients who have endoscopy procedure
* Being older than 18 years old
* Not having hearing problems
* ASA status between 1-3

Exclusion Criteria:

* Cognitive or psycological disorders
* Regular usage of analgesic/anxiolytic/sedaditive drugs
* Haemodynamic instability

Primary outcomes:
measure: State-trait anxiety inventory
timeFrame: 6 months
measure: Visual Analog Scale
timeFrame: 6 months
measure: Patient Information Form
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
References:
Clinical trial NCT05221619: Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
Official title: Nipocalimab Post-trial Access in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) Who Are Experiencing Clinical Benefit After Complete 28-Weeks Open-label Extension in MOM-M281-006
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Warm Autoimmune Hemolytic Anemia
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-02-03
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this post-trial access (PTA) program is to provide nipocalimab for the treatment of participants with Warm Autoimmune Hemolytic Anemia (wAIHA) who are experiencing clinical benefit after completing 28-weeks open-label extension in MOM-M281-006 (NCT04119050) study.


Eligibility criteria: Inclusion Criteria:

* Participants demonstrate clinical benefit (improvement of hemoglobin from baseline) at the Week 28 assessment in the open-label extension of the MOM-M281-006 (NCT04119050) study
* Participants does not have co-morbidities that would alter the risk-benefit of nipocalimab administration (determined by treating physician)
* Participants completed treatment in the 28-week open-label extension of the MOM-M281-006 (NCT04119050) study without receiving rescue treatment or discontinuation of the study prior to Week 28 visit

Exclusion Criteria:

* Participants have a serious or clinically significant infection (example: pneumonia, biliary tract infection, diverticulitis, Clostridioides difficile infection) requiring parenteral anti-infectives and/or hospitalization
* Participants have a chronic infection (example: bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or require chronic treatment with anti-infectives (example: antibiotics, antivirals)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01425619: The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Allergic Skin Reaction
Keywords: Anxiety Disorder due to Allergy Skin Testing
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allergy skin tests are occasionally associated with pain and anxiety in patients undergoing this procedure. The investigators intend to examine if medical clowns compared with local anesthetic cream can decrease these feelings in children.


Eligibility criteria: Inclusion Criteria:

* Any child undergoing allergy prick skin test

Exclusion Criteria:

* Children suffering from coulrophobia (phobia of clowns)
* Children with a known hypersensitivity to EMLA 5% cream
* Children who have undergone a painful medical procedure (surgery, dental procedures, blood drawing) over the past 3 months
* Children who, for medical reasons, must have their skin test performed on an area other than the volar aspect of the arm

Primary outcomes:
measure: The level of anxiety experienced by children undergoing allergy skin tests and receiving application of local anesthetic cream and/or care and treatment from medical clowns
timeFrame: 1.5 hour
Secondary outcomes:
measure: Severity of pain experienced by these children
timeFrame: 1.5 hour
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center
Study officials:
References: