louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02194036: Learning Oriented Physiotherapy - a New Approach
Official title: The Effect of Learning Oriented Physiotherapy on Health-Related Functioning and Quality of Life in Patients With Various Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Agitation
Anxiety
Dizziness
Pain
Numbness
Depression
Fatigue
Sleep Disturbances
Keywords: Ownership of body
Bodily and mental balance
Learning
Body image
Sensations
Expectations
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Health North Trøndelag
name: Health Møre and Romsdal
name: South Coast Hospital Hf Dps Aust-Agder Units Arendal
First posted: 2014-07-18
Enrollment: 81
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: Outpatients that suffer from different anxiety disorders may have physical ailments that negatively affect daily life functioning and quality of life. LOF is a physical therapy approach focusing on the link between bodily and mental balance and through defined, but simple movements, patients are expected to learn how to cope and reduce health complaints.

This study aims to investigate the short- and longterm effect of LOF compared to other standardized psychiatric treatments given in the clinic on levels of anxiety and depression, health related function and quality of life.


Eligibility criteria: The study population will be recruited among patients referred to three Norwegian psychiatric outpatient clinics for anxiety-like conditions. The same criteria for inclusion and exclusion will be applied for the experimental and active comparator group.

Inclusion Criteria:

Participants should be

* 18 years or older
* able to read, write and speak Norwegian
* understand the project information and consent

Exclusion Criteria:

Participants should not

* have ongoing substance abuse or addiction.
* be psychotic.

Primary outcomes:
measure: Changes in Health Related Quality of Life (HRoQL)
timeFrame: From baseline to 6, 12 and 18 months of follow-up
Secondary outcomes:
measure: Changes in Levels of Anxiety and Depression
timeFrame: From baseline to 6, 12 and 18 months of follow-up
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Regional Psychiatric Centre Aust-Agder
state: Aust-Agder
city: Molde
country: Norway
facility: Psychiatric Clinic
state: Møre And Romsdal
city: Levanger
country: Norway
facility: Psychiatric Clinic
state: North Trøndelag
Study officials:
affiliation: Oslo University Hospital, Department of Pain Medicine
name: Lars-Petter Granan, phD
role: STUDY_DIRECTOR
References:
citation: Britt Fadnes, Kirsti Leira and Per Brodal. Learning-oriented physiotherapy. Theory and practice. University Press, 2013.
Clinical trial NCT06304636: Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma
Official title: Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Keywords: Relapsed/Refractory
Relapsed Myeloma
Refractory Myeloma
Multiple Myeloma
Car-T
CART
Descartes-15
Descartes
Myeloma
T cells
cell gene
Lead sponsor: Cartesian Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Study consists of two parts. Part 1 is a single-arm dose escalation study. Part 2 is a dose-expansion study with 2 arms.
Primary purpose: TREATMENT

Brief summary: This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15


Eligibility criteria: Inclusion Criteria

* Patients must be 18 years of age or older at the time of enrollment.
* Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma.
* Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria.
* Patients must have clinical performance status of ECOG 0-2.
* Patients must have adequate vital organ function as defined by:
* Hemoglobin ≥8 g/dL
* Absolute neutrophil count \> 1000/ mm3
* Platelets \> 50,000/mm3
* ALT/AST levels lower than 3-fold of normal
* Creatinine clearance ≥45 mL/min/1.73 m2
* Normal cardiac and pulmonary function
* No thromboembolic events in the past 3 months
* No heparin allergy or active infection

Exclusion Criteria

* Patients who have any active and uncontrolled infection.
* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent).
* Patients who have active central nervous system disease.

Primary outcomes:
measure: Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM)
timeFrame: Day -60 to Month 12
Secondary outcomes:
measure: To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival
timeFrame: Day 1 to Month 12
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders (AON)
state: Maryland
Study officials:
References:
Clinical trial NCT02580136: Esthesioneuroblastoma: Outcomes After Treatment
Official title: Esthesioneuroblastoma: Outcomes After Treatment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Esthesioneuroblastoma, Olfactory
Keywords: Esthesioneuroblastoma
Tumor
Skull Base Surgery
Sinonasal Cancer
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with esthesioneuroblastoma (ENB)

Brief summary: The purpose of this study is to collect and organize data into a repository to gather relevant information for future research from patients diagnosed with a rare malignant sinonasal cancer called esthesioneuroblastoma (ENB) and are scheduled to undergo endonasal skull base surgery. Data being collected includes surgical data, demographics, disease presentation, MRI, CT, PET imaging, and post-operative assessments including pathology tests. After surgery, the investigators will collect chemotherapy and radiation data. Participants will also complete quality of life questionnaires at their follow-up visits.


Eligibility criteria: Inclusion Criteria:

* Between the age of 10-80 years
* Diagnosed with esthesioneuroblastoma

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Quality of Life
timeFrame: up to 120 months after treatment
measure: Progression-free survival and overall survival
timeFrame: Up to 120 months
Secondary outcomes:
measure: Number of participants with intraoperative complications
timeFrame: up to 120 months
measure: Number of participants with postoperative complications
timeFrame: up to 120 months
measure: Length of Hospital Stay
timeFrame: up to 120 months
measure: Time spent in operating room
timeFrame: up to 120 months
measure: MRI imaging evidence of resection
timeFrame: up to 120 months
measure: Surgical Technique
timeFrame: up to 120 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ricardo Carrau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05159336: Transcranial Alternating Current Stimulation (tACS) for Auditory Hallucinations
Official title: Intervention Treatment of Auditory Hallucination by Transcranial Alternating Current Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Transcranial alternating current stimulation (tACS) can modulate and restore neural oscillations that are reduced in patients with psychiatric illnesses such as schizophrenia. Here, we performed a open-lable study of clinical trial in 30 schizophrenia patients with auditory hallucinations to show that tACS is effective for auditory hallucinations.

Detailed description: Each week, the patient rested quietly with her eyes open while receiving alpha-frequency tACS for 40 minutes. Stimulation was delivered at 10 Hz with 1 mA zero-to-peak amplitude in-phase to the location 1 and the location 2 acquired by the MEG technique with 5\*5 cm electrodes. A 5\* 7 cm return electrode was centered on Cz. In total, 20 weeks.

Eligibility criteria: Inclusion Criteria:

* Schizophrenia with auditory hallucinations was diagnosed by DSM-IV, AHRS \>12, Take sufficient antipsychotics for at least 1 month.

Exclusion Criteria:

* current pregnancy, major medical illness affecting the central nervous system, significant neurologic disorders, intake of drugs including supplements like essential fatty acids that influence prostaglandins or niacin skin flush flash pathway metabolism, a history of suicide risk, or alcohol or drug abuse.

Primary outcomes:
measure: Evaluation of Auditory Hallucination Scale(the minimum is 0, maximum value is 47, and higher scores mean a worse outcome)
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Yegang Hu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Force RB, Riddle J, Jarskog LF, Frohlich F. A case study of the feasibility of weekly tACS for the treatment of auditory hallucinations in schizophrenia. Brain Stimul. 2021 Mar-Apr;14(2):361-363. doi: 10.1016/j.brs.2021.01.014. Epub 2021 Jan 27. No abstract available.
citation: Ahn S, Mellin JM, Alagapan S, Alexander ML, Gilmore JH, Jarskog LF, Frohlich F. Targeting reduced neural oscillations in patients with schizophrenia by transcranial alternating current stimulation. Neuroimage. 2019 Feb 1;186:126-136. doi: 10.1016/j.neuroimage.2018.10.056. Epub 2018 Oct 24.
Clinical trial NCT04103736: The Effect of Dietary Nitrates on Physical Performance and Vascular Function in Chronic Kidney Disease
Official title: The Effect of Dietary Nitrates on Physical Performance and Vascular Function in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Disease, Chronic
Endothelial Dysfunction
Keywords: chronic kidney disease
dietary nitrates
beetroot juice
endothelium, vascular
cardiovascular disease
exercise capacity
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the effect of acute ingestion of a concentrated beetroot juice supplement on vascular function and exercise capacity in patients with moderate to severe chronic kidney disease

Detailed description: People with Chronic Kidney Disease (CKD) are at an increased risk of cardiovascular disease. Blood vessel dysfunction and exercise intolerance are common in CKD. Blood vessel dysfunction has been shown to predict future cardiovascular events and decreased physical activity can contribute to an increased risk of cardiovascular disease. Therefore, this study investigates if dietary nitrate from beetroot juice, which has been shown to improve blood vessel function and exercise capacity in other cardiovascular disease pathologies, could be effective at improving these measures in patients with CKD. In a controlled, double blinded trial, stage 3-5 CKD patients will be randomly assigned to receive either beetroot beverage or a placebo and then complete measures of blood vessel function and an exercise test.

Eligibility criteria: Inclusion Criteria:

• Stage 3-5 Chronic Kidney Disease

Exclusion Criteria:

* History of cardiovascular disease
* Current pregnancy
* Uncontrolled hypertension
* Uncontrolled hyperlipidemia
* Current hormone replacement therapy
* Current use of tobacco products
* Current autoimmune disease
* Current hyperkalemia
* Diagnosis of a deep vein thrombosis (DVT) within the last 6 months

Primary outcomes:
measure: Microvascular Function, assessed by laser Doppler flowmetry coupled with intradermal microdialysis
timeFrame: 2.5 hours post ingestion of juice
Secondary outcomes:
measure: Endothelial function
timeFrame: 2.5 hours post ingestion of juice
measure: Blood pressure
timeFrame: Change from pre-ingestion baseline to 2.5 hours post ingestion of juice
measure: Arterial stiffness
timeFrame: 2.5 hours post ingestion of juice
measure: Pulse wave analysis
timeFrame: 2.5 hours post ingestion of juice
measure: Peak aerobic capacity
timeFrame: 2.5 hours post ingestion of juice
Other outcomes:
Locations:
city: Newark
country: United States
facility: Department of Kinesiology and Applied Physiology, University of Delaware
state: Delaware
Study officials:
References:
Clinical trial NCT03266536: Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet
Official title: Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Intestine Bacteria
Keywords: Gut microbiota
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Colorado State University
name: University of Minnesota
name: Imperial College London
First posted: 2017-08-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?

Detailed description: The gut microbiota is increasingly being implicated in disease. However, due to difficulty accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of bacteria in this area (secondary to luminal flow and bactericidal bile acids/gastric acid), the small bowel microbiota is infrequently evaluated in any studies of this nature. The small bowel microbiota continues to remain an unexplored area of the gastrointestinal tract. Characterization of the microbial community and its function is the first step in determining how it potentially affects health and disease.

Eligibility criteria: Inclusion Criteria:

* Adults between (and including) 18-65 years old.
* On a baseline healthy diet characterized by:

  * High fiber of ≥ 14 g/1000 calories/day
  * \< 10% of daily calories from added sugar
  * At least 5 servings of fruit and vegetables per day
  * \< or = 13% of daily calories from saturated fat

Exclusion Criteria:

* Patients who do not meet the above diet requirements.
* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions.
* Presence of abdominal symptoms based on baseline questionnaire.
* Commercial oral antibiotic or probiotic use within the past 4 weeks.
* Pregnancy or plans to become pregnant within the study time frame
* Vulnerable adults
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.

Primary outcomes:
measure: Transcriptional changes in gut microbiota present in stool.
timeFrame: Baseline, approximately three weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Purna C Kashyap, M.B.B.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03964636: Contraceptive Pills and Retinal Vascularization
Official title: Contraceptive Pills and Retinal Vascularization (Piluret)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Combined Oral Contraceptives Intake
Keywords: OCT-A
combined oral contraceptives
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-05-28
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of chilbearing age presenting to an ophthalmologic consultation at the Foundation Rothschild will be included in one of the 3 groups: no contraceptive intake, combined 1st/2nd generation oral contraceptives and 3rd/4th generation combined oral contraceptives, if they meet the inclusion and non-inclusion criteria

Brief summary: The main hypothesis is the taking of combined 1st and 2nd generation or 3rd and 4th generation oral contraceptives is associated with a change in retinal micro-vascularization compared to the absence of combined oral contraceptive intake.

Women of childbearing age will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to their medical and ophthalmologic history and their oestro-progestative contraceptive intake will be collected.

The objective is to find an association between retinal vascular density and combined oral contraceptives intake.


Eligibility criteria: Inclusion criteria

* for the control group : No Estro-progestin contraceptive treatment (oral, transdermal) for at least 6 months
* for the cases under combined 1st and 2nd generation pills : Estro-progestin contraceptive treatment for at least 6 months
* for the cases under combined 3rd and 2th generation pills: Estro-progestin contraceptive treatment for at least 6 months

Exclusion criteria:

* Menopausal woman
* Ametropia greater than + 3 hyperopia diopters or-3 myopia diopters
* Astigmatism greater than 2 dioptres
* Smoking patient (cigarette or e-cigarette)
* Caffeine intake within 2 hours prior to the OCT-A exam
* Any known retinal pathology
* Antecedent of deep vein thrombosis or deep arterial thrombosis

Primary outcomes:
measure: Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A.
timeFrame: At the inclusion consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A de Rothschild
Study officials:
References:
Clinical trial NCT02109536: The Use of Magnetic Endoscopic Imagers During Colonoscopy for Loop Recognition and Resolution
Official title: The Use of Magnetic Endoscopic Imagers During Colonoscopy for Loop Recognition and Resolution
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colonoscopic Surgical Procedures
Keywords: Colonoscopy
Looping
Loop recognition
magnetic endoscopic imager
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive male and female patients, 18 years or older, undergoing outpatient colonoscopy in the MEI room at Hotel Dieu Hospital in Kingston, Ontario, Canada will be considered for the study.

Brief summary: The purpose of this study is threefold. First, the ability of experienced colonoscopists to recognize the type of loop formed will be assessed and whether the use of the MEI improves this accuracy. Second, to determine which maneuvers are used for loop reduction and whether certain loops have set ways to reduce them. The third component will assess whether the colonoscopist thought that the imager helped or not.


Eligibility criteria: Inclusion Criteria:

* adults (18 years and older) undergoing colonoscopy

Exclusion Criteria:

* age less than 18 years old
* not willing to participate
* cardiac pacemaker
* internal cardiac defibrillator
* previous colonic surgery

Primary outcomes:
measure: Accuracy of loop recognition by experienced colonoscopists compared to the magnetic imager.
timeFrame: within 3 mths
Secondary outcomes:
measure: Qualitative description of maneuvers used for loop reduction.
timeFrame: within 3 mths
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University, GIDRU
name: Aman V Arya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University, GIDRU
name: Lawrence Hookey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University, GIDRU
name: Stephen Vanner, MD
role: PRINCIPAL_INVESTIGATOR
References: