louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05991492: Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
Official title: Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Insomnia is an important public health problem and the most common sleep disorder in the general population. Up to 20% of adults in the United States suffer from insomnia disorder, and it has been associated with increased morbidity, mortality, and healthcare costs. Cognitive behavioral therapy for insomnia (CBT-I) is the initial recommended treatment approach for insomnia. Combined therapy with CBT-I and medication has shown no advantage over CBT-I alone. CBT-I is not always accessible to patients, however, due to cost and availability of trained healthcare professionals. Web-based CBT-I is an inexpensive and effective self-management tool for treatment of insomnia.

This pilot study would test the efficacy of a new digital CBT-I application called Stellar Sleep, a cost effective and user-friendly version of wCBT-I, in patients with insomnia. This is the first digital CBT-I app that allows automatic entry of sleep diary data from wearable devices that track sleep (such as the Mi Band 5 or a FitBit, for instance). Testing the efficacy of this application will provide the preliminary data necessary for larger trials to further validate the application and determine its role for future patients. Use of this application can help bridge the gap in providing care to insomnia patients with transportation and cost barriers and to accommodate the long wait times for traditional in-person CBT-I. It will also be the first web-based CBT-I application that can directly upload data from a wearable device.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Daily access to a computer or smartphone with reliable internet connection

Exclusion Criteria:

* Currently pregnant or planning to become pregnant in the next year
* Visual impairment that prevents use of a computer
* Serious health conditions that will prevent taking part in the study over the next 3 - 6 months, such as severe medical or psychiatric disease, such as treatments for cancer or congestive heart failure, OR a condition that may require hospitalization or surgery
* Self-reported history of drowsy driving or fallen asleep while driving
* Night shift worker
* Prior exposure to Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment
* Insomnia severity index score \< 14

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01112592: NETs Formation in Patients With Recurrent Pyogenic Infections (NETS)
Official title: The Ability of Neutrophils From Patients With Recurrent Infections to Produce Neutrophil Extracellular Traps (NET).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pyogenic Infections
Keywords: NETs
Infections
Neutrophil function
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Max Planck Institute for Infection Biology
First posted: 2010-04-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are referred subsequent to recurrent, persistent, or unusual infections and after completing preliminary screening of the immune system and ruling out a humoral, cellular or complement immune deficiency.

Brief summary: We aim to study if pathological NETs formation could be the underlying pathology among patients with recurrent infections and a normal screening of the immune system.

Detailed description: Our laboratory at Meir Medical Center, Kfar Saba, is the country's main center for neutrophil function, and serves about 80% of Israel's population. Patients are referred subsequent to recurrent, persistent, or unusual infections and after completing preliminary screening of the immune system and ruling out a humoral, cellular or complement immune deficiency. Initial workup includes chemotaxis, superoxide production (SOP), and bactericidal activity (BA). Based on test findings, further evaluation for a qualitative phagocytic disorder is conducted. Overall, impairment of phagocytic activity is found in about 33% (impaired chemotaxis in 16%, SOP in 6%, and BA in 24%). In the other 67%, no impairment of the immune function is found that can explain their tendency for recurrent pyogenic infections.

In 2004 a novel function of the neutrophil was identified: formation of neutrophil extracellular traps (NETs). Apparently, neutrophils are able to extrude part of their cellular contents in the form of DNA, histones and proteases, to form extra cellular NETS that trap and kill bacterial pathogens without the need for phagocytosis. We aim to study if pathological NETs formation could be the underlying pathology among these patients with recurrent infections and a normal screening of the immune system.

Eligibility criteria: Inclusion Criteria:

* Patients with recurrent, persistent, or unusual infections
* Referred for Neutrophil Functions

Exclusion Criteria:

* None

Primary outcomes:
measure: Measure NET formation in patients with recurrent infections
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Baruch Wolach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00580892: Optical Coherence Tomography of Airway and Pleural Disorders
Official title: Optical Coherence Tomography of Airway and Pleural Disorders
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Disorder of Pleura and Pleural Cavity
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-12-27
Enrollment: 0
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: Study population will be selcted from University of California Irvine Chao Cancer Center.

Brief summary: The researcher can use Optical coherence tomography a near-infrared diode to emit light that can produce images of the specimen under investigation and provide information about tissue abnormalities without causing damage.

Detailed description: The researcher can use Optical coherence tomography endoscopic imaging to improve diagnosis and treatment of airway and pleural malignancy. In the events of burn injury and smoke inhalation injury, the Optical coherence tomography can determine the change of the airway tissues and severity of airway injury.

During endoscopic procedure the lesions will be biopsied and prepared by standard histologic methods. The Optical coherence tomography endoscopic imaging can measured histologic of the tissue samples and compared to standard histologic examination. The Optical coherence tomography endoscopic imaging can measured the epithelial thickness and compared to visual inspection of the mucosa on bronchoscopy.

Eligibility criteria: Inclusion Criteria:

* Adult 18 or older, male or female.
* Plans for bronchoscopic with possible biopsy procedures.

Exclusion Criteria:

* Age less than 18 years of age
* Not plan for bronchoscopic with possible biopsy procedures.
* Pregnant or breastfeeding.

Primary outcomes:
measure: histopathology
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Pulmonary and Critical Care Medicine
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Matthew Brenner, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03876392: Detection of Bone Marrow Metastases With Magnetic Resonance Imaging
Official title: Detection of Bone Marrow Metastases With Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Marrow Metastases
Magnetic Resonance Imaging
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to study the value and feasibility of magnetic resonance imaging in detection of bone marrow metastases

Detailed description: The patient was diagnosed as bone metastasis by pathology. CT showed no bone marrow biopsy site metastasis (anterior iliac spine or posterior iliac spine). After functional magnetic resonance examination, bone marrow biopsy was performed. Functional magnetic resonance imaging includes conventional SE sequence, T2W SPAIR, e-THRIVE,DWI,IVIM. With bone marrow biopsy as the gold standard, the sensitivity, specificity and coincidence rate of functional MRI in the diagnosis of bone marrow metastasis were evaluated.

Eligibility criteria: Inclusion Criteria:

1. Patients with malignant tumors (solid tumors or hematological malignancies) were definitely diagnosed by pathology or cytology.
2. patients with bone metastases confirmed by more than two imaging examinations.
3. Age 18-75.
4. ECOG score: 0-2.
5. The expected survival time is more than 3 months.
6. Sign the informed consent.

Exclusion Criteria:

1. Imaging findings suggest that bone metastases are present at the bone marrow puncture site.
2. The patient refused bone marrow puncture.
3. Puncture site with infection.
4. Severe coagulation dysfunction.
5. There are implanted instruments in the body, so magnetic resonance imaging can not be performed.

Primary outcomes:
measure: sensitivity
timeFrame: through study completion, an average of 1 year
measure: specificity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People'S Hospital
state: Other (Non U.s.)
Study officials:
References:
Clinical trial NCT04955392: Effects of an Osteopathic Treatment Protocol on Sleep Quality
Official title: Effects of an Osteopathic Treatment Protocol on Sleep Quality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorder
Keywords: Sleep quality
Heart Rate Variability
Stress
Osteopathic Manipulative Treatment
Manual Therapy
Lead sponsor: Ramon Mateos Fisioterapia y Osteopatía
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SIngle-centre interventional single-blinded randomized contsubjectsrolled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio)
Primary purpose: TREATMENT

Brief summary: SIngle-centre interventional single-blinded randomized controlled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio) and to be carried out with volunteers that present alterations in the quality of sleep. Eligible and accepting subjects participating in the study will be assigned to receive an osteopathic treatment protocol or a placebo technique

Detailed description: Intervention protocol in the intervention group:

The intervention protocol consists of 4 techniques that will be performed according to the following order:

1. Inhibition of the suboccipital muscles.
2. Parietal Lift.
3. Sutherland Technique of Sphenobasilar Synchondrosis.
4. Compression technique of the fourth ventricle (CV4).

Intervention protocol in the control group:

Placebo technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

Eligibility criteria: Inclusion Criteria:

* Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index

Exclusion Criteria:

1. Recent head injuries or fractures.
2. Having suffered a stroke or intracranial hemorrhage.
3. Tumors.
4. Epilepsy.
5. Bradycardia.
6. Hypotension.
7. Heart disease
8. Neurological problems
9. Psychiatric problems

Primary outcomes:
measure: Sleep Quality
timeFrame: 1 month
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: 1 month
measure: Perceived Stress
timeFrame: 1 month
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Ramón Mateos Fisioterapia y Osteopatía
Study officials:
name: Ramón Mateos Alpuente
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416192: 12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
Official title: 12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Kidney Diseases
Uremia
Keywords: Dialysis
MCO
Middle molecules
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2018-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The medium cut-off dialysis (MCO) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters.

The aim of this study is to compare levels of middle molecules after 12 weeks of MCO hemodialysis, compared to 12 weeks of hemodiafiltration using standard high-flux filter.


Eligibility criteria: Inclusion Criteria:

* Ongoing HDF treatment (\>3 months)
* Oliguric
* Albumin ≥ 30
* CRP \<15
* No acute myocardial infarction within 3 months.
* Swedish or english speaking.

Exclusion Criteria:

- Not able to understand the study information.

Primary outcomes:
measure: Comparison of predialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
timeFrame: 12 weeks
measure: Comparison of postdialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
timeFrame: 12 weeks
Secondary outcomes:
measure: Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
timeFrame: 12 weeks
measure: Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
timeFrame: 12 weeks
measure: Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
timeFrame: 12 weeks
measure: Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
timeFrame: 12 weeks
measure: Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.
timeFrame: 8 weeks
measure: Comparison of number of adverse effects during the study period.
timeFrame: 12 weeks
measure: Comparison of mean nPCR after 12 weeks.
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Region Skane, Lund University
name: Anders Christensson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04457492: Functional Electrical Stimulation for Facial Muscles
Official title: Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Facial Nerve Paresis
Keywords: Facial Nerve Paralysis
Functional Electrical Stimulation
Rehabilitation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Partial or complete facial paralysis is the weakness of muscles of facial expression. Facial paralysis causes physical, social and emotional problems. Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated, causing them to contract This study is designed to help patients with facial nerve weakness.


Eligibility criteria: Inclusion Criteria:

* Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.

Exclusion Criteria:

* History of epilepsy or seizures.
* Individuals with metal orthopedic implants in the mouth (e.g. plates or screws).
* Individuals suffering from fibromyalgia.
* Individuals currently receiving any form of transcranial brain stimulation (e.g. rTMS, ECT, or MST).

Primary outcomes:
measure: Change in Lagophthalmos Over 14 weeks
timeFrame: Measured at week 0, 7 and 14
measure: Change in Elevation of Corner of Mouth Over 14 weeks
timeFrame: Measured at week 0, 7 and 14
measure: Change House-Brackmann Scale Measurement Over 14 weeks
timeFrame: Measured at week 0, 7 and 14
measure: FaCE Questionnaire
timeFrame: Administered at week 0, 7 and 14
measure: Change in Facial Movements Over 14 weeks
timeFrame: Measured at week 0, 7 and 14
measure: Study Interview
timeFrame: Administered at week 0, 7 and 14
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Douglas Chepeha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05815992: Accuracy of the Characterization of Adnexal Masses, Indeterminate at Ultrasonography, Using a MRI Protocol Without Contrast: Validation of the Cambridge Score
Official title: Accuracy of the Characterization of Adnexal Masses, Indeterminate at Ultrasonography, Using a Magnetic Resonance Imaging Protocol Without Contrast: Validation of the Cambridge Score
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adnexal Mass
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 370
Sex: FEMALE
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: Patients with a diagnosis of indeterminate adnexal masses after ultrasonography that will undergo to an MRI examination can be included in this study

Brief summary: The aim of this prospective observational study is to evaluate the accuracy and to validate the Cambridge Score,a Test Index to predict the malignancy of the ovarian lesions on the basis of an MRI examination without contrast


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years;
* Indeterminate adnexal masses at the ultrasonography;
* Signed Informed Consent.

Exclusion Criteria:

* Diagnosis of an extraovary mass;
* Synchronous tumors;
* Previous history of neoplasy.

Primary outcomes:
measure: Evaluation of generalizability of the Cambridge Score through external validations
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Evaluation of Cambridge Score when diagnosed by different readers
timeFrame: Through study completion, an average of 3 years
measure: Evaluation of diagnostic agreement between the Non-contrast and contrast-enhanced MRI
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
Study officials:
References:
Clinical trial NCT00160992: Adoptive Cell Transfer Combined With Peptide Vaccination in Transiently Immunosuppressed Melanoma Patients
Official title: Phase I Study of in Vivo Expansion of Melan-A/MART-1 Antigen-Specific CD8 T Lymphocytes Following Transient Immunosuppression in Patients With Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Melanoma
Keywords: Adoptive cell transfer
peptide vaccination
melanoma
immunosuppression and homeostatic proliferation
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Fond'action contre le cancer
name: Barletta Foundation
name: NCCR (National Center of Competence in Resaerch, Switzerland)
First posted: 2005-09-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with advanced stage melanoma who underwent vaccination with the Melan-A/MART-1 peptide and who display detectable levels of Melan-A specific CD8+ T cells in peripheral blood are eligible for this trial. After collecting and freezing of these tumor specific T cells via apheresis, patients undergo a single cycle of immunosuppressive chemotherapy. 3 days after, cells are reinfused and peptide vaccination continued. The aim of this immunotherapy protocol is to boost tumor specific T cells during the immune recovery period in order to reinforce the patients' immune response against the tumor.

Detailed description: Patients who have previously been vaccinated with Melan-A/MART-1 peptide are eligible. Whole PBMC's containing Melan-A specific CD8+ lymphocytes are collected via lymphocytapheresis and freezed. Lymphodepleting chemotherapy consists of 2 days of Busulfan 2mg/kg at days -7,-6, followed by Fludarabine 30mg/m2 at days -5,-4,-3. At day 0, whole untreated PBMC's are reinfused to the patient and vaccination with Melan-A analog peptide is restarted and repeated every 4 weeks. Immunomonitoring with detailed FACS analysis using tetramers is performed at day 0,8,15,30, and then monthly. The aim is to boost Melan-A specific CD8 T cells in vivo during homeostatic proliferation after lymphodepletion and antigen driven proliferation due to peptide vaccination.

Eligibility criteria: Inclusion Criteria:

* Stage IV melanoma
* tumor expressing Melan-A
* patient of HLA-A2 subtype
* Detectable immune response after peptide vaccination with Melan-A
* Disease progression during peptide vaccination

Exclusion Criteria:

* Cerebral metastases
* rapidly progressive disease, that necessitates systemic chemotherapy

Primary outcomes:
measure: Toxicity and feasibility
Secondary outcomes:
measure: Immunomonitoring of the immune reconstitution period
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Multidisciplinary Oncology Center, University of Lausanne Hospitals
Study officials:
affiliation: Multidisciplinary Oncology Center, University of Lausanne Hospitals
name: Verena Voelter, MD
role: PRINCIPAL_INVESTIGATOR
References: