cyrilzakka/clinical-trials huggingface dataset:
Botulinum Toxin Relieves Anxiety, Depression and Sleep Disorderes in Patients With Blepharospasm

Blepharospasm (BSP) is a chronic, idiopathic, recurrent and progressive disease, which mostly occurs in both eyes. It is mainly manifested as involuntary spasm of muscles around the eyes, leading to uncontrollable narrowing or even closure of blepharospasm. Although there is no pain in BSP patients, it can cause social or psychological dysfunction, make patients feel difficult in driving, reading and working, and seriously affect the social, work and life of patients.

Depression and anxiety are common and harmful mental disorders. At present, less than 40% of patients with depression can get effective treatment. Using simple and effective screening tools can effectively improve the detection rate of depression, so that patients can get timely and effective treatment. It is also an effective measure to prevent suicide.

Botulinum toxin type A (BTX-A) has achieved gratifying results in the treatment of dyskinesia. It has been confirmed that BTX-A has a significant effect on BSP. The effective rate is 70% - 90%. About 50% of the patients can regain normal or near normal visual function. At present, no prospective studies have explored this association between blepharospasm and depression / anxiety, and whether BTX-A can improve this mood disorder. Therefore, our research goal is to further study the relationship between blepharospasm and depression / anxiety, sleep in a prospective way, and to determine whether BTX-A treatment will affect depression / anxiety symptoms, so as to provide more theoretical basis for clinical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with blepharospasm who received botulinum toxin injection therapy
* All patients must have had the symptoms of blepharospasm for over six months

Exclusion Criteria:

* Glaucoma
* Age-related macular degeneration
* Visual acuity of 20/200 or worse
* Chronic obstructive pulmonary disease
* Cardio cerebral diseases, psychosis
* Loss of limb
* Connective tissue diseases
* Dialysis dependence
* Anyone who was unable to cooperate with the examinations
Institut Paoli Calmettes Multiple Myeloma Database

Database of Institut Paoli-Calmettes patients diagnosed with multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma diagnosis

Exclusion Criteria:

* Diagnosis before 1st january 2008
Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage

Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP.

Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with dantrolene in patients with cVSP after SAH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with Dantrolene can improve the outcome of patients with cVSP after SAH.

Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of dantrolene, by determining the treatment related adverse events, in participants with cVSP after SAH; and 2) to determine the maximal tolerated dose to be adopted in subsequent studies and 3) to determine efficacy trends of dantrolene on brain vessels as assessed by ultrasound of brain vessels (transcranial Doppler).

We hypothesize that dantrolene is well-tolerated and has minimal serious adverse effects in patients with cVSP after SAH. The results can potentially bring a new treatment to patients with SAH. cVPS after SAH is a frequent cause of disability and death. A successful study demonstrating the safety of dantrolene in would be of considerable public health significance.

Eligibility Criteria:
Inclusion Criteria:

* Participants with aneurysmal SAH admitted to the Massachusetts General Hospital NeuroICU (Blake 12) and undergoing standard-of-care daily transcranial doppler (TCD).
* Participants with unilateral or bilateral anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA), or basilar artery vasospasm as defined by the following TCD criteria
* a \>50% mean velocity increase from the baseline mean TCD velocity (baseline is the first TCD measurement, usually within 24hrs of admission), or
* peak systolic TCD velocities of 200 cm/s or higher in the MCA or ACA (for MCA with a concurrent ipsilateral LR of 3.0 or higher), or peak systolic TCD velocities of 120 cm/s or higher in the PCA or basilar artery, or
* any daily 100 cm/s peak systolic TCD velocity increase from the previous day, or
* any longitudinal mean TCD velocity increase of 80 cm/s or more

Exclusion Criteria:

* Inability to obtain consent from patient or health care proxy
* Age \< 18 years
* Pregnancy
* Traumatic SAH
* Known allergy to dantrolene
* Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT \>165 Units/L, AST \>120 Units/L, alkaline phosphatase \>345 Units/L (three times upper limit of normal)
* Participants on verapamil
A Case Management Study Targeted to Reduce Health Care Utilization for Frequent Emergency Department Visitors

The aim of the study is to determine whether a nurse-managed telephone-based case-management intervention can reduce healthcare utilization and improve self-assessed health status in frequent emergency department users.

The study tests a nurse-run case-management intervention targeted towards frequent emergency department visitors. The aim is to reduce visits to emergency departments as well as to improve quality of life by facilitating coping mechanisms as well as redirecting these patients to more suitable health care facilities.

Eligibility Criteria:
Inclusion Criteria:

* Recent history of frequent visits to emergency department
* Anticipated sustained high visit frequency
* Living in one of five Swedish counties where trial is ongoing

Exclusion Criteria:

* Moribund patients
* Psychosis
* Severe hearing impairment or language difficulties
* Other factors that may make it impossible or impractical for a patient to participate in the study
Virtual PrEP: Rendering PrEP Delivery More Efficient

Gay, bisexual and other men who have sex with men (GBM) account for over half of new HIV infections in Canada each year, and have a 131-fold higher risk of HIV than other Canadian men. HIV pre-exposure prophylaxis (PrEP) using regular oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC) is an effective and safe HIV prevention option.

Despite growing interest, awareness and willingness to use PrEP there has been numerous challenges to the broader rollout of PrEP. This study will address some of these challenges by assessing participant satisfaction,feasibility and clinical outcomes associated with a web-based mobile health (mHealth) model of care for daily oral TAF/FTC PrEP compared to standard of care delivery of TAF/FTC PrEP in Canadian GBM/TGW, in the era of COVID-19.

The ultimate goal of this study is to provide a scalable model for remote PrEP delivery that minimizes the need for in-person interactions; respects guideline recommendations regarding how to optimally monitor patients; and is attractive to both patients and providers.

This study is a 1:1 open-label, pragmatic randomized controlled trial using a AB:BA crossover design, comparing the standard of care to an mHealth based model of care (Freddie® ) for TAF/FTC PrEP delivery over 72 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Self-reported gay, bisexual or other man who has sex with men (inclusive of transgender men) or transgender woman
2. Age ≥16
3. HIV seronegative, as documented by a 4th generation HIV antigen/antibody combination test performed within 14 days of baseline
4. No symptoms of acute HIV seroconversion (fever, myalgias, arthralgias, malaise, headache, rash, pharyngitis and/or diarrhea that is otherwise unexplained)
5. Meets clinical criteria for PrEP according to the prescribing clinician. Patients can be enrolled into the study regardless of whether they will be newly initiating PrEP, or are already receiving PrEP; those already receiving PrEP can be using any regimen (eg. daily TDF/FTC, on-demand TDF/FTC, daily TAF/FTC) as long as they are willing to transition to the study regimen of daily, oral TAF/FTC.
6. eGFR \>30ml/min
7. Has adequate access to the internet to permit use of the mHealth platform
8. Adequate facility in English to communicate with their provider

Exclusion Criteria:

1. Known hypersensitivity/allergy to TAF/FTC
2. Actively participating in another interventional trial related to the delivery of PrEP or sexual health-related care
3. Being unwilling or unable to perform self-collected pharyngeal and/or rectal swabs as part of routine PrEP care
4. Potential to become pregnant
5. Currently living in, or planning to move to a location that would render standard of care or ad hoc in-person visits to the study site impractical during the study period.
Evaluation of an Incontinence Product

The purpose of this study is to determine if the sponsor's Incontinence Product reduces patient exposure time to a wet and/or soiled incontinence pad.


Eligibility Criteria:
Inclusion Criteria:

* English speaking/reading adults, age ≥ 18 years
* Incontinent (fecal, urine, or dual incontinence)
* Patients with dual incontinence who require use of a fecal management system (but no urinary catheter)
* Absence of skin irritation, breakdown, and pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the Study Investigator
* Willing and able to provide written informed consent or legal authorized representative is willing and able to provide written informed consent

Exclusion Criteria:

* Presence of skin irritation and/or breakdown including but not limited to IAD or pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the study Investigator
* Require use of an absorbent undergarment (e.g. Depends) or catheter as the primary incontinence management strategy
* Is considered to be near death or requires hospice care
Phase 1b/2a, Where Patients Are Chosen Randomly to Test the Safety of SNIPR001 and to Assess How Well the Study Drug is Tolerated, How it is Absorbed in the Body and Its Initial Effectiveness in Patients With Certain Types of Blood Cancer

This is a Phase 1b/2a study in allogenic hematopoetic stem cell transplant patients to investigate the safety, PK, PD and preliminary efficacy of multiple oral administrations of SNIPR001 when given concomitantly with SoC levofloxacin.

Patients scheduled for allo-HSCT will be pre-screened for the presence (in the gut), of FQR E. coli cultured from a perianal swab.

Approximately 24 patients will be randomized 1:1 to oral dosing of SNIPR001 or matching placebo, to be taken concomitantly with SoC levofloxacin prophylaxis. Subjects will be followed until 30 days post allo-HSCT transplant

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age at the time of consent.
2. Patient is able and willing to provide written informed consent prior to any study-related procedure.
3. Confirmed diagnosis of any hematologic malignancy.
4. Planned to undergo an allogeneic hematopoietic stem cell transplant.
5. Patient is scheduled to receive fluoroquinolone (levofloxacin) prophylaxis.
6. Colonized with FQR E. coli (patients will be pre-screened for the presence of at least 1 FQR E. coli colony \[cultured from a perianal swab\] performed at the local hospital lab, qualitative assessment +/-).
7. Female patients must be of non-childbearing potential (surgically sterile or menopausal for at least 1 year) or agree to use a highly effective contraception method, per local standard, while receiving treatment with SNIPR001 and for 28 days after the last dose of SNIPR001. Male patients must utilize highly effective contraceptive precautions for the duration of SNIPR001 dosing and for 28 days after the last dose of SNIPR001.
8. Female patients of childbearing potential must have a negative serum pregnancy test at Screening and a negative serum or urine test on Day -2 prior to SNIPR001 dosing.
9. Are willing to comply with all scheduled visits, laboratory tests, and other study procedures, including drinking the study medications, in the opinion of the Investigator.

Exclusion Criteria:

1. Use of any treatment (approved or investigational product) considered to interact with the study drug, or which might impact the outcome of the study within 14 days (or 5 half-lives of the approved or investigational product, whichever is greater) prior to the first administration of study drug, as judged by the Investigator. Patients enrolled in any other clinical trials are excluded from participation.
2. Use or planned use of any antibiotics with intrinsic activity against E. coli in the gut (e.g., beta-lactam antibiotics) between Pre-Screening and end of study, with the exception of TMP-SMX and levofloxacin.
3. Have known hypersensitivity or allergy to any component of SNIPR001, levofloxacin and/or Alka-Seltzer Gold treatment.
4. Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples.
5. Female patients who are pregnant or lactating.
UCSF Research Participant Registry

The UCSF Clinical and Translational Science Institute (CTSI) Consultation Service provides recruitment services and facilitates the enrollment of research participants into UCSF clinical studies. The Recruitment Services will be accessible to all researchers at UCSF and affiliated institutions and will address the common problems that investigators encounter in the recruitment process.

Recruitment Services considered and integrated Committee on Human Research (CHR) and HIPAA regulations for ensuring human subject rights, participant privacy, and data security into the recruitment workflow and data collection/extraction methods. Recruitment Services, therefore, requests approval to implement these processes systematically for all studies that have already obtained CHR approval to begin recruitment activities.

The UCSF Research Participant Registry (http://registry.ucsf.edu) is a secure, standalone database that actively collects and stores data from willing volunteers who visit its website. The UCSF Registry is a cornerstone of the UCSF Recruitment Service (RS). Both the Registry and the RS are among several initiatives implemented by the UCSF Clinical \& Translational Science Institute.

The chief purpose of the RS is to facilitate the enrollment of research participants into UCSF clinical studies. The primary function of the Registry is to expand the pool of potential clinical research volunteers. The Registry stores self-reported identifiable health information in a searchable database that is compliant with the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA). This information is then used by the RS for the future identification and recruitment of potentially eligible participants for specific UCSF studies.

Registry participants whose data matches the major eligibility criteria for a specific study will be sent recruitment materials about the study. Contact information for the investigator or RS staff will also be included in the e-mailing. Participants are then free to choose whether to respond or ignore the study recruitment information.

Eligibility Criteria:
INCLUSION CRITERIA

* Adults age 18 years or older
* Minors/children with consent from parent or guardian (Parents or guardians must provide their own contact information and then complete the questionnaire using the child's health information.)

EXCLUSION CRITERIA

* Failure to provide consent
* Minors/children without consent of parent or guardian
Electrical Impedance Imaging of Patients With Cystic Fibrosis

The goal of this feasibility study is to evaluate the ability of Electrical Impedance Tomography (EIT) for providing regional and quantitative information about the extent and nature of bronchial obstruction in patients with cystic fibrosis. It is not being conducted to diagnose, treat, prevent, or cure any kind of disease. In electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. The computed properties are used to form an image, which can then be used for monitoring and diagnosis.

The goal of this study is to evaluate the ability of Electrical Impedance Tomography (EIT) hardware and software in patients with cystic fibrosis (CF) for providing regional and quantitative information for identifying regions of obstruction and consolidation, and determine whether these measures will correlate with improvements seen after hospitalized treatment for a pulmonary exacerbation (PE). In particular, EIT will be used to identify regions of obstruction (air trapping) and consolidation comprised of atelectasis and airway occlusion (consequences of mucus plugging) in CF patients, and to determine whether EIT can demonstrate the beneficial effects of antibiotic treatment for CF patients with an acute PE by correlating changes in quantitative EIT measures with clinical measures known to improve following therapy, with patients serving as their own controls. Regional changes in air trapping and consolidation from pre to post treatment as indicated by the EIT images will be calculated, with subjects serving as their own control.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 2 and 21 years (Groups 1 and 2)
* Between the ages of 8 and 21 years (Group 3)
* Healthy lungs (Group 1)
* Clinical diagnosis of cystic fibrosis (Groups 2 and 3)
* Clinically indicated for a pulmonary CT scan or will receive one as part of their routine care (Group 2)
* Receiving IV antibiotics for a clinically diagnosed pulmonary exacerbation (Group 3)

Exclusion Criteria:

* Under age 24 months or over age 21.
* No informed consent
* Known congenital heart disease, arrythmia, or history of heart failure, admission to the intensive care unit, wearing a pacemaker or other surgical implant.
* Pregnant or lactating
Investigation of the Relationship Between Body Image Perception, Proprioception, Cobb Angle and Posture in Individuals With Adolescent Idiopathic Scoliosis

Scoliosis is a three-dimensional torsional deformation of the spine and trunk. Chest deformity and pelvic asymmetry are often seen together with spinal deformity. Adolescent idiopathic scoliosis occurs from the onset of puberty until growth plate closure and is the most common of all scoliosis. One of the most common deformities among posture disorders is known as scoliosis. The change in load distribution resulting from this three-dimensional deformation causes postural changes in patients with idiopathic scoliosis. According to a study, it is thought that postural control and central information processing efficiency may decrease as the Cobb angle increases in people with scoliosis.

Scoliosis, shoulder asymmetry, midline asymmetry, trunk shift and lower extremity length inequality. Therefore, it affects body image perception negatively by limiting physical functions and mobility. In a study conducted with individuals with AIS, it was found that as the Cobb angle increased, body image was adversely affected.

It is also known that during the vertebral growth period in idiopathic scoliosis, postural reflex mechanisms originating from the proprioceptive organs and balance problems are associated with the displacement of the vertebrae. As a result of a study on vestibular effect and proprioception, it is concluded that it would be beneficial to include proprioception, balance and coordination exercises in the treatment of scoliosis. In the current literature review, no study was found that investigated the relationships between Cobb angle, proprioception, body image perception and posture variables in individuals with Adolescent Idiopathic Scoliosis.

The aim of our study is to explain the relationship between some problems accompanied by scoliosis in individuals diagnosed with idiopathic scoliosis. With the results that can be obtained from our study, we aim to explain how posture, proprioception and body image perception are affected in individuals with AIS and to contribute to the exercise programs that can be given to the person in line with these results.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with adolescent idiopathic scoliosis by a doctor,
* Not having cognitive, mental and psychological problems,
* Continuing exercise or brace therapy.

Exclusion Criteria:

* Having a history of spinal surgery
* Having a type of scoliosis other than idiopathic,
* Presence of musculoskeletal system pathologies,
* Vestibular system disorders.