cyrilzakka/clinical-trials huggingface dataset:
Cubii for Exercise in People With MS

The goals of this observational study are to evaluate (1) the feasibility, usability, and satisfaction with the Cubii elliptical and (2) the preliminary efficacy of the Cubii elliptical for increasing activity (primary outcome), physical function, and quality of life, and decreasing physical and psychological symptom (e.g., pain, fatigue, depression) severity in people with MS.

The main question it aims to answer is how usable and feasible is the Cubii as a mode of exercise for people with MS? Participants will use the Cubii as they choose and keep a written log of this use. They will answer questions about their demographics, MS disease-related variables (e.g., pain, fatigue, falls), activity, exercise, quality of life, and biopsychosocial symptom variables) and provide additional data regarding the feasibility, usability, and satisfaction with use of the Cubii.

Data indicates people with MS are less active than their peers in the general population. Exercise interventions are important non-pharmacologic approach to maximize function and quality of life for people living with MS. Based on current evidence and expert opinion, the National Multiple Sclerosis Society (NMSS) recommends that healthcare providers promote the benefits of exercise and lifestyle physical activity for every person with MS.

Individuals with at least moderate impairments (approximately 50% of MS population) often require adaptive exercise due to mobility and balance impairments. These individuals are likely to present with neurologic impairments that impact their gait and/or coordination and may experience limitations in walking distance and necessitate precautions for falls, as well as the use of assistive devices or compensatory strategies. The Cubii product line is well-placed for this subset of the MS population because it allows for safe, seated exercise that can still meet the recommendations for aerobic and resistance training.

This study will capitalize on a representative, heterogeneous sample of MS patients who are seeking to change their coping behaviors around MS, including by exercising more, and an existing exercise unit that can be utilized by people with a range of mobility.

Eligibility Criteria:
Inclusion Criteria:

* Clinician-confirmed MS
* 18 years of age or older
* Walks with the aid of an assistive device (e.g., cane, walker, forearm crutches)
* Able to read and speak English
* Lives in the greater Seattle metropolitan area
* All genders
* Has an iPhone or Android phone that can download apps

Exclusion Criteria:

- People unable to exercise for health reasons
Prevalence of Mucosal Biofilm Formations in Adenoidectomy Specimens

Rationale: Bacterial biofilms are defined as an assemblage of bacterial cells enclosed in a self-produced glycocalyx matrix. Adherence on surfaces, and resistance to both antibiotic treatments and host defenses are ones of the major clinical features of bacterial biofilms. Hence, biofilm formations represent a serious clinical problem: they persist in human tissues and play a role in a large number of chronic and resistant infections. It has been estimated that more than 65% of all human bacterial infections involve biofilms. Recently, the investigators have demonstrated the presence of mucosal bacterial biofilms in adenoid tissues removed during routine adenoidectomy. Bacterial biofilms were visualized using Confocal Laser Scanning Microscopy (CLSM) with a technique of double staining showing both the bacterial cells and the glycocalyx matrix. Although this study clearly established that adenoids tissues can harbour mucosal biofilms, the prevalence of 54% the investigators found suggested that some groups of children may contain more biofilm formations than others. In an effort to relate the findings of mucosal biofilm with the clinical presentation, the investigators have designed the present work to compare the prevalence of mucosal biofilms in adenoidectomy specimens in two groups: one group of children with chronic otitis media (COM) with effusion versus another group of children without any COM, having adenoids removed for chronic obstruction.

The aim of this case-control study is to compare the prevalence of biofilms formations in adenoid tissues of children with COM versus a control group without any COM.

Design: This is a monocentric, prospective, unrandomized case-control study comparing the prevalence of biofilm formations in adenoid tissues of two groups.

Clinical research study without direct medical benefit: during routine adenoidectomy, specimens are not used and thrown away. This study do not modify the common management of included children.

Number of subjects required: A considered approach of simple size calculation have been made using a method proposed by MIETINEN for Mc NEMAR Chi2 test. Simple size N=104 will allow 80% power to detect different of 20% (absolute), considering a total percentage of discordance pair at 30 %.

Expected results: a higher prevalence (30% estimation) of biofilm formations in group 1 in comparison with that in group 2 would be the first clinical research study bringing understanding of the role of adenoid tissues by harboring mucosal biofilms in otitis prone children.

Eligibility Criteria:
Inclusion Criteria:

* Group 1 and 2

  * obtained informed consent by both parents and child (if possible),
  * age \> 18 months and \<10 years
  * chronic serous otitis media lasting more than 3 months (group 1).
* Group 1 only:

  * chronic secretory otitis media
* Group 2 only:

  * hypertrophia adenoid vegetations without sinusal oropharyngeal infections

Exclusion criteria:

* No informed consent
* age \< 18 months or \> 10 years
* Eustachian tube dysfunction
* Immunodeficiency
* Tumor
Effects of Periodontal Treatment on HIV-infected Patients

Periodontal diseases, such as chronic periodontitis (CP), frequently occur in immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by the HIV infection can justify the high frequency and the difficult in controlling the CP in this group of patients, raising the possibility of additional factors associated to the development of CP in HIV patients. The aim of this study is to determine factors that can be involved in the CP pathogenesis in HIV patients, including Candida spp presence, and biomarkers involved on the inflammatory response against the microorganisms.

Investigators will develop one quasi-experimental study in HIV patients (N=15) and non-HIV patients (N=15) presenting CP. Candida spp count and salivary and gingival crevicular fluid concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. In order to minimize the influence of the immunosuppressive condition, patients have to present CD4 T lymphocytes \< 200cel/mm3 blood count, non-detectable viral load and the same protocol of antiretroviral therapy. Additionally, investigators intend to determine the immunophenotypic profile of the gingival tissue through immunohistochemical analysis. This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE: 50004415.1.0000.5419), and all patients need to provide written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* General for both groups/arms: Patients with at least 15 teeth; with chronic periodontitis (at least 2 sites with pocket probing depth ≥ 5mm and clinical attachment loss \>4mm); no use of antibiotics for the 6 months previous to study enrolment.
* For HIV-infected group: CD4 T lymphocytes \< 200 cel/mm3, stable HAART for the 6 months previous to study enrollment.

Exclusion Criteria:

* General for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.
CaboCHECK - Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study

This is a non-interventional study to retrospectively evaluate the safety and to describe the effectiveness of cabozantinib after immunoncologic treatment with nivolumab or nivolumab plus ipilimumab in routine clinical practice. It consists of a retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject
2. Patients with advanced or metastatic renal cell carcinoma, including all subtypes
3. Age ≥ 18 years
4. Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment

Exclusion Criteria:

1. Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial
2. Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)
Telavancin Observational Use Registry (TOUR)

The telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy.

This is a retrospective medical chart review, multicenter, observational study to examine telavancin efficacy and safety in a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.

Eligibility Criteria:
Inclusion Criteria:

-received at least 1 dose of telavancin since January 1, 2015

Exclusion Criteria:

* Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015
Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear

The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is collected retrospectively from clinical routine visits.

The study is a retrospective study. Therefore there will be no study visits for treatment or follow-up in the study.

Subject inclusion for this clinical investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower. To have a wide representative selection of subjects, enrollment will be spread over the 4 years since the device was available on the market since December 2016.

The endpoints in the study will investigate the improvement of hearing with the Ponto 3 SuperPower.

The data will be collected from the subjects in the time period from the clinical routine visit where the Ponto 3 SuperPower where fitted or just prior, and from the clinical routine visit following the fitting, where audiologic fitting follow-up procedures are performed (approximately 3 months).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have consented to Section 3 of the document: "GDPR - what this means to you" (Appendix A) as part of a clinical routine visit.
2. Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s)
3. Adult subjects (18 years or older)
4. Patient has attended a clinical routine visit where fitting of Ponto 3 SuperPower has been performed and at least one following clinical routine visit where audiological measurements has been performed

Exclusion Criteria:

There are no exclusion criteria in this study due to the retrospective nature of the study.

-
The Effect of NSAIDs After a Rotator Cuff Repair Surgery.

The main purpose of the study is to determine the effect of Non-steroidal Anti-inflammatory Drugs (NSAIDs) on the healing process after a rotator cuff repair procedure.

Furthermore, the study will also determine the rate of narcotic medications use and the retear rate after a rotator cuff repair procedure.

Eligibility Criteria:
Inclusion Criteria:

* rotator cuff tear
* age 45-75 years

Exclusion Criteria:

* diabetes
* pregnancy
* chronic kidney disease
* liver cirrhosis
* hematologic malignancy
* alcohol abusing
* drug abusing
Pattern of Admitted Cases in Respiratory Intensive Care Unit at Assiut University Hospitals

Human health comprises many different states, ranging from perfect health to critical illness, so medical facilities should be able to provide medical assistance tailored to the patient's degree of disease.

The Intensive Care Unit (ICU) serves as a place for monitoring and care of patients with potentially severe physiologic instability requiring technical and/or artificial life support. The level of care in an ICU is greater than that available on the floor or Intermediate Care Unit.

Because of the utilization of expensive resources, ICUs should, in general, be reserved for those patients with reversible medical conditions who have a "reasonable prospect of substantial recovery".

About one third of hospital mortality occurs in critically ill patients in the intensive care unit. On the other hand, critically ill patients are responsible for 10 - 20 % of global hospital costs.

It is well accepted that early appropriate referral of patients to an ICU can significantly reduce early and possibly late mortality in the critically ill.At the same time improper selection of patients for ICU who block ICU beds often limits bed availability in ICUs. This in turn adversely affects the dynamics the whole hospital.

The Respiratory Intensive Care Unit (RICU) is an area that provides closed monitoring and intensive treatment for patients with acute or exacerbated respiratory failure caused by a disease that is primarily respiratory.


Eligibility Criteria:
Inclusion Criteria:

Patients with the following conditions are candidates for admission to the respiratory Intensive Care Unit. The following conditions include, but are not limited to:

1. Acute respiratory failure requiring ventilatory support
2. Acute pulmonary embolism with haemodynamic instability
3. Massive haemoptysis
4. Upper airway obstruction

Exclusion Criteria:

Patients who are generally not appropriate for respiratory ICU admission:

1. Irreversible brain damage
2. End stage cardiac, respiratory and liver disease with no options for transplant
3. Metastatic cancer unresponsive to chemotherapy and/or radiotherapy
4. Patients with non-traumatic coma leading to a persistent vegetative state (7,8,9,10)
Retrospective Study of Patient Surveys

To collect data from Allergan Patient Surveys (patient surveys) and Allergan Patient Information Form (patient information form) to describe:

1. Patient demographics
2. Treatment patterns
3. Patient feedback and overall experience with MMS treatment


Eligibility Criteria:
Inclusion Criteria

* Subject has received MMS treatment in the abdomen and/or buttocks (with CoolTone prototype)
* Subject has completed the Allergan patient survey and information form on MMS experience between July 1, 2019 and December 1, 2019.

Exclusion Criteria

• There are no exclusion criteria for this study.
Lafiya HIV Self-testing Study Protocol

The study aims to address low testing and related issues such as stigma, low-risk perception, and concerns about confidentiality affecting testing. To overcome these challenges, the study proposes to adapt the Many Men Many Voices (3MV) into a modified version called LAFIYA to tackle intersectional stigma and improve HIVST among young sexual minority men in Ghana.


Eligibility Criteria:
Inclusion Criteria:

* YSMM: To be eligible to participate in the interview, the person must be between 18 to 25 years old, have no experience using unassisted HIVST kits, do not know their HIV status or tested negative, currently identifies as cis-gender man, and have had sex with another man within six months before engaging with the recruitment team and must reside within a slum community in the Greater Accra Metropolitan area.
* Providers: To be eligible to participate in the interview, the person must have experience providing sexual health services such as HIV testing, counseling, and linkage to prevention and care services for at least one year. Must reside within the Greater Accra Metropolitan area and have worked with YSMM on HIV prevention and care.

Exclusion Criteria:

* YSMM: Those who fall under 18 years or above 25 years will be excluded from the study. YSMM who have experience with unassisted HIVST kits, know their HIV status, or tested positive for HIV will be excluded from the study. YSMM who do not identify as cis-gender man and have not had sex with another man within six months before engaging with the recruitment team will be excluded from the study. YSMM who do not reside within a slum community in the Greater Accra Metropolitan area will be excluded from the study.
* Providers: Persons who do not have experience providing services such as HIV testing, counseling, and linkage to prevention and care services for at least one year will be excluded from the study. Providers not residing within the Greater Accra Metropolitan area and have not worked with YSMM on HIV prevention and care will be excluded.
Effect of Gene Polymorphism on Cognitive Function

The goal of this observational study is to study the effect of gene polymorphism on cognitive improvement in response to exercise in healthy participants. The main questions it aims to answer are:

To investigate whether FNDC5/Irisin genotype polymorphism affects cognitive function and inter-individual variability in exercise response.

To explore whether the FNDC5/Irisin gene polymorphism can act alone or interact with the BDNF gene to cause inter-individual differences in cognitive function responses to exercise gain.

Participants will be asked to perform high-intensity interval training( HIIT) on a cycle ergometer. Each high-intensity training period will be 30 seconds followed by a 4-minute rest period.

The participants will also perform cognitive tests (Vistorian stroop test and Fitlight trainer test) before and after the exercise.

Exercise has a significant effect on improving brain function. It can improve cognitive function, enhance learning effects, and prevent the occurrence of neurodegenerative diseases in the elderly. Exercise's mechanism of action to improve cognitive function includes stimulating the nervous system to secrete brain-derived neurotrophic factor (BDNF) and skeletal muscle to secrete irisin. However, the effect of exercise on improving physical function varies from person to person. This phenomenon is called inter-individual exercise response variability. Genetic differences may be responsible for this phenomenon. The genotype differences of BDNF and Irisin can cause cognitive function. However, the scientific community is still unclear whether the differences between the two genotypes are related to individual differences in exercise responses. The investigators suspect that genotype might be responsible for interindividual variability in motor responses and therefore designed this experiment to test this thesis. This study is expected to recruit 200 healthy adults to complete the genotype sequencing of BDNF and Irisin and use the cognitive function responses before and after a single high-intensity interval aerobic exercise to establish the model that genotype affects the variability of individual exercise responses. The experimental results of this study can help the scientific community understand the influence of genotype on individual differences in exercise response and further explore and refine the design of exercise prescription.

Eligibility Criteria:
Inclusion Criteria:

* Taiwanese National who perform less than 120 minutes of aerobic exercise per week.

The subjects will refrain from drinking alcoholic or caffeinated drinks 24 hours prior to the participation in the study

Exclusion Criteria:

Subjects who are diagnosed with

* Hypertension
* Arrhythmia
* Depression
* Color blindness
* Musculoskeletal injury within one year

Body Mass index higher than 25

Pregnant females
Relative Bioavailability and Food Effect Study

Primary objective: To determine oral bioavailability of the liquid formulation intended for pediatric use and potential food effects in healthy adults.

Secondary objective: To evaluate safety and tolerability measured by physical examination findings, vital signs, electrocardiogram (ECG), laboratory parameters, and adverse events (AEs).

Clinical pharmacology

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers
* Age 18-45 years
* Body mass index (BMI) 18.0-29.9 kg/m²
* Systolic blood pressure (SBP) 110-145 mmHg
* No drugs 2 weeks before treatment
* Nonsmokers for at least 12 weeks

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Medical disorder that would impair the subject's ability to complete the study in the opinion of the Investigator
* Known hypersensitivity to the study drugs (active substance or excipients of the preparations)
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Relevant diseases within the last 4 weeks prior to the first study drug administration
* Regular use of medicines
* Regular use of therapeutic or recreational drugs
* Use of any medication within the 2 weeks preceding the study