cyrilzakka/clinical-trials huggingface dataset:
Variants of SARS-CoV-2 Causing COVID-19 in Africa

The main objective of this research is to identify and characterize the different molecular variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine their role in the evolution of the pandemic.

The main objective of this research is to identify and characterize the different molecular variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine their role in the evolution of the pandemic.

The research will combine retrospective and prospective approaches to determine the evolutionary dynamics of the virus since the start of the pandemic. It is planned to sequence the entire Spike protein gene for 1550 viruses and make 300 entire genomes. This work will be supplemented by antibody seroneutralization and respiratory transcriptomics tests, in order to estimate the immuno-virological response of the COVID-19 disease associated with the identified SARS-CoV-2 variants.

Eligibility Criteria:
Inclusion Criteria:

* Major subject (cf. country)
* Presenting for a SARS-COV-2 diagnosis, whether symptomatic or not
* Not objecting to participating in the research

Exclusion Criteria:

* NA
CyberCycling to Reduce Therapeutic Side Effects and Improve Quality of Life in AYA Cancers

Only a few clinical trials evaluating the potential benefits of exercise have been conducted in adolescents and young adults (AYA) with cancer and, no prior studies have evaluated the potential effects of 'cybercycling' (exergaming on a stationary bike) in AYA cancer survivors. Therefore, the study aims to conduct a pilot trial to determine feasibility (adherence, user acceptance) and to explore potential effects of a 'cybercycling' exercise program on fitness, body composition, quality of life, sleep and cognition.

Objectives Specific Aim 1: To evaluate the feasibility (adherence; user acceptance: exercise tolerance, enjoyment and motivation) of performing an adaptive, moderate intensity, aerobic exercise program on a 'cybercycle' compared to control (stretching/resistance bands) in adolescent and young adults (AYA) with cancer.

(Exploratory) Aim 2: To explore the effects of an adaptive, moderate intensity aerobic exercise program using a 'cybercycle' compared to control (stretching/resistance bands) on changes in fitness, body composition, quality of life (QoL), fatigue, sleep and cognition.

Study Design/Overview:

This study is a randomized trial in 20 adolescent and young adult (AYA) cancer survivors (15-30 years old) which will comparing two intervention arms: 1) aerobic exercise on a 'cybercycle' (stationary cycling with exergaming/videogaming); and, 2) a stretching/resistance band 'control' condition.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed cancer
* completed primary treatment
* approved to be contacted by the treating oncologist/nurse practitioner
* meet screening criteria

Exclusion Criteria:

* patients unable to provide informed consent
* patients not available for follow-up testing
* patients with any pre-existing medical conditions that would be a contraindication to exercise.
Detection of Bladder Tumors After 30 Min Instillation of Hexvix

The objective of the study is to compare Hexvix® flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.

This study is an open, prospective, within patient, controlled, multi-center, Phase IIa study in patients with bladder cancer.

The bladder of all patients will be instilled with 50 mL Hexvix® 8 mM solution and evacuated after 30 minutes. After bladder evacuation, the bladder will be examined under white light cystoscopy using the Karl Storz flexible videocystoscope. Tumors visible under white light will be mapped. Then the bladder is evaluated with blue light and lesions seen by blue light will be mapped. Biopsies of all visible tumors will be taken using both white and blue light prior to resection of all lesions.

Eligibility Criteria:
Inclusion Criteria:

The patients should be indicated for a transurethral resection of the bladder (TURB) based on an outpatient cystoscopy and fulfil the following inclusion criteria:

* Patients with multiple bladder tumors, defined as ≥2 lesions, based on an outpatient cystoscopy.
* Patients with known urinary urge symptoms or patients who have problems or pain holding back the urine for a time longer than 30 minutes.
* Age 18 years or above

Exclusion Criteria:

* Patients with known tumors in the prostatic urethra or distal urethra
* Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
* Patient with porphyria.
* Hypersensitivity to the active substance or to any of the excipients of the solvent
* Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
* Women of child-bearing potential meaning that only post-menopausal women, women who had their ovaries removed, and women who are otherwise physically unable to bear children can be included.
* Patients who have received BCG or chemotherapy within three months prior to study inclusion.
* Conditions associated with a risk of poor protocol compliance.
* Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the clinical study.
* Patients unlikely to comply with protocol
Building Strength for Menopause

A pilot study investigating whether heavy resistance training is enjoyable, acceptable, and feasible for middle-aged women undergoing the menopausal transition. Additional outcomes to be assessed include changes to strength and muscle composition as well as changes to cognitive function and self-reported measures of fatigue, cognition, self-efficacy, and mood.


Eligibility Criteria:
Inclusion Criteria:

* 40-60 years of age at study enrollment
* Currently experiencing symptoms related to menopause
* Low physical activity levels at study enrollment (not meeting CDC guidelines of 150 minutes moderate/75 minutes vigorous activity per week)
* No regular (\>1x per week) participation in heavy resistance training or yoga exercise within the past 6 months
* Physician's consent to participate in strength testing and the exercise program (if deemed necessary)
* Ambulatory
* Absence of health conditions that may be exacerbated by exercise
* Good or corrected vision and hearing
* Intention to remain in the Boston area for the duration of the study
* Willingness to complete study assessments
* Ability to read, write and understand English
* Not currently enrolled in another PA study

Exclusion Criteria:

* Under 40 or over 60 years
* Pregnant or planning to become pregnant
* Moderate to high physical activity levels at enrollment (meeting CDC guidelines)
* Currently participating regularly (\>1x per week) in a heavy resistance training or yoga program
* Non-consent of physician (if deemed necessary)
* Non-ambulatory (e.g. use of walkers, wheelchairs)
* Presence of health conditions that may be exacerbated by exercise (arthritis, musculoskeletal disorders, etc.)
* Problems with vision or hearing
* Intent to move or take an extended (\>2 weeks) vacation during the testing time points (baseline, 4 months)
* Unwilling to complete study assessments
* Currently enrolled in another PA study
Exercise and Life Modification for Text-Neck

Objectives: The purpose of the study was to investigate the effects of exercise and life modification on pain and disability in "text neck".

Methods: Eighty-five participants were randomly divided into three groups: Exercise (n=29), Exercise+Life modification (n=28), and Control Group (n = 28). Pain intensity during rest, activity, and at night was evaluated with Visual Analogue Scale (VAS) and functional assessment was done by using Neck Disability Index at the beginning and at the end of 4 weeks.

Objectives: Smartphones or tablets have made an important place in our lives. However long-term use of technological tools causes postural disorders and neck pain called "text neck". The purpose of the study was to investigate the effects of exercise and life modification on pain and disability in "text neck".

Methods: Eighty-five participants with "text-neck" were randomly divided into three groups: Exercise (n=29), Exercise+Life modification (n=28), and Control Group (n = 28). First group received a home exercise program treatment for 4 weeks. Second group received life modification suggestions additional to home exercise treatment program. Control group did not receive any treatments. Pain intensity during rest, activity, and at night was evaluated with Visual Analogue Scale (VAS) and functional assessment was done by using Neck Disability Index at the beginning and at the end of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participants who were aged between 18 and 30, using technological devices as tablets and smartphones for more than 5 hours and having neck pain for more than 3 months were included in our study.

Exclusion Criteria:

* The exclusion criteria included those:

  1. who had any diagnosed pathology for neck region diagnosed by MR or BT,
  2. who had any shoulder pathology,
  3. with any neck or shoulder surgery,
  4. had whiplash syndrome,
  5. had fibromyalgia, Myofasial Pain Syndrome or vascular pathology and
  6. women who are breastfeeding.
Functional Electrical Stimulation in Cardiac Patients

The purpose of this study was to determine the effects of Functional Electrical Stimulation (FES) on physical performance and quality of life of patients in cardiac rehabilitation.

This randomized controlled trial aimed to evaluate the effects of functional electrical stimulation (FES) in patients with stage II and III cardiac rehabilitation (CR) on the variables strength, endurance and muscle tropism lower limb, functional capacity and quality of life. To this were invited to participate in the study cardiac patients registered in the database of the cardiology department of the University Hospital of Santa Maria. The sample included patients of both sexes undergoing coronary artery bypass grafting or valve replacement. The subjects were divided into two groups: placebo group (PG) or functional electrical stimulation group (FESG). To verify the effect of this intervention, before and after the protocol patients underwent the following evaluations: one repetition maximum test, sit-and-stand test, perimetry thighs, the six-minute walk test and evaluate the quality of life through The Medical questionnaire Study 36-item Short-Form Health Survey (SF-36).

Eligibility Criteria:
Inclusion Criteria:

* Patients in phase II and III of cardiac rehabilitation undergoing coronary artery bypass grafting or valve replacement

Exclusion Criteria:

* Patients with some cognitive impairment that prevents the completion of assessments, inability to understand the term of free and informed consent or with the following contraindications to the use of FES: epidermal lesions at the site of application, change of skin sensitivity or intolerance electrical stimulator;
* Patients undergoing cardiac surgery other than coronary artery bypass grafting or valve replacement;
* Patients who use pacemakers;
* Subjects with peripheral vascular changes in the lower limbs;
* Presence of comorbidities such as chronic obstructive pulmonary disease (COPD), cerebrovascular disease or skeletal muscle disease.
Cocaine Use and Outcomes of General Anesthesia

In this prospective study, investigators plan to evaluate the outcome of general anesthesia in the context of patients with a positive cocaine urine test. Patients with a positive urine cocaine test who do not appear acutely toxic and have normal vital signs may not have an increased rate of perioperative complications during elective surgery compared to similar patients with negative urine cocaine screening tests. Patients who are chronic cocaine users may have a higher anesthetic requirement.

Patients with a history of cocaine abuse who are scheduled to undergo surgery at Parkland Hospital will be asked to provide a urine sample for a screening toxicology test on the day of surgery. Patients will also be asked to fill out a questionnaire with questions pertaining to their drug use history. The remaining aspects of perioperative care, including the general anesthetic technique, will be standardized for all patients and will not differ from the standard of care. The anesthesia faculty, resident, or CRNA will identify patients and obtain consent and ask the patient to fill out the questionnaire. This prospective study is intended to enroll about 300 cocaine positive and negative patients over a 2 year period.

Blood samples will be collected for analysis of cardiac troponin T (cTnT) pre- and postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* ASA physical status classification 1 to 3
* Personal history of cocaine abuse
* Scheduled for a non-emergent operation that requires general anesthesia
* Vital signs within generally accepted ranges for normal \[HR 60-100, RR 12-20, SpO2 \> 96% on room air, BP 90-140/60-90 unless a diagnosis of hypertension is present, T 36-38 degrees)
* Willing and able to consent in English or Spanish

Exclusion Criteria:

* Age less than 18 or older than 70
* Unable to give informed consent for participation in the study
* Patient refusal
* Monitored anesthesia care (MAC) or regional anesthesia planned
* Pregnant or lactating
* Emergent surgery
* Acute cocaine intoxication based on clinical symptomatology (hypertension, tachycardia, agitation, delirium, hyperthermia)
* History of cardiac disease including coronary artery disease (CAD) and cardiac dysrhythmia
* History of stroke
* History of seizure disorder
* ESRD
* Prison patient
The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)

It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).


Eligibility Criteria:
Inclusion Criteria:

* Subjects of either sex, 14-60 years of age
* Diagnosis of Nephrotic syndrome with hypoalbuminemia (\< 3.0g/dl) and heavy proteinuria (\> 3.5g/24hr) and exclude secondary Nephrotic syndrome
* Refractory Nephrotic Syndrome

  1. Steroid resistant: failure to respond (either complete or partial remission) after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid therapy
  2. Steroid dependent: recurrence of nephrotic proteinuria during tapering of prednisone at a dose \> 10 mg/day or within the first 2 weeks after withdrawal of prednisone
  3. Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months
  4. Failure to respond (either complete or partial remission) even after CTX, MMF or CsA therapy combined with steroid
* eGFR ≥ 60 ml/min/1.73 m2
* Provision of written informed consent by subject or guardian

Exclusion Criteria:

* Systemic disease
* eGFR \< 60ml/min/1.73m2
* Diagnosed DM
* Malignant tumors (except fully cured basal cell carcinoma)
* Familial nephritic syndrome
* History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study
* Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C
* Known hypersensitivity or contraindication to tacrolimus, corticosteroids
* Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening
* Pregnancy, nursing or use of a non-reliable method of contraception
* Inability or unwillingness to provide written informed consent
* Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization or intravenous MP Pulse treatment
Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems

This is a randomized, parallel-group open-label trial to evaluate respiratory symptoms in ENDS users switching from banned flavors to a non-banned flavor (tobacco) or 'tobacco free' nicotine pouches.


Eligibility Criteria:
Inclusion Criteria:

* ENDS users as determined by: (a) using banned flavored ENDS with nicotine such as fruit, candy, dessert flavors, and/or any product that indicates such flavors (b) using ENDS daily, regularly for the past 6 months (self-reported).
* No smoking tobacco or using smokeless tobacco for the past 6 months.
* Subjects should be free of acute respiratory illness within the proceeding 30 days prior to recruitment (self-reported).
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
* After receiving information regarding the NYS flavor ban individuals must not want to quit vaping or stop using their flavored product for the next 90 days.

Exclusion Criteria:

* Individuals with health conditions and therapies that may affect immune responses and levels of inflammatory markers, including allergic rhinitis, aspirin/NSAID therapy, asthma, immunodeficiency (HIV or other), Guillain-Barre Syndrome, COPD, or fever/respiratory illness within 30 days prior to entry into study (self-reported).
* Pregnant or nursing female participants (self-reported on telephone screener, pregnancy test on Visit#1)
* Unable to communicate in English.
* Unable or unwilling to follow protocol requirements.
* Self-report having active, untreated medical/psychiatric conditions.
* History of serious side effects from nicotine or from any nicotine replacement therapies.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Vulnerable populations, such as cognitively impaired adults, individuals who are not yet adults, pregnant women, and prisoners.
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
* After receiving information about the NYS flavor ban, participants who report that they are thinking about quitting or stop using their flavor within the next 90 days.
Disrupting Fear-based Memory Consolidation

This project represents a unique collaborative opportunity to pursue the essential proof-of-principle demonstration that non-invasive interference of sensory cortical memory consolidation shortly after an emotional experience can attenuate the cued fear response and potentially reduce the risk of developing post-traumatic stress disorder (PTSD). If successful, the study results would anchor a potential advance in the treatment of patients after a traumatic event and seed future animal and clinical studies of emotional sensory cortical memory consolidation to reduce the prevalence and negative sequelae of PTSD.

This mechanistic study in humans will study an unexplored precision-based approach of non-invasive neuromodulation of sensory cortex with the aim to prevent PTSD by attenuating the sensory encoding of fear memory. The objective of this project is to explore the basic science and therapeutic potential of sensory-emotional reprogramming in humans, and translate this idea into a precise, individualized treatment to reduce the risk that negative emotional sensory experiences lead to PTSD. Understanding sensory-emotional programming in humans could anchor a breakthrough in the treatment of patients after a traumatic event and seed future animal and clinical studies of emotional sensory cortical memory consolidation to reduce the prevalence and negative sequela of PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Willingness to participate in study
* No history of musculoskeletal impairment or neurological disease
* Clinical diagnosis of PTSD for individuals in the PTSD group.

Exclusion Criteria:

* Any participant outside the age range
* Participants that show signs of dementia (score \< 20 on the Montreal Cognitive Assessment)
* Participants that have a history of major head trauma, a neurodegenerative disorder, or recent (\<6 months) substance abuse;
* Participants that had a recent history of Central Nervous System (CNS) active drugs that may influence cortical excitability or learning; or
* Participants that report contraindications to TMS or MRI - if participating in the TMS/MRI experiments
* Current psychoactive medication usage
* Current symptoms of psychosis or bipolar disorder (as indicated by study staff through a clinical interview as part of that study).
* The study will exclude adults unable to consent, individuals who are not yet adults, pregnant women and prisoners on scientific grounds and to minimize risk.
A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors

This is an open-label, single-arm, multicenter, Phase 1 study of LY3537982 as monotherapy in Chinese participants with KRAS G12C-mutant advanced solid tumors. The main purpose of this study is to determine how much of LY3537982 gets into the bloodstream and how long it takes the body to eliminate it in Chinese participants. The safety, tolerability and preliminary efficacy of LY3537982 will also be evaluated. Approximately 12 patients will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* - Native Chinese participants must be of an acceptable age to provide informed consent.
* Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1).
* Have disease with evidence of KRAS G12C mutation
* Have a histologically or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and must be appropriate candidates for study treatment.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Have adequate laboratory parameters.
* Must be able to swallow capsules or tablets.
* Estimated life expectancy ≥12 weeks

Exclusion Criteria:

* Have disease suitable for local therapy administered with curative intent.
* Have an active fungal, bacterial, and/or active untreated viral infection,
* Have a serious pre-existing medical condition(s) that would preclude participation in this study.
* Have a serious cardiac condition.
* Have untreated active symptomatic central neural system (CNS) malignancy or metastasis and/or carcinomatous meningitis.
* Have received prior treatment with any KRAS G12C small molecule inhibitor.
* Females who are pregnant or lactating.
* Have a known allergic reaction against any of the components of the study drug