cyrilzakka/clinical-trials huggingface dataset:
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
* Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
* History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
* Partial Response or better according to IMWG criteria at the time of randomization
* Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
* ECOG performance status ≤1
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
* Not pregnant and willing to use contraception

Exclusion Criteria:

* Plasma cell leukemia
* Amyloidosis, Waldenström's macroglobulinemia
* POEMS syndrome
* Known active CNS involvement or clinical signs of myelomatous meningeal involvement
* Previous MM maintenance treatment
* Prior treatment with BCMA targeted therapy
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
* Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
National Network for Cardiovascular Genomics: Advancing Cardiovascular Healthcare for Hereditary Diseases in Brazil's Unified Health System Through a Multicenter Registry

The goal of this observational study is to develop a registry of Brazilian patients with hereditary cardiovascular diseases, combining clinical and genomic data. The main questions it aims to answer are:

Which genes are most commonly affected? What is the frequency of these genetic alterations in our population? Participants will be interviewed in routine medical care visits and their DNA will be sequenced.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of a hereditary cardiovascular disease according to current clinical guidelines
* Agree to receive genetic counseling
* Sign informed consent form
* Provide the information required in the case report form

Exclusion Criteria:

* Signature absent from informed consent form
* Inadequate buccal swab (sample may be collected twice)
Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality

Reduced quality of vision and glare in twilight or night are frequently mentioned complaints within the optometric examination. A reason for these problems could be a myopic refractive shift in dark light conditions, commonly known as night myopia or twilight myopia.

The aim of this study was to investigate whether quality of vision in twilight or night could be improved by a spectacle correction optimized for mesopic light conditions. Moreover, objective refraction in large pupils measured by aberrometry was compared to subjective mesopic refraction.

After obtaining informed consent, aberrometry was performed in a darkened room (0.1 lux). Subjective photopic refraction and visual acuity were measured before light was turned off and mesopic refraction was obtained after a dark adaptation period of five minutes. Finally, frames and lenses were fitted by a centration system. Lens grinding was executed centralized by a grinding workshop. In the course of this study, subjects were randomly assigned to wear two glasses double-masked in turn. One with photopic subjective refraction data and another with mesopic subjective refraction data. Both were worn for 14 ± 2 days each.

Follow Up 1:

After two weeks, participants were asked for their subjective experiences with the first correction by a visual analogue scale questionnaire. After the evaluation, glasses were changed.

Follow Up 2:

Two weeks later, subjective experiences were evaluated again. After visual analogue scale questionnaire, subjects were asked to compare the two glasses concerning quality of mesopic vision and subjective safety level during night driving.

Eligibility Criteria:
Inclusion Criteria:

* Visual Acuity at least 0.8 (5/6)
* Binocular Vision

Exclusion Criteria:

* refraction more than sph +/- 6 D and cyl 2 D
* Difference between habitual correction and actual refraction more than 0.5 D
* Medication with an influence on visual system
* Disease or eye disease with an effect on the visual system
* pregnancy or other hormonal variances
* influence of drugs
* mental handicap
Cervical Lidocaine for Intrauterine Device Insertion Pain

The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be assessed using a visual analog scale prior to insertion. Using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.

Double blind randomized controlled trial.

Primary outcome: Pain reported on Visual Analog Scale (VAS) Intervention: 2% lidocaine gel at the tenaculum site and intracervical prior to intrauterine device placement

Eligibility Criteria:
Inclusion Criteria:

* age 18-45 yrs
* selecting intrauterine device contraception
* able and willing to consent

Exclusion Criteria:

* non-English speaking
* current intrauterine device use
* expulsion of intrauterine device within 2 weeks
* allergy to lidocaine or water based lubricant
Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects

The purpose of this study is to evaluate the safety profile, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) following single and multiple oral doses of BMS-963272 in healthy subjects.

Study Classification: Safety, PK/PD

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
* Body Mass Index (BMI) of 27 to 40 kg/m2 inclusive. BMI = weight (kg)/ \[height (m)\]2
* Females (not of childbearing potential and males, ages 18 to 55 years, inclusive. Female subjects must have documented proof that they are not of childbearing potential
* Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
* Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat.

  i)PR ≥ 210 msec ii)QRS ≥ 120 msec iii)QT ≥ 500 msec iv)QTcF ≥ 450 msec
* Positive urine screen for drugs of abuse
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
* Moderate anemia (hemoglobin \< 11 g/dL for men and \< 10 g/dL for women)
* aspartate aminotransferase (AST) \> 1.3x ULN
* alanine aminotransferase (ALT) \> 1.3x ULN
* Total bilirubin \> 1.3x upper limit of normal (ULN)
* estimated glomerular filtration rate (eGFR) \< 90 ml/min/1.73 m2 (calculated using CKD-EPI formula)
* HbA1c \> 6.5%
* Fasting total cholesterol \> 300 mg/dl
* Fasting triglycerides \> 400 mg/dl
* Systolic blood pressure \> 160 mm Hg and/or diastolic blood pressure \> 95 mm Hg, confirmed by repeat measurement
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
* History of lactose intolerance
Effect of Neurodynamic Exercises and Education Program Applied With Virtual Reality Assisted Telerehabilitation Method in Conservative Treatment of Carpal Tunnel Syndrome

The aim in this prospective, randomized and controlled, single-blind study; In the conservative treatment of patients diagnosed with carpal tunnel syndrome, to investigate the effects of neurodynamic exercises that applied with nonimmersive virtual reality technology and patient education program presented by the telerehabilitation method on pain-numbness, functional status and quality of life, to compare the effects of neurodynamic exercises that applied with traditional methods and standard education given to patients in outpatient clinic conditions on the same parameters.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Being diagnosed with CTS clinically and electrophysiologically

Exclusion Criteria:

* \<18 years or \>65 years
* Distal motor latency \> 6.0 msn.
* Thenar atrophy
* Surgery history for CTS
* Steroid injection for CTS
* Physical treatment for CTS in the last 6 months
* Cervical radiculopathy
* Tenosynovitis
* Peripheral polyneuropathy
* Another compressive neuropathy in the ipsilateral upper extremity
* History of trauma/fracture to the hand-wrist region
* Pregnancy
* Metabolic disease
* Rheumatic/autoimmune disease
* Kidney failure
* Lack of internet access
* Not having the equipment to make video calls at home
Tele-Clinic Visits in Pediatric Marfan Patients Using Parental Echo: The Future?

Marfan syndrome (MFS), a connective tissue disorder seen in 1 in 3,000 individuals, causes progressive aortic root dilation that can result in aortic dissection and sudden death. Clinical care focuses on monitoring the aortic root by serial echocardiography (echo) to guide medical treatment and elective aortic root surgery in a specialized clinic every 6-12 months. This monitoring protocol, coupled with surgical intervention, has doubled the median life expectancy which was previously only 32 years. However, this surveillance carries significant health care costs at \>$50 million dollars/year on echos alone (at $3-4K each) in children and adolescents in the US, as well as substantial burden on families residing far from specialized centers. A clinic visit delivered to MFS patients via live-video conferencing at home (tele-visit) could shift this paradigm, if a home echo could be obtained.

Here, the investigator will train parents of Pediatric Marfan patients to take echo images using a hand held device, height, weight, blood pressure, medical history, and listen to the heart of their child. Then, the investigators will ask them to take the equipment home and collect the same data at home during a tele-clinic visit, with further instruction by the study team through secure live-video conferencing.

In the proposed intervention, every patient (n=60) will have a tele-visit and an on-site clinic visit 1 day apart. Parents will have a 1-hour hands-on training session to acquire basic echo images on their children with the same hand-held device that will be used during the tele-visit. Tele-visit elements will include interim medical history by the parent and patient, and weight, height, vital signs, digital cardiac auscultation, and home echo (transferred via Internet for remote interpretation), all obtained by the parent. Two MFS physicians, following our routine MFS care protocol, will administer either the tele-visit or on-site clinic visit, masked to the findings of the other. Two independent echo readers will analyze home and clinic echos to measure reproducibility.

Eligibility Criteria:
Inclusion Criteria:

* 5-19 years of age (patient)
* seen in at least 2 prior clinic visits
* Marfan syndrome by revised Ghent criteria
* presence of parent at home

Exclusion Criteria:

* prior aortic surgery
* known cardiomyopathy
* known arrhythmia
* aortic root \> 4.5 cm in prior clinic visit
* pregnancy
Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury

This study is non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection, in subjects with acute spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* At the time of consent (whether oral or written consent), the patient's age is over 18 years old and under 89 years old
* Patients who have suffered a cervical spinal cord injury within the past 78 hours whose AIS classification was A at 66 - 78 hours after injury-Written informed consent has been obtained

Exclusion Criteria:

* The injury site is C1-C2 or C2-C3
* The patient cannot start rehabilitation necessary for recovery of function at an early stage, for example because tracheal intubation, tracheotomy, or mechanical ventilatory support is necessary
* It is predicted that it will not be possible to administer the first dose of the study drug within 78 hours after the cervical spinal cord injury
* A history of SCI (Spinal cord injury), or abnormal findings in the spinal cavity or marked breakdown of the meninges other than SCI
* Efficacy and safety cannot be evaluated properly due to such as concurrent multiple external trauma or concurrent organ injury
* High dose steroid therapy administered for spinal cord injury
* Disease such as serious liver disorder, renal disease, heart disease, blood dyscrasia, metabolic disease, or infections requiring systemic therapy
* History of malignant tumor
* Participation in a clinical study or research of pharmaceuticals or medical devices within 1 month before registration
* Drug allergies to drugs that will be (or may be) used
* Administration of the study drug to the site of spinal cord injury is inappropriate for a reason such as intrathecal infection or intrathecal mass
* Problems with the subject's ability to give informed consent in person
* The subject is breastfeeding or possibly pregnant
* The subject cannot be expected to survive more than 180 days after the start of administration of the study drug, in the judgement of the investigator
* It is inappropriate for the subject to be included in the study, in the judgement of the investigator
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC

This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Have previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Staging should be based on the 8th edition of the AJCC/UICC staging system
* Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
* Adequate tumor tissue sample blocks for central programmed death-ligand 1 (PD-L1) testing
* Measurable disease as defined by RECIST v1.1
* Adequate organ function
* Women of childbearing age without sterilizing or male, must agree to use contraception or practice abstinence at least 180 days after the last dose of study treatment

Exclusion Criteria:

* Any previous systematic anti-cancer therapy for lung cancer
* With active, known or suspected autoimmune disease of autoimmune disease
* Malignancies other than NSCLC within 5 years prior to randomization
* Has or suspected has a history of pneumonitis /interstitial lung disease or any serve lung diseases which will influence the examination of lung function
* Significant history of cardiovascular and cerebrovascular disease
* Significant haemorrhagic disease
* Has an arteriovenous thrombotic events
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known active Hepatitis B or Hepatitis C
* Allergic to monoclonal antibodies or other protein drugs
* Allergic to the intervention regimens
* Pregnant or lactating women
* Has known psychiatric or substance abuse disorders
* Confirmed COVID-19 infection or suspected COVID-19 infection or close contact with a person with known or suspected COVID-19 infection.
Influence of Fast and Slow Imagined Muscle Contractions on Muscle Function or Central Nervous System Properties

The goal of this randomized clinical trial is to learn if imagining fast or slow muscle contractions causes different responses for nervous system excitability and muscle function in young, healthy males and females in. The main questions are:

Does imagining fast muscle contractions cause greater nervous system excitability compared to imagining slow muscle contractions?

Does imagining fast muscle contractions increase muscle function compared to imagining slow muscle contractions?

A control condition (rest) will be compared with two intervention conditions: imagining fast and imagining slow conditions, to determine if the fast and slow increase outcomes more than control and if fast has the greatest response.

Participants will:

* Attend 4 laboratory visits
* Perform 50 imagined contractions fast or slow, but with no physical movement
* Physical muscle contractions and non-invasive brain stimulation would be completed before and after each condition.

Participants will complete 4 laboratory visits in a randomized order, including a familiarization session, a control condition, and 2 conditions involving imaginary muscle contractions. During visits involving imaginary muscle contractions, participants will complete 2 sets of 25 repetitions of either fast (i.e., less than 1 second to peak torque increase torque as fast as possible) or slow (i.e., 3 seconds to peak torque) isometric elbow flexions. Before and after each condition, single-pulse transcranial magnetic stimulation will be delivered to the primary motor cortex to measure the amplitude of motor-evoked potentials and the duration of the resulting silent periods in the bicep brachii to quantify changes in corticospinal excitability and inhibition, respectively. Rapid maximal voluntary isometric contractions will be used to measure changes in rate of torque development, peak torque, and rate of muscle activation.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 - 30
* Healthy (no medical conditions)
* If female, must be taking the same monophasic oral contraceptive for the past 6 months
* Have a body mass index between 18.5 - 30 kg/m2
* Have not performed structured cardiovascular or resistance exercise in past 3 years
* Be right-handed
* Not currently taking stimulants, antipsychotic, anxiety, or depression medications
* Have not suffered an upper extremity musculoskeletal injury within the past year

Exclusion Criteria:

* If transcranial magnetic stimulation (TMS) is not deemed appropriate depending on your responses to the TMS-specific questionnaire
* Being ambidextrous
* Although rare, you will be excluded if discernable muscle activation responses are not possible via TMS
Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department

This study evaluates the efficacy of melatonin 5mg in the prevention of Delirium in the older adults in emergency department. Half of the participants will receive melatonin 5mg and the other half will use a starch-based placebo.

Melatonia is useful for the treatment of sleep disorders due to the interruption of the circadian rhythm, secondary to alterations caused by the environment. The doses of 5 to 10mg oral or sublingual can improve the quality of the sleep-wake cycle and alertness in short-term use.

Mechanism of action of melatonin are:

1. Binding to membrane receptors: MT1 and MT2 coupled to G protein
2. - Union to nuclear receptors.
3. - Interaction with cytosolic proteins.
4. - Antioxidant of direct and indirect action.
5. - Interaction with mitochondria.

Melatonin circulates 80% bound to albumin and the rest in free form in plasma, 85-90% is metabolized by 6-hydroxymelatonin in the liver, which is then conjugated with sulfuric acid (70-80%) or glucuronic ( 5-3%), and is excreted in urine and feces.

Melatonin and its metabolites act as catalytic antioxidants to safeguard mitochondrial electron transfer reactions, therefore, increases the efficiency of energy metabolism. Melatonin synthesis decreases significantly as age progresses and changes in the circadian cycle have been associated with accelerated aging.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 60 who enter the emergency department with a stay in the ward for more than 8 hours and who will remain hospitalized for more than 48 hours due to admission pathology.
* Patients who agree to participate in the study by signing an informed consent (Signature by patient and / or family member).

Exclusion Criteria:

* Patients with a history of dementia or previous neurological diseases.
* Patients with a history of psychiatric disorder.
* Patients diagnosed with any type of liver disease.
* Warfarin treatment.
* Delirium data on admission to the emergency department.
* Patients under invasive mechanical ventilation and sedation.