cyrilzakka/clinical-trials huggingface dataset:
A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer

This research study is done to test the safety of the drug larotrectinib in adult cancer patients. The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells. The study also investigates how the drug is absorbed and processed in the human body. This is the first study to test larotrectinib in humans with cancer, for whom no other effective therapy exists.

The trial will be conducted in 2 parts: an initial dose escalation phase of larotrectinib in subjects with advanced solid tumors will be followed by an expansion phase in subjects with solid tumors having a NTRK fusion.

The objectives of the study are to determine the safety, pharmacokinetic profile, recommended dose and efficacy of orally administered larotrectinib in patients with NTRK fusions.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists
* Proof of a malignancy harboring a NTRK fusion
* Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 and a life expectancy of at least 3 months
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible
* Clinically significant active cardiovascular disease or history of myocardial infarction
* Active uncontrolled systemic bacterial, viral, or fungal infection
* Current treatment with a strong CYP3A4 inhibitor or inducer
* Pregnancy or lactation
Accurate Test of Limb Isometric Strength (ATLIS) in ALS

A strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure static limb strength in patients with ALS. The investigator will compare ATLIS data with data from the commonly used ALS outcomes measure, the ALS Functional Rating Scale-Revised (ALSFRS-R), as well as an exploratory measure, electrical impedance myography (EIM), in a prospective, longitudinal study. Both outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.

Cedars-Sinai Medical Center will enroll and collect data on 100 subjects. Subjects will ideally be tested every 1 to 4 months according to each patient's site visit schedule. Subjects will be tested at each visit using ATLIS, the ALSFRS-R questionnaire and EIM.

Eligibility Criteria:
Inclusion criteria:

* Subjects 18 years or older diagnosed with clinically possible, laboratory supported probable, probable or clinically definite ALS according to the World Federation of Neurology Revised El Escorial Criteria.
* Capable of providing informed consent and complying with trial procedures.
* Active movement of at least two limbs at the time of study entry
* Intend to routinely attend clinic for neurological care at the clinical site

Exclusion criteria:

* Patients, judged by the site clinical investigator to have medical conditions that may limit their ability to safely exert maximal force using the muscles in their arms and legs will be excluded from this study (e.g. unstable hypertension, significant cardiac disease, significant musculoskeletal disorders, or other medical conditions).
* Patients judged by the site clinical investigator to have significant clinical evidence of unstable medical or psychiatric illness will be excluded.
Assessing Electronic Cigarette Nicotine Flux

The purpose of this study is to determine differences in nicotine delivery, use behavior, carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.


Eligibility Criteria:
Inclusion Criteria:

* healthy (determined by self-report)
* between the ages of 18-55
* willing to provide informed consent
* able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria:

• Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection

The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.


Eligibility Criteria:
Inclusion Criteria:

* Antibiotic therapy for a minimum of 3 days and a maximum of 14 days
* Expected to remain hospitalized for a minimum of 5 days
* Patients who have received less than 36 hours of antibiotic therapy
* Negative pregnancy test at screening
* Obtained his/her informed consent after verbal and written information
* Patients having a telephone available (mobile, work, home)
* Patients having a fridge at home

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients presenting with active diarrhea (3 or more liquid stools per 24 hour period).
* Patients with a history of daily consumption of probiotics, fermented milk and/or yogurt;
* Patients known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. Non-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetal source), ascorbic acid, Colloidal silicon dioxide)
* Patients presenting with an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
* A previous documented C. Difficile infection \< 3 months prior to study initiation ;
* Ostomized patients, parenteral nutrition users
* Patients with an immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, acquired immune deficiency syndrome (AIDS))
* Ongoing or recent use of antibiotic therapy in the 30 days prior to the study product first administration.
* Patients with planned administration of antibiotics other than broad spectrum Penicillin, Cephalosporin or Clindamycin for the treatment of an infection;
* Patients with concomitant participation in another clinical trial;
* Patients who are not likely to comply with study requirements
De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx

This is a single-arm, observational registry study determining the effects of reduced radiation dose in select patients with human papillomavirus (HPV) positive oropharyngeal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry. Numerous studies have demonstrated near 100% agreement between p16 and HPV for patients with oropharyngeal cancer. As such, the use of p16 has been accepted as an appropriate surrogate for HPV status.
* Clinical stage I, II, or III disease (AJCC Eighth Edition); Note: Patients with M1 tumors (distant metastases) are not eligible;
* History/physical examination within 6 weeks prior to registration, including assessment of weight and recent weight loss;
* Age ≥ 18;
* PET/CT within 6 weeks prior to registration;
* Patients must sign a study-specific informed consent form prior to study entry.
* Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.

Exclusion Criteria:

* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
* Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded;
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
* Receipt of prior radiotherapy that would result in overlap with proposed field.
Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Injury During Cardiopulmonary Bypass

Remote Ischemic Preconditioning(RIPC) and remote ischemic postconditioning(RIPoC) seems to have a protective effect during ischemic period. Using cardiopulmonary bypass(CPB) during open heart surgery reduces pulmonary blood flow and may cause ischemic damage to lung tissue. The investigators anticipate that RIPC and RIPoC may reduce lung injury after CPB.

Cardiopulmonary bypass(CPB) can cause lung function deterioration through various mechanisms. Lung parenchymal tissue ischemia resulted by pulmonary atelectasis and decreased bronchial circulation during CPB is one of the reasons. There were few studies reported that RIPC and RIPoCcan benefit lung function of children or infant after CPB, but studies about adults are still lacking.

Purpose:

The purpose of this study is to evaluate effect of RIPC and RIPoC on the lung function after CPB.

Methods:

Patients will randomly allocated either in study group or control group. Study group will receive RIPC and RIPoC maneuver before and after CPB. Control group will have same automated cuff around their arm but it will not activated. Care givers will be blinded whether the automated cuff is on or not.

We will compare pulmonary parameters (PaO2/FiO2, dynamic and static compliances, Intrapulmonary shunts, etc.) between study group and control group, and check levels of plasma cytokines(IL-4, IL-8, IL-10, TNF-alpha) till 24hr after the operation.

Eligibility Criteria:
Inclusion Criteria:

* those who aged 18-80 years old and planned to undergo elective open heart surgery using cardiopulmonary bypass

Exclusion Criteria:

* emergent operation
* preoperative use of inotropics or mechanical assist device,
* left ventricular ejection fraction less than 30%,
* severe liver, renal disease,
* recent myocardial infarction (within 7 days),
* recent systemic infection or sepsis (within 7 days)
* peripheral vascular disease affecting upper limbs
* amputation of the upper limbs
* major combined operation such as aortic surgery or carotid endarterectomy
* descending thoracic aortic surgery
* rare surgeries; cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, etc
* significantly decreased pulmonary function before the planned surgery (e.g. using ventilator, oxygen therapy, tachypnea, orthopnea, active lung lesion on chest X-ray, FEV1/FVC less than 50% of predicted level, PaO2 less than 80 mmHg)
* intracardiac shunt
* severe pulmonary artery hypertension
* systemic or local steroid therapy
The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In brain tumor resection craniotomy, it is proven to be effective in improving postoperative hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives postoperative pain. In addition, many animal experiments show that DEX inhibits the proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral focal ischemic region (penumbra). However, the neuroprotective effects were never investigated clinically in patients undergoing brain tumor resection surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective craniotomy for supratentorial brain tumor resection or cerebral vascular surgery
* age between 20 to 80 yr

Exclusion Criteria:

* Fever, elevated white blood cell or C-reactive protein
* Impaired liver function, eg. AST or ALT \>100; liver cirrhosis \> Child B class
* Impaired renal function, cGFR\< 60 ml/min/1.73 m2
* Cardiac dysfunction, such as heart failure \> NYHA class II
PRimary Prevention Of Depression in Offspring of Depressed Parents

The purpose of this randomised controlled trial is to see whether a group-based psychological intervention for families can reduce the inflated risk of depression in children and adolescents who have at least one parent who suffers from depression (or who has suffered from depressed in the child's lifetime).


Eligibility Criteria:
Inclusion Criteria:

* At least one parent who meets diagnostic criteria for a current (or past, during the child's lifetime) diagnosis of depression
* The participating child is aged 8-17
* The participating child has an IQ of at least 85
* Both child and parent(s) have adequate German-language skills
* Both child and parents consent to intervention sessions being video-recorded

Exclusion Criteria:

* The participating parent(s) has current symptoms of bipolar disorder, psychotic symptoms, personality disorder, substance addiction, or is suicidal
* The participating child meets criteria for a current, or previous, episode of any psychiatric disorder
* The participating child is undergoing or has undergone treatment for depression
* The participating child or parent have serious symptoms of a disorder (or are in crisis) that may hamper their ability to take part in the study
Black Women's Life Experience On Cardiovascular Health Via Ongoing Monitoring

This pilot study uses a state-of-the-science combination of remote behavioral monitoring, real-time experience sampling, in-lab physiological assessments, and extraction of neighborhood-level characteristics to (1) Examine the impact of daily experience (i.e., racial discrimination, affective states, stress) on health behaviors (i.e., physical activity, sedentary behavior, sleep) at the intrapersonal level among Black women; (2) Test the association between daily behaviors and impairments in biomarkers associated with vascular function/health (i.e., augmented systemic inflammation and oxidative stress, impaired peripheral/cerebral vascular function, increased large artery stiffness), as well as the impact of daily experience on the relationship between behaviors and vascular function; and (3) Explore the influence of neighborhood-level characteristics (i.e., social environment factors: i.e., neighborhood income and poverty, racial composition; and built environment context, such as park density and walkability) on daily experience and health behaviors.


Eligibility Criteria:
Inclusion Criteria:

* born and identified as female;
* between 18-49 years old;
* self-identify as Black or African American;
* not currently pregnant;
* ownership of a smartphone with Internet access;
* able to speak and read English

Exclusion Criteria:

* diagnosed hypertension, cardiovascular, respiratory, metabolic, and/or neurological disorders;
* functional limitations or health issues that preclude physical activity;
* currently taking medications for thyroid function or psychological conditions such as depression, anxiety, and mood disorders;
* current use of oral or inhalant corticosteroids for asthma;
* have regularly smoked within the last 2 years.
Predictors of Pain Relief From Mindfulness-based Stress Reduction (MBSR) in Multiple Forms of Chronic Pain Patients

The overall objective of this study is to better understand how Mindfulness-based Stress Reduction (MBSR) is the most helpful in terms of management of chronic pain symptoms.

The studies hypothesis is that an Interventional Response Phenotyping study (light phenotyping) can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic pain disorders.

Participants enrolled in this study will receive 8 weeks of MBSR therapy and complete surveys at various time points pre-treatment - post treatment.

Eligibility Criteria:
Inclusion criteria for MBSR Study

* Ages 18+
* Any form of self-reported chronic pain (except cancer related pain)

Exclusion criteria for MBSR study

* Unable to speak and write English
* Visual or hearing difficulties that would preclude participation
* Chronic pain from cancer.
The Relationship Between Haemorrhoids and Pelvic Vein Reflux

This case series aims to find out in a group of female patients suffering from haemorrhoids, how many of them have pelvic vein reflux that feeds into their haemorrhoids.

This will be done by examining their ovarian and internal iliac veins for reflux, using a transvaginal scan.

Based on previous research, we believe that haemorrhoids could be caused by faulty valves in the veins running from deep within the pelvic region to the lower part of the abdomen (internal iliac veins)resulting in reflux in the tributaries.

We have already presented research showing that patients with severe pelvic vein reflux, particularly of the internal iliac veins and tributaries, are associated with a higher chance of haemorrhoids.

The aim of this study is to see in a group of patients suffering from haemorrhoids, whether all of them exhibit pelvic vein reflux feeding into the haemorrhoids.

If we are able to prove that either all or the vast majority of patients with true haemorrhoids do have pelvic vein reflux feeding into them, this will support our hypothesis that the internal iliac vein and tributary reflux is causative of haemorrhoids.

following this, in a future study we will treat internal iliac vein and tributary reflux to see if the results of haemorrhoid treatments are improved.

If we find only a few patients with haemorrhoids have associated internal iliac vein and tributary reflux feeding into the haemorrhoids, we will be able to refute the hypothesis that there is a causative association, and will not need to progress with the studies and will look instead for a different aetiology.

At the current time, there is no effective way of investigating male pelvic vein reflux. The gold standard investigation for pelvic vein reflux is transvaginal duplex ultrasound scan. As such this study will be restricted to females presenting with symptomatically haemorrhoids who are able and willing to undergo transvaginal ultrasound scan to assess their pelvic veins.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Symptomatic haemorrhoids
* Being able and willing to undergo transvaginal ultrasound scan to assess their ovarian and internal iliac veins
* Aged between 18 and 80 years
* good understanding of written and spoken english

Exclusion Criteria:

* male
* aged younger than 18 or older than 80
* Those unwilling to attend for a transvaginal scan at The Whiteley Clinic, Guildford
Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening

This is a pilot study to test the feasibility of using gene expression from saliva to identify patients with early-stage non-small cell lung cancer (NSCLC).

The primary objective of this study is to compare gene expression profiles from saliva from healthy controls and patients with early-stage non-small cell lung cancer.

To be eligible, patients with non-small cell lung cancer, must not yet have received treatment for their cancer (surgical removal, chemotherapy, or radiation therapy). Health control participants may participate if they meet eligibility criteria listed below.

Eligible enrollees will be asked to submit a one time saliva sample and complete a study questionaire.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with untreated stage I-II NSCLC OR Healthy control subjects: with a \> 20 pack year history of cigarette smoking OR Never smokers (defined as less than 100 cigarettes over subject's lifetime)

   * The investigators recognize that pathologic confirmation is not always available prior to surgical resection of a lung mass. To account for this, subjects with a suspicious lung mass concerning for lung cancer, can be enrolled on this trial, and submit a saliva sample prior to surgical resection (ideally within 45 days of planned surgery).
2. Adults age 40-79
3. Ability to understand the investigational nature of the study and sign the informed consent in accordance with institutional and FDA guidelines

Exclusion Criteria:

1. No active pulmonary infection, i.e. bronchitis or pneumonia for 6 months
2. No use of steroid inhalers for \> 6 months
3. No other prior malignancy is allowed except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancers from which the patient has been disease-free for 5 years
Single Ascending Dose Study of CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia

To evaluate the safety and tolerability of single ascending doses of CTI-1601 in participants with Friedreich's ataxia

Single Ascending Dose (SAD), Double-Blind, Placebo Controlled Study.

To evaluate the safety and tolerability of single ascending doses of CTI-1601 in subjects with Friedreich's ataxia.

Secondary Objectives:

1. To evaluate the pharmacokinetics (PK) of CTI-1601 following increasing single doses of subcutaneously (SC) administered CTI-1601.
2. To evaluate the pharmacodynamics (PD) of CTI-1601 following increasing single doses of SC administered CTI-1601.

CTI-1601 or Placebo - Dose/Mode of Administration: Single Dose/Subcutaneous

Eligibility Criteria:
Inclusion Criteria:

1. Subject has genetically confirmed Friedreich's ataxia diagnosis, homozygous GAA repeat expansions, with repeat sizing (if available) included on diagnostic report.
2. Subject is male or female, 18 years of age or older at screening.
3. Subject must have a mFARS_neuro score ≥ 20 and be able to traverse a distance of 25 feet with or without some assistive device (cane, walker, crutches, self-propelled wheelchair) and (a) be able to sit upright with thighs together and arms crossed without requiring support on more than two sides; (b) be able to transfer from bed to chair independently or with minimal assistance if, in the opinion of the investigator, the degree of physical disability does not result in undue risk to the subject while participating in the study; and (c) perform basic daily care, such as feeding themselves and personal hygiene, with minimal assistance.
4. Subjects must weigh \> 40 kilograms (kg).

Exclusion Criteria:

1. Subjects who are confirmed as compound heterozygous (GAA repeat expansion on only one allele) for Friedreich's ataxia.
2. Subject requires use of amiodarone.
3. Subject used erythropoietin, etravirine, or gamma interferon within 3 months prior to screening.
4. Subject use of investigational drug (other than CTI-1601) or device within 90 days prior to screening.
5. Subject use of daily biotin supplementation that exceeds 30 mcg/day, either as part of a multivitamin or as a standalone supplement, within 7 days prior to study drug administration and/or throughout the entire study.
6. Subject has clinically significant arrhythmia on electrocardiogram (ECG), or evidence of predisposition to significant ventricular arrhythmia on ECG, or evidence of active and unstable coronary artery disease.
7. Male subject who has an ECG QTcF \> 450 milliseconds or female subject who has an ECG QTcF \> 470 milliseconds.
8. Subject has a screening echocardiogram ejection fraction \<45 percent.
9. Subject has a history of aspiration, aspiration pneumonia, or recurrent episodes of pneumonia (greater than or equal to 2 episodes of pneumonia) within the last 12 months.
10. Subjects with known or suspected chronic use of cannabinoid products.