cyrilzakka/clinical-trials huggingface dataset:
A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma

This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed multiple myeloma with measurable disease.
* Disease refractory to last myeloma regimen.
* Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment.
* Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
* Additional criteria exist.

Key Exclusion Criteria:

* Prior treatment with carfilzomib, filanesib, or any other KSP inhibitor.
* Past or current plasma cell leukemia.
* Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
* POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
* Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment.
* Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study treatment.
* Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study treatment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.
* Known pulmonary hypertension of any severity.
* Concurrent cardiac disease that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
* Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C.
* Acute active infection requiring treatment.
* Additional criteria exist.
Pilot Study of Nursing Touch and Biobehavioral Stress

Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit.

Preterm infants will receive one episode of essential nursing care as standard care and one episode of essential nursing care that includes a nurse-administered comforting touch intervention approximately 24 hours apart in a randomized sequence. For 10 minutes prior to the start of the two observed care episodes, during the care episodes, and for 60 minutes after the conclusion of the care episodes, researchers will measure infants' biobehavioral stress responses. When infants reach 35 weeks post-menstrual age, researchers will perform a neurobehavioral assessment.

Eligibility Criteria:
Inclusion Criteria:

* Born prematurely between 27 and 30 weeks post-menstrual age.
* Born to mothers who are English-speaking and able to provide informed consent.
* No more than 10 days old at the time of enrollment.

Exclusion Criteria:

* Diagnosed with Grade III/IV intraventricular hemorrhage or other neurologic abnormality (e.g. seizure disorder) affecting sensory perception or motor function.
* Diagnosed with a congenital anomaly requiring surgery during the neonatal period.
* Receiving scheduled steroids or vasopressors.
* Skin conditions that preclude the attachment of sensors.
* Diagnosed with Neonatal Abstinence Syndrome or born to mothers with known illicit drug use, except marijuana, during pregnancy.
* Diagnosed with chromosomal abnormalities.
* Requiring special isolation with universal gloving for potentially infectious pathogens.
SPIROCOR Coronary Outcome by Respiratory Stress Examination

The purpose of this study is to validate the accuracy of the SPIROCOR System in indicating the presence of significant coronary artery disease (S-CAD), as defined in ACC/AHA Guidelines, in subjects with suspected S-CAD.


Eligibility Criteria:
Inclusion Criteria:

* Subject with suspected S-CAD
* Subject able to perform the guided breathing protocol and comply with study requirements
* Subject is able and agrees to sign the informed consent form

Exclusion Criteria:

* Resting (supine) ECG evidence of ST-segment depression ≥ 1 mm in any lead or left bundle branch block or significant arrhythmia
* Current digoxin therapy
* Subject has severe valvular heart disease
* Subject has congestive heart failure NYHA class III/IV
* Subject has known history of myocardial infarction (ST elevation or non ST elevation)
* Subject had previous coronary revascularization: CABG or PCI
* Subject has pacemaker or ICD that controls sinus
* Morbidly obese subject (BMI ≥ 40)
* Subject has any significant medical condition which, at the investigator's discretion, may interfere with the subject's optimal participation in the study; and
* Subject is currently participating in another investigational product clinical study that the investigator believes may interfere with the outcome of this study
Comparison of Two Different Intensity Exercises on Young Women With Obesity

Obesity is one of the most common preventable public health problems. Diet regulation and exercise practices are the most commonly used methods in reducing fat tissue. There are various exercise methods applied in the weight loss process and the effects of different types of exercise modalities on body fat rate and metabolic status.The aim of our study is to determine the effects of high intensity interval exercise and moderate intensity continuous exercise on serum , omentin, leptin and adiponectin levels, anthropometric measurements used in obesity follow up, body fat percentage and their effects on the quality of sleep and life of women with obesity.

Female participants aged 18-45 with a body mass index of 30-40 kg/m² who met the inclusion and exclusion criteria were randomized into two groups using a simple randomization method using a computer. One group will perform high intensity interval exercise with an Ergoline bicycle ergometry device for 45 minutes a day, 5 days a week for 8 weeks, while the other group will perform moderate intensity continuous exercise on the same device. Peripheral venous blood samples will be taken from all participants at the beginning and end of the study, anthropometric measurements used in obesity monitoring of all participants will be taken and noted, and participants will be asked to fill out questionnaires containing questions about their sleep and quality of life. The analysis of the blood samples taken will be carried out in the Biochemistry Laboratory of Kırşehir Ahi Evran University. The data of our study will be analyzed with the statistical package program SPSS version 23.0.

Eligibility Criteria:
Inclusion Criteria:

* Female between the age of 18-45
* BMI 30-40 kg/m²
* Primary obesity

Exclusion Criteria:

* Patients with cardiac, pulmonary, endocrinological, rheumatological diseases
* Pregnancy and breastfeeding
* Using antipsychotics, antidepressants (lithium, tricyclic antidepressants, mono amino oxidase inhibitors), anticonvulsants, antihistamines, glucocorticoids, antidiabetics (sulfonylureas, insulins, glitazones) sex hormones
* Using oral contraceptives
* History of bariatric surgery
* Patients using obesity medication in the last 6 months, complying with a regular diet and exercise program
* Presence of orthopedic or neurological problems that difficulty of participate aerobic exercise training
Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction

It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.

The aim of this study is To compare the efficacy of partial trans urethral resection of the prostate versus conventional resection of the prostate in improvement of lower urinary tract symptoms related to benign prostatic hyperplasia at 6 months. The secondary objectives are to compare the impacts of partial prostatic endoscopic surgery versus conventional endoscopic surgery on ejaculatory function, lower urinary tract symptoms, Global sexual life, Urinary flow, complication related to the surgery and the rates of re-treatment.

Investigators use a non-inferiority comparative single blinded (patient) multicenter randomized clinical trial in two parallel groups (Conventional endoscopic prostatic surgery Vs Partial surgery preserving the prostatic apex.

Eligibility Criteria:
Inclusion Criteria:

* Man over 40 years old
* Indication of surgical management for BPH
* Prostate volume ≥30 cc and ≤100 cc as evaluated by ultrasonography
* IPSS score ≥12
* Qmax ≤15 ml/s
* Affiliated to French national social security system
* wish and be able to comply with planned visits
* Able to express his consent
* Signed informed consent form

Exclusion Criteria:

* Unwillingness to accept the treatment
* No pre-operative ejaculation or sexuality
* Neurological pathology responsible for micturition disorders
* History of prostatic surgery
* History of prostatic arterial embolisation
* Stenosis of the urethra
* History of prostate cancer
* History of radiotherapy or pelvic surgery
* Patient refusing the principle of partial surgery
* Life expectancy \<3 years
* Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks.
* Participation in another clinical study involving an investigational product within 1 month before study entry.
Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

Purpose of this study is to examine the effectiveness of an experimental psychotherapy (talk therapy) for the treatment of bipolar II depression. The name of this psychotherapy is Interpersonal and Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). Subjects will be randomly assigned to receive either IPSRT-BPII or the medication Seroquel (quetiapine) to manage their symptoms of bipolar II depression. Subjects will receive the assigned therapy for up to 20 weeks.

The proposed pilot study is an experimental design intended to investigate the preliminary efficacy of Interpersonal Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). A total of 56 eligible subjects with a diagnosis of bipolar II disorder will be randomly assigned to one of two treatment groups : Seroquel (n=28) or IPSRT-BPII (n=28). Following baseline assessment, all participants will undergo up to 20 weeks of their assigned treatment. Patients assigned to IPSRT-BPII who fail to respond (at least 50% reduction in HRSD-25 scores and YMRS ≤ 10) by week 12 will have Seroquel added to IPSRT-BPII. Subjects who achieve remission (defined as 3 consecutive weeks where both HRSD-25 and YMRS scores average ≤ 7) and have participated in the trial for a minimum of 12 weeks will be moved into a continuation phase where they will receive maintenance treatment (bi-monthly therapy sessions and/or pharmacotherapy) until week 20. Patients who do not achieve remission by Week 20 will be discontinued from treatment and referred for follow-up care. All subjects (remitters and non-remitters) will be assessed at 20 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Meets DSM-IV Criteria for Bipolar Disorder, Type II, currently depressed;
2. HRSD-25 ≥15
3. Age 18-65 years;
4. Able to give informed consent;
5. Women of child bearing potential will be included if they agree to use adequate contraception for the duration of the study.

Exclusion Criteria:

1. Not competent to give informed consent in the opinion of the investigator (e.g., psychotic at time of evaluation);
2. Unwilling or unable to comply with study requirements;
3. Meets DSM-IV criteria for borderline personality disorder or antisocial personality disorder;
4. Active substance abuse within the past 6 months(episodic abuse related to mood episodes will not exclude a subject);
5. Currently a high suicide risk, as assessed by an active plan and intent to behave in a way that risks ending ones life;
6. Non-English speaking;
7. Significant, unstable, medical illness that might confound symptom scores or preclude treatment with pharmacotherapy
8. Currently applying for disability because of psychiatric illness (we have found that these individuals have a vested interested in appearing to remain ill which potentially confounds outcome scores).
9. Women who are pregnant, lactating or plan to become pregnant during their study participation.
A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder

This is a Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder (MDD)


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode
* Current major depressive episode must be at least 8 weeks and no longer than 2 years in duration
* History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode

Exclusion Criteria:

* Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
* Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, major or mild neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent/ follow study directions/ or otherwise safely participate in the study, borderline or antisocial personality disorder.
* Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
* Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.
The Effects of Individualized Respiratory Exercise Device in Healthy Individuals

Respiratory exercise devices can be grouped as respiratory muscle training (RMT) devices and incentive spirometers (IS). IS can improve pulmonary ventilation using visual feedback but cannot increase respiratory muscle strength. RMT devices strengthen the respiratory muscles by their resistance mechanisms but they cannot provide visual feedback. It has been stated that RMT increases exercise performance in healthy individuals. RMT devices usually allow only one of inspiratory muscle training or expiratory muscle training. The need to acquire 2 devices for combined training increases the cost. It is seen that the RMT devices available in Turkey do not allow combined training and a significant part of them do not offer sufficient loading range.

The aims of the project are; to develop a multifunctional individualized respiratory exercise device originating in Turkey, and to analyze the clinical effects of an individualized respiratory exercise device on pulmonary function, respiratory muscle strength, and functional capacity in healthy individuals. The device to be developed in this project will be the first multifunctional respiratory exercise device originated in Turkey. The device will have the clinical features of IS and RMT devices and can be individualized according to the desired purpose. With the same device, the individual will be able to both improve the ventilation of the lungs like the IS and strengthen the respiratory muscles in the direction of inspiration and/or expiration with wide loading intervals.

A total of 46 healthy individuals will be included in the study. The healthy individuals included in the study will be randomly divided into two groups experimental group (n=23) and control group (n=23). The individuals in the experimental group will be trained with an individualized respiratory exercise device for 5 days a week for 8 weeks. The individuals in the control group will be trained with Threshold® IMT + Threshold™ PEP training for 5 days a week for 8 weeks. In both groups, pulmonary function, respiratory muscle strength, and functional capacity will be assessed before and after the 8 weeks of training.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Answering "No" to the general health questions of the Exercise Readiness Questionnaire for all

Exclusion Criteria:

* Being an amateur or professional athlete who does sports-specific training at least 2 times a week
* Having a chronic disease
* Having history of spontaneous or trauma-related pneumothorax
* Having pathologies related to the middle ear (such as tympanic membrane rupture, otitis)
* Receiving routine medical treatment other than vitamin supplements for any reason
Evaluation of Corticosteroids Use and Clinical Outcomes in Hospitalized COVID-19 Patients: A Retrospective Study

Despite the recommendations to avoid using corticosteroids systematically for hospitalized coronavirus disease of 2019 (COVID-19) patients, healthcare professionals used personalized treatments, including corticosteroids, as adjuncts to treat their patients due to their limited access to treatment options. This study aims to evaluate the use of corticosteroids among hospitalized COVID-19 patients with all-cause mortality as the primary outcome and to assess the predictors of all-cause mortality associated with the characteristics of the patients and the corticosteroid regimens adopted.

A multicenter retrospective study was performed over three months targeting 422 COVID-19 patients from six hospitals in Lebanon. Data were collected from patients' medical charts retrospectively and covered a period of one year (September 2020 to August 2021). The study sample included 422 patients, predominantly males, with 59% of cases classified as severe or critical cases. Dexamethasone and methylprednisolone were the most used corticosteroids. Around 22% of the patients died during hospitalization. After adjusting for covariates, performing a polymerase chain reaction test before admission increased the mortality rate by 424% compared to doing it at hospital admission (adjusted Hazard Ratio (aHR) 4.24, 95% Confidence Interval (CI) 1.35-13.3), with 18.11 times higher mortality rate among critical cases (aHR 18.11, 95% CI 9.63-31.05). Exposure to side effects from corticosteroids increased the mortality rate by 514% compared to others (aHR 5.14, 95% CI 1.28-8.58). In particular, the mortality rate among patients having hyperglycemia dropped by 73% compared to others (aHR 0.27, 95% CI 0.06-0.98). Corticosteroids are frequently used in treating hospitalized COVID-19 patients. The all-cause mortality rate was higher among older and critical cases and lower among smokers and those treated for more than 7 days. Research exploring the safety and efficacy of corticosteroids is required to allow better in-hospital management of COVID-19 cases.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients admitted to the hospital after a confirmed COVID-19 infection, irrespective of the stage and severity of the disease, were included in the study.

Exclusion Criteria:

* Only those receiving corticosteroids as a treatment were in the study sample, with no preferences based on race or ethnicity.
Observational Study of Travellers Pathologies

Traveling to emerging countries is associated with a significant risk of encountering health issues specific to the destination, such as gastrointestinal and respiratory infections, malaria episodes, and road traffic accidents.These conditions are associated with behavioral, geographical, or environmental risk factors. A better understanding of these factors will enable the development of targeted recommendations to minimize travel related health issues.

The main objective of this study is to determine the incidence of pathologies occurring during travel outside the metropolitan territory.

Traveling to emerging countries is associated with a significant risk of encountering health issues specific to the destination, such as gastrointestinal and respiratory infections, malaria episodes, and road traffic accidents.These conditions are associated with behavioral, geographical, or environmental risk factors. A better understanding of these factors will enable the development of targeted recommendations to minimize travel related health issues.

The main objective of this study is to determine the incidence of pathologies occurring during travel outside the metropolitan territory.

Furthermore, two key aspects from a Public Health perspective are associated with travel and the globalization of exchanges: the acquisition of emerging pathogens or pathogens with antimicrobial resistance of concern.

To study these two aspects, the EOP study includes two sub-studies called EOP-Arbo and EOP-AMR.

* EOP-Arbo : The objective of this sub-study is to determine the risk of contracting an arboviral disease during travel, as well as the factors that may favor infection. For this, blood samples will be collected.
* EOP-AMR : The objective of this sub-study is to determine the risk of contracting an antibiotic-resistant bacteria during the trip. For this, faecal samples will be collected.

Eligibility Criteria:
1. Inclusion Criteria :

   1. For all participants in the EOP study :

      * Major subject (age ≥ 18)
      * Owns a smartphone compatible with electronic data collection
      * Preparing to travel outside mainland France
      * Affiliated with or covered by Social Security or private insurance
      * Willing to participate in the EOP study
   2. For the EOP-Arbo Sub-study :

      - Subject who has consented to participate in the EOP_Arbo study.
   3. For the EOP-AMR Sub-study :

      * Subject who has consented to participate in the EOP_AMR study.
2. Exclusion Criteria:

   1. For all participants in the EOP study :

      * Travel duration ≤ 3 days
      * Travel duration \> 12 months
      * Person traveling as part of an expatriation without planned movement outside the settlement in the destination country
      * Person under legal protection or unable to express consent for participation
   2. For the EOP-Arbo Sub-study :

      - Individuals deemed clinically and/or biologically unfit by the investigator to undergo the blood samples required for the study.
   3. For the EOP-AMR Sub-study :

      * No specific exclusion criteria.