cyrilzakka/clinical-trials huggingface dataset:
Study of Selinexor (KPT- 330), Lenalidomide, & Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients

This is an open-label, randomized clinical study with two stages to assess the maximum tolerated dose (MTD), efficacy, and safety of selinexor, lenalidomide, and dexamethasone (SLd) in patients with relapsed/refractory (RR) multiple myeloma (MM). The stages are dose escalation (Phase 1) and expansion (Phase 2).

In Phase 1 (Dose Escalation), patients will be randomized to either once-weekly (Arm A) or twice- weekly (Arm B) dosing with selinexor. Dose escalation will be performed within each arm for both lenalidomide and selinexor to determine the selinexor MTD for that arm. Each arm will be expanded until approximately 17 patients have been treated at the MTD in each arm. The Sponsor and Investigator will review the MTD, efficacy, and safety data from Phase 1 to determine which dose schedule (Arm A or B) to be used as the RP2D dose in the Expansion Phase.

In Phase 2 (Expansion), patients who had received the MTD dose that was nominated for RP2D will continue at the same dose. Patients who did not receive the RP2D for that arm will stay on their Phase 1 dose. Additional patients will be accrued, as needed, to achieve the target population size of approximately 34 patients at the RP2D.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis, measurable disease and evidence of disease progression of MM.
* Relapsed or refractory to the most recently received therapy. Relapsed is defined as documented evidence of PD after achieving at least SD for ≥ 1 cycle. Refractory disease is defined as ≤ 25% response (i.e., patients never achieved minimal response or better) or progression during therapy or within 60 days after completion of therapy.
* Symptomatic MM, based on IMWG guidelines. Patients must have measurable disease.

Exclusion Criteria:

* Smoldering MM.
* Multiple myeloma that does not express M-protein or FLC (i.e., non-secretory MM is excluded), and quantitative immunoglobulin levels cannot be used instead.
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
* Active MM involving the central nervous system (CNS).
Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors

Benign ovarian cysts are frequent during women's life. They are diagnosed with pelvic pain or fortuitously during an ultra-sonographic exam. In case of persistence,a surgery will be necessary to identify the nature of the cyst and assess its benignity. In some case, cysts are recurrent and multiple surgeries are needed leading to a significant risk of ovarian damage by follicular depletion. Oocyte cryopreservation is no longer considered as an experimental technique of Fertility Preservation since 2013 as it has been recognized to be efficient and safe. According to reproductive medicine scientific committees and the French ethic law, fertility preservation has to be proposed in every situation of infertility risk. To date, there is no cohort study dedicated to fertility preservation by oocyte freezing in this specific subgroup of patients. The purpose of the study is to prospectively evaluate the oocyte number and quality after controlled ovarian hyperstimulation in patients with recurrent ovarian cysts.


Eligibility Criteria:
Inclusion Criteria:

* women with benign ovarian tumor with high risk of recurrence, i-e, endometrioma, dermoid cysts or mucinous cysts.
* women with previous surgery and/or high risk of ovarian damage: bilateral cysts, cyst diameter higher than 5 cms
* Having a social insurance
* Able to give an informed consent

Exclusion Criteria:

* Borderline tumors
* Undetectable AMH levels
* Personal history of thrombo-embolic events
* pregnancy
COVID-19 Impact on Rheumatic Patients

A study to assess the impact of coronavirus disease 2019 (COVID-19) pandemic on the attitude, behaviour and mental health of rheumatic patients and to compare them with healthy individuals.

To assess the impact of coronavirus disease 2019 (COVID19) pandemic on the attitude, behaviour and mental health of rheumatic patients and to compare them with healthy individual. This is cross-sectional survey, 360 participants were included and divided into cases group composed of 180 patients with rheumatic diseases and control group composed of 180 healthy people. Data were collected via a self-administered structured questionnaire (Google form) which was sent to participants via social networks and emails to different rheumatic patients and healthy individuals. Mental health was measured by the five-item Brief Symptom Rating Scale (BSRS-5).

Conclusion: Mental health should be addressed in the same manner we deal with the infectious disease itself, being of no less importance. It is essential for mental health professionals provide psychological support to vulnerable populations, including the infected and chronically ill patients and their families, individuals, communities and health care workers.

Eligibility Criteria:
Inclusion Criteria:

* adult patient with diagnosed rheumatic disease

Exclusion Criteria:

-
Clinical Outcomes From Patient Self-management of Antivitamin K Treatment

ORION is a retrospective, observational, one center study to evaluate the incidence of complications (both thromboembolic and bleedings) in a cohort of patients receiving Vitamin K antagonists (VKA) under a self-management program, since 2002 at the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain)


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (older than 18) under chronic VKA treatment, whom performed patient self-management for any indication of oral anticoagulation.
2. Signed informed consent

Exclusion Criteria:

1. Patients younger than 18 years old
Study of Therapeutic Targets Tailored Ch and IMRT as Neoadjuvant Treatment in Rectal Carcinoma Patients

The parameter that best correlates with 5 years disease-free survival (DFS ) in patients (pts) with localized rectal cancer (RC) is the pathological TNM staging (ypTNM) after chemo-radiotherapy (Ch-RT). DFS is 97% in pts with ypT0N0M0 = ypCR and 42% in pts with ypN +. Standard 5-FU Ch-RT achieves 15% of ypCR. The use of IMRT achieves a high proportion of ypCR . This study aimed to demonstrate in a prospective manner the feasibility of personalizing Ch regimen base in TT in combination with IMRT in patients with RC. Secondary objectives included the number of ypCR and safety.

The parameter that best correlates with DFS in patients (pts) with localized rectal cancer (RC) is the pathological TNM staging (ypTNM) after chemo-radiotherapy (Ch-RT).Tumor regression grading (TRG) after Ch-RT has been correlated with DFS , 86% for TRG 4, 75% for grouped TRG 2 + 3, and 63% for grouped TRG 0 + 1 but this is not as good as ypTNM to predict pts outcome.

Standard 5-FU or capecitabine Ch-RT achieves 15% of ypCR with diarrhea and proctitis as the main grade 3 toxicities in the range of 10-15% . With the combination of oxaliplatin and capecitabine pCR rates are the same but the toxicity is the range of 25%. IMRT studies reported 30% ypCR but with 30-40% grade 3 toxicities Last years strategies have explored ways to integrate additional chemotherapeutic agents as capecitabine , oxaliplatin, irinotecan, bevacizumab and cetuximab in Ch-RT regimens and to find biomarkers of their effectiveness , but always in a retrospective way.

Our hypothesis is that with the actual knowledge and technology, a prospective tailored chemotherapy selection in combination with IMRT is feasible and could improve the outcome of patients with rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of rectal adenocarcinoma.
* Clinical stage II or III.
* Feasible patient for neoadjuvant Ch-RT.
* Availability of tumor tissue or possibility of a tumor biopsy to define therapeutic targets.
* Informed written consent was obtained from all patients

Exclusion Criteria:

* Contraindication to the administration of any of the drugs used in the study capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.
Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

* Patients who are contraindicated based on the product label
Cannabis for Spasticity in Multiple Sclerosis

The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.

The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.

Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.

Comparisons: Three treatment arms will be compared:

1. inhaled cannabis and oral placebo
2. inhaled placebo and oral THC
3. inhaled placebo and oral placebo

The effects of these agents analyzed at 3 weeks and 7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
* Moderate or severe spasticity
* Age 21 or older
* Must live close to the Sacramento, CA area

Exclusion Criteria:

* Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
* Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
* Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
* Pre-existing dementia, mania, depression or schizophrenia or other poorly controlled psychiatric illness
* Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
* History of or currently meets DSM-IV criteria for dependence on cannabis
* Use of cannabis, marijuana, or THC in the last four weeks
* Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
* Exacerbation of MS within 30 days prior to screening visit
* Current use of cyclophosphamide, mitoxantrone, or cladribine
* Arthritis, bony and soft tissue disorders interfering with spasticity measures
* Inability to provide informed consent
* Recent cannabis use of more than twice per week one month prior to study entry
* For females of child bearing potential, inability to comply with adequate contraception
A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China

The primary objective of the study is to assess the efficacy of DMF in Chinese participants with RMS at Week 48. The secondary objectives of the study are to assess the efficacy and safety of DMF in Chinese participants with RMS.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a baseline (pre-dose on Day 1) Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive.
* Must have experienced at least 1 documented relapse within the 12 months before screening, with a prior brain magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS or have showed evidence of GdE lesion(s) of the brain on an MRI performed within the 6 weeks prior to screening.

Key Exclusion Criteria:

* An MS relapse that occurred within the 30 days prior to screening and/or the participant has not stabilized from a previous relapse prior to screening.
* Current hepatitis C infection and current hepatitis B infection. Participants with immunity to hepatitis B from previous natural infection or vaccination are eligible to participate in the study.
* History of severe allergic or anaphylactic reactions or of any allergic reactions that, in the opinion of the Investigator, are likely to be exacerbated by any component of the study treatment.
* History or positive test result at screening for human immunodeficiency virus (HIV).
* Use at the time of enrollment and/or anticipated ongoing use of any traditional and/or unlicensed medicines and/or traditional therapies and/or herbal preparations, which are known or considered by the Investigator to affect MS and endpoints that are being considered in the study, including safety and efficacy.
* Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Stepping-Up: Partnering with the Community to Prevent Early Mobility Decline

Preclinical mobility limitations (PCML) manifest early in the process of declining mobility, and are not typically identified or acted upon by clinicians. These mobility limitations manifest as changes in how daily tasks such as walking are performed (slower speed, lower endurance). Persons in the PCML stage are at increased risk for the onset of disability and chronic disease. Persistent deterioration in mobility is a predictor of mortality and has been reported even in the absence of changes in activities of daily living over a two-year period. Further, older persons with mobility limitations, including reduced gait speed, are at risk for falls. These cumulative transitions of a person's life-long mobility form their mobility trajectory and preventing mobility decline at an early stage along this trajectory is the focus of this research initiative. This study will evaluate a novel intervention, STEPPING-UP, for improving walking ability in persons with PCML.


Eligibility Criteria:
Inclusion Criteria:

1. Community-dwelling
2. Age ≥55-75 years
3. PCML as assessed using a questionnaire that requires respondents to self-report difficulties with their mobility (walking 2.0km). Respondents will be considered in a stage of PCML if they report no task difficulty but report modification of task performance (i.e. modify frequency, method or time to complete the task)
4. Understanding of spoken and written English
5. Own a laptop computer, have an email address and have internet capabilities of running the video-conferencing platform, Zoom©.
6. Resident of Ontario, Canada

Exclusion Criteria:

1. A score of \<11 on the MoCA 5-Minute telephone screen
2. Major illness that would prevent participation
Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure

The purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histological diagnosis of squamous cell carcinoma
* Patients with unilateral or no neck involvement of the nasopharynx
* The submandibular transfer will be done on the uninvolved side of the neck.
* Karnofsky score greater than or equal to 70
* Expected survival greater than one year
* A signed informed consent

Exclusion Criteria:

* Bilateral neck nodes involvement. Involvement of level 1 lymph nodes on the side of the proposed procedure.
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared to an in-hospital approach for treatment of symptomatic AT/AF.


Eligibility Criteria:
Inclusion Criteria:

* chronic symptomatic HF despite stable, optimal drug therapy
* indication for a cardiac resynchronisation device with defibrillator backup according to current guidelines
* patients implanted with cardiac resynchronization device with dual (atrial and ventricular) defibrillation capabilities

Exclusion Criteria:

* Chronic atrial fibrillation
* Valvular disease
* patients who underwent or are planned for ablation of atrial fibrillation
* cerebral vascular accident/transient ischemic attack within 12 months from implant which lead to relevant impairment
* preexisting unipolar pacemaker
To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With NSCLC

Evaluated the correlation between the qualitative test results of Xiamen Aide the gene test specified by the test reagent and the efficacy of relevant targeted drugs in patients with non-small cell lung cancery, and the research data is used to support the registration and marketing of the assessment reagent


Eligibility Criteria:
Inclusion Criteria:

* 1)≥18;
* 2) advanced non-small cell lung cancer confirmed by histopathology;
* 3) Patients with NSCLC who have previously or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy, and the response to treatment can be assessed;
* 4) Have sufficient FFPE tissue samples within 5 years: 5 large specimens/case; There were 10 puncture specimens/case

Exclusion Criteria:

* 1) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
* 2)Maintenance therapy if the disease does not progress after treatment with other antitumor methods
Difficult Biliary Cannulation in Patients With Distal Malignant Biliary Obstruction: an Underestimated Problem

Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic procedure for many bilio-pancreatic diseases, and requires the first crucial step of the successful deep cannulation of the common bile duct through the Vater's papilla. Difficult biliary cannulation (DBC) is a well-recognized risk factor for adverse events (AE) and cannulation failure, which has been reported in about 11% of ERCP regardless of their indication and a relevant heterogeneity in definition of DBC is present in the available studies. More recently, DBC during ERCP has been precisely defined by the European Society of Gastrointestinal Endoscopy (ESGE) as follows: more than 5 contacts with the papilla whilst attempting to cannulate; more than 5 minutes spent attempting to cannulate after visualization of the papilla; more than one unintended pancreatic duct cannulation or opacification (4). To date, the rate of DBC has not been calculated for specific sub-groups of ERCP indications. In particular, the rate of DBC in the setting of distal malignant biliary obstruction (DMBO), a frequent indication for ERCP, has not yet been described. DMBO is generally secondary to pancreatic adenocarcinoma, distal cholangiocarcinoma, ampullary carcinomas or adenopathy/metastasis from other cancers, and could potentially increase the complexity of the procedure as the tumor compression or infiltration alter the normal duodenal/papillary anatomy or determine duodenal rigidity.

In this study, we aimed to investigate the rate of DBC and the outcome of patients undergoing ERCP for DMBO.


Eligibility Criteria:
Inclusion Criteria:

* With an age above or equal to 18,
* From which informed consent has been obtained,
* patients undergoing ERCP carried out by expert operators for DMBO due to pancreatico-biliary malignancies.

Exclusion Criteria:

- Patients who do not meet all of the listed inclusion criteria will be excluded from this study
Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg

The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Long-Duration Ultrasound for Knee Osteoarthritis

This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms of knee arthritis pain.


Eligibility Criteria:
Inclusion Criteria:

* Are you between 18 and 80 years of age (inclusive)?
* Can you speak, read, and write in English?
* Do you have knee pain that has lasted at least 3 months?
* Are you willing and able to self-administer the ultrasound device daily within your place of residence or during normal daily activity?
* Are you willing to keep all pain medications stable and discuss with the investigator any needs to change medications during the study period? This may include drugs administered topically, orally, transdermally, or by injection.
* Are you willing to document usage of any medications during the study period?
* Do you agree to discontinue all other interventional treatment modalities on the lower back during the study? (e.g., transcutaneous electric nerve stimulation \[TENS\], electronic muscle stimulation, traditional ultrasound, massage therapy, chiropractic services)
* On a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (pain as bad as you can imagine), how would you rate your average pain over the past week? Pain must be ≥4 for the subject to be enrolled in this study. This criterion will be assessed by self-report at Visit 1.

Exclusion Criteria:

* Have you participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening?
* Are you pregnant?
* Are you a prisoner?
* Are you non-ambulatory (unable to walk)?
* Do you have a pacemaker?
* Do you have a malignancy in the treatment area?
* Do you have an active infection, open sores, or wounds in the treatment area?
* Do you have impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia?
* Do you have a known neuropathy (disease of the brain or spinal nerves)?
* Do you have a hereditary disposition (tendency) for excessive bleeding (hemorrhage)?
* Do you have peripheral artery disease?
* Does the subject display any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions?