cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).


Eligibility Criteria:
Inclusion Criteria

* Confirmed diagnosis of symptomatic multiple myeloma (MM).
* Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
* Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) \[eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)\] with or without a CD38 monoclonal antibody, daratumumab + bortezomib/thalidomide/dexamethasone \[D-VTd\] and daratumumab + bortezomib/ lenalidomide/dexamethasone \[D-VRd\]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone \[D-VCd\], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
* Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria.

Exclusion Criteria

* Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
* Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
* Known central nervous system/meningeal involvement of MM.
* Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Effect of Antacid on Bioavailability of Febuxostat After Administration of a Febuxostat 80 mg Extended-Release Capsule

The purpose of this study is to assess the effect of antacid administration, and its timing, on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg.

The drug being tested in this study is called febuxostat extended-release (XR). Febuxostat XR is being tested to assess if antacids affect how the drug moves throughout the body. This study will look at lab safety and side effects in people who take febuxostat XR.

This cross-over study will enroll approximately 36 patients. Participants will be randomly assigned to one of four treatment sequences. All participants will receive the following study medications by the end of the study:

* Febuxostat XR 80 mg capsules
* Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent

All participants will be administered one dose of one or both of the study medications on Day 1 of four separate study periods.

This single-centre trial will be conducted in the United States. The overall time to participate in this study is up to 84 days. Participants will make 5 visits to the clinic including four 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy adult male or female aged 18 to 55 years, inclusive, by check-in (Day-1 of Period 1)
2. Weighs at least 50 kg (110 pounds), and has a body mass index (BMI) between 18.0 kg/m\^2 to 30 kg/m\^2, inclusive at Screening.
3. Has estimated glomerular filtration rate ≥90 mL/min

Exclusion Criteria:

Any participant who meets any of the following criteria will not qualify for entry into the study:

1. Has received any investigational compound within 30 days prior to the first dose of study medication.
2. Has received febuxostat in a previous clinical study or as a therapeutic agent.
3. Has a known hypersensitivity to any xanthine oxidase inhibitor, xanthine compounds or any component of the formulation of febuxostat tablets (see Package Insert) or to caffeine.
4. Has a known hypersensitivity to aluminum, magnesium hydroxide, or any component of the formulation of antacid (Maalox Advanced Regular Strength or equivalent) (see Package Insert).
5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
6. Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention \[eg, cholecystectomy\]).
Overuse Injuries in Road Cyclists, Prevalence and Prevention

The purpose of this study is to investigate the prevalence of overload injuries to road cyclists in Sweden, and if it 's possible to prevent low back pain by a simple exercise program for two months of training .


Eligibility Criteria:
Inclusion Criteria:

* Planning to ride "Vätternrundan 2014" in a subgroup .
* Cycled "Vätternrundan" at least twice in the past or bicycled for exercise at least 800 mil ( the equivalent of two seasons) .
* Age 18-55 years .
* Training cycle at least three hours a week or three days a week .

Exclusion Criteria:

* Do not have access to a computer.
Respiratory Measurement Using Infrared Camera and Respiratory Volume Monitor (ExSpiron 1Xi) for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia

In patients undergoing spinal anesthesia, the investigators used an Infra-red camera and a respiratory volume monitor to determine the accuracy of the ventilation rate of the infra red camera by measuring the respiratory rate, ventilation volume, and ventilation volume with respiratory volume monitor.


Eligibility Criteria:
Inclusion Criteria:

* An adult male who underwent endoscopic prostatectomy resection with regular surgery
* An adult male who underwent endoscopic bladder resection with regular surgery

Exclusion Criteria:

* Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity- pneumonectomy patient, severe ipsilateral destroyed lung patient
* Inability to understand or perform the procedure
* ASA(American Society of Anesthesiologists) class 4,5
Lonafarnib for Patients With Hutchinson-Gilford Progeria Syndrome or Progeroid Laminopathy

This treatment IND protocol will allow patients with HGPS and progeroid laminopathies access to lonafarnib, the only compound shown to have an effect on the HGPS disease process resulting in improved outcomes (Gordon et al, 2018). There are no approved treatments for HGPS and progeroid laminopathies.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HGPS or progeroid laminopathy by qualified medical doctor (based on common phenotype as described in Gordon 2015 and Merideth 2008). Confirmation with genetic testing is preferred but not required.
* Adequate hepatic function as defined by SGPT (ALT) and SGOT (AST) ≤ 5 times upper limit of normal range for age

Exclusion Criteria:

* Taking medications or foods that are known to be moderate or strong inducers or inhibitors of CYP3A4 or sensitive CYP3A substrates; or if a patient is taking one of these drugs and cannot safely discontinue or take an alternative drug, the dose of the inhibitor/inducer must be adjusted per the treating physician
* Taking digoxin, a P-gp substrate with a narrow therapeutic window.
* Severe renal impairment (GFR \< 30 mL/min/1.73m2).
* Uncontrolled infection.
* Presence of any active clinically relevant medical condition that in the opinion of the treating physician would preclude patient from safely participating in the program.
* Pregnant or breast-feeding or plan to become pregnant while on therapy.
A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients

SYH9056 tablets are a combination of valsartan and levamlodipine maleate. This is a multicenter, randomized, double-blind, parallel-controlled phase III study, designed to validate the efficacy and safety of SYH9056 tablets in patients with mild-to-moderate essential hypertension not controlled after 4 weeks of treatment with either levamlodipine maleate tablets or valsartan capsules, using either levamlodipine maleate tablets or valsartan capsules as a control. The study consisted of 4 phases: a screening period (2 weeks), an introduction period (4 weeks), a core treatment period (12 weeks), an extended treatment period (12 weeks), and a safety follow-up period (1 week), totaling approximately 31 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. 18-75 (inclusive) years old;
2. 18.0 kg/m\^2 ≤ BMI ≤ 35.0 kg/m\^2 and ≥ 50 kg for men and ≥ 45 kg for women at screening;
3. Diagnosis of mild or moderate essential hypertension;
4. Office blood pressure measurements meet any of the following at the time of screening:

   ① Patients who have not used any antihypertensive medication for at least 4 weeks prior to screening, with an average office sitting blood pressure (average of 3 measurements) of 150 mmHg ≤ SBP \< 180 mmHg and DBP \< 110 mmHg;

   ② Patients who have been using a stable dose of one or two component of antihypertensive medications (including single agents, two-drug combination or two-component combinations) for at least 4 weeks prior to screening, and who, in the judgment of the clinician, can be switched to levlevamlodipine maleate tablets (2.5 mg/day) or valacyclovir capsules (80 mg/day), and whose mean office sitting blood pressure meets 140 mmHg ≤ SBP \< 180 mmHg and DBP \< 110 mmHg;
5. Prior to randomization, mean office sitting blood pressure meets 140 mmHg ≤ SBP \< 180 mmHg and DBP \< 110 mmHg;
6. Medication adherence between 80% and 120% (including borderline values) during the introductory period.

Exclusion Criteria:

1. Rrefractory hypertension, hypertensive emergencies, hypertensive sub-emergencies and secondary hypertension;
2. Allergy (≥ 3 drug or food allergies) or known hypersensitivity to levamlodipine, levlevamlodipine, valsartan and related drugs (dihydropyridine calcium channel blockers, angiotensin II receptor blockers);
3. History of malignancy within the last 5 years (with the exception of cured basal cell carcinoma of the skin, limited squamous cell carcinoma of the skin, or cervical cancer in situ), or an underlying malignancy currently under evaluation;
4. Known or suspected symptomatic upright/postural hypotension ;
5. Uncontrolled diabetes mellitus;
6. Abnormal thyroid function;
7. Severe cardiovascular or cerebrovascular disease within 6 months prior to screening or randomization.
Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Advanced histological or cytological documentation of cancer
* life-expectancy of at least 12 weeks
* able to swallow pills
* ECOG status of 0,1 or 2
* adequate bone marrow
* liver and renal function

Exclusion Criteria:

* \> NYHA Class 2 CHF
* Serious myocardial dysfunction,
* or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed)
* History of organ allograft
* uncontrolled hypertension
* renal dialysis
* Bleeding event/hemorrhage within 4 weeks of study treatment
* major surgery within 4 weeks of study treatment
* Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose
Preventing Violence Against Children in Schools Study

To date, no interventions to prevent violence in refugee camp schools have ever been rigorously evaluated. The primary objective of this project is to test the effectiveness of the Empateach intervention to prevent physical violence from teachers to students in Nyarugusu Refugee Camp, Tanzania. Secondary objectives are to assess the impact of the Empateach intervention on student's depressive symptoms, experience of emotional violence and educational test scores. A two arm cluster RCT with parallel assignment will be conducted.

School is one of the most common settings where children may experience violence; and emerging evidence suggests that in some settings, school staff may be one of the most common perpetrator of violence against children.To date, no interventions to prevent violence in refugee camp schools have ever been rigorously evaluated. The primary objective of this project is to test the effectiveness of the Empateach intervention to prevent physical violence from teachers to students in Nyarugusu Refugee Camp, Tanzania. Secondary objectives are to assess the impact of the Empateach intervention on student's depressive symptoms, experience of emotional violence and educational test scores.

The aim of the Empateach intervention is to improve 'student and teacher well-being; self-regulation; teacher classroom management and teacher's use of positive discipline techniques'. Participants in the intervention condition will receive a 10-week group intervention.

A two arm cluster RCT will be conducted, with parallel assignment and an approximately 1:1 allocation ratio. Cross-sectional surveys of students will be conducted at three time points: a baseline, a midline immediately after the 10 week intervention; and an endline 6 months after then end of the intervention. The primary outcome, violence from school staff to students, will be measured using an adapted version of the ICAST-CI.

Eligibility Criteria:
Inclusion Criteria:

* At the school level, all 27 primary and secondary schools in Nyarugusu refugee camp in Tanzania, will be eligible. The intervention is delivered to individual teachers, and all teachers working in included schools will be eligible to receive the intervention. The hypothesized intervention effect will be in all students being taught by participating teachers; however we will measure effects of the intervention in students who are aged 9 years and over. Data will be collected from both students and teachers.
* At the level of individual students, all students who can speak Kirundi or Swahili, and who are capable of providing assent, will be eligible to participate
* At the level of individual teachers, all teachers who can speak Kirundi or Swahili, and who are capable of providing informed consent, will be eligible to participate

Exclusion Criteria:

* there are no exclusion criteria at the School level
* for individual students, those who cannot speak Kirundi or Swahili, or who are not capable of providing assent
* for individual teachers, those who cannot speak Kirundi or Swahili, or who are not capable of providing informed consent
Actinic Keratosis Study

The main purpose of this study is to determine the effectiveness of a new combination therapy for actinic keratosis. This study investigates a new indication for an FDA-approved topical medication, calcipotriol, for treatment of actinic keratosis, including how well it works and how safe it is when used in combination with the standard of care medication (5-fluorouracil) for the skin condition.


Eligibility Criteria:
Inclusion Criteria:

* Age of at least 50 years
* Presence of four to fifteen clinically typical, visible, and discrete actinic keratoses in 25 cm2 on any of the four anatomical sites: scalp, face, right upper extremity and left upper extremity
* Ability and willingness of the patient to participate in the study (Informed consent is obtained)

Exclusion Criteria:

* Treatment area is within 5 cm of an incompletely healed wound or a suspected basal-cell or squamous-cell carcinoma
* Treatment area contained hypertrophic and hyperkeratotic lesions, cutaneous horns, or lesions that had not responded to repeated cryotherapy
* Recent (within a month) use of medications that could interfere with evaluation of the treatment area (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids)
* Premenopausal Women (to avoid any risk of pregnancy)
* History of hypercalcemia or clinical evidence of vitamin D toxicity
Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty

This is a prospective, three-arm, comparative study with a provider-crossover design. The first arm will comprise the standard of care pain regimen after discharge, which comprises PRN oxycodone, tramadol, and acetaminophen. The second arm will comprise a multimodal pain regimen; however, patients will still be routinely provided PRN oxycodone and tramadol to use on an as needed basis. The third arm will comprise a multimodal pain management protocol, which does not routinely allow for opioid consumption. However, patients will be provided a one week supply of oxycodone and tramadol for emergency pain relief only.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral, primary cementless THA with underlying diagnosis of osteoarthritis.
* ASA I - III
* Spinal anesthesia
* Male and Female over 18 who are willing and able to provide informed consent

Exclusion Criteria:

* Opioid use within 3 months prior to surgery
* General anesthesia
* Non-english speaking
* ASA IV or greater
* Allergy/contraindications to protocol medications
* Renal insufficiency with Cr \> 2.0 or hepatic failure
* Sensory/motor disorder involving the operative limb
* Planned or unplanned discharge to rehab
* Length of stay \>3 days
* Revision or conversion THA
* Cigarette smokers
SpermQT Prospective Observational Trial

The goal of the study is to validate the ability of the Epigenetic Sperm Quality Test (SpermQT) to assess a man's sperm quality and corresponding success of infertility treatments.

This prospective study will consist of analyzing a man's semen sample to determine the patient's SpermQT score and following the success of each fertility treatment to produce a pregnancy and live birth. Physicians and patients will be blinded to SpermQT results.

Eligibility Criteria:
Inclusion Criteria:

* The subjects have been recommended to pursue IUI, or they have recently completed an IUI (regardless of outcome)
* Male partner is under 45 years of age
* Female partner is under 38 years of age
* The total motile sperm count from the raw semen analysis must be greater than or equal to 10 million

Exclusion Criteria:

* The female or male partner have a BMI equal to or greater than 40
* The male partner has undergone male testosterone replacement therapy in the last 6 months
* Either the female or male partner have a history of recurrent pregnancy loss, defined as 2 or more consecutive clinical/ultrasound pregnancy losses
* There are any known factors contributing to female factor infertility, such as but not limited to:
* Severe Endometriosis (stage 3 or higher, endometrioma on ovaries)
* Multiple uterine fibroids 5cm or larger
* Severe Asherman's Syndrome
* Severe Mullerian anomaly
* Lack of tubal patency in at least one fallopian tubes
Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)

This study plans to learn more about a new test to look at liver function, the HepQuant-Shunt (HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient testing in patients with liver disease.

The goal of this study is to demonstrate the HQ-SHUNT is safe, simple to administer, noninvasive, cost-effective, and well tolerated by patients. This study will compare the HQ-SHUNT to Hepatic Venous Pressure Gradient (HVPG) testing. In this study, 100 consecutive patients with various etiologies of liver disease who have undergone technically successful HVPG testing as standard of care will also undergo HQ-SHUNT testing.

Eligibility Criteria:
Inclusion Criteria:

* Liver disease patient scheduled to have an Hepatic Venous Pressure Gradient (HVPG) procedure
* At time of enrollment, being between the ages of 18 and 75

Exclusion Criteria:

* Concomitant treatment with both a beta blocker and an ACE inhibitor
* Concurrent hepatic malignancy. Patients with a history of treated HCC can be included if there is no evidence of recurrent disease at the time of this study.
* Unstable angina or history of myocardial infarction or congestive heart failure within 6 months prior to enrollment into this study
* Renal insufficiency with chronic kidney disease stage 4 or 5 (GFR \< 30 mL/min/1.73m2)
* Crohn's disease or any active intestinal inflammatory condition
* Having had an ileal resection
* Diabetic Gastroparesis
* Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed prior to HQ SHUNT testing.
* Inability to consent for one's self
Dryvax Dilution-Prev Vacc Adults

A double-blind, randomized, dose-response study of four dilutions of Dryvax in previously vaccinated adults in order to assess the clinical success rates, humoral responses, and virus-specific actifity of cytotoxi T cells and interferon-y producing T cells


Eligibility Criteria:
Inclusion Criteria:

* For cohort E (never vaccinated): Aged 18-31; Never been vaccinated for smallpox.
* If female, not pregnant or lactating.
* Promise to use an effective method of birth control for 7 months after vaccination.
* Negative result on a test for HIV, AIDS, Hepatitis B and C.
* Acceptable as blood donors.
* For cohorts A, B, C, D (previously vaccinated): Aged 32 to 60 years; known history of smallpox vaccination with a typical vaccinia scar; no smallpox vaccination after 1971.
* Healthy adults (aged 18-60).

Exclusion Criteria:

* Eczema or history of eczema, or other chronic skin disorder.
* Pregnancy or lactation.
* History of immunodeficiency, liver disease, severe kidney impairment, malignancy, HIV, Hepatitis B, or Hepatitis C.
* Household contact with persons who are under 12 months of age, pregnant or lactating, or have any of the specified diseases.