cyrilzakka/clinical-trials huggingface dataset:
Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis

The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.

This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical trial. Following a Screening and Qualification Period and a two-week Washout Period (for those subjects entering the study on a phosphate binder), eligible subjects will be randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic CKD subjects not on dialysis.

Eligibility Criteria:
Inclusion Criteria:

* Stage III to V Chronic Kidney Disease
* Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
* Ferritin 300 ng/mL or less
* Transferrin Saturation (TSAT) 30% or less
* Hemoglobin \>9.0 and \<12.0 g/dL
* Must consume a minimum of 2 meals per day

Exclusion Criteria:

* Parathyroidectomy within 24 weeks of study
* gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
* Requirement for dialysis or kidney injury within 8 weeks of study
* Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
* Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
* Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
* History of hemochromatosis
* Allergy to iron products
* History of malignancy in last 5 years
Effect of rIL-21 on Metastases in Lymph Nodes in Melanoma Skin Cancer

The trial is conducted in Europe. This trial aims for a comparison of the pathology in lymph nodes before and after the effect of recombinant interleukin-21 in patients with stage III melanoma

The decision to discontinue the NN028-1801 trial is not due to any safety concerns. The trial was terminated as a result of a strategic decision by the sponsoring company.

Eligibility Criteria:
Inclusion Criteria:

* Stage III melanoma
* ECOG performance status 0-1

Exclusion Criteria:

* Signs of stage IV melanoma
* Safety variables
Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults

This study is to assess the safety of a bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.

The primary study objective is to assess the safety of a bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them. Safety will be demonstrated by similar fever rates (oral temperature ≥101°F Days 0-7) in vaccine and placebo recipients.

Eligibility Criteria:
Inclusion Criteria:

* 18-49 years of age (not yet reached their 50th birthday);
* In good health;
* Available by telephone;
* Ability to understand and comply with the requirements of the protocol; and
* Signed informed consent and HIPAA authorization.

Exclusion Criteria:

* Any condition for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the preceding year;
* Acute febrile (\>100.0°F oral) and/or respiratory illness, including cough or sore throat, within the 14 days prior to enrollment;
* Hypersensitivity to egg or egg protein;
* Hypersensitivity to gentamicin;
* Any known immunosuppressive condition or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy;
* History of Guillan-Barré Syndrome;
* Household contact who is immunocompromised (participant should also avoid close contact with immunocompromised individuals for at least 21 days);
* Participation in another investigational trial within 30 days prior to enrollment or expected enrollment in another investigational trial during this study;
* Chronic or regular use of antipyretic or analgesic medication on a daily or every other day basis; Notes: A daily dose of 81 mg of aspirin is not considered a contraindication to enrollment. Discontinuation of prophylactic use of antipyretic or analgesic medications at the time of enrollment and for fourteen days following vaccination is not considered a contraindication to enrollment.
* Pregnancy or, in biologically capable women (e.g., menses within the last year) participant does not agree to use acceptable birth control measures as determined by the investigator continuously for three months after enrolling into the study (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result);
* Breastfeeding or lactating women;
* Administration of intranasal medications within two weeks prior to enrollment or expected receipt during this study;
* Employees of the investigational site or their family member or any individuals involved with the conduct of the study; and
* Any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.
A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster

The purpose of this study is to determine the pharmacokinetics and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster.

In cells infected with varicella-zoster virus, there is evidence to suggest that EPB-348 could offer clinically important advantages in the treatment of acute herpes zoster over currently available therapies due to rapid absorption and conversion to the active moiety as well as a longer intra-cellular half-life in infected cells. Clinically, these characteristics could translate into once-daily dosing versus thrice-daily dosing as seen with current therapy, leading to a higher rate of compliance and quality-of-life, especially among elderly patients. The objective of EPB348-0201 is to determine the pharmacokinetics and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster. This multi-center study will randomly assign patients to either EPB-348 1000 mg once daily or EPB-348 2000 mg once daily or valacyclovir 1000 mg three times daily.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults at least 18 years of age
* Patients with signs and symptoms consistent with acute herpes zoster disease, namely, a dermatomal vesicular rash which may be preceded by pain and parasthesias in the days before vesicular eruption
* Herpes Zoster associated rash present for ≤ 72 hours
* Patients who are deemed to be immunocompetent based on history and physical exam

Exclusion Criteria:

* Females who are pregnant or nursing
* History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, psychiatric, renal, urological, endocrine, opthalmologic, or immune mediated disease including HIV or HBsAg positivity
* Chronic genital herpes
* Patients who received cytotoxic or immunosuppressive drug therapy within 3 months prior to study participation
* Previous vaccinations against Herpes Zoster
* Patients with \> 50% of vesicles crusted at screen
* Patients who received topical or systemic antiviral medications or immunomodulatory agents for herpes zoster viral infections or capsaicin within 4 weeks of study participation
* Patients with a history of congenital, acquired, or corticosteroid induced immunodeficiency, including malignancy, significantly impaired renal function (creatinine clearance \< 50 cc/min), and impaired hepatic function (ALT or AST levels \> 3 times the upper limit of normal)
* QTc \> 500msec
* Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, or famciclovir
* Patients with gastrointestinal dysfunction that might interfere with drug absorption
* Patients, considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug
Efficacy of Aprepitant (Emend®) in Children

The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.

1.1 Primary Aim To determine the efficacy of aprepitant (Emend®) in preventing and reducing chemotherapy-induced nausea and vomiting (CINV) when added to standard antiemetic drug regimens for children receiving highly emetogenic chemotherapy. The working hypothesis will be that standard therapy + aprepitant is superior at preventing CINV than standard therapy + placebo.

1.2 Secondary Aim To evaluate the safety and toxicity of aprepitant (Emend®) in children receiving highly emetogenic chemotherapy when compared to standard antiemetic therapy + placebo.

Eligibility Criteria:
Inclusion Criteria:

under 20.99 years of age at enrollment

Scheduled to receive two identical cycles of highly emetogenic\[1\] chemotherapy for treatment of a primary malignancy, including:

Chemotherapy with any one or more of the following single agents in any combination:

* Carboplatin
* Carmustine \>250 mg/m2
* Cisplatin
* Cyclophosphamide ≥1 g/m2
* Dactinomycin
* High dose Methotrexate ≥ 5 g/m2

Or any of the following defined combinations:

* Cyclophosphamide + anthracycline
* Cyclophosphamide + etoposide
* Cytarabine 150-200 mg/m2 + daunorubicin
* Cytarabine 300 mg/m2 + etoposide
* Cytarabine 300 mg/m2 + teniposide
* Doxorubicin + ifosfamide
* Doxorubicin + methotrexate 5 g/m2
* Etoposide + ifosfamide

Exclusion Criteria:

* Patients who have received aprepitant in the past.
* Patients who demonstrate evidence of increased intracranial pressure.
Time-restricted Enteral Nutrition Versus Continuous Enteral Nutrition in Patients With Severe Stroke

In patients with severe stroke whose GCS score is ≤12 points or NIHSS score is ≥11 points, to evaluate whether time-restricted enteral nutrition can improve the incidence of poor 90-day prognosis (mRS ≥3 points) compared with continuous enteral nutrition.

Control the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 \~ 08:00, end time: 16:00 \~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first.

On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.

The control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first.

On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old and \<80 years old;
* Cerebral parenchymal hemorrhage or cerebral infarction within 72 hours of onset;
* GCS score ≤12 points or NIHSS score ≥11 points on admission,
* Enteral nutrition is planned, and the estimated enteral nutrition treatment time is ≥7 days;
* Signed informed consent form.

Exclusion Criteria:

* Complete parenteral nutrition is required due to contraindications to enteral nutrition;
* After gastrectomy or intestinal resection;
* Enteral nutrition treatment has been performed for \>12 hours;
* Accompanying diseases: a. Advanced cancer; b. Severe cardiac insufficiency \[ejection fraction ≤ 50%\]; c. Severe liver failure \[Child Pugh score ≥ 7\]; d. Severe renal failure \[glomerular filtration\] rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL\])
* Have a history of mental illness or mRS ≥ 3 points;
* The patient's doctor or nutritional therapist believes that the plan is not in the best interest of the patient;
* During the patient's admission, death is inevitable, and there are underlying diseases that result in a survival time of \<90 days;
* The patient participates in another clinical study.
A Randomized Field Trial of Smartphone-based Feedback to Encourage Safe Driving

The study team are proposing to conduct a randomized controlled trial to determine the effectiveness of focused feedback vs standard feedback and self-chosen vs assigned goals on driving behaviors targeted by behavior-based insurance apps: hard braking, fast acceleration, handheld phone use, and speeding. The interventions arms will receive feedback on their driving behaviors, tips for safe driving, and a UBI-like financial incentive. The Penn research team will use Meta advertisements to recruit for the study and determine eligibility via an online survey. Those who enroll will undergo a 6-week run-in period during which their driving trips will be monitored by a mobile app. Individuals with a sufficient number of trips during this period will be randomly assigned to one of four arms for the intervention period. Target enrollment is 1,300 participants (325 per trial arm). The power analysis assumed an attrition rate of 20% over the course of the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Has an Apple or Android smartphone (iPhone iOS 12 or later or Android OS 7 or later)
* Drives at least 2 days per week
* English reading ability
* Passes an attention check
* Provides valid email address, cell number, name, address, and date of birth

Exclusion Criteria:

-
Relaxation Treatment in Total Knee Arthroplasty

Surgical techniques and treatment methods of the arthroplasty have been improved and the results after total knee arthroplasty (TKA) are generally good. However, some patients have suboptimal postoperative results with respect to pain and physical functioning and may not be satisfied with the results of their TKA. Psychological symptoms were found to be associated with these suboptimal results. The aim of the present study is to determine weather relaxation techniques had beneficial effects on pain, sleeping quality, functional status and physiological symptoms in TKA patients during their hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* primary knee osteoarthritis, Female Patients who are scheduled for unilateral Total Knee Arthroplasty surgery, were included in the study.

Exclusion Criteria:

* having a previous knee or hip surgery or fracture, diagnosis of rheumatoid arthritis, severe obesity (BMI\>40 kg/m2), sensory and motor disorders in the operated limb, inability to understand pain assessment.
Comparing of the Clinical Outcome of Periodontal Accelerated Osteogenic Orthodontics With Horizontal or Vertical Releasing Incisions

The study aims to compare the effect of periodontal accelerated osteogenic orthodontics (PAOO) with horizontal or vertical releasing incisions on operation time, healing, adverse effects, and effectiveness of bone augmentation.

Methods: A total of 22 patients requiring PAOO surgery due to orthodontic treatment were enrolled in this trial, and randomly divided into test or control group, consisting of 11 subjects in each. The test group will receive PAOO with horizontal extending incisions on both sides of the flap; while the control group will receive PAOO with vertical releasing incisions; the two groups use the same surgical technic except for the incision design. Outcome measures include: operation time, postoperative scar, radiographic data (alveolar height and alveolar ridge thickness), gingival thickness, etc. Clinical evaluation will be performed at 1 week, 2 weeks, 3months, 6 months and 12 months after operation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18 and 40 years old, systemic healthy, undergoing or planning to undergo orthodontic treatment.
2. Patients with a thin alveolar bone or with dehiscence and/or fenestration on the labial side of maxillary or mandibular front teeth area.
3. Patients with expected tooth movement beyond the labial alveolar bone during orthodontic procedures.

Exclusion Criteria:

1. Smoker.
2. Pregnant or lactating.
3. Untreated periodontitis.
4. Presence of \<2mm keratinized gingival width(KGW) or thin gingival phenotype (as defined by dental probe transparency.)
5. History of orthodontic and/or orthognathic treatment.
6. With systemic disease (diabetes, hypertension, heart disease, malignant tumor, severe mental illness, and other surgical contraindications.)
7. Long-term medication (immunosuppressive drugs, bisphosphonates, etc.)
8. Poor adherence to complete one-year follow-up.
Curcumin Gel On Radiation Induced Oral Mucositis

The goal of this clinical study is to investigate the effect of a curcuma longa oral gel (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and provide a context for understanding if there is a relationship between the curcumin clinical effect and production of EGFs and IL8.

Researchers will compare between curcumin group and standard treatment group.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 16 years having histopathologically confirmed cancer in head and neck region who planned to have radiation with head and neck mask.
* Scheduled for 6-8 weeks of radiotherapy with 60-70Gy radiation (200cgy/fraction for 5 days/week).

Exclusion Criteria:

* patient with hodgkin lymphoma.
* Any allergy to curcumin or other condiments.
Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients

Hypertension is one of the most common chronic medical conditions. The concerned sequelae are the cardiovascular complications, especially acute myocardial infarction and stroke. In Thailand, the incidence of hypertension is increasing each year. Many clinical studies found that salt intake over the reference level (\>5 g/day) would result in elevated blood pressure (BP) and long-term morbidity. Dietary salt reduction campaigns were unsuccessful, in part, due to time limitation in the clinic, lacking of awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. Salt meter is a device used to detect sodium content in daily food. It will facilitate monitoring and control of salt intake. The 24-hour urinary sodium excretion is an acceptable method to reflect the quantity of sodium intake. This study aimed to compare the efficacy of salt meter plus dietary education compared with education alone in terms of salt intake reduction, blood pressure, salt taste sensitivity, and vascular consequence.

A randomized-controlled trial was conducted in hypertensive patients whose BP was uncontrolled (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite therapy or antihypertensive-naïve. Patients were randomized to receive salt meter to use in conjunction with dietary education (group A) or receive education only (group B), and were followed up for 8 weeks. Dietary education was provided by certified dietician without awareness of patients' allocation. The primary endpoint was change in 24-hour urinary sodium excretion. Changes in BP, salt taste sensitivity threshold, cardio-ankle vascular index (CAVI), as well as motivation to maintain low salt diet were also analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Mean SBP 140-179 mmHg or mean DBP 90-109 mmHg (average 3 times)
* Diagnosed of hypertension for at least 3 months
* No adjustment of antihypertensive agents for at least 1 month
* 24h Urine sodium ≥ 90 mmol/day
* eGFR ≥ 45 ml/min/1.73 sq.m.

Exclusion Criteria:

* eGFR \< 45 ml/min/1.73 sq.m.
* UACR \> 300 mg/g
* Serum potassium \> 6.0 mmol/l
* Serum sodium \< 135 mmol/l
* Unable to collect 24-hour urine
Supporting Patient Care With Electronic Resources in the United States

This proof-of-concept randomized trial evaluates the effectiveness of using an online decision aid (US-ANSWER-2) in the decision-making to start or switch biologic therapy in US patients with rheumatoid arthritis.

The proposed project aims to improve the process of making evidence-informed treatment decisions by patients with rheumatoid arthritis (RA) and ultimately empower patient self-management. Current RA treatment emphasizes: 1) the need for early and aggressive treatment, and 2) the use of a treat-to-target approach. However, patients often struggle with treatment decisions, especially when the options have both benefits and risks. To address this challenge, investigators based at Arthritis Research Canada have previously developed an online decision aid called ANSWER-2 (ANimated, Self-serve, WEb-based, Research Tool: Version 2) for RA patients who are considering a biologic, and this tool has been recently adapted for the US healthcare setting (called US-ANSWER-2).

Objectives: 1) To evaluate the effectiveness of US-ANSWER-2 in reducing patients' decisional conflict. 2) To assess the extent to which US-ANSWER-2 improves patients' knowledge about RA medications and confidence in managing their health. 3) To examine the experiences of patients and rheumatologists in using US-ANSWER-2.

The investigators will conduct a proof-of-concept randomized controlled trial with 80 patients with RA. Eligible individuals are those: 1) with a diagnosis of RA from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic or switching to another biologic, and 3) who have internet access and email. The Intervention Group will receive simple instructions to access the US-ANSWER-2 decision aid and complete the program on their own within two days. At the end of the session, a one-page summary will be produced to help them discuss their questions, concerns, and preferred choices with their health care providers. The Control Group will receive a standard online medication guide, reflective of usual practice. Participants will complete the Decisional Conflict Scale (primary outcome) before and after the intervention (US-ANSWER-2 or standard online medication guide). The following secondary outcome measures will be collected at baseline, Month 1, and Month 2: 1) Medication Education Impact Questionnaire, and 2) Partners in Health Scale. In addition, the use of healthcare resources will be collected at baseline and Month 2, and the use of biologics will be collected at Month 6. All participants and their rheumatologists will be invited to participate in a qualitative interview about their experience with the patient decision aid.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are as follows:

  1. with a diagnosis of RA from a rheumatologist
  2. whose rheumatologists have recommended initiating a biologic or switching to another biologic
  3. who have internet access and email.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria.