cyrilzakka/clinical-trials huggingface dataset:
Genius PillBox Study

The purpose of this study is to pilot test the how acceptable older adults find a commercially available pillbox organizer with embedded sensors and automated reminders to support medication adherence.

The purpose of this study is to pilot test how acceptable older adults find a commercially available pillbox organizer with embedded sensors and automated reminders to support medication adherence. Individuals who agree to participate in the study will be provided with the pillbox organizer and asked to use the pillbox for 1 month. The pillbox contains 7 compartments with embedded sensors that detects if there is a pill present. Blinking lights and a flashing letter specifying the day of the week, are used to alert users to take their medicines. After taking the first dose, a 24-hour count down timer will begin. If the medication specified for that day is not taken within the target time the device will beep to alert the user. Participants will complete a structured interview at baseline and 1 month follow-up to assess demographic and health related information, medication adherence and how they found using the pillbox organizer. Additionally, if individuals have a family member who supports their medication use, they will be asked to complete an interview at the 1 month follow-up to understand how they found using the pillbox organizer.

Eligibility Criteria:
Primary Inclusion Criteria are for older adults who manage multi-drug regimens. Inclusion Criteria:

1. Age 60 or older
2. Taking 3 or more medications
3. Takes medications twice per day or less
4. Adequate cognitive capacity (defined as less than 2 errors on 6 item cognitive screener).

Additionally, a family member that assists with a participant's medicines can also be invited to participate. The family member eligibility criteria is:

1. Age 18 or older
2. Support family member taking 3 or medications, twice a day or less
3. Adequate cognitive capacity (defined as less than 2 errors on 6 item cognitive screener)
Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation

Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES) implantation, were used in \< 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging criteria defining as an indicator relieving myocardial ischemia were not reported. The aim of this study was to investigate angiographic and IVUS parameters in which corresponding FFR and evaluate their optimal physiologic criteria after DES implantation.


Eligibility Criteria:
Inclusion Criteria:

* clinical angina pectoris who underwent IVUS and FFR during coronary angiography and after DES implantation.
* agree with informed consent
* At least one segment of three major epicardial coronary arteries were consecutively enrolled in invasive CAG.
* Post- stent FFR and IVUS measurement performed at the immediately after whole PCI procedures.

Exclusion Criteria:

* unable to get informed consent
* low left ventricular ejection fraction less than 35%
* chronic renal failure (Cr \> 2.0mg/dl)
* acute myocardial infarction related coronary artery
* allergy to adenosine injection
Mid-term Effect Observation of Biodegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury

To observe the Mid-term clinical effect of biodegradable conduit small gap tublization to repair peripheral nerve injury in multi-center．

In the study，150 cases of fresh peripheral nerve injury in the upper extremities are recruited in multi-center． After formally informed and obtaining the consent，the biodegradable conduit small gap tublization are used to repair the nerve．Their nerve functional recovery conditions are clinically observed according to the standard score methods provided by SHEN Ning-jiang and British Medical Research Council at 3 years after surgery．The excellent and good rates of the overall nerve functional recovery are calculated．

Eligibility Criteria:
Inclusion Criteria:

* fresh peripheral nerve injury in the upper extremities

Exclusion Criteria:

* acute myocardial infarction history within 6 months,
* old and pathological peripheral nerve injury,
* acute and chronic infection,
* various consumptive diseases
* unable to tolerate surgery
Environmental Influences on Vitamin D Status

Vitamin D deficiency is a common problem. The principal source of vitamin D for humans is solar exposure, with cutaneous synthesis of vitamin D by photoconversion of 7-dehydrocholesterol in the skin to pre-vitamin D3. Latitude, altitude, season, skin pigmentation, and age are recognized factors that influence how much vitamin D can be made by solar exposure. However, the relative influences of each are largely unknown and we cannot reliably answer the question of how much sun exposure an individual needs at various latitudes and at various seasons in order to ensure normal vitamin D status.

Purpose of the study: To determine the effect of environmental influences on Vitamin D status.

Specific Aims

1. To measure the prevailing 25D and Vitamin D levels in communities at diverse latitudes (Alaska and Hawaii).
2. To collect information on variables that influence Vitamin D status such as skin color, history of sun exposure and sunscreen use, diet history, vitamin and calcium supplements used, and BMI.
3. To collect typical food samples from the region for future analysis of their Vitamin D and 25D content.
4. To collect a blood sample for DNA analysis of inter-individual differences in Vitamin D metabolism (Gc or Vitamin D binding protein alleles).

Eligibility Criteria:
Inclusion Criteria:

* Able to consent and come for a study visit. Male or female males and females ages 18-60.

Exclusion Criteria:

* Unable to consent or come to a visit, taking Vitamin D supplements, anticonvulsants, barbiturates, steroids, having granulomatous disease, or liver or kidney disease as these medications and conditions interfere with Vitamin D metabolism.
Effect of Angiotensin-Neprilysin Inhibition (ARNI) on Prognosis of Chronic Heart Failure

This study is a randomized controlled multicenter clinical trial, in which about 340 patients with newly diagnosed or prior diagnosed chronic heart will be recruited. Patients will be randomly divided into Angiotensin-Neprilysin Inhibition (ARNI) group and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEI/ARB) group. All-cause death, cardiac death and re-hospitalization due to heart failure will be evaluated in 1, 3, 6, 12 months after recruitment.

Chronic heart failure is associated with poor prognosis in cardiac patients, although systemic effective drugs has been applied in these patients. European Society of Cardiology (ESC) has recommended ARNI Sacubitril/Valsartan as first-line drugs in replacement of ACEI (I, B) in 2016 for these patients. While American College of Cardiology and The American Heart Association (ACC/AHA) made a first-line recommendation that patients with heart failure due to reduced ejection fraction (HFrEF) could be administrated ARNI directly. Hence, we apply this trial to find if ARNI could replace ACEI/ARB to provide insights for better treatment of chronic heart failure in China. This study is a randomized controlled multicenter clinical trial, in which about 340 patients with newly diagnosed or prior diagnosed chronic heart will be recruited. Patients will be randomly divided into Angiotensin-Neprilysin Inhibition (ARNI) group and ACEI/ARB group. All-cause death, cardiac death and re-hospitalization due to heart failure will be evaluated in 1, 3, 6, 12 months after recruitment. Other safety assessment including left ventricular ejection fraction (LVEF), 6 minutes walk test will be followed up as well.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* HFrEF, defined as LVEF≤40% and New York Heart Association (NYHA) class ≥ II.
* Plasma NT-proBNP ≥ 600 pg/ml, or NT-proBNP ≥ 400 pg/ml if patients have been hospitalized for heart failure in 12 months.
* If patients have been taking ACEI/ARB at recruitment, a stable dose equivalent to at least 10mg/day of enalapril will be required.
* Volunteer for the study and sign the informed consent.

Exclusion Criteria:

* Symptomatic hypotension, systolic blood pressure \< 95 mmHg at baseline.
* eGFR \< 30 ml(/min\*1.73m2) at baseline.
* Serum potassium \> 5.4 mmol/L at baseline.
* Contraindication of ACEI or ARB.
A Study to Investigate the Effects of Rifampicin on the Pharmacokinetics of Aleglitazar in Healthy Volunteers

This open-label, fixed-sequence, three-period, single group study will evaluate the effects of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will receive single doses of aleglitazar in all three periods and single doses of rifampicin in periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is up to 14 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, aged 18 to 55 years inclusive at the time of screening
* Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
* Females must be surgically sterile or use two acceptable methods of contraception
* Non-smoker or currently smoking less than five cigarettes/day and willing to abstain from smoking during the study

Exclusion Criteria:

* Any clinically relevant abnormal laboratory test results at screening or on Day -1 of all periods, as judged by the Investigator
* A history of clinically significant disorders (e.g., gastro-intestinal, cardiovascular, hepatic)
* Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* An average alcohol intake of more than 14 units per week
* Volunteers diagnosed, or suspected of having porphyria, and subjects with first degree relatives diagnosed, or suspected of having porphyria
* Diagnosis of Gilberts Syndrome
* A positive screen for drugs of abuse at screening or on admission to the clinical unit
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression

This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features.

This study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 19 and \< 70 years at the time of informed consent
* Patients who are able to understand information required for providing a consent
* Patients who have received a mood stabilizer (lithium or valproic acid)
* Patients with bipolar I or II disorder accompanied by major depressive episode
* Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits

Exclusion Criteria:

* Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features
* Patients considered to have a high risk of suicide during the study period by the investigator based on current psychotic symptom and the patient's past medical history
Diagnostic Accuracy of Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury .

To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.

To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* adult patients \>= 18 years
* undergoing cardiac surgery with cardiopulmonary bypass and transesophageal echocardiography (TEE) probe placement

Exclusion Criteria:

* chronic kidney diseases (estimated GFR \< 60 ml/min/1.73m2)
* prior carotid endarterectomy
* known carotid artery stenosis of 50% or greater
* dissection or aneurysm involving renal or carotid arteries
* scheduled aortic or aortic valve surgery
* heart transplant
* intraaortic balloon pump, ventricular assist device, or exctracorporeal membrane oxygenation support.
Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH)

Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product every 4 weeks during the third product use period.

The MTN-034/IPM 045 trial is a multi-site, randomized, two-sequence, three-period, open-label, crossover Phase 2a trial. Young adult (18-21 years old) and adolescent (16-17 years old) female participants will be enrolled in a 2:1 ratio. All the enrolled participants will use both treatment regimens in sequence. All participants will be randomly assigned to one of two treatment regimen sequences to use for the first two study product use periods, and will be able to choose between treatment regimens during the third study product use period. The total length of follow-up is approximately one and a half years which includes up to 72 weeks of product use (two 24-week periods on randomized treatment regimen and one 24-week period on freely chosen treatment regimen) plus an additional week beyond the Period 3 end visit to collect data on any new or worsening AEs.

Eligibility Criteria:
Exclusion Criteria:

1. Become Pregnant and/or use oral PrEP outside the context of study.
2. At Screening or Enrollment, has a positive HIV test.

Inclusion Criteria:

1. Age 16 through 21 years at Enrollment, verified per site standard operation procedures.
2. Able and willing to provide adequate locator information and comply with all study procedural requirements.
Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS

Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders.

The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk.


Eligibility Criteria:
Inclusion Criteria:

* Women of fertile age presenting with PCOS
* Non-hyperandrogenic women of fertile age (these women will not receive the interventions and will serve only to obtain normative data for some variables)

Exclusion Criteria:

* Severe disease not related to the condition under study
* Pregnancy
* Medical or surgical treatment of PCOS during the previous 3 months
* Contraindication for the use of oral contraceptives or metformin
* Inability to understand the proposal of the study precluding effective informed consent
* Minors who are not accompanied by their legal representative
The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer

Niraparib is a potent and highly selective PARP-1/-2 inhibitor. The primary objective of this trial is to evaluate the pharmacokinetic (PK) properties of ZL-2306 (niraparib) and its metabolite M1 in patients from Mainland China with ovarian cancer, following a single and multiple oral administration of the study drug at the indicated dose (300mg, 200mg or 100mg), once a day.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent .
2. Female, age ≥ 18 years.
3. Histologically confirmed diagnosis of FIGO stage III or IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
4. Has received no further than second-line platinum-based chemotherapy, and has clinical complete response (CR) or partial response (PR) at least following 4 courses of the last platinum-based chemotherapy.
5. ECOG 0-1.
6. Has good organ function, including:
7. Patient of childbearing potential, has a negative pregnancy test when enrolled and promises to use an adequate method of contraception or abstain from activities that could result in pregnancy from enrolment to the end of study and during the 3 months after the last dose of the study treatment, or be of non-childbearing potential, can be enrolled in the study.
8. Is able to adhere to the protocol.
9. Has recovered from previous chemotherapy induced toxic side effects to ≤ grade 1 CTCAE or basal level, apart from ≤ grade 2 CTCAE peripheral neuropathy or hair loss symptoms at steady state.

Exclusion Criteria:

1. Has a known hypersensitivity to the active or inactive ingredients of ZL-2306 (niraparib) or compound which has similar chemical structure to ZL-2306 (niraparib).
2. Has symptomatic uncontrolled brain or leptomeningeal metastasis.
3. Major surgery or chemotherapy within 3 weeks of starting the study or patient has not recovered from any effects of the surgery.
4. Receive palliative radiotherapy encompassing \> 20% of the bone marrow within 1 week of entering the study.
5. Be diagnosed any invasive cancer other than ovarian cancer (apart from cured basal cell carcinoma and squamous cell carcinoma) within 2 years prior to study enrolment.
6. Has a history or current diagnosis of myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML).
7. Has other serious or uncontrolled disease
8. Has any disease, treatment and laboratory abnormality that may interfere the study results and affect the fully attendance of study. Or the patient is considered to be not suitable for the study by the investigator. Cannot receive platelet or red blood cell transfusion within 4 weeks of study drug administration.
9. Pregnant, breastfeeding or expecting to conceive children during the study treatment period.
10. Corrected QT (QTc) interval \> 470 msec.
11. Use proton pump inhibitors, antacids or histamine 2 (H2) blockers within 48hrs prior to the first drug administration for PK measurement.
The DTG-SWITCH Study: Longitudinal Analysis of Virologic Failure and Drug Resistance at and After Switching to Dolutegravir-based First-line ART

This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.

Dolutegravir (DTG), a second-generation integrase strand transfer inhibitor (InSTI), is widely used in high-income countries and is recommended by the World Health Organization (WHO) as an alternative first-line ART regimen. In countries where viral load monitoring is not routinely available many patients on first-line ART will be switched to a DTG-based regimen despite the detectable viral load, which could increase the risk of selection of resistance to DTG as the majority of patients with virologic failure on first-line EFV-based ART have NRTI mutations. The investigators hypothesize that the proportion of patients experiencing virologic failure 48 and 96 weeks after switching to a DTG-based regimen will be higher in patients who switched with virologic failure (VL\>400 copies/mL) compared to patients who switched with suppressed viral replication (VL\<400 copies/mL). This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. At the time of switching to DTG, a baseline study assessment will be done, and a blood sample will be taken. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.

Eligibility Criteria:
Inclusion Criteria:

Patients

* On first-line ART for 6 months or longer
* Switching to any DTG-based treatment

Exclusion Criteria:

* No informed consent
Evaluation of Inflammatory Markers in ph Negative Myeloproliferative Neoplasms: Impact on Outcome and Response to Therapy. Multicenter Retro-prospective Observational Study. The INFLA-ME (INFLAmmation in Myeloproliferative Disease) Study.

This study aims to observe inflammatory biomarkers and their trend over the history of the disease in patients suffering from MPN Ph negative; it also wants to identify any correlations between the aforementioned biomarkers and disease outcomes, considering first of all the occurrence of thrombo-haemorrhagic events and the evolution in the accelerated / blast phase of the disease, shedding light on new tools that can potentially guarantee a prompt and better risk stratification


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the time of diagnosis of MPN Ph negative
* Diagnosis of PV, ET, PMF or post PV and post ET MF, according to current WHO or IWG-MRT criteria (diagnosis since 2000)
* Obtaining informed consent

Exclusion Criteria:

* Life expectancy of less than 6 months
* Accelerated phase myelofibrosis or MPN with signs of leukemic evolution
Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.

The purpose of this study is to test the effectiveness, safety, and tolerability of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma. This is a phase II,open label,single center study. Patients will receive carboplatin, paclitaxel, and bevacizumab in an outpatient center by intravenous administration. The primary objectives is to study the progression free survival at 24 months after initiation of treatment and to determine the toxicity profile of the drug combinations. The secondary objectives are to estimate the overall survival and tumor response for this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Advanced Stage Endometrial Cancer (Stage 3 or 4)
* Any Histology including clear cell, and serous papillary carcinomas
* surgery must have had hysterectomy and bilateral salpingo-oophorectomy
* chemotherapy initiated 12 weeks after surgery
* sign informed consent
* Adequate End-organ function
* GOG (Gynecologic Oncology Group)Performance Status 0,1,2
* Patients must be 18 years or older
* Patients may have received radiation for the treatment of endometrial cancer.
* Patients may have measurable or non-measurable disease.

Exclusion Criteria:

* Patient with concomitant malignancy other than non-melanoma skin cancer
* Patients with prior malignancy who have been disease free for 5 years.
* Patients with serious uncontrolled infection, angina or serious peripheral neuropathy.
* Patients whose circumstances will not permit study completion or adequate follow up
* Patients who have received prior cytotoxic chemotherapy for treatment of endometrial cancer including chemotherapy used for radiation sensitization.