cyrilzakka/clinical-trials huggingface dataset:
mHealth Mindfulness With Patients With Serious Illness and Their Caregivers

Older adults with serious illness and their caregivers have high rates of anxiety and limited access to effective, non-pharmacological treatments. A recent National Academy of Medicine report recommended increased emphasis on disseminating and implementing evidence-based psychotherapies in order to have maximal public health impact. Through this work, I will identify a sustainable and potentially scalable dyadic intervention and delivery model to manage symptoms of anxiety in older adults with serious illness and their caregivers in primary care.

Research: Up to 70% of adults with serious illness have symptoms of anxiety. Undiagnosed and undertreated anxiety contributes to higher risk of pain, depression, fatigue, dyspnea, and polypharmacy. Patients with high symptom burden and anxiety heavily impact family caregivers, which nearly 8 million older adults in the U.S. rely on for assistance. Decades of research reveal the negative effects of caregiving on caregivers, (e.g., high levels of stress, depression, and anxiety). Furthermore, there is a mutuality of distress in the caregiver/patient dyad - when patients suffer psychologically, the caregiver suffers too. Unfortunately, older adults and their caregivers have limited access to mental health resources because of shortages of mental health providers as well as logistical issues including time constraints, transportation, and scheduling. The objective of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of Mindfulness Coach, an mHealth Mindfulness Therapy intervention developed by the Veterans Affairs, to reduce anxiety in older adults with serious illness and their family caregivers. An efficacious and scalable behavioral intervention that mitigates symptoms of patient and caregiver anxiety has the potential to reduce distress and enhance coping in the patient-caregiver dyad without contributing to polypharmacy or burdensome appointments. Research is urgently needed to evaluate the feasibility, acceptability, and preliminary efficacy of dyadic mHealth mindfulness therapy in older adults with serious illness and their caregivers.

Eligibility Criteria:
Inclusion Criteria:

* adults 60+
* Diagnosis of or caregiver for individual with serious illnesses (e.g., ESRD, Cancer, CHF, COPD, Liver Disease)
* Hads-A \> 8 for patient or caregiver
* Blessed\<6
* fluent in English
* vision and hearing does not interfere with mobile device use
* caregivers who must be 21+
* caregiver must identify as primary source of informal care for patient
* Caregiver blessed \<6
* caregiver is fluent in English
* Caregiver's vision and hearing does not interfere with mobile device use.

Exclusion Criteria:

* experience with mindfulness therapy in last 2 years
* not fluent in English
* vision or hearing that impairs use of mobile device
* cognitive impairment more than 6 on Blessed.
Carbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients

The purpose of this study is to test if carbachol infusion induces headache in migraine subjects as well as intra- and extra-cerebral vasodilatation.

To test if infusion of Carbachol induces headache in 12 migraine subjects as well as intra- and extra-cerebral vasodilatation in a double-blinded study

Eligibility Criteria:
Inclusion Criteria:

* Migraine without aura
* Weight 50-100 kg

Exclusion Criteria:

* Other significant diseases
* Migraine 5 days prior to experiment
Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy

This is an open-label, single arm study. Approximately 3-30 patients will be enrolled. Patients will receive Oral ciclopirox olamine (aqueous suspension), initial starting dose of 5 mg/m2/day administered as a single dose daily for 5 days. Three patients will initially be treated at each dose level in sequential cohorts. Dose escalation will continue for each subsequent cohort based on toxicity and plasma drug concentrations observed during the previous cohort. Dose escalation will continue until establishment of the maximum tolerated dose (MTD) has been met.

Patients who have demonstrated response to treatment, up to 6 total cycles of treatment may be administered. If additional cycles are warranted, ciclopirox olamine will be given at the same dose and frequency as the patient initially received.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18
2. Relapsed or refractory hematologic malignancies including AML, ALL, CLL, high risk myelodysplasia (International Prognostic Score \>2.5), CML blast crisis, multiple myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma for which all potentially curative therapy options have been exhausted.
3. ECOG (Eastern Cooperative Oncology Group) performance status \< 2.
4. Biochemical values within the following range:

   1. Serum creatinine \< 2x upper limit of normal.
   2. Total bilirubin \< 2x upper limit of normal, AST (asparatate aminotransferase) and ALT (alanine aminotransferase) \< 5x upper limit of normal.
5. Ability to maintain adequate oral intake of medication.
6. Ability to understand and sign informed consent.
7. Toxicity from prior chemotherapy has resolved

Exclusion Criteria:

1. Uncontrolled systemic infection.
2. Uncontrolled intercurrent illness
3. Pregnant or breast feeding
4. Active CNS (central nervous system) disease
5. Neurologic symptoms related to intracurrent illnesses or unexplained causes
6. Psychiatric illness that would limit compliance with study
7. Receiving other systemic chemotherapy, other than hydroxyurea to control circulating blast counts, within 10 days of study entry. Hydroxyurea is permitted, however the dose must be stable and unchanged in the 7 days prior to initiation with ciclopirox olamine
8. Concurrent therapy with topical ciclopirox olamine.
9. Use of other investigational anti-cancer therapy within two weeks of study entry.
10. Use of oral or intravenous metal supplements including iron, copper, zinc and nickel.
11. Resting ejection fraction \< 50%
Pharmacokinetically-driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis

Meta-analyses in adults suggest equivalence of clinical efficacy of intravenous cyclophosphamide and mycophenolate mofetil when dosed based on patient weight or body-surface-area (MMFBSA), as is the current standard for the treatment of proliferative lupus nephritis (LN) treatments in the U.S. Pharmacokinetically-guided precision dosing of MMF (MMFPK) may offer a beneficial modification of the current standard treatment in that MMKPK promises over 30% higher LN response rates than MMFBSA. The objective of the proposed randomized, controlled study is to compare the efficacy and safety of pharmacokinetically-guided precision dosing of MMF (MMFPK) with conventional dosing regimens of MMF (MMFBSA) among children with proliferative LN.


Eligibility Criteria:
Inclusion Criteria:

New diagnosis with proliferative LN based on kidney biopsy done within 4 weeks of enrollment Diagnosis with childhood-onset SLE (cSLE) as per the ACR criteria95, 96 Age 8 - 17 years at the time of enrollment96 Tolerates oral MMF

Exclusion Criteria:

Perceived or stated inability to adhere to study protocol, Lack of use of highly effective birth control method. Presence of cSLE features that a-priori suggest that the patient benefits from other therapy than that suggested by the study protocol, History of significant kidney disease prior to the diagnosis with cSLE, Need for renal replacement therapy at the time of enrolment, Concurrent therapy with CYC or rituximab.
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Naturally or surgically postmenopausal
* Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)
* Vaginal pH greater than 5.0
* 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

* Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology
* Abnormal Pap smear
* Uterine bleeding of unknown origin or uterine polyps
* Current vaginal infection requiring medication
Pre-operative 5% Dextrose Infusion & PONV

With this study, we aim to compare the efficacy of pre-operative dextrose-containing fluid infusion with other fluid for the prevention of PONV in middle ear surgeries.

We hypothesized that maintenance of stable level of blood glucose in addition to adequate hydration through preoperative intravenous dextrose 5% infusion will have a rule in decreasing the incidence and severity of PONV; as it reduces insulin resistance and decreases gastric acid secretion; which may contribute to PONV.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I and ll.
* Patients undergoing middle ear surgeries, mastoidectomy, or tympanoplasty

Exclusion Criteria:

* history of dependence or use of antiemetics
* history of motion sickness
* presence of psychiatric illness
* pregnant and lactating women
* cardiovascular disorders (Ischemic heart diseases, congestive heart failure and valvular diseases)
* Diabetic patients
Oxygenation of Paravertebral Muscles During Exercise in Chronic Low Back Pain Patients

The study evaluate paraspinal aerobic metabolism of chronic low back pain patients and healthy people during an original and standardized isokinetic protocol.

The aim of this study is to determine a potential alteration of muscular aerobic metabolism in low back pain patients, in order to establish the underlying cause of pain and muscular fatigability characterizing low back pain patients. Then, the aim is to determine if functional rehabilitation program can improve it.

the unit of care have access to metabolic adaptations in measuring the muscular oxygenation and the pulmonary oxygen consumption, using near infrared spectroscopy and gas analyser.


Eligibility Criteria:
Inclusion Criteria:

* For Low back pain patients: suffering from low back pain for at least 3 month
* For control subject: no back pain in the past year

Exclusion Criteria:

* Chronic cardiovascular, pulmonary, metabolic, neurologic disease
Circadian Rhythm Dysregulation in Offspring of Parents With Bipolar Disorder

This study aims to 1) investigate the differences and variances in circadian rhythms at several levels, including physical activity, dim light melatonin onset, diurnal patterns of cortisol, and body temperature between the offspring of patients with bipolar disorder (BD) and offspring of healthy parents by using a high-risk study design; and 2) determine whether these indicators correlate with psychopathological symptoms as measured by the psychometric measurements.

Bipolar disorder (BD), characterized by episodes of mania or hypomania with frequent depressive episodes, is commonly found in the general population with a lifetime prevalence of 1-2% in the world. The morbidities and mortality associated with bipolar disorder are huge and the repercussion on their family members is considerate. Nonetheless, there is no existing well-established prevention strategy that may prevent this distressing mental disorder. A major reason is that there was limited understanding of the prodromal phase of BD. On the other hand, the genetic background determines about 60-85% of risk variance of BD. In other words, the offspring carries significant risk and propensity to develop future BD. Limited existing studies suggested that offspring of patients with BD have a higher rate of sleep and circadian disturbances and mental disorders than those offspring of parents without BD. Nonetheless, it is still unclear whether sleep and circadian disturbances are prodromal markers or risk factors for the development of bipolar disorder in this high-risk population.

In light of our research and other studies' preliminary findings on the relationship between circadian rhythms dysregulation and BD and robust heritability in BD, we hypothesize that

1. Circadian rhythm dysregulations are prodromal features and endophenotypes of BD. The offspring of BD parents will have more circadian rhythm dysregulations than those offspring of healthy controls;
2. The biologic indices of circadian rhythm dysregulations will be correlated with subsyndromal psychopathology.

Eligibility Criteria:
1. Case offspring

Inclusion criteria:

1) aged 6-21 years old; 2) having at least one biological parent with a lifetime or current diagnosis of bipolar disorder; 3) being able to read, write and understand Chinese; 4) both the offspring and her/his parent(s) agree to sign the informed consent form

Exclusion criteria:

1) having lifetime history or current diagnosis of bipolar disorder; 2) having no good ability to attend this project, such as patients with dementia and mental retardation.

2. Control offspring

Inclusion criteria:

1) aged 6-21 years old; 2) having no biological parent(s) with lifetime or current diagnosis of mood disorders. 3) being able to read, write and understand Chinese; 4) both the offspring and her/his parent(s) agree to sign the informed consent form.

Exclusion criteria:

1) having lifetime history or current diagnosis of bipolar disorder. 2) having no good ability to attend this project, such as patients with dementia and mental retardation.
IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion

The goal of this research is to understand whether it is practical and safe to use an intracervical balloon catheter in addition to standard of care medications at the time of an induction of labor for an abortion or fetal death. The medical device used in this study is cleared by the Food and Drug Administration (FDA) and is used for induction of labor at term gestational ages (at or above 37 weeks of gestation). The study team will also collect data about patient-level experiences with the procedure, time in labor, and labor-related complications, such as higher-than-expected blood loss or infection.

Commonly, induction of labor in the second trimester is accomplished with the use of oral anti-progestin medications (i.e., mifepristone) at least 24 hours prior to administration of sublingual, buccal, or vaginal prostaglandins (e.g., misoprostol). Innovation over the past decade has largely been focused on the concomitant use of mechanical dilation for induction of labor in order to reduce the time from initiation of labor to delivery. However, limited data exist to demonstrate the efficacy of an intracervical balloon catheter during second-trimester induction of labor. Therefore, the principal investigator seeks to conduct a feasibility randomized controlled trial to evaluate whether an intracervical balloon catheter - commonly used for inductions of labor at later gestational ages - can be used during second-trimester inductions of labor.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age ≥ 18
* English or Spanish-speaking
* Cervical dilation \< 3 centimeters
* Gestational age between 22w0d and 27w6d

Exclusion Criteria:

* Maternal age \< 18
* Non-English- or Spanish-speaking
* Cervical dilation ≥ 3 centimeters
* Gestational age below 22w0d or above 27w6d
* Allergy to mifepristone or misoprostol
* Hemolysis, Elevated Liver Enzymes, and Low Platelets (HELLP) syndrome
* Disseminated intravascular coagulopathy
* Placenta previa or suspected placenta accreta spectrum disorder
* Placental abruption
* Suspected intraamniotic infection
* Rupture of membranes
* Untreated genitourinary tract infection
* 3 or more cesarean deliveries, classical cesarean delivery, or endometrial cavity-entering myomectomy
Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients

Diabetes peripheral neuropathy (DPN) affects up to 50% of the diabetes population. In the diabetic neuropathic foot, it commonly manifests as loss of protective sensation, foot deformity and skin dryness. Alongside with day-to-day weightbearing activities, this can lead to formation of callus over plantar pressure points. Studies have proven that callus formation leads to high plantar pressure and increased risk of diabetic foot ulcers. For podiatrists, diabetic foot screening and treatment is our daily practice. Plantar callus are commonly treated by sharp debridement to relief pressure from the hard skin build up and thus reducing the risk of ulceration. However, the effectiveness of callus sharp debridement is not commonly studied in researches. Only a few studies in the past evaluated the effectiveness of callus treatment by different outcome measurements. Among those studies only 2 were specifically done in diabetic patients, in which one reported results of diabetic neuropathic patients. All the available studies used peak plantar pressure only as their pedobarographic outcome measure. In this study, the treatment effect of podiatric sharp debridement of callus in diabetic neuropathic patients will be evaluated using a range of pedobarographic parameters and Foot and Ankle Outcome Score (FAOS) questionnaire. The immediate and short-term (3-4 weeks) effect of sharp debridement in DPN patients with callus could be quantified. Change in loading pattern could also be analysed based on different areas of the foot.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Active out-patient status in Podiatry department of Princess Margaret Hospital
3. Men and women
4. Ambulatory
5. Diagnosis of type I or II diabetes
6. Failed peripheral neurological assessment (Vibration perception threshold \>25 volts or unable to detect one or more sites of 4-point 10g Semmes-Weinstein monofilament test)
7. Presence of plantar callus
8. Compliance with instructions (in Chinese or english)
9. Ability to read and write (in Chinese or english)

Exclusion Criteria:

1. Peripheral vascular disease
2. Painful neuropathy
3. Charcot deformity
4. Undergone any form of callus debridement in the past 6 weeks
5. Active foot ulcer
6. Any dermatological condition other than callus that causes hyperkeratosis (e.g. verruca pedis, eczema, tinea pedis)
7. Any musculoskeletal condition that affects balance and gait
8. Allergic to chlorhexidine gluconate or alcohol
Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.

The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component
* Patients must be candidates for platinum based chemotherapy and previously untreated
* Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy
* Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides
* ECOG PS 0-1
* Adequate hematological, renal, and liver function

Key Exclusion Criteria:

* Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors
* Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior immunotherapy with IL 2, IFN α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
* Patients for whom, in the opinion of the Investigator, there is clinical benefit to administer bevacizumab as a first-line treatment and for whom bevacizumab is approved and available in this setting.
* Cancer for which intraperitoneal cytotoxic chemotherapy is planned
* Active autoimmune disease (some exceptions include diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)
Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Track (GIT) Symptoms in Thailand

This is a prospective , epidemiological, multi-centre, phase IV study, approximately 5,000 patients who suffer with upper gastrointestinal tract symptoms. Each patient will be assessed for GERD with GerdQ Thai Version.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Female or male aged at least 18 years
* Patient must be having symptoms suggestive of upper gastrointestinal tract symptoms such as heart burn/ regurgitation

Exclusion Criteria:

* Involvement in the planning and /or conduct of the study (applies to both AstraZeneca staff and /or staff at study site
* Participation in a clinical study(excluding non-interventional study or registry) during the last 3 months
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-3281 in Healthy and Hepatitis C Infected Male Participants (MK-3281-002)

This study will examine the safety, tolerability and plasma pharmacokinetics of multiple doses of MK-3281 in healthy male participants in Part I, and in Hepatitis C Virus (HCV)-infected male participants in Part II. The clinical efficacy of MK-3281, as measured by viral load reduction, will also be assessed in Part II. The primary hypothesis is that twice daily administration of MK-3281 for 10 days in healthy adult male participants and for 7 days in HCV-infected male participants is sufficiently safe and well tolerated, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.

The results of this study will guide dose selection for future studies in both healthy participants and HCV-infected participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
* Participant has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
* Participants with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
* Participant has a clinical diagnosis of chronic HCV infection (for Part II only).

Exclusion Criteria:

* Participant has a history of stroke, chronic seizures, or major neurological disorder
* Participant has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Participant has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
* Participant has positive Hepatitis B surface antigen (or other evidence of active Hepatitis B infection) at the prescreening (study) visit
* For Healthy Panel (Part I), participant has evidence of chronic Hepatitis C virus infection at the prescreening (study) visit
* Participant has a history of documented Human Immunodeficiency Virus (HIV) infection