cyrilzakka/clinical-trials huggingface dataset:
Vitamin D in Armenia: Vitamin D Repletion Strategies With Dibase, and Vitamin D and Vitamin D Binding Protein and COVID

This is a three-arm unblinded prospective interventional study of vitamin D supplementation in participants with insufficient vitamin D at three different induction and maintenance dosing regimens (high dose, low frequency; medium dose, medium frequency, and low dose, high frequency). Measurements of serum vitamin D will take place at 4, 8, 12, 24, and 36 weeks, and will be compared to determine which regimen was most effective at achieving and maintaining ideal serum vitamin D levels.

Data obtained from many epidemiological studies suggest that vitamin D deficiency is widespread throughout the world, despite increasing attention to the relationships between vitamin D deficiency and skeletal health as well as many other organ systems. This proposal is designed to optimally replace vitamin D deficient subjects with oral vitamin D solution (Dibase) among a well-characterized population whose mean vitamin D level have been established. In a recent nationwide study, this research team established that the country of Armenia has marginal levels of 25-hydoxyvitamin D among a free-living population of pre- and postmenopausal women: the average level was 19.76 ng/mL with 54% of subjects showing levels that are clearly insufficient. Equally impressive is the finding that fully 20% of women over 65 years of age, have levels that are below 12 ng/mL (\< 30 nmol/l).

Following consent, all participants will receive a unique participant identification number, and will then complete a brief questionnaire regarding demographics, selected medical history, and contact information. All participants will then be directed to the EcoSense laboratory, where they will provide blood sample via venipuncture for vitamin D.

For those participants with a 25-hydroxyvitamin D level of less than 30 ng/mL, they will be called back to EcoSense laboratory where they will provide blood sample via venipuncture for calcium, and then brought to the Osteoporosis Center, where they will be randomly allocated into one of three treatment groups.

Participants will be instructed on how to dose the supplement as appropriate for their assigned arm, and then receive 4 weeks of the vitamin D supplement. Participants will return to the Osteoporosis Center at the end of week 4 to obtain an interval history, be assessed for any adverse reactions, compliance, or symptoms of infection or illness. Blood samples will be obtained at weeks 4, 8, 12, 24, and 36 for measurement of 25-hydroxyvitamin D and calcium at the collaborating laboratory as described above, and all participants will be informed of their lab test results as they become available.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75
* Willing to participate in the study
* No vitamin D supplements for at least 1 year

Exclusion Criteria:

* Not meeting inclusion criteria
Follow-up Study of SyB L-0501 in Combination With Rituximab to Treat DLBCL

This study is a follow-up study to update the survival time data (overall survival, progression-free survival, and duration of response) of the subjects who received SyB L-0501 at least once in Phase III Study of SyB L-0501 in combination with rituximab to treat recurrent/relapsed diffuse large B-cell lymphoma study (2017002) by reviewing their follow-up information following the study completion of Study 2017002.

In this study, the follow-up information gathered until the end of the investigation period is reviewed after obtaining informed consent from the subjects or their legal representatives. Accordingly, no intervention, such as administration of the investigational product or examination, will be performed.

Investigative methods

1. The investigator or subinvestigator gives an explanation to a subject or his/her legal representative to obtain written informed consent to provision of information pertaining to this study.
2. After obtaining informed consent, the investigator or subinvestigator reviews the follow-up information following the completion of Study 2017002 in source documents regarding the following items:

1. Survival status 2. Aggravation (progression or recurrence) 3. Drugs or procedures used for treatment of DLBCL or prophylaxis against its progression or recurrence 4. Occurrence of other malignant tumors


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who received the investigational product at least once in Study 2017002
2. Subjects who or whose legal representatives gave written informed consent to provision of data pertaining to this study

Exclusion Criteria:

1. Subjects whose death was confirmed during the outcome investigation period in Study 2017002
Incidence and Risk Factors of Prolonged Grief in Palliative Care Units

The purpose of this study is to assess the incidence and risk factors of prolonged grief in family members of patients died in French palliative care units and to explore experience of bereaved families to build a scientifically valid management prevention program.

There is hardly knowledge on how bereavement is treated in palliative care patient's relatives. The field of bereavement needs studies that validate the theoretical underpinning of the research area. This study will depict the grieving process of individuals having lost a relative in palliative care in France. Having baseline data of incidence of prolonged grief, risk factors of relative's prolonged grief and identification of risk factors associated with the management of end-of-life issues in palliative care will contribute to target interventions that should help decrease bereaved families burden.

The investigator designed a quantitative study to assess the psychological effect of families after the death of the patient in palliative care unit and a qualitative study to examine the grieving prolonged process.

Eligibility Criteria:
Inclusion Criteria:

* Families of adult patients hospitalized more than 72 hours in a palliative care unit for end-of-life care.
* Eligibility of end-of-life cares are defined after the first evaluation by the palliative care physician.

Exclusion Criteria:

* Patients with less than 72 hours of life-expectancy
* Patients or families who refused the study
* Patients or families included in a study using the same questionnaires
* Patients without families visiting them in the first 24 hours after admission
* Patients not hospitalized for end-of-life issues
* Families not fluent in French
* Deaf or mute families
Enovis High Ankle Sprain Brace Testing

The goal of this clinical trial is to learn if a new ankle brace impacts athletic motions. The main questions it aims to answer are:

* Does it impact motions such as running and cutting?
* Is it comfortable?

Researchers will compare 5 ankle bracing conditions.

Participants will:

* Perform a running activity
* Perform a cutting activity
* Complete a survey


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 40 at the time of data collection
* English-speaking
* Not currently pregnant
* No history of lower extremity surgery or chronic ankle instability
* No ankle injuries that required medical attention or ≥ 7 days of modified physical activity within the last 3 months
* Currently cleared for all physical activity
* Comfortable running on a treadmill for 10 minutes at a self-selected pace
* Have prior experience wearing an ankle brace and / or ankle tape during sport activities
* Shoe size US Men's 7.5-11.5 or Women's 9-13
Gradual Withdrawal of Remifentanil Infusion Reduced Postoperative Pain and Opioid Requirement During Breast Surgery

Although remifentanil provides profound analgesia during operation, postoperative occurrence of hyperalgesia and tolerance after remifentanil administration could be a challenge to the postoperative pain control. Evaluation of analgesia and anti-nociception during anesthesia is still a challenging issue. Surgical Pleth Index (SPI) is a non-invasive and simple access tool used to monitor autonomous nervous system during anesthesia. This technique is based on photoplethysmographic wave and heart beat analysis. SPI values range between 0 (no stress) and 100 (high stress level). The purpose of this study was to determine the appropriate use of Remifentanil for pain control in patients with SPI.

Patients were randomized into either SPI-guided analgesia or standard practice (Control). In both groups, anesthesia was maintained with total intravenous anaesthesia(TIVA) to keep bispectral index values between 40 and 60.

In the Remifentanil gradual reduction group (test group), 20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes. The control group stopped remifentanil 10 minutes before the end of the operation.

SPI was recorded before the intubation, after the intubation, directly before the end of surgery. The number of unwanted somatic events, hemodynamics, Patient-controlled analgesia(PCA) consumption, narcotic analgesics consumption, and recovery times were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received the breast conserving surgery

Exclusion Criteria:

* Patients with arrhythmia who have poor SPI measurement
* When the patient refused
* Patients with decreased renal function of Cr\> 2
* Surgery for more than 3 hours, surgery expected to bleed more than 500 ml
Ursodiol Tablets 500 mg Under Fasting Conditions

The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference) after a single-dose in healthy subjects under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male and female subjects, 18 years of age or older.
* BMI ≥ 19 and ≤ 30.
* Negative for:

  1. HIV.
  2. Hepatitis B surface antigen and Hepatitis C antibody.
  3. Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
  4. Urine cotinine test
  5. Serum HCG consistent with pregnancy (females only)
* No significant diseases or clinically significant findings in a physical examination.
* No clinically significant abnormal laboratory values.
* No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
* Be informed of the nature of the study and given written consent prior to receiving any study procedure.
* Females who participate in this study are:

  1. unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy) OR
  2. willing to remain abstinent \[not engage in sexual intercourse\] OR
  3. willing to use an effective method of double-barrier birth control (e.g. partner using condom and female using diaphragm, contraceptive sponge, spermicide or IUD)
* Females who participate in this study are not pregnant and/or non-lactating.

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition.
* Known or suspected carcinoma.
* Known history or presence of:

  1. Hypersensitivity or idiosyncratic reaction to ursodiol and/or any other drug substances with similar activity.
  2. Alcoholism within the last 12 months.
  3. Drug dependence and/or substance abuse.
  4. Use of tobacco or nicotine-containing products within the last 6 months.
* On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
* Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
* Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 499 mL of blood in the previous 45 days OR Donated more than 499 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
* Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
* Females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
* Requirement of any non-topical medication (prescription and/or over-the-counter, with systemic absorption) on a routine basis.
* Difficulty fasting or consuming the standard meals.
* Do not tolerate venipuncture.
* Unable to read or sign the ICF.
Autologous Stem Cell Treatment for Chronic Lung Disease Study

The purpose of the Lung Institute is to collect and isolate a patient's own cells and platelet rich plasma (PRP) and deliver the product back to the patient the same day. Lung Institute's treatment is limited to self-funded patients with chronic lung disease- chronic obstructive pulmonary disease (COPD) and restrictive lung diseases such as pulmonary fibrosis (PF) and interstitial lung disease (ILD). The patient's cells and platelet rich plasma are harvested through venous or bone marrow collection techniques.

The hypothesized outcomes of therapy are safety and minimization of adverse events, a perceived improvement in the patient's lung condition (to be determined by their perceived quality of life), an improvement in the FEV1 among COPD patients, the ability to reduce supplemental oxygen use, the ability to function well without the use of rescue inhalers, reduction of secondary pulmonary infections, reduction in emergency room visits and exacerbations related to their disease.

Through the collection of outcomes data, Lung Institute aims to explore and describe the safety and efficacy of autologous stem cell treatment for chronic lung disease with dissemination to the public and to the medical community for the advancement of regenerative medicine. The study aims to confirm the safety of autologous cell therapy, explore the effect of autologous cell therapy treatment on pulmonary function over time, and to describe the anecdotal quality of life changes of patients following treatment using quantitative and qualitative measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients are included in treatment by self-referral and after consultation with a designated patient coordinator who determines initial eligibility, and then by the clinic nurse practitioner or physician of Lung Institute who determines final eligibility for inclusion. All eligible treated patients are eligible for the study.

Exclusion Criteria:

* Patients who are unable to provide informed consent, pregnant patients, prisoners, non-English speakers, patients with a history of cancer within the past 5 years, patients with active tuberculosis or pneumonia. In addition, patients on prescribed blood thinners, with a history of breast or prostate cancer of any time frame or with a history of osteoporosis are excluded from the bone marrow harvest option.
Construct Validity and Intra-Observer Reliability of the SDQ

The aim of the observational study is to investigate the validity and reliability of a self-report version of the Strength and Difficulties Questionnaire (SDQ) for 11-17 years in children with cerebral palsy (CP). That is, the current study explore if the self-report version of the SDQ would be valid and reliable in children with CP to report their mental health problems themself


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of CP, a communication level of I-III on the Communication Function Classification System (CFCS), and no severe intellectual disability

Exclusion Criteria:

* the presence of an inability to comprehend items on the SDQ and involuntary attendance of a possible re-test after two weeks (i.e., for re-test reliability)
A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

This research study is evaluating the feasibility and impact of an intervention to improve sexual function in stem cell transplant survivors on participants' sexual function, quality of life, and mood.

- It is expected that about 50 stem cell transplant survivors will take part in this research study.

Frequently survivors of stem cell transplantation report significant problems with their sexual function that impacts their quality of life, mood, and their intimacy and relationship with their partners. These issues can be very distressing to patients and their loved ones. The study doctors want to know if the introduction of an intervention focused on improving sexual function may improve a participant's overall care and quality of life.

The intervention includes a comprehensive assessment by a transplant clinician who is trained in sexual dysfunction assessment to explore the reasons for sexual dysfunction and focus on ways to improve the participant's symptoms. The study will use a series of questionnaires to measure a participant's sexual function, quality of life, and mood.

The main purpose of this study is examine whether this intervention is feasible and helpful for participants in terms of improving their symptoms and overall quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) with hematologic malignancy who underwent an allogeneic HCT at least 6 months prior to study enrollment.
* Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member.
* Positive screen for sexual dysfunction that is causing distress based on the National Comprehensive Cancer Network survivorship guidelines

Exclusion Criteria:

* Patients with relapsed disease post-HCT.
* Significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits the patient's ability to participate in the informed consent procedures.
Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma

Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of metastatic or recurrent renal cell carcinoma

Exclusion Criteria:

* Certain types of previous anti-cancer therapy for Renal Cell Carcinoma
* Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes
* Patients with a history of poorly controlled high blood pressure
The Effect of a Plant Protein Isolate on Muscle Protein Synthesis in Humans at Rest and After Resistance Exercise

Plant-based proteins contain several amino acids that are essential to signal growth, reconditioning, maintenance and preservation of skeletal muscle mass. This study aims to inform on the nutrient activation of muscle protein synthesis (MPS) by feeding a plant protein isolate equivalent to 0.33 g of protein per kilogram of body mass.

Participants: 32 young, healthy men and women aged 18 - 35 years. Intervention: Plant protein isolate (PPI) and nonessential amino acid control (NEAA) Study Design: Block randomised control trial. Two group parallel design. Primary outcome: Myofibrillar fractional synthetic rate (myoFSR).

Preliminary screening/familiarization consists of: medical history, dietary assessment and examination by a medical doctor and a qualified dietician, blood sample to be evaluated for health-related contraindications, body composition measurement by dual energy x-ray absorptiometry (DXA), isokinetic knee extensor strength tests.

Pre-trial: A metered dose of deuterium oxide (5ml/kg) will be ingested and blood and/or saliva (\~5ml) samples will be collected pre/post ingestion.

Experimental trial: Blood, saliva and bilateral m.vastus lateralis microbiopsies (\~100 mg) collected. A unilateral resistance-training session consisting of knee extensor contractions will be completed. Following exercise cessation participants will ingest 0.33 g/kg body mass of either: a nonessential amino acid formulation or a plant-protein isolate. A saliva sample and a 2nd set of bilateral m.vastus lateralis microbiopsies are collected 3 h postingestion.

Eligibility Criteria:
Inclusion Criteria:

- Men and women aged 18 to 35 years

Exclusion Criteria:

* Known intolerance to any item contained in the protein products.
* Blood borne disease risk, current illness or medication that would adversely affect participation
* Known adverse reaction to venepuncture and/or biopsy
* Inability to undertake resistance exercise
* Inability to adhere to protocol guidelines
GROW (Glioma Specialists Reaching Out With Support) Support

This research study is being done to test a participant and caregiver-driven model of follow-up survivorship care,GROW Support (Glioma Specialists Reaching Out With Support), for post-treatment, low grade glioma patients.

This research study is a Feasibility Study, which examines if a supportive intervention for people with low grade gliomas (LGGs) and their caregivers is acceptable and feasible to patients and their caregivers.

The research study procedures include: screening for eligibility and study interventions including filling out questionnaires and virtual or in-clinic supportive follow up visits to identify additional supportive needs that may arise.

Participants will be in this research study for up to 6 months.

It is expected that about 40 people will take part in this research study.

The Levitan-Zabin Fund for GROW Support is supporting this research study by providing funds for research team members to do this study.

Eligibility Criteria:
Inclusion Criteria:

* Patient inclusion criteria include:

  * Must be at least 18 years of age;
  * Diagnosed with low grade glioma (WHO grade 1 or 2)
  * Completed active treatment within the last 2 years and are undergoing surveillance follow-up
  * Must have at least one caregiver willing to participate as indicated below
  * Read and comprehend English such that they are able to complete required intervention sessions and psychosocial battery in English and are able to understand and willing to sign an electronic informed consent document.
  * Confirms willingness to undergo initial and follow-up questionnaire battery.
* Caregiver inclusion criteria include:

  * Must be at least 18 years of age
  * Read and comprehend English such that they are able to complete required intervention sessions and psychosocial battery in English and able to understand and willing to sign an electronic informed consent document
  * Consider themselves personally involved in the patient's care and decisions about the care they receive.

Exclusion Criteria:

* Bipolar disorder,
* Psychotic disorders and
* Confusion or altered mental state that would prohibit understanding and giving of informed consent. However, if the patient's bipolar disorder or psychotic disorder is currently treated/managed, the patient will be eligible for the study.
QOL, ADL and Pain Before and After Intervention With N3 From Krill With D3.

The aim of this project is investigation of patients' with chronic pain self-rated quality of life, ADL function and level of pain before and after 3 months of intervention with N-3 fatty acids from krill in combination with vitamin D3. Furthermore, the compliance of the patients and the effect of the intervention on the patients' vitamin D status and cardiovascular risk factors are studied.


Eligibility Criteria:
Inclusion Criteria:

* 18 year +
* can read and understand danish

Exclusion Criteria:

* shellfish allergy
* intake of anticoagulants and vitamin D
* pacemaker
* participating other studies