cyrilzakka/clinical-trials huggingface dataset:
A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma

This is a multi-center, open-label, Phase 1/2 study in China to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of CM336 in patients with relapsed or refractory multiple myeloma.

This study consists of a dose escalation part (Phase 1) and a dose extension part (Phase 2 ).

The safety and tolerability of CM336 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined.

The efficacy of CM336 will be evaluated in Phase 2 study.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
* Patients with relapsed or refractory MM who have failed or are intolerant to all therapies with known clinical benefit; patients must have received at least 2 prior anti-myeloma therapies which must contain at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 monoclonal antibody (if available).

Exclusion Criteria:

* Patients who had received BCMA-targeted therapy.
* Patients who had received CAR-T therapy.
* Patients who had received anti-tumor therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of CM336.
β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST

The aim of this study is to investigate the potential disease preventive effects of β-glucans from oat and barley.

Objective:

The primary aim is to examine whether consumption of oat and two different barley β-glucans exhibits hypocholesterolemic effects and to understand the underlying mechanisms.

Secondary aims are to investigate whether there are also effects on blood pressure, appetite regulation, insulin sensitivity, hemostasis, low-grade inflammation and the metabolic profile of different biological materials.

Intervention:

In each of the 4 intervention periods the participants drink a milk drink together with their three main meals for 21 days. This way they consume 5g β-glucan/d form either oat or barley in the three treatment periods, otherwise they maintain their habitual diet. They are not, however, allowed to eat any oat- or barley-containing products during the trial.

At the beginning and at the end of each intervention period the participants' blood pressure is measured and a fasting blood sample is drawn.

Further they collect feces for 72 hours and urine for 24 hours before and at the end of each intervention period.

Before and at the end of each intervention period a 4-hour meal test is undertaken to measure their subject appetite sensation. Here at first a fasting blood samples drawn and thereafter the milk drink is served. Appetite sensation is assessed every 30 min for 4 hours. Also blood samples are drawn at 2 hours and 4 hours at the meal tests which takes place before each intervention period.

At the subsequent "ad libitum" lunch meal the food intake is measured and then a final appetite registration is made.

Furthermore participants make 4-d food records before and at the end of each intervention period.

Eligibility Criteria:
Inclusion Criteria:

* normal weight or moderately overweight (BMI 18.5-30 kg/m²)

Exclusion Criteria:

* chronic diseases (e.g. diabetes, cardiovascular disease)
* elevated blood pressure
* hyperlipidemia
* consumption of dietary supplements during or 2 month prior to start of study (including vitamin tablets)
* consumption of oat and barley products from January 1st until the end of study
* smoking
* excess physical activity (\> 8h/week)
* medicine use (not included contraceptives or occasional pain killer consumption)
* pregnancy
* breast feeding
The Genetics Behind Vitamin D Status (VitDgen)

The overall purpose of the study is to investigate whether there is a relationship between 26 different single nucleotide polymorphisms (SNPs) in the vitamin D pathway, ultraviolet B (UV-B) irradiation of the skin and vitamin D status.

The hypothesis is that vitamin D status are influated by different genetic genotypes in the vitamin D pathway.

In this study approximately 80 participants (over 18 years) are included. All the participants has previously participated in the VitmaD intervention study (NCT01184716) .

Participants will in total receive 4 times UV-B irradiation (3 SED) with two day apart each time, to stimulate vitamin D production in the skin. The participants skintype will be measured. The study starts in January 2013 and runs to the end of Marts 2013. During this winter period, it is in Denmark not possible to produce vitamin D in the skin through sunlight exposure.

Eligibility Criteria:
Inclusion Criteria:

* Health participants over 18 years, that previously participated in VitmaD intervention study

Exclusion Criteria:

* skindiseases
* intake of medicin that causes photosensitive skin
* pregnant or nursing
* sun vacation 3 month before the intervention
* intake of vitamin D supplement 3 month before the intervention
Comparison of Taping Techniques in Plantar Fasciitis

The aim of this study is to investigate the effects of Low-Dye and Kinesio Taping on pain and function in individuals with plantar fasciitis.

Subject: In this study, the effects of Low-Dye Taping and Kinesio Taping (KT) on pain and function will be investigated in individuals with plantar fasciitis. There are studies on both Low-Dye banding and KT in the literature and they are popular applications recently. However, to the best of our knowledge, when we look at the Turkish and English literature, no study has been found comparing these two therapeutic massages in terms of pain, functionality and performance.

Purpose: Plantar fasciitis (PF) is a clinical picture characterized by degeneration of the plantar fascia resulting from repetitive microtrauma to the plantar fascia causing an inflammatory reaction. It is one of the most common causes of heel pain in adults. The plantar fascia has a fundamental role in the biomechanics of the foot, supporting the medial longitudinal arch (MLA), distributing forces and stresses of the foot during gait or other loading conditions. Disorders in the musculoskeletal and somatosensory system in patients with plantar fasciitis may cause pain and decrease in functional capacity. Therefore, its purpose is; This study was planned to show the effectiveness of taping methods applied in addition to ESWT in individuals presenting with heel pain. Thanks to the findings to be obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with plantar fasciitis by a physician
* Age between 18 and 30 years
* Agree to participate in the study

Exclusion Criteria:

* Not having surgery
* Disagree to participate in the study
* Infection
* Pregnancy
* Tumor
Cetuximab in Treating Patients With Stage IV Colorectal Cancer

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of cetuximab in treating patients who have stage IV colorectal cancer that has not responded to previous treatment.

OBJECTIVES: I. Determine the response rate of patients with irinotecan-refractory, stage IV colorectal cancer when treated with cetuximab. II. Determine the safety and toxic effects of this drug in these patients. III. Determine the time to progression of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours weekly for 6 weeks. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent stage IV colorectal cancer Any T, any N, M1 Documented progressive disease within 6 months of completing an irinotecan- containing regimen Bidimensionally measurable metastatic disease Meningeal or CNS involvement allowed Immunohistochemical evidence of EGFR expression (at least 1+)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history of uncontrolled angina, arrhythmias, or congestive heart failure Other: No other malignancy within the past 3 years except basal cell skin cancer or pre-invasive carcinoma of the cervix No uncontrolled seizure disorder No neuropathy greater than grade 2 or other neurologic disease No medical or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy or cetuximab Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy No other chemotherapy since completing irinotecan-containing regimen No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 30 days since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 21 days since prior surgery, except diagnostic biopsy, and recovered Other: At least 30 days since prior investigational agents and recovered
Exergaming in People With Major Neurocognitive Disorder

This randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (MNCD) residing in long-term care facilities.

This randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (MNCD) residing in long-term care facilities. Fifty inpatients with mild to moderate MNCD will be randomly assigned to three times weekly for eight weeks 15 min of exergaming versus watching preferred music videos. The Montréal Cognitive Assessment (MoCA), Short Physical Performance Battery (SPPB), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Dementia Quality of Life (DQoL), Katz activities of daily living (ADL) and Instrumental ADL (IADL) are measured at baseline and post intervention.

Eligibility Criteria:
Inclusion criteria included:

* a Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 diagnosis of MNCD (American Psychiatric Association, 2013)
* aged 65 years or older
* a score of minimum 10 on the Mini-Mental State Examination (MMSE)
* residing at least two weeks in the care facility at the time of inclusion
* being physically capable of doing standing exercises (whether or not with extra support).

Possible causes of MNCD were vascular dementia, Alzheimer's disease, mixed dementia, Parkinson's disease or Lewy body disease.

Exclusion criteria consisted of:

* any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation
* a score lower than 10 on the MMSE
* a planned transfer to another setting within the following two months.
Antioxidant Micronutrients in Malaria

In the last decade, the prevalence of malaria has been escalating at an alarming rate, especially in Africa. An estimated 300 to 500 million cases each year cause 1.5 to 2.7 million deaths, more than 90% occur in children under 5 years of age in Africa (WHO 1995). Malaria is Africa's leading cause of under-five mortality (20%) and constitutes 10% of the continent's overall disease burden. It accounts for 40% of public health expenditure, 30-50% of inpatient admissions, and up to 50% of outpatient visits in areas with high malaria transmission. Antioxidant micronutrients have immunomodulatory role and may have suppressive activity.

The pathogenesis of plasmodial infection hinges on intracellular invasion of host erythrocyte and hepatocyte with possible generation of free radicals that may contribute to cellular membrane damage. This will make uninfected erythrocyte and hepatocyte to be more susceptible to merozoite invasion. Zinc and Selenium has immunomodulatory properties. They enhance cell-mediated immune response in malaria infection. This may help to adequately suppress schizont maturation and inhibit the release of merozoites. However, it is possible that they have a direct chemosuppressive or blood schizonticidal effect. The following research questions emanated from this hypothesis;

1. Do the micronutrients in question have direct suppressive or schizonticidal effect?
2. Can they be used as short course therapy with standard antimalarials in uncomplicated malaria?
3. Is their effect enhanced when used in combination with each other or with standard antimalarials?
4. Do they have any prophylactic benefit?
5. Can their use alter the course of established malaria infection?

Eligibility Criteria:
Inclusion Criteria:

* age of \< 5 years
* asexual parasitemia of between 1,000 and 100,000/µl
* acute manifestation of malaria (e.g., history of fever in the preceding 24 hours or a temperature of \>37.5°C at baseline)
* body weight between 5 and 30 kg
* ability to tolerate oral therapy
* informed consent by the legal representative of the subject (the parents, if possible), oral agreement of the child if appropriate
* resident in the study area for a duration of at least 4 weeks

Exclusion Criteria:

* adequate antimalarial treatment within the previous 7 days

  * use of micronutrients in the last 2 weeks
  * antibiotic treatment for a concurrent infection
  * hemoglobin level of \<7 g/dl
  * hematocrit of \<25%
  * leukocyte count of \>15,000/µl
  * mixed plasmodial infection
  * severe malaria, any other severe underlying disease
  * concomitant disease masking assessment of the treatment response
  * inflammatory bowel disease, and any other disease causing fever
Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients

Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients

It is a randomized control trial comparing between isolated anterior cruciate ligament reconstruction with and without lateral extra articular tenodesis between high demand and high risk groups with high pivot regarding failure rate (primary out come) and patient reported functions score (IKDC and Lysholm)

Eligibility Criteria:
Inclusion Criteria:

* High demand patients (manual workers, athletes,...etc.).
* Normal average body mass index ( 18.5 - 24.9 ).
* Age \<40 years old.
* Patients will be diagnosed as ACL tear by the following:

  1. History of knee traumatic event.
  2. Clinical examination ( positive Lachman test and pivot shift test).
  3. Radiological evidence of ACL tear by MRI.
* patient with high pivot shift test.

Exclusion Criteria:

* Generalized ligamentous laxity.
* Other intra or extra articular knee injuries.
* Previous ACL surgery on the affected knee.
* Bilateral ACL injuries.
* Significant Articular surface injury.
* Medical comorbidities
* Patients with malalignment ( genu varum, genu valgum or genu recurvatum )
* Neuromuscular disorders
* Knee arthritic changes.
Reference Values of Intraepidermal Nerve Fiber Density in Children and Small Fiber Neuropathy in Neurometabolic and Neurodevelopmental Disorders in Children

Background: Small-Fiber-Neuropathy describes the degeneration of mildly or unmyelinated nerve fibers and causes neuropathic pain and autonomic dysfunction. Gold standard for the diagnosis is a small skin punch biopsy from the lower leg and the histological quantification of the intraepidermal nerve fiber density (IENFD). In children, the normal IENFD has not been systematically assessed and normal reference values are needed. In Parkinson´s disease, the neurodegeneration also affects the peripheral nerves and SFN is present already in the early stages. Whether neurodevelopmental disorders (NDDs) in childhood are likewise associated with SFN is largely unknown. The IENFD is age-dependent and declines with age.

Aims: In this study, we are establishing the reference values for the physiological IENFD in children from 0-18 years. Moreover, we are investigating if children with NDDs have a reduced IENFD and if SNF is a clinically relevant cause of pain and autonomic dysfunction.


Eligibility Criteria:
control patients

Inclusion Criteria:

* Elective surgical intervention from lower leg
* Interest to participate in the study, informed consent
* Unremarkable neurological development

Exclusion Criteria:

* Clinical signs of polyneuropathy, autonomic dysfunction
* Skin inflammation, scar, skin disease, other known chronic diseases that can cause small fiber pathology

Neurodevelopmental patients

Inclusion Criteria:

* Neurodevelopmental problems (developmental delay, muscular hypotonia, seizures, ataxia,...) with age of onset before the age of 18 years
* Interest to participate in the study, informed consent

Exclusion Criteria:

* Known polyneuropathy
* Skin inflammation, scar, skin disease, other known chronic diseases that can cause small fiber pathology
Validation of Severity of Illness Scoring Systems in Paediatric Intensive Care Units in Canada

This is a study of the validation of severity of illness scoring systems in Paediatric Intensive Care Units (PICUs) in Canada.

Outcome: Validation and comparison of 2 severity of illness scores in a Canadian PICU population.

Eligibility Criteria:
Inclusion Criteria:

* All children admitted to participating PICUs over a 1 year period.
Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients

1. Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.
2. Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression.


Eligibility Criteria:
Inclusion Criteria:

* The persons selected for the study are those who are:

  1. Colorectal cancer confirmed patients by imaging techniques (CT or MRI) and histopathological biopsy by Colonoscopy.
  2. Cooperative individuals attending South Egypt Cancer Institute - Assiut University of all ages and both sexes with confirmed diagnosis of CRC who agreed to be engaged in the study and were able to provide adequate samples.

CRC Patients will be divided into 4 groups:

Group 1: CRC patients without Blastocystis or Cryptosporidium infection. Group 2 : CRC patients with Blastocystis infection. Group 3 : CRC patients with Cryptosporidium infection. Group 4 : CRC patients with both Blastocystis and Cryptosporidium infection.

Exclusion Criteria:

* Patients having any type of tumors other than CRC. Patients taking anti-parasitic medications 2 weeks before sample collection.
Safety and Tolerability Study of an Edible Colon Preparation

The purpose of this study is to learn about a new bowel preparation that uses food to clean the colon.

In order to learn about this new food preparation, some people in this study will get the food preparation, and others will get the standard liquid bowel preparation.

Patients will be randomized (like flipping a coin) to one of five groups:

Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY

The purpose of this Phase 2 formulation screening/proof of concept study is to evaluate the safety, tolerability, and efficacy of up to 3 ECP-019 formulations/dosing regimens comprising a PEG 3350 Colon Prep Kit, containing electrolytes provided by the foods, in 3 formulations/ dosing regimens as compared to 2 comparators in a Phase 2 study.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose physician has prescribed colonoscopy for colorectal cancer screening or surveillance for colorectal cancer.
* Patients with a previous history of completing a bowel cleansing procedure for a colonoscopy.

Exclusion Criteria:

* Known intestinal stricture of any etiology.
* History of diabetes mellitus.
Detection of Heart Conditions Using Artificial Intelligence

The purpose of this study is to evaluate how Eko AI performs in the real world, front-line setting where the availability of sophisticated, expensive diagnostic tools is limited, and where there is a premium on detecting VHD early in its course.

Echocardiography is the state of the art for diagnosing VHD. However, without an effective pre-screening tool, many echocardiograms ("echos") are being ordered unnecessarily. A recent study found that greater than 66% of all echos performed in the United States do not alter clinical management, while an additional 4% may be deemed inappropriate altogether.

Because of this, echos now make up a disproportionately large segment of healthcare expenditure. Each year, 1 in 5 Medicare enrollees receives an echo at a total cost of $1.2 billion, or 11% of total Medicare spending on imaging services. This is compounded by the fact that an estimated 35 million Americans live in medically underserved areas, where patients must travel an average of 56 miles to see a specialist and receive an echo. This does not encourage compliance, and only adds to cost, lost working hours, and inconvenience.

There is therefore a growing, unmet need for better VHD screening tools. Tools that will consistently, reliably, quickly, and cheaply identify VHD when it is early and asymptomatic, when patients can be managed early and appropriately, and when they are at the lowest risk from an intervention. Such a tool will have a positive impact on the cost of care, patient and provider experience, and healthcare outcomes.

The FDA-cleared Eko CORE and Eko DUO electronic stethoscopes offer clinicians a familiar and inexpensive tool that is widely accepted by patients and providers, while at the same time offer sensors and artificial intelligence technology that can improve screening and detection of medical conditions such as VHD. Both the CORE and the DUO feature sound amplification during auscultation - the CORE also offers active noise cancellation - which improves the ability of the clinician to detect nuanced changes in heart sounds.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking adults who are 18 years and older
* Able and willing to provide informed consent
* Complete a clinical echocardiogram within 7 days before or after study procedures

Exclusion Criteria:

* Unwilling or unable to provide informed consent
* Patients who are hospitalized