cyrilzakka/clinical-trials huggingface dataset:
Importance of Dosing Regimen for the Effect of Vitamin D Supplementation

Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the body. Lack of vitamin D is associated with cardio-vascular disease (CVD), type 2 diabetes, cancer, infectious and immunological diseases, as well as risk factors for these diseases. However, intervention studies with vitamin D have been inconclusive regarding diseases and risk factors. This could be due to inclusion of subjects already vitamin D sufficient, and short and underpowered studies. In addition, there are indications that the dosing regimens may be important, so that daily doses with vitamin D are more efficient than intermittent doses, which so far have been generally used. This could be related to the concentration of circulating and thereby intracellular vitamin D concentrations, which probably is dependent on daily vitamin D doses. This will be tested in the present study where 60 subjects will be randomized to vitamin D 160 000 once, vitamin D 4000 IU/day, or placebo for four weeks. The primary endpoints will be effects on serum hepcidin and plasma cathelicidin after 4 weeks, with effects on serum PTH, RNA expression and microRNA in peripheral blood, telomerase activity in peripheral blood mononuclear cells and the ration between serum 1,25(OH)2D and 24,25(OH)2D as secondary endpoints.


Eligibility Criteria:
Inclusion Criteria:- Males and females 20 - 70 years

* 20 kg/m2 \> BMI \< 35 kg/m2
* systolic BP \< 175 mmHg, diastolic BP \< 105 mmHg
* Serum 25(OH)D level \< 50 nmol/L. Serum 25(OH)D \< 50 nmol/L is considered as vitamin D deficiency, and accordingly, effects of vitamin D supplementation will be easier to detect than if the included subjects were vitamin D sufficient.
* Hgb, SR, CRP, creatinine \< 130 umol/L in males, \< 120 umol/L in females, calcium, FT4 and TSH within the normal reference range; ASAT \< 90 mU/L ALAT \< 140 U/L, HbA1c \< 6.6 %
* The subjects must agree not to take any vitamin D supplementation, including cod liver oil or "mølje", use solarium or go on sunny vacation during the intervention period.

Exclusion Criteria:

* subjects allergic to peanuts
* subjects with primary hyperparathyroidism
* granulomatous diseases (sarcoidosis, tuberculosis, Wegner's granulomatosis)
* diabetes
* renal stones the last five years
* subjects seriously ill (or with chronic disease) and unfit for participation in the study (as judged by one of the study doctors)
* subjects using vitamin D supplements exceeding 800 IU per day or active vitamin D drugs (Rocaltrol or Etalpha)
* pregnancy
CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant

The purpose of this study is to learn more about the effects of (classification determinant) CD34+ stem cell selection on graft versus host disease (GVHD) in children, adolescents, and young adults. CD34+ stem cells are the cells that make all the types of blood cells in the body. GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes (a kind of white blood cell) against the recipient's body and organs. Study subjects will be offered treatment involving the use of the CliniMACS® Reagent System (Miltenyi Biotec), a CD34+ selection device to remove T-cells from a peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD.

This study involves subjects who are diagnosed with a malignant disease, that has either failed standard therapy or is unlikely to be cured with standard non-transplant therapy, who will receive a peripheral blood stem cell transplant. A malignant disease includes the following: Chronic Myeloid Leukemia (CML) in chronic phase, accelerated phase or blast crisis; Acute Myelogenous Leukemia (AML); Myelodysplastic Syndrome (MDS); Juvenile Myelomonocytic Leukemia (JMML); Acute Lymphoblastic Leukemia (ALL); or Lymphoma (Hodgkin's and Non-Hodgkin's).

Graft versus host disease (GVHD) is one of the serious complications following allogeneic stem cell transplantation. The incidence and severity of GVHD increase with the degree of HLA incompatibility between the host and donor. The most reliable way to prevent acute and chronic GVHD is to remove T cells from the graft. However, the incidence of graft failure increases with the efficiency of T cell depletion and low T cell numbers are predictive of graft failure. Immunomagnetic selection of HLA-mismatched CD34+ progenitor cells has demonstrated high levels of T cell depletion and successful engraftment in adult and pediatric patients with the malignant and nonmalignant disease.

Eligibility Criteria:
Inclusion Criteria: General Eligibility (All Patients)

* Must be \< 22 years of age
* Diagnosed with a malignant disease
* Must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent
* For unrelated donor: A human leukocyte antigen (HLA) 8/10, 9/10 or 10/10 matched unrelated adult donor (MUD) will be required for study entry
* For related donor: A 5/10, 6/10, 7/10, 8/10, 9/10 or 10/10 matched (or partially matched) family donor will be required for study entry
* Adequate renal function
* Adequate liver function
* Adequate cardiac function
* Adequate pulmonary function

Exclusion Criteria:

* Patients with documented uncontrolled infection at the time of study entry are not eligible
* Females who are pregnant or breast feeding at the time of study entry are not eligible
Sitagliptin Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans

Recent studies in both animals and humans has demonstrated that the hormone GLP-1 (glucagon like peptide 1) reduces intestinal production of lipoprotein particles. The investigators therefore hypothesise that the drug sitagliptin which prevents the breakdown of GLP-1 will reduce intestinal lipoprotein production in humans. The investigators are unable to speculate whether sitagliptin will affect hepatic lipoprotein production because of lack of of data from animal studies or in vitro data. Sitagliptin is already an approved treatment for type 2 diabetes.

Each subject will be studied twice 4-6 weeks apart in random order in this single blinded study. In study A they will receive a single dose of sitagliptin 100mg od. In study B they will receive placebo. A nasoduodenal tube will be sited under fluoroscopic guidance the day prior to the study. On the day of the study regular liquid formula (Great shake plus) will be infused from 4am through the tube to maintain a constant fed state. A pancreatic clamp (octreotide with replacement glucose, insulin and growth hormone) along with saline/sitagliptin will be started at 7am. From 9am an iv bolus of deuterated-glycerol (d5-glycerol) along with a regular infusion of deuterated leucine (L-\[5,5,5-2H3\]. Regular blood samples will be drawn to assess lipoprotein kinetics.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 18 to 60 years
2. Body mass index 20 kg/m2 to 27 kg/m2
3. Hemoglobin above 130g/L.
4. Normal glucose tolerance in response to a 75g, 2-hr OGTT

Exclusion Criteria:

1. Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
2. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr \> 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP \> 100 or systolic \> 180) or proliferative retinopathy
3. History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.
4. Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
5. Any laboratory values: AST \> 2x ULN; ALT \> 2x ULN TSH \> 6 mU/l
6. Current addiction to alcohol or substances of abuse as determined by the investigator.
7. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
8. Taking any prescription or non-prescription medications at the time of the study
9. Having donated blood three months prior to and three months post study procedures
10. A pregnancy test will be performed 1 to 3 days prior to each study in all female subjects. Those who test positive for pregnancy will be excluded.
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients

Hip fractures are common, costly and affect older people - Canadians spend 1 billion dollars to treat hip fractures each year. Unfortunately, as many as two-thirds of hip fracture cases suffer a complication known as delirium, or acute confusion. Patients with delirium may become frightened and agitated. This in turn leads to other serious problems. Having delirium doubles the chances of dying or can increase the need for admission into a nursing home. People with delirium spend an extra week in hospital on average.

Using ultrasound to locate and 'freeze' or block specific nerves can stop hip fracture pain almost immediately, and use of this technique is known to reduce delirium when administered by Anaesthetists to patients at the time of their hip operation. Unfortunately, patients with hip fractures commonly wait hours or even days in the Emergency Department (ED) prior to their operation. Currently, these patients are given narcotic pain killers like morphine to dull their pain, as most ED physicians have not been trained in using this 'freezing' technique and Anaesthetists are rarely able to leave the operating room to administer freezing to patient in the ED.

The EDU-RAPID study will test whether training ED physicians on how to use the nerve freezing technique will reduce the number of patients who develop delirium after a hip fracture. To study this, ED physicians will be trained at 6 hospitals in small groups every 6 weeks over 18 months. The study will look at how patients who are treated by ED physician who has been trained compare to patients treated by a ED physician who has not yet been trained. Also, the study will see if the training motivates ED physicians to use the block regularly.

If correct, this study could significantly improve the comfort, quality of life, and independence of patients who suffer a hip fracture. In addition, if the study shows a reduction in delirium rates, this could represent a significant cost reduction to the health care system.


Eligibility Criteria:
Inclusion Criteria:

* At the cluster level, ED physicians practicing at a participating site will be eligible.
* At the patient level, all hip fractures seen by a participating ED physician will be eligible

Exclusion Criteria:

* ED physicians who work casually (less than 0.25 Full Time Equivalent)
* ED Physicians who are routinely using U/S guided RA for hip fracture patients, or decline participation in the trial.
* Patients' age less than 65 years;
* Patients who are delirious on initial assessment by ED physician or severe dementia
* Patients with communication problems (critically ill, unconscious, language barrier despite use of secure telephone-based translation service)
* Patients with allergies to narcotics or local anesthetic; or anticoagulant use (e.g. warfarin, dabigatran, rivaroxaban).
* Patients with hip fractures not requiring surgery (e.g. greater trochanter avulsion) will also be excluded.
An Occupational Therapist Fall Prevention Intervention in a Geriatric Primary Care Setting

Purpose of the study: To identify if an intervention focused on decreasing fear of falling (FOF) in a geriatric primary care setting implemented by an occupational therapist (OT) has the potential to decrease falls and improve physical, psychological and social factors related to FOF.

The primary research question: Is there an association between fear of falling among geriatric populations and fall prevention interventions that are offered by occupational therapist in a geriatric primary care setting?


Eligibility Criteria:
Inclusion Criteria:

* cognitively intact with a score of 29/30 or higher on the Orientation Log (standardized assessment tool)
* living in the community
* English speaking
* had a fall or near fall in the past year

Exclusion Criteria:

* received OT services within the past 2 months
Sensory Training in Distal Radius Fractures

This randomized controlled trial examines the effectiveness of sensory training in patients undergoing rehabilitation for distal radius fractures. Forty-four participants (aged 18-65, with no prior upper extremity injuries) will be randomly assigned to a control group (conventional physiotherapy) or an experimental group (conventional physiotherapy plus sensory training, including desensitization and proprioception exercises). Assessments will be conducted at baseline, 4 weeks, and 8 weeks using grip strength, sensory function, fine motor skills, pain level, and functional capacity measures. The study aims to compare the impact of sensory training versus conventional physiotherapy on pain reduction, sensory recovery, grip strength, and functional hand use.

This study aims to investigate the effectiveness of sensory training in patients with distal radius fractures. Designed as a randomized controlled trial, the study will include 44 participants aged 18-65 years who have not had a prior upper extremity injury and are in the rehabilitation phase after a fracture. Participants will be randomly assigned to either the control group (receiving conventional physiotherapy) or the experimental group (receiving conventional physiotherapy plus sensory training, including desensitization and proprioception exercises).

Assessments will be conducted before treatment, at 4 weeks, and at 8 weeks. The evaluation tools will include grip strength (hand dynamometer \& pinch meter), sensory function (monofilament test), fine motor skills (Nine-Hole Peg Test - NHPT), pain level (Numerical Pain Rating Scale - NPRS), and functional capacity (DASH questionnaire).

The aim of this study is to compare the effects of sensory training versus conventional physiotherapy on pain reduction, sensory recovery, grip strength, and functional hand use.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Diagnosed with distal radius fracture
* In the rehabilitation phase after fracture healing
* No prior upper extremity injuries
* No neurological or psychiatric disorders affecting hand function
* Able to comply with the rehabilitation program

Exclusion Criteria:

* Any other musculoskeletal injury affecting the upper limb
* Previous upper extremity surgeries
* Severe neuropathy or sensory disorders
* Uncontrolled chronic pain conditions
Triceps Surae Ultrasonographic Characteristics in Hemiparetic Stroke Survivors

This study aims to evaluate, in hemiparetic patients, changes in muscle ultrasound structure about the focal treatment of spasticity with botulinum toxin type A. For this purpose, the analysis of the mean echo intensity will be carried out on ultrasound acquisitions, identifying the possible correlations between the muscle echogenicity, the variations in the pennation angle, and the length of the fascicles.

For image processing operations, ImageJ software was applied.


Eligibility Criteria:
Inclusion Criteria:

* unilateral ischaemic or haemorrhagic stroke (documented with clinical examination and neuroradiological findings)
* presence of spasticity at lower limb muscles, at least grade 1+ in the modified Ashworth Scale 3.
* age ≥ 18 years

Exclusion Criteria:

* inability to walk before stroke
* presence of severe cognitive impairment
* presence of other musculoskeletal, neurological or cardiopulmonary impairment which can interfere with clinical findings
* presence of skin lesions that can contraindicate BoNT-A treatment
* previous surgical myotendinous elongation
Rifaximin Use in Severe Alcoholic Hepatitis

This study aimed to investigate the effect of decontamination by rifaximin in severe alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be randomly allocated to rifaximin group or control group.


Eligibility Criteria:
Inclusion Criteria:

* Heavy alcohol drinking within 3 months (Over 40 g/day)
* Maddrey's discriminant function ≥ 32
* AST/ALT ration ≥ 2
* Bilirubin level ≥ 5mg/dL
* Any one of the following additional criteria : hepatic encephalopathy, enlarged, tender liver, or peripheral leucocytosis
* Age : 19-75
* Jaundice within 3 months

Exclusion Criteria:

* Other causes of chronic liver disease (HBV, HCV, or autoimmune hepatitis)
* Antibiotics or probiotics use within 8 weeks
* Drug induced hepatotoxicity
* Acute viral hepatitis (HAV or HEV)
* Hepatic abscess or cholagitis
* Hepatocellular carcinoma of modified UICC stage II, III or IV
* Malignant tumor other than HCC
* Pregnancy
* Severe chronic extrahepatic disease
* Type I hepatorenal syndrome
* Hepatic encephalopathy grade II or IV
* Severe infection
Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine

The goal of this clinical trial is to test the effect of nebulized lidocaine on the hemodynamic response in the participant undergoing double-lumen endotracheal intubation.

The main question it aims to answer is to evaluate the changes in mean arterial pressure after intubation.

Participants will inhale 5ml of 2% lidocaine by nebulization15min before intubation.

Researchers will compare saline group to see if saline effects


Eligibility Criteria:
Inclusion Criteria:

1. aged 18-65 years, American Society of Anesthesiologists class I-II
2. participants undergoing double-lumen endotracheal intubation under general anesthesia
3. signed informed consent and volunteered to participate in the experiment

Exclusion Criteria:

1. Poor control of hypertension
2. preoperative arrhythmia
3. severe coronary artery or heart valve disease
4. sequelae of cerebrovascular accident
5. severe lung, liver, kidney and immune system diseases
6. Suspected difficult airway
7. confirmed or suspected allergy to this trial drug
8. As judged by the investigator to be ineligible for the study, such as communication impairment (language or intelligence)
The Effects of ∆-9-THC and Naloxone in Humans

The purpose of this project is to examine the effects of mu-opiate antagonism on the rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis.


Eligibility Criteria:
Inclusion Criteria:

* At least one exposure to Cannabis

Exclusion Criteria:

* Cannabis Naive
Management of Shoulder Dystocia in Flipped Learning

Flipped learning is an innovative learning method in midwifery education. Studies that apply this learning method together with shoulder dystocia training have not been found in the current literature. For this reason, the study was designed as a randomized controlled study to examine the effectiveness of the flipped learning technique in shoulder dystocia management using high-valid simulation in midwifery undergraduate education.

Flipped learning is an innovative learning method in midwifery education. Studies that apply this learning method together with shoulder dystocia training have not been found in the current literature. For this reason, the study was designed as a randomized controlled study to examine the effectiveness of the flipped learning technique in shoulder dystocia management using high-valid simulation in midwifery undergraduate education.

Hypotheses of the research;

First Hypothesis H1: The use of flipped learning model in midwifery education has an effect on midwifery students' shoulder dystocia knowledge levels.

Second Hypothesis H1: The use of flipped learning model in midwifery education has an effect on midwifery students' levels of Student Satisfaction and Self-Confidence in Learning.

Third Hypothesis H1: The use of flipped learning model in midwifery education has an effect on midwifery students' Pagana Clinical Stress levels.

Eligibility Criteria:
Inclusion Criteria:

* - Agreeing to participate in the study,
* Being a 4th year student at the Department of Midwifery,

Exclusion Criteria:

* - Refusing to participate in the study,
* Being a 1st, 2nd and 3rd year student in the midwifery department
S9031-S9333-S0112-S0301-A Biomarkers Associated With Response to Cytarabine in Samples From Older Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood and tissue from patients with cancer treated with cytarabine in the laboratory may help doctors learn more about the effects of cytarabine on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research trial studies biomarkers associated with response to cytarabine in samples from older patients with acute myeloid leukemia.

OBJECTIVES:

* Refinement and testing of a multiparameter flow cytometry-based cell-signaling signature (FC classifier) associated with in vivo likelihood of complete response (CR) to cytarabine-based induction chemotherapy in elderly patients (56 years and older) newly diagnosed with non-M3 acute myeloid leukemia (AML).
* Identification of cell-signaling signature(s) associated with continuous CR to cytarabine-based induction chemotherapy at one year (CCR1) in adult patients 56 years and older with a newly diagnosed non-M3 AML.
* Identification of cell-signaling signature(s) associated with relapse-free survival at one year (RFS1) in adult patients 56 years and older with a newly diagnosed non-M3 AML who received cytarabine-based induction chemotherapy and achieved CR.
* To investigate changes in cell-signaling signature(s) between matched pre- and post-treatment specimens of relapsed/refractory patients.

OUTLINE: This is a multicenter study.

Cryopreserved specimens are incubated with cytokines (e.g., interleukins), growth factors (e.g., sargramostim or filgrastim), and chemotherapeutic agent (e.g., cytarabine, etoposide) and other modulators. Cells are then fixed, permeabilized, and stained with antibodies that recognize extracellular markers (for example, surface phenotypic markers such as clusters of differentiation, drug transporters, and receptors) in conjunction with intracellular activation-state-specific epitopes of designated signaling molecules. Subsequently, cell are analyzed by phospho-flow cytometry (FC) in a random manner (without knowledge of clinical variables and outcomes) to a training set (complete pre-specified FC) versus a testing set. Cells are also analyzed by proteomic assays. Results are then compared with individual patient scores, including predicted clinical outcomes.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed with non-M3 acute myeloid leukemia (AML)
* Pretreatment and relapse/refractory cryopreserved marrow and circulating mononuclear cells (MC) from patients who meet the following criteria:

  * Eligible and evaluable patients on study SWOG-9031, SWOG-9333 (Ara-C/DNR induction arm only), SWOG-S0112, or SWOG-S0301
  * Did not refuse consent for this use of specimens
  * Have 2+ vials of pretreatment marrow cells and/or 2+ vials of pretreatment peripheral blood cells in the Southwest Oncology Group (SWOG) AML/MDS Repository

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics