cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Replacement in Bronchiectasis

This study seeks to address the limitations in previous related studies on vitamin D replacement and bronchiectasis exacerbation occurrence through a self-controlled pilot study. The investigators aim to investigate whether vitamin D replacement in bronchiectasis patients with vitamin D deficiency can reduce hospitalized bronchiectasis exacerbation occurrence. Patients who participated in the prior study entitled "Prospective clinical study on serum 25-hydroxyvitamin D (25-OH D) level and risk of bronchiectasis exacerbation" (UW 22-317) will be invited for participation during regular clinic follow-up and management in Queen Mary Hospital. If participants are willing to join the further research, participants will be recruited in this self-controlled study. There are some differences from usual management to non-CF bronchiectasis subjects. The study subjects would be checked for their blood 25-hydroxyvitamin-D level during the study period. The non-CF bronchiectasis subjects with Vitamin D deficiency would be given 1000 IU and 2000 IU (if needed). The investigators aim to correct their Vitamin D deficiency completely, aiming at blood 25-hydroxyvitamin-D level \>=50, i.e. treat to target. The dose depends on the level of Vitamin D after replacement. If blood 25-hydroxyvitamin-D level is 50 or above, then 1000 IU is suffice. If blood 25-hydroxyvitamin-D level is still below 50, the investigators will increase to 2000 IU.


Eligibility Criteria:
Inclusion Criteria:

1. ages 18 years or above, male or female.
2. confirmed diagnosis of non-CF bronchiectasis based on high-resolution computed tomography (HRCT) scan.
3. participation in the prior study entitled "Prospective clinical study on serum 25-hydroxyvitamin D (25-OH D) level and risk of bronchiectasis exacerbation" (UW 22-317)

Exclusion Criteria:

1. underlying asthma, COPD and other co-existing respiratory diseases
2. underlying osteoporosis
3. supplementary Vitamin D in their regimen
4. advanced chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30mL/min
A Randomized Controlled Study Evaluating Modified Cup Anteversion Placement in Prevention of Postoperative Dislocation in Patients Undergoing Acetabular Tumor Resection and Reconstruction

The purpose of this clinical study is to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup.

The hypothesis is that patients with placement of the modified (( α-15°)±10°) anteversion angle of the acetabular component will have decreased risk of dislocation 1 year after surgery compared to patients with conventional anteversion angle ( α±10°) placement.

PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted

Hip dislocation is a common complication in patients who undergo reconstruction surgery after periacetabular tumor resection and most of these cases are anterior dislocations. Studies suggest that this type of dislocation may be closely related to the position and anteversion angle of the acetabular component. Therefore, properly reducing the anteversion angle of the acetabular cup during reconstruction might effectively prevent possible collisions between the cup and the femoral component, thereby reducing the potential risk of dislocation. Based on this theory, we aim to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup.

PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected size. A standard error within 10° is accepted.

Eligibility Criteria:
Inclusion Criteria:

* Age above 16 years old, gender is not limited.
* Tumor involving periacetabulum, femoral head, femoral neck or proximal femur
* Patients require 3D-printed hemipelvic endoprosthetic reconstruction following periacetabular tumor resection
* The subject has an estimated survival period of at least one year or more.
* The subjects with informed consent

Exclusion Criteria:

* The patient used to conduct surgery on his/her hip joint
* The patient's current surgery aimed for hip revision for implant failure or infection
* The patient didn't conduct hip endoprosthetic reconstruction
* Patients with congenital defects in the gluteal muscle group, neurological function or pelvic tilt deformity severe enough to affect functional activity
* Patients cannot self-assess postoperative function after surgery
* According to the judgment of the investigator/supervisor, there may be difficulties in completing postoperative follow-up
* Subjects have participated in similar research projects
Hydroxyzine and Risk of Prolongation of QT Interval

On 04/30/2015, ANSM (the National Security Agency of Medicines and Health Products) shared an information for general practicioners, pediatricians, anesthesiologists, dermatologists, geriatricians, psychiatrists, community pharmacists and hospital about using hydroxyzine and the associated risk of QT prolongation on the electrocardiogram.

Drugs containing hydroxyzine (the best known and most used is the Atarax®) are used in France in various indications including the treatment of minor manifestations of anxiety, premedication with general anesthesia and the symptomatic treatment of urticaria.

A prolonged QT interval is a known risk factor for occurrence of torsades de pointes which can cause sudden death. We distinguish congenital and acquired long QT interval. The main cause of acquired long QT interval is a drug inhibition of the HERG potassium channel 1. Many drugs have been reported to cause sudden death by prolongation of QT interval and occurrence of torsades de pointes (macrolides, anti -arythmics, some psychotropic ...) The molecules based on hydroxyzine are known to be at risk of prolongation of QT interval in an experimental point of view but is not clearly identified in daily clinical practice. Pharmacology unit of Caen was the first to publish a case of QT prolongation under hydroxyzine . Through this publication, associated with other clinical data, hydroxyzine has been added to the list of drugs that can induce QT prolongation .

Despite these recent recommendations, it does not seem that hydroxyzine prescriptions were changed daily and therefore the risk of QT prolongation persists. We therefore propose the study of the impact of hydroxyzine on the QT interval measured on the electrocardiogram in patients hospitalized at the University Hospital of Caen.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized at the University Hospital of Caen with a new prescription of oral hydroxyzine by their referring doctor.
* Patient 'stable' in hospital in a health service or surgery.
* Age \> 18 years old.

Exclusion Criteria:

* Unstable Patient hospitalized in an intensive care unit or intensive care.
* Patient refusing participation in the study.
* Age \<18 years old.
Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma

RATIONALE: Forodesine (BCX-1777) may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory stage IIA, stage IIB, stage III, stage IVA, or stage IVB cutaneous T-cell lymphoma.

OBJECTIVES:

* Determine the safety and efficacy of forodesine (BCX-1777) in patients with refractory stage IIA-IVB cutaneous T-cell lymphoma.
* Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral forodesine (BCX-1777) once daily on days 1-28. Courses may be repeated in the absence of disease progression or unacceptable toxicity.

Patients are followed periodically.

PROJECTED ACCRUAL: Not specified.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed cutaneous T-cell lymphoma

  * Refractory to prior treatment
  * Stage IIA, IIB, III, IVA, or IVB disease
* Measurable disease

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* At least 3 months

Hematopoietic

* Not specified

Hepatic

* AST and/or ALT ≤ 3 times upper limit of normal
* Hepatitis B and/or hepatitis C negative

Renal

* Creatinine clearance ≥ 40 mL/min

Immunologic

* Human T-cell lymphotrophic virus type I (HTLV-I) negative
* HIV negative
* No active serious infection not controlled by antibiotics

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known impaired absorption of the gastrointestinal tract
* No other illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* More than 21 days since prior chemotherapy and recovered

Endocrine therapy

* Concurrent topical corticosteroids allowed provided patient remains on a stable dose

Radiotherapy

* No concurrent radiotherapy

Surgery

* Not specified

Other

* More than 30 days since prior investigational agents and recovered
* No concurrent tanning bed use
* No other concurrent therapy for cutaneous T-cell lymphoma
Transcutaneous Pulsed Radiofrequency and Corticosteroids Injections in Management of Pain in Lateral Epicondylitis

The aim of the study is to compare between transcutaneous pulsed radiofrequency and corticosteroids injections in management of pain severity, forearm pain, functional disability and patient capability to operate daily activities in patients with lateral epicondylitis

Lateral epicondylitis (LE), or tennis elbow, is the most common elbow pain condition. Pain in the lateral aspect of the elbow, especially the extensor tendon origin (extensor carpi radialis brevis \[ECRB\] and extensor digitorum communis \[EDC\]), is the most consistent symptom. It affects up to 3 % of the population and is usually an overload injury that often follows minor and often unrecognized trauma to the extensor forearm muscles of the forearm.

Transcutaneous pulsed radiofrequency treatment is a noninvasive, needleless, painless, office/outpatient treatment that requires no recovery, sedation, or anesthesia. We were encouraged to research transcutaneous pulsed radiofrequency as a treatment option because of favorable outcomes in previous trials. Therefore, transcutaneous pulsed radiofrequency treatment used successfully in a type of orthopedic surgeries, we designed this trial to examine it in the management of pain in lateral epicondylitis.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18-65 years.
* Both sexes.
* Symptomatic lateral epicondylitis for more than 6 months.

Lateral epicondylitis was diagnosed when pain is elicited by two or more of these diagnostic exams:

1. Palpation of the lateral epicondyle.
2. Resisted wrist extension (Thompson test).
3. Chair test. With the shoulder flexed to 60° and the elbow extended, the patient attempts to lift a chair weighing 3.5 kg.

Exclusion Criteria:

* Severe systemic diseases (diabetes or rheumatoid arthritis).
* Cervical radiculopathy.
* Major trauma or prior surgery in the tendon of the elbow.
* Morbid obese patients (body mass index (BMI) of \>35 kg/m2).
* Infection at site of injection.
* Bleeding diathesis and coagulopathy.
* Patients who didn't consent to completing visual analog scale , rated tennis elbow evaluation (PRTEE), disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire. and refuse to participate in the study.
Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension

In addition to chronically elevated MSNA, there is a growing recognition that hypertension in states of insulin resistance and obesity may also be attributed to an increased vascular sensitivity to MSNA (1, 2, 13, 36-38). To study this phenomenon, we quantify vascular sensitivity to MSNA using an innovative, moment-to-moment assessment of the blood pressure response following individual bursts of muscle sympathetic nerve activity (MSNA), (10, 11, 34, 37). This approach is termed 'sympathetic-vascular transduction (SVT).' We will examine the hypothesis that SVT is exaggerated in obesity and insulin resistance and is attenuated by suppression of oxidative stress. Oxidative stress is the overabundance of reactive oxygen species and is another hallmark of hypertension, obesity, and insulin resistance. Oxidative stress can be safely reduced via intravenous infusion of ascorbic acid (Vit C) (4, 28). Therefore, we will use a randomized, double-blinded, placebo-controlled approach to test the hypothesis that elevated SVT will be attenuated by suppression of oxidative stress via ascorbic acid I.V. infusion compared with saline I.V. infusion (placebo) in obese adults with insulin resistance. Our study will identify a unique mechanism that can be targeted to reduce the excessively high prevalence of hypertension and risk for CVD in obesity and insulin resistance.

This is a randomized, double blind, placebo-controlled study. Eligible participants will have a total of 3 visits to the laboratory. At the first experimental visit individuals will be randomized in a double-blind fashion to either ascorbic acid or placebo and the alternative treatment will be given on the subsequent study visit. The KU Investigational Pharmacy will perform the blinded randomization.

1. Week 1 Visit 1 Screening
2. Week 2 Visit 2 Randomization and Experimental visit
3. Week 5 Visit 3 Experimental visit

Eligibility Criteria:
Inclusion criteria:

1. Obese: BMI \>25 m/kg2
2. Elevated insulin resistance: HOMA-IR \> 2.5 (calculation based on fasting glucose and insulin concentrations in blood)
3. Middle-aged: 35-65 years
4. Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior.
5. Able and willing to provide written informed consent

Exclusion criteria:

1. Currently taking a statin or antihypertension medication
2. Hyperlipidemia: Fasting triglycerides \< 250 mg/dL
3. Hypertension: \>130/80 mmHg
4. History of heart disease (e.g., myocardial infarction, stent)
5. History of vascular disease (e.g., bypass, stroke)
6. Individuals with narrow angle glaucoma

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Safety and Efficacy of Using MASTER to Perform Endoscopic Submucosal Dissection in Human

This trial is to evaluate the safety and efficacy of using MASTER, a robotics enhanced endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer in human.

This trial is to evaluate the safety and efficacy of using MASTER, a novel robotics enhanced endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer in human. The MASTER is a master-and-slave robotic system that is deployed through a standard dual-channel therapeutic endoscope. It introduces robotic control of endoscopic surgical tools and tasks through an ergonomic human-machine interface built around the original endoscopic paradigm. In doing so, it separates control of instrumental motion from that of endoscopic movement such that surgical tasks may be independently executed by a second operator via a human-machine interface. With it, endoscopically deployed instruments can be independently controlled, allowing thus bimanual coordination of effector instruments to facilitate actions such as retraction/exposure, traction/countertraction, approximation and dissection of tissue. Using the MASTER, operational dexterity is increased, thus making it easier for the operator to perform the ESD procedure as compared with using the conventional endoscope. This study will measure the ease of using the MASTER to perform the various surgical tasks involved in the ESD procedure, the time taken to perform the procedure, and record complications, if any, occurred during and after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed with early gastric or colon cancer, is deemed suitable to undergo endoscopic submucosal dissection and is able/willing to give informed consent.

Exclusion Criteria:

* case is deemed not suitable for endoscopic submucosal dissection
* is on warfarin or other blood thinning agents and those with bleeding disorders
* has uncorrected coagulopathy or severe thrombocytopenia precluding biopsy
* has serious co-morbidities such as heart disease, renal impairment and cancer
* has recently underwent surgery or has a personal history of stomach/colon cancer or surgery
* is unable/unwilling to give informed consent
* is pregnant or breast-feeding women patients who cannot undergo gastroscopies
Motivation for Exercise and Physical Activity Adherence

The limited success of our current approaches to increase adoption and maintenance of physical activity in adults with overweight and obesity is a substantial barrier to effectively address the current obesity epidemic. This mentored F32 application addresses the significant public health issue of obesity and associated risk of major chronic diseases by using mixed methods research to optimize an innovative, theoretically based physical activity intervention designed to enhance motivation for exercise in adults with overweight and obesity.

Physical activity (PA) is one of the best predictors of sustained weight loss and current guidelines recommend high levels of PA to prevent weight regain after weight loss. However, long-term adherence to PA is generally poor when adults with overweight/obesity are provided an exercise prescription consistent with current guidelines. Thus, it is essential to evaluate novel strategies to enhance adoption and maintenance of PA in adults with overweight/obesity. The overall goal of this mentored F32 application is to use mixed methods research to optimize an innovative, theoretically based PA intervention designed to enhance motivation for exercise in adults with overweight/obesity. Specifically, the objectives of this proposal are to evaluate and optimize a theory-based PA intervention (called MOVE) designed to enhance motivation for exercise as a sub-study of an ongoing weight loss "parent" trial (COMIRB, Protocol #17-0369). In Aim 1, adults from an ongoing behavioral weight loss trial (R01DK111622) will receive the MOVE intervention and participate in focus groups to explore how participants experience MOVE. In Aim 2, we will use a mixed methods convergent design to integrate quantitative results from a secondary data analysis and qualitative results (Aim 1) to optimize MOVE in preparation for a full evaluation of MOVE in a future randomized controlled study.

Eligibility Criteria:
Inclusion Criteria:

* A current study participant randomized to the parent trial in cohorts 2-4 for COMIRB, Protocol #17-0369
* Completed at least 2 of 3 MOVE program components (attended ≥80% of either group-based class and/or attended the one-on-one support session).

Exclusion Criteria:

* None
Application of Ideal Binary Masking to Disordered Speech

Dysarthria and hearing loss are communication disorders that can substantially reduce intelligibility of speech and the addition of background noise adds a further challenge. This proposal utilizes an established signal processing technique, currently exploited for improved understanding of speech in noise for listeners with hearing loss, to investigate its potential application to overcome speech-in-noise difficulties for listeners understanding dysarthric speech. Successful completion of this project will demonstrate proof-of-concept for the application of this signal processing technique to dysarthric speech in noise, and inform the development of an R01 proposal to perform a large-scale evaluation of the technology, and clinically meaningful implications, in a broad range of disordered speech types and severities.


Eligibility Criteria:
Inclusion Criteria:INCLUSION CRITERIA for All Participants

* Native speakers of American English
* No history of speech or language impairment
* No significant prior contact with persons having neurogenic speech disorders

INCLUSION CRITERIA for Participants with Normal Hearing

* 18 to 70 years of age
* Auditory thresholds of 20 dB HL or better bilaterally at octave frequencies from 250-8000 Hz (if under 55 years of age)
* Auditory thresholds of 25 dB HL or better bilaterally at octave frequencies from 250-4000 Hz (if over 55 years of age)

INCLUSION CRITERIA for Participants with Sensorineural Hearing Loss

* 18 to 90 years of age

Exclusion Criteria:

* EXCLUSION CRITERIA for All Participants
* Mild or profound hearing loss
* Conductive or mixed hearing loss
* Asymmetric hearing loss
* Obvious concomitant cognitive or mental impairment
* Unable to achieve upward of 20% words correct
Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I

Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).


Eligibility Criteria:
Inclusion Criteria:

* CML any phase with T315I mutation
* Ph+ ALL with a T315I mutation
* Being treated in the PACE trial according to the criteria of this phase II trial
* Or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen.

Exclusion Criteria:

* Ph negative patients
* Patients under 18 years