cyrilzakka/clinical-trials huggingface dataset:
Use of Teriparatide to Accelerate Fracture Healing

The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.

Teriparatide is a man-made form of a naturally occurring hormone called parathyroid. It increases bone density and bone strength to help prevent fractures and can be used to treat osteoporosis in people who have a high risk of bone fracture. The purpose of this study is to compare the effect of teriparatide to the effect of placebo on pelvic fracture healing.

This study will last 16 weeks. Participants will be randomly assigned to receive either teriparatide or placebo for the duration of the study. Participants will also be given calcium and vitamin D supplements to take daily throughout the study. At 4-week intervals, participants will undergo functional evaluations that will include the instrumented sit-to-stand test, the timed-up-and-go, and a gait velocity test. Participants will also undergo a DXA scan upon enrollment; undergo a CT evaluation upon enrollment and 16 weeks post-fracture; and complete specific pain, self-perceived function, mental status, and depression scales throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Females must be menopausal (no menses within the last 12 months)
* Low energy fragility fractures of the pelvis, including anterior column, posterior column, inferior or superior rami, or sacrum
* Maximum of 2 weeks post fracture
* Mental status consistent with completing the study protocol

Exclusion Criteria:

* Currently receiving any treatment for osteoporosis, including estrogen and estrogenic-like compounds
* Received radiation treatment to any site at any time in the past
* Received chemotherapy for cancer at any time in the past
* Any active cancer
* Surgical repair (or attempted repair) of the fracture site in the pelvis
* Use of any bone-active medications
* Use of anticonvulsant therapy
* Use of immunosuppressants
* Any renal, gastrointestinal, liver, or metabolic bone disease
* Pregnancy
* High calcium, parathyroid hormone, or alkaline phosphatase, as based on laboratory results
The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Neck Pain

Non-specific cronic low back pain is very common condition affecting 30-50% of adults. It is featured by neck muscles contractures which lead to pain and reduction of cervical spine mobility. High intensity laser therapy has been shown to be an effective treatment to improve symothoms in patient with non-specific neck pain.

The aim of this study is to assess the effects of a multi-wave locked system laser therapy in patient with non-specif neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain (\> 3 months)
* Body mass index \< 30
* Preserved cognitive ability to fully understand and observe indications received by medical personnel
* Ability to understand and give an informed consent

Exclusion Criteria:

* Spine surgery
* Spinal hernia
* spondylolisthesis
* Spinal infections
* Severe spine deformities
* Neural diseases
* Upper limbs radiculopathy
* Cervical rib
* Rotator cuff or other shoulder diseases
* Rheumatic diseases
* Diabetes
* Psychiatric diseases
* Vascular diseases
* Cancer
* Infectious diseases
* Skin abrasion
* Pregnancy or breastfeeding
* Recent injuries
* Known sensibility to Laser therapy
* Epilepsy
* Anticoagulant therapy
* Pacemaker
* hemorrhagic diathesis
* Photosensitizing drugs
* Known Photosensibility
* Neck Tattoos
Indocyanine Green Test for Evaluation of Perfusion of Staple Line of the Stomach During Laparoscopic Sleeve Gastrectomy

The investigators present the case of a 40-year-old female underwent laparoscopic sleeve gastrectomy. Intraoperative indocyanine green test was performed


Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 kg/m2

Exclusion Criteria:

* Non-obese patients
The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients

The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.

Elderly patients (65 years or older at the time of first administration) with type 2 diabetes who used Suglat Tablets within 3 months from its launch are included in this study. Followings are measured with the patients.

1. Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors.
2. Investigate the occurrence of urinary tract infection.
3. Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).
4. Investigate the occurrence of adverse drug reactions other than the above.
5. Factors that may possibly influence the safety of Suglat Tablets.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes who used Suglat Tablets within 3 months from its launch

Exclusion Criteria:

* off-label use patients
Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

Dendritic cells (DCs) serve as sentries for the immune system. DCs recognize foreign compounds (antigens) in the body, which they internalize and process. When DCs uptake foreign antigens, they migrate to secondary lymphoid organs, where the processed antigens are presented to T cells.

Various DC subsets with unique cell lineages, surface protein markers, and tissue localization determinants have been identified. For example, Langerhans cells (LCs) and interstitial dendritic cells (intDCs) are DCs found in stratified epithelia, such as the skin. Though both are expressed in the skin, they differ with respect to their origin and surface protein content and can activate distinct types of immune responses. They may also have different specificities for the capture of antigens and presentation to circulating T cells.

To date, it is unknown what role, if any, the different DC populations that reside or repopulate in the skin play in the development and progression of skin graft-versus-host disease (GVHD) following bone marrow transplant.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at enrollment
* Willing and able to sign the informed consent
* Current diagnosis/suspected diagnosis of acute skin GVHD OR Current diagnosis/suspected diagnosis of chronic skin GVHD

Exclusion Criteria:

* Known infection with Hepatitis B or C, HTLV, or HIV
* Pregnant females
A Better Everyday Life 1.0 - a Protocol for a Feasibility Study

The purpose of the study is to evaluate a) the feasibility and b) the potential outcomes of a first version of an occupational therapy intervention program aiming at enhancing the ability to perform activities of daily living (ADL) among persons living with chronic conditions.

In the study a pre-post test design is applied.

Introduction

Existing research has revealed that persons with chronic conditions experience decreased ability to perform both Personal ADL (PADL) and Instrumental ADL (IADL) tasks. Persons living with a chronic condition are offered various interventions. Besides medical treatment provided by physicians, to prevent or treat symptoms, persons with chronic diseases are often offered physical exercise in order to improve physical and/or mental body functions. Such interventions are founded on a belief that enhanced physical and mental body functioning also will result in improved ability to perform ADL tasks. However, existing research indicate that improvements in body functions not necessarily translate into improved ADL ability.

Research investigating the outcomes of rehabilitation services designed to enhance occupational performance, including ADL task performance, is sparse and insufficient. Existing research within this area is characterized by diversity and methodological limitations preventing development of clear intervention guidelines for clinical practice. Therefore, an occupational therapy program directly aiming at enhancing the ADL ability in persons with chronic conditions.

Aim

The purpose of this study is to evaluate a) the feasibility and b) the potential outcomes of a first version of an occupational therapy intervention program aiming at enhancing the ability to perform activities of daily living (ADL) among persons living with chronic conditions.

Methods

In the study a pre-test - post-test design is applied. That is, 30 participants living with chronic conditions are assigned to an eight week occupational therapy intervention program.

Outcome measures are self-reported and observed ADL ability measured using the ADL-Interview (ADL-I) and the Assessment of Motor and Process Skills (AMPS). Furthermore, various registrations (made by occupational therapists and participants) related to the feasibility of the intervention will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* diagnosed (by a physician) with one or more chronic condition(s)
* has participated in one or more the rehabilitation program at the municipality
* is living at home
* is experiencing problems related to performance of ADL tasks and is motivated to participate in the ADL intervention .

Exclusion Criteria:

* substance abuse
* other acute diagnoses affecting ADL task performance
* language barriers causing problems related to understanding Danish or participating in the program.
Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET)

Patients with end-stage renal disease (ESRD) who have elevated serum phosphate (P) levels have significantly higher mortality rates compared to those with normal P. In patients receiving conventional dialysis regimens, serum P may be lowered through dietary intervention and use of P binders, though these have potentially important side effects and may adversely impact quality of life. Whether lowering P, and / or targeting specific P levels improve survival and clinical outcomes is unknown. Despite this uncertainty, over 90% of patients with ESRD receive P lowering therapy and guidelines for the care of patients with ESRD are increasingly calling for more aggressive phosphate lowering. This intensive P lowering results in extra medications (and their associated side-effects), and higher health care costs. We are uncertain whether the intensification of P control results in measurable benefits to patients with ESRD. The overall goal of this pilot trial is to evaluate the feasibility of conducting a randomized controlled trial of intensive vs liberalized phosphate control among hemodialysis recipients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 yrs
2. Receiving chronic hemodialysis for \> 90 days,
3. Dialysis prescription is currently no more than 4 sessions per week and prescribed as 3-5 hrs per session
4. Most recent P value 1.30-2.50 mmol/L
5. Receipt of a calcium-based P binder

Exclusion Criteria:

1. Patient is booked (with a known surgical date) for a live donor kidney transplant in the next 26 weeks
2. Planned switch to a dialysis schedule that involves \> 16 hours per week of therapy within the next 26 weeks.
3. Planned switch to peritoneal dialysis within the next 26 weeks
4. Pregnancy
5. Albumin-corrected serum calcium \> 2.60 mmol/L in the past year requiring reduction of the calcium carbonate dose
6. History of calciphylaxis
7. Attending nephrologist believes that an otherwise eligible patient is mandated- on clinical grounds- to have a P value that is targeted to \< 1.50 mmol/L or \> 2.00 mmol/L
8. Attending nephrologist believes an otherwise eligible patient is not a candidate for escalation of the current calcium dose
9. Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the intervention provided herein
Direct and Indirect Impact of COVID-19 In Older Populations

This study propose to describe risk factors for acute and long term mortality of COVID 19 in patients up to 70 years old.

In December 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020, by WHO. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients exhibits more complications (ARDS, delirium, cardiac and renal insufficiency) needing intensive care, and often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%).

Very few data are available the specific burden of Infectious diseases (ID) in older populations. The large majority of literature is often related to intrahospital or direct mortality and only recently arise the idea of indirect impact of ID particularly in that populations. In that meaning, ID may be considered as a trigger of other medical events such as myocardial infarction, stroke, or other specific outcomes such as functional decline; For the last 10 years, the Specific interest group " GInGer "( Groupe Infectio-Geriatrique ) a network of infectiologist and geriatrician SPILF/SFGG) carried out several studies on different aspects of ID in theses populations and recently demonstrated the indirect and long term impact of influenza and Clostridioides difficile infections. As an example, In influenza study, death-rate increases from 12,2 % in hospital related death to 25% at 3 months with high rate of complications (57%), high rates of rehospitalisation (25%) and functional decline (35%) leading to high increase in nursing home admission. The cost of these indirect impact is high and underestimated.

Because of incidence and comorbidities rates, severity of the actual French older COVID 19-infected older populations and because of the potential indirect and long term impact of COVID19 in these populations, it seems essential to know whether 3 month related death is largely higher as for influenza, to determine risk factors for intra hospital and long term death, measure acute and long term complications, and describe the impact of COVID 19 on specific ageing outcomes such as functional status at Month 3 (M3).

Eligibility Criteria:
Inclusion Criteria:

* + positive PCR confirmed COVID 19 (confirmed case) or positive Thoracic CT Scan - (probable case)

Exclusion Criteria:

* Direct admission in Intensive care.
Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study

This trial investigates how a communication strategy works in increasing human papillomavirus (HPV) vaccines in community pharmacies among adolescents. Although pharmacies are vaccine providers, low vaccination rates are persistent as a result of low awareness of pharmacy services and poor engagement by pharmacy staff with adolescents about vaccines. The purpose of this study is to test a communication strategy that identifies vaccine-eligible children and teaches pharmacy staff how to effectively communicate with them about HPV vaccination in order to increase HPV vaccination rates.

OUTLINE:

AIM 1: Participants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of HPV vaccination in pharmacies.

AIM 2: Participants provide feedback on survey questions via cognitive testing. Pharmacy staff complete an online survey over 10-15 minutes to assess the acceptability, appropriateness, and feasibility of providing HPV vaccination to children aged 9-17 in their pharmacies. Pharmacy staff then attend two, 60-minute vaccine communication training sessions, consisting of identifying vaccine-eligible children and recommending HPV and other vaccines. Pharmacy staff employ the new communication strategy in their pharmacy up to 6 months, and then complete an online survey over 10-15 minutes.

Pharmacies of which the pharmacy staff participants work undergo an environmental scan to characterize the pharmacy's environment, vaccination workflow, and team dynamics.

Additionally, pharmacy audits will be conducted from the pharmacy electronic records to assess adoption of HPV vaccination, and the impact of the communication strategy on adoption of other adolescent vaccines (e.g., tetanus, diphtheria, acellular pertussis; meningococcal conjugate; influenza).

Eligibility Criteria:
Inclusion Criteria:

* AIM 1 (PARENTS/GUARDIANS): Individuals with children between the ages of 9-17 in their care who are English speakers, live in Washington state, and have access to a telephone or computer with internet access (up to 12 parents)
* AIM 1 (PHARMACY STAFF): Employed at a Western Washington Bartell Drugs pharmacy sites and have access to a telephone or computer with internet access
* AIM 2: Pharmacy staff employed at up to four independent pharmacies in western Washington state who speak English and have access to a computer with internet access

Exclusion Criteria:

* AIM 1 (PARENTS/GUARDIANS): Those who object to having their interview audio recorded
* AIM 1 and AIM 2 (PHARMACY STAFF): Floaters/per diem. Those who object to having their interview audio recorded
A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer

To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.

The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Estrogen and/or progesterone receptor positive adenocarcinoma of the breast with evidence of 1) unresectable 2)locally recurrent, or 3) metastatic disease
* Postmenopausal
* ECOG \[Eastern Cooperative Oncology Group\] \</=1
* Evaluable(e.g bone only disease allowed) and Measurable disease \[RECIST (Response Evaluation Criterion in Solid Tumors)\]

Exclusion Criteria:

* HER2 \[Human Epidermal Growth factor Receptor 2\] positive disease not previously treated with herceptin
* Any prior anti-angiogenic therapy, endocrine or cytotoxic anti-cancer therapy in the metastatic disease setting
* Radiation therapy within 2 weeks of first study treatment
Intrauterine Device (IUD) Self Removal

This pilot research study will teach patients how to self-remove intrauterine contraceptive device (IUD) through an educational video and simulation and evaluate patient perspectives and experiences related to IUD self-removal with two surveys. Patients will be recruited for this study at the time of presentation to the office for IUD removal. After consenting to the procedure, participants will complete a pre-intervention survey, watch a video explaining how to self-remove the IUD, and use two models to simulate IUD removal. After completion of using the models to practice IUD removal, participants will complete a second short survey. The participant will then be given the option of attempting self-removal and be given time to attempt the removal. If the participant elects to have the provider remove their IUD, the provider will do so. At the end of the encounter, participants will fill out a final survey. Research staff will measure the length of the strings of all IUDs prior to routine disposal of the device.


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* Present to Boston Medical Center Yawkey for removal of IUD and have been consented for removal
* Are eligible for removal of IUD in the office setting

Exclusion Criteria:

* Current incarceration
Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation

The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.

Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving marginal lungs procured from brain death donors and reconditioned by EVLP, with that of subjects receiving lungs procured from standard donors.

Eligibility Criteria:
Inclusion criteria for donor lung:

1. Recipient to undergo single or bilateral Lung Transplantation
2. Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function

Exclusion criteria for donor lung:

1. Massive lung contusion
2. Aspiration
3. Pneumonia
4. Sepsis
5. Malignancy
Effect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial

Orthokeratology is becoming popular for the treatment of myopia children. Many studies have shown that orthokeratology is effective in temporarily reducing refractive error, and is also helpful for controlling myopia progression. However, the mechanism for its slowing myopia progression and rebound effect after the treatment have not been clearly studied. In addition, the effect of orthokeratology among Chinese children has not been evaluated with randomized controlled trial.This study is to assess the effect of orthokeratology versus spectacles on myopia progression in school-aged Chinese children during two years.


Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 7 Years to 14 Years
* Genders Eligible for Study: Both
* Visual acuity 20/20 or better in each eye
* Spherical error ranging from -0.5 D to -5.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes
* No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development

Exclusion Criteria:

* Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)
* Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing