cyrilzakka/clinical-trials huggingface dataset:
Corticosteroid Injection Verses High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis

The purpose of this study is to prospectively compare the pain and functional outcomes of patients with chronic lateral epicondylitis treated with either intratendinous corticosteroid injection or high energy extracorporeal shock wave therapy (ESWT).

Corticosteroid injections and high energy ESWT are standard therapies for lateral epicondylitis at Walter Reed National Military Medical Center. While corticosteroid injections have been shown to be moderately effective in the short term for the condition, a significant minority of patients remains symptomatic. Low energy ESWT has mixed results in the orthopaedic literature, but to date no study has specifically examined the effects of high energy ESWT. The investigators plan to randomize a total of 80 patients with the diagnosis of lateral epicondylitis to either corticosteroid injection or high energy ESWT, and follow them for a total of 12 months. Primary outcomes will be Disabilities of the Arm, Shoulder, and Hand (DASH) score, Patient Reported Tennis Elbow Evaluation (PRTEE) score, Mayo Elbow Score, Veterans Rand-36, and return-to-work status. Patients will be surveyed at baseline, 6 weeks, 3 months, and 6 months. All assessments will be done by an independent physician examiner who is blinded to the treatment received.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to the WRNMMC orthopaedic hand surgery clinic for complaints of lateral elbow pain will be evaluated for inclusion in the study. Inclusions criteria will be:
* Clinical diagnosis of lateral epicondylitis based on primary complaint of lateral elbow pain and either (a) tenderness over the lateral epicondyle with direct palpation, or (b) exacerbation of pain at the lateral elbow with resisted dorsiflexion of the wrist
* Failure of previous trial of non-operative management of at least 4wks duration (to include rest/light duty, non steroidal anti-inflammatory drugs , physical/occupational therapy, home stretching regimen)

Exclusion Criteria:

* Age \<18yo
* Pregnant or planning to become pregnant during study period (based on verbal questioning)
* Steroid treatment (oral or injectable) within the previous 3mo
* Diagnosis of ipsilateral compressive neuropathy
* Allergy to Kenalog, lidocaine, or conductive ultrasound gel
* Diagnosis of inflammatory arthropathy or rheumatoid conditions
* Diagnosis of fibromyalgia, chronic fatigue syndrome, complex regional pain syndrome, or other chronic widespread pain syndromes
Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury

500 patients with normal renal function will be prospectively studied and incidence, spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied for 1 year. Also biomarkers will be studied and validated as early predictors of AKI (Acute Kidney Injury).


Eligibility Criteria:
Inclusion Criteria:

- Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled

Exclusion Criteria:

* Age \< 18 or \> 70 years
* Preexisting Chronic Renal Disease
* Patients with obstructive uropathy.
* Cirrhosis with HCC (HepatoCellular Carcinoma).
* Advanced cardiopulmonary disease
* Pregnancy
* Patients with extrahepatic malignancy
Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation

This study intends to compare the effects of NAVA and PSV on weaning success rate and mechanical ventilation time in patients with tracheotomy patients through a randomized controlled study.

For patients with difficult weaning, NAVA can shorten the time of mechanical ventilation, but there is no large-scale study to explore the effect of NAVA on the weaning success rate and mechanical ventilation time of patients with gas resection. Therefore, this study intends to compare the effects of NAVA and PSV on weaning success rate and mechanical ventilation time in patients with tracheotomy patients through a randomized controlled study.

It is a prospective, multicenter, parallel group, single blind, randomized controlled tria。

Eligibility Criteria:
Inclusion Criteria:

1. Tracheotomy and invasive mechanical ventilation is expected to be required for \> 48h;
2. When support pressure ≤ 15 cmH2O, it can withstand pressure support ventilation (PSV) time \> 1h;

Exclusion Criteria:

1. Age \< 18 years or \> 85 years;
2. Deep sedation.
3. Severe hemodynamic instability (norepinephrine or equivalent converted dose of other vasoactive drugs \> 1ug / kg.min or map ≤ 65mmhg)
4. Severe respiratory center depression, high paraplegia, neuromuscular disease;
5. Esophageal obstruction, esophageal perforation, severe esophageal variceal bleeding, upper gastrointestinal surgery, diaphragmatic hernia and thoracic deformity;
6. Patients with chronic respiratory diseases requiring long-term home oxygen therapy;
7. Patients with severe coagulation dysfunction (INR \> 1.5, APTT \> 44s, history of leukemia);
8. Severe other organ dysfunction is expected to die in a short time (7 days) or palliative treatment.
9. The estimated survival time of advanced solid organ or hematological system tumors is \< 30 days
10. Participate in other clinical studies within 30 days;
11. Failing to sign the informed consent form;
Technology-based Fall Risk Assessments for Older Adults in Low-income Settings

The goal of this observational study is to examine the associations among fall risk appraisal, body composition, and physical activity in older adults in low-income settings.

The main questions it aims to answer are:

* What is the feasibility of recruitment (e.g., how many older adults need to be screened to recruit the sample?), especially during the COVID-19 pandemic, and acceptability of technologies and procedures for use among older adults in low-income settings?
* What are the the dynamic relationships between fall risk appraisal, body composition, physical activity, and behavioral changes related to fear of falling?

Participants will:

* complete questionnaires about their characteristics, socio-demographic, medical history, cognition, depressive symptoms, anxiety, and fear of falling.
* participate in static and dynamic balance tests, body composition measurement and handgrip strength test.
* wear an accelerometer for physical activity assessment for 7 consecutive days.

The investigators will use a cross-sectional design to address aims. The investigators will administer the study instruments which consist of objective and subjective measures. Participants will complete questionnaires about their characteristics, socio-demographic, medical history, cognition, depressive symptoms, anxiety, and fear of falling.

Balance performance will be assessed by the BTrackS Balance System (BBS). This test consists of four, 20 seconds trials. For each trial, the participants will stand as still as possible on the BBP with hands on their hips, and eye closed. This test consists of four trials. This test will take about 5-10 minutes.

Body composition will be assessed using a bioelectrical impedance analysis (BIA): InBody S10. The BIA InBody S10 measures fat mass, muscle mass and body water levels. There are no risks, no dunking, no pinching, no discomfort associated with the use of bioelectrical impedance analysis. Test duration is 1-2 minutes.

Physical Activity (PA) will be measured by activity monitoring devices. All participants will wear the ActiGraph GT9X Link wireless activity monitor (ActiGraph LLC.), a tri-axial accelerometer, on the non-dominant wrist for 7 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 60 years of age
* no marked cognitive impairment \[Memory Impairment Screen (MIS) score ≥5\]
* speak English or Spanish
* live in Kinneret Sr. Apartments or in Orlando FL.

Exclusion Criteria:

* a medical condition precluding balance test (e.g., unable to stand on the balance plate) and/or PA (e.g., shortness of breath; feeling pressure when performing PA)
* currently receiving treatment from a rehabilitation facility
* have a metal implant.
Periapical Healing After One or Two-visits to Endodontic Treatment in Adolescents Patients

The main objective of this study is the prevention and repair of apical periodontitis in lower molars with pulp necrosis after the execution of endodontic treatment in one or two visits in adolescent patients. Moreover, it is also observed the frequency of postoperative pain in endodontic treatment.

This project is developed in adolescent patients who have need of endodontic treatment in necrotic molars. The patients were randomly divided into two groups of treatment: one and two visits. The treatment protocol is the same for both groups, except the number of visits and the use of intra canal medication in the group treated in two visits. Patients will be followed clinically and radiographically for a minimum period of two years. The data was collected by the evaluation of postoperative pain and to determine the healing of periapical lesions, characterizing the success of the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients healthy
2. Not have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the beginning of treatment
3. Lower first or second permanent molars with complete root formation and dental pulp necrosis with or without symptoms

Exclusion Criteria:

1. Presence of periodontal diseases
2. Pulp calcification
3. Acute dent-alveolar abscesses
4. Hemorrhage in the canal after access
Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide

The goal of this study is to evaluate the safety and clinical efficacy of personalized chemotherapy with low doses of cyclophosphamide administered taking into account the reparative cycle of tumor cells in participants with breast cancer (stage IV or disease progression). The main question it aims to answer is: Does personalized chemotherapy of breast cancer with low doses of cyclophosphamide, taking into account the reparative cycle of tumor cells, lead to a significant reduction in tumor size and improvement in the visual status of controlled tumor foci relative to their initial state? During the preparatory stage, a tumor sample from participant is harvested intraoperatively. The primary culture is obtained from this tumor tissue sample. Repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle G2/M phase is identified. The schedule of administering cyclophosphamide and DNAmix complex composite preparation is calculated according to the resulting time points. According to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days.


Eligibility Criteria:
Inclusion Criteria:

* stage IV breast cancer or progression of the disease with the presence of foci accessible for biopsy of tumor material;
* complete awareness of the patient about the prognosis of the disease and the proposed treatment;
* the volume of tumor material required for vital assessment of the time parameters of the individual reparative cycle of tumor cells must be at least 4 cm3;
* tumor cells transferred to primary culture must be in a state of proliferative activity.

Exclusion Criteria:

* severe decompensated cardiovascular, respiratory, hepatic, renal failure;
* presence of an acute infectious disease;
* intolerance to cyclophosphamide;
* severe neutropenia - the content of neutrophils is less than 1000 per 1 μl of blood;
* simultaneous participation in another clinical trial.
Treatment of Periodontal Intrabony Defects With A-PRF or OFD

The aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) toped flap debridement (OFD) in periodontitis patients.

Thirty (30) intrabony defects are randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects are filled with A-PRF+ (n=15) in the test group, respectively treated with open flap debridement in the control group, and fixed with sutures to ensure wound closure and stability.

Eligibility Criteria:
Inclusion Criteria:

* no systemic diseases
* a good level of oral hygiene
* presence of a 2-, 3-, or combined 2-3-wall intrabony defect with a defect angle of 20-40 (+/- 5) degrees
* with a minimum PPD of 6 mm and intrabony component of a minimum 4 mm as detected on radiographs
* no smoking

Exclusion Criteria:

* systemic diseases that could influence the outcome of the therapy
* poor oral hygiene
* smoking
* horizontal bone loss
Protein Needs Study

Severe muscle loss in patients with cancer has been associated with increased physical disability, extended hospitalization, infectious and noninfectious complications, increased risk of severe toxicity during cancer treatment, poor quality of life and shortened survival. Adequate protein is key to sustain muscle mass and overall health. However, current nutritional recommendations are not specific or evidence-based. The aim of this project is to determine the protein needs of patients with colorectal or breast cancer. Protein needs will be determined using a novel, non-invasive approach. Our results will inform nutritional recommendations and guidelines with the ultimate goal of improving outcomes for people with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients age 45-80 years;
* Patients attending the new patient clinic at the Cross Cancer Institute with a diagnosis of colorectal cancer or breast cancer (stages II to III);
* Able to complete baseline visits within approximately 4 weeks of starting chemotherapy OR after a minimum of 4 weeks post-surgery if not undergoing chemotherapy;
* Ambulatory.

Exclusion Criteria:

* Premenopausal women due to impact on protein requirements;
* Received anti-cancer hormone treatment or immunotherapy in the 4 weeks before first baseline visit;
* Renal impairment based on a creatinine clearance for estimated glomerular filtration rate (eGFR) of \<60 mL/min
* Abnormal glucose metabolism based on a fasting glucose level \>6mmol/L and an HbA1c \>5.7% or as reviewed by study team;
* Comorbidities or medications that would interfere with the participants ability to follow the study protocol or the quality of the data(e.g. diabetes, class III obesity, hormone therapy, another active cancer diagnosis);
* Unable/unwilling to provide urine, breath and blood samples (e.g. oxygen tank, catheter, etc.);
* Unable to eat the meals provided (i.e. receiving parenteral or enteral nutrition, severe allergies);
* Substance dependent (e.g. alcohol, cigarettes, illicit drugs) and unable to follow study protocols.
Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer

A study to evaluate the safety of Nivolumab in participants with advanced or metastatic non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Non small cell lung cancer (Squamous or non-squamous)
* At least one prior anti-cancer therapy that did not work
* ECOG Performance Scale 0-1

Exclusion Criteria:

* Cancer that has spread to the brain or leptomeninges unless there is no evidence of progression by MRI for 8 weeks after treatment is complete and within 28 days before first dose of study drug
* Active, known or suspected autoimmune disease or infection
* Prior immuno-oncology therapy
* Corticosteroids within 2 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria could apply
Functional Evaluation of the Total Knee Prostheses:Rising From a Chair

In this study, a functional evaluation of total knee arthroplasty (TKA) patients is performed. The patients are measured prior to surgery and 6 and 12 months after surgery. The measurements consist of questionnaires and rising from a chair. Also, two types of TKA are functionally evaluated. At last, the TKA group will be compared to a THP group.


Eligibility Criteria:
Inclusion Criteria:

* unilateral TKA

Exclusion Criteria:

* TKA bilateral
* recent THP
* movement disorders like Parkinson's disease, insults, that disturb equilibrium and movements
Effects of Lutein Supplementation on Subclinical Atherosclerosis

This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.

Atherosclerosis is the primary cause of cardiovascular and cerebrovascular diseases, both of which are the top two causes of death in industrialized countries including China. Lutein was found to be protective against atherosclerosis in some case control studies. However, the intervention on atherosclerosis have not been reported. In the present study, 192 subjects were randomly assigned to four groups treated with different amounts of lutein. The investigators observe the changes of serum lutein concentration by hyper-pressure liquid chromatography (HPLC), and compare the differences of common carotid IMT and arterial stiffness by carotid ultrasonography before and after the intervention. Serum biochemistry indexes including cholesterol (CHO), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C) and glucose (Glu) were measured at 0, 7 and 12 months of treatment by auto-analyzer.

Eligibility Criteria:
Inclusion Criteria:

* early atherosclerosis;
* aged 45 to 68 years;
* Han nationality

Exclusion Criteria:

* history of myocardial infarction,
* stroke,
* revascularization,
* coronary by-pass operation,
* local carotid IMT \> 1300μm or supplemental vitamin and/or mineral use for ≥ 4 week before the start of the study
Vasculera in Participants With Lipedema

This study is designed to gain preliminary information via a uniform protocol regarding the clinical effects of Vasculera in participants with lipedema and the possible role of the glycocalyx as a physiological target for Vasculera activity. It is anticipated that the results of this case study will inform the development of a formal randomized, double-blind, placebo controlled trial.

The goal of this type of clinical trial is to compare the measurement of participants legs before treatment and after using the treatment for approximately 3 months in clinic patients 20 to 70 years old with lipedema. The main questions it aims to answer are: does the leg circumference decrease and does the participants' overall wellbeing improve?

Participants will:

* Have physical examinations and measurements at baseline and 3 month visit
* Complete wellbeing self-assessments at baseline and 3 month visit
* Have blood drawn for chemical markers at baseline and 3 month visit
* Complete four visits total

Eligibility Criteria:
Inclusion Criteria:

1. established diagnosis of lipedema for at least one (1) year
2. women, ages 20 to 70 years
3. score of at least 4 out of 10 on self-assessment on a 0-10 scale (10=worst) for overall sense of well being
4. be willing to stop compression therapy for one week prior to each visit

Exclusion Criteria:

1. other forms of leg enlargement, including lymphedema
2. any primary systemic vasculopathy
3. history of exposure to Vasculera or other diosmin containing medication within one (1) year of the screening visit
4. concomitant use of warfarin, platelet inhibitors, factor Xa inhibitors or any medication intended to reduce blood coagulability
5. concomitant use of diclofenac, metronidazole or chlorzoxazone
6. uncontrolled hypertension (BP\>170/110), unstable cardiac disease, active skin ulceration
7. any other disease or condition that, in the opinion of the investigator, might put the
8. subject at risk by participation in this study OR confound evaluation of response to Vasculera
9. history of substance abuse within one (1) year of the screening visit or of current alcohol consumption more than one (1) unit daily. For purposes of this study, a unit of alcohol will be considered to be 12 oz of beer, 6 oz of wine or 1 oz of hard spirits.
Group Hydrotherapy Treatment for Athletes With Lower Back Pain

The effect of group hydrotherapy on chronic low back pain and function among athletes will be examined.

Low back pain is a common issue in Western society, especially among athletes who experience significant physical stress. One effective conservative treatment method is hydrotherapy, which involves exercising in water. This approach takes advantage of water's properties, such as buoyancy, weight reduction, and resistance. By using these properties, individuals can perform movements and exercises that may be painful or difficult to do on land.

The purpose of the study is to examine the effect of group hydrotherapy on chronic low back pain and function among athletes.

The study will involve participants with chronic back pain who will complete a 6-week intervention program led by a certified physiotherapist, including hydrotherapy treatment and guidance for independent exercises.

The exercise will include reduced-weight activities at waist-to-neck depth, resistance exercises at varying depths, and the utilization of buoyancy and resistance devices.

The evaluation indicators will be taken before and after the intervention period and will include: a demographic questionnaire, history of back pain and anthropometric details (height, weight), Oswestry questionnaire to assess function following back pain, a visual analog scale to assess the maximum degree of pain during the day, hip range tests, a forward flexion distance test, and a back alignment test. At the end of the intervention, a global rating of scale questionnaire will also be taken to assess the effectiveness of the improvement.

Eligibility Criteria:
Inclusion Criteria:

* Athletes who complain of low back pain for over 3 months,
* VAS\>3
* train more than 5 times a week.

Exclusion Criteria:

* acute back pain
* neurological signs (decreased muscle strength, decreased reflexes, radiating to the leg).