cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Tecar Device With Exercises in Ankle Sprain

The goal of this clinical trial is to evaluate the effect of applying TECAR therapy during active therapeutic exercises on pain, ankle dynamic balance, proprioception, and daily function in patients with acute ankle sprain.

the main questions it aims to answer are:

* Does there is a significant effect of applying TECAR therapy during active exercise after acute lateral ankle sprain on Pain?
* Does there is a significant effect of applying TECAR therapy during active exercise after acute lateral ankle sprain on balance?
* Does there is a significant effect of applying TECAR therapy during active exercise after acute lateral ankle sprain on proprioception?
* Does there is a significant effect of applying TECAR therapy during active exercise after acute lateral ankle sprain on daily function? The patients will be randomly divided into two groups. The control group (A) will receive the conventional therapy which is ankle and subtalar ROM in a pain-free range, calf muscle stretch, ankle strengthening exercises against resistance bands in all directions, weight-bearing exercise, forward lunges, bilateral and unilateral squats, bilateral and unilateral heel raises against bodyweight resistance, and balance training. The experiment group (B) will receive conventional therapy with TECAR therapy application during active therapeutic exercises.

Treatment will be for 4 weeks with 2 sessions per week. TECAR application will be 20 mins per session (10 mins capacitive and 10 mins resistive).

To the best of the researchers' knowledge, no study has proved the effects of applying TECAR therapy during active therapeutic exercises after an acute lateral ankle sprain has yet been done. Thus, the purpose of the present study was to prove if there an effect of applying TECAR therapy during active therapeutic exercises included in the conventional physiotherapy (PRICE with therapeutic exercises) and conventional physiotherapy alone on pain, ankle dynamic balance, proprioception, and daily function in subjects with an acute lateral ankle sprain.


Eligibility Criteria:
Inclusion Criteria:

* Gender will be male and female.
* Age from 20-40 years old.
* Grade \| and \|\| lateral ankle sprain.
* Patients who will be diagnosed and referred by orthopedic surgeon.
* acute stage of lateral ankle sprain.
* BMI ≤ 30.
* Positive confirming tests.

Exclusion Criteria:

* Ankle fractures such as talus bone fracture, tibia fracture, ankle dislocation.
* Unwilling to continue treatment.
* Contraindications to use TECAR therapy, such as pregnancy, the presence of malignant tissue, tumors, in the ankle, and electrical devices implanted in the body.
* Grade \|\|\| ankle sprain.
* Systematic diseases such as rheumatoid arthritis.
* Recently received intra-steroid injection
* Pain exacerbation during the intervention.
Planning Margin Requirements for Pediatric Radiation Oncology

The planning target volume (PTV) and planning organ at risk volume (PRV) margins used for pediatric radiation therapy are empiric, and quantitative assessment of these margins is needed to improve therapy planning and delivery.

Data will be gathered to develop a model to quantify the setup margin (SM) portion of the planning target volume (PTV) margin for pediatric tumor sites according to age, localization technique, treatment position, and the use of general anesthesia. Patient specific PTV and PRV margin recommendations will be developed based on the number of participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients will receive conformal or intensity-modulated radiation therapy (3D or IMRT).
* Research participant or legal guardian/representative gives written informed consent.

Exclusion Criteria:

* Unwillingness of research participant or legal guardian/representative to give written informed consent
Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)

Australia was one of the countries to implement a universal school-based male vaccination program - in 2013. This research project will examine the prevalence of HPV among young men who have sex with men (MSM) who have been offered school-based HPV vaccination.

HYPER-2, will be a cross-section study, using the same recruitment and testing strategies used in HYPER 1, which determined the prevalence of anal, genital and oral HPV among men who have sex with men aged 16-20 years. Given the differing age groups that will have been offered vaccination over the 2 study period, men aged 16-19 will be recruited in the first year (2017) and men aged 16-20 will be recruited in the second year (2018) to ensure that the participants included in the HYPER-2 study would have been eligible for the free male HPV vaccine in Australia. A total of 200 men will be recruited over a 2-year period, and HPV vaccination status for each participant will be verified against the National HPV Vaccination Program Register.

This 2-year cross-sectional study will recruit men who report sex with men aged from 16 to 20 years.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 16 to 20 (Must be aged 16-19 years from 1 January 2017 to 31 December 2017, and aged 16-20 years from 1 January 2018 to 31 December 2018)
* Report any previous type of sexual contact (including but not restricted to oral or anal sex) with at least one other man ever
* Able to complete all study requirements including questionnaire in English and completion of 2 visits
* Residing in Australia since 2013 (This is to ensure that males included in the study were present in Australia at the time HPV vaccination was offered)

Exclusion Criteria:

* Transgender male
A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)

The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years to 80 years.
* Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization.
* Presence of ongoing pain due to DPN for at least 6 months.
* Willing to discontinue protocol-specified prohibited pain medications for DPN throughout the duration of the study.

Exclusion Criteria:

* Painful neuropathies or painful conditions other than DPN that may confound evaluation of pain due to DPN during the study.
* Subjects who have failed previously on pregabalin (at the recommended label dose and for adequate duration) due to lack of efficacy.
* Subjects with any clinically significant medical or psychiatric conditions or clinically significant laboratory test abnormalities.
* Pregnant women, lactating mothers, men with partners currently pregnant, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.
Implementing Resistance Exercise to Reduce Frailty for Older Adult

To develop an intervention specifically targeted for these clients who have the frailty syndrome. The Investigators propose to develop an exercise intervention that can reduce frailty in older adults to facilitate their ability to age-in-place. The long-term objective of this work is to develop a package of interventions that can be administered within the existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal of this proposal is to develop a resistance exercise intervention to reduce frailty in older adults receiving long term care services in their home through the Illinois Community Care Program, a HCBS Waiver Program.


Eligibility Criteria:
Inclusion criteria for Home Care Aides:

- Employees of Help at Home, with one eligible client

Inclusion criteria for clients:

* aged 65+ years
* receive HCA services two or more days per week
* English-speaking
* not currently participating in regular exercise as defined as 30 minutes three or more days per week, - - no health problems that contraindicate participation in exercise based on the EASY: Exercise Assessment and Screening for You
* Telephone Interview for Cognitive Status score \> 26

Exclusion criteria for HCAs:

- no clients who enroll in the study

Exclusion criteria for clients:

* legally blind, no voluntary extremity movement
* physician does not provide clearance for participation
* classified as non-frail based on the SHARE-FI frailty testing
* Telephone Cognitive Status score \< 25.
The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Proteins

Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.


Eligibility Criteria:
Inclusion Criteria:

* women routinely taking tamoxifen or aromatase inhibitor therapy as prescribed by their oncologist

Exclusion Criteria:

* Use of heparin, warfarin
Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer

Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Her-2 positive metastatic breast cancer confirmed by biopsy
* Measurable disease
* Able to perform activities of daily living without considerable
* No previous chemotherapy with gemcitabine
* No more than one prior chemotherapy regimen for metastatic breast cancer
* Adequate bone marrow, liver and renal function
* Normal heart function
* Give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Received previous treatment with gemcitabine
* History of brain metastases
* Serious underlying medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries

This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male or female volunteers ages 18 or older
2. American Society of Anesthesiologists (ASA) physical status 1, 2 or 3.
3. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
4. Body Mass Index ≥18 and ≤40 kg/m2

Exclusion Criteria:

1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
2. Documented history of long-term diabetes, renal (serum creatinine level \>2mg/dL \[176.8 μmol/L\]) or hepatic dysfunction (serum alanine or aspartame transferase \> 3 times the upper limit of normal), coagulation or bleeding disorder and severe peripheral vascular disease
3. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
4. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
5. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
6. Previous participation in EXPAREL study
7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
8. Currently pregnant, nursing, or planning to become pregnant during the study
9. Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
10. Currently on neuroleptic agent \[e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.\]
11. Inadequate sensory function on the foot (monofilament test)
12. Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)

    In addition, the subject may be withdrawn from the study if the subject meets the following criterion during or post-surgery:
13. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course
The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section

This study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. One hundred and twenty women will be allocated to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. We will also examine possible effect of this infiltration of parameters of wound heeling and scar formation, six weeks post partum.

Among all other abdominal operations cesarean section is unique in two aspects. First, the requirement for rapid and as painless as possible recovery is not only important for the general good reasons, but there is the newborn baby, who needs maternal care. Second, in many cases the operation recurs in the same site, which may involve higher level of post operative pain.

Application of local anesthetics to the incision site have been tried for abdominal operation in several forms, ranging from pre-incision injection (1-6) through post incision injection (7 ) to indwelling catheter for protracted instillation (8-9). Where tried, these methods mostly contributed to the reduction of post operative pain and patients' satisfaction, although there is no consensus as to its efficacy. Yet, local, pre-incision injection of local anesthetics has not been tested for cesarean section.

The above not withstanding, it has been proposed that local infiltration of tissue with xylocaine may interfere with wound healing (10-11). Others suggested possible benefit due to antimicrobial activity (12) Conversely, Al- Asfour et al. (13) found no effect of topical oral application of xylocaine on experimental wounds in rabbits. Interestingly, Drucker et al. found that less collagen was deposited in healing wounds that were infiltrated with xylocaine prior to incision, while the strength of the scar was not affected (14-15).

Our proposed study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. It will also examine possible effect of this infiltration of parameters of wound heeling and scar formation.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for non-emergency cesarean section

Exclusion Criteria:

* Emergency cesarean section
* Known or suspected sensitivity to local anesthetics
* Pre-eclamptic toxemia
* Deranged liver function
* Deranged hemostasis
* Lack of adequate verbal communication
Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation

The purpose of the study is to evaluate the clinical equivalence and the general tolerability of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when administered to patients undergoing IVF.

This is a prospective, multicenter, randomized, investigator blind, parallel group, active control, phase III clinical trial. Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug (hCG-IBSA, IBSA) or the reference drug (Ovitrelle, Serono). Investigators will be blinded by not allowing them to have any contact with the study medications (supplied in boxes labeled in a manner that does not reveal the content of the boxes), and requesting that patients do not make any statements to the investigator that might indicate the treatment to which they were assigned. Equivalence testing with regard to the primary outcome variable will establish whether the two treatments are indeed similarly effective.

Eligibility Criteria:
Inclusion Criteria:

* \>/=18 and \< 40 years old;
* BMI between 18 and 30 kg/m2;
* less than 3 previous completed cycles;
* both ovaries present;
* regular menstrual cycle of 25-35 days;
* infertility attributable to a tubal factor, American Fertility Society grade I or II endometriosis, male factor or unexplained factor.
* within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through hysterosalpingogram, sonohystrogram or hysteroscopic examination;
* basal FSH level less than 10 IU/L;
* criteria for hCG administration fulfilled (at least 2 follicles with a diameter of 16 mm or more, with acceptable serum E2 concentration).
* a male partner with semen analysis within the past 6 months showing acceptable values of seminal parameters, defined as \> 3x10 exp 6 spermatozoa/ml;
* qualified to receive 150 - 300 IU FSH as starting dose.

Exclusion Criteria:

* age \< 18 and \> o = 40 years;
* primary ovarian failure or women known as poor responders (i.e. requiring more than 300 IU of FSH as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with an E2 serum concentration \< 3'000 pmol/L);
* ovarian cysts \> 20 mm, or enlargement not due to polycystic ovarian syndrome;
* patients affected by pathologies associated with any contraindication of being pregnant;
* hypersensitivity to the study medication;
* any bleeding since stimulation;
* uncontrolled thyroid or adrenal dysfunction;
* neoplasias;
* severe impairment of the renal and/or hepatic functions;
* use of concomitant medication that might interfere with study evaluations (e.g. nonstudy hormonal medications, prostaglandin inhibitors, psychotropic agents);
* more than 18 days of FSH stimulation.
Brazilian Prospective Hodgkin Lymphoma Registry

The study is a prospective registry of Hodgkin Lymphoma (HL) patients in Brazil.

The purpose of the study is to gather clinical, epidemiologic and outcomes data on the treatment of HL, on the basis of records collected by key Brazilian institutions, through a centralized web-based registry of clinical data verified by central board of hematopathologists.

Hodgkin Lymphoma is considered one of the malignancies with highest cure rates. Its prognosis improved substantially along the last three decades, as a result of relevant cooperative studies carried out in American and European institutions. Around 70-80% of the patients are cured with the available chemotherapy regimens.

However, data about HL in developing countries are scarce. It is well established that patients in underprivileged societies present with malignancies in more advanced stages. In studies of HL patients treated in Brazil during the 80's, most patients presented with advanced disease.

The creation of registry of patients with HL will provide a more reliable picture of the disease in the country, its prevalence in different areas and socioeconomic groups, and treatment outcomes. It will also foster the establishment of a network among hospitals in all regions of the country, which may serve as a platform for further development of cooperative studies engaging the main Brazilian Institutions.

The data collection allows comparison of data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Also, quality assurance addresses data validation and data analysis. Standard descriptive analyses will be carried out. For a crude association analysis, categorical data will be analysed using the chi-square or Fisher's exact test (two-sided). Survival curves will be estimated using the Kaplan-Meier method and compare using the log-rank test. Univariate and multivariate Cox regression analyses will be conducted to verify the prognostic factors regarding Progression free survival and Overall survival, adjusted for relevant prognostic clinical variables and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated HL patients
* Clinical data including baseline information on disease localization and laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating for at least 5 years are requested
* Written informed consent

Exclusion Criteria:

-
Normative Value for Navicular Drop Test in Older Adults

The aim of this study is to determine the normative values of navicular height and navicular drop in individuals over 65 years of age. The secondary aim is to investigate the effects of age, gender, and body mass index on these normative values.


Eligibility Criteria:
Inclusion Criteria:

* Being 65 years or older
* Having a body mass index between 18.5 and 29.0 kg/m2

Exclusion Criteria:

* Having chronic diseases that affect the foot structure and connective tissue (such as diabetes mellitus, rheumatoid arthritis, gout, etc.).
* Have had foot or ankle surgery in the last 6 months
* Having orthopedic or neurological deformities (related to stroke, Parkinson's, multiple sclerosis, spinal cord injury, etc.) that will affect the foot structure and mobility.
* Dependence on standing and ambulation (except independence gained through the use of assistive devices)