cyrilzakka/clinical-trials huggingface dataset:
Calcaneal Low Dye Taping Plantar Fascial Stretching and Sham Taping in Football Players

Showing the effect of calcaneal Low-dye Taping on acute planter heel pain and functional activity level in football players.

Planter fascia is a fibrous connective tissue originate from the medial calcaneal tubercle and help support the arch of the foot repetitive tensile overload from standing for long periods of time or running causes changes in the aponeurosis. Patient mostly present with pain on first step in the morning or after long non-weight bearing , Tenderness to anterior medial head. Its can first be treated conservatively where 90 % cases treated greater then 6 months of duration. Baseline treatment is given as Rest , Ice , compression and Elevation , with this NSAID ,shoe inset ,Taping, orthotics, deep friction massage and precautions are advised to the patients. Arch taping is most probably used and orthotics in acute treatment is commonly preferred due to its cost.Taping effects most probably overlooked in general gait parameters, patient feedback on pain relief and function recovery.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female football players
* Age (20-45 yrs)
* Pain with the first step upon walking
* Pain located at the heel or Planter surface of Mid-foot consistent with Planter fasciitis
* Presence of an everted calcaneus greater than or equal to 2°

Exclusion Criteria:

* Patient with surgery and treatment with previous 6 month
* History of Ankle or foot fracture
* Congenital deformity of the foot and ankle
* Sever Spasticity
* Use of an Assistive device
* Bilateral Planter heel pain
* Refusal to participate in study
Effect of Pilates Application on Abdominal Muscle Function, Core Stability, Musculoskeletal Pain, Quality of Life, Anxiety and Depression in Parkinson's Patients

In this study, it is aimed to investigate the effect of Pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in Parkinson's Patients.

Objective: In this study, it is aimed to investigate the effect of Pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in Parkinson's Patients.

Method: The study included 15 Idiopathic Parkinson's Patients over 18 years of age, under stage 3 according to the Hoehn-Yahr clinical staging. Patients were divided into intervention and control groups. Pilates training was performed for 6 weeks, twice a week and 60 minutes per session in intervention group. Demographic features will be questioned and recorded in the data recording form through mutual interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. All patients will be evaluated before treatment, after treatment, at the 3rd and 6th months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Idiopathic Parkinson's Disease
* Must be older 18 years old
* Must have 24 and above score on Mini Mental Test
* Must be the third or lower stage according to the Hoehn-Yahr staging
* Must have stable clinical status

Exclusion Criteria:

* Musculoskeletal or cognitive impairment at a level affecting evaluation and treatment
* Other neurological disease
Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with metastatic breast, lung, or prostate cancer.

OBJECTIVES:

* Determine the pharmacokinetics of docetaxel in older patients with metastatic breast, lung, or prostate cancer.
* Determine the response of patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Determine the short-term changes in functional status, in terms of activities of daily living, independent activities of daily living, and Karnofsky performance status, in patients treated with this drug.
* Correlate the number of comorbid conditions at baseline with declines in functional status in patients treated with this drug.

OUTLINE: Patients receive docetaxel IV over 30 minutes once weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven metastatic breast, lung, or prostate cancer
* Measurable disease
* No untreated CNS metastases
* No symptomatic CNS metastases requiring escalating doses of corticosteroids
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 65 and over

Sex

* Not specified

Menopausal status

* Not specified

Performance status

* Karnofsky 70-100%

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Hemoglobin at least 8.0 g/dL
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin normal
* SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) with alkaline phosphatase no greater than ULN OR
* Alkaline phosphatase no greater than 4 times ULN with SGOT and SGPT no greater than ULN

Renal

* Not specified

Cardiovascular

* No history of cardiac arrhythmia
* No congestive heart failure
* No myocardial infarction within the past 6 months

Other

* No prior severe hypersensitivity reaction to docetaxel or other drugs containing polysorbate 80
* No allergy to macrolide antibiotics
* No grade 2 or greater peripheral neuropathy
* No concurrent serious or uncontrolled infection
* Able to read, write, and converse in English

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Recovered from prior chemotherapy

Endocrine therapy

* See Disease Characteristics

Radiotherapy

* Recovered from prior radiotherapy

Surgery

* Not specified

Other

* No concurrent CYP3A4-inducing or inhibiting medications or herbal remedies
* No concurrent grapefruit juice
* No concurrent ethanol
Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial

Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (\< 50 copies/mL) (c/mL) at 48 weeks (W48)

Main Secondary objectives:

Comparison of the two arms for genotypic resistance profile in case of virological failure

CD4 changes from baseline

Evolution of the lipid profile and morphological changes in fat distribution, and safety

Efficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters


Eligibility Criteria:
Inclusion Criteria:

* Stable HAART ≥ 3 months
* HIV-1 RNA \< 50 c/mL ≥ 6 months
* No HAART failure history

Exclusion Criteria:

* Weight \> 45 kg
* No CD4+ cell count criteria
* No significant laboratory or clinical abnormalities
* Creatinine Clearance \> 60 mL/min
Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS

This single-arm, prospective, observational multicenter study will collect clinical data in a post-market setting across two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure). Investigators will perform the procedure using SFX Spiral PDS Plus in compliance with their standard surgical approach and the IFU.


Eligibility Criteria:
Inclusion:

1. Elect to have a Robotic Bariatric Sleeve Gastrectomy or Robotic Total Hysterectomy where STRATAFIX™ Spiral PDS™ Plus device is used for staple line re-enforcement or vaginal cuff closure, respectively
2. Are willing and able to give consent and comply with all study-related evaluations and treatment scheduled
3. Subjects are ≥ 18 years of age

Exclusion:

1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
3. Enrolled in a concurrent clinical study (drug/device) that might affect current study primary or secondary endpoints
4. Allergic to poly (p-dioxanon), IRGACARE®\* MP (triclosan) or D\&C Violet No. 2 colorant
5. Pregnant or lactating female subjects as confirmed prior to the procedure
6. Subjects undergoing radical hysterectomy (Type B, C and D) according to Querleu \& Morrow classification or gastric sleeve revision surgery
Long-Term Quality of Life in Patients With Metastatic Melanoma Treated With Checkpoint Inhibitors

To identify and describe long-term quality of life (QOL) issues in patients with metastatic melanoma treated with checkpoint inhibitors who achieved cancer control for a minimum of 12 months and remain on maintenance checkpoint inhibitor therapy.


Eligibility Criteria:
Inclusion Criteria:

* Be able to speak and read English
* Be able to provide informed consent
* Have been diagnosed with metastatic melanoma at age 18 years or older
* Have been treated with either single agent or combination checkpoint inhibitor
* Be at least 12 months since first dose of above named agents
* Received no other systemic therapy after initiation of immunotherapy (interval radiation or surgery will be permitted based on review with primary treating medical oncologist)

Exclusion Criteria:

* Patients with cognitive, visual, or motor impairment such that they cannot complete the survey as assessed by the research or clinical team
* Patients who developed a subsequent cancer after starting on checkpoint inhibitor(s), exclusive of non-melanoma superficial skin cancers
* Patients with clinical documentation of progressive disease on the most recent assessment in the electronic medical record
* Patients with symptomatic progression but continue on immunotherapy

  * Note: For any patients where the disease status is not clear, we will confirm that the disease is either stable or responsive with their primary treating medical oncologist
Cardiac Performance System Data Collection Study - Minnesota

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* 22 years of age or older
* Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.

Exclusion Criteria:

* Previous Heart Transplant
* Presence of Left Ventricular Assist Device
* Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
* Surgical scars/wounds/bandages/ports at the site of sensor placement
Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers

To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.

This Phase 4 study is a prospective, multicenter, randomized, vehicle-controlled, double-masked, two-arm, parallel treatment clinical trial of participants who have Demodex blepharitis and are current daily wear soft contact lenses wearers. The primary outcome measure is the reduction of collarettes at Day 43. The secondary outcome measures are the reduction of eyelid margin erythema at Day 43; subject-reported comfortable contact lens daily wear time; and total contact lens wear time. Safety will be determined by assessing adverse effects related to study drug administration as well as evaluating any clinically significant changes from baseline in visual acuity and slit lamp biomicroscopy findings.

Eligibility Criteria:
Inclusion Criteria:

* Be willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol
* Must meet the following criteria in at least one eye: Have more than 10 eyelashes (Grade 2 or higher) with collarettes on the upper or lower eyelid; have at least Grade 1 erythema of the lower eyelid; and have a total meibomian gland secretion score ≥ 12 but ≤ 32 AND have a minimum of 6 expressible glands for the 15 glands evaluated on the lower eyelid
* Currently wearing soft contact lenses on both eyes an average of at least 2 days per week with an average minimum wearing time of 6 hours each day over the past 3 months and is able and willing to continue to wear contact lenses during the study

Exclusion Criteria:

* Use of artificial tears or rewetting drops within 24 hours of the Screening visit or unwilling to forego the use of this treatment during the study
* Prescription AND systemic, drug delivery implant, ocular topical, or topical: antibacterial, anti-parasitic, or anti-inflammatory corticosteroid treatment within 14 days of the Screening or Day 1 visits
* Use of TYRVAYA™ Nasal Spray (varenicline solution, Oyster Point Pharma) within 14 days of the Screening visit or unwilling to forego the use of this treatment during the study
* Use of XDEMVY™ (lotilaner ophthalmic solution) 0.25%, Tarsus Pharmaceuticals, Inc., within 12 months of the Screening visit
* Treatment for blepharitis (e.g., tea tree oil-based products, hypochlorous acid-based products, commercial eyelid foams, eyelid wipes, lid scrubs, etc.) within 14 days of the Screening visit or unwilling to forego the use of these treatments during the study
* Use of artificial eyelashes or eyelash extensions at the Screening visit if they limit accurate eyelid margin assessment
* Currently pregnant or lactating
Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene.

Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued.

This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.


Eligibility Criteria:
Inclusion Criteria:

* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines

Exclusion Criteria:

* no significant previous use of bone health modifying treatments
* hip fracture within one year of enrollment
* known congenital or acquired bone disease other than osteoporosis
* significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
* abnormal calcium or parathyroid hormone level
* serum vitamin D \<20 ng/dL
* anemia (hematocrit \<32%)
* history of malignancy (except non-melanoma skin carcinoma)
* excessive alcohol use or substance abuse
* extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months
* known contraindications to denosumab, alendronate, or raloxifene
Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis

The objective of the study is to identify and validate predictive markers of infliximab responsiveness in RA patients by 2 approaches: i) measuring biochemical, immunological and bone markers in sera because of their involvement in pathogenic mechanisms; ii) identifying gene-expression signatures in PBMCs by the transcriptomic analysis.

Patients with active RA (ACR criteria) were given i.v. 3 mg/kg infliximab associated with metotrexate at weeks 0, 2, 6, and every 8th week. Infliximab efficacy was evaluated at week 14, using the EULAR response criteria.

1. Just before the starting of infliximab treatment, the following parameters were measured in the sera: i) immunological tests: rheumatoid factor (IgA, IgG, IgM), anti-CCP, autoAb recognizing the 27 C-terminal fragment (ACAST-C27) and domain I (ACAST-DI) of calpastatin, anti-G6PI, anti a-enolase, anti-keratin and anti-perinuclear factor; ii) biochemical markers: CRP, MMP-1, MMP-3, TIMP-1, TIMP-2; markers of bone resorption: pyridinolin, deoxypyridinolin, osteoprotegerin, sRANKL, COMP. The predictive value of each parameter for a response/non-response to infliximab was analysed using Fischer's exact, Mann-Whitney and Chi2 tests.
2. A blood sample was collected just before the onset of infliximab treatment and total RNAs were extracted from the peripheral blood mononuclear cells. The \[33P\] radiolabeled mRNAs were hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes spotted at a high density on nylon membranes. Data were normalized and filtered to allow the comparison between RNA samples. Statistical analyses were performed with the R software and hierarchical clustering was performed with the Cluster and Tree View softwares.


Eligibility Criteria:
Inclusion Criteria:

* Is age 18 years old or older Satisfies the 1987 American College of Rheumatology revised criteria for Rheumatoid arthritis Has active disease at the time of randomization as indicated by a DAS28\> 5.1 Has a disease at least refractory to DMARDs whose methotrexate or leflunomide Is capable of understanding and signing an informed consent form Agrees to use a medically accepted form of contraception during the study

Exclusion Criteria:

* Is pregnant or breast-feeding or without Has significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the study, uncompensated congestive heart failure, significant active infection or any underlying diseases that could predispose subjects to infections (whose tuberculosis) Has allergy to infliximab
A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes.
* Treated with a sulfonylurea for at least 2 months.
* Inadequate blood sugar control.
* Are not on any other medications to lower blood sugar.
* No major heart, liver or kidney problems.
* Women not pregnant or breast feeding.
Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (Pharmetrics)

Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured adult patients. Additionally, limited information exists on economic burden of adverse events associated with treatments for advanced/metastatic renal cell carcinoma. An objective of the current study is to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a US "real-world" setting. Another objective is to quantify the economic burden of severe adverse events with agents used in management of first line advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective cohort design. Analyses of health insurance claims data from a large commercially insured population will be employed in the current study. Study subjects will consist of all persons, aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December 31, 2009; these persons will be identified based in part on case-ascertainment algorithms. Analyses will be directed at estimating annual rates of incidence and prevalence of advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events associated with treatments used in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).


Eligibility Criteria:
Inclusion Criteria:

* two or more medical encounters with a diagnosis of kidney cancer (ICD-9-CM 189.0) or malignant neoplasm of the renal pelvis (189.1), and
* two or more medical encounters with a diagnosis of distant secondary malignant neoplasm (ICD-9-CM 197.XX-199.0, excluding 198.0 \[kidney metastasis\]) on different days \<120 days apart (the date of the earliest such encounter will be designated the "index date").

Exclusion Criteria:

* evidence of receipt of chemotherapeutic agents indicated or used in the treatment of advanced TCC, or
* evidence of cystoscopy, biopsy of the bladder, or radical cystectomy
* evidence of any other primary cancer
SSC-COVID in Patients After COVID-19

Analysis of occurrence of SSC-COVID in SARS-CoV-2-patients after the first wave of COVID-pandemic

In Central Europe, the first wave of SARS-CoV-2 peaked in April 2020 and ended in June 2020. Our tertiary care center, the University Hospital of Tübingen is located in a first-wave SARS-CoV-2 hotspot area that had the second highest 7-day incidence in Germany on March 31, 2020, exactly at the peak of the first wave in Germany (205.9/100,000, www.rki.de; the peak daily incidence in Tübingen was 179/100,000 on March 25, 2020). In this period, 249 patients were hospitalized for or with SARS-CoV-2 infection.

To gain fast knowledge about the new disease, a COVID-19 patient registry was established at our center, including all patients admitted to Tübingen University Hospital for or with SARS-CoV-2 infection and retrospectively collecting routine clinical data. After hospitalization, patients were followed up in the outpatient clinic of our department, the Department of Gastroenterology, Hepatology, Gastrointestinal Oncology, Geriatrics and Infectious Diseases.

Subsequently, several patients with secondary sclerosing cholangitis (SSC) after COVID-19 (SSC-COVID) were recognized in our center, either from our own cohort, or referred to our center due to the need for further treatment of end-stage liver disease including liver transplantation. SSC is a cholangiopathy estimated to be rare in ICU patients with an incidence of 1/2000 ICU patients. Pathogenesis has not been fully deciphered, but a combination of ischemic injury and increased bile toxicity during critical illness is suspected. This imposes acute damage on the biliary system, that, if not resolving early or spontaneously, may lead to the vicious circle of gradually destruction of the biliary tree over time, well known to hepatologists and endoscopists.

Eligibility Criteria:
Inclusion Criteria:

* post-COVID19-patients with required hospitalization during the first wave of COVID-19-pandemic
* patients controlled at the university ambulance for follow-up

Exclusion Criteria:

* children and patients younger than 18 years