cyrilzakka/clinical-trials huggingface dataset:
The Effects Of Yoga On Quality Of Life Among A Population Of Ovarian/ Fallopian Tube/ Primary Peritoneal Cancer Patients Receiving Chemotherapy: A Feasibility Study

This is a pilot study to establish the feasibility of an eight-week yoga intervention and to estimate the effect size on QoL in female patients with ovarian, fallopian tube and primary peritoneal malignancies receiving chemotherapy for the treatment of primary or recurrent cancer.

The primary objective of this study was to determine the feasibility of implementing a yoga program among gynecologic cancer patients receiving chemotherapy. The investigators concluded that it is not feasible due to the lack of participation and difficulty in recruiting patients. Of 25 consented patients, 16 agreed to participate in the control arm, 9 agreed to participate in the Yoga classes. Three (3) of those 9 changed their minds and withdrew consent. Of the 6 remaining patients, only 3 attended at least 1 of the 8 classes.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of epithelial ovarian/fallopian tube/primary peritoneal cancer
* Participant must be age 18 or older
* Participants must be 6 weeks post-surgery
* Participant must be currently receiving chemotherapy or beginning a regimen within the next four weeks
* Participant must be willing to attend the intervention sessions
* All subjects must have given signed, informed consent prior to registration in the study.

Exclusion Criteria:

* Participant has practiced yoga more than 4 times in the last year
* Participant has a surgical procedure scheduled during the 8 weeks that they would be part of the intervention
* Participant has an ECOG performance status less than or equal to two
Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis

The purpose of this study is to compare the efficacy of Intra-articular corticosteroid injection between Betamethasone (Diprospan) and Triamcinolone acetonide for treatment of knee osteoarthritis

After being informed about the study and potential risks, all patients giving written informed consent will be chosen for eligibility for the study entry. At day 0 (before intra-articular injection), patients who meet the eligibility criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Betamethasone (Diprospan 1 ml) or Triamcinolone acetonide (40 mg) single intra-articular injection

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic Primary knee osteoarthritis (Kellgren-Lawrence stage 2 or 3)
2. Failed other conservative treatment
3. Comply with protocol

Exclusion Criteria:

1. Allergy to any of the medications in this protocol (Betamethasone, Triamcinolone, Paracetamol, Tramadol)
2. Previous fracture or surgical procedure
3. Previous intra-articular injection in the past 6 months
4. Previous oral Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) (Glucosamine, Diacerein) used in the past 6 months
5. Current infection in the affected limb
6. Uncontrolled Diabetes Mellitus
7. Primary or secondary adrenal insufficiency
8. Coagulopathy or current anticoagulant used
9. Current steroid used
10. Lower extremity weakness
Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis.

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood. Also, it is associated with high risk of colon cancer, so there is a continuous need for introducing new therapies that decrease progression, and hence better outcomes


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Both males and females will be included
* Negative pregnancy test and effective contraception.

Exclusion Criteria:

* Breastfeeding
* Significant liver and kidney function abnormalities
* Colorectal cancer patients
* Patients with severe UC
* Patients taking rectal or systemic steroids
* Patients taking immunosuppressives or biological therapies
* Addiction to alcohol and / or drugs
Identification and Treatment of Renal Stenosis in Transplanted Kidneys

Renal artery stenosis is a complication that may follow kidney transplantation1-5. Renal artery stenosis greater than 50% of the lumen of the artery, associated with clinical symptoms or laboratory worsening of renal function, may lead to transplant failure, however, the indications for treatment and the modalities of treatment remain, to date, a debated topic in the literature. The guidelines of the European Society of Urology recommend endovascular treatment as the first-line treatment by means of angioplasty and/or stent placement6. A recent review of the literature7 examined the results of 56 studies: the results fully support endovascular treatment of the disease which appears to be effective and with a low rate of complications.

The primary objectives of the study are to evaluate the efficacy (in terms of technical success and graft salvage) and safety (in terms of complications) of endovascular treatment using stenting in patients with renal artery stenosis following kidney transplantation.

Patients undergoing endovascular treatment of renal stenosis following kidney transplantation at the Vascular Surgery Unit from January 2020 to April 2023 (retrospective phase) and from May 2023 up to 2 years from the start of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Indication of renal transplant and diagnosis of renal artery stenosis of the transplant
* Obtaining informed consent

Exclusion Criteria:

-
Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment

This study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization)


Eligibility Criteria:
Inclusion criteria:

* Male of female
* Aging from 0 to 30 years
* With typical aneurysmal bone cyst at initial imaging
* At least one interventional radiology procedure performed

Exclusion criteria:

* No initial surgery
* Patient refuses to participate
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts

The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.


Eligibility Criteria:
Inclusion Criteria:

* Patient has chronic renal failure and requires vascular access for hemodialysis
* Patient has given informed consent to participate in the trial and is willing to comply with the study protocol
* Patient is male or female, 18 years of age or older
* The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm)
* Patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center
* Patient has a vein 4 mm or larger to which the graft can be anastomosed

Exclusion Criteria:

* Patient is unable to comply with the study follow-up
* Patient has a known sensitivity to polyurethane or porcine heparin
* Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available
* Patient has an immunodeficiency syndrome
* Patient has a prior history of bacterial infection within 8 weeks of implantation of graft
* Patient has a severe coagulation disorder
* Patient has an elevated platelet count of greater than 1 million
* Patient has a history of heparin-induced thrombocytopenia syndrome (HIT)
* Patient is pregnant
* Patient has a fever greater than 100 degrees Fahrenheit
Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder

This study was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts.

This study was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts. The outcome measure including shoulder range of motion, pain condition, home exercise adherence and satisfaction of smartphone program

Eligibility Criteria:
Inclusion Criteria:

* gradual shoulder pain and stiffness at least 4 months
* loss of active and passive shoulder mobility, shoulder external rotation \<45 degree
* ability to use the smartphone

Exclusion Criteria:

* normal shoulder mobility
* diagnostic shoulder osteoarthritis
* nerve pain
* injection of corticosteroids in 3 months
Local Host Modulating Agents Alendronate & Aloe Vera for Treatment of Furcation Defects in Chronic Periodontitis

Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects

Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.

Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1% ALN gel (group 2) and SRP plus AV gel (group3). Clinical and radiographic parameters were recorded at baseline and gel were delivered at respective site. Then again all clinical and radiographic parameters were recorded after 6 and 12 months from baseline.

Eligibility Criteria:
Inclusion Criteria:Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study -

Exclusion Criteria:Subjects with any known systemic disease, allergic to alendronate or aloe vera, on systemic alendronate therapy, alcoholics, tobacco users, pregnant or lactating women

-
TTA in Treatment of Diabetes and Dyslipidemia

The aim of the study is to evaluate the short-term effects of tetradecylthioacetic acid (TTA) on plasma lipids and glucose in male patients with type 2 diabetes mellitus and dyslipidemia

The tight linkage of obesity, insulin resistance (and frank diabetes), dyslipidemia, and hypertension has been widely observed and has been named syndrome X, or the metabolic syndrome. For many years metformin has been the only drug in clinical use with effects on insulin resistance. Recently, agonists of the peroxisome proliferator-activated receptors (PPARs) have been introduced in the treatment of type 2 diabetes. The different PPARs seem to be activated by a wide range of lipids and lipid mediators, including fatty acids. 2-tetradecylthioacetic acid (TTA) is a modified fatty acid with high affinity for the PPARgamma receptor. In animal models of obesity-related insulin resistance (obese Zucker rats and dietary manipulated Wistar rats), TTA has an insulin sensitizing effect by enhancing the insulin mediated uptake of glucose in peripheral tissues. TTA treatment promotes fatty acid catabolism in experimental animals and this could casually be linked to the improved glucose tolerance.

The protocol for the present study describes a safety assessment and therapeutic exploratory evaluation of TTA in a small subset of male type 2 diabetes patients for 4 weeks. The primary safety parameters will include general physical observational parameters, liver function test and hematological parameters. To goal is to assess the efficacy of TTA on selected metabolic parameters including fasting blood glucose and insulin, fasting plasma lipids, antioxidant status, and fibrinolytic parameters, weight, BMI and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus with HbA1c 8.0-12.0%,
* fasting S-triacylglycerol 2.0-10.0 mmol/L,
* body mass index 25-40 kg/m2 and/or waist/hip ratio \> 0.90.

Exclusion Criteria:

* fasting total cholesterol \>10 mmol/L,
* blood pressure 170/110 mmHg
* other significant disease
* Use of any corticosteroid, anticoagulant or lipid-lowering drug 2 weeks prior to inclusion.
Thyroid Hormone Replacement for Subclinical Hypothyroidism and Chronic Heart Failure (ThyroHeart-CHF)

Based on accumulating evidence showing that hypothyroid status is associated with poor prognosis among heart failure (HF) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with HF and subclinical hypothyroidism. The study is a prospective, randomized, parallel-group trial to assess the efficacy and safety of levothyroxine replacement on evidence-based HF standard therapy in stable chronic heart failure patients with subclinical hypothyroidism.

The primary objective of this trial is to determine whether the 24-week L-T4 replacement therapy, as an adjunct to standard treatment, would improve exercise capability in chronic systolic heart failure patients with subclinical hypothyroidism compared to the standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older, male or female.
* Systolic heart failure with New York Heart Association (NYHA) class II-III.
* Left ventricular ejection fraction (LVEF) less than 40% by echocardiography during screening and randomization.
* SCH (TSH: upper limits of normal (ULN) -10mIU/L, and FT4 level within reference range).
* Having received standard HF therapy for at least 2 weeks, having reached target dose or max tolerable dose.
* Provided informed consent.

Exclusion Criteria:

* Acute heart failure or acute exacerbation of chronic heart failure within the past 2 weeks.
* Scheduled cardiac resynchronization therapy or heart transplantation.
* History of malignant tumor or life expectancy under 12 months.
* Already on medications that may affect thyroid function (L-T4, carbimazole, propylthiouracil, amiodarone, lithium).
* Pregnancy and lactation period.
* Participation in another clinical trial within the past 30 days.
* Contraindication or intolerance to evidence-based therapy for CHF, such as beta-blocker, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker.
* Known hypersensitivity to the trial treatment(s) or diluents (when applicable), including placebo or other comparator drug(s).
* Untreated adrenal insufficiency.
* Untreated pituitary insufficiency.
* Untreated thyrotoxicosis.
* Treatment with levothyroxine must not be initiated in patients with acute myocardial infarction, acute myocarditis, or acute pancarditis.
* Severe renal dysfunction (eGFR≤30 ml/min/1.73m2).
* Significant hepatic impairment (Serum GPT \> 120 U/L).
* Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol.
Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects

To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.

Study Type: Interventional Study Design: An open label, one period, randomized, vasoconstrictor assay study.

Official Title: Bioequivalence of two Clobetasol Propionate 0.05% Topical Lotions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

· Vasoconstrictor Response

Eligibility Criteria:
Inclusion Criteria:

* Non-tobacco-using female subjects, 18 to 50 years of age, inclusive.
* A demonstrated blanching response to Clobex TM (clobetasol propionate) Lotion, 0.05 %.
* A body mass index (BMI) 30 kg/m2 or less as calculated according to Novum Standard Operating Procedures.
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
* Signed and dated informed consent form which meets all criteria of current FDA regulations.

Exclusion Criteria:

* History of allergy to any systemic or topical corticosteroid (including clobetasol) or to any cream, lotion, ointment, gel, cotton, soap, cosmetic, rubber, or tape, which in the opinion of the Investigator would compromise the safety of the subject or the study.
* Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of skin blanching.
* Significant history or current evidence of chronic infectious disease, system disorder (especially hypertension or circulatory disease), or organ dysfunction.
* Presence of a medical condition requiring regular treatment with prescription drugs.
* Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
* Use of any topical dermatological drug therapy (including topical corticosteroids) on the flexor surface of the ventral forearms in the 30 days prior to dosing.
* Use of any tobacco products in the 30 days prior to dosing.
* Receipt of any drug as part of a research study within 30 days prior to initial study dosing.
* Pregnant or lactating.
The Relationship Between Needle Position and Injection Pressure During Femoral Nerve Block

Recent evidence suggests that injection pressure monitoring may be able to predict needle nerve contact in the brachial plexus nerve block model, but little is known about multifascicular nerves. The investigators hypothesize that injection pressure monitoring can reliably predict needle-nerve contact during femoral nerve block.

Single center, observational study. Patients scheduled for elective lower limb surgery with femoral nerve block will be recruited. Femoral nerve will be identified using a linear ultrasound transducer. A 22 GA 5 cm nerve block needle will be inserted with bevel downward and advanced to the following conditions:

1. Needle tip slightly indenting the fascia iliaca lateral to the femoral nerve
2. Needle tip advanced through fascia iliaca
3. Needle tip slightly indenting the anterior surface of the femoral nerve
4. Needle tip withdrawn 1 mm from nerve.

At each of these conditions, 1 ml of dextrose solution will be injected via an automated pump at 10 ml/min and the spread of injectate observed sonographically. Simultaneously, a blinded observer will measure opening injection pressure using both an electronic and a mechanical transducer. If opening pressure reaches 15 psi, this investigator will halt the injection. In addition, minimum threshold current required to elicit a motor response will be recorded for conditions 3 and 4. Patients will be contacted at 7 days and asked about any adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* ASA physical status I-III
* scheduled for lower limb surgery where femoral block is part of intended analgesic plan

Exclusion Criteria:

* Contraindication to femoral nerve block (e.g. infection)
* BMI \> 35 kg/m2
* inability to communicate postoperative symptoms
* pre-existing neurologic deficits in the operative extremity
* allergy to local anesthetics
* history of opioid dependence
Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

keratoconus is a progressive corneal ectatic disease characterized by paraxial stromal thinning and weakening, resulting in irregular astigmatism, corneal protrusion, and distortion of the anterior corneal surface. It is usually bilateral, although asymmetrical in most cases.

Intrastromal corneal rings are polymethylmethacrylate devices successfully used for the management of keratoconus, pellucid marginal degeneration, post-LASIK ectasia and myopia. Intrastromal corneal rings implantation is safe and reversible procedure that does not affect the central corneal area, and hence, avoids interference with visual axis. The goal of intrastromal corneal rings implantation is to improve visual acuity by regulariztion of the anterior corneal surface.


Eligibility Criteria:
Inclusion Criteria:

* Keratoconus grade I, II and III according to the mean K Amsler-Krumeich classification.
* Contact lens intolerance.
* Thinnest location is more than 400 um.
* Maximum keratometry (Kmax) between 48 and 64 D.
* Clear cornea with no Vogt's striae.

Exclusion Criteria:

* Previous corneal surgery.
* Grade IV with corneal scarring.
* Concurrent corneal disease in addition to KC.
* Autoimmune or systemic connective tissue diseases.
Effect of VR and Accommdation Relax on Controlling Myopia in Children

This study evaluates the effect of virtual reality and accommodation relax technique on controlling onset and development of myopia in school-aged children. Half of the children will receive head-mounted video display which shows video with virtual reality and accommodation relax technique in combination, while the other half will receive no intervention.


Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity \>=20/20 for each eye;
* Astigmastism less than 1.5 D;
* Anisometropia less than 1.0D;
* No other ocular or systematic diseases;

Exclusion Criteria:

* Can not endure virtual reality video;
* Can not cooperate with ocular examinations;
* Receiving other interventions for controlling myopia;