cyrilzakka/clinical-trials huggingface dataset:
T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer

This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer.

This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer. Patients will receive Abraxane on Day 1 of each 1-week cycle and T-DM1 on Day 1 of each 3-week cycle. Patients with take Lapatinib orally daily. Patients will receive the study treatment for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Documented metastatic Her2 over-expressed breast cancer.
* Age ≥ 18 years Patients must have received at least two prior therapies for their malignant disease.
* Patients must have \< Grade 2 pre-existing peripheral neuropathy (per CTCAE)
* Adequate organ function (cardiac ejection fraction of ≥ 45%),
* CBC not less than .75 of institutional lower limit.
* Patients must have adequate liver function: AST and ALT \< 2.5 X upper limit of normal, alkaline phosphatase \< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis Bilirubin \< 1.5 mg/dL
* Patients must have adequate renal function: creatinine \<1.5 mg/dL is recommended; however, institutional norms are acceptable.
* Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential
* Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed). Contraception method must be used during treatment and for three months after completing treatment Signed informed consent form (ICF)

Exclusion Criteria:

* Any medical or psychiatric condition that would prevent informed consent or limit survival to less than 4 weeks.
* Absolute QT interval of \>460 msec in the presence of potassium \>4.0mEq/L and Magnesium \>1.8mg/dl.
* Patient with HIV and post- transplant associated lymphoproliferative disorders.
* Patient with concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of Trastuzumab Emtansine, Lapatinib or Abraxane.
* Pregnant or lactating women.
* Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, lapatinib, abraxane, or their components.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
* Subjects with ulcerative colitis are also excluded.
Preoperative Levosimendan and Heart Failure

The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Acute surgery. Hip Fracture
* Patient with cardiac failure (EF \< 35%) or known coronary disease
* At least 2 of 11 comorbidities
* Patient has to use at least one heart failure medication
* Symptoms of heart failure
* NT-proBNP \> 2000pg/ml

Exclusion Criteria:

* \< 18 years old
* Participants in other pharmacological study
* Abuse of medicaments or alcohol
* Pregnant or breastfeeding women
* AMI at admission
* HOCM
* Serious aortic stenosis (\< 1 cm2)
* Sustained ventricular tachycardia
* Earlier episodes of "torsades de pointes"
* Sustained heartbeat \> 120/minute
* Systolic BP \< 90 mmHg
* Surgery planned not before 2 hours of study medication can be infused preoperative
* Cardiac surgery
* Dementia
* S-K \< 3 mmol/l
* Allergy levosimendan
* Serious liver failure (Known Class C Child-Pugh score)
* Serious kidney failure (GFR \< 30 ml/min.)
* Prolonged QTc-interval (male QTc \> 0,43 s, female QTc \> 0,45 s)
Clinical Study of Novel Diagnostic Techniques for Knee Osteoarthritis

The purpose of this study is to clarify the potential of intra-articular ultrasound imaging, non-invasive ultrasound imaging, quantitative MRI imaging, contrast-enhanced CT imaging and arthroscopy for diagnostics of knee osteoarthritis. All methods will be cross-correlated and compared with the arthroscopic findings.


Eligibility Criteria:
Inclusion Criteria:

* Kellgren-Lawrence grade = 1-3 or cartilage defect detected in MRI
* Age \>= 20 years

Exclusion Criteria:

* Tumor or inflammation in the knee
* Severe general diseases
* Diabetes
Effect of the Anticholinergic Drug Burden on Postoperative Delirium in Elderly Chinese Patients: A Nested Case-Control Study

This study aims to investigate the association between preoperative anticholinergic drugs burden and postoperative delirium in elderly Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

* patients over 65 years; Undergoing general anesthesia; Inpatients who had surgery between Aprill 1, 2020 and Aprill 1, 2022.

Exclusion Criteria:

* ASA grade V; preoperative Mini-Mental State Examination (MMSE) score \<24;history of neurological disorders (such as cerebrovascular disease or dementia); emergency surgeries; operative duration ≤30 minutes, and cases with \>5% missing data.
Effects of TDCS and Physical Therapy in Chronic Migraine

The aim of this clinical study is to compare the effects of tDCS, physiotherapy, and their association with the intensity in women with Chronic Migraine. For this purpose, the patients included in the study will be distributed among four groups following a factorial model.

A factorial, randomized clinical trial will be conducted to evaluate pain control, the number of migraine attacks, quality of life, emotional dysfunctions, and attentional processing of migraine patients.

Clinical outcomes will be evaluated through (I) a Visual Analog Scale (VAS); (II) pressure pain threshold; (III) a Headache Impact Test (HIT-6); (IV) a Migraine Disability Assessment (MIDAS); (V) Short-Form Health Survey Questionnaire de 36 items (SF-36); (VI) Patients' Global Impression of Change Scale (PGICS); (VII) Beck Depression Inventory (BDI); (VIII) State-Trait Anxiety Inventory (S-TAI); (IX) Perceived Stress Scale (PSS); and (X) Facial Expression Database.

Eligibility Criteria:
Inclusion Criteria:

* Women;
* 18-50 years old;
* with Chronic Migraine according to ICHD-3 beta;
* literate;
* stable on routine medications specific for MC for at least 2 months, who were not undergoing other types of non-pharmacological interventions for MC, not lactating or pregnant, without neurological diseases or serious neuropsychiatric diseases, without other types of associated headaches, without signs and/or symptoms of spinal radiculopathy, without metal implants located in the head and/or cochlear implants.

Exclusion Criteria:

* who perhaps become pregnant during the execution of the clinical trial
* present some disease that disables their continuity in the treatment
* start another type of treatment
* show changes in physical activity and/or eating routine during the research
* has severe depression (BDI \> 35).
Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke

Background: Stroke puts important economic and social loads on the society and was reported to be the most important reason for disability throughout the world.

Purpose: The present study aims to experimentally examine the effect of aromatherapy and foot massage on happiness, sleep quality, and fatigue levels of patients with stroke.

Material and method: The present study is a randomized clinical study with a control group. Participants were randomly divided into three groups (foot massage + aromatherapy, aromatherapy, and control). The study was carried out with 91 patients diagnosed with stroke. The data were collected using Sociodemographic Status Survey, Oxford Happiness Questionnaire, Piper Fatigue Scale, Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were performed using SPSS (IBM SPSS Statistics 24) package program. The results were interpreted using frequency tables and descriptive statistics. Foot massage group was given 30min foot massage sessions (3 days per week) for 4 weeks, whereas foot massage + aromatherapy group was given lavender oil inhaler during the foot massage.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were diagnosis of stroke at least 3 months, stroke levels of mild or moderate, no use of sleeping pill, volunteering in participation, not being allergic to aromatic oils, no problem with sense of smell, and no lung problem

Exclusion Criteria:

* Exclusion criteria were ulceration or lesion problem in foot, bone deformation in foot, history of allergy, cognitive or mental or language problems, difficulty in verbal communication, psychotic disorders, and not knowing the Turkish language.
Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

The present study is designed to test the hypothesis that resveratrol supplementation will improve the function of the endothelium in patients with type 2 diabetes mellitus.

The function of the endothelium will be tested with a non-invasive technique that uses ultrasound to measure the amount of dilation that occurs in the brachial artery following 5-minute cuff occlusion. To help us understand potential mechanisms of benefit, we will also collect blood, urine, and cell samples and test the effects of treatment on protein expression, nitric oxide production, and function of mitochondria.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* Age over 21 years old
* Body mass index less than 38 kg/m2
* Clinical stable type 2 diabetes mellitus

Exclusion Criteria:

* Women who are lactating or pregnant
* Treatment with an investigations product within 30 days of screening
* Clinically evident major illness of other organ systems, including cancer, renal failure, or other conditions in the opinion of the investigators that would make clinical study inappropriate
* Liver transaminase levels greater than 3 times the upper limit of normal
* History of psychological illness or condition that would interfere with the subject's ability to understand the requirements of the study
* Vitamin supplements exceeding two times the recommended daily allowance
* Resveratrol or other dietary supplements except for a daily multivitamin
Balance and Proprioception Training Program in Patients With Chronic Ankle Sprains

To examine the effects of an individualized balance and proprioception training program on pain, function, and the risk of recurrent ankle sprains.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-55 years
* History of at least two ankle sprains within the last 12 months
* Presence of ankle instability symptoms, such as recurrent giving way or chronic pain

Exclusion Criteria:

* Acute ankle injury within the last six weeks
* Lower extremity fracture within the last six months
* Other musculoskeletal or neurological disorders affecting the lower extremity
* Inability to comply with study requirements
Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19

This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.

Primary objectives are as follows:

1. To provide access to treatment with investigational convalescent plasma to inpatients with documented COIVD-19 infection
2. To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose (in NAb units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP multiplied by the volume in ml) and change or lack of change when comparing pre-treatment and day one NAb titers.

Secondary, exploratory objectives are as follows:

1. To evaluate the safety of convalescent plasma (CP) administration in hospitalized COVID-19 patients
2. To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on days 3, 7, and 14 after CP transfusion
3. To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment with CP transfusion
4. Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory support, LOS, and mortality)

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 18 years of age or older.
2. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma.
3. Patient (or legally authorized representative, LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
4. For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone.

Exclusion Criteria:

1. Female subjects with positive pregnancy test or breastfeeding.
2. Receipt of pooled immunoglobulin in past 30 days.
3. Contraindication to transfusion or history of prior severe allergic reactions to transfused blood products.
4. On ECMO or in refractory shock at entry
Epicutaneous Testing of Cosmetics for Skin Compatibility

The dermatological testing of cosmetic products which are new on the market, or existing products with novel formulations is common and a useful procedure, yet necessary to alleviate common irritants and contact allergic reactions. Cosmetic products contain a range of substances that may be considered as potential irritants or contact allergens. In order to estimate that risk, cosmetics are tested by applying patch tests.

The dermatological testing of cosmetic products which are new on the market, or existing products with novel formulations is common and a useful procedure, yet necessary to alleviate common irritants and contact allergic reactions. Cosmetic products contain a range of substances that may be considered as potential irritants or contact allergens. In order to estimate that risk, cosmetics are tested by applying patch tests, as with allergic reactions.

Eligibility Criteria:
Inclusion Criteria:

* Men and women older than 18 years old
* Persons undergoing a diagnostic patch test for reason of a skin disease
* Signed written informed consent

Exclusion Criteria:

* Acute skin inflammation and eczema on the back
* Systemic corticosteroid and immunosuppressive therapy as well as UV exposure of the back within the last 4 weeks
* Topical corticosteroids used on the back within the last two weeks
Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.


Eligibility Criteria:
Inclusion Criteria:

* Not previously treated.
* Off alcohol and marijuana for 6 months
* HCV RNA positive

Exclusion Criteria:

* HIV positive
* Advanced liver disease
* Advanced cardiopulmonary disease
* Chronic renal failure
Weekly Vitamin D in Pediatric IBD

The purpose of this study is to determine whether weekly dosing of oral vitamin D3 is effective in correcting low vitamin D levels in children and adolescents with inflammatory bowel disease (also known as Crohn's disease and ulcerative colitis).

The role of vitamin D in skeletal health is well established. More recently, vitamin D has been implicated in multiple other disease states and is currently a topic of much discussion in the pediatric and adult medical literature. Individuals with gastrointestinal or hepatobiliary diseases that limit the absorption of dietary vitamin D and those individuals with limited sunlight exposure or darker skin color are at risk for suboptimal vitamin D status. Recent joint guidelines from the North American and European Societies of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN and ESPGHAN, respectively) have recommended routine surveillance and treatment for vitamin D insufficiency/deficiency in children affected by inflammatory bowel diseases (IBD), namely Crohn's disease (CD) and ulcerative colitis (UC). Current recommendations are for prolonged daily dosing of oral vitamin D, but studies in children with other chronic diseases have demonstrated the benefit of improved compliance with less frequent, higher doses of vitamin D. The primary goal of this pilot study is to establish whether weekly dosing of vitamin D can correct suboptimal vitamin D status in children with inflammatory bowel disease. A secondary goal is to evaluate whether pediatric IBD patients with darker skin respond differently to vitamin D therapy than do their lighter-skinned counterparts.

Eligibility Criteria:
Inclusion Criteria:

1. Established diagnosis of inflammatory bowel disease made by a pediatric gastroenterologist and confirmed by histopathology
2. Serum 25-OH vitamin D level \<30 ng/mL at time of enrollment.
3. Age 8-21 years
4. Weight \> 20 kg
5. Parent, guardian, or subject (where applicable) able to give consent/assent

Exclusion Criteria:

1. Inability to ingest oral vitamin D3 capsules
2. Presence of known hepatobiliary disease
3. Presence of known kidney disease or history of renal stones
4. Use of systemic steroids within 60 days prior to enrollment.
FLuorescence Cholangiography Using Methylene Blue

Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* Patient who is unable or unwilling to give informed consent
* Known allergy to methylene blue
* Risk of serotonin syndrome (taking SSRI / G6PD deficiency / previous serotonin syndrome)
* Significant renal failure
* Pregnant / planning pregnancy or breastfeeding
VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita

VALO-2 is a multicenter, open-label extension (OLE) study enrolling patients with genotyped keratin mutations KRT6A, KRT6B and KRT16 who were previously treated with investigational PTX-022 during the VALO study. The purpose of the OLE study is to investigate long term exposure to investigational PTX-022 and evaluate safety and efficacy data. A sub-study is included to evaluate safety and efficacy of patients with genotyped keratin mutations of KRT6C and KRT17 not previously treated with investigational PTX-022.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult patients 18 years or older,
* Previously completed the VALO protocol, or VALO-2 K6C/17 sub-study, and received meaningful benefit from investigational PTX-022 as determined by the clinician.

Key Exclusion Criteria:

* Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022
Influence of CYP2C9 Genotype on Clinical Efficacy of Tenoxicam

The goal of this study is to evaluate the different gene haplotypes for the clinical efficacy of tenoxicam after third lower molar surgery for pain, edema and trismus, adverse reactions, need of rescue medication, patient satisfaction regarding the drug and the pharmacokinetics of the drug between the different gene haplotypes for CYP2C9 that are found in this population

Pharmacogenetics is an area of Pharmacology that studies the contribution of genetic factors to individual responses to drugs. This branch of science involves the variability in pharmacodynamics and pharmacokinetics through the study of polymorphisms in genes encoding receptors, as well as in drug metabolism, where this area of Pharmacology has been growing and achieving its first results with clinical use. The NSAIDS are metabolized by cytochrome P450 (CYP) family, predominantly CYP2C9. The goal of this study is to evaluate the different gene haplotypes for the clinical efficacy of tenoxicam after third lower molar surgery for pain, edema and trismus, adverse reactions, need of rescue medication, patient satisfaction regarding the drug and the pharmacokinetics of the drug between the different gene haplotypes for CYP2C9 that are found in this population. Therefore, 100 patients will be genotyped and phenotyped for this gene and their postoperative data will be confronted with the data found in the Brazilian population. For the analysis of the proposed gene, saliva will be collected and serve as a source of genomic DNA. For the molecular analysis, polymerase chain reaction (PCR) with tests validated and produced by Applied Biosystems® will be performed. The analysis of the results will be described with a significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Impacted lower third molar;
* not making use of nonsteroidal anti-inflammatory drugs in the last 7 days;

Exclusion Criteria:

* Local anesthetics allergy;
* History of gastrointestinal bleeding or ulcers;
* Kidney disease;
* Asthma;
* Allergy or sensitivity to aspirin or any other anti-inflammatory non-steroid agent;
* Pregnant or nursing women;
* Patients using antidepressant, diuretic or aspirin;
* Patients received antibiotics for 30 days prior to surgery.
Evaluation Study of SPOTme® Skin Cancer Screenings

This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.

Despite tremendous growth in both the interest and volume of skin cancer screenings at the national level, the actual utility and impact of the AAD SPOT me™ skin cancer screening programs have not been fully evaluated. This study will address this knowledge gap. Early detection is vital in the fight against skin cancer, the most common cancer in the United States. While the effects of skin cancer can be devastating, this disease is highly treatable when detected early.

This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the American Academy of Dermatology national screening program in 2016 or 2017
* Have a presumptive diagnosis (screening, non-confirmed) of melanoma
* Have provided the AAD with permission to be re-contacted
* Have provided the AAD with an email address
* Aged 18 years or older
* Able to read English

Exclusion Criteria:

* None