cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Plasma Exchange Adsorption Diafiltration

The purpose of this study is to evaluate the efficacy of coupled therapeutic plasma exchange adsorption diafiltration (PEAF )for treating septic shock with multiple organ dysfunction syndrome patients in ICU.

Septic shock with multiple organ dysfunction syndrome (MODS) is a life-threatening clinical condition due to coagulant disorder immunoparalysis to infection. For this reason the extracorporeal therapies for the treatment of septic shock with MODS have become widespread in the ICU and, at the same time, new extracorporeal depurative techniques have been developed for the removal of inflammatory mediators. One of these techniques is therapeutic plasma exchange (TPE) that remove pathologically elevated cytokines and simultaneously to replace protective plasmatic factors. other techniques is coupled plasma-filtration adsorption (CPFA) that uses a sorbent once the separation between plasma and blood has been obtained with a plasma filter. The others is Plasma dialysis filtration(PDF) that can remove inflammatory mediators for patients with multiple organ dysfunction syndrome.The purpose of this study is to evaluate the efficacy of PEAF (coupled therapeutic plasma exchange adsorption diafiltration )for treating septic shock with multiple organ dysfunction syndrome patients in ICU.

Eligibility Criteria:
Inclusion Criteria:

1. Age, gender: 18-75 years old, male or female;
2. basic conditions: 20 ≤ APACHE II score ≤ 35 points and 10 ≤ Sequential Organ Failure Assessment(SOFA)≤ 18 points;
3. septic shock : On the basis of sepsis, after adequate fluid resuscitation, sustained hypotension requires maintenance of vasoactive drugs, mean arterial pressure（MAP）≥ 60 mmHg and Lactate ≥ 2.0 mmol/L; MODS: if the patient's SOFA score is ≥2 points, it means there is organ dysfunction. When the patient has two or more organ dysfunctions, it is MODS.

Exclusion Criteria:

1. can not remove the cause (surgical patients refused surgery, pan drug resistant infection without drug use)
2. Allergic to AMPLYA™ series
3. Presence of relative or absolute contraindications to PFA
4. MODS caused by severe liver disease
5. malignant tumors
6. Chronic end-stage disease (predicted to survive no more than one month)
7. Maternal and possibly pregnant women
8. participated in drug clinical trials within three months
9. Admission from an other ICU where the patient remained for more than 24 hours
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).
* Have all of the following:

  * Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
  * Prior treatment with chemotherapy for locally advanced or metastatic disease.
  * No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
* Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
* Have adequate organ function.
* Women of child-bearing potential must have a negative pregnancy test.
* Are able to swallow tablets/capsules.

Exclusion Criteria:

* Are currently receiving treatment in a clinical study involving an investigational product.
* Have a serious concomitant systemic disorder.
* Have symptomatic central nervous system (CNS) malignancy or metastasis.
* Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
* Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
* Have a history of any other cancer.
* Had major surgery within 14 days prior to randomization.
* Are breastfeeding.
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
A Mouth Education Program for Dry Mouth

The goal of this cluster based intervention trial is to evaluate the effect of a nurse-led patient education program on dry mouth in patients with a life-limiting condition or frailty.

The Mouth Educational Program (MEP) is a nurse-led patient education program, in which trained nurses use current clinical, palliative dry mouth guidelines in a structured manner to discuss causes, consequences and interventions with the patients and to create an appropriate treatment plan. This intervention will be compared to a control group receiving care as usual.

Therefore, the main question it aims to answer is:

Does a nurse-led patient education program reduce dry mouth complaints in patients with a life-limiting condition or frailty?

Participants will be asked to answer questionnaires and, when part of the intervention group, partake in the Mouth Educational Program (MEP).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* life-limiting condition or frailty (definition from Kwaliteitskader Palliatieve Zorg Nederland (IKNL/Palliactief, 2017)),
* experience the complaint dry mouth ≥ 5 on an 11 point numerical rating scale (ranging from 0=no dry mouth to 10=worst dry mouth ever);
* fulfil the Surprise Question (SQ): 'Would I be surprised if my patient dies within the year? (no)

Exclusion Criteria:

* life expectancy less than 4 weeks;
* previous medical history of radiotherapy to the salivary glands or Sjogren's syndrome;
* a cognitive inability to understand and participate in an educational program (assessed by a member of the regular care team, either doctor or nurse)
Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting

This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3 months and 6 months. The intervention group will receive a minimum of 78 text messages related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited to respond to some text messages which will be in the form of a multiple-choice question and if they do, they will receive an additional text message in response to their answer.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of type 1 diabetes mellitus
2. Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)
3. Age 15-20 at study enrollment
4. English literate and English speaking
5. Ability to complete the required surveys
6. Have a personal cell phone with service compatible with EZTexting Platform
7. Able to provide informed assent or consent (if 18 years of age or older) and parental informed consent (if needed).

Exclusion Criteria:

1. Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.
2. Diabetes Diagnosis other than Type 1 Diabetes
3. Inability for the adolescent to respond to text messages (e.g. due to developmental delay)
The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome

The main hypothesis of the study is that telerehabilitation is an effective treatment method and it is not inferior than standard physiotherapy.The aim of this study is to evaluate the effectiveness of telerehabilitation in patients with subacromial pain syndrome by comparing it with standard physiotherapy.

Subacromial pain syndrome formerly known as subacromial impingement syndrome is the cause of approximately 44% to 65% of pain complaints related to the shoulder. Methods such as immobilization, drug therapy, injection techniques, physical therapy modalities and therapeutic exercises, manual therapy, acupuncture and surgery can be used in the treatment of the disease. Due to the Coronavirus disease 2019 (COVID-19) pandemic that started in Wuhan province of China in December 2019, the problems in patients' access to hospitals and rehabilitation services caused telerehabilitation to be on the agenda. Telerehabilitation can be summarized as the delivery of rehabilitation services to those in need by using communication technologies. This method covers the steps of evaluation, monitoring, prevention, intervention, control, training, and consultation. Although there are many studies on the effectiveness of telerehabilitation in the literature, there is no study on the superiority of telerehabilitation, physical therapy under supervision and home exercise program over each other.

Eligibility Criteria:
Inclusion Criteria:

* Having subacromial pain for at least 2 weeks
* Positive result of Hawkins-Kennedy, painful arc or infraspinatus muscle strength tests .
* To have internet access and equipment to participate in videoconference .
* Being literate and not having cognitive dysfunction.

Exclusion Criteria:

* Positive drop arm test
* Signs of adhesive capsulitis (restriction in range of motion-especially in abduction and external rotation)
* Grade 3 or full thickness rotator cuff tear
* Labral tears and other intraarticular structural pathologies
* History of shoulder surgery
Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan

Losartan, an angiotensin II receptor blocker, has already been established as a treatment for diabetic nephropathy due to its ability to reduce blood pressure and mitigate the progression of kidney damage. However, the addition of a diuretic like hydrochlorothiazide may offer synergistic benefits in reducing proteinuria by addressing both the underlying renal pathology and potential volume overload in these patients. The current study aims at determining and comparing the role of losartan alone vs hydrochlorothiazide plus losartan in reducing proteinuria in diabetic nephropathy patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders with ≥18 years of age.
* Presence of proteinuria/albuminuria at time of screening.
* Creatinine clearance of 30 mL/min or higher.

Exclusion Criteria:

* A systolic blood pressure of 180 mm Hg or higher, a diastolic blood pressure of 110 mm Hg or higher.
* Presence of a second primary renal disease in addition to diabetic nephropathy.
* Patients with type 1 diabetes.
* A history of a cardiovascular or cerebrovascular event within 3 months before inclusion.
* Serum potassium of 6.0 mmol/L or higher.
* Transplantation or immunosuppressive treatment.
* Contraindication for the use of losartan or hydrochlorothiazide.
* Pregnancy or lactation.
Evaluate the Effect of Hyaluronic Acid in the Treatment of Furcation Involvement

the effect Hyaluronic Acid in the Treatment of Furcation Involvement

The materials to be used in the study are the following:

* Hyaluronic acid
* Cone-beam computed tomography(CBCT) x-ray The patients with Grade II furcation will be divided into two groups. Both groups will have the same number of patients and the same procedure, such as the scaling root planning. However, the control group will use hyaluronic acid and membrane. The placebo group, on the other hand, will use hyaluronic acid without membrane and will use CBCT x-ray. The x-rays will be done at the beginning of the treatment. Then, two monitoring processes will be done. The first monitor will be done after three months. The data will be recorded. Then, after another three months, the patients will undergo an x-ray check again, and the data will be recorded. The goal is only to have the patients exposed to x-ray twice so they would not be compromised to the high dose of radiation. The evaluation to be done for the 3-month interval will only be clinical assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Selected teeth: Permanent first and second molars in the mandible.
2. Furcation dimension: Radiographic and clinical evidence of exhibiting defects due to Grade II furcation with at least 2 millimeters probing depth horizontally and at least 5 millimeters probing depth circumferential.
3. Gender: both males and females.
4. Age range: between 18 and 55 years.
5. Health status: healthy patients non-systemic diseased except controlled diabetic.
6. Compliance: Patients will be willing and able to comply with adequate oral hygiene protocols.

Exclusion Criteria:

1. Patients that received periodontal regenerative therapy within the past 12 months.
2. Patients that are lactating.
3. Pregnant patients.
4. Smokers.
5. Patients with pulp infection.
6. Patients with trauma resulting from occlusion.
7. Patients with receding gum.
8. Patients with tooth mobility greater than grade II.
9. Patients that will not comply with the hygiene protocols in Phase I therapy.
10. Patients with potential illnesses that can influence the periodontal therapy outcomes.
11. Patients that are taking medications that can interfere with the healing outcomes of the periodontal wound.
12. Patients allergic to any drugs.
Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study

Primary hyperparathyroidism (PHPT) and Hypoparathyroidism (HP) are two of the most frequent disorder of Calcium-Phosphorus (Ca-P) metabolism. The Ca/P ratio is an accurate tool to differentiate patients with PHPT from healthy subjects, according to a previous single-centre study. The reliability of this index is based on the fact that serum Ca and P are inversely related together either in healthy subjects or in patients with PHPT and HP.

The aim of this study is to investigate the accuracy and diagnostic value of Ca/P ratio in the diagnosis of primary hyperparathyroidism and hypoparathyroidism. The definition of a valid cut-off of serum Ca/P ratio for patients with these disorders will be of help especially in those patients with apparently normal biochemical profile, but suggestive for primary hyperparathyroidism and hypoparathyroidism.

Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosis of primary hyperparathyroidism
* patients with diagnosis of hypoparathyroidism
* subjects with normal Calcium-Phosphorus metabolism

Exclusion Criteria for both cases and controls will be:

* age younger than 18 or older than 90 years
* severe renal and liver diseases (i.e. glomerular filtration rate (GFR) \<30 ml/min)
* hyperparathyroidism secondary to Vitamin D deficiency
* active metabolic bone disease (e.g. Paget's disease of the bone, osteomalacia, rickets, etc)
* any type of cancer
* malnutrition
* severe obesity (BMI \> 40 kg/m2)
* a history of gastrointestinal malabsorption
* sarcoidosis
* hypercortisolism
* diabetes insipidus
* hyperthyroidism
* pseudohypoparathyroidism
* familial hypocalciuric hypercalcemia (FHH)
* treatment with steroids, active forms of vitamin D (calcitriol, ergocalciferol, etc), thiazides, phosphate binders, lithium, cinacalcet, bisphosphonates, and denosumab.
The Role of Echocardiographic Contrast (Optison) in Enhancing Tricuspid Regurgitation Spectral Doppler Signals

The investigators aim to correlate noninvasive pulmonary artery systolic pressure (PASP) measurements obtained with and without echocardiographic contrast (Optison) during transthoracic echocardiography (TTE) with those obtained invasively and simultaneously during right heart catheterization, as the gold standard.

In the United States, pulmonary hypertension (PHT) is an increasingly recognized cause of morbidity and mortality.

Echocardiography, due to its widespread use, versatility, portability, noninvasive nature, and safety, is routinely used as the primary method for diagnosis and evaluation of these patients. However, in this very cohort, its accuracy is frequently compromised by poor acoustic windows. The use of echocardiographic contrast (EC) in such patients may increase diagnostic accuracy, eliminate the need for performing more invasive, time-consuming, and expensive tests, and eliminate potential diagnostic and management errors.

Pulmonary Artery Systolic Pressure (PASP) is routinely measured noninvasively with transthoracic echocardiography (TTE) by obtaining the tricuspid regurgitant velocity (TRV) with continuous wave spectral Doppler and applying the modified Bernoulli equation.

The investigators aim to use the FDA approved perflutren-based EC agent Optison to augment inadequate TR CW spectral Doppler envelopes and determine if the TRV and PASP measurements obtained with the use of Optison correlate better with the invasive measurements obtained simultaneously during right heart catheterization as opposed to those measurements obtained without the use of EC.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients (age ≥ 18 years old) undergoing right heart catheterization catheterization laboratory for various clinical indications as part of routine medical care;
* only patients with poor acoustic windows will be included (based on previous studies, body habitus);

Exclusion Criteria:

* atrial fibrillation or other irregular rhythms (bigeminy, frequent ectopy)
* pregnant women
* known allergy to perflutren, blood products, albumin
* patients who cannot receive blood products due to religious beliefs
* evidence of intracardiac right to left shunting
A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.

This is a single-center, pilot study evaluating the addition of Ciprofloxacin (study drug) to standard-of-care gemcitabine and nab-paclitaxel chemotherapy in treatment-naïve metastatic PDAC patients. Patients who are recommended gemcitabine and nab-paclitaxel chemotherapy as a standard-of-care by their treating physician will be offered to participate in this study.

Oral ciprofloxacin (study drug) will be administered twice a day throughout each 28-day cycle of gemcitabine and nab-paclitaxel chemotherapy. The patient will start taking ciprofloxacin from the evening of day 1 of chemotherapy and end on the morning of day 29 of each cycle.

Ciprofloxacin tablets should be taken in the morning and evening at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Ciprofloxacin can be taken with or without food

With each study visit, the physician will prescribe 1-month supply of oral ciprofloxacin to be taken home and self-administered by the patient. The physician will have to indicate "pancreatic cancer microbiome study" on the remarks column for each cycle oral ciprofloxacin is ordered.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent. Written informed consent must be obtained prior to performing any study-related procedures.
* Age ≥ 21 years
* Histologically or cytologically confirmed, treatment-naïve, locally advanced or metastatic pancreatic adenocarcinoma planned to commence on gemcitabine and nab-paclitaxel chemotherapy.
* Patient must have measurable disease as defined by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1 guidelines)
* Life expectancy \>3 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* CrCl ≥ 30 ml/min

Exclusion Criteria:

* Known hypersensitivity or allergy to ciprofloxacin or other quinolones
* On tizanidine or theophylline and unable to stop these medication
* Known QTc prolongation (QTc \>500 msec) or torsade de pointes
* Presence of Clostridium difficile-associated diarrhea or colitis
* Known history of myasthenia gravis
* Known G6PD deficiency
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
* Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
* Prostate-specific Antigen (PSA) doubling time of ≤ 10 months and PSA \> 2ng/ml.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
* Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
* Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.

Exclusion Criteria:

* History of metastatic disease at any time or presence of detectable metastases.
* Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
* Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
* Use of estrogens or 5-α reductase inhibitors or AR inhibitors.
* Prior chemotherapy or immunotherapy for prostate cancer.
* Use of systemic corticosteroid.
* Radiation therapy within 12 weeks before randomisation.
* Severe or uncontrolled concurrent disease, infection or co-morbidity.
* Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
* Known hypersensitivity to the study treatment or any of its ingredients.
* Major surgery within 28 days before randomisation.
* Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
* Uncontrolled hypertension.
* Prior malignancy.
* Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
* Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
* Treatment with any investigational drug within 28 days before randomisation.
* Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.
Screening and Access to Health Care for Vascular Disease

This is a pilot study designed to validate our methods of recruitment, screening and data collection in the community. The project will help to establish the feasibility of the study design to lay the groundwork for a potentially larger study. The final study will allow us to estimate the incidence and prevalence of abdominal aortic aneurysm (AAA), carotid artery stenosis, and peripheral artery disease (PAD) in different geographic areas in a large urban setting, as well as determine patient access to healthcare and treatment for vascular disease as related to geographic and racial differences.


Eligibility Criteria:
Inclusion Criteria:

* age 55 or older
* willing/able to provide consent
* willing to participate in follow-up phone calls at defined intervals for up to 5 years

Exclusion Criteria:

* unable to provide consent to participate
* unwilling/unable to participate in the follow-up phone call