cyrilzakka/clinical-trials huggingface dataset:
A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function

The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body weight ≥ 45 kg and ≤ 120 kg
* BMI ≥ 18 kg/m\^2 and ≤ 35 kg/m\^2
* Heart rate ≥ 50 bpm and \< 95 bpm
* Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment
* No changes in medication within 30 days prior to study drug administration

Exclusion Criteria:

* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests
* History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
* History of headaches related to caffeine withdrawal
* History of migraine or cluster headaches
* Patients requiring dialysis will not be enrolled in this study

Other protocol defined inclusion/exclusion criteria could apply
A ReaL World Study of DS-8201

A ReaL world study of DS-8201


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 or above;
2. The Eastern Cooperative Oncology Group (ECOG) physical condition score of the United States is ≤2;
3. HER2 positive (IHC 3+ or IHC 2+ and ISH+) confirmed by tumor histology or cytology, and having received one or more anti-HER2 drug treatments previously; Or low expression of HER2 confirmed by tumor histology or cytology (IHC 1+ or IHC 2+ and ISH-), and having received at least one systemic treatment in the metastatic disease stage previously, or unresectable or metastatic breast cancer that relapsed during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy;
4. Receive goldtrastuzumab treatment in the advanced stage;
5. During the study period, voluntarily abide by this trial protocol and receive regular follow-ups;
6. All women of childbearing age, fertile men or their spouses who have no plans for fertility or sperm donation throughout the trial period until 6 months after the last dose, or who voluntarily take effective contraceptive measures.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Those with acute or chronic infections, or those with other serious diseases at the same time, are judged by the researchers as unsuitable for this study;
3. Having suffered from other malignant tumors within 5 years (excluding the following situations: cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma; A second primary cancer that has been completely cured and has no recurrence within five years; Researchers have clearly identified which primary tumor source the metastatic foci belong to.
4. Those with mental illness or mental disorders, poor compliance and inability to cooperate and describe treatment responses;
5. Those with severe organic diseases or major organ failure, such as decompensated heart, lung, liver or kidney failure, which makes them unable to tolerate treatment;
6. Patients allergic to trastuzumab;
7. Patients who changed their treatment regimens after trastuzumab treatment due to reasons other than disease progression or intolerable adverse reactions;
8. The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study
Effect of Rosiglitazone on ADMA in Critical Illness

The purpose of this study is to determine whether Rosiglitazone,decreases the ADMA concentration and thereby increases the arginine/ADMA ratio of critically ill patients.

Endothelial vasodilatation dysfunction precedes the development of arteriosclerosis. The endothelium plays a pivotal role in the control of the vascular tone by releasing nitric oxide (NO). The amino acid arginine is the sole substrate for the enzyme NO synthase (NOS). Asymmetric dimethylarginine (ADMA) is an endogenous derivative of arginine that inhibits NOS. Thus the arginine/ADMA ratio an important determinant of NO production by NOS. ADMA is an independent risk factor for cardiovascular disease, but elevated levels of ADMA have also been shown to be a strong independent predictor of ICU mortality. The central mechanism by which ADMA may cause deterioration in critically ill patients is by impairing organ blood flow and reducing cardiac function, especially during stress. Accumulation of ADMA could thereby be a causative factor in the development multi organ failure (MOF). Thus inhibition of NO production by ADMA may become especially important when cardiac demand is increased.

Eligibility Criteria:
Inclusion Criteria:

* critically ill patients
* age between 18 and 75 years
* SOFA score \> 7

Exclusion Criteria:

* history of Diabetes mellitus
* history of hypercholesterolemia
* history of hyperhomocysteinemia
* impaired hepatic function
Evaluation of a New Coating in Cement Less Femoral Stems

The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.

60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. This patients will be followed for at least 5 years. The outcome is evaluated by comparing stability measured by RSA and periprosthetic bone remodeling measured by bone densitometry.

Eligibility Criteria:
Inclusion Criteria:

* non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants

Exclusion Criteria:

* infection, revision surgery, severe morbidity and obvious bone loss
Serratus Intercostal Plane Block,New Analgesia in Supraumbilical Surgery

Background: The surgeries with upper abdominal wall incisions cause a severe pain and providing an adequate analgesia is an important challenge for the anesthesiologist. The serratus intercostal plane block (SIPB) has been already described as analgesic technique in open cholecystectomy.

The aim of this study is to evaluate its analgesic efficacy in pain control, opioids consumption and recovery quality in upper abdominal surgeries.

Methods: This blind, randomized controlled study was conducted on 102 patients undergoing open upper abdominal wall surgery under general anesthesia. All patients who received serratus intercostal plane block at the eighth rib as analgesic technique were included in group 0 (SIPB) and in Group 1 (control) those who received continuous intravenous morphine analgesia. In each group was evaluated pain scores in numeric verbal scale (NVS) and opioids consumption at 0,6,12,24 y 48h postoperative time. The quality of the postoperative recovery was evaluated with the modified Postoperative Quality of Recovery Score ( QoR-15 questionnaire) at 24h.

The scientific evidence always supports the employment of a multimodal analgesic strategy, especially in procedures that generate a severe postoperative pain2, as media laparotomy or subcostal incision. The purpose is to not retard the patients' recovery and to avoid complications. The thoracic epidural analgesia is still the reference analgesic technique in open abdominal surgery7, although it is not exempt of limitations and complications. That is why, since the introduction of thoracic and abdominal fascial blocks, they have been part of the analgesic strategy, being an alternative to considerer instead the epidural.

Eligibility Criteria:
Inclusion Criteria:

* informed consent signature
* patients \>18 years old,

  . American Society of Anesthesiologist (ASA) risk scale \< IV,
* supraumbilical laparotomy (elective laparotomy or laparoscopy conversion)

Exclusion Criteria:

* neurologic impairment,
* inability to give informed consent,
* used drugs allergy,
* contraindications to nerve block (coagulopathy, local infection at the site of the block)
* chronic pain treatment.
To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding

The study is single centered; prospective, parallel arm randomized controlled trial.The patients will be who presented to Institute of Liver \& Biliary Sciences with esophageal variceal bleeding or develop esophageal bleeding during hospital stay. All patients will be managed with continuous non-invasive cardiac and hemodynamic monitoring including cardiac rhythm, pulse rate, blood pressure, and oxygen saturation. Hemoglobin (Hb) will checked every 6 h for the initial 48 h and then every 12 h till discharge. Likewise, serum creatinine will checked daily. Packed red blood cells will be transfused to maintain target Hb of ⩾8 g/dl. Patients will be started on IV Proton Pump Inhibitor, with bolus dose of terlipressin (2mg) followed by Endoscopic variceal ligation. All patients will received prophylactic antibiotics; antibiotics will be stopped if there will no other indication to continue. After confirmation of EVB (Esophageal Variceal Bleeding) and successful initial hemostasis with emergency EVBL (Endoscopic Variceal Band ligation), patients will be randomly assigned into Group -A (Bolus terlipressin at 2mg every 4hourly) and Group-B (Continuous infusion of terlipressin @ 4mg/24hour initially) therapy for esophageal varices . They will then undergo HVPG (Hepatic Venous Pressure Gradient) measurement at baseline, 12hours and 24hours. Patient in continuous group will titrate dose. accordingly to HVPG (Hepatic Venous Pressure Gradient) measurement at 12 and 24 hours. At 24 hours patient will be directed to receive either TIPS (Transjugular Intrahepatic Portosystemic Shunt) or will continue Terlipressin for 48 hours.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with only acute esophageal variceal bleeding (as defined by Asian pacific Association for the study of Liver Disease)
* Informed consent to participate in the study
* Age 18 to 70 years

Exclusion Criteria:

* Pregnant and lactation
* Prior treatment with any vasoactive drugs
* Significant heart or respiratory failure
* Peripheral arteriopathy clinically significant
* Previous heart stroke or significant alteration of the Electrocardiogram
* Hemodynamically unstable
* Refusal to participate in the study
* Hypertension
Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
* Radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a T4 tumor and stage IIIB/IIIC disease) and not curable by local measures, such as radiation or surgery
* Positive status for human epidermal growth factor receptor 2
* Measurable disease as per Response Evaluation Criteria In Solid Tumors guidelines
* Karnofsky performance status of 70 to 100
* Life expectancy of at least 3 months

Exclusion Criteria:

* Prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
* Common Terminology Criteria Grade 2 or greater neuropathy
* Inadequate hematologic, hepatic, or renal function
* Known prior severe hypersensitivity reactions to agents containing Cremophor® EL or known hypersensitivity or prior intolerance to fluoropyrimidine
* Known or suspected dihydropyrimidine dehydrogenase deficiency
* More than 3 prior chemotherapy regimens in the metastatic setting
* Prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months
Establishing Guidelines for Manual Lymphatic Drainage

The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.

To determine if there is a difference in L-Dex Score and Segmental Limb Volume in participants with lower extremity lymphedema as measured in liters by the SOZO machine between participants who receive Manual Lymphatic Drainage (MLD) techniques utilizing light tactile pressure with 5-10 mmHg without skin stretch versus medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position, versus firm tactile pressure (\> 21 mmHg) and maximal skin stretch with therapist weight shift.

Eligibility Criteria:
Inclusion Criteria:

* All adults between the age of 30 - 75 years
* Lower extremity lymphedema

Exclusion Criteria:

* Pregnant women
* Participants who are unable to stand independently for up to 2 mins
* Participants who cannot make their own decisions
* Participants undergoing cancer treatment
* Participants with an Infection (active cellulitis)
* Participants with a known Iodine Allergy
* Participants who weigh more than 375 lbs
* Participants with cardiac arrhythmias or implanted electronic equipment
* Participants who have undergone joint replacement in involved extremity
* Participants with cardiac insufficiency
The Effect of a Low Sodium-High Potassium Salt on Blood Pressure in Vietnamese Adults

The purpose of this study was to investigate the effects of low-sodium, high-potassium condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults.


Eligibility Criteria:
Inclusion Criteria:

Untreated prehypertension or mild hypertension (systolic BP between 130 and 160 mmHg and/or diastolic BP between 85 and 100 mmHg) based on the mean of two measurements with a 1-week interval

Exclusion Criteria:

Diagnosed or self-reported cardiovascular disease Diagnosed or self-reported kidney disease
Endothelial Function in Patients With Scleroderma or Cirrhosis With and Without Pulmonary Hypertension

Pulmonary arterial hypertension (PAH) is a condition characterized by an increased pulmonary vascular resistance that can lead to right heart failure and death. Several diseases are known etiologies of PAH including scleroderma and cirrhosis. The presence of PAH in the context of systemic sclerosis or cirrhosis has a dramatic impact on prognosis and survival of the connective tissue or liver disease.

Despite advances in the diagnosis of PAH, echocardiography remains a necessary test for screening PAH in patients with scleroderma or cirrhosis. However, echocardiography is less than ideal for diagnosing PAH and predicting treatment response. Thus, there is a pressing need to identify methodologies that can accurately and non-invasively recognize the presence of PAH in patients with scleroderma and cirrhosis.

Hypothesis:

1. To measure endothelial function and exhaled gases in patients with scleroderma and cirrhosis. To assess whether they correlate with the presence or the development of PAH.
2. The degree of local (forearm) capillary vasodilation during treprostinil iontophoresis identifies patients who will develop PAH and in those already diagnosed PAH predicts response to PAH-specific therapies.

Patients with scleroderma are known to have endothelial dysfunction and limited data suggested an association between the degree of endothelial function in scleroderma and the presence of PAH. However, these data is preliminary and has not been used to predict response to PAH-specific therapy or the development of PAH. We will test patients with cirrhosis because they tend to have PAH in the context of a hyperdynamic instead of a hypodynamic state as observed in scleroderma and PAH.

Aims:

1. To measure endothelial function and exhaled gases in patients with scleroderma or cirrhosis to assess whether they correlate with the presence or the development of PAH.
2. To evaluate the degree of endothelial response to local treprostinil iontophoresis and determine if this test can predict the development of pulmonary hypertension or response to PAH-specific therapies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with scleroderma or cirrhosis.

Exclusion Criteria:

* Exclusion criteria include individuals younger than 16, etiologies of PAH other than scleroderma or cirrhosis.
Patient Blood Management - Use and Outcome

Study the influence of transfusion related Patient Blood Management Program actions on transfusion-related outcome measures and cost.

At the University Hospital of Zurich, an in-house designed monitoring and feedback system was introduced which electronically registers each transfusion of any allogeneic blood product, be it red blood cells, plasma or platelets as well as corresponding laboratory data. Results are reported quarterly to Department heads. The investigator analyzes whether the introduction of this monitoring and feedback system as part of a patient blood management Program has a significant influence on use of allogeneic blood product transfusions and transfusion-related costs, without compromising patient outcome.

Eligibility Criteria:
Inclusion Criteria:

* Only case records, all discharged patients of the University Hospital of Zürich

Exclusion Criteria:

* Not discharged from our Hospital.
Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia

Pelvic floor tension myalgia (PFTM) is increasingly noted in patients with chronic pelvic pain. Pelvic floor physical therapy is typically utilized and is at times combined with other therapies such as botox injections, trigger point injections or pudendal blocks. The investigators' study will randomize newly diagnosed patients with PFTM to weekly . Final patient assessment will be performed at 6 months to assess durability of response.

Primary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy will result in lower pain and pelvic floor muscle tension scores, lower baseline vaginal pressure and increase pelvic floor strength.

Secondary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy will result in a lower pain score in a shorter time frame, resulting in faster progress through physical therapy.

Participants will be identified within UC Irvine urogynecology and/or pelvic floor physical therapy practice with the underlying diagnosis of pelvic floor tension myalgia. This diagnosis may be secondary to various underlying etiologies including interstitial cystitis/painful bladder syndrome, vulvodynia, endometriosis, adhesive disease, unknown etiology, etc. At the time of enrollment, participants will be randomized into one of two groups: either standard pelvic floor physical therapy with weekly saline placebo injections or standard pelvic floor physical therapy and weekly pudendal blocks for 6 weeks. Standard physical therapy techniques will be utilized in both groups. Weekly injections of a mixture of a steroid and local anesthetic or saline will be administered depending on the randomization. Injections will be administered by a urogynecology physician. The participant and the treating physical therapist will be blinded to treatment assignment. The participant will be evaluated with for pelvic floor muscle strength and tenderness and will have pain assessed by a visual analog scale at baseline, weekly throughout the study, and at 6 months after study enrollment. Vaginal electromyography will be performed and standardized questionnaires regarding pelvic floor symptoms, quality of life and sexual function will be administered at baseline, after 6 weeks of injections and at 6 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant women over the age of 18 with the diagnosis of pelvic floor tension myalgia that are naive to pelvic floor physical therapy.
* Able to provide informed consent.
* Subjects must be willing to accept randomization.

Exclusion Criteria:

* Previously treated with physical therapy.
* An allergy to any component within the pudendal block.
* Bleeding disorders.
* Active vaginal infection.
* Inability to complete the questionnaires.
* Inability to read English (validated questionnaires are available in English only).
* Inability to complete the follow-up visits.
OPERA Database - Crohn's Protocol

The investigators believe that patients with Crohn's disease are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.


Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18 years of age) with physician diagnosed Crohn's disease
* A current or past prescription of anti-TNF
* Access to medical record for validation of clinical information

Exclusion Criteria:

* Unwilling or unable to provide informed consent for study participation
* Unable to access or use the internet
* Ulcerative colitis or IBD-U
* Illiterate or does not possess minimum level of literacy required to complete questionnaire
Virtual Visits in Heart Failure Care Transitions

This study evaluates the use of virtual visits in the post-discharge care of patients with heart failure. Participants admitted to the hospital with a primary diagnosis of heart failure will be randomized at discharge to either a virtual visit or outpatient visit for their 7-day post discharge follow up visit.

Published guidelines recommend that patients being discharged home after hospitalization for HF should be offered a 7-day post-discharge outpatient clinic visit as a way to increase engagement with care and reduce risk of poor outcomes. Unfortunately no-show rates for the 7-day post-discharge outpatient visit in this population are high, suggesting poor engagement. The investigators have previously observed a 76% no-show rate at the Cleveland Clinic Main Campus. This study is to evaluate whether use of 7-day post-discharge virtual visit versus in-person visit can improve adherence with post-discharge appointment.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized for primary diagnosis of HF;
2. Anticipated to be discharged home;
3. Agreeable to longitudinal post-discharge care at Cleveland Clinic Main Campus in the first few weeks after hospital discharge;
4. Patient or an individual in their social support network has the ability (equipment and connectivity) to do a virtual visit after hospital discharge;

Exclusion Criteria:

1. Being transferred to another hospital, or being discharged to an inpatient facility or nursing home;
2. Being discharged to hospice;
3. Subject currently enrolled in an interventional research study that requires an in-person clinical visit within 7 days post-discharge.
Evaluation of Intestinal Lesions and Disease Activity in Inflammatory Bowel Disease Based on 18F-FAPI PET Imaging

The goal of this observational study is to evaluate the role and effect of 18F-FAPI PET imaging in the identification of intestinal lesions and the assessment of disease activity in inflammatory bowel disease. The main question it aims to answer is:

Can 18F-FAPI PET imaging effectively identify intestinal lesions in inflammatory bowel disease and accurately assess disease activity? Colonoscopy, enhanced abdominal CT, and 18F-FAPI intestinal imaging were completed within 1 week, and major adverse outcomes (MAO) were followed up 12 months after enrollment.

Last updated on March 25, 2025


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with IBD according to clinical, imaging, endoscopic, and histopathological criteria;
* Patients ≥18 years old;
* 18F-FAPI PET/CT intestinal imaging, conventional endoscopic and enhanced CT were performed within 1 week;
* Intestinal segment matching was evaluated by endoscopy and imaging;
* Patients voluntarily participate and sign informed consent.

Exclusion Criteria:

* Pregnant or lactating patients;
* Imaging images are of poor quality and cannot be used for diagnosis and evaluation;
* Patients with contraindications for endoscopic or CT examination.