cyrilzakka/clinical-trials huggingface dataset:
An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension

Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension


Eligibility Criteria:
Inclusion Criteria:

* 1. 18 years of age.
* 2. Patients with stage II systolic hypertension
* 3. If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.

Exclusion Criteria:

* 1. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.

  2. History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.

  3. Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP \> 200 mm Hg).

  4. History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.

  5. Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.

  7. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter.

  8. Laboratory test values considered clinically significant by the investigator.

  9. Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin \> 3 times the upper limit of normal.

  10. Pregnant or lactating females.
* 11. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.
Bowel Preparation Impact on the Intestinal Microbiome: Oral Preparation vs Enema

Mechanical bowel preparation for left-sided colorectal surgery remains standard in most cases. However, there are some discrepancies on how to prepare the bowl, while rectal enema and oral agents are both available methods.

The knowledge of intestinal microbiome role on surgical outcomes is increasing, since few recent reports linked microbiome composition to postoperative complications, such as anastomotic insufficiency. Although, it is not clear how the bowel preparation affects the gut microbiome. Therefore, different bowel preparation techniques impact on gut microbiome will be studied.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 y.;
2. Signed informed consent;
3. Left-side colorectal resection for colorectal cancer;

Exclusion Criteria:

1. Anticipated ileostoma;
2. Allergy to oral preparation agents;
3. Multivisceral surgery;
4. Emergency surgery;
5. History of inflammatory bowel disease;
6. History of surgery disrupting gastrointestinal tract integrity;
7. Signs of tumor obturating the lumen of the bowel;
8. Pregnancy;
Capillary and Venous Blood Count Parameters

The purpose of this study is to compare capillary blood count parameters with the corresponding venous samples to verify the hypothesis that capillary and venous blood count parameters are equivalent.

In patients with haematological diseases regular blood count analyses are necessary. In haematology, capillary blood count analyses became established in routine diagnostics. The method and procedure of capillary blood sampling is well accepted by both the patients and the medical personal for a long time. However, only venous values are generally accepted in clinical routine. It is important to know whether or how capillary blood gives discrepant results for the various parameters. Values for therapeutic decisions, e.g. transfusion, are only known for venous values. So far, there are only deficient data available. Therefore, the aim of this study is (i) to compare capillary blood count parameters with the corresponding venous samples to verify the hypothesis that capillary and venous blood count parameters are equivalent, (ii) to include an adequate large number of adult haematological patients (with low and high values) and healthy adults, (iii) to obtain difference values for conversation of measured capillary values into the corresponding venous values.

Eligibility Criteria:
Inclusion Criteria:

* Patients with haematological diseases ≥18 years
* Healthy volunteers ≥18 years
* Informed consent
* No participation in another study 3 month before and during the study

Exclusion Criteria:

* Subjects \<18 years
* Healthy subjects with acute or chronic infections and autoimmune or malignant diseases
Long Term Follow-Up in Patients With Stage 0-IIIC Breast Cancer

This trial studies long term follow-up care in patients with stage 0-IIIC breast cancer. Collecting feedback from breast cancer patients may help researchers to define comprehensive long term follow-up care for breast cancer survivors, better understand health-related quality of life and long-term complications in breast cancer survivors, and to increase the knowledge of the mechanisms by which a patient's own immune system attempts to combat breast cancer, and what factors may make this response more successful.

PRIMARY OBJECTIVES:

I. To provide comprehensive care to breast cancer survivors diagnosed with stage 0 to IIIC, who received at least part of their treatment at City of Hope.

II. To use the information obtained from follow-up of breast cancer survivors to describe the magnitude of risk and associated risk factors.

III. To use the information gained from follow-up of breast cancer survivors to describe health-related quality of life (HRQL) concerns in breast cancer survivors and identify those at highest risk.

OUTLINE:

Patients undergo long term follow-up and complete questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer, stage 0-IIIC
* Partial or entire treatment at City of Hope
* Must be registered before adjuvant therapy and ideally before definitive local therapy

Exclusion Criteria:

* Stage IV breast cancer
* Recurrent breast cancer
* Prior cancers, chemotherapy or radiation \* (Note: Subjects who develop locoregional or systemic recurrence while enrolled on this protocol will be withdrawn, and will continue their care with their primary oncology providers only)
Sonication of Explanted Breast Implants for Detection of Subclinical Infection

Objective. Capsular contracture is a frequent complication after breast implantation with unclear etiology.

Summary Background Data: Microorganisms may trigger chronic periimplant inflammation with subsequent capsular fibrosis.

Study Hypothesis: The investigators hypothesize that with sonication adherent microorganisms can be detected on removed implants .

Methods: In a prospective multicentre study all breast implants explanted are collected to be analyzed by sonication. The resulting culture results are correlated with patient, surgical and implant characteristics.

The study is performed in order to find a correlation between the degree of capsular fibrosis and presence of biofilm bacteria on the surface of the implant.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or more
* Undergoing breast implant removal for any reason at one of the participating center
* Explantation of breast implant performed between February 2006 and March 2009

Exclusion Criteria:

* Obvious contamination of the breast implant in the operating room or during transportation.
Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

The goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. The main questions it aims to answer are:

* Investigating the alterations in brain functional connectivity in patients with refractory constipation and fluoxetine-sensitive patients
* Assessing the predictive value of brain functional connectivity regarding the efficacy of fluoxetine and standard protocol treatments for constipation.

Participants will receive:

* Standard physiological and psychological assessments of constipation
* BOLD-fMRI tests
* Standard protocol and fluoxetine treatment

If there is a comparison group: Researchers will compare:

Refractory group/Fluoxetine sensitive group to see the specific brain alterations.


Eligibility Criteria:
Inclusion Criteria:

* 18≤ age ≤ 45 years old
* Right-handed
* Patients diagnosed as functional constipation according to the Rome IV criteria
* Informed consent of patients

Exclusion Criteria:

* Complicated with gastrointestinal organic disease or significant functional abnormalities (tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, abnormal colonic transit test, etc.)
* Long-term intense exercise (continuous exercise for more than 8 hours per week, such as marathon runners or triathletes)
* No history of chronic pain, no recent major trauma
* Drug abuse or tobacco dependence (half a pack or more per day)
* Combined hypothyroidism and Parkinson's disease
* Patients with confirmed mental illness or neurological disorders who take psychotropic drugs, analgesics or hormones
* History of abdominal surgery (appendectomy, hysterectomy, or cholecystectomy)
* Contraindications to functional magnetic resonance imaging (claustrophobia, metal implants)
* Pregnant or lactating women with constipation after delivery
* Patients with other benign and malignant tumors and autoimmune diseases
* Infectious diseases such as hepatitis B, hepatitis C, AIDS, etc.
* Heart disease, organ failure and other chronic diseases that require long-term medication or affect the quality of life
Impact of Braun Anastomosis on Reduction in Delayed Gastric Emptying Following Pancreaticoduodenectomy

Pylorus preserving pancreaticoduodenectomy (PPPD) has been considered as only curative treatment modality for periampullary tumor. High mortality rates after PPPD have been reduced down to 1%. However, postoperative morbidities are still reported around 10 to 20 % even in high volume centers.The delayed gastric emptying syndrome(DGE) is one of major complications after PPPD. Many randomized control studies reported that pylorus preserving method was not related to the occurence of DGE. Thus,we assumed that large amount of biliary and pancreatic juice might affect DGE.

With the aim to prove that the use of Braun anastomosis after PPPD can prevent DGE, the investigators started the recruitment of patients with a periampullary tumors to this clinical trial from february 2013 with the study hypothesis that patients with Braun anastomosis had less DGE than those who only got conventional PPPD.

The investigators have calculated the number of patients necessaries to have statistical significant differences in 60 patients with a rate DGE expected to be higher than 30%.

The study include all the patients that usually arrive to our surgery department and who are indicated to PPPD for the curative treatment of periampullary tumor.

The study is randomized, double blind where the investigators and the patients do not know if the patients are in the Braun anastomosis group or not, and prospectively analyzed. All the clinical and laboratory or radiographic finds relative to the occurrence of DGE are recorded.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with periampullary disease who have to be treated by PPPD

   * pancreatic cancer, distal bile duct cancer, duodenal cancer, and so on.
2. 20 year to 80 year-old patients
3. In terms of general performance status, the patients with more than 70% of the Karnofsky score or ECOG 0 to 1.

Exclusion Criteria:

1. Patients with unresectable or locally advanced and metastatic cancer.
2. The patient who does not want to take the operation.
3. The patient with more than 3 of ASA score.
4. Drug abusers or alcoholics.
5. Non-compliances
6. The patient who does not want to participate the clinical trials.
7. The patients who can not read or understand about informed consent form such as a mentally retarded person, the blind, illiteracy, or foreigner.
8. The patient who have previous transabdominal surgery
9. The patient who have to have resection of other organs or vessels other than standard PPPD
10. The patient who is indicated to laparoscopic PPPD
Fish Oil Supplement in Rectal Cancer

Neoadjuvant treatment with radiotherapy (RDT) and chemotherapy (CT) are the treatment of choice for rectal adenocarcinomas in stages II and III. This results currently in pathologic complete response in 10% to 30% of cases. The immune and inflammatory response is altered in these individuals and is directly related to response to therapy. Both the disease and the treatment of colorectal cancer have an impact on quality of life and nutritional status. In studies with cells and animal models the incorporation of fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) - derived from fish oil - has been shown to interfere in the process of inflammation, cell signaling and gene transcription enhancing the response to treatment. Are reported ability to restore the apoptosis of tumor cells, sensitization of tumor cells to chemotherapy, production of less pro-inflammatory cytokines and the preservation of normal energy and protein metabolism. The aim of this study is to verify if the daily consumption of 2.4 g EPA + DHA for adults in neoadjuvant therapy can promote changes on inflammatory and immunological markers of host response to tumor and if this response is altered by nutritional status. It is expected that supplementation can reflect in control of inflammatory and immune response in favor of tumor cell death contributes to pathological complete response and that it happens with preservation of nutritional status. Subjects will be randomized as to supplementation. All will be assessed in four moments during neoadjuvant therapy and immediate postoperative. Results will be presented by comparing the intervention group and control group at each moment.


Eligibility Criteria:
Inclusion Criteria:

* Candidate to neoadjuvant therapy according AC Camargo Cancer Center protocol;
* Accept consume fish oil capsules and participate in clinical, pathological and nutritional assessments by signing the consent form.

Exclusion Criteria:

* Be allergic to fish and fish products,
* It has previously undergone treatment for colorectal cancer or in presence of other concomitant cancer treatment.
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).


Eligibility Criteria:
Main Inclusion Criteria:

* COPD patients having at least one exacerbation within last year
* FEV1/FVC ratio (post-bronchodilator) ≤ 70%
* FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

* COPD exacerbation not resolved at first baseline visit
* Diagnosis of asthma and/or other relevant lung disease
Analysis of Influencing Factors and Construction of Prediction Models of Artificial Joint Replacement in China

The project intends to analyze the epidemiological characteristics, risk factors, complications and resource utilization of artificial joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The HQMS database is a mandatory electronic inpatient database system developed by the National Health Commission of the People's Republic of China. Since 2013, tertiary hospitals have been required to upload their inpatient discharge records. By 2019, the HQMS database has included more than 230 million standardized inpatient discharge records of over 1000 hospitals across all 31 provincial-level administrative regions in mainland China. Patient demographics, clinical diagnosis, procedures and operations, drug use, costs and complications were all recorded in the HQMS database. The investigators planned to include five types of arthroplasty, including knee arthroplasty, hip arthroplasty, shoulder arthroplasty, ankle arthroplasty and elbow arthroplasty. The data analysis will be conformed to the principle of confidentiality and will not reveal the privacy of those patients. The data will be only used for this research project and there is no conflict of interest. It is in line with the principles of ethics, harmlessness and fairness. This study was authorized by the HQMS Committee Board and approved by the institutional review board, with waiver of informed consent.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty in HQMS

Exclusion Criteria:

* Patients who didn't undergo knee, hip, shoulder, ankle and elbow arthroplasty
* Patients with missing demographics or medical data
Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment

In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The purpose of this clinical study was to evaluate the in vivo drug dissolution and systemic absorption of the BCS Class IIa drug ibuprofen under fed and fasted conditions by direct sampling of stomach and small intestinal luminal content. Expanding current knowledge of drug dissolution in vivo will help to establish physiologically relevant in vitro models predictive of drug dissolution.

This is an in vivo study designed to acquire human gastrointestinal (GI) physiology data from healthy subjects under fasting and fed conditions which are necessary for mechanistic absorption model development. Each subject will be asked to complete two GI tube insertion procedures. Subjects will complete this study twice under the same conditions of the GI tract, either fasting state or fed state, in order to provide intra-subject variability. A minimum of 7 days will separate each GI tube insertion procedure. The objectives of this study are, as follows: Objective #1: To acquire human GI physiology data including GI motility, pH of GI fluids, and GI fluid volume under fasting and fed conditions; Objective #2: To measure drug concentration and calculate drug dissolution in the GI tract in vivo under fasting and fed conditions; Objective #3: To monitor plasma drug concentration and evaluate pharmacokinetics of administered drug during GI tube insertion studies under fasting and fed conditions. These in vivo results will be used to validate in vitro dissolution methods and to support computational and mathematical modeling efforts, in order to develop an oral drug product optimization process that may be applied to future drugs to maximize oral drug safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18 to 55.
2. Male or female voluntarily able to give informed consent.

Exclusion Criteria:

1. Adults unable to consent for themselves or mentally incapacitated.
2. Prisoners.
3. Significant clinical illness within 3 weeks prior to Screening.
4. Use of concomitant medications within 2 weeks prior to receiving study drug, including but not limited to prescription drugs, herbal and dietary supplements, over the counter medications, and vitamins. Birth control is permitted.
5. Received an investigational drug within 60 days prior to receiving the study drug.
6. History of gastrointestinal surgery.
7. Surgery within the past 3 months.
8. History of allergy to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs).
9. History of severe allergic diseases including drug allergies, with the exception of seasonal allergies.
10. Any other factor, condition, or disease, including, but not limited to, cardiovascular, renal, hepatic, or gastrointestinal disorders that may, in the opinion of the Investigator, jeopardize the safety of the patient or impact the validity of the study results.
11. History of drug addiction or alcohol abuse within the past 12 months.
12. Pregnant or lactating females.
13. Any clinically significant abnormal lab values during Screening.
Sheba Medical Center Home Monitoring Clinic Registry

The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.


Eligibility Criteria:
Inclusion Criteria:

* Approved indication for ICD or CRTD
* Implanted with or replaced with a Biotronik Lumax device
* Patient willing and able to sign consent form
* Willing and able to attend clinic visits and follow up schedule
* Transmission of more than 80% at 3-month follow up
* Patient older than 18 years

Exclusion Criteria:

* no indication for ICD or CRTD implant
* Life expectancy shorter than 12 months
* Pregnancy
* Participation in other clinical studies
Long-Term Safety and Clinical Outcomes of Livmarli in Patients With Alagille Syndrome (LEAP)

The goal of this observational study is to evaluate the long-term safety and clinical outcomes of Livmarli prescribed to patients with Alagille Syndrome (ALGS).

Livmarli® is a novel, minimally absorbed, pharmacological treatment for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS), a rare, genetic, autosomal dominant, complex multisystem disorder characterized by the presence of cholestasis (typically presenting as jaundice in the neonatal period) due to intrahepatic bile duct paucity. Livmarli inhibits the ileal bile acid transporter (IBAT) in the terminal ileum, leading to reduced levels of bile acids, thereby improving clinical manifestations and symptoms of cholestasis. Livmarli has been developed by Mirum Pharmaceuticals and approved by the US Food and Drug Administration (FDA) for the treatment of cholestatic pruritus in patients with ALGS who are 3 months of age and older.

To be eligible for the study, participants must meet the following criteria:

* A clinically and/or genetically confirmed ALGS diagnosis
* Participant prescribed Livmarli

Eligibility Criteria:
Inclusion Criteria:

* A clinically and/or genetically confirmed ALGS diagnosis
* Participant prescribed Livmarli

Exclusion Criteria:

* Refusal to provide informed consent/assent (if required by the local IRB)
* Previously or currently on Livmarli through participation in a clinical study or expanded access program
* Participants who have previously received an SBD or LT
* Any condition or abnormalities that, in the opinion of the investigator, may interfere with the participant participating in or completing the study
* Participants who have received an investigational drug within 30 days of the first dose of Livmarli