cyrilzakka/clinical-trials huggingface dataset:
The PCORnet Blood Pressure Home Monitoring Study

The PCORnet Blood Pressure Home Monitoring (BP HOME) Study is a patient-level randomized controlled trial that will compare the effectiveness of home blood pressure monitoring (HPBM) with versus without a linked Smartphone application ("app") for helping patients with uncontrolled hypertension achieve a reduction in systolic blood pressure. The trial will be conducted within the National Patient-Centered Clinical Research Network (PCORnet), which supports a research network that enables distributed querying of EHR data in a common data model. It will also use the Eureka Research Platform, an online research platform hosted by UCSF that supports eConsent, online surveys, and data collection from devices such as HBPMs. Data from these two data sources will be used together to accomplish the study aims. Given that HBPM is the guideline-recommended standard of care (without specification of Smartphone linkage), the HPBM devices and the app are all commercially available and currently in use, and that clinicians, with input from patients, will maintain full control of how BP is clinically managed, we believe participation in the project poses minimal risk to participants.

We have designed a patient-level randomized controlled trial that will compare the effectiveness of Smartphone-linked versus standard HBPM for helping patients with uncontrolled hypertension achieve a reduction in their Systolic Blood Pressure (SBP), and patient satisfaction with the device. Our original plan was to recruit 2000 patients who would be randomized in a 1:1 ratio to receive a Smartphone-linked or standard HBPM. However, to recruit higher diversity with more African Americans and LatinX patients, we extended the recruitment period.\* We will use data from the electronic health record (EHR), an online patient portal, and the home BP monitor (in the Smartphone-linked arm) to collect outcome data for a period of at least 6 months (for the primary outcome), and up to 18 months (for secondary outcomes, depending on enrollment date). The primary BP control outcome will be reduction in SBP, by clinic measurements, at 6 months. The primary patient satisfaction outcome will be the Net Promoter Score derived from self-reported likelihood of recommending the device to a friend, at 6 months.

\*edited after completing recruitment

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* At least one ambulatory visit in one of the participating study sites during the past year
* SBP \> 145 mmHg at most recent clinic visit (may be treated with BP meds already or not)
* A self-reported commitment to "work on lowering your blood pressure by 10 points or more to reduce your risk of heart attack and stroke"
* Owns a Smartphone (Android or iOS)
* Willing to receive text messages from the study
* Can read/write English well enough to use English-based Smartphone apps and fill out online surveys in English

Exclusion Criteria:

* Has an arm circumference \<22 cm or \>42 cm
* Owns a functioning HPBM and has used it in the last 3 months
Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia

The purpose of this study is to explore the safety, tolerability, and potential clinical efficacy of JNJ 40411813 in schizophrenic patients.

This is a first-in-human study of JNJ-40411813 in schizophrenic patients who are not currently receiving antipsychotic drug treatment (referred to as "(sub) acute" patients) and in patients who are currently taking antipsychotic drug treatment (referred to as "stable" patients). The study will consist of 2 parts: Part A and Part B. Part A will be open-label (patients will know the identity of study treatment), and (sub)acute schizophrenic patients will receive monotherapy (treatment with one drug) with JNJ-40411813. Part B will be double-blind (patient and study staff will not know the identity of study treatment) and will randomize (assign by chance) patients with stable but symptomatic schizophrenia to receive treatment with JNJ-40411813 or a placebo (treatment identical in appearance to JNJ-40411813 but does not contain active drug) as add-on therapy to their currently prescribed antipsychotic medication. Parts A (JNJ-40411813 monotherapy) and B (JNJ-40411813 add-on therapy) will run simultaneously. Patients will take JNJ-40411813 and placebo capsules orally (by mouth) twice daily (bid) with a meal. Part A: Patients will take JNJ-40411813 50 mg (1 capsule) bid up to 150 mg (3 capsules) bid for up to 12 weeks. Part B: Patients will take JNJ-40411813 50 mg bid or placebo bid for 4 weeks. After 4 weeks, the dose of JNJ-40411813 may be increased up to 150 mg bid for 6 weeks, and patients assigned to placebo may take JNJ-40411813 50 mg bid to 150 mg bid for up to 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive
* Medically stable on the basis of physical examination, medical history, vital signs, 12-lead ECG and clinical laboratory tests
* In- or outpatients who have been diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) at least 1 year prior to screening.

Exclusion Criteria:

* A current DSM-IV axis I diagnosis other than schizophrenia
* Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
* Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disorders), renal, hepatic, endocrine, or immunologic diseases
* PANSS score \<50 or \>120
* Other significant and/or unstable systemic illnesses
A Study of Advanced or Metastatic Non-small Cell Lung Cancer

The primary purpose of this study is to evaluate the efficacy and safety of LY2603618 in combination with pemetrexed and any side effects that might be associated with it along with determining the effects of LY2603618 in combination with pemetrexed in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Must agree to have a tumor biopsy at screening
* Must have a diagnosis of advanced or metastatic non-squamous non-small cell lung cancer that has progressed after certain prior treatment
* Must be available for the duration of the study and willing to follow the study procedures
* If participant is a woman that is capable of having children, must have a negative pregnancy test within 7 days of taking first dose of study drug
* Must have discontinued radiation therapy at least 4 weeks before entering this study

Exclusion Criteria:

* Must not have taken an unapproved drug as treatment for any indication within the last 28 days before starting study treatment.
* Must not be pregnant or lactating, are considering becoming pregnant, or are considering fathering a child. Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the participant's physician considers it safe to become pregnant or father a child.
* Must not have known positive test in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
* Must not have previously participated in a study involving LY2603618
* Must not have previously taken pemetrexed for cancer
* Must not have a known allergy to LY2603618 or pemetrexed
* Must not currently have an infection that may affect participant's ability to tolerate the therapy
* Must not have a serious medical condition or disorder that would make it unsafe for you to participate in the study such as uncontrolled diabetes or chest pain due to heart disease
* If taking certain medications called non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, must be able to stop taking these medications according to certain guidelines
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer

The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain cancer.


Eligibility Criteria:
Inclusion Criteria:

* The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging. High grade is defined by the following:

  * Uterine serous carcinoma
  * Clear cell endometrial carcinoma
  * Grade 3 endometrioid carcinoma
  * Endometrial carcinosarcoma
  * Clinical stage I grade 1-2 endometrial cancer also eligible with deep myoinvasion ≥ 50% shown on preop MRI and/or elevated preop CA-125 \> 35 U/ml.
* Age ≥18 years
* Hemoglobin ≥10 g/dL
* Plasma albumin ≥3 g/dL
* GOG performance status ≤2
* Plasma glucose ≤200 mg/dL
* Plasma creatinine ≤1.6
* Well-controlled hypertension
* Medical clearance for surgery and considered an appropriate surgical candidate
* Negative serum pregnancy test, if of child-bearing potential
* If, based on surgeon's assessment, the patient is recommended to undergo surgical staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is deemed eligible for surgical treatment of disease
* Participation in other research protocols does not exclude a patient from participation in this study

Exclusion Criteria:

* Hemoglobin \<10 g/dL
* Plasma albumin \<3 g/dL
* GOG performance status \>2
* Plasma glucose \>200 mg/dL
* Renal insufficiency with plasma creatinine \>1.6
* Uncontrolled hypertension
* Patient does not meet medical clearance for surgery and is not considered an appropriate surgical candidate
* Pregnancy

For Stage 2:

* Patient who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers of non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
* Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI
ARTIST: ARThrose Intervention STandardisée

International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving advices for these 2 points still low. This study evaluates the impact of a standardized medical intervention (patient education, weight reduction and physical exercise) in knee osteoarthritis patients.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic and ambulatory patients
* suffering from knee osteoarthritis (ACR criteria)
* 25\<BMI\<35
* signed informed consent

Exclusion Criteria:

* need to surgery within 6 next months
* co-morbidity
Metoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy

Early endoscopy is an integral part of the management plan for patients presenting with clinical signs of severe or ongoing UGIB. An accurate endoscopic diagnosis and successful endoscopic hemostasis is highly dependent on adequate visualization of the entire gastric mucosa. Metoclopramide has previously been investigated as a prokinetic agent to aid gastric emptying prior to endoscopy, but its widespread adoption is limited by a lack of high quality clinical evidence as well as concerns regarding side effects. Erythromycin is currently the only prokinetic agent recommended by the American and the European guidelines for use in selected patients in order to reduce the need for second endoscopy. Its clinical application, however, is limited by risk of arrhythmia, significant drug interactions, and frequent drug shortages. Azithromycin is structurally related to erythromycin, but is devoid of most adverse side effects associated with erythromycin use. Early evidence suggests that azithromycin may be an effective alternative to erythromycin in the treatment of gastroparesis. The current study, an interventional, randomized, triple-blinded, placebo-controlled clinical trial, is primarily aimed to evaluate the effectiveness of azithromycin as a prokinetic agent in the management of UGIB. It is also aimed to further evaluate the role of metoclopramide as a prokinetic agent in this setting. Outcome measures to be collected in this study include the need for secondary endoscopy, overall mortality, transfusion requirement, length of stay, requirement for surgery, and incidence of adverse side effects. Results from this study would help identify a safe, effective, and readily available prokinetic agent to be used prior to endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* 1. Adult patients ≥ 18 years of age at the time of presentation;
* 2. Admitted to Rhode Island Hospital (RIH) emergency room or inpatient services;
* 3. Presented with hematemesis, coffee ground emesis, or melena;
* 4. Upper endoscopy is planned within 24 hours of presentation or onset of bleeding.

Exclusion Criteria:

* 1. Known anaphylactic allergic reaction to erythromycin, azithromycin, and/or metoclopramide;
* 2. Concurrent use of certain medications associated with tardive dyskinesia (TD):
* a. Fluphenazine,
* b. Haloperidol,
* c. Loxapine,
* d. Paliperidone,
* e. Perphenazine,
* f. Pimozide,
* g. Risperidone,
* h. Thiothixene,
* i. Trifluoperazine;
* 3. Concurrent use of certain medications associated with torsade de pointes:
* a. Amiodarone,
* b. Chlorpromazine,
* c. Disopyramide,
* d. Dofetilide,
* e. Methadone,
* f. Procainamide,
* g. Quinidine,
* h. Sotalol;
* 4. Known history of TD, ventricular arrhythmias , or long QT syndrome;
* 5. Already received erythromycin and/or azithromycin within the past 10 days, or metoclopramide within the past 4 days for other indications;
* 6. Recipient of hematopoietic stem cell transplant;
* 7. History of Neisseria gonorrhoeae infection;
* 8. Pregnancy;
* 9. Prior gastrectomy.
Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum.

A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake and unsedated and ask for their feedback. Images will be taken using the OFDI system while the capsule travels from the esophagus into the stomach and into the duodenum.

Subjects including healthy volunteers as well as patients with Celiac disease will be recruited and asked to swallow the OFDI capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus, through the stomach and into the duodenum using natural propulsive force called peristalsis.

As the capsule progresses, multiple 2-dimensional cross sectional images of the duodenum are acquired. Images are analyzed at a later stage.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be over 18 years for healthy volunteers
* Subjects must be over 16 years for patients with Celiac disease
* Subject must be able to give informed consent

Exclusion Criteria:

* Subjects with an inability to swallow pills or capsules.
* Subjects with esophageal or intestinal fistulas.
* Subjects with known esophageal or intestinal strictures resulting in a luminal diameter smaller than the diameter of the capsule.
* Subjects with a history of intestinal Crohn's disease.
* Women who are pregnant.
A Trial to Reduce Referred Pain in the Shoulder Following a Laparoscopic Gynecological Surgery

Patients undergoing laparoscopic surgery suffer in 30-85% of cases of referred pain in the shoulder in the first days following their intervention. Pain can be disabling and may even delay the discharge of patients. Several techniques have been proposed to reduce this problem. Promising strategies include the reduction of CO2 insufflation flow, lung recruitment maneuvers and active aspiration of intraperitoneal air at the end of surgical procedure to force gas discharge. The investigators wish to perform a randomized controlled trial with 160 women, who will assess the effect of a combined approach, combining for the first time lung recruitment maneuvers and aspiration of pneumoperitoneum in the Trendelenburg position at the end of surgery and flow of insufflation reduces carbon dioxide (CO2) forming the pneumoperitoneum during surgery, on the intensity of shoulder pain postoperatively. In the control group the evacuation of the pneumoperitoneum will be done by opening the trocars and external abdominal pressure at the end of surgery. No study to our knowledge has tested the active aspiration maneuvers gas after laparoscopic surgery in gynecology. The study will be preceded by a pilot study in 15 participants, who will be assigned to the control group to determine the basic rate of referred pain in the shoulder in our people and improve test management.


Eligibility Criteria:
Inclusion Criteria:

* women, 18-65 years
* physical ASA score 1-2
* Elective laparoscopic surgery for benign cause
* patients who have been informed of the study and has agreed to sign the ICF

Exclusion Criteria:

* physical ASA score 3-4
* pregnant women
* chronic pain syndrome or preoperative pain syndrome
* narcotics consumption, chronic preoperative analgesia
* alcohol or drug dependence
* inability to provide telephone follow up at 48 hours
* laparoscopy not possible at the umbilical level.
Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients

This study is intended to be a multicenter, prospective, non-randomized, controlled real-world study. Patients receiving L-carnitine injection were included in the experimental group and the control group according to whether they received L-carnitine injection. Patients receiving L-carnitine injection were included in the experimental group, and those receiving L-carnitine injection were included in the control group.To observe the effects of L-carnitine on cardiac function in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Maintenance hemodialysis patients;
* 18 years\<80 years;
* Have clear consciousness and independent behavior ability;
* Before dialysis, the total carnitine concentration was less than 40 umol/L, or the free carnitine concentration was less than 35 umol/L.

Exclusion Criteria:

* Acute cardiovascular and cerebrovascular diseases occurred within 1 month;
* Infectious diseases occurred within 1 month; Treatment with glucocorticoid or immunosuppressant;
* Patients who have used L-carnitine within 2 weeks.
* Hematological system tumor or tumor;
Collaborative Care for Depression and Diabetic Retinopathy in African Americans

In this feasibility/pilot study, we will develop, refine, and evaluate the feasibility of a novel mental health/ophthalmologic intervention called, "Collaborative Care for Depression and Diabetic Retinopathy" (CC-DDR), which aims to treat depression and lower HbA1C in older African Americans with mild-to-moderate diabetic retinopathy (DR) and comorbid depression.

The Specific Aims are:

1. To develop the CC-DDR treatment protocol. This will involve:

   1. Creating an initial version of the CC-DDR treatment protocol.
   2. Refining the protocol based on input from an expert panel with expertise in DR, depression, and culturally relevant interventions for diabetes in older African Americans.
   3. Developing a tool to assess interventionist treatment adherence and competence.
2. To conduct an open trial of CC-DDR with 40 participants who have poorly controlled diabetes, depression, and mild or moderate DR. During this open trial we will:

   1. Evaluate the feasibility of CC-DDR.
   2. Refine the CC-DDR treatment protocol by incorporating feedback from participants, community health care workers (CHWs), ophthalmologists, and the expert panel.
   3. Refine procedures for recruitment and retention, outcome assessment, monitoring treatment fidelity, CHW training and supervision, quality assurance, and study administration, based on input from investigators, CHWs, participants, and the expert panel.
   4. Examine CC-DDR's impact on depression severity; diabetes self-management practices; HbA1C level; blood pressure; adherence to the ophthalmologist treatment plan; vision function; quality of life; and satisfaction with CC-DDR.
3. To complete a Manual of Procedures that characterizes all aspects of the planned efficacy trial of CC-DDR.

Eligibility Criteria:
Inclusion Criteria:

1. African-American race
2. age ≥ 65 years
3. type 2 diabetes
4. mild or moderate nonproliferative DR with or without macular edema
5. depressive symptoms (i.e., Patient Health Questionnaire-9 score ≥5)
6. HbA1C ≥ 7.0%

Exclusion Criteria:

1. treated proliferative DR
2. global cognitive impairment (i.e., Mini Mental Status score ≤ 20)
3. psychiatric diagnosis other than depression
4. treatment for depression started in the previous 3 months
5. life expectancy under 2 years
Psychoeducatıon Interventıon Postpartum Depressıon Breastfeedıng

This study was planned to evaluate the effects of psychoeducation intervention for postpartum care on postpartum depression and breastfeeding.

The pregnant women included in the sample were informed about the study and their written informed consent was obtained. Six interviews were conducted with the pregnant women, four at one-week intervals before birth, and one on the tenth day and sixth week after birth. These interviews were conducted with the women one-on-one and face-to-face.Women in the control group were not given any treatment other than routine care at family health centers. The psychoeducation program was applied to the women in the intervention group in six interviews.

Eligibility Criteria:
Inclusion Criteria:

* 20-34. Women who are at the gestational age,
* over 18 years of age,
* planning to breastfeed,
* have no visual,
* hearing or mental disabilities,
* have a healthy fetus on ultrasonography

Exclusion Criteria:

* Women with depression and other mental illnesses diagnosed by a physician,
* those taking medication related to their mental illness,
* those who gave birth prematurely,
* those with contraindications to breastfeeding and newborns (head and spine anomalies such as anencephaly/spina bifida, having a fetus with brain anomalies such as hydrocephalus/microcephaly, active substance use or HIV diagnosis, etc.),
* those who were included in the study in the 3rd trimester but whose birth weight was less than 2500 grams,
* those whose babies were taken to the neonatal intensive care unit due to any postpartum complications and those who had premature babies (born before 37 weeks of gestation),
* those who did not participate in more than one interview