cyrilzakka/clinical-trials huggingface dataset:
Pilot Atrial Fibrillation Information Technology Trial

AF is associated with significant social and medical costs, including diminished quality of life (QOL) and increased health care utilization (HCU). This pilot study will enroll 200 adults with prevalent, non-valvular AF of ≤3 year's duration at University of Pittsburgh Medical Center (UPMC). The primary objective at present is to obtain extensive feasibility and pilot data in implementing the Embodied Conversational Agent (ECA) in concert with the Kardia (KAC) heart rhythm monitor.

This pilot study is a single-center, two-arm randomized study that by design is unblinded. 200 total participants are planned. Each participant will be randomized in an unblocked manner to receive "usual care" or the ECA/KAC intervention. Participants will have study visits at baseline and time 30 days. Adherence to using the ECA/KAC in combination over 30 days will be quantified. Following participation study participants randomized to the ECA/KAC intervention will undergo an interview to determine their experience with the ECA/KAC. Participants and their physicians will receive a summary of ECA use and symptoms and correlated findings by KAC.

Eligibility Criteria:
Inclusion Criteria:

* CHADS2-VASc score ≥2; English-speaking (at level appropriate to provide informed consent and participate in this research protocol); no plan to relocate from the area within 12 months of enrollment

Exclusion Criteria:

* AF that is due to non-cardiac causes (e.g., sepsis, pneumonia, thyroid disorders, and intoxication); AF within 30 days of any cardiothoracic or thoracic surgery; Inability to complete training session with the smartphone and demonstrate use of the ECA; Inability to answer specific protocol-based questions correctly during consent.
Polymorphisms of Interleukins, Glypican, and Human Leukocyte Antigen Genes and Treatment Response in Multiple Sclerosis.

HLA-DRB1 \* Gene and some genes involved in inflammation and immunity (IL-7R, GPC5, CTSS) have been linked to risk of MS and the response to treatment with immunomodulators. This research aims to estimate the risk that confers some variations in the sequence of these genes.

Genes HLA-DRB1 \* and some genes involved in inflammation and immunity have been linked to risk of MS and the response to treatment with immunomodulators.

The HLA-DRB1 \* genes have been associated with risk and response to treatment in MS in multiple studies; however, other genes have been controversial. This research aims to estimate the risk for MS that confers some variations in the sequence of IL-7R, GPC5, CTSS, HLA-DRB1 genes. Furthermore, it seeks to determine whether these gene variants (polymorphisms) are associated with treatment response to immunomodulators.

Subjects with MS and healthy subjects will be taken to assess the risk for MS. Besides the investigators obtain the medical history of relapse to assess response to treatment in accordance with Expanded Disability Status Scale (EDSS) and relapses.

Eligibility Criteria:
Inclusion Criteria for Cases:

* Subjects with multiple sclerosis
* 18 and over
* EDSS less than 5
* Signed informed consent

Inclusion Criteria for Controls:

* Healthy subjects
* 18 and over
* Signed informed consent

Exclusion Criteria for Cases:

* Mental retardation
* Withdrawal of consent
* No immunomodulatory treatment

Exclusion Criteria for Controls:

* Mental retardation
* Withdrawal of consent
Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis.

Polycythemia vera (PV), a hematological neoplasm characterized by excessive erythropoiesis due to Janus kinase 2 (JAK2)- activating mutations. On the other hand, patients with secondary polycythemia (SP), a disorder mostly caused by an increased red cell mass due to chronic hypoxia (i.e, pulmonary disorders and smoking) and erythropoietin-producing tumors (such as leiomyoma, hemangiomas, renal cysts and various carcinomas), are phenotypically slightly different and are usually considered to have significantly better outcomes.

Red blood cell distribution width (RDW) reflects the heterogeneity of red blood cell sizes (anisocytosis) and is routinely reported as a part of complete blood count by automated instruments in hematology laboratories.

We will collect data about clinical manifestations at the time of diagnosis, history of thrombosis and investigations as complete blood picture, including Hematocrit and haemoglobin level, serum uric acid, JAK2V617F mutation status by real time PCR (Polymerase Chain Reaction), bone marrow aspiration and biopsy with reticulin stain.

Patients with secondary erythrocytosis will be included as controls and will be recruited from Sohag university hospital especially internal medicine department and chest department.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years and older who were newly diagnosed to have polycythemia vera between September 2014 and November 2022 at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic.

Exclusion Criteria:

* Patients were excluded if: (1) their disease was not newly diagnosed, (2) their disease met WHO criteria for chronic, acute myeloid leukemia or other myeloid neoplasms.
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging

Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging

The aim of this study is to obtain human muscle samples for cell culturing to analyze muscle cell development in real-time to uncover factors that influence growth.

Eligibility Criteria:
-Inclusion Criteria:

* men 20-29 yrs
* BMI between 20 and 34.9
* Fasting Glucose \<110 mg/dL
* Blood Pressure \<160/100mm Hg
* Non-Diabetic
* LDL-Cholesterol \<160mg/dL
* Triacylglycerol \<400 mg/dL
* Makers of kidney, liver, and heart functions within 10% of clinical normalcy
* \<1.5hr /wk of habitual aerobic exercise training and no resistance exercise training in the past 6 months

Exclusion Criteria:

* men \<20or\>29 yrs

  * BMI between \<20 and \>34.9
  * Fasting Glucose \>110 mg/dL
  * Blood Pressure \>160/100mm Hg
  * Non-Diabetic
  * LDL-Cholesterol \>160mg/dL
  * Triacylglycerol \>400 mg/dL
  * Pre-existing kidney or liver conditions

    --\>1.5hr /wk of habitual aerobic exercise training and no resistance exercise training in the past 6 months
  * Currently taking prescribed blood thinners
A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions

The purpose of this study was to evaluate the relative bioavailability of Paddock Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets, under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening

Exclusion Criteria:

* Positive test results for HIV or Hepatitis B or C
* History of allergy or sensitivity to Moexipril, Hydrochlorothiazide or related drugs
Comparison of Chest CT Findings Related to COVID-19 With RSNA and BSTI Guidelines

To present the first admission chest computed tomography (CT) findings of patients followed up with a diagnosis of COVID-19, and to compare the two classification systems by evaluating these findings according to the BSTI and RSNA guidelines.

A total of 764 adult patients who were diagnosed with COVID-19 inpatient of researchers' hospital 2020 were included in this study. The findings were recorded as typical, indeterminate, and atypical by the RSNA guidelines and as classical COVID-19, possible COVID-19, indeterminate, and non-COVID-19 by the BSTI classification. The data obtained according to both classification systems were compared with each other.

Eligibility Criteria:
Inclusion Criteria:

1. Who had single negative RT-PCR
2. Non-optimal chest CT , insufficient data
3. \<18 age of year
4. Thoracic trauma
5. Chest CT Negative

Exclusion Criteria:

1. RT-PCR positive and chest CT positive findings
2. At least two RT-PCR negative and chest CT positive findings
3. \>18 age of year
Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis

The primary aim of the study is to compare migration of the cemented Corail stem representing polished surfaced versions of the femoral stem. Two different methods will be used for reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be used in migration measurements.

Furthermore pain, postoperative outcome and patient satisfaction will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring cemented primary total hip replacement.
* Patients with a diagnosis of osteoarthritis, avascular necrosis or post-traumatic arthritis
* Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
* Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery

Exclusion Criteria:

* Patients who require revision of a previously implanted total hip replacement (THR)
* Patients who will receive a THR without cement
* Patients who have had a prior procedure of osteotomy on the femur
* Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI \>35)
* Patients with active or suspected infection
* Patients with malignancy
A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis

This open-label study will evaluate the pharmacodynamic and pharmacokinetic profile of CM4620-IE in patients with acute pancreatitis. The first five (5) patients will receive ≤ 2.08 mg/kg of CM4620-IE by continuous IV infusion on Day 1. If necessary, up to an additional 4 patients may be treated at a different dose of CM4620-IE as determined by the obtained PK and PD data. The infusion of CM4620-IE will start within 12 hours from the time the patient or LAR provides informed consent.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis, and 1 of the following 2 criteria:

   1. Serum lipase and/or serum amylase \> 3 times the upper limit of normal (ULN);
   2. Characteristic findings of acute pancreatitis on abdominal imaging;
2. Adults ≥ 18 years of age;
3. A female patient of child-bearing potential who is sexually active with a male partner must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE;
4. A male patient who is sexually active with a female partner of childbearing potential must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE and must not donate sperm for 365 days;
5. Willing and able to, or have a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and cooperate with all aspects of the protocol.

Exclusion Criteria:

1. Any concurrent clinical condition that a study physician believes could potentially pose an unacceptable health risk to the patient while involved in the study or may limit expected survival to \< 6 months;
2. Suspected presence of cholangitis in the judgment of the treating investigator;
3. Any malignancy being treated with chemotherapy or immunotherapy;
4. Any autoimmune disease being treated with immunosuppressive medication or immunotherapy (Section 5.3 for list of prohibited medications);
5. History of:

   1. Chronic pancreatitis, pancreatic necrosectomy, or pancreatic enzyme replacement therapy;
   2. Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy;
   3. Known hepatitis B or C, or HIV;
   4. History of organ or hematologic transplant;
   5. Myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1;
6. Current renal replacement therapy;
7. Current known abuse of cocaine or methamphetamine;
8. Known to be pregnant or are nursing;
9. Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1;
10. History of allergy to eggs or known hypersensitivity to any components of CM4620-IE;
11. Prior treatment with CM4620-IE.
Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes

Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin

This study investigated the pharmacokinetic (PK) and pharmacodynamic (PD) properties of Dance-501, a novel inhaled human insulin liquid formulation (INH) and device. Twenty-four subjects with type 2 diabetes (T2DM) received 3 INH doses: low (69 units), medium (139 units) and high (208 units) and 1 equivalent medium dose (18 units) of subcutaneous insulin lispro (LIS).

The medium dose was repeated to determine within subject variability. PD was investigated during a 12 hour euglycemic clamp.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus treated with insulin injections at a total daily dose less than 1.2 U/kg/day.
* Body mass index 25-40 kg/m2
* Hemoglobin A1c 6.5-9.5%
* Forced vital capacity and forced expiratory volume in 1 second at least 75% of predicted normal values.
* Fasting c-peptide less than 1 nmol/L

Exclusion Criteria:

* Any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators or subjects who smoke.
* Active or chronic pulmonary disease.
* Any major disorder other than type 2 diabetes.
* Decompensated heart failure or myocardial infarction at any time or angina pectoris within the last 12 months.
* Proliferative retinopathy or maculopathy or severe neuropathy.
Feasibility of Delivering a Complex Behavioral Intervention for Young Adults With Diabetes Via Telehealth

Feasibility of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will evaluate the feasibility of implementing a diabetes management intervention via telehealth in preparation for a large-scale randomized controlled trial (RCT) entitled Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study.

Feasibility of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) feasibility study will evaluate the feasibility of implementing a diabetes management intervention via telehealth in preparation for a large-scale RCT.

Young adulthood is a challenging life stage for many individuals with diabetes; only 17% of YAs age 18-25 and 30% age 26-30 attain recommended A1C targets, and fewer than 1/3 perform self-care in accordance with national guidelines. Yet, it is a crucial stage for establishing health habits that persist throughout adulthood. To address these issues, our research team developed REAL Diabetes (Resilient, Empowered, Active Living with Diabetes), a 6-month individually tailored occupational therapy intervention focused on incorporating diabetes self-care into participants' daily habits and routines, and evaluated its efficacy in a pilot randomized controlled trial (n=81). REAL was shown in intention-to-treat analysis to significantly improve A1C (0.9% reduction; p=0.01) and diabetes-related quality of life (p=0.04). While REAL was highly promising in terms of its positive impact on health and quality of life, the intervention was delivered through home visits, limiting its potential for broad dissemination. Given that our target population experiences significant logistical barriers to clinic attendance (the impetus for our in-home treatment model), we therefore will adapt REAL to be delivered via telehealth (REAL-T), a highly promising care delivery model, and evaluate REAL-T in a large-scale RCT.

The current feasibility study will evaluate the feasibility of implementing the REAL-T intervention via telehealth by enrolling 10 participants who are 18-30 years of age, conducting the REAL-T intervention with all participants over a 3-month period, and assessing the process of implementing the study (feasibility and participant satisfaction).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with either type 1 diabetes or type 2 diabetes for at least 12 months
* Hemoglobin A1C \>7.5%
* Resident of Los Angeles County with no imminent plans to relocate
* Fluent in English
* Previous participant in REAL Diabetes Study

Exclusion Criteria:

* Pregnant or planning to become pregnant within the next 4 months
* Diagnosed with a comorbid cognitive or intellectual disability
A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer

Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm, multicenter, phase II study

This phase II trial will evaluate the combination of fruquintinib and gefitinib in advanced NSCLC. The endpoint will be to evaluate the efficacy and safety of the combination.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form.
* Age between 18 to 75 years old.
* Histologically or cytological documented stage IIIB/IV non-squamous non-small cell lung cancer patients who have never received systematic treatment for the late-stage disease.
* ECOG 0-1
* Patients must have measurable lesions

Exclusion Criteria:

* Prior systematic treatment for the advanced NSCLC
* Absolute neutrophil count (ANC) \< 1.5×10\^9 /L, or platelet count \< 100 ×10\^9/L, or hemoglobin \< 9 g/dL
* Total bilirubin \> 1 ULN; SGOT (AST), SGPT (ALT), \> 1.5 ULN; for patient with liver metastasis，AST or ALT \> 3 ULN
* Known HIV positive
* Hypersensitivity to either of the investigation drugs
Ovarian Hyperstimulation Syndrome Prevention

Ovarian hyperstimulation is a very hazardous complication of ICSI

Ovarian hyperstimulation could be mild , moderate , severe or marked

Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS coming for ICSI

Exclusion Criteria:

* Women who donnot have PCOS
Nimotuzumab Plus S1 Versus Placebo Plus S1 as Maintenance Treatment in Patients With Unresectable Pancreatic Cancer

Background: Monotherapy with S-1, oral fluoropyrimidine, shows non-inferiority to gemcitabine in overall survival (OS) with good tolerability for advanced pancreatic cancer in Asian patients. It is also shown that nimotuzumab plus gemcitabine could improve OS and progression free survival (PFS) in patients with unresectable pancreatic cancer. However, it is still unknown whether nimotuzumab plus S1 would improve more to OS and PFS than single S-1. Maintenance treatment, as a new treatment pattern, has also been tried in these patients after first line treatment to improve the OS. Thus, this study is designed to compare nimotuzumab plus S1 to placebo plus S1 as maintenance treatment in patients with locally advanced or metastatic pancreatic cancer who has benefited from the first-line treatment of gemcitabine combined with nimotuzumab and S1 (complete response+partial response+stable disease).

Patients and methods: 60 patients will be enrolled,and randomized in a 1:1 ratio to group nimotuzumab plus S1 and group placebo plus S1. nimotuzumab/placebo: 400 mg/w, intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks. S1: oral, 40 mg (Body surface area\<1.5 m2) or 60 mg (Body surface area\>1.5 m2), d1-d14, every three weeks for a cycle. Treatment interventions will be stopped under the conditions of disease progression or intolerable toxic reaction or participants ask to quit. The primary endpoint is the time to disease progression since randomization (TTP), secondary points include OS, 3 years overall survival rate (OSR) and safety.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years;
* Karnofsky Performance Status≥ 60;
* histologically proven locally advanced or metastatic pancreatic cancer,and unsuitable for radiotherapy or surgery resection;
* benefited from the first line treatment of gemcitabine plus nimotuzumab and S1 (complete response+partial response+stable disease);
* at least 4 weeks from the end of the first-line treatment;
* with at least 1 measurable and evaluable lesion;
* anticipated over survival≥12 weeks;
* AST/ALT≤2.5 ULN (≤5 ULN for patients with hepatic metastases); total bilirubin≤2 ULN （≤3 ULN for patients with hepatic metastases); neutrophil count≥1.5×109/L; platelet counts≥100×109/L; hemoglobin level≥90 g/L; creatinine clearance rate≥ 60 mL/min
* written informed consent

Exclusion Criteria:

* previously received the following treatments: anticancer chemotherapy/molecularly targeted therapy as palliative treatment, or targeted chemotherapy and no progression, another interventional clinical trail within 4 weeks;
* underwent major surgery within 4 weeks;
* with brain or leptomeningeal metastases;
* history of malignancy other than pancreatic cancer;
* presented symptomatic abdominal fluid and needed treatment;
* with other serious diseases such as diabetes,active infection;
* known for allergy to anti epidermal growth factor receptor antibody
Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents

Prospective study to quantify the prevalence of possible tardive dyskinesia (TD) in outpatient psychiatry practices in the United States (US), as well as to describe the associated disease burden in a cohort of patients with one or more psychiatric disorders and a cumulative lifetime exposure to antipsychotic medication of three months or more.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a cumulative lifetime exposure to antipsychotic medication of three months or more
* Patient has a clinician confirmed diagnosis of one or more psychiatric disorder(s), as defined in the DSM-5
* Patient has a usual care clinic visit scheduled during the study recruitment window (i.e. a pre-defined 2-week period)
* Patient is able to read and understand English
* Patient is willing and able to comply with the study requirements

Exclusion Criteria:

* Patient is unable to provide informed consent.