cyrilzakka/clinical-trials huggingface dataset:
Home BP Monitoring

Most cases of high blood pressure in teens are missed for a number of reasons. One reason is that the most common way to make a diagnosis is to make three or more blood pressure measurements in a doctor's office on separate days. This can be inconvenient. Also, measuring blood pressure in the office might be inaccurate, since children (including teens) might have high values in the office but normal values at home. For these reasons, investigators wish to study a different way to identify teens with high blood pressure. Home BP measurements have been used in Europe to make a diagnosis, but not yet in the United States, and never in a higher risk population of teens. African American teens are at higher risk for high blood pressure than other teens. Investigators will compare the values received from the home BP machines to another method (24 hour ambulatory BP monitoring or ABPM) which is the best standard for diagnosis. Investigators also want to learn more about participants experience and their child's experience with both methods. A small sample of participating teens and parents will be invited to participate in short telephone interviews. This study plans to enroll a total of 750 teens at UH. Recruitment will not take place from other organizations.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify or identified by a parent as African-American or of partly African American ancestry

Exclusion Criteria:

* Prior hypertension diagnosis
* Prescribed BP medication
* History of congenital heart disease
* History of solid organ transplant
* Prescribed and using stimulants and other medications on a regular basis known to raise blood pressure such as testosterone and nicotine replacement
Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study

Cervical and upper thoracic esophageal cancer (ESCA) presents treatment challenges due to limited clinical evidence. This multi-center study (ChC\&UES) explores radical radio(chemo)therapy efficacy and safety

Cervical and upper thoracic esophageal cancer (ESCA) are relatively rare diseases, presenting treatment challenges due to limited clinical evidence. This multi-center study (ChC\&UES) explores radical radiotherapy efficacy and safety, especially focusing on radiation dose. This study collected all eligible patients diagnosed with cervical and upper thoracic ESCA from 6 medical centers (Tianjin Cancer Hospital, Cancer Hospital of the Chinese Academy of Medical Sciences, Fujian Cancer Hospital, Fudan University Shanghai Cancer Center, Shandong Cancer Hospital and the Fourth Hospital of Hebei Medical University) in China. Patients were categoried into two group (low dose radiation group and high dose radiation group) based on radiation dose. Basic clinical information, including age, gender, ECOG score, pathological type, smoking and drinking history, initial visit date, radiotherapy dose, radiotherapy method, concurrent chemotherapy modality, immunotherapy, targeted drug usage, treatment efficacy assessment, toxicity and side effects and survival time was collected. Kaplan-Meier method was used to calculate OS, survival differences were assessed using the log-rank test. Univariate analysis was conducted via Cox regression modeling, with variables demonstrating P values \< 0.1 being included in multivariate analysis. A significance level of two-sided P \< 0.05 was considered statistically significant. The aim of this study was to compared the overall survival time between low dose radiation group and high dose radiation dose group and compared the underlying side effects.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older.
2. Confirmation of esophageal cancer through histopathology or cytology.
3. Primary tumor location within the cervical or upper thoracic segment, extending from the upper esophageal sphincter to the azygos vein.
4. Absence of distant metastasis.
5. Patients unable or unwilling to undergo surgical treatment for various reasons.
6. Receipt of radical radiotherapy as the first-line treatment, with or without chemotherapy, immunotherapy, or targeted therapy.
7. Undergoing conventional radiation therapy (1.8-2.0Gy per session, once per day).
8. Receiving 3DCRT or IMRT radiotherapy.
9. Availability of complete radiotherapy prescription dose information and follow-up records.

Exclusion Criteria:

1. Receipt of radiation dose below 50Gy.
2. History of other malignancies (except for cured cancer in situ and malignancies cured for over 5 years) or laryngeal invasion.
3. Diagnosis of double primary esophageal cancer.
4. Prior chest radiation therapy within the past 5 years.
5. Recurrent or metastatic esophageal cancer.
6. Receipt of 2D radiotherapy, large fractionation, or hyper-fractionation radiotherapy.
7. Patients with incomplete radiotherapy dose and follow-up data.
Knowledge and Perceptions Regarding JSSK and RBSK in Patients and Nurses: A Comparative Study

Observational, cross sectional study, carried out with the help of a pre-designed and pre-tested questionnaire with the research hypothesis as: Knowledge and perception regarding JSSK and RBSK in nursing students is better as compared to in-service nurses as well as patients/patient attendants (attending LHMC and associated hospitals, New Delhi, India)

The objectives of the study were to:

1. To study knowledge and perceptions regarding JSSK and RBSK programs in the patients/patient attendants, nursing students and in-service nurses attending LHMC and associated hospitals.
2. To compare knowledge and perceptions regarding JSSK and RBSK programs in the patients/patient attendants, nursing students and in-service nurses attending LHMC and associated hospitals.
3. To identify factors contributing to knowledge regarding JSSK and RBSK programs in the patients/patient attendants, nursing students and in-service nurses attending LHMC and associated hospitals.

Eligibility Criteria:
Inclusion Criteria:

Group 1) Patients/Attendants:

* All study subjects must be female.
* Age more than 18 years.
* Written informed consent to participate in the study.

Group 2) Nursing Student:

* Students / intern at College of nursing LHMC pursuing Bsc Nursing
* Written informed consent to participate in the study

Group 3) In-service Nurses:

* Posted in Department of Paediatrics indoor/OPD/well-baby clinics/immunisation clinics or Department of Gynaecology and Obstetrics indoor/OPD/emergency/Ante-natal clinics/Post-natal clinics of Lady Hardinge Medical College and associated hospitals.
* Written informed consent to participate in the study

Exclusion Criteria:

* Males for the patient/attendant group 1
The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3

The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system.

IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.

IL-2, administered subcutaneously in combination with antiretrovirals, has resulted in increased CD4+ cell counts which may retard HIV disease progression. Using a smaller patient sampling, this Phase II study helps develop the clinical experience needed to consider formation of a larger, more complete Phase III trial.

Seventy-two HIV-infected patients (previously treated or naive) are randomized independently to receive either control therapy with antiretrovirals alone OR escalating doses of subcutaneous interleukin-2 (IL-2) plus antiretrovirals. In the absence of dose-limiting toxicity (DLT) in at least 9 of 12 patients in Group 1, 12 additional patients are entered into Group 2 and treated as indicated. In the absence of DLT in 9 of 12 patients in Group 2, the final 12 patients are entered into Group 3. Those patients enrolled in either of the first 2 dose groups who complete 3 courses of therapy have their dose escalated to a maximum dose. A course of treatment is defined as 5 days of IL-2 plus antiretrovirals followed by 7 weeks of antiretroviral therapy alone.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a CD4 cell count greater than or equal to 300 cells/mm3.
* Have no AIDS-defining illnesses.
* Are at least 18 years old.
* Have been on antiretroviral therapy for at least 7 days prior to study entry.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study.
* Have a history of the following: cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system abnormality, or an autoimmune/inflammatory disease.
* Are pregnant or breast-feeding.
* Have ever received IL-2.
Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)

The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena. The study drugs tested are tested against placebo ("dummy medication not containing any active drug"). Treatment period is followed by a one-month period when study drugs are not taken but Mirena use is continued.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Healthy female subjects requesting contraception
* Age: 18 - 45 years inclusive
* Successful interval insertion of MIRENA
* History of regular cyclic menstrual periods
* Normal or clinically insignificant cervical smear not requiring further follow up

Exclusion Criteria:

* Pregnancy or lactation
* Climacteric symptoms prior to the screening visit
* Known or suspected clinically significant ovarian cysts, endometrial polyps, fibroids, or other genital organ pathology, that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study
* Undiagnosed abnormal genital bleeding
* Current or history of thrombembolic disease, or established risk factors for venous thromboembolism
* Current migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, or exceptionally severe headaches
* Hypersensitivity to any ingredient of the investigational medicinal products or the non-investigational medicinal product
* Daily or frequent use of a nonsteroidal anti-inflammatory drug (NSAIDs) for any condition
* Not willing to use nonsteroidal anti-inflammatory drug (NSAIDs) medication as pain medication during the double blind treatment period
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.

This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male and non-pregnant or nursing female patients \>=18 years of age;
* body weight \<=150kg;
* moderate to severe active RA (DAS28 \>=3.2) of \>=6 months duration;
* on \>=1 non-biologic DMARDs at a stable dose for a period of \>= 8 weeks prior to start of treatment;
* inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
* if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.

Exclusion Criteria:

* major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
* rheumatic autoimmune disease other than RA;
* prior history of, or current inflammatory joint disease other than RA;
* functional class IV as defined by the ACR Classification of Functional Status in RA.
Clinical Features and Visual Prognosis of Infectious Endophthalmitis

The aim of this observational study was to retrospectively examine the clinical data of patients with infectious endophthalmitis and to analyse their clinical characteristics.

The main question it aims to answer is: to find the differences between endogenous and exogenous endophthalmitis and to provide new ideas for the diagnosis and treatment of infectious endophthalmitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with infectious endophthalmitis by specialist examination. The clinical diagnosis of endophthalmitis was established on the basis of clinical signs and symptoms, including ocular pain, loss of vision, eyelid oedema, conjunctival congestion, inflammation of the anterior chamber (flare-ups, cells, pupillary fibrin membranes, and pus accumulation in the anterior chamber), vitritis, and vitreous clouding on B-scan ultrasound. The diagnosis of infectious endophthalmitis was clarified by the aqueous vitreous pathogen detection test.

Exclusion Criteria:

* Patients with incomplete medical records; non-infectious uveitis, retinal tumour disease, ocular ischaemia syndrome and other diseases with similar manifestations to endophthalmitis.
The Neuroprotective Effects of RPC on the Neurosurgery

The current study is designed to clarify the neuroprotective effect of remote ischemic precondtioning on the patients underwent neurosurgery.

BACKGROUND: Brain ischemia and injury are commonly contributed to perioperative morbidity and mortality after neurosurgery. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective neurosurgery, a randomized trial will be performed in current study.

DESIGNING Thirty patients undergoing craniotomy for supratentorial meningioma will be randomize assigned to neurosurgery with RIPC or conventional neurosurgery (control). Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated. Cerebral injury was assessed by S-100b, NSE, and neurological function scores in different time points.

EXPECTED RESULTS RIPC will reduce the incidence of cerebral injury.

CONCLUSIONS:

In patients undergoing elective craniotomy for supratentorial meningioma, RIPC reduces the incidence of postoperative cerebral injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for primary elective neurosurgery were invited to participate in the study at the time of scheduling for operation

Exclusion Criteria:

* Potential participants were excluded if they were \>70 years of age
* Required concomitant procedures other than neurosurgery
* Had experienced an acute coronary syndrome or myocardial infraction within 3 months
* Were unable to give informed consent
* Were taking sulfonylurea oral hypoglycemic agents or nicorandil drug therapy because these agents have been shown to effect preconditioning.
Resistance Exercise and Cognition in People With Type 1 Diabetes

The aim of the current study is to determine the effects of resistance exercise on performance of the Paced Auditory Serial Addition Test and the Colour Trails Test.


Eligibility Criteria:
Inclusion Criteria:

* Physician confirmed type 1 diabetes for at least 1 year
* Stable insulin therapy for 3 months prior to the study

Exclusion Criteria:

* BMI of 45 or higher
* BP of 160/100mmHg or higher
* autonomic neuropathy
* severe proliferative retinopathy
* joint or limb injuries preventing weight-bearing activity
* autonomic neuropathy
* severe proliferative retinopathy
* any other medical condition that prevents participants from exercising safely.
Reducing Suicide Risk Associated With Weight Loss

The purpose of this study is to examine the efficacy of an intervention aimed at promoting a healthy lifestyle and reducing risk factors associated with eating pathology, nonsuicidal self-injury, and suicidal behavior. We are also interested in assessing whether this intervention has the potential to prevent future symptoms of eating problems and self-harm urges and behaviors. The broader goal of this research is to identify factors that may help us better understand the prevention of self-harm behaviors and develop more effective treatments for these problems.

The current study was designed as a proof-of-concept study to test the association between weight suppression (WS; difference between one's highest and lowest weight) and non-suicidal self-injury (NSSI). Previous research has found an association between current WS and lifetime NSSI and that this association was mediated by depressive symptoms and drive for thinness. The current study therefore modified an existing online cognitive dissonance-based program (the e-Body Project) using mixed gender content (from the Body Project 4 All scripts) to target posited mediators, i.e., depressive symptoms and weight and shape concerns, in a sample of individuals with WS and engagement in current NSSI.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old
* At least 5 pounds weight suppression
* Engaged in non-suicidal self-injury at least once in past month

Exclusion Criteria:

* Indicated being "sure" of suicide attempt on eligibility screener
* Live outside of the United States
* Currently pregnant
Brief Hospitalization for Schizophrenia: Strategies to Improve Treatment Outcome

The goal of this research program is to implement a series of psychoeducational training classes designed to teach individuals with schizophrenia the importance of medication treatment, how to identify and manage medication side effects, and how to make appointments and emergency plans. The skills taught to the research subjects will lead to demonstrable increases (compared to the control group) in adherence to both the prescribed medication regimen and scheduled outpatient appointments and thereby cause a decrease (again compared to the control group) in rehospitalization rates and bed-days during subsequent twelve months following the intervention. A secondary objective of this work is that if the CREP program is successful and/or illness education is effective, the data will be able to disseminated throughout the VISN 22 via the recently awarded Mental Illness Research Education and Clinical Center (MIRECC) program.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years of age.
2. DSM IV diagnosis of schizophrenia or schizoaffective disorder.
3. Competent to give informed consent.
4. Previously participated in "Brief Hospitalization for Schizophrenia: Strategies to Improve Treatment Outcome" Principal Investigator. Donna Wirshing, M.D.

Exclusion Criteria:

1. Physical or cognitive impairment of such severity as to adversely affect the validity of clinical ratings or impair capacity to give informed consent.
2. History of substantial substance dependence 6 months prior to the study.
3. Patients at high risk of suicide or other directed violence.
The Safety and Tolerability of LBS-007 in Patients with Relapsed or Resistant Acute Leukaemias

The most common types of acute leukaemia are acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). AML is a heterogenous clonal disorder of haemopoietic progenitor cells and the most common and severe malignant leukemia in adults and is responsible for the highest mortality from leukemia. ALL is a neoplasm characterized by the growth of malignant lymphoblasts of the B or T lineage, leading to an inhibition of proliferation of the normal blood cell lineages.

The primary objectives of this study are investigating the safety, tolerability, and the MTD of LBS-007. The secondary objectives are to assess the efficacy and to determine the pharmacokinetics (PK) of LBS-007. The exploratory objective is to study and correlate the changes in surrogate biomarkers in response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects greater than 18 years old, inclusive.
* Pathologically confirmed diagnoses of Relapsed or resistant AML or ALL.
* Patients who are ineligible for standard therapies that are anticipated to result in durable remission or cure, or who have no known therapy options of documented benefit.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

* Concomitant chemotherapy, radiation therapy, or immunotherapy.
* Receiving any other investigational agents concurrently or within 30 days prior to screening.
* Patient has acute promyelocytic leukaemia or leukemia with active CNS involvement.
* History of another active malignancy with 2 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively.
* Patient with mental deficits and/or psychiatric history
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 1 Diabetes mellitus (T1DM)
* Central laboratory C-peptide \< 0.7 ng/ml (0.23 nmol/L)
* Insulin use for at least 12 months per patient reported or medical records
* Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening
* Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to screening
* If on MDI insulin administration, subject must be on ≥ 3x injections per day
* Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%
* Body mass index (BMI) ≥ 18.5 kg/m2

Exclusion Criteria:

* History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity
* Taking any non-insulin antihyperglicemic agent within 1 month prior to screening
* Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration
* Taking metformin and/or thiazolidinediones within 2 months prior to screening
* History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening
* History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening
* Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening
* History of Addison's disease