cyrilzakka/clinical-trials huggingface dataset:
A Study of 1592U89 in HIV-Infected Adults

The purpose of this study is to see if it is safe and effective to give 1592U89 to HIV-positive adults. This study also examines the influence previous anti-HIV treatment has on the effectiveness of 1592U89.

Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

Erythropoietin, G-CSF and GM-CSF.

Patients must have:

* CD4+ cell count \< 100 cells/mm3.
* HIV-1 RNA \> 30,000 copies/ml.
* Signed, informed consent from parent or legal guardian for patient under 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Renal failure requiring dialysis.
* Hepatic failure evident by grade 3/4 hyperbilirubinemia and AST 5 times the upper limit of normal.
* Documented hypersensitivity to 1592U89.
* Serious medical conditions, such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that would compromise the safety of the patient.
* Participation in or ability to participate in an enrolling study of 1592U89.

Required:

At least 2 nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (or intolerance to one protease inhibitor and one NRTI due to trying at least 2 different regimens with at least one protease inhibitor).

Alcohol or illicit drug use that may interfere with the patient's compliance.
Virtual White Boards for Patient Satisfaction

Communication with patients on their clinical status is important in delivering care in the emergency department. During times of high volume or complex patients, there may be lapses in communicating with patients about their hospital course or plans of action. These miscommunications may be enhanced during the current COVID-19 pandemic as there is minimized in-person interaction with patients in order to conserve personal protective equipment and decrease the risk of disease transmission. This study utilizes a virtual white board to deliver updates to patients about the status of their emergency department stay.

The ultimate goal of this study is to understand the effect of delivering timely information about a patient's emergency department course of their satisfaction surrounding the emergency department stay. The experience of patients in the emergency department has been significantly altered by the COVID-19 pandemic due to decreased in-person encounters, and the use of PPE. Delivering information about their clinical course and expected hospital course is more difficult now given the emphasis on less in-person interaction. In response, the investigators have deployed in collaboration with e-ink, a virtual e-paper white board that can be remotely edited to help display pertinent hospital course information to patients in the emergency department. The investigators will conduct a randomized controlled trial to understand the effect of deploying these white boards on patient satisfaction in the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Patients in emergency department at Brigham and Women's Hospital
* Triaged to designated emergency department pods outfitted with virtual white board
* Expected emergency department stay of at least four hours
* Able to speak and read english
* Not primary psychiatric complaint

Exclusion Criteria:

* Medically ill or otherwise deemed unable to participate by the study PI and/or treating clinical team.
* Patients admitted to an inpatient bed but boarding in the emergency department over 10 hours.
* Previously participated in the study.
* Has COVID-19 risk flag or confirmed COVID-19 in electronic health record
Brain Injury Therapy of Exercise and Enriched Environment

The purpose of this study is to determine whether exercise or exercise with enrichment is beneficial in individuals who previously had a head injury. The enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk. A series of tests that measure mental function and balance will be done before and after the exercise or the exercise/enrichment program will be done to measure efficacy.

Traumatic brain injury (TBI) results in long-lasting physical and cognitive deficits. The purpose of this study is to determine whether exercise or exercise with enrichment is beneficial in individuals who previously had a head injury. The environmental enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk on 8 different cultures. Individuals will be evaluated using neuropsychological and physical tests before and after the intervention. Testing will consist of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trailmaking Test (TMT), Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Quality of Life in Brain Injury Questionnaire (QOLIBRI), 10 meter walk, and the NIH Toolbox Standing Balance Test. Initial testing will include the Disability Rating Scale to help balance groups (after random assignment) in terms of baseline ability.

In rodents, exercise or an enriched environment after TBI improve cognitive function and motor function and the combination results in even greater improvement. The mechanism of cognitive improvement from exercise or environmental enrichment relates to increases in brain derived neurotrophic factor and neurogenesis in the hippocampus. An additional possible mechanism of the positive effects of exercise or enrichment is a reduction in inflammation. Our hypothesis is that exercise or exercise with enrichment will result in better motor performance and improved cognitive ability.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury (TBI) person
* 1 to 15 year post-TBI
* Initial Glascow Coma SCale (GCS) of \< or = 12
* 18-75 years old
* able to perform standardized exercise program

Exclusion Criteria

* Inability to walk independently without assistive aids.
* Severe cardiovascular limitations limiting exercise of up to 5 metabolic equivalents.
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score \< 10 and \> 10. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
* Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion Criteria:

* Cancer
* Medicines that suppress the immune system
* Dialysis
Examining the Link Between Trace Elements and Cardiovascular Disease Risk Factors in Young Adults

Cardiovascular disease (CVD) affects millions of people in the United States; each year, more people die from CVD than from any other disease. There are many dietary and lifestyle factors that may increase the risk of developing CVD. Preliminary research has shown that the presence of certain trace elements may be associated with the development of CVD. This study will examine toenail clippings and laboratory data to evaluate the link between trace elements and CVD risk factors in young adults.

CVD is a disorder that affects the heart's ability to function normally. The most common cause of heart disease is narrowing or blockage of the coronary arteries, which supply blood to the heart. There are many risk factors for CVD, including inflammation, high blood pressure, high cholesterol, and obesity. Small quantities of trace elements, also known as micronutrients, are essential in maintaining a healthy body. Research has shown that some trace elements may be associated with the development of CVD, but more research is needed to confirm this connection. This study will examine concentrations of several trace elements in toenail samples of young adults participating in the Coronary Artery Risk Development in Young Adults (CARDIA) study. The CARDIA study is measuring changes in CVD risk factors in individuals as they age and is identifying lifestyle habits that influence those changes. The purpose of this study is to determine the link between trace elements and CVD risk factors in young adults. The results of this study may help to identify whether dietary, lifestyle, or environmental factors can be modified at a young age to prevent the development of CVD.

This study will examine laboratory and medical history data of participants who are already enrolled in the CARDIA study; there are no additional study visits specifically for this study. Toenail samples collected from participants during their Year 2 CARDIA study visit in the late 1980's will be examined to determine the presence of selenium, chromium, arsenic, and mercury. Participants' CARDIA study data will be reviewed and several CVD risk factors will be analyzed, including the thickness of heart arteries; calcium buildup within the arteries; inflammatory markers, such as high sensitivity C-reactive protein and interleukin 6; blood pressure levels; body weight; and levels of cholesterol, fat, and sugar.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the CARDIA study; this current study will be using existing CARDIA study data and will not be recruiting any new participants
A Stepwise Strategy Utilizing Buprenorphine and Methadone

The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.

The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy (STEP), where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.

For this purpose, 96 subjects at two centers (Uppsala and Stockholm) are randomized to MMT or STEP and followed for 6 months. Retention in treatment is the primary outcome. Secondary outcomes in completers are proportion urine samples free of illicit opiates on app. twice weekly sampling, and problem severity as measured by a semistructured interview, the Addiction Severity Index (ASI) at baseline and after 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Heroin dependence according to DSM IV \> 1year
* Age \> 20 years
* Acceptance of the stated treatment principles.

Exclusion Criteria:

* Severe psychiatric illness such as dementia or psychosis compromising the patient's ability to provide informed consent
* Other clinically significant psychiatric illness unless stable under treatment
* Severe medical condition such as advanced lung disease, unstable cardiovascular disease, severe liver disease
* Other clinically significant medical condition unless stable under treatment
* Treatment with anti-seizure drugs or disulfiram
* Pregnancy or intent to become pregnant within the next year
* Ongoing nursing
* Patients involuntarily discharged from a methadone or buprenorphine maintenance program within the last 3 months not eligible.
Exoskeleton for Post-Stroke Recovery of Ambulation

To determine the effect of using a robotic exoskeleton to allow walking practice after stroke, compared to usual physiotherapy care, on recovery of walking ability and secondary outcomes.

Participants admitted to inpatient stroke rehabilitation for physiotherapy services will be randomly assigned to either the Exoskeleton Program or Usual Care Program.

Individuals in the Exoskeleton Program will have their usual physiotherapy sessions replaced with the exoskeleton intervention. The exoskeleton will allow standing and walking from the first sessions in rehabilitation, as the exoskeleton provides the physical support to allow walking in full weight-bearing without being limited by therapist fatigue and lifting requirements. Individuals in the Usual Care Program will receive standard physiotherapy care, which is individualized and hands-on with their therapist to regain walking, mobility, and independent function.

Both groups will be conducted 3-5 days a week, 30-60 minutes per session until discharge (to a maximum of 8 weeks). Participants will be assessed at baseline, discharge, and 6-months after starting rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Have been admitted to a hospital unit for stroke treatment
* Stroke within last 3 months
* One-sided hemiparesis
* 19 years or older
* Requires 2-person assist to walk
* Able to communicate and follow instructions
* Prescribed to receive physiotherapy care

Exclusion Criteria:

* Stroke of non-vascular origin (e.g. tumour, infection)
* Significant musculoskeletal or other neurological condition
* Co-morbidities that would preclude activity
* Pregnant
* Unable to walk prior to stroke
* \<60 inches or \>74 inches in height
* \>220 pounds in weight
* Joint contractures or spasticity that would limit safe use of the Ekso exoskeleton
Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

The purpose of this study is to compare and determine the the efficacy of minimal stimulation and clomiphene citrate(CC) as the first-line treatment in infertile women with Polycystic Ovary Syndrome(PCOS).

All patients received 100 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. In group A (minimal stimulation), 2 vials of highly purified uFSH , 150 IU (Fostimon; IBSA, Lugano, Switzerland, 75 IU/vial) were given IM on cycle day 9. A total of 3 cycles was offered to each group.

Eligibility Criteria:
Inclusion Criteria:

* PCOS
* No other infertility factors
* No previous use of ovarian stimulation drugs

Exclusion Criteria:

* Congenital adrenal hyperplasia
* Cushing syndrome
* Androgen secreting tumors
Effect of Vitamin D on Offspring Obesity

The purpose of this study is to observe the effect of lack or excess of Vitamin D in the first, second and third trimester on child birth weight, fat content and the secretion of metabolism related hormone, and clinical follow-up their offspring obesity.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy women
* children
* Chinese

Exclusion Criteria:

-
Evaluation of Prognostic Monitoring for Young Breast Cancer Patients

The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer with completed standard treatment for young ladies will be studied.

200 patients younger than 35 with breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease specific protein complexes and pathological state of patients will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Female
* invasive breast cancer patients confirmed by postoperative pathology after surgery for breast lump
* Breast cancer-related chemotherapy and radiotherapy completed
* Young ladies with ages equal 35 or below

Exclusion Criteria:

* Male
* Aged above 35
* Breast Carcinoma in situ
* Women in pregnancy or breastfeeding
* Suffering from other malignant tumors
* Non-compliant patient
Trial of Transcranial Direct Current Stimulation (tDCS) Using Alternative Electrode Montages

Among antidepressant treatments, ECT stands as the most effective in treating acute depression. However, patient concerns with the cognitive side effects of ECT have encouraged the development of new and more focal forms of brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our current study of tDCS as a treatment for depression suggests that this technique has antidepressant effects and is safe, painless and well tolerated. However, not all patients may respond to this treatment in the way that it is currently administered and the concern of possible relapse in some patients who respond to tDCS has raised interest in finding alternative, possibly more optimal ways of administering tDCS. This study will investigate whether using alternative electrode montages can improve the antidepressant effects of tDCS in people suffering from depression.


Eligibility Criteria:
Inclusion Criteria:

1. Subject met inclusion criteria for study HREC 07305 (a sham controlled study of transcranial direct current stimulation (tDCS) as a treatment for depression).
2. Subject completed study HREC 07305.
3. Subject either did not reach remission at the end of trial (defined as MADRS score of ≤ 10) or suffered an early relapse (within a month of finishing the trial).

Exclusion Criteria:

1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); bipolar disorder; eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder current or within the past year); mental retardation.
2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
3. Inadequate response to ECT in the current episode of depression.
4. Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
5. Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
6. Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
7. Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
8. Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
Multisite Transcranial Direct Current Stimulation to Promote Hand Function Recovery After Stroke

A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond traditional stimulation which targeting only one region. It showed that the excitability following multisite HD-tDCS was more than double the increase following conventional tDCS. To consider the various lesion site of different stroke survivors. The electrode placements based on personalized lesion profiles and anatomical features can be determined using finite element modeling, with lesion profiles generated from fMRI and advanced algorithms calculating the current density to maximize the modulation effect. Combining motor network interaction and the new multisite electrode montage may further provide a potential to facilitate stroke recovery.


Eligibility Criteria:
Inclusion Criteria:

* first-ever stroke, the duration after stroke exceeds 12 months;
* mild to moderate upper extremity motor function deficit, determined by the Fugl-meyer assessment of upper extremity (FMAUE) scores between 15 and 53;
* detectable voluntary muscle sEMG signal from flexor digitorum (FD) and extensor digitorum (ED);
* scored below 3 in the Modified Ashworh Score (MAS) of FD and ED;
* sufficient cognitive function to follow the assessment and training instructions, determined by Mini Mental State Examination score of more than 21.

Exclusion Criteria:

* history of epilepsy, or any other contradictions of brain stimulation;
* severe joint contracture of elbow or shoulder, or pain induced by any other neurological, neuromuscular, and orthopedic diseases.
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening
* Screening urinary protein-to-creatinine ratio (UPCR) \>= 5 g/g from 24-hour urine collection after best supportive care for \>= 3 months prior to screening or screening UPCR \>= 4 g/g after best supportive care for \>= 6 months prior to screening
* eGFR \>= 40 mL/min/1.73m\^2 or qualified endogenous creatinine clearance \>= 40 mL/min/1.73m\^2 based on 24-hour urine collection during screening
* Other inclusion criteria may apply

Exclusion Criteria:

* Participants with a secondary cause of MN
* Pregnancy or breastfeeding
* Evidence of \>= 50% reduction in proteinuria during the previous 6 months prior to randomization
* Severe renal impairment, including the need for dialysis or renal replacement therapy
* Type 1 or 2 diabetes mellitus
* Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to or during screening; or cyclophosphamide, tacrolimus, or cyclosporin less than 6 months prior to or during screening
* Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude participant participation
* Known active infection of any kind or recent major episode of infection
* Major surgery requiring hospitalization within the 4 weeks prior to screening
* Current active alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening
* Intolerance or contraindication to study therapies
* Other exclusion criteria may apply