cyrilzakka/clinical-trials huggingface dataset:
Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART

The purpose of this study is to evaluate the safety and tolerability of repeat doses of T-cell immunotherapy (SB-728mR-T) following cyclophosphamide conditioning.

CCR5 is a major co-receptor for HIV entry into T-cells. Disruption of CCR5 by zinc finger nuclease (SB-728mR), blocks HIV entry into the T-cells, therefore, protects the T-cells from HIV infection. Safety (primary outcome) and anti-viral effect (secondary outcome) of zinc finger nuclease-mediated CCR5 disrupted autologous T-cells (SB-728mR-T) will be evaluated in the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older with documented HIV diagnosis.
* Must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption.
* Initiated HAART therapy within (≤) 1 year of HIV diagnosis or suspected infection.
* Undetectable HIV-1 RNA for at least 2 months prior to screening and at screening.
* CD4+ T-cell count ≥500 cells/µL.
* Absolute neutrophil count (ANC) ≥ 2500/mm3.
* Platelet count ≥ 200,000/mm3.

Exclusion Criteria:

* Acute or chronic hepatitis B or hepatitis C infection.
* Active or recent (in prior 6 months) AIDS defining complication.
* Any cancer or malignancy within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin or low grade (0 or 1) anal or cervical dysplasia.
* Current diagnosis of NYHA grade 3 or 4 CHF, uncontrolled angina or uncontrolled arrhythmias.
* History or any features on physical examination indicative of a bleeding diathesis.
* Received HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector.
* Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents within 30 days prior to screening.
* Use of Aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2 week period prior to leukapheresis.
* Currently participating in another clinical trial or participation in such a trial within 30 days prior to screening visit.
* Currently taking maraviroc or have received maraviroc within 6 months prior to screening.
A Study of the Safety, Tolerability and Effectiveness of Hydroxychloroquine and Itraconazole in Platinum-resistant Epithelial Ovarian Cancer

This is a phase I/II study to find the highest dose of hydroxychloroquine that can be given safely with itraconazole in patients with advanced platinum-resistant epithelial ovarian cancer. The study will also determine the safety, tolerability, and initially determine whether the combination is useful in the treatment of patients with advanced platinum-resistant epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Histologically or cytologically confirmed epithelial ovarian cancer.
* Platinum-resistant or refractory disease defined as a radiological or clinical progression less than six months after having finished platinum-based chemotherapy.
* ECOG performance status equal to or less than 1.
* Have clinically or radiographically documented measurable disease.
* All systemic therapy must have been completed 4 weeks or greater prior to enrollment with radiologic evidence of radiological disease progression.
* Life expectancy should be more than 3 months.
* Receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible.
* Acceptable laboratory requirements within 7 days prior to enrollment
* Treated and asymptomatic brain metastases are eligible. Patients that received palliative radiation (for brain metastases) are eligible if they have been asymptomatic for at least 2 weeks with use of maintenance steroid therapy, and last received radiation at least 4 weeks prior to start of therapy.
* Have the ability to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Have not recovered (grade 1 or less) from adverse events related to previous treatments are excluded with the exception of alopecia and lymphopenia. Peripheral sensory neuropathy must be at grade 2 or less.
* Have any other prior malignancy from which the patient has been disease free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site or any other cancer.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole or hydroxychloroquine.
* Known G6PD deficiency due to the risk of hemolytic anemia with the use of hydroxychloroquine.
* Known retinopathy due to the risk of worsening retinopathy with hydroxychloroquine.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic or asymptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Chronic Hepatitis B or hepatitis C infections should be excluded because of potential effects on hepatic function and/ or drug interactions.
* Human Immunodeficiency Virus (HIV) infection.
* Already have a clinical indication for treatment with itraconazole (e.g. chronic candidiasis or other fungal infection) or hydroxychloroquine (e.g. lupus).
Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain

The purpose of this study is to evaluate the feasibility, acceptability and credibility of a mindfulness-based dance/movement therapy (M-DMT) protocol that is delivered online; to assess and improve methodological procedures for conducting a randomized controlled trial (RCT) test of M-DMT; and to demonstrate proof of principle by gathering information about the process of change between M-DMT and a control condition.

This is the first study to address the potential of M-DMT as a creative, non-opioid intervention for chronic back pain. Therefore, the findings of this study will provide important methodological and protocol data and substantive pilot data necessary for the next phase of this line of research, namely a fully powered RCT to evaluate efficacy and treatment mechanisms of action. Data obtained as part of this study will be instrumental for informing the systematic evaluation of M-DMT for chronic back pain care.


Eligibility Criteria:
Inclusion Criteria

* age \> 18 years
* current non-specific cLBP that has persisted at least 3 months, and has resulted in pain on at least half the day in the past 6 months
* proficient in English
* average pain severity and interference ratings \>3/10 on a 0-10 numeric rating scale
* if taking pain medication(s), dosage must be stabilized for a minimum of 3 months
* patients agree not to seek additional therapies for the duration of this study beyond those already included in their current treatment regimen or new treatments prescribed by their physician
* naïve to DMT.
* those who have adequate computer literacy (e.g., know how to use a computer to perform basic tasks such as open/send emails, use internet, fill-out online surveys) and access to the virtual delivery format (i.e., internet service and a personal computer device such as laptop, desktop, tablet PC).

Exclusion Criteria:

* pregnancy
* severe and/or progressive medical, neurological, substance dependence within the last 6 months or severe mental illness (i.e., psychosis, mania) that would prevent active participation
* cognitive impairment that prohibits informed consent
* back surgery in the last 6 months
* low back pain attributable to a recognizable, known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome
* wheelchair-bound or unable to move without assistance
* involvement in impending litigation or judgment for disability or worker's compensation.
Healthy Homes/Healthy Families

The purpose of the study is to learn how to make homes more supportive of healthy eating and physical activity. As part of the study, participants will be randomly assigned to one of two groups. One group will receive materials with information on healthy eating and physical activity. The materials will be mailed 3 times over a 5 month period. The other group will work with a coach to make their homes more supportive of healthy eating and physical activity. Working with a coach involves 3 home visits and 4 coaching telephone calls over a 5 month period. This group will also receive materials by mail 4 different times. All participants will be asked to complete 7 telephone interviews over a 1 year period. Participants will also be asked to wear an accelerometer, a small portable device that tracks movement from physical activity, for 7 days at 2 different points in the study.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 35-65 years old
* BMI greater than or equal to 25
* Speak English
* Must live with at least one other person
* Live within 30 miles of 1 of 9 clinics referring patients in the study
* Must have no contraindications for physical activity
* Must have no contraindications for participating in a medically unsupervised study

Exclusion Criteria:

* 1 person per household
CHangeovers of Norepinephrine in Intensive Care

CHIC study's purpose is to compare the efficiency, in terms of blood pressure stability, of three changeovers of norepinephrine used routinely in ICU. The three techniques are:

* Quick change
* Double pumping
* Smart infusion pumps

The drugs used in intensive care units are numerous and their administration is based on a strong expertise in this context of urgency and complexity. Nurses role is not only to carry out preparation of a treatment but to implement a complex treatment that requires a risk management approach surpassing the simple task to which the decree of professional acts refers to.

In this context, the administration of catecholamines, widely used in intensive care medicine in the treatment of shock, appears to be a sensitive issue to study. These vasoactive drugs have a short half-life and a narrow therapeutic index. Administration should be careful ensuring both efficiency and prevention of complications such as hemodynamic instability or arrhythmias.

Administration of these therapeutic must be strictly continuous, that is to say delivered using electric syringe pumps. Syringe replacements appear as critical moments because of the risk of flow change or brief interruption of the infusion.

There are three main types of syringes relay techniques, but to date, no study has compared these techniques with each other. There is thus no recommendation based on objective datas to guide clinical nursing practice.

This study aims to provide evidence in order to secure the administration of catecholamines. It may also use as a reference for evaluation of new features that allow automation relays with called "smart pumps" and for which no study has demonstrated the added value in terms of security. No progress will be possible in securing the administration of drugs with a short half-life, narrow therapeutic index and significant side effects without a deep reflection of the conditions of their infusion. The choice of materials used and the development of care procedures must be based on reliable and timely recommendations. Patients expect safer care. Nurses must be able to have references enabling them to guide their practice to the benefit of patients.

Eligibility Criteria:
Inclusion Criteria:

* Admission in Intensive Care Unit
* Norepinephrine perfusion started for less than three hours in ICU
* Invasive monitoring of blood pressure

Exclusion Criteria:

* Age under 18
* Pregnant and breastfeeding women
* Previous participation in the trial
* No registration in any health care system
* Patient protected by law
* Patient study refusal
* Active therapeutic limitation decision
Nutrition and Lifestyle Behaviour Peer Support Program Among Malaysian Adults With Metabolic Syndrome (PERSUADE)

The outlook of a community-based intervention targeting nutrition and lifestyle behaviour modification among adults with metabolic syndrome (MetS) has not been fully explored. The primary aim of this study (PERSUADE) is to evaluate the effect of the peer support intervention on the clinical outcomes MetS components followed by improvements in the participants' dietary practices, physical activity levels and lifestyle behaviours. The program constructed using information obtained from the published clinical and dietary guideline in Malaysia.

Aim: To develop and assess a three-month, group-based community peer support program for Malaysian adults with MetS.

Method:

The PERSUADE module will be constructed using the Health Belief Model (HBM) to address relevant health messages from the appropriate guidelines and recent literature evidence on MetS among Malaysian adults. Following that, a minimum sample of 96 Malaysian adults with MetS will be randomised, either to the control group, who will receive one-time standard nutrition and lifestyle advice or the intervention group, who will participate in a three-month peer support program using the PERSUADE module. The participants will be followed up for three months post-intervention with data collection scheduled at baseline, 3-month and 6-month.

PERSUADE is thoroughly designed using the current available guidelines informed with gathered inputs on motivations and barriers towards healthy lifestyle among Malaysians. The program aims to improve the clinical outcomes of MetS component among participants of the intervention group, besides the impact of the peer support intervention on the dietary practices, physical activity levels and lifestyle behaviours of those participants. The successful outcome of this study can be an initiator for policy makers to encourage more rigorous promotion of such community-based programmes in the country.

Eligibility Criteria:
Inclusion Criteria:

1. Physically healthy men and women who are ≥ 18 years old.
2. Literate with a fair command of Bahasa Melayu and/or English.
3. Metabolic syndrome status confirmed according to Harmonised Criteria.
4. Willing to attend weekly peer gathering sessions.

Exclusion Criteria:

1. Pregnant, lactating or intend to become pregnant during the study period.
2. Diagnosed with Type 1 Diabetes Mellitus (T1DM)
3. Any predisposing condition compromising the quality of life or ability to participate according to protocol.
4. Reported severe complications (chronic heart disease, cerebrovascular disease, diagnosed HIV/AIDS, cancer, emphysema, chronic liver or kidney disease) that would affect the participants' ability to follow the participation in peer activity.
Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies

This study is a prospective single-arm open-labled phase I/II clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed/refractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 34 subjects will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

   -
2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

   -
3. CD19 positivity confirmed by flow cytometry and/or histopathology.

Exclusion Criteria:

1. Primary immunodeficiency.

   -
2. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.

   -
3. Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;
Survivorship and Outcomes of Robot Assisted Medial Partial Knee Replacement

The purpose of this study is to determine the survivorship rate of robotic assisted medial partial knee replacement at a two, five, and ten years.

The purpose of this study is to determine the survivorship rate of robotically guided MultiCompartmental Knee system (MCK) medial onlay Unicompartmental Knee Arthroplasty (UKA) implants at a two, five, and ten year follow up.

Eligibility Criteria:
Inclusion Criteria:

* over 21 years of age
* underwent primary robotically guided UKA and received a medial MCK onlay implant by the investigating surgeon
* at least 24 months post-operative

Exclusion Criteria:

* Patients will be excluded from participation in the study if they are cognitively unable to answer study questions
A Comparison Study of PF708 and Forteo in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects.

This is a double-masked, randomized, two-treatment cross-over study in healthy adult subjects. Half of the subjects will be randomized to receive PF708 first and Forteo second (Sequence A), and the other half will be randomized to receive the drugs in reverse sequence (Sequence B),

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-50 years at the time of Informed Consent.
* Able to understand and sign the written Informed Consent Form (ICF).

Exclusion Criteria:

* History of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus \[test for hepatitis C virus antibody (HCV Ab)\] or hepatitis B virus \[test for hepatitis B surface antigen (HBsAg)\].
* Female subjects who are pregnant or have a positive pregnancy test result, currently breastfeeding, or planning to become pregnant during the course of the study.
* Blood donation (greater than or equal to 500 mL) within 30 days prior to screening.
* History of Paget's disease of bone.
* History of prior external beam or implant radiation therapy involving the skeleton.
* Active urolithiasis or primary hyperparathyroidism.
* History of alcohol or substance abuse within 3 years prior to screening.
* Previous treatment, including for investigational purposes, with any products (e.g., Forteo, Natpara) derived from human parathyroid hormone (PTH).
Validity and Reliability of the 2-minute Step Test in Patients With Fibromyalgia

The objective of this study was twofold: first, to assess the validity and reliability of the 2 Minute Step Test (2MST) in patients with fibromyalgia; and second, to explore its relationship with objective assessment methods, specifically the 2 Minute Walk Test (2MWT) and the 6 Minute Walk Test (6MWT). Additionally, the study aimed to investigate the correlation between the 2MST and quality of life as well as chronic fatigue levels using the Fibromyalgia Impact Questionnaire (FIQ) and the Fatigue Severity Scale (FSS).

This cross-sectional study will include 55 female patients aged 18-65 who will be diagnosed with fibromyalgia according to the American College of Rheumatology 2010 Diagnostic Criteria. Demographic characteristics of the patients will be documented. The extent of impact on patients' quality of life will be evaluated using the Fibromyalgia Impact Questionnaire (FIQ), while the severity of chronic fatigue will be measured using the Fatigue Severity Scale (FSS). The intensity of chronic pain experienced by patients will be expressed using the Visual Analogue Scale (VAS). All patients will undergo an initial assessment using the 2-Minute Step Test (2MST), 2-Minute Walk Test (2MWT), and 6-Minute Walk Test (6MWT). To assess test-retest reliability, the 2MST will be repeated with a 7-day interval between assessments.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with fibromyalgia according to the American College of Rheumatology 2010 Diagnostic Criteria
* Female patients aged 18-65
* The absence of any pathological condition that would hinder walking

Exclusion Criteria:

* Uncontrolled hypertension
* Decompensated heart failure
* Presence of systemic diseases affecting lower extremity functions
* Presence of degenerative diseases affecting lower extremity functions
* Peripheral artery disease causing vascular claudication
* Psychiatric illness
* Neuromuscular disease
* Pregnancy
* Cognitive impairment
Expanded Access to Convalescent Plasma for Treatment of COVID-19

This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.

This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following enrollment on the protocol and provision of informed consent, patients will be transfused with approximately 200-500 mL of ABO compatible convalescent plasma obtained from individuals who have recovered from documented infection with SARS-CoV-2 and who have been found to have high anti-SARS-CoV2 titers. Safety information collected will include serious adverse events judged to be related to the administration of convalescent plasma. Other information to be collected retrospectively will include patient demographics, resource utilization (total length of stay, days in ICU, days intubated, and survival to discharge from the facility.

Eligibility Criteria:
Inclusion Criteria:

1. Age at least 18 years
2. Laboratory confirmed diagnosis of infection with SARS-CoV-2
3. Admitted to the hospital for the treatment of COVID-19 complications
4. Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
5. Informed consent provided by the patient or healthcare proxy
6. Severe COVID-19 is defined by one or more of the following:

   * dyspnea
   * respiratory frequency ≥ 30/min
   * blood oxygen saturation ≤ 93%
   * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
   * lung infiltrates \> 50% within 24 to 48 hours

Life-threatening COVID-19 is defined as one or more of the following:

* respiratory failure/mechanical ventilation
* septic shock
* multiple organ dysfunction or failure