cyrilzakka/clinical-trials huggingface dataset:
Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects

This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.


Eligibility Criteria:
Inclusion Criteria:

* Currently on a first-line antiretroviral regimen containing ATV with a confirmed rebound and a genotype that verifies the presence of an 150L mutation OR on a first-line regimen containing an NNRTI and PI-naive, with a confirmed rebound

Exclusion Criteria:

* Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
* Women who are pregnant or breastfeeding.
* A life expectancy of \<12 months.
* Presence of a newly diagnosed HIV-related opportunistic infection or any other medical condition requiring acute therapy at the time of enrollment.
* Active alcohol or substance abuse sufficient, in the investigator's opinion, to prevent adequate adherence to study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.
Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma

This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and anti-lymphoma activity of an autologous T cell product (ACTR707) in combination with rituximab in subjects with refractory or relapsed CD20+ B cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* signed written informed consent obtained prior to study procedures
* histologically-confirmed relapsed or refractory CD20+ B-cell lymphoma of one of the following types, with documented disease progression or recurrence following the immediate prior therapy: DLBCL (regardless of cell of origin or underlying molecular genetics), MCL, PMBCL, Gr3b-FL, TH-FL (prior dx of FL before transforming to DLBCL).
* biopsy-confirmed CD20+ expression of the underlying malignancy with disease progression following immediate prior therapy
* at least 1 measurable lesion on imaging.
* must have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following:

  * biopsy-proven refractory disease after frontline chemo-immunotherapy
  * relapse within 1 year from frontline chemo-immunotherapy and ineligible for autologous hematopoietic stem cell transplant (auto-HSCT)
  * for subjects with DLBCL, PMBCL, and Gr3b-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT
  * for subjects with TH-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT. At least 1 prior regimen with an anti-CD20 mAb in combination with chemotherapy is required following documented transformation
  * for subjects with MCL (confirmed with cyclin D1 expression or evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization (FISH) or polymerase chain reaction (PCR): relapsed or refractory disease after at least 1 prior regimen with chemo-immunotherapy (prior auto-HSCT is allowable)
* ECOG 0 or 1
* life expectancy of at least 6 months
* platelet count greater than 50,000/µL

Exclusion Criteria:

* known active central nervous system (CNS) involvement by malignancy.
* prior treatment as follows:

  * alemtuzumab within 6 months of enrollment
  * fludarabine, cladribine, or clofarabine within 3 months of enrollment
  * external beam radiation within 2 weeks of enrollment
  * mAb (including rituximab) within 2 weeks of enrollment
  * other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment
  * experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
* clinically significant cardiac disease
* clinically significant active infection
* clinically significant CNS disorder
* clinical history, prior diagnosis, or overt evidence of autoimmune disease
* known bone marrow involvement due to underlying malignant disease, in dose-escalation phase only
Concordance Between Central Blood PRessure dEvices In Nephrology Patients

The most accurate way to determine intra-aortic BP is to obtain invasive measures by vascular catheterization, which is not possible to perform routinely during the regular follow-up of patients. However, in recent years, devices used to estimate central BP have been designed and approved for clinical use. These devices can determine aortic BP in a non-invasive way using various techniques and algorithms and offer a high degree of precision when compared to invasive measurements of intraaortic BP. On the other hand, certain characteristics specific to the different devices mean that the central BP values obtained may not be interchangeable. It is therefore important to determine the degree of agreement of central BP values obtained using commercially available devices.

This study aims to determine the degree of agreement between central BP measurements obtained using 4 devices commonly used to measure central blood pressure, i.e. Mobil-o-Graph NG (IEM, Germany), WatchBP Office (Microlife, Taiwan), Oscar 2 with SphygmoCor inside (SunTech, USA) and BP+ (Uscom, Australia). These four devices record the shape of the pulsatile wave and then derive the central BP using an algorithm. The main differences between these devices lie in this algorithm, or "transfer function,", which is unique to each and the calibration used. All use a brachial cuff to capture the pulse waveform and can easily be used in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

- Age 18-80 years old

Exclusion Criteria:

* Ongoing atrial fibrillation
* Arm circumference incompatible with the blood pressure cuffs for all devices (\<18 cm or \> 50 cm)
* Incapacity to give consent
A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults with Dermatomyositis

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
* Adult subjects (18-75 years old)
* Active muscle and skin disease at screening and baseline
* Prior therapy OR current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant
* Weight \> 40 kg to \< 130 kg, and with a body mass index (BMI) \< 40 kg/m2.

Exclusion Criteria:

* Dermatomyositis with end-stage organ involvement
* Dermatomyositis with irreversible muscle involvement
* History of:

  * Any lymphoproliferative disorder
  * Active malignancy;
  * History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.)
  * Cancer-associated dermatomyositis
* Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
* Participants at a risk of thrombosis or cardiovascular disease
* Participants with a high risk for herpes zoster reactivation
* Participants with active or recent infections
Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)

This study evaluates the effectiveness of a cognitive behavioral multicomponent treatment program in improving pain, mood, and functioning while reducing medication non-adherence in breast cancer patients with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS).

PRIMARY OBJECTIVES:

I. To evaluate the effectiveness of a Multidisciplinary Pain Program for AIMSS, specifically determine the impact of the program on level of pain, functional status, and adherence to prescribed medication.

II. To identify predictors of improvement in pain, functional status, and mood following participation in the program.

OUTLINE: This is an observational study.

Patients attend a 2-day treatment program and complete questionnaires on study. Patients also have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Patients are 18 years old or more.

  * A breast cancer survivor ECOG =\< 2, stage 0-III HR+ who is experiencing musculoskeletal symptoms associated with aromatase inhibitors intake
  * Patients must be at least 6 months on aromatase inhibitors and for no more than 7 years

Exclusion Criteria:

* Breast cancer survivor patients that are not in aromatase inhibitor treatment or have less than 6 months of treatment or more than 7 years of treatment.

  * Asymptomatic patients
  * Patients less than 18 years old
  * Patient that are not being followed as a Mayo Clinic patient

    * Patients with stage IV breast carcinoma
    * Patients that are HR -
    * Patients that are ECOG 3 or more
Predicting Abdominal Reoperation

Nationwide retrospective study, to predict the risk of abdominal reoperation.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.

Exclusion Criteria:

* Positive history for abdominal surgery
Effect of Tofacitinib in Treating ANCA-associated Vasculitis

The goal of this study is to evaluate the efficacy and safety of tofacitinib 5 mg twice daily in AAV patients.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) represents a group of small vessel vasculitides characterized by granulomatous and neutrophilic tissue inflammation, often associated with the production of antibodies that target neutrophil antigens. The predominantly used treatment for induction of remission in AAV consisted of cyclophosphamide (CYC) plus corticosteroids (GCs) which leads to remission in about 90% of patients. However, relapses are frequent and remain a challenge. The optimal drug for maintenance treatment is not determined. Tofacitinib is a Jak inhibitor which has been proved to be effective in multiple inflammatory diseases such as rheumatoid arthritis. Considering that T cells and associated cytokine production play an important role in the pathogenesis of AAV via activation of the JAK/ STAT pathway, we hypothesized that tofacitinib-mediated inhibition of JAK signaling may represent an effective therapy for active AAV. In this prospective, open label, single arm study, tofacitinib 5mg twice a day will be added to the background treatment of GCs and immunosuppressants in AAV, the safety and efficacy of tofacitinib will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active AAV met the criteria of 1990 ACR and 2012 Chapel Hill criteria
* Age 18 to 75 years
* Written informed consent obtained before taking part in the study

Exclusion Criteria:

* Severe AAV defined as potentially organ- or life-threatening disease (i.e. alveolar haemorrhage, heart failure caused by myocarditis or pericarditis, progressive neurological symptoms, deaf, blindness, et al.)
* Serum creatinine\>120umol/L or proteinuria\>1.0g/d
* Receipt of a JAKi therapy previously
* Co-existence of another systemic autoimmune disease
* Secondary vasculitis (following neoplastic disease, an infection or antithyroid drugs)
* Malignancy or history of malignancy
* Infection by HIV, HCV, HBV or tuberculosis-
* Severe uncontrolled cardiovascular, pulmonary, liver, gastrointestinal, endocrine, hematological, neurological, or psychiatric diseases that are not related to systemic vasculitis
* Allergic to JAKi
* Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.5 x 109/L; Platelet count \<100 x 109/L; Alanine transaminase or aspartate aminotransferase or total bilirubin\>1.5 upper normal limit; Estimated glomerular filtration rate\<60ml/min/1.73m2
* Incapacity or refusal to understand or sign the informed consent form.
* Pregnancy, breastfeeding.
The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients

The aim of our study is to investigate the effects of the robotic hand exoskeleton, on the spasticity, motor control skills, level of daily living activity, quality of life and functional independence of stroke patients.

Stroke is a condition that occurs as a result of an ischemic or hemorrhagic intracranial vascular event, is the third leading cause of death in the world and can lead to disability. Depending on the localization of brain damage after stroke, it is possible to talk about different prognoses and therefore different functional losses in the lower extremities, upper extremities and hand and wrist.

Today, various neurophysiological approaches, exercise strategies, electrotherapy modalities and assistive devices are used in the rehabilitation program suitable for the patient after stroke. In addition to these, robot-assisted therapy is gaining a place as an innovative approach in stroke rehabilitation with the developments in technology. Robot-assisted therapy is thought to both facilitate and intensify treatment after stroke and increase motor development.

The normal functions of the hand, which has many abilities and a complex structure, is extremely important to lead a free and active life. When the literature is examined, the success rate in the recovery of skills and functional recovery of the hand in stroke rehabilitation is low compared to the lower extremity and shoulder joint. More interventions are needed to increase the functional recovery of the hand. Studies should be conducted on robot-assisted treatment methods that allow active and passive exercises in the hand after stroke and contribute to neuroplasticity with an intensified and standardized program.

Our aim in this study is to investigate the efficacy of the Robotic Hand Exoskeleton System developed at Marmara University in order to reduce the physiotherapy process and increase the responses of patients who have partially lost their hand functions due to stroke and need rehabilitation in stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with stroke by a neurologist
* At least 3 months have passed after the stroke
* Mini Mental State Examination score of at least 24
* To be able to maintain sitting balance during working with the robot,
* Having full range of motion in the metacarpophalangeal (MCP), proximal interphalangeal (PIF) and distal interphalangeal (DIF) joints,
* Spasticity in finger flexor and extensor muscles ≤ 3 according to the Modified Ashworth Scale (MAS)
* Being between the ages of 35-85

Exclusion Criteria:

* Other neurological or orthopedic problems that may affect upper extremity function,
* Cardiovascular vulnerability (severe uncontrolled hypertension, severe coronary artery disease, unstable angina)
* Behavioral and cognitive conditions that affect treatment and make compliance difficult
* Having botulinum toxin procedure in the last 6 months
* Cardiac pacemakers
* Those with skin ulcers
* Pregnancy
* History of metastatic cancer
D1 vs D2 Lymphadenectomy in Gastric Cancer

This study is a retrospective study with a propensity score-matched analysis in order to balance differences between patients with D1 and D2 lymphadenectomy for gastric cancer.The main aim is to analyse differences in the postoperative and oncological outcomes of patients with gastric cancer (GC) who underwent D1 and D2 gastrectomy.

In this propensity score-matched analysis of 128 patients, D2 lymphadenectomy improved long-term outcomes compared with D1 in patients with curative intent surgery for gastric cancer except for the group of patients older than 75 years and with early tumors.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with GC stage I-III who underwent a curative gastrectomy +/- perioperative chemotherapy

Exclusion Criteria:

* patients with adenocarcinoma Siewert type I/II, palliative surgery, R1/R2 resections and pathological stage (pStage) IV.
BOTOX® Economic Spasticity Trial (BEST)

This is a study to investigate if patients who have had a stroke and suffer from spasticity might benefit from being given BOTOX® in addition to the normal Standard Care. Spasticity is characterized by stiffness or frequent cramps accompanied by pain and abnormal movements and can prevent the carrying out of everyday tasks such as walking and getting dressed. BOTOX® is a neurotoxin, which is used to prevent the contraction of muscle fibre and has been shown to reduce spasticity significantly. Patients will be enrolled in this study at about 33 locations in Europe and Canada. Study participation will last for about 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stroke due to a primary cerebral hemorrhage/infarction
* Subarachnoid hemorrhage producing an upper motor syndrome affecting one body side which results in a hemi-paralysis/plegia

Exclusion Criteria:

* Patients with fixed contracture as a result of spasticity in the upper or lower limb planned to be treated and/or patients with other causes of spasticity (e.g. multiple sclerosis, spinal cord injury, etc.)
Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated with Radioactive Iodine for Thyroid Cancer

The association of radioiodine therapy for the treatment of thyroid cancer with nasolacrimal duct obstruction has been well documented in the medical literature. Prior case reports have documented radioactive iodine detection in the tears of patients following radioiodine therapy. It is possible that radioactive uptake by the cells in the lacrimal sac and nasolacrimal duct lead to inflammation, fibrosis, and obstruction of the tear duct over time. A recent study has shown that the administration of artificial tears decreases the level of detectable radioiodine in the tears of patients undergoing radioiodine therapy for thyroid cancer. The purpose of this study will be to assess whether administering tears after radioactive iodine therapy for thyroid cancer decreases the incidence of nasolacrimal duct obstruction in the two years following radioactive iodine treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Radio-iodine therapy for thyroid cancer
2. Radioiodine therapy ≥150 mCi
3. Age 18 or older

Exclusion Criteria:

1. Use of eye drops, other than artificial tears
2. History of periocular trauma with tear duct involvement/lacrimal gland trauma
3. History of lacrimal drainage disease: canaliculitis, dacryocystitis
4. Prior radiotherapy
5. Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)
6. Medical conditions that predispose to NLD stenosis (i.e. sarcoidosis, granulomatosis with polyangiitis, chronic lymphocytic leukemia)
7. Nasolacrimal duct obstruction at baseline
Diabetes Attitudes Wishes and Needs

The study is conducted in Africa, Asia, Europe, Japan, North America and South America.

The multinational surveys will explore the experiences and unmet needs of people with diabetes, as well as those of family members of people with diabetes, and of healthcare professionals treating people with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged at least 18 years with diabetes (type 1 or type 2: not only during pregnancy)
* Adults aged at least 18 years involved in the daily care of an adult (18 years or older) with diabetes (type 1 or type 2)
* General practitioners who personally treat at least 5 adults (18 years or older) with diabetes per month and initiate oral medication
* Diabetes specialists (endocrinologists/diabetologists) who personally treat at least 50 adults (18 years or older) with diabetes per month and prescribe oral medication, insulin or other injectable diabetes medications
* Diabetes educators (diabetes nurses/dieticians/other non-physician healthcare professionals) providing care for at least 5 adults (18 years or older) with diabetes per month
* Participants must have access to the internet, either at home or at a location convenient to them, or be able to attend a face-to-face or telephone interview, to participate in the survey
* Provision of informed consent before the start of any study-related activities

Exclusion Criteria:

* Individuals aged below 18 years and/or diagnosed with diabetes less than 12 months ago
* Inability to understand and comply with written and verbal instructions
Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders

The purpose of this proof of concept study is to use functional magnetic resonance imaging and behavioral assessments to investigate the effect of citalopram on restricted repetitive behaviors in people with autism spectrum disorders.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory status (outpatient) at time of consent
* Age 10-55 years
* Clinical diagnosis of Autism Spectrum Disorder
* IQ greater than or equal to 70
* Score greater than 8 on Children's Yale-Brown Obsessive Compulsive Scale
* Free of psychoactive medication for at least: one month for fluoxetine; two weeks for other SSRIs and neuroleptics; and five days for stimulants prior to MRI scanning \[excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder\]

Exclusion Criteria:

* Age less than 10 years or greater than 55 years, at time of consent
* Estimated IQ \< 70
* Uncontrolled epilepsy (seizure within 6 months prior to consent)
* 4. Presence of medical conditions that might interfere with participation, or where participation would be contraindicated
* History of neurological injury: head trauma, poorly-controlled seizure disorder (seizure within the preceding six months), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon as determined by interview
* History of claustrophobia
* Implanted or irremovable metal in the body (including certain tattoos and permanent make-up)
* Current pregnancy (as verified by testing prior to both initial dose administration of citalopram or placebo and prior to magnetic resonance imaging) due to the risk that may be associated with SSRI treatment and magnetic resonance imaging on fetal health
* Medical contraindications to SSRI therapy as determined by history (including induction of mania or hypomania during SSRI therapy, or known drug allergy)
* Concomitant medication that would interfere with study participation
* Prior history of citalopram treatment failure at appropriate doses and duration
* Prior history of treatment failure to two previous SSRI trials at appropriate doses and duration
* Ongoing need for psychoactive medication other than study medication \[excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder, or diphenhydramine (Benadryl®)for sleep\]