cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies

The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Must have received standard of care therapy, and there must be no potentially-curative treatment available, in one of the following cohorts:
* A newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) that has been treated with radiation therapy (RT) but no chemotherapy
* A histologically confirmed recurrent or progressive non-brainstem High Grade Glioma (HGG) previously treated with surgical resection and RT
* A histologically confirmed medulloblastoma that has relapsed or is resistant to at least one line of prior therapy including surgery, RT, and chemotherapy
* A histologically confirmed ependymoma that has relapsed or is resistant to at least one line of prior therapy including surgical resection and RT
* A histologically-confirmed high grade CNS malignancy "other than above" which is recurrent or progressive after at least one line of prior therapy
* Lansky play score (LPS) for ≤ 16 years of age or Karnofsky performance scale (KPS) for \> 16 years of age assessed within two weeks of enrollment must be \>= 60
* A tumor sample must be available for submission to central laboratory (not required for DIPG)

Exclusion Criteria:

* An active, known, or suspected autoimmune disease
* A concurrent condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

Other protocol defined inclusion/exclusion criteria apply
Health Evaluation in African Americans Using RAS Therapy

The purpose of this study is to determine if telmisartan, an FDA approved blood pressure medication, may also have beneficial effects on Alzheimer's disease prevention in African Americans, who are at high risk for Alzheimer's disease.

This study will assess if telmisartan, an FDA approved blood pressure medication, may also have beneficial effects on Alzheimer's disease (AD) prevention in African Americans, who are at high risk for Alzheimer's disease. Blood pressure medications known as angiotensin-receptor blockers have been associated with reduced risk of Alzheimer's in Caucasians because they act on the renin-angiotensin system (RAS), a key regulator of blood pressure in the body and the brain. The drugs appear to slow the progression of the disease by affecting flow of blood and the amount of plaque in the brain, but these benefits have not been tested in African Americans. The investigator will evaluate if telmisartan is able to influence the renin-angiotensin system in the brain and produce favorable effects on brain blood flow and enzymes that cause the brain plaques in Alzheimer's disease.The investigator will assess the mechanism by which telmisartan modifies the brain renin angiotensin system, cerebrospinal fluid amyloid-β, cerebral blood flow (CBF) and inflammatory markers in hypertensive African Americans.

Eligibility Criteria:
Inclusion Criteria:

* Mean resting systolic blood pressure ≥ 110 mmHg and ≤ 170 mmHg
* Family history of Alzheimer's disease
* African American

Exclusion Criteria:

* Currently in another investigational drug study
* Potassium \>5.0 meq/dL at baseline
* Creatinine \>1.99 mg/dL at baseline
* History of stroke or transient ischemic attack (TIA)
* Dementia
* Current use of a RAS acting medication
* Contraindication for lumbar puncture or magnetic resonance imaging
* Heart failure
* Diabetes Types I and II
* Pregnant or nursing women
Foot/Ankle At 7T MRI

* To evaluate standard clinical sequences for 7 Tesla MRI of the foot and/or ankle to improve detailed depiction of the complex anatomy of this region.
* To evaluate various pathologies of the foot and/or ankle (plantar plate tears, Morton neuroma, tendon tears, ligament tears etc.).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* at least 18 years old
* Study group: Patients with specific pathologies (i.e. Morton neuroma, tendon tears, plantar plate tears) as proven by 1,5 or 3T MRI or asymptomatic subjects (to look at the normal microanatomy of different structures, mainly the plantar plate)
* Control group: No evidence of the respective pathology.

Exclusion Criteria:

* previous foot surgery with metal in vivo
* pregnancy or breast feeding
* any MRI contra-indications
Japanese Phase 1 Multiple Ascending Dose Study

The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes Mellitus.

MAD study - Multiple Ascending Dose study

Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with Type 2 Diabetes Mellitus (T2DM) \[Fasting glucose \< 240 mg/dL, Hemoglobin A1c (HbA1c): 6.5% to 10.0% National Glycohemoglobin Standardization Program (NGSP)\] who are treatment-naive and managed with diet and/or exercises only, ages: 20 to 65 years

Exclusion Criteria:

* Patient who is taking any medication for T2DM
* Symptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial
* Insulin therapy within one year of screening
Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer

This study collects and studies tissue and blood samples from patients with prostate or bladder/urothelial cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other parts of the body. Studying samples of blood and tissue samples from patients with prostate or bladder/urothelial cancer in the laboratory may help doctors learn more about new biomarkers, potential drug targets, and resistance developing in response to treatment. It may also help doctors find better ways to treat the cancer.

OUTLINE:

Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.

Eligibility Criteria:
Inclusion Criteria:

* Patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured
* Ability to adequately understand and give informed consent
* Local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications Or the ability to obtain tissue with minimal risk of complication from a surgical procedure being conducted as a part of another research study Or for standard of care purposes or patients who have archival tissue collected for research or standard of care who are willing to donate archival tissue for this study
* Alternatively, men and women without cancer or who are at risk of developing cancer are eligible to have blood or normal tissue collected if acquired; tissue will only be acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder; in patients without malignancy, no additional tissue beyond that necessary for care will be procured
* Platelet count \> 50,000
* White blood cell (WBC) \> 1,500
* Hemoglobin (Hgb) \> 8.0
* International normalized ratio (INR) \< 1.5
* Partial thromboplastin time (PTT) \< 45
* No history of excessive unexplained bleeding from previous surgery

Exclusion Criteria:

* Patients unable to stop chronic anticoagulation with warfarin or Lovenox for less than 3 days
* Serious or uncontrolled infection
* Treatment with a vascular endothelial growth factor (VEGF) inhibitor (such as Avastin) within the past 28 days
Hematological Dynamic Scores for Predicting Survival and Treatment Response for Advanced Gastric Cancer After Neoadjuvant Therapy

HMDLS, based on hematological markers, could effectively distinguish the long-term efficacy of AGC patients after NAT. The predictive performance of nomogram-HMDLS was better than ypTNM stage, achieving better prognostic stratification and tumor treatment response prediction.

In this research, we incorporated a total of 320 patients from the Union Hospital of Fujian Medical University to form the training cohort (TC). Additionally, we included 122 patients from four distinct medical centers to serve as the external validation cohort (EVC). The Hematological Marker Dynamic Load (ΔHMDL) was determined using the following formula: ΔHMDL = (HMDL pre-surgery - HMDL pre-NAT) / HMDL pre-NAT, where HMDL represents the hematological marker levels before surgery and before the initiation of Neoadjuvant Therapy (NAT), respectively.

Employing LASSO regression analysis, we identified the most influential and statistically significant ΔHMDL indicators. These were then utilized to compute the Hematological Marker Dynamic Load Score (HMDLS), defined as: HMDLS = Σ(LASSO coefficient \* ΔHMDL), where the summation encompasses the products of the LASSO-estimated coefficients and the corresponding ΔHMDL values.

Further, leveraging the outcomes of a multivariate COX regression analysis, we integrated clinical parameters with the HMDLS to formulate a predictive model, termed the Nomogram-HMDLS model. The efficacy of this model in terms of predictive accuracy, clinical utility, and calibration was meticulously assessed and confirmed through several metrics, including the concordance index (C-index), Receiver Operating Characteristic (ROC) curve analysis, decision curve analysis (DCA), and calibration curves.

Eligibility Criteria:
Inclusion Criteria:

* (1) AGC with clinical stage T2-4NxM0 (cT2-4NxM0) before NAT, (2) no history of other malignant tumors, distant metastases or invasion of adjacent organs, and (3) patients who underwent radical gastrectomy after receiving NAT.

Exclusion Criteria:

* (1) history of upper abdominal surgery (except for the laparoscopic cholecystectomy), (2) history of upper abdominal radiotherapy, (3) emergency surgery, or palliative surgery, (4) continuous use of medications such as anticoagulant, antiplatelet, and leukocyte-boosting drugs that significantly affect hematological markers during therapy, and (5) incomplete clinical and follow-up data.
Bowen's Technique in Patients With Adhesive Capsulitis

This study will help the physiotherapists in overcoming the challenges and barriers in the treatment. It will also help researchers in acquiring sufficient knowledge for further research on the Bowen technique and its various applications as this technique is not widely applied in the field of physical therapy treatment.

The application of the Bowen technique, producing significant results, will be opted in treatment for the better, improved, and innovative noninvasive management of Adhesive Capsulitis. This study will help the physiotherapists in overcoming the challenges and barriers in the treatment. It will also help researchers in acquiring sufficient knowledge for further research on the Bowen technique and its various applications as this technique is not widely applied in the field of physical therapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Age 25 to 60 years
* History of worsening shoulder pain
* Painful movement from at least 3 month
* Grade 2 \& 3 adhesive capsulitis
* Both Diabetic and non-diabetic
* Limited Ranges in capsular pattern

Exclusion Criteria:

* Fracture
* Trauma
* Dislocation
* Ongoing physical therapy treatment
* Cortisone injection prior 3 months
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer

The purpose of this study is to refine and pilot test educational material developed to educate and support patients receiving immunotherapy for advanced cancer.

The intervention is an educational video and question prompt list (QPL) to promote communication between patients, caregivers, and the oncology team about the risks and benefits of immunotherapy.

This two-part study will 1) refine and 2) pilot test an intervention to improve participant's and caregiver knowledge and increase communication with the oncology team about immunotherapy.

* The intervention involves watching a video developed to educate patients regarding the risks, benefits, and potential outcomes of immunotherapy treatment and reviewing an immunotherapy-focused QPL prior to ICI initiation.
* In Part 1 of this study, investigators will conduct a small open pilot to refine the intervention and study procedures.
* In Part 2, investigators will conduct a single-site pilot randomized controlled trial including 130 patients and their caregivers, to evaluate the feasibility of intervention delivery, and the preliminary efficacy of the intervention in improving patient and caregiver knowledge.

Eligibility Criteria:
Inclusion Criteria:

* All participants (Patients and Caregivers)-Table 1

  * Age 18 or older
  * Ability to read and respond in English
* Patient Inclusion Criteria (in addition to Table 1)

  * Receiving care in the MGH Cancer Center
  * Diagnosis of advanced (stage IV) melanoma or advanced, incurable lung cancer, including stage IV non-small cell lung cancer (NSCLC), unresectable stage III NSCLC, extensive-stage small cell lung cancer.
  * Plan to initiate immunotherapy with an ICI (pembrolizumab, nivolumab, ipilimumab, atezolizumab or combination), per clinician documentation in the electronic health record or study staff communication with clinician
* Caregiver Inclusion Criteria (in addition to Table 1)

  * Identified as "a supportive person involved in their cancer care" by a patient enrolled in the study

Exclusion criteria

* Major psychiatric condition or comorbid illness that prohibits participation in the study
* Cognitive impairment that prohibits provision of informed consent or participation in the study
* Pregnant women
* Prisoners
Diabetes Prevention Program Outcomes Study

The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.

DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations.

The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (\~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.

The current DPPOS Executive Summary and protocol, as well as DPPOS protocol and lifestyle manuals and publications are available at: http://www.dppos.org

Eligibility Criteria:
Participation as a volunteer in the Diabetes Prevention Program (DPP).
Intracellular Phosphate Concentration Evolution During Hemodialysis by MR Spectroscopy

End-stage renal disease is associated with hyperphosphatemia due to a decrease of renal phosphate excretion. This hyperphosphatemia is associated with an increase of cardiovascular risk and mortality. Thus, three therapeutic options have been developed: dietary restriction, administration of phosphate binders and phosphorus clearance by hemodialysis (HD).

During a standard HD session, around 600 to 700mg phosphate is removed from the plasma, whereas it contains only 90 mg inorganic phosphate (Pi); 85% of phosphate is stored in bones and teeth in hydroxyapatite form, 14% is stored in the intracellular space (90% organic phosphate and 10% Pi), and 1% remains in the extracellular space.

Currently, the source of Pi cleared during HD remains to be determined. Phosphorus (31P) magnetic resonance spectroscopy allows reliable, dynamic and non-invasive measurements of phosphate intracellular concentration. The investigator's team recently published data obtained in anephric pigs, suggesting that phosphate intracellular concentration increases during a HD session. In parallel, we showed that ATP intracellular concentration decreased. These results suggest that the source of Pi cleared during HD could be located inside the cell.

In this study, investigators will measure intracellular phosphate and ATP concentrations and intracellular potential of hydrogen (pH) evolution during hemodialysis in 12 patients suffering from end-stage renal disease by MR spectroscopy.

If these results were confirmed in humans, it could explain, at least in part, HD intolerance in some patients and would lead to modify therapeutic approaches of hyperphosphatemia, for example, by modifying HD sessions time.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from end-stage renal disease, treated by chronic hemodialysis since at less 6 months
* Phosphatemia (at the start of the session) ≥ 1,5 mmol/L and ≤ 3 mmol/L
* written consent signed

Exclusion Criteria:

* Major subject protected by law
* Prisoners or subjects who are involuntarily incarcerated
* Denutrition (weight loss ≥ 5 kg in one months/10 kg in 6 months, Body Mass Index (BMI) ≤ 21 kg/m2, albuminemia ≤ 35 g/L)
* Obesity (BMI ≥ 30 kg/m2)
* Phosphatemia at the start of the dialysis \< 1,5 mmol/L or \> 3 mmol/L
* Secondary hyperparathyroidism with parathormone (PTH) ≥ 1000 pg/mL
* Adynamic osteopathy (PTH ≤ 50 pg/mL)
* Hypoparathyroidism with a history of parathyroidectomy
* Hemoglobin ≤ 100 g/L
* Contraindication to heparin
* Temporary vascular access
* Contraindication to resonance magnetic spectroscopy (pacemaker or insulin pump, metallic valvular prosthesis, valvular prosthesis not compatible with resonance magnetic spectroscopy, dental appliance, intracerebral clip, claustrophobic subject).
* Simultaneous participation to another research protocol
* Patient not affiliated to a social security system
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus

The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo in severely obese Type 2 Diabetes Mellitus (T2DM) participants after 12 weeks of treatment on: the percentage change in body weight from baseline and safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) greater than or equal to (\>=) 35 to less than or equal to (\<=) 50 kilogram per meter square (kg/m\^2) at screening
* Stable weight (that is, change of \<= 5 percent \[%\] within 12 weeks before screening based on medical or participant reported history)
* Hemoglobin A1c of \>= 6.5% and \<= 9.5% at screening and meets one of the inclusion criteria as: (a) on diet and exercise alone \>= 12 weeks prior to screening; (b) on stable dose of single oral antihyperglycemic agent (AHA) or dual-combination oral AHAs for \>= 12 weeks prior to screening
* Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise be incapable of pregnancy, or (c) Heterosexually active and practicing a highly effective method of birth control, or (d) Not heterosexually active
* Willing and able to adhere to specific the prohibitions and restrictions

Exclusion Criteria:

* History of obesity with a known secondary cause (example, Cushing's disease/syndrome)
* History of Type 1 diabetes mellitus, diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* Fasting C-peptide less than (\<) 0.7 nanogram per milliliter (ng/mL) at screening
* Fasting fingerstick glucose of \>= 270 milligram per deciliter (mg/dL) (\>=15 millimoles per liter \[mmol/L\]) on Day 1
* Ongoing, inadequately controlled thyroid disorder as assessed by the investigator's review of the participant's medical history. Participants taking thyroid hormone replacement therapy must be on stable doses for at least 6 weeks before the screening visit
Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy and safety of this combination in a Russian population of patients.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* R5 HIV infection on screening tropism test.
* Viral load \>1,000 copies/mL.
* Never previously treated with anti-HIV medicines.

Exclusion Criteria:

* Previously treated with anti-HIV medicines.
* Hepatitis B co-infection.
Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status

In this prospective, multicenter observational study we assess the diagnostic validity of the following standard screening instruments for delirium regarding sedation, analgesia and ventilator status in critically ill patients:

* Confusion Assessment Method for the ICU (CAM-ICU)
* Intensive Care Delirium Screening Checklist (ICDSC)
* Nursing-Delirium-Screening-Scale (Nu-DESC)

The definite delirium diagnosis (definite in terms of reference standard) is made according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition, text revised (DSM-IV-TR) published by the American Psychiatric Association (APA) which is the Gold Standard to diagnose delirium.

Primary research question: Does sedation, ventilator status and analgesia influence the sensitivity of delirium screening tools (DST)?


Eligibility Criteria:
Inclusion Criteria:

* Critically ill patient
* Patient age \> 18 years

Exclusion Criteria:

* Neurosurgical patients
* Severe brain injury, intracerebral bleeding, stroke
* Inability to communicate due to anacusia or severe hearing loss
* Insufficient language comprehension
* Patients \< 24 h total time of Intensive Care Unit stay
* Deep sedation (RASS \< -3) for ≥ 7 days during study participation