cyrilzakka/clinical-trials huggingface dataset:
Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension

The objective of this study is to examine the association between urinary and plasma biomarkers and change in estimated glomerular filtration rate (eGFR) among patients with pulmonary hypertension (PH).

PH is a severe, progressive disease associated with right ventricular dysfunction, right-sided heart failure (HF) and death. Kidney disease is present in approximately 35% of patients with PH, and its presence is associated with an enhanced risk for adverse outcomes, with the risk increasing incrementally with declining kidney function. Poor right ventricular function may increase venous congestion, alter ventricular interdependence, decrease effective cardiac output and activate the renin-angiotensin- aldosterone system, thereby aggravating kidney disease.

There is a crucial need to better understand the pathophysiological mechanisms linking the failing right heart and the kidney. To date, diagnostic and prognostic biomarkers of kidney disease in PH are lacking. The objective of this study is to examine the association between urinary and plasma biomarkers and change in eGFR among patients with PH.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients aged ≥18 years
* Undergoing right heart catheterization (RHC)

Exclusion Criteria:

* Active tumor disease requiring targeted therapy
* inflammatory or autoimmune disease with renal involvement requiring systemic immunosuppressive treatment
* Chronic kidney disease with eGFR \<20 ml/min/1.73 m2
* non-kidney failure requiring extracorporeal or peritoneal ultrafiltration for diuretic-resistant volume overload
* if they had received non-steroidal anti-inflammatory drugs or intravenous contrast within 72 hours before RHC
* prediagnosed glomerulonephritis
* polycystic kidney disease
* postrenal obstruction
* solid organ transplantation
* anticipated life expectancy of \<12 months
* likelihood of receiving advanced therapy (mechanical circulatory assist device/lung or cardiac transplant)
* pregnancy or possibility of pregnancy in the next 12 months
* refusal to participate
* not available for follow-up visits
Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer

The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality


Eligibility Criteria:
Inclusion Criteria:

* colorectal metastatic adenocarcinoma (stage IV) with unresectables, measurables and visibles secondary lesions
* primitive tumor must be operate
* patient age between 18 and 70
* OMS status performance \< 2
* life expectancy \> 12 weeks
* hematologic function : PNN \>/= 1.5x10\^9/L, platelets \>/= 100x10\^9/L
* hepatic function : bilirubin \</= 1.5xLSN, AST and ALT \</= 3xLSN, alcalin phosphatasis \</= 3xLSN
* plasmatimic creatin \</= 1.25xLSN
* No previous chemotherapy or pelvic radiotherapy
* men and women in age of procreate agreeing to use a contraception until 4 months after the end of treatment for women and until 6 months for men

Exclusion Criteria:

* nonmetastatic forms
* Colorectal tumor which requires preoperative radiotherapy
* nonmeasurable metastasis based on RECIST criteria
* previous chemotherapy for colorectal cancer
* previous irradiation of the primitive tumour
* specific indication against the treatment studied
* Patient considered as inoperable for physiological or carcinologic reasons
* Pregnant or breast feeding women
Investigational Biomarkers for Neurological Immune-related Adverse Events

Neurological immune-related adverse events (n-irAEs) are an emerging group of disorders of patients with cancer treated with immune checkpoint inhibitors, presenting with heterogeneous clinical manifestations and of uncertain outcome. Novel genetic, inflammatory, and neurogenerative biomarkers could be associated with distinct phenotypes and different outcomes. To test this hypothesis, the study will provide: a phenotypic characterization and outcome assessment of patients with n-irAEs; the analysis of biomarkers of genetic predisposition (HLA and other immunity-related genes), inflammation (serum and cerebrospinal fluid \[CSF\] cytokines and autoantibodies, peripheral blood and CSF lymphocytes and other immune cells, neuroimaging), neurodegeneration (serum and CSF neurofilaments, neuroimaging) and their correlation with clinical features and outcome.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of n-irAEs

Exclusion Criteria:

* Presence of an alternative diagnosis explaining the neurological syndrome
Naltrexone/Bupropion (Mysimba) to Optimize Weight Outcomes After Obesity Surgery

Limited/poor weight loss and weight regain are concerns following bariatric surgery, and weight regain may increase the risk for relapse of comorbidities related to obesity. Medications for weight reduction may assist further weight loss, and support weight maintenance, with positive effects on comorbidities. This pilot study will examine the effect of naltrexone/bupropion and lifestyle advice versus lifestyle advice alone for 7 months in patients with a suboptimal weight trajectory (either little weight loss or weight regain) 2 years or later following bariatric surgery.

Study aim and endpoints The aim of this pilot study is to evaluate the effect of Mysimba in patients with suboptimal weight loss or weight regain after bariatric surgery. The primary endpoint is body weight.

Objective The study objective is to understand whether patients with suboptimal weight loss or weight regain 2 years or more following bariatric surgery achieve better weight loss with Mysimba and dietary counselling compared with a control group treated with dietary counselling alone.

This is a phase IV, open label randomized controlled study conducted over 7 months with a 3-month post-intervention follow-up. The study will be conducted in accordance with good clinical practice. Patients meeting eligibility criteria will be randomized into one of two groups: an intervention group treated with Mysimba and lifestyle and a control group treated with lifestyle. The intervention group will be prescribed Mysimba gradually titrated to the maximum tolerated dose (maximum dose is 32 mg/360 mg divided in 4 tablets) with 2 week intervals. Both groups will receive the same follow up including dietary counselling during the course of the study. Randomization will be done using a standard internet-based program where group assignment cannot be anticipated. The study is not blinded.

Eligibility Criteria:
Inclusion Criteria:

Men and women aged 18-65 years who have undergone RYGB, mini-RYGB or sleeve gastrectomy 2 or more years previously and either

1. Have a percent total weight loss from time of surgery of \<20% OR
2. Have a regain of at least 5% or more of nadir weight (lowest weight at 12-18 months after surgery) AND
3. Meet current clinical criteria for use of Mysimba (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with obesity-related comorbidity (diabetes type 2, controlled hypertension, dyslipidemia)

Exclusion Criteria:

* Serious illness or complications due to bariatric surgery according to the judgement of the investigators and clinical records
* Use of any weight loss medications following bariatric surgery
* Pregnancy or breastfeeding
* Participation in other weight loss studies
* Contraindication for use of Mysimba. These include but are not limited to epilepsy or history of seizure, uncontrolled hypertension (blood pressure ≥150/95 mmHg with or without medication), previous or current eating disorder, substance abuse, bipolar depression, serious liver or kidney disease, use of certain medications)
Reduction of the Glycemic Index by a Novel Viscous Polysaccharide

Reductions of postprandial glucose levels have been demonstrated previously with the addition of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods.

Recently, a commercial novel viscous polysaccharide (NVP)complex has been developed which is marketed in both the USA and Canada under the trade name PGX® (PolyGlycopleX) (InovoBiologic Inc, Calgary, AB, Canada). This complex consists of three viscous non starch polysaccharides which are processed using proprietary technology (EnviroSimplex®) to produce compressed granules which delays the onset of viscosity and increases palatability of the fiber when added to food. Previously, this fibre was shown to lower postprandial glucose levels in a dose responsive manner when mixed with a glucose drink and sprinkled onto a standard white bread demonstrating that the processing did not interfere with the effectiveness of the fiber. From this study the reduction in GI was calculated to be 7 units per gram of NVP when added to a solid food, however it is not known whether this relationship would be maintained when the NVP was added to a range of commonly eaten foods. This study therefore evaluates the effect of the addition or incorporation of NVP into a range of foods on postprandial glycemia and whether the reductions in glycemic index could be predicted using.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals
* 18-75 years old
* BMI less than 35 kg/m2

Exclusion Criteria:

* Medications influencing gastrointestinal function
* Pregnancy
Open-Label Placebo for Non-Specific Pain in the ED

The aim of this study is to assess whether an intervention with open-label placebo (OLP) for non-specific pain in the emergency department is feasible.

This project is a collaboration between the Emergency Department at the University Hospital of Basel and the Faculty of Psychology at the University of Basel. The investigation will analyze whether an intervention consisting of open-label placebo tablets is feasible for patients with non-specific pain in the emergency department. Open-label placebos are administered without deception, meaning the patients are aware they are taking a placebo. Patients will be randomized into intervention group (OLP) or control group (treatment as usual) with ibuprofen. The study duration for patients is 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of non-specific acute pain
* Able to understand the study and its outcome measures
* Signed informed consent
* 18 years or older
* Sufficient German language skills

Exclusion Criteria:

* Chronic pain
* Treatment with pain medication for \> 7 days prior to ED visit
* Known allergy or intolerance to ibuprofen
* Known hereditary galactose-intolerance, lactase deficiency or glucosegalactose malabsorption
* Participation in another clinical trial with medicinal products
* Need for hospitalization
* Known pregnancy
Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder

The purpose of the project is to evaluate the efficacy of cognitive behavioral therapy (CBT) for adults with attention deficit hyperactivity disorder (ADHD) with and without stimulant medication and compare it to medication alone. Subjects will be randomly assigned to stimulant medication only, CBT only and combined CBT and stimulant medication group. Patients will be evaluated at baseline, following mediation optimization (for medicated groups), following 12 months of treatment, after 3 months of follow up, and after 6 months of follow up. The investigators hypothesize that the combined group will have the best outcome at all evaluation points. ADHD in adults is associated with significant morbidity and impaired academic, occupational, social, and emotional functioning. Developing optimal treatment approaches for this population is key in improving their functioning.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for adult ADHD of any of three subtypes via Conners' Adult ADHD Diagnostic Interview for the DSM-IV (CAAR-D) and clinician's assessment;
* Barkley Childhood and Current Symptom of ADHD (1998) completed by self and informants (parents or siblings). Required cut off's on these scales are scores 1.5 Standard Deviation above relevant gender and age norms;
* Conners' Adult ADHD Rating Scale (1999). Required cut off's on these scales are scores 1.5 Standard Deviation above relevant gender and age norms;
* Between 18 and 60 years old
* Be able to give informed consent and comply with study procedures;
* I.Q. of 80 or above on Wechsler Adult Intelligence Scale, 3rd edition (WAIS-III) subtests of three verbal and three nonverbal subtests
* Adequate command of English to be able to participate in CBT group.

Exclusion Criteria:

* Psychotic symptoms, past or current
* Current psychiatric comorbidity, e.g. bipolar disorder, depression, suicidality, current substance use disorder (must be free of substance abuse for 6 months)
* Medical condition that preclude use of the stimulant medication, e.g. hypertension, cardiac disease, Tourette's Syndrome, etc.
* Organic mental disorders or other significant neurological disorders, e.g. epilepsy, head injury, chorea, multiple sclerosis, deafness, blindness.
Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing neutrophilic granulocytopenia among chemotherapy patients.

Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with recombinant human granulocyte colony-stimulating factor injection as a control.

* Brief Protocol: Treat the patients taking Taxotere+Epirubicin+Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE) treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.
* Positive control：recombinant human granulocyte colony-stimulating factor injection.
* Targeted patients: breast cancer
* Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 3: positive control with TEC or TE treatment.
* Number of patients: 216
* Concomitant medicines will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65.
* Diagnosed breast cancer, suitable for TEC or TE .
* ECOG performance status 0 or 1.
* Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
* ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
* No obvious abnormal ecg examination.
* TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
* Cr, BUN≤2.5×ULN.
* Signed informed consent.

Exclusion Criteria:

* Chemotherapy within past 4 weeks
* Uncontrolled inflammatory disease,axillary temperature≥38℃.
* Merging other malignant tumor
* Pregnancy or nursing status.
* Participation in another clinical trial with and investigational product within 3 months prior to study entry.
* Severe diabetes mellitus, or poor blood sugar controller.
* Allergic disease or allergic constitution. History of protein allergy.
* History of drug addiction and alcoholism.
* Hematopoietic stem cell transplantation or organ transplantation.
* Chronic disease of severe cardiac, kidney and liver.
* Other conditions that would be excluded from this study according to doctors'judgment
Perioperative Closed-loop Glucose Control

The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated with grater complication rates, length of stay and mortality rates. Suboptimal glucose management in the perioperative setting remains a major barrier to optimal surgical care. While there are guidelines to manage perioperative diabetes care, implementation is challenging and inconsistent, in part due to a stretched workforce, involvement of several disciplines and clinical teams and shortcomings in clinical training and knowledge. Closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels. The use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* The subject is aged 18 years or over
* Diagnosis of type 2 diabetes using standard diagnostic practice (37)
* The subject is planned for an elective abdominal, thoracic or cardiovascular surgery at the University Hospital Bern expected to last ≥2 hours
* The subject requires treatment with subcutaneous insulin as part of the perioperative glucose management
* The subject is literate in German
* The subject is willing to wear study devices 24/7

Exclusion Criteria:

* Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
* Known or suspected allergy to insulin
* Type 1 diabetes
* Pregnancy, planned pregnancy, or breast feeding
* Medically documented allergy towards the adhesive (glue) of plasters or unable tolerate tape adhesive in the area of sensor placement
* Lack of safe contraception for female participants of childbearing potential for the entire study duration (medically reliable method of contraception are considered oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or any other methods judged as sufficiently reliable by the investigator in individual cases).
* Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
* Illicit drug abuse or prescription drug abuse
* Incapacity to give informed consent
* Droplet/airborne isolation precautions
* Participation in another clinical trial that interferes with the interpretation of the study results
Study of Tumor Samples in Patients Undergoing Treatment for Gastrointestinal Stromal Tumors on Clinical Trial ACOSOG-Z9001

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor samples in patients undergoing treatment for gastrointestinal stromal tumors on clinical trial ACOSOG-Z9001.

OBJECTIVES:

Primary

* To examine polymorphisms in selected genes involved in the detoxifying/metabolizing and DNA repair pathways in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from patients with gastrointestinal tumors (GIST) undergoing treatment on clinical trial ACOSOG-Z9001.

Secondary

* To examine approximately 758 polymorphisms among candidate genes involved in detoxification/metabolism, cell cycle control, and DNA damage/repair in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from GIST patients for hypothesis generation. (exploratory)
* To conduct an exploratory analysis of the polymorphism distribution in these patients. (exploratory)
* To examine the association between the above polymorphisms and major toxicity (Grade 3/4) of adjuvant imatinib mesylate. (exploratory)

OUTLINE: Tumor samples are used for polymorphism and mutation analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tumor samples from patients with gastrointestinal stromal tumors enrolled on clinical trial ACOSOG-Z9001
Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)
* Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1
* Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
* HbA1c between 7.0-10.0% (both inclusive)
* Body Mass Index (BMI) below 40.0 kg/m\^2
* Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed
* Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)

Exclusion Criteria:

* Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
* Calcitonin above or equal to 160 pg/mL
* Personal history of non-familial medullary thyroid carcinoma
* Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC)
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1
* Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)
Impact of Screening Patients With HIV for Kidney Disease

The Infectious Disease Society of America has recently recommended that patients with Human Immunodeficiency Virus (HIV) be screened for kidney disease on a regular basis. Screening involves non-invasive urine and blood test and a screening program has already been initiated here in the University of Mississippi HIV clinic. This study looks at the effect of this new screening program. Our Hypothesis is that screening for kidney disease is a cost effective and important addition to the care of patients with HIV.

The Infectious Disease Society of America has recently recommended that patients with Human Immunodeficiency Virus (HIV) be screened for kidney disease on a regular basis. Screening involves non-invasive urine and blood test and a screening program has already been initiated here in the University of Mississippi HIV clinic. However nobody knows for sure whether this will help doctors take better care of patient with HIV.

This study looks at the effect of this new screening program. We want to see how frequently abnormalities are seen on screening, how frequently certain kidney diseases are diagnosed, how often patients are referred to a nephrologist and how often a patient's management is changed by the screening. We will also estimate the cost-benefit ratio of the screening. We will review patient charts to determine what has happened in each case where screening was conducted.

This study will not involve any additional testing.

The benefit of this study will be improving our understanding of kidney disease in HIV. It will help us determine the value of screening for kidney disease and the frequency of certain kidney diseases in HIV in our clinic population.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with HIV who are seen by the University of Mississippi Infectious disease clinic at the Jackson Medical Mall or patient seen at the University of Mississippi Nephrology Clinic.