cyrilzakka/clinical-trials huggingface dataset:
Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

Acanthosis Nigricans is skin disease that associated with hyperinsulinemia. Clinical is velvety hyperpigmented plaques on neck, axilla, groin. If hyperinsulinemia is improved by treated with oral metformin and/ or diet control, acanthosis nigricans would be improved as well. Hyperpigmented plaques will be changed. We assess objective measurement by using spectroscopic and colorimetric analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have an elevated fasting insulin level, suggesting they are in an insulin resistant state.
2. Subjects must carry a diagnosis of acanthosis nigricans, which will be verified by a Dermatologist before entry into the study. If necessary, a small 4mm punch biopsy may be taken to document dermatopathology consistent with acanthosis nigricans.
3. Subjects must be willing and able to undergo treatment with Metformin, including initial referral and follow up.
4. Agree to abide by the investigator's guidelines
5. Be able to understand the requirements of the study, the risks involved and are able to sign the informed consent form
6. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

1. Subjects with Type 1 Diabetes are excluded because of their naturally insulin-deficient, rather than hyper-insulinemic, states.
2. Women who are lactating, pregnant, or planning to become pregnant.
3. Any reason the investigator feels the patient should not participate in the study.

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A Study of Non-invasive Measurement of Blood Glucose and Blood Pressure

The purpose of this research is to compare blood glucose, blood pressure and electrocardiogram (ECG) readings on the LIFELEAF Smartwatch compared to standard methods of measurement.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients on insulin undergoing four times daily blood sugar checks as part of standard of care.
* Patients undergoing continuous monitoring for heart rate and blood pressure as part of their routine care.
* Patients undergoing catheter ablation for atrial fibrillation.

Exclusion Criteria:

* Patients unable to provide informed consent.
* Patients without arms as these are needed to wear the wrist-based sensor.
Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial

Background Recent literature suggests that ADHD is a risk factor for the development of antisocial behavior that is more severe and persistent than in community and other psychiatric populations. The combination of stimulant medication and psychotherapy (particularly cognitive-behavioral therapy, CBT) is considered an evidence-based intervention for adults with ADHD. In contrast, few studies have evaluated the efficacy of medication in adult prisoners with ADHD, and the literature on the efficacy of psychotherapy is virtually nonexistent. Therefore, this article presents the protocol of a trial that will assess the efficacy of a formulation-based CBT program for inmates with ADHD.

Methods The study has a multicenter randomized controlled trial design. After screening and recruitment, participants will be randomly assigned to the CBT intervention, a general offender treatment program, or a waitlist. Pre- and post-treatment self-report and clinician-report assessments, as well as 6- and 12-month follow-up assessments will be conducted. These will include both clinical (e.g., ADHD symptoms, depression and anxiety symptoms, self-esteem, alcohol/drug abuse, treatment adherence, quality of life) and criminological (e.g., recidivism and risk of recidivism) measures. Linear mixed models will be used to assess differences between groups.

Discussion This study may be the first to evaluate the efficacy of a psychotherapy intervention in adult inmates with ADHD. It is expected that addressing the specific needs of ADHD would not only result in the previously reported clinical improvements (e.g., reduction in ADHD and comorbidity symptoms), but also reduce the risk and rate of recidivism compared to the general intervention or no intervention. However, the design may be limited by the difficulties inherent in the prison setting and in following up the sample after release.


Eligibility Criteria:
Inclusion Criteria:

* To have signed written informed consent to participate in the study
* To be between 18 and 65 years of age
* To meet the DSM-5 diagnostic criteria for ADHD (American Psychiatric Association, 2013)
* To have been convicted of at least one crime under Spanish or German criminal law
* To have been incarcerated for at least six months and three or fewer years since the completion of the conviction at the time of eligibility assessment.

Exclusion Criteria:

* To have a severe personality disorder, psychotic disorder, or pervasive developmental disorder as their primary diagnosis, as the intervention would not meet their clinical needs
* To have an IQ of 80 or less, as measured by a standardized IQ test (Raven et al., 1993), due to the complexity of the cognitive components in the CBT program
* To have participated in a previous psychological intervention for ADHD;
* To not be fluent in Spanish or German, depending on the study site.
Lanreotide In Polycystic Kidney Disease Study

LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014.

An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus.


Eligibility Criteria:
Inclusion Criteria:

* autosomal dominant polycystic kidney disease (clinical, familial, imaging grounds)
* measured GFR : 30 to 89 ml/mn/1.73m2
* age \> 18
* affiliated with health insurance
* written informed consent

Exclusion Criteria:

* iohexol /iodine allergy
* diabetes mellitus
* other associated nephropathy suspected
* evolutive or recent malignant disease ( in the previous 5 years)
* cholelithiasis
* uncontrolled hypertension (BP\>160/100 mmHg)
* cardiac failure of grade III or IV according to the NYHA (New York Heart Association) classification
* liver failure
* psychiatric illness
* pregnancy, lactation, lack of contraception
* use of somatostatin analogs during the last 6 months
Targeted Potassium Levels for Prevention of ICD Therapy

This study evaluates whether a rigorously controlled high-normal level of serum-potassium (4.5-5.0 mEq/L) using dietary recommendations, potassium supplements and mineralocorticoid receptor antagonists will results in a lower incidence of cardiac arrhythmias in patients with an ICD. Patients will be randomized to this treatment or a control arm, where patients will receive usual guideline recommended follow-up.

There is solid evidence that potassium-sparing drugs increase survival and ameliorates symptoms in heart failure patients and post-hoc studies have suggested that high-normal levels of blood potassium levels (p-K) markedly decreases the risk of malignant arrhythmias in cardiovascular patients.

This trial will randomize patients implanted with implantable cardioverter defibrillators (ICDs), who remain at high risk of life-threatening cardiac arrhythmias, to a standard therapy or standard therapy plus a regimen to keep high-normal p-K levels. The study will enroll 1,000 patients from the outpatient pacemaker clinics at Rigshospitalet and Gentofte hospital. Using a planned regime to increase p-K using inexpensive drugs and potassium supplements, the patients enrolled and followed with regular controls as well as continuous monitoring using existing home monitoring systems over a period of 4 years for the primary endpoint of appropriate ICD therapy and all cause mortality. Including analysis, the trial will be running for 5 years

Eligibility Criteria:
Inclusion Criteria:

* Implantable cardioverter defibrillator (ICD) or cardiac resynchronization pacemaker with ICD (CRT-D).
* Age \>18 years

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \<30 ml/h
* Pregnancy
* Lack of ability to understand and sign informed consent
A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib

To evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration. The combination treatment consists of verteporfin photodynamic therapy and either triamcinolone acetonide or pegaptanib added as an intravitreal injection.


Eligibility Criteria:
Inclusion Criteria:

* age \>50
* all types of untreated subfoveal choroidal neovascularization secondary to AMD
* lesion size \<5400 microns in greater linear dimension (GLD)

Exclusion Criteria:

* have a history of prior photodynamic therapy, external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
* known allergy to verteporfin, triamcinolone or pegaptanib
* have received prior treatment with Macugen, or other anti-angiogenic compound or any investigational treatment (e.g. Ruboxistaurin, Lucentis \[ranibizumab\], Retaane \[anecortave acetate\], squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD
* have the presence of fibrosis, hemorrhage, pigment epithelial detachments, tear (tip) of the retinal pigment epithelium or other hypoflourescent lesions obscuring greater than 50% of the CNV lesion
* have had previous pars plana vitrectomy in the study eye

Other protocol-specified inclusion/exclusion criteria applied.
GUIDING MULTI-MODAL THERAPIES AGAINST MINIMAL RESIDUAL DISEASE BY LIQUID BIOPSIES

The overall objective of this study is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice.

Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence.

Specifically, we want to determine the association between disease-free survival (DFS) and ctDNA detection status after (1) curative-intended surgery and (2) adjuvant chemotherapy.

The study will prospectively enroll patients who undergo potentially curative surgery for PDAC. The intervention is repeated blood sampling at pre-defined time points.

Patient identification Patients with PDAC are screened for eligibility by the involved physicians based on the protocol of the multidisciplinary tumor board (MDT). The screening will be done based on the electronic health record in the electronic journal (at present, for example, Take Care). The National Health Record may be accessed for some patients to complete the record.

Patient recruitment and informed consent The involved physicians screen patients meeting the inclusion criteria specified below. Eligible patients are approached in person or initially by phone, after they have been informed about the diagnosis and the planned surgery. Patients are given written and oral information about the project by a trained research nurse or by an involved physician. Informed consent will be obtained before the beginning of any study-related procedures.

The signed and dated consent forms are scanned into the project's electronic database and stored physically in a locked space.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic ductal adenocarcinoma, according to the assessment of the MDT.
* Age 18 years or older.
* Patient able to understand and sign written informed consent in Swedish.
* Scheduled for curative intent surgical resection.

Exclusion Criteria:

* Hereditary pancreatic cancer.
* Verified distant metastases.
* Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study.
* Other cancers (excluding prior pancreatic cancer or skin cancer other than melanoma) within 3 years from eligibility screening.
Fall Recovery Training for Individuals With Chronic Stroke

The purpose of this study is to quantify how fall-recovery training improves the fall-recovery response of individuals with chronic stroke. Up to 20 participants with chronic stroke will be recruited from the community. Over six laboratory visits, participants will undergo sessions of fall-recovery training. Each session is comprised of simulated trips and slips as participants stand on a computer-controlled treadmill. Trip-recovery training consists of treadmill-delivered disturbances that induce a forward fall. Slip-recovery training consists of a treadmill-delivered disturbances that induce a backward fall. Separate progressions focus on initial steps with the left and right limbs. The training intensity, as determined by the disturbance magnitude, is progressive and dependent on participant performance. Step length and maximum trunk angle will be calculated. The hypothesis is that, with practice, participants will recover from larger perturbations, and they will increase step length and reduce trunk rotation during fall recoveries.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years or older
* Participants must have had a single stroke of non-cerebellar origin

Exclusion Criteria:

* More than one stroke
* Unable to walk one block without stopping or using a walking aid, such as a cane
* Acute illness at the time of functional assessment or training
* Body mass greater than 136 kg (300 lbs)
* Lower extremity joint replacement or shoulder joint replacement within a year prior to participation
* Dementia
* Parkinson's disease
* A history of back surgery
* A history of neck surgery
* More than one occurrence of back or neck pain in the month prior to participation
* Current back or neck pain at the time of participant enrollment
* Bulging vertebral discs
* Spine, hip, or lower extremity fracture within a year prior to participation
* Open lesions on the lower extremity
* Insulin-dependent diabetes
* Use of a pacemaker
* Use of an ostomy pouch
* Pregnancy
* Osteoporosis
* Doctor recommendation to avoid moderate physical activity or exercise
* Any neural, muscular, or skeletal condition or injury that precludes safe participation in the training or introduces a confounding factor on the study, at the discretion of the clinician or study staff
Information or Physical Activity for Chronic LBP

The purpose of this study is to compare a specific fear-reducing information with symptom-based exercise


Eligibility Criteria:
Inclusion Criteria:

* Daily LBP, dominating over possible pain in leg or other joints/muscles
* Pain og \> 4 (scale 0-10) for more than 4 months

Exclusion Criteria:

* Cancer, inflammatory disease, previous back surgery, pregnancy
Prognostic Potential of Prehospital Biomarkers in TBI Patients

The PreTBI III study aims to investigate the prognostic potential of prehospital and repeated in-hospital S100B, NSE and GFAP measurements as predictors of neurological outcome in patients suffering severe TBI. Knowledge on prehospital S100B, GFAP and NSE levels as predictors of neurological outcome and mortality may underline the potential of a point-of-care analysis. Possibly, the early biomarker levels may contributed to accurate monitoring of biomarker dynamics and hereby support neurosurgeons and anaesthetists in the clinical decision-making regarding treatment and level of care offered to the patient.

Hypotheses:

1. Prehospital S100B level is a significant predictor of unfavourable neurological outcome (dichotomized disability rating scale (DRS) and glasgow outcome scale extended (GOS-E) measures) in severe TBI patients.
2. Prehospital GFAP level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
3. Prehospital NSE level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
4. combined panel of prehospital S100B, GFAP and NSE levels is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
5. Unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients can be predicted by dynamics in repeated measurements of S100B, GFAP and NSE.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with Glasgow Coma Score (GCS) GCS 3-8 suffering relevant trauma and displaying relevant clinical indices compatible with TBI as evaluated by EMS staff. Patients are considered incompetent due to on-going alteration of mental state.

Exclusion Criteria:

* \>6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.
Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

This is a Phase 1/2 study of zanubrutinib in Japanese participants with mature B-cell malignancies.

This study intends to assess the use of zanubrutinib as an investigational agent to develop new treatment options for Japanese participants with B-cell malignancies. No formal hypothesis testing will be performed given the small sample size.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants with Confirmed diagnosis of mature B-cell neoplasms including chronic lymphocytic leukemia/ small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma and Waldenström's macroglobulinemia
* Relapsed/refractory disease defined as disease that relapsed after, or been refractory to, at least 1 prior therapy
* Meeting at least one of criteria for requiring treatment
* Measurable disease by computed tomography (CT)/ magnetic resonance imaging (MRI) for mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular lymphoma (FL) participants and by serum immunoglobulin (Ig) M level \> 0.5 g/dL for WM participants
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2
* Life expectancy of \> 4 months

Key Exclusion Criteria:

* Known central nervous system involvement by lymphoma/leukemia
* Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
* Prior allogeneic stem cell transplant
* Systemic chemotherapy or radiation therapy within 2 weeks prior to first dose of zanubrutinib
* Active fungal, bacterial, and/or viral infection requiring systemic therapy
* Prior therapy with B-cell receptor inhibitor (eg, Bruton tyrosine kinase, phosphoinositide 3 kinase delta, and/or spleen tyrosine kinase inhibitor) or B-cell lymphoma 2 inhibitor (eg, venetoclax/ABT-199)
* Pregnant, lactating, or nursing women
* Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The Importance of Electrical Stimulation as a Treatment for Urinary Incontinence in Patients Prostatectomy

The use of electrical stimulation to reduce urinary incontinence in men undergoing prostatectomy exercises of the pelvic floor muscles (MAPs)

The study will be an experiment with active control, randomized, double-blind, parallel intervention. After met the eligibility criteria of the patients will be randomly allocated into two groups: Group exercises MAPs (GEX), which is the active control group and electrostimulation + exercises MAPs (GEEX).

Eligibility Criteria:
Inclusion Criteria:

* patients with urinary sphincter deficiency resulting from a radical prostatectomy surgery
* sent by urologists the same hospital where the experiment will take place
* having the maximum time six months after surgery
* to use 2 to 5 disposable protective per day

Exclusion Criteria:

* Symptoms of urinary tract infection
* symptoms of lower urinary tract obstruction
* anal fistula
* metallic implant in the body
* transurethral resection of prostate
* radiation therapy
* non-enforcement of the proposed treatment.
Reperfusion With Cooling in Cerebral Acute Ischemia

The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years old
* Symptoms consistent with an ischemic stroke with a large vessel occlusion (MCA, ICA-terminus) as determined by vascular imaging
* ASPECTS score of 5-7 on non-contrast CT of the brain
* Ability to undergo endovascular reperfusion therapy
* Must have no contraindications to general anesthesia
* A pre-treatment modified Rankin Score of 0 or 1
* Arterial puncture performed under 8 hours from symptom onset or last seen normal
* Immediate post reperfusion CT scan shows no hemorrhage

Exclusion Criteria:

* Bleeding diathesis with a platelet count \< 50,000 or INR \> 1.5
* Involved in another clinical trial
* History of dementia
* End stage renal disease on hemodialysis
* History of ventricular dysrhythmias
* Life threatening medical condition precluding survival under 6 months
* Presence of an IVC filter
* Contrast dye allergy with history of anaphylaxis
Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers by physical examination, vital signs, ECG, and safety laboratory parameters and results must be within normal ranges or considered not clinically relevant by the investigator.
* Age ≥ 18 years and ≤ 55 years.
* Body mass index (BMI) ≥ 18 and ≤ 30.
* Able/willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine-containing items when outside the Clinical Research Unit (CRU)
* Able to read Spanish and adhere to study requirements.
* Informed consent signed before any procedure required by the study.

Exclusion Criteria:

* Smoking.
* History or clinically relevant diseases.
* Be under administrative or legal supervision.
* Pregnancy and breastfeeding.
* Positive blood or urine drug of abuse test or breathalyzer prior to study drug administration.
* Any history, disease, disorder, condition, anomaly or clinical finding that is relevant in the judgment of the investigator that may interfere with the study.
* Known hypersensitivity to any drug or excipient of the drug.
* Use of medications, inhibitors, any prescription or over-the-counter products, including herbs, homeopathy, vitamins, minerals, and nutritional supplements, before or during the study, that may interfere with the conduct and results of the study.
* Donation or transfusion of blood or plasma before, during or after study drug administration.
* History of inadequate venous access and/or experience of difficulty donating blood.
* Not being able/unwilling to accept restrictions regarding diet, physical exercise and consumption of alcohol and/or articles containing xanthine when outside the CRU.
* Subject included in a clinical study in the 3 months prior to the study drug administration.