cyrilzakka/clinical-trials huggingface dataset:
Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study

To learn if a process called neuromodulation can help to improve pain due to CIP

Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds
* Patients seen at Pain Management Center at MD Anderson Cancer Center
* Patient ages greater or equal to 18 years but less than or equal to 85 years

Exclusion Criteria:

* Patients with cognitive dysfunction
* Patient with recent history (\<6 months) of drug or alcohol abuse
* Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
* Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds
* Patients seen at Pain Management Center at MD Anderson Cancer Center
* Patient ages greater or equal to 18 years but less than or equal to 85 years

Exclusion Criteria

* Patients with cognitive dysfunction
* Patient with recent history (\<6 months) of drug or alcohol abuse
* Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
* Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy
A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain

The purpose of this study is to evaluate the analgesic (painkiller) effectiveness and safety of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic cancer pain.

This is an open-label (all people know the identity of the intervention) study. A total of 35 participants will be enrolled in this study. Participants will receive tablet of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication as 1 to 2 tablets every 4 to 6 hours as needed for pain relief, up to maximum of 8 tablets per day. Rescue medication consisting of Extra Strength Tylenol (500 mg) 2 tablets daily for the first six days of the Open-label Phase will be allowed so that the total daily dose of acetaminophen will not exceed 4,000 mg. The total duration of the study treatment for each participant will be approximately 6 weeks. Safety will be evaluated by assessment of adverse events, clinical laboratory tests, skin site assessments, vital signs, and physical examination which will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants whose pain has reached a stage now requiring treatment with a weak opioid, according to the opinion of treating physician
* Participants who have received a regular weak opioid, for at least 48 hours and at a dosage appropriate for their pain at that time
* Participants with a histologically, radiologically or hematologically confirmed malignancy; whose pain is judged by the investigator to be caused by the malignancy

Exclusion Criteria:

* Participants who have already received regular treatment with a strong opioid for their cancer pain. This should not exceed more than 3 doses of a strong immediate release opiod in last 7 days, and none in last 24 hours
* Participants with significant abnormalities in hepatic or renal function which would in the opinion of the investigator, prevent the participants involvement in the study
* Participants with a history of allergy or hypersensitivity to tramadol or acetaminophen
* Participants who, at entry have treatments planned which may alter abruptly, the degree or nature of pain experienced (eg radiotherapy, neurological techniques surgery)
* Participants with a history of abuse of opioid analgesics prior to their diagnosis of cancer
Cardiac Symptoms in Patients With Treated Graves' Disease

Hyperthyroidism is a condition with increased production of thyroid hormone from the thyroid gland. Hyperthyroidism affects the heart's inotropy (contractile force) and chronotropy (rhythm). Therefore, patients often experience symptoms such as increased/irregular heart rate, pounding heartbeats, and shortness of breath. The cardiac symptoms often improve when hyperthyroidism is treated and biochemical euthyroidism is achieved. However, knowledge of the long-term effects on the heart is limited. Existing studies have generally shown that patients with hyperthyroidism have an increased morbidity and mortality.

The investigators conducted a questionnaire survey which showed that about 38% of patients with Graves' disease continue to experience cardiac symptoms even months after normalization of thyroid hormone concentrations in the blood. This observation supports the presence of a persistent cardiovascular dysfunction, which may be due to a modulation of genomic or non-genomic factors with an effect on the cardiovascular system. These reflections are the focus of this clinical study. The aim of the study is to investigate the possible pathophysiology for this new "syndrome" in biochemically euthyroid patients. It is not a repetition of previous similar experiments.

Cardiac symptoms are common i patients with Graves' disease. These symptoms often disappear when hyperthyroidism is treated. However, a subgroup of patients with Graves' disease experiences persisting cardiac symptoms after treatment. The aim of the study is to describe these symptoms and investigate their origin.

A total of 75 patients are included in the study. Patients were recruited from the Department of Nephrology and Endocrinology at Copenhagen University Hospital Rigshospitalet and the Department of Internal Medicine, Section of Endocrinology at Herlev Gentofte Hospital, Denmark. The patients were identified by extracting a list of patients with the International Classification of Diseases 10 codes (ICD 10 codes) E050 and E059. Also, a list of patients with positive thyrotropin receptor antibody (TRAbI measurements was extracted.

All patients had a thorough cardiac work up including blood samples, 12-lead resting electrocardiogram, 24-hour electrocardiogram monitoring (Holter), transthoracic echocardiography, and exercise stress test. The focus was to investigate whether the cardiac symptoms could be explained by structural or functional changes of the heart or by cardiac arrhythmias.

All patients were questioned about their symptoms including: type of cardiac symptoms, frequency and when they occured. The focus was to gain knowledge on the clinical presentation of cardiac symptoms in the subgroup.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Graves' disease
* Between the ages of 18 and 55 years
* Has been euthyroid for at least three months prior to inclusion
* Experiences cardiac symptoms

Exclusion Criteria:

* Cardiovascular disease
* Deemed unsuitable by project staff (e.g. due to language problems)
* Pregnancy
* Alcohol abuse or other abuses
Nationwide Awareness Campaign and Call for Dental Screening for HHT in Germany

HHT is a relative rare autosomal dominant inherited disorder of the fibrovascular tissue. Diagnosis of HHT is often delayed for decades (Pierucci 2012). However, it would be desirable to achieve an early diagnosis as early screening and treatment decrease disease-associated complications and increase life expectancy (Kroon 2018). Our approach is a nationwide call and awareness campaign to dentists in Germany, as nearly all persons visit a dentist from time to time. This approach is promising to us, as most patients develop nosebleeds and multiple, typical telangiectases of the skin or mucosa. A predilection site is the oral mucosa and the face, including the lips (Shovlin 2000).

The German self-help group is taking down the number of inquiries from patients and physicians per months since April 2017. In June 2018 an article about HHT is planned to be published in the journal of the German dental association and the Federal Association of Fund Dentists of Germany. This journal is distributed to all dentists in Germany and is a set book for them. Total circulation in 2017 was 77,621 (http://www.aerzteverlag.de/portfolio/fachwissen-medizindental/zm-zahnaerztliche-mitteilungen/profil/ ). The article describes the case of visceral abscesses after dental screening in a patient with HHT and pulmonary arteriovenous malformations. These could probably have been prevented if the dentist had prescribed an antibiotic prophylaxis to the patient. The article includes a call to search for telangiectases. If those are seen the dentist is recommended to ask the patient if he or relatives have nosebleeds. If both apply, the dentist is asked to inform the patient about HHT and give him the address of the national German self-help group.

After 3 and 6 months a reminder shall be published in the same journal.

Eligibility Criteria:
Inclusion Criteria:

* patients having telangiectasia and nosebleeds or nosebleeds in the family

Exclusion Criteria:

-
Vildagliptin on Gastric Accommodation

Dipeptidyl peptidase-4 (DPP-4) inactivates glucagon-like peptide-1 (GLP-1). Whether DPP-4 inhibition affects GLP-1 metabolism in vivo and/or food intake remains unknown.

The aim of this study is to evaluate the effect of vildagliptin (DPP-4 inhibitor) on gastric accommodation and ad libitum food intake in healthy volunteers (HVs).These effects will be evaluated in two randomized, placebo-controlled, single-blinded trials. Each protocol will include ten volunteers.

Protocol 1: Sixty minutes after treatment a nutrient drink (270 kcal) will be intragastrically infused and intragastric pressure (IGP) will be measured for one hour.

Protocol 2: 60 min after treatment the participants consume one nutrient drink (300 kcal). Thirty minutes hereafter, the participant will eat ad libitum from a free-choice buffet for 30 minutes. Blood will be collected at several time points to measure active GLP-1 plasma levels.


Eligibility Criteria:
Inclusion Criteria:

- Aged between 18 to 65 years old

Exclusion Criteria:

* presence of symptoms or a history of gastrointestinal diseases
* diabetes
* drug allergies
* psychological disorders
* major gastrointestinal surgery
Follow-up Visit of High Risk Infants

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort study in which surviving extremely low birth-weight infants undergo neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 month corrected age). The goal of the study is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment, including:

* Evaluating development of motor skills, cognitive skills, language and behavior
* Determining mortality and the prevalence of specific medical conditions
* Assessing the relationship between growth and neurodevelopmental outcome
* Assessing the relationship between the socioeconomic status and developmental outcome
* Assessing the use of special support services and early intervention programs by this population
* Evaluating the need for follow-up at school age.

The scheduled evaluations collect: demographic information; socioeconomic status; medical history; medications; medical equipment required; growth data; a detailed neurologic examination; Bayley Scales of Infant Development (mental, motor, infant behavior); Child Behavior Checklist.

A sub-study will assess a reference group comprised of a limited number of healthy term infants born in Network centers to meet the following three aims: 1) to avoid potential ascertainment biases due to examiner expectations when only extremely preterm or other high-risk infants are assessed 2) in the absence of well-developed norms for the Bayley Scales, to define thresholds for impairment based on data for a representative sample of healthy children born at term in our centers and concurrently assessed by the same examiners as for our high-risk infants; and 3) to help identify and address when "drift" occurs over time in conducting and scoring Bayley assessments.

Eligibility Criteria:
* Infants inborn at NRN centers
* \<27 weeks gestational age
* Infants enrolled in one or more additional NICHD NRN Follow-up studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 27 weeks may be included in the FU Study.

Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, infants with birth weights between 401 and 1500 grams who were admitted to NRN NICUs within 14 days of birth were included in the database.
The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's Disease

Difficulty in turning is common after Parkinson's Disease. Patients with Parkinson's Disease take a greater number of steps, longer duration, narrower base of support in turning. Thus, turning ability is systematically investigated in Parkinson's Disease. The aim of this study to invastigate reliability, validity, and responsiveness of the timed 360° turn test in Patients with Parkinson's Disease.

At baseline, the timed 360° turn test, Unified Parkinson's Disease Rating Scale, Hoehn and Yahr Scale, Berg Balance Scale, Functional Reach Test, Timed Up and Go Test, Four Square Step Test and Trunk Impairment Scale was applied to the patients with Parkinson's Disease when the patients were "on" period. The timed 360° turn test was repeated after seven days from the first application when patients with Parkinson's Disease were "on" period to evaluate its reliability.

Eligibility Criteria:
Inclusion Criteria:

* at least 40 years of age,
* neurologist-diagnosed Parkinson's Disease
* Hoehn \& Yahr (H\&Y) stages 1 to 4,
* were able to walk 10 m with or without aids

Exclusion Criteria:

* visual, auditory, and orientational problems affecting study results
* orthopedic problems affecting walking,
* other neurologic conditions, cardiovascular, musculuskeletal, and vestibular disease
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic Hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* History of bariatric or upper-gastrointestinal surgery (RYGB, VSG, gastrectomy, esophagectomy, or Nissen fundoplication) at least 12 months prior to the start of Screening
* History of recurrent hypoglycemia occurring after bariatric or upper-GI surgery, as documented in the medical record.
* Body mass index (BMI) of up to 40 kg/m2
* If female, must not be breastfeeding and must have a negative urine pregnancy test result

Exclusion Criteria:

* Major surgery within 6 months before randomization.
* History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g., insulin autoimmune hypoglycemia).
* Use of agents that may interfere with glucose metabolism
[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease

AIM: Investigate wether there are differences in the parasympathetic nervous system in Parkinsons patients compared to controls.

MATERIALS AND METHODS: We use the tracer \[11C\]donepezil to image the parasympathetic nervous system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged 40-80 in our study. The participants will receive a careful medical examination, including a neurological examination, as part of the inclusion process. The subjects also have an MRI scan of the brain. Then PET/CT scans with \[11C\]donepezil are conducted - once for the upper abdominal region and once for the head region. For evaluating the function of the parasympathetic nervous system gastric emptying time, heart rate variability and salivary flow will be measured. These measureless will be correlated to the PET findings.

PERSPECTIVES: The study will potentially result in the development of a PET ligand for imaging the parasympathetic nervous system. This will have applications for research in Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic nervous system is involved


Eligibility Criteria:
Inclusion Criteria:

* Age 40-80 years

Exclusion Criteria:

* dementia,
* psychiatric diseases,
* serious medical illness including any type of previous cancer
* any drug with known interaction with the autonomic nervous system
* metal in the body (because of MRI scan)
* pregnancy or breast feeding (because of radiation due to PET/CT)
* known diseases of the salivary glands, stomach, intestines.
* Prior major surgery to salivary glands, esophagus, stomach.
Treatment of In-Stent Restenosis 2 Study

The aim of this study is to compare the efficacy of sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR).

Current therapy for in-stent restenosis (ISR) is based on the drug-eluting stents (DES) or drug-eluting balloon catheters (DEB). In clinical practice, paclitaxel is used as an effective antiproliferative agent loaded into DEB (paclitaxel-eluting balloon catheters; PEB).

In contrast to paclitaxel, sirolimus is difficult to deliver on the balloon surface, due to insufficient tissue uptake and shorter tissue retention of limus drugs. It was found that phospholipid-encapsulated sirolimus nanoparticles could be used for coating balloon catheters to provide efficient drug transfer to vessel wall with high tissue concentration.

This prospective randomized non-inferiority study compares the efficacy of new sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR).

The primary end-point is in-segment late lumen loss (LLL) at 12 months as measured by quantitative coronary angiography (QCA).

Secondary end-points are the incidence of binary ISR (˃50% DS) and the overall incidence of 12-month major adverse cardiac events (MACE; cardiovascular death, non-fatal acute myocardial infarction \[AIM\], or target vessel revascularization \[TVR\]).

Eligibility Criteria:
Inclusion Criteria:

* patients with BMS- or DES-ISR (˃50% diameter stenosis; DS)
* ≥18 years of age
* willing to sign an Informed consent

Exclusion Criteria:

* concomitant diseases with an expected survival time of less than 12 months
* or that limited the possibility of control coronary aniography (e.g., advanced renal failure).
* impossibility of long-term (6 months) dual antiplatelet treatment
Multi-PAP: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy

This study assesses the effectiveness of a complex intervention in young-old patients with multimorbidity and polypharmacy aimed at improving physician drug prescription in primary care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) months from baseline compared to usual care.

Design: Pragmatic cluster randomized clinical trial with 12 months follow-up.

Unit of randomization: general practitioner.

Unit of analysis: patient.

Setting: Primary Health Care Centres in three different Spanish Autonomous Communities (Aragón, Madrid and Andalucía).

Population: Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months). N=400 patients (200 in each arm, 5 patients per physician) will be recruited by general practitioners before randomization.

Intervention: complex intervention.

Control group: usual care.

Variables: MAI, health care utilization, quality of life (Euroqol 5 Dimensions (5D-5L), drug therapy and adherence (Morisky-Green, Haynes-Sackett), clinical and socio-demographic factors. Economic appraisal variables: time spent training FPs, cost of teaching staff, time spent on physician-patient interviews, utilities measured using the EuroQol 5D-5L.

Analysis: All analyses will be carried out adhering to the intention-to-treat principle. Description of baseline characteristics. Basal comparison between groups. Analysis of main and secondary effectiveness (between-group difference in T1-T0 MAI score, with corresponding 95% Confidence Interval); multilevel analysis will be used to adjust models. Estimated quality-adjusted life years (QALYs) gained at the population level. Calculation of cost-utility ratio.

Eligibility Criteria:
Inclusion Criteria:

* Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months).
* Informed consent.

Exclusion Criteria:

* Institutionalized patient at nursing homes or similar
* Life expectancy \< 12 months