cyrilzakka/clinical-trials huggingface dataset:
PRECISION Pain Research Registry

The PRECISION Pain Research Registry enrolls participants with chronic low back pain (cases) and participants who are free of chronic pain (controls) to study the epidemiology and management of chronic pain. The vision of the registry is to conduct research to provide a future for all unbounded by pain.

Case participants complete case report forms at quarterly encounters, whereas control participants complete a case report form only at an initial encounter.

A series of validated or recommended research instruments are used or adapted by the registry for deployment in its case report forms. These may include some or all of the following at a given encounter:

* National Institutes of Health Minimum Dataset for Research on Chronic Low Back Pain
* Roland-Morris Disability Questionnaire
* Patient-Reported Outcomes Measurement Information System (PROMIS-29)
* History of Medical Conditions Inventory
* Pain Sensitivity Questionnaire
* Pain Catastrophizing Scale
* Pain Self-Efficacy Questionnaire
* Non-Pharmacological Treatments Inventory
* Pharmacological Treatments Summary
* Drug Adverse Events Index
* Physician Profile
* Physician Communication Behavior Questionnaire
* Physician Consultation and Relational Empathy Measure
* Patient Satisfaction Questionnaire (PSQ-18)

These instruments include measures that may serve as the independent or dependent variables in various substudies conducted by the registry over time, including observational studies (e.g., case-control studies, cohort studies) and randomized controlled trials.

The registry also maintains a biobank of biological specimens that have been collected from enrolled participants, including saliva and blood that may be used for DNA sequencing or biomarker analysis.

Eligibility Criteria:
Inclusion Criteria:

* Must reside within the contiguous 48 United States or District of Columbia
* Must provide a valid, government-issued identification with photo and birthdate
* Must have Internet access or telephone service to communicate with registry staff
* Must have sufficient English language proficiency to complete case report forms independently or with assistance from registry staff
* Must have a primary care physician or other physician who regularly provides health care
* Must provide the name, dose, and frequency of use of all current medications
* Case participants must have chronic low back pain
* Control participants must be free of any chronic pain and may include healthy volunteers

Exclusion Criteria:

* Must not be pregnant
* Must not reside in an institutional facility
Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy

This prospective observational cohort study aims to improve the postoperative course after minimally invasive pancreaticoduodenectomy (MIP) with stented pancreaticogastrostomy (sPG) for pancreatic head or peri-ampullary neoplasms. Patients are submitted to an enhanced recovery after surgery (ERAS) program with early enteral nutrition (EEN).

Pancreaticoduodenectomy (PD) is the standard of care for patients with malignant or benign disease of the pancreatic head or peri-ampullary region. The postoperative course after PD is strongly dependent of the occurrence of pancreatic fistula (POPF) and/or delayed gastric emptying (DGE). In a recent multicentre randomized controlled trial, the investigators have shown pancreaticogastrostomy (PG; without a stent in the pancreatic duct) to be associated with 8% POPF rate, significantly lower than pancreaticojejunostomy (20%) (1). Since then, PG reconstruction is considered the standard of care in PD, which is also underlined in more recent systematic reviews.

In patients without POPF after PD, the length of hospital stay is determined by the occurrence of DGE, which is poorly understood and currently lacks any effective treatment. Patients who developed DGE after PD with PG anastomosis (n=18; 20%) had a significantly (p=0.014) longer (mean + sem) length of hospital stay (LOS) of 26.3 + 1.58 days, as compared to 22.4 + 1.27 days for patients without DGE (n=69). These figures are observed in the investigators' center as part of the multicentre RCT.

Enhanced recovery after surgery (ERAS) or fast-track (FT) programs are able to reduce postoperative length of hospital stay (LOS). Indeed recently, ERAS or FT programs have been implemented successfully in PD (2). Patients were discharged 4 days earlier in the ERAS group, without a negative effect on the clinical outcome. Still, many surgeons are reluctant to implement ERAS programs because they fear compromising patient safety.

In efforts to improve the outcomes of PD, many surgical techniques have been evaluated to restore the pancreatic digestive continuity after PD. However, the best way to ensure this and whether or not to perform the procedure via standard open or minimally invasive, i.e. 2- or 3-dimensional laparoscopic (3D-LPD) or 3-dimensional robotic surgery (RPD), is still under debate. The investigators have passed the learning curve of 50 3D-LPD and hypothesize the implementation of ERAS and EEN in 3D-LPD can improve short-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients, male or female, who undergo MIP + sPG for a pancreatic or peri-ampullary tumor
* Patients with and without pre-operative biliary drainage (for obstructive jaundice)
* Patients fit for minimally invasive pancreaticoduodenectomy (MIP)
* Informed consent signed

Exclusion Criteria:

* Pregnancy
* MIP for pancreatic trauma
* MIP for complications of endoscopic retrograde cholangio-pancreaticography (ERCP)
* Reconstruction of the portal vein or superior mesenteric vein
* Any arterial reconstruction at the time of surgery
A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food

The main objective of this trial is to investigate the relative bioavailability of BI 1595043 under fed state (Test, T) and under fasted state (Reference, R).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  * Use of adequate contraception, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea
  * Sexually abstinent
  * Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) Unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply
Low-Field Bedside Brain Magnetic Resonance Imaging in Pediatric Extracorporeal Membrane Oxygenation

The primary object of the study is to further characterize safety and feasibility of low-field bedside MRI in pediatric and neonatal ECMO patients. To perform imaging assessments of an early-stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength. Collect qualitative data from the image assessments to optimize device performance using a low field magnetic resonance imaging device in a simulated use environment; Collect qualitative data from the image assessments using a high field magnetic resonance imaging, computed tomography and ultrasound devices. Generate anonymized image data for post-acquisition evaluation, performance measuring and planning for subsequent study size


Eligibility Criteria:
Inclusion Criteria

* Subjects admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit at Children's Mercy Kansas City
* Ages 0-17 years
* Undergoing venovenous or venoarterial ECMO

Exclusion Criteria

* Pregnancy
* Active implants such as:

  * Pacemaker
  * Implanted defibrillator
  * Implanted insulin pump
  * Deep brain stimulator
  * Vagus nerve stimulator
  * Cochlear implant
  * Programmable shunt
* MRI incompatible surgical hardware (e.g., staples, screws, etc.)
* Metal-containing tattoos or permanent make-up on head or neck
* Suspected metal in eye, e.g.,
* Former or current welders, metal workers, or individuals with a metal injury
* Metal shrapnel
* Passive implants are considered MRI conditional
Synbiotics for the Management of Malnutrition (Children)

In this study, dose related effect of synbiotics on the blood indices of severely acute malnourished (SAM) children (6-59 months) was carried out in hospitalized setting. Fifty SAM children were enrolled in a double-blind, randomized design.

The study was done at Nutrition Rehabilitation Unit (NRU), Department of Social \& Preventive Pediatrics, Mayo Hospital, Lahore, Pakistan, a Tertiary Care large urban teaching and referral hospital and was approved by human ethics Institutional Review Board (IRB) .Galacto-oligosaccharides (Oligomate) as prebiotics were procured from Yakult Pharmaceutical Industry, Japan and Resiton (lactobacillus paracasei subsp. paracasei) as probiotics were procured from MakNsons Pharmaceutical Industry, Italy. In the present study we enrolled 50 severely acute malnourished (SAM) in patients of 6-59 months of age while follow-up treatment was given at the out-patient department. We define SAM as weight-for height of less than 70% of the median, nutritional edema (Kwashiorkor), or both, mid-upper arm circumference (MUAC) of less than 11.5cm. Anthropometry protocols were followed by research standards

Eligibility Criteria:
Inclusion Criteria:

* In the present study we enrolled 50 severely acute malnourished (SAM) patients of 6-59 months of age while follow-up treatment was given at the out-patient department.

  * Patients having weight-for-height of less than 70% of the median, nutritional edema (Kwashiorkor), or both,
  * mid-upper arm circumference (MUAC) of less than 11.5cm

Exclusion Criteria:

* Participant taking other supplements or enrolled in other studies
Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis


Eligibility Criteria:
Inclusion Criteria:

* Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
* Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
* Subject must be in paid employment
* Subject has self-reported work impairment since onset of symptoms

Exclusion Criteria:

* A subject has chronic arthritis diagnosed before age 16 years.
* Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
* Subject has preceding treatment with any biological TNF antagonist
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
Effects of Brazil Nut Supplementation in Patients With Chronic Kidney Disease Undergoing Conservative Treatment

The aim of this study is to evaluate the effects of Brazil nut supplementation on inflammation, oxidative stress and intestinal microbiota in patients with chronic kidney disease undergoing conservative treatment.

Complications such as inflammation and oxidative stress are common in chronic kidney disease (CKD) and directly influence the rate of disease progression. Patients with CKD also have intestinal dysbiosis, which aggravates the inflammatory process and oxidative stress, forming a vicious circle between inflammation, oxidative stress and intestinal dysbiosis. Nutritional strategies try to alleviate this circle and Brazil nuts, rich in bioactive compounds, have already been proven effective in mitigating inflammation and oxidative stress in CKD patients on dialysis. However, to date, the effectiveness of Brazil nuts in patients with CKD in stages prior to dialysis (conservative treatment) has not been tested. The bioactive compounds in Brazil nuts are expected to contribute positively to the redox balance, reduction of inflammation and intestinal eubiosis in patients with CKD undergoing conservative treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with more than three months of nutritional monitoring at the Renal Nutrition Outpatient Clinic of the Universidade Federal Fluminense (UFF), between stages G3a and G4, will be included, according to KDOQI 2020 guidelines, and authorized by the medical and nutritionist team.

Exclusion Criteria:

* Current use or in the last three months of antibiotics, anti-inflammatories and/or antioxidant supplements. Patients who are allergic, intolerant, or regularly ingest Brazil nuts; pregnant/lactating women, smokers; undergoing cancer treatment, HIV-positive, or with any clinical condition that compromises the accuracy of the intervention.
Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder

The purpose of this study is to establish the potential of MEM 1003 as a safe and effective treatment for patients with an acute manic or mixed episode of bipolar disorder.

Bipolar affective disorder is one of the most common, severe, and persistent mental illnesses. It is characterized by periods of deep, prolonged, and profound depressions that alternate with periods of excessively elevated and/or irritable mood (mania). The pathophysiology of bipolar disorder is complex, and can include an inheritable component, administration of antidepressant medications, behavioral sensitization processes, and neuronal calcium dysregulation that leads to apoptosis of critical brain circuitry that regulates emotion. Addressing the dysregulation in calcium levels in the central nervous system by administering compounds such as MEM 1003 may have the potential for altering the cyclical course or progression of bipolar disorder.

MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel modulators.

Eligibility Criteria:
Inclusion Criteria:

* bipolar I disorder with acute manic or mixed episode, with or without psychotic features
* YMRS score of at least 20
* history of at least one previous manic or mixed episode requiring treatment in the last 10 years

Exclusion Criteria:

* history of failing to respond to treatment with two or more adequate trials of approved anti-manic medications for the current episode
* Axis I or Axis II disorder (other than bipolar I disorder) that requires treatment or has been the primary subject of treatment in the past 3 months
* defined substance abuse or dependency within the 3 months
* schizophrenia, schizoaffective disorder, delusional disorder, mental retardation or pervasive developmental disorder
* suicidal or danger to others
Registry Study on Intraocular Lenses Manufactured by Teleon Surgical B.V.

This is a retrospective, observational (Registry) study aiming to collect safety and performance data on the use of intraocular lenses (IOLs) manufactured by Teleon Surgical B.V. according to routine practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Diagnosis of cataract in at least one eye or seeking clear/refractive lens exchange
* Provide consent to retrospective data collection

Exclusion Criteria:

* Patients younger than 18 years
* Patients with congenital primary aphakia or secondary aphakia
An Observational Study on Long-Term Effectiveness and Safety of RoActemra/Actemra (Tocilizumab) in Daily Practice in Patients With Rheumatoid Arthritis (ICHIBAN)

This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active moderate to severe rheumatoid arthritis
* Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists
* Prescription of RoActemra/Actemra according to label

Exclusion Criteria:

N/A
PILOT for The Precision Exercise Regimen for Cancer Care (PERCC) Study

This study is designed to evaluate whether a precision exercise regimen is feasible to implement within cancer populations, specifically stage II-III primary lung cancer patients receiving multimodal therapy, and delivered through telehealth.

This is a pilot study evaluating the feasibility of the Precision Exercise Regimen for Cancer Care (PERCC) intervention in stage II and stage III Non-Small Cell Lung Cancer (NSCLC) patients receiving multimodal therapy at the Huntsman Cancer Institute (HCI) at the University of Utah. Eligible patients will begin the intervention at the pre-treatment clinic visit and continue until approximately two months post-surgery.

The PERCC intervention is a virtually supervised home-based exercise program. Participants will engage in exercise starting at least two weeks before receiving their first neoadjuvant treatment for lung cancer and continuing until two months after receiving surgical treatment. The exercise modes will include basic transfer and calisthenics mobility, aerobic, and resistance exercises and will be performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and older at time of diagnosis
* Patient diagnosed with stage II and III non-small cell lung cancer (NSCLC)
* Patient receives either neoadjuvant chemotherapy or immunotherapy and surgery
* Patient able to follow direction and complete questionnaires in English or Spanish
* Patient agrees to complete the PERCC intervention

Exclusion Criteria:

* Morbidly obese (BMI \>40 kg/m2 ) or anorexic (BMI \<17.5 kg/m2 )
* Abnormalities on screening physical exam per study physicians or physical therapist to contraindicate participation in exercise program compliance
* Alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer)
* Patient scheduled to receive single modality cancer treatment (unimodal therapy), scheduled to begin treatment within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started
Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

Ciprofloxacin and levofloxacin are both in guidelines to use for prophylaxis in autologous and allogeneic Stem cell transplant.Ciprofloxacin was recently replaced by levofloxacin as the preferred agent in some transplant centers. In some small retrospective studies ciprofloxacin prophylaxis was associated with a higher rate of breakthrough gram positive bloodstream infections. However, the optimum oral agent for antibacterial prophylaxis in transplant recipients remains uncertain.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18-75 years of age with a diagnosis of a hematological malignancy. Meet the stem cell transplant program criteria to undergo autologous or allogeneic hematopoietic stem cell transplantation.

Exclusion Criteria:

* Prolonged QT
* Allergies to ciprofloxacin or levofloxacin
Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

The benefit of anti-worm therapy as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not previously been studied. This study will compare recovery rates of children with SAM treated in the community with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of their case management.


Eligibility Criteria:
Inclusion Criteria:

* 12-59 months old
* Kwashiorkor and/or Marasmus
* Qualified for home-based therapeutic feeding with RUTF

Exclusion Criteria:

* Obvious congenital or other malformation that makes child a poor candidate for feeding with RUTF
* Unable to consume test-dose of RUTF in clinic
* Parent refusal to participate and return for follow-up