cyrilzakka/clinical-trials huggingface dataset:
Influence of Patient-Informed Choice in a Novel Treatment Model for LBP

1. (Primary) To compare the effectiveness of a patient guided choice of care using a patient decision support tool to clinical guided care within a novel care process for non-specific low back pain.

   (We hypothesize that the patient guided choice model will demonstrate significant improvements when compared to the clinician guided care approach)
2. (Secondary) To qualitatively investigate which components of the patient choice educational methods were most effective for informed decision making among patients who participate in the patient guided choice of care approach (We hypothesize that dialogue method of patient guided choice will be identified as most useful)

The purpose of this research study proposal is to evaluate patient choice within this physical therapist-led model for non-specific low back pain. Evidence exists that patients are eager to play an active role in decisions concerning their health. Recent evidence from research supports the benefit of decision aides for consumers, especially those that were accurate and refined to the specific problems of each patient. In our proposed randomized controlled trial (RCT), one group of patients in the study will have the opportunity to drive choices within their healthcare model; but only after receiving useful information on what the consequences of their selections will be. Patients will receive decision making information to assist in making an informed choice. The structured information will organize known results from the research literature to assist patients in understanding the likely outcome of their condition and what they need to adequately manage their own care. The control group of patients will receive the Physical therapist-directed care model that is presently used and has shown success. Patient outcomes will involve patient self report of improvement and whether or not the patient pursued care for the same condition over a 1 year period of time.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with mechanically producible LBP

Exclusion Criteria:

* the presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy.
Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel

This is a multi center open label study intended to provide photo documentation and time to response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to severe non-nodular inflammatory acne vulgarism.

This was a 12-week, multi-center, open label, two-arm study. Subjects will be assigned to treatment with 1% or 2% BPX-01 gel. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy. Photographs will be taken to document treatment effect.

Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, incidence of product related facial staining and collection of adverse events.

Eligibility Criteria:
Inclusion Criteria:

- moderate to severe inflammatory non-nodular acne vulgaris

Exclusion Criteria:

* female subject who is breastfeeding, pregnant or planning a pregnancy during the study
* have other skin condition or disease that would interfere with the study
* have had any prior treatment with minocycline
* have a known or suspected allergy to tetracycline class products
* have used OTC medications for the treatment of facial acne within the last 14 days
* have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days
* have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks
Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)

The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.

In recent years, ERCP is the standard procedure to remove the bile duct stones. The big stones(\>1.2 cm) require additional lithotripsy procedures for complete stone removal. Nevertheless, small stone fragments still remain in the common bile duct when the cholangiogram shows normal. The fragments are too small to be verified. These retained fragments may cause recurrence of stones. Another way to demonstrate residual CBD stones is to use intraductal ultrasonography (IDUS). However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system Spyglass gains widespread acceptance because of its independent washing channels and direct viewing. The investigators used Spyglass to detect if saline(50 or 100ml) infusion might clear the bile duct fragments after ERCP. Saline irrigation has many advantages such as easy stone removal, no additional cost and rare side effects. The purpose of this study is to evaluate the usefulness of saline solution irrigation in decreasing residual CBD stones.

Eligibility Criteria:
Inclusion Criteria:

* ERCP common bile duct stone patients were able to provide written informed consent;
* Size of stone large than 1.2 cm.

Exclusion Criteria:

* Unwillingness or inability to consent for the study;
* Coagulation dysfunction (INR\> 1.5) and low peripheral blood platelet count (\<50×10\^9 / L) or using anti-coagulation drugs;
* Previous ERCP;
* Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy;
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock;
* Biliary-duodenal fistula confirmed during ERCP;
* Pregnant women or breastfeeding;
* Presence of intrahepatic duct stone;
* Malignancy.
Surgeon Experience ReSTOR A +4 Intraocular Lens (IOL)

To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the United States.


Eligibility Criteria:
Inclusion Criteria:

* operable cataracts; candidate for presbyopic correcting intraocular lens (IOL)

Exclusion Criteria:

* ocular comorbidities confounding study outcomes
Stepped Care Treatment for Binge-Eating

Temple University is looking for women to participate in a study to evaluate the treatment options available to women living with binge eating disorder.

Binge-Eating Disorder is a significant public health problem for women. Despite this, there is limited research on how best to treat this disorder at varying levels of severity. The purpose of this NIMH-funded study is to enroll individuals in a brief form of cognitive-behavior therapy. If more intense treatment is needed, individuals will be randomly assigned to more intensive group and individual treatments (Cognitive-Behavior Therapy or Dialectical Behavior Therapy). Both of these treatments are talking therapies that have been adapted for women living with binge-eating disorder and are free of charge.


Eligibility Criteria:
Inclusion Criteria:

* Adult female, 18 years to 60 years
* Meets DSM-IV criteria for Binge Eating Disorder
* Resides within commuting distance
* Consents to research protocol, i.e.
* 18-24 months in assessment and treatment
* willing to be part of a biological assessment/physiological assessment
* have to be prepared that they will receive a brief individual treatment and if this does not work for them, that they will receive more intensive treatment including both group and individual treatment.
* agreement not to see other health professionals unless recommended
* seeing their own Primary care Physician/Nurse Practitioner for medical screening prior to study (i.e., before being allocated a guided self-help therapist)
* payment for their own medical assessment, monitoring, and medication if needed

Exclusion Criteria:

* Anorexia nervosa
* Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS, or Bipolar Mood Disorder
* Needs priority treatment for other debilitating conditions, e.g. current substance dependence requiring inpatient detox
* chronic absence of shelter
* IQ less than 70
* Impending jail/prison, court order to treatment, court order to treatment or to jail, or agency order to treatment or to loss of child custody (due to consequent inability to freely drop-out of treatment)
* Is pregnant, plans to become pregnant during treatment, or becomes pregnant before random assignment to study condition
* Medical instability
* Has had or is seeking Gastric bypass surgery
* On anti-seizure medication, beta-blockers, asthma medication, medication for heart disease, or any other medication that affects appetite or weight
* Psychotropics are acceptable if the doses are stable for at least 3 months prior to screening
Study to Evaluate Efficacy, Safety and Tolerability of HM15211(efocipegtrutide) in Subjects

This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH


Eligibility Criteria:
Inclusion Criteria:

* United States Sites: Adults ≥ 18 to ≤ 70 years.
* Korean Sites: Adults ≥ 19 to ≤ 70 years.
* BMI ≥ 18 kg/m2, with stable body weight (defined as change \< 5%) by history for 3 months prior to screening or since baseline liver biopsy, whichever is earlier.
* Subjects have a diagnosis of noncirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -7.
* MRI-PDFF performed at screening with ≥ 8% steatosis.

Exclusion Criteria:

* Subjects with a history of active or chronic liver disease, including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus (HIV).
* Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease \>12.
* Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines).
* Type 1 diabetes subjects, or T2DM subjects on insulin and/or GLP-1 receptor agonist therapy, or other therapies not allowed for this study
Optimization of a Fast-track Concept for Knee Joint Replacement

In an estimated 150,000 patients, a knee joint replacement is performed in Germany every year. The perioperative care of the patients aims at an optimal surgical technique, which leads to a high functionality in the joint, and above all at an adequate pain treatment. Patients experience pain especially intraoperatively and in the first days after the operation. The intensity of pain is a decisive factor that can hinder the patient's mobilization. In the KneeOptOut study (ethics application number EA4/009/17), which has already been successfully carried out and approved by this ethics committee, it was shown that the use of local infiltration anaesthesia (LIA) for pain therapy after primary knee endoprosthetics is comparable to catheter-supported regional anaesthesia (manuscript under review at the European Journal of Anaesthesiology). During surgery, the morphine requirement of patients in the LIA group was significantly higher than that of patients who underwent catheterization. Postoperatively, however, both subjective pain by VAS and opiate consumption were comparable.

In order to optimize the intraoperative opiate need/consumption, an early-intraoperative procedure for local infiltration anesthesia will now be compared with the previous late-intraoperative procedure. Both procedures correspond to SOP for the treatment of primary knee endoprostheses and are currently used depending on the surgeon's requirements.


Eligibility Criteria:
Inclusion Criteria:

• patients undergoing elective, primary knee joint replacement in combined general anaesthesia

Exclusion Criteria:

* heart insufficiency NYHA \>2
* liver insufficiency \> CHILD B
* evidence of diabetic polyneuropathy
* severe adipositas BMI \>40
* patients \< 18 years
* pregnancy
* in case of police custody
* participation in a paralleled interventional RCT in a time frame of 30 days
* chronic opioid therapy \>3 months before scheduled surgery
* allergy against medication required for surgery or anaesthesia
Immunity to Infection in Healthy Participants and Participants With Cancer

Many cancer patients are highly susceptible to infection and respond poorly to vaccination. This observational study will determine molecular and cellular features of immunity to viral pathogens in participants with cancer and compare them to healthy controls. The aim is to identify how antiviral immunity in participants with cancer differs from that in healthy participants to understand why cancer patients are more susceptible to infections. In this context, the investigators will also evaluate immunity to medically indicated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and seasonal influenza vaccine received by study participants during standard care (vaccines are not part of the study).

Cancer and its treatments are associated with dysregulated immune systems, and cancer patients are highly susceptible to infections (e.g., influenza, SARS-CoV-2). Importantly, cancer patients often respond poorly to vaccination. The molecular and cellular mechanisms underlying immune dysregulation and poor immunity in cancer patients are manifold, variable among individual patients/conditions, and poorly understood. An in-depth understanding of these mechanisms is essential to identifying novel strategies to prevent infectious diseases and developing individualized therapies.

In this observational study, the investigators will collect blood samples from 200 participants with hematological and oncological malignancies and healthy participants and analyze the cellular and humoral immune status in the context of SARS-CoV-2 and influenza infection and vaccination within these samples using systems biological tools. Medically indicated vaccination against SARS-CoV-2 and influenza during study participation is allowed.

This study aims to (1) examine the fundamental innate, cellular, and humoral immune responses to pathogens that form the basis of immunological memory and (2) identify molecular and cellular mechanisms responsible for the reduced immune immunity to viral pathogens in participants with cancer.

Eligibility Criteria:
Inclusion Criteria:

* You are aged 18 years or older.
* You are able to understand and give informed consent.
* Participants with cancer: you are suffering from cancer
* Healthy participants: you are a healthy individual.

Exclusion Criteria:

* You are unable to give informed consent.
* You have been suffering from an acute infection with fever during the last three days.
* You have a Hb level of less than 9 g/dl.
* You have a human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
Recurrent Hypoglycemia in Type 1 Diabetes (Aim 2)

This study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (IAH) in type 1 diabetics following exposure to experimental recurrent hypoglycemia (HG). To induce IAH, patients with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo three 2-hour long hypoglycemic clamps. Neurochemical profiles will be measured by high field MRS before and after induction of IAH. Subject glycemic variability and activity/sleep for 1 week before each study will be monitored as all factors have been shown to alter responses to HG.

The long-term goal of this project is to identify how recurrent hypoglycemia (HG) leads to the clinical syndrome of impaired awareness of hypoglycemia (IAH) in type 1 diabetes (T1D).

This study will test the hypothesis that recurrent HG in T1D leads to an upregulation in brain glucose transport and alterations in glutamatergic and GABAergic tone. The investigators will use MRS methodology that permits evaluation of cerebral cortex and hypothalamus in the same session to simultaneously evaluate the cerebral correlates/mediators of impaired awareness and impaired counterregulatory hormone responses (CRR). High MR data quality and reproducibility will be ensured by using high field MR scanners and technical advances (automated voxel placement, real-time voxel position, frequency, shim updates). Continuous glucose monitoring and actigraphy will be used to chronicle glucose variability and activity/exercise/sleep in the weeks before each experiment to assess the impact of these variables on IAH.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes diagnosed on clinical or laboratory grounds
* Diabetes duration 2 - 30 years
* Hemoglobin A1C \<8.5%

Exclusion Criteria:

* Impaired awareness of hypoglycemia as determined by the Cox and Gold questionnaires
* Pregnant or plan to become pregnant during the study period
* Uncontrolled hypertension (blood pressure \> 145/95 mmHg at screening)
* Evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis)
* Proliferative retinopathy
* Impaired kidney function (GFR \< 45)
* History of myocardial infarction, stroke, seizures, neurosurgical procedures, major depression requiring hospitalization within the last 5 years, arrhythmias
* Current substance abuse
* Use of drugs that can alter glucose metabolism including but not limited to glucocorticoids and niacin, and excluding insulin and glucose lowering drugs used to treat diabetes, as determined by a clinician
* Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs
* Unable to complete all study visits or procedures, as determined by the investigator
The Role of Ninjurin-1 During Systemic Inflammation

* With the underlying study the investigators address the question if Ninjurin-1 (Ninj1) expression is altered in patients with systemic inflammatory response syndrome (SIRS) in comparison to healthy volunteers.
* The adhesion molecule Ninj1 is induced following nerve injury where it contributes to nerve generation. Besides it is described to facilitate leukocyte migration especially in the nervous system.
* The investigators hypothesize that Ninj1 expression is increased in SIRS patients, which will fortify its impact during inflammation and the transferability from bench to bedside.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* cardiac surgery patients

Exclusion Criteria:

* included in an interventional study
* Preoperative Infection (e.g. Endocarditis)
Ocular Surface in Patients With Soft Contact Lenses

Contact lenses modify the structure of the tear film by biophysical and biochemical interactions. These changes may explain more common dry eye symptoms and may sometimes cause lens failure or discontinuation.

In recent years, the investigators have various objective non-invasive methods of tear film evaluation such as the non-invasive break up time, interferometry, and tears meniscus height. These measurements are performed in clinical practice during consultation by devices such as LACRYDIAG.

The improvement of lens comfort requires a better knowledge of the ocular surface in patients with contact lenses. But currently none of these objective parameters have been accurately described.

Therefore, the investigators would like to build a database to describe the different parameters of ocular surface in patients with soft contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Patients with soft contact lenses
* Patients with their contact lenses on the eyes at the time of the examination and having undergone a LACRYDIAG examination
* Only Right eye analyze

Exclusion Criteria:

* Patients with rigid contact lenses
* Patients not wearing their lenses at the time of the examination
Registry for Treatment of Upper Urinary Tract Tumours

The aim of this registry is to evaluate the incidence, indications and outcomes of patients presenting with UTUC in relation to the different treatment modalities used.

This is an observational international multi-center study in which data on consecutive patients with UUT tumours are collected. Centers from every continent may apply for participation in this registry. Data will be collected from consecutive patients over a five year period. Patients' data at baseline visit, at one year, three years and five years after inclusion in the registry will be recorded, as well as data on intra- and postoperative complications, recurrence and survival in the whole study period. Data from all participating centers will be collected through electronic case report forms (eCRFs), with use of an online Data Management System (DMS), which is located and maintained at the CROES Office.

Eligibility Criteria:
Inclusion Criteria:

* Is presenting with a suspected primary UTUC (any stage)
* Is scheduled for treatment of UUT tumour
* Has signed informed consent

Exclusion Criteria:

* No specific exclusion criteria are defined.
Sleep, Stress and Learning: an Experimental Pilot Study

To investigate the efficiency and effect of a programmed slow-breathing exercise in the evening to the heart rate variability, sleep quality and memory performance over night.

Background Stress and increased alertness in the evening are major reasons for sleep onset problems, poor sleep and insomnia symptoms. For instance, increased amount of REM, and decreased amount of slow wave sleep may result. Also, the function of sleep in memory consolidation may suffer. They also affect the sleep structure and continuity during the night. They are highly prevalent phenomena among the entire population, including healthy adults and children. However, at the physiological level, the concept of evening alertness is still understudied and often neglected.

Recent advances show that breathing exercise is an efficient tool to reduce stress. However, its use specifically prior to sleep onset and with measurement sleep stages and their microstructures with sleep EEG has been little been studied before. The overall objective of this study is to explore interrelations of stress, learning and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

* age 20-45

Exclusion Criteria:

* chronic disease requiring daily medication, acute sickness (e.g. a flu), jet lag from a recent travel, current diagnosed sleep disorder (such as snoring or insomnia) and any use of medication affecting autonomic nervous system function or sleep.