cyrilzakka/clinical-trials huggingface dataset:
An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder

The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with recurrent Major Depressive Disorder

Exclusion Criteria:

* Symptoms of current depressive episode for less than 30 days or more than 2 years
* Mild depression, as measured by standard clinical research scales
* Significant suicide risk
* Lack of sexual activity (including masturbation)
* Other psychiatric conditions that would obscure the results of the study
* History of failure to respond to antidepressant treatment
* Pregnancy or breast-feeding

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer

The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI and gadofosveset-enhanced MRI for the management of rectal cancer patients.

Rectal cancer is a common form of cancer, and the treatment stratification depends on tumour and nodal stage as determined on MRI. Unfortunately, the information provided by standard T2-weighted MRI is not sufficient to accurately assess nodal involvement and tumour response after neo-adjuvant chemoradiotherapy. Additional functional information is required for reliable (re)staging. Diffusion-weighted imaging and gadofosveset-enhanced MRI are two new imaging techniques that have all shown great potential in rectal cancer staging. In order to provide definite evidence there is a need for a multicenter study with a large patient population.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven primary rectal cancer (≤15 cm from the anorectal verge as measured in MRI)
* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* Ineligibility to undergo MRI (claustrophobia, pacemaker, non-MR compatible surgical implants, metal fragments in the eye)
* Pregnancy
* Locally recurrent rectal cancer
* A history of severe allergy to contrast agents
* Ineligibility to receive gadofosveset contrast (history of contrast allergy, impaired kidney function with a Glomerular Filtration Rate \<30 ml/min/1.73m2
* Incurable disease due to metastases or co-morbidity
Investigating Distress Tolerance in Adults With Tourette Syndrome

Although behavior therapy is recognized as a first-line intervention for Tourette's Disorder (TD), less than 40% of adults with TD respond to this evidence-based treatment. Limited tolerance for aversive premonitory urges and affective states that accompany tics may be one likely factor that impedes behavior therapy outcomes. This study examines the relationship between distress tolerance and tic inhibition among adults with TD, and investigates the mechanism and effect of therapeutic skills training to enhance distress tolerance abilities. Findings will determine the optimal approach to enhance distress tolerance among adults with TD and ultimately lead to better behavior therapy outcomes.

Tourette's Disorder and other persistent tic disorders collectively affect about about 1% of the population, cause significant distress, and functional impairment. Although behavior therapy is recognized as a first-line intervention for Tourette's Disorder (TD), less than 40% of adults with TD respond to this evidence-based treatment. Limited tolerance for aversive premonitory urges and affective states that accompany tics may be one likely factor that impedes behavior therapy outcomes. This study examines the relationship between distress tolerance and tic inhibition among adults with TD, and investigates the mechanism and effect of therapeutic skills training to enhance distress tolerance abilities.

Eligibility Criteria:
Participants will be eligible for participation if the following inclusion criteria are met:

* at least 18 years of age
* have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater than 14 (\>9 for adults with motor or vocal tics only)
* exhibit a tic frequency of at least one visible tic per minute
* be fluent in English
* have a total premonitory urge for tics scale (PUTS) total score greater than 17 at Visit 2
* have a total DTS score greater than 30 at Visit 2

Exclusion criteria for participants include:

* history of cardiovascular disorder
* history of fainting or seizures
* history of frostbite
* open cut or sore on hand to be immersed
* fracture to the limb to be immersed
* history of Reynaud's phenomenon
* inability to complete rating scales
* inability to attend study visits
Effects of Exercise and Metformin on Methylglyoxal Levels in Prediabetic Individuals

The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.

There is no comparative study in the literature evaluating the effects of exercise and metformin on MGO in prediabetic patients. The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were newly diagnosed with prediabetes by Oral Glucose Tolerance Test (OGTT) and/or HbA1C,
* who were assessed as physically inactive (Level 1) according to the International Physical Activity Questionnaire
* who had sufficient motivation to participate in the exercise program (assessed by one-on-one interviews conducted by the researchers),
* who were deemed suitable to participate in the exercise program after a cardiac examination by a cardiologist (with resting electrocardiogram and questioning of cardiac symptoms, and advanced tests such as exercise electrocardiogram test when necessary),
* who had the same weight (±2.5 kg) for 6 months before participating in the study.

Exclusion Criteria:

* having a serious medical condition that would prevent the person from participating in the exercise study (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.),
* having used metformin for 6 months before the study, having cardiovascular disease,
* heart failure, cancer, having a BMI \&lt;19 kg/m2, receiving hormone replacement therapy,
* having a life expectancy of less than 1 year, being HIV positive, substance use,
* functional dependence, having an orthopedic disease that prevents physical activity,
* having cognitive impairment and other diseases that would affect the study results (respiratory diseases, muscle diseases, non-alcoholic fatty liver disease, etc.),
* using medications or supplements that would affect the study results.
Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders

This randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (AN) delivered in the home setting, in the context of community-based mental health. Adolescents with AN-spectrum disorders (n=50) and their caregivers will be randomly assigned to either family-based treatment or integrated family therapy delivered in the home. Caregivers and adolescents will provide data on weight, eating, and putative treatment mechanisms, including caregiver self-efficacy, adolescent distress, and generalizability of treatment skills. Treatment feasibility, acceptability, and appropriateness will be measured among providers and participating families. The proposed study has clear potential to advance scientific and clinical understanding of the real-world effectiveness of psychological treatments for AN, including whether adapting them for the home setting may improve accessibility and effects on treatment outcome


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for AN or atypical AN according to DSM-5 diagnostic criteria.
* Currently living at home with caregivers who are willing to engage in family treatment.
* Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute) and receiving medical monitoring from a clinician throughout treatment.
* If on psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication for a co-morbid condition.
* Available for follow-up.

Exclusion Criteria:

* Associated physical illness that necessitates hospitalization.
* Psychotic illness/other mental illness requiring hospitalization.
* Current dependence on drugs or alcohol.
* Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight.
* Concurrent involvement in other psychological treatment for an eating disorder.
* Developmental delay that would preclude participation in the intervention.
Short Term Results of Tele-Rehabilitation

Most people who have coronavirus disease (COVID-19) recover completely without any sequelae. However, some patients continue to experience symptoms of COVID-19 even though their tests turn negative. This clinical spectrum that occurs after acute infection is called the post-COVID syndrome (PCS). Dyspnea, pain, decreased exercise capacity, limitations in activities of daily living, poor sleep quality, anxiety and depression are common symptoms in PCS. The aim of our study is to examine the effect of tele-rehabilitation-based exercise program on dyspnea, pain, functional capacity, sleep quality, anxiety and depression in individuals with PCS.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-75,
* Being in stable medical condition, conscious and cooperative,
* Having had COVID and continuing symptoms
* Volunteering to participate in the study,
* Own a device that can be connected online independently or with support from family members.

Exclusion Criteria:

SpO2 \< 92%,

* Hypotension (Systolic Blood Pressure \< 90 mmHg or Diastolic Blood Pressure \< 60mmHg)
* Having chronic respiratory disease (COPD, Asthma, etc.)
* Having a stroke or neurodegenerative disease.
* Not being willing to participate in the study
Is T-lymphocyte Calcineurin Phosphatase Up-regulated by Treatment With Tacrolimus?

The purpose of this study is to determine whether calcineurin phosphatase in the T-lymphocytes is up-regulated after long-term treatment with tacrolimus, a calcineurin inhibitor.

Background:

The immunosuppressive effect of both tacrolimus and cyclosporine is believed to be through inhibition of the enzyme calcineurin phosphatase (CaN) in T-lymphocytes. We have demonstrated, that tacrolimus decreases CaN activity in patients early after renal transplantation. In stable renal transplant patients treated this inhibition was hardly seen in patients treated with tacrolimus, while it was clearly demonstrated in patients treated cyclosporine. One explanation to this finding could be, that calcineurin phosphatase is up-regulated by long-term treatment with tacrolimus. The findings seem to imply, that tacrolimus has mechanisms of immunosuppression apart from inhibiting CaN. This could have implications for side-effects due to CaN inhibition. Among side-effects thought to be due to CaN inhibition is nephrotoxicity. The results may therefore be and indication of tacrolimus being less nephrotoxic compared to cyclosporine in long-term stable renal transplant patients.

Purpose:

The aim of the project is find out if long-term treatment with tacrolimus results in up-regulation of CaN in lymphocytes.

Study plan:

The general plan of the investigation is to compare CaN in lymphocytes in two groups of renal transplant patients treated with tacrolimus. One group just prior and just after transplantation compared to a group of stable renal transplanted patients a long time after transplantation. CaN is determined as enzyme activity, amount of protein, and by gen-activation.

Eligibility Criteria:
Inclusion Criteria:

Group 1 (early kidney-transplant recipients)

* Age over 18 years
* 20 consecutively kidney-transplant recipients at Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
* receiving tacrolimus as part of their immunosuppressive treatment
* receipt of graft from either deceased or living-related donor
* written consent to participate

Group 2 (stable kidney-transplant recipients)

* Age over 18 years
* Stable renal allograft function defined as S-creatinine \<200 µmol/l
* variation in S-creatinine \<20% for 6 months prior to inclusion
* kidney transplantation more than 2 years before inclusion
* receipt of graft from either deceased or living-related donor
* written consent to participate

Exclusion Criteria:

Group 1 (early kidney-transplant recipients)

* patients suspected of non-compliance
* patients receiving medications known to interact with tacrolimus pharmacokinetics
* patients who on day 8 after transplantation have not reached a trough level for blood tacrolimus concentration above 8 µg/l.

Group 2 (stable kidney-transplant recipients)

* patients suspected of non-compliance
* patients receiving medications known to interact with tacrolimus pharmacokinetics
Implementation of CareCube Negative Pressure Isolation Units

Pilot study to provide a descriptive analysis of the real-world feasibility of using a CareCube for COVID-19 patients in a high-volume tertiary care hospital.

The CareCube is a modular, disposable, negative pressure, isolation patient care system that can rapidly augment hospital's capacity to care for patients with contagious droplets or airborne pathogens. It is designed as a temporary single-use negative pressure isolation care unit with PPE for common patient care protocols built into the unit. The device is intended to be used in a healthcare setting as a temporary isolation of patients with suspected or confirmed diagnosis of COVID-19 to prevent Healthcare Practitioners (HCP) and patients' visitors from being exposed to pathogenic biological airborne particulates. The system includes three components: an isolation chamber, functional gown, and gloves. The isolation chamber functions in a similar manner to a hospital negative pressure, Airborne Infection Isolation Room. The gown and gloves provide an extra layer of barrier protection beyond PPE. The CareCube is designed to provide improved protection for front-line healthcare workers, while also conserving the vital supplies of N95 masks, face shields, and gowns, which are not required since there is no direct contact with the patient.

The goal of this project is to provide preliminary data to describe the experiences of 'patients', their caregivers, and providers with the CareCube.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female previously hospitalized during the COVID-19 pandemic
* At least 21 days post- positive COVID-19 test result
* Able to provide written informed consent

Exclusion Criteria:

* Under 18 years of age
* Unable to provide written informed consent on own behalf
Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Pharmacokinetics of Tamsulosin in Healthy Male Volunteers

Study to investigate the effect of CYP2D6 inhibition by paroxetine on the single oral dose pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability


Eligibility Criteria:
Inclusion Criteria:

All participants in the study are

* Healthy males
* Ranging from 21 to 50 years of age
* Body mass index (BMI) within 18.5 to 29.9 kg/m2
* In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or clinically relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (\> 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the reference range if indicative of underlying disease or poor health
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to treatment medication and/or related drugs of these classes
* Non extensive metabolizer (EM) for CYP2D6
A Study of Safety, Tolerability, and Pharmacokinetics of Single Doses of PHP-303 in Healthy Subjects

This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in healthy volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 3:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability of orally-administered PHP-303.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, ≥ 18 to ≤ 55 years of age.
* In good general health having no clinically significant diseases in medical history or evidence of clinically significant findings on physical examination, vital signs, laboratory results, and/or ECG at Screening, in the opinion of an Investigator.
* Willing to forego other forms of experimental treatment during the study.

Exclusion Criteria:

* Any clinically significant condition that, in the opinion of an Investigator, could preclude the safe participation of the subject in the study or would prevent the subject from meeting the study requirements.
* Major surgery in the 6 months preceding Screening.
* Clinically-significant abnormal laboratory parameters.
* Positive urine drug test for alcohol, cotinine, and/or drugs of abuse (cocaine, tetrahydrocannabinol, amphetamines, methamphetamines, or benzodiazepines) at Screening or on admission to the study site.
* Electrocardiographic Fridericia's corrected QT interval (QTcF) interval \> 450 msec for males and \> 470 msec for females, or any other clinically significant electrocardiographic abnormality.
* Blood pressure results \> 150 mmHg systolic or \> 95 mmHg diastolic
* Female subject who is pregnant (positive pregnancy test at the Screening Visit or on admission to the study site), lactating, or planning to become pregnant during the study period or within 3 months after the final dose of study medication.
* History of drug or alcohol abuse or dependence within 1 year prior to Screening.
* History of cigarette smoking within 3 months of Screening.
* Known intolerance to lactose.
* Regular use of prescription drugs within 14 days of the first administration of study drug or non-prescription (over-the-counter) drugs within 7 days of the first administration of study drug or unwilling to abstain from prohibited medications through the end of study.
Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation

Will participants with painful lower extremity diabetic peripheral neuropathy (DPN) that are treated with high frequency spinal cord stimulation (HF10 SCS) have improvements in lower extremity peripheral nerve function?

This research study is being conducted to find out if spinal cord stimulation (SCS) can improve nerve function. SCS is FDA approved for the treatment of intractable neuropathic (nerve) pain related to diabetic peripheral neuropathy. With SCS a wire is placed in the epidural space and the spinal cord is stimulated to interrupt the pain signal coming from the legs. The spinal cord stimulator is a device similar to a pacemaker (which helps treat abnormal rhythms of the heart). Recent studies have suggested that SCS with high frequencies can improve nerve function for subjects with painful peripheral neuropathy therefore, the investigators are looking to measure changes in nerve function after SCS for treatment of painful diabetic peripheral neuropathy.

The purpose of this research is to gather information on the effect of high frequency spinal cord stimulation (HF10) on nerve function with a spinal cord stimulator.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Refractory predominantly lower extremity neuropathic pain for \> 1 year
* Presence of length dependent peripheral neuropathy on sudomotor testing
* Completed spinal cord stimulation trial with 40% or greater pain reduction from baseline
* Failed medication trials or contraindication to gabapentin medications (gabapentin, pregabalin) and/or serotonin/norepinephrine reuptake inhibitors (tricyclic antidepressant (TCA) or duloxetine or venlafaxine)
* Average pain score on a visual analog scale (VAS) of ≥ 5 (with 0 representing no pain and 10 the worst pain imaginable)
* Appropriate surgical candidate for spinal cord stimulator

Exclusion Criteria:

* Severe Autonomic Neuropathy as measured by the composite autonomic scoring scale (10 point scale) with a score ≥ 7
* History of sympathectomy
* Uncontrolled arterial hypertension (Systolic Blood Pressure \>160)
* Baseline Foot TcPO2 \< 10 mmHg to exclude patients with severe peripheral arterial disease
* Hemoglobin A1c \> 8%
* Stable opioid regimen with oral morphine equivalent ≥ 100 mg/day
* Alternative principle cause for peripheral neuropathy or lower extremity neuropathic pain
* Disruptive psychiatric disorder (screened for during preoperative psychiatric evaluation)
* Pending litigations
* Women of child bearing potential unwilling to use contraception or found to be pregnant as part of perioperative screening
* Patients unable to hold medications that would impact autonomic testing