cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia

The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone or as added treatment to risperidone).


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged ≥18 years and ≤60 years with a body mass index (BMI) of ≥18.5 and ≤38 m2
* Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
* Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at the Screening Visit and Baseline Visit (Day -1)
* PANSS total score ≤80 at the Screening Visit and the Baseline Visit (Day -1)
* Score of 4 (moderate) of the following PANSS items at the Screening Visit and the Baseline Visit (Day -1): P7 (hostility), G8 (uncooperativeness)
* Minimal level of extrapyramidal signs, defined as a score ≤5 (moderately severe) in any of the four Clinical Global Impression of Severity (CGI-S) items of the ESRS-A; parkinsonism, akathisia, dystonia, and tardive dyskinesia at the Screening Visit and the Baseline Visit
* Willingness to be hospitalised for approximately 3 weeks after the Baseline Visit (Day -1)

Exclusion Criteria:

* The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
* The patient experienced an acute exacerbation requiring increase in antipsychotic medication (with reference to drug or dose) within the last 4 weeks

Other pre-defined inclusion and exclusion criteria may apply
High-intensity Exercise Training in Patients With Post-infarction Heart Failure

Introduction: Moderate-intensity endurance-training is known to reduce symptoms, increase exercise tolerance, and improve quality of life in patients with chronic heart failure. The training benefits have mainly been attributed to adaptations in the peripheral circulation and skeletal muscle rather than to adaptations in cardiac performance. However attenuation of left ventricular (LV) remodelling has been documented in some studies. The effects of high- vs. moderate exercise-intensity on LV-remodelling and endothelial function in patients with post-infarction heart failure are not definitively established and were studied in the present study.

Methods: Patients with post-infarction heart failure (45-87 yrs, 22-males, 5-females, all received b-blockers and ACE-inhibitors, EF 29%, peak oxygen uptake 13 ml/kg/min) were randomized to 12-weeks, 2-3 times per week, of either moderate exercise-intensity (70% of peak heart rate), high-intensity interval-training (95% of peak heart rate) or to a control group that received advise from their regular doctors. Patients in the two exercise-groups covered similar distance on the treadmill at each exercise-session so that only exercise-intensity differed; i.e. the duration of exercise was longer in the moderate-intensity group. Ultrasound was used to assess LV-dimension and function (including Tissue Doppler Imaging, TDI) and endothelial function in the brachial-artery.


Eligibility Criteria:
Inclusion Criteria:

Post-infarction heart failure and optimal treatment (ACE-inhibitors, Beta-blockade)

Exclusion Criteria:

Not able to walk on a treadmill, unstable angina, participating in another experiment, serious arrhythmia
Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor

To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate or severe classic essential tremor (bilateral, largely symmetric postural or kinetic tremor involving hands and forearms.
* Willingness to abstain from ethanol and caffeine intake for at least 48 hours prior to Days 1 and 4 and on inpatient days

Exclusion Criteria:

* Subjects with a clinically significant unstable medical abnormality, chronic disease or history or presence of significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, psychiatric, or metabolic disease or any other abnormality
* Subjects who are on sodium-restricted diets
* Subjects with a known history of sleep apnea
Clearance of 25-hydroxyvitamin D in Cystic Fibrosis

The goal of this study is to define 25(OH)D3 catabolism in CF patients using gold standard pharmacokinetics studies. Specifically, the investigators will evaluate the metabolic clearance of 25(OH)D3 among participants with CF and matched control subjects. The goal of this work is to provide the first comprehensive characterization of vitamin D metabolism in CF patients and promote novel hypotheses for subsequent studies.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Serum total 25(OH)D 10-50 ng/mL
* Diagnosis of cystic fibrosis in accordance with CF Foundation Guidelines; OR, normal CONTROL

Exclusion Criteria:

* Primary hyperparathyroidism
* Gastric bypass
* Tuberculosis or sarcoidosis
* Current pregnancy
* Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin \>=2 mg/dL, serum albumin \<=3.5 g/dL, or PT \>= 4 seconds)
* History of kidney transplantation or end stage renal disease treated with dialysis
* Use of vitamin D3 or vitamin D2 supplements exceeding a mean daily dose of 400 IU, within 3 months (wash-out allowed)
* Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce CYP24A1 within 4 weeks (wash-out allowed)
* Serum calcium \> 10.1 mg/dL
* Hemoglobin \< 9 g/dL
Level of Lacrimal Passage Obstruction

Detect anatomical level of acquired lacrimal passage obstructions among patients with epiphora. They were evaluated and divided into four groups Punctal, Canalicular, Nasolacrimal duct and Mixed groups according to level of obstruction

In a 3 years period adult patients with obstructive epiphora were evaluated clinically by Probing /irrigation of lacrimal passages to detect anatomical level of obstruction.

The main site of obstruction was the common canaliculus where 2/3 of patients had canalicular problems. The second common site of obstruction is nasolacrimal duct followed by the puncti.

Eligibility Criteria:
Inclusion Criteria:

* Watering of the eye
* Acquired lacrimal obstructions
* Adult patients with

Exclusion Criteria:

* No previous lacrimal surgery
* Congenital lacrimal obstructions
The Role of Clinical Pharmacist in Management of DDIs in CHF Patients

Drug-drug interactions (DDIs) are common in patients with chronic heart failure (CHF) and their incidence increases with the number of drugs that the patients are prescribed for treatment of their condition. Data bases often detect DDIs that are of high clinical relevance. The investigators have performed this study in order to detect clinically significant DDIs and to diminish their occurrence by sending notification about DDIs to attending physician.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with diagnosis of CHF I50.0 - I50.9 and I11.0 - I11.9 (ICD-10)
* patients treated with at least two drugs

Exclusion Criteria:

* Patients admitted to other conditions
Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp

The objective of this study is to assess the efficacy of using the Digiclamp device to remove achrocordons (skin tags). The hypothesis is that utilizing the device will result in low rates of re-occurrence, scars, scar tissue and discoloration at the site of removal.

Achrocorodons, or skin tags, are superficial cutaneous lesions that occur most commonly among middle aged adults, obese persons and those who suffer from Type 2 Diabetes. In most cases, the tags are not bothersome but there are instances when they can become infected or irritated. There are several skin tag removal options available, including suture ligature, freezing, cautery or excision. These procedures are often done in a dermatology office and are an out-of-pocket cost.

The Digiclamp device was invented to make skin tag removal procedures more accessible. The Digiclamp represents a new option that when placed in the hands of primary care clinicians, it will allow them to remove skin tags without having to purchase expensive devices or to refer them to a Dermatologist. The device is disposable, and relatively painless when used correctly, and requires minimal training.

The investigator is planning to enroll 100 subjects, who will have skin tags removed using the Digiclamp device. Subjects will return for follow up at 2-3 months after skin tag removal.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with simple skin tag(s) measuring up to 1 centimeter width at the base of the skin tag

Exclusion Criteria:

* Subjects with skin tags measuring greater than 1 centimeter width at the base
* Subjects whose skin tags appear infected or may need to be evaluated by pathology
* Subjects whose skin tags are located in genital areas or eyelids
* Pregnant subjects
* Subjects with bleeding disorders.
tDCS and Cognitive Training for Restrictive Eating Disorders

This study looks at adults with restrictive eating disorders who are currently receiving outpatient treatment for their eating disorder to examine whether a new brain stimulation technique called non-invasive transcranial direct current stimulation (tDCS) can enhance brain training. Participation involves interviews, assessments, 10 sessions of brain stimulation (active or sham), and computerized brain training over a 3-4 week period, with one post-intervention visit, and one 1-month follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Self-reported enrollment in outpatient-level treatment at local eating disorder treatment centers in the Twin Cities region, and meeting DSM-5 criteria for AN (mild severity, based on BMI greater than or equal to 17.0 kg/m2) or atypical AN diagnosis (based on MINI and EDE assessments).
* Participant must be capable of giving informed consent, based on UCSD Brief Assessment of Capacity to Consent (UBACC) risk assessment.
* Sufficient spoken English so as to be able to comprehend testing procedures. Normative ranges on a C-RENAL blood panel (panel and ranges specified here: https://labguide.fairview.org/showtest.asp?testid=3321)

Exclusion Criteria:

* Substance abuse in the participant
* Neurological condition or other developmental disorder
* Serious psychiatric disorder known to affect brain functioning and cognitive performance (e.g., schizophrenia, schizoaffective disorder)
* Medical instability, which will be evident based on required outpatient treatment status. In standard eating disorders treatment, individuals who are not medically stable are referred to higher levels of care (e.g., residential treatment, inpatient). Therefore, if a participant is enrolled in higher level care for their eating disorder diagnosis, this indicates medical instability and they will be excluded from enrollment in this study.
* tDCS contraindication (e.g., history of craniotomy, history of metallic cranial plates, screws, implanted devices).
* Acute suicidality (suicidalideation with a plan or intent), assessed via MINI suicidality module and Beck Depression Inventory suicide item
* Acute homicidality (homicidal ideation with a plan or intent), assessed via MINI
* Moderate, severe or extreme AN diagnostic severity, based on BMI as per DSM-5 criteria (e.g., BMI \<17.0 kg/m2)
Six Minute Walking Test and Breath-holding

To compare the relationship between breath-hold time and the distance in a Six Minute Walking Test in chronic obstructive pulmonary disease population.


Eligibility Criteria:
Inclusion Criteria:

* stable chronic obstructive pulmonary disease

Exclusion Criteria:

* contra-indication for six minutes walking test
* difficulty to walk
* musculoskeletal disorder
GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)

This study will attempt to measure the direct effect of pleasant skin touch on the developing infant brain. The massage intervention stimulates a specific class of unmyelinated C-fibres in the skin called C-touch (CT) afferents, and effects will be assessed by monitoring brain responses (GentleTouch Project) in a prospective cohort study.

This is a single-centre proof of concept translational study to determine how and when Somato-sensory evoked potentials develop over the first 4 months of life.

The aim of this study is to explore if the investigators can measure the cortical response from the scalp of infants using standard non-invasive EEG techniques, due to the activation of CT afferents and explore how the cortical response changes in regard to age. Preform a longitudinal study on 40 subjects at approximately 4 weeks and 4 months of age. The Gentle Touch study will examine the effect of gentle positive stimuli applied to an infant's forearm on cortical responses at two time points within the first 4 months of life.

Eligibility Criteria:
Inclusion Criteria:

* Infants born \> 37 weeks gestation
* Single births
* Not requiring admission to the Neonatal Unit
* Healthy infants without suspected congenital or metabolic anomalies
* Written Informed Consent

Exclusion Criteria:

* Infants born \< 37 weeks gestation
* Multiple births
* Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.
* Admission to the Neonatal Unit.
* No written Informed Consent obtained
Observational Prospective Study Describing the Global Patient Care and Follow-up of Prostate Cancer Patients Treated With Degarelix

The DUO study's main objective is to evaluate, in the real life, the prevalence of cardiovascular risk in patients with prostate cancer that hormone treatment of androgen suppression by Degarelix was introduced.

This study will also assess, at the initiation of therapy, the prevalence of osteoporosis, metabolic comorbidities, depression, sexual and geriatric patients suffering from prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male aged 18 years or older
* Diagnosed with prostate cancer
* Patient having received an antagonist of GnRH Degarelix prescription.
* Agreeing to and capable of completing in French during the visits all questionnaires on the impact of their illness and treatment.
* Patients having received oral and written study information, agreeing to the use of his anonymized data, and having signed a written Informed Consent Form.

Exclusion Criteria:

* Patient included in an interventional study assessing treatment for prostate cancer.
* Patient presenting hypersensitivity to Degarelix or one of its excipients.
* Patient treated by other hormonotherapy.
The Impact of Low Pressure Pneumo in RARP II

The purpose of this study is to evaluate clinical significance of low pressure pneumoperitoneum during robotically assisted radical prostatectomy (RARP).

Laparoscopic and robotic surgery has revolutionized post-operative outcomes across surgical specialties. However, the use of pneumoperitoneum comes with known risks given the change in physiological parameters that accompany its utilization. The effects of increased intra-abdominal pressure on cardiopulmonary function has been well documented. Increased pressure on the large vessels may lead to decreased cardiac output and thereby decreased blood flow to various organ systems and cause irreversible damage. Some studies have advocated lower pressures to further optimize cardiopulmonary parameters. McDougall, et. al, for instance, demonstrated a significant reduction in oliguria when pressures of 10mm Hg were used. The purpose of this study is to evaluate the effect of using lower pressure pneumoperitoneum in the abdominal cavity during RARP. The investigators hypothesize that low pressure pneumoperitoneum has a multitude of clinical benefits due to improved physiologic parameters including a reduction in the occurrence of post-operative ileus, reduced need for narcotics post operatively, and a decrease in cardiopulmonary complications. A previously completed study concluded a reduction in post-operative ileus at a pneumoperitoneum pressure of 8 mm Hg vs 12 mm Hg. This new study will evaluate the standard pneumoperitoneum pressure of 15 mm Hg vs 12 mm Hg in order to validate the previous study vs the standard pneumoperitoneum pressure.

The study is a prospective randomized blinded cohort study. Patients who meet eligibility criteria will be randomly assigned to undergo RARP at a pneumoperitoneum pressure of 15mm Hg or 12mm Hg. This will be done by computer generated randomization protocol. Surgeon and patients will be blinded to the pneumoperitoneum pressure used. A cover will be placed over the insufflation system so that the surgeon(s) are not able to visualize the pneumoperitoneum used during the procedure. The remainder of the procedure will be carried out based on current standard of care. All patients will be admitted post operatively and the same standardized orderset in EPIC EHR will be used for all patients in order to control for other factors, such as opioid use, to control for confounders.

Eligibility Criteria:
Inclusion Criteria:

- Male 40 years of age or older

* Diagnosis of prostate cancer
* Have been evaluated to be fit for proposed surgery
* Patients able to consent

Exclusion Criteria:

- Patients unable to consent (cognitively impaired)

• Non-English speaking
Observational Study of BIS in Hemodialysis Patients

This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.

This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. If changes in BIS parameters correlate with changes in fluid volume and patient symptoms, BIS may help provide a non-invasive way to estimate the amount of fluid to dialyze during a hemodialysis session. Data from this study may be used to inform the design of a future interventional trial of BIS use in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18 years of age;
2. End-stage renal disease with a GFR \<15 mL/min/1.73m\^2 and dialysis dependent requiring 3-times weekly dialysis;
3. Able and willing to remove shoes and stand on SOZO for BIS measurements;
4. Able to provide written informed consent and authorization to use and disclose health information.

Exclusion Criteria:

1. Is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion;
2. Has a clinical condition that would not allow them to complete the study;
3. Is pregnant or planning to become pregnant; women of childbearing potential (or premenopausal) must be on 2 forms of contraception;
4. Is lactating;
5. Has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator);
6. Has an amputation of a limb/s resulting in them being unable to make contact with the SOZO electrodes (amputations of fingers and toes are not an exclusion);
7. Patient determined by the attending physician unlikely to be compliant with study procedures.
ESWT on Human Gingival Fibroblasts

The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. Shockwave therapy was first introduced in Germany in 1980s and has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in head and neck region for sialolithiasis.

The present study 'Application of Extracorporeal Shock Wave Therapy on human gingival derived fibroblasts In-vitro study' was done to explore and evaluate the effect of shockwaves. Further, these cells were assessed for Cell - Cell interaction and Cell Viability.

In this in-vitro study, 20 fibroblast cells were included. 10 samples were considered for Control group and the remaining 10 samples were considered as Test group. Extracorporeal shockwave was applied to the Test samples. They were further analysed

BACKGROUND:

Improved understanding of human biology at the molecular level, scientific and technologic advances are emerging aspects in dentistry. The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. Shockwave therapy was first introduced in Germany in 1980s and has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in head and neck region for sialolithiasis.

AIM:

The present study 'Application of Extracorporeal Shock Wave Therapy on human gingival tissue derived fibroblasts In-vitro study' was done to explore and evaluate the effect of shockwaves. Further, fibroblast cells were assessed for Cell - Cell interaction and Cell Viability.

MATERIALS AND METHODS:

In this in-vitro study, 20 fibroblast cells were included. 10 samples were considered for Control group and the remaining 10 samples were considered as Test group. Extracorporeal shockwave was applied to the Test samples. They were further analysed using wound scratch assay which was used to assess Cell proliferative rate and scratch closure through live imaging. MTT assay and ATP assay was used to determine Cell viability after exposure to shockwaves.

Eligibility Criteria:
Inclusion Criteria:

* Viable human gingival fibroblast
* Healthy gingival tissue

Exclusion Criteria:

* contaminated samples
Factor Product Utilization and Health Outcomes in Patients With Hemophilia

Recombinant factor VIII Fc (rFVIIIFc) and recombinant factor IX Fc (rFIXFc) are extended half-life coagulation factors approved by Health Canada in 2014 for the treatment of severe hemophilia A and B, respectively. The objectives of this observational study is to describe the change in annual factor consumption, clinical and patient-reported outcomes for patients who switch from recombinant factor VIII (rFVIII) and recombinant factor IX (rFIX) to rFVIIIFc/ rFIXFc in Canada, and to explore clinicians' and patients' reasons for switching or not switching.


Eligibility Criteria:
Inclusion Criteria:

1. Males ≥12 years of age with severe and moderate congenital hemophilia A or B (baseline factor activity\<5%)
2. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or assent and authorization to use protected health information (PHI) in accordance with national and local privacy regulations.

Exclusion Criteria:

1. Unable or unwilling to provide informed consent
2. Patients with an existing bleeding disorder other than hemophilia A or B
3. History of hypersensitivity or severe allergic reactions to factor products
4. Patients currently participating in a phase 1-3 study with another factor replacement product
5. Unable to adhere to the study requirements based on the judgment of the Prescribing Physician (e.g. unable to enter accurate and timely infusion and bleeding records)