cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities

This multicenter, post marketing observational study (PMOS) was designed to evaluate the effectiveness of adalimumab over a period of 9 months as determined by the Psoriasis Area and Severity Index (PASI) in participants with moderate to severe plaque psoriasis with distinct co-morbidities. Secondary objectives of this study were to measure changes in psychological health via the Dermatology Life Quality Index (DLQI); changes in comorbidities with respect to gender; changes in quality of life using the Short Form Health Survey (SF-36); and evaluation of Minimal Clinically Important Differences (MCID).

Male or female participants ages 18 years of age and older for whom the treating physician had recently prescribed adalimumab were included in this study. Adalimumab was prescribed in accordance with the terms of the local marketing authorization with regards to dose, population, and indication. There were 5 planned visits during the study: baseline (Visit 1), 1 month (Visit 2), 3 months (Visit 3), 6 months (Visit 4), and 9 months (Visit 5).

Eligibility Criteria:
Inclusion Criteria:

Participants for whom adalimumab therapy is indicated and has been prescribed according to the product label and who meet the following criteria:

* Participant age ≥ 18 years
* Participants with moderate to severe plaque psoriasis participants who have at last one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression (diagnosed by a medical specialist for psychology, neurology, or psychiatry)
* Adalimumab naïve participants with moderate to severe plaque psoriasis after unsatisfactory response, non tolerability, or contraindication of systemic therapies such as ciclosporin, methotrexate or PUVA ( psoralen + UVA) or after biological disease modifying anti-rheumatic drugs (bDMARDs) failure (e.g.: infliximab, etanercept or ustekinumab)
* Participants of each country must fulfill any local treatment recommendation for use of bDMARD in psoriasis in their respective country. For Austria: participants must fulfill Austrian Treatment Recommendations for use of bDMARD in psoriasis (Chest X-ray and IGRA\* interferon gamma release assay or PPD-skin test negative for tuberculosis)
* Participant is willing to give informed consent to anonymous data collection and their forwarding to AbbVie as well as to informed consent if required in different countries.
* Participant must be able and willing to self-administer adalimumab injections or have a qualified person available to administer Humira® syringe or Humira® Pen injections

Exclusion Criteria:

The following participants will not be included in this observational study:

* Participants who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SPC) and Humira Pen® SPC
* Participants participating in another study program or clinical trial
* Participants who have been treated with Humira® before
Research-Action in Hematology From Hospitalization to Home

Objective :

To study and support the hospitalization and the return home of patients with the help of a psychological follow-up started in a hospital institution and which will continue in the patient's home, based on the concepts of transitionality and narrativity.

Material and method To do this, the subjects will benefit from psychological interviews where they will freely discuss what concerns them, whether it is illness, treatment, returning home, or any other personal subject.

They will be divided into two groups of 5 patients each, one of the groups will benefit from follow-up in an institution as contracted for several years between the Institute of Hematology and the psychologists of the UMDSP, another from the same follow-up but with the presence of the psychologist at the time of discharge extended to the patient's home after leaving the hospital for a period of 2 months.

To ensure a certain consistency in the evaluation criteria, these will be standardized in the form of questionnaires completed blindly by the patient, a caregiver and the investigator, at 3 key times of the research (entry, discharge from hospital, two months after this discharge)

Device tested:

The aim of this work is to test the benefits of a device based on transitionality, which can limit, thanks to the restoration of the symbolization process, the deleterious effects of each of the stages imposed by the disease, the care and the resumption of autonomy once the active phase of care has passed.

Narrativity is also at the heart of this transitional device. It makes it possible to evoke the present experience of the patient in connection with future projects and in the continuity of past, potentially traumatic events. It opens onto a dynamic temporal perspective where the trauma freezes.

The whole process promotes the subjective reappropriation of the experience and a psychic well-being.


Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized Protected Hematology Unit
* patient with haematologic cancer
* patient requesting psychological assistance or accepting proposed psychological assistance
* signed informed consent

Exclusion Criteria:

* patient refusing to participate
* patient not able to participate
How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Healthy Sample)

Both mindfulness meditation and expectancy effects are known to reduce anxiety, stress and catastrophizing, but it is unknown whether and how expectancy effects contribute to the overall effect of mindfulness meditation on these outcomes, especially during significant global events such as the coronavirus pandemic. This study includes four interrelated aims that will probe these effects and interactions.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Able to read and understand English

Exclusion Criteria:

* Recurrent pain (two or more days in the last month)
* Chronic pain (pain most days in the last three months)
* Incomplete or invalid data (response time \< 32 minutes, failing attention checks)
* Completing the 20-minute training module in \< 18 minutes or \> 90 minutes
Global Effects of a Probiotic Strain on Lactating Women

In this study, the investigators will try to confirm if application of probiotic strains isolated from breast milk actually have a beneficial effect on women suffering lactational mastitis. This project has been design to offer an integrated vision of the effects of probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators propose a multidisciplinary approach involving the application of microbiological, immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The hypothesis is that probiotherapy will cause different effects on the host, and the objective is the finding of markers that may support the beneficial effect of the strain in such condition.


Eligibility Criteria:
Inclusion Criteria:

* Normal term pregnancy
* Lactating women
* Healthy breastfed infant

Women with mastitis:

* Clinical symptoms of mastitis
* Painful breastfeeding
* Count of staphylococci, streptococci and/or corynebacteria in milk higher than 3,000 colony-forming units/mL
* Leukocyte count in milk higher 6 log10/mL

Women without mastitis:

* No clinical symptoms of mastitis
* No painful breastfeeding
* Count of staphylococci, streptococci and/or corynebacteria in milk lower than 500 colony-forming units/mL
* Leukocyte count in milk lower 5 log10/mL

Exclusion Criteria:

* Allergy to cow's milk protein
* Intolerance to lactose
* Antibiotic treatment
* Breast abscess
* Raynaud syndrome
* Any parallel disease
Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study

Right heart failure during cardiac surgery is associated with increased perioperative morbidity and mortality. In this context, it is imperative to develop simple diagnostic tools to detect right heart failure. The purpose of this observational study is to determine if ultrasound Doppler of the femoral vein can detect and predict right ventricular failure after cardiac surgeries requiring cardiopulmonary bypass. It is expected that an elevated pulsatility of the femoral vein before the induction of general anesthesia is associated with perioperative right heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Adults (at least 18 years old)
* Able to consent
* Undergoing elective cardiac surgery at the Montreal Heart Institute
* Surgery requiring cardiopulmonary bypass
* Peri-operative trans-oesophageal echography planned

Exclusion Criteria:

* Critical preoperative state, defined as vasopressor requirement, mechanical support including intra-aortic balloon, mechanical ventilation or cardiac arrest necessitating resuscitation
* Know condition that could interfere with femoral venous assessment or interpretation (such as femoral vein thrombosis, femoral instrumentation, ECMO, etc.)
* Planned cardiac transplantation, implantation of a ventricular assist device or surgery for a congenital condition
* Pregnancy
Validity and Reliability of the Baby Preparation and Worry Scale

Background: Reliable and valid measurement tools are needed to capture key components of prenatal distress, including anxiety and anxiety states that may put women and children at increased risk in the postpartum period.

Aim: The aim of this study is to determine the validity and reliability of the Baby Preparation and Worry Scale (Baby-PAWS), by adapting it to Turkish culture.

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Eligibility Criteria:
Inclusion Criteria:

- Women who were married, older than 18 years, at least primary school graduates, in the third trimester of pregnancy and who accepted participation in the study were included.

Exclusion Criteria:

- Pregnant women with chronic disease and psychiatric disease history were not included in the research.
Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
* Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
* Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
* Progressive disease on androgen deprivation therapy at enrollment;
* PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
* PSA doubling time ≤ 10 months;
* No prior or present evidence of metastatic disease;
* Asymptomatic prostate cancer;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Estimated life expectancy ≥ 12 months.

Exclusion Criteria:

* Prior cytotoxic chemotherapy;
* Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
* Known or suspected brain metastasis or active leptomeningeal disease;
* History of another invasive cancer within 3 years of randomization;
* Absolute neutrophil count \< 1000/μL, platelet count \< 100,000/μL, or hemoglobin \< 10 g/dL (6.2 mmol/L) at screening;
* Total bilirubin ≥ 1.5 times the upper limit of normal;
* Creatinine \> 2 mg/dL (177 µmol/L) at screening;
* Albumin \< 3.0 g/dL (30 g/L) at screening;
* History of seizure or any condition that may predispose to seizure;
* Clinically significant cardiovascular disease;
* Gastrointestinal disorder affecting absorption;
* Major surgery within 4 weeks of randomization;
* Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
* Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.
How Does Prostate Cancer Metastasize? Studying the Role of Secreted Packages (Exosomes) From Fat Tissue in Lean and Obese Patients

The investigators will be collecting prostate and fat tissue from participants undergoing radical prostatectomy to culture and study in the laboratory.

Both obesity and prostate cancer are major health problems in the UK, affecting 1 in 3 and 1 in 8 men respectively. Moreover, obesity increases the risk of developing aggressive disease and the risk of prostate cancer spreading. How this happens is not known. The investigators want to understand how fat cells communicate with prostate cancer cells. Investigators will be collecting prostate and fat tissue from radical prostatectomy participants for culture, in particular to look at exosome communication.

Eligibility Criteria:
Inclusion Criteria:

* All men undergoing radical prostatectomy at Charing Cross Hospital

Exclusion Criteria:

* Patients unable to consent
Splinting for Dupuytren's Contracture Release

This study is comparing two different kinds of splints for patients who have had a surgical contracture release of dupuytren's disease. It compares a static splint and a dynamic splint.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* males and females with Dupuytren's contracture
* patients with contracture of less than 30 degrees of MCP contractions and no contractions of the IP joints

Exclusion Criteria:

* previous surgical treatment for Dupuytren's
* contracture of MCP greater than 30 degrees
* contraindications for dynamic splinting (upper limb amputees, paresis, ect.)
Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial

The aim of this study was to investigate the effects of duloxetine on improvement of brain cortical activity in patients suffering from major depressive disorder using near infrared spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* HAMD-17 more than 12 points
* Participants could understand this study and sign permit
* Participants could receive NIRS measurements
* Participants could comply with the protocol of the study

Exclusion Criteria:

* alcohol or substance abuse within 3 months of the study
* ever participate other clinical study related to duloxetine
* previous poor treatment effects of duloxetine
* concomitant use of MAOi within 14 days
* concomitant use of Linezolid
* with uncontrolled glaucoma
Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction

This study will examine the potential differences between femoral nerve blockade (FNB) and adductor canal blockade (ACB) for pain control and quadriceps muscle activation for patients following anterior cruciate ligament (ACL) reconstruction.

Adequate pain control following anterior cruciate ligament reconstruction (ACL) often requires a regional nerve block. The femoral nerve block (FNB) has been traditionally employed. More recently, ultrasound application to regional nerve blocks allows for the use of alternatives such as the adductor canal block following ACL reconstruction. In 2009, Manickam et al. were the first to describe the ultrasound guided adductor canal technique for the purposes of knee joint analgesia. Unlike other traditional techniques that seek to cause a sensory as well as a motor blockade, the adductor canal block attempts to spare the motor block of the neighboring distributions in an attempt to offer selective analgesia and strength preservation. Chisholm et al demonstrated the adductor canal block provides similar and adequate postoperative analgesia when compared to the FNB, following arthroscopic ACL reconstruction with patellar tendon autograft. Their study focused on analgesia and did not evaluate quadriceps function or impact on rehabilitation. Sharma et al drew the first association between femoral nerve blocks and increased fall risk due to muscle weakness in total knee arthroplasty population. A randomized, blinded study to compare quadriceps strength following adductor canal versus FNB was performed by Kwofie et al. They showed that compared with FNB, adductor canal block results in significant quadriceps motor sparing and significantly preserved balance. These studies focused on acute muscle weakness after regional anesthesia and its relation to safety. Quadriceps function is very important in rehabilitation of ACL reconstruction. Luo et al demonstrated long term deficits related to FNB. They demonstrated that patients treated with FNB after ACL reconstruction had significant isokinetic deficits in knee extension and flexion strength at 6 months when compared with patients who did not receive a nerve block. Patients without a block were 4 times more likely to meet criteria for clearance to return to sports at 6 months. In addition, Krych et al found significantly inferior quadriceps strength and function at 6 months in FNB group. Based on the available literature, we aim to compare femoral nerve versus adductor canal block in regards to pain control and muscle strength in ACL reconstruction patients until return to sport.

Eligibility Criteria:
Inclusion Criteria:

* Males \& Females ages 16-30 yrs
* Undergoing ACL reconstruction by Co-Investigator (Walter Lowe)
* Receiving peri-operative FNB or ACB

Exclusion Criteria:

* Not enrolled within the COFAKS study
* Receiving intrathecal nerve blockade or no blockade
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus

The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants with 18 years of age or greater;
* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and at least 3 months with two anti-hyperglycemic agents (dual therapy);
* HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose \> 100 mg/dL at the screening visit;
* BMI (body mass index) \> 19 Kg/m2 and ≤ 45 Kg/m2.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to the formula components used during the clinical trial;
* Type 1 diabetes mellitus;
* Fasting blood glucose \> 300 mg/dL;
* Risk factors for volume depletion;
* Impaired renal function and end-stage renal disease;
* Participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent;
* Impaired hepatic function;
* Medical history of pancreatic diseases that may suggest insulin deficiency;
* Bariatric surgery in the last two years and/ or other gastrointestinal surgeries that can cause chronic malabsorption syndrome;
* Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels;
* Medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent;
* Current medical history of cancer and/ or cancer treatment in the last 5 years;
* Medical history of metabolic acidosis and/or using drugs that may cause lactic acidosis;
* Medical history of blood dyscrasia or any other hemolytic disorders;
* Participants using sulfonylureas and/or insulin therapy;
* Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.

Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations of T-esters \[testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)\] administered bis in die (BID) to 29 hypogonadal adult male subjects. TU was evaluated in total daily doses of 400 and 600 mg equivalents of T given twice daily for 7 or 8 days; TU + TE was evaluated in total daily doses of 600 and 800 mg equivalents of T given twice daily for 7 days. All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner. In Treatment Period 3 the effect of food on the study-state pharmacokinetics profile of the TU formulation was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male, ages 18-68
* Serum total T less than or equal to 275 ng/dL

Exclusion Criteria:

* Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness.
* Abnormal prostate digital rectal examination, elevated prostate-specific antigen (PSA), American Urological Association (AUA) symptom score of \>15, and/or history of prostate cancer.
* Hematocrit of \<35 or \>50%
* Body mass index (BMI) \>36
* Serum transaminases \> 2 times upper limit of normal or serum bilirubin \> 2.0 mg/dL
Association Between Peripheral Artery Stiffness and Cardiovascular Disease

Arterial pulse wave velocity (PWV) is strongly correlated with atherosclerosis, and the PWV of carotid or femoral artery could predict the severity of arterial atherosclerosis. Because the measurement of PWV is noninvasive, it would serve as a good clinical and screen marker to evaluate the extent of atherosclerosis. The study uses self-made PWV measurement device to investigate the correlation of the PWV in the high cardiovascular risk population, and compare it with normal population.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a high risk for cardiovascular disease