cyrilzakka/clinical-trials huggingface dataset:
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation

The study will investigate whether a nociceptin receptor antagonist will normalize neural and behavioral processes of approach/avoidance decision-making in unmedicated individuals with major depressive disorder (MDD) and anxiety disorders. More specifically, the study aims to investigate dysregulation within (1) corticostriatal-midbrain circuitry and (2) nociceptin/orphanin FQ peptide and the nociceptin receptor (NOPR).


Eligibility Criteria:
Inclusion criteria for MDD/anxiety disorder group:

* DSM-5 diagnostic criteria for MDD, Generalized Anxiety Disorder, Social Phobia, Panic Disorder, Post Traumatic Stress (diagnosed using the SCID-5)
* Written informed consent
* For MDD subjects, a baseline Hamilton Depression Rating Scale score \> 16 (17-item version)
* Right-handed
* Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)
* Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine, 6 months for neuroleptics, 2 weeks for benzodiazepines, 2 weeks for any other antidepressants)

Inclusion criteria for healthy controls:

* Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (diagnosed using the SCID-5)
* Written informed consent
* Right-handed
* Absence of any medications for at least 3 weeks
* Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)

Exclusion criteria for all participants:

* Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician
* Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception
* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
* History of seizure disorder
* History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, obsessive-compulsive disorder, patients with mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse; which will lead to exclusion)
* History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)
* History of use of dopaminergic drugs (including methylphenidate)
* History or current diagnosis of dementia
* Patients with mood congruent or mood incongruent psychotic features
* Current use of other psychotropic drugs
* Clinical or laboratory evidence of hypothyroidism
* Patients with a lifetime history of electroconvulsive therapy
* Failure to meet standard magnetic resonance imaging safety requirements
* Abnormal ECG and lab results
* History of seizure disorder or currently on anticonvulsants
Study to Evaluate Changes in Cognitive Function in Patients Treated With PCSK9 Inhibitors

The main objective will be to evaluate the changes in the cognitive function in naive patients treated with PCSK9 inhibitors (Alirocumab and Evolocumab) by using the Montreal Cognitive Assesment questionnaire (MOCA).

The secondary objectives will be: 1) To evaluate the levels of LDL-cholesterol changes from the beginning to the end of the study 2) To evaluate changes in Quality of Life among the EuroQol EQ-5D-3L questionnaire (it will also be associated to the cognitive function) 3) Assesment of direct costs in medications and outpatients consultations related with the health procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or over
* To start with the first funded dose of PCSK9 inhibitors ( LDL \> 100 mg/dL)
* Maximum dose or statin intolerance

Exclusion Criteria:

* Diagnosis of any disease related with cognitive deterioration
DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)

The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously developed M184V/I mutation that confers resistance to 3TC. The main question it aims to answer is to explore the rate of HIV suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until 48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to DOR/3TC/TDF with careful HIV-RNA monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Adult living with HIV
* Receiving stable antiretroviral treatment for at least 3 months
* HIV RNA VL\<50cp/mL for at least 6 months
* Presence of the M184V/I mutation in at least one previous genotype performed on plasma HIV RNA but absent from the genotype on current standard pro-viral DNA (Sanger technique)
* Signed informed consent

Exclusion Criteria:

* History of genotypic mutation associated with resistance to DOR or TDF according to the ANRS version 32 algorithm, i.e. :
* For DOR : V106A/M; Y188L; G190E/S; M230L; L100I + K103N; K103N + Y181C; K103N + P225H; F227C; At least 3 amongst: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y
* For TDF : At least 3 mutations among: M41L, E44D, D67N, T69D/N/S, L74V/I, L210W, T215A/C/D/E/G/H/I/L/N/S/V/Y/F; K65R/E/N ; Insertion at codon 69; K70E
* Contraindications to the use of DOR/TDF/3TC
* Hypersensitivity to doravirine, tenofovir, lamivudine or any of the excipients (lactose in particular)
* Current or recent treatment with a strong CYP3A4 inducer
* Breast-feeding
* Patients already on DOR
* Pregnant or breast-feeding women
* Patients under guardianship or trusteeship
Lymphedema Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy

The stage and lymphedema size can be detrimental to the quality of life and health of women, because the increase in circumference and member of the weight causes limitations in activities. Previous studies have shown that patients with lymphedema should not perform high intensity exercises, these exercises would cause the increase of lymphedema. Already, in current studies show that muscle strength exercises when properly applied, with controlled intensity and time, can help to reduce lymphedema. Thus, the main objective of this study is to compare the standard treatment of lymphedema through complex physical therapy versus the application of strengthening exercises for upper limbs together with complex physical therapy. The study design is a randomized controlled clinical trial. Participate in the study 50 patients, who will be allocated into two groups, group 1 (n = 25): Complex Physical Therapy; Group 2 (n = 25): Complex physical therapy in an exercise protocol, which will receive treatment twice a week for eight weeks. All patients will receive treatment and will be informed of the free and informed consent form at the beginning of the research. They will be met: the report cards, dynamometer testing and filling out questionnaires at the beginning and end of the study.

This study will be conducted in Onco Mastology clinic of the Department of Mastology the Department of Gynecology, Federal University of São Paulo (UNIFESP) - Paulista School of Medicine (EPM), in which patients will be recruited, selected and informed about the study objectives , its relevance, activities to be developed and the possibility of improvement and remedy your questions and concerns about the disease.The study design is a randomized controlled clinical trial. To define the treatment, 50 patients are allocated to two groups, group 1 (n = 25) Group 2 (n = 25) that receive treatment twice a week for eight weeks. Physical examination will be performed, completing the consent form, evaluation form, and questionnaires. Group 1 standard treatment : 25 women with lymphedema , perform complex physical therapy with manual lymphatic drainage, compression bandaging and exercises linfomiocinéticos . Treatment was given twice a week , 8 consecutive weeks , 6 sessions.Group 2 standard treatment + muscle strength : 25 women with lymphedema , perform complex physical therapy, manual lymphatic drainage, compression bandaging and linfomiocinéticos exercises and strengthening exercises with load.Treatment was given twice a week , 8 consecutive weeks , 16 sessions.

Eligibility Criteria:
Inclusion Criteria:

* With lymphedema resulting from postoperative unilateral breast cancer
* difference in circumference between the upper limbs

Exclusion Criteria:

* Patients with bilateral breast cancer
* Grade IV lymphoedema called elephantiasis
* renal dysfunction
* treatment involving the reduction of lymphedema in the last three months; acute inflammation ; deep vein thrombosis ; heart disease; skin infections and disease locoregional or distant active base.
Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of systemic sclerosis(SSc) who have been resistant to multiple standard treatments. The underlying hypothesis is that the SSc condition is caused by an abnormal immune homeostasis that can be restored by MSCT.

* To test a new approach using allogeneic derived mesenchymal stem cell based therapy (MSCT) to treat refractory SSc
* To determine the disease-free survival in SSc patients treated with MSCT
* To assess adverse events of allogeneic MSC transplantation
* To assess the association of remission for organ function, clinical score and SSc serology levels at baseline with disease-free survival

Eligibility Criteria:
Inclusion Criteria:

* All patients fulfilled the American College of Rheumatology (former American Rheumatism Association - ARA) for SSc
* Rapidly progressive disease \<2 years duration with a modified Rodnan skin score(mRSS) above 20, plus ESR \>25 mm/first h and/or Hb \<11 g/dL, not explained by other causes than active SSc
* lung involvement: with a vital capacity (VC) or DLCO below 70% predicted, or a mean pulmonary artery pressure (PAP) above 40 mmHg (measured by echocardiography)
* digestive tract involvement: with serum albumin ,25 g/L or weight loss exceeding 10% body weight in the preceding year
* kidney involvement: with 24-h urinary protein above 0.5 g or serum creatinine above 120 mmol/L

Exclusion Criteria:

* Uncontrolled arrhythmia, echocardiographic left ventricular ejection fraction (LVEF) \<50% or mean PAP \>50 mmHg, DLCO\<45% of predicted
* Creatinine clearance \<20 ml/min
* Platelets\<80 000/mm3, haemorrhagic cystitis
* (4) HIV or HTLV1 seropositivity, malignancy, pregnancy, a cardiac or vascular prosthesis, and no vascular access
Determination of Specific Biomarkers of Angioneurotic Crisis

Diagnosis of angioedema (AE) is difficult especially in emergency room. Two forms should be evoked: histaminic AE (allergic or not, which represent 95% of cases) and bradykinic AE (hereditary or acquired deficiency, with or without C1 Inhibitor) rarer but with more severe prognosis. The distinction is based on clinical features (spontaneous crisis duration, presence of concomitant hives, atopic history...). Sometimes it could be difficult to make the difference. Nowadays, there is no biological marker of the crisis. The search for biomarkers could improve the diagnostic and therapeutic management of AE. Previous work has identified targets: D-dimer, C4, and VE-cadherin. We wanted to know the sensitivity and specificity of these markers.

We conducted a prospective study evaluating the D-dimer assays, complement and VE-cadherin during an episode of AE. Three groups of patients were tested: bradykinic AE (peripheral or abdominal attacks), histaminic AE, and abdominal pain (non-bradykinic and non-histaminic etiology) at the time (day 0) and at distance from the crisis (D7).


Eligibility Criteria:
Inclusion Criteria:

* Histaminergic or bradykinin angioedema
* Abdominal pain

Exclusion Criteria:

* children \< 18 years
Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion.

The purpose of this study is to determine whether mindfulness based stress reduction are effective on improve anxiety, depression and quality of life in women with intrauterine adhesion

This is a parallel arm, randomized controlled trials, according to 1: 1 ratio assigned intrauterine adhesions patients to mindfulness based stress reduction group and wait-list control group.The study compared anxiety and depression levels and quality of life in patients with intrauterine adhesions before and after the completion of mindfulness based stress reduction program.Anxiety, depression and quality of life level measured by the Zung self-rating anxiety scale, Zung Self-Rating Depression Scale and The 36-item Short-Form Health Survey.

Eligibility Criteria:
Inclusion Criteria:

1. Meet intrauterine adhesions diagnostic criteria of ESGE.
2. Patients with clear consciousness, can correct understanding related content of the questionnaire.

Exclusion Criteria:

1. Have a history of mental illness.
2. Receiving psychological treatment currently.
3. Have acute mental disorders.
4. Experienced special stress life events within six months.
Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo

This study is being performed as a Phase IV FDA commitment study and is being powered adequately to assess changes in sperm concentration, FSH and testosterone in healthy male subjects treated with pregabalin as compared to placebo, in addition to confirming lack of effects on sperm motility.

This is a Phase 4 FDA commitment study. The purpose of the study is to evaluate the effects of pregabalin as compared to placebo on sperm concentration in healthy male subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy 18 to 55 years old males

Exclusion Criteria:

* Screening sperm count \<20 x 106/mL; screening sperm motility \<50% motile (a+b) or \<25% Class "a" motile or screening sperm morphology \<30% normal or semen volume \<1.5 mL or white blood cell count \>1 x 106 /mL on any screening visit sample
Understanding Visual Processing After Occipital Stroke

The purpose of this study is to investigate how visual orientation discrimination and metacognition (i.e., perceptual confidence) are affected by occipital stroke that causes hemianopia and quadrantanopia in adults. This research will provide insight as to how the residual visual system, which not directly damaged by the occipital stroke, processes orientation (assayed in terms of orientation discrimination) and metacognition (by measuring perceptual confidence for orientation discrimination). These measures will be used to refine computational models that attempt to explain how the brain copes with loss of primary visual cortex (V1) as a result of stroke. This knowledge is essential to devise more effective visual rehabilitation therapies for patients suffering from occipital strokes.


Eligibility Criteria:
Inclusion Criteria:

* Residents of the United States or Canada
* MRI and/or CT scans showing unilateral stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained 1-year or more prior to enrollment
* Reliable visual field defects in both eyes as measured by Humphrey, Macular Integrity Assessment (MAIA), Goldmann, and/or equivalent perimetry. This deficit must be large enough to enclose a 5-deg diameter visual stimulus.
* Ability to fixate on visual targets reliably for 1000ms (as demonstrated by visual fields, and verified in study participation)
* Willing, able, and competent to provide informed consent
* Cognitively able to understand and respond to written and oral instructions in English

Exclusion Criteria:

* Past or present ocular disease interfering with visual acuity
* Corrected vision worse than 20/40 in either eye
* Presence of damage to the dorsal Lateral Geniculate Nucleus
* Diffuse, whole brain degenerative processes
* Brain damage deemed by study staff to potentially interfere with testing ability or outcome measures
* Documented history of traumatic brain injury
* Documented history of drug/alcohol abuse
* Current use neuroactive
* Cognitive or seizure disorders
* Subjects with one-sided attentional neglect
Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy

Epidural PCA (patient controlled analgesia) for post-operative pain management are effective analgesic method. It is widely used in the postoperative pain management for decades.

PCA pumps typically set a fixed basal infusion rate to infuse the analgesics at a constant rate per every hour (conventional mode). In contrast, the newly developed computer-integrated patient-controlled analgesia (CIPCA) mode increases or decreases the basal infusion rate with the use of the patient's bolus button. The CIPCA mode sets the basal infusion rate, the increase / decrease rate of basal rate, and the increment / decrement interval. If the patient presses the bolus button within the set time interval, the set infusion rate is increased because the analgesic is more required. If the bolus button is not pressed during the set time interval, the infusion rate is decreased. Therefore, it can be said that it is an effective method to control the dose of analgesic agent more sensitively to changes in patient's needs and pain.


Eligibility Criteria:
Inclusion Criteria:

1. elective open gastrectomy due to stomach cancer
2. ASA classification Ⅰ-Ⅲ

Exclusion Criteria:

1. hematologic clotting defect
2. sepsis
3. distance metastasis
4. PCA drug (fentanyl, Ropivacaine) allergy
5. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
6. pregnant, lactating women
Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

Investigate the effects of CSMed® for preventing and managing radiation dermatitis in patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).

A prospective study was conducted at the University Hospital Medical Center. The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care. Record the difference between the part of the skin with dressing and undressed skin for each patient. The severity of acute radiation dermatitis was graded using the RTOG clinical scoring standard. From the beginning of the treatment to 4 weeks after the end of the treatment, skin pain, itching, local fever and tightness, as well as skin healing time were collected every week.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving radiation therapy (including undamaged skin and RTOG grade 1 dermatitis).
* Patients who voluntarily agree to participate in the trial and sign the subject's consent form.

Exclusion Criteria:

* Patients with dermatitis and burns not caused by radiation therapy.
* Involuntary patients without signed consent.
* Those who are allergic to the ingredients in this product.
Respiratory Viral Infection in Nursing Home Slovenia

This study will be conducted in a 208-bed nursing home in Maribor. The investigators will observe a group of a 100 nursing-home residents and 50 health care workers- employees in the nursing home- in a six months period.Influenza vaccination status will be recorded in all participants at the beginning.

At the beginning and at the end of the study the blood samples for vitamin D concentration determination and nasopharyngeal swabs for molecular detection of respiratory viruses will taken in all of the participants.

The study will observe number of viral respiratory tract infection in participants and identify the viral etiology of infections during 6 months observational period.Nasopharyngeal swab and blood sample will be taken in each of the participant who will suffer an acute respiratory tract infection (upper or lower respiratory tract infection) and viral agents of respiratory tract diseases will be searched for. The investigators will try to detect different viral agents of respiratory tract infection: human rhinoviruses, enteroviruses, influenza A, B, parainfluenza 1-4, respiratory syncytial virus, human coronaviruses, human metapneumovirus, adenoviruses and human bocavirus with newer molecular methods (real-time polymerase chain reaction, real-time reverse transcriptase polymerase chain reaction) in nasopharyngeal swab and in blood sample of the participants.

During the study period the investigators will monitor the daily number of visitors (adults, preschool children and pupils) in each nursing home room. The epidemiological aspect of respiratory viral infection will be assessed.

Our study hypothesis is that lower respiratory tract infections in elderly can be caused by viruses other than influenza.

The investigators would like to know if hypovitaminosis D is a risk factor for respiratory tract infections in nursing home residents and employees.

The investigators would also like to know if the number of respiratory tract infections in elderly correlates with the number of visitors in nursing home, small children in particular.


Eligibility Criteria:
Inclusion Criteria:

* resident of the nursing home or employee ni the nursing home

Exclusion Criteria:

* none
Egg Ingestion in Adults With Type 2 Diabetes

We propose a prospective, randomized, single-blind controlled crossover study to assess the effects of daily egg inclusion versus egg exclusion, on glycemic control, anthropometric measures, and overall diet quality in adults with Type 2 diabetes.

Hypothesis Inclusion of eggs in the diets of individuals with Type 2 diabetes mellitus will improve glycemic control, anthropometric measures and overall diet quality.

Restriction of dietary cholesterol, and thus the avoidance or restriction of egg intake, is routinely recommended to patients at increased risk for CVD, including those with diabetes. However, the relative importance of dietary cholesterol to serum lipids and the role of egg ingestion in cardiovascular risk are increasingly suspect. Further, the exclusion of eggs from the diet may lead to increased consumption of high-glycemic carbohydrate foods of particular potential harm to individuals with diabetes. The examination of how food-specific recommendations translate into effects on other food choices and overall diet quality, and in turn health effects, is a neglected area of research.

Eggs provide a complete profile of amino acids and an array of micronutrients, and are low in total fat. Although epidemiological and clinical studies largely suggest a lack of association between egg intake and harmful effects, the evidence is somewhat more ambiguous with regard to glycemic control for diabetes, or the risk for CVD among individuals with diabetes. Our own prior work shows no adverse effects of egg ingestion in healthy adults, hyperlipidemic adults, or adults with established coronary artery disease. As a satiating and protein-rich food, eggs have potential to foster calorie and weight control, and to reduce the dietary glycemic load, offering potential advantages in Type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* males age greater than 35 years;
* post-menopausal females not currently on hormone replacement therapy;
* non-smokers;
* clinical diagnosis of Type 2 diabetes mellitus for at least 1 year but no more than 5 years;
* 6.5% ≤ HbA1c ≤8.0% (5) BMI between 25 and 40 kg/m².

Exclusion Criteria:

* failure to meet inclusion criteria;
* anticipated inability to complete study protocol for any reason;
* current eating disorder;
* use of antihyperglycemic, lipid-lowering or antihypertensive medications unless stable on medication for at least 3 months;
* use of glucocorticoids, antineoplastic agents, psychoactive agents, or nutraceuticals;
* regular use of fiber supplements;
* restricted diets (i.e., vegetarian, vegan, gluten free);
* known allergy to eggs.