cyrilzakka/clinical-trials huggingface dataset:
Effects of Duloxetine vs. Escitalopram on Heart Rate Variability in Depression

Low heart rate variability is a marker of increased risk of cardiac mortality, and is observed in depressed coronary artery disease patients. Some antidepressants may themselves, however, decrease heart rate variability. We will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine (which has noradrenergic activity) than escitalopram (a selective serotonin reuptake inhibitor). We will also test the hypothesis that changes in heart rate variability are related to the magnitude of norepinephrine transporter occupancy.

Evaluation of heart rate variability (HRV) has been shown to be a valuable tool for measuring autonomic dysfunction associated with depression and with cardiac disease. Low HRV is a marker of increased risk of cardiac mortality, and is observed in depressed coronary artery disease patients and in anxious patients post-MI. Treatment with sympathomimetic antidepressants, such as MAO inhibitors and tricyclics, reduce HRV further, and have been associated with elevated heart rate, orthostatic hypotension, and with adverse cardiac events. Although there is increasing evidence that the selective serotonin reuptake inhibitor (SSRI) class of antidepressants have minimal effects on the cardiovascular system, the case is less clear with the SNRI antidepressants which block the reuptake of both serotonin and norepinephrine. It is possible that measures of the extent of norepinephrine transporter blockade or inhibition may relate to the HRV reduction seen with noradrenergic drugs. Given these considerations, we propose a study to compare the cardiovascular profile of the SSRI escitalopram (Lexapro), with the most recently available SNRI, duloxetine, in outpatients with depression. Using HRV methodology, we will test the hypothesis that greater reduction in HRV will be associated with duloxetine than escitalopram. In addition, we will measure the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug. This will allow us to examine the relationship between changes in HRV to the magnitude of transporter inhibiting effects of each drug.

Eligibility Criteria:
Inclusion Criteria:

* adults 20-60 years of age
* a primary diagnosis of depression using DSM-IV criteria
* written informed consent
* a negative serum pregnancy test for women of childbearing potential

Exclusion Criteria:

* history of cardiovascular disease
* history of hypertension
* history of bipolar disorder
* history of schizophrenia or other psychotic disorder
* alcohol or other substance abuse within the last 3 months
* history of cognitive impairment
Early Detection and Intervention for the Prevention of Psychosis

EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at six sites across the United States. The hypothesis is that very early identification and intervention will be effective in delaying or preventing onset of psychosis and improving social and occupational functioning.

The study is structured as a cutoff, regression discontinuity design, in which lower risk-for-psychosis participants will not be treated by protocol but followed up for two years. Those at higher risk will be treated with anti-psychotic, antidepressant and mood stabilizing medications by symptom indications, and systematically provided psychoeducational multifamily group treatment, supported education and employment, and intensive clinical case management, using key elements of Assertive Community Treatment. Both arms of the study will be followed for two years and assessed at 6, 12, and 24 months. Outcome measures include rates of conversion to psychosis, relapse of psychosis, development of psychotic disorder diagnoses, levels of positive, negative and general symptoms, social and vocational functioning, family functioning, and neurocognitive functioning.

The six sites include Sacramento, California; Salem Oregon; and surrounding counties, Ypsilanti and Washtenaw County, Michigan; Portland, Maine; Albuquerque, New Mexico and Glen Oaks, New York.

In addition to symptomatic and functional outcomes, impact on incidence of psychotic disorders, including schizophrenia, will be assessed, as will cost-benefit effects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects in the age range of 12-25 and living in the experimental catchment area may be enrolled in the EDIPP study based on meeting at least one of the inclusion requirements AND none of the exclusion criteria;
* Screening process indicates symptoms equivalent to a minimum rating of '1' on at least one positive symptom of psychosis;
* Screening process indicates a likely family history of first degree relative with psychotic illness plus a deterioration in functioning equivalent to a 30% drop in functioning score over the past year; OR
* Screening process indicates a likely history of schizotypal personality disorder plus a deterioration in functioning equivalent to a 30% drop in functioning over the past year.

Exclusion Criteria:

* Outside the age range of 12 to 25 years;
* History of intelligence quotient (IQ) below 70 (based on school records, not tested at PIER);
* More than one month duration of psychosis (guided by the criteria of at least one 6 on the Positive Symptom sub-scale of the Scale of Positive Symptoms (SOPS);
* History of previous psychotic episode, whether or not treatment was received;
* Taken antipsychotic medication for more than 30 days at a therapeutic dose for psychotic symptoms;
* Either the young person being screened for the study or both parents do not speak proficient English;
* Female is pregnant at baseline (inquired on the screening interview); AND
* Subject is a prisoner.
Coordination and Locomotor Problems in Patients With Covid-19 Virus

Coordination and Locomotor Problems in Patients With Covid-19 Virus


Eligibility Criteria:
Inclusion Criteria:

* COVID 19 diagnosis

Exclusion Criteria:

* Severe heart problems
* severe demeanor
* alcoholism
* drug problems
The Impact of Passive Heat Treatment on Glycaemic Response During an Oral Glucose Tolerance Test in Diabetic Patients

Type 2 diabetes mellitus (T2DM) is a metabolic disease with a rapidly increasing incidence world-wide. The disease is characterizedby a decreased glucose tolerance as a result of insulin resistance, resulting in poor blood glycaemic control. Blood glucose loweringmedications are widely available, but their effect stagnates as T2DM progresses. New treatment regimens are required to combatthe disease. Although therapies such as physical exercise have been shown to induce beneficial effects on glycaemic control inT2DM patients, not all patients are able to perform exercise. Passive heating treatment (PHT) might be an alternative strategy toreduce insulin resistance, as it has been postulated to have comparable effects on the cardiovascular system as exercise. PHT hasbeen linked to numerous health benefits, including improved cardiovascular- and pulmonary function, pain alleviation and metabolichealth. In addition, long term use of PHT shows promising effects on glycaemic control in T2DM patients. However, the acute effectsof PHT on glucoregulation are yet to be determined. Therefore, in this study we will assess the acute impact of passive heat treatment on the post-prandial glycaemic response during an OGTT in T2DM patients


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥50 years old
* Body mass index 18.5 - 35 kg/m2
* DM type 2
* Using oral blood glucose lowering medication
* Able to give informed consent

Exclusion Criteria:

* Insulin dependence
* Changes in diabetes medication in the past 3 months
* Allergy for one of the food items used
* \>5% weight change in the previous 6 months
* Participating in a structured (progressive) exercise program, or in the past 3 months.
* Frequent (once per week or more) user of infrared (or traditional) sauna in the past 3 months
* Inability to tolerate sauna/high temperatures
* Smoking
* Diagnosed with cardiovascular disease (e.g. unstable angina pectoris or recent myocardial infarction), kidney failure (eGFR \< 60 ml/min/1.73m2), rheumatoid arthritis
* Diagnosed musculoskeletal, GI tract, metabolic (except diabetes) or pulmonary (e.g. COPD) disorders that are expected to influence study outcomes
* Having a pacemaker, defibrillator, or any other type of metal implant
Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation

The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).

Eligible participants will be invited to two sessions, 2-7 days apart. In each session, either active tVNS or sham stimulation will be administered while the participants are performing tasks of executive functions. The order of the sessions (tVNS vs Sham) will be counterbalanced across participants.

Eligibility Criteria:
Inclusion Criteria:

In inpatient rehabilitation due to recent Traumatic Brain Injury, ages 18-65 years.

Ability to independently use a keyboard. Able to understand and communicate in English (according to clinical judgment). Able to independently provide consent to participate. Orientation to place, time, and situation (two consecutive scores of 25 or more on the Orientation Log(O-Log)40. This scale is routinely administered during acute rehabilitation stay.

Exclusion criteria:

Acute medical issues requiring close physician or nursing monitoring. Bioelectrical implants, including pacemakers. Pregnancy or persons who are lactating. Significant gross or fine motor weakness. Significant, ongoing communication or comprehension impairments (such as aphasia) that would affect an individual's ability to complete the required assessments.

Acute agitation or behavioral issues, as defined by a last Agitated Behavior Scale Score greater than 21 (routinely administered during acute rehabilitation stay, that would affect an individual's ability to participate in the required assessments.

Severely impaired memory retention (Score lower than 3 in the 3 Word Delayed Recall test, routinely administered during acute rehabilitation stay.

Diagnosis of depression. Active substance abuse.
Management of Skin Graft Donor Site Wound in Aged Patient

The complication of donor site in skin grafting often acts as a causing factor for extended treatment period. The elderly individuals tend to be afflicted by impaired wound healing. Herein, the investigators presented the outcome of skin regrafting in the elderly patients.


Eligibility Criteria:
Inclusion Criteria:

1. All patient who need to perform skin grafting surgery

Exclusion Criteria:

1. All patient who cannot be half or general anesthetized
2. severe comorbidities
Platelet Rich Plasma and Recurrent Implantation Failure

This study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with recurrent implantation failure. The study population consisted of infertile women with a history of recurrent implantation failure who had failed to achieve a clinical pregnancy which at least four good quality embryos transfers and are now candidate for IVF-ICSI or freeze embryo transfer cycles with and without intra uterine infusion of platelet rich plasma in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

Platelet Rich Plasma (PRP) is a blood product with a high platelet and a normal plasma fibrinogen level. Given the effective factors of RPR in repairing damaged tissues, its application in the field of regenerative medicine has widely been interested over the last three decades. According to the literature, PRP is an effective and safe treatment in the fields of orthopaedics, dermatology, ophthalmology, and repair of neurological, vascular, and connective tissue damage, but its application in the field of infertility is limited to a few pilot studies in which the effects of PRP on endometrium and recurrent implantation failure (RIF) were investigated. Given the importance of endometrial compliance and according to molecular studies, which indicate that endometrial growth factors in women with a history of RIF are lower than normal fertile women, PRP, along with other existing strategies, can be used to improve endometrial compliance in patients with a history of RIF. The present randomized, controlled clinical trial is proposed to determine the efficacy of PRP in the treatment of patients with RIF in the cycles of IVF-ICSI and frozen embryo transfer at Royan Institute.

Eligibility Criteria:
Inclusion Criteria:

1. Infertile women with a history of recurrent implantation failure who had failed to achieve a clinical pregnancy which at least four good quality embryos transfers
2. 20\<Age\<40
3. 19\<BMI\<29
4. Non endocrine, hematologic and autoimmune disorders
5. Non chromosomal and genetic abnormalities
6. Non uterine anomalies, surgical history, endometriosis, adenomyosis, hydro salpinx, uterine fibroids, Polycystic ovary syndrome
7. Having at least three good quality embryos

Exclusion Criteria:

1. Cervicitis
2. Recent fever condition
3. Use of corticosteroids (in up to 2 weeks before the procedure) or non-steroid anti-inflammatories (in up to 48 hours before procedure)
4. Anemia, thrombocytopenia, platelet dysfunction syndrome, hypofibrinogenemia
5. Septicemia, active infections with Pseudomonas, Klebsiella or Enterococcus
6. History of cancer
7. Patient's tendency for withdrawal
Ketone Production With Acute Caffeine Intake

Evaluate the effect of a caffeine supplement on the stimulation of lipolysis and the production of ketones in healthy adults (N=10).

The aim of the study is to evaluate the effect of a caffeine supplement on the stimulation of lipolysis and the production of ketones in healthy adults (N=10). Two different doses of caffeine (2.5 mg/kg of BW and 5 mg/kg of BW) are compared. All the participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* 18 years old and over

Exclusion Criteria:

* Drinking more than 300 mg of caffeine per day
* Diabetes or prediabetes
* Abnormal liver and kidney function
* Uncontrolled dyslipidemia, blood pressure
* Use of drugs known to influence the metabolism of lipids and carbohydrates (steroid, beta-blockers, diuretics, insulin sensitizer, etc.)
* Severe inflammation or infection
* Pregnancy
* Smoking
The Management of Erectile Dysfunction With Placebo Only

Placebo-controlled randomized clinical trials (RCT) are the gold standard to provide applicable evidence for clinical practice. A vast number of RCTs for treatment of several disorders has shown a mean placebo effect of 30%. Erectile dysfunction (ED) is a high prevalent disease and its first-line therapy is oral phosphodiesterase type-5 inhibitor (iPDE5) (i.e., sildenafil, vardenafil and tadalafil). Although the placebo effect in iPDE5 RCT occurred at a rate as high as 50%, in the last decade, with the revolutionary discovery of effective pharmacotherapy for ED, oral iPDE5 has become one of the most common prescribed drugs for men. The objective of this study is to evaluate the influence of patients' awareness on the composition of the therapeutic drug in the outcomes of the oral treatment for ED.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Complaint of ED for at least 6 months prior the start of the study, according to medical history and to the questionnaires IIEF, SEAR and QEQ.
* A stable heterosexual relationship.
* To be in good health prior the participation in the study, with no important clinical abnormalities, determined by: clinical history, physical examination, blood chemistry and hematology, urinalysis (If the standard values of the laboratory for these tests are not evidenced, subjects can be included if the researcher consider the changes as not clinically significant).

Exclusion Criteria:

* History of significant cardiovascular, pulmonary, gastrointestinal, hematological, neurological (including epilepsy), locomotor, immunologic, ophthalmic, metabolic, endocrine, thromboembolic, rheumatologic, cancer, kidney or liver disease.
* Diagnosis of psychiatric conditions, e.g. depression, anxiety, dysthymia, mania, panic, agoraphobia, social phobia, suicidal ideation, obsessive-compulsive disorder, post-traumatic stress, psychotic disorders, schizophrenia, alcoholism, dependence on psycho-active substances.
* History of HIV, hepatitis B or hepatitis C.
* Hyperprolactinemia or untreated hypothyroidism.
* Any condition, which, in the opinion of the investigator, may interfere with the participation of the subject in the study (e.g. difficulty to meet the requirements of the study, attend the consultations, answer the questionnaires).
* Report of significant clinical problems by the subject's partner, such as decreased sexual interest, pain during relations or other forms of sexual dysfunction that interfere in the relationship with the sexual partner.
* Patient or partner willing to undergo a surgical procedure during the study period, which may interfere in the results.
* Peyronie's disease, which may lead to impossibility to penetrate or cause pain during the sexual intercourse.
* Use of nitrates.
* Illiterate patient.
Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis

The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.


Eligibility Criteria:
Inclusion criteria:

* Outpatients 18 years of age and older (max 65 years)
* Patients with chronic plaque psoriasis on disease remission (i.e. PASI ≤75% of PASI before cyclosporine continuous treatment course) entering a maintenance period
* Disease remission obtained with only cyclosporine as systemic therapy (maximum dose 5 mg/kg/day) for \>8 weeks and \<16 weeks
* PASI still \<75% of PASI before cyclosporine continuous treatment course, at randomization to study treatment (8±2 days after disease remission)

Exclusion criteria:

* Abnormal renal function (creatinine ≥ 10% the upper limit of the reference range)
* Severe chronic degenerative diseases
* Severe uncontrolled hypertension
* Body weigh \>110 kg
* Abnormal liver function
* Hyperkalemia or hyperuricemia
* Clinically significant impairment of hematopoietic and cardiovascular function
* Concomitant therapy with nephrotoxic medications
* Patients with malignancy or a history of malignancy
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
* Clinically significant uncontrolled bacterial, viral or fungal infection
* Evidence of drug and/or alcohol abuse
Magnetomotoric Ultrasound for Diagnostic Purposes in Rectal Cancer

A magnetomotive ultrasound combines standard diagnostic ultrasound equipment with the application of an external time-varying magnetic field. The investigators aim to use this equipment to improve preoperative diagnostics in rectal cancer.

The investigators will compare magnetomotive ultrasound with MRI and pathology report on specimens extracted during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer
* Surgery with abdominoperineal resection

Exclusion Criteria:

* No informed consent
* Not fulfilling inclusion criteria
* No rectal cancer
Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement

To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women.


Eligibility Criteria:
Inclusion Criteria:

* Both primiparous or multiparous breastfeeding women
* BMI: ≤30-≥25 (14)
* Immediate puerperium with normal or C - section non-premature childbirth (19)
* Postnatal lactating mother with symptoms of breast engorgement

Exclusion Criteria:

* any breast infection, abscess, mastitis, breast cancer
* torn/bleeding or crack nipples
* any skin condition like dermatitis, psoriasis etc
* non-lactating mothers
* having heart pacemaker
Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease

The purpose of this study is to determine whether low-doses alemtuzumab and rituximab combination are effective in the treatment of chronic graft-versus-host disease (GVHD) after first-line therapy failure.

Graft-versus-host disease (GVHD) is the most common long-term complication in patients who underwent allogeneic transplantation. First-line therapy for chronic GVHD is based on immunosuppressive agents (usually cyclosporine and corticosteroids) achieving satisfactory response in around 30% of patients. There is no ideal second-line treatment for chronic GVHD; however, numerous studies have been published with therapeutic options such as alemtuzumab (anti-CD52) and rituximab (anti-CD20).

This is a prospective, longitudinal, nonrandomized study in which alemtuzumab and rituximab will be administered at low-doses to patients with refractory chronic GVHD. Clinical response will be evaluated based on the Working Group Report 2006, published by the National Institute of Health Consensus. Follow-up sessions will be weekly for four weeks, every two weeks until achieve response, and finally every four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic graft-versus-host disease.
* Patients over 18 years old.
* Patients who received first-line treatment with no response (failure), relapse or steroid dependance.

Exclusion Criteria:

* Patients with active bacterial or viral infections.
* Patients with hematologic disease progression.
* Patient's intolerance to drugs.
Treatment of AMD With Rheohemapheresis /RHF/

In this research rheohemapheresis will be used for the treatment of patients with high-risk dry form of age-related macular degeneration. Correction of rheologic parameters and activation of retinal functional reserves after the therapy will positively influence functional condition of retina. The newest special electrophysiologic methods will be used to determine retinal changes in time. The investigators will also evaluate some important immunologic factors and complement changes as well as define indication criteria more precisely.

With optimized therapeutic protocol we would prevent progression of the dry form of AMD into its devastating wet form and stabilize the situation. We suppose that retinal morphologic and functional conditions would improve in a high percentage of patients. Also possible technical and economic savings would not be less important with our own therapeutic protocol, especially, when blindness could be prevented.

Eligibility Criteria:
Inclusion Criteria:

Patients with AMD in the stage of soft drusen, grade 1-3 according to European Eye Study (EURYEYE) (see reference No 1), body weight over 50 Kilo and with other feasible indications for aphereses therapy (peripheral veins allowing vascular access to establish the extracorporal circuit).

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Exclusion Criteria:

* Study eye with exudative AMD
* Study eye with concomitant retinal or choroidal disorder other than AMD
* Study eye with significant central lens opacities and/or conditions that limit the view of the fundus
* uncontrolled diabetes, uncontrolled arterial hypertension
* insufficient antecubital venous access
* haemato-oncological malignancies
* patients who are unwilling to adhere to visit examination schedules . poor general condition (serious diseases - infections,cardiovascular or cerebral insufficience, severe IHD)