cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations

Generic medications should be the equivalent of brand medications with the exception of their price. Before a generic medication is introduced, its bioequivalence within a window of 80 to 125% of the original has to be demonstrated. There are reports that this criterion is not always followed in post-marketed periods. Such investigations were triggered by the observation that some patients previously stable on original medications relapsed when switched to a presumable equivalent generic. Several factors could account for this problem. Given reports of such problems occurring with the antidepressants citalopram and venlafaxine, some pharmacokinetic properties of specific brands of generics and the originals will be examined for these two medications. Twelve healthy male volunteers will participate in this crossover study. It is anticipated that there will be significant differences emerging between the two formulations given the clinical reports of patients deteriorating when switched from the original to the generic preparations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)

Exclusion Criteria:

* Psychiatric disorder
* Hepatic disease
* Renal disease
* Gastrointestinal disease
* Hematological disease
* Smokers
* Physical and/or neurological disease
* Positive urine drug screen
* Abnormal blood pressure
* Abnormal urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT, AST, total protein, glucose, and TSH)
Different Modalities of Aquatic Physiotherapy in Patients With Knee Osteoarthrosis

The aim of this study is to evaluate the effects of different modalities of aquatic physiotherapy on the biochemical and functional behavior of patients with knee's Osteoarthritis.

The subjects will be informed about the study and its potentials risks and sign the informed consent. The sample will be submitted to three different modalities of AF interventions: (a) low impact immersion, (b) conventional aquatic physiotherapy and (c) high intensity aquatic physiotherapy. The functional variables of flexibility, pain, joint volume will be evaluated before and immediately after each intervention whereas the biochemical variables will be evaluated from the analysis of peripheral blood following times: baseline moment (immediately before the intervention), moment 1 (immediately after the intervention), and moment 2 (24 hours after the intervention).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 50 years old and diagnosed with OA in at least one knee
* Presence of pain and at least one functional dysfunction for at least 6 months
* Absence of physical limitation that prevents the exercise protocol from being performed
* Kellgren and Lawrence ranking between I and IV
* walk independently and without auxiliary device

Exclusion Criteria:

* Inflammatory, rheumatic or autoimmune conditions
* Use of psychotropic, immunosuppressive and steroid medications
* Antioxidant consumption
* Alcohol and tobacco consumption
* Progressive ankylosis states
* neurological injuries
* Infections or skin diseases that contraindicate swimming pool immersion
* Surgical procedures on the knee joint in the last 12 months (excluding meniscectomy or arthroscopy)
* Lower Limb Joint Prosthesis
* Presence of inflammatory or infectious diseases, uncontrolled systemic arterial hypertension, uncontrolled diabetes, chronic obstructive pulmonary disease and history of ischemic heart disease
* Self-report of aquatic phobia and chlorine allergies
Description of the Use of Subcutaneous Acetaminophen in Palliative Care Unit in France: Descriptive Questionnaire Survey

Acetaminophen is a drug commonly used in palliative care unit, for its antalgic and antipyretic effects. Several administration routes are possible but the use of the sub-cutaneous route is actually not supported by recommandations.


Eligibility Criteria:
Inclusion Criteria:

* doctors responsible for palliative care unit in France

Exclusion Criteria:

-
Ocrelizumab for Psychosis by Autoimmunity

Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to "friendly fire." Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them. If this disease is caused by auto-antibodies, typically the person is well until they are 15 years of age or older, but seldom older than 35 years. Then, in a matter of a few months they begin to have hallucinations and the other symptoms. Doctors still do not know whether some people with schizophrenia or bipolar disease have auto-antibodies attacking their brain. For this reason, in this study some of these patients will receive a treatment that suppresses the auto-antibodies and their symptoms after treatment will be compared with the symptoms of a group of similar patients who are given a preparation that looks like the real treatment, but it is not.


Eligibility Criteria:
Inclusion Criteria:

* Individuals of either sex, 18-35 years of age.
* Having an active psychotic disorder meeting DSM-5 criteria, including a duration of at least six months, for Schizophrenia Spectrum Disorder, as defined by the Mini International Neuropsychiatric Interview (MINI).
* A total PANSS ≥ 60 and a score ≥ 4 on at least 2 of the PANSS positive symptoms.
* Normal academic performance at least until the age of 15 years and absence of psychiatric symptoms before the same age.
* Ability to assent or consent to the performance of the study and participate in testing procedures.

Exclusion Criteria:

* The dose of antipsychotic medication (if they are on one) has been changed less than two weeks prior to baseline PANSS testing (Visit 2, see below).
* Patient treated with a medication designed to suppress the immune system, other than standard analgesics or antipyretics, in the six months prior to randomization.
* Vaccinated with a live-attenuated vaccine less than 4 weeks before ocrelizumab infusion or with a non-live vaccine less than 2 weeks before infusion.
* Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus, syphilis, tuberculosis, PML).
* History of brain tumor, stroke, severe head trauma or multiple sclerosis.
* Active cancer, metabolic encephalopathy, severe cardiovascular or renal disease.
* In the judgment of the PI, psychosis related to substance abuse or metabolic disorders.
* Pregnancy or lactation.
* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
* History of or currently active primary or secondary immunodeficiency.
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
* Contraindications to or intolerance of oral or IV corticosteroids.
Spontaneous Atrioventricular Conduction Preservation

The aims of this study are to assess the clinical benefits resulting from SafeR by comparison with standard dual chamber programming (DDD) with a long atrioventricular (AV) delay.

The benefits will be assessed by comparing the percentage of ventricular pacing, the incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed through echo parameter and atrial natriuretic peptide/brain natriuretic peptide (ANP/BNP) measurements.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who fulfils one or more of the official guidelines to be implanted with a dual-chamber pacemaker (primo-implantation3) may be included in the study.

Exclusion Criteria:

The patients presenting with one or more of the following characteristics cannot be included:

Permanent complete AV block

* Permanent atrial and/or ventricular arrhythmias
* already implanted with a cardioverter-defibrillator (ICD)
* Likely to have a cardiac surgery in the next six months, mainly for:
* severe coronary artery disease
* severe valvular disease
* AV node ablation
* Refuses to sign an consent form after having received the appropriate information
* Refuses to co-operate
* Not able to understand the study objectives and protocol
* Not available for scheduled follow-up
* With a life expectancy less than one year
* Already included into another clinical study competing with the objectives of the CAN-SAVE R study
* \<18 years old
Evaluation in the Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction With Conventional Blood Culture.

The objective of this study is to evaluate the consumption of antimicrobial therapy in patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis.

Patients staying more than 48 hours in hospital with clinical suspicion of sepsis could be included in the study. Blood samples for cultures and multiplex PCR will be collected immediately prior to initiation of antibiotic therapy. Patients will be randomly selected into two groups. In Group I, the PCR results will be immediately reported to the medical researcher (6-12 hours), which will change the antimicrobial regimen (De-escalation). In Group II, the Multiplex PCR results will not be informed, being focused care as a result of blood culture (at least after 72 hours). The initial empirical antimicrobial therapy will be the same in both groups, according to the standardization of the institution.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 or more years old
* Patient staying more than 48 hours in hospital
* Patient with clinical suspicion of infection and presenting at leat two of the following criteria:temperature \> 38oC or \< 36oC, heart rate \> 90 beats/minute, respiratory rate \> 20 breaths/minute or PaCO2 \< 32 mmHg or leukocytosis \>12 000/μl or leukopenia \<4000/μl or normal white blood cell count with \>10% immature forms
* Patient or responsible able to provide informed consent

Exclusion Criteria:

* Patient submitted to cardiovascular surgery in the last fifteen days
* Patient or responsible are not able to provide informed consent
Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis

This is a dose-finding study for the investigational product Lancovutide (Moli1901) in the exploratory phase IIb to establish minimum effective dose, optimal dose, and maximum safe dose. Additionally, the tolerability of Moli1901 shall be investigated.

Study Moli1901-010B is a multi center, parallel group, placebo controlled, double-blind efficacy and safety evaluation of three different dosage schedules of aerosolized Moli1901 in adolescents (12 years of age or older), and adults. Study will start with a screening period (visit 1) followed by an 8 weeks double blind comparative treatment period (visit 2-7). Thereafter, subjects will be observed for additional 4 weeks without treatment (follow-up period and visit 8). Spirometry, pulse oximetry and other safety measurements will be performed up to 120 min after study medication inhalation. The study will be conducted in 30 sites in 9 European countries.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index
* Confirmed diagnosis of cystic fibrosis
* FEV1 between 50% and 85% of predicted
* Oxygen saturation level measured by pulse oximetry (SpO2) \>90 % on room air

Exclusion Criteria:

* Bronchial hyperresponsiveness
* Unstable lung function
* Pulmonary disease such as pneumonia, tuberculosis, or lung cancer
* Acute upper respiratory tract infection within the last 2 weeks
* Acute lower respiratory tract infection (requiring antibiotics or hospitalization) within the last 4 weeks
* Pulmonary exacerbation within the last 4 weeks
* Changes from routine maintenance therapy within the last 4 weeks
* Scheduled changes to inhaled antibiotics regimen during the course of the study
* Receive or are planned to receive any treatment via "on-off" regimen (e.g. Tobramycin - TOBI®); last dose of any "on-off" treatment within the last 6 weeks
* Any clinically significant liver, renal, cardiac, neurological, or hematological disease
* ABPA or colonization with Burkholderia cepacia
* Poorly controlled diabetes mellitus
Effect of Iron and Folic Acid on Skin Fungal Pattern in Patients With Arsenicosis

This study will be conducted to observe any change in fungal pattern on skin of arsenicosis patients before and after administration of iron (150 mg) and folic acid (0.5 mg) tablets.

Arsenicosis is remaining as a precarious issue in Bangladesh for the last few decades. The fact of resentment is that this perilous condition still remains unresolved worldwide. So, it has become the demand of era to address this issue. Different diseases are manifested in different way. In arsenicosis melanosis and keratosis are the most common manifestations. The actual mechanism of development of keratosis is unclear. Chronic ingestion of arsenic contaminated water causes accumulation of arsenic in keratin rich tissues like skin, hair, nail and producing characteristic skin manifestations like melanosis and keratosis. Metabolism of arsenic depends on folate pathway and dietary deficiency of folic acid reduced the total arsenic excretion and leads to development of cancer. In different study results shown that folic acid reduces the blood arsenic level. As arsenicosis is a chronic disease condition, fungal infection is more common to them. Moreover the skin fungal pattern in arsenicosis yet not known. Therefore, this study will be conducted to determine is there any change in skin fungal pattern in patients with palmar arsenical keratosis before and after administration of iron and folic acid. Forty two patients with palmar arsenical keratosis will be recruited on the basis of inclusion and exclusion criteria. Twenty one patients will be furnished tablet placebo once daily for 12 weeks without any interruption. Another twenty one patients will be furnished iron (150 mg) and folic acid (0.5 mg) once daily for 12 weeks without any interruption. Water and nail samples will be collected for confirming the diagnosis. Skin sample will be collected two times (before and after giving iron and folic acid) for qualitative analysis of fungi. So, this study will determine any change in fungal pattern after administrating tablet iron and folic acid.

Eligibility Criteria:
Inclusion Criteria: (Patients)

* History of drinking arsenic contaminated water(\>50 μg/L) for more than 6 months
* Patients having moderate palmar keratosis
* Patients those voluntarily agree to participate

Exclusion Criteria:

* Pregnant and lactating mother
* Any other chronic diseases like tuberculosis, diabetes mellitus, asthma
* Patient under treatment of arsenicosis on Criteria:
The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women.

Participants will be randomly assigned to one of three treatment groups to receive soyafoods (Alpro drinks) providing a low (\<10 mg), medium (35mg) or high-dose (60 mg) of isoflavones daily for a period of 12 weeks. The group receiving \<10mg isoflavones daily will serve as a low-dose control group. Women will be asked to avoid consuming any additional soya foods during the study.

Dietary intake will be assessed at baseline using the validated food frequency questionnaire a 4 day food diary will be completed at baseline and post-intervention. Weight and height will be measured and a general health \& lifestyle questionnaire will also be completed by participants at baseline. Cognitive function will be assessed at baseline and post-intervention using the well validated and widely used computerised test battery system. Menopausal symptoms, quality of life, mood, stress and coping will also be assessed.

Plasma concentrations of the soya isoflavones genistein and daidzein will be measured to assess compliance. Circulating concentrations of equol (a daidzein metabolite), will also be measured to investigate associations between equol and cognition and menopausal symptoms as a potential mechanism for the efficacy of soya.


Eligibility Criteria:
Inclusion Criteria:

* apparently healthy
* within 7 years postmenpopausal with the absence of vaginal bleeding for at least 1 year
* ≥ 24 in mini mental state examination
* not suffering from psychiatric distress as assessed using GHQ28 questionnaire

Exclusion Criteria:

* surgically induced menopause
* habitual consumers of soys foods (\> 2 serves/week)
* currently using hormone therapy
* currently on isoflavone supplements
* antibiotics use within last 3 months
* use of psychoactive medication
* history of CVD, cancer, diabetes, thyroid, renal or kidney disease, alcohol or drug abuse
* red-green colour blindness
Effects of Digital Pelvic Floor Muscle Training in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms

The aim of this study was to investigate the effects of digital pelvic floor muscle training and lifestyle recommendations in patients with Multiple Sclerosis having lower urinary tract symptoms.

Multiple sclerosis (MS) is an autoimmune, neurodegenerative disease of the central nervous system. Lower urinary tract symptoms (LUTS) are very common in MS. Pelvic floor muscle training (PFMT) is one of the first-line choices for the conservative treatment of LUTS.

According to our knowledge, no study has investigated the effects of digital pelvic floor muscle training and lifestyle recommendations in MS having LUTS, yet.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of MS and having at least two of the lower urinary symptoms
* Not having an attack in the last 1 month,
* No change in medical treatment in the last 3 months
* "Expanded disability status scale-EDSS" score is less than 6.5
* Not having any cognitive problems that would hinder cooperation and understanding
* Those who use digital devices such as computers, laptops, smartphones and tablets
* Volunteering to participate in the study

Exclusion Criteria:

* Pregnancy status
* Active urinary tract infection
* Another neurological disease that can cause incontinence
* A history of malignancy
* Prostate surgery
* Those with missing evaluation parameters
* Those who do not regularly participate in treatment programs
Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)

Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Before inclusion, all participants must be informed and must give consent for the use of his/her anonymized health data related to his/her treatment with Peginterferon alfa-2b (injection pen) and Ribavirin.

Exclusion Criteria:

* According to Peginterferon alfa-2b/Ribavirin label.
Prediction of 30-Day Readmission Using Machine Learning

This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict the likelihood of 30-day readmission throughout a patient's admission. This algorithm was then validated in a validation cohort.


Eligibility Criteria:
Was a subject in the Brigham and Women's Home Hospital study and has a completed record in the study's database.
Comparison of Surgery and Active Surveillance in the Treatment of Bosniak III Renal Cysts

The incidence of renal cysts is rising due to increased abdominal imaging. Renal complicated cysts have been traditionally classified according to the Bosniak classification, which distinguishes cystic masses by specific features of walls and septa. The categories I and II are benign and class IIF most probably benign but needs a short radiological follow-up. Categories III and IV have been traditionally operated due to the increased risk of renal cell carcinoma. However, recently published studies show that approximately 50% of the operated Bosniak III cystic masses are benign, which means that half of the cases are overtreated by surgery. It has also been shown that surgical pathology of stable Bosniak IIF cysts is malignant in less than 1%, while the cysts, which are upgraded to higher Bosniak classes will show malignant surgical pathology in 85%. So far, there is lack of prospective data on active surveillance in Bosniak III cystic masses.

The aim of the study is to compare active surveillance and surgery in patients with Bosniak III renal cystic masses. Patients will be randomized in active surveillance or immediate surgical excision of a cystic mass. In the active surveillance group, patients are followed according to the study protocol for 10 years and treated with delayed surgery if the cystic mass upgrades into Bosniak IV/solid, becomes symptomatic or grows over a preclassified threshold. The primary objective is to compare surgical pathology between patients treated with immediate surgery versus delayed surgery.

According to recent retrospective data, active surveillance of Bosniak III cystic masses is reasonable and oncologically safe. Therefore a prospective randomized controlled trial is needed to get high level evidence to support a change in the treatment strategy. The study may significantly reduce unnecessary operations performed in patients with Bosniak III cystic masses.


Eligibility Criteria:
Inclusion Criteria:

* A sporadic single CM of Bosniak 3 according to the Bosniak Classification v.2019 is diagnosed with CT or MRI
* Maximal diameter of CM 10-70 mm
* Age ≥50 years
* ECOG performance status \<2
* Life expectancy ≥5 years
* Patient is fit to undergo surgery and AS.
* Patient understands a national language or English
* Signed informed consent

Exclusion Criteria:

* Genetic syndromes associated with RCC
* Previously or simultaneously diagnosed and pathologically verified RCC
* Previously or simultaneously radiographically identified solid mass or CM of Bosniak 3/4 with diameter ≥10mm
* The target CM of Bosniak 3 has progressed in sequential imaging from Bosniak 1-2F
* Presence of radiographic findings which are suspect for nodal or distant metastatic disease
* Symptomatic CM
* Kidney insufficiency (GFR\<55 ml/min/1,73m2)
* Patients who have contraindications for both CT and MRI imaging. . Anatomically solitary kidney