cyrilzakka/clinical-trials huggingface dataset:
Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia

The principal clinical question to be answered by CHAT (Clozapine Haloperidol Aripiprazole Trial) is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared to combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time.


Eligibility Criteria:
Inclusion Criteria:

1. Current treatment with clozapine for the primary indication of schizophrenia (clinical diagnosis, guided by DSM-IV criteria).
2. Treatment with clozapine for at least six months at a stable dose of 400 mg or more per day, unless the size of the dose was limited by side-effects.
3. Unsatisfactory benefit from clozapine treatment, as indicated by the presence of positive symptoms (delusions, hallucinations, abnormal behaviour, clinical diagnosis)
4. Age 18 and above.
5. Agreement between investigator and patient to enter the study.
6. The patient is normally resident in Italy.
7. It is considered clinically reasonable to try combination treatment with clozapine and aripiprazole or with clozapine and haloperidol.
8. Uncertainty about which trial treatment would be best for the participant.
9. No medical disorder or condition contraindicates either of the investigational drugs.
10. Agreement between investigator and patient to discontinue any antipsychotic drugs other than clozapine (including long-acting antipsychotic drugs).
Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-60.
* Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
* Chronic HBV infection for ≥ 6 months.
* On NRTI therapy for at least 6 months.

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
* Significant liver fibrosis or cirrhosis.
* History or evidence of drug or alcohol abuse.
* History of intolerance to SC injection.
* History of chronic liver disease from any cause other than chronic HBV infection.
* History of hepatic decompensation.
* Contraindications to the use of Peg-IFNα.
Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (PROMISE)

The purpose of this study is to evaluate the effectiveness and safety of adalimumab as used in routine clinical practice in adult patients with moderate to severe chronic plaque psoriasis in Spain.

PROMISE is a 2 year post-authorization study of patients taking adalimumab for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with adalimumab. No study specific testing will be performed. Patients will be asked to provide data on their experiences with adalimumab approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry. A total of 547 subjects were enrolled: 532 in the ITT population were analyzed for efficacy (excluding 15 for lack of follow-up visits (n=8), non-fulfillment of the criteria of moderate to severe PS (n=6) and failure to initiate treatment at the baseline visit (n=1)); 542 were analyzed for safety (excluding 5 due to lack of evaluable safety data).

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older.
* Patient diagnosed with moderate to severe chronic plaque PS beginning treatment with adalimumab in accordance with the authorized conditions of use.
* Patient gives informed consent in writing.

Exclusion Criteria:

* Patients who cannot be treated in accordance with the local product label
* Patient participating or going to participate in a clinical trial during the study follow-up
* Patient with difficulties for adequately reading, understanding and completing a questionnaire
Carbohydrate Antigen 125-guided Therapy in Heart Failure

Preliminary data suggest a potential role for monitoring and up-titrate pharmacological therapy of plasma levels of antigen carbohydrate 125 (CA125) following and admission for acute heart failure (AHF).

This study will evaluate the effect of a CA125-guided management strategy versus standard therapy on the composite endpoint of 1-year all-cause mortality or readmission for AHF in patients recently discharged for AHF.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* At least 1 admission for AHF, in the last 180 days.
* Demonstrates functional New York Heart Association status of Class ≥II at the moment of enrollment.
* Objective evidence, either during the index admission or at least 180 days before enrollment, of a structural or functional abnormality of the heart at rest, and defined as: N terminal-pro-brain natriuretic peptide \>1000 pg/ml or brain natriuretic peptide \>100 pg/ml or echocardiographic abnormalities congruent with HF diagnosis such as: systolic left ventricular dysfunction (LVEF \<50%); left ventricular hypertrophy (defined as left ventricular septum or left ventricular posterior wall thickness ≥12 millimeters or left ventricular mass index \>104 g/m2 in women or 116 g/m2 in men); Ee'\>15 or significant valvular heart disease (moderate-severe).
* A plasma CA125 value \>35 U/ml in a recent test evaluation (at least 30 days before enrollment, and preferably assessed before hospital discharge).
* Patient must be capable of understanding and signing an informed consent form.

Exclusion Criteria:

* Life expectancy \<12 months due to other diseases different from HF.
* Having undergone a cardiac transplantation, coronary revascularization procedure (percutaneous coronary intervention and/or coronary artery bypass grafting) or cardiac valve replacement in the past 3 months.
* Angina pectoris higher than class II (Canadian Cardiovascular Society Classification).
* Pregnancy at the moment of enrollment.
* Valvular heart disease already scheduled for surgical intervention.
* Severe chronic obstructive and/or restrictive pulmonary disease, requiring continuous oxygen administration.
* Serum creatinine level \> 3 mg/dl or chronic renal insufficiency on dialysis treatment.
* Patients receiving resynchronization therapy during the index admission.
* Significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the screening period, endometriosis, cirrhosis, acute coronary syndrome within 6 months, uncontrolled hypertension, history of human immunodeficiency virus (HIV) infection, or a significant active infection.
* Participating in another randomized study.
Tissue Oxygenation of the Tibial Anterior Muscle After Clamping of the Femoral Artery

Ischemic preconditioning is defined as protection from cell damage induced by prolonged ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective, randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of the calf measurable by near-infrared spectroscopy. In addition to this, the effect of sevoflurane preconditioning on ischemia of the calf is measured.

Ischemic preconditioning is performed by clamping of the femoral artery for five minutes in 40 patients. In 20 patients sevoflurane preconditioning is performed five minutes before ischemic preconditioning by inducing sevoflurane anesthesia for five minutes. Muscle tissue oxygenation is measured bilaterally in the anterior tibial muscle by near-infrared spectroscopy (INVOS, SOMANETICS, Troy, Michigan/ USA) during preconditioning and following ischemia.Clinically relevant ischemia was defined as a decrease of tissue oxygen saturation to 95 % of baseline.

Eligibility Criteria:
Inclusion Criteria:vascular surgery with clamping of a femoral artery. -

Exclusion Criteria:

-
Lidocaine Infusion With ANI Monitoring in Spine Surgery.

To evaluate the analgesic effect of intraoperative continuous lidocaine infusion (1.5 mg/kg/h (ideal body weight)) in combination of analgesia nociception index and depth of anesthesia monitors guided anesthetics adjustment on enhanced recovery after surgery (ERAS) in patients undergoing elective lumbar spine surgery (≥2 sessions).

The patients undergoing elective lumbar spine surgery (≥2 sessions) are randomly assigned and divided patients into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. Patients in control group receive the same volume of saline injection. During the operation, the dose of anesthetic drugs (propofol, remifentanil and rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value, Entropy (or BIS) value at 40-60, and ANI at 50-70 in both groups. The pain score (numerical rating scale), cumulative amount of opioids used after the operation within 3 days, and the quality of recovery on the third day after the operation are recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Twenty to eighty-year-old
2. ASA class I-III patients undergoing
3. Elective lumbar spine surgery under general anesthesia

Exclusion Criteria:

1. Unable to understand the Numerical Rating Scale (NRS)
2. Severe mental disorder
3. Poor liver function
4. Pregnant or lactating women
5. Morbidly obese
6. History of epilepsy or allergy to any of the drugs used in this study
7. Current use of opioids
8. Baseline heart rate \<50 beats/min
9. Arrhythmia history with cardiac rhythm device
10. Body weight \<40 kg and \>80kg
A Comparative Study of Support Devices for Ventilator-Assisted ICU Patients

Assisting critically ill patients with early mobilization or early ambulation during their stay in the intensive care unit (ICU) can reduce the duration of mechanical ventilation use, length of ICU or hospital stay, probability of complications during hospitalization, and sedation days in the ICU and improve disease prognosis. However, over 80% of critically ill patients have endotracheal tubes and require the use of mechanical ventilators in the ICU, and due to the numerous invasive treatments and tubes, there are high concerns regarding the safety of tube stability and risk of tube dislodgement during early mobilization. Although there are commercially available fixed tracheal tubes or external support devices for breathing tubes to prevent displacement, they do not solve the problems of the weight of the breathing tube during ambulation or endotracheal tube slippage. Therefore, through interdisciplinary collaboration, the investigator has designed a "wearable support device" (Type A support device). The unique design of the fixed frame uses a plug-in-latch shape to fix the Y-shaped breathing tube to the patient's chest position. In addition to reducing the displacement of the free section of the endotracheal tube downwards, it can also fix the main body of the breathing tube. The dual-disc strap method allows adjustment of the position and tightness for patients of different body sizes, and a single specification can be used for patients of various body shapes. Currently, a modified version of this wearable support device (Type B support device) has been designed based on clinical suggestions.The purpose of this study is to compare the feasibility, safety, and comfort of using the Type A-support device and the Type B-support device to assist in supporting breathing tubes during early ambulation in ICU patients using mechanical ventilators.


Eligibility Criteria:
Inclusion Criteria:

1. Glasgow Coma Scale score of ≥6,
2. relatively stable respiratory status (oxygen saturation \>92%, settings on the mechanical ventilator: fraction of inspired oxygen ≤60%, positive end-expiratory pressure ≤10 cmH2O)
3. a stable cardiovascular system (resting heart rate ≤130 and \>40 beats per minute)
4. no requirement for high-dose vasopressors \>0.2 μg/kg/min).

Exclusion Criteria:

1. Patients with temporary limb immobilization as prescribed by the physician.
2. Patients with a tendency to bleed.
3. Patients with pre-existing mental abnormalities.
4. Patients who are expected to die within the next 24 hours or are primarily receiving palliative care in the intensive care unit.
5. Patients with sustained intracranial pressure elevation (\> 20 millimeters of mercury (mmHg)).
6. Pregnant patients.
7. Uncontrolled epilepsy.
8. Acute myocardial infarction or rapidly progressing neuromuscular diseases occurring in the intensive care unit.
9. Patients with abnormal skin conditions such as skin abrasions, redness, swelling, etc., in the chest/back area.
Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women

Studies showing the relationship between meal frequency, weight loss and anthropometric measurements are contradictory. This study is planned and conducted to observe the effects of meal frequency (3 meals+3 snacks vs 3 meals) on weight loss, anthropometric measurements and body composition with 3-month energy restricted Medical Nutrition Therapy program in 19-64 years old women with a BMI ≥ 27 kg/m2.

The study was conducted with 40 female volunteers between the ages of 19-64 years, with a Body Mass Index (BMI) ≥27. Energy restricted individualized weight loss programs were applied with different meal frequencies (3 meals+3 snacks/day vs 3 meals/day) in a 3 month follow up period. 20 participants were randomized in 3 meals+3 snacks and 20 participants were randomized in 3 meals group. Food consumption was questioned, and anthropometric measurements and body composition were measured before the study and repeated each week till the end of the study. Three day food records (2 week days and 1 weekend day) taken before the intervention were evaluated and five hundred calorie was subtracted from the average energy calculated form the food records to determine the energy of the weight loss plans . Breakfast, lunch and dinner are planned as main meals and the beverages and/or food eaten between main meals were planned as snacks (50-200 kcal). For both of the groups dietary weight loss program was planned by the same dietitian. Macronutrient composition of the weight loss plan was designed according to the recommendations of the Turkish Dietary Guidelines as 45-60 % carbohydrate, 10-20 % protein and 20-35 % fat for both of the groups.

Eligibility Criteria:
Inclusion Criteria:

* 19-64 years old Women,
* Healthy subjects with no chronic diseases,
* Subjects who were not taking any drug or dietary supplements,
* Subjects who have not made any changes in their physical activity or eating habits for weight loss in the last 6 months,
* Subjects with a BMI ≥ 27 kg/m2

Exclusion Criteria:

* Failure to meet the criteria for inclusion
Impact of Dexamethasone Added to Intra-articular Morphine and Bupivacaine for Post-operative Analgesia After Knee Arthroscopy

A randomized double-blinded clinical trial was carried out on 40 patients undergoing knee arthroscopy. Patients were divided randomly into two equal groups. All drugs used were injected intra-articularly at the end of arthroscopy. In the control group, patients were administered 10mg morphine added to bupivacaine 25mg. In the study group, patients were administered 10mg morphine and 8mg dexamethasone added to bupivacaine 25mg. Visual analog score for pain at rest and movement, time to first analgesic request, total analgesic consumption, duration of analgesia and adverse effects were recorded.


Eligibility Criteria:
Minimum Age: 18 years Maximum Age: 65 years Sex: Both Gender Based: No Accepts Healthy Volunteers: No

Criteria:

Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II
* Scheduled for minor arthroscopic knee surgeries (meniscectomy, chondroplasty, minor ligament repair and diagnostic arthroscopy)

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status above (II)
* Undergoing major knee surgeries
* History of allergies to any of the used drugs
* History of diabetes mellitus
* Contraindications of morphine use (e.g. asthmatic patient, chronic obstructive pulmonary disease, and addiction)
French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Studies have shown the importance of weight loss at the time of diagnosis and during the progression of the disease. However, the pathophysiological mechanisms behind weight loss remain unknown. Identifying these mechanisms could make it possible to propose an effective therapeutic strategy against weight loss for ALS patients, which could improve their survival and quality of life. In this context, the investigators are proposing an innovative multidisciplinary project aimed at structuring a large Franco-German cohort to identify the markers associated with weight loss in ALS.

Participants will undergo high quality standard care for ALS patients. In addition, participants will be asked to respond different questionnaires and blood samples will be taken for analysis to identify biological markers.

ALS is the most frequent adult onset motor neuron disease and is highly variable in terms of clinical features, genetics, and neuropathology. A large body of evidence has demonstrated the importance of weight loss at the time of diagnosis and during disease progression. Weight loss affects between one and two-thirds of patients and is adversely associated with survival. High caloric nutrition was able to slow weight loss and prolong survival in fast progressing ALS patients. Pathophysiological mechanisms underlying weight loss remain unknown because high-quality cohort data collecting clinical features, genetics, omics, and imaging related to the metabolic and disease status of patients are lacking. The investigators hypothesize that weight loss in ALS patients is biologically driven through specific pathways. The investigators propose an innovative and ambitious multidisciplinary project to structure a large French-German cohort to identify markers associated with weight loss. The investigators aim at identifying the biological correlates of weight loss to disentangle the mechanistic basis of this critical symptom and to determine clinical and biological profiles along with their impact on disease progression and survival.

Eligibility Criteria:
Inclusion Criteria:

* Incident cases included at the time of diagnosis with a definite, probable, probable laboratory-supported, or possible ALS according to El Escorial revised criteria and Gold Coast criteria for early diagnosis.
* Incident ALS cases identified and followed-up in the participant ALS \& Other Motor Neuron Diseases Referral Centres: seven in France and two in Germany.
* Patients who signed the informed consent form.
* Adults aged \>18 years old

Exclusion Criteria:

* Inability to understand the requirements of the protocol.
* Cognitive inability to sign and comprehend the informed consent form.
* Patients who will not accept Riluzole therapy during their follow-up.
A Retrospective Analysis of Spinal Anaesthesia for TURBT Procedures in Elderly Patients

The aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among elderly patients The basic methods for diagnosis and management of bladder cancer include endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour TURBT). The age of most patients is above 60, which increases the risk of complications during the perioperative period. Usually the leading anaesthesia method in TURBT procedures is regional, mainly spinal, anaesthesia. Although the prevalence of regional upon general anaesthesia is questioned, certain positive aspects of regional anaesthesia are indisputable. Maintaining logical communication with a patient during the procedure enables early diagnosis of complications (TUR syndrome, bladder perforation). Undeniably, regional anaesthesia ensures the best pain management in the early post-operative period. The simplicity of performing an efficacious spinal block and its cost-effectiveness are additional factors, which have contributed to the acknowledgement of the method as the standard of anaesthesia for transurethral procedures.


Eligibility Criteria:
Inclusion Criteria:

* TURBT procedure
* spinal anaesthesia
* age over 60

Exclusion Criteria:

* general anaesthesia
Magnetic Resonance Imaging for the Study of Patients With Neurological Disorders

This study is divided into two parts. The first part of the study will use MRI technology to view the brain structure of patients with neurological disorders and normal volunteers. This portion of the study will attempt to detect specific areas of damage in the brains of patients with amnesia and dementia. It will also try to correlate the amount of brain damage with performance on tests used to measure memory.

In the second part of the study, researchers plan to use MRI technology to study brain function of patients with neurological disorders and normal volunteers when they perform tasks. MRI signals during task performance will be used to record areas of the brain receiving more blood flow indicating increased activity.

Researchers believe this study will help improve existing methods of evaluating patients with neurological disorders. In addition, this study may contribute information about areas of the brain involved in thought processing and motor and sensory function.

We wish to use MRI technology to study brain structure (Part 1) and function (Part 2) in several neurological disorders and in normal controls. In Part 1 of this protocol, we describe our interest in using detailed MRI brain structure analysis to identify predicted specific neural structure atrophy in patients with selective amnesia and dementia and to attempt to associate the magnitude of atrophy in these neural structures with performance on selected memory tests. In Part 2 of this protocol, we outline our interest in utilizing newly developed MRI techniques to identify selective changes in local brain blood volume, blood flow, and other physiological parameters during functional stimulation. Recent developments permit recording of MRI signals that are indicative of regional cerebral blood volume and blood flow changes. Local changes in these physiological measures appear to topographically overlap with expected areas of functional brain activation. The advantage of this method over Positron Emission Tomography is the exquisite spatial resolution of MRI. This MRI technique is new and has had only limited use so far. The studies in Part 2 of this protocol should help develop the method and begin to answer fundamental biological and functional questions about the representation and activation of cognitive, motor, and sensory functions.

Eligibility Criteria:
INCLUSION CRITERIA:

Subjects between the ages of 18 and 80.

EXCLUSION CRITERIA:

Patient must be able to give informed consent.

Patients with ferromagnetic objects in their bodies which might be adversely affected by MRI (surgical clips or metal fragments in or near brain, eye or blood vessels, cardiac or neurological pacemaker, cochlear impairments) will be excluded.

Pregnant or lactating women will be excluded. A pregnancy test will be administered to women of childbearing age.