cyrilzakka/clinical-trials huggingface dataset:
Metacognitive Training in Schizophrenia

Over a period of 4 weeks, metacognitive training for schizophrenia patients (MCT), delivered both in a group and individually, is compared to cognitive remediation (CogPack training). Blind to treatment assignment, both groups are assessed before intervention and four weeks later with the Positive and Negative Symptoms Scale (PANSS), the Psychosis Rating Scales (PSYRATS) and cognitive tests. Delusion severity serves as the primary endpoint. It is assumed that MCT will improve delusion severity to a greater extent than CR in the course of 4 weeks taking medication into account.

Metacognitive training for schizophrenia patients (MCT) is a manualized group intervention that can be obtained cost-free online. MCT seeks to sharpen the awareness of schizophrenia spectrum patients on cognitive biases (e.g. jumping to conclusions) contributing to delusion formation and maintenance and conveys cognitive strategies to counter these. The present trial combines group MCT with an individualized cognitive-behavioral oriented approach entitled MCT+. Patients with schizophrenia are randomly allocated to either metacognitive treatment (MCT) or cognitive remediation (CogPack training). Blind to treatment assignment, both groups are assessed prior to intervention and four weeks later with the Positive and Negative Symptoms Scale (PANSS), the Psychosis Rating Scales (PSYRATS) and cognitive tasks. Delusion scores derived from the PANSS and PSYRATS serve as main outcome parameters. We also explore if MCT improves jumping to conclusions with a probabilistic reasoning task. To make results as generalizable as possible to a typical inpatient population, broad inclusion criteria are chosen. Patients are only excluded if age is \< 18 and \> 65 years and diagnoses do not meet criteria of a schizophrenia spectrum disorder.

Eligibility Criteria:
Inclusion Criteria:

* schizophrenia spectrum disorder

Exclusion Criteria:

* intellectual disability (IQ \< 70)
* unable to provide informed consent
* hostility on PANSS \> 4
* suspiciousness on PANSS \> 5
Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique

The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection.

The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.

This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.

They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.

The primary endpoints are:

* Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin
* Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure
* Urinary concentrations of cefoxitin


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent major abdominal surgery whose forseeable time exceeds 4 hours and requires an antibiotic prophylaxis by cefoxitin

Exclusion Criteria:

* morbid obesity (BMI \> 35 kg/m²)
* severe renal impairment (clearance creatinine \< 30ml/min)
* beta lactam hypersensitivity
* pregnancy
To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients

The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.
* A body mass index (BMI) of 19 to 27 kg/m2.
* Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.

Exclusion Criteria:

* Renal dysfunction GFR \< 60 mL/min.
* Systolic pressure (SBP) \> 160 mmHg or diastolic pressure (DBP) \> 95 mmHg
* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP.
* History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
A Nasal Treatment for COVID-19

The goal of this study is to test an investigational new inhaled medication called Optate.

The goal of this study is to test an investigational new inhaled medication called Optate. Investigational means it has not been approved by the Food and Drug Administration (FDA) for this use. The investigators hypothesize that Optate will reduce the length of symptoms and disease severity in patients with COVID-19 (Coronavirus disease of 2019) through inhibition of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) viral replication within the upper and lower airways. Testing this hypothesis is important because treatments for COVID-19 are needed alongside vaccines. COVID-19 begins in the nasal passages, so targeted therapies to the nasal passages at early stages of the disease may prevent severe disease from occurring.

Eligibility Criteria:
Inclusion Criteria: Subjects, 18 and above, with mild COVID-19 upper respiratory tract infection symptoms

* positive rapid COVID-19 test
* Ordinal Scale for Clinical Improvement \< 3 (OSCI, Appendix 2) and/or
* Fever \> 100 degree F and/or
* Nasal congestion

Exclusion Criteria:

* FEV1 (Forced Exhaled Volume) \< 55% predicted on the day of study procedures
* OSCI ≥ 3 (Objective Structured Clinical Exam)
* Pregnancy
* Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication
Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection

With the COVID-19 pandemic, the number of patients to be treated in rehabilitation increased .

Hospitalization for severe infection can induce muscular atrophy and muscular dysfunction that persists for several months and rehabilitation capacities may be exceeded.

Exercises in eccentric mode could be performed, inducing greater muscular hypertrophy, muscle strength, power and speed than concentric exercises.

The goal of this study was to compare functional recovery at 2 months after a training program in eccentric and concentric mode after severe COVID-19.

An effective rehabilitation could help reduce costs and duration of care.

This is a prospective, open, controlled randomized study (2 x 60 individuals) performed in 3 centers. Participants will perform 24 exercise sessions on cycloergometer (3 sessions/week, 8 weeks). The experimental group (eccentric) will perform 5 habituation sessions: the initial power of the exercise will be set to 10 Watts and then increased by 10% each session, depending on the muscle tolerance. The training power must correspond to 3 times that of the control group to obtain a similar metabolic stimulation. The control group (concentric) will perform exercise training at an intensity of 60% of the reserve heart rate determined during an initial cardiorespiratory test. The primary outcome will be the change in distance covered during the 6-min walk test between the initial assessment and month 2. Secondary outcomes will include study of sarcopenia, muscle strength, general and muscular fatigue, quality of life, blood metabolomic data, ex vitro data for mitochondrial and histo-biochemical functionality from muscle biopsies of the Vastus Lateralis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 80 years old
* Diagnosed for SARS-CoV-2 infection (COVID-19) requiring a rehabilitation program at least 1 month after the hospitalization
* Autonomy in daily life activities 1 month after diagnosis
* Able to walk for 6 min (discontinuous walking possible)
* Giving informed written consent to participate in the study
* Health insurance coverage

Exclusion Criteria:

* Cardiovascular or respiratory contraindication to the rehabilitation program
* Difficulty to perform an eccentric exercise on a seated ergometer
* Pregnant or breastfeeding
* Under guardianship, curatorship or deprived of liberty
* Taking antivitamin K anticoagulation (muscle biopsy)
* Refusal to participate
Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery

Comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia

The purpose of this study was to investigate whether remimazolam-based general anesthesia could reduce the incidence of hypotension in patients undergoing breast surgery under general anesthesia compared to propofol-based general anesthesia. The purpose of this study is to establish and test the hypothesis that the incidence of hypotension under general anesthesia based on remimazolam will be less than that of propofol based general anesthesia. In addition, this study compares the proportion of patients who require a vasopressor, the time taken for anesthesia induction, the time to recover from anesthesia, postoperative pain, the incidence of postoperative nausea and vomiting, the quality of postoperative recovery, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over the age of 19 undergoing elective breast cancer surgery under general anesthesia at Seoul National University Hospital

Exclusion Criteria:

* patients with acute narrow-angle glaucoma/ shock or coma/ acute alcohol poisoning/ sleep apnea/ alcohol or drug dependency/ severe or acute respiratory failure/ galactose intolerance/ Lapp lactase deficiency/ glucose galactose malabsorption/ severe hypersensitivity to dextran.
* Patients with myasthenia gravis/ pulmonary heart disease/ chronic obstructive pulmonary disease/ bronchial asthma
* Patients with cardiovascular diseases such as ischemic heart disease/ coronary artery disease/ angina pectoris/ myocardial infarction/ atherosclerosis/ arrhythmia/ cerebrovascular disease/ and stroke
* Patients with chronic renal failure
* Patients with severe hepatic impairment (Child Pugh class C)
* Patients with American Society of Anesthesiology score III or higher
* Patients with hypersensitivity to propofol and soy or peanuts
* Epilepsy patients
* Patient with fat metabolism abnormality
* Patients with high intracranial pressure
* Pregnant woman
* Patients unable to use supraglottic airway due to poor dental condition
* In cases that the researcher judges to be unsuitable for this clinical trial
Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors

Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors


Eligibility Criteria:
Inclusion Criteria:

* Oocyte donors included in the oocyte donation program of Clinica EUGIN.
* 1st oocyte donation cycle at Clínica EUGIN.

Exclusion Criteria:

* Polycistic Ovarian syndrome (PCOs).
* Estradiol levels on day 2 of menstrual cycle \>70 pg/ml.
* Hormone treatments up to 3 months before the oocyte donation cycle.
* Medical contraindication to the treatments used in the study
The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis

The aim of the study is to evaluate the role of balneotherapy in obese patients with knee osteoarthritis in terms of pain relief, improving joint function and deambulation, on endocrinological parameters, quality of life and of reduction the costs to "Servizio Sanitario Nazionale" (NHS).


Eligibility Criteria:
Inclusion Criteria:

* obesity II-III grade (BMI 35-45 kg/m2)
* knee pain
* patient compliance to the treatment

Exclusion Criteria:

* BMI\<34,9kg/m2 or BMI\> 45,1kg/m2
* previous knee surgery
* complicated diabetes mellitus
* ischemic cardiomyopathy and heart failure
* acute phase of osteoarthritis
* varicose veins, deep venous thrombosis (DVT)
* cancer
* cutaneous lesions
* NSAIDs administration \<1 week before the treatment
* knee infiltration \<2 months before the treatment
Brain Perfusion Assessment in the Acute Phase of Migraine Aura

The aim of the study is to determine the proportion of patients with change in brain perfusion during the acute phase of migraine attack with aura.

Migraine is a benign and frequent disorder. Migraine aura consists in reversible focal neurological symptoms developing gradually during attack. Its diagnosis relies mainly on patient's history, clinical examination and exclusion of other possible secondary causes to explain transient neurological signs. Thus it can be difficult particularly during first attack or during attack without headache to differentiate migraine aura from transient ischemic stroke. Considering the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest. MRI with diffusion, SWI, Flair 2D, ARM 3D TOF, ASL sequences' are routinely performed for the management of acute neurological deficit. Arterial spin labeling (ASL), as a MR perfusion method, will be used to describe brain perfusion during migraine aura. The study hypothesis is that hyperperfusion occurs in brain territories corresponding to the neurological symptoms during migraine aura.

Eligibility Criteria:
Inclusion Criteria:

* Age between greater than or equal to 18
* Able to undergo MRI during migraine aura

Exclusion Criteria:

* Pregnant females
* Contraindications towards MRI scanning
* History of epilepsy, psychiatric disease, or any other neurologic disease (brain tumors, stroke..).
* Presence of abnormalities on the MRI that could explain the neurological deficit.
* Adults under guardianship or trusteeship
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain

As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.

This is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with diclofenac potassium oral solution, based on weight, every 6 hours as needed for the treatment of mild to moderate acute pain for up to 4 days. PK samples will be collected through 6 hours after the first dose. Safety data will be collected throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between 2-12 years of age.
* Subjects must be post-op, having mild or moderate acute pain.

Other inclusions apply.

Exclusion Criteria:

* Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
* Subject has been taking analgesics for 48-72 hours prior to Screening.
* Subject has a history of any GI event greater than 6 months before Screening.
* Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
* Subject is requiring treatment for pre-existing hypertension.

Other exclusions apply.
Cervical Erector Spinae Block for Shoulder Surgery

Arthroscopic shoulder surgery is often associated with moderate to severe postoperative pain that may interfere with patients' early mobilization, recovery and quality of life.

In addition, by using an effective analgesic technique, a patient may experience less nausea, vomiting and drowsiness after surgery that are associated with the use of opioids to manage postoperative pain. Erector spinae plane block (ESPB) has been used in many different indications for acute pain treatment at different thoracic and lumbar levels. Recently, staining the roots of the brachial plexus has been reported in a cadaveric study of the cervical ESPB (1).

However, there are only few case reports related to efficiency and safety of this newly defined cervical ESPB technique (2) .

The primary objective of this randomized controlled is investigate the post-operative analgesic effectiveness of ultrasound guided single-shot cervical ESPB for patients undergoing arthroscopic shoulder surgery in comparison to those receiving conventional parentheral opioid analgesia alone.

Secondary objective is testing the safety of this newly defined block in terms of incidence of complications.

60 patients will be enrolled to in this study between June 2020 - October 2020. All patient will be randomly selected who will be operated for shoulder surgery. Age, weight, ASA score, body mass index, additional dissease status will be recorded. The patients will be divided in two groups. One group will have cervical ESPB before the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia.

Both groups will receive identical anaethesia protocols. Perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. In postoperative period, the pain scores of the patients will be recorded according to the numeric rating scale (NRS) in every three hours. If pain score raises over 3/10 on NRS the patient will receive tramadol 100mg as rescue analgesia. In case of persisting pain first, meperidine 50 mg will be applied and other multimodal analgesic drugs will be added to protocol. At the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* 18 -65 years of agge
* ASA I-II
* Undergoing elective shoulder surgery

Exclusion Criteria:

* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs
* obesity (body mass index \>35 kg/m2)
SPLATT to Peroneus Brevis vs TATT to Lateral Cuneiform

Congenital talipes equinovarus, is a common congenital foot deformity involving hindfoot equinus and varus, along with mid-/forefoot adduction and cavus. Currently, the Ponseti method is the preferred initial treatment for idiopathic clubfoot1

. Despite the initial phase's remarkable efficacy in correcting clubfeet, there remains a notable recurrence rate after Ponseti treatment2

* Numerous studies demonstrate a very high success rate during early follow-ups, ranging from 92% to 100%3
* Nonetheless, recurrence remains a challenge for orthopedic surgeons. A common trigger for recurrence is the dynamic supination of the foot, which results from excessive activation of the tibialis anterior muscle during ankle dorsiflexion4

Multiple studies indicate that tibialis anterior tendon transfer (TATT) is an effective tool for management of clubfoot recurrence, particularly dynamic supination5

* The widely used technique involves transferring the entire tendon through a drill hole in the lateral cuneiform and anchoring it on the plantar aspect of the foot using a sewing button and felt pad6
* While effective, this procedure raises the risk of pressure sores due to button placement on the sole7

Split anterior tibialis tendon transfer (SPLATT) to peroneus brevis is a well-described treatment strategy of varus foot deformities in patients with neuromuscular disorders8

* The technique has been reported to achieve successful deformity correction while avoiding skin problems associated with external button placement on the sole of the foot in tendon-to-bone transfers8

The present study aims to assess the outcome of utilizing SPLATT to peroneus brevis procedure in the treatment of recurrent CTEV in comparison to the original total TATT to the lateral cuneiform


Eligibility Criteria:
Inclusion Criteria:

* Recurrent CTEV
* Age between 4 years and 12 years
* Unilateral/bilateral
* Ankle dorsiflexion of at least 10° prior to tendon transfer

Exclusion Criteria:

* Non idiopathic CTEV
* Rigid deformity not suitable for acute correction
* Poor skin condition
An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer

The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg \[milligrams\] with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of hepatocellular carcinoma
* Patients must present with disease not amenable to curative surgery (i.e. either hepatectomy, or liver transplant).
* Evidence of measurable disease by radiographic technique
* Adequate organ function.

Exclusion Criteria:

* Prior treatment with any systemic treatment for liver cancer
* Presence of clinically relevant ascites
* Severe hemorrhage \<4 weeks of starting study treatment.
* Diagnosis of second malignancy within last 3 years
* History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
* Known human immunodeficiency virus (HIV)
* Serious acute or chronic illness
* Current treatment on another clinical trial
* Pregnant or breastfeeding