cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of tACS vs tDCS in Schizophrenia

This clinical trial aims to compare the efficacy and safety of transcranial Alternating current stimulation (tACS) vs. transcranial Direct current stimulation (tDCS) vs. sham stimulation in chronic schizophrenia.

The main question it aims to answer is:

• In comparison to tDCS, can tACS improve the clinical outcome of patients with chronic schizophrenia?

Participants will be randomised into 3 groups receiving either tDCS, tACS or sham stimulation and changes in psychopathology and neuro-cognition with the interventions will be compared within and between the groups. The primary outcome measure is the Positive and Negative Syndrome Scale (PANSS), while secondary outcome measures are the Auditory Hallucination Rating Scale (AHRS), Brief Cognitive Assessment Tool for Schizophrenia (B-CATS), and Global Assessment of Functioning (GAF).

The proposed double-blind RCT will be conducted over 3 years involving 2 centres among patients with chronic schizophrenia (moderate-severe symptoms) of either gender, aged between 18 and 60. Those with any psychiatric emergency or contraindications for tDCS will be excluded. At baseline, PANSS will be administered to assess the severity of symptom dimension, AHRS for auditory hallucinations, B-CATS for neurocognitive deficits and GAF for global functionality. Patients will be randomized equally to 3 treatment groups: tACS, tDCS, or sham stimulation (30 in each group). The intervention will involve Cathodal stimulation of left TPJ and Anodal stimulation of left DLPFC. The transcranial brain stimulations: tACS, tDCS, or sham stimulation, will be given 2 sessions per day for 10 days. Following the 5th day and after the last treatment session, PANSS, AHRS, B-CATS, and GAF will be readministered to observe for the changes in the various outcome parameters. Any new treatment-emergent serious adverse effect will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Schizophrenia as per ICD-10 DCR for more than 2 years
2. Moderate-severe symptoms (PANSS score \> 75 and/or CGI-SCH score\>4) \[24\]
3. On stable dosing of antipsychotic medications (no changes in medication or doses for 1 month prior to enrolment)
4. Both sexes; Age range: 18-60 years
5. Right-handed
6. Written informed consent by the patient

Exclusion Criteria:

1. Features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement)
2. Any contraindication to tDCS procedure: Metal in the head, Implanted brain medical devices, Local lesion or injury in the scalp / head
3. Co-morbid neurological disease
4. Left Handed
Comparison of HBV Reactivation Between Patients With High HBV-DNA and Low HBV-DNA Loads Undergoing ICI and Concurrent Antiviral Prophylaxis: a Prospective Observational Study

Immune checkpoint inhibitor (ICI), including programmed cell death protein-1 (PD-1) inhibitor or programmed cell death-Ligand 1 (PD-L1) inhibitor , is recommended to treat advanced hepatocellular carcinoma (HCC). However, the safety of ICI in patients with a high HBV-DNA load is unknown because of the potential risk of hepatitis B virus (HBV) reactivation. This study was to compare the HBV reactivation between patients with low HBV-DNA loads and high HBV-DNA loads undergoing antiviral prophylaxis and ICI.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Seropositive for hepatitis B surface antigen (HBsAg)
* Received concurrent antiviral prophylaxis and at least one cycle of ICI treatment. Prior use of antiviral therapy was allowed
* Adherence to antiviral therapy
* A life expectancy of 3 months or more
* An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2

Exclusion Criteria:

* other positive viral markers, including IgM antibodies to hepatitis A virus, the hepatitis C virus viral load, IgG antibodies to hepatitis D virus, IgM antibodies to hepatitis E virus
* Antibodies to human immunodeficiency virus,
* A lack of HBV DNA and liver function testing before the first immunotherapy and during the follow-up period.
Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest

International recommendations stress on the importance of no flow time reduction in cardiac arrest management. In fact, no flow time is an independent factor of morbidity and mortality.

In France, cardiac arrests are treated by first responders (including emergency nurses) before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The purpose of our study is to compare the no flow time between two strategies of out of hospital cardiac arrest management by first responders: conventional CPR with bag-valve-mask ventilation vs. compression only CPR with Laryngeal Tube ventilation.

Multicentric, prospective, controlled, randomized study with parallel groups in single blind.

Patients will be included in chronological periods to avoid selection biais (one month with the first medical device the next month with the other one). The determination of these periods will be centralized. The emergency vehicles will be supplied sufficiently with devices. This design has been chosen in order to answer to the emergency problem.

Patients will be included and ventilated by paramedical staff (first responders) before medical staff (Mobile Intensive Care Unit) intervention. Complete detailed information will be given to the patient or to the family and consent asked.

The comparison of no flow time between the two strategies in out of hospital cardiac arrest will be the following :

A : ventilation by bag valve mask and interrupted chest compression B : ventilation by laryngeal tube and continuous chest compression

Eligibility Criteria:
Inclusion Criteria:

* preliminary treatment of cardiac arrest by fire fighters (Basic Life support)
* more than 18 years
* patient affiliated to the social security system or equivalent

Exclusion Criteria:

* certain death
* patient deprived of freedom by judicial or administrative decision
* patient under legal protection
* Pregnancy, parturient or breast feeding
* facial trauma
Effect of Testosterone Replacement on Insulin Resistance

This study aims to determine whether testosterone replacement improves insulin sensitivity in non-obese men with low testosterone and the metabolic syndrome. The metabolic syndrome includes three of the following five conditions, 1) an elevated blood pressure (greater than 130/85), 2) a triglyceride level greater than 150 mg/dl, 3) an HDL-cholesterol less than 40 mg/dl, 4) glucose levels greater than 100 mg/dl, and 5) a waist measurement greater than 40 inches.

In this proposal, we will examine the relationship between hypogonadism and insulin sensitivity. The strongest relationship between hypogonadism and insulin resistance appears to reside in men with the metabolic syndrome who have a normal BMI. The causal relationship between these two conditions is unknown. Therefore, we propose to determine if testosterone replacement in hypogonadal non-obese men with metabolic syndrome will improve insulin sensitivity. Data obtained from this preliminary investigation, will hopefully result in a hypothesis that can be tested in a larger, more rigorous trial in the future.

Eligibility Criteria:
Inclusion Criteria: (subjects must meet both criteria)

* Metabolic syndrome (have 3 out of the following 4 criteria):

  1. BP \> 130/85 or on antihypertensive therapy
  2. Fasting glucose \> 100 mg/dl
  3. Fasting TG \> 150 mg/dl or on a triglyceride lowering agent (fenofibrate, gemfibrozil, niacin in doses of \>= 500 mg/day, or fish oils in doses of \>=2000mg DHA+EPA)
  4. Fasting HDL-C \< 40 mg/dl Note that the waist circumference will not be used as one of the criteria for the metabolic syndrome for this study because we are studying non-obese subjects.
* Total Testosterone less than 300 ng/dl

Exclusion Criteria:

* Women.
* Men less than 20 years of age.
* BMI \> or = to 30 kg/M2.
* Use of testosterone preparations within 1 year of the screening visit
* Use of hypoglycemic medications within the previous 3 months.
* Fasting blood glucose \> 126 mg/dl.
* The following men will be excluded because of the potential safety issues in the placebo treated group:

  1. Creatinine greater than 1.4 mg/dl
  2. Triglyceride levels greater than 500 mg/dl
  3. HDL-C levels less than 20 mg/dl
  4. Blood pressure greater than 160/90
* The following men will be excluded because of the potential side effects of testosterone therapy:

  1. Men greater than 65 years of age
  2. International prostate symptom score \>19
  3. PSA greater than 2.5
  4. History of benign prostatic hypertrophy
  5. History of prostate cancer
  6. Abnormal digital rectal exam
  7. Hg greater than 16 mg/dl or Hct greater than 48%
  8. peripheral edema
Systematic Evaluation of Continuous Glucose Monitoring Data

This study retrospectively evaluates continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) data and pursues two main objectives: First, the investigators analyze if glucose values are better controlled in the days directly before a consultation at our tertiary referral centre (so called "white coat adherence"). Second, the investigators use the collected CGM and FGM data to develop a hypoglycemia prediction model.

Substudy A.) Presence of white coat adherence in diabetic patients:

The investigators aim at evaluating the existence of a so called "white coat adherence" with regard to diabetes control, which means that blood-glucose is better controlled in the days immediately prior to a consultation at the diabetes clinic compared to the time-period further back. To analyse this phenomenon, the investigators use continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) of diabetic patients and compare CGM-/FGM data of the last three days prior to the consultation with the CGM-/FGM data of the days 4-28 prior to the consultation, as well as the last seven days prior to the consultation with days 8-28 prior to the consultation.

Substudy B.) Retrospective data collection for the development and evaluation of a hypoglycemia prediction model:

Scope of the study is to use retrospective data for training and evaluation of a deep recurrent neural network based system for predicting the onset of hypoglycemic event at least 20 min ahead in time. The study aims to: I, assess the ability of deep learning algorithm to predict hypoglycemic events using the data collected during substudy 1. II, assess the ability of global model to be personalized using the data collected during sub-study 1. III, investigate the amount of "history" to be involved to achieve maximum performance in terms of prediction ability. IV, develop a global model, which can be easily further personalized to achieve optimum prediction performance per patient.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* CGM and/or FGM available for at least 50% of the time in last 4 weeks before consultation
* Written informed general consent for the retrospective analysis of data

Exclusion Criteria:

* Pregnancy
Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg tablets under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.
TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)

Trichloroacetic acid 85% =TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2. The device system is to be used only in accordance with the approved Investigational Plan on subjects, who have given written informed consent.

High remission and regression rates are expected after a single topical treatment with 85% TCA. After a single topical treatment with 85% TCA for CIN 1-2 (Expected 70% or higher; null hypothesis: not higher than 55%). Regression is defined as improvement from high grade lesion (CIN 2) at baseline to low grade lesion (CIN 1) after TCA treatment. Regression from CIN 1 normal squamous epithelium after the TCA treatment is equal to remission and will be counted as a remission in combined analysis. Remission is defined as complete histologic remission of CIN back to normal squamous epithelium after the TCA treatment, i.e., no cervical dysplasia is detectable by histology or cytology after the TCA treatment. Type-specific HPV Clearance is defined as disappearance of the HPV type detected at screening.

Visit and assessment Schedule:

Visit1 Screening:

* Informed Consent,
* Inclusion/Exclusion Criteria,
* Medical History,
* Gynecological Examination
* Cytology
* HPV Test
* Colposcopy
* Biopsy
* VAS (Visual analog scale)
* Pregnancy test

Visit 2 Treatment Day with TCA 85%:

* Colposcopy
* TCA Treatment
* VAS
* Pregnancy test

Visit 3, Control 1, Week 10-14:

* Cytology
* HPV Test
* Colposcopy
* Biopsy
* 4-quadrant biopsy
* ECC
* Adverse event monitoring If there is no sign of CIN during the colposcopic examination 10-14 weeks a 4-quadrant biopsy and a ECC are performed

Visit 4, Control 2, Week 22-26:

* Cytology
* HPV Test
* Colposcopy
* Biopsy
* 4-quadrant biopsy
* ECC
* Adverse event monitoring
* Pregnancy test If there is no sign of CIN during the colposcopic examination 22-26 weeks after the TCA treatment, a 4-quadrant biopsy and a ECC are performed.

Visit 5, EOS , Week 24-30:

- Results Discussion

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven CIN 1/2
* adequate colposcopy (i.e. fully visible transformation zone and margins of any visible lesion)
* positive HPV test
* conducted negative pregnancy test
* women aged 18 to 50 years
* written informed consent

Exclusion Criteria:

* Exclusion criteria are a cytologically suspected CIN (Pap IIID, IV)
* inadequate colposcopy
* negative or missing biopsy
* cytology results indicating invasive disease (PAP V)
* if the cervical lesion recedes into the endocervical canal
* pregnancy
* any medical circumstance considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator
Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery

The enhanced recovery anesthesia concept has been widely adopted, including cesarean delivery. Modern obstetrical anesthesia aims to offer an experience to a patient undergoing a cesarean delivery similar to normal vaginal delivery in order to maximize postoperative comfort and facilitate bonding between the mother and her newborn. Therefore, early removal of the bladder catheter has been recommended. However, this is challenged by the administration of intrathecal morphine recommended to provide long-lasting postoperative analgesia after cesarean delivery.

This double-blind, randomized trial investigates the effects of intrathecal morphine on urinary dynamics in women undergoing CD under spinal anesthesia. The hypothesis is that the addition of intrathecal morphine (ITM) will delay micturition in women undergoing cesarean delivery. The primary outcome is the effect of ITM on urodynamics the difference in time to micturition. The secondary outcome is the need for bladder re-catheterization.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I and II
* Term singleton pregnancies
* Elective cesarean delivery under spinal anesthesia
* Between October 2021 and March 2022

Exclusion Criteria:

* Pre-existing or gestational hypertension
* Diabetes
* Cardiovascular disease
* Cerebrovascular disease
* Known fetal abnormalities
* Extremes of weight (\<40 kg or \> 100 kg)
* Contraindications to neuraxial anesthesia
* Twin pregnancies
* Excessive intraoperative bleeding (blood loss exceeding \> 1000 mL or requiring a blood transfusion)
DCN for ECD Livers

The goal of this observational study is to learn whether extended criteria donor livers can be safely transplanted after sequential hypo- and normothermic machine perfusion in recipients requiring a liver transplant for end-stage liver disease, including a long-term follow-up. The main questions it aims to answer are:

* Death censored graft-survival
* Overall patient survival
* Frequency of frequent post-transplant complications (e.g. non-anastomotic biliary strictures)

With the increasing shortage of suitable donor livers for transplantation, extended criteria donor (ECD) livers may bridge the gap between available donor organs and donor livers needed. However, these ECD livers are associated with a higher risk of posttransplant complications. With the development of machine perfusion (MP) strategies over the recent years, (dual) hypothermic oxygenated perfusion ((D)HOPE) is established as a safe and effective way to reduce ischemia reperfusion injury. This leads to a decrease in early allograft dysfunction and non-anastomotic biliary strictures (NAS). On the other hand, normothermic machine perfusion (NMP) is mainly used for hepatobiliary functional assessment of liver grafts prior to transplantation. Combining both perfusion techniques through 1 hour of controlled oxygenated rewarming (COR), enables safe selection and transplantation of ECD livers after DHOPE-COR-NMP. Long-term outcomes are now available from two centers.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old)
* Donor livers that required resuscitation and viability assessment through the previously published sequential hypo- and normothermic liver machine perfusion (DHOPE-COR-NMP) protocol based on a blood-based perfusate.

Exclusion Criteria:

* Multiorgan transplantation
* Split liver transplant
* Living donor liver transplantation
* Previous donor organ perfusion (e.g. Normothermic Regional Perfusion)
Concentrations of Remifentanil for Extubation

Condition of the State: (terminated, recruiting, etc.) Terminated

Study Design: Main Objective:

Compare the frequency and intensity of coughing at the time of extubation with two infusions of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through the technique of target controlled anesthesia

Phase of the study:

Phase IV

Intervention:

Drug: U Extubation

Other Names:

Concentration 2 - 3 ng/ml Dose of remifentanil according to the randomization: Letter U between 2 - 3 ng/ml. The infusions that were used to reach the (PC) target were: Group U = 2 - 3 ng/ml. 20 years old - 6.0 mcg/Kg/h, 30 years old - 5.7 mcg/Kg/h, 40 years old - 5.3 mcg/kg/h, 50 years old - 5.0 mcg/kg/h, 60 years old - 4.6 mcg/kg/h, 70 years old - 4.3 mcg/kg/h, 80 years old - 4.0 mcg kg/h.

Drug: Extubation T

Other Names:

Concentration 3 - 4 ng/ml Dose of infusion of remifentanil to reach a (PC) 3 - 4 ng/ml, in the following manner: The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient. The remifentanil dose was adjusted according to the randomization: Group T = 3 - 4 ng/ml. 20 years old - 9.0 mcg/Kg/h, 30 years old - 8.5 mcg/Kg/h, 40 years old - 8.0 mcg/kg/h, 50 years old - 7.5 mcg/kg/h, 60 years old - 7.0 mcg/kg/h, 70 years old - 6.5 mcg/kg/h, 80 years old - 6.0 mcg kg/h.

Number of arms:

2

Masking:

The patient had masking with regards to the anesthetic procedure from the unfamiliarity per se of the same and by agents used in this that induced anxiolysis and hypnosis.

To guarantee the masking to the viewer, which was the treating anesthesiologist, a nurse was trained in the adjustment of the infusion balloon. Ten minutes before concluding the procedure and by request of the anesthesiologist, the nurse proceeded to locate balloon in such a way that the infusion could not be seen by the anesthesiologist, then opened the envelope and adjusted the infusion according to the randomization (U) o (T). The evaluation of the cough, its intensity and the Ramsay were under the care of the anesthesiologist, who was unaware of the awakening infusion.

Allocation:

Two were allocated for the use: Concentration of remifentanil of 2 - 3 ng/ml (group U) and concentration of remifentanil of 3 - 4 ng/ml (group T).

Recruitment:

A patient was recruited between the period of January 2011 and July 2012.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18-70 years
* Risk Scale American Society of Anaesthesiologists physical status classification (ASA) I and II
* Undergoing elective ear surgery

Exclusion Criteria:

* Patients who are contraindicated remifentanil
* Patients undergoing emergency surgery
* Pulmonary Pathology (ASTHMA - COPD)
* Index of body mass greater than 35
* Background of respiratory failure three weeks prior to the procedure
* Smokers
Working on Asymmetry in Parkinson's Disease

Freezing of gait (FOG) is a disabling episodic gait disturbance that is common among patients with Parkinson's disease (PD). The symptoms of PD generally show an asymmetric onset and progression.

In particular, impairments in rhythmicity, symmetry, and bilateral coordination have been reported to be associated with FOG episodes. As the maintenance of gait depends on the precise alternating movements of both legs, irregularities in rhythm, symmetry, and bilateral coordination may impair gait sequence, potentially causing freezing.

Results of recent studies strongly suggest that bilateral uncoordinated gait and marked gait asymmetry are associated with FOG. Moreover, it has recently been hypothesized that this may lead to a degree of asymmetric motor function, and that FOG in parkinsonian patients is triggered by a breakdown in the bilateral co-ordination underlying the normal timing of gait. Aim of the study was to evaluate how the modulation of asymmetry through physical therapy might improve gait and FOG.

The patients will be'blind' to the study protocol and will be randomly assigned to one of the three study arms: 1) physiotherapy aimed to potentiate the more affected body side (worst side improvement, WSI); 2) physiotherapy aimed to potentiate the less affected body side (best side improvement, BSI); 3) physiotherapy aimed to potentiate both sides equally (standard treatment, ST). Each group will be undergo physiotherapy twice a week for three months. Each session will have duration of one hour and include a first part of warming up, a final part of cooling down (these two parts are the same for all the groups) and an active part (which is different from group to group). The active part includes exercises which are alike for all the groups but with a number of repetitions different from group to group according to the aim of potentiating the most affected side (WSI) or the least affected side (BSI) or both sides equally (in this case the number of repetitions was the same for both sides; ST). Medical treatment will be kept stable through all the study duration; medications are expressed as levodopa daily dose equivalent (LEDD).

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease, freezing of gait history, informed consent

Exclusion Criteria:

* depression, severe orthopedic diseases