cyrilzakka/clinical-trials huggingface dataset:
Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia

Introduction: In spite of recent advances in schizophrenia treatment, 30% of patients still do not respond properly to antipsychotic therapy. These patients are considered treatment-resistant or refractory, and the best choice for them is clozapine. However, even supported by the literature as the best known antipsychotic in terms of efficacy and rates of response, a considerable number of patients will still not respond to this treatment, remaining symptomatic and dysfunctional. These patients are classified as super-refractory (clozapine-resistent). In these cases, augmenting strategies are necessary, and some have been in use: typical and atypical antipsychotics, mood stabilizers, antidepressants and electroconvulsive therapy (ECT). Some studies have favored ECT, but no definitive conclusion has been drawn.

Objective: Test the electroconvulsive therapy efficacy and safety as augmenting strategy to clozapine-resistant patients, as compared to placebo (sham ECT).

Methods: This is a pilot double blind, placebo controlled and randomized study to assess electroconvulsive therapy efficacy as augmenting strategy to clozapine in super-refractory schizophrenia. The ECT treatment will be delivered with either a MECTA SPECTRUM 5000Q or 4000Q device, and the procedure is under general anesthesia and monitorization, after informed consent. The Hospital will follow national protocols and regulations on ECT. Sham ECT consists in habitual patient preparation and sedation, without stimulation. Patients that fit inclusion criteria will have their clozapine blood levels dosed and undergo structured assessments at baseline, after 6 treatments and at the end of the cycle of 12 ECT sessions (thrice a week protocol). The assessments will be based on CGI (Clinical Global Impression) and PANSS (Positive and Negative Syndrome Scale) scales. All medication will be maintained, except lithium carbonate.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia or schizoaffective disorder (DSM-IV-TR);
* Ages between 18 and 55 years old, both genders;
* Must be using adequate contraception if a fertile woman;
* Must be on clozapine treatment for at least 6 months, with or without augmenting strategies;
* Must be clozapine-resistent (super-refractory patient), defined by a CGI-severity ≥ 4, PANSS total score ≥ 60 and at least 4 items of the positive subscale ≥ 4 at baseline.

Exclusion Criteria:

* Clinical somatic disease not stabilized in the three months preceding the study;
* Other Axis I disorders (DSM-IV-TR);
* Laboratory tests with significantly abnormal values that persist for more than two weeks;
* Lack of permanent residence during the study period;
* History of poor treatment adherence.
* History of ECT use in the past six months that precede the start of the study.
Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa

This is a multinational, prospective, open-label, roll-over study in patients with severe haemophilia A, ≥6 years of age, who have completed participation in any of the parental studies with efanesoctocog alfa; XTEND-ed study (LTS16294), FREEDOM study (Sobi.BIVV001-001), or PK comparison study (Sobi.BIVV001-003). The aim of the study is to provide patients with continuous benefit from efanesoctocog alfa treatment and to further continue clinical monitoring for safety and efficacy until efanesoctocog alfa is commercially available in each patient's respective country (or until March 2027, whichever comes first).

The study starts with the Baseline Visit, which will be done in connection to the End of Study visit (or equivalent) in the respective parent study. Subsequent study visits (on site or phone call) will be done approximately every 13 weeks until End of Treatment. An End of Study safety phone call will be done 14 (+7) days after the End of Treatment Visit.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving signed informed consent. Parents or legally designated representatives' consent is required for patients who are below 18 years of age or unable to give consent. Patients who are below 18 years of age may provide assent in addition to the parents'/legally designated representatives' consent, if appropriate.
* Must have completed one of the required parent studies: Sobi.BIVV001-001, Sobi.BIVV001-003, or LTS16294, and be receiving a clinical benefit from the efanesoctocog alfa treatment, as judged by the Investigator.
* Willingness and ability of patient or their parent or legally designated representative to complete training in the use of the study patient diary and to complete the diary throughout the study.

Exclusion Criteria:

* Positive inhibitor result (assessed by central laboratory), defined as ≥0.6 Bethesda units (BU)/mL, at Baseline Visit.
* Ongoing or planned participation in any interventional clinical study at Baseline Visit.
* Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B

This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B


Eligibility Criteria:
Inclusion Criteria:

* Body weight between 50 and 100 kg, both inclusive
* Body mass index (BMI) between 18.0 kg/m2 and 25.0 kg/m2, both inclusive
* For haemophilia subjects only: Diagnosed with severe haemophilia A or B

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Surgery planned to occur during the trial
* Any major and/or orthopaedic surgery within 30 days prior to trial product administration
Investigation of the Accuracy of an Automated Refractor to Provide Well-tolerated Eyeglass Prescriptions

At the New England College of Optometry in Boston, MA, subjects ages 18-65 who have received or are receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and automated refraction, by way of the QuickSee Plus refractor. Subjects will then be randomized into one of two treatment plans: receive glasses from automated refraction first then subjective refraction second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a triple blind, case-crossover clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* who have had an eye exam at the NECO Center for Eye Care of Commonwealth or Roslindale
* who are aged between 18 years and 65 years

Exclusion Criteria:

* whose refractive error is outside of the detection range of the QuickSee Free Pro and QuickSee Plus devices: -13 D to +10 D (S) and -8 D to + 8 D (C)
* who are unable to provide consent
* who have undergone any eye surgery
* who have a history of ocular disease
* who are taking systemic drugs
* who wear more than one pair of single vision eyeglasses for distance
* who more than occasionally wear soft contact lenses
* who are unable and unwilling to wear the eyeglasses provided by the study for the required duration
Addressing the Cascade of Care in Vulnerable Populations With Poor Access to Healthcare in Madrid

Data on the prevalence of hepatitis C virus (HCV) for other vulnerable groups in Madrid, such as homeless persons and migrants, are scarce, and it is now necessary to implement intervention and elimination plans.

Vulnerable groups have poor access to healthcare and are therefore not systematically screened for HCV. On the occasions they are shown to be positive, subsequent follow-up in the health system and the possibility of cure are poor.

The use of a mobile unit to approach vulnerable populations is essential for better characterization of risk behaviors and of the magnitude of HCV. The integration of healthcare personnel in mobile units enables counseling on prevention and intervention when needed.

Primary objective Evaluate the impact of the HCV care cascade on vulnerable populations who gather at hot spots in Madrid (shantytowns, homeless shelters and places were street prostitution is practiced) by means of a multilevel outreach project.

SURVEILLANCE:

Active screening for HCV among vulnerable individuals in populations with a high prevalence of HCV will be carried out in hot spots in Madrid, namely, Cañada Real shanty town, mobile harm reduction units, institutions providing social assistance, public areas, homeless shelters and places where street prostitution is practiced. An agreement with the Madrid Council (MCC) is under way to provide social centers for HCV screening.

A mobile unit will approach the hot spots following a predefined schedule. The mobile unit consists of a van adapted for the project and a car. HCV screening of vulnerable individuals will be performed by a nurse and an educator hired specifically for that purpose.

Active HCV screening and prevention in vulnerable individuals should be a priority and a responsibility shared by both the MCC and the SERMAS (Servicio Madridleño de Salud). The investigators plan to establish an agreement with public health authorities to give continuity to this project and to carry out proactive HCV screening through integration with various centers and networks dependent on the MCC and SERMAS.

The project will establish the foundations of integrated cooperation between an HCV clinic in a hospital setting and harm reduction units and other resources and networks dependent on the institutions mentioned above. As has been observed with other interventions, the functional objective of this project is to provide continuity of care from the institutions.

Study Duration (in months) 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Vulnerable populations who include one or more of the following:

  * Persons who inject drugs,
  * Homeless,
  * Migrants
  * Sex workers

Exclusion Criteria:

* Not signing inform consent.
DS vs SIPS-Bariatric Surgery Comparasion

The aim of this study is to answer the question of whether the single anastomosis, 300 cm loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less nutritional and surgical risks than the standard duodenal switch (DS) operation. Please note, this study does not provide a stipend or coverage for surgery.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 40 to 65
* Agree to not use weight loss medications for the length of the study
* Compliance with standards of surgical program

Exclusion Criteria:

* Patients with a history of previous bariatric surgery except for patients who have had a previous gastric sleeve
* Previous complex abdominal surgery
* Poorly controlled medical or psychiatric disease
Brazilian Lung Immunotherapy Study

Immunotherapy with anti-PD-1/PD-L1 agents either as single agents or combined with chemotherapy is now considered the standard of care for patients with non-small-cell lung cancer. However, it has not been incorporated in the Brazilian Public Health System because of concerns about patient eligibility, safety and costs. It is known that simple biomarkers can be used to select patients for immunotherapy, such as EGRF, ALK and PD-L1 status in the tumors. We created a treatment protocol based on these 3 markers and treated 154 patients with non-small-cell-lung cancer in a Public Hospital in Brazil. The goal of this project is to identify the prevalence of these markers in the Brazilian population (to estimate patient eligibility), outcomes and costs of therapy.

Patients with metastatic non-small-cell lung cancer will undergo tumor testing for EGFR (by PCR), ALK and PD-L1 (by immunohistochemistry) and receive therapy based on these results.

* Patients with ALK-translocated tumors will receive first-line therapy with Alectinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel
* Patients with EGFR-mutated tumors will receive first-line therapy with Erlotinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel
* Patients with ALK/EGFRwt tumors and PD-L1\>=50% will receive first-line pembrolizumab, second-line carboplatin-pemetrexed and third line docetaxel
* Patients with ALK/EGFRwt tumors and PD-L1\<50% will receive first-line carboplatin-pemetrexed, second-line nivolumab and third line docetaxel.

Therapy costs will be estimated, including hospital admissions and reported for each treatment arm.

Eligibility Criteria:
Inclusion Criteria:

* Stage IIIc or IV Non-small cell lung cancer
* Good performance status (ECOG 0-2)
* Available tissue for tumor markers
* Plan to undergo systemic therapy

Exclusion Criteria:

* Inadequate cardiac, renal, liver of bone-marrow function
* Plan to undergo definitive radiation or curative surgery
* Consent withdraw
The Effect of Semi-solid Feeding After Percutaneous Endoscopic Gastrostomy (PEG) on the Incidence of Aspiration Pneumonia and Postoperative Length of Stay

Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure for long-term enteral tube feeding in patients with insufficient oral intake. Although peristomal site infection is often noted as the most common adverse event after PEG tube placements, it is seldom life-threatening and considered a minor adverse event. Feeding-related adverse events have been identified as the main cause of death after PEG, with up to 50% of postoperative early mortality (30 days) being attributed to aspiration pneumonia. This may be related to the persistence of gastroesophageal reflux (GER) of enteral feed after gastrostomy, even though PEG have been demonstrated to be superior to nasogastric tube feeding in terms of preventing GER. It has been more than a decade since semi-solid feeds were developed as an alternative to conventional liquid feeds to prevent feeding-related adverse events. Unfortunately, there is limited published literature on this topic despite the wide usage of this feeding method in Japan. Amidst the growing popularity of this method and the introduction of National Healthcare Insurance coverage for semi-solid feed prescriptions, we initiated a semi-solid feed protocol along with our existing post-PEG feeding protocols in 2014.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving gastrostomy tube placement in our hospital for enteral nutrition.

Exclusion Criteria:

* Patients receiving gastrostomy tube placement for decompression
* Patients with no gut usage more than 2 weeks before procedure
Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested.

Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants. Researcher want to study how the body absorbs, breaks down and excrete the new drug, also when given together with a test meal. In addition the study will investigate changes that take place in the body when BAY2328065 is given together with another drug.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG and vital signs
* Confirmation of the subject's health insurance coverage prior to the first screening examination/visit
* Body mass index (BMI) within the range 18 and 30 kg/m\^2 (inclusive)
* Male participants who are sexually active must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study participant and one method used by the partner) and not to act as sperm donor until follow-up
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
* The informed consent must be signed before any study specific tests or procedures are done
* Ability to understand and follow study-related instructions

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal
* Relevant diseases within the last 4 weeks prior to start of the first study intervention
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Existing chronic diseases requiring medication
* History of cardiovascular disease
* Known diseases as specified in protocol
* Regular use of therapeutic or recreational drugs
* Suspicion of drug or alcohol abuse
* Smoking equal or more than 10 cigarettes/day
* Clinically relevant findings in Electrocardiogram (ECG), blood pressure, heart rate, physical examination, laboratory examination
* History of COVID-19
* Contact with SARS-CoV-2 positive persons or COVID-19 patients within the last 4 weeks prior admission to the ward
* Positive SARS-CoV-2 viral RNA test
Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

Treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage


Eligibility Criteria:
Inclusion Criteria:

* Adults with symmetric facial photodamage grade 2 or 3 (Dover´s scale)
* Patients willing to participate
* Signed informed consent

Exclusion Criteria:

* Pregnant or nursing females
* Subjects with any photosensitizing disorder
* Any active infectious skin disorder
* History of herpes simplex in the face
* Subjects with less than 6 months of any previous rejuvenation interfering treatments
* History of systemic isotretinoin in the last year
* Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments
* History of hypersensitivity reactions
* Activities with high sun exposure during 48 hours after treatment
* Clinical suspicion of any systemic or local malignancy
Activity at Ventilation Threshold on Appetite and Food Intake in Boys

The investigators hypothesize exercise increases short term appetite and food intake, and interferes with satiety and satiations to a preload in normal weight, overweight and obese boys.

The effect of exercise (EXR) on short-term food intake (FI) and subjective appetite was investigated in normal weight (NW), overweight (OW) and obese (OB) boys were randomized into 4 treatments. Each boy consumed either a non-caloric sweetened control (CON) or GLU drink after either exercise (EXR) or sedentary activity. Subjects exercised at their ventilation threshold (VeT).

Eligibility Criteria:
Inclusion Criteria:

* Healthy boys with no emotional, behavioral or learning problems

Exclusion Criteria:

* Girls
Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases

To investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation.

Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients operated on for severe aortic regurgitation are included as control. Clinical and TTE data are compiled. Samples of aortic valve are collected at the time of the intervention. RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are validated by real time qPCR in both. Blood sampling are performed pre-operatively and at one-month follow up to assess the plasma level of previously identified gene modulators. In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for validation.

Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important information for the understanding of valve remodeling and disease. ECM gene modulators could represent pertinent molecular targets to stop the progression of AVD


Eligibility Criteria:
Inclusion Criteria:

* Patients with long-term left-ventricular assistance awaiting transplant
* Patients with severe aortic surgical spring deficiency
* Major Patient

Exclusion Criteria:

* Minor Patient
* Pregnant or nursing women
* Major under guardianship
* People in emergencies
* Persons not covered by the social security scheme
Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease.

The PRESTIGIO Registry is an Observational, prospective, multicentre study that includes patients, regularly followed by Italian Infectious Disease Centres, with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), protease inhibitors (PI), and integrase inhibitors (INSTI).

Main objective of this register is to evaluate in the study population:

* the long-term effectiveness of different antiretroviral regimes;
* evolution of the genotype and phenotypic susceptibility of antiretroviral drugs used in patients with virological failure;
* mortality;
* incidence of opportunistic AIDS-related infections and chronic conditions (comorbidity);
* determinants of clinical outcomes including virological/immunological/inflammatory markers.
* antiretroviral therapy (ART) compliance and health assessments;
* drug-economy indications related to the clinical management of this complex sub-population.

The PRESTIGIO Register consists of a systematic and continuous collection of data on clinical, laboratory and treatment characteristics of patients with documented resistance to the 4 classes of antiretroviral drugs that meet the defined inclusion and exclusion criteria.

All the clinical centres of Infectious Diseases of the different Italian regions can participate in the implementation of the Registry. Based on an analysis conducted on data collected in an AIFA register, established for the purpose of monitoring the use of dolutegravir (DTG) 50 mg Bis in Die (BID) and containing about 200 patients with the criteria specified in this protocol, the size currently conceivable for this register in Italy is about 300 patients.

The collection of clinical information and biological samples will begin once the Ethics Committee of the participating centers has approved the participation in the registry and will continue for at least three years.

Eligibility Criteria:
Inclusion Criteria:

* subjects with HIV-1 infection;
* age \>14 years;
* documented resistance to the 4 classes of antiretroviral drugs (NRTI, NNRTI, PI, INI), defined as resistance (at least intermediate) to at least one of the drugs in each class according to the Stanford algorithm. Resistance can be documented either at the time of inclusion in the study or previously documented throughout the patient's therapeutic history.

Exclusion Criteria:

* none