cyrilzakka/clinical-trials huggingface dataset:
A Neurofeedback Intervention to Improve Working Memory in Schizophrenia

Schizophrenia affects 2.4 million Americans and causes significant individual and societal costs. Cognitive deficits including poor working memory arise early in the course of illness, account for poor long-term outcomes and have been difficult to treat with available treatments. The investigators are proposing to develop a novel, computer-based brain training to improve working memory in schizophrenia patients, which, if successful could have significant personal, societal, and economic impact.

Schizophrenia (SCZ) is a chronic debilitating mental disorder that affects 2.4 million Americans and leads to considerable individual and societal costs. In patients with SCZ, cognitive deficits (CD) occur early in the course of the illness, are associated with more severe illness, and are the best predictor of functional outcomes. Nonetheless, to date, CD have been difficult to treat using available treatments. Recent studies suggest CD in patients with SCZ may arise from abnormal synchronization of distributed neural networks. Synchronization or synchronous firing of neurons, binds cortical areas into functional networks in a task and state-dependent manner. Thus novel therapies that improve abnormal neural synchrony may improve previously refractory symptoms arising from disordered brain networks.

Neural synchrony or coherence in the gamma band (GBR, 30-45Hz) plays a central role in top-down attention, multisensory processing, perceptual binding and working memory (WM). Patients with SCZ exhibit abnormal GBR, and the magnitude of impairment is associated with the severity of cognitive disorganization. Given these results, improving GBR should improve CD, including WM in SCZ. This hypothesis has been tested and confirmed using repetitive transcranial magnetic stimulation (rTMS). Additionally, EEG-based neurofeedback (NFB) is hypothesized to improve GBR and cognitive function in patients with SCZ. NFB is a low-cost, easily administered and well-tolerated treatment. In healthy controls, Gamma-NFB improves GBR and cognitive function including WM. Thus, the investigators propose testing the feasibility and effectiveness of improving GBR using gamma-NFB in patients with SCZ using the framework of the R61/R33 mechanism.

The first trial (R61) is a proof-of-concept study designed to assess target engagement and dose response curve. Thirty SCZ patients will receive G-NFB training for 12 weeks (2 weekly sessions of 30minute duration) and be assessed for 1) evidence of training, 2) Change in GBR, 3) Change in WM and 4) Change in community functioning. The second trial (R33) aims to confirm target engagement based on training parameters obtained from R61, and to assess whether G-NFB is superior to an active-placebo neurofeedback intervention in improving GBR, WM and community functioning.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia/schizoaffective disorder

Exclusion Criteria:

* Active substance use disorders in the last 30 days
* Medication changes in the last 30 days
* History of traumatic brain injury
* seizure disorder
* pregnancy
Non-ablative Er:YAG for Recurrent Candidiasis

The objective of the study wa to assess the safety, acceptability and effectiveness of non-ablative Er:YAG laser therapy for treatment of symptoms and microbiological conditions of women with recurrent vulvovaginal candidiasis (RVVC). Eligible patients have received 4 laser therapies within four moths and will be assessed at baseline, 3 months and 9 months after last laser therapy.

The effects of laser therapy have been assessed by following the vaginal microbial status, by assessing the five bothersome symptoms related to vaginal infection (burning, itching, dyspareunia, dysuria, and abnormal discharge), by assessing the overall patient satisfaction, and throughout the study the safety of the laser therapy has been monitored.

Genital candidiasis is a common fungal infection that affects both men and women, though it is more frequently observed in women. It is estimated that up to 75% of women will experience at least one episode of vulvovaginal candidiasis (VVC) during their lifetime. The primary causative agents are Candida albicans and other non-albicans pathogenic fungal species.

The likelihood of developing genital candidiasis can be influenced by factors such as age and hormonal changes. Women of reproductive age, especially those who are pregnant, using hormonal contraceptives, or experiencing hormonal fluctuations, are at higher risk. The highest prevalence rate, 9%, is reported among women aged 25 to 34 years. Antibiotic use, which can disrupt the body's microbial balance, is a known risk factor for genital candidiasis, along with other factors like obesity, uncontrolled diabetes, corticosteroid use, chronic stress, and certain lifestyle choices.

Clinical guidelines recommend oral fluconazole or itraconazole as the first-line treatment for recurrent vulvovaginal candidiasis (RVVC). However, after stopping maintenance therapy, a recurrence rate of 40%-50% is expected. While clinical resistance to antifungal agents is rare, overexposure to azoles can lead to resistant strains of C. albicans. Additionally, non-albicans Candida species, such as C. glabrata, often show dose-dependent susceptibility or resistance to fluconazole and other azole agents, and their prevalence is increasing. Given the limited therapeutic options, innovative treatment strategies are necessary.

Eligibility Criteria:
Inclusion Criteria:

* adult women (\> 18 years)
* diagnosis of recurrent vaginal yeast infection (\> 4 infection per year)

Exclusion Criteria:

* patients having contraindications to laser therapy (epilepsy, pregnancy, acute systemic infection)
Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor

We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.

Endoscopic submucosal dissection (ESD) is a technique for endoscopic tissue resection that enables endoscopists to control the depth and direction of diathermic knife incisions.Recently, the number of reports in which ESD has been successfully used to treat colorectal tumors has increased. But the complatios with colorectal ESD were higher than esophagus and stomach ESD.We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.

Eligibility Criteria:
Inclusion Criteria:

* Endoscopy proven colorectal polyp\>2cm, LST\>3cm, SMTs\<2cm Suitable for ESD No other organic disease of colorectal Removing a single lesion one time Informed consent

Exclusion Criteria:

* Complicated other colorectal diseases, such as,Crohn's disease Familial adenomatous polyposis With previous colorectal surgery Pregnancy or lactation Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III) ESD conversion to laparotomy Patients cannot receive ESD Patients and/or family members can not understand and accept this study
Validation of a miRNA Panel to Optimize Treatment Response in Patients With Metastatic Pancreatic Cancer (mirPANC 2)

This study is being conducted to better understand how pancreatic cancer behaves during treatment and how we can improve methods for monitoring disease progression. The research aims to determine whether small molecules present in the blood, called miRNAs, can help doctors assess whether the treatment is working or needs adjustment. With this, we hope to make cancer monitoring less invasive and more precise, allowing patients to receive more personalized and effective treatments.

Pancreatic cancer, particularly Pancreatic Ductal Adenocarcinoma (PDAC), has an extremely poor prognosis, with a 5-year survival rate of less than 3% for advanced stages. In 2020, Brazil saw about 11,893 deaths from this condition, with incidence rates expected to rise. The standard treatment for metastatic PDAC is the FOLFIRINOX regimen, but its response is variable and its effectiveness is limited, with few advancements in personalized therapy and response prediction. This research aims to develop and validate a panel of serum-based miRNA biomarkers using qPCR and large-scale sequencing (NGS) to evaluate treatment response in metastatic PDAC patients. The goal is to identify miRNA expression patterns that predict the effectiveness of FOLFIRINOX and assist in personalizing treatment based on individual responses. The study will use liquid biopsy to collect blood samples and analyze circulating miRNAs, enabling early detection of treatment responses and disease progression. This will allow for precise therapeutic adjustments and alternative treatment options based on the patient's profile. The innovative approach combines liquid biopsy with miRNA analysis as a low-cost, effective tool for monitoring and personalizing treatment. Using qPCR, a more affordable method than NGS and microarrays, enhances clinical feasibility. The research is highly relevant to the Brazilian Unified Health System (SUS), as an accessible miRNA panel could optimize resource use, reduce costs of ineffective treatments, and improve care quality and outcomes, aligning with SUS's goals for precise and accessible healthcare.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with metastatic PDAC;
* Patients who will start treatment with FOLFIRINOX;
* 18 years or older;
* Who agree to participate in the study by signing the Informed Consent Form;

Exclusion Criteria:

* Patients who have previously undergone chemotherapy, whether neoadjuvant, adjuvant, or any prior first-line treatment;
* Patients who do not meet the minimum criteria to receive the proposed regimen, such as those with hyperbilirubinemia, those who are not candidates due to age or performance status deterioration;
Comparison Of Videolaryngoscopes In Double Lumen Tube

Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation with double lumen tube. The use of Storz C-MAC D Blade and McGrath MAC X3 Blade videolaryngoscope were compared in intubation of single lung ventilation patients who underwent chest surgery in terms of duration of intubation, hemodynamic response and intubation-induced complications.

It is very important for anesthesiologists to evaluate and make the airway safe in order to start and continue surgical operations. Endotracheal intubation has many important reasons such as ensuring airway control safely during surgical procedure, increasing the depth of anesthesia, need interventions for surgical or anesthetic complications, reduction of dead space, reduction of respiratory effort and prevention of aspiration risk. Videolaryngoscope, developed in recent years and beginning to take place in the algorithms, facilitate difficult airway management and hence intubation.

The use of videolaryngoscope in patients with intubation such as double lumen tube, has been frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better quality video and camera system and improves the performance of videolaryngoscope with some technological changes. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope with D blade and McGrath MAC videolaryngoscope with X3 blade in respect to duration of intubation, haemodynamic response, and adverse events associated with intubation of patients undergoing lung surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology score III,
* 18-65 years,
* BMI\> 40
* Patients who was intubated with double lumen tube.

Exclusion Criteria:

* American Society of Anesthesiology IV,
* Under 18 years,
* Over 65 years,
* Under BMI\<40
* Obstetric patients,
* Uncontrolled cerebrovascular disease,
* Patients who refused written informed consent forms
Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

Primary:

To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites.

Secondary:

To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).


Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis of the liver.
* Patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator.
* Patients with recurrent ascites having undergone both of the following:

  * therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of = or \> 4 litres of fluid.
  * at least one other therapeutic paracentesis in the previous 3 months.

Exclusion Criteria:

* Patients with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt.
* Known hepatocellular carcinoma.
* Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
* Patients previously exposed to satavaptan in the past 12 months.
Prone Breast Radiotherapy Treatment Planning Observational Study

The study purpose is to evaluate whether or not clinical characteristics of women with breast cancer can predict which position for radiation treatment, prone or supine, will be associated with a dosimetry gain. Dosimetry gain in this study means the lowest radiation dose to non-target organs (heart, lungs, contralateral breast), while giving the prescribed dose to tumor bed and ipsilateral breast.

Retrospectively identify women who received curative radiation treatment after breast conserving cancer surgery, in whom simulation in prone and in supine position was performed. Compare the treatment plans for doses to targets and to non-target organs, according to clinical parameters of body mass index, size of breast, location of tumor and side. Furthermore, evaluate whether a single CT slide is enough or not to predict a dosimetry advantage.

Eligibility Criteria:
Inclusion Criteria:

* Breast conserving surgery
* Adjuvant radiation treatment
* Simulation done prone and supine

Exclusion Criteria:

* Simulation in only one position
A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body

The main objectives of this trial are to investigate pharmacokinetics, safety and tolerability of BI 1015550 in Chinese healthy male and female subjects following administration of single doses.


Eligibility Criteria:
Inclusion criteria

Chinese subjects will only be included in the trial if they meet the following criteria:

1. Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 28.0 kg/m² (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
5. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. Of note, oral hormonal contraceptives are not considered a highly effective method due to potential drug-drug interactions. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the patient information.

Exclusion criteria

Subjects will not be allowed to participate, if any of the following general criteria apply:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder or any history of suicidal ideation or behaviour)
8. History of relevant orthostatic hypotension, fainting spells, or blackouts. Further exclusion criteria apply.
Role of PCO2 Gap as Predictor of Clinical Outcome in ICU Septic Patients

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, if not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death. Sepsis is associated with high mortality, and the early recognition of the signs of tissue hypo perfusion is crucial in its management.

This prospective study was aimed to detect that PCO2 gap can be taken as a reliable prognostic tool in septic patients

In the community setting, sepsis often presents as the clinical deterioration of common and preventable infections. Sepsis also frequently results from infections acquired in health care settings, which are one of the most frequent adverse events during care delivery and affect hundreds of millions of patients worldwide every year The venous-to-arterial carbon dioxide difference (Pv-aCO2) can indicate the adequacy of microvascular blood flow in the early phases of resuscitation in sepsis. Hence, other resuscitation goals, such as PCO2 gap, have been suggested, due to their ability to predict adverse clinical outcomes and simplicity in patients achieving normal oxygen-derived parameters during the early phases of resuscitation in septic shock.

Blood lactate level is also useful in evaluating sepsis. Serum lactate is a good indicator of the presence of hypoxic tissue during septic shock, since its production takes place during Anerobic metabolism.

Procalcitonin (PCT) is the precursor of calcitonin, and higher levels are associated with the development of sepsis. Com¬monly, there is an elevation of PCT levels 4 h after the on¬set of symptoms, peaking between 8 h and 24 h.

Eligibility Criteria:
Inclusion Criteria:

* Adult septic patients ≥ 21 years old

Exclusion Criteria:

* Patients with history of chronic obstructive pulmonary disease and bronchial asthma.
Validation of the Turkish Version of QUALEFFO-31

The aim of this study is to investigate the adaptation and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 in patients with osteoporosis. Thus, to present a scale that will help us analyze the psychometric properties of patients with osteoporosis to the use of the Turkish people .

Osteoporosis has become an important public health problem due to low bone mass, decreased bone strength and increased risk of fractures. Today, the measurement of quality of life plays an important role in the approach to diseases. Quality of Life Questionnaire of the European Foundation for Osteoporosis-41 (QUALEFFO-41) has been used for many years as a well-established and fully self-administered questionnaire. In the following years, a shorter and more practical version was needed because the QUALEFFO-41 contains many questions and takes a long time. For this reason, the questionnaire was updated in 2006 and the version of QUALEFFO-31 was made and the validity of the current questionnaire was shown. The aim of this study is to conduct the reliability and validity study of Turkish version of QUALEFFO-31 and to evaluate the power of the questionnaire to distinguish patients with osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* To have Dual-energy X-ray absorptiometry (DXA) results and thoracolumbar lateral spine X-Rays taken for any reason in the last 6 months.
* To have calcium, phosphorus, parathormone (PTH) and 25-hydroxyvitamin D level in the last 3 months.
* To be independently ambulatory.
* To have a cognitive capacity to understand and complete the questionnaires.

Exclusion Criteria:

* To have malignancy.
* To have inflammatory diseases.
* To have a metabolic bone disease other than osteoporosis.
* To have neuromuscular diseases.
Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients

A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.

Asymptomatic adults between the ages of 18 and 70 will undergo screening of the colon using the aer-o-scope, under fluoroscopy, following by screening of the colon using a standard approved colonoscopy for determination of safety.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 18 and 70 years of age
* Patients who are generally healthy and classified as low risk for CRC
* Patients who are ready to undergo standard colonoscopy examination including colon prep.
* Signed informed consent

Exclusion Criteria:

* Patients with any known GI related symptoms complaints or GI diseases
* Patients with cancer or other life threatening diseases or conditions
* Patients with unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal' gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety. Patients with a known history of blood clotting problems and /or who are on anti-coagulant therapy and cannot stop treatment for the purpose of this study. (Patients taking up to 100mg aspirin for prophylactic treatment are acceptable for this study).
* Pregnant women
* Patients who underwent abdominal surgery that is deemed by the investigator to effect the procedure
* Morbid Obesity (BMI \> 40)
* Drug abuse or alcoholism
* Bed-ridden patient
* Inadequate communication with the patient
* Patients under custodial care
* Participation in current clinical study or clinical study within 30 days prior to the procedure