cyrilzakka/clinical-trials huggingface dataset:
Brain Stimulation, Clinical Symptoms and Cognition

The purpose of this study is to test the impact of non-invasive brain stimulation, transcranial direct current stimulation (tDCS), on auditory hallucinations, negative symptoms and cognition in schizophrenia. Clinical measures will be used to assess clinical symptoms and cognitive performance to test the hypothesis that a course of tDCS can reduce auditory hallucinations and negative symptoms in schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to sufficiently speak and understand English so as to be able to understand and complete cognitive tasks.
* All subjects must have the ability to give valid informed consent.
* No children under the age of 18 will be recruited.
* Diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
* Stable outpatient or partial hospital status
* Normal IQ (\>70; IQ will be measured by administering the Wechsler Abbreviated Scale of Intelligence (WASI) test)

Exclusion Criteria:

* Pacemakers
* Implanted electrical (brain and spinal) stimulators
* Implanted defibrillator
* Metallic implants
* Skin damage or skin conditions such as eczema at the sites where electrodes will be placed
* Hair styles hindering the placement of electrodes
* Cranial pathologies
* Head trauma
* Epilepsy
* Mental retardation
* Any known history of neurological disorders (including epilepsy, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, cerebral palsy, any DSM-5 axis I psychiatric disorder (for healthy control subjects), autism)
* Uncorrected vision problems that would hinder cognitive testing (this also pertains to subjects with color blindness in tasks where discriminating colored objects/items is necessary for successful performance)
* Pregnancy
* Substance dependence in the past six months
* Substance abuse in the past month
Evaluation of Fast, Same-day Delivery of Palliative Radiotherapy Without a Planning CT (FAST-METS)

Palliative radiotherapy is an effective treatment for patients with painful bone metastases. Standard workflows often involve long waiting times or multiple visits. Fast palliation completed during a single clinic visit can be achieved by omitting a planning CT scan, and using available diagnostic imaging for treatment planning. The adaptive treatment platforms provides the possibility to adapt positions differences between the diagnostic CT and radiotherapy treatment of the target and organs at risk. In this study, the investigators will investigate the experiences of patients who have been treated with this fast-adaptive workflow (FAST-METS) using 2 questionnaires.

Palliative radiotherapy is an effective treatment for patients with painful bone metastases, and currently the investigators have clinically implemented the FAST-METS procedure at the department. All patients referred for palliative radiotherapy, in whom diagnostic imaging performed within 4 weeks is available, are eligible for this adaptive workflow. Consultation by telephone is done beforehand to verify whether the complaints correspond to the location of the metastasis.

This single-institutional, explorative study will investigate the experiences and quality of life of patients who were treated with this workflow. Two study questionnaires are used, and informed consent will be obtained for both. The EQ-5D-5L questionnaire will be completed on the day of treatment, after 6 weeks and 3 months post-treatment. The other questionnaire used was developed for patients treated with adaptive radiotherapy. Two patients groups will be studied, namely those undergoing simple and complex palliative radiotherapy. Patients treated with complex palliative radiotherapy are defined as those referred for re-irradiation to the site of metastasis, patients undergoing concurrent systemic therapy, and patients treated with a single fraction radiation dose exceeding 8 Gy.

In addition, the study will evaluate time spent on treatment preparation and delivery proces, and dosimetric aspects of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for palliative radiotherapy to metastases
* Recent diagnostic CT scan (preferably \<4 weeks) of the metastasis with full body contour of the patient included.

Exclusion Criteria:

* A solitairy metastasis from a primairy tumor with good a prognosis
* A metastasis located in ventral ribs where respiratory motion of the target is expected
* Patients who are not fluent in Dutch
A Feasibility Trial of a Web Based App Intervention in Hormone Positive Breast Cancer Patients to Improve Adherence to Endocrine Therapy

This clinical trial looks at the use of an internet-based application (app) intervention in improving adherence to endocrine therapy (ET) among patients with early stage hormone receptor-positive HER2-negative breast cancer. ET can significantly reduce the return of the cancer in patients who are compliant with their treatment regimen. Despite this, adherence to ET is poor due to side effects, lack of social support and timely access to clinicians, and poor patient understanding of the necessity and effectiveness of the therapy. An internet-based app may help patients improve their adherence to ET by providing reminders, side effect mitigation strategies available in the educational videos and from contacting providers/ nurse on the research team directly via the app.

PRIMARY OBJECTIVE:

I. To assess the feasibility of a web-based app as an intervention to carry out functions such as weekly reminders, improving patient provider communication, improving patient education

SECONDARY OBJECTIVES:

I. To evaluate if high level of adherence to endocrine therapy can be maintained by using our web-based app in early-stage hormone positive breast cancer II. To assess whether the web-based app will improve patient satisfaction, whether patients feel the app helped improve their likelihood of adhering to endocrine therapy by making them feel more confident in their side effect management.

OUTLINE: This is a single arm, feasibility study. 30 patients will be enrolled.

In addition to standard of care, patients will receive access to the web-based application for the study duration (3 months). The app will have the following features: weekly text reminders to continue ET and prompts to report medication side effects, access to educational content explaining common side effects and symptom management strategies, prompts to patients to review this information when they report side effects, and most importantly, the patient will have access to their breast oncology providers to discuss their side effects and ask questions via the app. A feature unique to our app is the educational content readily available to patients. When a patient reports a side effect, the app will direct them to the relevant video explaining that side effect and going over strategies to mitigate them.

Eligibility Criteria:
Inclusion Criteria:

* Early-stage hormone receptor positive, HER2-negative breast cancer who have completed all recommended (neo)adjuvant chemotherapy, surgery and/or radiation therapy
* Age \>= 18
* Started on an aromatase inhibitor or Tamoxifen within less than or equal to six months prior to time of enrollment
* Access to internet from a desktop or a smartphone
* Ability to speak English

Exclusion Criteria:

* Patients who are her2 neu positive
Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia

Patients suffering from their first episode of schizophrenic disorders are randomly allocated to either a short "information centered psychoeducation" (ICP) of 8 sessions or a "cognitive behavioral treatment" (CBT). CBT includes 8 sessions of psychoeducation, 8 sessions of computer based cognitive training, 8 sessions with relatives and 20 sessions of focusing on stress management, relapse prevention and coping with persistent symptoms.

The primary endpoint is relapse at the one and two year follow up.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenic disorder according to ICD 10: F20
* first episode
* age between 18 and 55
* willingness to give informed consent also to a double blind pharmacological treatment study

Exclusion Criteria:

* residence outside of the catchment area
* insufficient knowledge of the German language
* substance abuse or addiction as primary clinical problem
* serious physical illness
* organic brain disease
* pregnancy
* contraindications to neuroleptic treatment
Biomarkers in Tumor Tissue Samples From Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

This research study is studying biomarkers in tissue samples from patients with stage III, stage IV, or recurrent endometrial cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. To determine the frequency of topoisomerase 2-alpha (TOPO2A) gene copy number alterations (including deletions, gains, and amplification), immunohistochemical expression, and chromosome 17 polysomy in tumor tissue samples from patients with advanced or recurrent endometrial carcinoma treated with anthracycline-based therapy on Gynecologic Oncology Group (GOG)-0177.

II. To assess the relationship between TOPO2A gene copy number alterations, TOPO2A protein expression, chromosome 17 polysomy, and human epidermal growth factor receptor 2 (HER2) status in tumor tissue samples from these patients.

III. To assess the association between TOPO2A status (TOPO2A gene copy number alterations and TOPO2A protein expression), or chromosome 17 polysomy and clinical covariates (e.g., age, race/ethnicity, cell type, histologic grade, disease stage, regimen type).

IV. To assess the association between TOPO2A status or chromosome 17 polysomy with measures of clinical outcome including response, progression-free survival, and overall survival of patients treated with this regimen.

V. To evaluate the potential identification of cut points for TOPO2A protein expression with potential prognostic value in patients treated with this regimen.

OUTLINE:

Archived tumor tissue samples are analyzed for topoisomerase 2-alpha gene alteration and expression and chromosome 17 polysomy by fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC). Clinical information associated with each endometrial carcinoma sample (e.g., age, race/ethnicity, cell type, histologic grade, disease stage, and regimen type) is also collected.

Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy-naïve women with histologically documented measurable Stage III, Stage IV or recurrent endometrial carcinoma with known HER2 status who participated in Gynecologic Oncology Group (GOG)-0177 are eligible
* Patients must have given permission for their archival formalin-fixed, paraffin-embedded primary, metastatic or recurrent tumor to be submitted and used for GOG-0177, and at least one to three unstained slides must be available for FISH analysis of TOPO2A and CEP17 and immunohistochemical staining for TOPO2A

Exclusion Criteria:

* Women who were not eligible or evaluable on GOG-0177
* Patients who do not have at least one unstained slide archival formalin-fixed, paraffin-embedded primary, metastatic or recurrent tumor available for fluorescence in situ hybridization (FISH) analysis of TOPO2A and CEP17 or immunohistochemical expression of TOPO2A
Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia

Previous research has shown beneficial effects of prewarming on preventing inadvertent perioperative hypothermia (IPH). Warming the surface of the body before the induction of anesthesia can reduce the temperature difference between the core and periphery, thereby reducing the degree of core-to-peripheral thermal redistribution. It has been proved that initiation of warming before surgery can be more useful for preventing IPH than warming only during surgery. Nevertheless, there are not many researches on effects of short period (\<30 min) prewarming, especially in gynecologic laparoscopic surgery. Accordingly, the investigators designed this study to test if IPH can be effectively prevented when 10 minutes of prewarming is added to intraoperative active warming in patients undergoing gynecologic laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1 or 2 patients
* patients who underwent gynecologic laparoscopic surgery under general anesthesia

Exclusion Criteria:

* preexisting hypothermia (\<36℃) or hyperthermia (\>37.5℃)
* anesthesia last for \<1 hour or \>2 hours
* conversion from laparoscopic surgery to laparotomy
* patients with a body mass index (BMI) ≥ 31kg/m2
* patients with known thyroid disease
Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

Several studies have shown poor immune response to conventional influenza vaccines in HIV-infected individuals. This study was conducted expecting the more potent immunogenicity of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected adults.

During the 2011/2012 pre-influenza season, three vaccines were used in HIV-infected adults (18 to 60 years): inactivated intramuscular vaccine (Agripal), reduced-content intradermal vaccine (IDflu9μg) and standard-content intradermal vaccine (IDflu15μg). Serum hemagglutination-inhibiting (HI) antibodies and INF-γ ELISpot assay were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine

Exclusion Criteria:

* known allergy to egg
* presentation of any febrile illness ≥37.5°C on the day of vaccination
* any history of hypersensitivity reaction to previous influenza vaccination
* any other vaccinations within the past one month
* use of immunosuppressive agent
* recipient of blood product or immunoglobulins during the previous three months
* any other conditions that might interfere with the study results
Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study

There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. aged between 18 and 80 years old;
2. TIA or non-disabling ischaemic stroke of the posterior circulation;
3. symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication
4. stenosis of the vertebral artery of 50% or greater, diagnosed by both CT angiography or angiography;
5. NIHSS≤ 6;
6. score on the modified Rankin scale ≤ 3.

Exclusion Criteria:

1. Active bleeding or coagulation disorders or severe renal/liver impairment
2. allergy to iodinated contrast agent or related medicines;
3. acute stroke in 3 weeks
4. more than 1 stenosis at the target vessel or Distal vascular dysplasia (diameter≤3mm)
5. a potential cause of stenosis other than atherosclerosis
6. Severe stenosis was found in the anterior circulation artery(\>70%)
7. intracranial hemorrhage or hemorrhagic stroke, intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm in 30 days;
8. ISR patients;
9. Severe calcification lesion；
10. obvious thrombosis in vessel;
11. pregnancy;
12. a potential cause of TIA or minor stroke other than stenosis in a vertebral artery.
Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

Cold laparoscopic cholecystectomy is the gold standard for the management of symptomatic vesicular stones. There is considerable controversy as to whether it should be practiced in outpatient surgery or as part of inpatient surgery, regarding to patient safety.

"Minor" surgical procedures, such as anal surgery or simple inguinal hernia interventions, were initially considered eligible for an outpatient procedure. Advances in surgical techniques, anesthesia and early rehabilitation have also made it possible to consider more "heavy" interventions, such as cholecystectomy.

The aim of this study is to identify eligible patients for laparoscopic cholecystectomy in outpatient surgery, taking surgical criteria into account.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had a laparoscopic cholecystectomy with a single cholecystectomy procedure without other associated interventions (bariatric surgery or other)

Exclusion Criteria:

* Pregnant women
* Diabetic patients under insulin treatment
* History of major abdominal surgery
* Acute cholecystitis as per anatomo-pathological examination
A Safety and Pharmacokinetics Study of ZB004 in Healthy Participants

The purpose of this study is to evaluate the safety and pharmacokinetics of single-ascending doses of ZB004.

Up to approximately 40 healthy volunteers across 5 cohorts randomized to receive ZB004 or placebo as single doses.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female participants 18 to 55 years of age.
* Body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants; body mass index of 18 to 35 kg/m\^2 for both male and female participants.
* Considered in good health as determined by the Investigator.
* Female participants of child-bearing potential must agree to abstinence or use an highly effective form of contraception. Female participants must also refrain from donation of eggs from the signing of the informed consent to 6 months after receiving their dose of study drug.
* Male participants must be surgically sterile or agree to use effective contraception. Male participants must also agree not to donate sperm from the signing of the informed consent to 6 months after the last scheduled dose of the study drug.
* Willing and able to understand the characteristics and purposes of the study, including possible risks involved, and willing to comply with all the study requirements and provide written informed consent for the study.

Exclusion Criteria:

* Surgery within 4 weeks before Screening or planned surgery during the clinical study.
* Use of prescription medications, biological products, or other medicines within 2 weeks before Study Day 1 or 5 half-lives of the product, whichever is greater. Use of over-the-counter medications or vitamins/dietary supplements within 7 days of dosing unless considered by the Investigator to not pose a risk or impact the study results.
* Clinically significant ECG abnormality.
* Positive for HIV, active hepatitis C or B, Covid-19 virus, tuberculosis.
* Bacteria, viruses, systemic fungi, parasites, or other opportunistic infections within 30 days before Study Day 1.
* History of drug abuse in the previous 12 months before Screening, or positive for urine drug Screening (Day -28 to Day -1).
* Donated blood (including component blood) or lost \> 400 mL within 3 months before Screening or received a transfusion within 3 months of Screening.
* History of relevant allergies (including allergy to any murine or human-derived protein or immunoglobulin products, rubber or latex, or other allergies that in the opinion of the Investigator make inclusion in the study inappropriate).
* Average daily smoking \> 10 cigarettes/day (or equivalent) within 6 months of Screening.
* Consume \> 14 standard units of alcohol per week (1 standard unit is equivalent to approximately 360 mL of beer, 45 mL of spirits with 40% alcohol, or 150 mL of wine) or a positive alcohol breath test on Day -1.
* Any disease that might interfere with the safety evaluation of the investigational product.
Role of the Environment and Endocrine Disruptors in Child Cryptorchidism

Cryptorchidism is the most frequent congenital defect of the male newborn. It requires surgery in childhood, increases the risk of fertility disorders and cancer. As a major public health objective, it's the subject of numerous recommendations. Its frequency is increasing in some countries faster than a single genetic cause could not explain it. It may occurs in a geographic cluster. The cause of cryptorchidism involves genetic, hormonal and environmental factors. Animal studies suggest that endocrine disruptors interfere with fetal testicular migration. The aim of the study is to find out if some environmental exposition may be associated with cryptorchidism.

Cryptorchidism is the most frequent congenital defect of the male newborn. It requires surgery in childhood, increases the risk of fertility disorders and cancer. As a major public health objective, it's the subject of numerous recommendations. Its frequency is increasing in some countries faster than a single genetic cause could not explain it. It may occurs in a geographic cluster. The cause of cryptorchidism involves genetic, hormonal and environmental factors. Animal studies suggest that endocrine disruptors interfere with fetal testicular migration. The aim of the study is to find out if some environmental exposition may be associated with cryptorchidism.

Eligibility Criteria:
Inclusion criteria:

- Parents of male children from the neonatal period to 18 years of age (during surgery) with cryptorchidism

Exclusion criteria:

* Parents of children without endocrine disease. (adrenal, hypothalamic-pituitary, phosphocalcic, thyroid, diabetes, etc.)
* Parents of children without an associated genital or urinary defect (hypospadias, micropenis, renal and bladder abnormalities)
* Testicular Ectopia (testis outside of normal migration path)
* Anorchidism and evanescent testicles, united or bilateral
* Abnormalities of the abdominal wall (laparoschisis, omphalocele, Prune Belly)
* Cryptorchidism integrating in the context of a polymalformative syndrome, including neurological.
Analysis of Microbiota Changes Induced by Microencapsulated Sodium Butyrate in Patients With Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is characterized by severe inflammation of the small bowel and/or the colon leading to recurrent diarrhea and abdominal pain.

Irritable Bowel Syndrome with diarrhea (IBS-D) is characterized by abdominal pain or discomfort, gas, loose and frequent stools.

Butyrate has shown anti-inflammatory and regenerative properties, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. The investigator proposes to investigate the effect of a microencapsulated form of sodium butyrate on the fecal microbiota of patients with IBD and IBS-D.

The IBDMicro is an interventional, randomized, double-blind, placebo-controlled study. A novel oral formulation of butyrate contained in a lipophilic microcapsule, that provides extensive capacity for intestinal diffusion and facilitates slow release of the active ingredient will be used ("Butyrose" produced by SILA SRL, Italy). A proof-of-concept study has been already published in this context, and preliminary data showed that butyrate administration was able to change the gut microbiota of patients with IBD and IBS-D after 12 weeks of treatment, in association with the changes of intestinal inflammation indexes (fecal calprotectin). In keeping, investigators will assess the microbiota before and after the butyrate administration. Also, clinical data will be collected by using validated disease-specific questionnaires (Rome IV and clinical indexes for IBD). Quality of life will be also recorded. The analysis of intestinal microbiota will be carried out by collecting a fecal sample and analyzed with metagenomics techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed diagnosis of Crohn disease (CD) or Ulcerative colitis (UC) in the last 6 months and undergoing followup colonoscopy.

Exclusion Criteria:

* (a) prior proctocolectomy;
* (b) presence of IBD extraintestinal manifestation;
* (c) treatment with antibiotics in the last 60 days;
* (d) extensive surgical resection;
* (e) presence of stoma.