cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer

The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD).

The purpose of this project is to verify the therapeutic effect of fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through randomized controlled clinical trials, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.

This study will divide patients into two sections, and eligible patients will be enrolled. Patients with locally advanced prostate cancer or oligometastatic prostate cancer were assigned to either fasudil hydrochloride and PD1 inhibitor combined androgen deprivation therapy or placebo combined androgen deprivation therapy based on a computer-generated random sequence. In addition to routine androgen deprivation therapy, patients in the treatment group were given 10mg of fasudil hydrochloride on the 1st to 5th day and PD-1 monoclonal antibody (triprilizumab, 3mg/kg, intravenous drip) on the 5th day. In the placebo group, the same size, color and dosage form of 0.9% sodium chloride injection was used, and the administration was the same as that in the treatment group. After starting the intervention, all patients should be followed up in our hospital every treatment cycle to review blood PSA and other indicators. At the end of the treatment cycle, imaging examinations were followed up and radical prostatectomy was performed 3 weeks later (±7 days).

Eligibility Criteria:
Inclusion Criteria:

* ① Age ≥18 years and ≤85 years;

  * Histologically confirmed prostate cancer without small cell features;

    * Metastatic prostate cancer was identified by imaging examination with ≤5 oligometastases (bone or lymph node metastases) or cT3-4 stages; ④The score of ECOG (Eastern Cooperative Oncology Group) was 0-1; ⑤ All patients voluntarily sign informed consent, and can adhere to treatment and follow-up;

Exclusion Criteria:

* ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.

  * Previous prostatectomy;

    * Any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient

      * Allergic to the drugs used; ⑤ Refuse to undergo radical prostatectomy; ⑥ According to the investigator's judgment, it is not suitable to participate in this clinical trial;
Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke

Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and have frequently been used for the treatment of acute brain infarction in Japan. The effect of combination therapy of these drugs, however, has not yet been elucidated. This study will test the safety and efficacy of the combination therapy with these agents in patients with acute non-cardioembolic and non-lacunar ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke \< 24 hours of onset
* Measurable neurological deficits caused by the present attack, ranging from 1 to 22 of NIHSS score on admission

Exclusion Criteria:

* Definite or possible cardiogenic brain infarction
* Definite lacunar infarction
* Prior ischemic stroke within 6 months
* Evidence of hemorrhagic brain infarction, epidural hematoma, intracerebral hematoma, or intraventricular hemorrhage
* Severe consciousness disturbances (semicoma to deep coma)
* Neurological signs clearing spontaneously
* Disability of 2 or more on mRS score before the index stroke aPTT being out of the normal range or 1.5 times longer than the pretreatment value
* If taking an oral anticoagulant, INR being 1.6 or more, or no INR data
* Treatment with urokinase, t-PA, heparin, ozagrel sodium, warfarin, or antiplatelet except for aspirin before enrollment
* Intravascular surgery, surgical operation, hyperbaric oxygen therapy, or hypothermia therapy before enrollment
* Serum creatinine \>1.5 mg/dL
* Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
* Neoplasm
* Pregnancy
* Hypersensitivity to test drugs
A Study on the Associations Between Microribonucleic Acid Gene Polymorphisms and Crohn's Disease

From January 2020 to January 2025, Crohn's disease (CD) patients and gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. The aim of this research is to explore the associations of microribonucleic acids (miRNAs) gene polymorphisms with the risk and clinicopathological characteristics of CD, and to analyze the effects of miRNAs gene variantions on the clinical response of ustekinumab (UST) treatment in CD patients at week 8.

From January 2020 to January 2025, a total of 312 CD patients and 527 gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University.The genotypes of miRNAs were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Unconditional logistic regression was employed to analyze the distribution of miRNAs gene polymorphisms between CD group and normal control group, as well as their influences on the clinicopathological characteristics of CD patients. Unconditional logistic regression model was used to explore the effect of miRNAs gene variation on the clinical response of CD patients in the treatment of UST at week 8.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed CD based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

Exclusion Criteria:

* rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.
Investigate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa in Type 2 Diabetes Mellitus

The purpose of this study is to determine whether administration of AZD1656 will affect the pharmacokinetics of Pioglitazone and vice versa in patients with Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed Type 2 Diabetes Mellitus for at least 1 year and treated with metformin alone or metformin and one other oral anti-diabetic drug
* Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria:

* Impaired renal function
* Clinically significant illness or clinically relevant trauma.
Nutrient Pattern Analysis in Critically Ill Patients (NAChO)

Little is known about nutritional Parameters that potentially influence the course of intensive-care unit acquired weakness (ICU - AW). The investigators aim to elucidate the nutritional profiles in blood, urine and muscle in respective patients at risk.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Written informed consent obtained from the patient's legal representative and later from the patients (as soon as possible)
* Individuals diagnosed with severe head trauma or intracerebral hemorrhage ("central nervous system group") or with severe sepsis/ septic shock ("Sepsis group") at any time from ICU admission until day 5 (i.e. day of screening)
* Patient on the ICU for ≥ 5 days ("ICU long stayer")

Exclusion Criteria:

* Language other than German or French
* Institutionalized Individuals (e.g. prisoners, severe pre-existing mental incapacity)
* Patients with known pre-existing neurological or psychiatric disease that will make informed consent likely impossible
* Patients with known pregnancy or known to be lactating will not be included to the investigation. Due to the observational/ diagnostical nature of the study, a pregnancy test will not be performed.
* Patients on extracorporeal membrane oxygenation (ECMO)
* Clinical signs of pre-existing malnutrition (Body mass index \<18)
* Pre-existing evidence for history of anorexia or bulimia
* Parenteral nutrition received within last 5 days (for more than 12 hours) or evidence for parental nutrition needed within next 7 days
* Terminal disease (i.e. life expectancy \<14 days)
* Patients with active malignancy
* Patients on biologicals interfering with metabolism (e.g. infliximab)
* Patients on chronic steroid medication (i.e. prednisone equivalent dose \>10mg/day)
* Patients on neuromuscular blocking agents on a regular basis (i.e. on a repetitive basis within last 48 hours or evidence for need within next 7 days)
* At screening (day 5): prescribed caloric intake substantially higher (i.e. \> 150% of caloric need of indirect calorimetry) than indirect calorimetric results (in intubated patients) or i.e. standard-of-care (25 Kcal/kg body weight/day)
* Severe adipositas defined as BMI \>40
* Known pre-existing allergy to standard enteral formulae
* Subject previously enrolled to an interventional trial that is not considered standard-of-care (e.g. investigation of new medication/drug or medical devices)
VICIS - Vienna Cirrhosis Study

Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the Medical University of Vienna will be offered to participate in this prospective observational trial.

Clinical parameters and laboratory parameters will be recorded for all patients and patients will undergo a regular follow-up schedule with clinical visits at the Vienna General Hospital.

This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, liver biopsies and stool collected from the study participants.

Patients with advanced chronic liver disease (ACLD) as evident by HVPG\>5mmHg or liver biopsy showing F3/F4 fibrosis or as suggested by liver stiffness measurement (LSM) ≥10kPa can be included in the VICIS study. In fact most patients will be recruited on the day of HVPG measurement for screening for clinically significant portal hypertension (CSPH) or on the day of upper GI endoscopy for screening for the presence of varices. Next to the detailled characterization of patient characteristics by epidemiologic, clinical and laboratory parameters, the degree of portal hypertension will be assessed by HVPG, liver stiffness will be assessed by transient elastography, the presence of ascites, splenomegaly, portosystemic collaterals, PVT and liver lesions will be assessed by ultrasound. In addition, the included patients will be asked to participate in biobank sampling including serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, stool, liver biopsies and stool. All patients recruited in the VICIS study will be prospectively followed every 3 months (decompenated ACLD) or every 6 months (compensated ACLD) patients with clinical visits at the Cirrhosis Outpatient Clinic at the Vienna General Hospital. These assessments include the recording of decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening for PVT and HCC, and recording of medications.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years and \<100 years
* Diagnosis of advanced chronic liver disease (by liver stiffness ≥10kPa, HVPG\>5mmHg or Histology F3/F4)
* Written informed consent

Exclusion Criteria:

* Withdrawal of written informed consent
Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

The purpose of this research study is to investigate the relationship between light, the thickness of the pigment at the back of your eye, melatonin levels, and memory. The study will investigate whether changing light distribution pattern from "on-axis"' (i.e., directed along the eye's visual axis to the fovea) to "off-axis" (i.e., directed on the periphery of the eye's visual axis) impact melatonin suppression in 24 mild cognitive impairment participants and 24 healthy, age-matched controls.

Eligible enrolled subjects will be exposed to 4 different lighting conditions in addition to one dark control condition. There will be 5 study session and each one will last for 90 minutes and will be separated by one week. Subjects will collect 3 saliva samples, each one 30 minutes apart for melatonin levels during each study session.

Eligibility Criteria:
Inclusion Criteria:

* mild cognitive impairment
* age matched healthy control
* macular pigment density either \< 0.3 or \> 0.5

Exclusion Criteria:

* extensive brain vascular disease
* Parkinson's disease
* bipolar disorder
* seasonal depression
* diabetes
* high blood pressure
* obstructing cataracts
* macular degeneration
* diabetic retinopathy
* use of melatonin supplements
* use of beta blockers
* use of sleep medications
* use of antidepressant medication
Treating Perfectionism Using Internet-Based Cognitive Behavior Therapy

Perfectionism is characterized by setting high standards and striving for achievement, sometimes at the expense of social relationships and wellbeing. Despite sometimes being viewed as a positive feature by others, people with perfectionism tend to be overly concerned about their performance and how they are being perceived by people around them. This tends to create inflexible standards, cognitive biases, and performance-related behaviors that maintain a belief that self-worth is linked to accomplishments. Cognitive behavior therapy has been shown to be a viable treatment for perfectionism, both in terms of reducing levels of perfectionism and improving psychiatric symptoms. Furthermore, a number of recent studies indicate that it can be successfully delivered via the Internet, both with regular support and guidance on demand from a therapist. In the present study protocol, a clinical trial for perfectionism is described and outlined. In total, 128 participants will be recruited and randomized to either a treatment that has already been demonstrated to have many benefits, Internet-based Cognitive Behavior Therapy for perfectionism (iCBT-P), or an active comparison condition, Internet-based Unified Protocol (iUP), targeting the emotions underlying depression and anxiety disorders. The results will be investigated with regard to self-reported outcomes of perfectionism, psychiatric symptoms, self-compassion, and quality of life, at post-treatment and at six- and 12-month follow-up. Both iCBT-P and iUP are expected to have positive effects, but the difference between conditions and adherence to respective treatment are currently unknown and will be explored. The clinical trial is believed to lead to a better understanding of how perfectionism can be treated, with the aim of providing efficacious treatments in an accessible format via the Internet.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years
* Adequate reading and writing levels in Swedish
* A computer, smartphone, or tablet with Internet access
* Elevated levels of perfectionism, as determined by a score of \>29 on the subscale Concerns over Mistakes on the Frost Multidimensional Perfectionism Scale

Exclusion Criteria:

* Diagnoses warranting immediate care, e.g., anorexia nervosa, substance abuse, bipolar disorder, psychosis, and schizophrenia
* Severe depression, as determined by a score of \>15 points on the Patient Health Questionnaire - 9 Items
* Suicidality, as determined by \>2 points on the item on suicidal ideation on the Patient Health Questionnaire - 9 Items
Role and Value of Inflammatory Markers in Brain Tumors : A Case Controlled Study

This study is a case controlled analytical study that analyzes the relationship between levels of inflammatory markers with the type of brain tumor. Samples of 35 people were then categorized according to the variables above and analyzing to measure its significance

This study is a case controlled analytical study to find the relationship between levels of inflammatory markers in patients with brain tumors. Samples were collected from patients at Haji Adam Malik Hospital in Medan, then the patient's blood serum was taken to be checked for these variables. Sample collection began in March - September 2020. The sample obtained was 35 people who met the inclusion and exclusion criteria.

Inclusion criteria:

1. Willing to be a sample
2. Complete medical records
3. Head scan and head contrast MRI have been performed to confirm the patient's diagnosis with a brain tumor

Exclusion criteria:

1. The patient's age is over 70 years
2. Patients with high comorbidities such as kidney failure, heart disease, diabetes, and others
3. Patients with a history of brain tumor surgery or previous brain tumor treatment

Samples were categorized based on demographic data (age and gender), then the samples were categorized based on the type of brain tumor suffered. Once categorized, the levels of inflammatory markers was examined. Specimens were taken from the patient's peripheral blood examination and analyzed in laboratorium. The results of these examinations are grouped on a nominal scale, and analyzed statistically.

Based on this analysis, it will be determined whether there is a significant relationship between levels of inflammatory markers in the incidence of brain tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to be a sample
2. Complete medical records
3. Head scan and head contrast MRI have been performed to confirm the patient's diagnosis with a brain tumor

Exclusion Criteria:

1. The patient's age is over 70 years
2. Patients with high comorbidities such as kidney failure, heart disease, diabetes, and others
3. Patients with a history of brain tumor surgery or previous brain tumor treatment
Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

To study the efficacy of everolimus combined with temozolomide as first-line treatment in advanced gastroenteropancreatic neuroendocrine carcinoma with a Ki67 of 20-55%, measured as disease control rate (non-progressive disease) at 6 months.

Guidelines for treating advanced gastroenteropancreatic neuroendocrine carcinomas (GEP-NECs) advocate the use of combination chemotherapy with a platinum-based chemotherapy combined with etoposide. No other regimen has consistently shown a benefit over this combination. NECs do not respond to treatments usually applied in other neuroendocrine tumours such as somatostatin analogues and interferon. In contrast to metastatic neuroendocrine tumours with a low Ki67, debulking surgery and surgery for liver metastasis is generally not recommended. Cisplatin /carboplatin and etoposide is established as standard treatment of advanced disease based on two small retrospective studies showing a response rate between 41- 67% and median survival of 15-19 months. In the current trial we propose an alternative treatment for a subgroup of patients with GEP-NEC based on new data, with the intention to improve response rates and clinical benefit rate without increasing toxicity

Eligibility Criteria:
Inclusion criteria

Histologically proven neuroendocrine carcinoma with a Ki67 of 20-55%.Primary gastroenteropancreatic tumor or cancer of unknown primary where metastases are mainly abdominalMeasurable disease according to RECIST by CT/MR

General conditions:

* \>18 years;
* WHO/ECOG performance status 0-1.
* Adequate haematological, renal and hepatic functions:
* Written informed consent prior to inclusion

Prior therapy:

* No prior chemotherapy treatment for advanced disease.
* Adjuvant chemotherapy must have ended \> 6 months before inclusion.

Prior or current history:

* No curatively resectable disease;
* No other serious illness or medical conditions (including: unstable angina, myocardial infarction within 6 months, unstable diabetes, immune suppression )

Concomitant treatments :

* No concomitant (or within 4 weeks before inclusion) administration of any other experimental drug;
* No other concurrent anti-cancer therapy.

Other :

* Not pregnant or breast feeding. Fertile patients must use adequate contraceptives and fertile females must have a negative pregnancy test.
The ATP Project (Antipsychotic-TEP-Psychosis)

The goal of this observational study is to the early impacts of psychosis and antipsychotic medications on brain metabolism in young adults recently diagnosed with a first episode of psychosis.

The main question aims to evaluate the effect of 4 to 6 weeks of antipsychotic medication on brain metabolism measured by PET scan (cerebral uptake of 11C-Acetoacetate + 18 Fluorodeoxyglucose).

Participants will undergo a multimodal imaging protocol with other measures of psychopathology (e.g., cognition, depressive symptoms, etc.) and (metabolic marker, inflammation, etc).


Eligibility Criteria:
Inclusion Criteria:

* Admission to the PEP clinic in Estrie, either outpatient or inpatient, according to the transdiagnostic PEP model.
* Willingness to begin taking an AP (regardless of type and dose, or change in type and dose during the study).
* Ability to read and express themselves in French or English.
* Capable of understanding and signing consent.

Exclusion Criteria:

* Pregnancy, childbirth in the last 6 months, or breastfeeding.
* Presence of a metallic object in the body that is incompatible with MRI.
* Any use of APs for more than 2 continuous weeks in the past year and/or 6 weeks in a lifetime (except for aripiprazole if taken at less than 2.5 mg/day or quetiapine at less than 50 mg/day, regardless of duration or timing of the prescription).
* The following comorbidities: psychosis + borderline or intellectual disability, autism spectrum disorder, substance use disorder with decompensation, psychosis induced by a medical condition, or psychosis induced by drug use or withdrawal.
* Type 1 diabetes.
* Uncontrolled acute suicidal ideation.
* Other conditions that could interfere with participation according to the judgment of the qualified physician.