cyrilzakka/clinical-trials huggingface dataset:
Psychological and Neurobiological Impact of a Retreat Based on Mindfulness and Compassion for Stress Reduction.

The study is aimed at comparing the differential effects of two widely used standardized meditation programs: Mindfulness-Based Stress Reduction (MBSR) and Compassion Cultivation Training (CCT) delivered in a retreat format with a cross-over design in a general population sample of healthy adults.

The main objective of the study is to evaluate the effects of two mindfulness-based intensive interventions: Mindfulness-Based Stress Reduction (MBSR) training or Compassion Cultivation Training (CCT), on psychological, physiological and epigenetic changes in a population of health volunteer adults. During a 7-day retreat participants will be randomised to two study arms: group 1 and 2, beginning either with a 3-day MBSR training or a 3-day CCT training. On the 4th day they will cross-over to the opposite intervention.

To address this goal, the effects will be measured by self-report questionnaires belonging to different domains (mindfulness, compassion, well-being, psychological distress, and psychological functioning), psychophysiological measures (EEG resting state, Diurnal cortisol slope, EKG and respiration patterns), epigenetic changes (DNA methylation biomarkers) and an objective stress task (Arithmetic Stress Test). Psychobiological outcome measures will be collected from both groups on day 1 (pre-intervention), on day 4 (post intervention and before beginning of the second intervention). The third assessment will be conducted on day 7 for both groups (post-second intervention). A 6-month follow-up assessment will be carried in both groups only for psychological questionnaires.

Data analysis will include change scores in psychological outcome measures as well as DNA methylation (by EPIC arrays) and gene expression (RNA-seq) measures.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult participants.

Exclusion Criteria:

* Current or past self-reported diagnosable serious or disabling mental disorder (in particular, PTSD, major depression, psychotic disorders, and/or Use of alcohol or drugs disorders).
* Presenting current health conditions that might affect the immune system (i.e. autoimmune disease, chronic severe infections, HIV, cancer) or past history of the same (less than 5 years from total recovery).
* Presenting current habits that might affect the immune system (i.e. smoking, alcoholism, substance abuse).
* Being under medical treatment that might affect the immune system response and inflammatory processes (i.e. corticoids).
* Travelling from a different time zone/long-travel times that might affect the immune system.
Early ECG Prediction of Multi-system Disease Cohort Establishment and Follow Up

This registered multicenter study aims to investigate the diagnostic efficacy of artificial intelligence-enhanced electrocardiography (AI-ECG) in detecting multi-system diseases. The research will utilize prospectively collected data from inpatient, emergency, and outpatient populations to develop ECG-based diagnostic, screening, and predictive models for multi-system diseases.

Recent advances in artificial intelligence (AI) have expanded the diagnostic capabilities of electrocardiography (ECG) beyond cardiovascular diseases. Emerging evidence demonstrates that AI-enhanced ECG analysis can provide valuable insights into age, gender, mortality risk, cardiac function, and systemic conditions such as electrolyte imbalances, renal dysfunction, and thyroid disorders. These findings position ECG as a promising tool for the identification and prediction of a broad spectrum of diseases.

To further investigate the underlying mechanisms linking ECG abnormalities with multi-system diseases and to develop ECG-based diagnostic, screening, and predictive models, we initiated a multi-center, prospective, observational registry study involving patients undergoing ECG examinations. The goals of the project are as follows:

1. AI-ECG Foundation Model Development

1. Diagnosis of traditional cardiovascular diseases (e.g., arrhythmias, myocardial infarction).
2. Screening of multi-system disorders, including: Circulatory, digestive, respiratory, and nervous system diseases, Endocrine/metabolic disorders, urogenital diseases, hematologic conditions, Neoplasms and mental health disorders.
3. Prediction of new-onset conditions (e.g., atrial fibrillation, heart failure, valvular diseases, NSTEMI, ventricular tachycardia) and 1-year mortality risk.

2. Clinical Utility \& Implementation

Leveraging the portability, cost-effectiveness, and non-invasiveness of ECG, our AI foundation model enables:

1. Rapid, large-scale screening in outpatient, inpatient, emergency, and community settings.
2. Early detection of multi-system diseases, guiding targeted diagnostic workups.

3. Mechanistic \& Interpretability Research Elucidating the diagnostic, predictive, and risk-stratification logic of AI-ECG foundation models.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who visited the study hospital.
2. Patients included should have both ECG data and discharge diagnosis codes (ICD-10) for inpatients and emergency patients.

Exclusion Criteria:

1. Patients who declined participation, cases with incomplete or missing clinical data, and pregnant individuals.
Virtual Reality and Its Use in Reducing Perioperative Stress in Cataract Surgery

This project is to evaluate the benefits of utilising virtual reality (VR) headsets with the aim of reducing peri-operative anxiety in cataract surgery and hence reducing the need for sedation in patients with significant stress levels noted during preassessment. This is a novel study, and with the increased use of VR technology throughout medicine, we may be able to offer our patients alternative management modalities to reduce stress and reduce need for medications with their subsequent potential side effects. It may also improve the quality of care provided and patients' experience with the cataract extraction procedure and might reduce the social care burden associated with standard sedation procedures. All patients will need to fill a quick preoperative anxiety and information scale questionnaire to assess their level of anxiety utilising The Amsterdam Preoperative Anxiety and Information Score.

Patients will be randomised into 2 groups:

1. Conventional group: patients will be prepared as per the standard routine clinical and further explanation of the procedure will be given. Before proceeding to the anaesthetic room, the patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out.
2. Interventional Group: patients will be prepared as per the standard routine clinical care; they will then be wearing the VR mask for 10 minutes. Before proceeding to the anaesthetic room, patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out.

Post operation, a record will be taken of the surgeon's decision on whether they want the second eye cataract surgery to be done under sedation (this is already standard practice at our centre). Finally, the patient will be asked to fill in one final grading score on whether they are happy with their decision to take/not take sedation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients listed for cataract surgery under local anaesthetic (topical or regional) with sedation planned.
2. First eye cataract procedures will only be included.
3. Capacity to give informed consent, cognitive and linguistic ability sufficient to understand and fill out questionnaire

Exclusion Criteria:

1. Epilepsy
2. severe vertigo
3. poor visual acuity (below 6/60 best corrected in the best seeing eye)
4. significant hearing impairment
5. recent facial injury/burn.
HMPL-453 in Advanced Malignant Mesothelioma

This is a phase II, single arm, multicenter and open-label study to evaluate the efficacy, safety and pharmacokinetic of HMPL-453 in patient with advanced Malignant Mesothelioma

Histologically confirmed patients with advanced malignant mesothelioma that who was failure of the first -line systemic therapy

Eligibility Criteria:
Inclusion Criteria:

* 1.Signed written informed consent;
* 2.18 years of age or older;
* 3.Histologically diagnosed malignant mesothelioma (including pleura, peritoneum, pericardium, and testicular tendon sheath origin, cell type epithelioid, sarcoma-like, or mixed type), and cannot be cured radically;
* 4.Received one to three regimen of prior systemic therapy and then experienced documented radiographic progression or intolerable toxicity;
* 5.Patients agreed to provide tumor tissue for FGF/FGFR testing;
* 6.Measurable disease by RECIST version 1.1 criteria;
* 7.ECOG performance status ≤ 2.;

Exclusion Criteria:

* 1.Previous treatment with any FGFR inhibitor;
* 2.Received systemic anti-cancer therapy within 3 weeks of the first dose of HMPL-453;
* 3.Major surgery within 4 weeks of the first dose of HMPL-453;
* 4.Use of a strong inducer or inhibitor of cytochrome P450 3A4 (CYP3A4) within 1 week of the first dose of HMPL-453;
* 5.Inadequate conditions as indicated by the following laboratory values:

  * Absolute neutrophil count (ANC)\<1.5 x 109/L
  * Hemoglobin \< 80 g/L
  * Platelet count \<80 x 109/L
* 6.Any of the following conditions of liver and kidney insufficiency:

  * Total bilirubin \> 1.5 x ULN
  * AST and ALT \> 2.5 x ULN (\> 5 x ULN for patients with liver metastases)
  * Creatinine clearance of \< 50 mL/min as estimated by the Cockcroft-Gault equation
* 7.International normalized ratio (INR) \>1.5 or activated partial thromboplastin time (aPTT) \>1.5 x ULN;
* 8.Clinical significant liver disease;
* 9.Known human immunodeficiency virus (HIV) infection
* 10.Previous history of retinal detachment;
* 11.Unable to swallow the study drug.
TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation

Serum Troponin levels pre- and postoperatively will be compared in patients receiving an entirely subcutaneous cardioverter-defibrillator.

To analyze the periprocedural myocardial damage the pre- and postoperative assessment of serum levels of high sensitive TroponinT (hsTnT) is done. The main objectives of the TROPIC register are to evaluate the level of high sensitive TroponinT before and after S-ICD device implantation and to compare these changes in TroponinT-levels with those after standard transvenous ICD-implantation.

Eligibility Criteria:
Inclusion Criteria:

* Indication for the implantation of an entirely subcutaneous cardioverter-defibrillator

Exclusion Criteria:

* None
4-step ASCOT in POI Women to Promote Follicular Rescue

To promote follicular development in POI women, G-CSF mobilized activated platelet rich plasma will be directly injected into the ovarian medulla.

This is a prospective, observational, multicentric, open, pilot-controlled randomized trial which seeks to evaluate the impact of the 4-step ASCOT technique on the ovarian reserve and reproductive outcomes of POI patients. The study will be developed in two phases.

In a first step, POI women will randomized to control or undergo the 4-step ASCOT technique based on the direct ovarian injection of G-CSF mobilized and activated PRP. Follow up (AFC, AMH, FSH and E2 determinations) will be developed for 3 month in the controls and for 6 months in the treated and COS initiated if growing antral follicles detected. In the second phase, POI women allocated to control group after completed the follow up period will undergo the 4-step ASCOT technique, as described in the previous phase but only one ovary will be injected, then they will undergo a 6-month follow up period as described above.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who meet the following will be considered eligible to participate in the clinical trial:

  1. Informed consent form dated and signed.
  2. Age between 18 and 38 (both inclusive)
  3. Women who meet the ESHRE criteria for POI \[41\]

     * presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months
     * biochemical confirmation as evidenced by an elevated FSH level \>25IU/L on two occasions \> 4 weeks apart
     * Or fluctuating POI when one of the above criteria is missing.

Exclusion Criteria:

* Subjects who meet one or more of the following will not be considered eligible to participate in the clinical trial:

  1. Simultaneous participation in another clinical study that, at the researcher's criteria, could interfere with the results of this study.
  2. Age ≥ 39
  3. Autoimmune origin of POI
  4. Genetic risk factors for POR (e.g. Turner Syndrome, FMR1 premutation, etc);
  5. Acquired conditions associated with POR (e.g. Chemotherapy);
  6. Clinical endometriosis
  7. Previous ovarian surgery considered as a risk of POR
  8. Previous gonadotoxic treatment
  9. Known intolerance or allergic reactions to components of the study product, i.e. lactose
Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Laparoscopic Sleeve Gastrectomy

Dexmedetomidine (Dex) activates the α2 adrenergic receptor that is present within the locus coeruleus, leading to anxiolysis, hypnosis, analgesia, and sedation.

We conducted our research to compare the effects of fentanyl and DEX on the postoperative analgesic profile and complications in morbidly obese patients after sleeve gastrectomy.

The participants were assigned to two groups of equal size (32 patients in each group) by the use of computer-generated numbers and sealed opaque envelopes. The participants allocated to the DEX group, also known as Group D, received an intravenous loading dose of DEX (1 μg/kg) over 15 minutes prior to the anesthetic induction. Following the intubation procedure, a maintenance infusion of DEX was delivered at a rate of 0.6 μg/kg/h. The infusion was discontinued upon trocars removal. The patients assigned to the fentanyl group (referred to as Group F) were administered fentanyl (1 μg/kg) that was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose. Following intubation, a continuous infusion of fentanyl was administered at a rate of 1μg/kg/hr. The infusion was discontinued upon the removal of the trocars.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) of 35 kg/m2 or more.
* American Society of Anesthesiology (ASA) physical status of II-III.
* all participants would have a laparoscopic sleeve gastrectomy (LSG).

Exclusion Criteria:

* allergy to α2 -adrenergic agonist.
* kidney, liver, neuromuscular disorders, and cardiac disease.
* or patients on opioid medications.
Adoptive Cell Therapy of Autologous TIL and PD1-TIL Cells for Patients With Glioblastoma Multiforme

At present, the investigators want to evaluate safety and efficacy of cell therapy based on Tumor-infiltrating T Lymphocyte (TIL）in glioblastoma. Here, we also constructed a transgenic modified TIL cells, stablely express a high-level full-length PD1 antibody (PD1-TIL cells), which can transduce signals to activate T cells and result in tumor killing. In this study, we design two group patients treated with TIL cells and PD1-TIL cells respectively to determine the safety and efficacy of autologous TILs or genetically modified TILs in patients with glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

1. Recurrent patients with histologically confirmed brain glioblastoma multiforme.
2. Patients with maximum safe resection of the tumor (≥95%) confirmed with contrast MR or CT within 72 hours after surgery.
3. Age from 18 to 70 years.
4. Karnofsky performance score ≥ 60.
5. Adequate organ function within 14 days of study registration including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count, (ANC) ≥ 1.0×10\^9/L, platelets ≥100×10\^9/L; hemoglobin ≥ 9 g/dL. Hepatic: bilirubin ≤1.3 mg/dL or 0-22 mmol/L, aspartate transaminase (AST) and alanine transaminase (ALT) \< 3×upper limit of normal (ULN). Renal: Normal serum Creatinine for age (below) or creatinine clearance \>60 ml/min/1.73 m2. Electrocardiogram: normal.
6. Written informed consent must be obtained from all patients.

Exclusion Criteria:

1. Pregnant or breast-feeding patients. Pregnancy testing will be performed on all menstruating females within 14 days of study enrollment.

   Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
2. Patients with history of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS, ongoing pregnancy, transplant immuno-suppression), or medication of cortisol.
3. Patients with any conditions that could potentially alter immune function (e.g., AIDS, multiple sclerosis, diabetes, renal failure).

Patients currently received any other investigational agents.

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High Flow Therapy for the Treatment of Respiratory Failure in the ED

The overall objective of this study is to determine if Vapotherm high flow nasal cannula therapy (HFT), when used to treat respiratory failure in the ED, is at least equivalent to the current standard of care for non-invasive ventilatory support, non-invasive positive pressure mask ventilation (NIPPV). Moreover, this study will investigate the potential that HFT has possible advantages over NIPPV, such as decreased time to patient stability from respiratory failure, and the ease of use as a first line intervention for respiratory failure in the ED environment.

The hypothesis is that HFT via the Vapotherm Precision Flow will demonstrate clinical non-inferiority when compared to NIPPV with regard to treatment failure by way of an impact on ventilation indices and a lower intolerance rate, and have a positive association with hospital disposition and length of stay.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 yrs of age)
* Presentation with acute respiratory failure according to the following criteria:
* If any of these are present: Respiratory Rate \>22 or labored; Suspected Acute Respiratory Acidosis, as defined as pH \<7.32 on initial blood gas(either arterial or venous); Hypoxemia, as defined as Pulse Ox \<92%;
* Clinical decision to escalate therapy to non-invasive ventilatory support, or to maintain non-invasive ventilatory support if delivered to the ED on such.

Exclusion Criteria:

* Suspected drug overdose
* Cardiovascular instability as demonstrated by hypotension relative to initial clinical presentation that requires immediate intervention
* End stage cancer
* Life expectancy \< 6 months
* Respiratory arrest or significant respiratory depression on presentation
* Glasgow Coma Scale score \< 9
* Cardiac arrest on initial presentation
* Need for emergent intubation
* Known or suspected cerebrovascular accident
* Known or suspected ST segment elevation myocardial infarction
* Patients with increased risk of pulmonary aspiration
* Agitation or uncooperativeness
Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients

The aim of the study is determining the prophylactic effect of ketorolac tromethamine drop 0.5% eye drop on the functional and anatomical ocular characteristics of the diabetic patients after the phacoemulsification surgery. Cystoid macular edema (CME) is a ocular disease which the retinal thickness is increased by 30 % incidence at least or the visual acuity is decreased to 20/40 according to clinical definition. Ketorolac tromethamine is an non steroidal anti inflammatory medication which is used for treatment and Prophylactic for CME. Teh aim of this study is prophylactic effect of ketorolac tromethamine on choroidal and retinal thickness after Phacoemulsification in Diabetic Patients. In this randomized clinical trial, 102 eyes of 102 diabetic patients were included. All patients were undergone phacoemulsification surgery at Torfeh Eye Hospital between September 2015 and January 2017. To evaluate the prophylactic effect of ketorolac tromethamine topical eye drop, all cases were asked to apply it one day before the s:surgery in each 8 hours and continue it for 4 weeks after the surgery. Controls were not received placebo. All study population were examined using Snellen visual acuity chart, enhanced depth imaging optical coherence tomography (EDI-OCT). All patients were followed at 6, 12 and 24 weeks after the cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients (type II) with cataract
* Eligible patients at age range of 20 to 95 years old

Exclusion Criteria:

* Cases with a diabetic macular edema
* proliferative diabetic retinopathy
* history of intravitreal injection of bevacizumab and macular photocoagulation prior three months to the cataract surgery
* glaucoma
* refractive errors of more than ±6 diopters
* history of previous ocular surgery
* ocular pathological disorders
* history of systemic diseases
* history of medications which have a side effect on the retinal thickness
* patients with a follow up of less than 6 months
* individuals with any intraoperative complications will be excluded from this study.
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis

The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic plaque psoriasis for at least 6 months before baseline
* Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)
* Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline
* Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment

Exclusion Criteria:

* Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study
* Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline
* Concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab, adalimumab, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; or any other biologic agent \<5 half-lives prior to baseline
* Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol
* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists
* Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study
* Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
* Have a known allergy or hypersensitivity to latex
* Have had any major surgery within 8 weeks of baseline or will require such during the study
* Have active or history of malignant disease within 5 years prior to baseline
* Significant uncontrolled disorder
* Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline
* Are women who are lactating or breast-feeding