cyrilzakka/clinical-trials huggingface dataset:
Anticardiolipin Autoantibodies and Mortality in Septic Patients

The detection of antiphospholipid antibodies (aPL) is of interest because of their importance in the pathogenesis of arterial or venous thrombosis and their responsibility for a wide spectrum of clinical manifestations such as infection. The aim of the study was to assess the performance of antiphospholipid antibodies biomarker to predict in- hospital mortality in intensive care unit (ICU) septic patient's.

the investigators conducted a prospective single-center observational study including consecutive critically ill septic adults admitted to the intensive care unit. Clinical and laboratory data including chemiluminescence immunoassay for antiphospholipid antibodies \[anticardiolipin (aCL), antiphosphatidylserine (aPS)\] were obtained. Blood samples were collected on days 1, 3, 5, 8 and 10 of hospitalization. The primary study endpoint was ICU mortality defined as death before ICU discharge. Secondary end points included correlation between SOFA score and biological parameters.

Eligibility Criteria:
Inclusion Criteria:

* patients, admitted to the ICU for sepsis and older than 18 years

Exclusion Criteria:

* pregnancy
* clinical history of antiphospholipid syndrome
* auto-immune diseases
* immunosuppressive treatment
A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m ²)
* Are either

  * individuals ≥40 years of age with established cardiovascular disease (CVD).

    * CVD is defined as meeting at least one of the following:

      * Coronary artery disease
      * Cerebrovascular disease
    * Peripheral arterial disease OR
    * individuals without established CVD but have the presence of cardiovascular (CV) risk factors (primary prevention)
    * women 55-69 years of age or men 50-64 years of age with at least 3 risk factors like tobacco use, dyslipidemia, hypertension at screening, or

      * women ≥70 years of age or men, ≥65 years of age with at least 2 risk factors at screening.

Exclusion Criteria:

* Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma
* Have laboratory evidence diagnostic of diabetes mellitus at screening of HbA1c ≥6.5% (≥48 millimole/mole (mmol/mol) or fasting glucose (FG) ≥126 milligram/deciliter (≥7.0 millimole/liter (mmol/L).
* Any one of the following CV conditions within 90 days prior to screening

  * MI
  * acute coronary syndrome
  * stroke
  * coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization, or
  * acute decompensated heart failure
* Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures.
* Have a history of chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
* Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements, determined by the central laboratory at screening
* Have a presence or history of malignant neoplasms within the past 5 years prior to screening.
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 75 years (at screening for Cohort 1 and 2)
* UC confirmed on endoscopy
* Moderately to severely active UC (May score 6-12)
* Currently receiving treatment with aminosalisylate, prednisone, or budesonide
* Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

Exclusion Criteria:

* Have severe extensive colitis as evidence by:
* Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
* Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
* Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
* Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
* History of uveitis or unknown macular edema
* Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening
The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension

We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in patients with essential hypertension - during baseline conditions and after activation of the sympathetic nervous system.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years.
* Body mass index less or equal to 30 kg/m2.
* Women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal.
* Arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmHg systolic or above 80 mmHg diastolic.

Exclusion Criteria:

* History of myocardial infarction.
* History of stroke.
* Heart failure.
* Endocrine organ disease.
* Lung disease.
* Clinically significant abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine (under 200 µmol/L will be accepted), P-albumin, p-bilirubin, p-alaninaminotransferase, P-alkaline phosphatase, p-cholesterol and B-glucose.
* Clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/L will be accepted).
* Renovascular hypertension.
* Malignant disease.
* Alcohol abuse.
* Usage of medical drugs besides antihypertensives or statins.
* Drug abuse.
* Pregnancy or breast feeding.
* Known intolerance or allergic to eprosartan or sodium nitroprusside.
* Blood donation within 1 month of the start of the study.
Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.

The primary objective of this study is to analyse the concentration dopamine and serotonin in thrombocytes of patients with renal cell carcinoma and neuro-endocrine tumours compared to the concentrations of these catecholamines in healthy volunteers. The concentration dopamine and serotonin in thrombocytes with and without medication will also be evaluated.

* To analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and low grade neuroendocrine tumours.
* To compare these concentrations with the concentrations catecholamines in thrombocytes of healthy controls.
* To analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and patients with low grade neuroendocrine tumours with and without medication.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or older.
* Patients with clear cell renal cell carcinoma with metastases or patients with a low-grade neuro-endocrine tumor with metastases.
* Written informed consent

Exclusion Criteria:

* Use of L-dopa or SSRI.
* Patients with a second primary malignancy.
The Effects of Exercise in Anxiety in Children With ASD

This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism.

This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism. Local special autism schools and primary and secondary schools with specialised classes for children with autism will be approached to participate in the project. The age profile of the children will be 4-18 yrs of age and they will have mild-severe levels of autism. The exercise programme will delivered 3 times per week in the schools over periods of 8-16 weeks dependent on the severity of autism within the children.

Questionnaires will be given to the parents and teachers of the children at the beginning and at the end of the programme to assess changes in anxiety levels and behaviour as a result of the exercise programme.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism spectrum disorder

Exclusion Criteria:

* Any medical condition which excludes the child from partaking in exercise
Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15 mg)

The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control pseudovitelliform detachment.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of patients with pseudovitellium detachment.
2. Patients must be at least 18 years of age.
3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
4. Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart

Exclusion Criteria:

1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
2. Patients who have undergone intraocular surgery within the last 2 months.
3. Patient participating in any other investigational drug study.
4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
5. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).
6. Patient with significant liver disease or uremia.
7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study
9. Patient has had insertion of scleral buckle in the study eye
10. Patient has received radiation treatment
11. Patient is on anticoagulant therapy with the exception of aspirin
12. Patient is pregnant or nursing.
Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

The purpose of the study is to examine the feasibility and acceptability of an exercise and nutrition "prehabilitation" program for patients preparing for pancreatic cancer resection (removal).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Biopsy-proven pancreatic ductal adenocarcinoma (PDAC), borderline resectable at diagnosis
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Undergoing neoadjuvant chemotherapy with treatment plan including chemoradiation therapy and surgical resection
* Ability to read and speak English

Exclusion Criteria:

* Regular engagement in RT (2x/week targeting all major muscle groups)
* Screen failure for exercise safety based on PAR-Q
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
* Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT
* Numeric pain rating scale greater than or equal to a 7 out of 10
* Myopathic or rheumatologic disease that impacts physical function
TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC

The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

For patients with hepatocellular carcinoma staged BCLC B/C(intermediate hepatocellular carcinoma)，TACE is a widely used treatments .However ,The efficacy of TACE in intermediate hepatocellular carcinoma is not very satisfactory.A series of study demonstrated that direct hepatectomy has better prognosis compared with TACE for these intermediate hepatocellular carcinoma patients.Despite of this ,The high recurrence risk, high probability of surgical complications, and poor treatment effect after recurrence of intermediate hepatocellular carcinoma after direct surgical treatment is a still a tough problem to be solved.Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver .In addition, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma.In this context，for those patients with potentially high recurrence risk after liver resection, the investigators carried out this prospective randomized control to demonstrate the superiority of TACE/HAIC combined with PD-1 antibody and lenvatinib as a neoadjuvant therapy before liver resection over direct hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age 18-70 years old, gender is not limited.
* 2)The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
* 3)Patients must have at least one tumor lesion that can be accurately measured.
* 4)Conform to any of the following criteria (1) multiple nodules \>3; (2) ≥2 nodules, any of which is \>3 cm; (3) invasion of the portal vein or hepatic vein.
* 5)According to the 2022 edition of the Chinese guidelines for the diagnosis and treatment of primary liver cancer, one-stage liver cancer resection is feasible after evaluation by the liver cancer surgery expert group
* 6)No previous anti-HCC treatment.
* 7)Eastern Co-operative Group performance status 2 or less.
* 8)Liver function: Child's A or B (score \< 7).

Exclusion Criteria:

* 1)Patients with definite tumor thrombus and distant metastasis in the main portal vein and inferior vena cava;
* 2) Allergy to the components of intervention-related drugs such as lipiodol and chemotherapeutic drugs;
* 3) Local treatment (including intervention, surgery, ablation, etc.) and systemic treatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) for liver cancer within the past 2 months
Antipsychotic Response in Schizophrenia

Motor slowing is a hallmark, clinical sign in mental illness. Slowness can be related to a specific disease process, as in negative schizophrenia or depression or it can be the result of medications used to treat forms of mental illness. Prior research has lead to a novel instrumental approach for distinguishing subtypes of motor slowing - one type related to cognitive processes and another related to parkinsonism. The purpose of this study is to test whether new medications used to treat schizophrenia improve the cognitive or parkinsonian components of motor slowing. Patients will be studied in the laboratory before and 8-weeks after starting a new antipsychotic. The n of this study = 60 patients. The results of this study will improve our understanding of the complex interactions between cognitive processing and motor behavior in patients with psychotic illnesses and how drugs work to treat these problems.


Eligibility Criteria:
Schizophrenia diagnosis currently treated with conventional antipsychotic willing to be switched to an atypical antipsychotic.
68Ga-AAZTA-093 PET/CT: First-in-human Study

68Ga-AAZTA-093 is a novel radiotracer targeting prostate-specific membrane antigen (PSMA). In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT in patients with prostate cancer.

Prostate cancer (PCa) is one of the most common malignancies worldwide in men. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga- or 177Lu- labeling have been developed. 68Ga-AAZTA-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the AAZTA chelator for labeling with 68Ga(III). This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT and compared with 68Ga-PSMA-11 and 68Ga-PSMA-617 PET/CT in the same group of prostate cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* confirmed treated or untreated prostate cancer patients;
* 68Ga-AAZTA-093 and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT within 1 week;
* signed written consent.

Exclusion Criteria:

* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women

Aim: This study aims to identify the effectiveness of an exercise program in reducing the severity of postnatal depression in women who had a spontaneous vaginal delivery.

Methods: This randomized control trial was conducted with 65 postpartum women residing in a city located in the south-eastern Turkey. In the first postpartum month, following random assignment of subjects, the experimental group (n=40) performed exercises for four weeks, and the control group (n=40) received standard cares. The participating women were administered the Edinburgh Postpartum Depression Scale.

Postpartum depression is characterized by irritability, guilt, burnout, anxiety, sleep disorders, and somatic symptoms that could have negative effects on the mother, baby, and family.

In a meta-analysis study including 219 prevalence studies from 56 countries that investigated different phases of postpartum using various data collection tools, Hahn-Holbrook et al. (2018) found the depression prevalence at the global level as 17.7% (Hahn-Holbrook, 2018). In Turkey, 23.8% of women in the postpartum period were reported to be suffering from postpartum depression, which underlines the need for health professionals to be concerned about the health of the women in the postpartum period.

Exercises done in the postpartum period are reported to enable psychosocial well-being, less anxiety and depression, better cardiovascular adaptation, body fat/weight control, less bone loss caused by lactation, and less stress incontinence. Studies have generally indicated the importance of regular exercise in the postpartum period. Studies have generally indicated the importance of regular exercise in the postpartum period.

Eligibility Criteria:
Inclusion Criteria:

1. must be score of 13 and over in the Edinburgh Postpartum Depression Scale (EPDS),
2. must being between 19 and 40 years old,
3. must had a spontaneous vaginal delivery between the 38th and 42nd weeks of pregnancy,
4. must had a healthy newborn baby with 2500 gr and over

Exclusion Criteria:

1. postpartum obstetric complications
2. psychiatric disease history before or during pregnancy
Impact of High-flow Nasal Oxygen During Awake Fiberoptic Bronchoscope Guided Intubation: A Retrospective Study

Retrospective data collection. The aim of this study is to investigate impact of high-flow nasal oxygen on safety(lowest oxygen saturation), efficiency (intubation time, need for multiple attempts) in patients underwent awake fiberoptic bronchoscope guided intubation.


Eligibility Criteria:
Inclusion Criteria:

1.Patients who underwent awake fiberoptic bronchoscope guided intubation for surgery

Exclusion Criteria:

1. Cases in which other procedures (e.g. arterial line cannulation) were performed prior to endotracheal intubation after entering operation room
2. Patients with Incomplete records of oxygen saturation, attempt number, and time taken for awake intubation
Real World Data Collection on the Synergy Cervical Disc

This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with degenerative cervical disc disease.


Eligibility Criteria:
Inclusion Criteria:

1. Over the age of 21 at the time of the surgery.
2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted
3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: herniated disc and/or osteophyte formation
5. Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.)
6. Failed a minimum of 6 weeks conservative treatment
7. Written informed consent given by subject, as applicable.

Exclusion Criteria:

1. Moderate to advanced spondylosis
2. Diagnosis of osteoporosis
3. Active systemic infection or infection at the operative site
4. Pregnancy
5. Marked cervical instability on lateral, coronal, or flexion/extension radiographs
6. Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level
7. Severe pathology of the facet joints of the involved vertebral bodies
8. Previous diagnosis of osteopenia or osteomalacia
9. More than one immobile vertebral level between C1 and T1 from any cause
10. Morbid obesity
11. Currently a prisoner