cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure

This study assessed the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (60 mg) in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Systolic or diastolic heart failure, diagnosed with either NYHA functional class II to III at least 3 months prior to screening and on stable medication for at least 12 weeks.
* Patients must have met either of the criteria at screening:
* Documented left ventricular ejection fraction (LVEF) greater than 20% but lower than 40% OR
* Patients with a documented LVEF greater than 40% and with a history of NT-pro-BNP\> 400pg/mL (or BNP \> 100pg/mL) within 12 months of screening.

Exclusion Criteria:

* Treatment with Angiotensin Receptor Blockers (ARBs), aldosterone receptor antagonists and diuretics (other than furosemide) within 3 weeks of first dose and during the study. Beta blockers were permitted provided the dose was stable for at least 3 weeks before the first dose and remains so throughout the study.
* Hypertrophic cardiomyopathy (HCMP).
* If a subject is currently treated with furosemide, the dose must be stable for at least 3 weeks before the first dose and the dose must not exceed 60 mg daily
* Stable heart failure requiring treatment with both an ACE inhibitor and an ARB or Current acute decompensated heart failure.
* Mean sitting systolic blood pressure ≥160 mmHg and/or mean sitting diastolic blood pressure ≥ 100mmHg and/or secondary forms of hypertension.
* Persistent sitting systolic blood pressure \<90 mmHg.
* History of angioedema.

Other protocol-defined inclusion/exclusion criteria may apply
Short Term Outcomes of Primary Percutaneous Coronary Intervention (PCI) Patients Presented with Acute Heart Failure in Assuit University Heart Hospital

Observational study outcome of PCI in patients presented with acute heart failure


Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years
* acute heart failure
* PCI

Exclusion Criteria:

* NSTEMI
* end stage renal disease
Shortening Duration of Antiarrhythmic Medication for SVT in Infants

The infants diagnosed with SVT are treated with antiarrhythmic medication to prevent the recurrence of SVT. This prospective observational cohort study evaluates efficacy and safety of shortening duration of antiarrhythmic medication to four months in infants with SVT. Primary outcome is incidence of recurrent SVT in infants after 4 months of antiarrhythmic medication compared to retrospectively reviewed cohort.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 months or less
* Documented SVT due to AVRT or AVNRT

Exclusion Criteria:

* Age \> 6 months
* Ectopic atrial tachycardia
* Atrial flutter
* Atrial fibrillation
* Permanent junctional reciprocating tachycardia
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia

This study will help to elucidate the treatment sites in the extremities and pelvis for which MR-guided HIFU heating is feasible, which has the potential to be beneficial for patients with conditions at those sites (soft tissue sarcoma, cervical cancer, etc.). The investigators anticipate that successful completion of this study will lead to clinical trials in those feasible sites of interest to determine the safety and efficacy of administering therapeutic levels of heat for hyperthermia or other applications.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Willing and able to provide informed consent
* Patients only: must have a tumor in extremity muscle tissue or in the pelvis.

Exclusion Criteria:

* Contraindications for MRI (e.g., unsafe MRI implanted devices, shrapnel, history of metal fragments in eyes, neurostimulators, excessive size and weight, claustrophobia)
* Pregnant
Electronic Referral and Booking of Outpatient Day Case Surgery Compared With Traditional Referral Routines.

We want in this study to investigate the cost-effectiveness and waiting time of direct electronic referral and booking of outpatient surgery compared to the traditional patient pathway where the patient is seen at the outpatient clinic prior to surgery.

Waiting time from referral to day case outpatient surgery is unacceptable long. In Norway it is as much as 48 weeks for common conditions like gallstones, inguinal hernia and sinus pilonidalis. Electronic standardised referrals sent by the Norwegian Healthcare Network, and booking of surgery by the general practitioner might be a way to reduce the waiting time and increase the cost effectiveness of outpatient surgery.

The trial is designated as a randomized controlled trial were selected patients (inguinal hernia, gall stone disease and sinus pilonoidalis) referred to the university hospital, were either randomized to direct electronic referral and booking for outpatient surgery (one stop), or using the traditional patient pathway where all patients are seen at the outpatient clinic several weeks before surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if they were diagnosed by their GP for an inguinal hernia, sinus pilonidalis or gallstone disease which require surgical treatment.

Exclusion Criteria:

* Patients with medical conditions making them unfit for outpatient surgery admitted to the surgical department prior to surgery are not eligible
Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)

The purpose of the study is to find out if the plasma concentration of galantamine extended release is changed when BMS-708163 is administered at the same time.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and postmenopausal women

Exclusion Criteria:

* Gastrointestinal disorders
* Bleeding disorders
* Peptic ulcer disease
* Cholecystectomy
* Seizure disorder
* Asthma
* Chronic obstructive pulmonary disease
* Urinary tract obstruction
* Cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access
OMNI in Open-angle Glaucoma Treatment

This single-center, prospective study will assess safety and effectiveness of 360 degree viscodilation followed by up to 360 degree trabeculotomy used in patients with early or moderate open-angle glaucoma in a real-world setting either as a standalone procedure in pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures.

Medication usage, IOP and secondary surgical procedures necessary for IOP control will be analyzed during the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with open-angle glaucoma including pigmentary and pseudoexfoliative glaucoma
* 0-3 topical ocular hypotensive medications at preoperative baseline. Fixed combinations counted as number of components
* Open angles (Shaffer grade ≥3)
* early or moderate glaucoma (based on visual field)
* Subjects with a combined procedure should have had uncomplicated cataract surgery (i.e. intact and centered capsulorrhexis, intact posterior capsular bag, no evidence of zonular dehiscence or rupture, well centered IOL)

Exclusion Criteria:

* Any of the following prior treatments for glaucoma:

  * Suprachoroidal stent
  * Laser trabeculoplasty ≤6 months prior to OMNI procedure
  * Trabecular bypass implanted ≤6 months prior to OMNI procedure
  * Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve
  * Prior canaloplasty, goniotomy, or trabeculotomy
* Forms of glaucoma other than OAG including: acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
* Under treatment with oral carbonic anhydrase inhibitor at the preoperative visit
* Clinically significant ocular pathology, other than age-related cataract and glaucoma. (e.g. wet AMD, uveitis, corneal edema, proliferative diabetic retinopathy, optic neuritis in medical history)
Identification of Surrogate Blood And/or Urine Biomarker for Immulina TM (trademark) in Normal Humans

This is a pilot study for identifying plasma and/or urine-derived adherence/surrogate biomarker candidates for verifying Immulina™ ingestion by human volunteers (collected before and after consumption of Immulina™, a natural dietary supplement).

This pilot study is interventional, and all participants will receive one 800 mg dose of Immulina™ (four 200 mg capsules), a natural supplement, after a baseline blood and urine collection, then follow with 1 hour, 3 hour and 6 hour post-Immulina™ blood and urine collections. Samples will be sent to UM National Center for Natural Products Research (NCNPR) to analyze and compare timed blood and urine samples using gas chromatography and liquid chromatography to detect volatile and non-volatile compounds, gamma-linolenic acid (GLA), sulfoquinovose (SQ), 5'-methylsulfinyladenosine (MSA), palmitic acid, linoleic acid, palmitoleic acid and oleic acid to screen the chemical fingerprints of the human samples. The mean of the 7 biomarkers for the 4 time points will be measured and compared.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18-50 years old
* If female of childbearing potential, using acceptable means of birth control or postmenopausal for at least two years
* Healthy

Exclusion Criteria:

* pregnant or lactating females
* significant acute disease
* recurrent medications for chronic disease
Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.


Eligibility Criteria:
Inclusion Criteria:

1. Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met.
2. Subject has been previously treated for ADHD with an adequate course of amphetamine therapy with no history of intolerance, or lack of efficacy, as determined by the Investigator.
3. Subject does not have any physical disability (eg. colorblindness, limitations with use of one or both hands, etc) that would interfere with the subject's participation in or performance on any of the neuropsychometric tests. For a number of these tasks speed is a key factor thus subjects cannot have any obvious impediments/impairments in the use of their hands.
A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma

To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followed by electroporation.

Eligible subjects will receive intratumoral injections of VCL-IM01 followed by electroporation of the injected tumor(s).

Subjects will be enrolled to receive one course of treatment. A course of treatment is two cycles, each cycle consisting of four weekly injection/electroporation administrations followed by an observation period of two weeks.

Subjects' tumors will be evaluated at Screening, at the end of Cycle 2, and at six months (Week 26) from the initial drug administration.

Eligibility Criteria:
Inclusion Criteria - Key criteria include:

* Confirmed recurrent metastatic melanoma
* Tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment
* Able to carry out normal daily activities and light work without assistance
* Not currently receiving chemotherapy or immunotherapy
* Normal blood chemistries and blood cell counts (elevation of LDH to less than or equal to 1.5 times normal is allowed)
* Able and willing to give informed consent.

Exclusion Criteria - Key criteria include:

* History of brain tumors (resected or stereotactically treated is allowed)
* History of liver tumors
* Subjects whose melanoma can be cured by surgery
* Pregnant
* Subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.
Identification of Serum Level of Glutathione Peroxidase 4

* Analysis of the level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients.
* The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.

Ferroptosis, first reported by Dixon et al. in 2012, is a form of non-apoptotic cell death driven by iron-dependent lipid reactive oxygen species (ROS) and accelerated by the accumulation of lipid peroxides, ultimately leading to oxidative damage to phospholipid membranes and cell death .

Ferroptosis could be induced by iron metabolism disorder, lipid peroxidation accumulation, deficiency of glutathione (GSH) and inactivation of the antioxidant enzyme glutathione peroxidase 4 (GPX4).

The morphological features of ferroptotic cells manifest as an aberrant mitochondrial ultrastructure, including a reduction in mitochondrial volume, an increase in mitochondrial membrane density, and the disappearance of mitochondrial cristae in ferroptotic cells .

Recent studies have increasingly reported on complex associations between ferroptosis and the immune system . The regulatory activity of ferroptosis in immune function and inflammation is multifaceted and involves innate, acquired, and autoimmunity.

Accumulating evidence in recent times has shown an association of ferroptosis with the pathogenesis and development of autoimmune diseases .

Spondyloarthropathy comprises a group of chronic inflammatory rheumatic diseases, including ankylosing spondylitis, reactive arthritis (Reiter syndrome), arthritis or spondylitis associated with inflammatory bowel disease, and psoriatic arthritis, as well as undifferentiated spondyloarthritis. These afflictions predominantly affect the axial skeleton, causing pain and stiffness.

Currently, research on ferroptosis is still in its early stages; therefore, exploring the pathogenesis of ferroptosis and its role in various diseases, and proposing effective and targeted treatment methods have significant theoretical significance and practical value.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as ankylosing spondylitis according to ASAS criteria . \[13\]
* Patients diagnosed as psoriatic arthritis according to CASPAR criteria. \[14\]
* Age (\>18).

Exclusion Criteria:

* Patient with other autoimmune Rheumatic diseases.
* patients with any of the following conditions: I) severe liver and kidney dysfunction; II) hematopoietic diseases; III) infectious diseases; IV) tumors; or V) other wasting diseases. \[15\]
* patients received certain drugs (for example, sulfasalazine, artemisinin, statins), and experimental reagents (such as erastin) .\[16\]
Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC

Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 70 or over
* SIOG group 2 (vulnerable)
* Life expectancy \> 12 weeks
* PS \< 2
* Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary).
* First line treatment
* At least one measurable lesion (RECIST)
* Stage II to IV
* Patients unsuitable for surgery of the primary tumour: non resectable tumor, anesthesia contra indication, patient's refusal, or organ sparing approach. Cervical nodes dissection authorized
* Patients planned to be treated in a curative intent with radiotherapy alone on primary tumor site and on at least one head and neck node area
* Consent form signed

Exclusion Criteria:

* Primary squamous cell carcinoma of sinus, the skin or of the salivary glands
* Stage I cancer
* Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy
* Prior radiotherapy of head and neck area
* Concurrent chemotherapy or immunotherapy or hormonotherapy
* Induction chemotherapy
* Concomitant infection requiring IV antibiotics
* cancer other than head and neck cancer within the previous 5 years (baso cellular skin carcinoma and cervix carcinoma excepted)
* conditions that could lead to bad compliance
Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries

The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational study to characterize patients with CDI as well as to understand treatment and management of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for CDT or toxigenic C. difficile, or colonoscopic findings of PMC
* Patients and/or legal guardian willing to provide informed consent and/or informed assent or data release, according to local regulations

Exclusion Criteria:

* Patients with diarrheal symptoms caused by bacteria other than C. difficile, such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli.
Tissue Perfusion and Blood Flow Monitoring Technology

The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. The hypothesis is that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.


Eligibility Criteria:
Inclusion Criteria

* Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements:

  * neuropathic diabetic foot ulcer
  * soft tissue radiation necrosis
  * crush injury
  * compromised/failed skin grafts and flaps
* Subjects must have signed the Informed Consent Forms.

Exclusion Criteria

* Subjects who are not candidates for HBO therapy for any reason, including but not limited to: untreated pneumothorax, uncontrolled congestive heart failure, seizure disorder, neoplastic tumors, claustrophobia (for those in the HBO Group).
* Female subjects who are pregnant or nursing.
* Anyone who is unable to give written informed consent.
* Subjects with end-stage renal disease or who require peritoneal or hemodialysis.
* Subjects with current malignancies.
Evaluation of Characteristics of Patients With Nonsurgical Complications After Bariatric Surgery and Quality of Life

Retrospective study: Analysis of characteristics of patients that were hospitalised with nonsurgical complications after bariatric surgery.

Cross-sectional study: To present and evaluate (clinical) parameters and quality of life measures of patients with nonsurgical complications after bariatric surgery compared to bariatric patients without hospitalisation for complications and obese patients.

Retrospective study: The general objective is to describe and evaluate the characteristics of patients with nonsurgical complications after bariatric surgery based on parameters registered in the medical record.

Cross-sectional study:

1. Primary objective: To evaluate how quality of life is perceived in patients hospitalised for nonsurgical complications after bariatric surgery compared to control groups through Health-related Quality of Life (HRQoL) questionnaires.
2. Secondary objectives: To evaluate and compare (clinical) parameters and scoring on questionnaires about impact of weight, physical activity, anxiety and depression, impulsivity, alcohol use and eating behaviour for different bariatric and obese populations.

Eligibility Criteria:
CROSS-SECTIONAL STUDY

Patients hospitalised with non-surgical complications of bariatric surgery

* Inclusion Criteria:

  * Signed informed consent
  * Patients underwent bariatric surgery
  * Patients are hospitalised for nonsurgical complications of bariatric surgery at the Endocrinology unit of UZ Leuven
* Exclusion Criteria:

  * Patients are not able to complete the questionnaires themselves
  * Patients who do not understand Dutch

Patients with bariatric surgery who were never hospitalised with non-surgical complications

* Inclusion Criteria:

  * Signed informed consent
  * Patients underwent bariatric surgery
  * Patients without history of hospitalisation for nonsurgical complications of bariatric surgery
* Exclusion Criteria:

  * Patients are not able to complete the questionnaires themselves
  * Patients who do not understand Dutch

Patients with obesity

* Inclusion Criteria:

  * Signed informed consent
  * Patients visit the Obesity Clinic of UZ Leuven
* Exclusion Criteria:

  * Patients are not able to complete the questionnaires themselves
  * Patients who do not understand Dutch
Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

Purpose The aim of this study was to analyze the microbiota of patients undergoing LSG or LRYGB on three levels of gastrointestinal tract, using oral swab and stool sample. We compared samples from patients achieving favorable outcomes in terms of weight-loss with patients, who did not respond optimally to the bariatric operation.

Materials and methods Design This prospective cohort study was conducted in one academic, teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI) ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2 .

Analysis and endpoints Primary endpoint was to determine the difference in microbiota present in oral cavity and large intestine between patients ing Group 1 and Group 2. Secondary endpoint was to compare the results of microbiota analysis between LSG and LRYGB.


Eligibility Criteria:
Inclusion Criteria:

* informed consent to participate in the study, meeting the eligibility criteria for bariatric treatment, either for LSG or LRYGB.

Exclusion Criteria:

* type 1 or type 2 diabetes, treatment with antibiotics within 30 days prior to gathering microbiological material, treatment with probiotics within 30 days prior to gathering microbiological material, gastrointestinal infections, inflammatory bowel disease, thyroid diseases, cancer (especially the digestive tract), immunodeficiency.