cyrilzakka/clinical-trials huggingface dataset:
Standardisation of Investigations of Mild Bleeding Disorders

Observational study aimed at evaluating the clinical impact of a standardised diagnostic procedure for the investigation of patients with suspected mild bleeding disorder (MBD).

The working hypothesis of this prospective diagnostic study is that a standardised procedure in investigating patients with suspected MBD will lead to a better discrimination between patients with and without MBD and a more precise characterisation of MBD.

The primary objective of this diagnostic study is to evaluate the efficiency of a standardised procedure of MBD in children and adults referred to their respective outpatient clinics for bleeding symptoms. The following endpoints will be evaluated:

1. The relative number of precise diagnosis (according to recognised classification of haemostatic disorders) in each clinical probability category;
2. The number of biological tests performed per patient in each clinical probability category;
3. The relative number of patients with no specialised investigations in the low risk group.

The secondary objective is to evaluate the bleeding events during a one-year follow-up. Follow-up will be performed with a phone call one year after the last consultation of the patient. The definition of a bleeding event will be any bleeding that promotes any specific medical attention (consultation, hospitalisation, transfusion, re-intervention in case of surgery). The detailed clinical history regarding each event will be collected. Bleeding events will be correlated to the clinical probability assessed at inclusion.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged more than two years-old referred by their physician (gynaecologist, paediatrician, general practitioner, surgeon, etc.) for investigations of a possible bleeding tendency will be included in this study. This prospective study will include consecutive patients attending the four outpatient clinics (Division of Angiology and Haemostasis and Paediatric Onco-Haematology Unit, University Hospitals of Geneva).

Exclusion Criteria:

* Pregnant women will be excluded because of modifications of the known modifications of the haemostasis system during pregnancy. Adult patients without discernment capacity will be excluded.
Neuromuscular Ultrasonography Assessment of Optic Nerve in Systemic Lupus Eryhematosus

assessing the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients.

Evaluating the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients.by measuring the diameter of optic nerve at certain site and comparing it to healthy subjects measurements and to asses NMUS ability to detect optic neuropathy in lupus patients in comparison to conventional techniques including opthalmologist evaluation and visual evoked potential

Eligibility Criteria:
Inclusion Criteria:

* Adult
* group of SLE patients, who fulfilled Systemic Lupus International Collaborating Clinics classification criteria for SLE (SLICC) with or without symptoms of optic neuropathy
* another group of apparently healthy subjects with no. history of chronic conditions

Exclusion Criteria:

* Any patient with optic neuritis due to causes other than lupus was excluded from the study: ex.

  * Post traumatic neuropathy
  * Purely degenerative neuropathy
  * Diabetic neuropathy
  * Toxic neuropathy
  * Neuropathies related to infections
  * Drug induced neuropathy e.g: quinine and some antibiotics, ethambutol
  * Infections e.g. measles, mumps, Lyme disease, etc.
  * Other Autoimmune diseases like sarcoidosis, B.D
  * Tumor causing Inc. intracranial tension.
Dopamine in Neonate

The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of dopamine which is used as treatment of hypotension in neonate and preterm infant.


Eligibility Criteria:
Inclusion Criteria:

* Admitted at NICU in Seoul National University Hospital, Seoul Asan Hospital or Severance Hospital
* Infants who were diagnosed with hypotension

Exclusion Criteria:

* Congenital heart disease
* Chromosomal anomaly
* Treated with ECMO or CRRT
* Arrhythmia
* Hypovolemic state
ONO-4059 Study in Patients With Steroid-resistant Pemphigus

ONO-4059-10:Multicenter, placebo-controlled, randomized, double-blind, Phase 3 study in patients with steroid-resistant pemphigus


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of pemphigus
* Patients with a re-increase in the pemphigus disease area index (PDAI) score before oral corticosteroid tapering to 10mg/day of prednisolone (PSL) equivalent

Exclusion Criteria:

* Patients with an active infection
* Patients with malignancy
* Patients with past history of serious allergy or anaphylaxis
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma

A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults ≥ 18 years of age with a life expectancy ≥ 6 months;
* Karnofsky performance status ≥ 70%;
* Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma;
* Candidate for AHCT consolidation therapy as assessed by their treating physician;
* Achieved a complete or partial response;
* Completed collection of at least 2.0 x 10\^6 CD34 cells/kg of autologous hematopoietic progenitor cells (HPCs) by apheresis;
* Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to ≤ grade 2;
* Clinical laboratory and organ function criteria meeting study ranges/limits LVEF ≥ 50%; FEV1 \> 65% of predicted measurement, DLCO ≥ 50% of predicted;
* Seronegative for HIV Ag/Ab combo, HCV, active HBV, and syphilis

Exclusion Criteria:

* Prior high-dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation;
* Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records;
* Use of any other investigational medication or device, or concurrent biological, chemotherapy, or radiation therapy;
* Myelodysplasia or any active malignancy other than HL or NHL, or \< 5 years remission from any other prior malignancy;
* Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia;
* Persistent marrow involvement (\>10%) with HL or NHL after salvage cytoreductive therapy and before stem cell mobilization;
* Not having sufficient bone marrow harvest to reach adequate cell dose for transplant;
* Active hepatitis B or C viral infection or HBsAg positive;
* Positive HIV antibody;
Comparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol

The purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg and niacin 1500 mg in patients with hypertriglyceridemia and low HDL-cholesterol. The primary end point is the percent change of apoB/A1 and the secondary end points are other lipid parameters and biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Triglyceride 150-500 mg/dL and HDL-cholesterol \< 45 mg/dL after 8 week dietary run in period
* 20-79 years old

Exclusion Criteria:

* Low-density lipoprotein (LDL)-cholesterol ≥ 130 mg/dL without any lipid-modifying drug
* History of cerebrovascular or cardiovascular diseases
* Creatinine \> 2.0 mg/dL
* Transaminase \> 2x upper limit of normal
* Gall bladder disease
* Cancer
* Pregnant or breast feeding women
* History of adverse events associated with test drugs
The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer

Neoadjuvant immunotherapy can significantly improve the pathological complete response (pCR) and major pathological response (MPR) rates in resectable stage III non-small cell lung cancer (NSCLC), and extend the event-free survival (EFS). However, the current means for evaluating its efficacy are limited. This study aims to utilize the convenient and non-invasive 68Ga-grazytracer PET imaging to detect the aggregation of CD8+ T cells in target lesions after neoadjuvant immunotherapy for stage III NSCLC, and to assess its value in efficacy monitoring, providing valuable information for clinical treatment decisions.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with stage III NSCLC, after assessment according to clinical guidelines, require neoadjuvant immunotherapy;
2. Fully-informed written consent obtained from patients;
3. Patient ability to comply with protocol requirements;
4. Age 18-75 years;
5. Life expectancy of at least 6 months.

Exclusion Criteria:

1. Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;
2. Intestinal perforation, complete intestinal obstruction;
3. Patients with uncontrolled diabetes mellitus or a fasting blood glucose value of ≥11 mmol/L on the day of the test;
4. Pregnant women and women who are potentially pregnant, as well as nursing mothers;
5. Patients with poor compliance.
Assessment of Abuse Potential of Rapastinel in Humans

Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the abuse potential of single doses of rapastinel as compared with ketamine, a NMDAR antagonist that is a Schedule III dissociative anesthetic, and placebo in recreational polydrug users.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be a current recreational polydrug user
* Have a supine systolic blood pressure (BP) ≥ 95 mm Hg and ≤ 145 mg Hg, or supine diastolic BP ≥ 50 mm Hg and ≤ 90 mm Hg at the Screening Visit.
* Have negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, alcohol, oxycodone and other opioids, and phencyclidine at any admission
* Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits

Exclusion Criteria:

* Evidence of drug or alcohol dependence (excluding nicotine and caffeine) within the past 2 years
* Suicidal risk based on the opinion of the principal investigator (or appropriately trained designee)
* History of violent or psychotic behavior when taking psychedelic drugs, or unwilling to take a drug that might alter perception in a controlled setting
* Have taken or require concomitant treatment with any CNS depressants, or cannot safely discontinue these medications within 14 days (or 5 half-lives, whichever is longer) before study treatment administration
* Previously participated in an investigational study of rapastinel.
* Participation in any other clinical investigation using an experimental drug within 30 days, 5 half-lives or twice the duration of the biological effect of the study treatment (whichever is longer), prior to study treatment administration or is concurrently enrolled in any clinical trial, judged not to be scientifically or medically compatible with this study
* Consumption of alcohol within 72 hours before administration of study treatment
* Breastfeeding
* Unable to refrain from consuming caffeine or xanthine-containing compounds such as tea, coffee, soft drinks, energy sports drinks or chocolate (more than 48 oz/day) from 48 hours before administration of study treatment.
* Have consumed dietary supplements or other foods or beverages that may affect various drug metabolizing enzymes and transporters (eg, grapefruit, grapefruit juice, grapefruit-containing beverages), vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats within 14 days prior to dosing or unable to refrain from consumption during the study.
* The ability to tolerate IV ketamine as judged by the Investigator, based on available safety data, as well as pharmacodynamic data.
Prevention of Cisplatin-induced Nephrotoxicity

The research design is a prospective, randomized, controlled clinical trial in children to study effect of aminophylline in preserving renal function in oncologic patient received cisplatin either combined with other CMT or used alone. The participants in both groups will receive standard protocol pre-cisplatin infusion which include hydration with 5%DNSS/2 with KCL and MgSO4 IV infusion. In the treatment group, the participants will receive aminophylline infusion in the first 24 hours along with cisplatin, followed by oral aminophylline oral three times daily orally for 4 consecutive days post cisplatin. The aminophylline serum level will be maintained at the therapeutic range 10-20 mg. The side effect of aminophylline including nausea, vomiting and ECG will be monitored. The collected data including urine volume, GFR (estimated by cystatin C-creatinine based equation and by radiopharmaceutical-Tc DTPA), and renal tubular biomarker (urine B2 macroglobulin and urine NGAL) will be collected at baseline before receiving cisplatin, 24 hours and 5 days post cisplatin.


Eligibility Criteria:
Inclusion Criteria:

* Age under 18 years old
* Oncology patients who receive cisplatin-based therapy

Exclusion Criteria:

* Preexisting renal anomalies
* Preexisting GFR less than 60 ml/min/1.73 m2
* Contraindication of aminophylline including structural heart disease, arrhythmia, hyperthyroidism, chronic liver disease, epilepsy
* Aminophylline use within 24 hours prior to study entry
Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata

This study is a randomized, double-blind, placebo-controlled, multi-center, dose-ranging study to characterize the efficacy and safety of BNZ-1 administered by slow IV push weekly for 3 months to adults diagnosed with moderate to severe alopecia areata, defined as having a \>50% loss of terminal hair on the scalp. The study has three periods:

* 30-Day Screening Period
* 3-Month Treatment Period
* 3-Month Follow-up Period The study will be conducted at approximately 15-20 clinical sites in the United States.


Eligibility Criteria:
Inclusion Criteria:

1. Must have a diagnosis of moderate to severe AA defined as the presence of ≥50% total terminal hair loss at baseline as measured using the SALT score for \> 6 months, but \<10 yrs. Includes Alopecia Totalis and Alopecia Universalis
2. Patients may be naïve to treatment or have been treated with intralesional (IL) steroids or other treatments for AA, with a washout of at least 30 days or 5 times the elimination half-life prior to Day 1.
3. Prior treatment with a janus kinase (JAK) inhibitor (e.g., tofacitinib, ruxolitnib) is allowed, but patients considered refractory to a JAK inhibitor are excluded from this trial.

Exclusion Criteria:

e subjects from this study if any of the following criteria are met:

1. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator. Other active dermatologic conditions, including but not limited to vitiligo, atopic dermatitis, or non-scalp psoriasis are not exclusionary.
2. Patients with active inflammatory skin disease on the scalp, including but not limited to psoriasis, seborrheic dermatitis or folliculitis, which cannot be adequately controlled prior to screening.
3. Ongoing treatment with an immune system modulator or suppressant that cannot be discontinued prior to screening and at least 30 days or 5-times the elimination half-life prior to treatment.
4. Any ongoing topical treatment for alopecia areata
5. History of or currently active primary or secondary immunodeficiency.
6. Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including latent tuberculosis \[TB\] unless treatment is documented or atypical mycobacterial disease \[but excluding fungal infection of nail beds, minor upper respiratory tract infection, and minor skin conditions\]), or any major episode of infection that required hospitalization or treatment with IV antibiotics within 60 days of study drug administration or oral antibiotics within 30 days prior to study drug administration.
7. Received other investigational products or therapy in the 60 days prior to study drug administration.
Pericoronary Fat Attenuation Index and High-risk Plaque in Patients With Acute Coronary Syndrome

This study aimed to investigate the relationship between CCTA-based pericoronary inflammation and plaque features as well as local immune-inflammatory biomarkers in ACS patients. It is hypothesized that perivascular FAI might serve as a reliable sensor of coronary immune-inflammatory disorder, and closely related to the plaque vulnerability.

The pericoronary fat attenuation index (FAI), which capture by standard coronary computed tomography angiography (CCTA), has emerged as a novel imaging biomarker of coronary inflammation. This study aimed to assess whether increased Pericoronary FAI on CCTA are associated with high-risk plaque (HRP) feature as well as local T cell subsets and their intracellular cytokines levels in non-ST elevation acute coronary syndromes ( ACS) patients. 195 lesions in 130 non-ST elevation ACS patients were prospectively enrolled and evaluated by CCTA and coronary angiography in this study. Blood were taken from coronary artery immediately after the diagnostic angiogram. Local T cell subsets and their intracellular cytokines levels were detected by Flow Cytometry. CCTA and pericoronary FAI examinations were performed using a 320-detecor (Aquilion ONE, Toshiba Medical Systems, Otawara, Japan) Systems. Coronary plaque characteristics were analyzed cross each of the main coronary arteries using commercialized software package (Qangio CT, Medis, The Netherlands).

Eligibility Criteria:
Inclusion Criteria:

* non-ST-elevation ACS (non-ST-elevation myocardial infarction or unstable angina) age from 18 to 75 years which underwent CCTA were prospectively enrolled in this study.

Exclusion Criteria:

1. Patients needed an immediate (\<2 h) or early invasive strategy (\<24 h) according to guidelines were excluded: including those presented with haemodynamic instability or cardiogenic shock, life-threatening arrhythmia or cardiac arrest, mechanical complication, acute heart failure, dynamic ST or T wave changes, GRACE score \>140;
2. Subjects with previous history of coronary artery bypass graft surgery or PCI, immune system disorder, tumor, acute/chronic infection, atrial fibrillation, end-stage renal failure, iodine-containing contrast allergy were also excluded.
3. After CCTA performance, we also exclude patients with no significant (≥50%) stenosis on major epicardial vessels and those refused subsequent angiography.
4. Participants with total obstruction on major epicardial vessel, or insufficient image quality for FAI and QangioCT analysis, as well as lack of blood sample were excluded.
MMA Embolization for Refractory Chronic Migraine

This is a prospective, multi-center, feasibility study to investigate safety and effectiveness of TRUFILL n-BCA liquid embolic system in bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine.


Eligibility Criteria:
Participant Inclusion Criteria, Candidates for this study must meet ALL the following inclusion criteria:

1. Patient is between 18 and 65 years of age (inclusive) at the time of consent.
2. Age of onset of Chronic Migraine ≤ 64 years.
3. Age of onset of migraine diagnosis \< 50 years.
4. Patient has a current diagnosis of refractory migraine.
5. Patient has a current diagnosis of Chronic migraine.

Participant Exclusion Criteria, Candidates will be excluded from participation if ANY of the following apply:

1. Patients with a history for the last 2 years of other types of headache. 2. Patients with diagnosis of hemiplegic migraine or migrainous infarct. 5. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc.

6. Women who are pregnant, lactating, or who are of childbearing age. 7. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required.
SAVES-IBD: Safety & Efficacy of Aspirin vs. Standard of Care for VTE Prophylaxis After IBD Surgery

Aim to determine if aspirin 81 mg orally twice daily is effective and safe as an extended VTE chemoprophylaxis agent after major abdominal surgery for IBD patients. Study will perform an open label trial of aspirin for VTE prophylaxis compared standard of care.

Patients with inflammatory bowel disease who undergo abdominopelvic intestinal surgery are at increased risk for developing venous thromboembolism, in the form of deep vein thrombosis, pulmonary embolism and mesenteric vein thrombosis for 90-days after surgery. Despite being high-risk, the standard of care is to provide mechanical and chemoprophylaxis (unfractionated heparin or low molecular weight heparin) only while they are hospitalized. There exists randomized data, in patients who have had surgery for abdominopelvic cancer, confirming the efficacy of extended post-discharge chemoprophylaxis with either unfractionated heparin or low molecular weight heparin for 28 days after surgery, but no such data exists for IBD. There has been a resistance to adopting this for IBD patients due to compliance and cost of the daily injections. However, recently, a large, multicenter, randomized trial in \>3000 patients who underwent total hip or total knee replacement found that extended aspirin (81 mg) twice daily post-discharge was both equivalent and non-inferior to prophylaxis using full-strength anticoagulation with a factor Xa inhibitor. This is a prospective, multicenter, open label clinical trial to assess the safety and efficacy of post-operative venous thromboembolism (VTE) prophylaxis with aspirin 81 mg orally twice daily for 30-days after surgery for IBD compared with controls receiving standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18yrs
* Major abdominopelvic surgery with colon or rectal resection
* Preoperative diagnosis of Crohn's disease, ulcerative colitis, indeterminate colitis
* Elective surgery
* candidate for standard of care VTE prophylaxis

Exclusion Criteria:

* age \< 100 yrs
* aspirin allergy
* loop ileostomy closure
* emergency surgery
* peptic ulcer disease
* cirrhosis
* bleeding or clotting disorder
* thrombocytopenia
* chronic renal insufficiency or failure
* severe anemia \< 7 preoperatively
* need for therapeutic anticoagulation or anti-platelet agents post-operatively including aspirin, warfarin, heparin, clopidogrel, rivaroxaban, others
The Fine Motor Dexterity Under Dual Task in Parkinson's Disease

This study was planned to investigate the contribution of dual task interference on dexterity related ADL disability in patients with Parkinson's disease. We hypothesised that the dual task interference is an indicator of dexterity related ADL difficulties.

We planned this study as a cross sectional trial. 53 patients with Parkinson's disease will be evaluated under 2 different task by nine hole peg test. Besides this assessment the cardinal symptoms (bradykinesia, tremor, rigidity) will be evaluated to determine their contribution on the ADL performance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease according to the criteria of the United Kingdom brain Bank by neurologist
* Age 50-90 range
* having sufficient cognitive status according to the Mini Mental Status Evaluation (24 or above from the Mini Mental Test)

Exclusion Criteria:

* Having orthopedic and neurological disorders affecting hand function,
* Having sensory problems,
* Having Diabetus mellitus