cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia

Assessed the efficacy of deferasirox in patients with non-transfusion dependent thalassemia based on change in liver iron concentration from baseline after 52 weeks of treatment. Provided further assessment of the long-term efficacy and safety of deferasirox in NTDT patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260 weeks.


Eligibility Criteria:
Inclusion Criteria:

Non-transfusion dependent congenital or chronic anemia inclusive of beta-thalassemia intermedia, HbE beta-thalassemia or alpha-thalassemia intermedia (HbH disease)/ Liver iron concentration \>/= 5 mg Fe/g dw Serum Ferritin \>/= 300 ng/mL

Exclusion Criteria:

HbS-beta Thalassemia, anticipated regular transfusion program during the study, blood transfusion 6 months prior to study start, significant proteinuria, creatinine clearance \</= 40 ml/min, serum creatinine \> ULN, ALT \>5 x ULN, active hepatitis B or C, cirrhosis

Pediatrics Only:

A patient's weight of at least 20 kg is required to allow dosing of 5 mg/kg with one tablet of 125 mg
Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device

The purpose of this study is to compare the diagnosis accuracy of 22G EUS Procore fine needle biopsy （FNB）device and 20G EUS Procore fine needle biopsy device for solid pancreatic lesions.

This is a single-blind, randomized, controlled trial. One thousand two hundred and twenty four patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to 4 arms. For arm A1 which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is slow pull(SP)-modified wet suction technique(MWST)-slow pull(SP)-modified wet suction technique(MWST). For arm A2 with 22G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. For arm B1 with 20G EUS Procore fine needle biopsy device, the pass sequence is SP-MWST-SP-MWST. For arm B2 with 20G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. All procedures will be performed by experienced echoendoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years old,\<85 years old;
2. Gender: Male or Female;
3. Presence solid occupying pancreatic lesions (the diameter\>1cm);
4. Must be able to receive examinations in the research center;
5. Must be able to sign the informed consent.

Exclusion Criteria:

1. Hemoglobin≤8.0 g/dl;
2. Pregnant women;
3. Coagulation disorders;
4. Took anticoagulants such as aspirin, warfarin in the latest week;
5. Acute pancreatitis in the past two weeks;
6. Cardiopulmonary dysfunction;
7. Cannot sign the informed consent
Beauty Image Efficacy Study

The objective is to evaluate the effects of oral supplement of a blend containing collagen peptides, phosphatidylserine, Saussurea involucrata and lutein (Beauty Image) on the improvement of skin aging in terms of hydration, gloss, melanin content, roughness and wrinkling, and anti-UV performance.


Eligibility Criteria:
Inclusion Criteria:

* Facial skin with problems of dull, uneven, inelastic, dryness and wrinkle/fine line (At least fit to two problems)
* In general good health and good mental state;
* Willing to read, understand and able to sign the Informed Consent Form;
* Willing to comply with all study protocol requirements.

Exclusion Criteria:

* Intention to become pregnant, pregnant, lactating or within 6 months of delivery;
* Participation in any clinical test or cosmetic product test on skin within 30 days;
* Existence of neurodermatitis, pityriasis, seborrheic dermatitis or psoriasis capitis on test area;
* Use of any anti-inflammatory drugs in the past 2 months;
* A history of skin diseases such as psoriasis, eczema, psoriasis, skin cancer, etc.;
* IDDM: Insulin dependent diabetic patients;
* Current treatment for asthma or other chronic respiratory diseases;
* Undergoing anticancer chemotherapy in the past 6 months;
* Existence of any other health problems or chronic diseases;
* Use of retinoids, alpha hydroxyl acid, ortho-hydroxybenzoic acid, hydroquinone nearly within 3 months; or use of prescriptions (such as antibiotics, retinoids, alpha hydroxyl acid or steroids), oral contraceptives (Use of same contraceptives for 6 months excepted);
* Existence of the following conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, diabetes, vascular disease, hepatitis, eczema, psoriasis.
Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors

The purpose of this study is to evaluate low oxygen areas called hypoxia within the tumor. These low oxygen areas are thought to be the reason why tumors are more resistant to radiation treatment. A tracer is an extremely small quantity of a substance. Tracer to which radioactivity has been attached may be used to "trace" events in the body. A tracer called iodo-azomycin galactopyranoside (or \*IAZGP) appears to be able to detect low oxygen areas within tumor.

Radioactive iodine in this molecule can be detected by an imaging technique called a PET scan. This present study involves obtaining three scans using this new imaging technique. The goal of carrying out many scans is to determine which scan will best show any areas in your tumor that may have low levels of oxygen.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have locally advanced cancer as determined by currently accepted diagnostic work-up, including CT/MR/US.
* KPS \>70%.
* Patients must be \> or equal to 18 years of age.

Exclusion Criteria:

* Patients will be excluded from the study if they fulfill any of the following criteria:
* Patients with abnormal baseline thyroid function tests, or any thyroid disorder including but not limited to hypothyroidism and thyroiditis. Patients with thyroid cancer who have had a thyroidectomy are not excluded.
* Patients who are pregnant or lactating.
* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
* Patients who cannot tolerate being in the PET scanner for the duration of the study.
The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

This registry will study the use of the Aurora® Surgiscope to provide surgical access and visualization in minimally invasive removal of hematoma in the brain. Many methods of hematoma removal are available and will be based on surgeon preference. The impact of patient selection and time to surgery from last known well time will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Subject Age is \> 18
* Subject with a Head CT that demonstrates an acute, spontaneous, primary, supratentorial ICH of volume \> 20 mL, assessed via standard of care techniques
* Subject Surgery can be initiated within 24 hours of the last known well time or, in patients with wake-up onset, within 24 hours of the time the patient awoke with symptoms.
* Subject has a NIHSS score \> 5
* Subject has a baseline Modified Rankin Scale (mRS) Score ≤ 2
* Subject with a CT Angiography demonstrating no vascular malformation

Exclusion Criteria:

* Subject has an underlying vascular lesion defined as causative source of ICH
* Subject has a profound neurological deficit defined as fixed/dilated pupils or bilateral extensor motor posturing
* Subject has an Infratentorial or brainstem ICH
* Subject has a known life expectancy \< 6 months
* Subject has an uncorrectable coagulopathy
* Subject has a mechanical heart valve
* Subject is pregnant
* Subject participates in another concurrent interventional clinical trial
* Subject who is unable to meet study follow-up requirements
Relationship of Vasoactive Peptide Levels to Portal Pressure and Patient Outcomes in Patients With Hepatic Cirrhosis

Investigate vasoactive medicators in portal hypertension on stored sera


Eligibility Criteria:
Inclusion Criteria:

* portal hypertension

Exclusion Criteria:

* Nil
Stress, Distress Intolerance, and Drug Dependence

This study is designed to evaluate the relative efficacy of a novel treatment (CBT-IC) versus a standard individual drug-counseling treatment. The novel treatment emphasizes exposure to emotional cues for drug use as part of a comprehensive, yet brief, treatment strategy. These treatments are delivered to opiate-dependent, often poly-substance dependent, individuals in a comprehensive methadone maintenance program who have failed to respond adequately to current treatments.

This study study is designed to test further the efficacy of Cognitive-Behavior Therapy for Interoceptive Cues (CBT-IC - a treatment with a central focus on enhancing a patient's tolerance to the myriad forms of distress-sadness, boredom, anxiety, withdrawal sensations, etc.-that are linked to the stressful lives of drug-dependent individuals, and breaking the link between these emotional cues and drug-related attempts to avoid emotional distress) for intervening with chronically-stressed and treatment-resistant opiate-dependent outpatients. Features of this study of particular relevance to to RFA DA-04-001 include: (1) a focus on opiate-dependent patients undergoing chronic stress; (2) a model for the way in which chronic stress translates into chronic drug use; (2) a focus on the way in which stress-related symptoms serve as trigger for drug use; (3) a focus on both mediators and moderators of treatment that will inform treatment-matching efforts, including a focus on gender differences and emotional avoidance/distress intolerance; and (4) the examination of treatment outcome in a Stage II treatment trial.

Eligibility Criteria:
Inclusion Criteria:

* The primary selection criteria include women and men between the ages of 18 and 65 who:

  1. Meet DSM-IV criteria for opiate dependence,
  2. Maintain a stable dose of methadone for two weeks prior to recruitment and,
  3. a) fail to achieve "take-home" status for methadone dosing during at least the first four months of methadone treatment, b) test positive on at least two toxicology screens for illicit drugs during the month prior to recruitment c) have never achieved two consecutive toxicology screens free of illicit substances since entering the current treatment episode.
  4. Meet study criteria for chronic stress

     1. unemployment criteria, and
     2. affective disorder criteria.

Exclusion Criteria:

* (1) Patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period).

  (2) Patients with a psychotic or organic mental disorder according to DSM-IV criteria.

  (3) Patients receiving medication affecting methadone metabolism (e.g. rifampin).

  (4) Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder).

  (5) Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.
Virtual Reality During the Removal of Chest Drains in Critically-ill Patients

Appropriate pain and anxiety management of critically-ill patients during bedside procedures remains a big challenge. Clinical Practice Guidelines recommend preemptive analgesia or non-pharmacological interventions, such as relaxation techniques or distraction, to prevent and treat pain during nursing procedures. One of the most painful procedures in the Intensive Care Unit (ICU) is the removal of chest drains in post-cardiac surgical patients.

Virtual reality (VR) is a computer-generated simulation of a 360º immersive world in which the patient can receive visual and auditory stimuli that distract them from the real environment. Current research has demonstrated that VR reduced pain and anxiety in intravenous catheter insertions or wound care.

The primary objective of the study is to evaluate the effectiveness of VR on pain and anxiety during the removal of chest drains, in post-cardiac surgical patients. The hypothesis is that VR reduces both pain and anxiety, in critically-ill patients, during the removal of chest drains in post-cardiac surgical patients.

This is a prospective, randomized, open-label, prospective study of two parallel groups of patients during the removal of chest drains:

Group 1: removal of chest drains according to the usual management protocol.

Group 2: removal of chest drains according to the usual management protocol supplemented by the use of virtual reality glasses (VR glasses)

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Patients with Richmond Agitation-Sedation Scale (RASS) between -1 to RASS +1
* Patients undergoing cardiac surgery
* Patients with chest drains
* Patients who voluntarily agree to participate (informed consent form)

Exclusion Criteria:

* Patients with a language barrier
* Patients with cognitive impairments
* Patients with neuromuscular blockers
* Patients with a previous history of documented anxiety
* Patients with epilepsy
* Hemodynamically unstable patients
* Face or ocular infections, with could contaminate VR glasses
Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome

In a longitudinal, prospective and observational study, patients with PCOS and controls wore the SenseWear Armband for 2 days. Resting metabolic rati (kcal/die), total energy expenditure (MET, kcal) were evaluated. Ultrasonographic pelvic examinations, hirsutism score, anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose tolerance test (OGTT) and lipid profile were performed.


Eligibility Criteria:
Inclusion Criteria:

* . PCOS diagnosed according with the Rotterdam Consensus Conference criteria

Exclusion Criteria:

* presence of a late-onset adrenal enzyme defect
* Significant liver or renal impairment
* pregnancy and nursing
* neoplasm
* cardiovascular disease
* other hormonal dysfunctions
Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.

To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.

The study is a prospective, randomized, single-blind, two-arm, parallel group, multi-center study to evaluate the safety and efficacy of FUSION™ Vascular Graft with Bioline (heparin) coating, compared with EXXCEL Soft ePTFE in a peripheral bypass setting, to support a claim of substantial equivalence.

Eligibility Criteria:
Inclusion Criteria:

* Patient required either above-knee or below-knee femoral popliteal bypass;
* Patient had Category 1, 2, 3 4 or 5 chronic limb ischemia as defined by the Rutherford Categories - chronic limb ischemia severity classification scale.
* Patient was at least 21 years of age;
* Patient had postoperative life expectancy of \>18 months;
* Patient was willing and able to have follow-up visits and examinations;
* Patient would not participate in other clinical trials that would conflict with this protocol
* Patient was willing and able to provide written, informed consent.

Exclusion Criteria:

* Patient had a previous history of bypass in the diseased extremity (below the iliacs arteries);
* Patient had percutaneous transluminal angioplasty or stenting of the target femoral or popliteal artery at the anticipated site of the proximal or distal anastomosis within the previous 30 days;
* Patient had active infection in the region of graft placement;
* Patient had an acute arterial occlusion requiring an emergent intervention;
* Patient needed a cardiac surgical procedure or a different vascular surgical procedure within 30 days of planned lower extremity revascularization. Planned endovascular procedures to address proximal stenotic lesions at the time of the index femoropopliteal bypass did not exclude a patient from the study;
* Patient required sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
* Patient had known hypersensitivity or contraindication to aspirin;
* Patient had known coagulation disorders including hypercoagulability;
* Patient had previous instance of heparin-induced thrombocytopenia type 2 or has known hypersensitivity to heparin; Patient was currently treated with Coumadin (warfarin) that had not been stopped within 72 hours of the planned procedure
* Patient had severe chronic renal insufficiency (plasma/serum creatinine \> 2.5 mg/dl), is undergoing hemodialysis.
* Patient had prior renal transplant;
* Patient had a stroke or myocardial infarction within 6 weeks of the procedure or had evidence of prior massive stroke (Modified Rankin Scale 3 or above);
* Patient had a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris;
* Patient had documented acute or suspected systemic infection;
* Patient was a woman of reproductive potential.
Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers

60 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "YHP2205" and "comparator" by cross-over design on day 1, 8

Subjects in group 2 will be administered "comparator" and "YHP2205" by cross-over design on day 1, 8.

Eligibility Criteria:
Inclusion Criteria:

* Those who are 19 years old or older at the screening visit
* Those whose weight is \> 60kg and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
* Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
* Those who express their voluntary consent to participate in the trial by signing a written consent

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
* Others who are judged ineligible to participate in the trial by the principal investigator.
* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
Irofulven in Treating Patients With Stage IV Melanoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have stage IV melanoma.

OBJECTIVES: I. Determine the response rate and duration of response in patients with stage IV malignant melanoma treated with 6-hydroxymethylacylfulvene. II. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-5. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of course 2 receive additional courses. Patients are followed every 3 months for 5 years, and then annually thereafter until death.

PROJECTED ACCRUAL: Approximately 16-35 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage IV malignant melanoma No prior chemotherapy OR No more than 1 prior chemotherapy containing regimen Measurable disease Brain metastasis allowed if adequately treated

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from any prior therapy No other concurrent therapy
Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination

The reconstitution of a functioning immune system after allogeneic stem cell transplantation takes months to years. Particularly memory B-lymphocytes reconstitute poorly with the current conditioning regimes. During the period of intense immune suppression the patients are extremely susceptible to bacterial, fungal and, most importantly, viral infections.The adoptive transfer of B-lymphocytes from the stem-cell donor might significantly enhance humoral immunity for the patient. Aim of the study is to evaluate a new cellular therapy with B-lymphocytes regarding safety. A booster vaccination after B-lymphocyte transfer will evaluate the functionality of the transferred B-lymphocytes in the patient.


Eligibility Criteria:
Inclusion Criteria:

1. patients after allogeneic stem cell transplantation
2. Serostatus for EBV: R-/D- oder R+/D- oder R+/D+

Exclusion Criteria:

1. Serostatus for EBV: R-/D+
2. Severe acute Graft versus Host Disease (GvHD) (Glucksberg grade III und IV)
3. Chronic GvHD in middle- or high-risk group according to NIH staging
4. Rituximab administration after SCT
5. \>10.000 EBV DNA copies/ml plasma
6. Recurrence of the haematological disorder needing therapeutic intervention
7. Secondary transplantation
8. SCT with transplant from a haploidentical donor
9. SCT with transplant from umbilical cord blood
10. CD34+-enriched transplant
11. in vitro T-cell depleted transplant
12. Pregnant or breast-feeding female
Sonography-guided Pericapsular Never Group Block for Hip Arthroplasty

In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip arthroplasty as a post-operative pain management technique, study the analgesia, opioid-sparing effects and motor-blocking effects of the PENG block

PENG Block group (PG) will receive 0.5%Ropivacaine in 20 ml of saline. Sham Block group (SG) will receive 20 ml of saline Patient will be sedated with IV midazolam before nerve block. After peripheral nerve block ,general anesthesia will be conducted using sufentanyl, propofol and rocuronium for induction and propofol and sevoflurane for maintenance. Tests will be operated after procedure，and recorded up to 48 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for hip arthroplasty

Exclusion Criteria:

* allergy to local anesthetics
* infection at the injection site
* patients receiving opioids for chronic analgesic therapy
* other lower limb neuropathies
* inability to comprehend visual analog scale (VAS)
* preexist cognitive dysfunction