cyrilzakka/clinical-trials huggingface dataset:
Study of IRNEA (Irinotecan, Etoposide, Cytarabine) for Refractory or Relapsed Acute Leukemia in Children and Adolescents

The purpose of this study is to determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric patient.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALL or AML.
* Prior therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.

  * ALL patients must have had two or more prior therapeutic attempts defined as

    * Persistent (BM blast\>5%) initial disease after two induction attempts, or
    * Persistent (BM blast\>5%) after re-induction attempt for first relapse or
    * Relapse after one re-induction attempt (2nd relapse)
  * AML patients must have one or more prior therapeutic attempts defined as

    * Refractory (BM blast\>20%) initial disease after one induction attempts, or
    * Persistent (BM blast\>5%) initial disease after two induction attempts, or
    * Relapse after one induction attempt (1st relapse)
  * Relapse after stem cell transplant: Patients are eligible 12 weeks after allogeneic stem cell transplant as long as patients are not actively being treated for GvHD and have recovered from transplant-related toxicities. Patients are eligible 8 weeks from the day of stem cell infusion for myeloablative autologous stem cell transplant, if hematological and all other eligibility criteria are met.
* Age: ≤ 21 years.
* Performance status: ECOG 0-2.
* Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.

  1. Heart: a shortening fraction ≥ 28%
  2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal.
  3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
* Patients must lack any active viral infections or active fungal infection.
* Patients (or one of parents if patients age \< 19) should sign informed

Exclusion Criteria:

1. Pregnant or nursing women.
2. Malignant (except acute leukemia) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
4. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks

This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in subjects with hereditary angioedema (HAE). Eligible subjects will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.


Eligibility Criteria:
Key Inclusion Criteria:

1. A clinical diagnosis of HAE type I or II
2. Documented HAE attacks within a defined calendar period; in the absence of documented HAE attacks, subjects will be required to enter a run-in period to document attacks
3. Access to acute attack medications
4. Sexually active women of child-bearing potential and sexually active men must utilize highly effective contraception

Key Exclusion Criteria:

1. Women who are pregnant or breast-feeding
2. Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study
3. Use of C1INH or tranexamic acid for prophylaxis of HAE attacks
4. Current participation in any other investigational drug study or within the last 30 days
5. History of or current alcohol or drug abuse
6. Infection with hepatitis B, hepatitis C or HIV
A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection


Eligibility Criteria:
Inclusion Criteria:

* Chronically infected with HCV genotype 1
* Treatment naive
* HCV RNA viral load of ≥10\*5 IU/mL
* BMI 18 to 35kg/m²

Exclusion Criteria:

* Women of childbearing potential (WOCBP)
* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
* HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment
* HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin
* HIV and/or HBV positive
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder

The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:

  * symptoms of urinary urgency (defined as a level of \>=3 in a 5 point urgency scale) at least two episode per 24 hours and
  * symptoms of urinary frequency ( \>8 micturitions per 24 hours)
* On a stable dose of tamsulosin for at least 1 month

Exclusion Criteria:

* Previous history of acute urinary retention
* Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
* Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
* Symptomatic acute urinary tract infection (UTI) during the screening period
* Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
* A 5-alpha reductase inhibitor if started less than 3 months prior to screening
* Patients with previous urethral, prostate or bladder neck surgery
Research on the Effects of Combined Neurostimulation Protocols on Stress

The study examines the effects of the combined use of two different non-invasive brain stimulation (NIBS) techniques targeting the DLPFC on stress reactivity and recovery.

Transcranial Direct Current Stimulation (tDCS) will be combined with intermittent Theta Burst Stimulation (iTBS) in order to maximize the effects coming from each of the techniques on their own. A group of 74 healthy participants wil be submitted to two different stimulation protocols (sham tDCS + active iTBS and active tDCS + active iTBS) with one-week in between and results on stress reactivity will be examined. In order to improve therapeutic protocols, this study with healthy participants is a crucial first step in order to further conduct clinical studies with psychiatric samples.

Eligibility Criteria:
Inclusion Criteria:

- Aged between 18-45 years old

Exclusion Criteria:

* The presence of psychiatric disorders
* Usage of psychotropic medication
* Any or cardiovascular neurological condition
* Personal or family history of epilepsy or other neurological disorders
* Unstable medical condition, as well as chronic pain conditions, (such as fibromyalgia) or increased blood pressure
* Eye disease(s)
* Current substance abuse
* Inner ear prosthesis
* Any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker)
* Any implanted metal device in the head region
* Metal objects or magnetic objects in the brain or around the head (only removable earrings \& piercing are allowed)
* Recent neurosurgical interventions
* Pregnancy
* Skin problems in the head region
* Recent fractures or wounds on the hand
TOCCATA - Touch+™ for Catheter Ablation

The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation. In addition, the study will characterize the use and value of contact force measurement during ablation, and the long term success (12 months) of the ablation procedure using this technology.

Safety: The primary safety endpoint assesses the incidence of procedure or device related SAEs from procedure to 7 (±1) days post-procedure or hospital discharge, whichever is longer, for patients with right-sided SVT or 3 months (±2 weeks) post-procedure for patients with atrial fibrillation. Secondary safety objectives were to demonstrate safety (operative and post-operative complications) over the 12 months post-procedure.

Performance: The primary performance endpoint is to demonstrate successful catheter deployment, irrigation and ablation at the target area during supra-ventricular cardiac ablation. The secondary performance endpoint is to demonstrate successful and effective contact force reading between catheter tip and heart wall during mapping and ablation at all locations and all angulations.

Efficacy: Secondary effectiveness objectives will consider acute and chronic elimination of the target arrhythmia, the cost-effectiveness of the system and procedure-related parameters

Eligibility Criteria:
Inclusion Criteria:

* Patients with right-sided SVT (including: atrioventricular nodal re entry tachycardia \[AVNRT\], accessory pathway Wolff Parkinson White \[WPW\] syndrome, atrial tachycardia or isthmus-dependent atrial flutter) or paroxysmal atrial fibrillation

Exclusion Criteria:

* Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass graft surgery
* Moderate or severe structural heart disease (ventricular dysfunction or valve disease) as demonstrated by transthoracic (TTE) or transesophageal echocardiogram (TEE) of all four chambers of the heart
* Known cerebrovascular disease, including a history of stroke or transient ischemic attack
* Left ventricular ejection fraction of \<35%
* Previous heart ablation procedure (surgical or catheter) to the target chamber
Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic Leukemia

This study is to provide idelalisib (IDELA) to individuals with relapsed, previously treated chronic lymphocytic leukemia (CLL) who have limited treatment options and are not eligible for other Gilead-sponsored studies.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age with a diagnosis of B-cell CLL established according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria and documented within medical records
2. CLL that warrants treatment (consistent with accepted IWCLL criteria for initiation of therapy)
3. Prior treatment for CLL comprising any of the following:

   1. Prior treatment with ≥ 1 regimen containing a therapeutic anti-CD20 antibody or
   2. Prior treatment with ≥ 2 regimens containing ≥ 1 cytotoxic agent
4. CLL progression \< 24 months since the completion of the last prior therapy for CLL
5. Appropriate for noncytotoxic-containing therapy based on the presence of any of the following factors:

   1. Grade ≥ 3 neutropenia or thrombocytopenia attributable to cumulative myelotoxicity from prior administration of cytotoxic agents (as documented by bone marrow biopsy obtained since last prior therapy), or
   2. Estimated creatinine clearance \< 60 mL/min (as determined by the Cockcroft-Gault method), or
   3. A Cumulative Illness Rating Scale (CIRS) score of \> 6
6. A negative serum pregnancy test for female subjects of childbearing potential
7. Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
8. Lactating females must agree to discontinue nursing before the study drug is administered.
9. Evidence of a personally signed informed consent

Exclusion Criteria:

1. Known hypersensitivity to the idelalisib, its metabolites, or formulation excipient(s)
2. Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
3. Known myelodysplastic syndrome
4. Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
5. Ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension
6. Ongoing drug-induced pneumonitis
7. Ongoing inflammatory bowel disease
8. History of anaphylaxis in association with previous administration of monoclonal antibodies
Aortic Stiffness and Distensibility as Predictor to Severity of Coronary Artery Disease

Assess the relationship of Aortic root distensibility and stiffness with the extent of coronary artery disease as assessed by SYNTAX score compared to a matched cohort of patients with normal coronary angiography

Cardiovascular disease leading cause of death, resulting in a number of annually deceased people higher than from any other. The great incidence of cardiovascular diseases in the world spurred the search for new solutions to enable an early detection of pathological processes The early detection based in multi-parameters of pathological condition is the key to the patient survival .The arterial stiffness is the first vessels modification, responsible for several pathological processes, which can lead to cardiovascular diseases.

The normal aging process is associated with an increase in vascular stiffness which is accelerated by atherosclerosis, hypertension, and diabetes mellitus. Several studies have revealed that increased aortic stiffness is a risk factor for cardiovascular diseases and also is a predictor of cardiovascular morbidity and mortality.

Interest in arterial stiffness waned in the early 1900s with the advent of the sphygmomanometer, which offered a quantitative measure of blood pressure and risk prediction .

Another factor is Aortic distensibility which is a measurement of vascular elasticity, and reflects the stiffness of the aorta . Aortic distensibility is markedly decreased in patients with known coronary artery disease . and is inversely proportional to the severity of Coronary artery disease .

Two-dimensional and tissue Doppler imaging derived parameters of ascending aorta have been found to be abnormal, indicating increased Aortic stiffness and impaired Aortic distensibility in subjects with coronary artery disease, hypertension, and diabetes mellitus. However, the direct correlation of Aortic stiffness with Coronary artery disease is hard to examine as most of these patients are old and have comorbidities such as hypertension, So Investigation of these parameters should be done in patients who are normotensive as most of these patients do not have confounding factors that increase Aortic stiffness.

Although the relationship between Aortic distensibility and Aortic stiffness and atherosclerosis is well known , the possible relation between them and the extent and complexity of coronary artery disease. as assessed using SYNTAX score has not been clearly determined yet.

The SYNTAX score is a lesion-based angiographic scoring system originally devised to grade the complexity of coronary artery disease.

. It is related to adverse cardiovascular events and predicts mortality and morbidity in patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* all patients suspected to have coronary artery disease

Exclusion Criteria:

* -Hypertension( SBP\>140mmhg or DBP\>90mmhg)
* Previous coronary stenting
* Previous CABG
* Renal diseases.
* Decompensated liver disease.
* Connective tissue diseases.
* Aortic valve disease ( more than mild aortic stenosis or regurgitation)
Reliability of the Incremental Shuttle Walk Test in University Students

The aim of this study is to evaluate the inter-rater and intra-rater reliability of the incremental shuttle walk test in university students.

The incremental shuttle walk test (ISWT) is a valid and reliable field test developed to evaluate functional exercise capacity. This test requires the participant to walk up and down a 10 m course marked by two cones placed 9 m apart. The walking speed, determined by an audio signal, is slow at first, but gradually increases every minute.

Although validity and reliability studies have been conducted in different disease groups and healthy populations, there is no study evaluating the inter-rater reliability of the incremental shuttle walk test in healthy individuals. Our research aims to evaluate the inter-rater and intra-rater reliability of the incremental shuttle walk test in university students.For this purpose, undergraduate nursing students will be included in our research.ISWT will be administered to students by two different researchers on the same day. For test-retest reliability the ISWT will be administered again by the same researchers on a different day (retest).

Eligibility Criteria:
Inclusion Criteria:

* Being a student of Siirt University Faculty of Health Sciences, Nursing Department
* Being between the ages of 18-26
* Understanding and speaking Turkish

Exclusion Criteria:

* Having a systemic, orthopedic or neurological disease
* Participant wishes to withdraw from the study
A HAPA-based Multicomponent Fall Intervention on Older Adults With Declines in Intrinsic Capacity in Nursing Homes

Falls are a common geriatric syndrome that impedes healthy aging and are the primary cause of accidental death in older adults. Globally, more than 50% of older adults experience falls in nursing homes each year. Intrinsic capacity (IC) is a quantifiable measure of healthy aging, and consists of five dimensions: cognitive, locomotor, vitality, sensory (vision and hearing), and psychological capacity. Decline in IC is an independent factor in the occurrence of falls in older adults. A related theoretical framework indicates that healthy behaviors are the key to enhance IC. The health action process approach (HAPA) has been shown to have positive effects on health behavior promotion. Therefore, the aim of this study is to examine the effect of multidimensional fall management based on HAPA on fall risk, fall efficacy, and healthy aging among older adults with declines in IC in Chinese nursing homes.

Method： First, a randomly selected nursing home in Huzhou, will be selected for the study using the WHO Intrinsic Ability Screening Scale for older adults with declines in IC. A baseline assessment will be conducted followed by clustered randomization to divide into an intervention group (n=50) and a control group (n=50). All subjects will be intervened, after signing the informed consent. The subjects will be assessed by blinded evaluators for primary and secondary outcomes at at study baseline (T0), 4 weeks for the intention intervention (T1), 12 weeks for the action intervention (T2), and 8 weeks for the follow-up (T3). Finally, data collection and statistical processing will be carried out.

Expected results:

Reduce falls risk among the nursing home residents of the intervention group. Improvement of IG among the intervention group. Improvement of healthy aging among the intervention group.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60 years.
2. Living in the nursing home for ≥ 3 months.
3. WHO screening tool identifies at least one dimension of decline in IC.
4. Ability to move independently (non-disabled) with a score of ≥ 4 on the SPPB.

(4) Voluntary involvement in the trial and informed consent provided by the participant.

Exclusion Criteria:

1. Have severe visual or hearing deprivation.
2. Have severe mental impairment or severe cognitive deficits (i.e., severe depression, schizophrenia).
3. Have severe and terminal heart, liver, brain, and kidney disease (i.e., tumors, brain trauma).
4. Other trials received within 6 months prior to the study.
Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

The infrapyloric (No.206) and greater curvature (No.204) lymph node metastasis in adenocarcinoma located at hepatic flexure and right half of transverse colon has not been well discribed and analysed. The aim of this study is to assess the rate of this lymph node metastasis and to reveal its prognostic value for colon cancer located at hepatic flexure and right half of transverse colon. Meanwhile, we can evaluate the safety and feasibility of this extented lymphadenectomy in right hemi-colectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* American Society of Anesthesiologists (ASA) score I to III
* A biopsy proven histological diagnosis of colorectal carcinoma
* tumor located at hepatic flexure and right half of transverse colon
* Undergoing right hemi-colectomy with extented lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node
* Preoperative staging cT2-4aN0M0 or cTanyN+M0
* Willing to participate and informed consent signed

Exclusion Criteria:

* Pregnant or lactating women
* Synchronous colorectal carcinoma
* History of colorectal cancer or other malignant tumors
* Clinical evidence of metastasis
* Preoperative staging cT1N0 or cT4bNany
* Emergency procedure
Biodistribution of [11C]PIB in Patients With Risk Factors for Alzheimer's Disease

Participants enrolled at the Alzheimer's Disease Research Center (ADRC) at Wake Forest School of Medicine will be invited to take part in this study. The purpose of this study is to identify and measure the amount of a protein called amyloid in the brain.It is thought that the build up of amyloid may be related to the development of Alzheimer's disease.

Brain amyloid will be measured using PET with \[11C\]PiB. Participation will involve an initial brain scan and possibly a follow-up brain scan two years later.

The data collected in this study will help explain amyloid deposits in several groups of participants including adults with and without signs of memory impairment. The information collected will help find out who is more likely to have brain amyloid and when it increases the risk for developing memory problems. Research studies suggest that people with elevated levels of brain amyloid are at an increased risk for memory decline, but this does not mean that every person with amyloid build up will develop AD.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a study with the Alzheimer's Disease Research Center.

Exclusion Criteria:

-