cyrilzakka/clinical-trials huggingface dataset:
Ascorbic Acid Levels in MDS, AML, and CMML Patients

This study is a non-interventional, specimen collection translational study to evaluate vitamin C levels in the peripheral blood of Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or Chronic Myelomonocytic Leukemia (CMML) patients.

It has previously been established that hematological cancer patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) often exhibit severe vitamin C deficiency from a cohort of patients in Copenhagen. In this study, the investigators aim to determine if those results are conserved in another population/geographical location.

Eligibility Criteria:
Inclusion Criteria:

* Patients actively receiving treatment for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).
* Patients diagnosed with AML, MDS, or CMML and are treatment naïve.
* Patients who are 18 years old or older.

Exclusion Criteria:

* Patients deemed as too ill to participate as determined by the clinical investigator.
* Non-English speaking patients
* Patients unable to provide informed consent.
Prophylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic Purpura

Congenital thrombotic thrombocytopenic purpura (TTP), also called Upshaw-Schulman Syndrome or hereditary or familial TTP is a rare, but severe disease. The purpose of this study is to determine how infusions of plasma to patients with congenital TTP correlate with symptoms and signs of activity of the disease, and to determine why some patients need more frequent infusions of plasma than others to prevent acute attacks of the disease.

Patients with congenital TTP have an inherited lack of function or amount of a protein in plasma called ADAMTS13, that otherwise is responsible for cleaving large von Willebrand-molecules into smaller parts. The patients suffer recurrent attacks of clotting of small blood vessels, that can cause damage to major organs, including the central nervous system. Acute attacks can be treated successfully with infusions of human plasma, and some patients also receive regular plasma therapy for prevention of acute attacks. A small group of patients receive preventive plasma infusions twice or more weekly, indicating a much higher need for plasma than what is otherwise recommended for preventive therapy. Do these patients have an ongoing activity of their disease despite a stimulus? Or a higher turn-over of transfused ADAMTS13? Have these patients developed antibodies against transfused ADAMTS13? Are any symptoms correlated with signs of disease activity?

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of congenital TTP
* On regular prophylactic plasma treatment: \> Once weekly (group 1) or \>1 \<3 times monthly (group 2)
* Between 18 and 65 years
* Capable of understanding and complying with the protocol

Exclusion Criteria:

* Pregnancy
* Acute bout of TTP requiring daily plasma infusions or -exchange for more than 3 days, within the last 2 weeks before intervention period
Perception of Time by Individuals With Eating Disorders

The objective of the study was to determine how patients with eating disorders perceive time, and in particular whether their experience of time differs from that of healthy individuals. Another goal was to examine the relationship between the mood of the subjects and their time perspective. The subjects were 30 women with eating disorders and 30 age-matched healthy female controls. The three measures applied were: the Time Metaphors Questionnaire by Sobol-Kwapinska, the Time Perspective Inventory by Zimbardo, and the UWIST Mood Adjective Checklist (UMACL) by Matthews et al.

The objective of the study was to determine how individuals with eating disorders perceive time, and in particular whether their experience of time differs from that of healthy persons. Another aim was to investigate the relationship between the mood of the subjects and their time perception as well as determine a variable moderating that relationship.

First, it was expected that eating-disordered patients experience time as a rather aversive and unfriendly force marked with chaos and void, in contrast to healthy subjects, who were predicted to treat it as something more friendly, appreciating its subtleties and the significance of the moment (Hypothesis 1).

Moreover, it was expected that individuals with eating disorders would exhibit a more negative temporal orientation, whether past or present, as compared to healthy controls, who would reveal more positive past, present, or future orientations (Hypothesis 2).

Finally, it was predicted that eating disorders moderate the relationship between mood and time perception (Hypothesis 3).

The study encompassed 30 women with eating disorders (19 patients with anorexia nervosa and 11 patients with bulimia nervosa) and 30 age-matched normal healthy controls. The clinical group consisted of patients of the residential eating disorder therapeutic center "Drzewo zycia" in Malawa as well as some outpatient clinics in Poland; some of the patients were not being actively treated at the time of the study. The controls included psychology students from two Polish universities (the Cardinal Stefan Wyszynski University and the University of Finance and Management, both in Warsaw), as well as researchers and educators who volunteered for the study.

The three measures applied in the study were:

* The Time Metaphors Questionnaire by Sobol-Kwapinska;
* Time Perspective Inventory by Zimbardo (Zimbardo \& Boyd, 1999; see also Zimbardo \& Boyd, 2009);
* The UWIST Mood Adjective Checklist (UMACL) (Matthews at al.; see also Gorynska, 2005).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of eating disorders (anorexia nervosa or bulimia nervosa)
* Age between 18 and 40 years

Exclusion Criteria:

* diagnosis of other (except eating disorders) mental disorder
* Age below 18 years and above 40 years
Forodesine Hydrochloride (BCX-1777) for B-Cell Acute Lymphoblastic Leukemia

A Phase I/II, Multi-Center, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride Infusion in Patients with B-cell Acute Lymphoblastic Leukemia with an Option of Extended Use of Forodesine Hydrochloride


Eligibility Criteria:
Inclusion Criteria:

* Documented B-cell acute lymphoblastic leukemia (B-ALL), which under WHO Guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma
* Must have failed at least 1 treatment regimen for B-ALL, which under WHO Guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma
* Performance status of ≤2 by Eastern Cooperative Oncology Group (ECOG) criteria
* Any age is allowed
* Life expectancy of at least 3 months
* Adequate liver function (aspartate transaminase \[AST\] and/or alanine transaminase \[ALT\] not \>3 times upper limits of normal \[ULN\])
* Adequate kidney function (calculated creatinine clearance \>40 mL/min)
* Negative serum or urine pregnancy test within 2 to 7 days prior to the start of study treatment in females of childbearing potential
* Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study in such a manner that the risk of pregnancy is minimized. Acceptable contraceptives include intra-uterine devices (IUDs), hormonal contraceptives (oral, depot, patch, or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
* Signed informed consent form (ICF), minor assent form (if applicable), prior to start of any study-specific procedures

Exclusion Criteria:

* Active serious infection not controlled by oral or intravenous antibiotics
* Treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy was given
* Rapidly progressive disease with compromised organ function judged to be life-threatening by the Investigator
* Patients with clinical evidence of active central nervous system (CNS) disease
* Concurrent treatment with other anticancer agents
* Pregnant and/or lactating female
* Patients with known human immunodeficiency virus (HIV) infection HIV testing will be performed at the Screening visit for patients who have not been tested within 6 months of receiving study drug, as well as those patients who have had exposure or have been transfused with blood products that were not appropriately screened.
* Patients with known active hepatitis B and/or hepatitis C infection Hepatitis testing will be performed at the Screening visit for patients who have not been tested within 6 months of receiving study drug, as well as those patients who have had exposure or have been transfused with blood products that were not appropriately screened.
* Hypersensitive or intolerant to any component of the study drug formulation
Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake

The investigator aim to understand whether food-induced glucocorticoids influence fat mass in overweight and obese people.

In a randomized, cross-over study, 23 overweight and obese volunteers will receive a block and replace therapy that mimics physiological glucocorticoid (GC) rhythm (metyrapone plus hydrocortisone) or placebo. Participants will undergo two identical overfeeding periods with each treatment. With the block and replace therapy food-induced GC peak will be suppressed. Metabolic and immunological parameters will be compared to reveal the effects of GCs during excessive overfeeding, particularly to understand changes in body fat.

Obesity is one of the most serious health problems of the 21st century, and new therapies are urgently needed.

Glucocorticoids (GCs) increase with acute food intake. Several clinical studies have found that glucocorticoids contribute to common obesity, but the underlying mechanisms remain unknown. Here, the investigator aim to understand whether GCs influence the total body fat in obese and overweight study participants during excessive overfeeding.

In a randomized, cross-over study, 23 overweight and obese individuals will receive a block and replace therapy that mimics physiological GC rhythm (Metyrapone plus hydrocortisone) or placebo. Participants will undergo two identical overfeeding periods with each treatment. With the block and replace therapy, food-induced GC peak will be suppressed. Metabolic, autonomic, and immunological parameters will be compared.

A) Participants will receive hydrocortisone 19.9mg/d day 1 to day 6 and 12mg on day 7 subcutaneously via a pump in a pulsed fashion (eight times/day) and metyrapone per os (starting with a dose of 750mg/d on day 1 to 2500mg on day 3, which will be kept constant until day 6 and then reduced to 750mg on day 7)

B) Participants will receive placebo (0,9% NaCl solution) 19.9mg/d day 1 to day 6 and 12mg on day 7 subcutaneously via a pump in a pulsed fashion (eight times/day) and placebo pills per os (starting with a dose of 750mg/d on day 1 to 2500mg on day 3, which will be kept constant until day 6 and then reduced to 750mg on day 7)

Eligibility Criteria:
Inclusion Criteria:

* Males aged 18 to 50 years
* BMI≥ 25 kg/m² with a stable weight within past three months before study initiation

Exclusion Criteria:

* Any severe acute or chronic disease, including diabetes mellitus type 2
* Intake of GLP-1 agonists or hormone therapy
* Hypercortisolism
* Casual smoking (more than 6 cigarettes per day)
* Frequent, heavy alcohol consumption (more than 30g/day)
* Frequent, heavy caffeine consumption (more than 4 caffeinated drinks/day)
* Regular physical exercise (more than 4hrs per week)
* Shift work
* Participation in an investigational drug trial within the past two months
* Intake of any steroid-containing drugs, including topical steroids and inhalers, within 4 weeks of the study initiation
* Known allergy to metyrapone
* Inability or unwillingness to provide informed consent
The Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases

The aggregate of data pertaining to brain metastases suggests that optimal results are achievable with a 2-pronged approach that addresses both the specific focus (with surgery or radiosurgery) and the surrounding brain parenchymal tissue that may harbor micrometastases. Patterns of failure following treatment of metastases that arise in the posterior fossa have not been reliably defined. Although most would agree that radiosurgery alone is not sufficient treatment for focal metastases in the cerebellum, it may be possible to deliver less than WBI as an "expanded port" beyond the SRS volume.

The current study acknowledges that at least two therapeutic modalities are requisite for patients with cerebellar metastases but hypothesizes that it is unnecessary to extend the treatment of ostensibly uninvolved brain tissue beyond the limits of the posterior fossa. In so doing, it is hoped that the putative advantage derived from foregoing whole brain irradiation (e.g., reduction in neurocognitive impairment) will not be at the expense of excessive surpratentorial failure.

SCHEMA:

* Posterior Fossa Irradiation as defined by diagnostic MRI and CT simulation.
* 37.5 Gy in 2.5 Gy fractions administered via conformal beams.
* Radiosurgical boost (with dose titrated to parameters of RTOG 9005).
* Contrast enhanced MRI will be obtained at baseline and then at 3, 6, and 12 months following completion of posterior fossa irradiation.
* The Mini Mental Status Examination will be used to evaluate global cognitive function at baseline and then at 3, 6, and 12 months following completion of posterior fossa irradiation.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant disease
* All primary tumors exclusive of:

  * Small cell lung cancer
  * Renal cell cancer (hypernephroma)
  * Melanoma
  * Sarcoma
* 1-3 intraparenchymal metastases
* Age ≥18 years
* RPA(14) 1 or 2
* Patients who have undergone resection are eligible provided residual disease is evident on imaging
* No clinical or radiographic evidence of progression of extracranial disease in month prior to enrollment on study.

Exclusion Criteria:

* Major psychiatric illness
* Lesions in brainstem, midbrain, pons, medulla
* Patient who have undergone complete resection of all known infratentorial disease
* Patients with leptomeningeal metastases
* Patients with hepatic metastases
* Patients with metastases from the following primary tumors are ineligible: Small Cell Lung Cancer; rena Cell Carcinoma; Melanoma; Sarcoma
* Previous cranial irradiation
US-guided Sciatic Nerve Block: Evaluation of the Intraneural Ropivacaine Minimal Effective Volume (MEV90)

This prospective, double-blinded study evaluates intraneural ropivacaine 1% Minimal Effective Volume (MEV90) for ultrasound-guided (US) popliteal sciatic nerve block, with Up-and-down methodology.

To evaluate any neurological complications, an electrophysiological assessment will also be performed preoperatively and at 5 weeks after surgery.

At least 45 patients undergoing hallux valgus repair will be enrolled. A baseline bilateral sciatic nerve electrophysiological study will be performed preoperatively.

Patients will be placed in prone position and a high-frequency (8-12 MHz) linear array transducer (Snerve, Sonosite, USA) will be used to identify the sciatic nerve in a transverse cross-sectional view at the apex of the popliteal fossa. As the best view of the sciatic nerve with its paraneural and neural sheath, just proximal to the point of bifurcation, will be obtained, the nerve dimension (medial-lateral and cranio-caudal diameters) will be determined and registered.

An 80 mm 22-gauge needle (Sonoplex, Pajunk, Germany) will be inserted using the US-guided in-plane technique under the epineurium. The positioning will be evaluated injecting 1 ml of sodium-chloride 0.9% solution and observing the nerve swelling, if correct the local anaesthetic (LA) solution will be injected.

The first patient will receive 15 ml of ropivacaine 1% (150 mg). Following patients will receive LA volume based on Up-and-down methodology.

Clinical follow-up will be performed at 12, 24, 48 hours, 1 and 5 weeks and 6 months after surgery.

At 5 weeks electrophysiological study will also be performed in all patients and repeated at 6 months in case of positive findings.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old
* ASA I-III
* Signed informed consensus

Exclusion Criteria:

* ASA IV
* Unstable neurological disease
* DM type I-II
* Allergy to ropivacaine-mepivacaine
* Opioid chronic treatment
* Consensus refusal or not valid
* Rheumatoid arthritis
* Baseline electrophysiological study positive finding
* Postoperative intensive care required
Neutrophil-lymphocyte and Platelet-lymphocyte Ratios and Their Relations to Vascular Comlications and Glycemic Control in Patients With Type 2 Diabetes Attending The Diabetes Center of Assiut University Hospitals

Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM

Vascular complications of DM result from various disorders including metabolic, cellular, and blood disturbances. Excessive production of pro-inflammatory adipokines from adipose tissue, resulting in low-grade chronic inflammation, causing insulin resistance (IR) and type 2 DM \[3\]. Hematological changes affecting the red blood cells (RBCs), white blood cells (WBCs), platelet function, and the coagulation factors are detected to be associated with DM . It is important to add that, high WBC count, one of the chief components of inflammatory process, sharing to atheroscle-rosis development and cardiovascular diseases (CVD) . Lately, the neutrophil-to-lymphocyte (N/L) and the platelet-to-lymphocyte (P/L) ratios, were offered as markers of inflammation in cardiac diseases, neoplasms and diabetes-related complications . Moreover, high leucocyte counts have been used as diagnostic and prognostic markers in vascular complication of diabetes

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (T2DM) patients with good glycemic control and have HBA1C \<7and ages ranging from ≥18 old. And poor glycemic control and have HBA1C ≥7 and ages rang from ≥ 18 years old

Exclusion Criteria:

* Patients with, type 1 diabetes mellitus

  1. Idiopathic thrombocytopenic purpura,
  2. liver cell failure
  3. Myeloproliferative neoplasm
  4. patients on anticoagulant drugs , anti platelet drugs or on steroids were excluded from the study
Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?

The purpose of this study is to investigate whether the addition of a medication called epinephrine to spinal medications prolongs the duration of the anesthesia. The medication standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain medication (morphine). These medications typically last about 2 hours. The investigators want to determine if adding epinephrine to the spinal medications prolongs the anesthetic without side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean section. Epinephrine is known to prolong the action of some local anesthetics, but the investigators want to specifically study combining it with the medications the investigators use regularly for cesarean section.

You may qualify to take part in this research study because you are having a repeat cesarean section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want to determine if epinephrine will prolong the anesthetic.

Spinal anesthesia with bupivacaine is a commonly used anesthetic in the obstetric population. It is most frequently carried out as a single shot intrathecal injection. This method can be utilized for both labor analgesia and surgical anesthesia for cesarean section. One of the concerns in using a single shot spinal injection for surgical anesthesia is the duration of adequate surgical conditions. This concern is especially relevant to repeat cesarean sections, as each subsequent procedure has the potential to be more complex than the prior and, therefore, prolonged. A reliable way to prolong surgical anesthesia provided by single shot spinal injection of bupivacaine could prove invaluable in the setting of repeat cesarean section. It has been well documented that adding epinephrine to intrathecal lidocaine will increase its duration1, but the evidence for augmenting the duration of anesthesia provided by adding epinephrine to bupivacaine is much more equivocal and less robust. This is a randomized control trial investigating whether or not adding epinephrine to a standard single intrathecal injection of hyperbaric bupivacaine for repeat cesarean will prolong its duration. It will be investigated using women who are undergoing scheduled repeat cesarean section in whom neuraxial anesthesia is the appropriate primary anesthetic. The investigators will compare the onset, quality and duration of both sensory and motor components of the spinal block as well as the incidence of known side effects.

Eligibility Criteria:
Inclusion Criteria:

* Non-emergent repeat cesarean section
* Neuraxial anesthesia as the planned primary anesthetic
* Informed consent obtained
* Females age 18-50

Exclusion Criteria:

* Emergency cesarean section
* Anesthetic other than neuraxial
* Allergy to local anesthetics, morphine, or epinephrine
* Pre-existing sensory/motor deficit
Smoking Cessation in NYC

The investigators tested the feasibility of a culturally and linguistically sensitive smoking cessation program with combined counseling and pharmacological components for Chinese smokers in New York City; identified factors and techniques that enhance the administration and appropriateness of the intervention program; and examined the effectiveness of this program on quit attempts, quit rates, and overall smoking reduction.


Eligibility Criteria:
Inclusion Criteria:

* Primary eligibility criterion for inclusion in the study cohort was current smoking status. Other inclusion criteria were:

  1. self-identification as ethnic Chinese,
  2. aged 18 years and older,
  3. having smoked or puffed on a cigarette during the previous week,
  4. willingness to participate in the smoking cessation study,
  5. access to a functional telephone,
  6. expected presence in the study geographic area for a year or more, and
  7. not having been enrolled in the past or at the current time in any smoking cessation treatment programs.

Exclusion Criteria:

1. being currently pregnant and
2. having had a recent diagnosis of cardiovascular disease.