cyrilzakka/clinical-trials huggingface dataset:
Effects of Core Stabilization Exercises in Children with Acute Lymphoblastic Leukemia

The goal of this clinical trial is to investigate the effects of core stabilization exercises applied in addition to the conventional exercise program on physical function, functional muscle strength, functional exercise capacity, postural control and fatigue in children with acute lymphoblastic leukemia receiving maintenance treatment.

Participants will be divided into two groups; the first group will be given a conventional exercise program, while the second group will be given core stabilization exercises in addition to the conventional exercise program.

Acute Lymphoblastic Leukemia (ALL) is a malignancy resulting from the abnormal proliferation of lymphoid cells that can invade the bone marrow, blood, and extramedullary regions, and it is the most common malignancy in childhood. Specific chemotherapy-related problems are frequently observed in children with ALL. These include a reduction in cardiopulmonary fitness, balance, posture, proximal muscle strength, and flexibility, as well as postural control issues and functional mobility impairments, in addition to fatigue.

The aim of this study is to investigate the effects of core stabilization exercises, applied in addition to a conventional exercise program, on physical function, functional muscle strength, functional exercise capacity, postural control, and fatigue in children with Acute Lymphoblastic Leukemia undergoing maintenance therapy.

Participants will be divided into two groups: the first group will follow a conventional exercise program, while the second group will receive core stabilization exercises in addition to the conventional program. All participants will be randomly assigned to the groups using the software available at http://www.randomizer.org. The exercise sessions will be conducted three times a week for a total of 8 weeks, with 24 sessions in total. Demographic information will be recorded for participants who agree to take part in the study and meet the inclusion criteria. The scales and tests designed to assess the participants' physical function, functional muscle strength, functional exercise capacity, postural control, and fatigue will be administered both before and after the study.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 7-18
* Diagnosed with ALL
* In the maintenance phase of chemotherapy
* Children without acute thrombosis, active ischemia, hemodynamic instability
* Children without uncontrolled pain
* Children who can follow verbal instructions.

Exclusion Criteria:

* Children who have received or are receiving cranial radiotherapy
* Children with any cardiovascular disease, acute or chronic respiratory disease
* Children with acute or chronic bone, joint, muscle problems
* Children diagnosed with neuromotor deficits or genetic disorders
* Children with vision problems other than refractive errors
A Study of OSI-7904L Versus 5-FU/LV as Treatment in Patients With Biliary Tract Cancer

Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer.


Eligibility Criteria:
Inclusion Criteria:

Documented locally advanced or metastatic adenocarcinoma of the biliary tract; Adequate bone marrow, hepatic and renal function; Bilirubin \<= 1.5 times the upper limit of normal; Age 18 years or older; Predicted life expectancy 12 weeks or more; Prior surgery and radiation therapy permitted provided patient has recovered adequately; At least 1 target lesion \>= 20 mm (or \>= 10 mm on spiral CT-scan); ECOG Performance Status 0-2; No prior chemotherapy for locally advanced or metastatic disease. Adjuvant/neo-adjuvant permitted if therapy was completed at least 12 months prior to study entry;

Exclusion Criteria:

Concurrent anticancer therapy while on study; History of other malignancy within the past 3 years except basal or squamous cell carcinoma or in situ cervical cancer; Symptomatic brain metastases which are not stable or have required radiation in the past 28 days;
Cardiovascular Function and Physical Activity in COVID-19

The purpose of this study is to a) assess how coronavirus 2019 (COVID-19) affects cardiac function in middle age and older adults and b) assess if a physical activity intervention (increased daily step count by 2,000) can affect cardiac function in a population with a history of COVID-19.

Cardiac function will be assessed by obtaining arterial stiffness, comprehensive echocardiography measurements and haemodynamic monitoring. Arterial stiffness will assess primarily pulse wave velocity (PWV) and echocardiography. Graded cardiopulmonary exercise stress testing coupled with non-invasive gas exchange and haemodynamic monitoring will also be performed. Physical activity will be assessed objectively using pedometers and accelerometry. Quality of life, sleep/ circadian rhythm, fatigue, anxiety and depression will be measured using the validated Short-Form-36 (SF-36) questionnaire, Pittsburgh Sleep scale (PSQI), Chalder fatigue (CF) scale and the Depression, Anxiety and Stress Scale (DASS-21).

Eligibility Criteria:
Inclusion Criteria:

* Between 50-85 years old
* Up to date with all COVID-19 vaccinations
* COVID participants - had a positive test for COVID-19 over 28 days of initial visit but before 18 months. Non-COVID participants - never received a positive COVID-19 test result, and no symptoms during periods where testing was unavailable.

Exclusion Criteria:

* Chronic respiratory and cardiovascular conditions i.e., chronic obstructive pulmonary disease (COPD), emphysema, pulmonary hypertension, coronary artery disease
* Severe hypertension
* Acute or chronic neurological impairment or progressive neurological disease
* Use of medication known to directly affect cardiac function
* Current smoker
* Body mass index \> 35 kg/m2
* People who exceed current physical activity guidelines defined by the World Health Organization (WHO).
Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma

The purpose of this study to assess the image quality of the rapid magnetic resonance imaging (MRI) compared to the standard MRI.

This is a pilot study to compare a rapid 10-minute liver magnetic resonance imaging (MRI) protocol to standard MRI in participants with suspected hepatocellular carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. underlying liver disease
2. have a lesion on a prior imaging study
3. must have prior standard MR

Exclusion Criteria:

1. Contra-indication for MR imaging including pacemaker, claustrophobia, pregnancy, electronic or vascular devices that are contraindicated;
2. patients with severe kidney dysfunction
Therapy for Migraine Prevention in Children 6-11 Years of Age

The aim of this study is to evaluate the effect of SPN-538 for the prophylaxis of migraine in pediatric patients 6 to 11 years old.

The study is to assess the efficacy and safety of SPN-538 in reducing the monthly migraine headache frequency in pediatric patients with migraine.

SPN-538 (or matching placebo) will be administered in patients diagnosed with migraine with or without aura based on the International Headache Society criteria.

The frequency of the migraine attack will be assessed as the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Otherwise, healthy male or female (6 to 11 years of age at the time of screening) with a history of migraine with or without aura for at least 6 months prior to screening, 3 to 14 headache days (migraine and non-migraine) per month during the 3 months prior to screening and during Baseline Period, and a PedMIDAS Disability score of \> 10 and \< 50.

Exclusion Criteria:

* Subjects with chronic migraine (\>14 headache days per month), cluster headaches, or migraine aura without headache and, with \> 14 headache days during the Baseline Period.
* Use of migraine preventive medication other than topiramate within 14 days prior to the start of the Baseline Period; or used onabotulinumtoxinA (Botox®) 3 months prior screening and non-pharmacologic complementary and alternative prophylactic approaches for migraine prevention.
* Failure to respond to topiramate prophylaxis therapy (2 to 3 mg/kg/day) for a minimum of 3 months, or to more than 2 clinical trials with an established prophylactic anti-migraine regimen.
* Current use or history of antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, β-blockers, tricyclic antidepressants, AEDs, calcium channel blockers, corticosteroids (i.e., systemic, inhaled or topical), daily NSAIDs, sedatives, serotonin selective reuptake inhibitors (SSRIs), non-selective reuptake inhibitors (NSRIs), high-dose magnesium supplements (≥600 mg/day), high-dose riboflavin (≥100 mg/day), calcitonin gene-regulated peptide (CGRP) receptor antagonists, omega-3, melatonin or cannabidiol (CBD) oil.
* Overuse of analgesic or migraine-specific agents for acute treatment of migraine (\>10 treatment days/month of ergot-containing medications or triptans; or \>15 treatment days/month with simple analgesics (including non steroidal anti-inflammatory drugs \[NSAIDs\])
* Diagnosis of psychiatric disorder (e.g., psychosis, bipolar disorder, major depression, generalized anxiety disorders), or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation).
* Subjects with seizures or a history of seizure-like events.
* Known history of visual field defects, neurological disorder or structural disorder of the brain from birth; head trauma or previous CNS surgery.
* Evidence of active suicidal ideation and/or suicidal behaviors, pregnancy, active liver disease or abnormal kidney function.
A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

Part A Escalation Cohorts:

o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies

Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:

* Tumors with all histological diagnosis or tissue origin may be enrolled
* Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease.

  * Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC)
  * At least 18 years of age
  * Performance Status of 0 or 1
  * Adequate organ function

Exclusion Criteria:

* Hematologic malignancies
* Pregnant or lactating
* Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders
* Myocardial infarction within the last 6 months
* Unstable angina, or unstable cardiac arrhythmia requiring medication
* Surgery within the last 28 days
* Systemic fungal, bacterial, viral, or other infection
* History of bleeding diathesis within the last 6 months
* Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
Pilot Study of Using Copeptin to Predict Response to Tolvaptan

This pilot study will investigate the association between levels of the peptide copeptin and response to tolvaptan, a drug that blocks the action of the water retaining hormone vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45) selected by targeting upper and lower quartile copeptin levels at screening (10 each). The treatment phase of the study will be a prospective, single-arm, open label protocol. All patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan with body weight, fluid intake, and urine output monitored in a research unit for 24 hours.

For analysis of study endpoints, patients in the single intervention arm will be stratified by a prospectively determined cut-point of copeptin level into two groups (≥10 versus \<10 pmol/L). The copeptin level used for the two group stratification will be the blinded copeptin value obtained at baseline from the hospital phase prior to administration of tolvaptan.

The study screening strategy will be designed to enroll an enriched patient population by identifying patients at the high or low end of the spectrum of copeptin levels for outpatients with stable heart failure. This will be accomplished by blinded review of copeptin levels obtained during screening.

The primary endpoints for analysis will be 24 hour urine output and the change in body weight over 24 hours during the inpatient stay.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients with a history of chronic symptomatic heart failure, defined as dyspnea on exertion or edema, due to cardiac dysfunction, of at least one month's duration
2. Left ventricular ejection fraction ≤ 45% as documented by quantitative assessment by an accepted imaging technique within one year of screening
3. Meet baseline copeptin criteria for entry
4. Currently taking a diuretic (with diuretic defined as any loop or thiazide diuretic or aldosterone antagonist at any dose)

Exclusion Criteria:

1. Current New York Heart Association Functional Class IV heart failure
2. Patients who are felt to be volume depleted based on clinical examination or need to reduce diuretic administration
3. Presence of clinical contraindications to tolvaptan
4. Episode of acute myocardial infarction or acute coronary syndrome within the past 3 months
5. Cardiovascular surgical procedure within the past 4 weeks
6. CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.
7. History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
8. Chronic uncontrolled diabetes mellitus as determined by the investigator.
9. Supine systolic arterial blood pressure \< 90 mmHg at screening
10. Serum creatinine \> 3.5 mg/dL at screening
11. Serum potassium \> 5.5 mEq/L or \< 3.5 mEq/L at screening
12. Subjects currently treated with hemofiltration or dialysis

j. Subjects judged by the investigator to be unable to maintain accurate intake and output during their hospitalization related to medical or other problems
Depiction of Prostate Cancer Treatment Alternatives in Greece

A retrospective, registry analysis of the socio-economic and demographic characteristics of patients suffering from locally advanced or metastatic prostate cancer, as well as the depiction of the therapeutic algorithms followed in the Greek clinical practice.

* Target Group: Patients with locally advanced or metastatic prostate cancer.
* The first 10 consecutive patients records that meet the entry criteria.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Locally advanced or Metastatic Prostate Cancer after 2002.
* Patients that received Hormonal therapy.

Exclusion Criteria:

* Males that are aged less than 18 years
Intestinal Metaplasia Cohort for Gastric Cancer Prediction

In this study, we aim to establish a prospective cohort of patients with endoscopically and histologically confirmed intestinal metaplasia, collect gastric mucosal tissue samples from this cohort, and follow the development of gastric cancer over time.

Patients visiting Seoul National University Hospital, who have previously received an incidental diagnosis of intestinal metaplasia during a prior gastroscopy examination, will be considered as potential candidates for this study. Upon obtaining their informed consent to participate, the initial endoscopy procedure will involve the collection of biopsies to ensure an accurate histological diagnosis of intestinal metaplasia. These biopsies will be taken from the antrum and body of the stomach, according to the protocol of the updated Sydney system, to pathologically diagnose the extent and severity of intestinal metaplasia. One to two pieces of tissue remaining from this diagnostic process will be retained for future analysis. Subsequently, patients will be followed up on an outpatient basis to track the development of gastric cancer through routine screening endoscopies. In cases where patients develop gastric cancer, a comparative analysis will be conducted with those who do not develop gastric cancer, to determine the differences in expression of markers in the gastric mucosal tissue that was collected during the initial endoscopy. Our ultimate aim is to identify potential biomarkers that may serve as predictive indicators for the development of gastric cancer in patients with a preexisting diagnosis of intestinal metaplasia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who visit Seoul National University Hospital
* Patients who have been visually diagnosed with intestinal metaplasia at a prior exam

Exclusion Criteria:

* Patients who have been previously diagnosed with gastric cancer or adenoma
* Patients who have previously received gastrectomy
Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block

Prospective, patient-blinded study utilizing a novel Continuous Reassessment Method that concomitantly considers both block success and block side effects (lung dysfunction) for brachial plexus nerve blocks.

Success or failure of the brachial plexus block for any given volume will be determined by the verbal analogue pain scale score obtained 60 minutes after surgical end time. Volumes will be determined by continuous reassessment method.

Eligibility Criteria:
Inclusion Criteria:

* Surgical candidate for Arthroscopic rotator cuff surgery
* ASA I-III
* BMI\<40
* Age \>18

Exclusion Criteria:

* Inability to give informed consent
* Inability to complete consent process in English
* allergy to ropivacaine
* neuropathy
* contraindications to peripheral nerve block per ASRA guidelines
* chronic opioid use
* infection at the injection/catheter site
* limb restriction due to medical history
* history of moderate - severe lung disease.
Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility

If no metastases are observed, patients will start a short protocol of four courses of weekly neo-adjuvant chemotherapy (12 weeks). If response to chemotherapy results in a tumor of less than 2 cm, cervical conisation will be performed.

The standard treatment of stage Ib1 2-4 cm cervical cancer in women who wish to preserve fertility is an abdominal radical trachelectomy with pelvic lymph node dissection. Since the number of take home babies after completing this procedure is below 10%, there is a need for exploration of alternative treatment modalities with better chances of preserving fertility at equal risk of recurrence. Since low fertility rates after abdominal radical hysterectomy are observed due to the radical surgery performed on the uterine cervix, less radical surgery is warranted. To enable less radical surgery by cervical conisation, neo-adjuvant chemotherapy to reduce tumor size is incorporated to the multi-modal treatment scheme of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Stage Ib1 cervical cancer measuring ≥2 - ≤4 cm on physical examination and imaging in any direction
* Histologic type: squamous cell carcinoma (SCC), adeno cell carcinoma (ACC), adeno-squamous cell carcinoma (ASC)
* Lymph vascular space invasion allowed (LVSI)
* Age ≥18 years and ≤ 40 years
* Wish to preserve fertility
* Written and signed informed consent
* Negative serum or urine pregnancy test within 14 days prior to registration, and an effective method of contraception must be used during treatment
* MRI abdomen and pelvis, chest X-ray must be performed and negative for metastatic disease within 12 weeks of enrolment
* No metastases on pelvic lymph node dissection
* Laboratory values: serum creatinine \< 140 μmol/L; creatinine clearance \> 60 ml/min(Cockroft formula); white blood cell count \> 3.5 x 109/l; platelets \> 100 x 109 /l

Exclusion Criteria:

* Other high grade histologies like neuro-endocrine and clearcell carcinoma
* FIGO stage Ia, Ib1\< 2 cm, Ib2, II, III and IV disease
* Involvement of tumor in uterine corpus on MRI or hysteroscopy if performed
* Evidence of metastatic disease on imagining (PET/CT/MRI) performed within 12 weeks of enrolment
* other malignancy
Administration of DHEA in Patients With Poor Response to Ovarian Stimulation for IVF

Poor responders to ovarian stimulation represents one of the most frustrating problems in reproductive medicine. The investigators hypothesize that ovarian response of those patients could improve by treating these patients with 25 mg DHEA tid for 12 weeks prior to stimulation.

Patients diagnosed with poor ovarian response will be included in the study. The definition of poor response was based on the presence of at least one of the following criteria: Age \> 40 years old, day 2 FSH \>9.5 mIU/ml, AMH \< 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of HCG. All patients will be counseled regarding their prognosis and other treatment options including oocyte donation as well as adoption were also presented and discussed in detail. All patients will be aware that the use of DHEA is experimental and informed consent was obtained for those agreeing to use the medication. Women in the DHEA group will receive 25 mg of DHEA three times a day for at least 12 weeks. During this period, women will be subjected to monthly measurements of early follicular phase FSH and estradiol. Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment and at the end of the observation period. Patients will be stimulated with a short GnRH-antagonist protocol. Briefly, all women will have measurements of serum FSH and estradiol and a pelvic sonogram on the second day of their cycle. Providing that serum FSH is \< 17 mIU/ml and estradiol is \< 70 pg/ml on day 2 , ovarian stimulation will be initiated with 450 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH. All patients will be re-evaluated on day 5 of the stimulation, and dosage adjustments will be made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) will be initiated. When at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU of hCG ( Pregnyl, Organon, Greece Inc.). Oocyte retrieval will be performed 34 to 36 hours later. All patients will undergo ICSI. Patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval.

Eligibility Criteria:
Inclusion Criteria:

* Women with poor response to ovarian stimulation. The definition of poor response was based on the presence of at least one of the following criteria: Age \> 40 years old, day 2 FSH \>9.5 mIU/ml, AMH \< 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of HCG.

Exclusion Criteria:

* All other women that do not fulfill the above mentioned criteria