cyrilzakka/clinical-trials huggingface dataset:
Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML)

This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML.

The Pilot Safety portion of the study will evaluate the safety of obatoclax administered by a 3 hour infusion for 3 days in a row. The Pilot Schedule portion of the study will randomize 16 patients in to one of two cohorts: 1) patients receiving obatoclax administered by a 3 hour infusion for 3 days in a row or 2) patients receiving obatoclax administered by a 24 hour infusion for 3 days in a row. The schedule with the best overall efficacy and safety in the Pilot Schedule portion of the study will then be utilized in the Phase II portion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed AML
* No prior chemotherapy for AML (with the exception that the patients enrolled in the Pilot Safety evaluation may have had 1 prior therapy)
* Age ≥70 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
* Patients must have normal organ function as defined below:

  1. Total bilirubin \< or = 2 mg/dL unless resulting from hemolysis,
  2. Aspartate transaminase (AST \[SGOT\])/alanine transaminase (ALT \[SGPT\]) \< or = 2.5 x institutional ULN
  3. Creatinine within normal institutional limits, OR creatinine clearance \> or = 50 mL/min/1.73 meters squared for patients with creatinine levels above institutional ULN

Exclusion Criteria:

* Patients who have received or are receiving any other investigational or commercial agents or therapies administered with the intent to treat their malignancy (with the exception that the patients enrolled in the pilot safety evaluation may have had 1 prior therapy)
* patients with history of allergic reactions attributed to components of the formulated product (PEG300 and polysorbate 20)
* patients with history of seizure disorders or central nervous system leukemia
* patients with uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled, systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements
* Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
Cyanobacteria Allergy in Lake Kineret

People swimming or surfing in lake Kineret , sometimes complain of nasal stuffiness , sneezing and itching .Typically, it happens during or immediately after contact with the lake's water . The symptoms are compatible with immediate allergic reaction. Previous reports suggested a connection between similar symptoms and contact with different cyanobacteria (living in fresh water lakes). In this study we intend to prove the mechanism of these reactions. To prove the exact allergen that causes allergic rhinitis allergists perform skin tests with different suspected allergens. Likewise, we would like to perform skin tests to different proteins extracted from cyanobacteria collected in lake Kineret.


Eligibility Criteria:
Inclusion Criteria:

* age above 18
* exposed to Lake Keneret water by swiming or sirfing

Exclusion Criteria:

* age under 18
* pregnancy
PRospective Prostate biOmarker Study

• Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness

The main objective of this study is to correlate a glycoprotein panel with prostate biopsy outcome, i.e. distinguishing PCa from benign prostatic conditions as well as high-grade cancer. The quantities of the two protein analytes cathepsin D (CTSD) and thrombospondin 1 (THBS1) are measured in human serum samples. In combination with percent free PSA (%fPSA), the results are correlated with prostate biopsy outcome. The potential future benefit of using this glycoprotein panel is to validate positive tPSA tests in men with negative digital rectal examination (DRE) and enlarged prostates to reduce the need for undergoing a biopsy, thereby reducing unnecessary biopsies and potentially predicting high-grade disease.

Eligibility Criteria:
Inclusion Criteria:

* Male patient between 45 and 80 years old.
* tPSA between 2 and 10 ng/ml
* Prostate volume \>=35 ml
* Non-suspicious DRE for prostate cancer
* Scheduled for prostate biopsy
* Patient must give written informed consent

Exclusion Criteria:

* Patient not undergoing biopsy of the prostate
* Prior prostate biopsy within the last 12 months
* Transurethral resection of the prostate (TURP) in the last 5 years
* Patients with known acute or chronic prostatitis/cystitis or other known prostate abnormalities
* Patient taking 5-alpha-reductase inhibitor
* Any other prior treatment of the prostate (cryoablation, hifu, ire, radiation therapy, alcohol instillation, etc.)
Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

The purposes of this study are:

* To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
* To determine the feasibility and toxicity of the combination of topotecan and docetaxel.

The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.

Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.

Eligibility Criteria:
Inclusion Criteria:

* Recurred greater than 90 days after initial treatment
* At least 1 measurable lesion
* Only 1 prior chemotherapy
* Must be over 18 years of age
* ECOG performance status of 0 - 2
* Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

* No prior use of topotecan, docetaxel, or irinotecan
* No symptomatic brain metastases
* History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
* No prior investigational agents within 1 month prior
* Lung cancer of mixed histology
* Known uncontrolled seizure disorders
Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis

Diastasis Rectus abdominis is a common condition in pregnant and postpartum women, where the connective tissue between the two muscle bellies of the rectus abdominis muscle is stretched and weakened, causing an increased inter-rectus distance. Treatment of this condition aim to reduce the inter-rectus distance, and conservative treatment including therapeutic exercise is the primary treatment of choice. To date, there is no generally accepted protocol of therapeutic exercises for this condition, and the evidence as to which exercise modality is the most effective and feasible in reducing the inter-rectus distance in women presenting with diastasis rectus abdominis is both sparse and weak. As this condition occur during the last two trimesters of pregnancy and as there is a paucity of high-quality studies on a pregnant population, investigators will conduct a randomized controlled trial on the effect of a specific exercise program during pregnancy on diastasis rectus abdominis.

100 pregnant women in gestation week 25 presenting with diastasis rectus abdominis of ≥ 28 mm will be included. Participants will be allocated to either an intervention group or a control group by block randomization. The intervention group will participate in a 12-week specific exercise program, consisting of two group sessions and two self-managed sessions weekly. The control group will not participate in any exercise intervention; however, participants will be recommended to follow national guidelines for general exercise during pregnancy. Participants will be assessed prior to intervention, post intervention at gestation week 37, and 6 weeks, 6 and 12 months postpartum. The primary outcome measure will be change in the inter-rectus distance in mm, measured by two-dimensional ultrasonography.


Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women
* in gestation week 25
* presenting with an inter-rectus distance of 28 mm or more at the level of the umbilicus, and/or 2 cm above and below the umbilicus at rest on initial assessment. Participants presenting with a protrusion along the Linea Alba will also be included, even if they do not meet the inclusion criteria with an inter-rectus distance of 28 mm or more
* Both primi- and multigravida women will be included, and there will be no limitations on number of fetuses

Exclusion Criteria:

* pregnancies where exercise is contraindicated
* serious illnesses regarding both mother and fetus
* inability to understand Scandinavian languages
* failure to complete and present an informed consent form
* presence of chronic physical or mental illness incompatible with the intervention

Exclusion criteria during the study period is stillbirth or premature birth before gestation week 37; onset of serious illnesses regarding both mother and foetus; and pregnancies where exercise is contraindicated
Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals

A convenience sample of 20 participants, 18 years or older healthy individuals were recruited. Participants were excluded if they report being pregnant or being treated for a musculoskeletal injury. After explanation of the study and consent were obtained, each participant completed background information and the Cumberland Ankle Instability Tool (CAIT). Participants began by completing a 1 minute, 3mph walking gait assessment while unbraced, followed by a 2-minute, 6mph unbraced running assessment. Following the unbraced condition participants were randomly assigned into 1 of 4 conditions: \[1\] Active Ankle 329 Ankle Sleeve, \[2\] AS1Pro, \[3\] Eclipse 1, or \[4\] Eclipse 2. Participants placed an assigned brace on each ankle and then repeated the walking gait and running assessments. After this test the participants filled out a 10-item satisfaction questionnaire, and then were randomly assigned a second brace. The protocol was repeated until they have completed the walking, running, and satisfaction survey in all 4 brace conditions.

A convenience sample of 20 participants, 18 years or older healthy individuals were recruited. Participants were excluded if they report being pregnant or being treated for a musculoskeletal injury. After explanation of the study and consent were obtained, each participant completed background information and the Cumberland Ankle Instability Tool (CAIT). Participants began by completing a 1 minute, 3mph walking gait assessment while unbraced, followed by a 2-minute, 6mph unbraced running assessment. Following the unbraced condition participants were randomly assigned into 1 of 4 conditions: \[1\] Active Ankle 329 Ankle Sleeve, \[2\] AS1Pro, \[3\] Eclipse 1, or \[4\] Eclipse 2. Participants placed an assigned brace on each ankle and then repeated the walking gait and running assessments. After this test the participants filled out a 10-item satisfaction questionnaire, and then were randomly assigned a second brace. The protocol was repeated until they have completed the walking, running, and satisfaction survey in all 4 brace conditions.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals who are able to run for 10 minutes total

Exclusion Criteria:

* pregnancy, lower body injury
Assessment of Ventilation Using Respiratory Volume Monitor Compared to Capnography During Intravenous Sedation

A. Determine if Respiratory Volume Monitor (RVM) can be used during procedural sedation to adequately monitor patient's respiratory status as compared to capnograph Aims B. Compare the time of capture of respiratory events (depression, arrest, etc...) on both the RVM and the capnograph C. Compare the incidence of missing or poor quality readings between the RVM and the capnograph D. Compare RR readings between the RVM and the capnograph (during periods with adequate data quality on both devices) E. If RMV can identify respiratory obstruction. Capnography

Rationale for Proposed Research: Continuous respiratory monitoring using the ExSpiron System will be particularly beneficial to patients receiving intravenous propofol breathing spontaneously with natural airway. Assessment and management of respiratory function and early intervention when indicated is a multifaceted, complex task often complicated by the unavailability of a cohesive and continuous monitoring system to guide clinical decisions. The ExSpiron system is designed for these patients and is intended to address some of the limitations of the current generation of hospital monitors and to provide healthcare providers with continuous real-time data regarding the patient's respiratory status. Recent RVM data has shown that stratification of patients based on the MV % of predicted, prior to opioid dosing has made it possible to identify patients who are at risk for further decrease in MV and opioid-induced respiratory depression (OIRD).

1. In the spontaneously breathing, non-ventilated patient, current monitoring devices do not provide continuous, objective non-invasive, continuous real time information of important respiratory parameters such as TV, MV and RR.
2. Current monitoring of non-intubated patients mostly relies on oximetry data, subjective clinical assessment and occasionally EtCO2 measurements. In appropriate clinical settings, the ExSpiron system can provide direct quantitative measure of ventilation parameters for use in clinical assessment and trend prediction as well as response to medications and other interventions.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria: patient's ≥ 20 years of age receiving intravenous sedation, or intravenous general anesthesia with propofol.

Exclusion Criteria:

Criteria: patients not able to give informed consent, Inability to place the PadSets on the thorax. Existence of an active implanted neurostimulator.
Acceptability and Palatability Study of Paediatric Amino Acid Feed

Product acceptability and palatability data from a minimum of 15 participants are required to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) for Ireland for product registration

The study product, Alfamino Junior (neutral or vanilla flavour) is a is a food for special medical purposes, as defined by EU Regulation No 609/2013, ACBS approved, prescribable on FP10 (GP10 in Scotland).

Alfamino Junior (neutral or vanilla flavour) is is for complete nutritional support of children ≥1 year with cows' milk allergy, multiple food allergies and other conditions where an amino acid formula is recommended.

This is an open label nonrandomised acceptability, palatability and compliance study to evaluate the tolerance of the study formulas in 15 children.

Palatability is recorded over a 7day study period, acceptability is recorded days 1-7 and days 22-28 of the study period, with patient compliance recorded over the full 28 day study period

Eligibility Criteria:
Inclusion criteria:

* Children ≥1 year of age who require an amino acid-based formula (ideally already established on Alfamino or another amino acid formula dependent on feasibility of reaching required numbers or currently on a plant-based milk and need extra nutrition from an amino acid formula) for the dietary management of presumed CMA, or multiple food allergies and other conditions where an amino acid formula is recommended
* All children ≥1 year of age where they are consuming either orally or via a tube 200mls or more of amino acid formula.
* Children with the ability to indicate palatability of the formula (NB there will be simple symbols to help young children and nonverbal children indicate whether the formula is palatable). If an infant is tube fed if they are able to have tastes orally.
* Willingly given, written, informed consent from patient or parent/guardian.

Exclusion Criteria:

* Inability to comply with the study protocol, in the opinion of the investigator.
* Children less than 1 year of age
* Children with significant renal or hepatic impairment
* Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator e.g. thickener, PPIs etc (must be recorded in patient case record file).
* Participation in another intervention study within 2 weeks of this study.
* Caregiver unable to read and write in English (will need to complete 1 month of forms at home on behalf of participants).
The Correlation Between Psychological Capital, Intention to Leave, Work Job and Environment Satisfaction, and Political Skills Among Different Generations Nurses

Purpose

1. To understand the current status of demographic characteristics, inclination to resign, Psychological Capital, work environment and job satisfaction, and political skills among incumbent clinical nursing staff across different generations.
2. To understand the correlation and interaction between demographic characteristics, inclination to resign, Psychological Capital, work environment and job satisfaction, and political skills among incumbent clinical nursing staff across different generations.

Expected outcomes

1. This study will provide objective and empirical data on the psychological capital, turnover intention, work environment and satisfaction, and political skills of clinical nursing personnel from different generations. By examining demographic variables, further exploration of the correlations among different attributes such as units, age, and positions (e.g., clinical nurses, nursing supervisors, specialist nurses) can be conducted. Through the research findings, the current status and needs of clinical nursing can be understood.
2. The results of this study will enable clinical nursing units in the future to implement measures to improve the psychological capital and address turnover intentions of nursing personnel from different generations and positions. Based on this objective and concrete data, relevant courses or training programs can be developed to retain excellent clinical nursing personnel.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or older.
* Currently employed in a hospital and possessing a nursing license.
* Willing to participate in this study.
* Currently employed as full-time or part-time nursing staff at the hospital.

Exclusion Criteria:

* Nursing staff who do not possess a nursing license.
* Nursing staff who are unwilling to participate in the study.
* Nursing staff who have already completed the related research questionnaire in the pilot study.
Bioavailability of ABT-450 and ABT-267 With Ritonavir

A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in combination with each other and Ritonavir(r).

Absolute bioavailability of ABT-267 and ABT-450 in the body when given together

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or non-pregnant, non-lactating healthy females
2. Body mass index of 18.0 to 30.0 kg/m2
3. Must be willing and able to communicate and participate in the whole study
4. Must provide written informed consent
5. Must agree to use an adequate method of contraception
6. In a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

1. Participation in a clinical research study within the previous 3 months or in an absorption, distribution, metabolism, and excretion (ADME) study within the previous 12 months
2. History of any drug or alcohol abuse in the past 2 years or current smokers and those who have smoked within the last 12 months or a positive cotinine urine test at screening and admission
3. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
4. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
5. Donation or loss of greater than 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within the previous 8 weeks
6. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies within the 14 days or any drug by injection (including vaccines) within 30 days or within 10 half-lives of the respective medication, whichever is longer, before Investigational Medical Product (IMP) administration
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children

The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI) administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.


Eligibility Criteria:
Inclusion Criteria:

* subjects of both sexes
* aged between 6 and 25 years,
* weight : ≥ 20kg
* with suspected GAS-induced tonsillitis (erythema and/or exudate of the pharynx and/or tonsils with oropharyngeal pain and/or odynophagia, fever ³ 38°C, appreciable satellite adenopathy)
* confirmation by positive RDT
* provision of throat swabs for culture
* ability to swallow tablets

Exclusion Criteria:

* Related to the study disease:

  * suspected viral infection (concomitant dysphonia, cough, conjunctivitis, rhinitis)
  * adenophlegmon, peritonsillar abscesses.
* Related to the study treatment:

  * known or suspected allergy to beta-lactamines (penicillin, cephalosporin)
  * suspected infectious mononucleosis (increased risk of skin disorders)
  * phenylketonuria (due to the presence of aspartame)
  * congenital galactosaemia, glucose/galactose malabsorption syndrome, lactase deficiency (due to the presence of lactose, in powder or suspension form)
  * allergy to pristinamycin and/or virginiamycin
  * history of pustular rash with pristinamycin
  * hypersensitivity or gluten intolerant (due to the presence of wheat starch)
  * ongoing treatment with cyclosporine, methotrexate, colchicine, allopurinol, tacrolimus or oral anticoagulants.
* Related to previous treatment:

  * subjects receiving antibiotic therapy in the month prior to inclusion, except for azithromycin, for which the exclusion period is 3 months.
  * subjects on short-term corticosteroids. Subjects on long-term corticosteroids initiated before the start of the study and taken at a controlled dosage may be included.
* Related to subjects:

  * breast-feeding women
  * women either pregnant or attempting to conceive
  * subjects likely, during the course of the study to receive treatments prohibited by the protocol
  * treatment with other investigational drugs in the 4 weeks prior to inclusion in the study
  * immunodepression, clinically significant endocrine disease, cardiovascular disease, neurological disease, or any other marked diseases resulting in complications in performance of the study or interpretation of the study data
  * known hepatic impairment
  * known renal impairment (creatinine clearance \< 30 ml/minute)
  * cancer, blood dyscrasias
  * previous history of drug or alcohol abuse.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.