cyrilzakka/clinical-trials huggingface dataset:
A Study of MK-4827 for the Treatment of Mantle Cell Lymphoma (MK-4827-002)

This study will investigate the efficacy and safety of MK-4827 in participants with relapsed mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the Ataxia-Telangiectasia Mutated (ATM) gene.


Eligibility Criteria:
Inclusion Criteria :

* Participant must have a diagnosis of MCL that has relapsed after at least one prior chemotherapy regimen or for which the participant has refused standard therapy
* Participant has measureable disease defined by lymphadenopathy, organomegaly, bone marrow involvement and/or circulating lymphoma cells. At least one lesion must be \> 2 cm in the longest diameter and measurable in 2 perpendicular dimensions
* Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Female participants of child-bearing potential agree to use two approved contraceptive methods or remain abstinent throughout the study
* Male participants agree to use an adequate method of contraception throughout the study
* Participant has no history of prior cancer except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no recurrence for five years, or is deemed at low risk for recurrence
* Participant has not had any platelet or red blood cell transfusions or colony stimulating factor support during the month prior to treatment
* Participant has a pre-study diagnostic formalin fixed paraffin-embedded tumor tissue sample available

Exclusion Criteria :

* Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of screening
* Participant has a history of central nervous system (CNS) lymphoma
* Participant requires the use of corticosteroids
* Participant is pregnant, breastfeeding, or expecting to conceive or father children during the study
* Participant is known to be human immunodeficiency virus (HIV)-positive
* Participant has a history of Hepatitis B or C
A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

This research study is designed to look at the effects of the combination of vorinostat (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The investigators will do this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2 weeks.

Key eligibility criteria include:

* Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment
* No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the study)
* No prior or current use of any therapy to treat the current breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Stage I-III invasive breast cancer
* Awaiting surgery or neoadjuvant treatment
* ECOG performance status 0, 1 or 2
* Adequate organ function
* Prior use of hormone contraception or replacement therapy must have been discontinued at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo an additional biopsy for the study)

Exclusion Criteria:

* Prior or current treatment of any kind for the current breast cancer
* Current use of any other investigational drugs
* Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or psychiatric illness
Efficacy of Electroacupuncture (EA) for Women With Pure Stress Urinary Incontinence (SUI)

The purpose of this study is to preliminarily assess the efficacy of electroacupuncture (EA) for women with pure stress urinary incontinence (SUI).

This was a pilot randomized, placebo controlled trial to preliminarily assess the efficacy of EA for women with pure SUI. Eligible participants were randomly assigned to EA group or sham EA group in a 1:1 ratio via a central randomization system by acupuncturists. Participants, outcome assessors and statisticians were blinded to treatment allocation. Subject blinding is achieved via the aid of adhesive pads used in both groups, placebo needle with a blunt tip and sham EA electrode lines. Assuming a two-sided alpha of 0.05, power of 90%, and a 20% drop-out, a sample size of 36 would be needed for each group. The investigators expanded the sample size to 80 cases (40 cases per group) to increase the reliability of the study. The investigators performed statistical analysis based on the intention-to-treat principle. All patients accepting randomization were included in the analysis. Missing data were filled in by the last observed value. Student t tests or Mann-Whitney U tests were used for the comparison of continuous variables; chi-square tests, Fisher's exact tests or Kruskal-Wallis H tests were used to compare categorical variables, as appropriate. For measures collected at two time points, paired t-tests or Wilcoxon signed rank tests were used as appropriate. A statistically significant difference was set at P\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Eligible women were 40 to 75 years of age, and met the clinical diagnosis recommendations of SUI by the International Consultation on Urological Diseases:

  * involuntary urine leakage on effort, exertion, sneezing or coughing which stopped when the stress ends;
  * visible involuntary leakage from the urethra synchronous with increased abdominal pressure, or a pad weight gain \>1 g in 1-hour pad test;
  * without symptoms of urinary frequency and urgency.

Exclusion Criteria:

* Women were excluded from the study if they met any of the following criteria: \*other type of urinary incontinence (UI) (urge, mixed, or overflow UI, etc);

  * symptomatic urinary tract infection;
  * ever received UI or pelvic surgery;
  * a severity of pelvic organ prolapse ≥ degree 2;
  * residual urinary volume \>30 ml;
  * maximum flow rate ≤ 20 ml/s;
  * limited in walking, stairs climbing and running;
  * receiving specialized treatment for SUI, or taking medicine affecting bladder function;
  * serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, multiple system atrophy, injury of cauda equina, or myeleterosis;
  * being pregnant or breastfeeding;
  * with cardiac pacemaker, metal allergy or severe needle phobia;
  * unlike to give written formed consent.
A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers

A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 18 to 55 years
* Informed consent document signed by the subject or a legally acceptable representative
* Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening
* Conditions possibly affecting drug absorption
* 12-lead ECg demonstrating QTc \> 450ms or any other clinically significant abnormalities at screen
* Positive urine drug screen
* Hypersensitivity to moxifloxacin or PF00610335
* Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication
A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer

This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven gastric or gastroesophagic junction adenocarcinoma
* Measurable disease at least in a unidimensional manner. If a unique metastasis constitutes the only disease symptom, histological confirmation will be required
* Metastatic or locally non-surgical primary gastric cancer
* Recurrent gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant chemo-radiotherapy of at least 6 months
* Serum bilirubin\< 2 mg/dl
* Serum creatinine \< or =to 2 times normal superior limit
* Absolute neutrophil count \> or =to 2000/dl
* Platelet count \> or =to 100000/dl
* Hemoglobin \> or =to 10 g/dl
* AST/ALT \< or =to 2.5 times normal superior institutional limit
* Alkaline phosphatase \< or =to 5 times the normal superior institutional limit
* Age \> 18 years
* Performance Status ECOG 0-2
* Written informed consent signed and dated

Exclusion Criteria:

* Symptomatic sensory peripheral neuropathy
* Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial hypertension)
* Any other malignancy diagnosed within 5 years previous to the gastric cancer, with the exception of " in situ " cervix carcinoma or non-melanoma skin cancer
* Concomitant anti-tumoral treatment
* Cerebral metastases
* Unstable heart disease, even though under treatment
* Myocardial infarction within the last 6 months
* Pregnancy or nursing (or women in reproductive life without adequate contraception)
* Significant neurological or psychiatric disorders
Effectiveness of Surgery for Atraumatic Shoulder Instability

We will conduct a randomised clinical trial with the primary aim of determining whether surgical intervention followed by physiotherapy rehabilitation improves pain and disability outcomes more than physiotherapy rehabilitation alone in patients suffering from atraumatic shoulder instability associated with bony/capsulolabral damage. The results of this study will have direct and immediate impact on clinical decision making by establishing definitively if patients presenting with joint damage associated with atraumatic shoulder instability should be referred for surgery before commencing physiotherapy rehabilitation. The results of this study may also result in significant cost savings to the National Health Service if surgical intervention for atraumatic shoulder instability does not result in greater improvement than physiotherapy alone.

A two-arm, patient, physiotherapist and assessor-blinded, randomised controlled clinical trial will be conducted. 140 patients will be randomly allocated into one of 2 groups: a stabilisation surgery group and a control group. Primary outcomes (pain and disability) and secondary outcomes (participant-reported improvement and incidence of shoulder dislocations) will be evaluated at baseline and 6, 12 and 24 months after randomisation. Additional secondary outcomes of shoulder rotation range of motion and strength will be evaluated 6 months after randomisation.

Eligibility Criteria:
Inclusion Criteria:

* feelings of insecurity (apprehension) at their shoulder joint
* provocation of apprehension with drawer and apprehension tests
* evidence labral/capsular injury in the shoulder joint

Exclusion Criteria:

* a history of a high collision shoulder injury precipitating apprehension symptoms
* evidence of bony injury around glenoid rim/and or humeral head
* a pristine joint i.e. no evidence of any structural injury to the joint, capsule or labrum.
* a rotator cuff tear
* neural damage affecting the upper limb
* previous shoulder surgery
1-Day CBT Workshops for PPD

Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each setting and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families (1,2). Indeed, the cost of one case of PPD is estimated to exceed $150,000 (3). Unfortunately, fewer than 15% of women with PPD receive evidence-based care (4), which is at least partly due to difficulties accessing treatment, particularly therapies that are most preferred (e.g., psychotherapy (5)).

Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment (6). Moreover, consensus recommendations such as those made by the US Preventive Services Task Force suggest that screening only occur in settings where evidence-based counselling such as CBT is readily available (7). In order to increase access to treatment, screening efforts have been undertaken by public health units province-wide in Ontario. This has occurred despite the widespread availability of evidence-based psychotherapies.

A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each of 5 settings (Simcoe County, Kitchener-Waterloo Region, Halton Region, Prince Edward County, Elgin County), and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

If this intervention is eventually proven effective, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.

Eligibility Criteria:
Inclusion Criteria:

* infant \<12 months
* 18 years or older
* EPDS score \>10

Exclusion Criteria:

-
Effects of Exercise on VLDL-TG Metabolism

Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis. New evidence indicates that NAFLD is associated with development of heart failure, abnormal ventricular glucose and fatty acid (FA) utilisation and cardiosteatosis. The mechanisms behind cardiac involvement and the progression from NAFL to NASH are poorly understood but must include altered cardiac and intrahepatic lipid handling. In collaboration with renowned research groups from Oxford, Mayo Clinic and Copenhagen we plan comprehensive kinetic studies of heart and liver FA uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (TG) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with NAFL and NASH and the relationship with heart function. In addition, we will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in these subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. We will address these questions using innovative tracer techniques (11Cpalmitate, 11C acetate, 18FDG glucose PET tracers and TG tracers) in combination with hepatic vein catherisation to study cardiac and liver substrate trafficking, as well as NMR spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. Effects of acute exercise as well as GLP-1 agonist and SGLT-2 inhibitor treatment (alone and in combination) will be assessed. The overarching goals are to define abnormalities and differences between NAFLD and NASH in hepatic lipid (FA and TG) metabolism and to assess hepatic, adipose and skeletal muscle lipid and substrate utilisation.


Eligibility Criteria:
Inclusion Criteria:

* • 8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI \> 30).

  * 8 obese subject men with NASH (MR spectroskopi, fibro scanner) (BMI \> 30).
  * age between 40-70 years Written consent before the start of the study

Exclusion Criteria:

* known current disease
* Fixed medical drug consumption except antihypertensive drugs and statins. However, pause statins 3 weeks before the examination date
* Blood donation within the last 3 months prior to the study
* Participation in experiments involving radioactive isotopes within the last 3 months
* Alcohol abuse (over 21 items per week for men and 14 for women)
* Smoking
* Weight over 130 kg
* Cancer patients
* Large intake of medication
AirSense 10 AHI Validation Study

The AirSense 10 platform is able to detect respiratory events at night and report these data via telemonitoring. The accuracy of the AirSense 10 will be compared with scoring with polysomnography (PSG). 100 patients will be observed in a sleep facility under PSG and AirSense treatment.

Sleep disordered breathing is commonly assessed by calculating an Apnea-Hypopnea-Index AHI and a Hypopnea-Index HI to define how frequent breathing or breathing efforts stop during the night. The severity of sleep apnea (SA) is determined by the number of occurring apneas and hypopneas. The respiratory disturbance index (RDI) captures these events and is calculated comprising an AHI but also RERAs via the flow signal. Polysomnography (PSG) is being used in the sleep laboratory as the Gold standard method to document a patient's sleep behavior by tracking air flow, respiratory effort, blood oxygen and electrocardiac as well as electromyographic signals. This way a comprehensive sleep pattern analysis can be created and different forms of SA can be detected. However, the method is laborious and cost-intensive, so it could save time and costs to have events accurately scored by the device itself. Device data become important when tracking a patient's sleep night by night and not only once. Reliable sleep data can be a valuable tool for tailoring sleep therapy to specific patient's needs. Accurate device data also build the foundation for analysis of large amounts of data, which can help us understanding how sleep disorders develop.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years who are able to understand and follow the instructions of the study personnel
2. Patients with an indication for PAP therapy or currently adherent to PAP therapy (device usage ≥4 h/ night) for moderate to severe sleep apnoea and diagnostic AHI ˃15/h and/or a residual CAI ˃5/h
3. Patients with currently titrated fixed CPAP pressure ≥8 cmH2O; or 95th percentile APAP pressure ≥8 cmH2O; or ASV therapy with a 95th percentile IPAP of ≥8 cmH2O
4. Patients who are established PAP users (PAP use duration ≥6 weeks)
5. Dated and signed written informed consent

Exclusion Criteria:

1. Patients with moderate to severe obstructive airway disease and/or respiratory insufficiency
2. Patients with heart failure in NYHA class III or IV, unstable hypertension, paroxysmal/persistent atrial fibrillation, unstable angina pectoris, cardiac or cerebral ischemic events within the last 6 months before screening
3. Patients with current primary or secondary insomnia
4. Patients who are pregnant or breastfeeding
5. Patients who are physically unable to comply with the protocol
Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza

A Pilot Study to Evaluate the Safety and Efficacy of interferon-Alfacon1 (INFERGEN) in the treatment of patients hospitalized with Influenza-like illness caused by a novel swine origin Influenza virus and other circulating Influenza Viruses.

The use of Interferon-alfacon1 as a co-treatment along with the standard of care antiviral is hypothesized to be safe. Clinical improvement of patients is hypothesized to be quicker.

The purpose of this study is to see if using a medication called INFERGEN, can help get rid of the virus and/or can help the immune response to prevent the illness from getting worse in the lungs. We hope that INFERGEN will either prevent patients from getting worse and requiring intensive care or will decrease the time for which they will need intensive care.

The Interferon-alpha (also called Interferon-alphacon1 or IFN-alphacon1 or INFERGEN) is an immune molecule, which has been shown to work against different viruses (anti-viral). Interferon is the standard of treatment for patients with chronic (infection that has been there for a long time) hepatitis C (a virus which affects the liver over many years) by giving it for 6-12 months. It has also been used for a shorter time of up to 14 days, in a small study for patients with respiratory disease caused by SARS and seemed to help these patients get better more rapidly. It also has been shown to stop different Influenza viruses from growing in test tubes and in lung tissue. It has also been shown to decrease the immune response to prevent it from over-reacting to viruses.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Aged \>=18 and \< 70
* Hospitalized
* suspect, probable, confirmed influenza A
* symptom onset \<8 days
* able to attend all scheduled visits

Exclusion Criteria:

* known hypersensitivity to interferon preparation
* pregnancy
* chronic liver disease
* moderate to severe congestive heart failure, grade III or IV left ventricular function
* previous history of serious psychiatric illness
* history of severe or active autoimmune disease