cyrilzakka/clinical-trials huggingface dataset:
Study of Intratumoral Hypoxia Using Pre-operative Administration of Pimonidazole

This study involves the administration of a hypoxia marker, pimonidazole hydrochloride, taken orally approximately 24 hours before surgical resection of a pancreatic tumor in order to identify areas of lower oxygen content on tumor samples.

Intratumoral hypoxia (low oxygen concentration or pO2) occurs when oxygen consumption exceeds its delivery by the vascular system. Hypoxia is associated with adverse patient outcome in many human cancers and this association is hypothesized to be due to a combination of treatment resistance and aggressive tumor biology.

The study of hypoxia is also important as new cancer drugs are being developed that are specifically active on cancer cells in area of tumors with lower oxygen levels.

his study involves administering the hypoxia probe pimonidazole hydrochloride to patients prior to resection of pancreatic adenocarcinoma to evaluate the extent, molecular context and clinical relevance of hypoxia in clinical pancreatic cancer samples and the subsequently derived primary xenograft tumors.

We propose accrual of patients over a 5-year period to evaluate hypoxia within 100 clinical tumor specimens and corresponding primary xenograft tumours where available. The complementary techniques of wide-field multicolor fluorescence image analysis microscopy and high level flow cytometry will be used to identify potential relationships between intratumoral hypoxia and cell proliferation, differentiation, and the expression of putative cancer stem cell markers.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* provisional diagnosis of pancreatic cancer
* scheduled resection at UHN
* consented to ICGC Pancreatic Cancer Genome Project
* surgery planned for \>2 days away (drug administration has to be 16-20hrs before surgery)

Exclusion Criteria:

* not participating in ICGC
* contraindications to pimonidazole (allergy)
* surgery scheduled for same or next day (not enough time to arrange for drug administration)
Cancer, Physical Activity and Quality of Life- a Longterm Follow up

This project is a 6-8-years follow-up of a randomized controlled trial testing a stepped care stress management program. The main goal is to examining differences in long-term effects on cancer-related stress reactions and emotional reactivity between the intervention and control group. Secondary objectives is to investigate consequences of cancer and its' treatment over time, such as long term quality of life, objectively physical activity and experiences concerning follow-up and the transition from specialist health services to municipal health services.

Major improvements in cancer detection and treatment lead to longer life expectancy among cancer survivors. This may in turn lead to more late effects and many have to deal with long-term consequences of the disease and its' treatment. Returning to everyday life and to work is often an important part of returning to normal life for cancer survivors. There is increasing knowledge concerning late effects, but there is still lack of knowledge concerning the life of those experiencing late effects. There is a need for more knowledge about late effects' impact on the return to work prosess, physical activity and quality of life over time. Both quantitative and qualitative methods will be utilized. Standardized questionnaires will provide information on the effect of the intervention over time, in addition to quality of life over time. Sensewear armband will provide information about their physical activity over time. Official register data from the Norwegian Labour and Welfare Administration (the NAV administration) will provide us information about the work- and benefit situation through the whole follow-up period of 6-8 years. The register data include information about type of social benefits (sick-leave benefit, work assessment allowance (WAA), disability pension, unemployment benefit and retirement pension), as well as information about occupation, income and sick leave diagnosis. Focus group interviews will give us insight in the cancer survivors own experiences with quality of life over time, the transition from the specialist health services to the primary health care and the follow-up in the municipalities.

Eligibility Criteria:
Inclusion Criteria:

* Stage I-III disease
* Scheduled for neo/adjuvant or curative treatment (i.e. chemotherapy, radiation therapy or hormonal therapy or any combination of these therapies)

Exclusion Criteria:

* On-going psychiatric condition
* Lack of fluency in Norwegian
* A previous diagnosis of cancer
ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices

This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
2. Male and female patients ≥18 years at day of inclusion
3. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
4. Patients that have an LVAD implanted for chronic heart failure and which are clinically stable for at least 6 months after LVAD implantation in the opinion of the investigator
5. 6 min walk distance \>50 m
6. Mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration ≥7 g/dl and \<12 g/dl in females or ≥8 g/dl and \<13 g/dl in males, and serum ferritin \<100 µg/l, or 100-300 µg/l and transferrin saturation \<20% at screening
7. Women of childbearing potential must:

Have a negative pregnancy test at screening Agree to use reliable methods of contraception during the course of the study

Exclusion Criteria:

1. Active hematological disorders other than iron-deficiency anemia
2. Other medical condition that according to the investigator's assessment is causing or contributing to anemia
3. Active malignancy
4. Active infectious disease
5. Active bleeding
6. Severe renal insufficiency (requiring dialysis)
7. Severe liver injury as indicated by serum aminotransferases \>3 x upper limit of normal or bilirubin levels \>50 µmol/l
8. Ongoing oral or intravenous iron supplementation
9. Concomitant erythropoietin medication
10. Pregnancy or lactation period
11. Subject has received any investigational medication or any investigational devices within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/ devices trial, or is scheduled to receive investigational drug/devices during the course of the study.
12. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
13. Known haemochromatosis or other iron overload syndromes
14. Patients who have been receiving repeated (\>1) blood transfusions during the past 6 months
Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years


Eligibility Criteria:
Inclusion Criteria:

* At least 6 and maximally 11 years of age
* Diagnosis of asthma
* Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start

Exclusion Criteria:

* Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study
A Double-Blind Study to Evaluate the Effect of Femarelle® on Menopausal on Vasomotor Symptoms

The purpose of this study is to test the effects of Femarelle ( a plan-derived SERM) on hot flushes and quality of life in menopausal women. Our hypotheses are that compared to placebo, Femarelle reduces the daily number of hot flushes and their severity and also improves the quality of life as measured by validated dairies and questionnaires.

Symptomatic menopausal women will be divided to treatment with Femarelle or placebo for 12 weeks after two weeks of baseline record. Hot flashes daily diary will be recorded daily and a quality of life questionnaire will be filled at the beginning and at completion of the study.

Eligibility Criteria:
Inclusion Criteria:

1. postmenopausal women, i.e 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/
2. More than 7 hot flushes per day or over 50 per week at baseline.
3. Women should have documentation of a negative screening mammogram (obtained at screening or within 1 year of study enrolment.
4. Normal pelvic and breast exams by investigator prior to enrolment.
5. All subjects who have a uterus should have endometrial thickness of less than 5mm in vaginal sonogram exam at randomization.
6. Informed consent to participate in the study.

Exclusion Criteria:

1. Use of any medication or supplements for menopausal symptoms, such as estrogen/progestin containing drug products, Isoflavons, phytoestrogens and SERM within a minimum of 8 weeks prior to pre-study screening period.
2. Use of SSRIs, St. John's Wort, within a minimum of 8 weeks prior to pre-study screening period.
3. Any clinically unstable or uncontrolled renal, hepatic, endocrine, respiratory, hematological, neurological, cardiovascular or cerebrovascular disease that would put the subject at safety risk or mask measure of efficacy
4. Evidence or history of vascular disease (such as ischemic heart disease), Cerebrovascular accident (such as stroke or transient ischemic attack) or deep vein thrombosis (blood clots), or thromboembolic disorders.
5. Personal history of breast cancer
6. Abnormal clinically relevant vaginal bleeding
7. Any clinically relevant (opinion of investigator) abnormal finding during physical, gynecological and breast examination at screening
8. Abnormal, clinically significant results of mammography
9. Malignancy with the exception of BCC of the skin
10. Known hypersensitivity to gluten, soybeans, soy protein, estrogens and/or progestins
11. History of severe recurrent depression, or severe psychiatric disturbance. Untreated or uncontrolled high blood pressure (hypertension)
12. Participation in a clinical trial within 30 days prior to screening Known substance abuse (alcohol or drug)
13. Unable to comply with study protocol
Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

The study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the treatment of fibromyalgia; a second phase intends to evaluate if the addition of pregabalin to patients who have shown a partial response to trazodone additionally improves fibromyalgia symptomatology.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria
* written, informed consent
* able to understand and comply with the requirements of the study

Exclusion Criteria:

* pregnancy or breastfeeding
* unwillingness to discontinue other prescribed medications before entering in the study
* patients who had previously received trazodone without improvement or who did not tolerate the drug
* patients who had previously received pregabalin without improvement or who did not tolerate the drug (only for the phase II of the study)
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).

Eligible subjects must meet the International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD). Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol titrated to either 150 mg, 300 mg, or placebo once per night shift for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Meets International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD)
* Provides written informed consent to participate in the study before the conduct of any study procedures.
* Male or female, aged 18 to 65 inclusive.

Exclusion Criteria:

* Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.
Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects

The purpose of this study is to investigate the safety and tolerability of trospium chloride (Sanctura XR™) and metformin hydrochloride (Glucophage) when co-administered.


Eligibility Criteria:
Inclusion Criteria:

* Weight within +/-30% of ideal body weight for height and frame size
* Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 1 months prior to the screening visit).
* Willing to abstain from caffeine-containing food and beverages for 24-hours prior to dosing, alcohol-containing food and beverage for 48 hours prior to dosing, and Seville oranges (eg orange marmalade), grapefruit, or grapefruit juice for 7 days prior to the dosing and abstain from all throughout the study.
* Willing to abstain from taking medications (with the exception of hormonal contraceptives) and nonprescription medication including vitamins, food supplements, and herbal preparations for 7 days prior to Day-1 of the first treatment period and throughout the study.

Exclusion Criteria:

* Uncontrolled systemic disease
* Known allergy or sensitivity to the study medication(s) (Trospium, Metformin)or its components
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
* History of myasthenia gravis or closed-angle glaucoma.
* Considering or scheduled to undergo any surgical procedure during the study.
* History of alcohol or substance abuse within 1 year prior to Day-1 of the first treatment period.
* History of serious mental or physical illness.
* Donated in excess of 500 mL of blood in the 30 days prior to the screening visit.
* Required treatment with any medications, either prescription or nonprescription (including vitamins, antacids, acid-reducers, food supplements, and herbal preparations, excluding hormonal contraceptives), within 7 days prior to Day-1 of the first treatment period during the study.
* Had an acute illness within 5 days prior to Day-1 of the treatment period.
* Had a history of hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of human immunodeficiency virus (HIV) infection or demonstration of HIV antibodies.
* Planned radiologic study requiring intravenous contrast administration of iodinated contrast material during the study period Serum Creatinine greater than 1.4 mg/dL.
Research of Predictive Factors to Immune Thrombopenic Purpura

It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.

It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.

The principal endpoint is to evaluate if the medullary cytogenetics is the predictive factor of the diagnosis of PTI in front of a thrombopenia isolated in elderly.

The secondary endpoints are :

* to identify at the time of the diagnosis, the factors and/or predictive markers correlated in the final diagnosis of PTI or SMD
* to study the respective frequency of the PTI and the SMD in front of a thrombopenia seemingly isolated of the subject of more than 60 years.

  200 patients will be included. 160 patients should be assessable at the end of study by considering the excluded patients, the dead and the lost sight.They will be followed every 4 months, during two years.

In every visit, will be realized a clinical examination, a blood film, a haemogram.

If the haemogram is abnormal, a bone marrow biopsy is realized. The patient who presents a myelodysplastic syndrome is excluded.

Eligibility Criteria:
Inclusion Criteria:

* Rate of platelet \< 100 G/l for less than 12 months ,
* age = ou \> 60 years,
* haemoglobin \> ou = 12 g / dl at the woman, \> ou = 13 g/dl at the man,
* polymorphonuclear neutrophil \> ou = 1.7 G/l,
* monocytes \< ou= 1 G/l,
* lymphocytes \< ou = à 4 G/l,
* VGM \< 100 fL, blood film normal,
* informed consent,
* expectation of life \> 6 months

Exclusion Criteria:

* hepatomegaly,
* splenomegaly,
* hepatic abnormality,
* blood coagulation abnormality,
* antecedent of auto-immune disease,
* drug thrombopenia,
* HIV, VHB or VHC positive,
* antecedent of malicious tumor in the 5 years before inclusion
Comparison of Three Methods for Fetal Weight Estimation

The aim of this study was to compare maternal, clinical and ultrasound estimations of fetal weight in women with severe (BMI\>35) and morbid (BMI\>40) obesity and to determine the effect of maternal body mass index (BMI) on these estimations.

Accuracy of fetal weight estimation is of key importance in antenatal care, as well as in the planning and management of labor and mode of delivery. In order to achieve more accurate prenatal fetal weight estimations and align these with a risk-optimizing mode of delivery, additional tools supporting the standard of use with ultrasound are needed.

The main ultrasonic methods used to calculate the weight of a fetus are based on measurement of fetal abdominal circumference (AC) and estimated fetal weight (EFW) using a formula first described by Hadlock, and the sufficient accuracy of this model has recently been proven.

Leopold's maneuvers have a long-standing tradition in obstetrics and midwifery. By placing both hands on the woman's abdomen the examiner can describe the position of the fetus as well as the level of the uterine fundus and thus detect a disproportion between fetus and the female pelvis. Experienced examiners are able to give a clinical estimation of fetal weight after performing Leopold's maneuvers including symphysis-fundal height and abdominal palpation. Maternal body mass index (BMI) has been shown to affect the accuracy of EFW. For example overweight (BMI\>25) patients had found an absolute % error \>10% in fetal weight estimation in 42.2% and 24.4% of cases, using Leopold's maneuvers and ultrasound, respectively. Maternal estimation of the fetus weight is as accurate as physicians; clinical estimations, and is advised as a complementary method of assessment. The aim of this study was to compare maternal, clinical and ultrasound estimations of fetal weight in women with severe (BMI\>35) and morbid (BMI\>40) obesity and to determine the effect of maternal body mass index (BMI) on these estimations.

Pregnant women ≥ 37 weeks and with BMI ≥ 35 with singleton who are admitted before delivery will be offered to participate in the study.

1. A clinical weight estimate will be performed by a trained professional physician using Leopold's maneuvers.
2. An ultrasonographic estimate will be performed in our ultrasound unit and a calculation by the ultrasound machine is based on Hadlock's formula \[3\] including measurement of biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL).
3. For maternal estimate, patients will be asked to give a fetal weight estimation.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ≥ 37 weeks
* BMI ≥ 35
* Singleton pregnancies
* Fetal weight estimate within two weeks from delivery

Exclusion Criteria:

* Primiparity
* Women who will give birth in a different hospital
* Multiple pregnancy
* Moderate to severe polyhydramnios
* Severe fetal malformations - such as hydrocephalus, hydrops fetalis
* Maternal age \< 18 years
Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain

The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of osteoarthritis (OA) of the knee
* OA knee pain present for at least 3 months
* OA knee pain is the predominant (ie, most painful) pain condition
* Patients require medication on at least 4 of 7 days per week to treat OA knee pain for at least 1 month.
* Dissatisfaction with current OA knee pain treatment and willingness to stop taking all pain medications except for the study drug and allowed rescue medication
* Average daily pain rating of at least 5 on a 0 to 10 point numerical rating scale during the 1 week prior to randomization
* Female patients either postmenopausal, surgically sterile or practicing a medically acceptable method of contraception
* Male patients either status post-bilateral vasectomy or using barrier contraception

Exclusion Criteria:

* Knee pain due to a disorder other than OA
* Other pain that can confound the assessment of, or contribute to, pain at the reference knee
* Surgery at the reference knee within 6 months of Screening or a history of joint replacement surgery at the reference knee
* Trauma to the reference knee within 6 months of Screening with active symptoms
* Steroid injections in the reference knee within 3 months of Screening
* Hyaluronic acid injections in the reference knee within 6 months of Screening
* Body Mass Index \> 40 kg/m2
* Patient with any protocol-excluded or clinically significant medical, surgical, or medication history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments