cyrilzakka/clinical-trials huggingface dataset:
Study of Cytochrome P450 Polymorphisms (CYP2D6, CYP3A4/5 and CYP2C19) in Breast Cancer Patients

The genetic polymorphisms of the cytochrome P450 may influence on the metabolism of tamoxifen.

The investigators want to

* evaluate the frequency or incidence of the genetic polymorphisms of cytochrome P450 subfamilies(CYP2D6, CYP3A4/5 and CYP2C19) in breast cancer patients, and
* analyze the association between the genetic polymorphisms of cytochrome P450 subfamilies and clinical outcomes in breast cancer patients treated by adjuvant tamoxifen therapy.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Breast cancer patients who underwent surgery

Exclusion Criteria:

* None
Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring

The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.

32 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water drinking test (WDT). SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will be measured on the contra lateral eye using Goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes.

After the water drinking, IOP will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. The IOP will be measured again every 20 minutes until 2 hours after the water drinking.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer without previous ocular medical history
* 18 years or more at inclusion
* Maximal weight: 100kg
* BMI lower or equal to 30 kg/m2
* Subjects having provided informed consent

Exclusion Criteria:

* Silicone allergy
* Cardiovascular disease
* Diabetes
* Narrow or closed iridocorneal angle
The Effects of SlumberCurve™ Following Rotator Cuff Surgery: a Randomized Control Trial

The purpose of this study is to investigate the effects of a novel sleep aid known as SlumberCurve™, which serves as an adjustable form of a wedge pillow, on sleep quality and pain management following rotator cuff repair. The researchers hypothesize that SlumberCurve™ will significantly improve sleep quality and reduce night-time pain.

Poor sleep quality is prevalent among patients undergoing rotator cuff repair surgery, and negatively affects the potential for proper healing. Without adequate sleep, the production of anabolic steroids and inflammatory cytokines are diminished. These anabolic steroids and inflammatory cytokines play a key role in postoperative healing, resulting in adequate pain regulation and increased patient satisfaction. Therefore adequate sleep quality is important not only for quality of life, but for postoperative healing. A recent systematic review revealed that some studies reported varying degrees in both the time and magnitude of change in return to adequate sleep quality following rotator cuff repair. This study hopes to address this gap in the literature by investigating a novel sleep aid, SlumberCurve, and its effect on sleep quality and night-time pain relief. SlumberCurve is a Class I Medical Device and is currently advocated to relieve tension and diminish pain in patients undergoing rotator cuff repair surgery. The device provides adjustable elevation of the torso as well as concave positioning, placing the shoulder in a more forward position. This novel sleep aid has the potential to increase sleep quality, and therefore enhance both patient satisfaction and postoperative recovery from rotator cuff repair surgery.

Eligibility Criteria:
Inclusion Criteria:

• Any male or nonpregnant female aged 18 years or older with a full-thickness rotator cuff tear undergoing rotator cuff repair surgery

Exclusion Criteria:

* Patients who receive workers' compensation benefits
* Patients with irreparable tears
* Patients undergoing revision surgery
* Patients with concomitant severe glenohumeral arthritis or concurrent adhesive capsulitis
* Sleep apnea disorder or other diagnosed sleep disorder
* Neuropsychiatric disease
* Use of sleep medication
* Prior shoulder surgery
* Rotator cuff arthropathy with pseudo paralysis
* Acute fractures involving the proximal humerus or shoulder girdle
REmodeling the Left Ventricle With Atrial Modulated Pacing

New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with approved indications for pacing to determine if elevated pacing therapy is tolerated and whether there is a signal for efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Subject has had a market released dual chamber Medtronic Pacemaker with a Sleep function for at least 3 months
* Subject is stable on current medications
* Subject has dyspnea with exertion or diagnosed as New York Heart Association (NYHA) Class II or III Heart Failure
* Subject has had a prior Echo in past 6 months with: Ejection Fraction (EF) ≥ 50% and Diastolic volume \<80 ml/m²
* Subject has evidence of hypertrophy (indexed to body surface area: men 115 g/m², women 95 g/m² or indexed to height: men 49.2 g/m2.7, women 46.7 g/m2.7) or Relative Wall thickness \>0.42, or Wall Thickness\>1.2cm (posterior wall)
* Subject is willing to sign and date the study Informed Consent Form (IC Form) - Subject is 18 years of age or older, or of legal age to give informed consent per local law
* Subject is expected to remain available for follow-up visits

Exclusion Criteria:

* Subject has permanent atrial fibrillation (AF) or AF noted on baseline interrogation rhythm strip
* Subject has uncontrolled BP; (systolic pressure needs to be \>100 mmHg and \<160 mmHg on medications)
* Subject has severe stenosis of the aortic or mitral valve, defined as valve area ≤1.0 cm² or severe regurgitation of the aortic or mitral valve
* Subject has symptomatic Chronic Obstructive Pulmonary Disease (COPD) requiring oxygen
* Subject's Pacemaker has less than 6 months of Pacemaker battery life
* Subject had an aortic valve replacement (surgical or TAVR) procedure less than 9 months prior to enrollment
* Subject's programmed upper rate limit is less than 100 bpm because of concerns of elevated pacing
* Subject is unable or unwilling to perform the 6 Minute Walk Test at all scheduled study visits
* Subject is currently enrolled or planning to enroll in a potentially confounding trial during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager)
* Subject is pregnant
* Subject meets any exclusion criteria required by local law
* Subject's life expectancy is less than 12 weeks
* Subject with medical condition that precludes the patient from participation in the opinion of the investigator
* Subject has known coronary disease with Class II angina
Guided Biofilm Therapy for Periodontal Patients.

Periodontal patients will be treated with Guided Biofilm Therapy. At the baseline (T0), the following clinical indices will be collected: BoP, BS, CAL, PPD. A plaque disclosing agents will be used to instruct the patients to proper oral hygiene procedures. At this stage, using a split-mouth design, quadrants will be randomized to:

* Airflow and Scaling and calculus removal with EMS Prophylaxis Master handpiece
* Airflow and calculus removal with Mectron Combi handpiece

Patients will be visited after 1 month (T1) and 2 months (T2), in which the periodontal indexes will be collected again.

After all the procedures, VAS for pain will be assessed, with Schiff Air Index, comfort (patients), comfort (operator), timing for the procedures (minutes), satisfaction questionnaire (for patients and for the operator), consumption of the powders for the two handpiece.

Periodontal patients that respond to the inclusion criteria and agree to participate in the study will be treated with Guided Biofilm Therapy.

At the baseline (T0), the following clinical indices will be collected: BoP, BS, CAL, PPD. A plaque disclosing agents will be used to instruct the patients to proper oral hygiene procedures. At this stage, using a split-mouth design, quadrants will be randomized to:

* Airflow and calculus removal with EMS Prophylaxis Master handpiece
* Airflow and calculus removal with Mectron Combi handpiece

Patients will be visited after 1 month (T1) and 2 months (T2), in which the periodontal indexes will be collected again.

Together with periodontal assessment, VAS for pain will be assessed, with Schiff Air Index, comfort (patients), comfort (operator), timing for the procedures (minutes), satisfaction questionnaire (for patients and for the operator), consumption of the powders for the two handpieces.

Eligibility Criteria:
Inclusion Criteria:

* professional dental hygiene performed at least 6 months before enrollment
* periodontal disease: grading A or B and staging I-III

Exclusion Criteria:

* neurologic, psychiatric and mental diseases
* patients taking antibiotics during the study
* pregnant and breastfeeding women
* patients undergoing anticancer treatment
* patients undergoing anticancer therapy
MR-PET for Staging and Assessment of Operability in Ovarian Cancer - a Feasibility Study

The importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. We believe that combined magnetic resonance imaging and positron emission tomography (MR-PET) can be of great clinical value in preoperative staging of patients with ovarian cancer.

Recently, the academic hospital Maastricht invested in an integrated MR-PET system (Biograph mMR, Siemens Healthcare, Erlangen, Germany), ready to use for routine clinical application. Applications of this system are numerous and various types of cancer, including ovarian cancer, could benefit from the possibilities. The whole-body MR-PET system integrates the strengths of MRI and PET within a single examination. MRI provides anatomic detail in staging local tumor extent due to its high soft tissue resolution and advanced functional techniques such as DWI further enhance both local and distant lesion detection and characterisation. PET imaging complements this structural and functional information with molecular imaging technology useful in staging of adenopathy and metastatic spread. These characteristics contribute to a wide spectrum of possible clinical oncological applications, from primary tumor detection to local and distant staging, selection of patients for neoadjuvant therapy and assessment of response to chemotherapy and finally evaluation of recurrent disease.

The importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. We believe that combined magnetic resonance imaging and positron emission tomography (MR-PET) can be of great clinical value in preoperative staging of patients with ovarian cancer. Both positron emission tomography (PET), computed tomography (CT) and magnetic resonance imaging (MRI) have proved to be useful in ovarian cancer staging but understaging due to difficulties in depicting peritoneal dissemination remains a great problem. In conclusion, the best method for staging ovarian cancer and assessing operability remains to be discovered, hence this study.

Eligibility Criteria:
Inclusion Criteria:

* Expected FIGO stage IIB-IV epithelial ovarian carcinoma
* Scheduled for primary debulking or interval debulking surgery
* Written informed consent

Exclusion Criteria:

* Patients estimated to have more benefit from chemotherapy
* Ineligibility to undergo MR-PET examination (Non-MR compatible metallic implants or foreign bodies (ferromagnetic aneurysm clip, pacemaker, neurostimulation system, metal splinters etcetera) or claustrophobia)
* Pregnant or lactating patients.
* Incapacitated subjects
The Pharmacokinetics (PK), Safety, Tolerability of SR750 in Healthy Volunteers

This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR750 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females who are 18 to 45 years of age.
2. Based on medical history, physical examination, laboratory examination, chest X-ray, abdominal B-ultrasound, vital signs and ECG, the investigator considered that the results were normal or abnormal but no clinical significance.
3. Bodyweight of male \> 50 kg, Bodyweight of female \> 45 kg and body mass index (BMI) between 18 and28 kg/m2
4. Male subjects must agree to use contraception methods.
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

1. Known history of renal dysfunction or creatinine clearance \< 90 mL/min (calculated using the Cockcroft-Gault formula) at Screening.
2. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
3. History of regular alcohol consumption within 6 months of screening defined as: an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~285 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
4. History of significant drug abuse within one year of screening or use of soft drugs (such as marijuana) within 3 months prior to screening or hard drugs (such as cocaine, methamphetamine, crack) within 1 year prior to screening.
5. History of sensitivity to any of the investigational medicinal products (IMPs), or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation.
6. History of asthma (excluding resolved childhood asthma), severe allergic responses.
7. History of hypercoagulable state or history of thrombosis.
8. A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody.
9. Within 6 months of screening, Smoking more than 4 cigarettes per day (including e-cigarettes).
10. A positive drug/alcohol result at Screening or Day -1.
11. Donation or lost in excess of 500 mL of blood within 56 days of Day 1 or donation of plasma within 14 days of Day 1.
12. The subject has participated in a clinical trial within 3 months of receiving IMP.

    Use of medication other than topical products without significant systemic absorption.
13. Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 24h prior to the first dose of IMP until the Safety Follow-up visit.
14. Female subjects with positive pregnancy test results.
15. The investigator will determine any conditions in which subjects are not suitable for the study.
Non-invasive Risk Stratification of CR AMN/SSP

The purpose of this study is to determine the clinical utility of stool and blood methylation tests for detection of advanced mucosal neoplasia (AMN) and sessile serrated polyps (SSP).

By not only diagnosing colorectal cancer (CRC) at an early stage, but also removing precursor lesions (adenomas), colonoscopy with polypectomy reduces the risk of developing and dying from CRC. Approximately 90% of polyps are less than 10 mm and are easily removed by competent endoscopists. Laterally spreading lesions (LST) and sessile lesions of the colon, also known as advanced mucosal neoplasia (AMN) are underrecognised types of lesions that are more likely to progress to cancer. They include sessile serrated polyps (SSP), an emerging entity of flat polyps with malignant potential. Detection of hemoglobin (a component of blood) in stool is an established validated screening tool for CRC. Its specific role in the prediction of AMN, and particularly SSPs is yet to be defined. Blood tests measuring the level of tumour derived methylated deoxyribonucleic acid (DNA) in blood circulating have been demonstrated to have clinical utility for detection of CRC and AMN. A blood based CRC screening test has the potential to increase compliance. This study aims to determine the clinical utility of stool and blood methylation tests for detection of AMN and SSPs. Stool and blood will be obtained from consenting patients referred for endoscopic removal of known ANM and SSP (study arm) as well as from consenting patients scheduled for colonoscopy screening (control arm). The level of stool hemoglobin and methylated tumour derived DNA in circulation will be measured in the two study groups. Cutoff values will be generated to assess best predictive capability of high risk lesions based on these tests.

Eligibility Criteria:
Inclusion Criteria:

* Individuals capable and willing of proving satisfactory informed consent
* Individuals with colonic lesions larger than 20mm
* Individuals diagnosed with laterally spreading or sessile polyp morphology
* Individuals schedules for screening colonoscopy and with no prior history of CRC
* Ability and willingness to collect stool sample at home
* Ability and willingness to undergo venepuncture procedure

Exclusion Criteria:

* Individuals not able or unwilling to provide informed consent
* Individuals less than 18 year of age
* Individuals who undergo an incomplete colonoscopy or resection, which raises doubt as to the status of the colon (post-hoc exclusion)
* Individuals with a prior history of CRC
* Individuals with a history of Irritable Bowel Disease (IBD), hereditary nonpolyposis colorectal cancer (HNPCC) or Familial adenomatous polyposis (FAP)
* Individuals with bleeding diathesis
* Pregnancy
Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy

Cancer patients face a number of symptoms related to treatment or disease which may impair quality of life, such as decreased functional capacity, fatigue, nausea an vomiting, distress, depression and unmet psychological needs. Due to this array of symptoms, cancer patients often seek supportive complementary and alternative medicine, which many patients use along with conventional treatments. Qigong, a type traditional chinese medicine, is a mind-body exercise that combines meditation, slow physical movements, and controlled breathing. The investigators hypothesise that Qigong therapy is better in the reduction of anxiety and depression levels and the improvement of quality of life in patients with lung and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared to standard exercise training.

As per summary above

Eligibility Criteria:
Inclusion Criteria:

1. A pathologically (histological or cytological) confirmed clinical diagnosis of non-small cell lung cancer (NSCLC) or GI cancer
2. Stage 3 or 4 disease and eligible for anti-cancer treatment
3. Performance status (PS) of 0 - 2 as determined by the Eastern Cooperative Oncology Group-Performance Status
4. Life expectancy estimated at \> 4 months
5. Age 18 years or older
6. Willing and able to provide informed consent
7. Must be approved for participation by the oncology treatment team
8. Able to communicate in French or English

Exclusion Criteria:

1. Contraindication to exercise as determined by the oncology treatment team
2. Severe cardiac or neuro-muscular/skeletal disease
3. Engaging in interventions to address anxiety or depressive symptoms
4. Brain metastases
5. Active psychiatric conditions
6. Pregnant or breast-feeding mothers
To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy

This study aims to assess the activity of PD0332991 in monotherapy and in combination with the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the patient has progressed in the previous line for advanced breast cancer in order to reverse endocrine resistance.

In a clinical context, there is a lack of molecular compounds with demonstrated clinical activity in delaying/reversing resistance to endocrine agents. CDK 4/6 inhibitors may represent a biologically-driven option in this context.

With the present study investigators aim to complement the ongoing trial on PD0332991 by acquiring information on its clinical activity in post-menopausal patients with ER positive, Her2 negative advanced breast cancer patients already pretreated with a first-line or second line endocrine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease
* ER positive tumor ≥ 10%
* HER2 negative breast cancer by FISH or IHC
* Progression of advanced breast cancer on first or second line endocrine therapy for advanced breast cancer
* Paraffin-embedded tumor available for centralized assessment of biomarkers
* Measurable disease according to RECIST 1.1 (bone only disease is allowed only if measurable).
* Postmenopausal status
* Eastern Cooperative Oncology Group (ECOG) Performance status 0 -2
* Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade \>1
* Adequate organ function

Exclusion Criteria:

* Unstable brain metastases
* Prior treatment with more than one line of CT or more than two lines of HT advanced breast cancer or any CDK inhibitor
* Current treatment with therapeutic doses of anticoagulant
* Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors / inducers, drugs that are predominantly metabolized by CYP3A with narrow therapeutic indices, drugs with the potential of prolonging QT interval
* Diagnosis of any secondary malignancy within the last 3 years
* Active inflammatory bowel disease or chronic diarrhea
* Known human immunodeficiency virus infection; active hepatitis C, active hepatitis B
Fertility Decision-Making in Youth and Young Adults

The aim of this study is to test if using a web-based medical decision-making tool on the topics of fertility and fertility-preservation increases knowledge among transgender youth and young adults.

The pilot trial of Aid for Fertility-Related Medical Decisions (AFFRMED) is a single-arm, pre-/post- feasibility, acceptability, and preliminary efficacy trial. 10 transgender adolescents and young adults (AYA) and 10 parents of transgender AYA participated in a 90-120 min, virtual research visit via Zoom. During this visit they completed pre-test measures of fertility knowledge and decisional self-efficacy, followed by up to 1 hour to freely navigate AFFRMED decision aid. After using AFFRMED, participants completed post-test measures of fertility knowledge and decisional self-efficacy, as well as implementation outcomes measures (Acceptability of Intervention, Intervention Appropriateness Measure, and Feasibility of Intervention Measure).

Eligibility Criteria:
Inclusion Criteria:

* (1) youth is between the ages of 8-14 years
* (2) youth self-asserts a transgender identity
* (3) youth has expressed interest in GnRHa or is currently on GnRHa treatment; or
* (1) AYA is between the ages of 13-24 years,
* (2) AYA self-asserts a transgender identity, and
* (3) AYA has expressed interest in gender-affirming hormone (GAH) or is currently on GAH treatment.
* Parents of eligible youth will be eligible to participate.

Exclusion Criteria:

* (1) youth/parents are unable to read, speak or understand English
* (2) youth/parents are unable or unwilling to provide consent/assent/parental permission for study participation.