cyrilzakka/clinical-trials huggingface dataset:
eMOTION Formative Study

The eMOTION Study is a two-part ORBIT model phase 1 trial. The first part, called the Formative Study, will assess acceptability and feasibility of a novel physical activity intervention in adults at increased risk for cancer due to overweight or obesity.

The eMOTION Study is a two-part ORBIT model phase 1 trial. The first part of the eMOTION Study, the Formative Study, will iteratively test and refine the implementation of a novel treatment to manipulate affective mechanisms during physical activity among individuals at higher risk for cancer due to overweight or obesity. Acceptability and feasibility of content, delivery, device usage, engagement, and achieving clinically meaningful changes in affective mechanisms will be addressed. Treatment components targeting intensity-based goals and affect-based goals will be tested separately in four groups.

Eligibility Criteria:
Inclusion Criteria:

* adults aged ≥18 years
* residing in the United States
* self-reported BMI ≥ 25
* currently engaging in \< 60 minutes per week of structured physical activity
* owning a personal smartphone device
* residing in an area with Internet or Wi-Fi connectivity during the study period
* able to speak and read in English
* interested and willing to start a physical activity program
* willing to wear a Fitbit Versa smartwatch provided by the study team everyday continuously (including at work and during physical activity), in place of any Fitbits or smartwatches they previously wore, for the duration of the study period
* able to read the small font on a smartwatch screen without glasses, or willing to carry reading glasses during physical activity for the purpose of reading the smartwatch screen

Exclusion Criteria:

* unable to provide informed consent due to cognitive disability
* unable to engage in one or more key treatment components, including those with medical conditions that preclude physical activity engagement or who cannot wear an accelerometer on the wrist for any reason
* currently pregnant
A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Metastatic Breast Cancer in Australia

The purpose of this study is to learn about how a class of medicines called CDK4/6 inhibitors, are used for the treatment of breast cancer in patients in Australia. The study looks at how the CDK4/6 inhibitor class of drugs are used for treating breast cancer that is advanced or metastatic (has spread to other parts of the body).

This study does not include patients. Instead, this study looks at already available data to describe characteristics (like age and sex) of patients who have already taken these medicines.

This study will focus on one of these medicines called palbociclib and will look at the data to learn what amounts of the study medicine (palbociclib) patients receive, and how long patients take it for in the real-world in Australia. This study will also learn what other anti-cancer medicines patients receive, including chemotherapy. Chemotherapy is the treatment that uses medicines to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older when first received CDK4/6i breast cancer treatment
* Patient who has received CDK4/6i during study period

Exclusion Criteria:

* There are no exclusion criteria for this study
Efficacy and Safety Study of Trastuzumab, Paclitaxel and Carboplatin on HER2+ Preoperative Breast Cancer

To compare the efficacy in terms of the pathological complete response rate (pCR) to preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH)

Currently Herceptin has moved to Neoadjuvant treatment combined with chemotherapy. Paclitaxel and Carboplatin are two of the best partners with high pCR. The significant efficacy and good safety profile of Herceptin® combination with taxane as adjuvant treatment on EBC are accepted; 1 year of Herceptin as adjuvant treatment is one standard therapy. This study is one small Phase II trial to explore the efficacy and safety of QW and Q3W of PCH as Neoadjuvant treatment, we only plan 60 pts and the trend of the two curves is anticipated

Eligibility Criteria:
Inclusion Criteria:

1. Women aged equals to or more than 18 years and no more than 70 years with life expectancy more than 12 months
2. Histologically confirmed invasive breast cancer (excluding inflammatory breast cancer) by core needle biopsy, T2N1 or local advanced breast cancer, with no evidence of metastasis
3. HER2 positive confirmed by FISH/CISH+ or IHC 3+
4. With no history of cancer other than in situ uterine cervix cancer or skin basal cell carcinoma
5. Adequate hematopoietic function: Neutrophil larger than 1.5\*109/L; Hb larger than 100g/L; PLT larger than 100\*109/L
6. Adequate hepatic and renal function

   * serum AST less than 60U/L
   * Total bilirubin less than 1.5 ULN
   * serum creatinine less than 110umol/L
   * BUN less than 7.1mmol/L
7. LVEF 55% by MUGA scan or echocardiography
8. Adequate coagulation function
9. ECOG PS 0-1
10. Willing to take biopsy before surgery and during chemotherapy and willing to take pre-operative chemotherapy and related treatment
11. Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to take an adequate contraceptive measure
12. Signed written informed consent; Able to comply with the protocol

Exclusion Criteria:

1. Prior systemic or loco-regional treatment of breast cancer, including chemotherapy
2. Metastatic breast cancer
3. Patients with medical conditions that renders them intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, Diabetes Mellitus, severe infection, active peptic ulcer, Coagulation disorder, connective tissue disease or myelo-suppressive disease
4. History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (Systolic BP more than 180mmHg or Diastolic BP more than 100mmHg）
5. grade 1 peripheral neuropathy from any cause
6. Patient is pregnant or nursing
7. Not willing to take pre-operative biopsy or neo-adjuvant therapy
8. Patients with psychiatric disorder or other disease leading to incompliance to the therapy
9. Known hypersensitivity to any ingredient of the regimen
10. Treatment with any investigational drug within 30 days before the beginning of treatment with study drug
Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)

People with Chronic Obstructive Pulmonary Disease (COPD) suffer from dyspnoea, which may be exacerbated by psychological outcomes including anxiety and depression. Previous studies suggest that relaxation techniques may have positive effects on pulmonary rehabilitation. The main aim of this study is to explore both the respiratory and psychological impact of a quick, one-session, relaxation training for people with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent;
* Chronic Obstructive Pulmonary Disease (COPD) diagnosis confirmed by a specialized physician;
* basal FEV1/FVC \<70%, using the standards established by Global Initiative For Chronic Obstructive Lung Disease (GOLD);
* Modified British Medical Research Council Questionnaire (mMRC) ≥ 2;
* COPD Assessment Test (CAT) ≥ 10.

Exclusion Criteria:

* Pregnancy;
* psychiatric disturbances;
* oncological diseases;
* comorbid states that determine an immunosuppressive condition.
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer

The purpose of this study is to find out the effects of exercise therapy on indicators of prostate cancer in people with low-risk prostate cancer who are on active surveillance. The exercise therapy in this study will be regular home-based walking sessions on a treadmill, and that therapy will be assigned by an exercise physiologist (a medical professional who studies how exercise affects the human body). Some participants in this study will have the assigned exercise therapy, and some participants will participate in their usual exercise routines. Researchers will compare how the assigned exercise therapy and the usual exercise routines affect indicators of prostate cancer in participants. This study will not provide treatment for prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Men with histologically confirmed localized prostate cancer undergoing active surveillance.
* Inactive, defined as not meeting the national exercise guidelines for cancer patients (\<150 minutes/week of moderate or vigorous exercise)43 as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry (general physical activity screening assessment via smart watch).
* Screening clearance by an MSK Exercise Physiologist (i.e., review of ECG)
* BMI \<40 kg/m\^2
* Cleared for exercise participation as per pre-screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+) (Appendix B)

Exclusion Criteria:

* Enrollment in any other program that may alter the impact of exercise on tumor outcomes (e.g., weight loss program)
* Any neoadjuvant anticancer treatment of any kind for prostate cancer in the last 5 years
* Any history of systemic anticancer therapy in the last 15 years
* Distant metastatic malignancy of any kind
* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

All data entered into the registry documenting the patient cohort characteristics (disease, demography, therapy) are analyzed using descriptive statistics. Survival data are analyzed with Kaplan-Meier statistics. Multivariate Cox Proportional Hazard Models are used to identify potential prognostic and predictive factors. In particular, a risk- adjusted comparison of the outcome criteria with a propensity score is planned.

The data are stored in a SQL-based online database. Patient data are pseudoanonymized. The registry has received approval of the data protection officer of the State of Northrhine-Westphalia.

The study steering committee is blinded towards the identity of the participating institutions. Each participating institution receives an annual report with own data vs. benchmark. Scientific analysis can be proposed by the steering committee, by a participating institution or by other scientists, subjected to the approval of the independent scientific advisory board.

An export function has been built in to allow data exchange with the HIPEC Registry of the German Society for General and GI surgery (http://www.dgav.de/studoq/studoqhipec.html).

Eligibility Criteria:
Inclusion criteria:

* verified peritoneal metastasis
* colorectal cancer
* ovarian cancer
* gastric cancer
* appendical cancer
* pseudomyxoma peritonei
* malignant mesothelioma
* pancreatic cancer
* gallbladder cancer
* small bowel cancer

Exclusion criteria

- bowel obstruction
A Prospective Total Joint Surgery Registry to Monitor Short- and Long-Term Clinical Outcomes

The investigators propose a prospective longitudinal registry study to collect and compare preoperative and postoperative information from patients who undergo total joint arthroplasty (TJA). Outcomes will be assessed with common, routinely available patient-reported outcomes measures (PROM's) such as the HOOS Jr., Oxford score, Knee Society Score, Harris Hip Score, and other patient satisfaction and function assessments in use in Orthopedics.

The investigators propose a prospective longitudinal registry study to collect and compare preoperative and postoperative information from patients who undergo total joint arthroplasty (TJA). Outcomes will be assessed with common, routinely available patient-reported outcomes measures (PROM's) such as the HOOS Jr., Oxford score, Knee Society Score, Harris Hip Score, and other patient satisfaction and function assessments in use in Orthopedics. Investigators will also record both demographic and clinical data about the subject's history of joint pain, past treatment, medical co-morbidities, and surgical procedure.

Additionally, gait analysis and standardized physical capacity testing will be included as an option. All patients undergoing hip or knee replacement with the primary investigator will be included for data collection. All procedures and treatment will follow the standard of care, and all prosthetic implants with be FDA-approved. Data will be used to evaluate the effect on both short and long-term comfort and function of patients diagnosed with hip or knee pain who undergo joint replacement. The main purpose of the study is to provide quality improvement data on the patients in the Principal Investigator's (PI's) practice currently undergoing joint surgery. This project creates a data repository to store participants' data for this and possible future research.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo TJA by the Principal Investigator

Exclusion Criteria:

* Age \< 18
* Unable to speak and read English
* Prisoners or any other patients who, in the opinion of the investigator, are unlikely to return for follow-ups or unreliable in completing the assessments
LISA-study : Levothyroxin in Nodular Goiter

Primary objective:

* To evaluate change in total volume of all nodules.

Secondary objectives:

* To evaluate change in goiter volume after a 12-months treatment, number of nodules and echogenicity of nodules.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* Normal TSH value (target range between 0.6 - 3.0 mU/l)
* Thyroid nodules in a normal sized or enlarged thyroid at least one nodule (smaller/equal 20 % of volume with cystic change) with greater/equal 1.0 cm diameter, for nodules greater 1.0 cm the diagnosis must be performed according to the guideline for diagnostic standards of thyroid disorders.

Exclusion Criteria:

* Thyroid therapy within the last 3 years
* Known focal or diffuse structure autonomous thyroid
* Contraindication to iodine
* Concomitant treatment with iodine containing medication (i.e. amiodarone)
* Use of iodine-containing contrast medium within the last 6 weeks
* Presence of TPO antibodies (maximum two fold normal value)
* Symptomatic coronary heart disease
* Endocrine orbitopathy
* Known autoimmune thyreopathy
* Former radioiodine therapy or surgery
* Dermatitis herpetiformis
* Pathological laboratory results
* Participation in another clinical study with investigational medication within the last 30 days
* Pregnant or nursing female patients
* Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
* Severe or unstable cardiovascular diseases (e.g. severe angina pectoris, postmyocardial infarction syndrome and ventricular extrasystoles, symptomatic coronary heart disease), clinically relevant renal or hepatic diseases or disorders, any other clinically relevant condition that might enhance the risk for the study participant.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Multicentre GMK UNI Anatomical Cementless Study - FR

Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current post-marketing surveillance study aims to monitor GMK-UNI monocompartmental knee prosthesis performances over a 10-year time period.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with disease that meets the indications for use for Medacta implants included in this study (on-label use);
* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery;
* Patient's age between 18 and 75 years old;
* Patients must be willing to comply with the pre and postoperative evaluation schedule.

Exclusion Criteria:

* Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study;
* Any patient who cannot or will not provide informed consent for participation in the study;
* Patients who need a revision surgery
* Patients unable to understand and take action;
* Any case not described in the inclusion criteria;
* Patients aged under 18 years;
* Patients aged over 75 years;
The Influence of Sampling Site When Assessing Glucose Tolerance or Insulin Sensitivity With Oral Glucose Ingestion

For decades, it has been known that post-meal blood glucose concentrations were associated with the risk of T2D, which was reflected in early diagnostic guidelines. The oral glucose tolerance test (OGTT) has been used since at least 1923 and has remained the most common test for assessing glucose tolerance. Arterial blood (or arterialised blood using heated hand technique) is most appropriate for determining glucose tolerance and insulin sensitivity since this best represents the concentrations of metabolites and hormones that peripheral tissues are exposed to. It is essential to investigate whether venous blood (sometimes used during an OGTT) is representative of arterialised blood during an OGTT, and under different metabolic conditions.

The investigators want to understand whether OGTT-derived insulin sensitivity indices differ from venous and arterialised blood; and 2) investigate whether metabolic status (i.e. rest vs lower-limb exercise) influences the difference between forearm venous and arterialised concentrations of glucose and insulin during an OGTT.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-49 years
* Able and willing to safely comply with all study procedures
* Able to provide written informed consent for participation

Exclusion Criteria:

* Diagnosis of any bleeding disorder or taking medication which impacts blood coagulation
* The presence of any contraindications to maximal exercise testing, as determined using a physical activity readiness questionnaire (PAR-Q).
* Any diagnosis of metabolic disease (i.e. cardiovascular disease or type 2 diabetes).
Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation to Prevent Atrial Fibrillation After Cardiac Surgery

The goal of this clinical trial is to learn if an epicardial radiofrequency left atrial posterior wall isolation (box lesion ablation) prevents atrial fibrillation after cardiac surgery. The main question it aims to answer is:

- Does box lesion ablation lower the number of patients experiencing de-novo atrial fibrillation requiring any treatment after cardiac surgery? Researchers will compare box lesion ablation to no ablation to see if ablation prevents postoperative atrial fibrillation.

Participants will undergo ablation or no ablation at the time of other cardiac surgery.

Data will be collected while in hospital. Additional information will be collected on 30th day after surgery by telephone call or during a visit.

Postoperative atrial fibrillation (POAF) is a common complication after heart surgery that occurs in 10-60% of patients. It can cause hypotension, tachycardia, stroke, systemic embolism, or heart failure, and is associated with increased mortality rates, prolonged hospital stays and increased costs. Several studies have investigated the use of radiofrequency ablation (the standard of surgical care for atrial fibrillation during concomitant cardiac surgery when the diagnosis is known preoperatively) to prevent POAF. However, these studies were limited mainly to pulmonary vein isolation and had methodological limitations such as small sample sizes, inclusion/exclusion criteria, and randomization procedures, and have not translated into clinical practice changes. The current study aims to investigate the use of radiofrequency left atrial posterior wall isolation, also known as box lesion ablation, as a more effective treatment compared to pulmonary vein isolation, in a properly designed randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing cardiac surgery by a single surgeon (V.K.)
* Informed consent

Exclusion Criteria:

* History of atrial fibrillation/flutter
* Minimally invasive approach
* Off-pump surgery
* Emergent/salvage surgery
* Severe pericardial adhesions
Dexmedetomidine vs Dexamethasone as Adjuvant to Bupivacaine in Bilevel Erector Spinae Plane Block in Breast Surgeries

High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries.

High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries. Adding adjuvant drugs as dexmedetomidine or dexamethasone can augment the local anesthetic effect for the regional block used.

Eligibility Criteria:
Inclusion Criteria:

* Female patients scheduled for Modified Radical Mastectomy MRM
* Physical status ASA II, III.
* Age (18-65) years
* Body mass index (BMI): (20-35) kg/m2.

Exclusion Criteria:

* Patient refusal.
* Age \<18 years or \>65 years.
* BMI \<20 kg/m2 and \>35 kg/m2.
* Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids, dexamethasone, dexmedetomedine).