cyrilzakka/clinical-trials huggingface dataset:
Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver

The purpose of this study is to determine the response of liver tumors to radiation therapy using Tomotherapy.

The purpose of this study is to determine the response of liver tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety. The usual treatment for this type of disease for patients who are eligible is surgery to remove the tumors. For patients who aren't eligible for surgery or who chose not to have surgery, they are treated with low daily doses of radiation given over many weeks; however this type of treatment has not been very effective.

Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of solid primary tumor metastatic to liver
* Age greater than or equal to 18 years old
* Zubrod performance status less than or equal to 1
* Negative pregnancy test for women of child bearing potential
* Informed consent
* Less than or equal to 3 liver metastases
* Each lesion must be less than or equal to 6 cm in maximal diameter
* No prior radiation to lesions being treated
* Patient is not a surgical candidate or refuses surgery
* Absolute neutrophil count ≥ 1800
* Platelets ≥ 100000
* Hemoglobin ≥8.0
* Systemic therapy (chemotherapy) completed at least 2 weeks prior to SBRT
* At time of radiation treatment planning, at least 700 cc of normal liver must receive less than 15 Gy

Exclusion Criteria:

* Contraindications to radiation
* Pregnant or lactating females who chose to breast feed
* Patients must have recovered from toxicity of prior therapy
* Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
* Patients currently receiving anticoagulation with coumadin or IV heparin
* Liver cirrhosis
* Clinical ascites
* Bilirubin \> 3, Albumin \< 2.5, liver enzymes 3 times above normal, Creatinine \> 1.8
Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors

This randomized control trial seeks to determine whether a tailored and supervised exercise program adopting mobile-health technology will be able to improve fitness and quality of life among lymphoma survivors.

Lymphoma is the most common cancer diagnosed in young adults. While curing 80% of patients, lymphoma treatment has a significant impact on young adults' health and psycho-social wellbeing by increasing fatigue and anxiety, risk of cardiovascular disease and other chronic disorders, all of which compromise one's quality of life. Regular exercise has the potential to reduce the side effects associated with cancer treatments. Thus, the most recent guidelines suggest that cancer patients should engage in adapted exercise programs during and after their treatment.

However, these guidelines are not systematically recommended by doctors and are often not followed by patients. Fatigue and lack of motivation are the main barriers to exercise among cancer survivors. Our study aims to identify young adults lymphoma patients and encourage them to adhere to the exercise guidelines with the help of an exercise physiologist and a fitness tracker. The investigators will evaluate the efficacy of these strategies in motivating exercise among young adults lymphoma survivors. Our proposed study carries significant implications for the prevention of complications of treatment for young adults lymphoma survivors.

Eligibility Criteria:
Inclusion Criteria:

1. newly diagnosed lymphoma patients who received an initial diagnosis at the age of age 18-39,
2. approved by their hematologist as having no contra-indications to vigorous exercise,
3. receiving or has received chemotherapy with curative intent within the past 6 months,
4. own a cellular phone that is able to download the Fitbit app and to complete the study questionnaires online in either French or English, and
5. has an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom).

Exclusion Criteria:

1. The patient has contra-indications to vigorous exercise,
2. the patient doesn't want to wear a fitness tracker due to various concerns (as no Fitbit data could be collected).
The Role of Exercise Training in the Treatment of Resistant Hypertension

The main purpose of this study is to assess whether exercise training reduces ambulatory blood pressure in patients with resistant hypertension. To accomplish these goals 60 patients with resistant hypertension will be recruited and randomized into exercise training or control groups and followed up for 6 months. The patients in the exercise group will participate in a 3-month outpatient program. The control group will receive usual medical care. At baseline, after the intervention and 3 months after the end of the intervention both groups will undergo several evaluations, including casual and ambulatory blood pressure, body composition, cardiorespiratory fitness, quality of life, arterial stiffness, autonomic function, and endothelial and inflammatory biomarkers.


Eligibility Criteria:
Inclusion Criteria: confirmed resistant hypertension, who in the previous 3 months had unchanged medication

Exclusion Criteria:

1. Patients with secondary hypertension
2. Evidence of target organ damage
3. Patients with heart failure
4. Previous cardiovascular event
5. Peripheral artery disease
6. Renal failure
7. Chronic obstructive pulmonary disease
8. Systolic office blood pressure superior to 180 mmHg
9. Biomechanical limitations to physical activity
10. Those participating in regular physical activity
Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis

The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of blepharoconjunctivitis
* Must be willing to discontinue contact lens wear for the duration of the study
* Additional inclusion criteria also apply.

Exclusion Criteria:

* Have known sensitivity or poor tolerance to any component of the study medications.
* Have any clinically significant cardiovascular disorders
* Have any history of liver or kidney disease resulting in persisting dysfunction
* Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device.
* Additional exclusion criteria also apply.
Accuracy of Endometrial Volume Measured by VOCAL Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps

Endometrial volume will be assessed by 3DUS and VOCAL and compared to the results of office hysterscopy to measure the abilty of this technique to diagnose endometrial polyps in women complaining of abnormal uterine bleeding.

The safety of both procedures will be compared .


Eligibility Criteria:
Inclusion Criteria:

* Age more than 20 years
* Patients with irregular vaginal bleeding

Exclusion Criteria:

* Age less than 20 years
* Postmenopausal women
* presence of uterine fibroids
* Causes of vaginal bleeding due to systemic pathology , anticoagulant use , patients on hormonal contraception or using Intra Uterine Contraceptive Device ( IUCD ) .
Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS

The study was designed to comparison the effectiveness of recruitment maneuvers(RM) and lung protective ventilation strategy(LPVS) for patients with moderate to severe ARDS.

ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality.

ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 70 years old.
* Patients with hypoxemia receiving endotracheal mechanical ventilation therapy.
* The ARDS diagnostic criteria of Berlin Definition, arterial oxygen tension \[PaO2\]/fractional inspired oxygen \[FiO2\] ratio (PaO2/FiO2) \<200 mm Hg, recent appearance of bilateral pulmonary infiltrates consistent with edema and no clinical evidence of left atrial hypertension.
* Within 72 hours after ARDS diagnosis.

Exclusion Criteria:

* Pregnancy.
* Participate in other interventional trials at the same time during the acceptance period.
* Severe trauma combined with rib fracture or pneumothorax, subcutaneous emphysema, and mediastinal air accumulation within three months.
* Severe chronic respiratory diseases that require long-term use of oxygen therapy or home mechanical ventilation.
* Have a history of cachexia or terminal cancer.
* Use immunosuppressants, chemotherapy or radiation therapy.
* Contraindications for hypercapnia, such as patients with acute brain injury due to intracranial hypertension or craniotomy.
A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)

This was a prospective, randomized, controlled, open, and multi-center trial conducted to compare the clinical efficacy and safety of ertapenem with it's comparator before or following adequate surgical management of complicated intra-abdominal infection.


Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.
Evaluation of VISIOCYT Bladder Cytology in Real Life

The study will be offered to all consecutive patients undergoing scheduled cystoscopy at the Hospitalisation De Jour (HDJ) Chirurgicale, either as part of a diagnostic approach in the event of suspected bladder tumor (exploration of macroscopic hematuria in particular), or as part of the follow-up of a bladder tumor, according to current recommendations (French ccAFU guidelines - update 2020-2022: bladder cancer).

Once non-opposition has been obtained, clinical data at the time of inclusion will be collected and pseudonymized. Urine is collected prior to cystoscopy, on voided urine, for a minimum sufficient quantity of 50 ml. The urine sample is then separated into transport jars, one of which is used for standard cytological analysis, the other for VISIOCYT cytology (sent to a laboratory platform).

In the event of a tumor or suspicious lesion detected at the cystoscopy, a trans-urethral bladder resection (TURB) will be scheduled. Anatomopathological data from this RTUV will also be collected for comparative analysis to establish the diagnostic performance of the test.

The tests performed (apart from the urine sample) are part of the usual care pathway. No additional visits will be specifically requested by the protocol. Data from examinations carried out as part of standard pathology management, or suspected pathology, will be used for this research.

At the same time, prospective questionnaires on patients' preferences with regard to the various diagnostic examinations for bladder tumours (discrete choice analysis) will be given to patients and completed at the time of cystoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age,
* Signed consent to participate,
* Affiliation with a social security scheme, or beneficiary of such a scheme,
* Patient to undergo cystoscopy for diagnosis (suspected bladder tumor) or follow-up of bladder tumor

Exclusion Criteria:

* Patients managed or followed up for a bladder tumor of non-urothelial histology,
* Renal transplant patients,
* Patient having received pelvic radiotherapy,
* Pregnant or potentially pregnant women (of childbearing age, without effective contraception) or nursing mothers,
* Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express consent,
* Inability to undergo medical follow-up for geographical, social or psychological reasons.
Impact of Different BRCA1/2 Gene Variants on Response to Therapy and Prognosis of Ovarian Cancer

Identify any significant differences in terms of drug response and survival between the different possible alterations in the BRCA1/2 genes, in order to stratify ovarian cancer patients with a view to increasingly personalised and thus effective therapy.

Ovarian carcinoma (OC) is the leading cause of death among gynaecological neoplasms. It is, in fact, a neoplasm that is not very frequent but highly lethal: in Emilia-Romagna, the incidence is about 17 cases per 100,000 inhabitants and the mortality rate is around 15 cases per 100,000, with a very high mortality/incidence ratio (0.83). The high mortality rate is mainly due to the fact that, due to the non-specific and late symptoms, 75-80% of patients arrive at the diagnosis at an advanced stage of the disease (III-IV), characterised by a 5-year survival of less than 25%.

The primary therapeutic approach for this tumour is a combination of debulking surgery and platinum-based chemotherapy generally associated with taxanes, while as far as maintenance therapies are concerned, PARP inhibitors (PARPi), drugs capable of blocking a DNA repair mechanism alternative to that of homologous recombination, have been gaining in importance in recent years. They have proved particularly effective in tumours that present alterations in the BRCA1 and BRCA2 genes, which are key players in homologous recombination. For this reason, the detection of mutations in the BRCA1 and BRCA2 genes is predictive of the efficacy of PARPi maintenance therapy and, consequently, as of 2015, the BRCA test has been indicated in all women newly diagnosed with ovarian cancer (excluding borderline and mucinous forms), possibly from tumour tissue, given the evidence that in addition to constitutional (inherited) variants, somatic variants (acquired and tumour-confined), present in about 9%, are also associated with a PARPi benefit.

Recent data, however, have challenged the assumption that functionally significant variants for which a predisposing role has been demonstrated for hereditary breast and ovarian cancers are necessarily predictive of drug response. Furthermore, the fact that somatic mutations are present in only a limited fraction of the DNA copies analysed in a tumour suggests that there may be residual BRCA activity that compromises effective PARPi activity.

Eligibility Criteria:
Inclusion Criteria:

* ovarian cancer diagnosis by 31/12/2021;
* BRCA test at the UOC of Medical Genetics of the IRCCS AOU of Bologna Policlinico S.Orsola by 31/12/2021;
* follow-up and/or treatment at Medical Oncology and/or Gynaecological Oncology of the IRCCS Azienda Ospedaliero-Universitaria (AOU) of Bologna for a period of time of at least 1 year and by 31/12/2021 and for a minimum period of 6 months

Exclusion Criteria:

* ovarian carcinoma of 'mucinous' or 'borderline' histotype.
Study Efficacy and Safety of INC280 in Patients With Advanced Hepatocellular Carcinoma.

This study is to find out if INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway.

This study was designed as a Phase II, single arm, open-label, multicenter study to evaluate the safety and efficacy of INC280 as first-line treatment in patients with advanced hepatocellular carcinoma (HCC) who were not eligible for or had disease progression after surgical or locoregional therapies, with c-MET dysregulation.

The study included a Dose-Determining Part and a Dose Expansion Part. Pharmacokinetic and safety profiles of INC280 in the setting of liver dysfunction were determined in the Dose-Determining Part. The Dose Expansion Part started when the appropriate dose for patients with liver dysfunction was determined based on pharmacokinetics (PK) and safety data from the Dose-Determining Part and other INC280 clinical studies. The initial dose of INC280 assessed during the dose expansion part was 600 mg twice daily (BID) administered as capsules of 50 mg. Later during the dose expansion part, a tablet with higher dosage strengths (50 mg, 150 mg, and 200 mg) was developed and introduced to improve the convenience of study drug administration for patients. PK data on INC280 tablet at 400 mg BID from other studies (NCT01324479, NCT01546428 and NCT01610336) showed that systemic exposure to INC280 was in the range of that achieved with the capsule at 600 mg BID.

During the Dose Expansion part of the study, Novartis halted the enrollment in Dec-2016 due to difficulty in identifying patients who met the definition of c-MET high as defined in the inclusion criteria. Patients who were already enrolled and signed the informed consent were allowed to continue in the study according to the protocol. The enrollment halt was not a consequence of any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed c-MET pathway dysregulation.
* Advanced hepatocellular carcinoma which could not be suitable for treatment with locoregional therapies or has progressed following locoregional therapy.
* Measurable disease as determined by RECIST version 1.1.
* Current cirrhotic status of Child-Pugh class A with no encephalopathy.
* Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2.

Exclusion Criteria:

* Received any prior systemic chemotherapy or molecular-targeted therapy for hepatocellular carcinoma such as sorafenib.
* Previous treatment with c-MET inhibitor or hepatocyte growth factor targeting therapy.
* Previous local therapy completed less than 4 weeks prior to dosing and, if present, any acute toxicity \> grade 1.
* Known active bleeding (e.g. bleeding from gastro-intestinal ulcers or esophageal varices) within 2 months prior to screening or with history or evidence of inherited bleeding diathesis or coagulopathy.
* Clinically significant venous or arterial thrombotic disease within past 6 months.
* History of acute or chronic pancreatitis, surgery of pancreas or any risk factors that may increase risk of pancreatitis.
A Brief Intervention to Improve Cost-effective Resource Use Among Medicine Housestaff

OBJECTIVE: To test a brief intervention designed to improve the cost-effectiveness of care provided by medicine housestaff for hospitalized patients.

HYPOTHESIS: A brief intervention in which medicine residents receive itemized bills for recent patients cared for by them, followed by a discussion on approaches to reducing unnecessary inpatient costs, can result in significant cost reductions without adversely affecting patient outcomes.

We designed a brief educational intervention with two primary objectives: 1) to increase awareness among residents about how their decisions impact the costs of inpatient medical care; and 2) to improve the cost-effectiveness of care provided by residents without adversely affecting patient outcomes. We hypothesized that a brief intervention in which residents receive bills for patients they recently cared for, followed by a discussion on approaches to reducing unnecessary inpatient costs, would reduce costs without adversely affecting patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Internal Medicine Residents on Inpatient Rotations at Brigham \& Women's Hospital

Exclusion Criteria:

* Having a team member who was in either the control group or intervention group in a prior round of this study.
Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin

Primary: To evaluate the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects.

Secondary: To assess the safety and tolerability of the coadministration of lecozotan SR and digoxin.


Eligibility Criteria:
Inclusion Criteria:

* Women of non childbearing potential and men aged 18 to 55 years at screening.
* Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight 50 kg (BMI = weight (kg)/\[height (m)\]

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any clinically important deviation from normal limits in physical examination, vital signs or clinical laboratory test results.
Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer

The goal of this research is to explore how a patient decision aid tool (website) given to patients prior to their survivorship care visits, may impact patient-provider communication about fertility and family-building after cancer; and assess the impact of using the tool on patient reported outcomes. The overall purpose of this research is to improve survivorship care by establishing a multi-disciplinary approach to managing cancer and fertility issues and prompt early referral to supportive and medical care resources.

Objective 1: Establish feasibility and acceptability of conducting research with YA-F cancer survivors at the Stanford Cancer Institute (SCI) and Lucile Packard Children's Hospital (LPCH).

Hypothesis 1: Study procedures will be feasible in the given timeframe and acceptable to patients, as evidence by recruitment, enrollment, and completion rates and participant feedback.

Objective 2: Evaluate the impact of using the tool as a part of survivorship care on patient reported outcomes (PROs; i.e., information needs, fertility distress, decision-making uncertainty, and satisfaction with care).

Hypothesis 2: In a single-arm pilot study (N=20), use of the decision aid tool will lead to improvements in fertility distress, decision-making uncertainty, and satisfaction with care.

Eligibility Criteria:
Inclusion Criteria:

* completed cancer treatment at least 6-months prior, excluding long-term adjuvant or maintenance therapies
* report an interest in discussing fertility/family-building with a provider
* understands verbal and written English
* access to the Internet and use of a computer, tablet, or smartphone
* has a scheduled cancer survivorship visit within the study time frame

Exclusion Criteria:

* Prior hospitalization for a mental disorder or history of psychosis

Note: Survivors on adjuvant maintenance or endocrine treatment, such as tamoxifen, will not be excluded because clinical guidelines allow treatment delay or hiatus to accommodate fertility