cyrilzakka/clinical-trials huggingface dataset:
Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer

The purpose of this study is to test the safety and feasibility of placing and removing a small device that contains anti-cancer drugs in a breast tumor of patients who plan on having breast surgery without treatment prior or patients who plan on receiving standard preoperative chemotherapy prior to their breast surgery. This device may be able to predict what types of treatment work best against an individual's breast cancer. With this device, the investigators hope to be able to personalize treatment choices based on an individual's type of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed invasive breast cancer that is: Triple negative (ER\<10%, PR\<10%, and HER2 0/1+ or 2+/FISH not amplified)
* Tumor size 2cm or greater; N any; M0
* Tumor size 1cm or greater; N any; M0 (Cohort 1)
* Tumor size 2cm or greater; N any; M0 (Cohort 2)
* Candidate for curative breast cancer surgery (Cohort 1 or 2)
* Candidate for neoadjuvant chemotherapy with a standard of care, anthracycline-based regimen (Cohort 2 preferred over Cohort 1)
* Age \>18 years of age
* ECOG performance status of ≤2
* Serum or urine pregnancy test negative within 2 weeks for women of childbearing potential.
* Willing and able to provide informed consent

Exclusion Criteria:

* Prior treatment including surgery, chemotherapy or radiation therapy for the current primary breast cancer.
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational device administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this
Energy for Lymphocytes

CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors.

From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou Hospital), which included patients between August 2016 and October 2019 and ended follow-up in April 2020.

Patients were treated with nivolumab, at a dose of 3 mg/kg every 2 weeks, or pembrolizumab, at a dose of 2mg/kg every 3 weeks. The investigators report findings from an evaluation of rest energy expenditure (REE) assessed using indirect calorimetry in the outpatient setting before treatment with checkpoints inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Stage IV histologically proven Non Small Cell Lung Cancer (NSCLC)
* Monotherapy with nivolumab or pembrolizumab.
* Patients were required to have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Exclusion Criteria:

* Active malignancy other than NSCLC,
* ALK or EGFR mutated NSCLC
* Anticancer therapy or surgery within the past 2 weeks or inability to breathe under the calorimetry.
Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis

The purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cytologically or histologically documented HCC, who are candidates for TACE
* Child-Pugh Child A or B
* Age \>= 18
* Measurable disease by RECIST criteria;
* Performance status ECOG 0-2
* Previous local therapy completed \> 4 weeks
* Written informed consent signed
* Normal organ and marrow function defined as:

Haematopoietic:

* WBC ≥ 3,000/µlplatelet count \> 80,000/mm3
* haemoglobin \> 9g/dL
* Hepatic: Albumin ≥ 2.8 g/dl.serum total bilirubin ≤ 3 mg/dl; AST or ALT \< 5 x ULN
* Renal: creatinine \< 1.5 x ULN

Exclusion Criteria:

* Metastases
* Prior or concomitant chemotherapy or radiation therapy
* VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
* Severe and/or uncontrolled medical conditions:
* Congestive heart failure, serious cardiac arrhythmia, active coronary artery
* Severe renal impairment
* Patients who anticipate receiving major surgery during the course of the
* Pregnant or breastfeeding patients
* Evidence of bleeding diathesis
Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago

The purpose of this study is to assess the efficacy end tolerability of a new drug containing the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components alone in the treatment of acute lumbago.

To assess the efficacy and tolerability of a new drug containing the combination meloxicam and cyclobenzaprine in the treatment of acute lumbago, compared to the same components alone.

Some eligibility criteria:

Have a normal X-ray of the lumbar spine for the age; Have a baseline score in the VAS higher than or equal to 40 mm

Eligibility Criteria:
Inclusion Criteria:

* Sign, initial and date the Informed Consent Form (ICF);
* Be between 18 and 75 years old;
* Have acute lumbago with onset in less than 72 hours;
* Have a normal X-ray;
* Have a baseline score in the VAS higher than or equal to 40 mm;

Exclusion Criteria:

* Use of triptans;
* Use of monoamine oxidase inhibitors;
* Use of NSAIDs within the last week;
* Previous use of narcotics;
* Have any rheumatologic disease;
* Conditions of chronic pain;
* Have any significant chronic comorbidity;
* Previous history of gastrointestinal bleed or ulcers;
* History of allergy to any of the components of study medications;
* Recent history of a myocardial infarction, cardiac arrhythmia, cardiac conduction block or change, or congestive heart failure;
* Female patients who are pregnant or breastfeeding or who wish to become pregnant or who deny using safe contraceptive methods during the study will not be enrolled in the study;
* Have participated in another clinical trial within the last 12 months.
Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression

The objective of this study is to investigate the antidepressant efficacy of rTMS, and to assess cortical metabolism before and after rTMS sessions in patients with major depression. We also aimed to investigate differences between the responders and nonresponders to rTMS and what would predict clinical response to rTMS.

The specific aims of this study is to: (1) evaluate the antidepressant efficacy of rTMS on major depression; (2) evaluate the effects of rTMS on cognitive function in depressive patients; (3) assess the effects of rTMS on cerebral glucose metabolism in depressive patients as measured by 18FDG PET; (4) investigate the differences of the regional cerebral glucose uptake changes during rTMS between responders and nonresponders to rTMS.

Eligibility Criteria:
Inclusion Criteria:

* Twenty patients fulfilling the diagnostic criteria of major depression according to DSM IV will be enrolled in the study.
* Antidepressant medication will be maintained throughout the study period.

Exclusion Criteria:

* Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.
* To exclude the effect of drug changes on post-rTMS cerebral glucose metabolism, the combinations and dosage of pre-rTMS antidepressant drugs will remain unchanged until the post-rTMS 18FDG PET is done.
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions

To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets

To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg Buspirone HCl Tablets under fasting conditions, following administration of a 30 mg dose

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, 18-45 years of age
* Weighing at least 60 kg, who are within 10% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983)
* Physical examination and laboratory tests of hematologic, hepatic and renal functions
* Medically healthy subjects with clinically normal laboratory profiles will be enrolled in the study

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease
* The presence of alcoholism or drug abuse within the past year
* Hypersensitivity or idiosyncratic reaction to buspirone HCl
* Subjects who have been receiving monoamine oxidase inhibitors
* Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study
* Subjects who, through completion of the study, would have donated in excess of 500 mL blood in 14 days, or 500-750 mL of blood in 14 days (unless approved by Principal Investigator, 1000 mL blood in 90 days, 1250 mL blood in 120 days, 1500 mL blood in 180 days, 2000 mL blood in 270 days, 2500 mL blood in 1 year
* Subjects who have participated in another clinical trial within 28 days of study start
Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH

The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX).


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic proof of LCH who have multifocal or multisystem disease involvement.
* Patients must have a life expectancy of at least 8 weeks.
* All patients must have ECOG performance level rating of-\< 2.
* Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study, using commercially available drugs.
* Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of chemotherapy.
* Patients must have adequate liver function (bilirubin _\< 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine \<_ 1.5 mg/dl, creatinine clearance \>_ 60 ml/min/1.73 m2) and normal electrolytes.
* Patients should have a granulocyte count \> 500/uL and a platelet count \>_ 100,000/uL (unless due to disease involvement of the bone marrow).
* Male and female patients of child-bearing age should use effective methods of contraception, if sexually active.

Exclusion Criteria:

* Patients with active infections or significant medical conditions other than their disease (LCH) shall be excluded.
CUHK Jockey Club HOPE 4 Care Programme - Ankle Robot

The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community. The Exoskeleton Ankle Robot is a robot-assisted Ankle-Foot-Orthosis to facilitate gait training of person after stroke with drop foot.


Eligibility Criteria:
Inclusion Criteria:

* have the ability to walk on the ground independently or with one personal assistance with or without walking aids
* able to understand simple commends

Exclusion Criteria:

* have other neurological, neuromuscular, and orthopedic diseases
* uncontrolled cardiovascular or respiratory disorders
* moderate to severe contractures in the lower extremities
Laboratory Outcome Predictors in Coronary Surgery

Evaluate less employed markers of tissue hypoperfusion as venoarterial carbon dioxide partial pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) combined to other classically studied markers as predictive factors of complicated clinical course after cardiac surgery in patients with left ventricular dysfunction.

Patients with left ventricular dysfunction are more susceptible to tissue hypoperfusion and presents more frequently both low cardiac output syndrome and systemic inflammatory response, what results in prolonged stay in intensive care unit (ICU), and higher mortality rates when compared to patients with normal ventricular function.

The early prediction of prolonged ICU stay through the detection of tissue hypoperfusion may improve the management of care and decrease morbidity of this particular group of patients. However, classic markers of tissue hypoxia as central venous saturation, base excess, lactate may not be predictors of outcome in cardiac surgery patients with left ventricular dysfunction.

The question addressed in this study is if less employed markers of tissue hypoperfusion as as venoarterial carbon dioxide partial pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) have predictive value of prolonged ICU stay in patients with left ventricular dysfunction submitted to coronary artery bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* adults
* left ventricular dysfunction (ejection fraction \< 50%)
* patients undergoing coronary artery bypass surgery requiring the use of Cardiopulmonary Bypass (CPB)

Exclusion Criteria:

* renal failure (creatinine clearance lower than 40 ml/min/m2),
* hepatic dysfunction
* endocrinologic disorders
* pulmonary disease
* uncontrolled diabetes mellitus
* a history of fever or infection within the week before surgery
* previous anemia (hemoglobin ≤ 10.0 g/dL)
Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes.

Epithelial Ovarian cancer (EOC) is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually.

State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.

In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.

Aim of this study:

There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.

Epithelial Ovarian cancer is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually. Treatment and survival of the patients depend primarily on the stage of the disease. Of all EOC patients only 25% are diagnosed at an early stage while the tumour is confined to the pelvis. In these cases the five-year survival rate is 80% to 90% and the disease can often be cured by the combination of surgery and chemotherapy. Unfortunately, almost 75% of women affected have advanced stage disease with metastatic spread throughout the abdominal cavity or to retroperitoneal lymph nodes at the time of diagnosis; five-year survival rates drop to 10%-30% for advanced disease, despite maximum surgical effort and combination chemotherapy.

State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.

In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.

Aim of this study:

There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.

Eligibility Criteria:
Inclusion Criteria:

* suspected ovarian cancer
* verified ovarian cancer

Exclusion Criteria:

* pregnant
* incapacitated persons
Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives

This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Parent of 1-month old baby
* Over the age of 18
* Be able to speak and read English

Exclusion Criteria:

-
A Digital Game on Promoting Family Well-being

Advances in information communication technologies (ICT) allow for ICT-assisted health promotion to become more common. Integrating ICT in health promotion has been suggested to offer many advantages compared to traditional approaches to promote family well-being. Research has also shown the positive effects of game-based approaches in enhancing health promotion interventions, especially with children. We will develop and conduct an online survey to assess the use of games and gamification for health promotion, as well as a family-based randomized controlled trial to promote healthy living.

With growing emphasis on the development and maintenance of healthy lifestyles, the family role has increasing importance. A family-based health promotion strategy can be instrumental in helping disseminate and reinforce knowledge and behaviours on family well-being and better equip families to protect themselves and promote family well-being beyond the COVID-19 pandemic. Additionally, the pandemic led to increased sedentary behavior and unhealthy eating. New, innovative health promotion strategies and approaches to increase physical activity and healthy diet and enhance well-being are needed.

This study aims to investigate and use a game-based approach to enhance knowledge and behaviours on healthy living and family well-being. We will conduct quantitative and qualitative evaluation. The findings would provide evidence of the feasibility and effectiveness of such an approach in a family-based context. It would also guide the direction for future health education and awareness trials and related projects and campaigns for health promotion efforts and to help improve family well-being in the Hong Kong community and elsewhere.

Eligibility Criteria:
Inclusion Criteria:

* Chinese-speaking;
* Parental consent for those under 18;
* Able to understand and play the game;
* Has a smartphone.

Exclusion Criteria:

• Individuals who cannot meet the inclusion criteria.
An Exploratory, Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in COPD Subjects

The purpose of this study is to monitor adherence to a clothing-attached breathing monitor, respiratory patterns, and activity levels in COPD patients, and correlate those respiratory patterns and activity levels with patient-reported symptoms and events. To achieve this purpose, Spire will collect data from a wearable monitor that participants attach to the participant's clothing, an associated smartphone application, and completion of weekly questions. The wearable monitor and the consumer smartphone application to be used are consumer products and currently available in the market.

This study does not include clinical intervention and no doctors will be involved in this study.

No clinical tests or office visits are included in this study. All data will be collected through an online survey tool and remotely through the wearable sensors.

This is an exploratory, observational, non interventional, single-arm, open label, remote pilot study involving up to 150 self-reported COPD participants. Eligible participants will wear the Spire biophysiological health monitors for a period of 9 months while the participants report symptoms on a weekly basis via brief surveys. If and when participants incur a COPD-related exacerbation which results in a medication change after hospitalization or contact with a healthcare provider, participants will report this on the weekly surveys. When this survey is read by a study nurse, the nurse will follow up with the participant by phone to conduct a post-exacerbation phone screening. This data would provide context to inform how to correlate the biosensor-sensed physiological parameters with the exacerbation self-reported data. All study participants will be remotely distributed throughout the United States.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Self-reported diagnosis of moderate to severe COPD
* \>=1 self-reported COPD-related hospitalization within the previous 12 months
* Currently using an iPhone 6 or newer and willing to install the Spire smartphone app
* Willing to wear Health Tags 80% of each 24 hour period and answer the email-based self-assessments weekly for the study duration
* Willing to provide consent to participate and abide by study protocol for study duration (9 months)
* Must be able to read and understand English
* Access to Wi-Fi at home and at work, for at least 20 hours per day (and smartphone connected to Wi-Fi throughout the study duration)

Exclusion Criteria:

* Diagnosed with another medical condition that may confound the respiratory symptoms of COPD (ex: cystic fibrosis, lung cancer, bronchiectasis, idiopathic pulmonary fibrosis, or chest wall deformities).
* Diagnosed with any neurodegenerative disorder (e,g, Parkinson's, Alzheimer's or Epilepsy)
* Pregnant at the time of study or expecting to become pregnant throughout the course of the study.
Prevalence and Clinical Significance of Co-infection of Mycoplasma Pneumoniae in Patients With Pulmonary Tuberculosis

Several case report showed that the co-infection of Mycoplasma pneumoniae in patients with pulmonary tuberculosis. The aim of this study is to elucidate the prevalence and its clinical significance of co-infection of Mycoplasma pneumonia in patients with newly diagnosed pulmonary tuberculosis.


Eligibility Criteria:
Inclusion Criteria:

* Bacteriologically or clinically diagnosed pulmonary TB
* Older than 17years

Exclusion Criteria:

* HIV positive
* Immune-compromized