cyrilzakka/clinical-trials huggingface dataset:
Safety/Efficacy Study of Immunoconjugate With Docetaxel in Non-small Cell Lung Carcinoma

This randomized phase II clinical trial evaluates the combination of a monoclonal antibody-based drug (SGN-15) with a chemotherapeutic agent compared to chemotherapy given alone in patients with non-small cell lung cancer that has failed at least one prior systemic therapy. The objective of the study is to determine the safety and clinical benefit, as measured by tumor response and quality of life, to the combination regimen.

Monoclonal antibody therapy has been used in other types of cancer to target therapy to the tumor, thereby allowing for the chemotherapeutic agent to have a lesser effect on normal, healthy tissue.


Eligibility Criteria:
INCLUSION CRITERIA:

Patients with pathologically confirmed NSCLC which is metastatic or recurrent (non-resectable), who have failed at least one but no more than two prior therapies for advanced stage disease or have a recurrence within 6 months of completing adjuvant chemotherapy.

Lewis-y antigen expression documented by immunohistochemistry for all patients.

Patients must have:

* Bidimensionally or unidimensionally measurable disease on the basis of physical exam or imaging studies, or
* Evaluable disease: bone metastases defined on bone scan or malignant pleural effusion

Performance status ≤ 2 (ECOG scale) with a life expectancy of at least 3 months

Patients must be at least four weeks from prior treatment (chemotherapy, hormonal therapy, or definitive radiotherapy)

EXCLUSION CRITERIA:

Prior therapy with TAXOTERE (docetaxel)

Cumulative anthracycline exposure \> 300 mg/m2.

More than one primary malignancy with the exception of:

* Non-melanoma skin cancer
* In situ carcinoma of the cervix
* Localized prostate cancer
* Completely resected stage I or II disease with no evidence of recurrent cancer from which the patient has remained disease free for more than 3 years.

Uncontrolled significant non-malignant disease (e.g. congestive heart failure, bleeding, renal failure, hepatic failure).

Uncontrolled, symptomatic brain metastasis.

Peripheral neuropathy \> grade 2.

Concomitant therapy with other anti-neoplastic agents or experimental agents except for small volume radiation to a solitary bony metastasis.

Active viral, bacterial or systemic fungal infections including known HIV or Hepatitis B or C.

Women who are pregnant or breastfeeding

Any serious underlying medical condition, which would impair the ability of the patient to receive the planned treatment including prior allergic reactions to recombinant human or murine proteins.

Dementia or altered mental status that would prohibit the understanding and rendering of informed consent.

Patients with uncontrolled peptic ulcer disease will be excluded.
Healthy Lifestyle Program: A Novel Group-based Training

The Healthy Lifestyle Program involves twelve, 2-hour seminars during which participants will learn how to build healthy behaviors through a combination of individual and group exercises. Participants will use lessons from the seminars to pursue health goals and learn the basics of physical fitness, nutrition, sleep \& recovery, stress management, and weight management for optimal health. Throughout the program, participants will be supported by a behavior coach along with dedicated fitness training, dietary strategy, and stress management support. As part of this next installment of the program, we are conducting a study of the Healthy Lifestyle Program to capture outcome data, including weight/BMI, blood pressure, hemoglobin A1c, and lipid profile.


Eligibility Criteria:
Inclusion Criteria:

* Preferential access to the HLP is provided folks who live in the neighborhoods of Roxbury, Dorchester, and Mattapan. However, this is certainly not exclusive and we continue to have participants from all around the greater Boston area, especially now that the program is being delivered virtually.

Exclusion Criteria:

* There are no groups of people who are excluded from participating in the program, except for the specified by the age cut offs.
Music to Improve Sleep Quality in Adults With Depression and Insomnia

Insomnia is a common sleep disorder for patients with depression. This has a major impact on the quality of life for the individual.

The aim is to investigate, whether music intervention is effective in

1. improving sleep quality,
2. reducing symptoms of depression and
3. improving quality of life

Participants use a sound pillow and selected music in the The Music Star app at home as a sleep aid in 4 weeks.

Depression is a common health problem in Denmark with a prevalence for depression of 17-18%. Depression has serious personal and social consequence. Sleep disorders are common in patients with depression. Resolving sleep disturbances in depression may prevent worsening of symptoms and relapse.

Music listening is widely used as a sleep aid. A study from the Cochrane library shows consensus that music may be helpful to improve sleep quality in insomnia. It remains unclear if music listening is helpful to patients with depression as it is to a broader population.

A randomized controlled trial address the use of music as a supplementary treatment to improve sleep in depression.

Eligibility Criteria:
Inclusion Criteria:

* Out patients in treatment for depression in psychiatry, Unit for Depression, Aalborg University Hospital.
* ICD-10 diagnosis of unipolar depression F32 or F33.
* Sleeping problems identified by HAM-D by a total score of 3 on sleep items 4-6, or a single score = 2 on at least one sleep item.
* Following treatment standards according to national guidelines.(pharmacological treatment, psychotherapy, psycho education, Electro Convulsive Therapy).
* 4 weeks of treatment and/or in stabilized pharmacological treatment

Exclusion Criteria:

* ICD-10 diagnosis of depression F32 or F33 and psychotic episodes
* substance or alcohol abuse
* sentence to treatment by law
* restless legs syndrome
* obstructive sleep apnoea or other organic sleep disorders
* hearing loss
* dislike of music
Safety and Tolerability of the D1 Dopamine Receptor Antagonist Ecopipam in Patients With Lesch-Nyhan Disease

The purpose of this study is to determine the effects of ecopipam in patients with Lesch-Nyhan Disease (LND). Ecopipam specifically blocks the actions of one chemical in the brain that helps nerves talk to one another; ecopipam does this by stopping the chemical (dopamine) from binding to one of its family of receptors (i.e, the D1 family). LND is a very rare genetic disease. The sponsor is doing this study to find out what side effects ecopipam causes in LND patients, and whether ecopipam may be able to relieve the self-injurious behaviors seen in these patients.


Eligibility Criteria:
Inclusion Criteria

* Diagnosis of Lesch-Nyhan disease with moderate to severe Self- Injurious Behavior and are routinely restrained
* Male - 6 years of age and above
* Body weight greater than or equal to 44 pounds

Exclusion Criteria:

* Taking Neuroleptic or Dopamine Depleting medications
* Currently treated with medications for depression or seizures
* Impaired renal function
* Medical conditions that may interfere with completing the study
Accuracy of Rhythm Detection by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)

It is an attempt to see the reliability of the Wearable Smart Watch in identifying atrial fibrillation and other arrhythmias compared to the data detected from ILRs.

The sensitivity, specificity, positive and negative predictive values for successful identification of normal sinus rhythm, atrial fibrillation and other rhythm disorders from the smart watch will compared to that of an ILR.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Patients who have an implantable loop recorder for heart rhythm monitoring purposes
* Having IOS iphone device that can be integrated into Apple Watch
* Willing to sign a consent form and participate in the study

Exclusion Criteria:

* Hemodynamically unstable patients
* Over 90 years of age
* Presence of wrist tattoos
* Presence of AV fistula on the wrist on which the wearable is worn. (If the contralateral wrist is unaffected, those patients can be included)
* Presence of Implantable Cardiac Pacemaker and/or ICD
* Patients with Parkinsons disease or tremors
Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease

This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619 in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria (Groups 1 \& 2):

* Normal body mass index (BMI)
* Non-smoking for a minimum of 3 months
* Subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ECG.

Group 1 Only:

* Subjects a Mini Mental State Examination score between 12-22, inclusive.
* Diagnosis of probable Alzheimer's Disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* Subjects must have a reliable caregiver.

Exclusion Criteria (Groups 1 \& 2):

* Subjects with clinically significant heart disease, pulmonary disease, diabetes, neurologic or psychiatric disease (Group 1 subjects must have Alzheimer's Disease), or any other illness that could interfere with interpretation of study results.
* Subjects with a past or current history of seizures cannot participate.
* Current use of donepezil, rivastigmine or galantamine.
Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male of 20 years or above
* Subject with prostate cancer with TNM stage T2\~4NxMx
* Blood testosterone concentration ≥ 100ng/dl
* Bilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN
* WHO ECOG performance status ≤ 2
* Signed written informed consent

Exclusion Criteria:

* Hormone-Refractory Prostate cancer
* Brain metastasis
* Another primary malignant tumor except for prostate cancer
* Other conditions which in the opinion of the investigator preclude enrollment into the study
Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes

The study evaluates the use of noninvasive hemoglobin with In Vivo feature and PVi monitoring using pulse-oximetry based technologies and their effect on the management of transfusion and infusion decisions and clinical outcomes for the surgical patient.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing major surgeries associated with possibility of significant blood loss (e.g. such that blood is cross-matched and available before the start of the case as per hospital routine practice) under general anesthesia.
* At least one finger available and accessible for performing non-invasive hemoglobin monitoring.

Exclusion Criteria:

* Patient has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent the proper fit and application of the sensors
* Procedures performed using robotics surgery
* Any patients with a known hemoglobinopathy
* Any patients undergoing Cardio-Pulmonary Bypass (CPB)
* Any patients who cannot be transfused or has refused consent for a blood transfusion
* Patients being treated by any artificial oxygen carriers within 30 days of hospital stay
* Patients being managed outside of an operating room in the participating centers, or in operating room with conditions not conducive to perform and complete the study procedures (including use of the hemoglobin monitoring device)
* Patients younger than 18 years old
* Patients who are pregnant
* Patients with cardiac arrhythmia
* Patients with tidal volume setting \< 6ml/kg
* Patients with PEEP \>= 10cm H2O
* Patients undergoing cardiac and/or any open chest procedures
* Emergency patients due to the foreseeable difficulty in consenting
* Patients deemed not suitable for study at the discretion of the Principal Investigator
Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma

This is a Phase II clinical trial for Decitabine plus Camrelizumab resistant/relapsed patients with Hodgkin Lymphoma. The purpose is to evaluate the efficacy and safety of the combination therapy of Chidamide plus Decitabine Plus Camrelizumab.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
2. 12 to 75 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
6. Subjects must be relapsed or resistant for the treatment of Decitabine plus Camrelizumab. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation

Pneumatization of the maxillary sinus may lead to insufficient bone volume for dental implant placement in the edentulous posterior maxilla. Sinus floor elevation (SFE) surgery with the lateral window technique is a safe and predictable surgical intervention to restore bone height in the maxillary premolar and molar areas. According to the literature, several bone graft materials may be successfully applied for SFE surgery. There is a lack of evidence regarding the application of biphasic calcium sulfate (BCS) for SFE. The healing period following staged SFE is 2-9 months.

The aim of this study is:

* to evaluate the success of SFE surgery using BCS as graft material,
* to compare the microarchitecture of the augmented bone depending on the healing period,
* to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years,
* Patients who need dental implant-borne prostheses,
* Patients with insufficient bone height in the posterior maxilla due to sinus pneumatization.

Exclusion criteria:

.• Patients who had major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV),

* psychiatric contraindications,
* patients on medication interfering with bone metabolism, including steroid therapy and antiresorptive medication,
* radiation to the head or neck region within the previous five years,
* localized periapical disease, odontogenic and nonodontogenic cysts, and maxillary sinusitis,
* evidence of uncontrolled periodontal disease,
* Alcohol Use Disorder defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5),
* recreational drug abuse,
* heavy smoking (\>10 cigarettes/day),
* diseases of the oral mucosa, including blisters and ulcers, i.e.: red and white lesions, pigmented lesions, benign tumors of the oral cavity, and oral cancer. Leukoplakia, Erythroplakia, Precancerous lesions, Oral squamous cell carcinoma and malign tumors of the soft and hard tissues, Oral candidiasis, Oral lichen planus, Psoriasis, Pemphigus, and Pemphigoid.
* pregnancy or nursing,
* poor oral hygiene
Therapy of Radiation Enteritis With Glutamine

Objective: To evaluate the effects of perioperative glutamine supplemented total parenteral nutrition support on nutritional status, immunologic function and intestinal permeability of patients with chronic radiation intestinal injury.

Methods: The 40 patients with CRII were randomized into two groups, the standard TPN group and glutamine-enriched TPN group. The patients were administered total parenteral nutrition for at least four weeks (two weeks pre-operation and two weeks post-operation). The nutritional status, immunologic function, plasma concentration of glutamine and intestinal permeability were measured at 1 day, 1 week and 2 weeks pre-operation, 3 day, 1 week and 2 weeks post-operation. Nutrition status was determined the plasma concentrations of hemoglobin, albumin, prealbumin, transferrin and triglyceride. Immunologic function were measured by the percentages of CD4+T cells and CD8+T cells, the ratio of CD4 +T cells to CD8+T cells ( CD4 +/CD8 +) was calculated， and serum IgA, IgM and IgG．The intestinal permeability was detected by the urinal ratio of lactulose and mannitol.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic radiation enteritis
* Need the operation
* Malnutrition

Exclusion Criteria:

* Hepatic failure
* Kidney failure
* Neoplasm recurrence
* Serious cardiovascular/metabolic disease
* Pregnancy and lactation
Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study

Open, multicenter, non randomized, single arm, pilot trial.

Open, multicenter, non randomized, single arm, pilot trial. The study is aimed at patients infected with HIV in triple antiretroviral therapy based on Dolutegravir (DTG) who experience neuropsychological adverse effects related to the treatment. After signing the informed consent, DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Infection with chronic HIV-1.
* On triple therapy antiretroviral therapy based on abacavir/lamivudine (ABC/3TC) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC), whose third component is DTG in a dose of 50 mg / day.
* Presence of neuropsychiatric symptoms (insomnia, sleep disturbances, reduced concentration, dizziness, headaches, depression, restlessness or nervousness) with an intensity ≥ 2 on the DAIDS scale.
* Written informed consent to participate in the study.

Exclusion criteria:

* Pregnant women, nursing or of childbearing age who want to get pregnant.
* Concomitant use of any medication with potential risk of interaction with the therapy under study.
* Intolerance, hypersensitivity or previous resistance to the therapy under study or presence of any contraindication of it.
* Subjects in therapy with immunosuppressants or chemotherapy with cytotoxics, including interferon and interleukin-2 at the time of their inclusion in the study.
* Abuse of alcohol or any other substance that may interfere with adherence to treatment.
* Subjects who are participating in any other clinical study with the exception of those in which the treatment under study has been suspended for more than 12 weeks.
* AIDS event at the time of diagnosis of HIV infection or in the 3 months prior to its inclusion
* Any other clinical condition or previous treatment that makes the subject unsuitable for the study or that compromises their ability to comply with the treatment dosing requirements.
* History of mental illness or diagnosis of neuropsychological symptoms prior to the use of DTG.
* Presence of genotypic mutations that confer resistance to ABC, TDF / TAF, 3TC or FTC.
* Chronic liver disease in the cirrhosis phase (either by ultrasound criteria or fibroscan ≥ 14.5 KPa)
* Consumption of tobacco ≥ 20 cigarettes / day.

Additional Exclusion Criteria (for patients recruited at the Costa del Sol Hospital in Marbella only):

* History or diagnosis of claustrophobia, or inability to lie flat on the back inside the positron emission tomograph or MRI chamber for a period of 20 minutes.
* Contraindication to perform an MRI, including the presence of a cardiac pacemaker or other electronic device or ferromagnetic metallic foreign bodies in vulnerable positions evaluated by a standard questionnaire prior to MRI.
Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI colimycin either as an aerosol or after IV injection, the administration being separated by 5 to 10 days intervals


Eligibility Criteria:
Inclusion Criteria:

* Males and females, adults.
* Suffering from stable cystic fibrosis
* Colonized by P. aeruginosa
* Having given informed consent.
* Able to follow the protocol
* Having a social insurance

Exclusion Criteria:

* Renal insufficiency
* Allergy to colistin or polymixins
* Myasthenia
* Recent severe hemoptysis
* Liver cirrhosis and hepatic insufficiency
* Hypoalbuminemia
* Colonization by Burkholderia cepaea or Stenotrophomonas maltophilin
* Pregnancy
Evaluation the Association of Microbiome Between Respiratory Tract Samples and Stool Samples in Pneumonic Patients Accompanied by Respiratory Failure

A prospective observational study. Enrolled participants admitted to ICU due to pneumonia and respiratory failure need mechanical ventilator support. Investigators collected the residual specimens, such as sputum from endotrachea aspiration, bronchoalveolar lavage fluid in those participants as the usual care in the ICU. Those residual samples were sent to extract RNA and sequence by using high-throughput sequencing (next-generation sequencing) method.

Investigators will compared the microbiome feature between lower respiratory tract and stool specimens in those participants diagnosed as pneumonia with respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged than 40 years old
* Diagnosed as pneumonia
* Respiratory failure with mechanical ventilator support

Exclusion Criteria:

* Less than 40 years old
* Has been treated with antibiotics more than 7 days within two weeks before enrolling into study
* Suspected or active pulmonary tuberculosis infection
High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain

* The purpose of this study is to determine the efficacy and safety of an evaluation strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed by coronary computed tomography angiography (CCTA) in patients with low-intermediate risk chest pain consistent with a possible acute coronary syndrome compared to a standard of care (SOC) strategy.
* Unicentric, randomized, controlled, open label clinical trial that will compare a fast strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac biomarkers followed by stress/rest imaging study).


Eligibility Criteria:
Inclusion Criteria:

* Patients with chest pain consistent with possible acute coronary syndrome.
* Age \> 18 years.
* Informed consent.

Exclusion Criteria:

* Previous history of coronary artery disease.
* Electrocardiogram diagnostic or suggestive of myocardial ischemia.
* Condition other than coronary artery disease as cause of an imbalance between myocardial oxygen supply and/or demand (eg. anemia, fever, arrhythmias).
* Chronic kidney disease (GFR \<30 mL/min/1,73 m2).
* Iodine contrast allergy.
* Incapability to perform treadmill stress test.
* Barthel activity of daily living scale index \< 100.