cyrilzakka/clinical-trials huggingface dataset:
Imaging With a PET Agent for Detection of Cancers of the Head and Neck

The purpose of this study is to test the safety of a study drug called PARPi-FL. This drug has been tested in animals but not yet in people. The purpose of this study is to test if a PARPi-FL scan can be used to take pictures of head and neck cancer. The usual approach to imaging this cancer includes several different imaging scans, including x-rays, CT (computed tomography), MRI (magnetic resonance imaging), and PET (positron emission tomography). These tests take pictures of the cancer.


Eligibility Criteria:
Inclusion Criteria:

Part 1:

* Age ≥18 years
* ECOG performance status 0 or 1
* Biopsy (histologically or cytologically) proven Squamos Cell Carcinoma
* Oral cavity, oropharynx, or nasopharynx primary site
* At least one tumor lesion on standard of care imaging with a minimum diameter of at least 1.5 cm
* Scheduled to undergo treatment at MSKCC
* Willingness to sign informed consent

Part 2

* Age ≥18 years
* ECOG performance status 0 or 1
* Biopsy (histologically or cytologically) proven Squamous Cell Carcinoma
* Oral cavity,oropharynx, or nasopharynx primary site
* Scheduled to undergo surgery (neck dissection and/ or neck dissection + surgical removal of the primary) at MSK
* Willingness to sign informed consent
* Should have had a standard-of-care \[18F\]-FDG PET/CT scan before surgery (to minimize the possibility of new alterations developing between the two scans both scans should be acquired within a maximum time difference of one month).

Exclusion Criteria:

* Significantly impaired organ function that may interfere with the excretion and metabolism of the imaging agent. Specifically, patients will be excluded if they meet the following criteria:
* Hematologic

  o Platelets \<75K/mcL
* Hepatic

  * Bilirubin \>2.0 x ULN (institutional upper limits of normal)
  * AST/ALT \>2.5 x ULN
* Renal

  o Creatinine \> 2.0 x ULN
* Claustrophobia interfering with PET/CT imaging

  * Known allergy to PEG300
  * Pregnancy or breastfeeding
A Randomized Controlled Trial (RCT) to Determine the Efficacy of a Multidisciplinary CBT Based Pain Management Program for the Treatment of Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) in Breast Cancer Survivors

The purpose of this research is to evaluate the effectiveness of a multidisciplinary pain management program for AIMSS in reducing pain, subjective cognitive complaints, psychological distress, and impaired functional status resulting in improved adherence to Aromatase Inhibitor medications compared to usual care. We want to identify predictors of improvement in pain, functional status, subjective cognition and mood following participation in the program.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* ECOG ≤ 2
* Stage 0-III HR+ breast cancer in need of strategies to reduce symptoms and improve quality of life

Exclusion Criteria:

• Less than 18 years of age.

- Stage 4 HR+ breast cancer
FL-101 in Surgically Resectable Non-Small Cell Lung Cancer

Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have surgically resectable Non-Small Cell Lung Cancer.

A 2-Cohort, Phase 2, multicenter, parallel-design trial that will study patients with surgically resectable, stages I-IIIA, non-small cell lung cancer (NSCLC) . The clinical study will focus on whether FL-101 has direct anti-tumor activity when given alone prior to surgery, and if FL-101 improves the anti-tumor response when given in combination with nivolumab prior to surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Previously untreated and pathologically confirmed, surgically resectable Stage IA3, IB, II, or IIIA NSCLC of squamous or non-squamous histology.
2. ≥1 radiologically measurable tumor \>2cm in diameter.
3. Smoking history ≥10 pack years.
4. Available tissue block for analysis from a core needle biopsy(or similar sample)
5. High-sensitivity C-reactive protein (hsCRP) level ≥2 mg/L

Exclusion Criteria:

1. Any prior exposure to chemotherapy, radiotherapy or systemic anti-cancer therapy (e.g., monoclonal antibody therapy) for lung cancer.
2. Malignancies other than NSCLC within 2 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome
3. Currently participating in, or has participated in, a trial of an investigational agent within 4 weeks prior to the first dose of study treatment or 5 half-lives, whichever is longer and with recovery of clinically significant toxicities from that therapy.
4. Tumors known to express driver mutations of the EGFR or ALK pathways.
5. Known severe hypersensitivity (Grade ≥3) to FL-101, its active substance, or any of its excipients
6. Known history of human immunodeficiency virus or active Hepatitis B or Hepatitis C infection

Additional Exclusion Criteria for Patients with Stage II and III Disease

1. Prior treatment with anti-PD-1, anti-CTLA-4, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
2. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to Cycle 1, Day 1
3. Known severe hypersensitivity (Grade ≥3) to nivolumab or chemotherapy agents or to any of their excipients.
Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

This is a single site, prospective, cross-sectional, controlled clinical study on a total of 66 subjects. The subjects are divided into two groups: Hypertonic Saline Non-Responders (33 subjects) and Hypertonic Saline Responders (33 subjects). After completion of questionnaires, the subjects will undergo Dry Eye Disease testing and functional nerve testing. Subjects who qualify will be dispensed 4 weeks of preservative free artificial tears and instructed to instill one drop into each eye twice daily. Subjects will return for a follow up visit 4 weeks later (± 4 days), during which subjects will complete the questionnaires again and the Dry Eye Disease tests and functional nerve tests will be repeated.


Eligibility Criteria:
Inclusion Criteria:

Group 1 (Hypertonic saline non-responders):

* At least 18 years of age
* Ability to consent
* Diagnosis of Dry Eye Disease (DED) based on:

  * Symptoms of DED, shown with SANDE score of 50mm or greater
  * Two or more of the following objective signs in the same eye: 1. Schirmer test of 10 mm or less over 5 minutes; 2. Fluorescein tear break-up time (FTBUT) of 7 seconds or less; 3. Meibomian gland expression (MGE) grade of 2 or greater for at least 3 out of 5 glands
* HS response result of one of the following:

  * Reduction of discomfort/pain rating
  * No change of discomfort/pain rating
  * Increase in discomfort/pain rating score of 1 step or less

Group 2 (Hypertonic saline non-responders):

* At least 18 years of age
* Ability to consent
* Diagnosis of DED based on:

  * Symptoms of DED, shown with SANDE score 50mm or greater
  * Two or more of the following objective signs in the same eye: 1. Schirmer test of 10 mm or less over 5 minutes; 2. Fluorescein tear break-up time (FTBUT) of 7 seconds or less; 3. Meibomian gland expression (MGE) grade of 2 or greater for at least 3 out of 5 glands
* HS response result of an increase in discomfort/pain rating of greater than 1 step

Exclusion Criteria:

* Presence of centralized pain as indicated by a proparacaine challenge test (PCT) of less than 50% ocular surface discomfort reduction
* Unable to speak English
* History of ocular surgery, corneal infection, or corneal injury within the last 3 months
* Active ocular allergies or other condition that could impact the study results
* Allergic to benzalkonium chloride "BAK" (an eye-drop preservative)
* Changes in topical or systemic medications in the last 3 months or anticipated changes in medication during the course of treatment
* Use of other topical treatments
* Concurrent enrollment in other studies that in the opinion of the investigator will interfere with the results of this study
* Use of contact lenses within the last month
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.


Eligibility Criteria:
Inclusion Criteria:

1. Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.
2. Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24.
3. Participant understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Exclusion Criteria:

1. There are no exclusion criteria for this study.
Efficacy of Oxepa Enteral Feeding in LTAC (Long Term Acute Care Hospital) Patients on Chronic Ventilation- a Pilot Study

Patients with mechanical ventilation have shown improved weaning rates when enteral tube feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting.

LTAC Patients on chronic mechanical ventilation will have decreased days an mechanical ventilation, decreased mortality rates and decreased organ failure when fed an enteral product high in EPA, GLA and antioxidants compared to an isotonic high fiber enteral nutrition product.


Eligibility Criteria:
Inclusion Criteria:

\>18 years old with Respiratory failure on mechanical ventilation with failure to wean Diagnosis of ARDS (Acute respiratory Distress Syndrome) Bilateral infiltrates -

Exclusion Criteria:

History Of pulmonary fibrosis, Terminal illness/ malignancies, \<28 day life expectancy, Hemodialysis, Active bleeding or bleeding disorder: DIC ( Disseminated intravascular Coagulation), Sickle Cell Anemia, Hemophilia Hemorrhagic or ischemic stroke, Liver failure, Head trauma with Glasgow coma scale score of \<5, Immunosuppression: WBC(White Blood Cell Count) \<5000, HIV positive, use of immunosuppressant drugs, Pregnancy, and Heart Failure with EF(Ejection Fraction) \<35%

-
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old
2. Breast cancer
3. Recurrent brain metastases from breast cancer
4. At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
5. Neurologically stable
6. Karnofsky Performance Status (KPS) score ≥ 70
7. Adequate hematology and serum chemistry laboratory test results
8. Expected survival of ≥ 3 months

Exclusion Criteria:

1. Prior treatment with ANG1005/GRN1005
2. Evidence of symptomatic intracranial hemorrhage
3. Pregnancy or lactation
4. Inadequate bone marrow reserve
5. Any evidence of severe or uncontrolled diseases
6. Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
7. History of interstitial lung disease or evidence of clinically significant interstitial lung disease
8. Severe cardiac conduction disturbance
9. Central nervous system (CNS) disease requiring immediate neurosurgery intervention
10. Known severe hypersensitivity or allergy to paclitaxel or any of its components
Impact of Transcranial Direct Current Stimulation Intensity on Leg Muscle Fatigability in Healthy Adults

Transcranial direct current stimulation (tDCS) is a painless,non-invasive means of increasing brain excitability. It has been used for several years and in many populations to improve physical and psychological outcomes. Although many tDCS devices are capable of a range of stimulation intensities (e.g., 0 mA - 5 mA), the intensities currently employed in most tDCS research are ≤ 2 mA, which are sufficient to elicit measurable improvements; but, these improvements might be expanded at higher intensities. In the beginning, when the safety of tDCS was still being established for human subjects, careful and moderate approaches to stimulation protocols were warranted. However, recent work using stimulation at higher intensities, i.e. up to 4 mA, has been performed in many populations and was found to have no additional negative side-effects. Now that the safety of tDCS at higher intensities is better established, work exploring the differences in performance between moderate (i.e. 2 mA) and higher (i.e. 4 mA) intensities is necessary to determine if increasing intensity increases the effectiveness of the desired outcome.

Prospective participants will include 40 healthy young adults (all right-side dominant) that will be recruited to complete four randomly ordered stimulation sessions (Baseline, 2 mA, 4 mA, and sham), separated by at least 5 days. Each session will involve one visit to the Integrative Neurophysiology Laboratory (INPL) and will last for approximately one hour. We expect data collection to last 6 months. The first session includes leg strength measurements and fatigue tasks of both legs, as well as a baseline 6 min walk test (6MWT) to determine fatigued walking characteristics. The following three sessions will include performing a random tDCS condition (2 mA, 4 mA, or sham) over the brain area that controls the participant's dominant leg for 15 minutes prior to and then throughout the duration of the fatigue task of the dominant leg (16-20 min total stimulation time). The fatigue task for the nondominant leg will be performed after a 10 minute energy recovery period. After the fatigue task has been completed for both legs, the participants will perform the 6MWT.


Eligibility Criteria:
Inclusion Criteria:

1. Young adult (18-30 yrs)
2. right-side dominant
3. able to independently walk for 6 min
4. at least 30 min of moderate-intensity, physical activity on at least 3 days of the week for at least the last 3 months
5. without chronic neurological, psychiatric, or medical conditions
6. not taking any psychoactive medications

Exclusion Criteria:

1. pregnant
2. known holes or fissures in the skull
3. metallic objects or implanted devices in the skull (e.g., metal plate)
4. current student of study personnel
5. under the direct supervision of study personnel
Fascial Dehiscence and Mortality

Nationwide cohort study on short- and long-term mortality of patients with and without postoperative fascial dehiscence.

The cohort will be comprised of patient undergoing open colonic resection for colonic cancer registered in the Danish Colorectal Cancer Group Database. The exposure is fascial dehiscence and the outcome of interest 30-day, 3- and 5-year mortality.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent open colonic resection identified in the DCCG

Exclusion Criteria:

* None
Study of the Effect of Probiotics on Respiratory Morbidity After Influenza Vaccination of Elderly in Nursing Homes

The purpose of this study is to determine whether probiotic treatment improves the protection against respiratory infections after influenza vaccination in elderly living in nursing homes.

Influenza virus is a member of the orthomyxovirus family and causes an acute viral disease of the respiratory tract. The illness is usually self-limiting. Hospitalization and deaths mainly occur in high-risk groups (elderly, chronically ill). Response to vaccination is subject to high levels of variability due to age, stress, nutritional stage, etc.

Lactic acid bacteria are naturally commensal bacteria in the small and large intestines. These bacteria protect the host against potential pathogens by competitive exclusion and also by the production of antibacterial agents known as bacteriocins. It has only been recently shown that another mechanism whereby probiotic bacteria may provide a health benefit is by modulating immune responses.

Lactobacillus casei strain Shirota (LcS) is widely consumed in fermented milk products. Several studies, in animals as wells as in humans, report on the immunomodulatory functions of LcS.

The aim of this multicentre, randomized, placebo controlled, double blind study (RCT) is to assess if probiotic treatment with Lactobacillus casei Shirota improves the protection against influenza(-like) infections after vaccination with trivalent influenza vaccine in elderly residing in nursing homes.

Trial endpoints:

1. Clinical outcome: difference in incidence in upper respiratory tract infections (influenza-like illness)
2. Serological outcome: difference in influenza vaccine specific serum IgG between probiotic and control treatment

Eligibility Criteria:
Inclusion Criteria:

* healthy male and female volunteers of 65 years or older
* volunteers reside in residential homes
* volunteers must be willing to swallow Yakult/placebo 2x/day for 3 weeks prevaccination and 5 months follow-up
* participants must be able to comply with requirements of study (e.g. assessment of respiratory symptoms, Yakult/placebo administration)
* participants must read and sign written Informed Consent Form after the nature of the study has been fully explained

Exclusion Criteria:

elderly with:

* any medical or practical condition which make the volunteer not suitable for participating in this study at discretion of the investigator
* any current relevant infectious disease
* any current known disorder having negative repercussions on the volunteer's immune system, such as auto-immune diseases, COPD requiring oxigen, cancer, chronic inflammatory disease
* allergy to influenza vaccine, eggs, neomycin, amphotericin B, erythromycin, amantadine
* ongoing treatment with immunosuppressive drugs, chemotherapeutics or other antineoplastic medication
* current use of antibiotics or use 6 weeks prior to study entry
* use of any investigative drug (other drugs who are also under investigation) within 90 days prior to study entry
* with markedly abnormal results in any of the screening laboratory tests
Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (CCRT) with CCRT alone in patients with locoregionally advanced nasopharyngeal carcinoma(NPC), in order to confirm the value of induction chemotherapy in NPC patients.

Patients Patients with non-keratinizing NPC T3-4N1M0/TxN2-3M0 (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy plus CCRT or CCRT alone. Patients in both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles, concurrently with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor. The induction chemotherapy plus CCRT group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. Our primary endpoint is failure-free survival(FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
* Tumor staged as T3-4N1/N2-3 (according to the 7th AJCC edition).
* No evidence of distant metastasis (M0).
* Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
* Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN.
* Adequate renal function: creatinine clearance ≥ 60 ml/min.
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
* Age \> 65 or \< 18.
* Treatment with palliative intent.
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
* History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Treatment of Osteopenia With Melatonin

The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.

Background: Melatonin is known for its regulation of circadian rhythm. The production falls with age, which explains why elderly may have disturbed sleep patterns. Laboratory study and animal experimental studies suggests that melatonin also may protect against bone loss through increased osteoblast- and inhibited osteoclast activity. However, so far human studies have not been performed.

Design and patients: Double blinded randomised controlled study. Eighty post-menopausal women (aged 55-75) with osteopenia are randomized to receive 1mg, 3mg or placebo (daily - at night time) for 12 months.

Methods and results: Effects of melatonin on BMD, bone- structure and mass will be assessed through DXA-scans, pQCT, and QCT. Quality of life, sleep, and activity level will be assessed though questionnaires. Calcium homeostasis will be analyzed through blood and urines samples. As safety parameters, balance and muscle function will also be performed.

Conclusion: Expected improvements in BMD, quality of life and sleep.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women between 55 and 75 years.
* Osteopenia verified by DXA-scans of total hip or lumbar spine (t-score between -1 and -2.5)
* Written informed consent after oral and written information

Exclusion Criteria:

* Severely impaired renal function (plasma creatinine \>60 eGFR ml/l).
* Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) and/or alkaline phosphatase more the doubled compared to upper limit of reference value).
* Coagulation factors PP \<0.6
* Hypercalcemia (p-ion calcium \> 1.32 nmol/l)
* Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy).
* Diseases affecting the calcium homeostasis including untreated thyroid diseases.
* Regular use of medicine affecting the calcium homeostasis; including diuretics, lithium, antiepileptica, glucosteroids.
* SSRI-product with fluvoxamin.
* Treatment with carbamazepin
* Treatment with rifampicin
* Severe malabsorption syndrome including gastric or intestinal resection.
* Alcohol or drug abuse.
* Smokers
* Major medical or social problems that will be likely to preclude participation for one year.