cyrilzakka/clinical-trials huggingface dataset:
A Study of Oncobax®-AK in Patients With Advanced Solid Tumors

Akkermansia muciniphila is a naturally occurring bacterium found in the healthy human gastrointestinal tract.

Analysis of the gut microbiota of NSCLC or RCC patients shows that the presence of Akkermansia is associated with the clinical efficacy of immunotherapy. In preclinical models, oral administration of the Akkermansia p2261 strain reverses resistance to PD-1 blockade. In the clinical setting, it is therefore hypothesized that the oral administration of Oncobax®-AK to cancer patients under immunotherapy, but whose gut microbiota is deficient in Akkermansia will restore / improve the efficacy of immunotherapy in patients with NSCLC or RCC.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC
3. NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease
4. NSCLC-specific criterion: PD-L1 expression \> 50%
5. ECOG Performance Status = 0-1
6. Negative stool PCR test for Akkermansia
7. At least one measurable lesion per iRECIST
8. Hemoglobin ≥ 100 g/L
9. Albumin \> 35 g/L
10. Signed informed consent

Exclusion Criteria:

1. Symptomatic brain metastases
2. AST or ALT \> 5 x ULN
3. Calculated creatinine clearance \< 45 ml/min
4. Auto-immune diseases requiring systemic therapy
5. Immunosuppressive therapy (\> 10 mg prednisone/day equivalent)
6. Radiotherapy (\> 30 Gy) to the lung(s) within 6 months of signed informed consent
7. Active infection
8. Co-morbidities that may increase the risk of treatment-related adverse events
9. Pregnancy
10. Inability to comply with protocol-specific assessments
13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)

Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath Test). The aim of the trial is to observe the effect of different PPIs on the breath test and choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a minimal effect on the UBT while using selected PPIs.

Adult subjects with suspected H pylori infection will be recruited and will undergo a 13C -Urea breath test (including citrica) with the BreathID test device. Those were found positive will undergo selected PPI treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second breath test. Those found to be negative (false negative), will undergo additional breath tests.

* Those subjects that underwent any antibiotic, bismuth or PPI therapy 4 weeks prior to the trial, are to be excluded.
* Furthermore, pregnant or nursing women and subjects with an allergy or sensitivity to one of the tests substrates, will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Adults with H.pylori infection.

Exclusion Criteria:

* Pregnancy,
* Nursing,
* Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,
* Known sensitivity to Urea or citrica.
Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Diet/exercise therapy with sulfonylurea (SU) for at least eight weeks
* HbA1c greater than or equal to 7.0% and less than 10.0%
* BMI less than 35 kg/m2

Exclusion Criteria:

* Treatment with insulin within the last 12 weeks
* Treatment with any drug that could interfere with the glucose level
* Any serious medical condition
* Females who are pregnant, have intention of becoming pregnant or are breastfeeding
Investigation of the Effect of Systemic Steroids on Treatment and Prevention of Recurrent Tracheal Stenosis in Postoperative Patients

tracheal stenosis is the result of abnormal wound-healing processes leading to hypertrophic scar formation and obstruction of the airway lumen by excess granulation tissue. This process is progressive so treatment and prevention is essential. Resection-anastomosis of the trachea is becoming the standard of care in many centers and gives the most consistent results in both adult and pediatric patients. But recurrence stenosis, re-granulation and re-inflammation are probable. This study aimed to assess the efficacy of systemic prednisolone on prevention of recurrent tracheal stenosis after surgery.

Tracheal stenosis affects 4-13% of adults and occurs in 1-8% of neonates after prolonged intubation in United States. The causes of adults' tracheal stenosis include trauma, chronic inflammatory diseases, benign neoplasm, malignant neoplasm and collagen vascular diseases. The most common cause of tracheal stenosis continues to be trauma, which can be internal (prolonged endotracheal intubation, tracheostomy, flame, burn injury) or external (neck trauma). Approximately 90% of chronic subglottic stenosis in children and adults results from endotracheal intubation or tracheostomy and about 10% results from other causes.

The resection anastomosis is the most effective treatment to cure this condition. The other treatments are mechanical dilation (dilators, rigid bronchoscopes), stents, laser co2, diode, and cold knife. But they are not as effective as resection anastomosis. Rigid bronchoscopes or dilators may shear the mucosa leading to further damage. Resection of all damaged segments of the airway, approximation and anastomosis of the two intact ends by means of fine synthetic absorbable sutures with minimum tension. Steroids with anti-inflammatory effect widely use as first line therapy for this condition.

Patients who underwent resection anastomosis during 2014-2016 for treatment of post-intubation tracheal stenosis will be included in this study. Systemic prednisolone will be used for treatment and prevention of recurrent tracheal stenosis in post-operative patients. Post-operative patients will divide in two groups, one of them will receive prednisolone and the other will receive placebo for 30 days. The results will be compared by bronchoscopy (FOB or rigid) after 30 days.

Eligibility Criteria:
Inclusion criteria:

1. Post-operative resection anastomosis patients.
2. Age more than 10 years old.
3. no severe tension in surgery by the opinion of surgeon.

Exclusion Criteria:

1. Pregnancy
2. History of significant medical condition not controlled by medicines. Ex: cardiovascular diseases, endocrine impairments and etc.
3. Weight is ≥200% ideal body weight
4. Severe chronic liver disease
5. immunosuppression including HIV+ status, history of bone marrow or solid organ transplantation, current malignancy, neutropenia
6. Fungal systemic infection
TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised to be of potential benefit for treating AD.

Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 15 study subjects for a period of one month, followed by a 5 month and a 6 month possible study extension, with serial testing of cognition and function monthly.

Eligibility Criteria:
Inclusion Criteria:

* NINCDS-ADRDA Criteria for Alzheimer's disease
* CT or MRI consistent with AD

Exclusion Criteria:

* active infection
* CHF
* demyelinating disease
* uncontrolled diabetes mellitus
* vascular dementia
* clinically significant neurologic disease other than AD
* Hachinski \>4
* history of lymphoma
* TBC
* wbc\<2500
* platelets\<100,000
* HCT\<30
* pregnancy
* premenopausal, fertile not on acceptable birth control
* change in neuroactive medication within 4 weeks of study initiation
Bioequivalence Study of Lu AF35700

The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged ≥18 and ≤55 years
* Body Mass Index (BMI) of ≥18.5 and ≤32 kg/m2
* Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination

Exclusion Criteria:

* The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
* The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser
* The subject has previously been dosed with Lu AF35700

Other protocol defined inclusion and exclusion criteria may apply
Studying Students at Risk for COVID-19

The goal of this longitudinal observational study is to learn about how the COVID-19 has impacted and continues to impact students at the University of Michigan. We hope to determine whether a combination of (1) continuous heart rate obtained from wearable devices, (2) self-reported data from surveys and symptom logs, and (3) saliva samples can be used to help students self-monitor for infection and eventually be able to create a predictive model to detect illness early.

The study was originally intended to last one year, however, it was expanded to follow the study participants over several years.

During this study, participants will be asked to:

* Provide a baseline self-collected saliva sample
* Download and use a suite of mobile apps (e.g., Fitbit, Social Rhythms, Roadmap 2.0)
* Complete surveys online
* Wear non-invasive Fitbit smartwatch
* Grant the study team access to their university academic records (optional)

The study will use these tools to monitor participants' physical activity and mental health over the course of at least three years. The study will also examine whether there is a connection between mental health and academic performance.

Eligibility Criteria:
Inclusion Criteria:

* Students at the University of Michigan who have moved back to Ann Arbor or who are completing schooling completely online.
* For those completing school online, must be able to provide a mailing address within the United States where they can receive study tools
* Possession of a smartphone (Apple or Andriod)
* Ability to understand and demonstrate willingness to sign a written informed consent.

Exclusion Criteria:

* Unwilling or unable to comply with the study procedures.
Photobiomodulation Therapy in Exercise Capacity Assessed by 6MST in Patients With COPD

Chronic obstructive pulmonary disease (COPD) is characterized by dyspnea, as well as musculoskeletal and systemic manifestations. Photobiomodulation therapy (PBMT) with use of low-level laser therapy (LLLT) and/or light emitting diode therapy (LEDT) is an electrophysical intervention that has been found to minimize or delay muscle fatigue. The aim of this study is to evaluate the acute effect of PBMT with combined use of lasers diodes, light emitting diodes (LEDs), on muscle performance, exercise tolerance and metabolic variables during the 6-minute stepper test (6MST) in patients with COPD. Twenty-one patients with COPD will completed the 6MST protocol over 2 weeks, with 1 session per week. PBMT or placebo (PL) will be performed before each 6MST (17 sites on each lower limb, with a dose of 30 J per site, using a cluster of 12 diodes: 4 × 905 nm super-pulsed laser diodes, 4 × 875 nm infrared LEDs, and 4 × 640 nm red LEDs; Multi Radiance Medical™, Solon - OH, USA). Patients will be randomized into two groups before the test according to the treatment they will receive. Assessments will be performed before the start of each protocol. The primary outcomes are oxygen uptake and number of steps, and the secondary outcome are perceived exertion (dyspnea and fatigue in the lower limbs).

All patients will have a diagnosis of COPD according to the global initiative for chronic obstructive lung disease (GOLD) criteria. The patients will be at a stable phase of the disease, indicated by a lack of change in medical therapy (including oral steroids) or an exacerbation of symptoms in the preceding 4 weeks. Patients with other known severe chronic diseases, including cardiac, neuromuscular, or orthopedic disorders, will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients
* Patients are at a stable phase of the disease

Exclusion Criteria:

* Patients with cardiac diseases
* Neuromuscular diseases
* Orthopedic disorders
The Role of the Pharmacist and Pharmacogenomics in the Care of Seriously Ill Patients

Researchers are trying to learn more about how pharmacists and pharmacogenomic testing can help care providers improve control of symptoms and quality of life in seriously ill patients.

Participants in the study will be randomized to A) standard of care, B) standard of care with medication therapy management provided by a pharmacist, or C) standard of care with medication therapy management by a pharmacist who has access to the patient's pharmacogenomics profile accessible to guide them. We will be measuring level of symptom control in each group over the subsequent 6 months.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Age 18 years and older
* Palliative Medicine is consulted for the first time in either the outpatient setting for symptom management and plan to continue to follow up with the Palliative Medicine team in the outpatient setting for the foreseeable future.
* Insurance accepted at Mayo Clinic Arizona.
* Live within metro Phoenix area.

Exclusion Criteria:

* Vulnerable adults
* Under 18 years of age
* Pregnant Patients
* Subjects whose medical insurance requires use of specific pharmacies
* Non English Speaking Patients
* Patients that lack capacity for medical decision making
* Patients who live outside the metro Phoenix area
* Patients who are lost to follow up secondary to enrolling in hospice, die or failure to show or answer surveys within 2 months of enrollment.
* Patient with uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
* Patient's previously established within the Palliative Medicine Clinic who receive ongoing Palliative Medicine services.
Open Reduction Internal Fixation of Calcaneus Fractures With and Without Bone Graft

The purpose of this study is to compare patient functional outcomes for surgical fixation of calcaneus fractures with and without tricortical iliac crest bone grafting

This study was designed as a randomized, prospective evaluation of patients who have sustained an intra-articular calcaneus fracture that requires open reduction with internal fixation as the preferred method of treatment. Patients who desire to participate in this study will be randomized into one of two groups. Group A will be made up of patients that undergo open reduction with internal fixation and Tricortical iliac crest bone grafting. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting. All other surgical techniques and management of the fracture and patient will remain unchanged.

Eligibility Criteria:
Inclusion Criteria:

* intra-articular calcaneus fractures requiring open reduction and internal fixation
* Adult patient (19 years or older)
* Mental capacity to comply with post-operative regimen, evaluation and data collection

Exclusion Criteria:

* non-operative fractures for primary or secondary reasons
* prior surgery to the hindfoot of the involved lower extremity
* inability to comply with post-operative regimen, evaluation and data collection
* inability or unwillingness to give informed consent
Efficacy of ONE A DAY Weightsmart Advanced Versus Caffeine and Placebo on Energy Expenditure, Thermogenesis and Perceived Energy Levels in Women.

The study is considered research because efficacy (how well a drug works) information is needed in healthy, 25-45 year-old, female subjects with moderate caffeine intake. The investigational product is available in the United States without a prescription (over-the-counter) as a nutritional supplement. The purpose of this study is to assess whether One-A-Day Weightsmart Advanced is safe and can increase metabolism and perceived energy in female subjects compared with caffeine or placebo (inactive drug). Participation in this study will last approximately 4 weeks and require about 4 outpatient visits to St. Luk's-Roosevelt Hospital Center. About 21 subjects are expected to participate in this study.

- Primary efficacy endpoints are area under the curve (AUC) over the first 2 hours and the last 2 hours of Resting Metabolic RateRespiratory Quotient- The secondary efficacy endpoints are:Perceived Energy scales Visual Analog Scale (VAS) Change from baseline for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) respiration, average heart rate over 1st 20 minutes, average heart rate over last 20 minutes, and temperature

Eligibility Criteria:
Inclusion Criteria:

* Be a healthy, ambulatory female between the ages of 25 and 45 years old with a Body Mass Index (BMI) between 20 and 35 kg/m2 (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, brief physical examination, including vital signs, and clinical laboratory tests)
* Consume a habitual caffeine intake (\<300 mg/day or \</= 2 caffeinated drinks/day)

Exclusion Criteria:

* Pregnant, planning to become pregnant or lactating females
* Using ephedra- or caffeine-containing products or chronic medications other than contraceptives or HRT
* Lost or gained more than five pounds of weight in the preceding three months
* Engage in intense physical activities
* Use of tobacco or nicotine products
* A medical history with known thyroid disease, blood pressure \>140/90 mmHg, diabetes, depression, psychiatric disorders, glaucoma, or seizure disorders and other relevant illnesses that can interfere with the trial in the opinion of the Investigator
A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)

This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

* No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG
* Schirmer's I Test ≥ 10mm/5 minutes with anesthesia
* Corrected Snellen acuity of 20/40 or better in both eyes

Exclusion Criteria:

* Subjects diagnosed with any ocular disease other than refraction error
* Subjects with intraocular pressure \>21 mmHg
* Use of a contact lens within 7 days prior to administration of the first dose
* Subjects with history of ocular surgery
* Subjects with a history of laser refractive surgery
Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg

Efficacy and safety of morphine titration on acute pain in emergency medical mobile units with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus of 0.05 mg/kg plus 0.025 mg/kg

STUDY OBJECTIVE : Assess the efficacy of a morphine dose of 0.1 mg/kg versus a morphine dose of 0.05 mg/kg in pre-hospital pain METHODS : Consecutive patients with severe, acute pain defined as a verbal rating scale (VRS) of 60/100 or higher may be included. 106 patients at all are required in the study. They will be randomised in two groups : group A will receive an initial intravenous injection of 0.05 mg/kg then injections of 0.025 mg/kg every 5 minutes and group B will receive an initial intravenous injection 0.1 mg/kg then injections of 0.05 mg/kg every 5 minutes. The pain scale will be checked every 5 minutes during 30 minutes. The titration will be stopped before, if the VRS is \< or = 30. The patient will be followed during the study until 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Severe, acute pain defined by a VRS of 60/100 or higher
* Male or female over 18 years
* Cared by a medical emergency care unit
* Written informed consent
* Affiliated to social security

Exclusion Criteria:

* A known opioid or paracetamol hypersensitivity
* Patient not agree ta participate at the study
* Pregnancy
* Uncontrolled epilepsia
* Incapacity to understand the VRS
* Renal, respiratory, or liver disease
* Patients who have received sedative drugs or alcohol (\< 6h)
* Acute respiratory, haemodynamic or neurologic failure
* Patients who have already received an analgesic (\< 6h)
* Drug addiction
* Patients under protection of justice
Plating Clavicle Fractures

The anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.

Compare the rates of soft-tissue irritation with two different methods of plating for clavicle fractures. Patients will be randomized to anterior-inferior or superior plating. Validated shoulder scoring systems will be used to assess outcome. Specific follow-up questions will address the patient's ability to wear his/her uniform, body armor, ruck sack, and other shoulder-borne equipment over the surgical site.

Eligibility Criteria:
Inclusion Criteria:

* Active duty, Reservists, National Guard service members
* completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments)
* a fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment)
* chronic nonunion and malunion fractures
* no medical contraindications to general anesthesia
* provided informed consent.

Exclusion Criteria:

* an age of less than eighteen years or greater than sixty five years
* a fracture in the proximal or distal third of the clavicle not amenable to plating
* a pathological fracture
* an associated head injury (a Glasgow Coma Scale score of \<15 at 21 days after injury)
* an inability to comply with followup
* a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy)
* a lack of consent.