cyrilzakka/clinical-trials huggingface dataset:
Taste Acuity and Caloric Intake After Acute Morphine Administration

This study will investigate the effects of acute morphine administration on taste acuity and how much a person eats. It is hypothesized that there will be a dose dependent decrease in taste acuity and dose dependent increase in food intake associated with acute morphine administration. Knowledge from this study will impact the future of feeding behavior and obesity research in the general population. Results will also promote exploration of the long-term effect of opioid abuse on taste acuity and feeding behavior in substance abusing populations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and female volunteers
* Ages of 18 to 65

Exclusion Criteria:

* History of drug dependence (including opioid use disorders)
* History of taste dysfunction
* Significant medical or Axis I psychiatric disorder
* Any trauma or surgical procedures to the head or neck region
* Medication or illicit drug more than 4 out of the last 30 days.
* Pregnancy
* Abnormal electrocardiogram findings
* Negative rating of greater than 40% of the foods available for consumption
A Study in Recurrent Glioblastoma (GB)

The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299 plus lomustine therapy or lomustine plus placebo can help participants with brain cancer


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmed diagnosis of relapsed intracranial GB
* Progressive Disease (PD) following standard chemoradiation
* Prior surgical resection allowed
* Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Adequate hematologic, hepatic and renal function
* Discontinued all prior cancer treatments for cancer \& recovered from the acute effects of therapy
* Tumor specimen must be available for a central pathology review and prognostic and predictive biomarker evaluation

Exclusion Criteria:

* Moderate or severe heart disease based on New York Heart Association (NYHA) criteria
* Prior nitrosurea therapy (including lomustine or Gliadel)
* Prior bevacizumab as 1st line treatment for GB (if treatment was concluded 12 months prior to enrollment, the patient may be eligible to participate in the trial)
* Current acute or chronic myelogenous leukemia
* Second primary malignancy that may affect the interpretation of results
* Serious concomitant systemic disorder
Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)

The purpose of this study is to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery.

Postoperative complications are associated with a significant and quantifiable rate of both morbidity and mortality, increased length of hospital stay and cost of care. Intra-abdominal surgery, especially upper abdominal surgery, is an important risk factor of both pulmonary and extra-pulmonary complications. Up to 15-20% of patients will develop postoperative respiratory failure which may require respiratory support.

Recent data from both experimental and clinical studies suggested that, compared with conventional ventilation using high tidal volume (TV) without positive end-expiratory pressure (PEEP), intraoperative lung protective ventilation using low tidal volume, PEEP and recruitment maneuvers (RM) could reduce postoperative complications. Conventional ventilation promotes sustained cytokine production and could therefore contribute to development of lung injury with in patients with normal lungs. Conversely, lung protective ventilation was found to reduce pulmonary and systemic inflammation.

The primary objective is to compare a lung protective ventilation with conventional ventilation (high tidal volumes without PEEP) during abdominal surgery: 1- Conventional ventilation with TV of 10-12 mL/kg predicted body weight (PBW) without PEEP; 2- Protective lung ventilation with TV of 6-8 mL/kg PBW, PEEP of 6-8 cmH2O and RM.

Our hypothesis is that lung protective ventilation could reduce postoperative pulmonary and extra-pulmonary complications compared with conventional ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Planned intrabdominal surgery
* Expected duration ≥ 2 hours
* Age ≥ 40 yr (and \<90 yr)
* Risk of postoperative pulmonary complications (Arozullah score ≥2)

Exclusion Criteria:

* Noninvasive ventilation in the last 30 days
* Recent history of pneumonia, ALI/ARDS (in the last 30 days)
* History of pulmonary resection
* History of neuromuscular disease
* Patient refusal
The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer

The purpose of this study is to learn if bladder cancer patients can follow a diet and exercise program during treatment and whether the program will improve results of their treatment.

This study will examine the effects of a carbohydrate restricted (CR) diet in bladder cancer patients with diabetes. The goal of this pilot study is to determine if the CR diet and exercise routine are feasible for this patient population to follow.

Participants in this study will receive meals tailored to their specific needs. A registered dietitian will work with them to establish guidelines for the meals and to follow their progress throughout the study.

Participants will be asked to be in this study for up to 12 months. A participant will be asked to make a total of 16 in-person visits over the course of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-muscle-invasive bladder cancer
* Have completed Transurethral Resection of Bladder Tumor (TURBT) procedure
* Diagnosis of diabetes or pre-diabetes, or use diabetic medication, or show signs of diabetes which would prompt a diabetic screening

Exclusion Criteria:

* Evidence of muscle-invasion or metastatic disease
* BMI less than 18.5 and/or score in the "severe malnourished" category of the patient generated subjective global assessment (PGSGA)
* Unable to complete the exercise regimen or deemed a fall risk
* Participating in a research study involving any form of treatment intervention
S-Asenosyl-L-Methionine Vs Placebo for Osteoarthritis of the Hands

The primary objective of this study is to demonstrate the feasibility of evaluating SAMe tolerability, analgesic benefits, and daily functional improvement in patients with osteoarthritis of the hands compared to placebo. The secondary objective of this study is to generate preliminary data on discomfort, function, quality of life in patients with osteoarthritis of the hands when taking SAMe compared to placebo.

At week 0, all patients giving written informed consent and meeting eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to SAMe (400mg orally, twice daily) or placebo (400mg, twice daily) for 8 weeks. Followed by a one week wash out period followed by another 8 weeks of SAMe (400mg, twice daily) or placebo (400mg, twice daily) for 8 weeks (whichever was not given during the first 8 week period).

Participants will complete weekly surveys during the entire study regarding hand discomfort, functional limitations and side effects

Eligibility Criteria:
Inclusion Criteria:

* Current primary care provider within the Dartmouth Health system
* Office visit at Dartmouth Health in the past 3 years
* Participants must be 40 or older at the time of signing the informed consent
* Participants have discomfort or functional limitations of one or both hands AND either:

  1. Objective findings of at least one hand meeting diagnostic criteria based on the American College of Rheumatology (ACR)\* or
  2. Existing radiographic evidence of osteoarthritis as judged by a radiologist
* Patients taking OTC or prescription analgesics who are willing to stop their current analgesics for two weeks prior to study entry and remain off those medications over the course of the study
* \*Objective inclusion criteria (see poster schematic)

Swelling or deformity of 2 of the following ten joints: the 2nd and 3rd distal interphalangeal (DIP) of each hand, the 2nd and 3rd proximal interphalangeal (PIP) of each hand, and the 1st carpometacarpal joints of both hands.

Exclusion Criteria:

* Patients taking prescription medications other than NSAIDs for their OA who are unable to stop their medication
* Patients with diagnoses of arthritis from conditions other than OA
* Patients whose symptomatic joint is an artificial joint
* Patients with Bipolar Disorder
* Patients taking any of the following medications at study entry OR starting any of these medications during the study period:

  1. daily opioids (including tramadol or buprenorphine)
  2. gabapentin or pregabalin
  3. prednisone
  4. Prescription NSAIDs that they are unable to stop or topical diclofenac
  5. SNRI drugs (Effexor, Cymbalta, Fetzima, Pristiq)
* The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2)

The goal of this monocentric interventional study is to evaluate the efficacy, in terms of objective response rate, of the 188Re-SSS lipiodol SIRT in patients with non-operable HCC.

This study is an open-labelled treatment administration study conducted with an exact one-stage one-arm study plan.

The study plans to included 35 patients and to treated 26 patients (take into account screen failures and SIRT contraindications).

The treatment is delivered by a one-day procedure leading to the injection of 188Re-SSS lipiodol. In details, the patient is hospitalized for one night. Two steps are performed while the patient is hospitalized: the pre-treatment simulation step and the treatment step itself.

After treatment, patients are followed until progression, new systemic or locoregional (in the same treatment area) antineoplastic therapy or death, within a maximum 24-month period following the SIRT.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* ECOG Performance Status 0-1
* HCC with histological diagnosis or non-invasive diagnosis according to AASLD criteria
* Non operable and not accessible to ablation therapy
* At least one measurable lesion using mRECIST
* Tumor involvement \<50% of the liver
* BCLC classification A to C
* Compensated cirrhosis (Child Pugh A or B7), if cirrhosis present
* Registration with a social security scheme
* Written and informed consent of the patient or his/her legal representative

Exclusion Criteria:

* Inadequate hematological, hepatic, renal, thyroid and coagulation functions:

  1. Hemoglobin \< 8,5 g/dl
  2. Granulocytes \< 1500/mm3
  3. Platelets\< 50 000 /mm3
  4. Bilirubin level ≥ 35 mol/l
  5. Transaminases \> 6 UNL
  6. Creatinine \> 1,5 UNL
  7. TSH \< 0,2 µUI/L
* Chronic respiratory insufficiency history
* Known hemophilia with exophytic tumor \> 1 cm
* Extra-hepatic metastasis except hilum node \< 2 cm
* Lung shunt \>20% evaluated with 99mTc albumin macroaggregate (MAA)
* Poor tumor targeting with 99mTc albumin macroaggregate (MAA)
* Previous SIRT
* Previous systemic treatment within 4 weeks before radioembolization
* More than 2 previous TACE (or embolization), in the area to be treated
* Other neoplasia except if complete remission from at least one year
* Contraindication related to the technique, in particular severe arterial pathology of the lower limbs or the aorta contraindicating or making difficult an arteriography by femoral approach
* Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 1 month after the end of the treatment
* Minors, individual deprived of liberty, or under any kind of guardianship or trusteeship.
* Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.
Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care occupational therapy in children with perinatal brachial plexus injury. Participants are randomized to receive either the intervention (CIMT) or control first, then cross over to receive the other one.

Children with perinatal brachial plexus injury routinely receive occupational therapy intervention to improve strength and function in their weak or paralyzed arm.

Constraint-induced movement therapy (CIMT) is known to increase upper extremity function in children with weakness or disuse as a result of cerebral palsy. However, it is unknown if this therapy is effective for treating arm weakness or disuse as a result of perinatal brachial plexus injury. The addition of CIMT to usual and standard occupational therapy care is evaluated in this trial.

Eligibility Criteria:
Inclusion Criteria:

* Participant has perinatal brachial plexus injury
* Participant walking at time of study inception
* Ability to cooperate with interventions and assessment
* Participant currently receiving occupational therapy 1+ hour per week and planning to continue for duration of study

Exclusion Criteria:

* Co-morbid diagnosis not related to perinatal brachial plexus injury
* Flaccidity of the involved upper extremity or no observable hand function
* Planned surgery or drug intervention during the study period
* Allergy or intolerance to constraint intervention materials
Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study

In western Kenya the prevalence of malaria in \<5 year olds has fallen from 70% in 1997 to 40% in 2008, where it has now stagnated. Innovative approaches are needed to continue towards elimination. Ivermectin is a broad spectrum antiparasitic endectocide widely used for the control of onchocerciasis and lymphatic filariasis at a dose of 150-200 mcg/kg. Ivermectin at this dose has a potent, but short-lived effect for 6-11 days on mosquito survival, egg-laying, and parasite sporogony. Higher doses are needed to prolong its mosquitocidal effects. Previous studies have shown ivermectin is very well tolerated and safe even up to 2,000 mcg/kg. This dose finding study will evaluate the transmission blocking effect of high-dose ivermectin to define the optimal dose for future use of ivermectin in combination with artemisinin-based combination therapy (ACT) for mass drug administration (MDA). It explores a research question of global relevance. A prolonged transmission blocking effect of ivermectin could have substantial consequences for malaria control in the next decades. The results are expected to inform national malaria control programs in malaria endemic countries, to inform WHO guidelines, and to contribute to the regulatory process.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic, uncomplicated Plasmodium falciparum infection
* Positive malaria microscopy or malaria RDT (pLDH)
* Age: 18-50 years
* Provide written informed consent
* Agree to be able to travel to clinic on days: 1, 2, 7, 10, 14, 21, and 28

Exclusion Criteria:

* Signs or symptoms of severe malaria
* Unable to provide written informed consent
* For women: pregnancy or lactation
* Hypersensitivity to ivermectin or DP
* QTc \>460 ms on ECG
* Body Mass Index (BMI) below 16 or above 32 kg/m2
* Haemoglobin concentration below 9 g/dL
* Taken ivermectin in the last month
* Taken dihydroartemisinin-piperaquine in the last 12 weeks
* Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan
* History and/or symptoms indicating chronic illness
* Current use of tuberculosis or anti-retroviral medication
* Previously enrolled in the same study
The Antioxidant Efficacy of a Product Probiotic in Research

Determine the efficacy of the investigational product versus placebo in reducing stress oxidative during the performance of a physical exercise of a certain intensity and duration.

The effectiveness of a probiotic for oxidative stress after eight weeks of the product to study will be checked. the sample will be formed by cyclists that will submit to a baseline exercise and after the product is taken.

Eligibility Criteria:
Inclusion Criteria:

* Age: between 18 and 45 years
* Sex: male, of Caucasian race, selected from the general population.
* Subjects that perform aerobic physical exercise between 2 and 4 times a week.
* Volunteers capable of understanding the clinical study, willing to grant consent informed in writing and to comply with the procedures and requirements of the study

Exclusion Criteria:

* Subjects with a history of any chronic disease.
* History of bronchial asthma or chronic obstructive pulmonary disease, disease Reactive airways such as bronchial asthma, a history of bronchial asthma or severe chronic obstructive pulmonary disease.
* Sinus bradycardia, second or third degree of atrioventricular block, insufficiency manifest cardiac or cardiogenic shock.
* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures.
* Subjects diagnosed and / or under treatment for arterial hypertension.
* Smoking subjects (\> 10 cigarettes a day).
* Subjects with body mass index greater than 35 Kg / m2 (BMI\> 30).
* Subjects with a history of drug, alcohol or other substance abuse or other factors that limit their ability to cooperate during the study.
* Subjects whose condition does not make them eligible for the study according to the researcher's criteria.
Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy

This trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies.

Prior to the current standard of care utilizing estrogen deprivation or antiestrogen therapy to treat hormonally sensitive breast cancers, treatment with pharmacologic doses of estrogen was a common technique used to treat post-menopausal women with hormone sensitive metastatic disease that resulted in durable responses with regression of disease. A randomized trial comparing tamoxifen and pharmacologic doses of estrogen demonstrated similar rates of response with long-term follow-up data confirming a survival benefit for those treated with the estrogen preparation. Additional data has shown that post-menopausal women with hormonally sensitive tumors that have progressed on prior endocrine therapies responded to treatment with pharmacologic doses of estrogen. These data, coupled with pre-clinical data that postmenopausal levels of estrogen can be used to cause apoptosis (programmed cell death within the tumor) and tumor regression in exhaustively treated endocrine resistant disease form the rationale for the proposed clinical trial. This trial seeks to confirm the response rate for estrace treatment in a patient population heavily pre-treated with modern endocrine therapies.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed estrogen and/or progesterone receptor-positive breast cancer metastatic breast cancer
* Clinically determined evaluable disease
* Post-menopausal woman
* Previous clinical benefit from prior anti-estrogen therapies and subsequent failure of at least 2 prior endocrine therapies.
* May have had chemotherapy for adjuvant \&/or metastatic disease.
* May have had radiation therapy but not to the only site of disease.
* Ecog performance status \</= 2.
* Life expectancy of \> 6 months

Exclusion Criteria:

* Chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical trial
* Brain metastasis
* Prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary embolus
* Current vaginal bleeding
* Hypercalcemia or hypocalcemia
* History of or active hepatic adenoma
* No other malignancies within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
Developing Self-Management Interventions After HCT

This is a prospective, longitudinal, observational trial to evaluate quality of life in hematopoietic stem cell transplant survivors.

Hematopoietic stem cell transplant (HSCT) survival rates continue to increase as treatment protocols improve. However, HSCT survivors face many mental, emotional, and physical challenges that threaten quality of life (QOL), which, according to the American Society of Clinical Oncology, is the most important treatment outcome next to survival. Psychoneurologic symptoms (PNS) significantly diminish QOL after HSCT. PNS often co-occur and may be associated with inflammation related to perturbations of the gut microbiota. This project will track the interplay among these factors in 50 adult survivors of HSCT to lay the groundwork for a targeted dietary self-management intervention to mitigate PN symptoms.This is to be achieved by elucidating the complex bio-behavioral mechanisms of distressing symptoms in HCT patients such as neurocognitive dysfunction, fatigue, anxiety, depression and pain, inflammation (cytokines and C-reactive protein), gut microbiota \[(GM) richness and diversity\] and diet (macronutrients: carbohydrates, fats and proteins).

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for HSCT with the Bone Marrow Transplant Program at the UF Health Cancer Center (UFHCC) \[specifically bone marrow diseases, myelodysplastic-myeloproliferative diseases, lymphoma, bone marrow neoplasm or leukemia\]
* Written informed consent obtained from the subject to take Mini-Mental State Examination (MMSE) prior to enrollment on the study and to comply with all the study-related procedures.
* Score at least a 24 on the Mini-Mental State Examination (MMSE) prior to enrollment

Exclusion Criteria:

* Subjects with any of the following will not be eligible for study participation:
* Patient has prior history of HSCT
* Patient has diagnosis that could interfere with neurocognitive function such as dementia, a concurrent diagnosis of systemic lupus erythematous or multiple sclerosis, diagnosis of a major depressive disorder, schizophrenia or untreated bipolar disease.
* Pregnant women are not eligible for transplant therefore will not be enrolled on the study
* Inability to comply with the study and/or follow-up procedures.