cyrilzakka/clinical-trials huggingface dataset:
ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study

The aim of this study is to collect initial efficacy and safety data on the use of a new treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment with pemetrexed alone


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic NSCLC on entry into study suitable for pemetrexed therapy
* Patients that meet one of the following criteria: - progressed following one prior platinum-based chemotherapy regimen for locally advanced or metastatic disease; -progressed within 6 months of adjuvant platinum-based chemotherapy
* Life expectancy of \> 12 weeks

Exclusion Criteria:

* Prior treatment with pemetrexed in the last 12 months.
* Prior therapy with an ET receptor antagonist
* Any recent surgery, unhealed surgical incision, severe concomitant medical condition (eg, unstable cardiac, hepatic or renal disease) or significant laboratory finding which makes it undesirable for the patient to participate
Newborn Health Information Study

This is a randomized, controlled trial to test the use of an educational video during the newborn well-child visit. Parents who watch the video during their medical visit will be compared to those parents who receive traditional paper handouts. Measures obtained at baseline and 2-week follow-up include knowledge of infant development, self-efficacy with infant care, and problem-solving skills.


Eligibility Criteria:
Inclusion Criteria:

* Baby's first visit to the pediatric office

Exclusion Criteria:

* Baby \> 1 month old
* Parent/Caregiver \< 18yrs old
* Inability to understand English
* No access to a working telephone
Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort

In the current study the effects of proprietary Perilla frutescens leaf extract in comparison to Maltodextrin, a fully digestible carbohydrate (placebo control), on gastrointestinal discomfort and bowel function were investigated. The study was performed double-blind and placebo-controlled with a 4 week intervention period. Study products were taken two times daily (each one capsule before breakfast and dinner).


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
* BMI: 19-30 kg/m2
* Reduced bowel movements defined as an average of \>1 and ≤ 3.5 stools per week for at least the previous 6 months
* Gastrointestinal symptoms of at least 5 points
* Male or female
* Age ≥ 30 and ≤ 70 years
* Nonsmoker
* Written consent to participate in the study
* Able and willing to follow the study protocol procedures

Exclusion Criteria:

* Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
* Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening
* Subjects with stool frequency of ≤ 1 stool every 7 days or \> 3,5 stools per week
* Subjects not willing to avoid pre- and probiotics for the duration of the study
* Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
* Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)
* Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
* Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results.
* Known food intolerance or allergy.
* Subject involved in any clinical or food study within the preceding month
Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes

Previous qualitative research among Somali American adults in Minnesota have identified high levels of hookah or shisha (hereafter shisha) use in Somali households. Household shisha use exposes all family members, including children, to secondhand smoke (SHS) that contains toxins that can cause many different acute and chronic disease, including increased levels of several cancers such as lung, bladder, and oral cancers. Despite the high levels of shisha use, gaps in the knowledge of the risks of shisha use and how to mitigate the potential harmful health consequences of shisha use exist among Somali Americans.

This study aims to pilot test the feasibility of a newly developed CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families. Pre-/post-measurements of family members' (1 adult and 1 child) urine or salivary cotinine levels will be obtained along with a brief pre-/post-survey to characterize household tobacco use and the presence of home smoke-free rules.


Eligibility Criteria:
Inclusion Criteria:

Eligible families will identify as

* Somali American,
* have one or more children between 6 months and 18 years of age in the home, and
* have at least one adult who uses shisha at home. Families with other forms of tobacco use in addition to shisha use will be included.

Exclusion Criteria:

* Participation in previous qualitative study to inform intervention development
* Inability or unwillingness to provide informed consent and complete all study procedures
Modification of the "Edmonton Protocol" to Allow for Successful Islet Transplantation From a Single Pancreas and Extension of the "Edmonton Protocol" to Kidney Transplant Recipients

The experience of the Edmonton Group with islet transplantation and use of the "Edmonton Protocol" provides much promise for T1DM patients. However, the need to use 2 or more donor pancreases to achieve freedom from insulin shots limits the widespread use of this protocol. Two classes of oral antidiabetic drugs improve insulin action and reduce the amount of insulin needed to have normal blood sugars. The first part of the proposed project (Group 1) will use these drugs in conjunction with the Edmonton Protocol to allow for successful islet transplantation from islets isolated from a single pancreas.

The Edmonton Protocol is a treatment, not a cure. It requires the long-term use of powerful immunosuppressive drugs that are expensive and increase the risk of infection and cancer. T1DM patients who have a functioning kidney transplant already have to use immunosuppressive drugs, and they are still at risk of recurrent diabetic kidney disease and other complications of diabetes. Islet transplantation in these patients has only rarely been successful in the past in part because the usual immunosuppressive drugs used in kidney transplantation cause diabetes and actually harm the transplant kidney in other ways. The immunosuppressive drugs used in the Edmonton Protocol are less likely to cause diabetes and are also less harmful to the kidney. In the second part of this project (Group 2), we will transplant islets into kidney transplant patients after they have switched to the immunosuppressive medications used in the Edmonton Protocol. Even if some of the patients do not get islet transplants or still need insulin shots after islet transplantation, we expect to see improvement in kidney function and blood glucose control.

We anticipate that successful islet transplantation will establish a group of islet cell transplant patients who have normal blood sugars and do not need insulin injections. Some of this group will have received a kidney transplant as well. All these patients will be studied in great detail along with other investigators in our islet cell program to understand better the mechanisms of efficacy and side effects of islet transplant and these new immunosuppressive drugs.

Eligibility Criteria:
Inclusion Criteria:

Type 1 diabetes for \> 5 years AND Hypoglycemia unawareness, not felt adequately by patient (glucose \< 54mg/dL) in last 1.6 years, not otherwise explained, requiring outside help OR Metabolic lability/instability, characterized by hypoglycemia or ketoacidosis (\>2 hospital \< 12 mo), chaotic glucose profile (MAGE \> 120mg/dL), disruption in lifestyle or danger to life, to self, to others OR Failure of intensive insulin management, as judged by an independent endocrinologist.
Digital Addiction Among University Students

The aim of this study is to contribute to our understanding of digital media addiction by investigating the prevalence of digital addiction among university students and examining the relationship between variables such as body awareness, physical activity levels, hand grip strength, upper extremity function and pain-dash, quality of life, depression, stress, anxiety, sleep quality, and cognitive levels and digital addiction.

After recording the demographic information of all individuals participating in the study, screen addiction, BMI, body awareness, physical activity levels, handgrip strength, upper extremity pain and function and pain-dash, quality of life, depression, stress, anxiety, sleep quality, cognitive levels will be evaluated. Individuals will be asked to fill out self-report questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* University students aged 18 and over
* Those who have been using smartphones for more than a year

Exclusion Criteria:

* People under the age of 18,
* Those diagnosed by a doctor with any musculoskeletal, rheumatic, neurological, cardiovascular system diseases or diagnosed with a mental disorder, sleep disorder such as narcolepsy or addiction to alcohol, substances, etc.
* Those with any history of injury or surgery in the upper extremity
Intrathecal Magnesium and Postoperative Analgesia

Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the central nervous system \[1\]. Magnesium deficiency is associated to an increased activation of these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium may have anti-hyperalgesic effect when administered intrathecally \[2\]. As intrathecal magnesium has already been used in humans for treatment of eclampsia, we stated that it could also improve postoperative analgesia and reduce the need for auto-administered morphine if given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and sufentanil) injected for orthopedic surgery.

Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the central nervous system \[1\]. Magnesium deficiency is associated to an increased activation of these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium may have anti-hyperalgesic effect when administered intrathecally \[2\]. As intrathecal magnesium has already been used in humans for treatment of eclampsia, we stated that it could also improve postoperative analgesia and reduce the need for auto-administered morphine if given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and sufentanil) injected for orthopedic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Total hip replacement under intrathecal anesthesia.

Exclusion Criteria:

* General anesthesia (alone or not)
* Intolerance to morphine
* Misunderstanding of the use of the device for intravenous patient-controlled administration of morphine.
Manage Diarrhea in Patients With Multiple Myeloma While Receiving Conditioning Chemotherapy for Autologous SCT

For patients who receive a hematopoietic cell transplant (HCT), there is a risk of developing a diarrhea secondary to the chemotherapy which we give. Diarrhea is usually harmless in healthy adults; however, in transplant patients, diarrhea can result in dehydration, negative impact on quality of life, and prolonged hospitalization. The purpose of this study was to see if Colesevelam (Welchol) and Serum-derived bovine immunoglobulin-protein (SBI) result in a change in the frequency or consistency of your bowel movements.

This was a randomized, double-blind, placebo-controlled pilot study of SBI, colesevelam, and placebo in patients undergoing autologous HSCT for the clinical care of multiple myeloma.

The number of adults undergoing hematopoietic stem cell transplant (HSCT) has grown significantly over the past two decades as a result of the availability of therapies for advanced hematologic and solid tumor malignancies, and the broader selection criteria for eligibility to receive these transplants. Generally, the stem cell transplant procedure consists of administration of chemotherapy and/or radiation therapy to ablate all residual malignancy (called conditioning therapy), followed by intravenous infusion of hematopoietic stem cells to restore bone marrow function. Generally, HSCT has a positive effect on survival, despite serious adverse effects and life-threatening complications.

Diarrhea can affect up to 91% of patients receiving autologous or allogeneic HSCT and is identified by 9% of the patients as the single most debilitating adverse effect post-HSCT. Other commonly encountered symptoms are nausea and vomiting (13%) and mouth sores (42%). The impact of diarrhea can be significant and result in dehydration, negative impact on quality of life, prolonged hospitalization with an increased cost and risk, and the diarrhea may be potentially life-threatening.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years, male or female
* Diagnosis: multiple myeloma undergoing Autologous Stem Cell Transplantation (SCT)
* Planning to receive conditioning chemotherapy (Melphalan) for autologous stem cell transplantation and standard prophylactic antibiotics treatment.
* Can drink 200ml of mannitol and agrees to undergo stool, urine, and blood checks 3 times during the study.
* Agrees and able to take the investigational products or placebo starting from the day of completing conditioning therapy for a total of 4 weeks

Exclusion Criteria:

* Patients with history of inflammatory bowel disease will be excluded from the study.
* Patients with prior GI tract surgical (small or large bowel) resections
* The concurrent presence of systemic light chain amyloidosis
* Subject has known allergy or intolerance to beef or to any ingredient used in the product
* Women who are pregnant, breast-feeding and of child-bearing potential
Pharmacogenomics of Warfarin in Hispanics and Latinos

Warfarin is a commonly used blood thinner to treat and prevent blood clots. It is important to take the right dose of warfarin because too much can increase the risk of bleeding and too little can increase the risk of blood clots. This is why patients are closely monitored especially when they begin warfarin therapy. When clinicians prescribe warfarin, they have to consider different factors such as patient's age, body size, diet, and other medications that can interact with warfarin.

Certain genes have also been found to affect warfarin dose. Individuals have variations in these genes, which can help explain why some patients need higher dose and others require less. These factors have been used to better predict a patient's warfarin dose requirement. However, these predictions were created based on Caucasian populations and they may not be accurate in predicting a safe warfarin dose if a patient is not Caucasian. This study aims to identify new genetic variation that affects warfarin dosing in Hispanic and Latino populations and try to better predict a Hispanic or Latino patient's warfarin dose requirement.

If the patient is willing to hear about the study, during routine clinical care, one of the patient's providers will approach patients meeting the study criteria about participation in the study. Study personnel will not approach potential participants unless permission is given to the patient's provider. If the patient would like to participate in the study, study personnel will discuss details of the study in person during the patient's routine clinical care visit. There will also be a flyers available for posting and for distribution to potential participants.

Participants consenting to the study will be asked to provide a cheek swab or mouthwash sample to provide buccal cells for DNA extraction. If the patient is receiving a blood draw during their regular clinical appointment, participants will be asked for a blood sample of 15 milliliters. Genomic DNA will be isolated for genotyping and patient plasma samples will also be stored.

Linear regression will be used to test association of SNPs with therapeutic warfarin dose using the algorithms derived by the International Warfarin Pharmacogenomics Consortium. The primary phenotype (weekly stable warfarin dose) will be transformed by square root. SNPs and other variables associated with warfarin dose will be assessed in univariate analyses and entered into stepwise linear regression to determine the adjusted association with dose requirements using R2. Quality control procedures will include deviation from Hardy-Weinberg Equilibrium, and SNP and sample exclusions based on call rates. Ancestry-informative marker (AIM) analysis will be performed to estimate ancestry in each individual.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Ability to give informed consent
* Therapeutic INR for at least 2 consecutive clinic visits
* Self-identifies as Hispanic or Latino

Exclusion Criteria:

* Less than 18 years old
* Unable to give informed consent
* Severe hepatic impairment
The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health

To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors

This is a single center, randomized, double-blind and placebo controlled study. Subjects are informed to consume the samples every day for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 30 years old, no gender limit;
* Patients with high blood pressure (systolic blood pressure\> 120 mmHg or diastolic blood pressure\> 80 mmHg) or high blood lipids (TC ≥ 5.18 mmol/L or TG ≥ 1.7 mmol/L), and no medication is used;
* Fully understand the purpose, benefits, potential risks and side effects of this research, and can objectively cooperate with doctors to complete the examination and assessment of diseases and physical conditions;
* People who voluntarily agree and sign an informed consent form.

Exclusion Criteria:

* People with a history of dyspepsia would affect the absorption of the test product;
* Any situation that may affect trial process, including difficult-to-control organic disease or infection, unstable angina pectoris, congestive heart failure and other severe disease;
* People with symptomatic and difficult-to-control neurological, mental diseases or mental disorders;
* Pregnant or breast-feeding women or women who have a positive result on a pregnancy test;
* Allergic to the components of the test product;
* Take supplementary foods and health supplements with the same efficacy two weeks before and during the test.
Investigation of Neurophysiological Functioning During Oral Comprehension Task

The oral comprehension (OC) of a second language (L2) involves different cognitive processes, specially during the learning phase. This study aims at investigating the neurophysiological functioning of different steps involved in this oral understanding.

Here, the investigators seek for the different neurophysiological processes involved in OC according to the level of understanding (2 levels) and its different phases (fluid, hindered and metacognitive feedback).

This study therefore requires three different research methodologies :

1. an interactive system dedicated to the boundary delimitations of obstacles during OC
2. an investigation of the autonomic nervous system responses (measurement of electrodermal activity and heart rate variability) that will likely occur differently during different phases of the OC process
3. an investigation of the central responses (through fMRI technique), coupled with autonomous responses, that will identify the different neural networks in the different stages of the OC process.

Eligibility Criteria:
Inclusion Criteria:

* French learner in Italian language
* right-handed
* affiliated to French social security
* informed consent signed

Exclusion Criteria:

* pregnant woman
* audiologic pathology impacting the capacity of hearing
* neurologic or psychiatric pathology that may interfere with oral comprehension
* learning disability (for instance: dyslexia)
* contra-indication to MRI and to EDA acquisition
A Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo

A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120 patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to evaluate the efficacy of different dose of Levophencynonate Hydrochloric, and provide the effective dosage for phase IIb clinical study, to study the safety of Levophencynonate Hydrochloric.

This study will conduct in 15 sites to enrolled 120 patients with vertigo under 7 days treatment and 7 days follow-up. The study includes three arms: high dose, low dose and placebo control.To observe the efficacy by change of vertigo severity and duration,and safety by vital sign,adverse event,etc.

Eligibility Criteria:
Inclusion Criteria:

1. At the age more than 18 years old male or female;
2. Patients with vertigo caused by Posterior Circulation Infarction.
3. Patients diagnosed Posterior Circulation Infarction based on the criteria of Posterior Circulation Ischemia of America;
4. Meet the diagnose criteria of vertigo: Visual Motion (External Vertigo), or Rotation, Swing, Lift and Tilt Sensation (Internal Vertigo);
5. Ability to sign the statements of informed consent;

Exclusion Criteria:

1. Female patients having Pregnant, Lactating or Birth plan recently;
2. Non-posterior circulation infarction patients;
3. Vertigo caused by any other diseases;
4. Long-term alcohol abuse, or drug abuse;
5. Been in critical condition, difficult to make a precise evaluation of efficacy and safety of new drugs;
6. History of allergies on Levophencynonate Hydrochloric or these compositions;
7. Participation in another clinical trial in three months;
8. Investigator thought that should be excluded due to other reason;