cyrilzakka/clinical-trials huggingface dataset:
Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.

Gastric Electrical Stimulation is an established treatment for drug-refractory patients who have the symptoms of gastroparesis/gastropathy. The symptoms of GP are nausea, vomiting, anorexia/early satiety, bloating/distention and abdominal pain and are classically associated with delayed gastric emptying of solids. The technique of GES was first used, in a patient seen at University of Tennesse-Memphis in 1993 and has undergone several clinical trials, particularly the GEMS trial, a feasibility trial starting in 1995 and the WAVESS trial, a double-blind trial begun in 1997. Both were international trials, showing promising results, and both have been published in the last 2 years. However, a number of issues related to who would benefit the most from Gastric Electrical Stimulation therapy have emerged. Among these issues are whether patients with etiologies other than diabetic or idiopathic gastroparesis, such as post-surgical gastropathy, which is often related to rapid, not delayed gastric emptying could be helped.

Most recently a technique for the temporary placement of a Gastric Electrical Stimulation electrode in the stomach with an upper endoscope, combined with an external Gastric Electrical Stimulation device, has been tried and validated, first at UAMS in Little Rock, AR, beginning in 2001 and more recently here at UMMC, beginning later in 2001 and up until the present time. Using the technique of temporary gastric electrical stimulation, we have been able to demonstrate that TempStim can quickly demonstrate (in a manner of days) that a patient will respond to temporary GES, as quantified by a decrease in GI total symptoms and an improvement and normalization in solid gastric emptying.

Eligibility Criteria:
Inclusion Criteria:

* Sex: Male of Female
* Age Range: 18 to 70 inclusive
* Patients with GP of diabetic, surgically related or idiopathic etiology.
* Symptoms of GP for \>/= 1 year.
* Refractory or intolerant to antiemetic drug classes (antihistamines and phenothiazines, serotonin receptor antagonists, dopamine receptor antagonists)
* Chronic vomiting and/or nausea with 7 or more episodes per week for either symptom irrespective of GET values.
* The patient is willing and able to provide informed consent.
* The patient is willing and able to return for required follow-up visits.

Exclusion Criteria:

* Patients \< 18 or \>70 years in age.
* Patients with an active infection of any kind.
* Patients who the investigator determines are not candidates for endoscopic procedures.
* Women who are pregnant
* Inability or unwillingness to provide informed consent
* Unwilling or unable to return for required follow-up visits and examinations.
* Patients who are currently enrolled in another investigation of a medical device or drug.
New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

This is an experimental study in which the efficacy of three psychophysiological intervention modalities based on retrieval-extinction procedures is analyzed.

Behavioral inhibition processes are a particularly relevant in relapses of patients with alcohol dependence. One of the current behavioral techniques to improve inhibitory abilities of these patients is the alcohol Approach Avoidance Task (AAT). However, this technique could be more efficient if patients, before training in this task, were exposed to a variety of alcohol-conditioned stimuli (retrieval) and take advantage of the window period of reconsolidation of these memories to carry out this task (extinction training). This project will attempt to show the pattern of brain connectivity underlying retrieval-extinction learning, its relationship with markers such as Brain-Derived Neurotrophic Factor (BDNF) and their usefulness to reduce relapses of individual with alcohol dependence. To carry out this study 115 patients with alcohol dependence who will be randomized into three groups: Group 1 (N = 35) where the extinction training is performed within the window period (10 minutes); Group 2 (N = 35) extinction will take place outside the time window (6 hours); Group 3 (N = 35), these subjects will be exposed to "non-retrieval" but with extinction-training within the window period. Changes in connectivity will be assessed with Electroencephalogram (EEG) at baseline and after 4 training sessions, using the HERMES platform. BDNF levels will be determined as peripheral markers of neurogenesis. These changes will be are correlated with relapses in the 12 weeks of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol-dependent patients who have been detoxified and abstinent take 10-14 days.

Exclusion Criteria:

* Patients who do not sign the informed consent.
Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis

Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.

AR is a common clinical chronic nasal disease, affecting 10% to 20% of the world's population, and has become a global health problem. AR not only seriously affects the quality of life of patients, resulting in patient fatigue, impaired learning, attention, and decision-making ability, but also causes a heavy social burden.

AR has a variety of classification methods. According to the type of allergen, it can be divided into seasonal (SAR, common allergens are seasonal allergens such as pollen) and perennial (PAR, common allergens are indoor allergens such as dust mites or occupational allergies), which is a classification method often used in clinical studies. According to the course of the disease, it can be divided into intermittent (symptom onset \< 4 days/week, or \< 4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, and ≥ 4 consecutive weeks). According to the severity of the disease, it can be divided into minor AR (mild symptoms, with no significant impact on quality of life) and moderate-severe AR (more severe or severe symptoms, with significant impact on quality of life). The results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population, accounting for 52.2%, indicating that the treatment and control of AR has become an urgent problem to be solved.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily sign the informed consent form.

Exclusion Criteria:

* Have any condition that are not suitable for participating in this study.
A Lead-in Study Evaluating Efficacy of GuessWhat Mobile App Therapy for Children With Autism

The following study aims to assess the efficacy, safety data, and best outcome measurements of the mobile game platform, GuessWhat, in delivering behavioral therapy to children with Autism Spectrum Disorder (ASD). GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen.

The following study aims to understand the efficacy and safety of the mobile game platform, GuessWhat, in delivering behavioral therapy to children with Autism Spectrum Disorder (ASD). GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen. The study will enroll parents who are at least 18 years old and have a child between 3 and 12 years old with a formal ASD diagnosis. Parents will be asked to complete two clinical outcome measure questionnaires immediately prior to and up to 1 week after playing GuessWhat with their child 3 times per week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Parent who is at least 18 years old of child with autism.
2. Child with autism is between 3 and 12 years old at time of baseline data collection.

Exclusion Criteria:

1. Parent is unable to read English.
2. Parent does not have an Android or iOS smartphone compatible with GuessWhat App--the app will be available on Android after further development and we will notify interested families when it becomes available.
Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)

This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of participants treated with aprepitant is similar to that of participants treated with fosaprepitant at certain timepoints.

The third arm of the study (Aprepitant 250 mg) will only be conducted if the real-time assessment of the NK1-receptor occupancy data between fosaprepitant 150 mg \& aprepitant 165 mg reveals that the primary hypothesis will not be supported.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Female participants must be of non-childbearing potential
* Non-smoker or has not used nicotine or nicotine-containing products for at least 6 months

Exclusion Criteria:

* History of a clinically significant psychiatric disorder over the last 5 to 10 years
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* History of neoplastic disease
* Excessive consumption of alcohol (3 drinks/day) or caffeinated beverages (6 servings/day)
* Major surgery, donated or lost 1 unit of blood within 4 weeks
* Participated in another investigational study within 4 weeks
* History of significant drug allergy or any clinically significant adverse

experiences related to EMEND™, dexamethasone, or ondansetron

* History of significant multiple and/or severe allergies
* History of anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Current drug/alcohol abuse, or history of such within 2 years
* Participation in a PET study or other study involving administration of a radioactive substance or ionizing radiation within the prior 12 months
* Extensive radiological examination within the prior 12 months
* Magnetizable metal prostheses or devices (Magnetic Resonance Imaging (MRI) hazard)
* History of claustrophobia
Randomized Controlled Trial of Wellness Recovery Action Planning

The purpose of this research study is to test the effectiveness of a standardized peer-led intervention to teach self-management skills in improving outcomes of individuals with a severe mental illness. The intervention is known as Wellness Recovery Action Planning or WRAP, co-developed by Dr. Mary Ellen Copeland. The focus of the inquiry is on whether and how developing an individualized plan for successful living: 1) lowers psychiatric symptoms; 2) enhances psychosocial outcomes such as self-perceived recovery, empowerment, self-advocacy, coping, and social support; 3) increases knowledge of personal mental illness self-management strategies; and 4) enhances satisfaction with the service delivery system. The study evaluated the following hypotheses:

Hypothesis #1: Compared to wait-list control subjects, those who participate in the WRAP intervention will report reduced levels of psychiatric symptoms.

Hypothesis #2: Compared to wait-list control subjects, those who participate in the WRAP intervention will report enhanced enhanced feelings of empowerment, hope, recovery, quality of life, and functioning.

Hypothesis #3: Compared to wait-list controls, those who participate in the WRAP intervention will report increased levels of social support.

Hypothesis #4: Compared to wait-list controls, those who participate in the WRAP intervention will report increased use of peer services, higher satisfaction with services, and have lower overall service costs.

Hypothesis #5: Compared to controls, those who participate in the WRAP intervention will report increased knowledge of mental illness self-management, including making/using a WRAP plan.

Hypothesis #6: There will be no difference in employment rates of control vs. intervention subjects.

Eligibility criteria included having a diagnosis of serious mental illness and experiencing severe functional impairment in one or more life roles. All study participants completed telephone interviews at three points in time: study entry (pre-intervention); 8-weeks later (immediate post-intervention); and 6-months after intervention (approximately 8 months after study entry). Blinded interviewers administered valid and reliable outcome assessments that measured changes in subjects' knowledge about mental illness; emotional well-being; empowerment; hopefulness; quality of life, and functioning. All study participants were compensated for their time at each interview. All WRAP facilitators were people in recovery from serious mental illnesses who were certified and experienced WRAP facilitators. Fidelity to the WRAP curriculum was assessed on an ongoing basis throughout the study.

Eligibility Criteria:
Inclusion Criteria

* age 18 years or older
* English speaking
* severe mental illness as confirmed by: 1) a Kessler Self-Report Measure (K-6) score of 13 or higher; and/or 2) enrolled as a client of the public mental health system in the state of Ohio.

Exclusion Criteria

* non English speaking
* not meeting clinical criteria for severe mental illness
Factors Predicting Recurrence in Rectal Cancer After Surgery

Colorectal cancer is one of the most frequently diagnosed cancers and a major cause of cancer deaths worldwide. Recurrence after curative surgery is one of the major factors affecting the long-term survival and its frequency is estimated to be 22.5% at 5 years. of which 12% have local recurrence. The overall survival in case of recurrence of 11% at 5 years.

Several patient-, tumor-related and treatment-related prognostic factors have been found to be associated with the risk of recurrence of rectal adenocarcinoma. Some of these factors such as TNM stage, lymphatic and perineural invasion and vascular emboli have been found to affect recurrence free survival in most studies. While the impact of other factors such as distal resection margin, tumor size, extra capsular spread and neoadjuvant chemoradiotherapy on recurrence remains controversial. Moreover, most of the previous studies on prognostic factors have been from American and European countries with very little data from African countries. Recognition of these factors helps in identification of high-risk patients who require close and more rigorous postoperative surveillance. Hence this study was conducted to determine the factors affecting recurrence after curative resection of rectal cancer in African population.


Eligibility Criteria:
Inclusion Criteria:

- all the patients who underwent curative resection for rectal adenocarcinoma between January 2000 and December 2015 at the Department of Digestive and Visceral Surgery of Sahloul Hospital, Sousse, Tunisia

Exclusion Criteria:

* patients who underwent palliative surgery
* patients with microscopically or macroscopically positive resection margin
* patients with tumors other than adenocarcinoma
* patients who died in the postoperative period due to complications.
Benefit and Tolerability of a Probiotic Product in Infants With Abdominal Discomfort

To demonstrate benefit and tolerability of a probiotic product in infants with abdominal discomfort.


Eligibility Criteria:
Inclusion Criteria:

* Male or female singleton
* ≥ 2 weeks and ≤ 12 weeks of age
* Exclusively breastfed at screening
* Abdominal discomfort (infant colic) in the week prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
* Episodes of fussy crying that lasted at least 3 hours a day for at least 3 days in the 7 days prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
* Voluntary, written informed consent of the parent(s) and/or guardian(s) to participate in the study
* Born at full term (37-42 after last menstruation period)
* Birth weight: 2500 - 4500 g
* Weight-for-age ≥ 3th and ≤ 97th percentile according to WHO growth tables / charts
* Apparently healthy at birth (Apgar ≥ 8) and at screening visit
* No major complications during pregnancy or at birth
* Mother 19-45 years of age at childbirth
* Ability of parent(s) and/or guardian(s) to attend visits, interviews and willingness to fill out questionnaires

Exclusion Criteria:

* Intolerance to investigational product/its ingredients
* Severe medical condition or illness, congenital abnormality
* Gastrointestinal disorders (e.g. reflux esophagitis)
* Intake of probiotics and/or antibiotics in the week preceding recruitment and during the study
* Formula feeding at screening/randomisation
* Allergy or atopic disease (family history)
* Participation in another study
* Mother's health condition that may interfere with her ability to take care of her infant
* Mother affected by hepatitis B, HIV or Guillain-Barré Syndrome
* Use of antibiotics by the mother in the week
Weight Loss Maintenance and Compensatory Mechanisms Activated With a Very-low Calorie Diet

Very-low calorie diets are relatively safe and effective in inducing significant weight loss, when used in selective individuals and under clinical supervision. However, weight loss maintenance in the long-term remains the main challenge, with many experiencing a significant weight regain. Several compensatory mechanisms are activated under weight reduction, both at the level of energy intake (such as increased appetite) and energy expenditure (such as reduced energy expenditure), and increase the risk of relapse.

The main aim of this study is to compare the effect of two multidisciplinary lifestyle interventions on weight loss maintenance at one year, after initial weight loss during 8 weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an outpatient program in the obesity unit of the local hospital, or to an inpatient program consisting of a "continuous care" intervention, with three intermittent stays (each with three-week duration) in a rehabilitation center over a one year period. Moreover, the investigators aim to assess the impact of weight loss (achieved with a very low calorie diet) and weight loss maintenance on compensatory mechanisms activated during weight reduction.

This study included a sub-study (n=30) to determine the timeline over which compensatory mechanisms (at both the level of energy expenditure and appetite control system) are activated with progressive weight loss. Additional measurements were taken at day-3, 5 and 10 % weight loss, and after 4 weeks weight stabilization (after gradually reintroduction of food).

Eligibility Criteria:
Inclusion Criteria:

* volunteers from Central Norway
* if female: taking oral contraceptives or post-menopausal
* body mass index 30-45 kg/m2
* stable weight (\<2kg variation in the last 3 months)
* not currently dieting to lose weight

Exclusion Criteria:

* Pregnancy
* breast feeding
* drug or alcohol abuse within the last two years
* current medication known to affect appetite or induce weight loss
* enrollment in another obesity treatment program
* history of psychological disorders
* history of eating disorders
* history of diabetes type 1 or 2
* gastrointestinal disorders (particular cholelithiasis)
* kidney -, liver -, lung- or cardiovascular disease
* malignancies
A Capacitance and Transepidermal Water Loss Test to Determine the Ability of Sunscreen to Moisturize Skin

To evaluate the ability of 2 Helioblock SX Cream formulations to moisturize skin using capacitance and transepidermal water loss methodology


Eligibility Criteria:
Inclusion Criteria:

* Healthy,male or female subjects 18 years to 55 years of age, with a minimum Stanfield score at baseline of "2" at the forearm sites intended to be assessed in the study
* Female subjects of childbearing potential using a reliable form of contraception during the course of the study(oral contraceptive pill, intrauterine device, bilateral tubal ligation, abstinence, or other reliable forms at the discretion of the Investigator.) or of non childbearing potential(i.e.,post-menopausal(one year without menstrual period), hysterectomy or bilateral ovariectomy)
* Subjects who have read, understood and signed an informed consent
* Subjects who are willing and capable of cooperating to the extent and degree required by the protocol
* Absence of any visible skin diseases which might be confused with a skin reaction from the test material

Exclusion Criteria:

* Subjects with a condition, or in a situation, which in the Investigator's or Sub-Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or may interfere with the subject's participation in the study.
* Subjects with known sensitivities to any of the study preparations or to other skin care products
* Subjects who have participated in a clinical research study, including consumer products studies, within the last 30 days prior to enrollment
* Subjects who are currently receiving medication(prescription or OTC) that in the opinion of the Investigator may interfere with the evaluations made in this study (e.g.vasoactive substances)
* Pregnant or nursing females or women who are planning to get pregnant during the study
Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)

The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding.

A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* A person who is 45 years or older and is mentally competent to provide a signed written informed consent.
* A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention.
* If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion Criteria:

* Pregnancy
* Recent stroke
* Active internal bleeding or a history of a bleeding disorder
* Increased risk of bleeding
* Severe high blood pressure
* Liver or kidney disease
* Low platelet count
* Condition such as alcoholism, mental illness, or drug dependence
* Ongoing chest pain
* Planned or ongoing treatment with a blood thinning medication
* A serious condition or illness that would interfere with participation in the study