cyrilzakka/clinical-trials huggingface dataset:
Role of Serotonin in Acute and Subacute MDMA Effects

The purpose of this study is to measure the effects of MDMA (particularly its emotional effects) and to determine the role of serotonin in these effects. Serotonin is a neurotransmitter, which is a chemical that is released by some brain cells to communicate with other brain cells. Many of the effects of MDMA are thought to be the result of increased serotonin release.

In order to understand the effects of MDMA and role of serotonin in these effects, we will administer MDMA alone and in combination with the antidepressant citalopram (one trade name for this is Celexa). Citalopram decreases the ability of MDMA to release serotonin. Citalopram will therefore decrease any of MDMA's effects that are the result of serotonin release; we want to measure this.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women aged 18 to 50 years
* Experienced with MDMA

Exclusion Criteria:

* Significant physical or psychiatric illness which might impair the ability to safely complete the study or that might be complicated by the study drugs, including prior seizures (after age 8), history of major depression, or other active neurological disease or clinically significant abnormalities on physical examination or screening laboratory values
Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm

This study evaluates the effect of melatonin 4 mg on circadian rhythm and visual function of patients with diabetes mellitus. Half of the patients will receive melatonin (arm-1) and the other half will receive placebo (arm-2), both groups in 3 weeks. After a week of washout, the patients will cross over to the other treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients
* Age range 40-75 years
* Participant should be legally competent

Exclusion Criteria:

* Other known eye disease.
* Eye disease manifestation during ocular examination.
* Competing neurologic and systemic conditions affecting retina.
* Use of any drugs influencing pupillary light reflex and sleep pattern.
* Refractive error with need of \> 6 diopter lenses.
* Pregnancy
* Alcohol consumption during the trial
* Lack of cooperation
* Allergy to melatonin and/or preservatives in melatonin and placebo
* Reduced hepatic function
* Fluvoxamin intake due to drug interaction
* Consumption of Alpha-1 and beta-1 adnergic antagoists.
* Alcohol consumption during treatment
Improving Diabetes Control Through Peer Counseling and Incentives

The specific aims of this study are to test whether in a cohort of low-income minority veterans with poor diabetes mellitus (DM) control:

1. Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).
2. Financial incentives are an effective means of reducing HbA1c. This is a randomized controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial incentives without peers. Ultimately, contingent on the success of this intervention, the researchers plan to apply for funding for a large scale intervention employing both peer counseling and incentives to improve DM control in low income and minority patients who are at high risk for premature morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* African American veteran
* 50-70 years old
* ICD-9CM diagnosis code consistent with DM (any ICD-9CM code starting with 250)
* For patients: last two HbA1c greater than 8% with at least one measure being within 3 months of enrollment
* For peer counselors: HbA1c of greater than 8% in the past 3 years and an HbA1c less than or equal to 7.5% within 3 months of enrollment

Exclusion Criteria:

* Unstable medical condition that would likely prevent the subject from completing the study
* Patients enrolled in Telehealth will be excluded as such enrollment does not constitute usual care
Treatment of Primary Menstrual Pain With Kanion Capsule

The objectives of this clinical trial are:

* To further study the safety of Kanion Capsule (GF) in primary dysmenorrhea subjects;
* To further evaluate the efficacy of GF in treatment of primary dysmenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* primary dysmenorrhea

Exclusion Criteria:

* secondary dysmenorrhea
Severe Head Injury Brain Analysis

Safety and feasibility study investigating brain biopsy in severe head injury. When a patient undergoes craniotomy or ICP bolt insertion for trauma, a biopsy of brain tissue is taken.

Blood, saliva, urine and faeces samples are also taken for 7 days following the brain biopsy.

CSF is collected if a CSF drainage device is used.

A minor amendment was submitted to allow histological and immunohistochemical analysis of the samples.

Eligibility Criteria:
Inclusion Criteria: Severe traumatic brain injury -

Exclusion Criteria: Coagulopathy

-
Social-Economics Profile of the Asthmatic Patients Attended at Nucleus of Integrated Medical Care

This study had a descriptive, retrospective, transversal character with quantitative approach, which aimed to delineate the social-economics profile of the asthmatic patients that used the health service available at the Care Nucleon Medical Integrate (NAMI)

The need of studies to develop programs of pharmaceutical attention for asthmatics was given because of the increase of incidence and prevalence of the disease in the population. This study had a descriptive, retrospective, transversal character with quantitative approach, which aimed to delineate the social-economics profile of the asthmatic patients that used the health service available at the Care Nucleon Medical Integrate (NAMI). The studied population was composed of 40 asthmatic patients who attended between April and May, during 2006. Data collection was performed through a semi-structured stereotypic questionnaire, with closed and opened questions. The age range of the interviewee between 0 to 5 years old represents the biggest percentage of patients, obtaining 60% of the answered questionnaires. According to social-economics conditions, 55% were illiterate or were learning to read, 75% were using some drug prescribed at NAMI, 72.5% deny completely the disease, 52.5% recognized the factors that triggered the asthmatic crisis and 55% said having often crisis. Seventy per cent (70%) of the interviewee showed some difficulty related to the use of the drugs; 47.5% have different problems related to the access to the medications. Through the analysis of the social-economics profile delineated of the asthmatics patients attended at NAMI, it could be revealed that the biggest part of the patients are people with little instruction, due to the social exclusion in which they are found; being the majority of them children of the female gender.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in regular Nucleus of Integrated Medical Care;
* Patients presented within the age group above to 80 years;
* Patients accepted voluntarily join the search;
* They used any medicine that received at the pharmacy of Nucleus of Integrated Medical Care.

Exclusion Criteria:

* Patients who don´t residing in the neighborhood of community;
* Patients who don´t accepted part of the study by answering the questionnaire;
* Have not made use of medicines in the last 60 days or have not received in the pharmacy of of Integrated Medical Care.
Megestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With H&N Cancer Who Receiving CCRT

Primary Objective:

To evaluate the population prevalence of critical body weight loss ( more than 5% from baseline) in patients with Head and Neck cancer.

Secondary Objectives:

To evaluate the impact of appetite, and performance status; To evaluate the change of quality of life (QoL); To evaluate the incidence of infection and hospitalization; To evaluate the safety profiles

Hypothesis testing will be used to determine the patient number in this study. According to a preliminary data at CGMH-LK, the investigators have the untreated patients with population prevalence of critical weight loss that is 0.56, and the investigators assume the study treated population prevalence is 0.4, power set in 0.9, alpha set in 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patient who is confirmed the diagnosis of head and neck cancer and will receive concurrent chemoradiotherapy (CCRT).
* Patient who is capable to understand and complete questionnaires
* Patient who is convenient to receive body weight measurement
* Life expectancy of at least 12 weeks
* Age over 20 years old at registration
* Voluntarily signed the written informed consent form

Exclusion Criteria:

* Special populations that needs unique risk/benefit considerations. (Ex. Pregnant or nursing women or mental disorder patients, et al.)
* Any significant co-morbid medical condition that out of medication control. (Ex. Heart/renal/hepatic failure or poorly controlled diabetes, et al.)
* Any evidence of mechanical obstruction of the alimentary track, malabsorption, or intractable vomiting.
* Any thromboembolism event, e.g. cerebral or peripheral vascular disease
* Judged ineligible by physicians for participation in the study due to any safety concern.
Reminder Emails to Improve Pneumococcal Vaccine Completion at 12 Months of Age

The goal of this clinical trial is to assess the effectiveness of enhanced email reminders in improving vaccine coverage at the 12-month visit in CANImmunize app users. The main questions it aims to answer are:

* Do enhanced email reminders improve coverage of the 12- month dose of the pneumococcal vaccine and the timely completion of its immunization series at the 12-month's visit in CANImmunize app users?
* What are the predictors of predictors of timely completion of the 12-month's series of pneumococcal vaccines in the CANImmunize app users?

Participants will be randomized to either receive enhanced reminder/recall materials via email or the standard CANImmunize notifications. Researchers will compare the enhanced reminder group to the standard notification group to see if there is a difference in vaccine coverage at the 12-month visit.


Eligibility Criteria:
Inclusion Criteria

To be included in the study, CANImmunize account holders must have:

* Enabled the reception to receive emails from CANImmunize, and
* Record(s) for an infant aged between 10- and 11-months, who have already received the earlier doses of the pneumococcal vaccine in accordance with their provincial/territorial routine immunization schedule.

Exclusion Criteria

* The account holder (parent, or guardian of the child) has an inactive or undelivered email address, or
* No record(s) for an infant aged 10- and 11-months, or
* The record for the 10- or 11-month-old indicates that he/she has not received the prior pneumococcal vaccine doses.
Extended Pessary Interval for Care (EPIC Study)

Objectives: Pelvic organ prolapse (POP) is a common condition for which pessaries are commonly used in conservative treatment. Despite their prevalence, there is no literature to guide the management of pessaries. Our objective is to determine whether patients managed with a pessary for POP are more satisfied with follow-up at 3 or 6 month intervals and if there is any difference in complications rates between the two groups.

Hypothesis: The investigators hypothesize that there will be higher patient satisfaction in the group randomized to 6 month follow-up intervals and that there will be no difference in complication rates between the two follow-up groups.

Method: The investigators will conduct a prospective randomized control trial comparing patient satisfaction and complication rates between patients with pessaries randomized to either 3 or 6 month follow-up intervals over 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Females with POP who have opted for conservative management with a pessary
* Able to read and write English
* First time pessary users
* Successful fitting with a covered ring or Gellhorn pessary, as determined at the usual early follow-up visit 2-4 weeks after initial fitting (successful defined as: no expulsion on movement, squatting or valsalva, no urinary retention, no discomfort, and still retained pessary after 2 weeks)
* Patients agree to use vaginal estrogen (either tablet or cream twice weekly) during the study period; patients may not use a vaginal estrogen ring since this requires changing every 3 months, and will interfere with the study follow-up schedule

Exclusion criteria:

* Current presence of vaginal bleeding, vaginal abrasions or ulcers, or vaginal infection
* Significant cognitive impairment
* Pessary used for indication other than POP (ie. urinary incontinence)
* Use of a pessary that is not a covered ring or Gellhorn (i.e exclude cube, donut, etc.)
* Contraindications to vaginal estrogen
* Unsuccessful pessary fitting (successful defined as: no expulsion on movement, squatting or valsalva, no urinary retention, no discomfort, and still retained pessary after 2 weeks)
Use of Tamoxifen in Systemic Mastocytosis

In this study, the investigators will determine the utility of Tamoxifen, a non-cytotoxic agent, to improve quality of life, biochemical parameters, and bone marrow involvement in systemic mastocytosis patients having 1) up to 40% bone marrow infiltration by mast cells and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard "non-cytotoxic" medications regardless of the percentage bone marrow involvement by mastocytosis. The dose of Tamoxifen will be 40 mg/day and the duration of treatment will be for one year. Patients currently taking interferon alfa, imatinib mesylate, or cladribine will be excluded until these medications have been stopped.

Not desired

Eligibility Criteria:
Inclusion Criteria:

* Systemic Mastocytosis

Exclusion Criteria:

* Current treatment with Imatinib mesylate, cladribine or interferon alpha.
Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration

Long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (AMD) under Macugen treatment.

Ophthalmologists who are experienced in doing intravitreal injections in Germany

Eligibility Criteria:
Inclusion Criteria:

* patients with neovascular age-related macular degeneration

Exclusion Criteria:

* none
the Food Effect Pharmacokinetic, Material Balance and Metabolite Identification of SP2086 in Healthy Volunteers

All eligible subjects were randomly assigned to group A and group B sequences, each sequence has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study ,the investigators collected the blood samples,urine samples and fecal samples to analyze.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency
* Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SP2086 or any of the excipients of the formulation of SP2086
High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia

The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)

Open-label, parallel-group, randomized study with a 1:1 allocation ratio to check the hypothesis of whether high-frequency-SCS (HF-SCS) is better than conventional low-frequency (LF-SCS) for pain relief in patients with chronic limb-threatening ischemia (CLTI).

Eligibility Criteria:
Inclusion Criteria:

* non-reconstructable critical limb-threatening ischemia (CLTI)
* Fontaine stage IIB-IV
* VAS score 5/10 or more
* succesful SCS trial

Exclusion Criteria:

* intractable acute infection
* allergy to SCS component
* ulcerations larger than 3 cm2
* inadequate patient compliance
* life expectancy less than 12 months
* patient refuse to participate in any stage of the study
Safety and Efficacy Study of Non-Surgical MC Device for Adolescent Male Population Including Contraindicated Subjects

A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically shift the MC landscape. PrePex is an innovative circumcision device requiring no injected anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally skilled healthcare professionals rather than surgeons. Two initial studies conducted in Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was performed by skilled physicians

Rwanda Has also completed a third study to assess the safety and efficacy of MC when performed by nurses using PrePex in both rural and urban hospitals, Device safety was assessed by the rate of clinical adverse events and device-related incidents attributed to the PrePex device and its procedures, the study report was shared with the WHO Male Circumcision Technical Advisory Group. On February 2011 the WHO provided Rwanda with recommendation to phase in MC scale up with the PrePex device on adults. Moreover the WHO recommended Rwanda to study the PrePex for use on adolescent population, starting on ages 15-17 and thereafter on ages 12-14 and 10-12.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent Males in ages - 10 to 17 years
* Uncircumcised
* Subject wants to be circumcised
* Subject assent to the procedure
* Legal guardian consent to the procedure
* Subject with or without the following conditions: Preputial adhesions and /or narrow foreskin/Phimosis
* Able to understand the study procedures and requirements
* Agrees to abstain from sexual intercourse for 8 weeks after circumcision
* Agrees to abstain from masturbation for at least 2 weeks after Removal
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 weeks total)
* Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
* Subject agrees to anonymous video and photographs of the procedure and follow up visits.

Exclusion Criteria:

* Legal guardian withholds consent
* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
* Subject with the following diseases/conditions: paraphimosis, warts under the prepuce, torn or tight frenulum, hypospadias, epispadias
* Known bleeding / coagulation abnormality, uncontrolled diabetes
* Subject that to the opinion of the investigator is not a good candidate
* Subject does not agree to anonymous video and photographs of the procedure and follow up visits.
To Develop a High Quality Health Care Delivery Model for the Management of Hypertension and Diabetes at CHCs and District Hospitals of Himachal Pradesh.

Hypertension and diabetes are major risk factors for cardiovascular diseases. Although these two conditions can be detected much early in life and are amenable to interventions at primary health care level, the health system in India fails to provide adequate interventions at primary health care level which translates to huge burden of undiagnosed and uncontrolled hypertension and diabetes in the community. This study aims to design a feasible and sustainable evidence-based, decision support-enabled, health care delivery model for the management of hypertension and diabetes in the primary health care facilities of Himachal Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs) and District Hospital of Solan District, Himachal Pradesh using both qualitative and quantitative methods. The design and development of the model will be carried out in the initial six months followed by piloting the services at the CHCs and District Hospital. The impact of the model on quality of care will be assessed in a pre-post design measuring changes in both clinical and process indicators.

This study aims to design a feasible and sustainable evidence-based, decision support-enabled, health care delivery model for the management of hypertension and diabetes in the primary health care facilities of Himachal Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs) and District Hospital of Solan District, Himachal Pradesh using both qualitative and quantitative methods. The design and development of the model will be carried out in the initial six months followed by piloting the services at the CHCs and District Hospital. The impact of the model on quality of care will be assessed in a pre-post design measuring changes in both clinical and process indicators.

Eligibility Criteria:
Inclusion Criteria:

* All consenting adults of age \>30 years attending the Community Health Centre's and Civil Hospital of Solan District of Himachal Pradesh.

Exclusion Criteria:

* Person not willing to consent
* \<30 years of age
* History of coronary heart disease or stroke
* Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods)
* Malignancy or life-threatening diseases
Recruitment Messages for Current Smokers Recently Diagnosed With Cancer

The objective of this study was to conduct a pilot factorial randomized trial to identify the message frames that are most effective in promoting participation in a tobacco treatment trial for current smokers recently diagnosed with cancer. To do so, we used a multimethod approach to evaluate 3 different message frames across evaluation, effectiveness, and outcome measures. We combine findings from a message design experiment with textual analytic software to provide a holistic understanding of how message frames may or may not differentially affect tobacco treatment trial participation within the context of a cancer diagnosis.

Background: A cancer diagnosis can catalyze motivation to quit smoking. Tobacco treatment trials offer cessation resources but have low accrual rates. Digital outreach may improve accrual, but knowledge of how best to recruit smokers with recent diagnoses is limited.

Objective: This study aims to identify the message frames that were most effective in promoting intent to talk to a physician about participating in a tobacco treatment trial for smokers recently diagnosed with cancer.

Methods: From February to April 2019, current smokers diagnosed within the past 24 months were recruited from a national web-based panel for a multimethod pilot randomized trial (N=99). Participants were randomized to a 2×3 plus control factorial design that tested 3 unique message frames: proximal versus distal threats of smoking, costs of continued smoking versus benefits of quitting, and gains of participating versus losses of not participating in a tobacco treatment trial.

Eligibility Criteria:
Inclusion Criteria:

* Speak and understand English
* A recent cancer diagnosis (within the past 24 months)
* 18 years or older
* Report any cigarette use within the past 30 days

Exclusion Criteria:

* Do not speak or understand English
* Have not been diagnosed with cancer within the past 24 months
* Below the age of 18
* Does not report any cigarette use within the past 30 days