cyrilzakka/clinical-trials huggingface dataset:
Pre Post Evaluation of Temperature, Steps, and Glucose With Additional Time Spent Outdoors in an Urban and Rural Setting

This research was designed with partners to determine differences in temperature exposures in urban and rural communities in Alabama. The investigators hypothesized that significant differences in temperature exposure exist between urban and rural settings. Time spent outdoors has been previously positively associated with greater physical activity. Built environment components in urban versus rural environments and ambient temperatures experienced during the summer may pose barriers to time spent outdoors. Persons with Type II Diabetes Mellitus may find it more difficult to overcome temperature barriers due to reduced thermoregulation capacity. This analysis will result in a more precise picture of temperature exposure as well as behavioral factors that may mediate exposure.

The investigators gathered individual-level temperature exposure data by asking 180 female participants to wear a small thermometer on their shoe for 7 days. Ninety participants were recruited from Birmingham AL (urban) and 90 from rural West Central Alabama. The first two days participants were asked to go about their normal daily activities. During the next 5 days of participation, participants were asked to add an additional 30 minutes of time spent outdoors. As a secondary outcome, steps were measured via pedometers worn by participants. A subgroup of participants with self-reported doctor diagnosed Type II Diabetes also recorded their fasting glucose each morning of participation.

Eligibility Criteria:
Inclusion Criteria:

* Female, age 19 to 65, willing to wear a small thermometer on shoe and pedometer on waist for one week.

Exclusion Criteria:

* Medical condition that limits the amount of time able to be spent outdoors.
The Effects of Non Harmonic and White Noise on Human Pain Sensitivity: a Study of Healthy Volunteers

Study the effects of 60dB and 80dB white noise, 50-70dB and 70-90dB non harmonic tones on the basic pain threshold of subjects, including the threshold and tolerance of electrical stimulation pain,the threshold and tolerance of cold pain stimulation, and the threshold and tolerance of tenderness stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 35, regardless of gender
* No serious chronic diseases
* There is no self-reported history of chronic opioid drug use or neuropathy

Exclusion Criteria:

* A history of alcohol or drug abuse
* Pregnant or lactating
* Severe cardiovascular, kidney, or liver diseases
Prospective Pain Study Comparing Different Treatments After Hand Surgery

The purpose of the study is to evaluate the efficacy of three different types of pain medication (Oxycodone - an opioid, Ibuprofen - a non-steroidal anti-inflammatory, and Acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist performed exclusively under local anesthesia without sedation. The results of this study will help define optimal prescribing guidelines following the two most common hand surgeries while also potentially validating the use of opioid alternatives post-operatively in order to help mitigate excessive or unnecessary dispensal of opioid analgesics.


Eligibility Criteria:
Inclusion Criteria

1. Patients indicated to undergo primary, unilateral carpal tunnel release or trigger finger release surgery under local anesthesia alone.
2. Age eligibility is \> 18 years of age.
3. Local anesthesia with 1% lidocaine with 1:100,000 epinephrine and Bicarbonate.

Exclusion Criteria

1. Bilateral procedures.
2. Additional soft tissue or boney procedures performed simultaneously.
3. The use of sedation and/or general anesthesia.
4. Pediatric patients (age \< 18 years).
5. Pregnant female patients.
6. Non-English speaking patients.
7. Known allergies or medical contraindications to Oxycodone, Ibuprofen, Acetaminophen.
8. History of chronic pain and/or narcotic use preoperatively.
Indomethacin Use in Pain Relief During Intrauterine Device Insertion

The aim of the investigators study is to test the analgesic effect of rectal indomethacin during Intrauterine device insertion.


Eligibility Criteria:
Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to intrauterine device insertion
* Women who will accept to participate in the study

Exclusion Criteria:

* Any contraindication to intrauterine device placement
Assessment of DW-MRI Measures : Reproducibility and Repeatability in Pelvic Imaging on MR-Linac With Healthy Volunteers

This study evaluates the reliability of functional MRI measurements in pelvic disease through quantifying repeatability and reproducibility, using healthy volunteers. The aim is to provide insights into the consistency of results across sessions and observers, informing the trustworthiness of functional MRI in assessing pelvic disease and particularly rectal cancers and guiding protocol optimization.

Volunteers will be required to complete a questionnaire to ensure their eligibility and safety for undergoing an MRI. This questionnaire, along with safety information, will be reviewed before each MR session.

Subsequently, volunteers will undergo three MRI sessions, ideally two on the same day, with the last session scheduled 10 to 17 days apart from the previous ones. Each session is expected to last approximately 60 minutes (several sequences), and no contrast agent will be injected at any point.

On the first day, volunteers will have an MRI on the 1.5 Tesla MR-Linac Unity (Elekta device) and an MRI on a standard 1.5 Tesla MRI (Siemens). Between days 10 to 17, they will exclusively undergo an MR-Linac session.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 yo
* Healthy
* Volunteer
* Ability to undergo an MRI

Exclusion Criteria:

* \< 18yo
* Contraindication to undergoing an MRI (see safety questionnaire)
* Previous pelvic irradiation
* Pelvic pathology
Trial of Enhanced Pre-Consent Discussion

Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster randomized controlled trial to determine whether, in parents (of children with Crohn's Disease) or patients \> 18 years old being approached for trial participation, a pre-consent discussion enhanced with decision aids is more effective than the standard pre-consent discussion in transferring knowledge to parents/patients related to trial participation.


Eligibility Criteria:
Inclusion Criteria:

* Parent of a child who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)
* Patient who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)

Exclusion Criteria:

* Non-English speaking
iDecide.Decido: Diabetes Medication Decision Support Study

Two of AHRQ 's consumer-focused guides, "Pills for Type 2 Diabetes" and "Premixed Insulin for Type 2 Diabetes" could be of great use to underserved ethnic and racial minority adults. The presentation of content and delivery mechanisms of these Guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations.

To achieve this goal, a long-standing collaboration among African American and Latino community organizations, health care centers and systems, public health organizations, and academics (the REACH Detroit Partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (University of Michigan's Center for Health Communications Research \[CHCR\] and Center for Behavioral and Decision Sciences in Medicine \[CBDSM\]).

The investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (CHWs) to provide personalized patient education materials to underserved diabetic African American and Latino adults in Detroit, Michigan.

The Specific Aims of this study are:

Aim 1: To use the information in the two diabetes medications consumer CERSGs to build an interactive, computer tailored diabetes medication guide that will enable patients to assess their treatment goals, personal preferences, and side-effect concerns and generate a personally tailored assessment of their current diabetes treatments with, as appropriate, options for improving their diabetes care;

Aim 2: To determine the extent to which this personally tailored diabetes medication guide compared with the print consumer guides reduces Latino and African American diabetes patients' decisional conflict, through improved knowledge of anti-hyperglycemic medications and satisfaction with information received.

Aim 3: To examine the computer tailored program's effects on participants' changes in medications (medication intensification), self-reported medication adherence and beliefs and A1C levels between baseline and follow-up compared to participants receiving the print consumer guides.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* stated concern about diabetes and diabetes treatment
* poor glycemic control
* over 21 years of age

Exclusion Criteria:

* blind, deaf, otherwise unable to use the telephone or visual resources
* pregnant
* currently enrolled in other REACH Detroit research study
* in hospice care
* current radiation or chemotherapy
Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct

Patients presenting with acute ST elevation myocardial infarct urgently need revascularization. Standard of care is establishing bloodflow through the coronary vessels using thrombus aspiration catheter, and securing the result by using a metallic drug eluting stent. New kinds of non-metallic bioresorbable stents are now available. They have however challenges in structural strength.

The investigators want to compare the new bioresorbable scaffold with traditional metallic stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120 patients. The investigators will use an imaging technique, optical coherence tomography, to evaluate the results after 12 months.

The investigators also want to see if modern multislice computed tomography can give useful information in the follow-up of stented coronary arteries after 12 and 24 months.

Patients presenting with ST elevation myocardial infarction for primary PCI (percutaneous coronary intervention) will be screened. After thrombus aspiration, patient will be asked for oral consent if TIMI flow 2-3. Patient will then be randomized between drug eluting stent (Xience pro, Abbott Vascular Solutions) and bioresorbable scaffold (Absorb, Abbott Vascular Solutions). Optical coherence tomography (OCT) will be performed before stenting and after final result. Stent will be deployed without further predilatation if possible. Follow up at 12 months (clinical, angio with OCT and multislice CT coronary angiogram (MSCT-CA)) and 24 months (MSCT-CA).

Eligibility Criteria:
Inclusion Criteria:

1. History of chest pain \< 12 hrs
2. ST elevation of ≥ 2 mm in ≥2 contiguous precordial leads (V1-V6), and/or ≥ 1 mm in ≥ 2 contiguous standard leads (I, II, III, aVf, aVr,aVl).
3. Clinical decision to treat with primary PCI
4. \> 18 years
5. Oral informed consent

Exclusion Criteria:

1. Contraindications to long term double antiplatelet therapy
2. Known kidney failure with GFR \< 45
3. Cardiac arrest or severe cardiogenic shock (Persistent BP \<90 mmHg, despite adequate treatment)
4. Other severe illness with life expectancy of less than 12 months (eg. malignancy, severe malnutrition, degenerative disease)

Procedural contraindications:

1. Heavy calcification, tortuous vessel or large side branch (\> 2,5 mm) at culprit lesion.
2. TIMI 0-1 flow after aspiration
3. Unable to advance thrombus aspiration catheter
Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).

The goal of this interventional study is to assess the effects of either physical exercise program or combined with cognitive training (dual motor and cognitive training program) on breast cancer survivors. The main questions it aims to answer are:

* Analyze the effectiveness of a supervised dual-task training program or a physical exercise program on the executive functions of the participants.
* Evaluate the impact of both interventions on physical function, emotional aspects, and important biomarkers related to muscle-brain crosstalk.

Participants will perform a 20-week supervised and controlled program, three times a week, along with weekly calorie and step challenges.

Researchers will compare the dual-task training group, with the physical exercise group, and with a control group, which will perform the guideline recommendations of physical activity (non-supervised) to see how these intervention approaches can impact cognitive functions, physical functions, emotional aspects, and biomarkers related to muscle-brain crosstalk.

Assessments will take place at three-time points: at baseline, after the intervention (20 weeks post-baseline) and after a 12-week follow-up period (32 weeks post-baseline).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stage I-IIIA breast cancer
* Completed primary treatment, including surgery, radiotherapy and/or chemotherapy
* Scheduled to receive adjuvant endocrine therapy, or currently receiving adjuvant endocrine therapy
* Without functional limitations or other illnesses that condition and prevent them from practising intense physical exercise
* FACT-Cog questionnaire score ≥ 10th percentile considering age groups
* Fluency in Spanish (spoken and written)

Exclusion Criteria:

* Undergoing radiotherapy and/or chemotherapy
* FACT-Cog questionnaire score ≤ 10th percentile considering age groups
* Congenital heart disease
* Chronic lung disease
* Severe psychiatric disorders
* History of substance abuse, or dependence (other than tobacco)
* Mood disorders require treatment (anxiety or depression)
* Relapses (2-3 months before the study start)
Patient-reported Outcome Follow-up Based on the Northern Shanghai Community Chronic Disease Management System

Influence of patient-reported outcome follow-up based on the northern Shanghai community chronic disease management system on the follow-up compliance and satisfaction of patients with atrial fibrillation after cryoablation.

Influence of patient-reported outcome follow-up based on the northern Shanghai community chronic disease management system on the follow-up compliance and satisfaction of patients with atrial fibrillation after cryoablation.Among patients with left atrial fibrillation after cryoablation at several sites, 240 consecutive eligible patients were randomly assigned to routine follow-up (control) and PRO (test) for 12 months. Follow-up, comparison of postoperative follow-up compliance, satisfaction, etc.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years old;Symptomatic, paroxysmal atrial fibrillation with cryoablation；Ability to understand and sign informed consent；

Exclusion Criteria:

* none
Impact of Anesthetic Environment the Sex Ratio of the Children of Female Assistants

The aims of this multi center retrospective study was to determine:

* whether the sex ratio of the offspring of female assistants in anesthesia-resuscitation differs from that of the population at large
* whether the assistants' work environment at the time of their offspring's conception influences the sex of their offspring


Eligibility Criteria:
Inclusion Criteria:

* Female assistants in anesthesia-resuscitation in the Wallonia-Brussels Federation (Belgium) who conceived one or more children in the course of their training between 2009 and 2019 and who delivered before the end of 2019 (cut-off: midnight on 31 December 2019)

Exclusion Criteria:

* Male assistants in anesthesia-resuscitation
* Female assistants in anesthesia-resuscitation who trained before 2009 or after 2019.
* Female assistants in anesthesia-resuscitation who relied on medically assisted reproduction.
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
* Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital

Exclusion Criteria:

* Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
* Need for continued anticoagulant therapy
* Significant renal impairment or known significant liver disease
Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain

Postoperative pain is generally caused by inflammation and oedema related to tissue trauma. Surgical tissue trauma is caused by many factors such as cotery-related burns, surgical incisions, dissections, and instrumental procedures like cutting, stretching, or compression.

The pain stimulus is triggered by mediators released by the traumatic tissue and transmitted to the spinal cord and then to the upper centres of the brain. Tenoxicam is an analgesic, anti-inflammatory, and antipyretic drug with a long duration of action, included in the oxicam subgroup of NSAIDs. Tenoxicam has been studied and found effective for many rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, gout, extra-articular disorders, bursitis, tendonitis, and osteoarthritis. The primary aim of this study was to compare the effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination analgesic applications on the postoperative VAS score of double-jaw surgery patients. The secondary aim was to investigate the effects of these interventions on the number of both opioid and rescue analgesic drug consumption postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-50 aged of both genders who were scheduled for elective bimaxillary surgery
* Classified as American Society of Anesthesiologists (ASA) risk class I or II

Exclusion Criteria:

* having liver or renal dysfunction
* coagulopathy disorder,
* having psychiatric or medical conditions that might impair communication or compliance with the study procedures
* having allergy or contra-indications to the study drugs .pregnancy.
* patients who were planned to undergo additional simultaneous surgical procedures such as genioplasty were not included in the study. -
Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety

Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

Eligibility Criteria:
Inclusion Criteria:

* Parents to premature infants, after releasing the mother

Exclusion Criteria:

* Term infants
* Hospitalized mother
Influence of Vitamin-B-complex on Cognitive Ability of Kindergarten Kids

Vitamin-B and Folic intake of Kindergarten kids in Germany is only 50-70% of the official recommendations. In studies with adults it has been found that for example providing people suffering from Alzheimer´s disease improved their mental and cognitive abilities when provided with a high intake of these vitamins.The hypothesis is, that kindergarten kids, 4-6 years of age, could also improve mentally from a recommended intake of B-vitamins and Folic Acid.

1. screening study: The urine of 1200 kindergarten kids will be analyzed for metabolites of these vitamins, and the 250 kids with the lowest results will be invited for a randomized double blind intervention study.
2. intervention study: Participating kids will get an one hour mental and cognitive testing before and after the intervention. The intervention will be one portion of the recommended dosage of a vitamin B complex and folic acid , given in a drink (milk, tea, etc). The assumption is, that the treatment group will perform better than the placebo group in the second test phase.


Eligibility Criteria:
Inclusion Criteria:

* age: 4-6 years
* kindergarten kids in Munich
* fluent in German
* healthy
* no medication

Exclusion Criteria:

* not fluent in German
* chronic illness
* intake of multivitamin supplements