cyrilzakka/clinical-trials huggingface dataset:
Effect of Videogames on Real-life Triage Patterns

In 2016 and 2017 the investigators conducted two clinical trials in which emergency medicine physicians were randomized either to an intervention (customized, theoretically-based video games) or to a control (nothing or text-based education). This study will now assess long-term outcomes for physicians enrolled in those two trials to evaluate the effect of the interventions on triage practices for trauma patients who presented initially to non-trauma centers in the US between December 2016 and November 2018.


Eligibility Criteria:
Inclusion Criteria:

* Participated in two prior clinical trials (Physician)
* ≥65 years old (Patient)
* enrolled in Medicare fee-for-service
* sustained a moderate-severe injury (i.e. ISS \[injury severity score\] \>15) (Patient)
* treated by physician enrolled in prior clinical trials (Patient)

Exclusion Criteria:

* Did not participate in two prior clinical trials (Physician)
* \<65 years old (Patient)
The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers

The purpose of this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI.

Inclusion criteria:

1. patients undergoing 1st trial ICSI
2. unexplained infertility
3. negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA

Exclusion criteria:

1. previous IVF/ICSI
2. Any cause of infertility
3. Suspected and/or unexpected poor response during ovulation induction
4. positive immunological markers
5. Age \> 40 years.

All participants will undergo IVF/ICSI cycle using the Long luteal phase protocol. the dose of gonadotropins will be calculated according to patient age and BMI. All patients will have 2-3 embryos transferred at D5 according to their age. the primary outcome will be LBR. secondary outcomes will include biochemical pregnancy rate and clinical pregnancy rate.

Eligibility Criteria:
Inclusion Criteria:

* age less than 38 years
* at least 12 months of infertility
* women with unexplained infertility

Exclusion Criteria:

* age more than or equals 38 years
* serum AMH level less than or equals 1 ng/ml
* patients of anticoagulant therapy
* immune-compromised patients
* patients with contraindications to low molecular weight heparin
* positive immunological markers
* patients with other than unexplained infertility
* male factor infertility
* refusal of participation
* patients with unexpected poor or over response during induction of ovulation
Asthma Control Through Telemedicine

The purpose of this research study is to evaluate the impact of pharmacist led educational interventions on Asthmatic patients, and also determine their medication adherence.

Pharmacist's intervention aims to answer:

1. How a pharmacist intervention program impact medication adherence in persistent asthma?
2. To assess how pharmacist led educational intervention like patients' counseling and medication reminders through Telemedicine have an impact on patient's asthma control?
3. Which mode of communication (Verbal instructions, videos and pamphlets) for the patient counselling is most beneficial for the patients in asthma control.

This is a randomized, pharmacist-led, two-group, longitudinal descriptive interventional study performed through in person (Public and private hospitals) and telecommunication (WhatsApp, network calls and messaging). The investigator will use snowball method to approach patients through telecommunication. Recruited patients will be randomly divided into two groups: the Control and the experimental group. The Control Group will not receive any intervention, and experimental group will receive special counseling about persistent asthma, it's medications and medical devices, their appropriate use, and side effects. Using Telemedicine as message and call reminders to increase medication adherence and improve their asthmatic condition. The intervention will be conducted for one month on the experimental group according to the recruitment date and time of the patients.

Pre-validated questionnaires will be used for the assessment

1. The adherence to asthma medication questionnaire (AAMQ-13).
2. Asthma Control test TM (ACT).

Eligibility Criteria:
Inclusion Criteria:

* Age above 11 years.
* Persistent Asthma Patient.
* Patients taking medications and inhaler.
* Patient who will consent for the study.
* Patient with basic telecommunication facility.
* Patient who responded to messages and calls.

Exclusion Criteria:

* Patients who will refuse to participate in study will not be included.
* Irresponsive patients to messages and calls
Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment

The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.


Eligibility Criteria:
Inclusion criteria

* Pathologically-proven diagnosis of melanoma.
* Patient must have a test or procedure that has the potential to provide left-over tissue that can be banked for future research purposes OR the patient has already had a diagnostic or therapeutic procedure but who has not yet been approached to participate is also eligible.

Exclusion criteria

* Any patient with significant contraindications to venipuncture (e.g., severe anemia) will be excluded from blood collection procedures. However, if the patient provides consent and a paraffin-embedded block or 10-15 unstained slides of their tissue diagnosis, they will not be excluded from this protocol.
* Any patient unable or unwilling to provide consent.
Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia

the study will evaluate the effect of transversus abdominis plane block (TAP) on chronic post-groin surgeries orchalgia (chronic testicular pain)


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were patients with chronic scrotal pain (orchialgia) that fulfilled the following criteria:

  1. pain intensity ≥ 5 on the visual analog scale (VAS),
  2. pain that lasted for more than 3 months after groin surgeries,
  3. failed conservative treatment with nonsteroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria:

* The exclusion criteria were:

  1. patients with other causes of scrotal pain, e.g., epididymitis, orchitis, and hydrocele,
  2. patients complaining of groin infection and coagulopathy,
  3. patients suffering from hypertension, ischemic heart disease, or psychiatric disorders
Observational Study of Digital Biomarkers of Myotonia and Gait in Adults and Children With Myotonic Dystrophy

The goal of this observational study is to assess movement in individuals with Myotonic Dystrophy Type 1 (DM1) and Type 2 (DM2) using digital biomarker tools. The long-term aim of this study is to incorporate these outcomes into clinical trials of DM1 and DM2 therapies. Participants will complete a series of assessments that allow for researchers to measure hand myotonia and walking quality, including a Video Hand Opening Test (VHOT), grip strength, 10 meter walk/run test, 6 minute walk test, Timed Up and Go (TUG), Motor Function Measures-32 (MFM-32) test, and more. These assessments may be recorded to detect and map participants motion and walking patterns. Several patient reported outcome (PROs) questionnaires will also be recorded. Participants may also be asked to monitor exercise and sleep activity at home using an Actigraph wearable device. This study is divided into 2 parts: Part A consists of a single visit. Part B consists of a 1-year longitudinal study with 3 clinical follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Age 12-90 years old at the time of informed consent
* Genetic confirmation of DM1 or DM2
* Ability to comply with study assessments
* Clinically apparent myotonia equivalent to hand opening time of at least 2 seconds, in the opinion of the Investigator
* Ambulatory (orthoses allowed, canes and walkers not allowed) and able to walk at least 25 meters at screening

Exclusion Criteria:

* Ongoing medical condition (e.g. wasting or cachexia, severe anemia) that would, in the opinion of the Investigator, interfere with the conduct or assessments of the study
* Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, suicidal ideation, suicide attempt, or untreated major depression ≤ 90 days of screening, which in the opinion of the Investigator may interfere with the study procedures
* Treatment with an investigational drug, biologic agent, or device within one month of screening, or 5 half-lives of investigational agent, whichever is longer
* Inability to comply with study requirements
* Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrolment
The Efficacy of 308nm Excimer Laser in White Striae

The purpose of this study is to determine whether 308nm Excimer Laser therapy are effective in the color correction of white striae.

The use of excimer laser in modified program in white striae during a few months.

Eligibility Criteria:
Inclusion Criteria:

* White Striae

Exclusion Criteria:

* Red Striae
Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels

The purpose of this study is to determine the effect of JTT-302 on the increase of High Density Lipoprotein-Cholesterol (HDL-C) levels when administered daily for four weeks in subjects with low HDL-C levels.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a Body Mass Index (BMI)≤ 35 kg/m2
* Subjects with the following lipid parameters at Visit 1 (screening visit) and Visit 3 (diet stabilization period):
* HDL-C ≤ 40 mg/dL (Men) and ≤ 50 mg/dL (Women)
* TG ≤ 500 mg/dL
* LDL-C ≤ 190 mg/dL
* Subjects who are generally healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead ECG

Exclusion Criteria:

* Females who are pregnant or breast-feeding
* AST, ALT or total bilirubin ≥ 2.0 x ULN at Visit 1 (screening visit) or Visit 3 (diet stabilization period)
* Serum thyroid stimulating hormone (TSH) and levothyroxine (T4) outside of the central laboratory reference range at the screening visit
* Medical history of diabetes mellitus or two fasting serum glucose measurements \> 126 mg/dL at the screening visit
* Subjects with hypertension, or two blood pressure measurements ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic at the screening visit
* History of drug or alcohol abuse within 12 months of the screening visit
* Use of medications defined in the protocol within six-weeks prior to the screening visit and throughout the study
* Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol within four weeks of the screening visit and throughout the study
Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1

Currently one in five high school students smokes. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers.

Among adolescents, the short-term health effects of smoking include damage to the respiratory system, addiction to nicotine, and the associated risk of other drug use. Adolescents are at greater risk for long-term health problems because most young people who smoke regularly continue to smoke throughout adulthood. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation to quit.

This open-label study will last a total of 6 weeks. Baseline measurements will be taken twice a week at study visits for the first two weeks to assess vital signs and smoking behavior. Participants will aslo use a computerized device outside of study visits to monitor their own smoking habits. At Week 3, participants will be randomly assigned to receive bupropion, a nicotine patch, nicotine gum, or placebo. Participants will be asked to limit the frequency of their smoking to 75% of what it was during baseline. During Weeks 4, 5, and 6, participants will be expected to reduce smoking behavior to 50% of what it was at baseline. Customized doses of nicotine patches and nicotine gum, relative to the amount of cigarettes a participant smoked during baseline, will be dispensed weekly. Participants receiving bupropion or placebo will receive medication at each study visit and will take one pill daily. During treatment, study visits will occur once weekly. At each study visit, all participants will receive a 10- to 15-minute standardized behavioral therapy session aimed at supporting smoking reduction. Smoking habits and vital signs will be assessed and the effects of the treatments will be determined. There will be one follow-up visit 3 months post-intervention, at which time smoking status will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* At least 6 months of daily cigarette smoking
* No use of other tobacco products
* Motivated to reduce or quit smoking
* Not currently using medications to quit smoking
* Agree to use an effective form of contraception throughout the study

Exclusion Criteria:

* People for whom use of nicotine replacement therapy or bupropion is medically inadvisable
* History of alcohol or drug abuse within 6 months of enrollment
* History of emotional problems (as assessed by the Adolescent Symptoms Inventory) within 6 months prior to enrollment
* Currently on an unstable dose of psychoactive medications
* Currently taking medications that may react with one of the treatment medications
* Pregnant
External Validation os the ACME Scoring System

Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is surgical treatment (ST) and the accepted mortality is \<1%, but in severe and/or fragile patients is higher. Despite the Tokyo Guidelines, there no consensus on who is the unfit patient for ST. A recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (ACME) and could help to develop new guidelines in ACC. The aim of this study is to perfom an external validation of the new simplified scoring system for mortality in ACC.

This is a prospective multicenter observational study of 10.000 adults with ACC during 2 consecutive years (2025/2026), including baseline demographic characteristics, comorbidity severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines severity classification and the new ACME Scoring system. The primary outcome is to study the prediction of mortality of ACME score. Secondary outcomes include complications following Clavien-Dindo's classification, C-statistic, and ROC Curves.

Eligibility Criteria:
Inclusion Criteria:

* Acute Calculous Cholecystitis

Exclusion Criteria:

* Acute Cholangitis
* Chronic Cholecystitis
* Neoplasia
* Acute Pancreatitis
* Pregnant
Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16

The purpose of this study is to examine the subjective, psychomotor, and reinforcing effects of combined alcohol and nitrous oxide intake in healthy volunteers.


Eligibility Criteria:
Please contact site for information.
Effects of Music on Motor Skills of Children With Attention Deficit and Hyperactivity Disorder

Physiotherapists have positive effects on motor skills, executive functions and symptoms of children with attention deficit and hyperactivity disorder. However, progression takes time due to the symptoms of the disease. Physiotherapists need strategies to manage the symptoms of ADHD. Music can be used as a strategy because music is known to reduce the symptoms of children in this group. There is no study in the literature on how motor skills will be affected with musical accompaniment. The aim of this study is to compare motor skills performed with and without music in children with ADHD. When we evaluate motor skills like in a treatment session, the usability of music as an environmental factor will be investigated according to the positive, negative or ineffective results of the music effect.

The American Psychiatric Association defines attention deficit and hyperactivity disorder (ADHD) as one of the most common mental disorders affecting children and adults. The etiology of ADHD is not fully known. Attention deficit, hyperactivity and/or impulsivity are seen as the main symptoms of ADHD. ADHD is grouped into three subtypes according to these symptoms. These three subtypes consist of attention-deficit-dominant type, hyperactivity-dominant type, and combined type with both hyperactivity and inattention symptoms. Researchers reported that 45-70% of children with ADHD have problems in fine and gross motor skills. It is known that problems in motor skills are associated with main symptoms. Balance, gait and postural control are affected in terms of gross motor skills. It has been observed that they perform more slowly in activities that require fine motor skills such as cutting, doing crafts or drawing, and in consecutive finger movements. In addition, handwriting disorders such as dysgraphia are seen in 70% of children with ADHD. During the dual tasks, the sources of attention are divided. Due to this division, the secondary task affects postural performance.

Music is one of the therapy options in some conditions and known as music therapy. It is used in many diseases and conditions such as dementia-alzamer, autism, cerebral palsy, cancer, prematurity, depression and ADHD. Now that music is known to reduce the symptoms of children with ADHD, physical therapists may use music as a strategy. Thus, the purpose of this study is to compare motor skills of children with ADHD with and without music conditions.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with ADHD combined type by a child psychiatrist
* Having adequate cognitive skills to understand the commands of the physiotherapist

Exclusion Criteria:

* Having hearing and/or vision problems
* Having any neurological and/or orthopedic problems that would prevent him from performing the tests
* Having a psychiatric disorder other than ADHD
Translational Research Center in Lung Cancer Disparities (TRACER) Project 2

The purpose of this study is to examine racial differences in smoking behaviors and stress responses between African American and white male smokers.

Cigarette smoking is a leading cause of morbidity and mortality from lung cancer among adults in the US. Stress relief and smoking cessation is the best preventive strategy for reducing lung cancer risk and addressing racial disparities in outcomes. Despite this, racial differences are found among those that make quit attempts. Stress has been found to be related to smoking initiation, maintenance, and relapse. Yet, differences in stress responses have not been examined between African American and white smokers. Therefore, this study will examine racial differences in stress responses and smoking behaviors between African American and white male smokers

Eligibility Criteria:
Inclusion Criteria:

* African American and white males
* Between the ages of 18-75 years old
* Smoke at least 5 to 10 cigarettes per day

Exclusion Criteria:

* Smokers who have a serious cognitive disorder
* Have a personal history of lung cancer
* Personal history of usage of illicit drug and alcohol abuse
* Enrollment in a smoking cessation treatment program during the past 6 months
* Current use of a nicotine replacement therapy
* Have any positive responses on the Mini International Neuropsychiatric Interview (MINI) screener
APPLICATION OF MOLECULAR TECHNIQUES FOR IMPROVING THE DIAGNOSIS AND TREATMENT OF NODULAR THYROID LESIONS.

To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System)

Aim of the study To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System).

Design: Retrospective observational study. Scope: The study will be peformed at the Pathology Service, from cytological samples and paraffin file post-diagnosis. Mutations are detected by pyrosequencing technique.

Subject of study:

Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí.

Methodology:

* Identification of cases
* Detection of BRAF V600E mutation, initially in histological material from the surgical specimen, and if present, detection in cytological material.

The statistical analysis will use SPSS. Univariate and bivariate analysis will be done. Results will be presented in the form of frequency tables and percentages for qualitative variables and by average, median and standard deviation for quantitative variables. Pearson chi-square or Fisher's exact test will be applied. The Student t test or the Mann-Whitney test will be performed for quantitative variables.

Eligibility Criteria:
Inclusion Criteria:

* Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí

Exclusion Criteria:

* Non available cytological or histological material
Using Facebook to Support Opioid Recovery Among American Indian Women

The purpose of this study is to find out whether a Facebook group will help Native women in recovery from opioid use.


Eligibility Criteria:
Inclusion Criteria:

1. AIAN person based on self-reported race/ethnicity
2. Gender identity as a woman
3. At least 18 years of age with no upper age limit
4. Resides in Minnesota
5. Meets criteria for OUD based on the DSM-5 Checklist (American Psychiatric Association, 2013)
6. Self-reports at least one month of abstinence from opioid use based on TLFB interview and negative urine opiate screen
7. Current use of MOUD
8. Is comfortable speaking and reading English
9. Has an existing Facebook account or willing to set one up
10. Is willing and able to participate in the Facebook intervention for 3 months
11. Has access to broadband internet on a mobile phone/computer/tablet at any location
12. Is willing and able to travel to a community clinic in Minneapolis, Minnesota for the UDS or is willing to and able to complete a virtual Zoom UDS visit.
13. Provides written informed consent

Exclusion Criteria:

1. Self-reports current suicidality based on the Concise Heath Risk Tracking scale
2. Participated in prior study phases (Aim 1 formative work) of NIDA CTN-0123