cyrilzakka/clinical-trials huggingface dataset:
Brief Alcohol Screening for Community College Students (BASICCS)

The present study focuses on examining the feasibility, acceptability, and preliminary effects of an adapted alcohol intervention for high-risk college students attending community colleges. Investigators adapted BASICS (an efficacious in-person intervention developed for high-risk drinkers attending 4-year colleges and universities) to a web-conferencing format that allows the facilitator and participant to see and discuss live web-based personalized feedback. SMS text messages with protective behavioral strategies were also provided. The objective of the R34 was to establish feasibility and acceptability as well as to determine preliminary or likely effect sizes.

Young adulthood (ages 18-29) is associated with increased risk for alcohol-related negative consequences; however, little is known about effective interventions for young adults attending community colleges (CCs). Thus, it is critical to develop an intervention that meets the various needs and demanding lifestyles of CC students. The investigators proposed to develop a user-friendly and convenient intervention that addresses relevant social norms, the impact of high-risk alcohol use on health and well-being in relevant life domains beyond student life and academic achievement, and provides ongoing exposure to behavior change strategies. To address the notable differences between CC students and traditional 4-year students, the investigators adapted BASICS to a web-conferencing format that allows the facilitator and participant to see and discuss live web-based personalized feedback (FB). This intervention for CC students, BASICCS, will focus on relevant normative feedback and alcohol's impact on multiple roles and personal goals of the CC student. Providing tips and protective behavioral strategies (PBS) after BASICS interventions via handouts or mailed postcards is standard practice and with preliminary evidence supporting the use of mobile phone text messaging (TM) or short message service (SMS) to reduce heavy-episodic drinking; thus, in this study SMS text messages were used to deliver ongoing protective behavioral strategies (PBS) the month after participating in the BASICCS session. The objective of this research was to establish feasibility and acceptability as well as to determine preliminary or likely effect sizes. CC student drinkers were recruited to participate and if eligible, they were randomized to one of two conditions (BASICCS or assessment-only control) and completed 1- and 3-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* being 18-29 years old; enrolled full- or part-time at one of the three community colleges where data collection took place; consuming 4+/5+ drinks for women/men on one occasion in the past month or exceeding weekly NIAAA drinking recommendations (8+/15+ for women/men); and possessing a cell phone with text-messaging capability

Exclusion Criteria:

* not meeting inclusion criteria, not consenting to participate
Swiss Childhood Health and Nutrition Survey

The aim of the present study is to assess the prevalence of overweight and obesity in 6 to 12 year old children in Switzerland. This data will be used to investigate trends in the development of overweight and obesity in Switzerland. In addition, a questionnaire will be used to assess data on physical activity, nutrition, health and socioeconomic background and waist circumference as well as skin fold thicknesses will be measured.


Eligibility Criteria:
Inclusion Criteria:

* age between 6 and 12 years

Exclusion Criteria:

* none
Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women

The study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean section

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study.Subjects sat in cross leg sitting position: patients sit with both thighs abducted, knees flexed medially, each feet soles were under their contralateral thighs. The back was flexed maximally, subjects' chin approaching the sternum, and subjects hugged a pillow. Lumbal puncture was done using Quincke needle 25G/27G at L4-5 intervertebral gap until the it reached subarachnoid space (confirmed by free flow cerebrospinal fluid). Data recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and blood vessel puncture incidence. Data was analyzed by using Statistical Package for Social Scientist (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-45 years old, with American Society of Anesthesiologists (ASA) physical status I-III who were planned to undergo caesarian section with spinal anesthesia in crossed leg sitting position.
* Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form

Exclusion Criteria:

* Subjects with contraindications for spinal anesthesia
* Subjects with fetal's head trapped, umbilical prolapse, and foot presentation
* Subjects with pre-eclampsia
* Subjects with cardiovascular diseases
* Subjects with scoliosis
* Subjects with recent lumbal surgery history
* Subjects who cannot sit in crossed leg sitting position.

Drop out criteria:

* Subjects with worsening conditions before spinal anesthesia
* Subjects with failed spinal needle insertion and thus received general anesthesia
* Subjects with twin pregnancy
* Subjects drop out the study.
The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study

Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to influence the bacteria gut interaction. Our aim is to determine if components of the diet affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure whether after being on a diet high or low on certain factors there is a change in the timing and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS symptom severity.


Eligibility Criteria:
Inclusion Criteria:

* Meet Rome III criteria for IBS
* Willing to undergo dietary intervention

Exclusion Criteria:

* History of Gastric, Small Bowel or Colonic Surgery
* History of Inflammatory Bowel Disease
* Celiac Disease
* Unable to come off following medications: antibiotics, laxatives, narcotics, sedatives
* On a pre specified diet
* Pregnant
The Effect of 10 Repetitions of Deep Breathing Exercises

The goal of this clinical trial is to learn and assess the effect of 10 repetitions of deep breathing exercises every 3 hours compared to 3 repetitions of deep breathing exercises on the sleep quality of patients after heart surgery.

The main questions it aims to answer are:

How does 10 repetitions of deep breathing exercises every 3 hours affect the sleep quality of patients after heart surgery?

Researchers will compare 10 repetitions of deep breathing exercises every 3 hours to 3 repetitions of deep breathing exercises to see if 10 repetitions of deep breathing exercises every 3 hours work to improve sleep quality.

Participants will:

1. Respondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days.
2. Respondents in the control group performed 3 repetitions of deep breathing exercises for 3 days.

1. Researchers carried out recruitment when the patient had undergone surgery.
2. Researchers determine potential respondents who meet the inclusion criteria.
3. Researchers explain to potential respondents the procedures, objectives, benefits and risks of the research being conducted.
4. Researchers provide time and opportunity for potential respondents to confirm research procedures.
5. The researcher provided an informed consent sheet as a form of respondent's agreement to their involvement in the research.
6. Researchers determine respondents for the intervention and control groups.
7. Respondents do a pretest. The pretest was administered by administering a sleep characteristics and quality questionnaire.
8. Researchers provide education to patients regarding deep breathing exercise procedures.
9. Respondents in the intervention group performed deep breathing exercises with 10 repetitions every 3 hours for 3 days. Respondents in the control group did 3 repetitions of deep breathing exercises.
10. Respondents are monitored in the implementation process using a monitoring form.
11. Respondents who completed the exercise will conduct a post-test assessment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone cardiac surgery, both on-pump and off-pump.
* The patient's hemodynamic condition is stable.
* More than equal to 18 years old.
* Able to communicate, read and write in Indonesian.

Exclusion Criteria:

* Patients who receive sleeping medication or sedative therapy.
Effect of Mulligan Movement Mobilization Technique on Elbow Joint Proprioception

Investigating The Effects of Mulligan Movement Mobilization Technique on Elbow Joint Proprioception

Investigating The Effects of Mulligan Movement Mobilization Technique on Elbow Joint Proprioception by joint position sense assessment

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years

Exclusion Criteria:

* having any elbow condition
* having any neurological condition
Hearing Impairment of Nasopharyngeal Carcinoma

This observational cohort study was aimed to evaluate the hearing toxicity at multiple time points from baseline to 1 year after radical chemoradiotherapy among nasopharyngeal carcinoma patients.

With the development of radiotherapeutic techniques and equipment as well as advances in treatment modalities, the 5-year overall survival of patients with non-disseminated NPC has exceeded 80%. However, the incidence of hearing toxicity did not decrease significantly compared with the past. The hearing loss remains the second most common toxicity after xerostomia. Audiometry, acoustic impedance testing, eustachian tube pressure measurements, and distortion product otoacoustic emissions will be used to compare hearing before treatment and up to 1 year after radical chemoradiotherapy. The related factors affecting the hearing of NPC patients will also be investigated and explored.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
2. About to undergo radical chemoradiotherapy with intensity-modulated radiotherapy (IMRT).
3. Eastern Cooperative Oncology Group performance status≤1.
4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin

   ≥90g/L, and platelet count≥100×10e9/L.
5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST)

   ≤2.5×upper limit of normal (ULN), and bilirubin≤ 1.5×ULN.
6. Adequate renal function: creatinine clearance rate≥ 60 ml/min (Cockcroft-Gault formula).
7. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

1. Age \> 60 or \< 18.
2. Receiving additional targeted therapy or immunotherapy except for radiotherapy and chemotherapy.
3. With a condition that could cause hearing impairment, such as ear canal cerumen blockage, ear canal foreign body blockage, cholesteatoma, tympanic membrane perforation, cholesteatoma otitis media, middle ear granulation tissue growth, inner ear labyrinthitis, sudden nerve deafness, Meniere's disease, acoustic neuroma, and so on.
4. Patients who received aminoglycoside antibiotics or macrocyclic lipid antibiotics (such as streptomycin, gentamicin, kanamycin, neomycin, tobramycin, minocycline, erythromycin, roxithromycin, etc.) orally or intravenously within 30 days before treatment.
5. Patients with hearing loss at the baseline（except for those with conductive hearing loss diagnosed by at least two deputy chief physicians as nasopharyngeal carcinoma-related）
6. Patients who received additional treatment during the observation period due to disease progression.
7. Pregnant or breastfeeding.
8. Patients with prior malignancy who have received systemic chemotherapy or head and neck radiotherapy.
9. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis

The aim of the study is to evaluate in patients with history of periodontitis the clinical, microbiological and radiological outcomes of implants with a modified implant design consisting on a machined surface in the coronal third of the implant.

In this 12-month, parallel-arm, randomized controlled trial, patients with history of treated periodontitis and in need of dental implants for single-unit or short edentulous spaces (i.e. two implants) will be randomly assigned to a test group (implants with a hybrid surface, presenting a machined coronal third; HS) or a control group (conventional moderately rough implants; RS). Implants will be restored 3 months later with fixed implant supported reconstructions. Radiological, clinical, microbiological and patient-related outcome measures (PROMs) will be assessed 3, 6 and 12 months after the prosthetic installation.


Eligibility Criteria:
Inclusion Criteria:

•\> 20 years of age

* Presence of ≥1 adjacent missing teeth, in either maxilla or mandible (up to three missing units).
* A natural tooth had to be present mesially to the most proximal implant site, although free end situations were allowed, and opposing dentition had to be natural teeth or implant supported fixed restorations.
* History of treated and controlled periodontitis.
* Presence of adequate bone volume to achieve primary implant stability without concomitant regeneration

Exclusion Criteria:

* Diseases affecting bone metabolism or wound healing (e.g.)
* History of radiation therapy, leukocyte dysfunction, or any other immunodeficiency
* Drug abuse
* Intrasurgical exclusion criteria, such as the lack of primary stability, the need of bone augmentation or the impossibility of placing the implant based on prosthetic requirements. �
Influence of Reward and Punishment on Goal-directed and Habit Learning in Adolescent Anorexia Nervosa

The proposed study of adolescents with anorexia nervosa (AN) will examine the association of behavioral differences in constructs of decision making, brain structure and connectivity, and eating disorder (ED) symptoms. This study tests the novel hypothesis that goal-directed and habit learning for reward and punishment is altered in AN and is uniquely associated with divergent symptoms and differences in corticostriatal connectivity and microstructural integrity. We will recruit 78 females currently ill with AN and 26 controls ages 13-17 to investigate how goal-directed and habit learning for reward and punishment correspond to 1) clinical symptoms collected via interviews, self-report assessments, and ecological momentary assessment (EMA), and 2) brain structure and connectivity in the resting state. Data collection will rely on a technology called functional magnetic resonance imaging (fMRI).


Eligibility Criteria:
Inclusion Criteria:

AN Group:

* Between the ages of 13 and 17 years old
* Meet DSM-V criteria for AN-R or AN-BP
* Medically stable per American Academy of Pediatrics and the Society of Adolescent Medicine requirements, at least 75% adjusted ideal body weight, but still symptomatic as assessed by the Eating Disorders Examination and clinical report
* Be at least 75% of adjusted ideal body weight

Healthy Control Group:

* Between the ages of 13 and 17 years old

Exclusion Criteria:

All Groups:

* Psychotic illness/other mental illness requiring hospitalization
* Current dependence on drugs or alcohol defined by DSM IV criteria. Additionally, positive test results for drug use on the day of the scan, apart of marijuana, will result in cancelling or rescheduling the scan because acute use will impact MRI measures.
* Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
* Neurological disorder, neurodevelopmental disorder, or history of head injury with \>30 min loss of consciousness
* Any contraindication to undergoing an MRI
* Primary obsessive compulsive disorder or primary major depressive disorder

Additional Exclusion Criteria for AN Group:

* If taking other psychotropic medication, any change in dosage in the 2 weeks before scanning

Additional Exclusion Criteria for Healthy Control Group:

* Meet or met criteria for the diagnosis of any psychiatric disorder in their lifetime
* Any history of binge eating or purging behaviors, including self-induced vomiting, laxative or diuretic misuse
* Use of any psychoactive or other medication known to affect mood or concentration in the last 3 months
* Have maintained 90% to 120% ideal body weight since menarche
Effectiveness of the Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea

Hypothesis: What is the best modulation of pulse frequency in transcutaneous electrical nerve stimulation in dysmenorrhea? Purpose: To determine the effect of hypoalgesia frequency modulation pulse by transcutaneous electrical nerve (TENS) in dysmenorrhea. Methods: A controlled clinical study and prospective developed at the School of Physiotherapy Clinic / UFPI. Forty students were randomized into four distinct groups of the modulation frequency TENS: group 1 - 100 Hz, 100μs, group 2 - 4 Hz, 100μs, group 3 - placebo (apparatus off), group 4 - placebo induced (2 Hz, 40μs). All were initially evaluated by a questionnaire developed for the study, the visual analogue scale (VAS) (before, after 20, 30, 40, 50, 60 minutes) and the McGill Pain Questionnaire (before and after 20 minutes). The total duration of TENS application was 20 minutes and all protocols were performed in a single session. The analysis of variance (One-way ANOVA) followed by the Tukey procedure was applied to identify differences between experimental groups for each variable analyzed. The level of significance was p\< 0,05.


Eligibility Criteria:
Inclusion Criteria:

* be the first or second day of menstruation
* dysmenorrhea present at the time of application of TENS
* not having undergone any procedure analgesic six hours before the application of TENS

Exclusion Criteria:

* not to mention dysmenorrhea at the time of evaluation
* pregnant women
* were using some method of hormonal contraception on an ongoing basis
* had sensory deficits or cognitive and cases of contraindication to TENS application.
Treating Chronic Pouchitis With a Low FODMAP Diet

We aim to determine whether low FODMAP diet in patients with chronic pouchitis will improve symptoms and pouch inflammation.

Following recruitment for entry into the study, subjects be asked to complete symptom surveys and provide a fecal sample for calprotectin measurement. Shortly after their screening visit, patients will be randomized 1:1 to either the low FODMAP diet (experimental) or regular diet (control) group. Patients in the experimental group will schedule a telephone visit with a registered dietician. During this approximately hour-long session, patients in the low FODMAP cohort will be counseled regarding FODMAP containing foods. They will be asked to adhere to this diet over the next 6 weeks. At the end of the 6 week period, subjects will complete a 3-day food diary. Those in the regular diet group will be contacted by the dietician and given an educational handout at the beginning of the study period regarding best dietary practices. At the end of the 6 week study period, both groups will again be asked to complete another set of symptom surveys and provide a fecal sample for calprotectin measurement.

Eligibility Criteria:
Inclusion Criteria

* Patients aged 18-65 with a diagnosis of ulcerative colitis that have undergone ileal pouch-anal anastomosis following proctocolectomy for medication-refractory disease
* Either ≥4 episodes of pouchitis per year (antibiotic-dependent) OR persistent symptoms despite 4 weeks of antibiotic therapy (antibiotic-resistant)

Exclusion Criteria

* Diagnosis of indeterminate colitis or Crohn's disease
* Celiac disease
* Current use of low FODMAP diet
* Known dietary allergies
* Current use of antibiotics for reasons other than treatment of pouchitis
* Clostridium difficile infection
* Complication following ileal pouch-anal anastomosis requiring reoperation
A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Sodium ST20 in Healthy Volunteers

A safety and pharmacokinetic study of a single dose of ST20 in healthy volunteers

A Phase 1 study in healthy volunteers to assess the safety and pharmacokinetics of ST20 after oral administration of a single-dose. In addition, a comparison of the pharmacokinetics and exposure of a single dose of ST20 under fasting and non-fasting conditions will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Be a healthy male or female
* Be between the ages of 18 and 45 years old, inclusive
* Be able and willing to give informed consent
* Be able to comply with all study procedures
* If female, not be pregnant, including negative serum pregnancy test
* If female, must not be of childbearing potential or must agree to use one or more of the following forms of contraception during screening and throughout the study: hormonal (i.e., oral, transdermal, implant or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence. Male subjects must also agree to use one or more of the above forms of birth control for either themselves or their partner, as appropriate throughout the course of the study
* Must not be receiving prescription medication within the 2 weeks before administration of the test dose, except for multivitamins or contraception
* Have white blood cell count, hemoglobin, hematocrit and platelet count within normal range for the testing facility
* Must have serum chemistry values and urinalysis values within the limits of normal for the testing facility
* Must have coagulation parameters within the limits of normal for the testing facility
* Must have a negative urine test for substances of abuse including marijuana, cocaine, cocaine derivatives, opiates and methadone

Exclusion Criteria:

* Have clinically significant vital signs
* Have any clinically significant laboratory value (CBC, serum chemistry, or urinalysis)
* Have made a blood donation of 500mL within the 2 months before administration of study medication
* Have received a blood transfusion within the 3 months before administration of study medication
* Have an acute febrile illness or upper respiratory tract illness within 72 hours prior to administration of study medication
* Have received another investigational agent within the 4 weeks before administration of test drug
* Have received any other investigational agent during this study
* Have any acute or chronic disease (e.g., history of hepatitis or HIV-1)
* Have cardiac disease including congestive heart failure or arrhythmia
* Have a history of central nervous system disease, such as seizures
* Be breast feeding a child
* Have been a smoker in the past 12 months
* Have Body Mass Index (BMI) \> 33 kg/m2