cyrilzakka/clinical-trials huggingface dataset:
STEPS Implementation Trial

This study will inform understanding of how to support emerging adults with autism spectrum disorder (ASD). The investigators will use a theoretically informed and research-based transition support program developed for people with ASD and test how effective it is when delivered by community agencies. Results will provide information on the effectiveness of the program as well as on mechanisms of change and contextual factors that promote or impede implementation.

The long-term goal of this research is to improve adult outcomes for people with autism spectrum disorder (ASD). Autistic adolescents and young adults tend to have worse outcomes with respect to employment, education, and quality of life, than neurotypical peers. These outcomes include under-enrollment into college, unemployment, and limited functional independence. Research-informed transition planning that addresses core impairments in skills related to adult autonomy, including self-knowledge, self-determination, and self-regulation, may improve outcomes for this growing population. In prior research, investigators developed a stakeholder involved transition program (STEPS) and found it to be feasible, acceptable, and efficacious. Data from a small randomized controlled trial (RCT) focusing on feasibility indicated that it was acceptable to participants and suggested STEPS was effective in improving readiness for transition to adulthood. The team will now test the effectiveness of STEPS, and engagement of target mechanisms, in partnership with four community agencies. This study is designed as a Hybrid Type 1, which focuses primarily on intervention effectiveness with a secondary focus on factors related to implementation. Immediate (post-treatment) and longer-term (six month follow-up) clinical outcomes of adult functional outcomes and vocational engagement will be assessed. The degree to which STEPS leads to change in the theoretical mediating mechanisms (i.e., adult autonomy skills) will be examined, as well as a formal test of mediation (i.e., the degree to which change in adult autonomy skills leads to change in adult functional outcomes). Providers will provide qualitative information on implementation such as thoughts on STEPS' cultural sensitivity, and quantitative data on the appropriateness, feasibility, and acceptability of STEPS. Providers' sustained use of STEPS with clients in the six months after study enrollment has ended will also be tracked. This research will produce findings that have the potential to shift clinical practice related to transition to adulthood for people with ASD. In light of the fact that approximately 70,000 people with ASD age into adulthood every year and the economic burden associated with ASD, the potential public health impact of this research is considerable.

Eligibility Criteria:
Inclusion Criteria:

* 16-25 years of age
* have confirmed diagnosis of ASD
* want to participate in STEPS
* have a caregiver/parent who can complete assessments

Exclusion Criteria:

* presence of suicidal/homicidal intent
The Effects of Two Different Home-exercise Programmes on Women Suffering Long Term Neck/Shoulder Muscle Pain

The purpose of this study is to investigate the effects of specific neck/shoulder muscle exercises on pain, function, biochemistry and psychological factors in women suffering chronic neck/shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* female
* 20-60
* long term neck/shoulder muscle pain
* willing to exercise

Exclusion Criteria:

* widespread pain
* pregnancy
* major trauma in medical history
* tendonitis in upper extremities
* neurological causes of the pain
* inflammatory and hormonal disorders
Association Between Dietary Habits and Gestational Diabetes

Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance of varying severity with onset or first recognition during pregnancy. The diagnosis of gestational diabetes is important, because of the increased risk of adverse maternal and feto-neonatal outcomes. In addition, GDM also confers a future risk of type 2 diabetes to mothers and their fetus. Dietary components associated with GDM risk include macronutrients, micronutrients, and individual foods, such as refined carbohydrates, saturated fats, soft drinks and processed meats. The Pre-pregnancy dietary patterns may affect women risk of developing GDM. A diet high in red and processed meat was associated with a significantly elevated risk.

\*Aim of the work: To investigate associations between maternal dietary patterns and GDM.

* Patients and Methods:

  * Study design: A cross sectional study was conducted.
  * Study site: GDM Outpatient Clinic of Assiut University Hospital.
  * Study population: The study will include all pregnant women at 24th to 28th gestational age, who attending to GDM Outpatient Clinic during the period of The Study.
  * Inclusion criteria include pregnant women at 24th to 28th age of gestation.
  * Exclusion criteria include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation.
  * Instrument: Structured designed questionnaire: Which consists of socio-demographic characteristics, Medical and obstetric history and other risk factors for GDM including previous GDM, family history of diabetes, twins in current pregnancy, history of PCO and macrosomic baby in current or previous pregnancy, also contains information about regularity and frequencies of daily meals taken by the women, and information about food group frequencies per week, food groups like vegetables, fruits, fast food , red and processed meat, fish and seafood, whole grains, cereal fiber, sweetened beverage, dessert food and use of multivitamins.
  * Data collection: Direct interview will be done with each participant separately for filling the food frequency questionnaire by the researcher himself during the period from January 2017 to June 2017
* Clinical examination:

  * BP (mmHg)
  * Pulse
  * Body Weight (kg)
  * Height (cm)
  * BMI

Laboratory Examination

* OGTT (75gm) 2hr
* HBA1c (if Bl. Glucose ≥ 200mg/dl).

Eligibility Criteria:
Inclusion Criteria:

* include pregnant women at 24th to 28th age of gestation.

Exclusion Criteria:

* include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation.
The Effect of Deep Friction Massage on the Achilles Tendon Blood Flow

Background: There is a hypothesis in literature that the mechanical action of deep transverse friction massage (DTF) produces vasodilatation and increases blood flow. But as yet, no experimental study has confirmed the effect of DTF on blood flow in the Achilles tendon. Objective: The purpose of the present study was to investigate whether one session of DTF can influence the Achilles tendon blood flow.

Design: a randomized pre- posttest trial was set up. Patients: Sixty-two healthy participants volunteered. Each person underwent the following four steps of the procedure: 1. Measuring the tendon blood flow (PRE), 2.fifteen minutes of DTF on the Achilles tendon, 3. Measuring of the tendon blood flow (POST), 4.follow - up measurement after 20 minutes of rest (POST20).

Intervention: one leg of each person was randomly assigned to deep transverse friction session, the other leg was used as a control leg. Friction was applied continuously for a total of 15 minutes. Measurements: the microcirculation was determined at 2 and 8 tissue depths at the distal and the proximal midportion of the Achilles tendon. For each level, the capillary blood flow, the tissue oxygen saturation, and the postcapillary venous filling pressure was registered.


Eligibility Criteria:
Exclusion Criteria:

* a history of lower leg injury
* systematic disease
* persons using drugs
* subjects with circulatory disorders or cardiovascular diseases
Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.

The goal of this clinical trial is to learn about breast cancer lipodome signature in patients waiting for surgery with different Body Mass Index.

The main question it aims to answer are:

* To highlight a specific lipidome molecular signature for breast cancer patients overweight and obese (BMI \> 25 Kg/m2) compared with patients of normal weight (BMI\<25 kg/m2).
* Evaluate the effect of the pool of biochemical, nutritional and anatomical-pathological data of breast cancer patients and the correlation between molecular profile and body weight.


Eligibility Criteria:
Patients

* Age \<65 years (not to have influence on functioning of desaturase enzymes that decline with older ages).
* Neoplastic pathology: primary invasive breast cancer or ductal in situ (DCIS) newly diagnosed, in the pre-operative phase and which has not already undergone chemo- or radiotherapy.
* Absence of serious intestinal and hepatic pathologies, diabetes, both insulin-dependent and in hypoglycaemic treatment or other pancreatic affection, thyroid affections in pharmacological treatment.
* Absence of supplementation with omega-3 based supplements for at least 6 months.
* Homogeneous distribution by BMI (1:1 ratio subjects with BMI≥25 and BMI\<25, respectively).
* Informed consent to participate in the study.

controls

* Age \<65 years;
* Not be affected by cancer;
* BMI \<25kg/m2;
* Informed consent to participate in the study

Exclusion Criteria:

patients

* Age ≥65 years (would affect the functioning of desaturase enzymes that decline with older age).
* Invasive primary breast cancer or ductal in situ (DCIS) previously treated with chemo- or radiotherapy.
* Metastasis at diagnosis.
* Presence of serious intestinal and hepatic pathologies.
* Presence of diabetes, both insulin-dependent and in hypoglycaemic treatment or other pancreatic disease, thyroid disease in pharmacological treatment.
* Supplementation with omega-3 based supplements for at least 6 months.
* Failure to sign the informed consent to participate in the study.

controls

* Age ≥65 years;
* Suffering from tumor pathology;
* BMI ≥25kg/m2;
* Refusal to sign informed consent to participate in the study.
The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action .

The investigators hypothesise that bilateral stimulation of the NAcc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their Levomethadone usage.


Eligibility Criteria:
Inclusion Criteria:

* Proficiency in Mandarin language
* Long lasting heroin addiction (determined by diagnostic-criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
* Duration longer than 6 months
* A lack of response to long-term treatment
* Capacity to provide informed consent (understanding of the study purpose and methods)
* Substitution methadone treatment at a constant dose within three months prior to inclusion.

Exclusion Criteria:

* Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases with psychotic symptoms)(MINI 6.0)
* Past stereotactic neurosurgical intervention
* Neurological disease (Abnormal PET-CT, MRI, EEG)
* Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
* Contraindications of stereotactic intervention, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
* Serious and unstable organic diseases (e.g. unstable coronal heart disease)
* HIV positive
* Pregnancy and/or lactation
Treatment Effect According to Timing of Administration of DWP14012 40 mg

The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.

Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 19 and 75 years old based on the date of written agreement
* Those who have been diagnosed with erosive esophagitis of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days

Exclusion Criteria:

* Those who have undergone gastric acid suppression or gastric, esophageal surgery
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
Echo-guided Percutaneous Electrical Nerve Stimulation of the Femoral Nerve

Introduction. Variables such as pain and strength can be modified in the short and medium term by the application of currents. The percutaneous form of percutaneous needle-guided acupuncture can eliminate the impedance of the surrounding tissues that limit the optimal diffusion of the current to the target tissue. It is necessary to objectify the metabolic response of this technique and its effects in terms of strength and metabolic response.

Objective. To evaluate the safety and efficacy, in acute and subacute phases, of percutaneous electrical nerve stimulation in healthy subjects.

Method. Single-blind randomised clinical study. Thirty-two subjects will be recruited and randomised to the experimental and control groups. The intervention in the experimental group will consist of a percutaneous percutaneous electrical nerve stimulation of the femoral nerve, while in the control group the same intervention will be performed without increasing the intensity of the current. The primary variable will be vertical jump height (My Jump® iOS app) and the secondary variable will be skin temperature (Hikmicro M60 model Hangzhou).


Eligibility Criteria:
Inclusion Criteria:

* Persons aged 18 and 24.
* Of both sexes.
* Who practice sport at least twice a week.
* Who sign the informed consent document.

Exclusion Criteria:

* Medical diagnosis of chronic systemic diseases or diseases that may interfere with thermographic imaging (rheumatoid arthritis, fibromyalgia, deep vein thrombosis, etc.).
* Having undergone lower limb surgery in the 24 months prior to the study.
* Intake of drugs that may influence the thermographic response (antipyretics, non-steroidal anti-inflammatory drugs, topical solutions on the area to be studied, etc.).
* People with nickel allergy or belonephobia (needle phobia).
Validation of the Fluid Responsiveness Index in Critically Ill Patients

Fluid therapy is an important part of the management of patients with hemodynamic instability in the intensive care unit. By increasing cardiac preload, it aims at elevating cardiac output (CO) and thus restoring hemodynamic conditions in patients who are preload responsive. By contrast, volume administration can be deleterious in terms of pulmonary edema formation or other manifestations or fluid overload, especially in patients who are not preload responsive. Functional dynamic parameters that use heart-lung interactions, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are considered accurate predictors of preload responsiveness in patients receiving fully controlled mechanical ventilation.

However, in cases of spontaneous breathing activity where heart-lung interaction indices fail to predict fluid responsiveness, one needs parameters able to reliably predict the hemodynamic response of fluid administration.

A new index that could indicate fluid responsiveness, so-called the fluid responsiveness index (FRI), has been elaborated. The advantage is that it could be used in patients who are not in control mechanical ventilation as well as in patients who are fully adapted to mechanical ventilation.

The FRI is based upon the analysis of continuous arterial and continuous central venous pressure. The FRI is determined by the relation of cardiac and respiratory activity; both are evaluated by means of power spectrum analysis of the pressures recorded.

The aim of this study is to test the value of the FRI to predict the hemodynamic response to fluid infusion in patients with hemodynamic instability not receiving fully controlled mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Hospitalization in an intensive care unit
* Presence of an acute circulatory failure as defined by the presence of at least one clinical sign of inadequate global perfusion
* Decision by the attending physician to give fluids will not be taken upon criteria predefined by the study protocol but considers:

  * systolic arterial pressure \< 90 mmHg (or fall of systolic arterial pressure of more than 50 mmHg in known hypertensive patients)
  * urinary flow \< 0.5 ml/kg/hr than two hours
  * tachycardia ≥ 100 beats/min
  * delayed capillary refill
  * mottled skin
  * high lactate
  * CO (Cardiac Output) that is not considered adequate and
  * low GEDV (Global EndDiastolic Volume)
* Monitoring by a PiCCO2™ device (Pulsion Medical Systems, Munich, Germany) already in place as part of the routine hemodynamic monitoring

Exclusion Criteria:

* Clinical evidence of pulmonary edema, hypervolemia or ELWI \> 10 ml/kg
Peppermint Oil Pharmacokinetics/Dynamics

In children 7-12 years of age with functional abdominal pain (n=42) determine:

Aim 1 - To examine and characterize the threshold of the exposure (PK) vs. response (PD) relationship of PMO (menthol)

Aim 2 - PD of PMO as assessed by:

1. Microbiome composition (16S RNA sequencing)
2. Transit rate/contractile activity (using the SmartPill®) Aim 3 - Evaluate the potential association between PD response and clinical symptoms (abdominal pain and stooling pattern via validated diary), psychosocial distress (anxiety, depression, somatization), and characterize potential side effects (questionnaire)

An initial single-dose PK study will be carried out. Forty-two children (n=21 per dose) will be randomized to receive approximately 10.9 mg·kg-1·d-1 of PMO or to receive approximately 18.2 mg·kg-1·d-1 (1.67-fold the median dose).

Following the single-dose PK study, a PD study will be carried out wherein the subjects will receive their assigned dose of PMO for 7 days.

At baseline (before the PK study) and after the PK study (i.e., during the PD study), subjects will keep a pain and stooling diary, collect stool for microbiome analysis, and swallow a SmartPill to measure gut motility and transit time. At baseline only, anxiety, depression, somatization will be measured. During the PD study, any side effects will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 7-12 years who are able to assent to the procedures
* Able to complete the diaries which have been validated for use in this age range
* The history and medical evaluation reveal no organic reason for the abdominal pain
* The child has abdominal pain that meets the definition of FAP according to pediatric Rome IV
* Ability to understand study procedures and to comply with them for the entire length of the study
* Childrens' body weights will not vary by more than 10-15 kg (so that dose per kg is comparable within the two dosing groups)

Exclusion Criteria:

* Past bowel surgery
* Documented GI disorders (e.g., Crohn's disease)
* A serious chronic medical condition (e.g., diabetes)
* A weight and/or height \< 2 SD for age
* Chronic conditions with GI symptoms (e.g., cystic fibrosis)
* Autism spectrum disorder, significant developmental delay, psychosis, depression, or a history of bipolar disorder
* Antibiotic/probiotic treatment within 2 mo.
* Allergy/sensitivity to PMO or its ingredients
* Inability to swallow the PMO capsule or the SmartPill®
* Inability to speak English - testing materials are available only in this language
* Unable to discontinue laxative, prokinetic, or neuromodulator from 3 wk prior to Visit 1 through the end of the study
Correlation Between BMI and Craniovertebral Angle and Their Impact on Hand Grip Strength and Neck Functional Disability in Egyptian University Student

Objective: To find the relation between cranio-vertebral angle and hand grip strength in university student mobile users.

Design: cross sectional study. Setting: Ahram Candian University Subjects:100 male and female university students with age ranged from 20 to 30 years old will participate in this study.

Intervention: cross sectional study to detect the relation between cranio-vertebral angle and hand grip strength in university student mobile users.

Main measures:

* FHP app (Pyeongtaek, South Korea) mobile application
* Hand dynamometer (the JAMAR® Hydraulic Hand) (Lupton-Smith et al.,2022)
* Mechanical height and weight scale
* Visual Analogue Scale
* Arabic Neck Disability Index Results: The results will be obtained via one-way analyses of variance (ANOVA).


Eligibility Criteria:
Inclusion Criteria:

* • Their ages will range from 20-30 years old.

  * Their BMI will be between than 20- 30kg/m2.
  * All of them suffer from mild degree of neck pain.
  * The subjects complain from neck pain for 1 month ago
* Exclusion criteria:

Exclusion criteria were a history of any of the following condition:

* inflammatory diseases or any rheumatic disorders,
* a history of vertebral fractures
* surgical spinal fixation.
* •any neurological disorders like MS
In Vitro Maturation of Human Eggs

Because a large proportion of the embryo's quality is dependent upon the egg, this investigation focuses on treatment of the oocyte during in vitro maturation (IVM). In typical IVF cycles, the egg is recovered when it is mature and ready to be fertilized. However, at this point the oocyte's quality has been set, and cannot be altered. Therefore, to have an impact on oocyte quality the use of in IVM is critical. Development of a successful IVM protocol for clinical use would not only provide an option for women of advanced maternal age, it would also reduce the cost of IVF due to fewer exogenous gonadotropins used for stimulation, and significantly lessen the risk of ovarian hyper-stimulation.

The objective of this research study is to evaluate a newly developed oocyte maturation media system for human clinical use in assisted reproductive technology (ART).

The novel device (IVM media system), is designed to support nuclear maturation of immature oocytes recovered after minimal ovarian stimulation with no LH/hCG administration, and improve oocyte competence. This may result in development of a greater number of embryos to the blastocyst stage.

FSH is administered starting on cycle day 3 to stimulate follicle growth. When the leading follicle reaches 12-14 mm, egg retrieval will be scheduled. No hCG/LH trigger will be administered. Specially designed maturation media is used to collect and culture the immature eggs once recovered from the follicle. Once the eggs have matured in vitro, fertilization and embryo culture, vitrification and comprehensive chromosomal screening will be completed as per standard operating procedures.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women who desire to conceive and come to CCRM for infertility treatment using IVF will be candidates for this study.
* Women with PCOS
* Patients can be of any race, culture, sexual orientation or ethnicity.

Exclusion Criteria:

* Minors are excluded from participation in this study.
* Women with a BMI greater than 40
* Women whose health is such that becoming pregnant carries risk significantly greater than healthy women are excluded from this study, unless they use a gestational carrier under the direction of their physician.