cyrilzakka/clinical-trials huggingface dataset:
Self- Administered Acupressure for Diarrhea Predominant Irritable Bowel Syndrome

This study aims to assess the effect of active self- administered acupressure compared to sham self- administered acupressure on the health outcome for patient with diarrhea predominant Irritable Bowel Syndrome

Research suggests promising benefits of acupuncture in terms of symptom control and quality of life improvements in patients with irritable bowel syndrome. but the cost of the needle and the invasive nature of the procedure decreases patient compliance with acupuncture. in this respect, acupressure can be taught to patients to allow them to perform it themselves, instead of being administered by practitioners. Self-administered acupressure is less time-intensive, low-cost, and flexible to perform. Nurses involved in irritable bowel syndrome patient care play an active role in the practitioner-patient relationship By assessing the specific symptoms that are present, determining the severity of symptoms and the impact on the irritable bowel syndrome patient's life, and being knowledgeable of available treatment options, the nurse involved in irritable bowel syndrome care becomes an essential conduit of information and a valuable facilitator of a positive practitioner-patient therapeutic relationship. In this way, nurses can help to limit the negative consequences of this common disorder and improve overall treatment outcomes in this population. . Thus this study will be conducted to assess the effectiveness of active self-administered acupressure on diarrhea-predominant irritable bowel syndrome

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diarrhea irritable bowel syndrome symptoms following Rome IV diagnostic criteria
* Agreed to be on a fixed dose of the pharmacological therapy throughout the study

Exclusion Criteria:

* Patients with severe lesions in major organs such as the heart, liver, and kidney, hematopoietic diseases, or tumors
* Eating disorders
* History of major abdominal surgery
* History of neurological and mental illness
* Usage of other treatment rather than the medical treatment regularly 2 weeks before randomization and throughout the study
* Previous history of drug or alcohol abuse 6 months before randomization
* Pregnant and lactating women.
* Patient reporting of adequate relief of their irritable bowel syndrome symptoms the week preceding the randomization
* Patient has too mild symptoms ( obtaining less than 75 on Irritable bowel syndrome symptoms severity scale at the baseline assessment)
* Currently participating in other clinical trials
A Study Investigating the Pharmacokinetic Profiles of Four Extended Release Paracetamol Formulations

A study investigating the pharmacokinetic profiles of four extended release paracetamol formulations


Eligibility Criteria:
Inclusion Criteria:

* Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Age:Aged 18 to 50 years inclusive.
* Body Mass Index (BMI):Body Mass Index must be in the range 19 - 28 kg/m2.
* Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
* General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
* Contraception:Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.

Exclusion Criteria:

* Pregnancy:Women who are pregnant or who have a positive serum pregnancy test.
* Breast-feeding:Women who are breast-feeding.
* Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* Clinical Study/Experimental Medication:a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. b) Previous participation in this study.
* Substance abuse:Recent history (within the last 5 years) of alcohol or other substance abuse.
* Personnel:An employee of the sponsor or the study site or members of their immediate family.
* Disease: a) Current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure). b) Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
* Vegetarians:Subjects who are vegetarian.
* Hepatitis and HIV Screening:Positive screening for Serum Hepatitis B Surface Antigen, Hepatitis C or Human Immunodeficiency Virus (HIV).
* Medications:Current (within 14 days of screening) or regular use of any prescription, OTC, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing, (e.g. barbiturates, theophylline, cimetidine, or erythromycin).
* Smoking:Non-smokers of less than 3 months or current use of nicotine-containing products.
* Blood:Subject has donated or experienced significant blood loss within 56 days of Visit 2, donated plasma within 7 days of Visit 2, or has a hemoglobin value of = 12.0 g/dL.
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography

The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography

Exclusion Criteria:

* Patients with an ankle brachial pressure index (ABPI) of 0.3 or less
* Patients with allergy to contrast media
* Patients with serious hepatic impairment
* Patients with serious renal impairment
Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions

The aim of this randomized, controlled prospective clinical trial is to evaluate and compare the performances of three different universal adhesives using a flowable universal composite resin in the restoration of non-caries cervical lesions over 48-month period.Participants over 18 will be included to the study. Oral hygiene instructions will be given before procedures. All the lesions will be restored by the same clinician who will not participate to the selection of patients for eligibility. Each patient will receive at least three restorations and randomization will be applied using a table of random numbers. All lesions will be cleaned before restoring. Adhesive procedures and restorations will be placed according to manufacturers' recommandation.

The flowable universal composite resin will be placed in bulk and light-cured for 40 seconds. The restorations will be contoured and polished with Optidisc discs (Kerr Coorporation, Orange, CA, USA).

Patients will be recalled at baseline and will be recalled at control periods after placement.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old with 20 teeth under occlusion. They will be required to have at least three NCCLs needed restoration in different teeth. All the NCCLs selected were in similar sizes varying between 1-3 mm.

Exclusion Criteria:

* Patients with severe periodontal disease, rampant, uncontrolled caries, xerostomia, serious medical problems preventing them from attending review visits, poor gingival health, heavy bruxism and removable partial dentures will not be included in the present study. Also, participiants will be excluded, if they are undergoing bleaching treatment or orthodontic treatment.
Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer

Phase II, Multicenter, Open-label, Randomized Study evaluating neoadjuvant chemotherapy (FOLFOX4) in patients with stage II and III colorectal cancer with standard chemoradiation Defined by Magnetic Resonance Imaging

This is a biomedical research, phase II, multicenter, open-label, randomized study, comparing neoadjuvant CT with FOLFOX4, versus immediate preoperative chemoradiotherapy (CRT), in patients with locally advanced rectal cancer. Randomization in a 1: 1 ratio, neoadjuvant chemotherapy or chemoradiation. The purpose of the study is to evaluate the efficacy, tolerability, and comparability of new standard preoperative chemotherapy with FOLFOX4 in patients with stage II and III colorectal cancer compared to routine chemoradiation.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with rectal adenocarcinoma;
* radiologically measurable tumor size;
* general condition (ECOG 0-2 points);
* stage II or III rectal tumor clinically (pelvic MRI and endorectal ultrasound),
* in the absence of long-term spread of the disease (confirmed by radiological examinations (computed tomography of the thorax and abdomen));
* during preoperative proctoscopy, the tumor is detected 0 -15 cm from the anus;
* Blood tests 28 days before the start of treatment:

and general blood count: neutrophils greater than 1.5x10 9 / l, platelets greater than 100 x 10 9 / l, Hemoglobin greater than 80 g / l, liver enzymes (Aspartate aminotransferase (AST/GOT), alanine aminotransferase (ALT/GPT) not more than 3 times upper limit), and renal function (creatinine up to 1.5 times the upper limit of normal) is normal; women of childbearing potential - negative pregnancy test;

• A signed informed consent form.

Exclusion Criteria:

* patients with signs of intestinal obstruction at the start of treatment;
* previous lower abdominal radiation therapy;
* other tumors over a five-year period;
* pregnant or breastfeeding women;
* men and women of childbearing potential who do not agree to use adequate contraception;
* Patient co-morbidities that would make the patient unsuitable for this study or significantly interfere with the assessment of safety and toxicity.
PedBot Ankle Rehablitation

The primary objective of the study is to determine engagement with use and adherence to a home exercise program with our PedBotHome ankle rehabilitation device. We will place the device in the home for 90 days and consider the study a success if used for at least 30 minutes a day for at least 3 days a week during this period.

The major secondary objective is to determine if the range of motion of the ankle has improved through use of PedBotHome. Other secondary objectives will measure ankle strength and control.

Secondary outcomes will include a measurable increase in range of motion across the ankle joint (in any direction) and a measurable increase in strength in plantarflexion, dorsiflexion, inversion, and eversion. Improvement in gait and speed of ambulation will also be considered secondary outcome measures as an indication of better ankle control.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy

Exclusion Criteria:

* Healthy volunteers
Improving Detection of Fetuses at Risk - Who Needs Systematic Training?

Detection of growth restricted fetuses relies primarily on abdominal ultrasound examinations during pregnancy. Many clinicians, however, have not received systematic training and may therefore perform inadequately. We wish to examine, whether systematic, simulation-based training can improve diagnostic accuracy of estimated fetal weight by ultrasound at different levels of clinical experience.

Participants are physicians working at obstetric departments. Participant characteristics (age, experience in years and number of monthly scans) are recorded. Participants perform two abdominal growth scans prior to randomization and estimated fetal weight is compared to birth weight. Mean absolute percentage error is calculated as a measure of diagnostic accuracy.

Participants are then randomized to either control (no intervention) or intervention. The latter group receives training on the Metaphor Scantrainer trans abdominal ultrasound simulator until they pass a previously validated test. After completing the training the participants use a mannikin to practice systematic approach and 'knobology'.

All participants then perform another two growth scans. Diagnostic accuracy before and after the intervention or control period is compared.

We wish to examine the effect of systematic training on the diagnostic accuracy of estimated fetal weight by ultrasound across different levels of clinical experience.

If an effect can be found in the inexperienced participants, simulation-based training in obstetric ultrasound could be implemented as a part of basic obstetric training and/or as a means of maintaining skills.

Eligibility Criteria:
Inclusion Criteria:

* proficiency in the Danish language
* no prior experience with obstetric ultrasound simulation
* doctors who work within the field of gynecology and obstetrics

Exclusion Criteria:

* lack of proficiency in the Danish language
* prior experience with obstetric ultrasound simulation
Longitudinal, Multi-Dimensional Assessment of Recovery and Added Benefit of a Behavioral Health Intervention for Children With Abusive Head Trauma

Family dynamics and caregiver responses to a child with traumatic brain injury are implicated both as precipitating events as well as factors influencing outcomes of abusive head trauma (AHT). However, no family behavioral health intervention exists to meet the unique needs of families with infants and very young children with AHT. The study was initially designed as a randomized controlled trial (RCT) to assess the efficacy of an evidence-based behavioral intervention to improve outcomes for families and children with AHT. However, rates of recruitment were so low that the investigators and funder amended the study to be intervention only (with IRB approval). At that time, there were five participants and only one had been assigned to the intervention arm. Only one additional family was recruited, and that family did not complete study measures prior to the time at which the intervention would start and did not receive the intervention. The investigators did examine outcomes in multiple dimensions, including clinical, cognitive, family, caregiver, child behavior, and service usage over time but connot compare to patients not receiving the intervention. The investigators were not able to examine characteristics of patients and families best suited for this behavioral health intervention.

27 children (ages 3 months to 2 years) and their caregiver referred to the Non-Accidental Brain Injury Care Clinic at the Children's Hospital Colorado (CHCO) were recruited for participation in the study, 7 families consented. One family received the Attachment and Biobehavioral (ABC) intervention. One family discontinued participation. The data collection schedule was 1 month post-injury, 3 months, 6 months, 9 months, and 12 months. Outcomes in multiple dimensions, were assessed including clinical recovery, cognitive, language, and motor functioning, family functioning, caregiver mental health including anxiety, depression, competency, and stress. The investigators also examined service use over time. Analyses will assess trajectories of recovery for both groups using data for all time points.

Eligibility Criteria:
Inclusion Criteria:

* Children who have experienced AHT as determined by the CHCO Child Protection Team
* Caregivers who speak English
* Families who live in the Denver Metro area and,
* Child-victim age between 3 months and 2 years of age

Exclusion Criteria:

* Those with significant disability that would inhibit participation in the intervention,
* Those scoring below 6 months on developmental measures will not be eligible.
interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA

The purpose of this study is to determine if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation. Patients undergoing total knee arthroplasty will be followed for 10 weeks during their outpatient physical therapy course. Subjects will undergo standard physical therapy or physical therapy paired with InterACTION for 10 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Between ages 40 to 80 years of age;
2. Have undergone primary unilateral total knee arthroplasty;
3. Being referred for post-operative outpatient physical therapy;
4. Agree to and able to perform pre-defined exercises that they would normally perform in a physical rehabilitation program.

Exclusion Criteria:

1. Patients with BMI \>40 at the time of surgery;
2. Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of rehabilitation exercises;
3. Individuals who cannot physically receive or understand audio and visual feedback from the joint motion tracking system during or after performance of rehabilitation exercises;
4. Individuals who are discharged post-operatively to a skilled nursing facility instead of to their residence;
Duration of Sciatic Nerve Block After Injection of Local Anesthetic In or Around the Nerve

This study was designed to assess whether the injection of local anesthetic into the nerve (intraneural), as opposed to around it (perineural), leads to longer anesthesia and analgesia of the leg.

Some reports of accidental intraneural injection mention an extremely long duration. When different drugs and doses were evaluated in a clinical trial of intraneural injection, a longer-than-expected duration was reported.

The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference in duration.

This randomized, controlled trial will investigate prospectively for differences in sensory and motor block duration after intra- or perineural injection of 1.5% (wt/vol) mepivacaine, a short-acting local anesthetic.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing non-emergent orthopedic procedure of knee, leg, foot with thigh tourniquet
* ASA Physical Status Class I-III
* Consenting to surgery under peripheral nerve block anesthesia (sciatic + femoral/saphenous block)

Exclusion Criteria:

* Unable to understand or communicate for the purpose of the study
* Exhibiting signs of neuropathy in the ipsilateral extremity
* Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist
Examination of the Link Between Sun Exposure Routine and Bacteria Population of the Skin

These days many studies are conducted testing the symbiosis between the bacteria population to the human body's functioning. The research of the connection between the skin condition and the bacteria population is in its early stages. There is a characterization of different bacteria for different body areas depending on their composition, humidity etc. In addition, there are preliminary findings of biological receptors that react to the contact with bacteria on the surface of the skin and turn on the immune system, awakening it to cope with the new invader. Based on the above information, the investigators hypothesis is that there is a connection between the degrees of sun exposure of individuals to the growing of beneficial bacteria populations on the surface of the skin. The study will compare between the bacteria population on the skin of Israeli subjects, divided to two groups, one with an excessive exposure to the sun on a daily basis, (such as agricultural workers, lifeguards, construction, etc.), and the other of the office worker who spend most of the day in a closed shaded room.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between the age of 20-60.

Exclusion Criteria:

* Pregnant or lactating women.
* Volunteers with a known allergy to one of the tested materials or to their ingredients.
* Treatment with medication such as anti-inflammatories, antihistamines,corticosteroids, systemically or topically applied, unless stopped for 2 weeks prior to the trial in the case of systemic treatment and 3 days in the case of topical treatment.
Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

The purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Moderate-severe or severe TR while in atrial fibrillation.
* Ambulatory (not wheelchair/scooter dependent).

Exclusion Criteria:

* Systolic pulmonary artery pressure\>70 mmHg with a fixed pulmonary vascular resistance \>7 Wood units by catheterization.
* Ejection fraction \<40%.
* Obstructive hypertrophic cardiomyopathy.
* Constrictive pericarditis or tamponade.
* Active myocarditis.
* Complex congenital heart disease.
* Other valve disease requiring surgical intervention.
* Terminal illness (other than HF) with expected survival of less than 1 year.
* Pregnancy or breastfeeding mothers.
Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism

To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with acute intermediate-high pulmonary embolism

Exclusion Criteria:

* Patients less than 18 years of age.
* Low risk, intermediate low risk, acute pulmonary embolism
* patients with RV masses will be excluded.
* Patient refusal of treatment strategy.
CMP vs Fascia Iliaca Block

Complete motorsparing protocol (CMP) has been developed to try to minimize the motor nerve block that is created when using Facia iliaca nerve block. The blocks performed in the (CMP) are the cluneal nerve block, Pericapsular nerve group block and lateral femoral cutaneous block. On the clinical trial, the investigators will randomize the participants that meet criteria to CMP or Fascia iliaca Block and compare the amount of opioid needed post op during 24 hours and their pain scores.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Patients undergoing total hip arthroplasty posterior approach.
* Patients willing to participate and sign informed consent

Exclusion Criteria:

* Severe COPD/other contraindication to general anesthesia that spinal would be more suitable.
* Patient with a weight of less than 41 kg
* Dementia, not alert or Oriented to person, place, or time
* Chronic pain patient with daily opioid use at home.
* Patient with allergy to local anesthetics
* Patient refusal
* Total hip arthroplasty revision
* Concomitant pain in different area from operative site.
* Pregnancy
* Patient with active infection on the injection sites for the blocks
* Patients unable or willing to understand or comply with the study protocol