cyrilzakka/clinical-trials huggingface dataset:
Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System

The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

Ten healthy volunteer subjects and ten volunteers with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study.

The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis.

Images of the esophagus will be acquired in real time to be analyzed later.

Eligibility Criteria:
Inclusion Criteria:

* A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
* Subjects must be over the age of 18 but less than 70 year of age.
* Subjects must be able to give informed consent
* Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Exclusion Criteria:

* Subjects over 70 years of age
* Subjects with the inability to swallow pills and capsules.
* Subjects with a strong gag reflex
* Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
* Pregnancy. If the subject is unsure, she will be asked to take a pregnancy test.
A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed to remove bile duct stones.Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) are 3 methods used to enlarge the papillary orifice, but their efficacy and safety remains controversial. This study aimed to compare these methods for treating common bile duct (CBD) stones.

Investigators first divided the patients with different sizes of common bile duct stones into two groups. The bile duct stone diameter of group A is less than 1.0cm while group B is more than 1.0cm and less than 1.5cm. Each group compared Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) in ERCP. Through the postoperative comparison of relevant inspection test indicators, the recovery of patients, whether the occurrence of complications, including infection,bleeding,pancreatitis,perforation , and 1 year stone recurrence rate,Investigators assess the advantages and disadvantages in three different strategies in different sizes of common bile duct stones , and finally get a relatively objective evaluation to guide our daily ERCP work on the choice of duodenal papillary sphincter treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-80 years old
* CT or MRCP diagnose the patients with Common bile duct stones
* The diameter of the stone is less than or equal to 1.5cm
* Patients with the indications for ERCP
* Patients and their families agree to participate in the trial

Exclusion Criteria:

* Stones are too large (\> 1.5cm)
* A history of gastrointestinal surgery
* ERCP and EST or EPBD surgery history
* Patients generally poor, total bilirubin\> 200umol / L or PT time extension\> 3s
* Patients with mental illness or other serious heart and lung disease
Contributing Factors of Solitary Drinking Among Adolescents and Young Adults

A convenience sample of 40 solitary drinkers aged between 10 and 24 will be invited to complete a structured questionnaire and a individual semi-structured interviews.


Eligibility Criteria:
Inclusion Criteria:

* 10-24 years old,
* able to speak Cantonese
* self-report as exhibiting solitary drinking behaviour

Exclusion Criteria:

* None
Comparison of Tension Free Primary Closure, Karydaks and Limberg Flap Methods

Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.

There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in between those methods is the closing of the defect that occurs after the excision of the sinus tract. The defect can be closed by primary sutures or it can be left for secondary healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap procedures are commonly used. However, it has been reported that there is no difference between flap procedures and tension free primary closure. This result triggered the controversy that; if the healing side is tension free, midline suturing may have no importance. The aim of this study is to compare the results of 3 different surgical procedures used in treatment of pilonidal disease.


Eligibility Criteria:
Inclusion Criteria:

* having pilonidal sinus disease
* desire for surgical treatment
* accept to be involved in the study

Exclusion Criteria:

* patients under age of 18
* recurrent cases
Efficacy of a Compassion Program in University Students

University life is a challenging period. College students are exposed to a large number of stressors such as increased workload, multitasking, new responsibilities, changes in sleep and eating habits, social stressors, financial concerns and future employability, unlimited access to technology, etc. The participation of some of them in unhealthy activities should also be noted.

There is sufficient evidence to affirm that high levels of stress cause different alterations in students, such as attention and concentration deficits, difficulties in memorizing and solving problems, low productivity and poor academic performance. Due to this, in addition to the psychological and social impact of said mental health problems, the academic functioning of the students decreases and the dropout rates increase, which represents a problem for themselves and for the institutions. On the other hand, students and future professionals in training run the risk of suffering burnout as a consequence of the chronic stress to which they are subjected, with the consequent negative effects on their future professional practice.

The main objective of the present research is to evaluate the efficacy of a six-week compassion program for the reduction of psychological distress in university students compared to an active control condition based on relaxation.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-30 years old.
* Study undergraduate or master's degrees at the University of Zaragoza.
* Understand perfectly spoken and written Spanish.
* Grant informed consent.

Exclusion Criteria:

* Any diagnose of disease that may affect central nervous system (brain pathology traumatic brain injury, dementia, etc.).
* Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.) except for anxious pathology or personality disorders.
* Any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk.
Dopamine Treatment in Children With Cerebral Palsy With Dystonia- A Double Blind Controlled Study

Background:

Cerebral palsy (CP) is the main cause of childhood immobility and is defined as a non progressive injury to the developing central nervous system in children younger than 3 years, resulting in neurological and musculoskeletal abnormalities. The main pathophysiological causes are encephalopathy of prematurity (periventricular leukomalacia) hypoxic ischemic encephalopathy. Infections, infracts and migration defects are other less common causes of CP. The brain injury leads to functional motor impairment impacting on daily activities commonly manifests as a movement disorder: pyramidal, leading to spasticity and extra-pyramidal leading to dystonia and chorea. In most cases extensive brain injury causes a mixed movement disorder. Dystonia is defined as involuntary muscle contractions causing twisting and abnormal postures. While the neurological underpinnings of CP remain unknown, a link between low dopamine and increased acetylcholine release has recently been reported in dystonia. Dopamine is considered the first line of treatment in children with dystonia and CP followed by anticholiergic treatment with trihexphenidyl. The recommendation of dopaminergic treatment is based on need to rule out dopamine-responsive-dystonia, a rare genetic disorder, and on single case study reporting improvement in CP. A double blind study support or refute the use of dopamine treatment for dystonic CP was never reported. Working hypothesis and

Aims:

In children with CP due to a clear underlying pathology, dopamine treatment will not improve daily function. Methods: the investigators will perform a double blinded randomized controlled crossover study. 50 children ages 4-18 years with a clear pathophysiological cause for CP will be enrolled. Each child will receive dopamine and placebo treatment for 2 weeks with a 2 week washout interval. Participants will be randomized into 2 groups; one will receive placebo followed by dopamine and the other vice versa. The primary outcome measure, goal-attainment-scale, and secondary outcome functional measures (such as box and blocks, 9 hole pegs, pronation/ supination, finger sequencing) will be assessed at the beginning and end of each treatment as well as parent questionnaires regarding satisfaction and side effects.

Expected results:

No functional improvement with dopamine treatment compared to placebo.

Importance:

supplying sufficient data to support or refute the use of dopamine treatment for dystonic CP.

Probable implications to Medicine:

this may lead to a change in medical treatment guidelines for children with CP.


Eligibility Criteria:
Inclusion Criteria:

* clear pathophysiological cause for CP
* disabling dystonia in upper limbs

Exclusion Criteria:

* significant contractures
* psychiatric disorder
Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA

This is a safety study to determine the skin sensitization potential of ZuraPrep™ and ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects. Indications of both sensitization and skin irritation will be evaluated.

This study is designed to determine if the test product, ZuraPrep™ is a skin sensitizing agent when applied to human skin. The study, a modified Draize skin sensitization evaluation, will be conducted in three discrete phases: 1) induction, 2) rest, and 3) challenge. During the Induction Phase, skin sites are exposed to the test product repeatedly for 21 consecutive days. The Rest Phase, a 14-day period when no treatment is performed, serves to provide adequate time for the immune system to react to ZuraPrep™, given any of its components serve as antigens. During the Challenge Phase, the subjects' skin is re-exposed to the test product (ZuraPrep™) to determine if it is likely to be immunosensitizing.

Eligibility Criteria:
Inclusion Criteria:

* Subjects may be of either sex, at least 18 years of age and of any race
* Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions or other disorders of the skin of the back.
* Subjects must be in good general health

Exclusion Criteria:

* Known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate.
* Exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period.
* Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period.
* Current or recent severe illness such as asthma, diabetes, hepatitis, organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition such as AIDS or HIV positive.
* Pregnancy, plans to become pregnant, breast-feeding
* Any active skin rash or breaks in the skin of the back
* Any sunburn or tattoos on the skin of the back
* Current active skin disease or inflammatory skin condition including contact dermatitis
* Participation in a clinical study in the past 7 days or current participation in another clinical study
* Any medical condition or use of any medications that, in the opinion of the Principal Investigator, would preclude participation
* Unwillingness to fulfill the performance requirements of the study
Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases

This study evaluates the immunomodulatory effects of subcutaneous progesterone in patients undergoing IVF by determination of anti-nuclear antibodies (ANA),extractable nuclear antigen antibodies (ENA),anti- neutrophil cytoplasmic antibodies(ANCA),anti-DNA antibodies, anti-cardiolipin antibodies (ACA),Lupus anticoagulant antibodies (LAC) and C3 and C4 fractions of complement on the day of beta hCG dosage and during the eigth week of gestation.

The aqueous progesterone preparation for s.c. injection is the first systemic progesterone of its kind for the provision of luteal phase support (LPS) in patients undergoing IVF.

The the high solubility and rapid absorption of the new preparation are enhanced using cyclodextrins that are starch residues with no therapeutic activity and with a particular molecular structure that closely resembles a 'cap'.

Once absorbed after injection, the progesterone molecule is immediately dissociated from its cyclodextrin 'cap', remaining free in the circulation as if produced endogenously by the ovaries.

In comparison to progesterone-in-oil preparation, the new aqueous solution administered by s.c.route resulted in a 3 fold higher and more rapid progesterone peak serum concentrations.

The immunomodulating effects of progesterone are mediated outside of the pelvic cavity, on the peripheral cell of the immune system. For this reason only the injection procedure has this advantage Furthermore, the faster absorption rate and the higher peak serum concentration should increas the systemic immunomodulatory effect of subcutaneous progesterone compared to the vaginal and intramuscular administration

Eligibility Criteria:
Inclusion Criteria:

* Infertile patients affected by autoimmune diseases undergoing IVF

Exclusion Criteria:

* infertile patients without autoimmune diseases, fertile patients affected by autoimmune diseases
Implications of Pacifier Use in Israeli Children

The purpose of this study is to examine pacifier sucking habits among children, and to assess implications of the oral habit - for example malocclusions and drooling. The effect of pacifier sucking will be recorded and compared to pacifier type and frequency of use.

Pacifier study protocol

* The study will take place in children day care centers in Jerusalem and "HaSharon" area.
* First step = Receiving an approval from the Children's parents and the day care management for the research.
* Next step = Examine a total of 400 children who use a pacifier, with a dental mirror in regular lighting condition.
* The procedure is short, no need of repetition or tracing and without any side effects or discomfort.

Part 1- a short questionnaire of demographic background- will be answered by the parents:

1. Personal details- Parents names and ages, child's name and ID number, relation to the child (mother, father...)
2. Social economic status - mother's education, place of residence, number of children in the family.
3. Child's personal details -gender, age, number of siblings
4. Pacifier use habits- period of use, type of pacifier, frequency of use, reason of using a pacifier.
5. Child's Dental condition- drooling, cross bite, open bite.
6. Parents' Awareness of pacifier's effect on mouth development.
7. Parents' approval for child examination. Part 2- clinical- visual examination for identification of relevant findings

1. Child's pacifier type. 2. Dental clinical examination performed in a lightened room:

* Diagnosis of caries- data will be written in a chart.
* Diagnosis of malocclusion- open bite or cross bite 3. Diagnosis of drooling from mouth corners which indicates malocclusion. Redness or dryness around lips and chin can imply drooling.

Eligibility Criteria:
Inclusion Criteria:

* healthy children aged 3-4 years that use a pacifier

Exclusion Criteria:

children suffering from a chronic or developmental disease that can affect the orofacial region

* finger sucking children children suffering from low muscle tonus, abnormal drooling
BIS-Guided Sedation Monitoring

This study looks to assess whether monitoring sedation status in mechanically-ventilated Medical Surgical Intensive Care Unit (MSICU) patients using Bispectral index (BIS) monitor-augmented sedation monitoring as opposed to Richmond Agitation Sedation Scale (RASS) score is associated with decreased duration of mechanical ventilation.

Investigators hypothesize that using BIS monitors to help monitor depth of sedation in mechanically ventilated ICU patient will result in a decreased duration of mechanical ventilation when compared to solely utilizing clinical sedation scales such as RASS.

Participants will be randomized into two groups, the intervention group will receive sedation monitoring with BIS monitoring plus RASS. The control group will receive sedation monitoring with RASS score only. Randomization will be accomplished through online randomization software.

For randomization purposes, the intervention group will be labeled as the "A" group. The control group will labeled as the "B" group. In the BIS-augmented group, sedation requirement will be titrated according to an average of BIS reading in the 5 minute period prior to assessment with a goal of maintaining a value of (60-70) in addition to a RASS score goal of (-1 to -2), provided no noxious stimulation such as endotracheal suctioning and/or wound dressing has occurred for at least 30 minutes, BIS values have been stable for at least 5 minutes, signal quality index (\>80%), minimal EMG interference (\<50%), patient is not shivering, and patient does not have warmer or other devices that may produce an electric current on their body or nearby. In the RASS group, sedation requirements will be titrated to maintain a RASS score of (-1 to -2), will be assessed via the nurse taking care of the patient provided no noxious stimulation has occurred for at least 30 minutes prior to assessment.

Both groups will have sedation assessment at least every 6 hours during a 12 hour shift and as needed as per ICU RN and/or physician. Nurses will be free to exercise their judgment if they deem that their patients require more or less sedation that is inconsistent with patient's BIS or RASS score, they will, however, be required to provide a rationale for their judgment and record such events on a special form created for this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age.
* Patients expected to be mechanically ventilated and sedated with continuous intravenous infusions of Propofol or Midazolam and fentanyl for \>= 24 hours within 12 hours of screening.

Exclusion Criteria:

* Patients with Seizure disorders acute neurological injury, severe dementia or anoxic brain injury.
* Patients with tracheostomies.
* Patients requiring neuromuscular blocking agents (NMBA).
* Patients transferred from another ICU while mechanically ventilated.
* Patients with cardiac pacemakers.
* Peri-cardiac arrest patients.
* Patients with induced hypothermia.
* Pregnant patients.
* Patients with no known Legally Authorized Representative (LAR).
Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis

The sacroiliac joint is Located between the pelvis and base of the spine, the sacroiliac joints are strong, stable joints that allow for little movement. While these joints do not bend like a knuckle or knee, they are susceptible to degenerative arthritis. Sacroiliac joint pain is one of the most common causes of chronic low back pain, accounting for 10% to 27% of patients with chronic lower back pain. It is known to be caused by abnormal motion in this joint, namely, too much motion or too little motion. Patients with pain experience various degrees of pain in the low back, groin, buttock, or posterior thigh.

The pain starts when the Sacroiliac joint gets inflamed. There are several reasons it could happen. It could be hurt when playing sports or if fall down.

Sometimes start hurting when the ligaments that hold the SI joint together are damaged, which may make the joint move abnormally. The pain associated with sacroiliitis most commonly occurs in the buttocks and lower back. It can also affect the legs, groin and even the feet.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have chronic pain more than 6 months and have failed medical treatment.

Exclusion Criteria:

* Infection at the site of injection
* Opioids addiction
* Coagulopathy or another bleeding diathesis
* Those who refuse to participate in the study
* Ankylosing Spondylitis patients
Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate 1 risk MDS. The HI-E, HI-N, HI-P rates \[by International Working Group (IWG) 2006 criteria\] and safety of each treatment group will be evaluated to select the optimal dose of ezatiostat in combination with lenalidomide for future studies.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of primary or de novo MDS using WHO classification
* Non-del(5q) low or Intermediate-1risk MDS
* ECOG performance status of 0-1
* Documented significant cytopenia for at least 2 months
* Must have discontinued growth factors (EPO, G-CSF, GM-CSF) for at least 21 days prior to study entry
* All study participants must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®
* Females of childbearing potential should have two negative serum pregnancy tests with a sensitivity of at least 50 mIU/mL. The first test should be performed within 10-14 days, and the second test within 24 hours of prescribing lenalidomide (prescriptions must be filled within seven days)

Exclusion Criteria:

* Known hypersensitivity to Telintra™ (intravenous or oral)
* Known prior therapy with or hypersensitivity to thalidomide or lenalidomide
* Prior allogenic bone marrow transplant for MDS
* History or prior malignancy

  * Except for treated carcinoma of uterine cervix, basal cell or squamous cell skin cancer, or other cancers (e.g. breast, prostate) for which patient has been disease-free for at least 3 years.
* MDS evolving from:

  * A pre-existing myeloproliferative disorder
  * An autoimmune disease
  * Secondary to prior treatment with radiation or chemotherapy
* History of MDS IPSS score\>1.0
* Pregnant or lactating women
* Leptomeningeal or leukemic meningitis
* Prior treatment with DNA methyltransferase inhibitors (DMTI) \[e.g., azacitadine, decitabine, etc.\]