cyrilzakka/clinical-trials huggingface dataset:
Effect of Abdominal Massage on Prevention of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy

Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) are the preferred techniques for treating common bile duct stones (CBDS) due to their advantages of minimal trauma, rapid recovery, low cost, and high success rates of up to 95%. Despite these benefits, the recurrence rate of CBDS in patients after endoscopic therapy ranges from 4% to 25%, posing a significant challenge for endoscopists and an urgent problem to be addressed.

Abdominal massage is a promising non-invasive physical intervention for preventing recurrent CBDS. This technique is a simple, effective, and non-invasive technique that can be utilized for patient self-management and is widely used in the field of digestive diseases. External pressure applied to the common bile duct during abdominal massage may promote bile excretion from the duct to the duodenum, similar to the effect of gallbladder movement flushing bile, which can prevent bile deposition in the common bile duct, thereby preventing the formation of new stones or flushing away newly-generated small stones.

Therefore, investigators plan to conduct a prospective, multicenter, randomized controlled study to investigate the preventive effect of abdominal massage in patients with recurrent CBDS.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75;
* Patients with common bile duct stones recurrence;

Exclusion Criteria:

* Incomplete clearance of recurrent common bile duct stones;
* Anatomical changes (such as Billroth I/II, Roux-en-Y);
* Contraindications to abdominal massage (such as abdominal surgery, active gastrointestinal bleeding, intestinal obstruction, acute abdomen, etc.);
* Expected lifespan of less than two years;
* Unstable hemodynamics;
* Malignant arrhythmia;
* Pregnancy or lactation;
* Unwillingness or inability to sign an informed consent form.
A Clinical Comparison of Two Daily Disposable Contact Lenses.

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years to 45 years
* Current daily soft contact lens as habitual optical correction:
* Refraction:

  * Best sphere (corrected for back vertex distance) -1.00 to -6.00D
  * Cylinder 0.00 to - 0.75D
* Best spectacle corrected visual acuity of 6/9 or better in each eye
* Willingness to adhere to the instructions set in the clinical protocol
* Signature of the subject on the informed consent form

Exclusion Criteria:

* Systemic or ocular allergies which might interfere with contact lens wear
* Systemic disease which might interfere with contact lens wear
* Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
* Use of medication which might interfere with contact lens wear
* Active ocular infection
* Use of ocular medication
* Significant ocular anomaly
* Presence of two or more corneal scars in either eye
* Pregnancy or lactation
* Any medical condition that might be prejudicial to the study
* Participated in any other clinical studies in the past month
* Currently wears monovision
Efficacy of Propolis in the Prevention of Oral Mucositis

The study was carried out to determine the efficacy of propolis in the prevention of oral mucositis and gastrointestinal symptoms associated with oral mucositis in patients with leukemia, lymphoma, and myelodysplastic syndrome receiving high-dose chemotherapy and/or hematopoietic stem cell transplantation. 64 patients, 32 in the propolis and 32 in the control group, were involved in the prospective randomized controlled experimental study. While the standard oral care treatment protocol of the clinic was administered to the control group, aqueous propolis extract was applied to the propolis group in addition to the standard oral care treatment protocol.

Objective: The study was carried out to determine the efficacy of propolis in the prevention of oral mucositis and gastrointestinal symptoms associated with oral mucositis in patients with leukemia, lymphoma, and myelodysplastic syndrome receiving high-dose chemotherapy and/or hematopoietic stem cell transplantation.

Study Design:

The study was conducted as a randomized controlled experimental study. Approval from the Ethics Committee and written permission from the Institution were obtained. After the participants were informed about the purpose of the study, their written consents were obtained. 64 patients, 32 in the propolis and 32 in the control group were involved in the study that was performed in the Hematology and Bone Marrow Transplantation Unit.

The control group patients used the standard oral care treatment protocol (Tanflex (3x1) and NaHCO3 (1x1)) of the clinic , while the propolis group used the aqueous extract of propolis in addition to this protocol. The individuals in the propolis group gargled 4 times a day (after meals and before going to bed at night) with 5 ml aqueous propolis extract. All patients underwent a daily intraoral examination up to 21 days from the start of high dose chemotherapy. Oral mucositis was recorded on the WHO oral toxicity scale and other gastrointestinal symptoms were recorded on the National Cancer Institute-Common Terminology Criteria for Adverse Events scale

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Ability to communicate verbally
* Not having a diagnosed psychiatric disease
* Receiving inpatient high dose chemotherapy (diagnosed with leukemia, lymphoma and MDS)
* Hematopoietic Stem Cell Transplantation patients
* Zero OM score according to the World Health Organization Oral Toxicity Scale (WHOOTS)
* Karnofsky Performance Scale (KPS) score of 80 and above

Exclusion Criteria:

-
Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

A prospective, non-randomized study to evaluate the performance of the MyoScience Tissue Remodeling Device for the treatment of glabellar lines (frown lines), lateral orbital lines (crow's feet), and frontalis lines (horizontal forehead lines).


Eligibility Criteria:
Inclusion Criteria:

* The subject must be a female 30 to 70 years of age.
* The subject must have a clinical examination prior to treatment including assessment of hyperdynamic line severity.
* The subject must have a wrinkle rating of at least "1" at rest in one or more of the following treatment areas (glabellar, lateral orbital, or frontalis).
* The subject must have signed an informed consent form.
* The subject should not have undergone any other facial cosmetic procedures at or above the level of the cheekbones within the past 6 months.
* The subject should not be participating in any other facial cosmetic research study.

Exclusion Criteria:

* The subject is on a regular regimen of prescribed or over-the-counter anticoagulants.
* The subject has an infection or skin problem at the injection site.
* The subject has a history of facial nerve palsy.
* The subject has marked facial asymmetry.
* The subject has ptosis.
* The subject has excessive dermatochalasis.
* The subject has deep dermal scarring.
* The subject has thick sebaceous skin.
* The investigator is unable to substantially lessen facial lines by physical separation.
* The subject has a history of neuromuscular disorder.
* The subject has undergone prior surgery that alters the subcutaneous anatomy of the areas being treated.
* Subjects with laxity of the canthal tendon and/or with lower lid retraction, and subjects who recruit their zygomaticus major muscle to animate their crow's feet.
* The subject has any physical or psychiatric condition that in the investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study.
Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

Observational study in patients with non-focal congenital hyperinsulinism showing that restrictive surgery may improve the metabolic situation

In non-focal congenital hyperinsulinism (CHI) the current doctrine warrants subtotal pancreatic resection in all children who do not respond to medication. However, the rate of diabetes after these extensive resections is very high. In this study investigators show that a less aggressive approach may suffice to wean many children from all medication or to get them manageable medically.

Eligibility Criteria:
Inclusion Criteria:

* patients with non-focal congenital hyperinsulinism

Exclusion Criteria:

* patients with focal congenital hyperinsulinism
Comparison of Liquid Kaletra and Low Dose Kaletra Tablets

Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective medications that are approved and available for young children who are HIV+. The liquid form is reported to have a very nasty taste and presents difficulties for the children who must take the medication twice a day and for their parents who must enforce the medication regimen. The children are often well into their teens before they weigh enough to be able to take the adult dose tablet (200mg/50mg). A new smaller dose tablet (100mg/25mg) is now available. However, it is not known if the liquid and tablet act the same in children. The purpose of this study is to switch children from the baseline treatment with the liquid to the study intervention treatment with 100mg/25mg tablet form of Kaletra. The study will compare children pre-switch and post-switch in terms of how well their HIV is controlled . Comparisons of parent and child satisfaction will also be made. Eight to 10 HIV+ children currently well managed with a medications including liquid Kaletra will be invited to switch from the liquid to the low dose Kaletra tablet. The parent and/or child will complete a satisfaction survey for the liquid Kaletra and lab values will be taken from the chart. At the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the parent and/or child will complete the satisfaction survey. In addition, at the switch and 1 month post switch, a day will be spent in clinic with 5 blood draws to see how much of the drug is in the blood stream at different times after the medicine is taken.


Eligibility Criteria:
Inclusion Criteria:

* HIV+ children aged 3-18.
* Baseline treatment includes liquid Kaletra
* currently on a stable (on same regimen \> 3 months, Viral Load\< 5,000), Highly Active Antiretroviral Therapy (HAART) regimen
* able to take pills or willing to undergo pill training prior to enrollment
* weight must be greater than or equal to 15kg

Exclusion Criteria:

* Unable to swallow pills
* Concomitant treatment with Rifampin or St. John's Wort which have been shown to decrease plasma concentrations of lopinavir.
* Concurrent use of drugs primarily metabolized by CYP3A, which metabolizes ritonavir: Astemizole, Cisapride, Dihydroergotamine, Ergonovine, Ergotamine, Flecainide, Lovastatin, Methylergonovine, Midazolam, Pimozide, Propafenone, Simvastatin, terfenadine, Triazolam
* Baseline treatment does NOT include Kaletra
Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients

In many of urothelial carcinoma patients, one does not find common risk factors such as smoking. The medical center is located in an industrial city with known air and water pollution. The investigators decided to check the presence of nano particles and traces of metals in urinary samples of patients known and suspected for urothelial carcinoma and compare the results to both cystoscopic and cytological findings. The patients will fill a validated epidemiological respiratory disease survey and the results will be compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

Study group :

1. Patients that need cystoscopy due to suspicion/known bladder malignancy.
2. Patients that can read, understand and sign an informed consent form.

Control group:

1. Patients that need cystoscopy due to others reasons than malignancy.
2. Patients that present to the Department of Urology for surgery unrelated to malignancy of the urinary system ( prostatectomy, Incontinence repair, circumcision, hydrocele/ varicocele repair, ureteroscopy etc).

Exclusion Criteria:

Study group:

1. Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
2. Patients with a technically improper urine test.

Control group

1. Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
2. Patients with a technically improper urine test.
A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

The primary objective of the study is to evaluate the PK of AMG 510 administered in the fasted and fed state in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential.

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment

The purpose of the proposed research is to study the potential changes in biomarkers of patients with neurodevelopmental disorders in response to treatment in clinical trials or in private psychiatry practice utilizing non-invasive psychophysiological measurements. The investigators plan to obtain psychophysical measurements throughout several periods of treatment.

This study will employ a non-invasive custom-built four-point vertical displacement stimulator. This is used to deliver sinusoidal vibrations at very low amplitudes (0-400 microns) to the tips of the fingers. The forearm of the subject rests on the stimulator, the finger tips are vibrated, and the subject answers questions prompted by a computer monitor about their perception of the stimuli. Research staff may explain questions and prompts in a way that may be better understood by the subjects if the subjects experience any difficulty.

This device will be used to obtain objective psychophysical measurements as subjects undergo treatment. The investigators hope that this study will eventually assist in the long term goal of studying ways to develop diagnostic methods, based on changes in cortical information processing capabilities that occur with neurodevelopmental disorders. This would enable clinicians to more objectively determine prognosis and the best course of intervention for their patients.

This study will consent up to 60 subjects who are have initiated or changed pharmacologic treatment as either a participant in a clinical trial or as a private patient of one of the study doctors. Subjects who are a participant in another clinical trial may be one an active medication or a non-active medication(placebo). Subjects will have 7 visits in this study (w0 prior to initiating new treatment, and 4,8, 26 52,78 and 104 weeks after starting the the new treatment. The latter visits may occur either while the individual is taking the medication or after the individual has stopped treatment (in order to assess persistence of treatment-related changes).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are eligible to participate in a clinical trial conducted by Dr. Sikich or individuals who have initiated/changed pharmacologic treatment (as private patient of a study physician)
* Diagnosis of autism spectrum disorder (ASD), psychotic spectrum disorder (PSD), or Fragile X syndrome.
* Ages 3-45 inclusive

Exclusion Criteria:

• Non-English Speaking subject or parent/guardian
Fluid in Neonatal Hyperbilirubinemia

Hyperbilirubinemia is a common neonatal problem. bilirubin is potentially toxic to central nervous system and can cause serious permanent complication called kernicterus, in which brain stem nuclei and basal ganglia are damaged,resulting in cerebral palsy.In Hyperbiliubinemia,rapid reduction of serum bilirubin level is of utmost importance.

Two commonly used mode of therapy are phototherapy and exchange transfusion. Phototherapy has some side effects such as diarrhea, skin rash, dehydration, overheating, mother-baby bonding disruption.On the other hand, complication of exchange transfusion include infections, emboli,anemia,apnea and hypocalcemia.

while IV fluid supplementationis postulated to decrease bilirubin concentration directly through a reduction of haemoconcentration, increasing enteral feed volume is proposed to decrease bilirubin concentration through reduced enterohepatic circulation via an increased gut peristalsis.

Bilirubin encephalopathy or kernicterus Unconjugated bilirubin is lipid soluble and therefore can cross the blood brain barrier .There it can deposit in areas of the brain, with a predilection for deposition in the basal ganglia, auditory pathways, and oculomotor nucleus. This deposition and accompanying damage result in the classical symptoms associated with kernicterus. Hypoxia, acidosis, prematurity, and genetic predispositions all increase the risk for kernicterus.In well term babies risk for kernicterus increases after bilirubin levels cross (20 mg/dL) and it is very high above (30 mg/dL). In preterm babies the threshold for damage from bilirubin could be as low as(20mg/dl). The risk increases with increasing serum levels of unconjugated bilirubin.

Acute bilirubin encephalopathy presents as lethargy, high pitched cry, poor feeding, abnormal tone, opisthotonus, upgaze palsy and seizures. Aggressive treatment at this stage can reduce the damage caused. Chronic bilirubin encephalopathy leads to conditions like choreoathetoid cerebral palsy, high frequency hearing loss, dental dysplasias and oculomotor palsies.

Eligibility Criteria:
Inclusion Criteria:

1 -Ful term ,Body weight (≥2.5kg). 2- total serum bilirubin range(≥18mg/dl to≤25mg/dl). 3-Non -haemolytic type of jaundice. 4-Ratio of conjugated bilirubin :unconjugated bilirubin is 1:5

Exclusion Criteria:

1 - Body weight ≤2.5kg. 2- Evidence of haemolysis. 3- Obvious features of dehydration. 4- Major congenital malformation . 5- Baby received already IV fluid for any reason. 6- Septicemia . 7-GIT functional or organic obstruction .
Ultrasound Elastography of Salivary Glands

Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients with sicca syndrome and pSS.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* More than 18 years old
* Consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome
* Consent agreement

Exclusion Criteria:

* No consent agreement
* No sicca symptoms
Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

The purpose of this study is to compare cognitive behavior therapy (CBT) to medical care-as-usual for the treatment of patients with high levels of medically unexplained physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.

Patients with Somatization Disorder suffer from medically unexplained physical ailments and experience significant distress and disability. This disorder is an important problem for the primary health care system because patients with Somatization Disorder use health care resources extensively but receive little benefit. To date, no medical or psychiatric intervention has been demonstrated in controlled trials to produce clinically significant and lasting symptom relief or improved functional status in Somatization Disorder patients.

Patients in primary care settings with multiple unexplained symptoms are treated with 10 weekly sessions of CBT or "treatment as usual." Physical symptoms, comorbid psychiatric symptoms, disability, and health care utilization are measured and assessed through a combination of structured interviews and self-reports. Assessments are performed at study start, mid-treatment, end of treatment, and at a 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Somatization disorder

Exclusion Criteria:

* Bipolar disorder
* Schizophrenia or other psychosis
* Major Depression
Improving Cancer Symptom Management

Patient-reported outcome measures (PROMs) is an umbrella term that refers to any report on a health status measure that is reported directly by the patient, without the influence of clinicians or anyone else. PROMs have been shown to more closely reflect a patient's daily health status when compared to physician-reported measures. However, research is needed to evaluate if patient symptom reporting during definitive-intent radiotherapy allows earlier and improved detection of treatment toxicity.

The IMPROVE pilot study will describe the proportion of patients with cancer with changes in physician-perception of treatment-related toxicity that result from routine physician review of PROMs reported during definitive radiotherapy.

Patient-reported outcome measures (PROMs) is an umbrella term that refers to any report on a health status measure that is reported directly by the patient, without the influence of clinicians or anyone else. PROMs have been shown to more closely reflect a patient's daily health status when compared to physician-reported measures. However, research is needed to evaluate if patient symptom reporting during definitive-intent radiotherapy allows earlier and improved detection of treatment toxicity, and leads to individualized interventions which may improve the toxicity outcomes for patients with locally-advanced and oligometastatic cancer.

The investigators hypothesize that routine physician review of PROMs during on-treatment visits will (1) increase proportion of patients with an increased in their physician' s assessment of their overall toxicity burden during definitive radiotherapy, and (2) correspondingly increase the proportion of patients receiving physician-directed interventions for treatment-related symptoms.

The IMPROVE pilot study will describe the proportion of patients with cancer with changes in physician-perception of treatment-related toxicity that result from routine physician review of PROMs reported during definitive radiotherapy. The IMPROVE study will also describe (1) the proportion of patients with changes in the management of treatment-related symptoms and (2) the type of management changes that result from routine physician review of PROMs reported during definitive radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years of age
* Able to read and write in English or able to understand/answer questions with the aid of an interpreter
* Histologically confirmed loco-regional to advanced primary cancer, including but not limited to lung cancer, esophageal, or gastro-intestinal cancers at risk of developing radiotherapy-related toxicity.
* Receiving definitive conventionally-fractionated radiation treatment with or without chemotherapy

Exclusion Criteria:

* Patients receiving radiation for palliative intent
* Patients who do not provide informed consent
* Patients who chose to withdraw from the study

Radiation Oncologists

Inclusion criteria:

• Must be the physician overseeing the care of the patient who answers the PROMS

Exclusion criteria:

• Have not provided informed consent