cyrilzakka/clinical-trials huggingface dataset:
Reducing Opioid Prescription After Kidney Stone Removal Surgery

The purpose of this study is to implement and assess a standard way of prescribing opioid pain medication following PCNL (a kidney stone removal surgery) to ensure patients are being discharged with an appropriate quantity of pain management medication.

Participants in this study will have their opioid pain medication prescription at discharge following PCNL (Percutaneous Nephrolithotomy, a kidney stone removal surgery) determined by an algorithm in addition to physician judgement. The goal of the algorithm is help physicians refine pain medication prescribing patterns for patients who have undergone PCNL in order to discharge patients with an appropriate quantity of pain management medication. The effectiveness of the algorithm will be assessed through participant surveys. Participants will complete a brief online survey on Days 3, 7, and 14 following hospital discharge and another phone-based survey 26-30 days after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.

Exclusion Criteria:

* Unable or unwilling to provide informed consent.
* Patients who require Intensive Care Unit admission after surgery.
* Patients who have Clavien grade III or greater postoperative complications requiring additional intervention \< 30 days after index procedure.
Phosphatidylcholine Supplementation in Infants

Sensory gating is defined as the automatic process of inhibiting brain response to repeated auditory sounds. Infants who brains respond similarly to two identical sounds presented about 1/2 second apart are more likely to have later problems with attention than infants who suppress response to the second sound. This study will examine whether providing a nutritional supplement, phosphatidylcholine, for two months in infancy will result in an increased likelihood of developing more robust sensory gating.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infant has an age (adjusted for gestational age at birth) of 1-7 weeks
* Diminished P50 sensory gating (ratio greater than or equal to 0.50)

Exclusion Criteria:

* No maternal reported tobacco use for greater than 1 year and no current tobacco use (as measured by urine cotinine levels)
* Trimethylaminuria, renal disease, liver disease, known chromosomal abnormality, chronic neurological disorder, premature birth, prenatal exposure to exogenous steroid use
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)

Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* FEV1 \< 60% predicted
* FEV1 \< 70% of FVC
* Smoking history of 10 pack-years

Exclusion Criteria:

* Significant other disease than COPD
* Recent history of MI (1 year or less)
* Cardiac arrhythmia requiring drug therapy
* History of asthma, allergic rhinitis or eosinophil count \> 600 mm3
* Symptomatic prostatic hypertrophy or bladder neck obstruction
* Known narrow-angle glaucoma
* Abnormal baseline hematology, blood chemistry or urinalysis
* History of cancer within last 5 years
* Life-threatening pulmonary obstruction
* Cystic fibrosis or bronchiectasis
* Tuberculosis
* Pulmonary resection
Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma

The purpose of this pre-approval access program is to provide talquetamab for the treatment of participants with relapsed or refractory multiple myeloma.


Eligibility Criteria:
A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients

The purpose of this study was to compare the effectiveness of two rehabilitation programs (one month) in patients with multiple sclerosis. The first program is combined with physiotherapy, endurance training and resistance training. The second one is physiotherapy in private practice. Another purpose is to assess the length of the benefits of the combined program.

This study will include 240 patients with a diagnosis of Multiple Sclerosis and with an Expanded Disability Status Scale ≤ 5. Patients will be divided into 2 groups, according to a randomization design. At recruitment (J0), after rehabilitation (M1) and at follow up (M3 and M6) each patient will be tested for the primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 year or over
* Able to walk independently without use of assistance 200 meters Expanded Disability Status Scale ≤5
* No relapse within the last three months
* No current or recent (six months) participation in intensive rehabilitation
* No recent modification (six months) of medications for MS
* Patients who received and signed information and informed consent

Exclusion Criteria:

* Cognitive impairments which could interfere with the ability to fully engage the rehabilitation program.
* Recent involvement (three months) in another interventional research study
* A complicating medical condition or orthopedic diagnosis that limits rehabilitation
* Cardiac or respiratory disease that interfere with endurance training
* Patient with safety measure
* Pregnant women, breastfeeding
* No affiliation to a social security
Intervention Study to Prevent Obesity in Sedentary 8 Year Old Swedish Children

The purpose of this study is to study whether a targeted intervention can increase physical activity in inactive 8-yr old children and how it affects secondary measures such as metabolic- and cardiovascular risk factors and markers, self-reported quality of life, BMI, body composition and aerobic work-capacity.

Background Between 3 to 5 % of Swedish 10 yr olds are obese and an additional 20 % are over-weight. Being physically inactive in childhood increases the risk for becoming obese both in child- and adulthood and a correlation between BMI and arterial-sclerotic markers can be seen already in childhood. Physical activity (PA) in children improve their insulin sensitivity and reduce metabolic risk regardless of the proportion of fat mass. Published questionnaire data suggests that the level of PA has decreased in children between the years 1968 to 2001.

Study aims To study whether a targeted intervention can increase PA in sedentary 8-yr old children (2nd grade Swedish elementary school) and how it affects secondary measures such as; metabolic- and cardiovascular risk markers; self-reported quality of life, PA and motor skills; BMI; body composition; bone mineral density (BMD); PF. To identify factors of success that could be implemented in schools and pre-schools and in the commune and health-care parent support.

Subjects and methods With informed written consent of parents/caretakers we will screen at selected schools with questionnaires and accelerometers to identify sedentary children. The 30% most inactive children will be offered participation in the study. Cut off values for inactivity is obtained from a large reference-material based on 1800 measurements on 6 - 10 yr old children from the STOPP study. The intervention will be delivered through sessions aiming at developing healthy habits regarding PA and via supplementation with fish liver oil. The sessions will be performed by trained health workers (coaches) and carried out in the families' homes and later on via telephone. All families will meet with their coach during at least 6 times. The coaches will use the technique of Motivational Interviewing (MI). However, extra efforts, such as group work-out sessions and out-door activities, will be made. The individual work with these families is delicate and the intervention staff group will therefore have continuous education and guidance from a qualified MI tutor. All included children will be randomized to equally sized intervention or control group. All outcome measures will be assessed at 0 and 15 weeks (completion) of the intervention. The study is limited by the school semesters. Screening is therefore scheduled to the fall- and intervention program to spring semester.

Eligibility Criteria:
Inclusion Criteria:

* Level of physical activity below the 30ieth percentile cut off point derived from a large reference population.

Exclusion Criteria:

* Family not being able to participate in the program or take part in at least the physical activity assessment.
* Morbidities that affects the outcome parameters.
A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization

This is an open label prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure detection system for detecting Generalized Tonic-Clonic (GTC) Seizures.

The Brain Sentinel® GTC Seizure Detection and Information System is an ambulatory system designed to continuously monitor and perform real-time analysis of surface electromyography (sEMG) data to detect GTC seizures and to provide an alarm to alert caregivers within 30 seconds of bilateral, appendicular, tonic extension that a seizure is occurring. The System is for recording and storing sEMG data, which is subsequently reviewed by a trained healthcare professional in the outpatient clinical setting. The Brain Sentinel® GTC Seizure Detection and Information System is intended for real time monitoring of pediatric and adult patients who have an arm circumference ranging from at least 16 cm to no greater than 51 cm at the biceps. It may be used in the home or healthcare facilities for real-time monitoring during the day, night, or for continuous monitoring, including during the titration of, or the withdrawal from anti-epileptic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization
* Male or female greater than 2 years of age
* Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 16-51 cm)
* Be able to tolerate wearing the device on the upper arm
* Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments
* Subject and/or Primary Caregiver must be competent to follow all study procedures.
* Is able to read, speak and understand English
* At least 2 or more Emergency Department visits in the previous 12 months for seizure related care

Exclusion Criteria:

* The subject is homeless or in a home without a power supply.
* The subject is allergic to adhesives or any component of the electrode patch assembly.
* The subject self-reports that she is pregnant or planning to become pregnant while using the device.
A Major Determinant Focused on the ECG or Echocardiogram for PICM and Its Clinical Outcome (PICM Syndrome)

Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM). Several parametes make difference of effect on the occurrence of PICM and its subsequent clinical outcomes. In particular, recognition of a major determinant focused on the ECG or echocardiographic parameters including strain or genetic factor for occurrence of PICM may lead to better identification of patients at high risk. Investigators prospectively enroll a participant with documented high risk of PICM and clinically follow-up to idenify clinical impact of PICM (PICM syndrome) over a long period of time.

Investigators investigate a major determinant focused on the ECG or echocardiogram or genetic factor to predict the PICM after implantation of pacemaker. Not only QRS duration and mechanical strain but also genetic factor could be also investigated to predict the occurrence of PICM before diagnosis fo PICM

Eligibility Criteria:
Inclusion Criteria: mandatory (1 and 2) and optional (3 or 4)

1. Willng to participate in the study and able to sign informed consent
2. Undertaken ECG and echocardiogram including strain before and after device implantation
3. Below preserved left ventricular dysfunction in the echocardiogram
4. Above 15% pacing-rhythm in the device interrogation

Exclusion Criteria:

1. Less than 18 years of age
2. Being pregnant or plan to become pregnant
3. Advanced heart failure waiting in heart transplantation
4. Have a life expectancy of less than 1 year
Electrogastrogram (EGG) Reproducibility Study: EEG Readings in Normal Subjects and Dyspeptic Patients

The primary objective of this study is to determine whether EGG readings obtained from both normal subjects and dyspeptic patients are reproducible from one EGG recording to another on a different day.

The secondary objective of this study is to determine whether the EGG readings are analyzed and diagnosed consistently when reviewed and compared by multiple blinded readers when the same tracing is reviewed.

This is a single-center study. The duration of this trial is estimated to be six months. A total of Forty (40) subjects will be recruited into this study. It will be two Groups; ten (10) normal healthy subjects will be recruited by poster advertisement and thirty (30) patients who either present to the Gastroenterology Department of Temple University Hospital with varying signs, symptoms or complaints of gastric discomfort, or who are scheduled to undergo an EGG test by their Gastroenterologist.

Each study subject/patient will have a total of two (2) EGGs with Water load tests performed for this study. Each EGG exam will be performed approximately one (1) week of each other, but no more than 4 weeks apart, and will be read in a blinded fashion by three (3) separate independent readers, in order to see if the readings are consistent with the previous readings that were obtained, as well as, by the readers themselves (Inter-reader rater reliability). Each reader will be blinded to the subject status (normal/healthy or patient) and also to the specific test they are reading (initial exam \[Visit 1\], or follow-up exam 1 week after Visit 1 \[Visit 2\]). All EGG exam results will be coded in order to keep them blind.

Eligibility Criteria:
For normal healthy subjects:

Inclusion Criteria:

1. Male or female patients who are 18 years of age to 72 years of age.
2. Normal healthy subjects with no signs or symptoms of gastrointestinal discomfort.

Exclusion Criteria:

Patients will not be included in this study if they are:

1. \< 18 years of age or \>72 years of age
2. Subjects with known gastrointestinal or liver cancers, pancreaticobiliary tract diseases, active peptic ulcer disease or uncontrolled lactose intolerance.
3. Subjects with cardiovascular, pulmonary disorders, or subjects with diabetes mellitus, a malignancy or who are known to be HIV positive.
4. Subjects with a history of gastric, intestinal or colonic resections. Subjects who are at less than a three month status for either: post appendectomy, cholecystectomy, or hysterectomy with or without oophorectomy.
5. Subjects who are unable to give informed consent or adequately express their subjective complaints.
6. Subjects who abuse drugs or alcohol.
7. Female subjects who are pregnant.

For functional dyspepsia patients:

Inclusion Criteria:

1. Male or female patients who are 18 to 72 years of age.
2. Patients who present with varying gastric complaints of discomfort
3. Patients who meet all Rome II criteria for functional dyspepsia (see Rome II criteria checklist)

Concomitant medications are allowed during the study period.
Oral Lactoferrin Versus Iron Supplementation During Pregnancy

Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores \[Sharma JB; et al., 2004\]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection \[ So¨lvell L; et al., 1970\].

Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores. This allows the normal mechanism of absorption to be used, in addition to being an inexpensive and effective treatment \[Sharma JB; et al., 2004\]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection \[ So¨lvell L; et al., 1970\].

Furthermore, routine iron supplementation has recently been challenged. The British Society for Hematology, Obstetric Hematology Group (BSH OHG) and the British Committee for Standards in Hematology (BCSH) recommend screening by Full blood count (FBC) at booking and at 28 weeks instead of universal iron supplementation \[Pavord S. 2012\]. Lactoferrin is a high-affinity cationic iron binding glycoprotein \[Baker EN, 2005\]. Bovine Lactoferrin is currently available pharmaceutical preparation. It is in to safe and effective in treating pregnant women suffering from ID and IDA \[Mohamed Rezk, et al. 2015\]. This study will compare the efficacy of these three available options.

Eligibility Criteria:
Inclusion Criteria:

• Pregnant women (aged 20-40 yrs.) with single fetus, in the second trimester, with normal haemoglobin level (Hb level ≥10.5 gm /dl) will be enrolled.

Exclusion Criteria:

* Women with anaemia (Hb level ≤10.5 gm. /dl) due to any causes, such as chronic blood loss, haemolytic anaemia and thalassemia (including thalassemia trait).
* History of peptic ulcer.
* Medical complications with pregnancy (such as cardiovascular, thyroid, pituitary, nutritional, renal, liver diseases, diabetes mellitus (DM) and hypertension (HTN).
* Fetal abnormalities such as microcephaly, intrauterine growth restriction (IUGR).
ProGrip Mesh Repair vs Lichtenstein Operation

The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein Operation with lightweight polypropylene mesh.

Single-center patient-blinded randomized clinical trial comparing self-gripping mesh (Parietex ProGrip) and standard Lichtenstein method using lightweight polypropylene mesh. Patients will be randomly allocated to the Lichtenstein Operation (L) and ProGrip Repair (R) group. Patients will be followed for one year. The primary outcome measure are: postoperative pain using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS). Assessments will be made before the surgery, in the day of discharge, 1, 6 and 12 months postoperatively.

Secondary endpoints: recurrence rate, post-operative complications (short and long-term), foreign body sensation, incidence of surgical-site injury, costs, hospital stay, surgery duration, safety and patients satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* All patients with primary inguinal hernia
* Signed consent

Exclusion Criteria:

* Recurrent hernia
* Emergency procedure
* Patient not willing to participate
Return to Everyday Activities in the Community and Home

The purpose of this study is to test feasibility for the delivery and perceptions of a lifestyle model for middle-aged and older adults by involving participants in its development. The goal of the program is to reduce sedentary behaviour, increase physical activity, and increase strength and balance. An optional walking program will be run in parallel to emphasize the importance of moving more. Participants will be asked to fill out questionnaires on course delivery, content and effect throughout the program and 2-3 recorded interviews throughout the study. We will collect measurements of physical performance before and after the program.

This study aims to describe the delivery of a lifestyle model for older adults. Return to Everyday Activities in the Community and Home (REACH) is a health promotion program aimed at middle-aged and older adults. The goal of REACH is to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC. We will gather pre- and post-intervention measures of program perceptions, delivery psychological variables and physical performance outcomes. We will also collect participant feedback about course delivery, content and effect throughout the program. This study will allow us to describe the delivery strategies of REACH and involve the participants in the development of the REACH program. The optional walking program will emphasize the importance of increasing daily physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Participants included will be women aged 55 and older.
* Participants must speak English.
* Participants must be able to walk a minimum of four city blocks, climb a flight of stairs and take part in a physical activity and walking program.
* Participants must be cleared by a health care professional to participate using the Physical Activity Readiness Questionnaire for Everyone (Par-Q+) assessment to determine if they are physically able to take part in the activity program.

Exclusion Criteria:

* Individuals will be excluded if they are men, under the age of 55 and/or do not speak English.
Gut Microbiome in People Living With HIV and HBV

Building a Microbiome Data Platform and Conducting Clinical Evidence Research in Individuals Infected with the Human Immunodeficiency Virus (HIV) and Hepatitis B virus.

Chronic HIV infection, which often results in metabolic disorders, leads to shifts in the gut microbiota, contributing to immune activation and chronic inflammation. This study seeks to compare the gut microbiota in individuals with chronic HIV infection and chronic hepatitis B patients. The objective is to identify specific gut bacterial strains and metabolic pathways linked to the metabolic disorders commonly observed in HIV patients.

Eligibility Criteria:
Inclusion Criteria:

1. HIV patients

   * Inidividuals over 19 years old
   * HIV patients on antiretroviral therapy (ART)
2. HBV patients

   * Individuals over 19 years old
   * Chronic hepatitis B patients with either chronic hepatitis, liver cirrhosis or hepatocellular carcinoma

Exclusion Criteria:

1. Patients with indeterminate colitis
2. Individuals who have used antibiotics or steroids within 24 hours of the microbiome sample collection (excluding antiviral treatments for hepatitis B and HIV)
3. Individuals who have used vaginal or external medications, including antifungal agents, within 24 hours of microbiome sample collection
4. Those with acute illnesses, with or without fever, of moderate or severe severity; however, sampling may be postponed until the subject recovers.
5. Individuals with gastrointestinal disorders that may impact microbiome analysis and are currently medically uncontrolled or under treatment for the respective condition
6. Individuals with a positive result in a urine pregnancy test, pregnant, or breastfeeding at the time of microbiome sample collection
7. Individuals for whom medical opinions suspect that they may have an impact on the sample collection at the time of microbiome collection.