cyrilzakka/clinical-trials huggingface dataset:
Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

The purpose of this study is to determine whether a specific diet may help children with irritable bowel syndrome.

Many children experience stomach pain or discomfort at some point during their lives. Some children have belly discomfort frequently while others rarely have this problem. There have been very few studies to test treatments for recurrent stomach discomfort in children. Recently, studies in adults with recurrent stomach discomfort suggest that diet changes may help. Currently, we do not know if these same diets will work in children with the same problem.

In this study, two different diets will be provided (delivered) for two days with at least 5 days in between each provided diet. The child's symptoms will be recorded over the two days of each diet. Children will be asked to capture samples of their breath during the last day of the each two day delivered diet. Stool samples will also be collected.

Eligibility Criteria:
Inclusion Criteria:

Must include all of the following:

1. Children between the ages of 7-17 years;
2. Meet the criteria for IBS based on the Questionnaire on Pediatric Gastrointestinal Symptoms Rome III Version, including pain/discomfort a minimum of twice per week;
3. Negative physician evaluation for an organic etiology of the pain within the past year

Exclusion Criteria:

Will include any of the following:

1. Diabetes or other disease process requiring specialized dietary management;
2. Malnutrition or obesity (BMI \>95%);
3. Inability to eat by mouth;
4. Antibiotic or medicinal probiotic usage within the past 3 months (excluding yogurt);
5. Neuromodulator (e.g. amitriptyline) usage within the past 3 months
6. Start of, or change in gastrointestinal medication (e.g. laxative) dose that may cause or ameliorate abdominal symptoms within the past month
Transition From Pediatric to Adult Cystic Fibrosis Care Center

The main objective of register-SAFETIM is to assess the impact of the transition from pediatric to adult cystic fibrosis care center on changes in lung function and nutritional status of patients.

This is a multicenter, observational, longitudinal, with analysis of the French national registry data of patients with cystic fibrosis.

Our study will assess the clinical features of adolescent patients with cystic fibrosis during the transition from pediatric care to adult care. It will explore factors associated with the impact of the transition on the clinical course of adolescent patients (respiratory and nutritional functions).


Eligibility Criteria:
Inclusion Criteria:

- patients who switched from pediatric cystic fibrosis care center to an adult cystic fibrosis care center during 2013 or 2014, regardless of their clinical status.

Exclusion Criteria:

- Patients whose transition year is not given in the French national register, that is to say patients from some mixed care center.
Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis

Elastography is a new non-invasive medical technique for measuring the stiffness at a distance from a tissue. Recent advances in the development of elastography sequences for cardiac exploration suggest a more clinical approach to cardiac elastography. This study propose to compare myocardial stiffness of a group of coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction versus a group of patients who should benefit from a surgical aortic valve replacement for aortic stenosis.

The hypothesis is that the physiological adaptation to pressure overload constituted by aortic stenosis is responsible for a significant increase in myocardial stiffness compared to a reference group.


Eligibility Criteria:
Inclusion Criteria:

* Group I (aortic stenosis):

  1. Patient undergoing planned surgical aortic valve replacement (SAVR) for aortic stenosis (aortic valve area \<1cm² or an aortic valve area index \<0.6 cm² / m²);
* Group II: coronary bypass 2. Patient undergoing planned myocardial revascularization surgery (coronary bypass);
* Groups I and II 3. Patient over 18 years of age; 4. Patient having read and understood the information letter and having signed the consent form; 5. Patient affiliated or benefiting from a health insurance scheme

Exclusion Criteria:

* Group II: coronary bypass

  1. Ratio in TM mode of the wall thickness over the radius of the left ventricle (h / r \[0.45\]) confirmed by the TTE;
  2. Scar of myocardial infarction defined by an ECG anomaly and / or hypo-akinesia on TTE, and / or a late enhancement in MRI;
  3. Acute coronary syndrome less than 3 months old;
  4. Significant aortic stenosis (Vmax\> 1.5 m / s);
  5. Anomaly of segmental kinetics;
  6. Presence of left ventricular hypertrophy
* Groups I and II 7. Mitral valve disease (\> 1/4 confirmed by TTE); 8. Aortic insufficiency (\> 1/4 confirmed by TTE); 9. Left ventricle ejection fraction (LVEF) \<50% confirmed by TTE; 10. Hospitalization for heart failure less than 3 months old; 11. Urgent surgery; 12. Infiltrative heart disease; 13. Hostile pericardium defined by a history of mediastinal radiotherapy, tamponade or complicated pericarditis; 14. Decompensated or severe arterial hypertension. 15. Functional inability to walk preventing the performance of the walk test; 16. Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ; 17. Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship 18. History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent
Preoperative Pain Threshold and Rapid Recover Programs

To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.

A minimum of 200 patients, 100 hip and 100 knee arthroplasty participants, will be recruited for this study. Preoperatively, patient pain threshold will be recorded both objectively (Pressure algometer) and subjectively (brief pain inventory). In terms of location, objectively this will be tested during the preoperative visit in clinic by the approved, trained research staff, as well as the subjective brief pain inventory.

Objective pain measure: Pressure algometer will be obtained in the standard fashion as follows: the probe is applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds. The participant is instructed by the measurer to say "stop" when the sensation of pressure became the very first sensation of pain. There will be three spots to test patients, one for familiarity of the testing and the other 2 for data collection.

1. This is initially performed once on ipsilateral the tibialis anterior as a "warm up."
2. Then 3 measurements are taken on the operative medial epicondyle (for TKA) or ipsilateral lateral iliac crest (for THA) and averaged for the official score.
3. Lastly, three measurements are also taken on the contralateral olecranon to measure systemic pain sensitivity. If the contralateral elbow has had prior surgery or active bursitis, the ipsilateral elbow will be used. Of important note, the algometer has a max force lock out of 100N to prevent any harm to the patient.
4. Dominant Hand Grip strength measured by the average of 3 attempts on a Dynamometer.

Subjectively, the brief pain inventory is a validated pain outcome measure which will be filled out by the participant during their preoperative clinic visit.

Postoperative, the study team will ask the participant at the 6 week mark:

1. How many and what kind of opiates did the participant require?
2. How many days did the participant require opiates?
3. Did the participant require a refill? a. If so, did the participant have this filled in clinic preemptively or place a phone call to the office?

Eligibility Criteria:
Inclusion Criteria:

* any participant undergoing elective primary total knee arthroplasty or total hip arthroplasty
* Participants of the following investigators will be approached: Bolognesi, Wellman, Attarian, and Seyler

Exclusion Criteria:

* previous hip or knee surgery in the operative joint
Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis

This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions. Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels. Blood tests will be performed to measure the amount of drug and changes in measures of inflammation.

Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid Arthritis on a stable dose of methotrexate
* Rheumatoid Arthritis disease activity as assessed by blood tests

Exclusion Criteria:

* Serious or uncontrolled medical conditions
* Current or recent treatment with disease-modifying drugs other than methotrexate including but not limited to leflunomide, sulfasalazine, etanercept, infliximab, adalimumab, abatacept, rituximab
* Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent
Study of Prevalence of Eating Disorder in Liver Transplant Patients

The main goal of this observational study is to measure the prevalence of binge eating disorder in liver transplant patients by evaluating the responses to the Bulimia Test.

Secondary objectives of the study are to:

* Determine the prevalence of binge eating disorders in liver transplant patients following alcoholic cirrhosis, evaluated by the Bulimia Test;
* Study the association between the presence of eating disorder behaviours and liver damage : hepatic steatosis and fibrosis determined by Fibroscan (Transient elastography and controlled attenuation parameter)
* Study the association between presence of eating disorder behaviours and alcohol use disorder, measured by Alcohol Use Disorders Identification Test-Consumption


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* had a liver transplant and followed at University Hospital of Poitiers
* responded to the Bulimia Test-Revised and to the Alcohol Use Disorders Identification Test-Consumption
* had a Fibroscan within the year

Exclusion Criteria:

* Patient without Fibroscan and not responded to both scale : Bulimia Test-Revised and Alcohol Use Disorders Identification Test-Consumption
Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Patients Undergoing Cardiac Surgery

This is a prospective, multi-center, double-blind, randomized clinical trials.

Prospective randomized multi-center trial involving about 502 subjects will be enrolled in 3 centers. Patients will be randomized to two groups in equal proportion. Investigators set a hypothesis that precision cardiac anesthesia, which involves the modification of several crucial anesthetic modalities, would reduces the incidence of postoperative cognitive function and delirium in patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Aged≥18 years;
2. ASA:I to III;
3. Hemodynamic stability, LVEF≥40%;
4. Cardiac surgery including CABG, valve surgery, CABG combined with valve surgery, surgical repair of ASD,VSD and atrial myxoma, and other types.

Exclusion Criteria:

1. Declined to get involved;
2. Emergency cases, heart transplantation;
3. Severe hepatic insufficiency (Child-Pugh grades C),Severe renal insufficiency (requirement of renal replacement therapy);
4. Previous history of drug and alcohol abuse,allergy to general anesthetics;
5. Preoperative severe dementia, language barrier and mental illness
6. Preoperative schizophrenia, epilepsy, stroke and Parkinson's disease
7. Previous history of craniocerebral injury or neurosurgery;
8. Any other conditions that are considered unsuitable for study participation.
Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation

This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period
* Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study subgrouped
* Have been treated in the metastatic setting with 0 to 2 prior systemic regimens for mSTS (Systemic treatment regimens given in the neoadjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for the purposes of this protocol. Prior anthracycline-based regimen is allowable but not required. Subjects with extra-skeletal small round blue cell sarcomas, including rhabdomyosarcomas, must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy.)
* Have measurable disease, as defined by RECIST v 1.1 assess within 2 weeks of study entry and have radiologically documented disease progression greater than or equal to a 10% increase in the sum of the longest diameters of target lesions present within 6 months prior to randomization
* Have tumor tissue available for TEM-1 biomarker studies
* Be willing and able to provide written informed consent

Exclusion Criteria:

* Have received more than 2 prior systemic treatment regimens for mSTS
* Have received either gemcitabine or docetaxel in any previous treatment for mSTS (regardless of the line of treatment)
* Have a diagnosis of primary bone sarcoma of any histological type.
* Have a history of clinically significant heart disease, or clinically significant arrhythmia on ECG within the past 6 months
* Have a history of allergic reaction to prior monoclonal antibody or biologic agent
* Have received previous treatment with MORAb-004 (anti-TEM-1)
* Have a medical condition with a high risk of bleeding (e.g., a known bleeding disorder, a coagulopathy, or a tumor that involves the major vessels) or have a recent (within past 6 months) history of a significant bleeding event
* Have undergone major surgical procedures or open biopsy, have significant traumatic injury within 30 days prior to the first date of study treatment, or have major surgical procedures anticipated during the study
* Have a serious non-healing wound, an ulcer (including gastrointestinal), or a bone fracture
Behavioral Activation - From Inpatient to Outpatient Services

The purpose of this study is to compare the effectiveness of Behavioral Activation and Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts during inpatient care and can continue in an outpatient facility if the patients are discharged before 12 sessions has been completed.

Psychiatric inpatient care is reserved for individuals with the most acute mental health problems. The period after discharge is associated with increased risk for relapse, non-adherence and suicide. Delivering high quality psychosocial interventions during and after acute psychiatric inpatient care is known to be a difficult challenge. This study will investigate the effectiveness of adding either Behavioral Activation or Supportive Therapy to the standard acute psychiatric inpatient care. Subjects with different psychiatric diagnoses and elevated depressive symptoms are assessed and randomized after admission. Therapists from the nearest outpatient facility initiate 12 sessions of Behavioral Activation or Supportive Therapy as soon as possible. The 12 sessions are delivered twice weekly at the inpatient unit or at the outpatient facility, depending on whether the patient is admitted or discharged. Treatment as usual interventions(medications, nursing etc.) are not manipulated in the study. The main assessment points are pre-, post, 6 months follow-up and 12 months follow-up. The main outcome measure and some process measures are also administered at session 3, 6 and 9.

Eligibility Criteria:
Inclusion Criteria:

* Admitted into one of four acute psychiatric inpatient units in Dalarna
* MADRS-S 20 and above at acute admission and and after 2-3 days on the ward
* Psychiatric disorder according to M.I.N.I (Sheehan et al., 1998)
* Read and Speak Swedish

Exclusion Criteria:

* Acute psychotic symptoms
* Acute manic symptoms
* Confusion
* Primary eating disorder
* Primary alcohol or substance abuse disorder
* Self rated score on AUDIT (Saunders et al., 1993)of 20 or greater
* Mental retardation
Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn

Core temperature should be monitored under general anesthesia. Recently developed 3M Spoton skin temeprature which is applied on temporal artery is correlated with core temperature measure by esophageal prove in several studies. Conventional skin temperature over carotid artery is also correlated with core temperature in several studies. The purpose of this study is comparing 3 methods of temperature monitoring. First, conventional core temperature measure by esophageal stethoscope. Second, 3M Spoton applying on temporal artery. Third, 3M Spoton applying on carotid artery

Core temperature should be monitored under general anesthesia. Because patients are prone to hypothermia during surgery. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But some of them are invasive and impossible in sometimes. Recently developed 3M Spoton skin temeprature which is applied on temporal artery is correlated with core temperature measured by esophageal prove in several studies. Its mechanism is making zero heat flux on skin applied. But it also cannot apply in head or facial surgery. Other studies showed conventional skin temperature over carotid artery is also correlated with core temperature. The investigators hypothesized using Spoton on carotid artery could be alternative method measuring core temperature. The purpose of this study is comparing 3 methods of temperature monitoring. First, conventional core temperature measure by esophageal stethoscope. Second, 3M Spoton applying on temporal artery. Third, 3M Spoton applying on carotid artery

Eligibility Criteria:
Inclusion Criteria:

* Age 19\~60 years old
* Who need surgery more than 2 hours under general anesthesia
* American Society of Anesthesiologists physical status 1 or 2

Exclusion Criteria:

* Body mass index \< 35
* Head and neck surgery
* Patients with fever \> 38'C
* History of malignant hyperthermia
Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making

The objective of this proposal is to test whether a multi-media website (www.prepareforyourcare.org) that is focused on preparing older adults for communication and medical decision making can help people engage in advance care planning.

PREPARE is a website (www.prepareforyourcare.org) that teaches patients how to identify what is most important in life, how to communicate their preferences to clinicians and loved ones, and how to make informed decisions. It is written at a 5th grade level and includes voice-overs of text and closed captioning of videos that model advance care planning behaviors. The goal of this proposal is to test the efficacy of PREPARE plus an easy-to-read advance directive, versus an advance directive alone, to improve patient engagement in multiple advance care planning behaviors including discussions with surrogate decision makers and clinicians in addition to advance directive completion. The investigators will also determine whether PREPARE can empower and activate patients within clinical encounters with their clinicians and help to decrease health disparities in advance care planning.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking older adults (≥55 years)
* ≥ 2 chronic illnesses determined by International Classification of Diseases-9 (ICD-9) codes
* ≥ 2 visits with an outpatient primary care clinician at San Francisco General Hospital in the past year
* ≥2 additional outpatient/inpatient visits to San Francisco General Hospital in the past year

Exclusion Criteria:

* deaf, blind, or demented as determined by ICD-9 codes
* too mentally or physically ill to participate as determined by their clinicians
* Moderate or severe cognitive impairment as determined by the Short Portable Mental Status Questionnaire (SPMSQ), and mild cognitive impairment as determined by the SPMSQ plus an abnormal Mini-Cog
* self-reported poor vision and inability to see the words on a newspaper
* lack of a telephone
* traveling or moving out of the area for ≥3 months during the study follow- up period
A Unique Regimen for Treatment of Helicobacter Pylori Infection

The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori.

However, the efficacy of this triple regimen has been seriously challenged, and they are gradually becoming ineffective

Growing rates of treatment failure are observed worldwide and the eradication rate of triple therapy has declined over the past few decades. Helicobacter pylori infection has become increasingly resistant to traditional first line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates .So there is a considerable interest in evaluating new antibiotic combinations and regimens .

Eligibility Criteria:
Inclusion Criteria:

* Patients aged older than 21 years Presenting by Dyspepsia Infected by H. pylori (as proved by positive stool antigen test) Agreed to participate in the study and signed the consent

Exclusion Criteria:

* Patients who have received treatment with proton pump inhibitors within 2 weeks, NSAID or antibiotics within 4 weeks before study entry Patients who had received H pylori treatment before. Patients presenting by upper gastrointestinal bleeding Pregnant females Patients who have significant gastrointestinal, renal, hepatic, cardiovascular, metabolic, hematological disease.
Ultrasound Measured Hyomental Distance to Tongue Thickness Ratio as a Predictor of Difficult Intubation in Infants

Evaluation the role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants

Sonographic assessment of the airway after induction of anesthesia and Master Degree Thesis / MFA/ISRO/ Faculty Of Medicine/ASU Page 6 intubation: All infants will be placed in a supine position with their heads slightly extended. Then, the low-frequency probe (curved) will be first placed under the chin in the midsagittal plane and adjusted to show a clear view of the entire tongue outline and the border of the mandible and hyoid bone on the screen. The image will be frozen and stored. On the image the tongue thickness will be measured, which is the maximum vertical distance from the sub mental skin to the tongue surface (Yao W, Wang B 2017). After that, the HMDE will be measured, which is the distance from the lower border of the mentum of the mandible to the upper border of the hyoid bone.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged 1 to 12 months

Both sexes.

Physical status ASA I or II

Exclusion Criteria:

* Restricted mobility of temporomandibular joint
* Absent anesthesia or surgical consent
* Maxillofacial trauma or tumors
* A large mass or scar under the chin