cyrilzakka/clinical-trials huggingface dataset:
The Effect of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability

RATIONALE: The prevalence of migraine is higher in patients with various intestinal diseases. An explanation could be that migraine is caused by a 'leaky gut': an increased intestinal permeability that allows food particles to pass the gastrointestinal wall. Probiotics may be able to improve intestinal barrier function.

OBJECTIVE: To test whether probiotics, as adjuvant therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability.

STUDY DESIGN: 12-week placebo-controlled randomized double-blind intervention with selected probiotics.

STUDY POPULATION: Adults who experience at least 4 migraine attacks per month. INTERVENTION: Subjects will receive either one daily dose of 2 g of Ecologic® Barrier or 2 grams of the placebo, containing only the carrier material (both provided by Winclove Probiotics).

MAIN STUDY PARAMETERS/ENDPOINTS: Incidence and severity of migraine attacks, measured by diaries and validated headache questionnaires will be measured at baseline and after 4, 8, and 12 weeks of probiotic/placebo administration. Secondary, intestinal permeability will be measured by the lactulose/mannitol absorption test in urine (screening, baseline and 12 weeks) and by fecal zonulin (baseline, 4, 8, and 12 weeks). Inflammation will be assessed from blood C-reactive protein and cytokine concentrations (baseline, 4, 8, and 12 weeks). Fecal samples will also be used for microbial analysis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects confirm to have migraine characterized by :

  * Recurrent attacks of moderate to severe headaches, often one-sided and pounding, often with nausea and/or vomiting, aggravated by physical activity
  * Sensitivity for light or sounds is possible but not exclusive.
  * Attacks last for 4 to 72 hours.
* Self-reported frequency of migraine attacks (or days) at least 4 per month
* Fairly predictable/stable pattern of migraine attacks (frequency, duration, intensity)
* Age ≥ 18 years
* Good overall health (self-reported in medical questionnaire)

Exclusion Criteria:

* Migraine patients who suffer from chronic daily migraine/headaches
* Migraine patients who suffer from medication-dependent headaches
* Subjects who suffer from cluster headache or tension-type headaches
* Subjects who used antibiotics up to two months before the start of the study
* Subjects who are unwilling to stop taking probiotics other than study products
* Patients with a chronic use of non steroid anti inflammatory drugs (because of increased gut permeability)
* Patients with inflammatory bowel diseases (because of increased gut permeability)
* Pregnancy or lactation (because of their possible effect on migraine incidence)
Influence of Tracheal-bronchial Anatomy Changes on Multi-detector Computed Tomography Scan of the Chest Upon Placement of Left-Sided Double Lumen Endotracheal Tube

One-lung ventilation (OLV) is used for thoracic surgical procedures to facilitate surgical exposure. Lung isolation is performed using a double-lumen endotracheal tube (DLT) and optimal position is achieved with the use of fiberoptic bronchoscopy. The most common technique used to place a left-sided DLT is the blind method technique, which consists of direct laryngoscopy and rotation of the DLT into the trachea with the aim to intubate the entrance of the left main bronchus. The DLT will be rotated counterclockwise blindly after the tip of the DLT passes the vocal cords under direct laryngoscopy. However, in some occasions, the tip of the DLT migrates into the right bronchus because the alignment between the trachea and right bronchus is more vertical. The identification of the misplacement can be challenging, which could lead to the failure of lung isolation. In order to avoid the unsuccessful lung isolation, Investigators are interested in identifying the factors that potentially influence the incorrect tube DLT placement diverting into the opposite bronchus.

Recently, multi-detector 3-dimensional computed tomography (MDCT) scan of the chest is becoming a routine study for patients requiring thoracic surgical procedures. On the day of thoracic surgery, the participant will be intubated with a left-sided DLT and investigators will confirm the correct insertion of the left-sided DLT at first pass under direct laryngoscopy. This information will be recorded and saved. After the study is completed, investigators will review the MDCT of the chest to review any abnormal findings and correlate it with the success of the insertion of the left-sided DLT into the left bronchus. Investigators will conduct a pilot study to determine the most influential anatomical change that leads to the DLT misplacement at the first pass based upon the changes of the tracheal-bronchial anatomy on MDCT.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Adult patient undergoing scheduled thoracic surgery which requires left side double lumen tube placement

Exclusion Criteria:

* More than 90 years of age
* Patients with emergency surgery
* Prisoners
* Patients who cannot provide their own consent
* Patient refusal
* Non-English speaking patients
Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy

Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles of this chemotherapy and to estimate the response rate to this combination in children and adolescents with recurrent solid tumors and lymphomas.

Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles of this chemotherapy and to estimate the response rate to this combination in children and adolescents with recurrent solid tumors and lymphomas.

Temozolomide is given by mouth one hour prior to each daily irinotecan dose days 1-5 of each cycle. 100 mg/m2/day. Irinotecan is given IV in dose escalation (minimum of 3 and up to 6 patients per cohort) starting at 15 mg/m2/day daily for 5 days for 2 weeks. Vincristin is given IV 1.5 mg/m2/dose (max dose 2mg) days 1 and 8 of each cycle. Vantin is given 10 mg/kg/day divided in 2 oral doses (max dose 400 mg/day) started 48 hours prior to the start of each treatment cycle and continued for 48 hours after last irinotecan dose. Cycle repeated every 28 days.

Therapy will continue for a minimum of two cycles unless there is progression of disease or unacceptable toxicity and may be continued as long as patient tolerates therapy and there is continued disease control up to one year of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Under age 21 years at time of study entry
* Malignant solid tumor, including CNS tumors and lymphomas
* Recurrent or refractory disease not amenable to other potentially curative therapies
* At least three weeks since last myelosuppressive chemotherapy \> 6 months from allogeneic stem cell transplant
* Adequate renal and hepatic function
* Adequate peripheral blood counts unless bone marrow is involved

Exclusion Criteria:

* Patients with leukemia not eligible
* Patients with uncontrolled infection excluded
* Patients who have received more than 4 prior chemotherapies
* Patients who are receiving P450 enzyme-inducing anticonvulsants
* Patients who are receiving any other cancer chemotherapy or any other investigational agent
* Possible pregnancy will be excluded
Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit

Wearable, commercially-available physical activity monitors are being increasingly incorporated into chronic pain self-management interventions as a tool to help patients set goals and to tailor intervention content based on patient progress. Yet older adults from resource-challenged communities may face significant barriers to using these monitors and reporting activity data. Our pilot study will focus on wearable monitor use among older adults in Detroit with chronic musculoskeletal pain, testing the feasibility and validity of various technology-based strategies for reporting daily step count data. The study will also assess whether six weeks of monitor use is associated with improvements in functioning, relative to a control group.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years
* Ambulatory with or without assistive device
* Community living
* Have a SMS-capable cell phone
* Internet access (via smartphone, in-home or elsewhere);
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months)
* \>4 (0-10 scale) average pain level over last week
* \>1 day/previous 30 when pain made it difficult to do usual activities
* Ability to travel to study location in Detroit for a one-time session

Exclusion criteria:

* Serious acute illness or hospitalization in last month
* Planned surgery in next month
* Severe cognitive impairment
The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease

A growing body of evidence links Chlamydia pneumoniae to the progression of coronary heart disease. The purpose of this study is to determine the positive and negative effect of 14 days treatment with clarithromycin 500 mg daily in patients already suffering from stable coronary heart disease. The participants will be followed for at least two years after the treatment.

Abbott Laboratories supplied Clarithromycin and placebo tablets.

Basic science suggests a fundamental role for inflammation in mediating all stages of coronary heart disease (CHD), and a large number of clinical studies have reported an association between markers of inflammation and CHD. Consequently, infectious agents have been proposed as promoters of atherosclerosis and/or acute coronary syndrome (ACS). Many studies have suggested a relation between Chlamydia pneumoniae (C. pneumoniae) infection and CHD, and C. pneumoniae has been demonstrated in atherosclerotic tissue.

Macrolide antibiotics are effective in eradication of C. pneumoniae from atherosclerotic plaques. Two small trials showed significant beneficial effects of macrolides on cardiovascular morbidity in patients with ACS. To corroborate and extend these findings, we undertook a randomised, placebo-controlled trial with clarithromycin in patients with stable CHD in order to test the hypothesis that intervention with a macrolide would reduce cardiovascular risk with regard to mortality and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 to 85 years and
* previous acute myocardial infarction (AMI) or
* previous or present angina pectoris and
* signed informed concent

Exclusion Criteria:

* AMI or unstable angina pectoris within the last three months
* revascularisation (PTCA or CABG) within the preceding six months
* severe heart failure (New York Heart Association (NYHA) functional class IV)
* known impaired renal or hepatic function
* active malignancy
* intolerance to macrolides
* treatment with methylxanthines, carbamazepine, cisapride, astemizole, terfenadine, or coumarin anticoagulants
* earlier inclusion in the CLARICOR Trial or participation in another drug trial within four weeks
* participation in other clinical trials within one month before this trial
* individuals incapable of managing own affairs or not able to sign written consent
* lack of written consent
* women of childbearing age not using reliable contraceptives
* breast feeding women
The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements

The purpose of this study is to evaluate if applying a compression bandage on the leg alters early outcome following TKA.

The primary objective of this study is to evaluate leg swelling by measuring leg circumference following simultaneous bilateral total knee arthroplasty (TKA) with and without the application of compression bandage.


Eligibility Criteria:
Inclusion Criteria:

* All patients receiving elective simultaneous bilateral primary total knee arthroplasty, treated by Rothman physicians at the Thomas Jefferson University Hospital or Rothman Specialty Hospital.

Exclusion Criteria:

* Previous venous thromboembolic event.
* Lymph edema in one or both legs.
* BMI \> 40
* Prior surgery (other than arthroscopy)
Cascading Dissemination of a Foster Parent Intervention

The primary goal of this study is to test the effectiveness of KEEP (Keeping Foster Parents Supported and Trained), an intervention intended to increase supports and consultation to foster parents, and to evaluate the transferability of the proposed intervention from Oregon to the foster care system in San Diego.

Children in the foster care system are growing in number, are at high risk for psychological problems, and are increasingly challenging to their foster parents. Foster parents who are trying to provide care and nurturing to these children are often doing so without benefit or meaningful or relevant consultation on developmental and mental health issues. The study tests the effectiveness of an intervention intended to increase supports and consultation to foster parents. A major aim of this study was to test the transferability of the proposed intervention from Oregon to the foster care system in San Diego in 3 regions of Health and Human Services. A cascading dissemination model will be employed, where the original developers train and supervise staff in San Diego to implement the intervention, and in the second iteration of the of the intervention, the involvement of the original developers lessened. The intervention is designed to provide foster parents with general support and specific parent management training (PMT), a well-documented and effective intervention approach. In a previous efficacy trial, PMT had positive effects with foster parents in three areas: 1) reduction of child symptoms, 2) lower rates of disruption in foster care (changes in placements for negative reasons), and 3) fewer foster parents in the PMT condition dropped out of providing foster care. Outcomes will be evaluated at multiple levels, including child symptoms, functional behavior, environments, consumer perspectives, and system using a multi-method/multi-agent strategy. Implementation fidelity will be assessed, as will contextual factors, including the organizational climate and social isolation/insularity of the foster parents. It is hypothesized that, compared to controls, foster parents in the intervention group will improve on parenting skills, feel more supported, and have less stress, which in turn will result in more positive child outcomes, including fewer reported child symptoms and higher levels of child functional behavior in three domains (i.e., home, school, with peers). Improvements in foster parent outcomes and child outcomes are both hypothesized to predict system-level outcomes, including child use of mental health services, foster parent retention, and placement disruptions. Contextual factors are expected to impact foster parent outcomes directly and child and system outcomes indirectly, through implementation fidelity.

Eligibility Criteria:
Inclusion Criteria:

* Any child between ages 5 and 12 years in relative or non-relative foster care

Exclusion Criteria:

* Only medically fragile children
Evaluating a Two Stage Intrapartum Fetal Assessment in India

An intrapartum fetal monitoring training programme (on intermittent auscultation and cardiotocography) will be delivered at Government Medical College (GMC) to all relevant staff. This quality improvement project and training evaluation aims to assess and evaluate the impact of this training. This will allow the investigators to understand if it is feasible and acceptable to staff, increases knowledge and improves patient outcomes.

As part of Misoprostol or Oxytocin for Labour Induction (MOLI) randomised controlled trial (RCT) (CTRI no. NCT03749902), Government Medical College (GMC) plans to increase the number of cardiotocography (CTG) machines available on labour ward and provide a United Kingdom (UK) based obstetrician to deliver training on cardiotocography (CTG) interpretation in order to improve fetal monitoring for this high risk population.

An intrapartum fetal monitoring training programme (on intermittent auscultation and cardiotocography) will be delivered at Government Medical College (GMC) to all relevant staff. This quality improvement project and training evaluation aims to assess and evaluate the impact of this training. This will allow the investigators to understand if it is feasible and acceptable to staff, increases knowledge and improves patient outcomes. It will be done through staff questionnaires, pre-and-post test scores and by examining the effects on maternal and perinatal outcomes using Kirkpatrick's training evaluation.

The whole project aims:

* To understand current practice and maternal and perinatal outcomes in Government Medical College (GMC)
* To improve intrapartum fetal monitoring with intermittent auscultation and cardiotocography (CTG)
* To improve perinatal morbidity and mortality rates
* To reduce caesarean section rates for presumed fetal compromise

Eligibility Criteria:
Inclusion Criteria:

* All women that deliver within the obstetrics department in Government Medical College (GMC) during the study period (8 months)

Exclusion criteria:

* Deliveries in A\&E/medical wards
* Home deliveries
* Patients delivered in other hospitals/ambulance deliveries
* Macerated still birth
* Fresh still birth with no fetal heart on admission to hospital
Value of 3D Printing for Comprehension of Liver Surgical Anatomy

To our knowledge, it has not been analyze whether 3D printed liver model would improve the perception of a given liver tumor or the precision of operation planning in liver surgery. We design this prospective controlled trial to test whether the 3D-printed patient specific liver model could be more informative than standard MDCT (multi-row detector computed tomography ) and 3D visualization system in predicting the surgical anatomy of liver.

The primary objective was to investigate whether 3D printing can improve localization of hepatic pathology. The secondary objective was to investigate whether 3D printing can improve the precision of surgical proposal.

The dataset of patients were prepared and stratified into MDCT, 3D visualization system and 3D printed liver model groups. The process started from MDCT scan image acquisition and moved through image segmentation and 3D rendering to end up with 3D printing.

Surgical residents were assigned to three different groups to study different modes of patients' data. Residents were ask to state the liver segment in which the tumor resides and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue. Residents were recommended to proceed in a classic way by resecting the whole liver segment. The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.

Eligibility Criteria:
Inclusion Criteria:

* Surgical residents
* Must had experiences with MDCT and 3D visualization system

Exclusion Criteria:

* Non surgical residents
* No experiences with MDCT or 3D visualization system
Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure

Administration of loop diuretics to achieve decongestion is the current cornerstone of therapy for acute heart failure. Unfortunately, there is a lack of evidence of how to guide diuretic treatment. Recently, urinary sodium, as a response measure of diuretic response, has been proposed as a target for therapy. The hypothesis of this study is that natriuresis guided therapy in patients with acute heart failure will improve diuretic response, decongestion, and reduce length of hospital stay, as well as heart failure rehospitalisations.

Objective: To assess the effect of natriuresis guided therapy in acute heart failure to improve diuretic response, decongestion, and clinical outcomes

Study design: Randomised, controlled, open label study

Study population: 310 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics.

Intervention: natriuresis guided treatment versus standard of care

Main study parameters/endpoints:

Co-primary outcome: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months Secondary outcomes: 48- and 72-hours natriuresis, length of hospital stay, percentage change in NT-proBNP at 48 and 72 hours.

Safety endpoint: doubling of serum creatinine at 24 or 48 hours, worsening heart failure.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Primary diagnosis of acute /decompensated heart failure as assessed by treating physician

   a. Acute Heart failure can be de novo or exacerbation of known heart failure and diagnosis is based on criteria in the ESC HF guidelines
3. Requirement of intravenous diuretic use

Exclusion Criteria:

1. Dyspnoea primarily due to non-cardiac causes
2. Patients with severe renal impairment receiving dialysis or requiring ultrafiltration
3. Inability to follow instructions
4. Any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study
Manual Manipulation and Ex Vivo Flexible Ureteroscopic Lithotripsy to Salvage Deceased Donor Kidneys With Renal Stones: A Case Series

we report the manual manipulation and Ex Vivo Flexible Ureteroscopic Lithotripsy to Salvage Deceased Donor Kidneys with Renal Stones,including nine cases,Renal transplantation was performed with the treated kidney after removing the stones, and the short-term postoperative outcomes were promising. cases were thoroughly reported in this paper.

The presence of donor kidney stones may lead to ureteral obstruction after transplantation, affecting the recovery of postoperative renal function. Thus, donors with kidney stones are often considered marginal kidney donors and likely disqualified,Here we describe a series case of multiple kidney stones in a donor kidney treated with the combined application of fURS and holmium laser lithotripsy (HLL) before transplantation. Renal transplantation was performed with the treated kidney after removing the stones, and the short-term postoperative outcomes were promising. The case was thoroughly reported in this paper.

Eligibility Criteria:
Inclusion Criteria:

* get renal transplantation donor kidney with stones

Exclusion Criteria:

* without renal stones the renal stones without Ex Vivo Flexible Ureteroscopic Lithotripsy