cyrilzakka/clinical-trials huggingface dataset:
The Factors Causing Treatment Failure in Children Receiving Oxygen Therapy With High-flow Nasal Cannula

The goal of this observational study is to identify the variables that predict treatment failure in order to identify the patients in which HFNC treatment may fail and not delay the transition to advanced respiratory support treatments in these patients.

The main questions it aims to answer are:

* What factors contribute to the failure of HFNC treatment in these children?
* What is the frequency of HFNC treatment failure in children with moderate and severe respiratory distress? Researchers will compare the group whose HFNC treatment was successful with the group whose HFNC treatment failed to identify factors that cause treatment failure.

Oxygen therapy with a high-flow nasal cannula (HFNC) is a well-tolerated, relatively new, non-invasive alternative ventilation treatment modality. On the other hand, HFNC failure delays advanced respirator supportive treatments, prolongs hospitalization in the intensive care unit, and emergency department, and causes a significant increase in morbidity and mortality with hypoxemia, neurological impairment, and/or hemodynamic instability. The investigators aimed to identify the variables that predict treatment failure in order to identify the patients in which HFNC treatment may fail and not delay the transition to advanced respiratory support treatments in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe respiratory distress
* Oxygen therapy with high-flow nasal cannula

Exclusion Criteria:

* Chronic lung disease (those with CO2 retention or hypoxia in their daily life)
* Cyanotic congenital heart disease
* Craniofacial malformation
* Trauma patients
* Hypotonic patients
* Cases with tracheostomy
* Patients using HFNC therapy for respiratory support after extubation
Analysis of the Personality Characteristics and Lifestyle of Young People Who Access Psychiatric Outpatient Clinics

Considering the growing importance of services psychiatric and psychological for adolescence and adulthood incidence of discomfort expressed in this age group, comes assessed the need to provide adequate and targeted services.

Reasons:

The study aims to evaluate the characteristics and trends of adolescents who access the service, in order to frame the type of discomfort expressed and the expectations with respect to access to the service and the resource base on which it can the therapeutic intervention must be thought out and organised. Furthermore, the study aims to identify the factors that influence the request for help and evaluate the quality of the assistance received, with the aim of improving it effectiveness.


Eligibility Criteria:
Inclusion criteria:

- Participants will be selected based on their age between 13 and 21, their availability to sign the informed consent.

Exclusion criteria:

* Patients who do not give their consent are excluded from the study.
* Patients who do not speak fluent Italian or those who due to cognitive and/or thinking characteristics would not be able to understand or complete the questionnaire are also excluded.
Modulation of Bifidocentric Dysbiosis Through Bifidobacterium Bifidum PRL2010 Supplementation in Caesarian-born Infants

This study is aimed to manipulate the composition of the intestinal flora of the infants born by caesarian section through the administration of the probiotic strain "Bifidobacterium bifidum PRL 2010", in order to evaluate its effects on gut dysbiosis during the first 6 month of life.

There has been increasing interest in the field of human microbiome, considering its impact on health and diseases. The gastrointestinal tract represents the most heavily inhabited organ with microorganisms, counting 10 times the total number of human cells; for this reason, the gut microbiome has recently been referred as a proper organ. Intestinal microbial composition is unique for each individual and it is influenced by numerous factors, of which delivery mode is an important one with gestational age of the newborn, type of feeding and intrapartum or neonatal antibiotic therapy. Recent reports suggest that dysbiosis secondary to delivery mode affects the subsequent regulation of immune response and may be associated with several pathologic conditions, for example allergic diseases or obesity. Moreover, gut microbiome seems to impact on neurodevelopment during first six months of life. Bifidobacteria is the most represented group of intestinal microbiota in the newborn, followed by Enterobacteria, and it plays an important role in the infant gut. This includes the fundamental function performed by Bifidobacterium bifidum: it supplies the nutritional material to the rest of the microbial community, particularly Bifidobacterium breve and Bifidobacterium longum infantis that are the other typical bifidobacteria of the newborn. It is a powerful metabolizer of the intestinal mucus and the HMOs (Human Milk Oligosaccharides) present in breast milk. Thanks to its exocitable enzymes, the degradative catabolism occurs in the intestinal environment. Thus, B. bifidum favour the increase in intestinal richness and biodiversity (9), which correlates with the host's state of health. However, bifidobacteria is reduced in infants born by cesarean delivery.

Aim of the study is to assess if the Bifidobacterium Bifidum PRL2010 supplementation effectively ameliorat bifidocentric dysbiosis due to the delivery mode and we want to confirm this by analyzing fecal microbiota in caesarean birth infants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants born by caesarian delivery
* Parents informed written consent

Exclusion Criteria

* Suspension of the administration of the probiotic strain for a period of time exceeding 7 days
* Interruption of the administration of the probiotic strain before the completion of the sixth month
* Replacement of Bifidobacterium bifidum PRL2010 with another strain
* Refusal to collect the fecal sample expressed by parents
* Major congenital birth deformities
* Acute illness at enrollment
* Any condition affecting food intake or metabolism
* Maternal mental and psychosomatic diseases
Bela 8 Week Dosing

The purpose of this study is to transition patients who have been stable on Belatacept for one year after kidney transplant from standard 4-week to an investigational 8-week belatacept dosing schedule. The investigators hypothesize that renal function and acute rejection rates will be non-inferior with 8-week belatacept dosing.

The current dosing protocol for patients who have undergone a kidney transplant requires that Belatacept be given as an infusion every 4 weeks. The investigator wants to assess if the patients who have been stable for one year after transplant can be safely transitioned to an 8-week Belatacept infusion schedule. Renal function and any episodes of acute rejection will be closely monitored.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥18 years currently),
* First-time renal transplant recipients of either living donor or deceased donor,

  1. who were initiated on belatacept at the time of transplant and
  2. are at least one year post-transplant and off CNI therapy for at least 6 months.
* Patients at low immunologic risk, defined as

  1. patients with a first transplant who have a PRA \< 50 against class I and class II antigens,
  2. no DSA (donor-specific antibodies),
  3. who have not had more than one episode of rejection, and
  4. no episodes of rejection within the last 6 months prior to enrollment, and
  5. no rejection with a grade of IIB or above.

Exclusion Criteria:

* Not first renal transplant, or multi-organ transplant recipient
* History of greater than one episode of biopsy-proven acute rejection, or of rejection of Banff 97 grade IIB or greater, or rejection within the last 6 months.
* Pregnancy (women of childbearing potential must use adequate contraception during study)
* Unwilling to receive all belatacept infusions at the Emory Transplant Center
* Calculated Glomerular Filtration Rate (GFR) less than 35.
* Serum creatinine at enrollment over 30% higher than 3 months (±4 weeks) prior to randomization
* HbA1C greater than 8 at enrollment
* Recent history of significant proteinuria (protein/Cr ratio \>1)
* Non-standard belatacept dosing (e.g. dose other than 5 mg belatacept/kg body weight)
* Cellcept dose less than 500 mg po bid.
* Prednisone dose greater than 5mg po qd within 3 months of randomization
* Patients not currently taking prednisone
* Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization
* Evidence of Cytomegalovirus (CMV) viremia or clinical CMV infection within last 3 months.
* Polyomavirus BK PCR (polymerase chain reaction) load greater then 4.3 (copy number greater than 20,0000) within 3 months of randomization
* Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)
* Known HIV (human immunodeficiency virus infection) (testing not required)
* Presence of donor specific antibody by Luminex single antigen assessment, or panel reactivity (PRA) above 50%.
* History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.
Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1.

This study aimed to investigate the efficacy of midodrine plus octreotide versus norepinephrine and to determine the predictive factors of response in patients with HRS-AKI.

Both sexes aged 18 years or older having cirrhosis, ascites, and a diagnosis of HRS-AKI based on the 2015 International Club of Ascites (ICA) diagnostic criteria \[2\] were eligible for participation.

Screening and eligibility criteria were verified upon admission to the ICU. A diagnosis of AKI was established through comparing sCr value at time of ICU admission to that recorded in the patient's file. Patients who meet all other diagnostic criteria of HRS-AKI provided by the previous definition \[2\] were enrolled in the study. Qualified patients were subjected to baseline assessments after informed consent signature. It included vital sign measurements, presence of comorbidities, height and weight, Child-Pugh score and Sequential Organ Failure Assessment (SOFA) score. Vital signs, Blood urea nitrogen, sCr, serum sodium, serum albumin, total bilirubin, and complete blood count with differential were measured at baseline and at daily basis throughout the study period. Patients were randomized in a 1:1 ratio to receive either continuous infusion of norepinephrine in an initial dose of 0.5mg/h (Maximum 3 mg/h or oral midodrine 5mg three times/day (Maximum 12.5mg three times/day) plus octreotide 100μg/6h as subcutaneous injection (Maximum 200 μg/6h). Duration of treatment was allowed to extend to a maximum of 10 days. Administration of albumin at doses of 20 to 40 gm/day was recommended, as clinically indicated, for all patients in both study arms as per current ICA guidelines.

Eligibility Criteria:
Inclusion Criteria:

* All patients that will be included in the study have cirrhosis as diagnosed by clinical, biochemical, and ultrasound findings, with HRS type 1, the absence of bacterial infections; however, patients with bacterial infections could be included in the study if renal failure persisted after infection resolution by clinical, laboratory indices up to 48 hours.

Exclusion Criteria:

* Patients will be excluded if there are advanced cardiovascular diseases due to poor prognosis or any extrahepatic disease that could affect the short-term prognosis, the presence of advanced hepatocellular carcinoma or presence of contraindication to norepinephrine as hypotension due to blood volume deficits except emergency measure, mesenteric or peripheral vascular thrombosis unless there is life-saving procedure, profound hypoxia or hypercarbia.
Acupuncture for Lumbar Spinal Stenosis

The clinical trial aims to evaluate the efficacy and safety of acupuncture in alleviating neurogenic claudication symptoms among patients with degenerative lumbar spinal stenosis (LSS).


Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnosis criteria of LSS;
2. Aged between 50-80 years;
3. Neurogenic claudication (NC) for more than 3 months;
4. Able to walk for at least 20 meters continually without device assistance, and forced to stopped walking out of NC within 30 mins in the meanwhile;
5. The average pain of buttocks and/or legs scores≥4 on the Numerical Rating Scale (NRS) when walking, standing, or extending the back in the past week;
6. More severe pain in the buttock and/or leg than in the lower back;
7. Score at least 7 on Modified Roland-Morris Disability Questionnaire（RMDQ）;
8. Central sagittal diameter stenosis of lumbar spinal canal as manifested by MRI or CT scan;
9. Volunteer to participate the trial and provide written informed consent.

Exclusion Criteria:

1. Non-degenerative LSS, such as congenital, post-traumatic or spondylolisthesis LSS; operation indications, such as segmental muscular atrophy, bowel and bladder disfunction, and spinal instability; tuberculosis or tumor in the lumbar area; or multiple vertebral compression fracture or compression fracture in the segment of stenosis;
2. Vascular claudication;
3. Severe heart, pulmonary, liver and/or kidney diseases;
4. Clinical comorbidities that may interfere with the assessment of pain intensity or walking ability, such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury, severe diabetes, and severe hypertension etc;
5. Unable to complete motorized treadmill test at the speed of 2km/h;
6. Severe psychiatric disorder or cognitive impairment that prevent the understanding of the outcome evaluating questionnaires;
7. A history of lumbar surgery;
8. Have received acupuncture treatments in the previous 2 weeks;
Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD

INTRODUCTION: Relationship between comorbidities and COPD is two-sided. While the number of comorbidities increasing, the frequency of acute exacerbations of COPD (AECOPD) is increasing, too. Comorbidity indexes can be used for recognition of comorbidities while managing COPD patients. In the present study, it is aimed to compare comorbidity indexes such as Charlson Comorbidity Index, COMCOLD and COTE in the matter of exacerbation frequency.

METHOD: Subjects hospitalized for AECOPD, admitted to the study. Exacerbation severity, frequency, further exacerbations for a 1-year period in the follow-up period and CCI, COMCOLD and COTE scores were recorded. High and low comorbidity groups were compared for AECOPD frequency, severity, and further exacerbations.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients
* Admitted to the ward for AECOPD

Exclusion Criteria:

* Not giving informed consent
* Unable to perform PFT
* Lost to follow-up
Diagnostic Evaluation of Esophageal Motility Disorders Using the Chicago IV Protocol in Egypt

Esophageal motility disorders (EMDs) encompass a spectrum of conditions characterized by abnormal movement and coordination of the esophagus, leading to symptoms such as dysphagia, chest pain, regurgitation, and heartburn . These symptoms can severely impact quality of life, often requiring detailed diagnostic evaluations for appropriate management . High-resolution esophageal manometry (HRM) has emerged as a critical diagnostic tool, providing comprehensive assessments of esophageal motility and improving our understanding of the pathophysiology behind EMDs . The advancements in HRM technology have significantly enhanced diagnostic accuracy, leading to more effective treatment strategies.

The Chicago Classification (CC) was introduced to standardize the interpretation of HRM findings and facilitate communication among clinicians. Since its inception in 2009, the classification has undergone several updates to reflect ongoing advancements. The most recent update, Chicago Classification version 4.0 (CC v4.0), resulted from two years of collaboration by an international working group of motility experts . This version places a greater emphasis on clinical relevance, refining diagnostic criteria to include standardized assessments in both the supine and upright positions, as well as the use of provocative maneuvers to provide a more thorough evaluation of esophageal function

. These enhancements aim to improve the understanding and diagnosis of complex motility disorders Although CC version 3.0 (CC v3.0) has been widely utilized, it has limitations that CC v4.0 effectively addresses to enhance esophageal motility testing. By requiring assessments in both supine and upright positions, CC v4.0 captures motility abnormalities in more physiologically relevant conditions, The inclusion of provocative testing methods, such as multiple rapid swallows (MRS) and solid swallows, further increases sensitivity for detecting disorders under stress. Moreover, CC v4.0 offers a comprehensive analysis of esophagogastric junction (EGJ) function, introducing criteria for EGJ outflow obstruction and EGJ typing, which clarify interactions with the lower esophageal sphincter . This updated framework also emphasizes bolus transit and metrics for fragmented peristalsis, facilitating the identification of subtle motility issues that may impact bolus clearance In Egypt, the majority of manometric devices are configured to automatically interpret results using CC v3.0, limiting the integration of newer diagnostic criteria. By manually applying CC v4.0 in this study, we seek to determine whether its updated metrics offer enhanced diagnostic precision and a better correlation with clinical symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years) at Ain Shams University presenting symptoms such as dysphagia, chest pain, regurgitation, or heartburn.

Exclusion Criteria:

* Patients with prior esophageal surgeries, significant structural abnormalities, or those unable to provide informed consent will be excluded.
Gemcitabine-Cisplatin-90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma

The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of 90 Y TARE (Y90) in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma (ICC).

Gemcitabine and cisplatin chemotherapy is the current standard for the treatment of unresectable intrahepatic cholangiocarcinoma. 90Y TARE combined with the current standard may be an ideal way to improve disease control in the liver as almost all patients die from their disease in the liver. The data from this trial would then be used to move to a phase II trial to determine efficacy to see if a phase III trial would be warranted. In addition, assessment of the molecular classification of intrahepatic cholangiocarcinoma could determine if there is difference in survival with chemotherapy and 90Y TARE. Finally, MRI before and after treatment will be used to determine if utilizing the percent increase of mean ADC correlates with survival.

Eligibility Criteria:
Inclusion Criteria:

* Histologic Documentation: Core needle biopsy or surgical specimen that confirms intrahepatic cholangiocarcinoma (ICC). Patients must be determined to be unresectable by a multidisciplinary team that includes a hepatobiliary surgeon.
* No prior liver radiation therapy or immunotherapy for cholangiocarcinoma.
* Only one previous single agent chemotherapy for ICC allowed.
* Patient may have prior liver resection.
* Age \> 18 years of age.
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (see Appendix E)
* Child's Pugh score of A (see Appendix F)
* Life expectancy of greater than 4 months
* Normal organ and marrow function as outlined in the protocol.
* Willingness to use effective contraceptive methods during the study. Patient may participate in the female (or female partner of male subject), either is not of childbearing potential (defined as postmenopausal for \> 1 year or surgically sterile) or is practicing two forms of contraception. Sexually active male participants must agree to use a physical barrier method (male latex rubber condom with or without spermicide).
* Patients with well controlled HIV infection are eligible if their CD4 count is \>499/cu mm and viral load is \< 50 copies/ml.
* Pre-certification for the 90Y TARE should be performed prior to enrollment on this study.
* All patients must be informed of the investigational nature of this study and must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have had major surgery within 4 weeks prior to entering the study or those who have not recovered from complications from a surgery more than 4 weeks earlier.
* Patients may not be receiving any other investigational agents.
* Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association (NYHA) Criteria
* Patients must NOT have liver disease such as cirrhosis or sever hepatic impairment as defined by Child-Pugh Class B or C
* Pregnant women are excluded from this study.
The Effect of Probiotic and Zinc Supplementation on the Common Cold

The purpose with this study is to investigate the preventative effect of a supplement containing a combination of probiotic bacteria and fungi as well as zinc on the common cold. The hypothesis is that it will shorten the duration, alleviate the severity of symptoms or even decrease the number of infectons during the intervention period. This study is a randomzed placebo controlled human study were healthy adults will consume the supplement for three months.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Diagnosed gastrointestinal disorders
* Autoimmune diseases or immuno compromized
* Antibiotic treatment in the last month
A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects

To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or 3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI = Body weight (kg) / \[Height (m)\]2: at least 18.5 and less than 25.0
* Judged by the investigator or subinvestigator to be healthy based on test results at screening and prior to administration on Day 1 of the treatment period

Exclusion Criteria:

* Findings (sunburn, abrasions, tattoos, etc) on the back that affect the evaluation of the safety of the skin
* Judged by the investigator or subinvestigator as inappropriate to participate in this trial for any other reasons