cyrilzakka/clinical-trials huggingface dataset:
Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors

This study evaluates longitudinal data associating changes in gut microbiota composition and diversity, defecation, performance status and adverse reactions in response to prebiotic fiber supplementation in patients with gastrointestinal cancer chemotherapy-related diarrhea. 120 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm A (intervention group) will receive prebiotic fiber and loperamide hydrochloride capsule(a drug for standard treatment). Arm B will receive maltodextrin placebo and loperamide hydrochloride capsule.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65, be able to comply with the protocol
* Life expectancy greater than 3 months
* Patients with cytologically or histologically confirmed diagnosis of gastrointestinal cancers
* Undergoing chemotherapy, not synchronized with radiotherapy and other anti-tumor treatments
* Chemotherapy-related diarrhea grade 2-4
* Not experience diarrhea before chemotherapy

Exclusion Criteria:

* age\<18 or \>65
* Patients who cannot eat by mouth for example chewing disorders, difficulty swallowing, intractable vomiting, gastrointestinal obstruction or gastrointestinal tract bleeding
* Other acute or chronic diarrhea or colostomy
* Patients with other severe adverse effects of chemotherapy other than diarrhea
* Patients with severe diseases of heart, kidney, liver and other major organs
* Use of any other drug for promoting intestine movement
* Use of any other drug or dietary supplement for chemotherapy-related diarrhea such as other fiber supplements, probiotics, octreotide
* Allergic to the components of the intervention dietary supplements;
* Pregnancy (positive serum pregnancy test) and lactation
* Any other serious or uncontrolled illness which the investigator think is undesirable for the patient to enter the trial
Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes

The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days.

The data published this year from a multicenter study in Brazil presenting the patterns of use and clinical outcomes of PICC indicated that centers with vascular access teams, adoption of best practices, and current technologies result in low rates of complications, such as primary bloodstream infections related to the catheter, deep vein thrombosis, and reversible occlusion. Despite these more recent data showing that complications related to PICC can be mitigated by the use of technology, vascular access teams, adoption of best practices, and infection control measures, there is still room to incorporate new techniques in PICC insertion with the aim of further reducing avoidable complications. For example, recent studies with robust methodology have demonstrated the benefit of the tunneling technique compared to the conventional insertion technique. A randomized clinical trial showed that the dwell time of the device inserted using the tunneling technique was longer compared to the conventional technique without tunneling in adult patients, along with a lower incidence of thrombosis and infection. At the Hospital de Clínicas de Porto Alegre, recently, nurses from the PICC Team were trained in the tunneling technique at a reference center in Brazil. The initial results of tunneling in adult, pediatric, and neonatal patients are encouraging.

The observed results of implementing the technique indicate that there is potential to reduce avoidable complications and prompt us to propose a multicenter randomized controlled trial involving two additional institutions with similar profiles regarding the composition of Vascular Access Teams, adoption of best practices related to catheter care, and active ongoing education. To our knowledge, robust studies of this nature are not currently being conducted in Brazil.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (\>= 18 years old) admitted to medical clinics, surgical clinics, or ICU, who have an indication for PICC insertion;

Exclusion Criteria:

* patients with Chronic Kidney Disease, whether dialytic or not;
* patients in critical or unstable condition characterized by the need for intubation, respiratory rate \<8 or \>35 breaths per minute, oxygen saturation \<90%, heart rate \<40 or \>140 beats per minute, systolic blood pressure \<90mmHg, decreased Glasgow Coma Scale \>2 points, or prolonged (\>5 minutes) or repeated seizures;
* patients with cognitive deficits that impair their understanding of the study and do not have a responsible party to assist in this stage.
Mental Simulations and Early Mobilization of Patients After Cesarean Section

Mental simulations can motivate patients for their first verticalization after cesarean section, although perceived anxiety before verticalization may reduce a positive effect of mental simulations.


Eligibility Criteria:
Inclusion Criteria:

* must be qualified to and undergoing delivery using Cesarean section,
* must be undergoing conduction of anesthesia during Cesarean section,
* must be undergoing the analgesic therapy in the postoperative period,
* must be qualified to mobilization by the medical staff,
* must be fluent in Polish in speaking and writing.

Exclusion Criteria:

* any orthopedic dysfunction,
* any neurological dysfunction,
* any psychiatric disease.
Cardiovascular Evaluation Before Renal Transplantation

Due to rising importance of cardiovascular disease before and after renal transplantation we have changed our standard diagnostic procedure and perform stress echocardiography and myocardial scintigraphy. We would like to monitor these results and the outcome of our patients.

Chronic kidney disease is a well-known risk factor for cardiovascular disease. Patients waiting for a renal transplantation usually undergo an extensive diagnostic procedure to avoid complications after transplantation such as neoplasia or inflammation. In the past years, cardiovascular complications before and after renal transplantation have gained more attention. We therefore have changed our standard diagnostic procedure before renal transplantation and perform stress echocardiography and myocardial scintigraphy. Thus we would like to evaluate our new standard diagnostic procedure and observe the results of these diagnostic procedures as well as their impact on clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* endstage renal disease
* preparing for renal transplantation

Exclusion Criteria:

* children (\< 18 years)
* women who are pregnant or nursing
* patients who are also awaiting heart transplantation or have already a heart transplant
* severe mental illness
Ovarian Reserve in Women With Cystic Fibrosis and the Correlation With Demographic and Clinical Parameters

The main objective of this study is to assess the ovarian reserve of CF patients via measurement of AMH and AFC. Secondly, we aim to correlate between the ovarian reserve and demographic and clinical characteristics of these patients.

Outcomes measured will be levels of AMH and AFC, as compared to standard means in the general population. There is no need for a control group in this study since the standardized means of AMH and AFC in the general population are a more accurate comparable measure, which is based on data collected from large-scale populations, and thus accounts for confounding age factor in a more complete manner than can be obtained via a control group (Almog et al., 2011, La Marca et al., 2012, Penzias et al., 2020).


Eligibility Criteria:
Inclusion Criteria:

* Female patients diagnosed with CF according to genetic testing.
* Age 18-45 years old.
* Routinely attended the CF Center at Hadassah Medical Center.

Exclusion Criteria:

* Refusal to participate in the study.
* Age under 18 or above 45.
* Use of hormonal contraceptives (for the purpose of AFC).
4SCAR-T Therapy Post CD19-targeted Immunotherapy

This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Anti-CD19 immunotherapy based on antibody conjugated drugs or CD19-CAR-T cells has demonstrated unprecedented positive response in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many patients still relapse and up to 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse usually have a poor prognosis. The mechanisms underlying CD19-negative relapses are not fully understood and it is important to develop solutions to supplement post-CD19 immunotherapies.

Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, the 4th generation CAR gene-modified T cells targeting CD22, CD10, CD20, CD38, or CD123 have been considered in post anti-CD19 treatment. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-escaped B cell malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 6 months.
2. B cell malignancies relapsed after anti-CD19 immunotherapy.
3. Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20.
4. The KPS score over 80 points, and survival time is more than 1 month.
5. Greater than Hgb 80 g/L.
6. No contraindications to blood cell collection.

Exclusion Criteria:

1. Complications with other active diseases, and difficult to assess patient response.
2. Bacterial, fungal, or viral infection unable to control.
3. Living with HIV.
4. Active HBV and HCV infection.
5. Pregnant and nursing mothers.
6. Under systemic steroid use within a week of the treatment.
7. Judged difficult to cooporate for continued evaluation.
ASSESMENT OF TONSIL VOLUME WITH ULTRASONOGRAPHY IN BOTH CHILDREN AND ADULTS

The tonsil volume is an important factor in the decision of the tonsillectomy operation. For this reason, it is important to evaluate the tonsil size before the surgery. Ultrasonography was used in a limited number of studies about tonsil tissue assessment and also those studies include only the pediatric population. In this study, we investigate the success of ultrasonography in adults additionally pediatric population as a contribution to literature.

Tonsillectomy is a common procedure performed on both adults and children. Recurrent tonsillitis, snoring and obstructive sleep apnea is among the most important indications for this surgery. Tonsil volume, in addition to recurrent tonsillitis frequency, are both considered in deciding tonsillectomy operation. Moreover, recent studies showed a correlation between tonsil hypertrophy and tonsillitis frequency. For this reason, a reliable assessment of tonsil volume is crucial both during clinical follow-up and surgery decision.

Today, a number of clinical staging systems are used to assess tonsil volume; with 'Friedman Scale' and 'Brodsky Scale' being the most commonly used systems. Those staging systems employ physical examination and are graded on palatine tonsils' midline extension. In other words, clinical staging uses just the transverse length of tonsils and vertical length and depth are dismissed. In addition, other factors such as patient non-compliance, size of the tongue and tongue base, hyperactive gag reflex and trismus make a clinical assessment difficult. For those reasons, a correct clinical assessment of tonsil volume is not always conceivable.

Ultrasonography (USG) was used in a limited number of studies about tonsil tissue assessment despite high patient compliance, low cost and its non-radioactive nature. Also, those studies include only the pediatric population.In this study, we would like to assess the success of USG in objective measurement of tonsil volume in both pediatric and adult populations and comparison of those results with clinical findings

Eligibility Criteria:
Inclusion Criteria:

* Tonsillectomy patients with recurrent tonsillitis
* Tonsillectomy patients with obstructive sleep apnea syndrome.

Exclusion Criteria:

-Tonsillectomy patients with suspected malignancy
Efficacy of Dexamethasone to Improve Clinical Outcomes in Coronary Artery Bypass Patients

This is a single-center, double-blind, randomized controlled clinical trial comparing four groups: placebo conventional coronary artery bypass graft (CCABG) group, dexamethasone CCABG group, placebo off-pump coronary artery bypass (OPCAB) group, and dexamethasone OPCAB group. The primary outcomes of this study is comprised of presence of arrhythmia, major adverse cardiac events (MACE), myocardial infarction, stroke, renal failure, respiratory failure, inflammation, and death. These primary outcomes were assessed during the surgery, 18 hours post surgery, every day during the hospital stay, 14 days and 30 days post surgery.

A single center randomized controlled clinical trial was conducted at Harapan Kita National Cardiovascular Center, Jakarta, Indonesia, as the tertiary cardiovascular referral hospital. The RCT was conducted from July 1st, 2018 to March 31st, 2019 (current status: completed). This study assessed the efficacy of intraoperative high dose dexamethasone administration (1 mg/kg BW, maximum dose 100 mg) in reducing inflammatory response and improving clinical outcome in patients undergoing coronary artery bypass surgery. The study groups consist of placebo CCABG, dexamethasone CCABG, placebo OPCAB, and dexamethasone OPCAB. The subjects were adults indicated to undergo elective coronary artery bypass surgery with no evidence of prior inflammation nor allergic reaction to dexamethasone. Both the patients and the principal investigators were blinded for the treatment-control allocation. The patients were purposively selected and were randomly assigned to one of the arms with block randomization. The primary outcomes of this study is comprised of presence of arrhythmia, major adverse cardiac events (MACE), myocardial infarction, stroke, renal failure, respiratory failure, inflammation, and death. These primary outcomes were assessed during the surgery, 18 hours post surgery, every day during the hospital stay, 14 days and 30 days post surgery. The minimum sample size required for this study was 100 subjects (25 each group).

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease patients indicated for elective coronary artery bypass surgery
* Patients aged \>18 years old
* Patients who agreed to participate in this study

Exclusion Criteria:

* Patients with preoperative systemic inflammation evidenced by high axillary temperature (≥38◦C) and high leukocyte count (≥15.000 ul)
* Patients with chronic arrhythmia
* Patients who are indicated to undergo other procedures than coronary artery bypass (i.e. valvular repair, septal repair)
* Patients with history of severe organ dysfunction (class IV congestive heart failure, renal failure, respiratory arrest, and stroke with sequelae)
* Patients with history of cardiac surgery
* Patients who takes routine corticosteroids or immunomodulators
* Patients who are allergic to corticosteroids
Analysis of Expression of Specific Markers in Hepatocellular Carcinoma

Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out. This will be done retrospectively using available hepatocellular carcinoma tissue samples.


Eligibility Criteria:
Inclusion Criteria:

* The patient had pathologically proven hepatocellular carcinoma
* All the data required are available from patient's records
* A sufficient amount of RNA is available for all three tissue samples

Exclusion Criteria:

N/A
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).


Eligibility Criteria:
Key Inclusion Criteria:

* Participants with Myelodysplastic Syndrome (MDS) defined according to World Health Organization classification, with Revised International Prognostic Scoring System (IPSS-R) prognostic risk category of intermediate, high, or very high risk.
* Adequate performance status and hematological, liver, and kidney function.

Key Exclusion Criteria:

* Immediate eligibility for allogenic stem cell transplant (SCT), as determined by the investigator, with an available donor.
* Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents.
* Any prior antileukemic therapy for treatment of intermediate, high, very high risk MDS per IPSS-R.
* Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which participants are not on active anticancer therapies and have had no evidence of active malignancy for at least ≥ 1 year.
* Contraindications to azacitidine.
* Clinical suspicion of active central nervous system (CNS) involvement by MDS.
* Known active or chronic hepatitis B or C infection or human immunodeficiency virus in medical history .
* Active hepatitis B virus and/or active hepatitis C virus, and/or HIV following testing at screening.
* Pregnancy or active breastfeeding.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy of Gut-Brain Neuromodulators in the Treatment of Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a common chronic digestive system disorder with a high prevalence and a notably increasing trend. It imposes significant costs in terms of treatment expenses and impacts patients' quality of life. Acid suppression remains the primary treatment for GERD. However, numerous clinical studies have shown that 20-30% of patients still exhibit poor response to proton pump inhibitors (PPIs) even after completing a standard course of acid-suppressive therapy. Many studies have demonstrated that the incidence of abnormal psychological conditions, such as anxiety, depression, and obsessive-compulsive disorder, is higher in GERD patients compared to the general population. Current international consensus acknowledges that the application of psychosomatic medicine principles and the use of neuromodulators can effectively alleviate symptoms in patients with gut-brain interaction disorders. Nevertheless, with the growing emphasis on digestive-psychosomatic-holistic medicine in clinical practice and the deepening of research on "gut-brain interactions," recent studies in the field of psycho-gastroenterology have challenged the notion that psychological processes are unique to gut-brain interaction disorders. Instead, these processes may play a universal role in symptom generation across the entire spectrum of GERD. Previous experiments have confirmed that Flupentixol-Melitracen (FM) can improve symptoms in GERD patients with a low incidence of adverse reactions. Therefore, we aim to verify the efficacy and safety of neuromodulators in patients with GERD, reduce healthcare costs, and provide new insights for optimizing treatment strategies for GERD patients in the future.


Eligibility Criteria:
Inclusion Criteria:

- Adults aged 18-70 years with gastroesophageal reflux disease (GERD) meeting diagnostic criteria.

Exclusion Criteria:

* Patients with organic gastrointestinal disorders (e.g., celiac disease, inflammatory bowel disease, history of gastrointestinal malignancies);

Severe dysfunction of major organs (e.g., class IV cardiac dysfunction, hepatic failure, uremia, respiratory failure) or congenital diseases (e.g., hemophilia, Wilson's disease);

Hypersensitivity to study medications;

Patients who are pregnant, lactating, or planning pregnancy;

Use of monoamine oxidase inhibitors (e.g., linezolid or intravenous methylene blue) within the past 5 weeks;

Severe psychological symptoms or cognitive impairment (GAD-7 \>15 or PHQ-9 ≥15);

Circulatory failure, central nervous system depression (e.g., acute alcohol, barbiturate, or opioid intoxication), or coma.
MR Textural Analysis in Low Grade Gliomas

WHO classification of low grade gliomas now relies on tumoral molecular patterns, especially on IDH mutation and 1p/19q co deletion status. Textural analysis on medical imaging is studied in several fields, and could provide help in patients with brain tumor due to possible complications of brain biopsy. The purpose of this study is to determine if specific textural signature on MR imaging could be found for low grade gliomas. The investigators included patients with LGG diagnosed at CHU of Nice abd whose first MRI was available on the PACS of the CHU. Textural data are extraxted by tumoral contouring and specific logiciel (LifeX) and histopathologic data are assessed for each patient. Then the investigators analyze it to dtermine if textural indices can predict molecar status.


Eligibility Criteria:
Inclusion Criteria:

LGG diagnosed at CHU of Nice abd whose first MRI was available on the PACS of the CHU

Exclusion Criteria:

-