cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Postoperative Application of HFNC at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients

This is a prospective study that uses the treatment guideline of our chest surgery ICU. Investigators recruited 90 patients who underwent MIE in the National Taiwan University Hospital. The clinical data collected included vital signs (blood pressure, heart rate, respiratory patterns and frequencies, saturation of blood oxygen and carbon dioxide, etc.), blood tests, images and bronchoscopic analysis of sputum.

The goal of this study is to analyze common care problems and complications patients may encounter during the acute stage in ICU after MIE. By comparing the differences between the treatment group and the control group, investigators can interpret the role of HFNC.

In recent years, for resectable esophageal cancer lesions, the National Taiwan University Hospital has developed MIE from the traditional open-abdomen and open-chest reconstructive surgeries. Because the wounds of minimally invasive surgeries are smaller, most of the patients can be extubated soon in the operation rooms. During the period when the patients are sent to ICU for observation, they do not need endotracheal tubes for positive pressure or sputum suction. Thus, high standards are needed for the inspections of post-operative chest care, depth of respiration and ability of expectoration in these patients.

The HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many times higher than the traditional nasal cannula. In addition, HFNC provides heating and moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out. This way, the patients can wear HFNC continuously for many days. Furthermore, when the patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses.

This is a prospective study that uses the treatment guideline of our chest surgery ICU. Investigators recruited 60 patients who underwent MIE in the National Taiwan University Hospital between January 2018 and December 2018. The clinical data collected included vital signs (blood pressure, heart rate, respiratory patterns and frequencies, saturation of blood oxygen and carbon dioxide, etc.), blood tests, images and bronchoscopic analysis of sputum.

The goal of this study is to analyze common care problems and complications patients may encounter during the acute stage in ICU after MIE. By comparing the differences between the treatment group and the control group, investigators can interpret the role of HFNC.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of esophageal cancer. Underwent minimally invasive esophagectomy surgery.

Exclusion Criteria:

1. The patient return to the intensive care unit without extubation 2. The patient who underwent tracheostomy surgery 3. Blood loss more than 1000c.c during the surgery 4. The patient who underwent CPR procedure or other emergent resuscitation management during surgery 5. The patient who is unable to communicate in words or speech

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Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil

An evaluation of the molecular and epidemiological aspects of endometrial cancer in Brazil is necessary to understand the high frequency of advanced disease. A better understanding of the current situation will generate essential data for the future development of national or international cooperative programs that aim to improve outcomes in these patients and generate additional knowledge for much-needed clinical trials in this population.

This is a retrospective observational cohort study. In this study, we will include patients diagnosed with endometrium cancer from January 2016 to December 2019 in participating sites and collect data on demographics, clinicopathological characteristics, treatment patterns, and outcomes. Data will be collected from medical records in selected centers that comprise different regions of Brazil.

The patient data sources will be the medical records of the patients. Patients will continue to receive treatment and clinical evaluations for endometrial cancer according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. To minimize patient selection bias, physicians should invite all consecutive eligible patients.

This study also provides for the collection and archiving of tumor tissue material. The samples will be tested to characterize the molecular subtype of endometrial cancer and will be sequentially stored in a biorepository to enable future translational studies, according to national regulations.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥18 years
* Histological diagnosis of endometrial carcinoma.
* Diagnosis of endometrial cancer between January 2016 and December 2019.
* FIGO (International Federation of Gynecology and Obstetrics, 2018) Stage I - IV.
* Site and investigator with access to a medical record chart from which data can be abstracted.
* Presence of a sample of tumor tissue (primary tumor or metastasis) available for biomarker testing.

Exclusion Criteria:

* Noninvasive endometrial cancer.
* Patients with a history of concurrent or previously treated non-endometrial malignancies except for appropriately treated 1) non -metastatic non-melanoma skin cancer and/or 2) non-metastatic low-grade thyroid tumors and/or 3) in situ carcinomas, including cervix, colon, and skin.
* Nonepithelial histology (leiomyosarcoma, adenosarcoma, endometrial stromal sarcoma, undifferentiated sarcoma, or other mesenchymal tumors.
Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol

The purpose of this study is to determine whether the use of both a nurse-driven sedation protocol and daily sedative interruption, compared with a sedation protocol alone, result in better outcomes for mechanically ventilated adults.

All critically ill, mechanically ventilated patients in the Intensive Care Unit receive medications to relieve pain and anxiety. However, accumulation of these medications can be associated with serious complications, most notably longer time on the breathing machine and in the ICU. Two strategies have been shown to dramatically improve patient outcomes: nurse-directed protocols for giving sedation, and daily interruption of sedation. However, these strategies have not been widely adopted, because of physicians' concerns, and because it is unclear which strategy is better. Given that patient outcome is improved with either of these strategies, the fundamental question that arises is whether patients managed with a combination of two strategies which both reduce drug accumulation (protocolized sedation and daily interruption) have an even better outcome than patients managed with only one of them (protocolized sedation).We are conducting a multicenter randomized trial in which 400 critically ill, mechanically ventilated patients will have their sedation managed with protocolized sedation alone, or both strategies. Primary outcomes are duration of mechanical ventilation and ICU and hospital lengths of stay. Secondary outcomes are the incidence of delirium, the use of neurologic tests, nurse and respiratory therapist effort associated with the sedation management, the incidence of patient self-removal of lines and tubes, and patient recall of the ICU stay. The results of this large multi-center trial will help to inform best practice with regard to sedation management of critically ill patients in Canada and elsewhere.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* Mechanically ventilated, with anticipated need for MV ≥48 hrs
* ICU team has decided to initiate continuous sedative/analgesic infusion(s)
* informed consent from patient and/or SDM

Exclusion Criteria

* Admission after resuscitation from cardiac arrest
* Traumatic brain injury
* Currently receiving neuromuscular blocking agents
* Allergy to midazolam and lorazepam
* Lack of commitment to aggressive treatment
* Previous enrolment in SLEAP, or current enrolment in related trial
Preference of Protein Intake and FTO rs1558902 Gene Polymorphism Among Women Obese

The concept personalized gene-based nutrition combines genetic information with specific dietary intake that is crucial in managing obesity. Obesity experienced by adult women is generally caused by inapproriate diet and sedentary lifestyle. Variations in the fat mass and obesity-related gene (FTO) has been linked with susceptibility to obesity, but diet seems to change the relationship. A single nucleotide polymorphism (SNP) in the fat mass and obesity-associated gene (FTO) is a potent predictor of human obesity. Higher protein diets were more appropriate than standard protein diets, and frequently recommended as a weight loss plan as it prevents the loss of lean tissue mass. Nevertheless, high intakes of proteins may adversely affect metabolic functions. Multi studies have explored associated FTO polymorphisms with obesity in different populations. However, the contribution of the FTO common variants to obesity is controversial in Asian people, some studies showed rs1558902 was statistically associated with BMI, but other results reported FTO gene is not statistically associated with obesity. Given the diversity of Asian populations, the investigators generated a hypothesis whether relations between preference protein intake and FTO rs1558902 gene polymorphism exist in selected Indonesian obesity women

The sample size was calculated based on the difference in the proportion of variation of the gene FTO rs1558902 allele A between obese participants, which previous study estimated to be approximately 6% for populations from Malaysia. Using a power of 80% and a level of significance of 5%, the investigators required 100 obese participants.

BMI and body fat which were assessed by SECA body analyzer (SECA 201). Blood samples were collected after a 12-h minimum fast by Prodia Laboratory for DNA isolation and biochemical analysis

Eligibility Criteria:
Inclusion Criteria:

* Body Mass index \> 25 kg/m2
* waist circumference \> 80 cm

Exclusion Criteria:

* chronic disease
* have pregnancy
* consume diet supplement, drugs
Clinical Performance Comparison of 2 THERANOVA 400 Dialyzer Prototypes in HD With High-Flux Dialyzers in HD and hv HDF Mode

The study investigates the performance of a new dialyzer (Theranova 400) containing a membrane with increased pore sizes. The performance will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Two different Theranova 400 prototypes (AA and BB) operated in hemodialysis mode will be compared with a Cordiax Fx-80 dialyzer, operated in hemodialysis mode, and with a Cordiax Fx-800, operated in high volume hemodiafiltration mode. Safety events and albumin loss into the dialysate will be monitored


Eligibility Criteria:
Inclusion Criteria:

1. Patient has end-stage renal disease (Chronic kidney disease stage 5D)
2. Patient is 18 years of age or older
3. Patient is male or female
4. Patient, if female, is non-pregnant; and if capable of becoming pregnant, will be using a medically acceptable means of contraception during participation in the study 5 .Patient has been receiving HD or HDF therapy for \>3 months prior to study enrollment and is expected to survive for at least 12 months after enrollment.

6. Patient has a stable functioning native fistula 7. Patient is willing to comply with the study requirements for therapy during the entire study treatment period 8. Patient is capable fo providing written informed consent to participate in the study

Exclusion Criteria:

1. Patient is undergoing single-needle dialysis
2. Patient has an known abnormal k/λ ratio (less than 0.37, or greater than 3.1)
3. Patient has a known active infection and is currently receiving antibiotic treatment
4. Patient has known active cancer
5. Patient has a known positive serology test for human immunodeficiency virus (HIV) or hepatitis B,C or E
6. Patient has a known serious hemostasis disorder
7. Patient has a known monoclonal gammopathy
8. Patient has a known polyclonal gammopathy
9. Patient has a unstable condition as judged by the treating physician based on medical history, physical examination and laboratory testing including (but not limited to) any of the following:

   * Myocardial infarction within the last 3 months
   * Tachyarrhythmia or bradyarrhythmia absoluta
   * Unstable angina pectoris
   * Left ventricular ejection fraction \<30%
   * Significant pericardial disease
10. Patient has any other known comorbidity that could, in the opinion of the Investigator, potentially conflict with the study purpose or procedure
11. Patient has a known significant psychiatric disorder or mental disability that could interfere with the patient's ability to provide informed consent and/or comply with protocol procedures
12. Patient has a history of non-compliance with the dialysis prescription, as assessed by the Investigator
13. Patient has participated in another interventional clinical study in the past 3 months, or is currently participating in another interventional clinical study
An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD

This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs.

This second early feasibility study will give valuable information on the usability of Previct Drugs once being used in the intended population, i.e, patients with confirmed Substance Use Disorder (SUD). It will also give valuable information on the feasibility of Previct drugs function to measure pupils and eye movements in this population including evaluating the safety when using the device.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Male and female
* A recurrent visitor at Sprututbytesprogrammet in Uppsala defined as visited the clinic within the last three (3) months
* SUD in accordanve with DSM-5 criteria according to investigator/designee judgement
* Age 18 and above
* Negative urine pregnancy test for all fertile women
* Been informed of the nature, the scope, and the relevance of the clinical investigation
* Voluntarily agreed on participation and has duly singed the Informed Consent Form

Exclusion Criteria:

* Participating in another clinical investigation which may affect the study outcome according to clinical judgement
* Pregnancy or lactating
* Blind
* Deaf
* Any ECG dangerous arrythmia according to the investigator or designee judgement
* Any disease or condition that may influence pupillary reflexes based on clinical judgement
* Undergone eye surgery that may influence pupillary reflexes based on clinical judgement
* Not able to read or understand the local language
* Any planned travel or treatment which will make it impossible to participate according to the investigator or designee
* Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate
* That according to the Declaration of Helsinki is deemed unsuitable for study enrolment
Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: a Randomized Controlled Trial

Theoretical Framework: Cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with Substance Use Disorders (SUD). Smoking exacerbates both physical and mental health issues, further complicating the treatment of SUD. Current therapeutic approaches for SUD often prove inadequate, indicating a need for new strategies. Recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction.

Objectives: This study aims to investigate the therapeutic potential of smoking cessation for individuals with SUD, using a six-week intervention within a therapeutic community. The research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. It is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems.

Methods: A randomized controlled trial (N=100) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. Metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. Assessments on a behavioural level will take place at a 3-months follow-up.


Eligibility Criteria:
Inclusion Criteria: Informed consent, a diagnosis of a form of substance use disorder (F1x.x) by a licensed psychiatrist according to ICD-10, minimum age of 18 years, sufficient knowledge of the German language, willingness to quit smoking.

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Exclusion Criteria: lack of consent, age below 18, inability to provide informed consent, acute psychotic symptoms or acute suicidal tendencies, cardiovascular disease, pregnancy or breastfeeding, severe mental or organic illnesses (such as epilepsy, brain tumors, recent major surgery), tumor diseases, dementia (Mini Mental Score \<20), severe autoimmune diseases or immunosuppression, acute infections, or acute diarrhea, prior gastrointestinal surgery (except appendectomy), probiotic intake within the last 6 months, or those consuming dietary supplements, probiotics, antibiotics, or prebiotic supplements during the study, prior participation in a smoking cessation programme.

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Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal

To evaluate the visual acuity, macular thickness, morphological changes after cataract surgery in eyes with previous vitrectomy for macular pucker. Associated risk factors were also investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patients had macular pucker surgery before cataract surgery.
* Follow up over 1 year.

Exclusion Criteria:

* Patients had any surgical complications such as posterior capsule rupture, vitreous loss, prolapse through the wound or iris trauma
* Patients had diabetes mellitus.
* Patients had uveitis or other inflammatory eye disease.
* Patients had history of retinal vein occlusion.
* Patients had retinal detachment; or previous vitrectomy for a disease other than macular pucker.
Monitoring Minimal Residual Disease（MRD）in Pediatric B-acute Lymphoblastic Leukemia

This study aimed to investigate the performance of next-generation sequencing (NGS) techniques measuring immunoglobulin heavy chain (IgH)-variable, diversity, and joining (V\[D\]J) clonal rearrangements （IgH-V\[D\]J NGS） compared with flow cytometry (FCM) in detecting of minimal residual disease (MRD) for children with acute lymphoblastic leukemia treated with South Chinese Children Leukemia Group (SCCLG)-ALL 2016, and to predict the relapse of the disease in the early stage and to assess the prognosis, so as to provide the basis for early intervention treatment and reduce the hematological relapse and improve the survival rate.

The measurement of residual leukemia levels, "minimal residual disease" (MRD), during therapy has now emerged as the most important predictor the outcome in acute lymphoblastic leukemia (ALL). As a result, risk-classifications based on MRD assessment has become an essential part of determining disease risk and directing therapeutic approach for children and adults with ALL.

Recently, next-generation sequencing (NGS) techniques measuring immunoglobulin (Ig) or T-cell receptor (TCR) clonal rearrangements as a method of detecting MRD have been introduced. These approaches expand the sensitivity of MRD detection to as high as 1 in 10,000,000 cells and have been shown to be predictive of relapse in children with ALL receiving standard chemotherapy.

In this study, the investigators will determine the sensitivity and specificity of IgH-V(D)J NGS and compared its capacity to measure MRD with that of flow cytometry using diagnostic and follow-up samples from more than 100 patients with ALL. Patients under age of 18 years with newly diagnosed ALL will be recruited and receive the treatment strategy of (SCCLG)-ALL 2016. After identifying a trackable clone in diagnostic samples (Baseline), MRD was measured using IgH-V(D)J NGS and FCM on bone marrow at 3 time-points: fifteen days after induction therapy (D15), thirty-three days after induction therapy (D33) and then at the end of induction therapy. Event-free survival (EFS), Relapse-free survival (RFS) and overall survival (OS) were assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Age≤18 years.
2. Newly diagnosed B-ALL.
3. No previous treatment.
4. Signed informed consent in keeping with the policies of the hospital.

Exclusion Criteria:

1. History of other malignancies, except in situ carcinoma or malignancy treated with curative intent.
2. Patients with active or uncontrollable infections such as hepatitis B, hepatitis C or HIV infection.
3. Patients with uncontrolled autoimmune diseases or immune defects. Other protocol-defined Inclusion/Exclusion may apply.
Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients

The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are:

Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL.

Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute T cell lymphoblastic leukemia
* With available minimal residual disease parameters assessed by flow cytometry and/or quantitative polymerase chain reaction
* Willing to undergo haploidentical hematopoietic cell transplantation and having a suitable haploidentical donor
* With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
* Signing an informed consent form, having the ability to comply with study and follow-up procedures

Exclusion Criteria:

* With other malignancies
* Failing to acquire a suitable unrelated cord blood unit
* With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy
* With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation
* With severe organ dysfunction
* In pregnancy or lactation period
* With any conditions not suitable for the trial (investigators' decision)