cyrilzakka/clinical-trials huggingface dataset:
Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section

The aim of this study is to assess influence of probiotic Lactobacillus reuteri DSM 17938 on formation of gut microbiota in infant born by Caesarean section. It is anticipated that daily using of probiotic Lactobacillus reuteri DSM 17938 can prevent development of early dysbiosis of gut microbiota induced by Caesarean section.

This is a single-center prospective randomized double-blind placebo-controlled clinical study. The planned duration of the study for each included infant will be 16 weeks, 4 weeks of study drug intake and 12 weeks of follow-up. 140 healthy infants born by Caesarean section will be included in the general group of the study, and 60 healthy infants born by natural vaginal delivery will be included in the control group. For infants included in the control group, all the same protocol requirements and procedures will be applied as for infants in the general group, except for randomization and the study product / placebo intake. Infants included in the general study group will be randomly assigned into the study product / placebo subgroups in 1: 1 ratio. During the study the gut microbiota will be analyzed. Feces samples should be collected no later than 72 hours after birth, and also on 14th day of life ± 3 days, 30th day of life ± 3 days and 112th day of life ± 3 days. Short-chain fatty acids (SCFA) will be analyzed in feces samples.

Eligibility Criteria:
Inclusion Criteria:

* gestational age more than 37 weeks and less than 41 weeks
* age of enrolment is not more than 48 hours
* birth weight is corresponded to gestational age
* Apgar score ≥8 at 5 minutes
* Absence of congenital anomaly and/or clinical or physical abnormalities identified during clinical examination
* Primarily breastfeeding during the first days of life (more than 50%)
* Parent(s) are willing to comply with the exclusive breastfeeding regime during study period
* Parent(s) are willing to follow dietary recommendations during study period
* Parent(s) are willing to fill in the Diary every day
* Availability of the parent(s) and the infant during study period
* Written informed consent of the parent(s)

Exclusion Criteria:

* Chronic diseases or serious health problems of mother or child
* Gastrointestinal tract diseases of mother or child
* Delay in development
* Congenital abnormalities
* Intake of antibiotics by mother orally and / or vaginally during the last trimester of pregnancy
* Intake of probiotics by mother during the last trimester of pregnancy
* Using of general anesthesia during Caesarean section
* Emergency Caesarean section
Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU

The NUTRIREA-4 trial will test the hypothesis that an individually tailored rehabilitation program combining nutritional therapy, physiotherapy, and physical activity and started early in the ICU then continued uninterruptedly throughout the post-ICU stay and at home after hospital discharge improves the long-term outcomes of critical-illness survivors, compared to usual care.

From ICU admission to recovery at home, the trial patients will receive either usual care or the early extended rehabilitation program. Usual care will consist in nutritional support and physiotherapy according to usual local practice in each participating ICU. The early extended program will consist of nutritional therapy, physiotherapy, and physical activity according to a standardized protocol tailored to general- and muscle-health improvements achieved in each individual patient over time.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation (MV) started in the ICU within the past 24 h, or started before ICU admission with ICU admission within the past 24 h, and expected to be required for at least 48 hours after randomization
* Treatment with a vasoactive agent for shock (adrenaline, dobutamine, or noradrenaline)
* Nutritional support expected to be started within 24 h after intubation (or within 24 h after ICU admission if intubation occurred before ICU admission)
* Age 18 or older
* Patient and/or next-of-kin informed about the trial and having consented to participation in the trial. If the patient is unable to receive information and no next-of-kin can be contacted during screening for the trial, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with French law.
* Covered by the French public health-insurance system

Exclusion Criteria:

* MV started more than 24 hours earlier
* Specific nutritional needs, such as pre-existing long-term home enteral or parenteral nutrition for chronic bowel disease
* Dying patient, do-not-resuscitate order, or other treatment- limitation decision at ICU admission
* Social circumstances hindering follow-up and telephone/video consultations (no fixed address, non-European residence)
* Inability to provide a stable personal mobile phone number (temporary number or not in the owner's name)
* Communication difficulties via telephone or video consultation (pre-existing severe hearing or visual impairment)
* Pre-existing chronic illness with life expectancy \<6 months
* Pre-existing cognitive impairment
* Pre-existing spinal injury
* Inability to walk before the critical illness
* Acute or chronic neuromuscular disease
* Brain injury, e.g., due to cardiac arrest, stroke, or severe trauma
* Pregnancy, recent delivery, or lactation
* Adult under guardianship
* Correctional facility inmate
* Institutionalized patient
* Prior inclusion in a randomized trial designed to compare rehabilitation programs delivered to patients during critical illness
A Study to Assess the Safety and Tolerability of SOBI003 in Pediatric MPS IIIA Patients

MPS IIIA, also known as Sanfilippo A, is an inherited lysosomal storage disease (LSD). MPS IIIA is caused by a deficiency in sulfamidase, one of the enzymes involved in the lysosomal degradation of the glycosaminoglycan (GAG) heparan sulfate (HS). The natural course of MPS IIIA is characterized by devastating neurodegeneration with initially mild somatic involvement. The aims of the present study is to assess the dose related safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SOBI003, a chemically modified recombinant human (rh) Sulfamidase developed as an enzyme replacement therapy (ERT).

This is an open-label, non-controlled, parallel, sequential ascending multiple-dose, multicenter study to assess the dose related safety, tolerability, PK and PD of SOBI003 in pediatric MPS IIIA patients. Patients between 1 and 6 years of age who have not received previous treatment for MPS IIIA with an ERT, gene- or stem cell therapy will be eligible to participate in the study. The study is planned to consist of 3 dose cohorts, each comprising 3 patients. Treatment initiations will be staggered within each cohort in order to be able to observe, interpret and treat possible adverse reactions. SOBI003 is administered as weekly i.v. infusions over a period of 24 weeks. Upon completion of the 24-week treatment period with satisfactory tolerability, the patient is offered to receive continued SOBI003 treatment by participation in an extension study.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained from the patient's legally authorized representative(s)
2. Patients with MPS IIIA, as confirmed by both:

   * A documented deficiency in sulfamidase enzyme activity in concordance with a diagnosis of MPS IIIA, and
   * Normal enzyme activity level of at least one other sulfatase measured in leukocytes
3. Chronological age of ≥12 and ≤72 months (i.e., 1 to 6 years) at the time of the first SOBI003 infusion and a developmental age ≥12 months at screening as assessed by the Vineland Adaptive Behavior Scales, Second Edition (VABS-II)
4. Medically stable patient who is expected to be able to comply with study procedures

Exclusion Criteria:

1. At least one S298P mutation in the SGSH gene
2. Contraindications for anesthetic procedures, surgical procedure (venous access port) MRI scans and/or lumbar punctures
3. History of poorly controlled seizures
4. Patients is currently receiving psychotropic or other medications which in the investigator's opinion, would be likely to substantially confound test results
5. Significant non-MPS IIIA-related central nervous system (CNS) impairment or behavioral disturbances, which in the investigator's opinion, would confound the scientific integrity or interpretation of study assessments
6. Prior administration of stem cell or gene therapy, or ERT for MPS IIIA
7. Concurrent or prior (within 30 days of enrolment into this study) participation in a study involving invasive procedures
Standard Motorcycle Child Safety Helmet Initiative (MCHI) Program

The main aim of this intervention study is to test the hypothesis if helmet initiative program will significantly increase helmet usage in primary school students. The secondary aim of this intervention is to evaluate the behavioral change in standard child safety helmet usage among the parent/adult riders. The study was conducted in 23 primary school in Selangor from 1st January 2016 to 31st December 2018 in three different phases.

In Malaysia, the road traffic plans estimated that the number of death on road traffics might increase almost 23% from 2014-2020 (Royal Police of Malaysia, 2017). The main road crash involved the motorcyclist and the main cause of death was due to the severe head injuries. Previous study in Malaysia had reported only 20% of proper helmet usage among the adult riders (Malaysian Institute of Road Safety Research, 2015). This highlights the need to transfer the knowledge to the parent/adult riders on the importance, proper usage and availability of the standard child safety helmet and hence increase the prevalence of standard helmet usage for the pillion riders especially for the children.

Eligibility Criteria:
Inclusion Criteria:

* primary school students from selected school
* aged 7 - 12 years old
* Travel to school by motorcycle.
* the adult rider able to speak/read Malay and English

Exclusion Criteria:

* Students who are travelling to school using mode of transport other than motorcycle.
* pre school students
The Effects of Written Emotional Disclosure on Eating Disorder Pathology in a Clinical Eating Disordered Population

A technique that has been found to be effective at relieving the physical and psychological symptoms associated with inhibiting emotions and emotional thoughts is written emotional disclosure. The goal of this study is to evaluate the effectiveness of written emotional disclosure on the remediation of eating disorder behaviour, cognitions, and management of emotions.

New Partial program participants complete a packet of questionnaires during their initial appointment, which will be used as baseline levels of eating disorder symptoms and psychological health. Participants will complete the writing as part of their eating disorder therapy. The writing will be completed individually. The writing will consist of continuous writing for fifteen minutes on three consecutive days. The experimental group will write about traumatic or stressful experiences, while the control group will objectively describe events. A post-writing packet of questionnaires will be completed one week after completing the writing. A follow-up evaluation will occur four-weeks after completion of the post-writing packet and will include completing a packet of questionnaires and debriefing.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign consent form

Exclusion Criteria:

* Unwilling to sign consent form
Pectopexy Surgery Without Mesh

it is aimed to examine the effect of laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse Measurement (POP-Q) and quality of life of the patient.

Every gynecological patient with prolapse is evaluated with POP-Q staging. The POP-Q staging to be performed before the laparoscopic pectopexy operation without mesh (performed by using non-melting sutures with natural tissue repair) performed on the patients will be compared with the POP-Q staging that will be performed 6 months after the operation. In addition, the quality of life of patients before and 6 months after the operation will be compared with the incontinence quality of life scale questionnaire of Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12).

Eligibility Criteria:
Inclusion Criteria:

* having pelvic organ prolapse greater than stage 2 according to POP-Q evaluation system
* being sexually active

Exclusion Criteria:

* Disease requiring chronic steroid use
* Asthma
* Having chronic obstructive pulmonary disease
* Having malignancy,
* Having metabolic and rheumatological diseases that impair tissue healing, such as scleroderma
Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma

The purpose of this study is to determine safety and the maximum tolerated dose (MTD) of GRN163L and Velcade with and without Decadron when administered to patients with refractory or relapsed multiple myeloma.

GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease)
* Relapsed or refractory disease
* ECOG performance status 0-2
* Adequate hepatic/renal function and platelet count
* If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50%
* Fully recovered from any previous cancer treatments and/or major surgery

Exclusion Criteria:

* Prior allogeneic bone marrow transplant, including syngeneic transplant
* Bone marrow transplant within 12 weeks prior to study
* Known intracranial disease or epidural disease
* Inability to tolerate Velcade
* Inability to tolerate Decadron
* Prior malignancy (within the last 3 years)
* Clinically significant cardiovascular disease or condition
* Active or chronically recurrent bleeding (eg, active peptic ulcer disease
* Prolongation of PT or aPTT \> the ULN or fibrinogen \< the LLN
* Clinically relevant active infection
* Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease
* Any other cancer therapy within 4 weeks prior to study, with nitrosourea within 6 weeks prior to study
* Investigational therapy within 4 weeks prior to study
* Anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of IV access devices
* Radiation therapy within 4 weeks prior to study
* Major surgery within 4 weeks prior to study
* Active autoimmune disease requiring immunosuppressive therapy
* Known positive serology for HIV
Jinfukang Oral Liquid Combined With Chemotherapy for Treating Driver Gene-negative Advanced NSCLC

This is a prospective, randomized, multicenter real-world study, which aims to investigate the efficacy and safety of Jinfukang oral liquid combined with chemotherapy as first-line treatment regimen for patients with driver-negative advanced NSCLC. 328 patients with unresectable stage IIIB-IV NSCLC and Qi-Yin deficiency will be divided into experimental (n=164) and control groups (n=164) according to the stratified blocked randomization.


Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years of age;
2. Patients with stage ⅢB-IV NSCLC are diagnosed by histopathology and cytology;
3. Patients' tumor tissues are unresectable as assessed by the investigator;
4. Have measurable disease based on RECIST 1.1;
5. Driver gene (EGFR/ALK/ROS1) is negative;
6. Patients who are receiving first-line platinum-doublet chemotherapy with remaining no fewer than 4 therapeutic cycles;
7. Patients in chemotherapy who combined with other systemic therapy (including but not limited to immune checkpoint inhibitors and anti-vascular targeted drugs) are not suitable, but with radiotherapy can be permitted;
8. During chemotherapy cycles, patients who take prior treatment with anticancer Chinese medicine less than 4 weeks can be enrolled after stopping medication. If administration time is longer than 4 weeks, at least 4 weeks washout period should be performed;
9. Patients are diagnosed with Qi-yin deficiency by the Syndrome Differentiation of Traditional Chinese Medicine;
10. The expected survival time ≥3 months;
11. The subjects volunteer to sign the informed consent.

Exclusion Criteria:

1. Allergy or hypersensitivity to ingredients of the study treatment formulation;
2. Pregnant or lactating women;
3. Patients with multiple brain metastases, multiple bone metastases and liver metastases, which have great influence on survival times；
4. Patients are enrolling in other therapeutic trials;
5. The investigator does not consider the participant to be eligible for this study.
Clinical Decision Support to Improve System Naloxone Co-prescribing

The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months.

Clinical decision support tools help clinicians make treatment decisions based on routinely collected data and offer a promising strategy to implement evidence-based practices for safe and effective pain management. This project will use clinical decision support tools embedded into electronic health records to help healthcare providers make treatment decisions that align with opioid prescribing guidelines from the Centers for Disease Control and Prevention (CDC). The project will also use information from prescription drug monitoring programs, insurance claims, and mortality data to evaluate patient outcomes. This research will evaluate how prescribing practices that align with CDC guidelines affect patient outcomes and whether clinical decision support tools provide an advantage over standard care practices for pain management.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving an opioid prescription at discharge from inpatient/ED or close visit in outpatient settings where the clinical decision support (CDS) is implemented

Exclusion Criteria:

* Patients \<12 and \>89 year of age
* Cancer diagnosis
* Hospice care/palliative care
* Sickle cell disease diagnosis
* Patients who arrived in error
* Patients who were triaged to obstetrics
Sustained Viral Response in Patients Achieved HBsAg Level≤100 IU/ml After Completed Interferon Treatment

Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring good long term outcomes in patients with chronic hepatitis B. it was not clear whether patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained viral response and the state of HBsAg level≤100 IU/ml.

The patients with chronic hepatitis B and achieved HBsAg level≤100 IU/ml after completed interferon treatment will be enrolled and observed for 96 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period, liver function tests were performed every 3 months also. The liver ultrasonic examination would be taken every 3-6 months. The primary endpoint is HBV DNA reaction. The secondary endpoints is HBsAg loss.

Eligibility Criteria:
Inclusion Criteria:

* patients who had chronic hepatitis B and achieved HBsAg level≤100 IU/ml with undetectable HBV DNA level by interferon treatment

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver