cyrilzakka/clinical-trials huggingface dataset:
Pilot Testing a New Computer-based Screening Tool to Detect Cognitive Impairment

A computer-based neuropsychological assessment tool is being developed to help primary care physicians detect neurological and psychiatric disorders. The first version will be tested against current tests to confirm the tool's effectiveness. Data will be collected on how well the tool detects disease, how well patients understand the instructions and enjoy performing the tasks, and if particular trials or stimuli are too difficult or too easy for all subjects. Adjustments can then be made to the assessment tool, if needed. The initial participants will be age fifty-five to seventy-five with early dementias or mild cognitive impairment to reduce variability.

The investigators are developing a computer-based neuropsychological assessment tool to help primary care physicians detect neurological and psychiatric disorders. To confirm the tool's efficacy, the investigators will first test the prototype against established tests. The investigators propose to collect preliminary data on a limited group of subjects and age-matched controls. Collecting data on a limited group of subjects provides early insight into how well the tool detects disease, how well patients understand the instructions and enjoy performing the tasks, and if particular trials or stimuli are too difficult or too easy for all subjects. With this information, the investigators can make adjustments to the tool if needed and collect additional data on revised versions of the tool. The data will be used to establish the validity, reliability and sensitivity of the tool to generate consistent and accurate scores. The investigators will initially focus on a limited age range (age fifty-five to seventy-five) and limited set of diseases (early dementias or mild cognitive impairment) to reduce variability within the patient and control groups and to gain more statistical power with a smaller group of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Any subject with mild impairment from who has already undergone or will soon undergo a full neuropsychological evaluation.
* Subjects with Clinical Dementia Rating Scale CDR of 0.5-1.0 and Mini-Mental Score 20-26 (or MOCA equivalent, borderline/mild dementia) will be eligible for this group.
* Normal controls without exclusion criteria.

Exclusion Criteria:

* Subjects whose impairment is severe enough to limit their ability to perform the computer-based tasks and/or to provide consent.
* Subjects with history of learning disabilities or mental illness including major depression, bipolar disorder, anxiety disorders, and addiction are excluded because these problems can affect cognitive performance.
Low Dose of Diltiazem for Rate Control of Atrial Fibrillation

This study is to show the efficacy and safety of low dose diltiazem for the treatment of atrial fibrillation with rapid ventricular response in emergency room. We will compare the standard dose of diltiazem(0.25mg/kg) with low dose diltiazem(0.1mg/kg)in atrial fibrillation with rapid ventricular response in ED.


Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation with rapid ventricular response in emergency room

Exclusion Criteria:

* age\<18
* systolic blood pressure\<90mmHg
* no consent
The Effect of Parental Participation on Newborn Comfort During Diaper Care

It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants.

H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort.

H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants.

H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants.

The expectation of all parents is to have a healthy baby at the end of the pregnancy. However, newborns being born unexpectedly early and being admitted to the neonatal intensive care unit is a stressful situation for both newborns and parents. During this process, parents of preterm infants experience anxiety, loss of control, fear of the future, depression, role change and concerns about the improvement of the baby's condition. It is important for parents to actively participate in care within the framework of family-centered care practices in order to reduce the newborn's stress level, increase its comfort and improve its environment and to increase the families' ability to cope with this situation.Infant care, which is repeated many times a day in the Neonatal Intensive Care Unit, is one of the care practices that include tactile stimuli. Studies have observed that preterm infants' stress increases during diaper changes. For this reason, it is important to plan the necessary invasive practices to increase comfort during diaper changes, to include parental participation in these procedures, and to determine the effect of these interventions on the infants' comfort and to include them in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Infants whose gestational age is between ≥34 weeks and ≤36+6 weeks at the time of application
* Infants with stable health conditions

Exclusion Criteria:

* Intubated
* Those with very low and extremely low birth weight at the time of procedure
* Having a chronic disease
* Those with congenital anomalies
* Having undergone a surgical procedure
* Having neurological symptoms
* Receiving oxygen support
* Diagnosed with sepsis
* Sedated
* A pharmacological analgesic method was used four hours before.
* Parents who do not want to participate in care
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults

To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
* Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
* Willing to adhere to contraception requirements.
* Satisfactory medical assessment with no clinically significant or relevant abnormalities.

Exclusion Criteria:

* Current or recurrent/chronic disease
* Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
* Acute or chronic hepatitis C virus infection.
* History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
* Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
* Participation (that is, last protocol-required study visit) in a clinical study within 90 days before initiation of dosing on Day 1.
* Serum ceruloplasmin value outside of the normal range at Screening
* Female participants who were breastfeeding.
* Prior exposure to ALXN1840.
* Major surgery or hospitalization within 90 days prior to dosing on Day 1.
A Study of Pemetrexed Plus Oxaliplatin as First Line Therapy in Advanced Gastric Carcinoma

Open label single arm phase II study of Pemetrexed plus Oxaliplatin in patients with advanced gastric carcinoma not previously treated with palliative chemotherapy. 43 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: 6 cycles/21 days of Pemetrexed 500 mg/m2 followed by Oxaliplatin 120 mg/m2. This study will also include pharmacogenomic and pharmacogenetic investigations in order to assess determinants of efficacy and toxicity of the treatment with Pemetrexed and Oxaliplatin in the study population.


Eligibility Criteria:
Inclusion Criteria

* Histologically proven diagnosis of adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction)
* Stage IIIB or Stage IV disease, according to American Joint Committee on Cancer criteria, not amenable to curative surgery or radiation
* Disease status must be that of at least of one measurable disease as defined by RECIST criteria.
* Performance Status of 2 on the ECOG Scale.
* Adequate organ function including the following:
* Bone marrow: absolute neutrophil count (ANC) \>or equal to 1.5 \* 109/L, platelets \>or equal to 100 \*109/L, hemoglobin \> or equal to 10 g/dL.
* Hepatic: bilirubin \< or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) \< or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin \> or equal to3g/dL.
* Renal: Calculated creatinine clearance major or equal to 45 ml/min (using the standard Cockcroft-Gault formula).

Exclusion Criteria

* No Prior palliative chemotherapy for advanced disease
* Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment
* Known or suspected brain metastasis
* Second primary malignancy (except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed plus oxaliplatin
Laparoscopic Cholecystectomy Using Airseal in Children

The goal of this observational study is to compare the use of Airseal versus a standard insufflation, in children who underwent laparoscopic cholecystectomy, between January 2021 and December 2022.

The main questions it aims to answer are:

* amount of analgesics consumed postoperatively
* mean digital pain scale

Data are directly extracted from patients medical files.

The investigators will compare the Airseal group (A group) to the Standard insufflation group (S group) to see if the A group consumes significatively less analgesics and are less painful than the S group.

Choosing to enter the A or the S group depends on the surgeon's choice.

Only the surgeon, the anesthetic and the nurses in the operating room know which type of insufflation has been chosen.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged under 18 years old
* Who underwent laparoscopic cholecystectomy
* From January 2021 to December 2022

Exclusion Criteria:

* Patients older than 18 years old
Evaluation of Exercise Tolerance During Pregnancy

To evaluate the exercise tolerance during pregnancy and after thanks the 6MWT


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old
* healthy women

Exclusion Criteria:

* BMI (before pregnancy) \> 25
* complication with their pregnancy
Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects

This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design.

Part II is the drug-drug interaction study, an open-label and sequential design. 32 healthy subjects are planned to be enrolled and divided into group A and group B. Group A is to evaluate the influence of itraconazole as CYP3A4 strong inhibitory on HLX208. Group B was to evaluate the effect of rifampicin as a strong inducer of CYP3A4 on HLX208.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial. Must be able to communicate with the investigator, understand and comply with all study requirements;
2. Male or female subjects aged 18 to 45 (including 18 and 45);
3. Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 19 and ≤26 kg/m2. BMI = weight (kg)/\[height (m)\]2;

Exclusion Criteria:

1. Known history of drug or food allergy;
2. Those who have a positive urine drug screen or have a history of drug abuse;
3. Excessive smoking (≥ 5 cigarettes/day);
Influence of Intraoperative Blood Salvage and Autotransfusion on Tumor Recurrence After Deceased Donor Liver Transplantation

The practice of intraoperative blood salvage and autotransfusion (IBSA) during deceased donor liver transplantation (DDLT) for hepatocellular carcinoma (HCC) can potentially reduce the need for allogeneic blood transfusion. However, implementing IBSA remains debatable due to concerns about its possible detrimental effects on oncologic recurrence. Hence, a nationwide multi-center study was conducted to investigate further the association between IBSA and post-transplant HCC recurrence, including a stratified subgroup analysis.


Eligibility Criteria:
Inclusion Criteria:

* adult-to-adult deceased donor liver transplantation for hepatocellular carcinoma

Exclusion Criteria:

* patients under 18 years of age
* presence of extrahepatic metastasis
* combined kidney transplantation
* reduced-size or split liver transplantation
* re-transplantation
Chatbot for Depression, Anxiety, and Eating Disorders

The research team would like to test how efficacious an artificial intelligence chatbot is in delivering supportive behavioral interventions in populations with anxiety, depression, or eating concerns.

The research team has developed a deep learning-powered application that can provide support and therapeutic suggestions via natural dialogue. The chatbot is designed to be highly scalable such that it could address access issues (to address the majority of persons who do not not have access to therapy). Eventually, it is hoped this intervention can provide accessible therapy for those with anxiety, depression, and eating disorders, among other mental illnesses. The chatbot has been trained with intervention-oriented text conversations written by research assistants, employing a variety of therapeutic techniques, including cognitive-behavioral therapy. The research team hopes to test how well the chatbot can respond and aid those with mental health symptoms. The chatbot's effectiveness will be monitored based on the participants' interactions with the chatbot, as well as the participants' scores on the PHQ-9, GAD-IV, SWED, and general satisfactory questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* We will recruit participants online using Facebook, Google Ads, Reddit, MTurk, listservs, and other online platforms.
* These individuals must meet the criteria for anxiety, depression or disordered eating, according to the PHQ-9, GADQ-IV, and SWED 3.0.

Exclusion Criteria:

* Individuals currently being treated for active suicidality (measured with C-SSRS), Bipolar I/II, and active psychosis will be excluded from the study.
the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients

The prognosis for cholangiocarcinoma is bad. Potentially, early management by a palliative care team could increase overall survival. We will also assess whether early management by a palliative care team could impact progression-free survival, the place of death and the date of the last chemotherapy, in particular to avoid unnecessary chemotherapy cures in an imminent end of life


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years old
* intra- or extra-hepatic CCK or histologically proven vesicular adenocarcinoma
* Locally advanced and / or metastatic disease from the start or recurrent
* Initial diagnosis or recurrence between 1/01/2013 and 31/12/2019

Exclusion Criteria:

* \<18 years old
* death less than one week after the diagnostic
Probiotic Supplements in Chronic Kidney Disease

This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with Chronic kidney disease.

Chronic kidney disease (CKD) with gut microbiota was different from a normal person. Some gut microbiota produces short-chain fatty acids or induces functional enzymes beneficial to patients. On the other hand, some gut microbiota may also metabolize amino acids into p-cresol and indole which were leading to the accumulation of urinary toxins and damage to the kidney. This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins, inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with CKD.

Eligibility Criteria:
Inclusion criteria:

1. Aged over 20 years old.
2. Patients with 2\~3a stage chronic kidney disease.
3. Those who can cooperate with the research plan for 3 visits and retain samples (blood, urine).

Exclusion criteria::

1. Use of other probiotics during the study.
2. Those with active infectious diseases in the past month.
3. Those who have used antibiotics within the past 1 month or during the study.
4. Women who are pregnant or breastfeeding.
5. Obstructive nephropathy within the past month.
6. Polycystic kidney disease (polycystic kidney disease).
7. Acute kidney disease within the past 3 months.
8. Gastrointestinal bleeding within the past 3 months.
9. Malignancy.
10. Severe cardiovascular disease (cardiovascular disease) in the past 3 months, such as coronary artery disease (coronary artery disease), myocardial ischemia (myocardial ischemia), NYHA class IV myocardial failure, cerebrovascular disease, or peripheral artery disease.
A Study to Compare the Amount of Drug in the Blood After a Single Tablet EC905 Containing Solifenacin and Tamsulosin is Taken by Healthy Males Compared to Separate Tablets of Solifenacin and Tamsulosin

A study to assess the amount of drug in the blood of young to middle aged, healthy, male subjects after they received the final formulation of EC905 compared to solifenacin (Vesicare®) and tamsulosin OCAS (Omnic OCAS®).

Subjects are given a single dose of the combination tablet EC905, Vesicare® and Omnic OCAS® in 3 separate periods.

The subjects are randomized to one of 6 treatment sequence groups.

Subjects are admitted to the clinical unit on Day -1 for pre-dose assessments. They remain in the clinic for two periods of 11 days and one period of 14 days.

After randomization the subjects receive a single dose treatment on Day 1 followed by blood sampling for pharmacokinetic (PK) assessment. For both EC905 and Vesicare®, blood sampling continues for 10 days after dosing; for Omnic OCAS®, it continues for 3 days after dosing.

Each period is separated by a wash-out period of at least 4 day, and subjects are checked for eligibility again one day prior to the start of a new dosing day.

Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.

A blood sample is drawn for CYP2D6 genotyping, in order to evaluate the effect of the CYP2D6 genotype on the PK of tamsulosin.

Subjects return for an End of Study Visit (ESV) 7 days after the last on-site period, or after withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 18.5 and 30.0 kg/m2, inclusive

Exclusion Criteria:

* Known or suspected hypersensitivity to solifenacin, tamsulosin, EC905, Vesicare, Omnic OCAS or any of the components of the formulations used.
* Any of the contraindications or precautions for use as mentioned in the applicable sections of the SPC's of tamsulosin or solifenacin.
* Use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the Clinical Unit, as reported by the subject.
* Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2
Blood Management Program in the Post - Operative Period.

A care path in the field of transfusion medicine was creates at ASMN - IRCCS addressed to patients undergoing complex surgical procedures.

This pathway is called Blood Management Program (BMP).

The implementation of this process should improve transfusion therapy in the peri-operative period in order to:

* correct the transfusional approach to surgical patients
* optimize the management of transfusional resources (red blood cells, plasma, platelets)
* optimize the management of plasma derivatives, drugs and techniques designed to limit the use of homologous blood

Eligibility Criteria:
Inclusion Criteria:

-All patients undergoing complex surgical procedures

Exclusion Criteria:
Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions

The primary goal of this project is to develop a tailored screening, brief intervention and referral to treatment (SBIRT) model for youth with chronic medical conditions (YCMC) for delivery at point of care during a routine healthcare visit, through conducting a rigorous randomized control trial among adolescent patients with type 1 diabetes (TID) or rheumatologic conditions. The secondary goal is to assess the attitudes and knowledge of parents of these same adolescents, to explore links between parent beliefs and adolescent behavior around substance use.

The proposed project is a randomized control trial to assess the efficacy of an SBIRT model tailored to youth with chronic medical conditions. This trial is being built into a larger, longitudinal cohort study to assess whether a set of brief, substance specific questions can accurately predict adolescent substance use outcomes when compared to more lengthy, criterion standard assessment questions, in cross-sectional and prospective analysis. The first component of the project will consist of pre-testing an assessment battery and brief electronic intervention with a small sample of 14-17 year old youth. In the second component the investigators will randomize consented eligible participants into intervention or control arms of the study and administer the 1) Baseline Assessment Battery and the 2) Brief Intervention OR Treatment as Usual (TAU). In the third component the investigators will follow up with all participants at 6 and then 12 months after study entry to reassess rates of substance use through follow up assessment batteries.

At baseline, the investigators will also attempt to enroll parents of all participants who are present at the time of enrollment. The investigators will separately consent and administer a brief assessment battery to parents to assess their knowledge and attitudes around substance use, as well as opinions and attitudes regarding other health and risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* 14-17 year-old youth presenting for routine medical care in the Rheumatology clinic or Endocrinology clinic at Boston Children's Hospital (BCH)
* A diagnosis of type 1 diabetes for at least a year or a diagnosis of a Rheumatologic condition for at least a year.
* Able to read and understand English at a middle school level or greater
* Consent to participation in the study and consent to the 6 month and 12 month follow up assessments.

Exclusion Criteria:

* Patients who are medically or emotionally unstable or otherwise unable to provide assent at the time of their appointment as determined by their clinician or the research team
* Unable to speak/read English at a middle school reading level
* Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire
* Do not consent to 6 month and 12 month re-assessment.
* Patients who are pregnant at baseline