cyrilzakka/clinical-trials huggingface dataset:
Does a Follow-up Appointment Help Parents of Children on PICU?

The aim of our study is to determine the feasibility of carrying out a randomized controlled trial (RCT) to investigate whether screening parents of children admitted to pediatric intensive care unit (PICU) so as to target follow-up at those most at risk of developing posttraumatic stress disorder (PTSD), is effective at reducing adverse psychological sequelae.

The study will assess the feasibility of offering a follow up clinic to parents identified to be vulnerable for future psychological difficulties after their child's admission to the Paediatric Intensive Care Unit (PICU) at Bristol Children's Hospital. Both mothers and fathers of children admitted to PICY for a duration of at least 12 hours will be invited to participate in this study. Screening measures will be used to identify vulnerability to future post-traumatic stress disorder (PTSD) and depression. Where one or both of the parents has been scored as high risk they will be randomised to receive the intervention or the control arm of the study (ratio 1:1). The intervention involves a follow-up clinic two months pots admission, staffed by the unit Clinical Psychologist, a PICU doctor and PICU nurse. In the control arm no follow-up clinic will be offered (i.e. current standard care).

Objectives:

i) To investigate the recruitment rates, clinic attendance and follow-up rates in order to perform an accurate sample size calculation for a larger study.

ii) To carry out initial statistical analysis to estimate the odds ratio and 95% confidence interval of developing PTSD, anxiety and depression after being offered the follow-up intervention as opposed to not being offered it.

iii) To assess the acceptability of providing targeted follow-up both to those who receive it and those who are excluded due to low risk.

The study is of importance to the public because not only does PTSD negatively affect quality of life, it is also associated with increased use of health care services and resources.

Eligibility Criteria:
Inclusion Criteria:

* All parents of children admitted to paediatric intensive care for over 12 hours.

Exclusion Criteria:

* Parents deemed unsuitable for the study by the responsible consultant. This will include families where a child's condition is suspected to result from non-accidental injury or where withdrawal of care is being discussed due to a child's critical condition. Families will be excluded if their child died during or after admission, as these families are already followed up routinely.
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis

The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis


Eligibility Criteria:
Inclusion Criteria:

* Participants with moderate to severe UC as defined by a total Mayo score of ≥6, with a rectal bleeding subscore of ≥1 and an endoscopic subscore of ≥2;
* Participants must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC: Oral, intravascular, or intramuscular corticosteroids; Immunosuppressants (azathioprine \[AZA\], 6-MP, or methotrexate \[MTX\]); Anti-tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab, or golimumab); Anti-integrin inhibitors (eg, vedolizumab); JAK inhibitor (eg, tofacitinib); Anti-IL-12/IL-23 inhibitors (eg, ustekinumab).

Exclusion Criteria:

* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, or Crohn's disease
* Participants displaying clinical signs of fulminant colitis or toxic megacolon;
* Participants with evidence of colonic dysplasia, adenomas or neoplasia.
The Efficacy and Safety of KN046 Combined With Axitinib

Evaluation of the efficacy of KN046 combined with acitinib as a neoadjuvant therapy for resectable NSCLC through primary pathological response rate and surgical resection rate

The purpose of this study is to evaluate the rate of major pathological remission (MPR) with preoperative use of KN046 versus axitinib, and thus to assess the efficacy of KN046 in combination with axitinib in patients with Stage IB-IIIB (Stage IIIB only T3N2M0) NSCLC (according to the 8th edition of the AJCC classification) who are scheduled to undergo surgery. Eligible subjects for this study were candidates for surgery for resectable stage IB-IIIB (stage IIIB only T3N2M0) NSCLC as judged by the investigator, with no evidence of distant metastases as assessed, and no evidence of unresectable local regional tumour extension.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is at least 18 years old and\<75 years old on the day of signing the informed consent form, regardless of gender, and is willing to follow the research procedure;
2. Confirmed by histology or cytology as non-small cell lung cancer;
3. NSCLC patients evaluated by researchers as resectable in stage IB-IIIB (stage IIIB only limited to T3N2M0) (AJCC 8th edition);
4. Has not received any anti-tumor treatment in the past, including but not limited to systemic chemotherapy, immunotherapy, or radiotherapy;
5. No allergenic EGFR mutation or ALK change;
6. The ECOG score is 0-1 points.

Exclusion Criteria:

1. The lesion of squamous non-small cell lung cancer presents as a central type of lung cancer accompanied by cavity formation or invasion of blood vessels, with a high risk of hemoptysis;
2. Previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy;
3. Previous history of allogeneic bone marrow or organ transplantation;
4. Subjects who have undergone major surgical treatment (such as abdominal or thoracic surgery; excluding diagnostic puncture or peripheral vascular pathway replacement surgery) or have not recovered from surgical treatment within 28 days before the administration of this trial;
5. Prior to allocation, they have received systemic anti-cancer treatment, including research drugs targeting current malignant tumors;
6. Other known malignant tumors are progressing or require active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding bladder carcinoma in situ) who have received possible radical treatment are not excluded;
7. Pregnant and/or lactating women.
Comparing Three Different Doses of Intrathecal Ketamine

The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.

A meta-analysis of adult human randomized controlled studies that compared single dose perioperative intrathecal ketamine plus intrathecal bupivacaine to bupivacaine alone in spinal anesthesia suggests that there is a benefit to using intrathecal ketamine as an adjunct to bupivacaine in multimodal analgesia. However, there are still knowledge and experience gaps regarding neuraxial ketamine dosing in this regard.

Aim of the study:

The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 years.
* BMI: 20-30 kg.m2
* Sex: both males and females.
* ASA physical status: I-III.
* Operation: knee arthroscopy.

Exclusion Criteria:

* Patient's refusal to participate in the study.
* Aged less than 18 years,
* known allergy to L.A.,
* Coagulopathy or thrombocytopenia,
* height less than 150 cm, morbidly obese infection at the site of injection.
* Chronic pain syndromes,
* pregnant woman
* Patients on regular use of analgesic or who received analgesic 24 h before surgery.
A Multicentre Phase I-II Study to Investigate the Combination of Bendamustine With Weekly Paclitaxel as First or Second Line Therapy in Patients With Metastatic Breast Cancer

The aim of the study is to establish a feasible combination of bendamustine and paclitaxel in a weekly schedule. The two agents have different toxicity profiles and are well tolerated when given in a weekly fashion. The combination might be of special interest for elderly patients with hormone insensitive breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
* Pathological confirmed primary carcinoma of the breast.
* Locally advanced or metastatic disease
* Up to one previous palliative chemotherapy that did not contain docetaxel or paclitaxel. Previous adjuvant treatment with taxanes is allowed when the last application of the taxane was given at least 1 year before entering the trial.
* Patients must have either measurable or non-measurable lesions according to the WHO criteria
* At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease.
* Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated
* Karnofsky-Index ≥ 60 %
* Age ≥ 18 years
* Absolute neutrophil count ≥ 1,500 cells/µl, platelets ≥ 100,000/µl, and hemoglobin ≥ 9 g/dl
* Bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase ≤ 5x upper normal limit
* Serum creatinine ≤ 2.0 mg/dl
* Normal left ventricular ejection fraction (LVEF) by echocardiogramme
* Patients of childbearing potential, pregnancy test must be negative
* If fertile effective contraception must be used throughout the study

Exclusion Criteria:

* Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances;
* Concurrent immunotherapy or hormonal treatment for cancer (Bisphosphonates may be continued)
* Symptomatic parenchymal brain metastases not responding to treatment
* Life expectancy less than 3 months
* Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
* Concurrent treatment with other experimental drugs or any other anti-cancer therapy within the last 28 days;
* History of congestive heart failure or other significant uncontrolled cardiac disease
* Pregnant or nursing women
Effectiveness of Bupropion in Treating Marijuana Dependent Individuals

A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. Bupropion (Zyban) is a medication currently used to treat withdrawal symptoms associated with tobacco use. The purpose of this study is to determine if bupropion will help individuals stop using marijuana.

A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. This syndrome includes alterations in mood, sleep disturbances, and cognitive performance. Many of nicotine's withdrawal symptoms are similar to those observed with marijuana withdrawal. Bupropion has been shown to be effective in treating nicotine addiction.The purpose of this study is to determine if bupropion is effective in treating marijuana dependent individuals. Specifically, this study will determine if bupropion alleviates withdrawal symptoms associated with marijuana abuse.

Participants in this 21-day, double-blind study will be randomly assigned to receive either bupropion or placebo. Treatment with bupropion will occur for one week before stopping marijuana use (quit day). Bupropion will be administered at 150 mg per day for 3 days, followed by 300 mg per day for the remainder of the study. Quit day will occur on Day 8, at which time participants will be required to remain abstinent from marijuana for the duration of the study. Participants will provide daily urine specimens. Changes in vigilance, memory, reaction time, and psychomotor performance as well as withdrawal symptoms will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Current marijuana use and dependence
* Marijuana use of at least 5 times in the past 7 days or more than 25 times per month for the 3 years prior to enrollment
* Unsuccessful in a previous attempt to quit marijuana

Exclusion Criteria:

* Axis I disorder
* Any drug abuse or dependence other than marijuana
* Currently taking antipsychotic or antidepressant medication
* Heavy alcohol drinker (more than 20 drinks per week)
* Current nicotine dependence
* History of a seizure disorder
* Current or prior eating disorder (e.g., bulimia or anorexia nervosa)
* Heavy caffeine use (more than 300 mg per day)
* Life threatening or unstable medical illness
* Pregnant
Association Between Local Cerebral Oxygenation Monitoring and Postoperative Delirium in Carotid Endarterectomy

Postoperative delirium (POD) is a common perioperative complication, which can lead to adverse outcomes. Patients undergoing carotid endarterectomy (CEA) were elderly, complicated with vascular risk factors, cognitive dysfunction, some also had a history of stroke, and the circulation fluctuated greatly during the operation, often resulting in hypoperfusion of cerebral tissue and hypoxia. Therefore, they're the high-risk group of POD. Near-infrared Spectroscopy (NIRS) can continuously and noninvasively monitor local cerebral oxygen saturation (SctO2) to identify the mismatch of oxygen supply and demand in brain tissue. However, for CEA patients, the association between intraoperative SctO2 changes and POD remains unclear. This study intends to explore the association between them and determine the SctO2 threshold for predicting POD. We will monitor SctO2 intraoperatively, follow up and collect data postoperatively.


Eligibility Criteria:
Inclusion Criteria:

Scheduled carotid endarterectomy; Signed informed consent.

Exclusion Criteria:

Severe cognitive impairment(Mini-Mental State Examination, MMSE\<18); History of psychotropic drugs; Previous intracranial surgery history; Poor hearing or vision; Language barriers
Sugar-replacement Sweeteners, and Blood Sugar Control

Several sugar-replacement sweeteners are currently on the market, including saccharine (ex. Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study is to examine wether non caloric sweeteners affects how well the body works to control blood sugar. The study includes detailed blood sugar testing after drinking liquids that may contain sucralose. The investigators hypothesize that drinking liquids with sucralose will effect the amounts of specific appetite-affecting substances naturally produced by the body.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) over 30.
* Homeostasis model assessment of insulin resistance (HOMA-IR) \< or = 2.6

Exclusion Criteria:

* smoking or smoked within last six months
* pregnant or breastfeeding
* have malabsorptive syndromes
* intestinal inflammatory disease
* diabetes
* liver or kidney disease
* fructose intolerance
* consuming more than one can of diet beverage or one spoonful of non-nutritive sweeteners (e.g. sucralose, aspartame, or saccharine) a week.
* taking any medication that might affect metabolism or taste.
Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening

The overall objective is to assess the acceptability and feasibility of offering personalized breast cancer (BC) screening.

The specific objectives are: 1) To design an information system; 2) To evaluate the barriers and facilitators of the coordination of health care services and the screening program; 3) To develop a proof of concept of personalized screening; and 4) To evaluate cost-effectiveness.

Methodology:

1. Prototype information system with basal and longitudinal variables relevant to a personalized screening system;
2. Qualitative study with focus groups and survey. The attitude and acceptability on a sample of 210 health professionals will be assessed;
3. Prospective observational study, for proof of concept. Participants will be professionals working in Primary Care, Population Breast Screening Program, or Hospital Breast Unit. It will include 385 women, aged 40-50 from the city of Lleida. Various indicators of acceptability and feasibility will be assessed in women and health professionals;
4. Probabilistic analytical models will be used to evaluate cost-effectiveness.

The present protocol addresses the specific objective number 3, the proof of concept of personalised screening.

Expected results: The investigators expect to provide valuable and necessary information for the design of personalized screening.


Eligibility Criteria:
Inclusion Criteria:

* Not having had a mammogram in the last 12 months or with a mammogram in this period available to evaluate breast density.
* Sign the informed consent.

Exclusion Criteria:

* Previous diagnosis of breast cancer.
* Breast study in process.
* Fulfill clinical criteria defined by the Medical Oncology Spanish Society (SEOM to refer to the genetic counseling unit in cancer.
* Do not understand or speak Catalan or Spanish.
* Cognitive disability for mental or mental illness.
* Physical disability that prevents a mammogram.
Meditation Effects on Brain Function in Rheumatoid Arthritis

The purpose of this study is to determine the neural mechanisms supporting meditation-based pain relief in rheumatoid arthritis (RA) patients. The scientific premise is that RA patients' use of different meditation practices during noxious thermal stimulation will alter neural function in brain areas associated with pain, evaluation, and emotional appraisal. The investigators will randomize RA patients to a brief 4-session course of Intervention A (n=20) or Intervention B (n=20). At post-intervention, participants will undergo functional MRI (fMRI) using a perfusion-based arterial spin labeling (ASL) technique during noxious thermal stimulation to determine if the meditation practices differentially alter neural function during noxious thermal stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Withheld to preserve recruitment integrity.

Exclusion Criteria:

* Withheld to preserve recruitment integrity.
An Evaluation of the Safety and Efficacy of FID 114657

The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of dry eye
* NaFl Corneal Staining sum score ≥ 3 in either eye

Exclusion Criteria:

* Must not have worn contact lenses for 1 week preceding enrollment
Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention

The purpose of this research is to apply this smoking cessation program on oral cancer patients, and to analyze the effectiveness of it.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of oral cancer
* current smoker
The Investigation of a Fluorescence/Elastic Scattering Spectroscopy (F-ESS) Device for Oral Tissue Characterization

The overall objective of this work is to identify changes in the optical properties of oral tissues to develop a non-invasive tool for the detection, diagnosis and screening of oral pathology so that treatment can be provided at the earliest possible time.

Specifically, we will be obtaining optical spectroscopic data using a fiber optic contact probe that exploits elastic-scattering spectroscopy and fluorescence spectroscopy. Both of these technique have independently shown to provide signatures for the onset of cancer, with varied success. The purpose of this effort is to combine the two techniques and develop and understanding of the signatures obtained in both normal and abnormal oral tissue with simultaneous collection of these optical signatures.

Eligibility Criteria:
Inclusion Criteria:

* adult over 18 years of age

Exclusion Criteria:

* younger than 18 years of age
The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis

This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of CM326 in moderate-severe AD subjects.

The study consists of 3 periods, a up-to-4-week Screening Period, a 12-week randomized Treatment Period and a 12-week Safety Follow-up Period.

Eligibility Criteria:
Inclusion Criteria:

* With confirmed Atopic Dermatitis (AD) at least 12 months before the screening
* Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline
* Investigator's Global Assessment (IGA) score ≥3 at screening and baseline
* Body Surface Area (BSA) of involvement of atopic dermatitis ≥10% at screening and baseline
* The weekly mean score of daily peaks in pruritus NRS at baseline ≥4
* Provide signed informed consent

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
* Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \> 2 times of upper limit of normal (ULN), total bilirubin \>1.5 times of upper limit of normal (ULN) or serum creatinine level \> upper limit of normal (ULN).
* Womens who are pregnant or breastfeeding, or who plan to become pregnant during the study.
A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment

Weight-for-height/length z-score is one of the indicators used to diagnose acute malnutrition. In the existing method, the assessment involves three steps and takes significant time with a wider room for errors. A new tool is developed to address these drawbacks. A preliminary testing done show encouraging results, but a more robust study is needed. This research will b done with the objective of comparing diagnostic efficiency and reliability of the 'new' method against the 'existing' one using a diagnostic randomized clinical trial method.

Acute malnutrition is a major underlying and direct cause of child death. Weight-for-height/length z score (WHZ) is one of the indicators used to assess nutritional status of children. In the existing method, the assessment involves three steps; measuring height, measuring weight and deciding WHZ using a reference graphs or tables. The assessment takes significant time and has wider room for errors. Due to these drawbacks, it is not used at community level where regular active finding takes place.

A new tool is developed to address these drawbacks. It reduces the steps to two aiming at reducing errors and saving time and energy. This study will compare efficiency and reliability of WHZ assessments done with the new tool against the existing method using a diagnostic randomized clinical trial.

Trained health workers will do WHZ assessments in under five children mobilized for nutrition screening program. The 'average time' needed and proportions of 'classification errors' will be compared between the new and the existing methods. Assessments done by two anthropometry experts will be used as gold standard.

The study will determine the gains of the new tool and can potentially change the global practice and help early detection of huge number of wasted children that are being missed.

Eligibility Criteria:
Inclusion Criteria:

* All children under five years of age living in the study area.

Exclusion Criteria:

* Children for whom weigh-for-height assessments can not be done due to physical deformities and disabilities.