cyrilzakka/clinical-trials huggingface dataset:
Incubation of Alcohol Craving During Abstinence

In order to determine whether the 'incubation of craving' phenomenon also occurred in alcoholics, investigators employed an experimental approach to investigate the time course of cue-induced craving in alcoholism. Eighty male participants were randomly divided into Four groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced alcohol craving . Another group including 19 patients was repeatedly tested for the cue-induced alcohol craving at the above abstinence days. Other psychological and physiological measures were administered at the four abstinence time points.

All subjects provided written informed consent after a full explanation of the protocol design.

Eligibility Criteria:
Inclusion Criteria:

* met the criteria of DSM-IV for alcohol dependence
* aged 18-60 years,male

Exclusion Criteria:

* current or past history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) axis I disorders
* with other serious physical diseases (respiratory disorders, cardiovascular disease and so on)
* other drug abuse except for nicotine
Mental Effects of Analgesic Drugs: Paracetamol and Ibuprofen

The objective of the present study is to study paracetamol effects on social pain and empathy under standardized international conditions (ICH-GCP) for planning, conduction and reporting of clinical pharmaceutical studies in humans. The study included MRI imaging of brain activity, analysis of genomic biomarkers potentially explaining interindividual variation. It is controversial whether the effects are of immediate nature or develop during a period of about 10 days. Therefore, the study is separated into two study phases. Single dosing (SD) is applied in study phase 1 and multiple-dosing (MD) in study phase 2. The study compares paracetamol with placebo and in the study phase 1 also with ibuprofen as analgetically active control.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained prior to study.
2. Willingness to meet the study instructions and to co-operate with the study personal.
3. No clinically relevant pathological findings in any of the investigations at the screening visit; minor deviations of laboratory values from the normal range may be accepted if judged by the investigator to have no clinical relevance.
4. Body weight not less than 48 kg and body mass index (BMI) not less than 17 kg/m² and not greater than 32 kg/m².

Exclusion Criteria:

1. Pacemaker devices, implantable or external ones.
2. Involvement in the planning and conduct of the study (applies to staff directly employed at the study site / department).
3. Known pregnancy or lactation period.
4. History of alcohol and / or drug abuse and / or any abusive use of medicaments.
5. Any disease affecting liver or kidney or impairment of the liver or kidney-function.
6. History of severe hypersensitivity reactions, anaphylaxis, psychiatric or neurologic disorder.
Determining the Needs of Aging People With Disabilities

Heterogeneous modalities of aging lead to describe three categories of elderly patients: 1-healthy without frailty, 2- healthy with frailty, 3- patients with chronic disease(s) and frailty. Frail people have a high risk of losing functional independence and as a consequence they require more help for day to day life. It is known in elderly that physical activities, nutrition, social environment are important to maintain functional independence.

For patients with disabilities, less is known about the occurence of dependance with aging. That is of growing importance because life expectancy of disabled patients has increased a lot during last decades, and because caregivers, often parents, also become elderly and frail.

So the investigators will require tools to anticipate prevention and supportive needs for this specific population.

The goal of this study is to evaluate if the participants (disabled patients over 40 years old) of a well-defined region in the south-east of France (400000 inhabitants), and to assess their needs, using the Functional Autonomy Measurement System (SMAF) developed for assessment of the elderly, by Rejean Hebert \& Nicole Dubuc's team in Sherbrooke University (Quebec/Canada).


Eligibility Criteria:
Inclusion Criteria:

* adult 40 years or older
* must need help allocated by government social health services (Committee on Rights and Autonomy of Disabled People = french CDAPH)
* must live

  1. either in dedicated units or specialized homes (french medicalized care homes, or dedicated community homes)
  2. or at home but working in specialized dedicated centers (So called french Etablissement et Service d'Aide par le Travail) or requiring intervention of specialized services (Support Service for Social Life or Medical-Social Support Service for Disabled Adults)

     Exclusion Criteria:
* patient or patient's legal guardian opposed to participate
A Study To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Subjects With Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Induced Gastropathy

The main purpose of this study is to evaluate clinical efficacy of bismuth tripotassium dicitrate (De-Nol) in combination with pantoprazole versus pantoprazole monotherapy in subjects with NSAID-induced gastropathy in 14±2 days of treatment.

This study has a screening period (up to 3±2 days duration). Randomization will be held in each stratum (H. pylori-positive and H. pylori-negative) on the Visit 1. Treatment period will consist of 2 visits: Visit 2 (up to 14±2 days after Visit 1) in subjects with completely healed ulcer(s) and erosions after control esophagogastroduodenoscopy (EGDS) and Visit 3 (up to 28±2 days after Visit 1) in subjects with not healed ulcers and erosions after control EGDS on Visit 2. The period of follow-up safety assessments will last 1 week after the end of the study treatment

Eligibility Criteria:
Inclusion Criteria:

* Verified diagnosis of NSAID-induced gastropathy:

  * Presence of gastric ulcer(s) and/or erosions (modified Lanza score greater than or equal to 5) based on EGDS findings at screening and;
  * NSAIDs administration within 7 days before screening.
* Negative pregnancy test at screening and at Visit 1 (for females only using test strip to detect chorionic gonadotropin in urine),
* Subjects' consent to use a reliable contraception method starting from screening throughout the whole study and for 1 week after its termination.

Exclusion Criteria:

* Severe complications of NSAID-gastropathy (bleedings, perforations, etc.)
* The subjects requiring concomitant therapy using the drugs specified in "Forbidden concomitant therapy".
* Ulcerative esophagitis grade C and higher according to Los-Angeles classification.
* Expressed hepatic and renal impairment.
* Any esophageal and gastric surgery that can make subject ineligible for study participation.
* Abuse of psychoactive substances including alcohol which may interfere with the subject's participation and fulfillment of all the protocol requirements.
* Participation in other clinical studies within 30 days prior to Screening Visit.
* Administration of bismuth products less than 2 months prior to screening.
* Administration of PPIs or histamine Н2-receptor antagonists less than 2 weeks prior to screening.
* Hypersensitivity to any of the components of the study drugs or contraindications to them.
* Pregnancy and lactation.
* Inability to perform follow-up EGDS after 2 and/or 4 weeks of the study.
* Any condition or concomitant disease and laboratory parameter abnormalities which renders the subject ineligible for the study.
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis

Efficacy and Safety of imsidolimab in Participants with Ichthyosis

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in adolescent and adult participants with ichthyosis. This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with ichthyosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ichthyosis
* IASI total score ≥ 18, erythema score ≥ 2
* Participant has been using emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily at the same frequency throughout the study

Exclusion Criteria:

* A participant with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded.
Treatment for Acute Spinal Cord Injury

This clinical trial aims to treat a damaged spinal cord by injecting your own bone marrow stromal cells (autologous bone marrow stromal cells) into cerebrospinal fluid through the lumbar puncture, and assess the safety and efficacy of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury is confirmed with MRI
* Methylprednisolone therapy according to this study can be started within 8 hours after the injury
* Bone marrow stromal cells (BMSCs) incubation can be started within 72 hours after the injury
* Age between 15 and 60
* With the informed consent of obtaining bone marrow and injecting incubated BMSCs.

Exclusion Criteria:

* Complete disruption of spinal cord
* Central spinal cord injury
* Spinal canal stenosis before the injury
* Brain or spinal cord disease before the injury
* Positive serologic test in at least one of the following; HBs antigen, HCV antibody, HIV antibody, or HTLV-1 antibody
* Pregnancy
Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Liver Transplantation

The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but preoperative medication and intraoperative colloid administration and hemodynamic parameters have not been evaluated. Therefore, we attempt to evaluate perioperative risk factors and develop simplified clinical risk scoring model.

Ischemia/reperfusion injury occurs during graft harvesting, cold storage, and surgical procedures in liver transplantation. Ischemia/reperfusion injury in liver graft results in major organ damage including kidney, lung and heart as well as graft dysfunction. Graft dysfunction and renal injury after liver transplantation are major clinical issues and are associated with prognosis and low survival rate. The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but perioperative medication, metabolic variables (albumin, glucose, uric acid), intraoperative colloid administration and hemodynamic parameters have not been evaluated. In addition, a neutrophil-lymphocyte ratio (NLR), which has been reported to be related to systemic inflammation and associated with prognosis of cardiac and cancer patients, might be related to the development of AKI after LDLT. Therefore, we attempt to evaluate these perioperative risk factors and develop simplified clinical risk scoring model.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent living donor liver transplantation between 2010 and 2013 in Samsung Medical Center

Exclusion Criteria:

* Incomplete data regarding pre- and postoperative creatinine and estimated Glomerular Filtration Rate
* patient who underwent retransplantation
Effects of Fruit Juices on Hormone Metabolism

The purpose of this study is to determine whether grapefruit juice alters the metabolism of cortisol following intense exercise.


Eligibility Criteria:
Inclusion Criteria:

* Young men and women, not taking medications known to alter glucocorticoid metabolism

Exclusion Criteria:

* Diabetes, uncontrolled hypertension, obesity, any medication known to interact with grapefruit juice
The Effects of Dexamethasone Administration on Jaundice Following Liver Resection

The investigators were aiming to evaluate whether dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and decreases the rates of post-hepatectomy liver failure and its safety in the subjects who developed elevated serum total bilirubin.

Post-operative jaundice is one of the most common complications after hepatectomy for various liver tumors. Glucocorticoids, including dexamethasone, prednisolone, and methylprednisolone, were widely used to treat jaundice in the patients with severe hepatitis, liver dysfunction or liver failure. It was reported that glucocorticoids decrease the rates of liver dysfunction or mortality in those patients. However, whether post-operative glucocorticoids administration alleviated jaundice or deceased the rates of post-hepatectomy liver failure (PLF) yet to be determined. In this study, the investigators were aiming to evaluate whether dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and decreases the rates of PLF and its safety in the subjects who developed elevated serum TB.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent open hepatectomy for liver tumors
* Preoperative liver function was Child-Pugh A, and the liver shear wave elastography (SWE) \< 30 kPa
* Postoperative serum total bilirubin \> 2.5 ULN in 7 days after hepatectomy

Exclusion Criteria:

* Patients with hilar cholangiocarcinoma or other disease with obstructive jaundice
* Complicating disease with severe dysfunction in respiratory or circulation system or kidney.
* Patients with contraindication of glucocorticoids, including severe infection, active GI bleeding
4XL Study - Obesity Surgery in Adolescence

The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.

The study has two intervention arms:

Experimental: Group A Surgery; laparoscopic gastric bypass

Active comparator: Group B Patients from Child Obesity Registry of Vestfold who get standard conservative treatment in a multidisiplinary team at Morbid Obesity Center.

All patients are referred to Morbid Obesity Center from other hospitals or general practionairs in Norway. The procedure will take place at the Vestfold Hospital Trust The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month at the Morbid Obesity Center. Total follow-up time is ten years.

Eligibility Criteria:
Inclusion Criteria:

* Between 13 and 18 years of age at inclusion
* Tanner stage 4-5
* BMI \> 40 kg/m2 or BMI \> 35 with at least one comorbidity (type 2-diabetes, obstructive sleep apnea, serious hypertension or cerebral pseudotumor)
* At least one year multidisciplinary treatment completed

Exclusion Criteria:

* Tanner stage \< 4
* Substantial risk for lack of compliance
* Obesity syndrome (e.g., Prader Willi syndrome)
* Obesity related to brain damage
* Serious general disease
* Monogenic obesity
Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy

The investigators have previously proposed a prediction model for difficult transoral and submental thyroidectomy through a retrospective study. In order to better promote transoral and submental endoscopic approach for thyroid surgery and to set up an appropriate training course, the investigators aim to renovate and validate the prediction model through a prospective study.

Male sex, age, BMI, neck length and certain thyroid disease such as thyroiditis and hyperthyroidism have been long cited as indicators of a difficult thyroidectomy. The investiagtors hypothesized that neck extension was critical to the exposure and visualization of the surgical field in the endoscopic thyroidectomy. Therefore, several measurements were innovatedly integrated into the prediction model, including neck circumference, thyromental distance, sternomental distance, ratio of height-to-thyromental distance, ratio of height-to-sternomental distance.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
* Clinical diagnosis of benign thyroid nodule with a maximum diameter not exceeding 6 cm
* Absence of suspicious lateral lymph nodes or distant metastases

Exclusion Criteria:

* Participants with fusion or fixation of lymph nodes in the neck
* Participants with history of neck surgery or radiation
* Participants with vocal fold fixation by preoperative fibrolaryngoscope
* Participants with preoperative examination suggestive of extrathyroidal invasion
* Participants with a significantly restricted neck and/or jaw
A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma

This study aims to assess the concordance of international asthma guidelines in the diagnosis of asthma and explore the presence of airways disease using additional non-guideline physiologic criteria, such as IOS (impulse osciollometry), not included in the guidelines, but available in the Portsmouth lung function service.

Asthma is a widespread condition that affects millions of people worldwide. It is characterized by symptoms such as difficulty breathing, coughing, and wheezing. Diagnosing asthma involves identifying certain indicators like airflow obstruction, airway sensitivity, and inflammation. However, different international guidelines, including those from organizations such as NICE (National Institute for Health and Care Excellence), GINA (Global Initiative for Asthma), and BTS (British Thoracic Society)/SIGN (Scottish Intercollegiate Guidelines Network), have varying criteria for diagnosis. This can lead to inconsistencies in identifying patients with asthma.

This study aims to evaluate the effectiveness of different diagnostic approaches, including impulse oscillometry (IOS), in diagnosing asthma. IOS is a simple and non-invasive test that measures lung function. It has the potential to enhance the accuracy and ease of asthma diagnosis. Despite its promise, current research on the role of IOS in diagnosing asthma in adults is limited.

To address these gaps in knowledge, the study will examine the data of patients attending the severe asthma service at Queen Alexandra Hospital in Portsmouth. With an "opt-out" consent process, routine outpatient lung function data will be analysed, paying special attention to the usefulness of IOS compared to other lung function indices in diagnosing asthma.

By conducting this study, the aim is to contribute valuable insights to the field of asthma diagnosis. The study findings may help refine the methodology of diagnosing asthma and potentially expand the diagnostic toolkit to include IOS. This could improve the precision and ease of managing asthma, leading to better outcomes for patients.

Eligibility Criteria:
Inclusion Criteria:

* The patient will meet all the following criteria to be considered eligible for the study:

  * Aged 18 years or over.
  * All patients who have attended full asthma workups from November 2021 till date
  * Willing and able to consent to use their data in this study (opt-out form or e-consent).
  * Patients referred to the Portsmouth asthma service for diagnosis and further management of presumed asthma. Comorbidities are common in asthma, thus patients with co-existing conditions such as obesity, bronchiectasis or COPD will be included.

Exclusion Criteria:

* The participant may not enter the study if either of the following apply:

  * Unable to comprehend the study and provide informed consent, e.g., insufficient command of English in the absence of someone who can adequately interpret.
  * Patients with other primary respiratory conditions, such as ILD.
CB1R in Synthetic Psychoactive Cannabinoids

The purpose of this research study is to determine whether the CB1R availability is lower in synthetic psychoactive cannabinoid subjects using the most widely available synthetic psychoactive cannabinoids at the time the study is initiated.


Eligibility Criteria:
Inclusion:

* Able to provide written consent
* Age 18-55
* Current Synthetic Psychoactive Cannabinoids consumption

Exclusion:

* MRI metal exclusions and claustrophobia
* Education completed is less than 12 years
The OsteoStrand Plus Deformity Study

A clinical study evaluating outcomes for patients with spinal deformity.

A clinical study evaluating deformity patients treated with Demineralized Bone Matrix as compared to patients treated with Bone Morphogenetic Protein.

Eligibility Criteria:
Inclusion Criteria:

-≥18 years of age

* Indicated for deformity correction surgery
* Require spinal fusion at four or more levels
* Are willing to return for follow-up visits
* Willing to sign the Informed Consent Forms

Exclusion Criteria:

* Uncontrolled diabetes
* Morbid obesity
* history of alcohol or drug abuse
* Corticosteroid use
* Fever or leukocytosis
* Systemic infection
* Active malignancy
* Elevation of white blood cell count
* Osteoporosis
* Disease of bone metabolism
* Unsuitable or insufficient bone support
* Skeletal immaturity
* Prior fusion
* Use of steroids, immune suppressants, osteoporosis medications
* Use of internal bone stimulators
* Institutionalized or a prisoner
* Undergoing (Undergone) a worker's compensation case
* Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration)
* Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during this clinical study
* Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study
First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction

Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be explained by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for patients receiving tacrolimus. Here, we assessed the tacrolimus dose prediction by comparing CYP3A5 expression and tacrolimus dosage using tacrolimus concentration after single dose administration prior to kidney transplantation.

Plasma tacrolimus trough level was measured at 12 hours after first dose of 0.1 mg/kg of tacrolimus (TacC12), orally administered in 51 new kidney transplant recipients. Patients with CYP3A5 inhibitor/inducer co-medications were excluded. Genotyping for CYP3A5 expression were carried out by RT-PCR. The dosages of tacrolimus at post-operative day 7 and dosage which provided stable therapeutic levels in post-operative month 1 to 3 (C0 5-8 ng/mL) were recorded.

The genotyping, TacC12, and target tacrolimus dosage have good correlations.


Eligibility Criteria:
Inclusion Criteria:

* All KT recipients

Exclusion Criteria:

* Recipient who not receiving tacrolimus