cyrilzakka/clinical-trials huggingface dataset:
Dietary Treatment Strategies and Metabolic Control in Glycogen Storage Disease Type I

The present project will specifically assess metabolic effects of dietary interventions with controlled intake of fructose and fructose/galactose in GSDI, with the aim to provide evidence whether relaxed dietary restrictions of fructose and galactose may be justified in treatment recommendations at least for adults, which would considerably enlarge food choice in everyday life of the patients with an expected positive impact on the quality of life of patients with this rare disorder.

To assess relaxed restriction of fructose and fructose/galactose intake on secondary metabolic alterations in GSDI, (i) by looking at the traditional parameters for assessing metabolic control in clinical chemistry (lactate, triglycerides, uric acid), and (ii) by using a broad analytical approach relying on targeted metabolomics/lipidomics.

It is hypothesized that relaxed restrictions on the intake of fructose and/or galactose as part of the diet in everyday life may lead to an increase in blood lactate levels (=primary outcome), triglycerides, and uric acid to a certain degree compared to baseline. However, this increase is expected to remain within a range that is not clinically relevant for adult patients, especially when fructose/galactose intake is not excessive and stays within the usual daily allowances for healthy individuals, as planned in this study.

Eligibility Criteria:
Inclusion Criteria:

* Genetically and/or enzymatically confirmed diagnosis of GSDI (GSDIa or GSDIb)
* Male or female ≥ 18y
* Restriction of fructose intake in usual dietary treatment
* Written informed consent

Exclusion Criteria:

* Non-compliance with routine dietary treatment
* Pregnancy or lactation
* Liver transplant
* Recurrent hospitalisations due to metabolic decompensation within the last 12 months
* Severe chronic kidney disease with glomerular filtration rate (GFR) \< 30 ml/min
* For GSDIb: Severe, uncontrolled symptomatic inflammatory bowel disease
Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance

The purpose of this study is to determine whether antioxidants (vitamin E, selenium and lycopene)can change(reduce)prostate tumor size or blood flow to the prostate as determined by MRI imaging among men on Active Surveillance.


Eligibility Criteria:
Inclusion Criteria:

* MRI detectable prostate cancer
* PSA less than 15 ng/ml
* Gleason score \<= 7
* Prostate cancer staging T1c or T2a

Exclusion Criteria:

* Concurrent use of high-dose vitamins which include selenium, lycopene, vitamin D or vitamin E
* Other malignancies diagnosed or requiring treatment within the past 5 years (except superficial bladder cancer or basal cell carcinoma)
* Current use of Proscar or Avodart
Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers, Study 1

To investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers. The specific aim is the comparative evaluation of the metabolism, pharmacokinetic behavior, and tolerability of the isomers of PQ (RPQ and SPQ and the racemic mixture RSPQ) in normal healthy human volunteers.

The primary objective of this project is to investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers.

The overall approach is as follows: in 36 healthy volunteers with documented normal G6PD activity, we will administer a single oral dose of RPQ, SPQ, or RSPQ. At various times after dosing, we will draw blood samples, in which we will record the plasma levels of the parent drugs, along with plasma and urinary metabolites. The comparative pharmacokinetics, tolerability and hematological effects of these two enantiomers and the racemate will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18-60 years of age)
* Informed consent
* Healthy

Exclusion Criteria:

* Known history of liver, kidney or hematological disease;
* known history of cardiac disease, arrhythmia, QT prolongation;
* Autoimmune disorder;
* Report of an active infection;
* Evidence of G6PD deficiency
A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty

This study evaluates two routinely used drug combinations for periarticular injection following total hip and knee arthroplasty for pain control. One group will receive liposomal bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive ropivacaine, clonidine, epinephrine and ketorolac.

A key component of the multimodal approach to pain management is the intra-operative surgical site injection of a local anesthetic or drug cocktail. There are many formulations used for this purpose. A formulation documented in the literature was implemented by this institution which has dropped the average length of stay dramatically. Concern over the limited half-life of the administered anesthetic and the continued need for opioid administration has led to a search for better drug formulations and administration vehicles. Recently, the FDA approval of an extended release bupivacaine called liposomal bupivacaine was thought to extend the effective half-life of the anesthetic agent and thereby prolong post-operative anesthesia. Use of liposomal bupivacaine in total joint surgery was almost universally adopted after its recent approval and has been an integral part of the "same day total joint" movement.

Studies have suggested improvement in pain control and shortened hospitalizations with the use of liposomal bupivacaine. Other studies have raised questions about the effectiveness of this agent. Recently a randomized double blind study was performed with total knees which demonstrated no improvement in pain management with the addition of liposomal bupivacaine to the multimodal pain management protocol. This study has not been performed in the hip arthroplasty population.

Eligibility Criteria:
Inclusion Criteria:

* Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis)

Exclusion Criteria:

* Current use of opioid drugs
* Revision surgery
* Surgical complication (femoral fracture with implant insertion)
* Inability to provide Informed Consent
Optimization of the Skin Test Procedure With Iodinated Contrast Products for Certain Patients Suspected of Immediate Hypersensitivity

Hypersensitivity to iodinated contrast products (ICP) affects 1 to 3% of injected patients. These reactions require an allergological assessment with skin tests in order to distinguish allergic immunological mechanisms from other non-specific mechanisms. Current recommendations recommend carrying out prick tests followed by intradermal reactions up to a 10th dilution. However, undiluted IDRs are carried out by several teams under certain conditions, without this having been validated. Experience tends to show that these IDRs are relevant in certain patients to make the diagnosis without risk.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject treated in the allergology department in the period from June 1, 2020 to July 3, 2023 for suspected allergic hypersensitivity to ICPs and having had at least one undiluted intradermal reaction to one or more ICPs.
* Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing Cesarean Hysterectomy

Objectives: To evaluate the effect of oxytocin in reducing intraoperative blood loss in patients with PAS disorders planned for cesarean hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy of singleton living fetus
* Previous one or more cesarean sections
* Gestational age: \> 32 weeks
* The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesicalhypervascularity".
* Preoperative hemoglobin more than 10 gm/dl
* Cases with PAS that will undergoing CS Hysterectomy

Exclusion Criteria:

* Maternal medical disorders e.g.: coagulation defects, cardiac diseases etc.....
* Any known or reported hypersensitivity to the used medication.
* All cases with spontaneous placental separation at laparotomy.
* All patients undergoing conservative management of PAS.
* All cases which necessitate emergency termination.
Effect of Short-term Portable Air Purifier Use on Occupant Health Indicators

The purpose of this research project is to examine whether short-term use of portable air pollution filtration can result in changes in indoor airborne pollutants and impact on cardiovascular and respiratory health outcomes of the inhabitants.

This study will focus on evaluating the short-term benefits of a common portable air purifier technology in reducing air pollutant exposure and the anticipated concomitant health impacts. High ambient levels of various air pollutants in the Shanghai area serve as a useful model to test the portable air purifier intervention in a realistic setting. As most people using a portable air purifier would only be able to do so in their residences, the investigators have designed our study only to test residential air purifier use. Our hypothesis is that the reduction in pollutant concentrations in indoor air caused by the air purifier will result in measurable reductions in risk factors for cardiovascular and respiratory diseases.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking adults
* Live in the dormitory building at Shanghai First People's Hospital (South Section).

Exclusion Criteria:

* Current smokers
* Has any of the following diseases: chronic respiratory, cardiovascular, liver, renal, hematological disease; diabetes mellitus;
* Has any other diseases that may confound or complicate the effects of the intervention
* Pregnant females
Artificial Intelligent Decision Support for Skin Cancer Diagnostics in Primary Care

Background: Artificial intelligence has in numerous studies shown high accuracy in detecting skin cancer when trained on various databases of dermatoscopic images. However, there are very few prospective studies conducted in real clinical settings directed at patients seeking healthcare for assessment of skin lesions, and nosuch studies at all in primary care, where the majority of patients are managed.

Project aim: To study the accuracy, reliability, and clinical utility of an AI-based decision support system (Dermalyser), developed for primary care, in distinguishing skin cancer from benign lesions.

Method: Cluster-randomized controlled trial at approx. 30 primary care centers in Sweden, Germany, Scotland, the Netherlands and Australia. At study start, the participating primary care centres in each country are equally randomised to either be enabled to use the Dermalyser (intervention phase) or to assess patients according to the standard clinical procedure (control phase). When half of the intended sample size (i.e. 1500 of 3000 participants) have been included, the primary care centres switch phase from intervention to control, or vice versa. During the intervention phase, the physicians may use (if found indicated) Dermalyser as a part of their clinical evaluation, whereas during the control phase the physicians follow their ordinary diagnostic routine without support from Dermalyser. This will direct the participants to either an intervention or a control cohort. Both groups will be followed for up to 5 years, with regard to the tumour diagnoses, proportions of skin cancer/benign lesions, and morbidity and mortality in skin cancer. Possible between-group differences will be investigated statistically.

Potential benefits: If the Dermalyser prooves to be safe and diagnotically reliability, it could enhance the chance of detecting skin cancer in early stage in primary care, and to reduce the proportion of benign skin lesion unnecessarily excised or referred to dermatologist.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending a primary care facility in order to have one or more skin lesions checked for skin cancer, or patients presenting with one or more skin lesions raising suspicion of skin cancer when noticed by the primary care physician.
* Willingness and ability to provide informed consent.

Exclusion Criteria:

* Individuals with skin type V and VI according to the Fitzpatrick's scale (darker brown or black coloured skin)
Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

Hypoxemic pneumonia is a major cause of hospitalization in Pulmonology. The patient's dependency on oxygen prevents early discharge from the hospital. An automated oxygen therapy is a system that allows administration of oxygen with a flow that is automatically adjusted to the patient's saturation, which is continuously monitored. This system has proven to be particularly effective with chronic obstructive pulmonary disease (COPD) patients, by decreasing the time spent in hypoxia and hyperoxia, and by accelerating the weaning of oxygen. Our hypothesis is that automated oxygen therapy leads to a diminution on the length of hospital stay.

Prolonged hospitalization has many consequences, including loss of autonomy and nosocomial infection. Moreover, these complications themselves lead to an extension of the length of stay. This has an impact on the cost of care: several studies have shown that hospitalization is the most costly factor in the management of pneumonia, and that even a small amount of hospital stay, led to significant financial savings. Automated oxygen therapy is a device that automatically adjusts with the saturation the amount of oxygen administered. Investigator hypothesis is that automated oxygen therapy could shorten the length of stay of patients hospitalized for hypoxemic pneumonia. One group of patients will receive the automated oxygen therapy and the other group will receive the standard Oxygen therapy. The investigator will compare in each group the average length of stay, the duration of oxygen therapy, the time spent outside of the target saturation, the cost on the medical-economic level and the patient's experience.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Patient living at home or in an institution
* Patient hospitalized for less than 48 hours
* Pneumonia defined (according to the 2006 French-speaking infectious pneumology society (SPILF) criteria) by:

  * respiratory functional symptoms (cough, sputum, dyspnea, chest pain) and
  * Hyperthermia \>38,5°C or hypothermia \<36°C and
  * Radiological Signs of Pneumonia
* Hypoxia : SpO2 \< 94% in ambient air and/or PaO2\< 60 mmHg in ambient air

Exclusion Criteria:

* Pneumonia acquired at the hospital.
* Patient hospitalized in another department more than 48 hours before admission
* Chronic respiratory failure
* Active neoplasia
* Patients undergoing oxygen therapy and / or long-term NIV
* Associated cardiac decompensation (clinical signs and / or NTproBNP\> 1800ng / mL) (3
* Initial Need for high flow oxygen therapy or ventilatory support (NIV, VI)
* Difficulties expected from home support.
Role of Spectrophotometer in Early Prediction of Weaning Induced Cardiac Dysfunction

Weaning induced cardiac dysfunction is a common cause of weaning failure in critically ill patients. plethysmography variability index (PVI) is a non-invasive, real-time, and automated parameter for evalu¬ating fluid responsiveness.

By proving the validity of (PVI) in predicting successful spontaneous breathing trial Massimo can be used an easy noninvasive method that help in deciding the right time for weaning.


Eligibility Criteria:
Inclusion Criteria:

1. Intubation and mechanical ventilation
2. Fulfilling criteria for extubation
3. Fraction inspired oxygen less than 50%

Exclusion Criteria:

* a. Hemodynamic instability b. b. tracheostomy
Diazepam at the Active Phase of Labor

Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and asphyxia and requires early detection and appropriate clinical response. The risks for complications of prolonged labour are much greater in poor resource settings. Active management of labour versus physiological, expectant management, has shown to decrease the occurrence of prolonged labour. Administering sedatives during labour could also lead to faster and more effective dilatation of the cervix. Interventions to shorten labour, such as sedatives, can be used as a preventative or a treatment strategy in order to decrease the incidence of prolonged labour. As the evidence to support this is still largely anecdotal around the world. (Cochrane Database of Systematic Reviews 2013,CD009243.pub3.; Cochrane Database of Systematic Reviews 2012, CD009223.pub2.)

Hypothesis: Diazepam reduced the duration of labor and the severity of pain in labor.


Eligibility Criteria:
Inclusion Criteria:

* primigravida
* at term
* singleton pregnancy
* cephalic presentation
* spontaneous labour
* intact membranes at the beginning of active phase

Exclusion Criteria:

* induced labour
* spontaneous rupture of membranes at randomisation
* obstetric complications, or medical complications
* previous uterine scarring, or cervical surgery
* cervical dilatation of more than 5 cm
* other antispasmodics in the first stage
* malpresentation, macrosomia, cephalopelvic disproportion
Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak

In the context of quarantine with COVID-19, we wish to study the experience and psychological impact in adult patients living with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with osteoporosis
* Patient in confinement
* Patient with sufficient understanding of the French language

Exclusion Criteria:

* Non adult patient
* patient without quarantine
Effect of Arshvidya After School Program on Cognitive Processes in Elementary School Children

The impact of Arsha Vidya program on cognitive performance was examined in elementary school children. The study compares the effects of arsha vidya after school routine with usual after school routine in healthy 8-11 year-old Indian children.

The main objective of the study is to investigate the effect on cognitive function, behaviour and emotions.


Eligibility Criteria:
Inclusion Criteria:

* Be 8 - 11 years of age at the start of the intervention
* Healthy Children
* Not start new activity within the intervention period
* Parental conset
* Parents to allow and participate where needed in intervention

Exclusion Criteria:

* Serious chronic illnesses and diseases
* Diagnosed with any psychiatric illness
* Intake of medication that may affect study outcomes
* not able to continue for 12-weeks of participation
Determination of Longus Colli Muscle Thickness by Ultrasonography

This study aims to assess the longus colli muscle thickness by ultrasonography in order to guide stellate ganglion blocks

Stellate ganglion block is an interventional pain management procedure that is often performed for diagnostic and therapeutic purposes. It has long been performed with the guidance of fluoroscopy, and despite the increasing use of ultrasonography in recent years, fluoroscopy is still the gold standard method.

In traditional fluoroscopic method, the needle is directed to the transverse process of the C6 vertebra, after touching the anterior tubercle (Chassaignac's tubercule) the needle is slightly withdrawn and following a negative aspiration, injection is performed.

The ideal placement of the needle should be anterolateral to the longus colli muscle and deep to the prevertebral fascia. Further placement may cause intramuscular spread and superficial placement may cause injection in the carotid sheath or vascular structures. These are the most important reasons for clinical ineffectiveness. How far should the needle be withdrawn? Data is inconsistent in the literature.

The primary aim of this study is to determine the distance from transverse process to longus colli muscles anterior border and from transverse process to carotid sheath's posterior border. Secondary aim is to investigate the relationship between longus colli muscle thickness and age, gender, height, weight, BMI and neck circumference.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 - 65 years,
* Giving informed consent for examination, ultrasonographic evaluation and study participation

Exclusion Criteria:

* Having a chronic neck pain for more than 6 months,
* Having any neurological or musculoskeletal conditions that may affect the anatomy of cervical region (cervical disc herniation, torticollis, severe scoliosis, vertebral malformation, spinal stenosis, myopathies, etc.)
* Having a history of surgery or radiation therapy in the cervical region
Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy

Patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into experimental and control groups. the primary efficacy end point was RFS, and the secondary end point was the rate of abdominal implant metastases and OS.To analyze the efficacy of HIPEC.

Patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into groups: experimental group: surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy, and control group: simple surgical resection.

At further follow-up, the primary efficacy end point was time to Recurrence free survival (RFS) ,the time from the patient's treatment until the discovery of abdominal metastases or until the follow-up period, and the secondary end point was the rate of abdominal implant metastases, that is, according to the postoperative follow-up test and imaging findings, the incidence of abdominal implantation and metastasis, until the end of abdominal recurrence or metastasis or observation period. Overall Survival OS and survival rate: the time from the time the patient underwent partial hepatectomy until death from tumor causes or the end of the observation period. To analyze the efficacy of HIPEC.

Eligibility Criteria:
Inclusion Criteria:

1. according to the clinical diagnostic criteria of primary liver cancer (2022 edition) or confirmed by pathology/cytology;
2. preoperative diagnosis of rupture and hemorrhage of liver cancer by clinical manifestation, examination and imaging;
3. Age 18-80 years;
4. Child-pugh class A or class B after liver protection and albumin correction, without severe heart, lung or renal dysfunction, without absolute contraindication to surgery;
5. ECOG-PS score of 0-1;
6. without other neoplastic diseases;
7. Sign and perfect the informed consent form before operation;
8. without postoperative liver failure, without major complications such as massive hemorrhage, purulent infection and multiple organ failure, and without discharge from hospital.

Exclusion Criteria:

1. having other active malignant tumor;
2. the expected survival time is less than 3 months;
3. Child-pugh class C, complicated with severe organic disease of important organs, complicated with severe cirrhosis.