cyrilzakka/clinical-trials huggingface dataset:
Food Choice, Psychological Bias, and Genetic Predisposition

This project aims to assess if food choice is impacted by loss aversion (LA), and if this differs based on genetic predisposition to LA, in a UK healthy cohort.

Food choice, defined as how individuals decide on what to buy and eat, involves the acceptance and rejection of specific foods. Food customisation is becoming more common amongst food retailers, allowing customers to alter their meals to their preferences by removing or adding items. Today, food choice is viewed as more complex, food choices are not just dictated by taste but nutritional quality, allergens, and habits. For example, the framework provided for food customisation (e.g. pizza with toppings or a build you own pizza) and the perceived 'healthiness' of food items (e.g. the pizza toppings) can alter food choice. Psychological reasoning, the process by which humans make decisions by drawing conclusions can play a role in food choice; however, humans can possess a psychological bias leading to illogical decision making. Genetics can too play a role in decision making resulting in predetermined influence on food choice. This research wishes to determine if individual's genetics can affect their food choices by researching psychological biases to food choices.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (no known health condition)
* 18 + years of age
* UK based

Exclusion Criteria:

* Vegetarian
* Vegan
* Other dietary pattern that restricts the consumption of animal products
Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of the study is to examine how well two types of treatment follow up work compared to one another:

1. standard community follow up
2. medication monitoring plus tailored case management follow up.

A child's participation will involve 3 months of treatment consisting of medication and psychological, behavioural, and academic interventions tailored to their individual needs.

Following this treatment, the child will be randomly assigned to receive two years of either community follow up or medication monitoring plus tailored case management follow up delivered by the study team. During both types of follow up, at 6 month intervals, the parent and child will be asked to complete interviews with our study personnel and comprehensive assessments pertaining to ADHD symptoms and various other areas of functioning.

Parents will also be asked to obtain information from the child's teacher regarding the child's functioning at 6 month intervals during the school year.


Eligibility Criteria:
Inclusion Criteria:

* age 6 to 12 years
* DSM-IV ADHD diagnosis by a specialist i.e. child psychiatrist or developmental paediatrician (DSM 5 ADHD criteria do not differ dramatically from DSM IV criteria for children)
* Intelligence Quotient (IQ) \> 80 as per the Wechsler Intelligence Scale for Children (WISC-IV)
* Proficiency in English or French

Exclusion Criteria:

* History of Autism Spectrum Disorder (ASD) or psychosis
* Significant brain traumas (encephalitis, head injury requiring hospitalization, etc.)
* Major medical conditions or impairments that would interfere with the ability of the child to complete testing or take psychostimulants, e.g., epilepsy, cardiac abnormalities, or renal abnormalities.
The Knack on Female Stress Urinary Incontinence

The aim of the present study is to test the hypothesis that voluntary pelvic floor muscle pre-contraction (the Knack) (alone) can be a treatment for urine leakage during efforts. For this purpose, the following parameters will be analysed and compared amongst 1) the Knack, 2) pelvic floor muscle training and 3) the Knack + pelvic floor muscle training groups: urine leakage as assessed by the pad test, urinary symptoms, muscle function, quality of life, subjective cure, adherence to exercises in the outpatient setting and at home and perceived self-efficacy of pelvic floor muscle exercises.

The study population will comprise women with mild to moderate stress urinary incontinence or mixed urinary incontinente (with predominant stress urinary incontinence) as assessed by means of the one-hour pad test (leakage ≥2 g). Leakage up to 10 grams will be rated mild stress urinary incontinence and of 11 to 50 grams as moderate stress urinary incontinence. The sample will also include women with grade 2 muscle strength (normal contraction with elevation of the anterior vaginal wall) on the two-finger assessment rated according to the Oxford scale.

The primary outcome measure will be the objective cure of urinary incontinence as assessed by means of the one-hour pad test three months after randomization.

Secondary outcome measures: three-day bladder diary, 1 hour pad test, International Consultation on Incontinence Questionnaire - Short Form, Incontinence Quality of Life Questionnaire, Subjective cure of stress urinary incontinence, Self-efficacy/outcome expectation to pelvic floor muscle exercises, Frequency of the outpatient sessions, adherence to home exercises and pelvic floor muscle function, morphometry, strength and vaginal squeeze pressure.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate stress urinary incontinence or mixed urinary incontinence (with predominance of stress urinary incontinence) as assessed by means of the one-hour pad test (leakage ≥2 g). Mild stress urinary incontinence will be defined as leakage up to 10 g and moderate stress urinary incontinence as leakage of 11 to 50 g.
* Able to have a gynaecological examination

Exclusion Criteria:

* Symptoms of overactive bladder alone
* Chronic degenerative, uncontrolled metabolic, neurological or psychiatric diseases
* Previous participation in a pelvic floor re-education programe and/or previous pelvic floor surgery or currently receiving other treatment for urinary incontinence
* Pelvic organ prolapse greater than stage II according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
* Use of medication for urinary incontinence or medication that interferes with the musculoskeletal system
* Loss of stools or mucus
* Active urinary or vaginal infection in the past three months
* Body mass index ≥35 Kg/m2
Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus

Using of herbal medications as topical chamomile which has antioxidant, anti-inflammatory and anticarcinogenesis effect with little side effects is the aim for the future treatment of OLP.

Oral lichen planus (OLP) is a chronic inflammatory T cell mediated autoimmune disease that affects skin and any mucous membrane particularly oral mucosa.The patient complains of burning sensation, pain; interference with eating, swallowing and speech leading to worsening of quality of life.Oxidative stress plays a role in pathomechanism of OLP disease. Enzymatic and non- enzymatic anti-oxidants act as a physiological guard against reactive oxygen species (ROS) and cytokine-mediated toxicity.Herbal treatment is the aim of the future therapy.Chamomile has anti-oxidant , anti-inflammatory effect and accelerate healing.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic OLP.
* Patients with no history of taking corticosteroids for the last 6 months.
* Patients who agree to take medication.
* Medically free

Exclusion Criteria:

* Patients with oral lesions other than OLP.
* Lichenoid reaction .
* Pregnant females and lactation.
* Smokers
A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound

This is a phase I study to evaluate the safety of ALLO-ASC-DFU for the treatment of deep second-degree burn wound patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years of age and older.
2. Subjects who have deep second-degree burn ≥100 cm\^2.
3. Negative for urine beta-HCG for women of childbearing age.
4. Subject is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Subjects who have been enrolled in another clinical study within 30 days of screening.
2. Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
3. Subjects who are receiving steroids, immunosuppressive, or anticoagulant.
4. Subjects with active infection.
5. Subjects with hemorrhagic and hemocoagulative disease
6. Subjects who are unwilling to use an "effective" method of contraception during the study.
7. Subjects who have a history of malignant tumor within the last five years, or is currently undergoing.
8. Subjects who are pregnant or breast-feeding.
9. Subjects who are considered to have a significant disease which can impact the study by the investigator
10. Burn wound is present on any part of the face.
11. Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site).
12. Subjects who are considered not suitable for the study by the investigator.
13. Subjects who are not able to understand the objective of this study or to comply with the study requirements.
Family Intervention Following Traumatic Injury

The purpose of this study is to investigate the effectiveness of a manualized intervention (FITS) to families living with brain injury or spinal cord injury. The intervention will be provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes duration. The intervention group will be compared to a control group receiving treatment as usual, one psycho-educational group session of a 2 hour duration.


Eligibility Criteria:
Inclusion Criteria:

* Acquired brain injury or spinal cord injury
* Talk and read Danish
* Minimum 6 months to 2 years since discharge
* Family members must be actively involved in the patient's rehabilitation

Exclusion Criteria:

* Severe aphasia
* Families, where other family members require a substantial amount of care
* Prior psychiatric or neurological disease
Prospective Cohort Study on Antibiotic Course and Efficacy After Two-stage Revision in PJI.

This is a multicenter prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before phase II revision surgery. Eligible patients will be included in this study after signing the informed consent form. After the second stage revision, according to the patient's symptoms and examination results, the attending physician used a reasonable antibiotic treatment scheme (including intravenous and oral medication). All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the time points of 1, 3, 6, 12, 18 and 24 months after the start of antibiotic treatment after phase II revision. The infection control rate of patients was evaluated by follow-up at least 2 years after operation, so as to analyze the effect of antibiotic treatment course after two-stage revision of periprosthetic joint infection.

Inclusion criteria：

1. A diagnosis of PJI was made according to MSIS criteria
2. Received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision.
3. Age ≥18 years old
4. The patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. He has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study.

Exclusion criteria：

1. Follow up data were not available;
2. The investigator judged that the patient no longer met the criteria of the study due to compliance problems.

Recruiting time：2021.10 -2023.10.31 Interventions Group：No Sample size：500 Study Population Description: Patients who underwent secondary replantation surgery for prosthetic joint infection at the First Affiliated Hospital of Fujian Medical University and other sub-centers were selected.

Eligibility Criteria:
Inclusion Criteria:

- 1. A diagnosis of PJI was made according to MSIS criteria. 2. Received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision.

3. Age ≥18 years old. 4. The patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. He has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study.

Exclusion Criteria:

* 1. Follow-up data not available. 2. Researchers judge that patients no longer meet the standards of the study due to compliance problems
Value of Tomosynthesis for the Detection of Sacro-iliitis (TOMOS SI)

Spondyloarthropathies (SpAs) are chronic inflammatory diseases encompassing ankylosing spondylitis, psoriatic arthritis, reactive arthritis, enteropathic arthropathy, and undifferentiated SpA.

In 2001, the estimated prevalence of SpA was 1.5% worldwide. Sacroiliitis is a condition caused by inflammation within the sacroiliac joint. It is the most frequent damage of SpA depicted at imaging evaluation.

Conventional radiography (X-ray) is usually used to depict the structural changes associated with sacroiliitis.

However further evaluation often requires additionnal computed tomography (CT).

Tomosynthesis is an Xray-based imaging technology which allows reconstruction of multiple section images from a set of projection images acquired as the x-ray tube moves along a prescribed path. The advantagee of tomosynthesis is the significant reduction of radiation dose exposure compared to CT Tomosynthesis is currently used in the field of breast imaging and pneumology. Very few studies have examined the value of tomosynthesis for osteoarticular imaging.

The study aims at evaluating the diagnostic performances of tomosynthesis as compared to standard X-ray and CT, in patients with a clinical suspicion of sacroiliitis.

the investigators hypothesize that tomosynthesis is superior to conventional radiography for detection of sacroiliitis and is at least equal to CT with lower irradiation.

Consecutive patients referred to CT for exploration of sacrollitis will be included and investigated with standard radiography, CT and tomosynthesis of SI joints.

Imaging examinations will be performed at day of enrollment as follow : X-ray and CT as standard management and tomosynthesis as additional evaluation. CT will be considered as the reference standard Sacroiliitis will be assessed in a centralized, blind and randomized retrospective reading of all imaging modalities by two independent radiologists.

Diagnostic performances and radiation doses of tomosynthesis will be compared to those of standard CT and X-ray examinations.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over referred for suspected sacroiliitis.
* Patients who have entered into their participation agreement by signing the informed consent form.
* Patient affiliated to a social security scheme or beneficiary.

Exclusion Criteria:

* Pregnant or lactating women.
* Vulnerable people according.
* Major people placed under guardianship or curatorship.
Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia

This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1). Only in the case a serious adverse event (SAE) arises, will there be a follow up phase (visit 4).


Eligibility Criteria:
Inclusion Criteria:

* Subject should fulfil criteria for the subscription of AVODART as these are mentioned in the SPC
* Subject should be diagnosed with benign prostate hyperplasia
* Subject's prostate volume should be equal or greater than 30 cm3

Exclusion Criteria:

* Known hypersensitivity to any of the AVODART compounds
* Suffers from a serious illness which either is not properly controlled or as per investigator´s judgment could interfere with the subject´s compliance into the trial
* Receives treatment with enzyme inhibitors CYP3A4 and CYP3A5.
* History of severe liver failure
Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress

Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and complication of TTN.

The aim of the study is to determine whether positive end expiratory pressure therapy (PEEP) administered early via a T piece based infant resuscitator (Neopuff) would safely reduce the incidence of TTN and the need for neonatal intensive care unit (NICU) admission of near term and term infants with respiratory distress.

Eligibility Criteria:
Inclusion Criteria:

* Near term infants (36-37 weeks gestational age) and Full term infants (38-41 weeks gestational age).
* Presence of signs of respiratory distress (Tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth.
* Cesarean section (CS) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary CS.

Exclusion Criteria:

* Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization.
* Presence of any other cause of respiratory distress, eg.

  * congenital malformations affecting the cardiorespiratory system ,
  * chromosomal aberrations,
  * depression at birth (Apgar score at 5 minutes of \< 7 or umbilical artery pH of \< 7.10),
  * fetal hydrops,
  * persistent pulmonary hypertension,
  * and meconium aspiration syndrome.
Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington Disease

The purpose of this project is to study the efficacy of an anaplerotic treatment on brain energy profile evolution at an early stage of the Huntington disease.


Eligibility Criteria:
Inclusion Criteria:

* 5 \< UHDRS \< 50
* Age \> 18 years
* Ability to undergo MR scanning
* Covered by french social security

Exclusion Criteria:

* Evidence of psychiatric disorder
* Attendant neurological disorder
* Contraindications to MRI (claustrophobia, metallic or material implants)
* Severe head injury
* Unable to understand the protocol
* Pregnancy
* Failure to give informed consent
* Subjects with exclusion criteria required by french law (e.g. subjects who require a legally authorized representative to obtain consent)
* Unwillingness to be informed in case of abnormal MRI
Comparison of Misoprostol Ripening Efficacy With Dilapan

The purpose of this study is to find out if Dilapan works as well as Misoprostol for preparing the mouth of the uterus (cervix) for inducing labor in women who need to undergo this procedure. The primary objective is to assess the efficacy of Dilapan for cervical ripening compared to Misoprostol in women undergoing Induction of labor (IOL) at or more than 37 weeks gestation.

In developed nations 25 % of pregnant women undergo labor induction for various indications. Likelihood of vaginal delivery depends on the degree of ripeness of cervix. Majority of women undergoing induction of labor are candidates for cervical ripening. Dilapan is an osmotic hygroscopic dilator of cervix commonly used for cervical preparation for mid trimester abortions. It has been proven safe for use for induction of Labor (IOL) at term. Misoprostol is a synthetic prostaglandin E1 analogue, widely used for cervical ripening and IOL in United States and is considered as standard of care.

This is a non-inferiority, unblinded randomized, controlled trial where 322 eligible participants undergoing IOL at \>37 weeks gestation and admitted to labor and delivery unit will be enrolled and randomly assigned in a ratio 1:1 to either receive Dilapan or Misoprostol for cervical ripening.

After randomization all participants will undergo assessment as per standard of care. Participants will have either 1-5 Dilapan rods inserted into their cervix by the providers or receive 25 mcg of misoprostol orally every 2 hours to a maximum of 6 doses over 12 hours. Participants will be evaluated for artificial rupture of membranes and initiation of oxytocin for inducing uterine contraction. A diagnosis of failed IOL will be made if patient does not go into active labor within 24 hours after initiation of Oxytocin and Artificial Rupture Of Membranes (AROM). Intrapartum management will be according to institutional guidelines. All participants will be followed up and contacted by phone 2 weeks after discharge regarding their experience with the method of induction.

Eligibility Criteria:
Inclusion Criteria:

1. Women undergoing labor induction with a gestation of ≥37 weeks (based on a sure last menstrual period and an ultrasound done before 22 0/7 weeks)
2. Live fetus with in cephalic presentation
3. Singleton pregnancy
4. Able to provide informed consent for participation in the study

Exclusion Criteria:

1. Contraindication for vaginal delivery
2. Age less than 18 years
3. Prior uterine scar from a cesarean section or myomectomy
4. Patients who have HELLP syndrome or eclampsia
5. Active genital herpes at the time of labor induction
6. Complex medical problems that may require assistance with second stage of labor
7. Bishop score ≥ 6
8. Major fetal congenital anomalies (as assessed by investigator)
9. Premature rupture of membranes
Evaluation of Ventilatory Strategies During Laparoscopic Surgery

Atelectasis involving declive areas often occurs during general anesthesia and may persist postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve, Stress Index (SI), during constant flow inflation can lead ventilator setting during general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiology (ASA) I, II;
* age \> 18 years;
* elective surgery

Exclusion Criteria:

* ASA III, IV;
* Age \< 18 years;
* emergency surgery