cyrilzakka/clinical-trials huggingface dataset:
The Research for New Clinical Diagnostic Strategy of Specific Biomarkers for Traumatic Brain Injury

Traumatic brain injury (TBI) is the most common type of nerve injury and it severely endangers the public health. It is necessary to accurately measure the early neurological function of brain injury for monitoring its prognosis and therapeutic interventions. Glasgow Coma Score (GCS) and Computed Tomography (CT) are often used to diagnose the severity of TBI. However, GCS has its drawbacks in the observation of prognosis, because it is interfered by analgesics, sedatives and relaxants in the evaluation of neurological function. CT may miss the diagnosis of diffuse axonal injury (DAI) and the monitoring of intracranial pressure (ICP). Secondary injuries after TBI, such as oxidative stress, inflammatory damage, and abnormal metabolism, can destroy cerebral blood vessels and structures, which also affect the diagnosis of injury. Therefore, there is an urgent need for new methods to quickly identify which patients are likely to suffer brain injury or even cause persistent disability. Detection of brain injury biomarkers based on blood and brain tissue has long been used to assess the severity of TBI, but no biomarkers have been found for early diagnosis of mTBI and prognosis of different degrees of brain injury. Protein and metabolic product differences were detected from blood or the lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform, and diagnostic markers of potential traumatic brain injury were found, and their differential and diagnostic values were discussed.


Eligibility Criteria:
Inclusion Criteria:

1. Male and Female, aged from 18 to 65.
2. Patients with brain injury within 24 hours after injury
3. Non-brain injury group refers to patients with limb injury or systemic injury except brain injury.
4. The subject reads and fully understands the instructions of the patients and signs the informed consent.

Exclusion Criteria:

1. Male or female, aged below 18.
2. Patients with definite history of central nervous system or cardiovascular system or taking drugs affecting the central nervous system.
3. Patients with severe metabolic diseases.
4. Pregnancy.
Predicting Long-Term Clinical Outcomes in Chinese Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

At present, the majority of studies on neoadjuvant chemotherapy (NAC) in patients with breast cancer (BC) use pathological complete response (pCR) as a surrogate marker for patient prognosis, with significant improvements in pCR indicating better long-term survival. However, there is still a lack of non-invasive tools for accurately predicting the prognosis and pCR of BC patients undergoing NAC. Recent research has introduced emerging artificial intelligence machine learning (ML) and deep learning (DL) algorithms such as Bayesian methods, K-nearest neighbors (KNN), decision trees, support vector machines (SVM), XGBoost, ResNet, convolutional neural networks, and Transformer models, which have brought new avenues of exploration for cancer researchers.

The integration of AI with imaging, pathology, genomics, and other multi-omics has non-invasively improved preoperative diagnosis of breast cancer and, when combined with clinical factors, can assess postoperative survival. Moreover, current research data is limited, and reliable predictive models require extensive data for training. Therefore, establishing a multi-center database is essential.


Eligibility Criteria:
Inclusion Criteria:

1. Women with invasive breast cancer who received neoadjuvant chemotherapy (NAC) treatment in various hospitals from 2008 to 2019 (follow-up endpoint December 31, 2024)
2. Women with primary breast cancer (Stage II-III) confirmed by pre-NAC needle biopsy, along with recorded clinical, pathological, and prognostic information
3. With MR images before the first cycle of NAC and before surgery
4. With pathological HE staining images, including biopsy pathology and postoperative major pathology

Exclusion Criteria:

1. Any form of treatment was received before NAC, including endocrine therapy, radiotherapy, and chemotherapy
2. Disease metastasis occurred during NAC
3. Breast cancer patients with secondary malignancies from other cancers
4. Patients did not complete surgery and were lost to follow-up
Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo

To date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. Therefore, the planned project will test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning response, in an open-label placebo design, investigating their influence on placebo analgesia.

The current project will consist of one experimental study and one qualitative study:

1. the effects of open-label, and deceptive placebo administration on placebo analgesia will be directly compared when both groups have a comparable expectancy-inducing scientific rationale;
2. subjective meaning models will be assessed by comparing subjective narratives of the placebo effect in open-label and deceptive placebo groups in a nested qualitative study.

The experimental study will be a randomized experiment with healthy subjects (N=120), and pain will be induced using a standardized heat pain paradigm (Medoc, Ramatishai, Israel; thermo-sensory analyzer (TSA)-II). Effects of the experimental conditions will be assessed both objectively (i.e. heat pain threshold and tolerance) and subjectively (i.e. subjective pain ratings, pain intensity and unpleasantness). Furthermore, investigators will randomly select 30 participants to take part in a nested qualitative study in order to qualitatively assess the meaning response by comparing subjective narratives of the placebo effect in the open-label and deceptive placebo groups, as well as in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults aged 18-65
* Healthy by self-report statement, thus no known current or chronic somatic diseases or psychiatric disorders
* Right-handedness (Oldfield, 1971),
* Willing to participate in study

Exclusion Criteria:

* Medicine or Psychology Students
* Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes) as well as skin pathologies, neuropathies or nerve entrapment symptoms, sensory abnormalities affecting the tactile or thermal modality
* Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
* Insufficient German language skills to understand the instructions
* Previous participation in studies using pain assessment (threshold and tolerance) with Peltier Devices
* Daily consumption of more than three alcoholic standard beverages per day (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits)
* Current or regular drug consumption (THC, cocaine, heroin, etc.)
Evaluating Adapted Structured Clinical Management for People With a Diagnosis of Personality Disorder

Camden and Islington NHS Foundation Trust in London has a Personality Disorder Service (PDS) which offers a number of evidence-based interventions to people with a diagnosis of Personality Disorder. One team in the PDS, the Community Team, offers an adapted form of Structured Clinical Management (SCM; Bateman and Kravitz, 2013). As these adaptations are novel, this study aims to formally explore the effectiveness of this intervention, through a sample of clients under the team, with outcomes (proxy measures of distress such as inpatient admissions) pre- and post- intervention.


Eligibility Criteria:
Inclusion Criteria:

* Allocated to a care coordinator at the PDS for greater than one year (a reasonable time period for therapeutic rapport to form and the effect of the intervention to manifest).

Exclusion Criteria:

* No existing notes for one year prior to allocation.
* No primary diagnosis of Personality Disorder.
Clinical Investigation on the Effects of a Vegetable Juice Treatment

The purpose of the investigators study is to investigate the impact of a commercial vegetable juice on dietary vegetable intake and select cardiovascular risk factors in a generally healthy population. The study was a 12 week study with 3 groups who received 0, 8 or 16 fluid ounces daily of vegetable juice, along with education on the DASH (Dietary Approaches to Stop Hypertension) diet. All participants came in for 3 study visits at 0, 6 and 12 weeks into the study.


Eligibility Criteria:
\*\*\*Inclusion Criteria\*\*\*

* Age 40 to 65 yrs
* Subject's body mass index is between 18.5 - 34.9 kg/m2
* Subject is willing and able to comply with the study protocols
* Subject is willing to consume a vegetable-based beverage daily for three months

\*\*\*Exclusion Criteria\*\*\*

* Physical signs of health impairment
* Uncontrolled diabetes or hypertension
* Pregnant or lactating
* Active tuberculosis or lung disease (i.e. COPD)
* Renal or Liver disease
* Heart Disease, which includes Cardiovascular events and Stroke
* Cushing's syndrome
* Exercise trained individuals
* History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year
* Anxiety medications
* Use of MAOI inhibitors within the last 1 year (e.g., phenelzine (Nardil), tranylcypromine (Parnate), etc.)
* Quality of life score of 21 or above
* Routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids, erectile dysfunction drugs
* Asthma (can be worsened by mild to moderate food allergies)
* Indications of substance or alcohol abuse within the last 3 years
* The volunteer is undergoing nicotine cessation therapy
* Laboratory values outside the reference range if determined to be clinically significant by Dr. M. Eric Gershwin
* Individuals with known salt-sensitive hypertension
* History of stage 1 high blood pressure defined as systolic \> 140 and diastolic \> 90, with or without use of HTN medications
* Multi-Vitamin use other than a One-A-Day essential
* Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils and unwilling to discontinue use while participating in the study
* Allergies to vegetables
Early Amniotomy After Vaginal Prostaglandin E2 for Induction of Labor at Term: a Randomized Clinical Trial

This study evaluates the effectiveness and safety of early amniotomy after vaginal prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other half of participants) until the membranes rupture spontaneously.

During induction of labour, amniotomy (defined as artificial rupture of fetal membranes) is commonly used in combination with induction of labor. However, there is a lack of data on both effectiveness and ideal timing of this procedure. Yet for patients with an unfavorable cervix, a sharply ripening agent may be considered. As is well known to all,prostaglandin works efficiently in cervical ripening and labor induction. So dinoprostone surely performs quite well in promoting cervical ripening and labor induction since its main component is prostaglandin E2 (PGE2).

Eligibility Criteria:
Inclusion criteria

1. singleton pregnancy,
2. gestational age ≥34 weeks,
3. intact membranes,
4. cephalic presentation,
5. bishop score ≤5,
6. had obstetrical indications for induction of labor,
7. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria:

1. Patients who have contraindications for vaginal delivery,
2. previous uterine surgery,
3. fetal malpresentation,
4. multifetal pregnancy,
5. more than three contractions in 10 minutes,
6. contraindications to prostaglandins,
7. a category II or III fetal heart rate pattern,
8. anomalous fetus,
9. fetal demise
10. women with immediate delivery indications -
A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder

The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.


Eligibility Criteria:
* a) Participants extended from B058(1701A3631) study.
* b) New participants.

Inclusion Criteria

* a) Participants who have completed 7 weeks of dosing in the B058(1701A3631) study and give signed informed consent to continue duloxetine administration in this study.
* b) Participants diagnosed with Major Depressive Disorder or persistent depressive disorder and completely meet the criteria of major depressive episode as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) ver.7.0.2.
* b) Participants whose incipient age of depression was ≥7 years old.

Exclusion Criteria:

* a, b) Have a current or previous diagnosis (DSM-5) of the following as judged by the investigator:

  * Neurodevelopmental disorders
  * Schizophrenia spectrum and other psychotic disorders
  * Bipolar and related disorders
  * Trauma and stressor-related disorders
  * Disruptive · Impulse Control · and Conduct disorders
* a, b) Have a current diagnosis (DSM-5) of the following as judged by the investigator:

  * Obsessive-compulsive and related disorders
  * Anorexia nervosa, Bulimia nervosa, Binge-eating disorder
  * Sleep-wake disorders
  * Neurocognitive disorders
  * Disruptive mood dysregulation disorder
* a, b) Have personality disorders, in the judgment of the investigator.
The Placenta Previa and Fetal Weight

Placenta previa is a placenta that implants at lower uterine segment, it occurs in about 0.3-0.5% of pregnancies at term. It is a significant risk for development of maternal morbidity, as well as maternal mortality secondary to maternal hemorrhage . Also, this abnormal placenta has a negative concern about fetal well being due to prematurity and perinatal mortality, in addition to its undesirable effect on fetal growth. Several factors may be behind of the effect of placenta previa on fetal growth. Firstly, the blood supply to the lower uterine segment is less than at the upper segment apparently resulting in less feto-placental blood perfusion . Secondly, recurrent bleeding attacks from placental previa may affect fetal oxygenation and fetal growth.

In spite of above evidences; many studies in literature denied the relation between placenta previa and fetal growth and concluded that the association between low birth weight and placenta previa is mainly due to preterm delivery and to a lesser extent with fetal growth restriction. However; the major drawback of all these studies is lacking of reporting the effect of placenta previa of feto-maternal blood flow representing in studying of Doppler blood flow in both uterine and umbilical artery in those patients. The uterine artery blood flow is usually affected by the presence of placenta previa and placenta accreta which reflected on feto-placental blood flow. So the uterine artery Doppler velocimetry is a useful tool for predicting placenta accreta .

So in the light of above evidences; we aimed, in the current study, not only to investigate the effect on placenta previa on fetal weight but also to walk around the effect of placenta previa on the uterine and umbilical arteries blood flow in trial to explore this conflicting issue. To our knowledge, no previous trial had studied this interesting subject before.


Eligibility Criteria:
Inclusion Criteria:

1. Women who are sure of her pregnancy.
2. Women aged 20-35 years.
3. Women with BMI 18-22 kg/m2.
4. Estimated gestational age is ranging between 30- 32 weeks gestation.
5. Singleton pregnancy.
6. Placenta previa; either major or minor degrees as regard the cases.
7. Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
8. Women with normal Doppler indices in uterine and umbilical arteries at time of recruitment.
9. Women should be living in a nearby area to make follow-up and early transportation are reasonably possible.

Exclusion Criteria:

1. Women aged \< 20 and \>35 years.
2. Smoker ≥ 11 cigarettes/day.
3. Severe attack of bleeding requiring an immediate intervention.
4. Fetal heart rates instability or non reassuring.
5. Multiple gestations.
6. Previous Intrauterine growth restricted fetus.
7. Intrauterine fetal death or major fetal anomalies.
8. If associated with abruptio placentae.
9. Patients with known bleeding disorders or on anticoagulant therapy
POCS in Liver Transplantation Patients

A prospective, multi-center, non-randomized, observational, consecutive case series, which will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy Glass Digital System (DS) procedure at 5-10 centers.

The objective of this study is to demonstrate the clinical utility of cholangioscopy with Spy Glass Digital System (DS) in cadaveric donor or live donor liver transplantation patients who are referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct stricture(s). A secondary study objective is to generate a hypothesis for a randomized controlled trial comparing ERCP alone to ERCP with Per- Oral Cholangioscopy (POCS) in patients referred for ERCP post liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Liver transplantation at least 1 month prior to POCS procedure
2. Abnormal Liver Function Tests (LFTs) and/or biliary obstructive symptoms
3. Prior cross sectional imaging (MRI and/or US and/or CT)
4. Suspicion of anastomotic biliary stricture(s)
5. Diameter of bile ducts deemed sufficient to accommodate cholangioscopy system based on baseline imaging
6. Willing and able to provide a written informed consent to participate in the study
7. Willing and able to comply with study procedures and follow-up schedule

Exclusion Criteria:

1. Contraindication for an ERCP per local standard of practice
2. Deemed contraindicated for POCS per local standard of practice
3. Prior biliary treatment of biliary anastomotic stricture
4. \< 18 years old
5. Documented life expectancy of less than 12 months.
Acceptability, Representations and Experiences of the COVID-19 Pandemic

The "ARECOVID" project is a comprehensive sociological study of what is being played out in organizational terms in the face of the COVID-19 pandemic. Through quantitative methods (questionnaires) and qualitative methods (semi-directive interviews), we would understand the essential views of the populations concerned by COVID-19, but also that of actors taking care of vulnerable elderly non-COVID. Special attention will be paid to the care pathway of elderly people with and without the virus, in a health system in full reorganization. We will try to understand the needs and experiences of all health actors (hospital/city) involved in COVID-19 and the experience of confinement and the Covid-19 of the elderly living at home, in order to reflect on a possible improvement in the health response of elderly people in the event of an epidemic health crisis.

understand the needs and experiences of all health actors (hospital/city) involved in COVID-19 and the experience of confinement and the Covid-19 of the elderly living at home

Eligibility Criteria:
Inclusion Criteria:

* For older people : minimum age : 65 years
* For caregivers : works in gerontology

Exclusion Criteria:

* Person with a neurological disease
* Person under guardianship or curatorship
Mesh Debate Awareness Among Non-urogynecologists. A Practical Survey Study.

This study evaluates the awareness of mesh discussions in urogynecology among non-urogynecologists. A web-based questionnaire will be sent to four groups. Group-1 is King's College Hospital doctors. Group-2 is Uludag University Hospital doctors. Group-3 is doctors from the United States, and Group-4 is doctors from all over the world.

There has been a great deal of discussion about mesh complications in urogynecology. During the following decade, vaginal mesh operations for pelvic organ prolapse increased exponentially all over the world, particularly in the United States. Once the complications started to increase, the publication of mesh-related complications on social and broadcast media and the increase of medico-legal claims the United States led to an extensive FDA (Food and Drug Administration) restriction on vaginal mesh procedures in 2013. On January 5, 2016, the FDA reclassified surgical mesh for transvaginal repair of the pelvic organ prolapse into class III, which require premarket approval. Finally, on April 16, 2019, the FDA ordered all manufacturers of urogynecological mesh intended for transvaginal repair to stop selling and distributing their products immediately. However, awareness of the other doctors in branches of medicine outside of gynecology and urology is unknown.

Eligibility Criteria:
Inclusion Criteria:

* Doctors from all branches of medicine
* Basic sciences: Immunology, Medical Biochemistry, Microbiology and Infectious Diseases, Forensic Medicine, Family Medicine, Public Health, Medical genetics, Medical pharmacology.
* Pediatrics: Pediatric allergy, Pediatric respiratory, Pediatric dentistry, Pediatric endocrinology, Pediatric gastroenterology and nutrition, Pediatric haematology, Pediatric nephrology, Pediatric neurology, Pediatric oncology, Pediatric ophthalmology, Pediatric surgery, Child and adolescent psychiatry, Pediatric orthopedics.
* Basic internal medicine specialties: Gastroenterology, Medical Oncology, Rheumatology, Hematology, Nephrology, Endocrinology
* Other internal medicine specialties: Neurology, Nuclear medicine, Radiology, Radiation Oncology, Psychiatry, Sport medicine, Respiratory medicine, Physical medicine and rehabilitation, Geriatrics, Dermatology, Cardiology
* Surgical Departments: Emergency and Accident Medicine, Heart and vascular surgery, Ophthalmatology, Orthopedics and Traumatology, Plastic and reconstructive surgery, Medical pathology, Anesthesiology and reanimation, Neurosurgery, General surgery, Chest surgery

Exclusion Criteria:

* Obstetricians and Gynaecologists,
* Urogynecologists,
* Urologists,
* Perinatologists ,
* Gynecological Oncologists,
* Doctors from Reproductive Endocrinology and Infertility,
* Uro-oncologists
* Andrologists.