cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty

Vertebral compression fractures in osteoporotic patients is a major healthcare problem. Percutaneous vertebroplasty is commonly used to restore stability of the vertebra and to alleviate pain. However, the anesthetic techniques commonly used during these procedures such general anesthesia or a combination of local anesthesia and sedation are not satisfying as they are associated either with side effects or insufficient pain reduction.

This study compares the standard procedure of local anesthesia to a new technique of fluoroscopy-guided epidural anesthesia carried out by the radiologist.

The investigator's hypothesis is that fluoroscopy-guided epidural anesthesia

* provides better pain relief during the injection of high viscosity cement
* and thus, reduces the need of additional intravenous analgesia by remifentanil (morphine analogue)
* minimizes remifentanil potential adverse effects such as respiratory depression, hypoxemia, pruritus and nausea
* improves working conditions and satisfaction of the radiologist
* improves the global satisfaction of the patient

It is a monocentric, prospective, comparative and randomized study.


Eligibility Criteria:
Inclusion Criteria:

* - Two osteoporotic vertebra compression fractures in the low thoracic or lumbar spine
* men and women \> 18 years old
* patients with healthcare insurance
* signed and dated informed consent

Exclusion Criteria:

* men and women \< 18 years
* pregnant or breastfeeding women
* patients under trusteeship or guardianship or patients under the protection of court
* bad comprehension or cooperation
* bleeding disorders
* local or general infection
* intracerebral or severe cardiac affections
Association of Hb F Level With Clinical Severity of Beta Thalassemia

The production of Hb F after birth is an important factor in modifying the clinical severity of beta thalassemia because an increased gamma-globin level will bind the additional a-globin and form Hb F. The objective of this project is to evaluate the association of Hb F level with phenotypic diversity of patients with beta thalassemia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with beta-thalassemia

Exclusion Criteria:

* Iron Deficiency Anemia
TAILORx Tissue Bank

This is an exploratory, translational, non-interventional and multi-centre biobank. The aim of the development of such a biobank is to identify potential biomarkers that are indicative of disease relapse.

The primary objective is to develop a biobank, tissue microarrays (TMAs) and full face sections, which will be used to identify candidate/ novel biomarkers prognostic for disease relapse and predictive for endocrine and/or chemotherapy resistance.

The secondary objectives are:

* To validate emerging signatures/biomarkers identified.
* To develop new assays for the breast cancer clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients that were registered with the ICORG 06-31 TAILORx trial and participated in trial arms
* Patients with adequate tumor tissue available
Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy

To investigate the changes in MRI-derived markers of joint inflammation and destruction and in biochemical markers of connective tissue metabolism and angiogenesis in rheumatoid arthritis patients treated with Enbrel and Enbrel+methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* In the case of contra-indications for MRI, the patient may participate in the remaining part of the project.

Exclusion Criteria:

* N/A
An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx.
* Recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
* No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are met
* ECOG Performance Status of 0-1
* Measurable disease by CT or MRI per RECIST 1.1 criteria

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma)
* Participants with untreated CNS metastases are excluded
* Participants with carcinomatous meningitis
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

Other protocol defined inclusion/exclusion criteria could apply
Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

The objective of this study is to investigate the relative contributions of nicotine replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms, cognitive task performance and 90-min ad libitum usual-brand smoking behavior in smokers with schizophrenia and non-psychiatric smokers.

This study used a mixed between- and within-subjects design to investigate the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content \[VLNC\] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine \[NIC\] vs. placebo \[PLA\] patches) in smokers with schizophrenia and control smokers without psychiatric illness. Each session contained a 5-h controlled administration period in which participants underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, Usual Brand cigarettes + no patches. Next, participants completed measures of cigarette craving, nicotine withdrawal, smoking habit withdrawal, cigarette subjective effects, psychiatric symptoms and cognitive task performance followed by a 90-min period of ad libitum usual-brand smoking.

Eligibility Criteria:
Inclusion Criteria:

* schizophrenia or no psychiatric illness
* 18 and older
* men and women
* cigarette smokers, 20-50 cigarettes per day
* would like to quit someday

Exclusion Criteria:

* medical conditions excluding transdermal nicotine replacement
* pregnancy or lactation
Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.

The aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by NIRS (near-infrared spectroscopy ), and the FHbF (fraction of fetal hemoglobin) and absolute HbF (fetal hemoglobin) concentration in postnatal conditions in term and preterm neonates.

During gestation the main fetal oxygen carrier is fetal hemoglobin (HbF). HbF exhibits a significantly higher affinity for oxygen when compared to adult hemoglobin (HbA), which makes it more suitable for oxygen extraction at the lower partial oxygen pressures in utero. Although the regulation of HbF expression is determined developmentally, recent studies report a respectable variation in the fraction of HbF in neonates.

Such data suggest that the differences in HbF expression could affect end-tissue oxygenation in neonates.

The methodology for measuring oxygen saturation and extraction in cerebral and peripheral tissues of neonates using the near-infrared spectroscopy (NIRS) has been well practiced in our study group. However, the method has not yet been used to investigate whether the fraction of fetal hemoglobin (FHbF) plays a significant role in cerebral and peripheral oxygenation in neonates.

The aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by NIRS, and the FHbF and absolute HbF concentration in postnatal conditions in term and preterm neonates.

Eligibility Criteria:
Inclusion Criteria:

* Term and preterm neonates admitted to the neonatal intensive care unit (NICU)
* Decision to conduct full life support
* Written informed consent

Exclusion Criteria:

* No decision to conduct full life support
* No written informed consent
* Congenital malformations
* Family history of haemoglobinopathies (e.g. sickle cell anaemia, thalassaemia)
Characteristics and Inflammatory Markers in Children with Eosinophilic Esophagitis (EoE)

Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers

Participants with a diagnosis of EoE are recruited from Rady Children's Hospital Eosinophilic Gastrointestinal Disorders (EGID) during routine clinic and/or endoscopy visits.

Medical information including clinical symptoms, endoscopy, histopathology, medical and surgical history, lab and imaging findings, are entered into a UCSD database at each clinic or endoscopy visit. Blood and biopsy specimens are procured and utilized for analysis of inflammatory molecules and for isolation of structural cells. This protocol continues our clinical database and sample collection in children with EoE. The database provides a cohort of EoE patients for studies of natural history, therapeutic response, and disease progression. In a relatively new disease of increasing incidence, these studies will provide information on disease progression and the clinical characteristics of patients who have varying disease phenotypes as well as the associations between clinical phenotypes, molecular changes, and disease course. The procurement and storage of tissue, cells, and serum samples provides a repository for studies of EoE-related molecules and peripheral markers in clinically phenotyped patients. In addition, the study of these esophageal cells will provide an in vitro model system for assessing the molecular mechanisms of disease pathogenesis in EoE.

Eligibility Criteria:
Inclusion Criteria:

* Have a known EoE diagnosis
* Complain of dysphagia, vomiting, or abdominal pain, especially if recalcitrant to acid blocking therapy (but does not have to be recalcitrant to acid blocking medications)
* Present with food impaction
* Present with esophageal stricture
* Have characteristic endoscopic findings of EoE of pallor, linear furrows, lichenification, white plaques, or concentric rings

Exclusion Criteria:

* None
Pilot Study:Role of Dietary Fiber in PCOS Anovulation

The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).

We hypothesize that 6 months of fiber supplementation will improve ovulation in women with PCOS by improving insulin sensitivity independent of weight loss. In this pilot study, we will determine the feasibility of conducting a larger double-blind, randomized trial in women with PCOS to test this hypothesis. We will evaluate 15 women over a 10-month period, starting with a 4-month intervention-free observation period to determine the effect on ovulation of adding up to 22g/day of fiber supplementation to their usual weight-maintenance diets (to achieve 28-36 g fiber/day assuming baseline dietary fiber intake, could feasibly be translated into clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS between the ages of 18-45 years and with a body mass index of less than or equal to 45
* Less than or equal to 8 periods annually
* elevated serum free testosterone concentrations
* normal thyroid function tests and serum prolactin
* exclusion of late-onset adrenal hyperplasia
* acceptable health based on interview, medical history,physical examination, and lab tests
* ability to comply with the requirements of the study
* ability and willingness to provide signed, witnessed informed consent

Exclusion Criteria:

* Diabetes mellitus
* Clinically significant pulmonary,cardiac ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease
* high blood pressure
* current or recent(within 2 months prior to study entry) injection of any drugs known or suspected to affect reproductive function including oral contraceptives,metformin,thiazolidinediones,glucocorticoids, GnRH-agonists, or anti-androgens (spironolactone,flutamide,etc)
* documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism
* ingestion of any investigational drugs within 4 weeks prior to study onset
* pregnancy or lactation(less than or equal to 6 weeks postpartum)
Maximal Inspiratory Pressure at Extubation: Relationship With Mortality

The process of weaning from mechanical ventilation was decided after clinical judgment and weaning predictive index. Nevertheless, indexes predicting weaning outcome like Maximal Inspiratory Pressure (MIP) are frequently inaccurate. However the long-term involvement of respiratory muscles in critically ill patients has not been established. The objective of this study was to assess the relationship on MIP at extubation on one-year mortality in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation at least at 24 hours

Exclusion Criteria:

* Delirium
* Cognitive dysfunction
* refusal to participate
Clinical Study of TBF Regimen in Allo-HSCT in Patients With CNS Leukemia

Central nervous system (CNS) leukemia is a poor prognostic factor for allogeneic hematopoietic stem cell transplantation (allo-HSCT). Thiotepa can penetrate the blood-brain barrier and has immunosuppressive effects and similar effects to irradiation in allo-HSCT. This project aims to investigate whether the TBF regimen is superior to the traditional modified BuCY2 regimen to improve the long-term survival of the CNS leukemia patients.

Central nervous system (CNS) leukemia is a common extramedullary leukemia and a poor prognostic factor for allogeneic hematopoietic stem cell transplantation (allo-HSCT). There is a blood-brain barrier (BBB) in the CNS. The treatment effect of CNS leukemia is seriously limited by the low penetration of conventional chemotherapy drugs into cerebrospinal fluid. Thiotepa can penetrate the BBB and has immunosuppressive effect and myeloablative effect similar to irradiation in transplantation. Therefore, it is speculated that cestipide has certain advantages as a conditioning regimen in transplantation for CNS leukemia. This project aims to investigate whether the TBF regimen is superior to the traditional modified BuCY2 regimen to improve the long-term survival of the CNS leukemia patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with central nervous system leukemia by MICM meet one of the following conditions: corresponding symptoms and signs of central nervous system involvement; cerebrospinal fluid pressure increased by 200 mm water column; the white blood cell count in cerebrospinal fluid was 0.01×10\^9/L; cerebrospinal fluid protein qualitative test was positive or protein quantification was 45 mg/dL; leukemic cells can be found in the cerebrospinal fluid; cranial imaging suggested central involvement.
* Aged 14-60 years, male or female.
* KPS score: ≥80.
* Signed the informed consent.

Exclusion Criteria:

* Patients intending to receive autologous hematopoietic stem cell transplantation.
* Patients with transplantation contraindications.
* Those who refuse to sign the informed consent form.
Effect of Skate Skin Extract on Body Fat in Overweight Adults

Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in adults

Our aim is to investigate the effect of oral ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in adults by a randomized, double-blind, and control-group study.

Eligibility Criteria:
Inclusion Criteria:

* BMI 23\~30 kg/m2

Exclusion Criteria:

* Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)
* Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
* Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
* Those who are treated with hypothyroidism or hyperthyroidism
* Creatinine levels: more than twice the normal upper limit
* AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit
* Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion
* Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking
* Participated in the commercial obesity program within the last 3 months.
* If you have participated or are planning to participate in another clinical trial within the past month If yes
* Alcohol abuser
* Smoking abstinence within 3 months
* If they are pregnant or lactating or have a pregnancy plan during the clinical trial
* Those with allergic reactions to the constituent food
* Any person deemed inappropriate by the researcher for other reasons
Far-infrared Ray Effect on CV12 Acupoint

The purpose of the present study was to investigate the effect of far-infrared ray at CV12 acupoints area on the skin temperature and skin blood flow of palm central area of right hand, and the correlation between them.

The purpose of the present study was to investigate the effect of far-infrared ray at CV12 acupoints area (the center is CV12 acupoints and the diameter is 10 cm) on the skin temperature and skin blood flow of palm central area of right hand, and the correlation between them.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers, male or female, ages between 20 and 40 years
* Neurological and physical examination without abnormal functions
* Far-infrared ray illumination without allergic reaction and contra- indication
* The participants were explained the objective of the study, agreed to accept the test and signed a letter of consent

Exclusion Criteria:

* People less than 20 years of age or more than 40 years
* Women in pregnant or lactating
* People with mental or behavioral anomalies could not follow the researchers
* People suffered from serious diseases such as myocardial infarction , heart failure, serious arrhythmia, hypertension, diabetes, autoimmune disease, chronic obstructive pulmonary diseases, and kidney failure, liver cirrhosis and cancer
* People suffered from limb edema and serious skin diseases
* People did not sign a letter of consent
How Does Eating Behavior and Hunger in Virtual Reality Meals Compare to Real Meals?

Objective: To investigate the differences between eating virtual and real-life meals and test the hypothesis that eating a virtual meal can reduce hunger among healthy women.

Methods: Twenty healthy women will be recruited and partake in a randomized crossover study. The subjects will be asked to eat one introduction meal, two real meals, and two virtual meals, all containing real or virtual meatballs and potatoes. The real meals will be eaten on a plate placed on a scale which communicates with analytical software on a computer. The virtual meals will be eaten in a room, where participants are seated on a real chair in front of a real table, and fitted with the virtual-reality equipment. The eating behavior for both the real and virtual meals will be filmed. Hunger will be measured before and after the meals using questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 kg/m2 to 29 kg/m2
* "normal" physical activity (measured using the short version of the international physical activity questionnaire, IPAQ)

Exclusion Criteria:

* pregnant or breastfeeding
* smoker
* temporomandibular disorder
* recent serious dental surgery (last 6 months)
* undergoing treatments known to affect appetite (e.g., use of some psychotropic drugs)
* previous history of eating disorders
* vegetarian
* aversion to the food served
Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

Tacrolimus is a commonly used immunosuppressant after liver transplantation. A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good efficacy and safety. Moreover, there is evidence that this prolonged-release formulation mitigates renal impairment and metabolic syndrome in transplant recipients. Foreign studies have confirmed that it is safe and feasible for liver transplant recipients to switch from immediate-release tacrolimus to prolonged-release tacrolimus during the stable period. At the same time, patients with early conversion are more likely to benefit in terms of graft survival and renal function recovery, and the proportion of drug conversion needs to be further explored.

This study aims to assess the efficacy and safety of switching from immediate-release tacrolimus to prolonged-release tacrolimus three months after liver transplantation. Furthermore, it seeks to investigate the impact of this conversion on indicators such as liver function, kidney function, metabolic disease incidence, and infection incidence in patients.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old and above
2. 3 months after liver transplantation;
3. Stable use of immediate-release tacrolimus for at least one month before enrollment in the study;
4. The serum levels of aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\] were within the normal range; ....

Exclusion Criteria

1. Multi-organ combined transplantation or multiple liver transplantation;
2. Multiple organ recipients or those who have previously transplanted any organs；
3. Adjuvant liver transplantation or use of bioartificial liver therapy;
4. Prior to joining the group, they had received treatment with immune checkpoint (ICIs);
5. Participation in any other clinical study within 3 months prior to enrollment;
6. Use of tacrolimus sustained release capsules before enrollment;
7. Tacrolimus trough concentration lower than 5 ng/ml at the time of screening;
8. Acute rejection occurred within one month prior to enrollment; ....
Different Hemostasis According to the Anesthetic Agents

We investigated the hemostatic differences according to the main anesthetic agents by analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based anesthesia would impair postoperative coagulability more than the sevoflurane-based anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* All patient scheduled for ophthalmic surgery under general anesthesia
* American Society of Anesthesiologist physical status I or II

Exclusion Criteria:

* hematologic disorder
* severe anemia
* liver disease
* kidney disease
* taking a medication interfering with hemostasis