cyrilzakka/clinical-trials huggingface dataset:
Safety Study of BMS-823778 in Subjects With Type 2 Diabetes

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Drug naive or on stable metformin therapy
* HbA1c 7-10%
* FPG ≤ 240mg/dL

Exclusion Criteria:

* History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
* Congestive heart failure
* Active liver disease
* Impaired renal function
* Hepatitis C, B and HIV

This list is not inclusive; additional information is provided in the protocol
A Plaque Test Comparing the Anti-psoriatic Effect of Marketed Products for Topical Use for Psoriasis Vulgaris

The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test


Eligibility Criteria:
Inclusion Criteria: (in summary)

* Subjects having understood and signed an informed consent form
* All skin types
* Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable
* Subjects willing and able to follow all the study procedures and complete the whole study
* Subjects affiliated to social security system

Exclusion Criteria: (in summary)

* Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
* Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration
* Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
* Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy
* Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy
* Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
Emotions in Multiple Sclerosis

Through this study, a group composed of multiple sclerosis patients will be compared to a healthy volunteers group to determine if the positive emotions recognitions is preserved in the first group.

Different studies have highlighted the specific deficiency concerning emotions recognition in multiple sclerosis. Patients with multiple sclerosis are reported to have more difficulty recognising negative emotions, especially anger and fear.

In this context, RECODE study has a twofold objective:

* To determine whether the positive emotions recognition remains preserved by combining behavioural and neurophysiological measures (electrodermal activity).
* To study this disorder's etiology through a comparison between a multiple sclerosis patient group and a control group (matched in sex, age, and education's level).

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 55 years old.
* Understand and able to express themselves in French.
* EXPERIMENTAL GROUP :
* Relapsing-remitting form (RRMS)
* With an EDSS \< 4 (Expanded Disability Status Scale)
* No significant motor, cerebellar or somatosensory disorders of the upper limbs or visual disorders (EDSS specific parameter \<2)
* No flare-up in the last 6 weeks
* No corticosteroids taken in the last 4 weeks
* CONTROL GROUP :
* Lack of global cognitive deterioration (according to Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) standards).
* Gender, age and education level matching to the multiple sclerosis patients
* Understanding and signing the informed consent and information letter regarding participation in the study.
* Benefiting from health insurance coverage.

Exclusion Criteria:

* Persons with previous neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general affections, perceptive or dysarthric disorders preventing verbal communication or reading,
* People with sensory disorders (visual and auditory) that interfere with the performance of neuropsychological tests;
* Treatment with psychotropic drugs (except benzodiazepines and hypnotics).
* Refusal to participate after clear and fair information about the study.
* Major persons under guardianship, under judicial protection, persons deprived of liberty.
* Pregnant or breastfeeding women
Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up

The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO);
2. Associated with TIA or cryptogenic stroke;
3. Patients was implanted with the investigational device as per IFU instructions;
4. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.

Exclusion Criteria:

1. Any contraindication mentioned in the corresponding IFU;
2. Patients did not conduct any follow up visit after hospital discharge.
Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

Functional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health impairment. Almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as having the postprandial distress syndrome (PDS) variant. However, studies evaluating dietary modifications in PDS are sparse.

The investigators will perform a single-centre randomised trial evaluating traditional dietary advice (TDA) in PDS.

50 patients with PDS will be randomly assigned to a leaflet explaining reassurance-alone +/- TDA. The reassurance-alone group will be informed of the absence of organic disease and provided a diagnostic explanation of functional dyspepsia. The TDA group will receive the same information but also be recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre.

Questionnaires are to be completed during the 4-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Napean Dyspepsia Quality of Life Index.

The primary endpoint(s) to define clinical response will be evaluated over weeks 3-4 as, i) ≥50% adequate relief of dyspeptic symptoms, and ii) \>0.5-point reduction in the PDS subscale of the LPDS (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating).


Eligibility Criteria:
Inclusion Criteria:

* Fulfil Rome IV symptoms criteria for functional dyspepsia
* Normal upper gastrointestinal endoscopy within last 3 years
* Online access
* English literate

Exclusion Criteria:

* Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease)
* Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)
* Documented H.pylori in the last 3 months
* History of eating disorders
* Body mass index \<20
* Current use of opioids or anti-inflammatory drugs
* Severe systemic disease (e.g. cardiac, renal, respiratory) necessitating frequent medical consultations
* Pregnant
* Diabetes mellitus
* Scleroderma
* Memory impairment
* Current dietary interventions
Mortality Score in Elderly Patients With Colon Cancer

CR-POSSUM is one of the most used surgical scores to predict mortality after colorectal surgery. Its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. The primary aim of the study is to develop a new surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population. The secondary objective is to analyze its efficacy compared to CR-POSSUM.

Patients aged 80 and older undergoing surgery for colon cancer from 2011 to 2017 in an Italian hospital were retrospectively selected. MECC score \[Mortality in Elderly patients with Colon Cancer\] was calculated summing up the scores relating to: arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine. Once CR-POSSUM was calculated, the two scores were compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches

Exclusion Criteria:

* Surgical resections for rectal cancer and surgical procedures for non-neoplastic colon pathologies
Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain

The focus of this project is on developing and optimizing community-based programs for the self-management of back or neck pain for individuals from populations that experience health disparities (BP-PEHD). Community-engaged research approach will be used to conduct quality improvement activities that involves gathering feedback from multiple stakeholders to inform development of the study interventions and materials which will be followed by a randomized pilot study to evaluate feasibility.

Supported by the National Center for Complementary and Integrative Health through the National Institutes of Health's HEAL initiative (https://heal.nih.gov/)"


Eligibility Criteria:
Inclusion Criteria:

* Provide a signed and dated informed consent form
* State willingness to comply with all study procedures outlined in the consent form
* Be 18 years of age or older
* Have self-reported chronic back pain (defined as pain in the low or mid back, or neck pain) which has lasted for 3 months or longer
* Have a score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10)
* Be a member of one or more of the following NIH-designated health disparity populations: American Indian/Alaska Native, Asian, Black/African American, Hispanic/Latino, Native Hawaiian/Pacific Islanders, Socioeconomically disadvantaged (annual household income less than $50,000)

Exclusion Criteria:

* Hospitalization for severe mental illness in past six months because the mindfulness and behavioral mind-body practices (e.g., meditation, progressive muscle relaxation, etc.) in the experimental intervention may aggravate symptoms of severe mental illness
* Active psychotic symptoms, suicidal ideation, or manic episodes in the past three months for the same reasons noted in #1
* Self-reported cancer with active treatment involving radiation or chemotherapy due to the potential for complications of their back or neck pain and impact on health outcomes
* Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment due to safety risks (e.g., not being able to follow directions for safe physical exercise)
* Self-reported pregnancy due to the fact that back pain is often associated with pregnancy and differs from non-pregnancy related back pain and thus might have different impacts on health outcomes
* Children under the age of 18
Effect of Different Left Lateral Table Tilt for Elective Cesarean Delivery Under Spinal Anesthesia

The recommended position of the mother under caesarean section after spinal anesthesia is 15 degrees left. However, recent research has challenged the basic principles and practicality of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly prove that in the supine position, the position of the full-left 30 degrees of the full-term pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the left-angle of 15 degrees did not. Therefore, there are more and more controversies about the choice of cesarean section position. This experiment aims to explore effects of different positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.

When the pregnant woman in the third trimester is in the supine position, the enlarged uterus may oppress the inferior vena cava, thereby reducing the amount of blood and heart output of the pregnant woman. This affects the mother mainly, such as dizziness, nausea and vomiting, chills, and severe irritability，difficulty breathing or even cardiac arrest, the impact on the fetus is mainly the reduction of blood flow in the placenta, affecting the blood exchange of the uterus placenta, causing neonatal respiratory distress, acidosis and even death. The recommended position of the mother under caesarean section after spinal anesthesia is 15 degrees left. However, recent research has challenged the basic principles and practicality of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly prove that in the supine position, the position of the full-left 30 degrees of the full-term pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the left-angle of 15 degrees did not. Therefore, there are more and more controversies about the choice of cesarean section position. This experiment aims to explore effects of different positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy at term via elective cesarean section
* Height from 150 cm to 180 cm
* American Society of Anesthesiologists (ASA) grade from I to II grade
* BMI（Body Mass Index，mearsured weight divided by height squared）less than 35 kg/m2.

Exclusion Criteria:

* Transverse lie
* Fetal macrosomia
* Uterine abnormalities (e.g., large fibroids, bicornuate uterus)
* Polyhydramnios
* Ruptured membranes
* Oligohydramnios
* Intrauterine growth restriction
* Gestational or nongestational hypertension, diabetes, eclampsia
* Hypertensive disorder or any condition associated with autonomic neuropathy (e.g., diabetes mellitus for more than 10 yr), with renal failure
* Have contraindications for spinal anesthesia（Such as low back infection, spinal deformity, etc.）
* Participants refused to sign informed consent.
Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

RATIONALE: Acupuncture may help relieve hot flashes in patients with prostate cancer.

PURPOSE: This clinical trial is studying how well acupuncture works in treating hot flashes in patients with prostate cancer who are undergoing androgen deprivation.

OBJECTIVES:

* Determine the impact of acupuncture therapy on the frequency and intensity of hot flashes and the quality of life of patients with prostate cancer undergoing androgen deprivation.
* Determine if blood serotonin and urinary 5-HIAA are increased in patients treated with acupuncture.
* Determine if plasma calcitonin gene-related peptide and MHPG are reduced in patients with hot flashes due to androgen deprivation treated with acupuncture.
* Determine the ability of tongue diagnosis, a traditional Chinese clinical assessment method, to predict clinical and biological changes in these patients.
* Determine the effect of acupuncture on insomnia and loss of vitality caused by hot flashes in these patients.

OUTLINE: Patients undergo acupuncture for 30 minutes twice weekly for 4 weeks and then once weekly for an additional 6 weeks.

Quality of life is assessed at baseline, at weeks 2, 4, 6, and 10, and then at 6 weeks after completion of study treatment.

After completion of study treatment, patients are followed at 6 weeks.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of prostate cancer
* Hot flash score ≥ 4 per day
* Prior or concurrent treatment with 1 of the following :

  * Bilateral orchiectomy
  * Gonadotropin releasing-hormone (GnRH) agonist or antagonist therapy
  * Antiandrogen therapy

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No mental impairment

PRIOR CONCURRENT THERAPY:

Chemotherapy

* No concurrent chemotherapy

Endocrine therapy

* See Disease Characteristics
* More than 4 weeks since prior estrogen or progestational drugs

Surgery

* See Disease Characteristics
* No prior placement of a pacemaker or other implantable electrical device

Other

* More than 4 weeks since prior gabapentin
* No concurrent antidepressant drugs
Effects of Nursing Care Provided to Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope

The aim of this study is to determine the effects of nursing care provided based on the Watson's Theory of Human Caring to the relatives of palliative care patients on caregivers' spiritual well-being and hope. This research was conducted with 60 patient relatives (intervention group: 30, control group: 30) taking care of their patient in palliative care unit.

Every year, millions of patients as well as millions of patients are primarily involved in the palliative care process. It is emphasized that from the very start of palliative care process until grievance stage, patient relatives require a myriad of physical, psychological, social and spiritual needs. It has been widely reported that among relatives of palliative care patients, there is a high incidence of mental distress, depression, anxiety, sleep disturbance, fear and despair. The maintain of hope and spiritual well-being are important in dealing with this difficult process. Accordingly, nursing care is important, which supports the hope and spiritual well-being of patients' relatives. Nursing care that supports hope and focuses on spiritual dimensions is important in Watson's Human Care Theory.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 and above
* willingness and motivation to participate in research
* literacy
* being the primary caregiver
* lack of mental or verbal deficiency to respond the questions

Exclusion Criteria:

* aged 18 below
* unwilling to participate in research
* illiterate
* non-primary caregiver
* mental or communicative disabilities
The Development and Study of a 3D-Printed Model for Surgical Planning of Lung Cancer with Realistic Subsegmental Boundaries and Complete Tissue Structures

This project focuses on the development of a precision multi-organ surgical planning model aided by artificial intelligence (AI), computer-aided design (CAD), multi-material 3D printing, and multimodal 3D modeling. The integration of these advanced technologies aims to enhance the accuracy and efficiency of preoperative planning for complex surgical procedures involving multiple organs. By leveraging AI and CAD, the project seeks to create detailed, patient-specific 3D models that incorporate various imaging modalities. These models will be used to guide multi-material 3D printing, producing highly accurate replicas of anatomical structures. The ultimate goal is to improve surgical outcomes by providing surgeons with precise and comprehensive tools for planning and executing intricate surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lung cancer
* Complete clinical case data;
* All patients underwent surgical treatment;
* Voluntarily participate in the study and sign the informed consent.

Exclusion Criteria:

* Severe comorbidities, such as uncontrolled heart disease or diabetes
* History of major surgeries or other interventions
* Unwillingness to participate in the study
A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis

The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with bradykinesia, combined with resting tremor and/or myotonia.
* Appendix CT suggested chronic appendicitis evaluated by two experienced experts.
* All subjects and their guardians give informed consent to the content of this study and sign informed consent.
* Normal coagulation function.
* If the patient had taken oral anti-PD drugs, it had been stable for at least 2 weeks at enrollment.

Exclusion Criteria:

* Treatment with dopamine blockers or dopamine depleters in doses and time courses consistent with drug-induced parkinsonism.
* Neuroimaging examination of presynaptic dopaminergic system function was normal.
* Patients who had suffered severe brain trauma or underwent complex craniotomy within 5 years prior to enrollment.
* Cognitive disorders that are not on the Parkinson's spectrum, such as Alzheimer's disease, frontotemporal dementia, and Niemann-Pick disease, have been diagnosed.
* People diagnosed with severe neuropsychiatric disorders (epilepsy, bipolar disorder, major depressive episode, etc.) according to DSM-V.
* Complicated with serious systemic diseases, disorders of consciousness, stroke, serious coronary heart disease, diabetes, liver and kidney diseases, and serious visual and hearing disorders.
* Patients with severe organic or functional dysphagia;Those who were deemed by the researcher to be unable to complete the visit and auxiliary examination as required by the study protocol.