cyrilzakka/clinical-trials huggingface dataset:
Establishing the Collaborative Care Model of Traditional Chinese Medicine and Western Medicine-Pediatric Atopic Dermatitis

In Taiwan, there are many patients suffer from pediatric atopic dermatitis. Because of the clinical characteristic of repetitive and scratchy, which will affect the patients' quality of life and lead to the medical heavy budget. TCM may play an important role in this disease and help patient to improved their health. In this project, we aim to establish a Collaborative Care Model of TCM and Western Medicine, to achieve the multiple goal in clinical treatment, research and medical training. By establishing a collaborative care model, including the Chinese medicine doctor and Western medicine doctor, nurses, pharmacists and case managers, to cooperative satisfy the patient needed in the medical service, to improve the clinical presentation, patients'quality of life, and reduce exposure to corticosteroid. Besides, we can also build a training environment and reduce medical cost in long term purpose. Furthermore, by establishing a collaborative care model, we can provide a medical education and training opportunity to educate the medical student and clinician the necessary knowledge of pediatric atopic dermatitis by caring patients and learning from clinical case. According to the above training program, we not only aim to strengthen the competitiveness of Chinese medicine doctor in Taiwan, but also make the Western medicine doctors comprehend the TCM characteristic and may find out the even more opportunity to cooperate in clinical practice. To make this collaborative care model as a beginning milestone of cooperation between Chinese medicine and Western medicine.


Eligibility Criteria:
Inclusion Criteria:

* age 0-18
* meets the Hanifin and Rajka diagnostic criteria
* SCORAD score ≧ 25

Exclusion Criteria:

* Drug abuse
* Pregnent or lactating women
* Mental or behavioral abnormalities
* Allergic to the ingredients of the test regimen
* Any potentially life-threatening disease or dysfunctional organ system l
Incidence of pNeumonia and Related ConseqUences in Nursing Home Residents

In the present proposal, we hypothesize that specifically targeting pneumonia events with preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes Agées Dépendantes) setting (thus, improving the health status and quality of life of patients) may simultaneously produce relevant reductions in the healthcare costs. In fact, although the number of pneumonia cases may be numerically limited, the consequences of each event are potentially catastrophic for both the patient and the healthcare system. Unfortunately, to date, information about the incidence and economical effects of pneumonia in the older population living in the French EHPAD are extremely scare. To adequately evaluate whether there is room to implement preventive interventions aimed at reducing the onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this specific population are needed. This first step is crucial towards the appropriate design and conduction of possible future large-scale intervention trials in the EHPAD setting.


Eligibility Criteria:
Inclusion Criteria:

* Groups Iso-Resources (GIR) ranging between 5 (included) and 2 (included)
* Ability and willingness to participate to the study and to provide informed consent
* Agreement with the patient's physician about the enrolment to the study

Exclusion Criteria:

* Refusal of the EHPAD to participate
* Patients with severe disability (GIR 1)
* Patients with no evidence of functional impairment (GIR 6)
* Patients living in the participating EHPAD for less than 30 days since the baseline study visit
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg

This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
* Requiring hormonal treatment
* Postmenopausal women defined as a woman who has stopped having menstrual periods

Exclusion Criteria:

* Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
* Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
* An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
Immune/Inflammatory Biomarkers in Postpartum Depression

This will be a very straightforward study assessing changes of immune/inflammatory peripheral biomarkers before/after delivery with postpartum mood and the psychopathological features of postpartum depression (PPD), and with MRI measures of functional and structural brain integrity.

Multimodal assessment of peripheral cytokines, PBMC gene expression, FACS immunophenotyping, and IDO activation, will be validated with (a) clinical data about the presentation of PPD, (b) self- and observer ratings of psychopatology, (c) results coming from neuropsychological assessment of cognitive functions, and (d) multimodal brain imaging outcomes (WM integrity, functional connectivity, GM volumes).

It is expected that worsening or stabilization of mood, and the diagnosis of PPD, will be paralleled by worsening or stabilization of these measures, thus providing new markers to estimate the susceptibility to the disorder, to identify targets for treatment, and to predict and monitor treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

-Signed informed consent, able to understand, speak and write the national language

Exclusion Criteria:

* History of bipolar disorder, schizophrenia, schizoaffective disorder, psychosis NOS; anorexia or bulimia nervosa;
* Taking following medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants
* Active infection requiring antibiotics therapy;
* Immunosuppressed patient
* Other chronic diseases
* Signs of active infection requiring treatment
* Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder. - - Forbidden treatment: corticosteroids, NSAD, immunosuppressant IV-Ig based treatment
* Ongoing fever, infection treated by antibiotics or uncontrolled diabetes type I or II;
* Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer);
* Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), Parkinson's or Alzheimer's disease, or any other serious condition likely to interfere e with the conduct of the trial;
* Abuse of drugs or alcohol in the past 6 months
* Presence of chromosomal disorders
Lumbar Infiltration With Steroids - Effects on Pain Reduction

Questionnaire for patients who got a lumbar infiltration in our clinic. The patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study)

Questionnaire are given to patients who got a lumbar infiltration in our clinic of rheumatology. These patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study).

Eligibility Criteria:
Inclusion criteria:

* Patients who got a lumbar infiltration in our clinic.

Exclusion criteria:

* Infiltration of thoracal or cervical spine.
Digital CBT-I for Insomnia Disorder

This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder.

This study aims to examine the effectiveness of a fully-automated web and app-based digital CBT-I for insomnia compared to sleep hygiene education (SHE) in individuals with a diagnosis of insomnia disorder. Primary outcomes of interest include changes in insomnia severity, sleep onset latency, and wake after sleep onset throughout the course of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥22 years old
* Insomnia Disorder diagnosis
* Score ≤16 on the 8-item Sleep Condition Indicator
* \> 30 minutes sleep onset latency (SOL); and/or \> 30 minutes wake after sleep onset (WASO)
* Current resident of the USA
* Oral and written fluency in English
* Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form

Exclusion Criteria:

* Must not be currently receiving or be expecting to start CBT for insomnia during study participation, or have previously received CBT for insomnia in the past 12-months (self-report)
* If on psychoactive medication, including sleep medication, this must be stable for at least 5 half lives
* Past or present psychosis, schizophrenia, bipolar disorder, assessed by self-report and/or seizure disorder
* Occupation that requires alertness / caution to avoid accidents, for example long-haul driving, long distance bus driver, heavy machinery operator, air traffic controller
* Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT-I or SHE in the opinion of the investigator
* Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures
* Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities
Embryo Transfer With Self-spent Culture Medium

Embryo Transfer With Self-spent Culture Medium or new Culture Medium in Vitro Fertilization - Embryo Transfer Process, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two?

Although some metabolites are present in self-spent culture medium, there are some embryonic exocrine factors secreted by embryo.These factors may have a positive impact on embryo implantation and subsequent development. So it is necessary to compare the two ways of embryo transfer with Self-spent Culture Medium or New Culture Medium in vitro fertilization - embryo transfer process.

The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two?

Eligibility Criteria:
Inclusion Criteria:

* Infertility female patients with tubal factors,
* Infertile female patients with spouse factors

Exclusion Criteria:

* Intrauterine adhesions,
* Endometriosis,
* Primary ovarian insufficiency，
* Infectious disease
Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes

Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.

The investigators aim to study 40 subjects ages 5-11 with T1D to evaluate the feasibility of LCD. Participants will be asked to attend a total of 5 visits (4 in person and 1 phone visit) during the 6 month-duration of the study. Participants will be randomized to an intervention group with a LCD (50% of carbohydrate recommended daily allowance) vs. the standard diet.

During the screening visit, participants will be assessed by a dietitian to categorize their existing dietary regimen before randomization to either the LCD or the standard diet. In addition, participant's insulin regimen (either pump settings or multiple dose insulin injection therapy) will be reviewed for insulin dose adjustments as needed over a 2 week-period.

Eligibility Criteria:
Inclusion Criteria:

* Patients 5-11 years of age, with history of Type 1 diabetes for longer than 2 years,
* No carbohydrate restrictions at the time of recruitment.
* No medications that could affect appetite
* Regular attendance at the clinic (3-4 times per year),
* Glycated hemoglobin (HbA1c) \<10%.

Exclusion Criteria:

* Impaired renal or liver function,
* Chronic seizures or global developmental delay,
* Diagnosed with ADHD and/or on ADHD medications
* Use of drugs other than insulin affecting glucose metabolism
* Severe eczema
* Celiac disease
Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"

Our study aims to measure the impact of cognitive rehabilitation workshops on the development of cognitive functions and quality of life of patients expressing a cognitive complaint

The main objective of our study was to evaluate, in patients treated for cancer expressing the cognitive complaint during or after treatment, interest workshops on improving cognitive rehabilitation felt their cognitive functions and their quality of life.

The primary endpoint was the proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after treatment. The FACT-Cog is a self-administered questionnaire assessing the patients felt their cognitive difficulties (memory, attention, concentration) and the impact of these difficulties on their quality of life. The improvement is defined as an increase of 7 points \>= cognitive score won by the (a) patient (e) after the treatment

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Solid tumor or haematological
* Chemotherapy and / or targeted therapy in the adjuvant or metastatic
* Sequential processing
* Subjective cognitive complaints during or after treatment assessed by four items of the FACT-COG (impact on quality of life). Score ≥ 4/16 questions Q35, Q37, Q38 and Q41 FACT COG - Patient in remission or pause therapeutic
* Subjective between 1 month and 5 years after the end of chemotherapy and / or targeted therapy cognitive complaints (ongoing treatment with Herceptin is not a non-inclusion criteria)
* Lack of personality disorders and / or psychiatric disorder scalable
* No known brain metastases
* Lack of primary brain tumor
* Lack of analgesic treatment with opioids or Class 3
* Having signed informed consent to participate in the study
* Mastery of the French language

Exclusion Criteria:

* Primary cancer of the central nervous system or brain metastases
* Pathology malignant hematologic
* Disorders of higher functions documented
* Pathology psychiatric scalable
* Use documented drug
* Cancer treated in childhood
* Patient or opioids analgesics in Class 3
* Consumption of alcohol
* Patient unable to respond to cognitive tests and cognitive rehabilitation
* Refusal to participate
Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-70 years of age.
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
* The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration.

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
* Patients with a history of meeting DSM-IV-TR criteria for any:

  * manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode;
  * any depressive episode with psychotic or catatonic features;
  * panic disorder with or without agoraphobia;
  * obsessive-compulsive disorder;
  * schizophrenia, schizoaffective, or other psychotic disorder;
  * bulimia or anorexia nervosa;
  * presence of borderline personality disorder or antisocial personality disorder;
  * mental retardation, dementia, amnesia, or other cognitive disorders;
  * patients who are considered a suicide risk.
AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study)

Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.

The purpose of the AngioSculpt® Scoring Balloon Catheter For Bifurcation Coronary lesions (ABC registry) is to demonstrate the acute procedural success, device performance and long term outcome associated with use of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) for lesion preparation in the treatment of bifurcation lesions in native coronary arteries

Eligibility Criteria:
Inclusion Criteria:

* Patients with significant (≥ 50% diameter stenosis) native coronary artery disease involving a bifurcation (Medina class (x,x,1)).

Exclusion Criteria:

* Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
* Additional planned coronary interventions for a non-target lesion within 30 days of the study procedure.
Acute Limb Ischaemia (ALI) Management With 'Indigo' Mechanical Aspiration System

International Multi-Centre registry recording comprehensive data on the use of 'Indigo' Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or critical limb ischaemia.

A detailed registry has been designed and approved to be used world wide in vascular and trauma centres, already providing endovascular service for the management of critical limb ischaemia (CLI).

Recent campaigns have shown little is done to improve flow to the lower limbs (legs) of patients to avoid amputation rates. During this time many devises have been used and available on the market. The 'Indigo' system by Penumbra was originally designed from the acute stroke system "ACE". Similar principles were applied in designing the 'Indigo' system. This is currently being used in many centres to manage acute clot causing lower limb ischaemia, however no official registry or international clinical trial has been done to show its significance in managing this disease.

The investigator groups, have created this to come up with enough data to evaluate the Indigo system in the management of (ALI) and offer tips and tricks to other clinicians. The aim is for a single arm, multicenter, retrospective analysis of patients in whom (ALI) was performed with the Penumbra/Indigo System (study device), and gather greater data and information than the PRISM trial in 2013-2014 which obtained only 79 patients.

Eligibility Criteria:
Inclusion Criteria:

* Acute lower limb Ischaemia with acute soft clot.

Exclusion Criteria:

* Calcified plaques/ chronic disease causing critical limb Ischaemia
e-Natureza Project - Affective Validation of Nature Images for Hospital Use

Randomized clinical trial about the evaluation of the use of nature photographs in the positive and negative affects of oncological patients.

In recent decades there has been growing interest from researchers in understanding how the adoption of natural elements in daily life, even in hospitals, can characterize restorative environments and reflect in better health for patients. Contact with nature can be done indirectly through photographs. This clinical trial aims to verify the therapeutic potential of the nature images, previously validated in another part of this study, in the care of cancer patients undergoing chemotherapy. Anchored on the assumptions of the theory of Biophilia, and the environmental theory of Florence Nightingale our study hypothesis is that this intervention promotes well-being and promote more positive mood states, and reduce symptoms resulting from the treatment during chemotherapy session.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation;
* Signed in the Informed Consent Form;
* Who are undergoing chemotherapy treatment;
* Patients need to be on the first chemotherapy session, independently of oncological disease;
* Patients with clinical conditions and preserved communication function, in other words, lucid patients.

Exclusion Criteria:

* Blind patients;
* Patients without the capacity for judgment, in other words, with dementia;
* Patients who have their clinical condition aggravated during the chemotherapy session.
Scleroderma Registry

Scleroderma is likely caused by a combination of factors, including an external trigger (infection or other exposure) and a genetic predisposition. The Scleroderma Registry will conduct genetic analyses for disease-related genes in patients with scleroderma and their family members (parents, brothers, and sisters).

Scleroderma refers to a group of diseases that involve the abnormal growth of connective tissue, which supports the skin and internal organs. Scleroderma can affect the skin, making it hard and tight; it can also damage the blood vessels and internal organs such as the heart, lungs, and kidneys. Estimates for the number of people in the United States with the systemic (body-wide) form of scleroderma range from 40,000 to 165,000. The number of people with all scleroderma-related disorders is between 250,000 and 992,500.

Researchers believe that several factors interact to produce scleroderma, including abnormal immune activity, potential environmental triggers, and genetic makeup. Scleroderma is not passed on from parents to child, but certain genes may make a person more likely to develop the disease. The goals of this project are to identify the genes that influence disease susceptibility and expression in systemic scleroderma and to establish a repository of DNA, plasma, and serum samples from single case scleroderma families, multicase families, and healthy unrelated volunteers for the use of researchers interested in studying this disease.

Participants in the Registry will have a phone interview regarding disease characteristics and family history. Participants will be sent a blood kit to get a blood sample drawn locally for shipment to the Registry lab. Blood samples will be made available (anonymously) for studies by researchers around the country. In some cases, participants will be asked to sign a release of medical information so that medical records can be obtained to verify the diagnosis.

As of May 2009, this study is no longer enrolling family members.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of systemic sclerosis or family members of patients with systemic sclerosis

Or

* Healthy volunteer with no autoimmune disease and without a first-degree relative with a systemic autoimmune disease