cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Efficacy of FFOCT Imaging for Tissue Sample Obtained by EUSFNB

In most Asian medical centers, rapid on-site cytology evaluation is not available, the number of needle passes of EUS-FNA is decided by endoscopists. Full-field optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the morphological structure and pathological changes in minutes without conventional tissue preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability information of cells/tissue, which could be more important in sample rapid evaluation.

Light-CT, a special-designed pathology-approximation system which is based on the lighting feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue in fresh specimens. Morphological structure and pathological changes could be captured in minutes, which implies a possible application in intraoperative diagnosis. The investigators aimed to evaluate the diagnostic efficacy of FFOCT for the tissue samples obtained from EUS-FNB of pancreas.

Eligibility Criteria:
Inclusion Criteria:

* Tissue samples can be obtained via EUS-FNB
* Signed informed consent letter

Exclusion Criteria:

* Unable or refuse to provide informed consent
Spectral Lighting and Intestinal Failure

The goal of this exploratory n-of-1-study is to compare markers of metabolism in infants with intestinal failure between two lighting environments. Investigators are seeking to learn whether supplementing the lighting environment of infants with intestinal failure with blue and violet wavelengths of light will allow more efficient utilization of the nutrition provided to participants by influencing hormones involved in regulation of growth and development as compared to a conventional lighting environment.

Pre-clinical studies suggest that violet and blue wavelengths of light are involved in molecular pathways that help regulate metabolic activity.


Eligibility Criteria:
Inclusion Criteria:

* greater than or equal to 32 weeks post-menstrual age (PMA)
* diagnosis or anticipated diagnosis of intestinal failure by qualified provider
* have an anticipated hospital stay of at least 5 weeks following initiation of study participation

Exclusion Criteria:

* Infants with major congenital anomalies outside of the gastrointestinal tract
* Infants with aneuploidy (having an abnormal amount of chromosomes)
* Infants \<32 weeks post-menstrual age (PMA)
* Infants who are anticipated to require a major surgery after enrollment other than anastomosis.
Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients

Cytomegalovirus (CMV) establishes a chronic infection in 60% of the general population. In renal transplant recipients, it is responsible for morbidities occurring mainly in the first 6 months after transplantation. These include viral reactivations linked to immunosuppressive treatment inhibiting the anti-CMV T lymphocyte response. CMV infection, a sign of uncontrolled viral replication, is defined by the detection of viral DNA in the peripheral blood (DNAemia). CMV disease is defined as the association of an infection and symptoms attributable to the virus.

In transplant recipients carrying the virus before transplantation (positive serology: CMV+), two infection prevention strategies are recommended: either close monitoring of DNAemia with antiviral treatment in the event of positive detection (pre-emptive strategy), or antiviral treatment for the first 3 months following the transplant (prophylactic strategy). Both strategies result in the occurrence of CMV infection in 15 to 20% of patients within the first 6 months, with the majority of events occurring between 3 and 6 months.

Numerous studies show that the evaluation of the anti-CMV T lymphocyte response, either before (D0) or early after transplantation (D15), or when antiviral prophylaxis is stopped, allows the identification of patients at risk of CMV infection. No study has yet demonstrated the contribution of such an evaluation in a preventive strategy. We therefore propose such a study.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant patient for 1 to 12 days
* CMV seropositivity on the day of transplantation: IgG threshold =6 AU/mL CMIA CMV IgG, Architect i4000 (Abbott)) (Serology performed on D0, before the transplant)
* Non-depleting inducing immunosuppressive treatment (Basiliximab) (implementation before the transplant)
* Affiliation to a social security scheme
* Patient having read and understood the information letter and signed the consent form

Exclusion Criteria:

* Active CMV infection (detectable CMV DNAemia - peripheral CMV DNAemia ≥ 305 IU/mL)
* Patient with hypersensitivity to valganciclovir, ganciclovir, aciclovir or valaciclovir or to any of the excipients
* Lympho-depleting inducing immunosuppressive treatment (antithymoglobulins)
* Neutropenia (neutrophils \< 500/mm3) or thrombocytopenia (platelets \< 25,000/mm3) or anemia (hemoglobin \< 8G/L) identified on routine care samples taken on the day of inclusion
Metformin In Prevention of Lupus Nephritis

Lupus nephritis (LN) is a main manifestation of systemic lupus erythematosus (SLE), which will largely effect the prognosis of SLE patients. Our previous 10-year data showed that the development of LN is most common in the first year of SLE, occupying about 17%. And our group has established a prediction model to predict the 1-year probability of LN for SLE patients without renal involvement. Our previous proof-of-concept trial and multicenter, randomized, double-blind, placebo-controlled trial indicated that metformin seemed to have potential to reduce the new-onset of LN in SLE patients (Unpublished data, in review). So the investigators tried to illustrate whether metformin has effect to prevent the development of lupus nephritis in high risk SLE patients based on LN prediction model.


Eligibility Criteria:
Inclusion Criteria:

* New-onset of SLE (within 1 year)
* Meet the 1997 ACR criteria of SLE
* 1-year risk of developing LN higher than 50% based on LN prediction model.
* All the patients received standard care of therapy. (mycophenolate/azathioprine/cyclosporin/tacrolimus/methotrexate/leflunomide were allowed).
* Sign the informed consent.

Exclusion Criteria:

* Patients with kidney involvement at screening were excluded
* Patients with severe SLE were excluded, such as neuropsychiatric and cardiac involvement
* Cyclophosphamide or biologics were not allowed.
* Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min;
* Previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin;
* Patients who diagnosed of diabetes mellitus;
* Pregnancy or lactation.
Training Model on Insertion Techniques for Postplacental Intra Uterine Device

This study aimed to compare special guided training model with standard procedure on insertion technique for post-placental intra uterine device that provides IUD location close enough to fundal part of uterus to prevent expulsion

The standard of insertion IUD postplacental can not provide prevention of expulsion. Special techniques on insertion IUD is needed for preventing expulsion. This training model is consisted of the special techniques to provide intra uterine device post placental close enough to fundal part of uterus to prevent expulsion

Eligibility Criteria:
Inclusion Criteria:

* 37-42 weeks gestation pregnancy women in delivery, singleton pregnancy, without any uterine anomaly

Exclusion Criteria:

* Any bleeding and infection complication
Peer Facilitated Waitlist Controlled Transportation Study

The goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. This project aims to address the following hypotheses:

1. Individuals with SMI receiving either of the two peer-mediated travel training transportation interventions will experience an increase in transportation self-efficacy and transportation skills.
2. Participants in the intervention arms will increase their transport utilization, participate in significantly more activities in the community, and make significantly more trips in the community.
3. Individuals with SMI receiving peer-mediated travel training interventions will retain post-test levels of community participation and self-efficacy 2 months after intervention.

Participants will be assigned to an 8-week travel-training intervention either using a bike-share program or public transportation. All participants will complete three data-collection research interviews.

This project proposes using a two-armed, waitlist controlled trial to test the effectiveness of peer-facilitated travel interventions and their ability to enhance community mobility and increase feelings of self-efficacy in individuals with serious mental illness (SMI). The first intervention arm is an 8-week bikeshare intervention, which consists of individual trainings on using a bike sharing program; the second intervention arm is an 8-week public transportation intervention, which consists of individual trainings for using public transportation in the Philadelphia area. The investigators seek to enroll a total of 180 individuals from community mental health agencies in the Philadelphia area and expect recruitment to take 3 years. Eligible participants will be individuals who meet criteria indicating that they have an SMI, are between the ages of 18-65, and are both willing and able to learn to use public transportation and ride a bicycle. Data will be collected via face-to-face or web-based video call interviews at 3 time points: baseline, 2-months post-baseline, and 4-months post-baseline. Participants will also complete short surveys about their travel behaviors over the phone in the seven days after each interview. There will also be a subsample of participants who will provide additional GPS data.

Eligibility Criteria:
Inclusion Criteria:

* are between the ages of 18 and 65
* are diagnosed with a SMI (confirmed via the MINI)
* score at least an 8 on a travel skills assessment
* indicates that they can ride a bicycle
* have expressed interest in using a bikeshare and public transportation
* are able to provide informed consent

Exclusion Criteria:

* score less than 8 on a travel skills assessment
* express no interest in independent transportation
* are non-English speaking individuals
* are unable to provide consent
* are living in a setting where mobility and participation is restricted
* have a limiting physical condition that would prevent their ability to ride a bicycle independently
Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction

To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction

Objective: To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert Ⅱ adenocarcinoma of esophagogastric junction.

Methods: A prospective, multi-center, randomized, controlled study will be performed. Patients who meet the eligibility criteria will be registered in the study and undergo radical surgery via transhiatal/transabdominal or thoracoabdominal approach. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.

The primary endpoints :3-year disease-free survival. The secondary endpoints:(1) Surgery and oncology indicators ;(2) The incidences of postoperative complications and mortality.

Eligibility Criteria:
Inclusion Criteria:

* 1.18\~75 years old
* 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(SiewertⅡ) .
* 3.Histological diagnosis of adenocarcinoma
* 4. American Society of Anesthesiologists(ASA) physical status class is less than or equal to 3
* 5.Informed consent of patients

Exclusion Criteria:

* 1.Patients with distant metastasis (M1) or invasion of surrounding organs
* 2.History of esophagectomy and gastrectomy (including endoscopic mucosal resection/endoscopic submucosal dissection for gastric cancer and esophageal cancer)
* 3.History of other malignant tumors within 5 years
* 4.The researcher believes that the patient is not suitable to participate in the clinical trial
* 5.Patients who persist in withdrawing from clinical trials
Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients

The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, when being added to lamivudine, in the treatment of adults with chronic hepatitis B infection who are co-infected with HIV.


Eligibility Criteria:
* Documented history of co-infection with HIV and HBV
* Stable Anti Retroviral Therapy regimen containing lamivudine 150 mg BID for at least 24 weeks prior to enrollment;
* Documented HBV viremia on screening and at least at 4 weeks prior to screening
* HBe Ag-positive or HBe Ag-negative / anti-HBe-positive
* HIV viral load below 400 copies/mL by the Roche Amplicor(TM) 1.5 HIV PCR assay at screening and equally low at least 12 weeks prior to screening
* Absence of Co-Infection with hepatitis C virus (HCV) or hepatitis D virus (HDV)
* Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease
* Less that 1/2 weeks of prior therapy with nucleoside/nucleotide analogue (excluding lamivudine) with activity against HBV (including e.g. famciclovir, tenofovir, ganciclovir, adefovir). No receipt of any of these therapies within 24 weeks prior to randomization into this study.
Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma

This study will collect bone marrow (BM) aspirate samples from patients with relapsed refractory multiple myeloma (RRMM) prior to the start of a new treatment regimen for the purposes of prospectively measuring single-cell mass accumulation rate (MAR) as a biomarker of patient response to that regimen.

The primary study objective is to explore whether the single-cell MAR biomarker can predict patient response in RRMM patients. In order to enable this primary objective, two patient cohorts will be required. First, a small vanguard cohort of patients with treatment naïve disease to define drug concentrations used for testing, and second, the main RRMM patient cohort. Data will be collected to estimate the biomarker's predictive properties (accuracy, sensitivity, specificity), and to support improvement of the MAR biomarker through additional research and discovery within the study dataset.


Eligibility Criteria:
Inclusion Criteria:

1. Written Informed Consent provided by patient
2. MM, with the following conditions:

(CLOSED) \*For patients in the Vanguard cohort\*

1. Treatment naïve disease with BM clinically indicated

\*For patients in the RRMM cohort\*

1. Relapsed/refractory disease with BM samples clinically indicated
2. Within 4-weeks prior to initiation of 2nd-line or later therapy
3. Patient's oncologist must be planning to change the patient's next line of treatment to a monotherapy or combination therapy composed exclusively of drugs from the following list: Bortezomib (Velcade), Carfilzomib (Kyprolis), Lenalidomide (Revlimid), Pomalidomide (Pomalyst), Cyclophosphamide (Cytoxan), Dexamethasone, Ixazomib (Ninlaro), Venetoclax (Venclexta), Selinexor (Xpovio)

Exclusion Criteria:

1. Unable or unwilling to provide informed consent
2. Daratumumab/Elotuzumab or other antibody-based therapeutic regimens as immediately planned treatment (as prior therapy is acceptable)
3. Patient enrolled/enrolling in a clinical trial where data or specimen sharing provisions preclude use in this study
4. Prior exposure to CAR-T therapy
5. Prior allogeneic stem cell transplant
6. Has received any systemic chemotherapy or RT, including palliative, within 7 days prior to BM biopsy
7. Has received any Ab therapy within 4 weeks prior to BM biopsy
ACT Combined Yoga for Parental Burnout in Parents with Autistic Children

OBJECTIVE: To explore the intervention effect of ACT combined with a yoga intervention program on parenting burnout in parents with ASD.

METHODS: This study used a combination of qualitative research and quantitative analysis to examine the intervention effects of an ACT-centered intervention program on parenting burnout in parents of children with ASD, and to clarify the evaluations and perceptions of parents with ASD about the research program through qualitative research.

RESULTS AND CONCLUSION: To clarify the intervention effect of ACT combined with yoga intervention program on parenting burnout of ASD parents.

This study will focus on parents of children with ASD, and through literature review, intervention research, qualitative research, and other methods, based on PRO, adopt acceptance commitment therapy as the core intervention program to explore the improvement of parenting burnout, stress level and quality of life of parents, to enhance the psychological flexibility of parents with ASD, so that parents can positively cope with negative emotions and adverse events in life, and to promote the physical and mental health of parents and the quality of child care, so as to enhance the well-being and quality of life of families with ASD, and to enhance the well-being and quality of life of families with ASD. The program promotes the physical and mental health of parents and the quality of care for their children, thereby enhancing the well-being and quality of life of families with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children diagnosed with ASD based on DSM-5
* Parental burnout exists in parents
* Parents have normal speech, hearing and cognitive functioning
* Is the primary caregiver for children
* Informed consent and voluntary participation

Exclusion Criteria:

* Untreated ongoing or severe psychiatric disorders such as anxiety disorders, depressive disorders, schizophrenia, etc.;
* other more serious psychosomatic disorders that would interfere with the intervention.
Music Against Psychological Pain in Suicide

This study compares the efficacy of music therapy associated with standard care versus the standard care alone on the psychological pain in suicidal patients.

Music therapy consists of using the Music Care tool. Each patient randomized in the music therapy arm should perform 4 music therapy sessions of 30 minutes on 48h.

Before and after each music therapy sessions, the psychological pain will be measured by the analogical visual scale.

Standard care consists of a medical and paramedical interview lasting 20-30 minutes. At the end of the interview, a drug treatment (BZD anxiolytic and/or hypnotic) is prescribed and the patient is hospitalized. During hospitalization, patient is regularly interviewed in order to evaluate his psychological status.

Eligibility Criteria:
Inclusion Criteria:

* Patient with suicidal ideas, thoughts or surviving suicide attempt
* Patient whose emergency somatic management lasted less than 48h
* Patient who, according to the physician, is still in suicidal mood
* Patient admitted in the psychiatric hospitalization unit of the Public Mental Health Establishment
* Patient with voluntary admission and agrees to stay in hospital from 48h to 60h
* Patient able to write and read in french
* Patient affiliated to a social security scheme
* Patient who gives his Informed consent before any procedure related to the study

Exclusion Criteria:

* Patient with attempt suicide requiring a somatic care (intensive, surgery, gastric lavage...)
* Patient with medical history of audiogenic and/or musicogenic epilepsy
* Patient with major impairment of hearing function
* Patient unable to support the headhset earphone
* Patient with contra indication to BZD, hypnotics (Zopiclone) or requiring more sedative and/or psychotic drugs
* Patient under guardianship or under judicial protection
* Patient hospitalized at the request of a third party or ex officio
Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

This trial is conducted in Europe.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Treated with OAD(s) for more than or equal to 2 months
* Body mass index of (BMI) less than or equal to 40.0 kg/m2
* HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7.0% and less than or equal to 10.0 % for subjects on OAD combination therapy

Exclusion Criteria:

* Recurrent major hypoglycaemia
* Current smoking or smoking within the last 6 months
* Impaired hepatic or renal function
* Cardiac disorders
* Uncontrolled hypertension
* Proliferative retinopathy or maculopathy
Upper Trapezius Stretching in Patients With Cervical Spondylosis

This study aims to investigate the effectiveness of upper trapezius stretching exercises on pain intensity, neck range of motion, and disability in patients with cervical spondylosis. Patients with diagnosed cervical spondylosis will be randomly assigned to either a study group performing upper trapezius stretches or a control group. Both groups will receive heat treatment and strengthening exercises. The study group will additionally perform specific upper trapezius stretching exercises. Outcomes measures will be assessed before and after 4 weeks of intervention and will include neck pain intensity, range of motion, and disability using the Neck Disability Index. The study hypothesizes that the study group will demonstrate greater improvements in pain, range of motion, and disability compared to the control group. The study findings could provide data to guide physical therapy management of cervical spondylosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cervical spondylosis confirmed by orthopedic specialist
* Presence of neck pain for at least 3 months
* willingness to participate in the study and comply with the intervention

Exclusion Criteria:

* Recent neck trauma or fractures (within 6 months)
* Previous neck surgery
* Concurrent medical conditions that could affect neck pain and range of motion (e.g. rheumatoid arthritis)
* Concurrent physical therapy or rehabilitation for neck or shoulder
* Use of corticosteroids within past 3 months
* Pregnancy or serious circulatory conditions (due to use of heat pack)
* Known hypersensitivity to heat or cold
* Cognitive impairment that could interfere with ability to understand and complete self-report questionnaires and comply with interventions