cyrilzakka/clinical-trials huggingface dataset:
Mesenchymal Stem Cells to Treat Type 2 Diabetes

Umbilical cord mesenchymal stem cells indicate the therapeutic effects and safety on type 2 diabetes by characteristics of secretion and immune Immunomodulation.

Umbilical cord mesenchymal stem cells can improve insulin resistance of the target tissues, reduce the islet progressive damage, ease or regenerate of the islet beta cells and improve hyperglycemic state of diabetes by secreting a variety of cytokines. It can induce damaged alpha cells differentiate into beta cells in the islet transformation to realize the islet beta cells in situ regeneration by improving microenvironment of islet beta cells. Umbilical cord mesenchymal stem cells also have immunosuppressive effect, it can promote islet cell repair and regeneration by the inhibition of T cell mediated immune response to beta cells.

Eligibility Criteria:
Inclusion Criteria:

1. 20 ≤ age ≤ 65 years;
2. Duration of type 2 diabetes ≤20 years;
3. 24.0 kg/m2 ≤ BMI ≤40.0 kg/m2;
4. Stable exogenous insulin dose between 0.5-1.0 U/Kg/Day with or without oral hypoglycemic agents (Dipeptidyl peptidase-4 (DPP-4) inhibitor, Glucagon like peptide 1 receptor (GLP-1R) agonist and Sodium-glucose co-transporter 2 (SGLT-2) inhibitor excluded) for at least 3 months;
5. 7.0% ≤ HbA1c ≤ 12.0%;
6. Fasting C-peptide ≥ 1ng/ml;
7. Willingness to participate in the trial.

Exclusion Criteria:

1. Patients with ketonuria, tumor, serum creatinine level more than 175μmol/L, myocardial infarction in the previous year, current angina or heart failure, more than one major vascular event, retinopathy requiring laser treatment, malignant hypertension, uncorrected endocrine disorder, occupations precluding insulin therapy;
2. Severe concurrent illness limiting life expectancy, inadequate understanding of the study protocol, drug abuse, pregnant willing and allergic constitution.
Home-based Assessment of PRO Measures in SCD Using A Smartphone App Platform: A Feasibility Study

The overarching goal of this proposal is to identify modifiable behavioral strategies based on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) that will improve hydroxyurea (HU) adherence among adolescents and young adults with sickle cell disease (SCD). In this proposed study, we intend to test the functionality of a PROs-toolbox feature, which will be integrated into our existing smartphone application platform (SCD-app), over a 24-week period in a cohort of SCD patients and their caregivers.

Adherence to hydroxyurea is a multi-factorial dynamic process, and, to date, predictors for changes in adherence levels over time remain unclear. Changes in HRQOL data could serve as surrogate markers for changes in hydroxyurea adherence over time, and could suggest when patients might or might not need or benefit from an intervention based on worse or better HRQOL scores, respectively.

The main hypothesis of this study is that the assessment of patients' HRQOL at home using a SCD smartphone application platform (app) is feasible and acceptable, and that less frequent assessments of HRQOL at home will have an overall higher completion rate when compared to more frequent ones. We plan to assess HRQOL using the NIH-developed patient reported outcomes measurement information system (PROMIS®) with computerized adaptive testing (CAT) approach. PROMIS®-CAT approach is a reliable and valid PROs assessment platform that has been used in limited studies in SCD.

The study will include the following specific aims:

1. To evaluate the feasibility and acceptability of the assessment of patients HRQOL at home using smartphones with PROMIS®-CAT measures integrated into a SCD-app.
2. To examine the effect of the frequency of required HRQOL assessments on participants' completion rate over 24-week period with HRQOL evaluated every 2 weeks (Group 1) versus every 4 weeks (Group 2).
3. To explore participants' experience and preferences with the process and the frequency of HRQOL assessment at home using their smartphones with PROMIS®-CAT measures integrated into a SCD-app.

Eligibility Criteria:
Inclusion Criteria:

* Age 12 years or older at the time of study enrollment;
* SCD diagnosis (all genotypes) confirmed by hemoglobin electrophoresis;
* Own or have access to a smartphone or a tablet; and
* Speak and read English.

Exclusion Criteria:

* Patients or caregivers with cognitive impairment;
* Patients or caregivers physical impairment; and
* Patients or caregivers who will not be able to complete study assessments.
Evolution and Adaptation to Caregiver of a Socio-geriatric Evaluation

With the COVID-19 pandemic, elderly people (EP) living at home have seen their health deteriorated, thus increasing their needs in support and care. Indeed, while it was estimated that before the pandemic120 000 unattended living at home EP required care and services (taking bath, access to medication and food, etc.), the number doubled after COVID-19. Therefore, the waiting list for socio-medical services for unattended vulnerable clientele without a family doctor grew from 1300 à 1715 EP in a couple of months during the pandemic. With these numbers, it becomes clear that an intervention is needed. Truly, the Institut National d'Excellence en Santé et Services Sociaux (INESSS) conclude that it was pivotal to first identify the most vulnerable EP and second re-orient them according to their needs. Thus the investigator developed the Évaluation et orientation SOcio-GÉRiatrique (ESOGER) questionnaire available on a secure digital plateform enabling both a rapid evaluation and intervention to asses EP needs and provide the adequate ressources. Investigator's previous research has demonstrated that ESOGER is one of the rare clinical tools of first contact in telehealth while being global, multidimensional, and equitable. For this study, the investigator aims to evaluate the effect of ESOGER on EP physical and mental health, loss of autonomy, social isolation, quality of life and ressources consumption.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and more
* Living at home on the territory CIUSSS-Centre-Sud de l'île-de-Montréal (CCSMTL) of Jeanne-Mance
* Brief Geriatric Assessment (BGA) score of 1/14 or more defining a severly to milidly frail health.

Exclusion Criteria:

* Principal address outside of the CCSMTL's Jeanne-Mance territory
* Participate at another clinical trial, to avoid interferences
* Not understand written or spoken French or English, questionnaires are only available in French and English.
Influence of Human Platelet Derivatives on Dental Implant

The goal of this randomized controlled trial is to evaluate the benefit of PRF membrane on bone around dental implant in patients who need treatment with dental implant.

Aims of the study:

* To study the effect of PRF membrane (with or without bone substitute on increasing bone dimension around dental implant.
* To investigate the effects of compositions of PRF (platelets count, WBC count) on bone healing.

Materials and methods:

PRF will be obtained from a blood sample that is taken from the patient at the time of surgery in 10-mL tubes, the blood-containing tube is placed in a centrifuge at specially controlled rotations, temperature and time. The result is the separation of blood, basically from two by-products, including PRF. The PRF clot will be placed in specific box ( P.R.F -System; Surgident, CE ) to create a PRF membrane with specific thickness that will be placed on the bone around dental implant.

Evaluation of the results

* Alveolar bone width around dental implant will be measured.
* Histological examination of the tissue that excised during dental implant uncover surgery.
* Evaluate pain by visual analogue score (VAS).
* Estimate the count of WBC and platelets in whole blood will be obtained from a laboratory results.

Eligibility Criteria:
IInclusion criteria

* Non- smoker.
* No medical history of any systemic diseases that affect the bone metabolism.
* Did not receive any systemic drugs.
* Has edentulous area that needs dental implant.

The exclusion criteria were as follows:

* Systemic disease or medication compromising bone and soft tissue healing.
* Pathology in the edentulous region.
* Bruxism.
* Disease of the oral mucosa.
Glucose and Fructose Stimulated Brain Activity in Obese Subjects

The objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI. Administration of glucose as well as fructose is followed by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese humans.


Eligibility Criteria:
Inclusion Criteria:

* right-handed healthy males, no drugs, non-smoking

Exclusion Criteria:

* drug abuse, smoker, left-handed, claustrophobia
Feasibility of a Process of Digital Validation of Chemotherapies in a Day Treatment Unit

The aim of CPV 2.0 study is to evaluate a process of digital prevalidation of outpatients chemotherapy thanks to a numeric application. This digital tool is based on the combination of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to a decisional algorithm.

After cycle 1, chemotherapy digital prevalidation will be done with the help of a nurse for two consecutive cycles (cycles 2 and 3). Patients will then have to use to application by themselves for the two following cycles (cycles 4 and 5)


Eligibility Criteria:
Inclusion Criteria:

* Age \<80 (if age\>70 years, a G8 score\>14 is required)
* ECOG\<3
* Pathology (solid tumor, in neoadjuvant, adjuvant or metastatic setting)
* Patient receiving an IV cytotoxic chemotherapy in a day treatlent unit for at least 5 cycles, with at least an injection at day 1, day 8 and day 15
* Familiar with digital tools

Exclusion Criteria:

* Emergency
* patient feeling unease with the use of a smartphone
Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia

The main purpose of this study is to compare treatment efficacy of focused and radial extracorporeal shock waves on spasticity in chronic stroke patient

This study is a prospective and double-blinded randomized control trial. Thirty-two stroke patients with spastic equinus were randomly assigned to receive three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals. The intensities that were used during FSWT (0.1 mJ/mm2) and RSWT (2 bar) were comparable. Patients were evaluated at baseline and at 1, 4, 8 weeks after the final shockwave treatment. The primary outcome measure was modified Ashworth scale (MAS) score. Secondary outcome measures were Tardieu scale, ankle passive range of motion, plantar contact area during gait, and gait speed. A linear mixed model with repeated measures was used to compare each outcome measure between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* aged greater than 18 years old;
* at least 6 months since onset of last stroke;
* triceps surae muscle tone graded at least 1+ on the Modified Ashworth Scale (MAS) score;
* ability to walk alone with/without orthosis.

Exclusion Criteria:

* Exclusion criteria included fixed ankle joint contracture, previous treatment of the affected leg with neurolytic or surgical procedures, concomitant progressive central nervous system diseases, and skin breakdown, vascular disease in the affected leg
Microbiome Immunotherapy Neoadjuvant Assessment

Predictive biomarkers of response to combination chemotherapy and immune-checkpoint inhibitors are urgently needed to help tailor treatment recommendations for patients with early-stage TNBC. Tumour-associated microbiota in primary breast tumours represent promising and novel candidate biomarkers modulators of the efficacy of therapies for patients with TNBC. It has been shown that microbes colonizing breast tumours can modulate the efficacy of commonly used drugs and that the microbiome of breast tissue biopsies could represent a new biomarker. Data on the microbiome of patients with cancer indicate the potential for a new class of bacteria-based oncological biomarkers, for exploitation in precision oncology.


Eligibility Criteria:
Inclusion Criteria:

1. Be willing and able to provide written informed consent for the trial in accordance with national/local guidelines.
2. Be a male or female subject 18 years of age on day of signing informed consent.
3. Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:

   HER2 negative in primary tumour pre-treatment by local pathology assessed according current ASCO/CAP guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 \< 2.0 or single probe average HER2 gene copy number \< 4 signals/cell), OR Immunohistochemistry (IHC) 0 or IHC 1+.

   ER and PR negative in primary tumour pre-treatment defined as \< 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
4. Unresected, untreated breast cancer planned to undergo neoadjuvant systemic therapy, that meets one of the following clinical stages (see Appendix A):

   o T2, T3, or T4a-d lesion, any N, M0
5. Be willing to undergo mandatory research biopsy procedure at baseline (up to 4 core samples may be taken from this procedure).

Exclusion Criteria:

1. Patients who are pregnant or breast-feeding
2. Current use of any investigational agents
3. History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.
Culinary Art Therapy Group for Adults With Eating Disorders.

The study will assess the influence of culinary art therapy group (a new therapeutic tool) for adults with eating disorders. It will assess changes in thinking patterns and behavioural patterns associated with food and eating.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of eating disorder
* Body Mass Index (BMI) \> 15

Exclusion Criteria:

* No active participation in three group sessions
* Refusal to take an active part in the sessions
Dual Site-Dual Channel Non-invasive Brain Stimulation for Language and Cognitive Function in Healthy Subjects

The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of language and cognitive function in healthy. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on left inferior frontal cortex, ii) anodal stimulation on left dorsolateral prefrontal cortex. 2) IFG stimulation: anodal stimulation on left inferior frontal cortex; 3) DLPFC stimulation: anodal stimulation on left dorsolateral prefrontal cortex area. 4) sham stimulation


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects with age over 19 years old

Exclusion Criteria:

* history of disorders involving central nervous system
* patients with severe medical or psychiatric disease
Propess Versus Prostin for Induction of Labour in Women With Term PROM

Premature rupture of membranes (PROM) at term is a rupture that occurs at term (\> 37 weeks) before the start of labor.

The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor in women with term PROM Propess (Controlled release dinoprostone, Vaginal Delivery System) and Prostin E2 (Dinoprostone vaginal Tablet).

Women will be randomised to two treatment groups.

Although some studies support efficacy of the Propess for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with PROM at term.

The study is going to include all pregnant women with in-term PROM (after week 37 of pregnancy) without contractions if they meet the inclusion criteria. If the cervix is still non-inducible after 4-6 hours and there are no contractions, the medication to be administered to them will be determined by means of computer randomization. The success rate of induction with Propess vs. Prostin tablets will be compared. Soon after PROM, there can be the onset of contractions and cervix dilation that lead to childbirth.

In case of some pregnant women, there are no contractions and cervix dilation even after the event despite PROM and water breaking. If the status remains unchanged, the risk of intrauterine infection, fetus infection, and later on an infection of the newborn increases. The expecting mother can also eventually lose hope for a successful vaginal birth and starts thinking about having a caesarean delivery. To avoid that, the investigators use medications that accelerate the onset of vaginal birth in clinical practice.

The investigators know several ways to induce labour after PROM. References give no clear and reliable data on the best approach. The investigators can use medications such as oxytocin, dinoprostone, or misoprostol.

Our ward has been using Prostin 3 mg (dinoprostone) vaginal tablets to induce labour in case of PROM for several years. They have proven to be an efficient and safe procedure in our clinical practice.

Propess is used for the induction of labor with intact membranes. Based on the information from references and according to our experience, the medication is highly effective and safe, as well as easy to use.

Our study aims at establishing whether it can also be used with pregnant women with PROM.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Gestational age 37 weeks or more
* Singleton pregnancy
* Cephalic presentation
* Unfavorable cervix (BISHOP \<6)
* No contraindications for vaginal delivery
* Without uterine surgery
* Without chorioamnionitis

Exclusion Criteria:

* Age less than 18 years
* Multiple gestation
* Previous cesarean section
* Suspected intraamniotic infection
* Any contraindication to vaginal delivery
* Bishop score \>7
* Pathological ctg
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients

The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma patients for autologous transplantation.

A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim is better than filgrastim alone in helping non-Hodgkin's lymphoma patients collect at least 5 million stem cells in four or less apheresis sessions.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria (Abbreviated List):

* Non-Hodgkin's lymphoma in first or second complete or partial remission
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* White Blood Cell count (WBC) \> 2.5\*10\^9/L
* Platelet (PLT) \> 100\*10\^9/L

Exclusion Criteria (Abbreviated List):

* Failed previous stem cell collection
* Prior autologous or allogeneic transplant
* Brain metastases or bone marrow involvement \> 20%
* Radiation to pelvis
* Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

This study evaluates physical performance in cancer outpatients during a multimodal therapy. Half of the patients will receive physical exercise und nutrition program in combination with a specially formulated whey protein supplement, while the other half will receive standard care.

The time period of Intervention will last 3 month, measurements will be conducted at baseline and 3 month. After 6 month there will be an additional follow-up test point to assess the sustainability of the intervention. The 3-month intervention study consists of a physical exercise program and nutrition counseling in combination with a specially formulated whey protein supplement high in leucine. The standardized training program will be performed twice a week in the physical department of the Kantonsspital Winterthur (KSW) and once a week in a home based setting. Additionally, participants of the intervention group will be aks to consume 15 g of the nutrient supplement powder with approximately 150 ml water. On workout days the supplement should be taken twice a day and on the remaining days once a day. During the three month intervention study participants will take part in a nutrition counseling for at least three times.

Eligibility Criteria:
Inclusion Criteria:

* Advanced cancer patients not eligible for curative treatment: lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, ovarian cancer, pleural mesothelioma, urothelium carcinoma, renal cell carcinoma
* WHO performance status ≥ 2
* Able to walk independently at least 100 meters
* Estimated life expectancy of ≥ 6 month

Exclusion Criteria:

* Patients currently using nutritional supplements with branched chain amino acids
* Enteral or parenteral nutrition within 1 month
* History of ileus within 1 month
* Psychiatric disorder precluding understanding of information on trials related topics and giving informed consent
* Milk protein allergy