cyrilzakka/clinical-trials huggingface dataset:
The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease

The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters:

* Increase in natural killer (NK) cell activity.
* Increase in total T-cells (OKT-11).
* Increases in absolute number and percentage of T-helper cells (OKT-4).


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer.
* Lymphoid malignancy.
* Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus.
* Heart disease (especially if receiving cardiac glycosides).
* Hemophilia.

Patients with the following are excluded:

* Kaposi's sarcoma or overt opportunistic infections as follows:
* Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus.
* Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV).
* History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
* Critical illness.
* Condition requiring hospitalization.
* Women of childbearing age are excluded.
* Hemophilia.

Prior Medication:

Excluded:

* Steroids.
* Cytotoxic immunosuppressive agents.
* Antiviral medicine.

Prior Treatment:

Excluded:

* Radiotherapy.

Patients who have unexplained immunodepression and are at risk of developing AIDS.

* Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites).

IV drug abuse.
Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis

The Primary Objective: To observe and determine the safety and tolerance of allogeneic hepatocyte transplantation in patients with liver cirrhosis and to establish the maximum-tolerated dose (MTD) and evaluate the dose-limiting toxicities (DLTs).

The Secondary Objective: To observe the therapeutic efficacy of allogeneic hepatocyte transplantation for liver cirrhosis.

* A traditional 3 + 3 dose escalation design will be implemented.
* Successive cohorts of participants (3 or 3+3 participants /cohort) will start on a fixed cell numbers of allogeneic hepatocyte in three cohorts separately: L dose (low cell numbers); M dose (medium cell numbers); H dose (high cell numbers).
* The 1st cohort will be given dose of L.
* The 2nd cohort will be given dose of M.
* The 3rd cohort will be given dose of H.
* Dose escalation will continue until the maximum-tolerated dose (MTD). If no DLTs are observed for 28days after administration of the last dose, a new cohort will be enrolled at the next planned dose level. If DLTs are observed in 2 of the three participants, the MTD will be determined to be the dose administered to the previous cohort. If DLTs are observed in one participant in the cohort, another three participants will be treated with the same dose level. If the new three participants aren't observed DLTs, another cohort will be enrolled at the upper dose. If at least one of the new three ones are observed DLTs, the below dose will be the MTD.
* MTD will stopped by testing increasing up to the H dose.
* Toxicities will be graded using the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0).

Eligibility Criteria:
Key Inclusion Criteria:

* The age at the time of signing the informed consent from 18 to 70 years old (including the boundary value), both male and female;
* Clinical diagnosis of liver cirrhosis;
* Be able to understand and sign informed consent.

Key Exclusion Criteria:

* Combined with liver cancer or other malignant tumors;
* Patients who can't cooperate;
* Prothrombin time (PT) exceeded the upper limit of normal control for 3-5 seconds or more;
* International normalized ratio (INR) \>1.5;
* PLT\<60×109/L；
* Recently use of anticoagulant or antiplatelet drugs (last 7 days);
* Recently (last 4 weeks) had upper gastrointestinal bleeding or spontaneous celiac inflammation;
* Moderate or large amount of ascites;
* The investigator assesses that the patient is unable or unwilling to comply with the protocol.
Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage.The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate.

Rheumatoid Arthritis is a chronic autoimmune disease characterised by synovial inflammation and cartilage and bone degradation, leading to joint destruction and progressive disability.

The aim of the study is to evaluate the safety and tolerability of MBS2320 in patients with RA following chronic administration. In addition, the study aims to evaluate the effects of MBS2320 on measures of disease activity.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of childbearing or non-childbearing potential with with active RA, receiving stable once-weekly methotrexate
* between 18 and 75 years of age, inclusive.

Exclusion Criteria:

* Patients who are currently pregnant or breastfeeding.
* Patients who are being treated with biological or non-biological disease-modifying anti-rheumatic drug therapy.
* Patients with a history of any other inflammatory or arthritic disease in addition to RA that may interfere with the study.
Feasibility and Safety of Acupuncture in the Prevention of Late Irinotecan-related Diarrhea in Pediatric Patients

To evaluate the feasibility of an acupuncture protocol in the prevention of late diarrhea due to irinotecan in pediatric patients with solid tumors, a pre-post pilot study will be conducted.

Pre-post pilot study non-randomized, open label, single arm study. There will be a single study group that will be used at the same time as your own control. The intervention will take place for approximately one year.

Pre-post pilot study non-randomized, open label, single arm study.

The objective of this pilot study is to demonstrate that cancer acupuncture pediatric treatment is a safe and feasible treatment in the prevention of late-onset diarrhea related to with irinotecan.

This pilot study will include patients between 0 and 18 years of age with a solid tumor (nephroblastoma, neuroblastoma, central nervous system tumors and rhabdomyosarcoma) receiving their first cycle of irinotecan, in our center, at 50 mg/m2/intravenous dose daily for five days (cumulative dose weekly = 250 mg/m2) and who do not receive concomitant abdominal radiotherapy. Acupuncture will be applied as a complementary treatment along with the usual regimen of prophylaxis and treatment of late diarrhea.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 0 to 18 years old with solid tumors who start treatment in our center with irinotecan at 50 mg/m2/intravenous dose in day hospital.
* Blood tests prior to the start of the appropriate chemotherapy cycle to receive acupuncture with continuous stimulation needle insertion: neutrophils greater or equal to 1000 cells/mm3 and platelets greater than or equal to 50,000 cells/mm3.
* Signature of informed consent by parents in the case of children under 12 years of age and assent of the minor.
* Signature of informed consent in the case of those over 12 years of age

Exclusion Criteria:

* Participate in a clinical trial that is developed in the Pediatric Oncology Area of the Hospital Sant Joan de Deu where acupuncture intervention is not permitted.
* Have received acupuncture treatment in the last ten days.
* Receive concomitant abdominal radiotherapy.
* Have diarrhea on day 1 of the cycle
Effects of LMWH in Healthy Subjects Treated With TB-402 and Effects of TB-402 in Healthy Subjects Treated With Warfarin

Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin


Eligibility Criteria:
Inclusion Criteria include:

* Males 18 to 45 years of age
* Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine

Exclusion Criteria include:

* Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke
* History of important bleeding episodes
* Previous allergic reaction to immunoglobulin
* Present or previous history of severe allergy, for example asthma or anaphylactic reactions
* FVIII:C \<50% at screening
* Clinically significant out of range values for any coagulation test during screening
* Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402
A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)

This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a history of allergic rhinitis symptoms which flare up during the study season
* Patient is a non-smoker
* Patient is in otherwise good health
* Patient is able to chew a tablet

Exclusion Criteria:

* Patient is hospitalized
* Patient is pregnant or nursing mother, or \<8 weeks post partum
* Patient and/or parent intend to move or vacation away from home during the trial
* Patient has had a major surgical procedure within 4 weeks of the prestudy visit
* Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study
* Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study
* Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder
HCC Response Assessment by MRI After SBRT

The aim of this work was to describe SBRT different presentations, to study predictive factors for tumor responses following treatment, and to compare tumor response assessments according to the Response Evaluation Criteria


Eligibility Criteria:
* Inclusion Criteria: the standard criteria for treating HCC patients with SBRT : an Eastern Cooperative Oncology Group (ECOG) score of 2, inoperable tumors (e.g. the patient being unfit for surgery, or tumor-related contraindications), and a maximum tumor diameter of 6 cm. The HCC diagnosis could be histological or based on the radiological criteria of the American Association for the Study of Liver Diseases (AASLD)
* Exclusion Criteria:no follow-up by MR imaging
Feasibility of Outpatient Appendectomy for Acute Appendicitis

The aim of our monocentric prospective in intention-to-treat study is to evaluate the feasibility of outpatient appendectomy for non complicated acute appendicitis.

Acute appendicitis is one of the most common surgical emergencies and corresponds to an high number of admissions (about 120.000) in France. It mainly affects young adults and is associated to fewer complications and to a short length of stay. The notion of outpatient refers to a shorter hospital length to stay i.e. less than 12 hours without an overnight hospitalization. This notion came from 3 learned society recommendations' (SFCD, ACHBT, and AFCA) and has been considered as a national priority.

There is no consensus about appendectomy in an outpatient setting.

Eligibility Criteria:
Inclusion Criteria:

* Non complicated acute appendicitis which has been diagnosed at physical, paraclinical and morphological examination
* Adult patient
* Patient with sufficient understanding
* Good compliance with medical prescription
* Hygiene and housing equivalent to a hospitalization
* Availability of an accompanying able to prevent the surgeon if necessary, to accompany the patient and stay at night next to him
* Less than one hour from an health care adapted to the surgical structure
* Quick access to a telephone
* Patient affiliated with social protection

Exclusion Criteria:

* complicated appendicitis
* pregnancy or breastfeeding
* unstable vital signs or fever
* objective signs of diffuse peritonitis
* ward of court or prisoners
* Discovery of a complicated shape (severe sepsis, abscess, generalized peritonitis)
* Discovery of an alternative diagnosis
* Performing an associated gesture (colectomy or typhlectomy, annexectomy...)
An Invivo Study to Compare the Stability of Dental Implants With or Without Platelet Rich Fibrin Application

The purpose of this study was to evaluate the effects of (Platelet Rich Fibrin) PRF application on implant osseointegration in the early phase of healing.

Objectives:Achieving accelerated implant osseointegration could provide immediate or early loading of implants. Platelet-rich fibrin (PRF) is widely used to accelerate soft and hard tissue healing. Activated platelets in PRF release growth factors resulting in cellular proliferation, collagen synthesis and osteoid production. The aim of this study was to compare the stability of dental implants inserted with one-stage surgical protocol with or without PRF application.

Design: Non-randomized, Active Controlled Trial. Material and Methods: Twenty healthy patients (n=10 test group, n= control group) with adequate alveolar bone, having 2 or more adjacent missing teeth, extracted at least 6 months ago were included in this study. Minimum two tapered implants (Ankylosis, DentsplyFriadent) were placed to each patient. After surgical preparation of implant sockets, PRF that was prepared preoperatively was placed randomly to one of the sockets (PRF+). Acellular plasma portion of PRF was used to wet the implant placed into the PRF-coated socket. Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.

Key Words: Dental implant stability, Platelet Rich Fibrin, Resonance frequency analysis

Eligibility Criteria:
Inclusion Criteria:

* The absence of any lesions in the oral cavity, and sufficient residual bone volume to receive two or more adjacent implants of ≥3.5 mm in diameter and 11.0 mm in length, and extracted at least 6 months ago.

Exclusion Criteria:

* Insufficient bone volume
* Parafunctional habits
* Smoking more than 10 cigarettes per day
* Excessive consumption of alcohol
* Localized radiotherapy of the oral cavity
* Antitumor chemotherapy
* Liver, blood, and kidney diseases
* Immunosuppression
* Current corticosteroid or bisphosphonate use
* Pregnancy
* Mucocutaneous diseases involving oral cavity
* Poor oral hygiene
Thromboprophylaxis by Low Molecular Heparin During the Post-partum Period

The purpose of this study is to determine the current level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period. The institutional protocol is based on national and international guidelines.

Venous thromboembolism (VTE) became the 4th cause of maternal mortality and the 2nd direct cause of maternal mortality in France.

The re are only few randomized studies on the thromboprophylaxis during the post-partum period. This expose some discrepancy between French guidelines, French Society of Anesthesia \& Intensive Care Medecine (SFAR) and National College of French Gynecologists and Obstetricians (CNGOF ).

The duration and adequate dose of low molecular heparin prescriptions are unclear.

The level of adequacy of thromboprophylaxis prescriptions at Centre Hospitalier Sud Francilien with the SFAR recommendations appears to be less than 50 % in a preliminary unpublished study.

Since this assessment, institutional protocol synthesizing thromboprophylaxis guidelines during the post-partum was exposed and validated among medical staff (both anaesthesiologists ang obstetricians).

Eligibility Criteria:
Inclusion Criteria:

* \>18 ages
* Who had given birth at Centre Hospitalier Sud Francilien
* Hospitalized during the puerperium at Centre Hospitalier Sud Francilien
* Being informed of the clinical trial and had offered any opposition for data collection

Exclusion Criteria:

* Curative treatment of thrombosis by Low molecular-weight or unfractioned heparin during pregnancy or post-partum period
* Curative anticoagulant therapy for any cause
Evaluating Control of Hypertension - Effect of Social Determinants

This study evaluates the impact of a large-scale, national expansion of Medicaid on hypertension incidence, screening, treatment, and management. Social Determinants of Health will be assessed as moderators, and comparing states that did versus states that did not expand Medicaid will also be evaluated.

The Affordable Care Act (ACA) enacted several provisions intended to improve healthcare for vulnerable populations,including expanding Medicaid eligibility to those earning ≤138% of the federal poverty level (FPL). Since the expansion was not required, as of March 2018, 32 states (and District of Columbia) implemented the expansion and 18 did not. Simulated models predicted the ACA would improve health outcomes and reduce disparities for patients with hypertension, yet actual changes are not yet available. In addition, there is new interest in tracking and utilizing Social Determinants of Health (SDH) in the primary care setting but there is currently little information on how this information will impact Hypertension (HTN) care, especially related to changes to health insurance availability. This study will build on current understanding of how health insurance impacts HTN incidence, screening, treatment, and management by comparing states that did versus did not expand Medicaid as part of the ACA and seeks to understand the influence of SDH on these changes. the investigators will address the following specific aims: Aim 1: Compare HTN incidence, prevalence of undiagnosed HTN, and rates of HTN screening, in Medicaid expansion versus non-expansion states before and after the ACA. Aim 2: Compare HTN treatment (e.g., medication use), and management (e.g., HTN control, systolic and diastolic blood pressure change, risk factors related to HTN control) in Medicaid expansion versus non-expansion states before and after the ACA. Aim 3: Assess the extent to which rates of HTN incidence, screening, and treatment effectiveness among patients who gained insurance versus those continuously insured or uninsured, pre-post ACA, are moderated by individual-level SDH (e.g., race, ethnicity), in expansion states. Aim 4: Explore the interaction between community-level SDH (e.g., neighborhood racial segregation and deprivation) and HTN incidence, screening, treatment, and management among patients who gained insurance relative to those who were continuously insured or uninsured, in expansion states. The findings from this project will be extremely relevant to policy and practice, informing further improvements in the US healthcare system to ensure access to healthcare for vulnerable populations.

Eligibility Criteria:
Inclusion Criteria:

* Patients in intervention and control states aged 19-64

Exclusion Criteria:

* Patients outside of age range 19-64
Smartphone App-assisted Short-term Antibiotic Therapy

Outpatients with short-term antibiotic treatment should start and finish the treatment according to medical advise that is, the intake pattern (named adherence) should be regular. The research question is: Can a smartphone-based program including intake reminder and two text messages improve adherence to a short-term antibiotic treatment in ambulatory setting?

Participants will be asked to record every antibiotic intake in an app on their smartphone over the prescribed therapy duration and to note their symptoms once daily. One group will obtain reminder + text messages, and the control group will have no reminder + no text messages.

This study is planned as a monocentric, cluster-randomized, double-blind, two-arm study in a primary care setting with outpatients newly prescribed co-amoxicillin for a short-term therapy. Participating community pharmacies will recruit patients entering with a prescription for co-amoxicillin and offer the service. Randomisation will take place on the pharmacy level via computer generated list of numbers (1: with intervention; 2: with no intervention). Pharmacists and participants will not know that the intervention is not the app itself, but rather the combination of a reminder and text messages (= double-blind). The intervention will consist of the use of a smartphone reminder (e.g. alarm clock or a reminder app; a list with suitable examples will be given and patients will choose one of them) and two personalized motivational and educational text messages that will be sent by the pharmacy during the treatment duration. The control group will have no reminder and no text messages. All participants will use a simplified version of the freely available medication management app TOM to record their medication intake (= adherence measurement method). Participants in both groups will obtain a consultation driven by their adherence report with the study team at the end of the treatment to discuss their individual adherence data, their symptom course and well-being. After that, patients will receive a link to an online survey where they will evaluate their satisfaction with the service and the smartphone application. Participating pharmacists will be interviewed by the study team regarding their experience and satisfaction after the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* is min. 18 years old;
* is newly prescribed a co-amoxicillin treatment of 3-14 days;
* has symptoms that correspond to bacterial infection;
* accepts to use of one of the medication adherence application with reminder function from the provided list;
* accepts to use of the electronic monitoring application TOM™ during the study period;
* is capable of using the TOM™ application;
* signs the informed consent form;
* understands and speaks (Swiss) German.

Exclusion Criteria:

* in the opinion of the pharmacists, unlikely to comply with the study schedule or are unsuitable for any other reason.
* does not manage medication himself/herself
* already using a medication intake reminder
Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)

The purpose of this study is to evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells, whereas the intravitreal injection should non-selectively stop the RPE leakage.

To evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation in twelve eyey per group versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells. BCVA in EDTRS score, OCT, and leakage in FLA, static perimetry of both groups will be correlated to a control group without treatment over 10 months.

Eligibility Criteria:
Inclusion criteria:

* CSC of \>4 months duration

Exclusion Criteria:

* History of macular or chorioretinal inflammation
* Lens / corneal opacities