cyrilzakka/clinical-trials huggingface dataset:
Effectiveness & Tolerability of Novel, Initial Triple Combination Therapy vs Conventional Therapy in Type 2 Diabetes

In this study, the investigators will assess the efficacy and tolerability of a novel, initial triple combination therapy with metformin, saxaglipitin, and dapagliflozin, compared to conventional stepwise add-on therapy in drug-naïve patients with recently onset type 2 diabetes.

ADA/EASD guideline recommends sequential treatment approach starting with metformin, and adding other classes of anti-diabetic medications if target HbA1c is not achieved. However, several clinical studies clearly showed that initial dual or triple combination therapy was more favorable in terms of glycemic control.

A DPP-4 inhibitor saxagliptin increases serum level of GLP-1, and potentiates its action of increasing glucose-dependent insulin secretion and lowering glucagon secretion. A SGLT-2 inhibitor dapagliflozin lowers hyperglycemia via blocking SGLT-2 to increase glucosuria, that is, in an insulin-independent manner. Therefore, the mechanism of action of these drugs are complimentary to that of metformin, and all of these have a low risk of hypoglycemia and weight gain.

Eligibility Criteria:
Inclusion Criteria:

* Drug-naïve patients with type 2 diabetes by American Diabetes Association criteria
* HbA1c ≥ 8%, \< 10.5% at screening
* Age ≥ 18 years, \< 65 years
* Body mass index (BMI) ≥ 23 kg/m2, \< 35 kg/m2
* Estimated GFR (eGFR) ≥ 60 ml/min/1.73m2

Exclusion Criteria:

* Uncontrolled hyperglycemia \> 270 mg/dl after an overnight fast
* Diabetic ketoacidosis
* Type 1 diabetes
* Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening
* Congestive heart failure (New York Heart Association functional class IV)
* severe hepatic dysfunction (serum levels of either AST, ALT, or alkaline phosphatase above 3 x upper limit of normal (ULN))
* alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
* pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women
* use of systemic glucocorticoid
Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.

The purpose of this trial is to determine the effect of HuMax-CD4 as a treatment for early stage cutaneous T-cell lymphoma (CTCL). Almost all participants who are affected by CTCL have cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in this trial; all participants will be treated with HuMax-CD4. During the trial, the response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated.


Eligibility Criteria:
Inclusion criteria

* Medical diagnosis of CTCL, and positivity for the CD4 receptor.
* Early stage CTCL
* Have received at least two prior therapies with inadequate effect, including phototherapy and/or electron beam, and/or chemotherapy.
* Histopathological evidence of large cell transformation or poorly differentiated tumors or prior treatment with anti-CD4 monoclonal antibodies excluded participants from inclusion in the study.

Exclusion Criteria

* Certain rare types of CTCL.
* Previous treatment with other anti-CD4 medications.
* More than two previous treatments with systemic chemotherapy.
* Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial.
* Some types of steroid treatments less than two weeks before entering the trial.
* Prolonged exposure to sunlight or UV light during the trial.
* Other cancer diseases, except certain skin cancers or cervix cancer.
* Chronic infectious disease requiring medication.
* Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases.
* Pregnant or breast-feeding women.
* Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
* If you are participating in another trial with a different new drug 4 weeks before you enter this trial.

Note: Other protocol defined Inclusion and Exclusion criteria may apply.
Multi-Omics and IPSCs to Improve Diagnosis of Rare Intellectual Disabilities

Background Genetic factors play a major role in intellectual disability (ID) but the underlying cause is not determined in many cases.

This proposal is the continuation of the previous interregional project HUGODIMS, the aim of which was to perform whole exome sequencing (WES) in 69 thoroughly selected simplex ID parent-child trios. Thanks to HUGODIMS consortium, the underlying genetic cause of ID was determined or highly suspected in 48 cases (69.5%) and 7 novel ID genes were identified.

Hypothesis Investigators hypothesize that an approach combining genomics, transcriptomics, metabolomics and morphological analyses performed on induced pluripotent stem cell (iPSC)-derived neural cells would improve diagnosis of ID. The current proposal is therefore a proof-of concept project aiming at assessing the relevance and effectiveness of this multi-omics approach.

Aims and Methods Ten individuals with ID recruited through HUGODIMS, in whom WES have failed to identify pathogenic variants will be included.

The workflow is the following:

1. Whole genome sequencing (WGS) (Nantes) of these 10 negative trios.
2. Bio-informatics analyses
3. In 3 WGS negative cases, 3 positive controls bearing distinct mutations in CAMK2a (a novel ID gene identified thanks to HUGODIMS), and 3 healthy negative controls:

   1. Derivation of induced pluripotent stem cell (iPSC)-derived neural progenitors (iPSC core facility at Nantes)
   2. Targeted and non-targeted metabolomics analyses performed on iPSC-derived neuronal cells (Angers)
   3. RNA sequencing performed on the 9 cell lines (Rennes)
   4. Morphological analyses of differentiated neuronal cell lines derived from 3 affected individuals and 3 positive controls bearing CMK2a mutations (Tours)
   5. Integration and validation of data from multi-omics and morphological approaches

Expected results and impact Investigatrors expect that this approach combining multi-omics and iPSC will help to improve diagnosis and understanding of genetic ID of unknown cause


Eligibility Criteria:
Inclusion Criteria:

* 3 Whole Genome Sequencing negative cases
* 3 positive controls bearing distinct mutations in CAMK2a

Exclusion Criteria:

* no informed consent/refusal
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in comparison to the clinical data related to other types of fixation material.

The present study will be a prospective multicentric non-randomized and non-controlled trial involving 55 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.

The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of CELLIS Rectopexy used in rectal prolapse repair by ventral rectopexy.

All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.

The study will be conducted in France in 3 investigational centres including 55 patients scheduled for the repair of rectal prolapse.

Each patient will participate in one assessment period including a screening visit, followed by the day of surgical procedure and a hospitalization period. Patients will return for ambulatory visits at Day 30 (+/- 7 days), Month 6 (+/- 2 weeks), Month 12 (+/- 2 weeks) and Month 24 (+/-2 weeks).

The surgical technique used to repair rectal prolapse will be either Laparoscopic Ventral Rectopexy (LVR) or a robotic assisted rectopexy with the use of the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA).

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥18 years,
* Patient with an indication of rectal prolapse repair by ventral rectopexy (external and internal rectal prolapse),
* Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
* Patient being informed of the porcine origin of the device in advance of the procedure.

Exclusion Criteria:

* Patient with known hypersensitivity to porcine materials,
* Patient with an existing infection not appropriately treated,
* Patient who are pregnant,
* Patient having refused to participate to the study,
* Patient refusing to come back to the follow-up visits.
Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium

The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.

During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.

Eligibility Criteria:
Inclusion Criteria:

* Over 60 years of age
* Inpatient and scheduled for surgical procedure at MGH

Exclusion Criteria:

* Blindness, deafness or the inability to speak English
* Inability to provide informed consent

Objective Drop Criteria

* Post-operative intubation greater than 24 hours
Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)

Prevailing microorganisms causing neonatal sepsis in neonatal intensive care unit of Assiut University children Hospital Methods prospective study conducted in the neonatal intensive care unit in Assiut university children hospital.

Sepsis remains a leading cause of death in the intensive care units and in all age groups worldwide.sepsis was defined as the host's immune response(systemic inflammatory response syndrome) to injury and/or infectious stimuli in the presence of a known(or strongly suspected) infection .early onset neonatal sepsis occurs in utero or might become infected when exposed to potentially pathogenic bacteria,viruses,or fungi during passage through the birth canal.

Eligibility Criteria:
Inclusion Criteria:

* both preterm and full term neonates
* both early onset and late onset neonatal sepsis

Exclusion Criteria:

* Genetic diseases immunocompromized neonates
* Neonates of diabetic mothers
* Neonates of HIV mothers
Effects of Red Ginseng on Gastrointestinal Symptoms and Microbiota After Surgery for Gastrointestinal Cancer

After surgery for gastrointestinal cancer (stomach cancer, pancreaticobiliary cancer, colorectal cancer), many patients experiences various symptoms such as weight loss, diarrhea, constipation and excessive gas due to structural and functional changes in the gastrointestinal tract. These changes are thought to be influenced by alterations in gut microbiota following surgery, but prospective studies are still lacking. It is anticipated that the prebiotic effects of red ginseng may lead to positive changes in total gut bactera after gastrointestinal caner surgery.

Through this study, Investigators aim to investigate the impact of red ginseng consumption on gut microbiota composition, gastrointestinal symptoms, and nutritional status improvement following surgery for gastrointestinal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed with gastrointestinal cancers (stomach cancer, pancreatobiliary cancer, colorectal cancer) prior to surgery.
2. Clinically staged and anticipated to not receive adjuvant chemotherapy after surgery.
3. Eligible for complete surgical resection (R0 resection).
4. ASA (American Society of Anesthesiologists) score of 3 or below.
5. Intereseted in health functional foods.
6. Not consumed probiotics or prebiotics for at least three months prior to study enrollment.
7. Willing to refrain from consuming additional probiotics or prebiotics during the study period, apart from the provided red ginseng tablets.

Exclusion Criteria:

1. Patients aged 80 years or older.
2. Patients who received neoadjuvant therapy before surgery.
3. Patients with underlying gastrointestinal disorders (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's disease, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, short bowel syndrome, other hereditary gastrointestinal diseases, and autoimmune diseases).
4. Patients unable to orally consume red ginseng tablets.
5. Patients with a history of previous abdominal organ surgery, radiation therapy, or chemotherapy.
6. Patients with intestinal obstruction before surgery.
7. Patients regularly taking probiotic or prebiotic supplements.
8. Patients requiring formation of an ileostomy after surgery.
9. Patients with uncontrolled diabetes that may affect gastrointestinal function.
10. Patients with underlying conditions such as liver failure or renal failure.
11. Patients allergic to red ginseng.
12. Patients who received more than two weeks of antibiotic treatment during hospitalization.
Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in children. Although ablation of the retina with laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP the visual outcomes after treatment are often poor. Vascular endothelial growth factor(VEGF) has an important role in the pathogenesis of ROP and inhibition of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP. The aim of this study is to determine the safety and efficacy of intravitreal bevacizumab in the treatment of retinopathy of prematurity


Eligibility Criteria:
Inclusion Criteria:

* Retinopathy of prematurity stages III, IV and V in which we can not treat with laser o cryotherAPY

Exclusion Criteria:

* PATIENTS THAT COULD BE TREATED WITH CRYOTHERAPY OR LASER
Pneumocystis Primary Infection in Non-immunosuppressed Infants

To determine the prevalence of P. jirovecii in nasopharyngeal aspirations of neonates and infants hospitalized for symptomatic respiratory infection.

It is recognized that primary infection with Pneumocystis, an opportunistic and transmissible fungus, occurs early in childhood. Early investigations of primary infection considering the detection of P. jirovecii in respiratory specimens suggests that primary infection in infants without immunodeficiency could be either asymptomatic or symptomatic. The infection may be identified as an apparently benign respiratory infection evolving on its own, but may also be contemporaneous with another viral or bacterial respiratory infection. In addition, there are little data available on the genotypic characteristics of P. jirovecii in infants developing primary infection.

In this context, the project will focus on the detection of P. jirovecii in hospitalized infants, presented with symptoms, and without overt immunodeficiency. The prospective collection of biological, clinical and epidemiological data in these infants will make it possible to identify risk factors for the acquisition of the fungus and to address its role in symptoms and clinical presentation. A second focus will be on the identification and comparison of genotypes in infants developing primary infection and in immunocompromised adults developing PPC or colonized by the fungus. These two approaches are the necessary steps to address the putative role of these patient populations (infants and adults) in the human reservoir of the fungus. A third focus will be the detection and genotypic identification of P. jirovecii in infants and the exhaled air of infants in their environment. The potential role of infants as potential infectious sources may be determined.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic newborns and infants who underwent NPAs for microbiological diagnoses

Exclusion Criteria:

* asymptomatic newborns and infants, newborns and infants who did not undergo NPAs, infants \> 12 months or children \> 2 years; newborns and infants whose parents did not accept to participate
Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19

Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure

This study aims to recruit the required number of patients for statistical identification of the effectiveness of vibroacoustic therapy in patients with COVID 19. Obligatory performance criteria will be presented by the duration of the course of respiratory failure and the duration of mechanical ventilation in the main and control groups. Optional performance criteria will be represented by oximetry values and standardization of laboratory parameters

Eligibility Criteria:
Inclusion Criteria:

1. adults
2. P/F less 300 torr
3. ARDS by Berlin convention
4. COVID 19 bilateral pneumonia

Exclusion Criteria:

1. children
2. acute brain stroke
3. acute coronary syndrome
4. pulmonary embolism
5. implanted pacemaker
Breathing Disorders in Patients With Congestive Heart Failure

The investigators prospectively evaluated 89 consecutive outpatients (29 female) with stable congestive heart failure. The presence of sleep disordered breathing (SDB) and Cheyne-Stokes respiration (CSR) while awake were investigated by overnight polysomnography. Males and females were similar in age, body mass index, and LVEF. Prevalence of SDB was higher in males than females. During follow up of 25±10 months, 27% of the population died. Nonsurvivors had lower LVEF (p=0.01), worse NYHA class (p=0.03) a higher proportion of CSR-awake (p\<0.001) than survivors.

Bakground: There is little information in sleep disordered breathing (SDB) in women with congestive heart failure (CHF). We studied consecutive CHF patients in order to compare SDB characteristics according to gender, and to determine overall mortality impact of SDB and Cheyne-Stokes respiration (CSR) while awake.

Methods: Eighty nine consecutive outpatients (29 female) with stable CHF (LVEF\<45%) were prospectively evaluated. The presence of SDB, as characterized by obstructive sleep apnea (OSA) and CSR during sleep, as well as CSR while awake before sleep onset, were investigated by overnight polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* Patients with resting left ventricular ejection fraction (LVEF) of less than 45% as determined by echocardiography;
* Stable clinical condition as defined by no changes in drug therapy for at least one month before evaluation.

Exclusion Criteria:

* Patients with neurological, pulmonary, renal, musculoskeletal disease, unstable angina, primary valvular heart disease or previous diagnosis of sleep disordered breathing.
The GentleWave Registry

The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage. The registry population includes up to 500 subjects that have been treated with the Sonendo GentleWave System at up to 25 clinical sites in the United States.

The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage.

Up to 25 clinical sites in the United States. Up to 500 subjects that have been treated with the Sonendo GentleWave System. To assess outcomes for teeth treated with the GentleWave System in a commercial setting.

Eligibility Criteria:
Inclusion Criteria:

* One or more teeth treated with the Sonendo GentleWave System

Exclusion Criteria:

* Institutionalized patients or prisoners
Treatment of Patients With Chronic Osteoarthritis With Ginger Kidney Compress - a Randomized, Controlled Trial

The investigators hypothesize that by a 5-week treatment with ginger kidney compresses at least 2 of 3 main symptoms of the WOMAC (pain, stiffness, functionality) will be reduced at least 30% at the time of the post-measurement (after 5 weeks of therapy) in comparison to the respective control group (waitlist).


Eligibility Criteria:
Inclusion Criteria:

* Chronic osteoarthritis, mainly osteoarthritis of the knee
* osteoarthritis symptoms for at least six months
* written consent to participate in the study
* Age: 30 years and more

Exclusion Criteria:

* Rheumatoid Arthritis
* Fibromyalgia
* Oncological or other serious diseases
* Use of corticosteroids
* Nephropathy
* Non-intact skin conditions in the area of application
* Hypersensitivity / allergy to ginger
* Simultaneous participation in another clinical trial