cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Assess the Effect of Increasing Intake Amounts of Two Novel Glycans on the Gut Microbiota of Healthy Subjects

This exploratory, randomized, open label study aims to explore the safety, tolerability, pharmacokinetics, and effects of increasing intake amounts of two novel glycans on the gut microbiota of healthy subjects.


Eligibility Criteria:
To be eligible for inclusion, the patient must fulfill all of the following criteria at screening:

* Able and willing to provide informed consent
* Willing to provide multiple stool samples
* Be male or female, ≥18 and ≤65 years of age
* Have a body mass index ≥20 and \<40 kg/m2
* No current renal, hepatic or metabolic disease, significant dyslipidemia, or infection.
* Willing to adhere to dietary requirements as stated in the protocol.
* Willing to continue his/her normal diet and exercise routine.
* Willing to continue taking any current supplements and vitamins, (with the exception of prebiotic or probiotic supplements) that the subject is currently taking, for the duration of the study.
* Negative urine drug screen
* If subject is female, have a negative urine pregnancy test at Screening and be willing to engage in method of contraception until completion of the study

Patients will be excluded from the study if they meet any of the following criteria at screening:

* Currently taking probiotic or prebiotic dietary supplements, or have taken them in the past 28 days (prior to Screening Visit), or unwilling to avoid probiotic or probiotic dietary supplements for the duration of the study
* Currently taking, or have taken in the last 7 days, drugs or other compounds to modulate gastrointestinal motility
* Recent history (within six weeks of Screening) of the following conditions requiring medical attention or treatment, including over-the-counter medications: constipation, diarrhea, and/or acute GI illness.
* Systemic antibiotics taken within the previous three months (prior to Screening Visit).
* History of or active inflammatory bowel disease
* History of or active irritable bowel syndrome
* History of or active autoimmune disease
* History of or active GI malignancy
* Established pre-diabetic status (eg, multiple fasting blood glucose measurements 100 to 125 mg/dL inclusive, or history of failed glucose tolerance tests) and as assessed by HbA1c test
* Have used an investigational drug or device within 30 dyas of study or be concurrently enrolled in another investigational drug or device study within 30 days of the study (prior to the Screening Visit)
* Subject is a current smoker
* Subject has a history of drug and/or alcohol abuse
* Contraindications, sensitivity, or known allergy to the use of the study product(s) or their components
* Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study (prior to the Screening Visit)
* Individuals who, in the opinion of the PI, are considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures
Thrombin Generation and Gestational Outcome

In total 120 pregnant women's with history of recurrent miscarriages, are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). The relation between pregnancy outcome and thrombin measurements will be determined


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* signed inform consent
* first trimester
* two early miscarriages(before week 10) or one later abortions (after week 10)

Exclusion Criteria:

* Chronic treatment with aspirin or other anticoagulants
TENS and Orthognathic Surgery

All patients with skeletal deformity will undergo orthognathic surgery after orthodontic treatment. After surgery TENS electrodes( rubber electrodes with the same size 5.3×4.8 cm) will be Placed bilaterally on ant temporalis and bilaterally on superficial masseter muscle...Time : 30 min /3 times per week/ 6 weeks


Eligibility Criteria:
Inclusion Criteria:

* Class II facial deformity
* absence of temporomandibular joint pain and preoperative opening mouth limitation
* normal cranial form
* presence of dentition
* Fit to GA

Exclusion Criteria:

* temporomandibular joint pain and preoperative opening mouth limitation;
* craniofacial anomalies and abnormal cranial form
* absence of facial trauma, mandibular condylar fracture
Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab

Aims of the trial: Establishing the profile of the growth factors and other mediators of angiogenesis in different ocular fluids (aqueous humour, vitreous gel and ocular liquid in vitrectomized eyes), in the 2 most frequent proliferative retinopathies - diabetic proliferative retinopathy (PDR) and exudative age related macular degeneration (AMD). Following up the dynamic of this profile before and after intravitreal administration of Bevacizumab (Avastin) as an anti-VEGF blocker.

Materials: The research will be conducted on the following categories of patients groups:

* nondiabetic patients without AMD or any other diagnosed proliferative ocular disease (controls)
* patients with age related macular degeneration (AMD groups) before and after intravitreal injections with Avastin
* diabetic patients with different types of diabetic retinopathy, before and after intravitreal Avastin (diabetic groups) Methods: Samples from different ocular fluids will be collected from each group of patients. 10 growth factors and other 10 cytokines will be determined in the ocular fluids samples.

Results: The results from the biochemical measurements will be statistically interpreted in order to obtain conclusions for the clinical practice.

Conclusions: The conclusions of this trial will be used exclusively for research publications and communications, as well as for clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* age over 20 years
* nondiabetic patients requiring cataract surgery or vitrectomy for different posterior segment nonproliferative disorders - controls groups
* diabetic patients asking ophthalmologic treatments for different degrees of decreasing of visual acuity - diabetic groups
* diabetic patients requiring cataract surgery or vitrectomy - diabetic groups
* age related macular degeneration patients asking ophthalmologic treatments for different degrees of decreasing of visual acuity - age related macular degeneration groups
* age related macular degeneration patients requiring cataract surgery or vitrectomy - age related macular degeneration groups

Exclusion Criteria:

* patients under the age of 20 years
* patients that did not accept and signed the informed consent of the trial
* patients that received any anti-VEGF therapy for any proliferative or inflammatory ocular disease
* patients that received any type of intraocular injection with any pharmaceutical agent
* patients with any clinical type of malignancy in their pathologic antecedents
* patients with recent penetrating trauma (less than 1 year old)
* patients operated for different ocular disorders requiring combination with antimetabolites (ex. 5-FU or Mitomycin C with trabeculectomy)
* patients with intraocular inflammations or infections or other pathologies that contraindicate open globe surgery or intraocular injections with anti-VEGF blockers
Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

It was conducted a prospective study with a series of 63 patients treated with O.R.I.F. (Open Reduction and Internal Fixation) (group A) and with RSA (Reverse Shoulder Arthroplasty) (group B) for three and four-part proximal humeral fractures according to Neer classification system. One independent observer performed clinical and a psychological evaluation at one(T0), six(T1) and twelve months(T2) postoperatively.

The Constant's score and The Disabilities of the Arm, Shoulder and Hand (DASH score) were used for clinical evaluation, while General Anxiety Disorder-7 (GAD-7) and Caregiver Strain Scale (CSS) were used for psychological evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Three and four-part proximal humeral fractures according to Neer classification system;
* Patients seventy years or older;
* Shoulder surgery within one week after trauma

Exclusion Criteria:

* Exposed fractures;
* Pathological fractures;
* Proximal humerus fractures with metaphyseal or diaphyseal extension;
* Contraindications to surgery associated with organ dysfunctions or with coagulopathy;
* Allergy or hypersensitivity to the orthopedic implants;
* Patients who were unable to attend the different follow-ups;
* Patients with psychiatric disorders
Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)

Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular or neuropathic complications; in addition to an optimal treatment, prevention of diabetes complications requires to control associated risk factors, such as hypertension or dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and marked morbidity and mortality, one increasingly interesting aspect is its relationship with metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be underestimated in this population. In this context, it appears to be important to estimate the prevalence of sleep respiratory diseases in patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 75 years
* Type 1 diabetic
* Treated on insulin therapy by external pump
* Take home monitoring as part of a usual care for insulin therapy by external pump
* Voluntary to participate in research with written informed consent
* Patient affiliated to the social security or similar regime

Exclusion Criteria:

Privited person of liberty by judicial or administrative decision, person covered by legal protection (pregnant or lactating women, patients under guardianship) Article L1121-8

* In exclusion period of other studies
* Patient may, at the discretion of the investigator, not comply with the study procedures
Microincision Versus Smallincision Combined Surgery

The purpose of this study is to compare refractive outcomes after two different types of combined cataract surgery, namely microinscision cataract surgery and smallincision cataract surgery, and sutureless 23-gauge vitrectomy in patients presenting with vitreoretinal disorders and coexisting cataracts.

Purpose:

To compare refractive outcomes after combined cataract and vitreoretinal surgery.

Methods:

Patients with a diagnosis of vitreoretinal disorder and a coexisting significant cataract were randomly assigned to be treated with a microincision cataract surgery and a 23-gauge vitrectomy (treatment group 1) or with a smallincision cataract surgery and a 23-gauge vitrectomy (treatment group 2).

Main outcome measures:

Refractive outcomes, stability of the intraocular lens (IOL), intraocular pressure (IOP) and functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis vitreoretinal disorder with coexisting cataract
* combined surgery
* age over 60 years
* IOL master for preoperative intraocularlens (IOL) calculation

Exclusion Criteria:

* ultrasound for IOL calculation due to hazy media (dense cataract,vitreous hemorrhage)
* macular edema, proliferative diabetic retinopathy
* myopia or hyperopia more than 5 diopters, astigmatism more than 2 diopters
* previous refractive surgery, retinal detachment surgery, glaucoma surgery and vitrectomy
Triage Score VS Quick-Sofa Score in Septic Patients in the Emergency Department

Sepsis represents by its frequency, its morbidity and mortality and its cost to society a major public health issue with a constantly increasing incidence. It affects millions of people around the world each year and is the 2nd leading cause of death in intensive care units.

The incidence of sepsis has been estimated by the World Health Organization (WHO), based on US data, at 15 to 19 million cases of sepsis per year worldwide.

This is a descriptive, mono-center study aimed at comparing a local triage score with that of qsofa in patients presenting to the Sahloul Emergency Department with sepsis.

A local triage score was calculated for each patient consulting the emergency room; this score makes it possible to classify patients according to severity and to predict the time to treatment.

A form is completed prospectively for each patient admitted to the observation unit whose diagnosis of sepsis is confirmed and validated by a senior during the morning staff.

The validated data were included in the ReSSUS register (Sepsis Register of the Sahloul Emergency Department). This is an observational database on the management of sepsis admitted to the emergency department in Sahloul. It ensures a high level of confidentiality and protection of medical data.

Subsequent follow-up of patients was done by telephone contact to verify mortality at one month and one year.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* each patient diagnosed as an acute Sepsi consulting the emergencies of CHU Sahloul, Sousse

Exclusion Criteria:

* no exclusion
to Assess the Accuracy and Reliability of the Ga68-Dolacga Positron Emission Tomography Compared to Computer Tomography Volumetry and Indocyanine Green Retention Test for Measurement of Liver Reserve

This is a phase 2 open-labeled study to compare the Ga68-Dolacga positron emission tomography with computer tomography volumetry and indocyanine green retention test for measurement of liver reserve among scheduled surgery operation patients.

This is a phase 2 open-labeled study to compare the Ga68-Dolacga positron emission tomography with computer tomography volumetry (CTV) and indocyanine green retention test (ICGR15) for measurement of liver reserve among scheduled surgery operation patients. The goal is to enroll 30 eligible subjects scheduled for surgery operation.

CTV and ICGR15 will occur within 7 days prior to the imaging visit for all eligible subjects. During the imaging visit (visit 2, Day 1), subjects will receive an iv bolus injection of 2.0±1.0 mCi Ga68-Dolacga Injection. Ga68-Dolacga PET will be kinetically performed 60 minutes immediately after iv injection.

Two follow-up visits (visit 3 at Day 7±2 and visit 4 at Day 14±2) will be conducted to confirm subject well-being and to collect information about any new adverse events (if any).

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled operation subjects with diagnosed hepatic carcinoma. The eligibility criteria for operation refer to protocol Appendix II: Diagnosis and Treatment Guidelines for Hepatocellular Carcinoma in Chang Gung Memorial Hospital;
2. Subjects without ascites or with controllable ascites;
3. Serum total bilirubin level \< 2.0 mg/dL;
4. Written informed consent must be obtained before any assessment is performed.
5. Male or female subjects aged 20 or above, inclusive, at date of consent.

Exclusion Criteria:

1. Presence of distant metastases;
2. A body weight loss of \>10% during the 6 months before operation;
3. Presence of seriously impaired function of vital organs due to respiratory, renal, or heart disease;
4. Cholangiocarcinoma;
5. General PET exclusion criteria;
6. Pregnant women, lactating or breast-feeding women;
7. Patient who can't be followed up for any reason.
A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Have an eosinophilic esophagitis (EoE) diagnosis prior to screening and histologically active disease with an esophageal peak eosinophil count (PEC) of ≥ 15 eosinophils per high powered field (eos/hpf)
* Have dysphagia, defined as solid food going down slowly or getting stuck in the throat with an average frequency of ≥ 2 episodes per week over 2 weeks during the Screening period

Inclusion Criteria for the Extension Treatment Period

* Completion of the Week 24 study visit \[including esophagogastroduodenoscopy (EGD)\]
* Compliance with study procedures during the Double-Blind Treatment Period as assessed by the Investigator
* No notable safety concerns during the Double-Blind Treatment Period, as determined by the Investigator
* Willing to comply with all study visits and procedures for the Extension Treatment Period

Exclusion Criteria:

* History of any of the non-EoE conditions or procedures that may interfere with the evaluation of or affect the histologic (eg eosinophilic gastritis), endoscopic (eg, high-grade esophageal stenosis), or symptom endpoints (eg, esophageal resection) of the study
* Undergone dilation of an esophageal stricture within 12 weeks prior to Screening EGD
* Use of corticosteroids for the treatment of EoE within 8 weeks prior to Screening EGD
* Discontinue, initiate, or change dosing (dosage/frequency) of the following therapies for EoE within 8 weeks prior to Screening EGD. Participants on any of the following therapy need to stay on a stable regimen during study participation:

  1. Elemental diet
  2. EoE food trigger elimination diet
  3. Proton pump inhibitor (PPI) therapy
* Used any immunotherapy/desensitization including oral immunotherapy (OIT) or sublingual immunotherapy (SLIT) within 12 months prior to the Screening EGD. Note: Stable (ie, ≥ 6 months prior to the Screening EGD) subcutaneous immunotherapy (SCIT) is permitted. Participants on SCIT need to stay on a stable treatment during study participation
* Used any protocol-specified immunomodulatory therapies within the protocol-specified timeframe prior to Baseline (eg, dupilumab, benralizumab, omalizumab, or infliximab within 12 weeks; a sphingosine-1-phosphate receptor modulator at any time)
* Use of any investigational agent or device within 12 weeks prior to Baseline
* Females who are pregnant
Development and Feasibility Testing of a Mobile Phone-Based HIV Primary Care Engagement Intervention

This is an open-trial pilot study in which adult methadone maintenance treatment patients who are living with HIV but are not engaged in HIV primary care (i.e., missed appointments, non-adherence to medication) will be recruited to participate in a HIV primary care engagement study. The purpose of this study is to develop and test the feasibility and acceptability of a mobile phone-based health (mHealth) text messaging intervention to improve engagement in HIV primary care among substance abusing populations with HIV.


Eligibility Criteria:
Inclusion Criteria:

* Client of a methadone maintenance treatment program
* HIV positive (status confirmed by medical records)
* At least 18 years of age
* English speaking
* Comfortable using a mobile phone (to send and receive text messages)
* Lives in New York City
* Willingness to attend at least two design sessions
* Willingness to attend one usability testing session, and participate in a post-usability survey and exit interview.
Observational Study on Efficacy, Safety and Convenience of Using Mixtard® 30 NovoLet® Alone or Combined With OHA in Treatment of Type 2 Diabetes in Routine Clinical Practice

This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral hypoglycaemic agent (OHA) in the management of type 2 diabetes mellitus in an out-patient setting.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Not adequately controlled on their current therapy
MIVetsCan: Can-Coach Trial (Phase 2)

The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.

All study interactions will be done virtually.

Eligibility Criteria:
Inclusion Criteria:

* United States Veteran
* Experiencing chronic pain (pain lasting 3 or more months)
* Moderate to severe chronic pain
* Are planning or currently using cannabidiol (CBD) or cannabis products for pain management
* Able to read and speak English sufficiently to allow for informed consent and active participation in the educational intervention sessions
* Willingness to attend all study visits (conducted virtually)
* Willingness to fill out periodic assessments via smartphone to assess symptom status and cannabis use (protocol has more details)

Exclusion Criteria:

* Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
* Participant states participant is pregnant
* Current diagnosis or past history of a psychotic disorder (schizophrenia spectrum, except substance/medication -induced or due to another condition)
* Current diagnosis or past history of bipolar disorder
* Unable to attend study visits
* Risk for imminent harm - Suicidal ideation or wish to die as assessed with the Positive and Negative Suicide Ideation (PANSI) questionnaire and further risk assessment by study team members
* Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol
Sleep Apnea Syndrome and Vitamin D

Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with multiple comorbidities.

OSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity. However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus and/or unstable neuromuscular output seem to be involved in this collapsus.

A normal vitamin D status is necessary for normal muscle function and neuromuscular output. As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D deficiency.

Prospective, longitudinal, double bind, randomized study of the effect of vitamin D supplementation in OSAHS patients with hypovitaminosis D.

After written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe obstructive sleep apnoea (AHI \> 15)
* With or without continuous positive airway pressure for a minimum of six months
* aged 30-75 years
* Vitamin D2D3 level \< 30 ng/ml

Exclusion Criteria:

* Diseases or therapy known to interfere with phospho-calcium or vitamin D metabolism
* Patients with mixed sleep apnoea (central and obstructive)
* Patients with CPAP use \< 4 hours per night
* Patients with maxillofacial or oro-pharyngeal diseases)
* Patients with chronic respiratory failure, hypercapnic patients
* Muscle diseases
* Alcohol intake \> 2 glasses per day
* Body mass index \> 40 kg/m2