cyrilzakka/clinical-trials huggingface dataset:
Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)

The imbalance of diabetes is associated with an increased risk of maternal and fetal complications. In women, it can cause abortion, hypertension, preeclampsia, and obstructed labor; in the fetus, it increases the risk of many malformations, including neurological and cardiac, fetal death in utero, intrauterine growth retardation, macrosomia, prematurity and metabolic complications.

Despite the various therapeutic tools available and used during pregnancy, maintaining blood sugar levels within this narrow range remains a challenge.

Automated Insulin Therapy (IA) Could Further Improve Outcomes With Continuous Glucose Monitoring and Increase Percentage of Time Spent on Target Between 63 and 140 mg/dL The objective of this observational study is to describe the clinical characteristics, metabolic data on MCG and maternal and/or fetal complications in women with T1D treated during pregnancy with an AI system available in France.

Diabetes imbalance is associated with an increased risk of maternal and fetal complications, and achieving target blood glucose levels before and during pregnancy in women with type 1 diabetes (T1DM) significantly reduces these complications. In women, it can cause abortion, hypertension, pre-eclampsia, and dystocic deliveries; in the fetus, it increases the risk of numerous malformations, including neurological and cardiac, fetal death in utero, intrauterine growth retardation, macrosomia, prematurity, and metabolic complications at birth such as neonatal hypoglycemia and hypocalcemia.

The recommended glycemic targets during pregnancy are strict: HbA1c \< 6.5% and time in target (between 63 and 140 mg/dL) \> 70% (6).

Despite the various therapeutic tools available and used during pregnancy, maintaining blood glucose within this narrow range remains a challenge.

Automated insulin therapy (AI) could improve further on the results obtained with continuous glucose monitoring and increase the percentage of time spent in target between 63 and 140 mg/dL The objective of this present observational study is to describe the clinical characteristics, metabolic data on MCG and maternal and/or fetal complications in women with T1DM treated during pregnancy with an AI system available in France, whether this system is used before the beginning of the pregnancy or during it.

Eligibility Criteria:
Inclusion Criteria:

* aged at least 18 years
* had been diagnosed with type 1 diabetes before pregnancy
* using an hybrid closed-loop insulin delivery system before or at any time of pregnancy

Exclusion Criteria:

* Patient opposed to the research
A Study to Assess the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With Chemotherapy Combined With Bevacizumab

The purpose of this study is to explore the relationship between sarcopenia, as defined by computed tomography, treatment related outcomes and other body composition related parameters in a patient population receiving bevacizumab beyond progression.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated in first line with bevacizumab for whom it is decided, and who are clinically considered eligible, to continue the treatment with bevacizumab beyond PD1.
* Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
* Availability of specific retrospective data at diagnosis and during 1st line treatment

Exclusion Criteria:

* Patients who are participating or participated in first line in any other interventional clinical trial involving non-standard of care procedures impacting the body composition
* Dementia or another mental condition making it impossible to fill out questionnaires
Long-term Follow-up of Subfoveal Neovascular AMD

Treatment naive patients with subfoveal nAMD initially treated monthly with intravitreal anti-VEGF and subsequently PRN, will be included in this study. Patients will be investigated for the first 2 years monthly and subsequently according to disease activity but at least every two months. Patients will be examined with 4m BCVA ETDRS distance visual acuity, reading acuity measured by Radner-Reading-Charts, contrast sensitivity by Pelli-Robson score, microperimetry and HD-OCT.


Eligibility Criteria:
Inclusion Criteria:

* treatment naive subfoveal AMD, written informed consent, able to read

Exclusion Criteria:

* choroidal neovascularisation due to other ocular diseases, mature cataract
Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head

Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction. Core decompression is currently the treatment of choice for early stage osteonecrosis of the femoral head. This method consists in decompressing the rigid intra-osseous chamber to promote revascularization, thus halting progression of the disease and stimulating repair. Still this treatment remains highly controversial, since the success rates of the first studies have not been repeated.

The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated. Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures, microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells recruitment.

Three studies have indicated the potential clinical benefits of cell-based approaches for the treatment of osteonecrosis (Hernigou 1997, Hernigou \& Beaujean 2002, Gangji et al. 2004). This is on the basis of these observations that a proprietary population of autologous osteoblastic cells (PREOB®) has been developed.

This Phase 2B study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. The primary goal of this study was to investigate the safety and efficacy of the implantation of the investigational product PREOB® (human autologous bone marrow-derived osteoblastic cells) in comparison to bone marrow concentrate (BMC) when implanted at the osteonecrotic lesion of the femoral head, with a follow-up period of up to 5 years.


Eligibility Criteria:
Inclusion Criteria:

* ARCO stage I or II non-traumatic osteonecrosis of the femoral head, confirmed by conventional X-ray and magnetic resonance imaging (MRI) of the hip
* Aged 18 or higher
* Ability to provide a written, dated and signed informed consent prior to any study-related procedure to understand and comply with study requirements

Exclusion Criteria:

* Evidence of malignant disorder in the past five years
* Positive serology for hepatitis B, hepatitis C, HIV
* Patient unable to undergo a MRI
Diode Laser and Green Indocyanine in the Non-surgical Treatment of Periodontitis

This is a parallel-group, randomized controlled clinical trial aimed to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and green indocyanine in the full-mouth ultrasonic debridement of patients affected by periodontitis.

Periodontitis is a chronic inflammatory disease affecting the supporting tissues of the teeth and is primarily caused by the subgingival inflammation induced by the bacterial oral biofilm. Several risk factors may condition its development and progression and, if untreated, periodontitis may lead to tooth loss and severe functional and aesthetic impairments.

A central role in the non-surgical treatment of periodontitis is played by the manual and ultrasonic debridement of supra and subgingival bacterial deposits. The benefit of a fully ultrasonic approach lies in the knowledge that removing radicular structure is not a prerequisite for periodontal healing.

However, non-surgical therapy has limitations due to limited access to some sites (furcation areas, concavities, grooves, distal sites of molars, and deep pockets), which may impair periodontal healing due to the persistence of pathogens and subsequent recolonization. In this context, the use of diode laser in combination with photoactivated solutions has been proposed as an adjunct treatment to conventional periodontal therapy to enhance the antibacterial effect and improve clinical effects, especially in areas of difficult access.

In view of theme relevance and the existence of conflicting results in the literature, the aim of the present parallel-group, randomized controlled clinical trial is to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and indocyanine green (DLIG) in the full-mouth ultrasonic debridement (FMUD) of patients affected by periodontitis.

24 patients will be treated by FMUD and, after 7 days, randomly allocated half to the test and a half to the control group. In the test group, patients will receive an adjunctive treatment in periodontal sites with an initial pocket depth \> 4mm consisting of the use of a diode laser device (Fox ARC, Sweden \& Martina, Due Carrare, Italy) after pocket irrigation by a solution of indocyanine green (Emundo®, Sweden\&Martina, Due Carrare, Padova, Italy), whereas the patients in the control group will receive sham treatment (ST). The same treatment will be repeated three weeks after in both the test and control groups.

Clinical assessment and microbiological analysis of subgingival plaque will be performed at baseline and after 3 and 6 months.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of moderate to severe periodontitis
* Systemic health

Exclusion criteria:

* Systemic diseases requiring antibiotic prophylaxis or other systemic medication that could affect the patient's clinical response
* Periodontal treatment within the last 12 months or systemic antibiotic intake in the last 3 months
* Pregnancy
Diets With a Spectrum of Fat Intake for Preventing Obesity: A Randomized Controlled-feeding Trial

The aim of the current study is to evaluate the effects of diets with three levels of dietary fat on weight change and related cardiometabolic risk factors in a 6-month randomized controlled-feeding trial.


Eligibility Criteria:
Inclusion criteria:

* Students in Zhejiang University or working stuff in the Chinese PLA General Hospital
* 18 ≤ age ≤ 35
* Body Mass Index \< 28\*
* Are willing to eat all of the study foods even when full
* Are willing to eat only foods provided
* Are willing to avoid strenuous activity during the 6-mo intervention Exclusion criteria：
* Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg
* Total cholesterol ≥ 239 mg/dL
* Low-density lipoprotein cholesterol ≥ 159 mg/dL
* Triglycerides ≥ 199 mg/dL
* Blood glucose ≥ 110 mg/dL
* Change in body weight exceeding ± 10% during the prior year
* Energy intake is too low or too high
* Unwillingness or special requirement for diet that could not be modified
* Poor adherence during the recruiting meeting or unsatisfactory completion of keeping food diary or filling questionnaire at any time before randomization
* Eating disorder or any psychosocial or scheduling factors that could impede study outcomes
* Have a history of diagnosed CVD, diabetes, cancer or inflammatory diseases
* Have a history of a mental illness
* Have diagnosed endocrine, pulmonary or hematological disease
* Have diagnosed bowel disease or malabsorption that would prevent the participants from complying with the dietary restrictions of the feeding trial
* Renal or liver insufficiency
* Other chronic disease thought to interfere with the effect of the diet or with participation or adherence
* Current use of supplements or anti-inflammation medications or medications affecting glucose, lipid metabolism and blood pressure
* Smoking or alcoholic beverage intake \>1 times per week
* Current or planned pregnancy prior to end of study, or breast-feeding
* Irregular menstrual cycles
* Have birth control medication
The Prevalence of Sub Optimal Anti Coagulation

A study on warfarin administration to show whether noncompliance of the patient will affect our target (INR) during therapy or not beside its drug and dietary interactions.

The study will show the prevalence of sub optimal anti coagulation among patients with prosthetic cardiac valves that will undergo warfarin therapy.

Besides the risk of infective endocarditis, thromboembolism from the foreign body structures of the prosthesis remains a major problem, which can be effectively reduced, but not inhibited by the use of oral anticoagulants in patients with prosthetic cardiac valves.

Warfarin as a vitamin k antagonist is widely used to decrease risk of thromboembolism but need strict monitoring for INR to avoid warfarin failure or hemorrhage.

It acts through inhibiting an enzyme called the vitamin K1 2,3 epoxide reductase complex, subunit1 (VKORC1).

All patients with mechanical heart valves need the oral anticoagulation to keep the INR between 2.5:3.5 according to valve type, position and other comorbid conditions.

However some patients need higher than expected doses of warfarin to get their (INR) into the target therapeutic range.

Resistance to warfarin has been described as the inability to prolong the prothrombin time or raise the international normalized ratio (INR) into the therapeutic range when the drug is given at normally prescribed doses.

Resistance is different than warfarin failure ,which is defined as a new thrombotic event despite a therapeutic prothrombin time and INR .

The causes of warfarin resistance can be either acquired from high consumption of vitamin K or C ,decreased absorption or increased clearance of the drug ,dietary or drug interactions or hereditary by genetic factors that result either in faster metabolism of the drug (a form of pharmacokinetic resistance) or in lower activity of the drug (pharmacodynamic resistance).

Eligibility Criteria:
Inclusion Criteria:

All patients of prosthetic cardiac valves undergo warfarin therapy with sub optimal anti coagulation

Exclusion Criteria:

* Refusal of the patients
* Patients with target INR (2.5-3.5)
* Patients with hypoalbumenimia and chronic liver diseases
Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.

Inappropriate medication prescribing is highly prevalent among comorbid medical patients and leading to adverse drug events (ADE), re-admissions, quality of life and mortality. Thus, the aim of this study is primary to investigate the feasibility of a interdisciplinary intervention focused on deprescribing and medication optimization in the Integrated Outpatient Department at Copenhagen University Hospital, Amager, Denmark.

Participants in the intervention group receives a medication review by a clinical pharmacist and physician with a follow up after 7 and 30 days. The control group receives standard care.

The FMA-CPH trial is designed as a single-blinded randomized controlled pilot trial starting at the first consultation and end 30 days after.

Patients that meet all inclusion criteria and none of the exclusion criteria are invited to participate. After signing a written informed consent, the participants are block randomized to either the intervention or control group.

Medication prescription for comorbid patients is challenging and may be attributed to marked inter-individual variations in general health, organ function, pharmacokinetic and pharmacodynamic properties, biological age and physical performance. The intervention group receive a medication review.

It is hypothesized that the intervention is feasible and more patients in the intervention group will complete ≥1 deprescribing and/or ≥1 medication optimization 30 days after the beginning of the intervention than the patients in the control group.

Secondary it is hypothesized the patients in the intervention group:

A. Complete more deprescribing compared to the control group (30 days after intervention) B. Complete more medication optimization compared to the control group (30 days after intervention) C. Have a higher knowledge about own medication (14 days after intervention) D. Have a higher level of satisfaction with medication information (14 days after intervention)

Eligibility Criteria:
Inclusion Criteria:

* Consultation at Integrated Outpatient Department subacute track
* Multi morbidity/Comorbidity
* Drug Prescribing
* Mentally fresh
* Understand and speak Danish

Exclusion Criteria:

* Unable to cooperate cognitively
* Language problems
* Admission
The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis

The purpose of this study is to evaluate the effect of nitro-glycerine on the microcirculation (smallest vessel type) in patients with severe sepsis and septic shock.

Nitro-glycerine is a well known medicine in cardiology and is used to improve circulation. In this ICU the investigators use nitro-glycerine to improve the organ perfusion; but it's no common therapy in the rest of the world. The investigators now compare nitro-glycerine and placebo by looking to the sublingual microcirculation by a small camera (SDF imaging).

This study starts at admission of the patient on the ICU. In the next 24 hours the patient receives nitro-glycerine or placebo (randomised). At time = 0, ½, 2, 12 and 24 hour we evaluate the microcirculation by SDF imaging and monitoring of hemodynamic parameters.

Informed consent is obtained of the relatives.

Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis
* Proven infection
* Informed consent

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Use of nitroglycerine within 24 hours prior to ICU admittance
* Necessity to use nitroglycerine iv for instable angina
Efficacy of VRx MyBiotics Oral Lozenges

This study will test the efficacy of Viome's VRx MyBiotics Oral Lozenges at improving the oral microbiome.

This is a single arm, interventional trial on adults residing in the United States. The study will test the efficacy of personalized oral biotic lozenges (VRx MyBiotics Oral Lozenges) at improving oral microbiome health according to Viome's Oral Health Score.

Eligibility Criteria:
Inclusion Criteria:

* Any person with a US address that is 18 years old or older
* Able to speak and read English
* Willing and able to follow the trial instructions, as described in the recruitment letter
* Signed and dated informed consent prior to any trial-specific procedures.

Exclusion Criteria:

* Systemic antibiotic treatment 30 days prior to enrollment or during the trial
* Not willing to stop sporadic use (less frequently than daily) of any mouthwash.
* Significant diet, supplements, or lifestyle change in the previous 1 month or next 2 months once enrolled
* Allergy to tapioca, peppermint, or sweet potato
* Current diagnosis of periodontitis or other advanced oral disease (chronic recurrent caries, oral cancer, etc)
* No dental procedures 30 days prior to enrollment or during the trial (regular cleanings, bone grafts, dental implants, etc)
* Pregnancy or planned pregnancy
* Currently have cancer or undergoing cancer therapy
* Dentures
* Fewer than 20 teeth
* Use of at home teeth whitening products 30 days prior to enrollment or during the trial
* Start new medications or supplements during the trial
Pilot Study on the Use of iENTER, iCONSENT and iPARTICIPATE E-tools

Precision oncology is the future of fighting cancer. Cancer Core Europe (CCE) developed a precision medicine trial, i.e. the Basket of Basket (BoB) study, to provide personalised treatment to a large number of patients by incorporating a molecular profiling platform. The EU-funded CCE_DART project, developed within the CCE Consortium, is aimed at improving efficiency and transform platform trials into data-rich translational research programmes. Within the CCE_DART project working area D "Patient involvement through information and partnership" three interconnected web e-tools were developed aimed at promoting patient information, recruitment, and involvement as well as facilitating adherence to the CCE BoB trial: 1) iENTER: informative web site addressed to potential BoB trial participants, their caregivers, patients' advocates, and the public; 2) iCONSENT: web app for remote management of the informed consent process in the CCE BoB trial.3) iPARTICIPATE: web app allowing remote access to BoB trial patients trial visits calendar, medications list and posology, to upload documents and download reports, messaging between patients and clinical staff. The main objective of this study is to carry out field testing and assess usability of the e-tools iENTER, iCONSENT and iPARTICIPATE. The study is also addressed at collecting patients' suggestions for improvements of the e-tools.


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients, or their informal caregivers, candidates to precision oncology trials. Patients or caregivers able to surf the internet and to fill in a simple online form.

Exclusion Criteria:

* People with clinically evident cognitive impairment.
Behavioral and Cognitive Predictors of Persistent Pain and Opioid Misuse in Chronic Pain

Chronic lower back pain (CLBP) affects approximately 20% of the global population. The study objective is to determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in patients with chronic pain. This is a prospective consented cross-sectional study characterizing behavioral and cognitive phenotypes using both patient-reported survey measures and cognitive testing. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and risk for opioid misuse (Primary outcomes: COMM scores, SOAPPR scores). Secondary outcomes is BPI measurement. A Certificate of Confidentiality will provide additional protections for participants.


Eligibility Criteria:
Inclusion Criteria:

* With diagnoses related to chronic lower back pain
* Age above 18yrs
* Non pregnant

Exclusion Criteria:

* Cancer pain
Multimodal Analgesic Protocol to Moderate Acute Pain

With a prospective, observational study assess post-surgery pain levels and patient's use of opioids and other analgesic drugs to moderate pain following third molar surgery.

SPECIFIC AIMS Using the UNC surgery clinic multi-modal protocol of drugs/dosages to control acute pain after third molar surgery assess each post-surgery day(PSD) the patient reported

1. pain levels post-surgery as recorded by Likert-type and Gracely scales
2. quality of life(QOL) outcomes for lifestyle and oral function
3. number of opioid doses taken by subject-patients
4. number of NSAID and acetaminophen doses taken by subject-patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA I,II At least two lower 3rd molars scheduled for removal

Exclusion Criteria:

* Patient being treated for opioid addiction/abuse including having Rx for suboxone, methadone