cyrilzakka/clinical-trials huggingface dataset:
Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)

At the moment in France, one delivery on four is induced for a medical indication. In this context, the practitioners are exposed to an additional difficulty when the clinical examination of the patient reveals a unfavorable cervix because the main drug used for the releases cannot be used and the cervix must be previously mature.

There is a pharmacological method used and estimated in these indications of cervical maturation: the dinoprostone (Propess®).

Other methods using a mechanical process, are under development and of evaluation as it is the case of the probe of dilation with double balloon (Cook®).

The population of the obese women is a population in constant increase in France and presenting deliveries to higher risks of maternal and foetal complications. At these patients, the medicinal releases seem also more difficult and at greater risks of failures.

The investigators wish compared the efficiency of the cervical ripening balloon to the dinoprostone within the framework of a medical indication in a release with a unfavorable cervix in obese pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Term ≥ 37 weeks of amenorrhea
* Singleton pregnancy
* Cephalic presentation
* Medical indication of release and unfavorable cervix (Bishop \<6)
* BM pre-pregnancy ≥ 30 kg/m2
* Having given their agreement for the participation of the study
* Patient receiving social coverage

Exclusion Criteria:

* Age \< 18 years
* Term \< 37 weeks of amenorrhea
* Multiple pregnancy
* Favorable cervix (Bishop ≥ 6)
* Contraindication of vaginal delivery: praevia placenta, transverse presentation, cord prolapse
* Evolutive urinary tract infection (positive urine dip: leukocytes/ nitrites)
* Not affiliated with a legal protection regime
* Patient trust, guardianship, under legal protection measure, deprived of freedom

Balloon's contraindications:

* Abnormal pelvis structure
* Evolutive genital herpes
* Invasive cervical cancer
* Anomaly of foetal heart rate
* Breech presentation
* Maternal heart disorder
* Hydramnios
* Serious and uncontrolled arterial high blood pressure
* Rupture of membranes
* Medical histories of hysterotomy, classic uterine section, myomectomy or quite different uterine section of full thickness
* Presentation above superior pelvic strait

Dinoprostone's contraindications:

* Scarred uterus
* Prostaglandin's hypersensitivity
Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery

This randomised controlled trial aims to evaluate the difference in surgical site infection following excision of soft tissue sarcomas. The intervention is a negative wound pressure therapy dressing for 120 hours, the control is standard absorbent dressings

Hypothesis: The application of a negative pressure wound therapy (NPWT) dressing will reduce rates of wound breakdown in patients with resection of soft tissue sarcomas which are primarily closed.

Patients will be randomised into either NPWT or standard absorbent dressings with primary outcome measure of surgical site infection according to the Health Protection Agency guidance. Secondary outcomes are; time to wound dryness, delayed discharge from hospital, adverse events, cost estimation

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing primary soft tissue sarcoma excision which is primarily closed.

Exclusion Criteria:

* Unable to consent
* Children
* Post radiation sarcomas or sarcoma in presence of active infection
* Multiple metastatic disease
* Presence of Endoprosthesis
Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patient has Type 2 diabetes
* Currently taking metformin \>1500 mg/day for at least 10 weeks
* Male or female

Exclusion Criteria:

* Patient has peripheral edema
* History of type 1 diabetes
* Patient required insulin within prior 8 weeks
* Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
* Participating in a weight loss program
Stroke complicAtions After TraUmatic expeRieNces and Stress

The primary aim of this retrospective cohort study is to test the hypothesis that previous traumatization (long) before an ischemic stroke increases the degree of stroke-induced PTSD symptoms at 9-13 months after the stroke event. Secondary outcome parameters include quality of life and depression.

Neuropsychiatric consequences of brain ischemia play a critical role in shaping long-term stroke outcome. Unfortunately, however, as of now, clinical research and clinical practice have not adequately addressed this growing challenge. A good case in point is posttraumatic stress disorder (PTSD). Previous trauma exposure and posttraumatic stress symptoms may increase the risk of cardiovascular events (Sumner et al., 2015). Moreover, unbeknownst to most clinical neurologists, a significant portion (approximately 25%) of their stroke patients develop symptoms of post-traumatic stress disorder (PTSD) within the first year post-event. PTSD-related symptoms after an acute coronary syndrome increase the risk of recurrent cardiac events and mortality (Edmondson et al., 2012). Similarly, stroke-induced PTSD has been linked with worse long term stroke outcome, in particular, recurrent stroke, greater disability, non-adherence to medications, and comorbidities (Goldfinger et al., 2014; Kronish et al., 2012).

For a period of 22 months, all stroke patients treated at the Charité Medical Center will be screened retrospectively 9-13 months after a first-ever ischemic stroke (\~2000). All eligible patients will be contacted by mail 9-13 months after their hospital stay with the request that they complete the questionnaires. The mailing will also include an information statement, the consent form, as well as a stamped return envelope.

Eligibility Criteria:
Inclusion criteria:

1. Patients treated at the Charité Medical Center for acute ischemic stroke
2. Confirmation of diagnosis by CT or MRI
3. Age \> 18 years
4. Ability to give informed consent

Exclusion criteria:

1. Stroke secondary to complications from an intracranial aneurysm, arterial-venous malformation, intracranial tumor or neoplastic process
2. Major diseases at the time of the hospital stay that would be expected to obviate meaningful follow-up assessments such as life-threatening heart or respiratory failure, renal or hepatic failure, cancer

2. Severe comprehension deficits, e.g. severe aphasia, dementia 3. Substantial pre-stroke disability (e.g. from a previous stroke)
A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder

This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.

The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.

Eligibility Criteria:
Inclusion Criteria:

* eligible subjects will be men or women aged 18 to 65 years inclusive;
* body mass index (BMI) 18 to 30 kg/m2;
* healthy adults must be in general good health with no clinically significant abnormalities that would affect ability to complete study.
* subjects with asthma must be non-smokers who have a forced expiratory volume in one second (FEV1) ≥ 60% of predicted for race, age, sex, and height;
* subjects who smoke must have at least a 12-month, 0.5 pack of cigarettes per day history or the equivalent consumption of cigars and a positive result for plasma cotinine.

Exclusion Criteria:

* subjects with asthma will be excluded for more than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness;
* asthma exacerbation within 8 weeks of before screening;
* unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening;
* history of intubation or intensive care unit admission for asthma in the past 5 years.
* Subjects who smoke will be excluded if they have intrinsic lung disease including asthma or chronic obstructive pulmonary disease (COPD) with an FEV1 of \<60% of predicted and a score of ≥2 on the Medical Research Council Dsypnea Scale (MRC);
* any cardiovascular risk factor or contraindication for the use of triptans
* use of nonselective monamine oxidase inhibitors (MAOI), serotonin reuptake inhibitors (SSRIs), propranolol, or cimetidine within 4 weeks prior to the Screening Visit, or planned use during the study;
* positive serology test (hepatitis B virus surface antigen \[HBsAg\], hepatitis C virus \[HCV\] antibody, human immunodeficiency virus \[HIV\] 1 \& 2 antibodies).
Patient Information Videos on Operations Trial

This study evaluates whether rapid sequence animation videos (RSAV) are of use as an additional learning resource for the elective pre-operative patient. The investigators aimed to do this by comparing the change in knowledge and anxiety in two groups; Half of the patients were allocated to the normal patient pathway and the other half received the educational video as an additional preoperative learning resource.

This single centre single-blinded randomised controlled study evaluates whether rapid sequence animation videos (RSAV) are of use as an additional learning resource for the elective pre-operative patient. The investigators aimed to do this by comparing the change in knowledge and anxiety from baseline to immediately preoperatively. Patients were block randomised to either the normal patient pathway or to receive the educational video as an additional preoperative learning resource.

Patients over 18 years of age electively listed for lower segment caesarean section (LSCS) and transobturator / transvaginal tape (TVT/TOT) were included.

Two RSAV were created explaining LSCS and TVT/TOT. Participants were block-randomised in groups of 10 to either control (no video) or intervention (video). Two questionnaires assessing anxiety were completed at baseline and immediately preoperatively using a Visual Analogue Scale (VAS) and a State- Trait Anxiety Inventory (STAI). Patient knowledge was assessed using a custom questionnaire. Primary outcome measures were the change in knowledge and anxiety scores.

Eligibility Criteria:
Inclusion Criteria:

* Patients due to have one of the following operations: Elective Caesarean Section, Trans-Vaginal / Trans-Obturator Tape
* Patients must be consented for the operation before participating in stage 2 of the study.
* English speaking

Exclusion Criteria:

* Any conditions which may affect capacity: eg dementia, previous CVE or reduced cognitive ability
Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm

To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.

A study to evaluate the performance of a modification to the G4 Platinum CGM system in adults with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes on Intensive Insulin Therapy (ITT)
* Willing to participate in a clinic session

Exclusion Criteria:

* Use of Acetaminophen during study period
* Pregnancy
* Hematocrit (HCT) \<35% (females) and 38% (males)
* Dialysis, history of cardiovascular disease, epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia within the last 6 months.
* Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose and excessive risk to study staff.
Open Versus Laparoscopic Ablation of Liver Malignancies

The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery.

Liver malignancies is a major cause of cancer-related mortality and the incidence is increasing. Patients with liver malignancies are often left with limited surgical treatment options due to extensive tumor burden or comorbidities. Ablation is a less invasive treatment for these patients that can be performed percutaneously, by laparoscopy or open surgery. Ablation during open surgery has a high potential of complications. Laparoscopic ablation presumably has a lower complication rate than during open surgery, yet still offers some of the same advantages needed for tumors in locations not favorable for percutaneous ablation. This study aims to compare laparoscopic ablation with ablation during open surgery to investigate a treatment option with a supposed lower complication rate and equally treatment effectiveness after one month.

Eligibility Criteria:
Inclusion Criteria:

* One or more tumors not amenable to percutaneous ablation, age ≥ 18, signed informed consent, diagnosis of primary liver cancer or liver metastases from any primary tumor, and tumor suitable for ablation as primary treatment.

Exclusion Criteria:

* Ablation performed in conjunction with resection, patients who cannot cooperate with the study, and patients who do not understand or speak Danish.
HVNI Ambulation Feasibility Study

The pilot/feasibility study evaluates the ability of High Velocity Nasal Insufflation (HVNI) therapy to facilitate ambulation and mobilization in patients experiencing shortness of breath, as compared to simple oxygen therapy.

The hypothesis is that HVNI therapy, when implemented in conjunction to ambulatory practices, will be more effective than TAU to improve patient mobility by reducing the patient's perceived dyspnea and exertion via maintaining oxygenation (reduced desaturation) and supporting ventilation (reduced work of breathing \[WOB\]). The primary endpoint is exercise performance, defined as the distance and duration of patient ambulation.

To provide a sample data set, The investigators will enroll up to 32 subjects to complete this feasibility assessment, with a calculated sample size of N=26 plus a 20% failure rate. This will provide sufficient initial data to inform the appropriate sample size of a follow-on randomized study.

This will be a feasibility study, performed as a prospective, crossover controlled trial to evaluate the potential patient improvement during ambulation while on HVNI relative to TAU. Patients who fit the criteria for inclusion will perform ambulation for each study arm: the control arm (TAU) followed by the test arm (HVNI). Control group will receive the site TAU (not HVNI), and the test group will receive HVNI therapy. In both cases the clinical management will otherwise remain unchanged based on the site SOC practices. The patient FiO2 and flow values will be recorded while on any supplemental oxygen. Subjects will wear appropriate gear and, when applicable, have mobile carts to provide supplemental oxygen therapy (e.g. HVNI VTU) during ambulation. If they meet criteria for intubation or are deemed to need intubation by the critical care team, they will undergo prompt intubation and be managed according to standard practice. After each of the study arms, the clinicians will complete perception score assessments.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 years
* Demonstrated respiratory distress upon mild to moderate exertion (e.g. dyspnea upon standing, walking, etc.)
* Candidate for clinical ambulation/mobilization

Exclusion Criteria:

* Hypoxemia at resting baseline: unable to maintain SpO2≥88% with supplemental oxygen
* Inability to provide informed consent
* Pregnancy
* Known contraindication to perform ambulation, per site SOC practices
* Inadequate respiratory drive or any known contraindications to HVNI
* Inability to use nasal cannula and HVNI therapy
* Agitation or uncooperativeness
* Determined by the attending clinician to be sufficiently unstable or unsuitable for this feasibility study
Clinical Value of DWI-ADC Matching in the Short-term Prognosis of Wilson's Disease

In earlier studies, it was found that patients of Wilson disease with new diagnosed who only has neurological symptoms often had DWI hyper-intensity in brain MRI, which was more common in putamen and midbrain, indicating that the disease was in the acute stage. However, many patients had ADC hyper-intensity or hypo-intensity at the same time, and the two different signals represented different disease processes from an imaging perspective. The former indicating T2 penetration effect, and the latter represents diffusion limitation, which indicating the presence of local inflammation, edema, etc. Whether the signal changes of these two different matching modes have guiding significance for the early de-copper treatment for WD, one is the core point of our study. We hope to exploring the predictive value about DWI-ACD signal matching for symptoms changes in the earlier time of de-copper treatment through this study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients had been previously diagnosed with WD who both had DWI hyper-intensity and ADC hyper-intensity or hypo-intensity at the same time；
2. Patients who accept de-copper treatment in hospitalization for 4 weeks or more.

   Exclusion Criteria:
   1. Patients who only with liver injury;
   2. Severe complications;
3. Combined with other diseases.
Prediction of Progression of Age-Related Macular Degeneration

The goal for this study is to initiate a randomized, controlled clinical trial to test the viability of personalized AMD progression prediction models. Early and intermediate AMD patients will be recruited and randomly assigned them to a control or test group. The test group will include patients who will receive personalized follow-up care based on their predicted risk, and collect baseline and follow-up data.

This work will advance the AMD field by improving the identification of high-risk patients as candidates for more frequent screening and earlier treatment, leading to better clinical outcomes.

More than 90% of patients with advanced AMD have severe vision loss. Predicting AMD progression from an early or intermediate stage is crucial, since prompt intervention after a choroidal neovascularization (CNV) event and geographic atrophy (GA) monitoring can greatly improve visual outcomes. Patients at higher risk of progression should have more frequent follow-up visits, since progression often occurs before any visual changes are noticed by the patient. Previous work has determined the risk factors for AMD progression based on drusen features in fundus photos, Optical Coherence Tomography (OCT) and from genetic factors. However, current models are limited by their ability to make predictions over short intervals, which limits their utility in guiding screening intervals.

In this study we will recruit patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion. We will perform a randomized trial where we will randomly assign them to a control or test group (personalized follow-up care starting at 3 months based on their predicted risk from algorithm results), and collect baseline genetic, demographic, imaging, and clinical data and first follow-up data at the 3 month and 6 month follow-up time points. Outcomes will be measured to determine if an algorithm predicting early follow-up for high-risk patients (3 month) is advantageous over the standard 6 month follow-up time point.

Eligibility Criteria:
Inclusion Criteria:

* Non-neovascular AMD at baseline in at least one eye with no signs of GA,
* \> 45 years of age,
* willingness to participate through a signed consent form.

Exclusion Criteria:

* Pregnant women and vulnerable populations
* Participation in an investigational trial that involves treatment with any drug (with the exception of vitamins or minerals) within 3 months prior to Day 1.
* Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid
The Role of Matrix Metalloproteinases (MMPs) in Orthodontic Tooth Movement

The purpose of this study is to test whether the two MMPs can be up-regulated during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different periods of time in volunteers.

Long treatment time is a major factor causing high fees for orthodontic treatment. Patients would have dental caries or periodontitis resulting from improper oral hygiene care during this long treatment period. How to speed up the tooth movement which determines the duration of orthodontic treatment, can help more people to obtain good occlusion and esthetics. Orthodontic force on a tooth induces bone resorption on the compression side and bone deposition on the tension side, thus the bone remodels and then the tooth moves. Therefore, bone resorption is the rate-limiting step of a lengthy orthodontic treatment.

Bone resorption is a complex process. The mineral component is dissolved by acid from osteoclasts. On the other hand, the organic components are digested with proteolytic enzymes secreted from osteoblasts and osteoclasts. We focus on our study on specific proteases which can digest extracellular matrix, called matrix metalloproteinases (MMPs). Osteoblast-derived MMPs play an important role during initiation of bone resorption. However, the mechanism of its regulation is not clear. The past studies applied stretching or tension on single layer of cultured cells to characterize cellular response to the mechanical stimulation. Now we simulate part of the bone resorption process by cultivating osteocyte-like cells in three-dimensional collagen gel under periodical compression.

In a preliminary study, we focus on transcriptional changes of MMPs upon compression in an osteosarcoma cell line MG-63. Initial data form microarray indicated specific increase of two MMPs expression after one day of compression. This increased expression was specific because the levels of house-keeping genes (ex. Beta-actin or GAPDH) and bone-specific markers were unaltered. Therefore, we proposed that increased MMP expression of osteoblasts under compression is the first step for bone remodeling switching from synthesis to degradation of osteoid. In order to test this hypothesis, the following specific aims will be achieved:

1. To test whether these two MMPs can be up-regulated during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different periods of time in volunteers. In situ hybridization and immunohistochemistry analysis for MMPs will reveal their roles in this physiological process.
2. To optimize the regulation by changing the magnitude and frequency of the pressure, and characterize the time table for these changes.

Eligibility Criteria:
Inclusion Criteria:

* Two mandibular third molars containing at least one mesially angular impaction with crown exposed to oral cavity

Exclusion Criteria:

* Pregnancy