cyrilzakka/clinical-trials huggingface dataset:
Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease

The purpose of this study is to determine whether pamidronate is effective and well-tolerated in the treatment of painful degenerative disk disease, also known as Modic type 1 changes

Erosive degenerative disk disease, also known as Modic type 1 changes, is usually characterized by low back pain, with an inflammatory pain pattern, as seen in spondylarthropathies. Intravenous pamidronate has proven effective in patients with ankylosing spondylitis, and in painful bone diseases in general. We therefore hypothesized that pamidronate would be effective in treating back pain associated with Modic type 1 changes.

This study aimed to determine pamidronate's efficiency in reducing pain, with the primary outcome being a between-group difference of 30 points on a 100mm VAS at 3 months. Secondary outcomes are the improvement in functional status and the drug's tolerance. Primary and secondary outcome criteria will be assessed at each visit (inclusion, at 6 weeks, 3 months, and 6 months). If the primary goal is not attained, a rigid or semi-rigid back brace will be proposed to the patient, regardless of the treatment group.

In total, 48 patients will need to be recruited. These patients will be randomly assigned to one of the two groups, with each group comprising 24 patients: one group will be given pamidronate and the other placebo. Pamidronate will be administered at a dose of 90mg per day, 2 days in a row, and every patient, regardless of the treatment group, will be given paracetamol, in order to maintain blinding by preventing drug-induced fever.

Eligibility Criteria:
Inclusion Criteria:

* - Age from 18 to 60 years old
* Low back pain
* Daily pain since at least 3 months
* VAS for pain \> 40/100 during the last 48 hours
* Inefficiency, intolerance, or contraindication to NSAIDS
* Inefficiency of a rigid or half-rigid back brace
* Modic 1 discopathy (diagnosed on MRI and confirmed by trained radiologist)
* Dental check-up within the last 6 months
* Signed informed consent

Exclusion Criteria:

* - Static disorders of the spine
* Contraindication to pamidronate (hypocalcemia, severe kidney failure, or allergy)
* Underage patients, patients under the protection of the law
* Previous treatment with bisphosphonates
* Pregnancy
* Local or general infection
* Previous discal surgery
* Systemic corticosteroid therapy in the last month
* Epidural or facet joint corticosteroid injection in the last month
* History of septic spondylodiscitis
* Ankylosing spondylitis
* Low back pain associated with radiculalgia
* Active psychiatric disorder
* Inability to read or understand French
* Body temperature above 38°C (fever) or Erythrocyte Sedimentation Rate above 20mm/hour
Comparison of MIS Anterior Versus MIS Anterolateral Approach

Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS (minimally invasive surgery) anterior approach with the MIS anterolateral approach to the hip.

The surgical approach to the hip is reportedly an important factor influencing implant stability and postsurgical muscle functioning. Reviewing the literature, controversial studies towards minimally invasive hip surgery can be found. Currently, none of the approaches can be considered superior, but the trend is towards minimally invasive techniques, as it is generally accepted that muscle trauma and damage of the periarticular structures should be minimized. However, a surgical approach that causes no damage to surrounding muscle is unrealistic. Whether the muscle is stretched, transacted or partially torn, injury will occur.

Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS anterior approach with the MIS anterolateral approach to the hip. The investigators questioned, which technique would be the less invasive? Pain and functional performance will be measured using the Harris Hip Score, the Western Ontario McMaster, and the UCLA (University of California) Activity Score. Subject quality-of-life will be determined by evaluation the Short-Form 36 Health Survey. Standard radiographs of the hip are required to be captured before surgery and at 3, 6 and 12 months postoperatively. MRI scans will be performed to evaluate tendon defects, fatty atrophy and changes in the muscle cross-sectional area. Next, the patients will be referred for hip sonography, performed by a radiologist who is experienced in imaging of the musculoskeletal system who will be unaware of the clinical examination results of the patients. Moreover gait analyses will be performed preoperatively, 3 and 12 months after surgery. Pre- and postoperative standard blood tests and specific serum trauma markers will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* unilateral, noninflammatory end-stage osteoarthritis of the hip
* willingness and ability to cooperate in the required post-operative therapy
* willingness and ability to provide written informed consent
* age 50-80 years

Exclusion Criteria:

* inflammatory arthropathies
* prior hip surgery
* prior infection of the hip
* severe morbidity
* severe osteoporosis
* inability to tolerate general anesthesia
* no contraindications to MRI e.g. pacemakers, claustrophobia
* neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care
* known alcohol or drug abuse
* unwillingness to participate
Clinical Performance of Posterior Indirect Adhesive Restorations

Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated.

Indirect adhesive restorations are indicated in large Class II defects, replacement of large compromised existing restorations or endodontically treated teeth where cuspal protection is required. The need to perform adhesive restorations of posterior teeth is not only linked to esthetic purposes, but also have possibility of strengthening the remaining tooth structure. Indirect technique decreases polymerization shrinkage, reduces microleakage and also improves the marginal seal when comparing direct resin composites. Furthermore, it provides improved physical and mechanical properties, ideal occlusal morphology, more precise control of proximal contours and contacts. Indirect adhesive restorations are classically delivered with an adhesive procedure including dual-cure cement. Updated approaches now include the use of composite resins as luting agent.

This study will be carried out as a prospective study, with assessment of the restorations after three years. PASS 11 Software was used to calculate the sample size. At least 77 indirect adhesive restorations will be included for this study. Patients referred to Istanbul Okan University Faculty of Dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study. 83 indirect adhesive restorations in at least 60 patients will be included. The patients who will not meet all the inclusion criteria will be excluded from the study. A signed informed consent form will be obtained from all patients before beginning the study.

Restorations will be evaluated clinically according to FDI World Dental Federation criteria. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5. Statistical analysis will be performed using R (v.3.5.3) Software and the SIGN.test function in the BSDA package (p \<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Significant loss of dental hard tissue
* Endodontically treated teeth in posterior region
* Replacement of large compromised existing restoration
* Large Class II restoration
* Age of 18-60 years
* Good oral hygiene
* Presence of interproximal contact to at least one neighboring teeth • In occlusion with antagonist teeth
* Cavity preparation with at least one cuspal coverage

Exclusion Criteria:

* Serious medical problems or allergies to substances and/or products to be used
* Severe periodontal problems
* Poor oral hygiene
* Direct pulp capping
* Presence of parafunctional behaviors
* Pregnant or breast feeding
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial

A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.

Purpose: To evaluate the safety and efficacy of THV-9300 (20mm) for patients who have severe symptomatic aortic stenosis attributed to calcification and degeneration of a valve leaflet and for whom undergoing a surgery safely would be difficult.

Enrollment: 15 patients (No.of patients needed: 12)

Follow-up: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 months and annually for 5 years.

Clinical sites:

1)Osaka University Hospital, 2)Kurashiki Central Hospital, 3)Sakakibara Heart Institute, 4) Kokura Memorial Hospital

Eligibility Criteria:
Inclusion Criteria:

* Patients who were judged difficult to safely undergo AVR
* Severe senile degenerative aortic valve stenosis
* NYHA Functional Class II or greater
* Signed Informed Consent

Exclusion Criteria:

* Aortic valve is congenital unicuspid or bicuspid
* Annulus size between \< 16 mm or \> 19 mm
* LVEF \< 20 %
Comparison of the Block Characteristics of USG Guided Costoclavicular and Infraclavicular Block With the Perfusion Index

With this study, it was aimed to compare the block characteristics evaluated with traditional methods in infraclavicular and costoclavicular block applications performed in upper extremity surgery in our clinic with the perfusion index

Peripheral nerve block is to anesthetize the dermatomes belonging to the nerve or nerve group to which the block is applied, by performing sympathetic, sensory and motor blocks. Brachial plexus blockade; It is a peripheral nerve blockage that can be used in surgical operations to be performed on the upper extremity and can be performed at the level of interscalene, supraclavicular, infraclavicular, costoclavicular, axillary and terminal nerves.

The costoclavicular brachial plexus block has been used as an alternative to lateral sagittal infraclavicular block, due to its ease of application, its rapid onset of action and its high success rate. The effectiveness of the block is measured by sensory, motor and sympathetic block effects. The sensory block can be evaluated by cold or pinprick test, and motor block by traditional methods such as the patient's response to verbal commands and can be objective.

Sympathetic block manifests itself with vasodilation and an increase in blood flow rate and can be measured with the more quantitative perfusion index (PI). The perfusion index represents the ratio of pulsatile blood flow to static blood flow in peripheral tissue and can be measured continuously and noninvasively from a pulse oximeter. Successful peripheral nerve blockade; It is seen as local vasodilation, increased local blood flow, some increase in skin temperature and loss of sensation in the extremity due to the blockage of sympathetic fibers. It can be a guide in determining the effectiveness of the block because it is noninvasive and easy, providing rapid evaluation, without requiring patient cooperation to evaluate the success of the block.

Eligibility Criteria:
Inclusion Criteria:

* All costoclavicular and infraclavicular block patients who have undergone hand,forearm and arm surgery
* Patients over the age of 18

Exclusion Criteria:

* Patients who do not want to participate in the study
* Patients whose peripheral block administration is contraindicated
STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS

A phase1 study to evaluate the PK (single dose and multiple doses) and safety of talazoparib 1 mg Once Daily in Chinese adult participants with advanced solid tumors. A maximum of approximately 15 participants will be enrolled such that approximately 12 evaluable participants complete the study.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of locally advanced or metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
* ECOG Performance Status 0 or 1.
* Adequate Bone Marrow, Renal and Liver Function.

Exclusion Criteria:

* Participants with brain metastases.
* Current or anticipated use of P gp inhibitor and/or inducer within 7 days prior to study intervention from lead-in to end of Cycle 1; concomitant use of potent P gp inhibitor after Cycle 1 until the end of treatment.
* Prior treatment with a PARP inhibitor.
Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes Among Socioeconomically Disadvantaged Communities

This study aims to investigate whether a novel artificial intelligence based screening strategy (AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education or AI-BRIDGE), which allows primary care providers to screen patients for vision-threatening diabetic eye disease in the primary care clinic, improves screening and follow-up care rates across race/ethnicity groups and reduces racial/ethnic disparities in screening.

This is a multicenter clinical trial and University of Wisconsin is the coordinating center of the study.

A stepped-wedge cluster randomized clinical trial will be conducted. The investigators will evaluate the effectiveness of two standard diabetic retinopathy screening strategies at primary care clinics; (1) AI-based eye screening program called AI-BRIDGE, eye photos of the patients will be obtained in the primary care clinic by trained clinic staff. Images will be reviewed using autonomous artificial-intelligence (AI) algorithm (Digital Diagnostics). Patients with referrable diabetic retinopathy are detected within minutes and patients with referrable disease will be assisted with scheduling an in-person follow-up eye care visit (2) usual care screening, primary care providers refer patients with diabetes to an eye care provider for an in-person dilated eye exam.

After adapting AI-BRIDGE protocols to clinics and training of clinic personnel, stepped wedge randomized clinical trial begins with sites transitioning from usual-care to AI-BRIDGE in 4 steps.

Primary Objective:

* Compare the proportion of patients, by race and ethnicity, who follow-up with recommended eye care in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.

Secondary Objectives:

* Compare the difference in proportion of White vs Hispanic and White vs Black patients who get screening in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.
* Compare proportion of patients, by race and ethnicity, who receive eye screening in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients include patients older than 21 years
* Diagnosed with type 1 or 2 diabetes
* No known diabetic eye disease
* Medicaid as their primary insurance
* Not had an eye exam in the prior year

Exclusion Criteria:

-
A Pilot Study Swiftsure

The purpose of this study is to investigate the feasibility of using the Swiftsure Complete Care System (CCS) device as an adjunct to standard oral care procedures among intubated adult patients undergoing mechanical ventilation in the intensive care unit (ICU).

This is a small study intended to gather initial feasibility before conducting a larger study. The feasibility of using the Swiftsure CSS device will be studied among 20 patients at a single study site.

This is a prospective, single-center, single-arm, non-blinded trial to assess the feasibility of using the Swiftsure CSS device as an adjunct to the standard oral care among intubated adult patients undergoing mechanical ventilation in the ICU.

The CSS intervention will be performed 1 times per subject. The nurse performing the intervention will be asked to complete the study questionnaires after each device use.

Eligibility Criteria:
Inclusion Criteria:

* Cardio-Vascular Intensive Care Unit (CVICU) patients recovering from surgery and expected to undergo mechanical ventilation for at least 6 hours
* 18 years or older

Exclusion Criteria:

* Unable to consent
* Maxillofacial trauma
* Agitation
* Tested positive for COVID-19 at screening
* Any condition precluding positioning required for device use (e.g. increased intracranial pressure, spine instability, presence of spine drain etc)
* Oropharyngeal injury or infection
* Respiratory infection
* Difficult Airway Grade III or higher
* Intubated with a double lumen tube
* Tracheostomy
* Endotracheal tube cuff air leak, defined as inspiratory-to-expiratory tidal volume difference higher than 10% or audible gurgling at cuff pressure higher than 30 cmH2O
* Poor dental status
* Hemodynamic instability, defined as need for 2 or more vasopressor agents, or use of mechanical hemodynamic support (e.g. intra-aortic balloon pump, Impella heart pump, Left Ventricular Assist Device, venous- arterial extracorporeal membrane oxygenation)
* Respiratory instability, defined as PaO2/FIO2 \< 300 mmHg on PEEP \> 10 cmH2O, or respiratory acidosis with pHa \< 7.30 and respiratory rate \> 20, or use of inhaled pulmonary vasodilators
* Pregnancy or not using anti-conceptional agents in child bearing age
* Patients with difficult intubation
Behavioural Treatment of Hypertension

The objective of the study is to determine whether psychological therapy (self-help or individualized intense stress management) is different than a single drug treatment in terms of their effectiveness for lowering blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* must be at least 19 years of age
* subjects can be male or female
* subjects must have an average resting blood pressure of \>140 systolic pressure an/ or \>90 diastolic pressure off anti-hypertensive medication

Exclusion Criteria:

* must not be on more than 2 blood pressure lowering drugs
* must not have known or suspected of having secondary hypertension on initial examination
* must not be pregnant or anticipating pregnancy during study period
* must not have history of allergy, hypersensitivity or intolerance to diuretics
* must not have medical condition that may result in an unacceptable risk of complications due to uncontrolled hypertension during time period of study
* must not have average resting BP readings that exceed 190 systolic, or 115 diastolic, or have two consecutive readings of 180 systolic or 110 diastolic
Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses

To detect the effect of sildenafil citrate on Doppler parameters in fetuses suffering from growth restriction to support its use later as prolonged therapy in those pregnancies at higher risk for such complication.

Participants were randomized in 1:1 ratio into one of the following drug regime:

Group (I): "sildenafil citrate group" This group consisted of 22 women who received single oral dose of 50 mg sildenafil citrate.

Group (II): "placebo group" This group consisted of 22 women who received single oral dose of placebo. All participants were evaluated by ultrasound once they admitted and again after 2-hours following administration of either of the treatment tablets. One sonographer was allocated to evaluate all mothers included in the study.

Eligibility Criteria:
Inclusion Criteria:

Patients were admitted to the study based on the following inclusion criteria:

1. Any age and any party.
2. Body mass index between 25 and 35.
3. Singleton pregnancy.
4. Gestational age of 24 weeks or more. Gestational age was established on the basis of menstrual dates and confirmed by first or second trimester ultrasound for booked patients, however, if a difference of \> 7 days or \> 10 days during first or second trimester respectively, then ultrasound value was used. For unbooked patients they still have the chance to be included in our study if they can bring a scan that showed gestational age during the same period mentioned before.
5. Idiopathic intrauterine growth restriction.
6. Intrauterine growth restriction due to maternal malnutrition, maternal medical disorder as anemia, pregnancy induced hypertension, or chronic renal disease.
7. Intrauterine growth restriction due to substance abuse (including smoking).
8. With or without past history of intrauterine growth restriction .

Exclusion Criteria:

1. Intrauterine growth restriction due to fetal causes as congenital abnormalities, fetal infection, or multiple gestation.
2. Any drug therapy that can affect fetal growth or fetal blood supply.
3. Maternal diseases that contraindicates the use of sildenafil citrate
ADHERE-LPV Advancing Delivery of High-Quality Evidence-Based Respiratory Efforts in Lung-Protective Ventilation

This study is a cluster randomized trial across 10 hospitals, stratified by hospital size (hospitals with greater than 100 mechanically ventilated patients a year will be classified as large, while those with 100 or fewer will be classified as small). Randomization will occur at the hospital level, ensuring an even distribution of large and small hospitals between study arms. Hospitals assigned to the intervention group will implement an EHR-based strategy designed to enhance adherence to lung-protective ventilation (LPV) for a 9-month intervention period, after which the strategy will be rolled out to all hospitals. The intervention focuses on modifying the ventilator order within the Electronic Health Record (EHR) to encourage default settings aligned with LPV principles. This study design allows for comparison of patient outcomes before and after implementation within each hospital while also enabling simultaneous comparisons between hospitals that have and have not yet received the intervention. The cluster randomization approach is necessary, given the order is controlled at the hospital level.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over
* Requires mechanical ventilation

Exclusion Criteria:

* The patient opted out of research
* The mode ordered does not require a set tidal volume
* Requires ECMO prior to ICU admission
* Data during the use of ECMO
* Hospitalization was for an elective surgery
* The duration of mechanical ventilation was less than 12 hours (these are not the patients that would benefit from LPV)
* Admission code documentation of Do Not Intubate. While rare, in situations where a patient was intubated but whose preferences are contradictory to the current care, mechanical ventilation is managed differently while undergoing goals of care conversations.
* Height was documented as less than 4 feet given the PBW formula was not validated below this height.