cyrilzakka/clinical-trials huggingface dataset:
Dry Needling on Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain

Background: Non-specific shoulder pain has a high prevalence in older adults and provokes functional alterations. Besides, there are difficulties for its clinical diagnosis, lack of effectiveness in the treatment and not much evidence is found regarding invasive physical therapy techniques in this population.

Purpose: To determine the efficacy of a single physical therapy intervention with deep dry needling on latent and active myofascial trigger points in older adults with non-specific shoulder pain.

Methods: Pilot Study, Single Blind Randomized Controlled Clinical Trial on 60 subjects aged 65 and over, will be diagnosed with nonspecific shoulder pain. The study will be approved by the Clinical Research Ethics Committee of the area. Sample will be recruited at their home and at a care center, and randomly will be distributed in Experimental Group (n=30), which will be received a session of Deep Dry Needling on an active and a latent Myofascial Trigger Points of the infraspinatus muscle; and Control Group (n=30), receiving a session of Deep Dry Needling only on an active Myofascial Trigger Point. A blind examiner will be evaluated Pain Intensity, Pain Pressure Threshold (anterior deltoid; extensor carpi radialis brevis) and Grip Strength, before, immediately after intervention and after a week of treatment.


Eligibility Criteria:
Inclusion Criteria:

* people aged 65 or over with uni or bilateral non-specific shoulder pain and with at least one active and one latent MTrP in the infraspinatus homolateral to the painful shoulder

Exclusion Criteria:

* prior diagnosis of myopathy or neuropathy; cognitive deficit in the medical record; cervical spine, rotator cuff tendons or glenohumeral joint problems in the medical record; corticoid infiltration or local anaesthetic during the previous year or during follow-up; surgical procedure affecting the upper limb or preceding cervical; ingestion of antiaggregant, anti-coagulant, analgesic or anti-inflammatory medication or abusive substances in the week prior to treatment and during follow-up were excluded from the study
Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers

Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a device which by themselves are effective for the treatment of wounds.

You are being asked to take part in this study because you have a wound on your body which has not responded to standard treatments.

The researchers will be studying whether the combination of two treatments will make wounds heal faster. For those in study, the investigators will treat them with a vacuum device on their wound. Also, some of the people in the study will receive a special ointment and researchers will use special tests to determine if the two treatments together are working better than just one treatment alone.

Evaluate the effectiveness of Collagenase Santyl ointment when used in conjunction with NPWT for the treatment of chronic pressure ulcers and determine whether the addition of Collagenase Santyl ointment has a positive effect on wound healing. Through volumetric changes and histological evaluation, we wish to test the hypothesis that the application of Collagenase Santyl ointment in conjunction with NPWT facilitates improved wound healing and mitigates some potentially harmful effects of NPWT alone (e.g. pain with dressing removal and tissue ingrowth

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 year-old competent adults in inpatient setting (no prisoners, mentally ill, or children)
* Pressure ulcers to pelvis/abdomen/trunk and or upper extremities which have been refractory to prior treatment interventions and contain less than or equal to 25% necrotic tissue in wound bed (as percentage of total surface area)

Exclusion Criteria:

* Lower extremity/foot wounds related to arterial insufficiency, incarcerated individuals, patients with untreated osteomyelitis, uncorrected coagulopathy, malignancy, sensitivity to collagenase, wounds with evidence of clinical infection (via swab culture or punch biopsy)
XACT ACE Observational Registry

Compile real world data on the use of the XACT ACE Robotic System

The purpose of this observational post-market study is to compile real world data on the use of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures.

The objectives are to 1) evaluate the proportion of procedures in which the instrument reached the pre-defined target, based on the physician's determination and CT imaging confirmation, 2) To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the at the end of the instrument insertion, and 3) Incidence of intra- and post-procedural adverse events.

Up to 500 patients will be enrolled in this multicenter, nonrandomized, single arm registry.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite
3. Subject is willing to sign informed consent for the purposes of data collection

Exclusion Criteria:

1. No exclusion criteria other than listed in the product Instructions for Use (IFU)
Complicated Rhinosinusitis

Rhinosinusitis is among the most common conditions encountered in the primary care clinic.

serious sequelae of ARS, including orbital and intracranial complications as Like Periorbital oedema and Displaced globe and Double vision and Ophthalmoplegia Reduced visual acuity

Eligibility Criteria:
Inclusion Criteria:

* Patients with orbital complications of rhinosinusitis

Exclusion Criteria:

* 1- Previous maxillofacial trauma history. 2- Previous nasal or paranasal surgery. 3- Invasive fungal rhinosinusitis. 4- Cases with odontogenic rhinosinusitis. 5- Immotile cilia syndrome, cystic fibrosis
Assessment of Osseointegration Properties of Nano-Hydroxy Apatite Coated Titanium Implant

the purpose of this trial is to evaluate the osseointegration properties of nano-hydroxy apatite coated titanium implants in posterior maxilla. 30 patients will be included in this trial divided into two groups, control and intervention. Primary and secondary implant stability will be measured


Eligibility Criteria:
Inclusion Criteria:

1. Patients with missing at least one maxillary posterior tooth
2. Patients free from any systemic disease
3. Patients who approve to be included in the trial and sign the informed consent
4. Patients with no intra-bony defect.
5. Adults aged 18 years old and above

Exclusion Criteria:

1. Patients who are allergic to titanium
2. Heavy smoker patient
3. Patients receiving chemotherapy or radiotherapy
4. Patients who refused to be included in the trial
Central Corneal Thickness With SENSIMED Triggerfish

Investigation of the occurrence of possible corneal swelling after continuous Intraocular pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.


Eligibility Criteria:
Inclusion Criteria:

* glaucoma and ocular hypertension scheduled for overnight hospitalisation
* stable IOP-lowering treatment since at least 4 weeks before study
* at least 18 years
* having provided informed consent

Exclusion Criteria:

* contact lens wear within the last 2 years
* contraindication for silicone lean wear
* corneal abnormality in either eye
* ocular infection or inflammation
* history of ocular surgery within the last 3 months
* full-frame metal glasses during IOP monitoring with SENSIMED Triggerfish
* pregnancy and lactation
* patients not able to understand the nature of the research
* patients under tutelage
* patients committed to an institution by virtue of an order issued either by the courts or by an authority
* simultaneous participation in other clinical research
Effects of Fish Oil and Colesevelam (STAIR7007)

If treatment of colesevelam, fish oil in conjunction with ezetimibe, will lead to further reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that treatments with fish oil, colesevelam and ezetimibe will maximize decrease in plasma concentrations of sitosterol and other plant sterols in sitosterolemia patients.

Ezitimibe significantly lowers plant sterol levels in the blood of patients with sitosterolemia. However, plant sterol levels remain substantially elevated compared to those in healthy individuals. Thus, combination therapy needs to be considered. Agents that provide cardiovascular benefits such as colesevelam, a second-generation bile acid sequestrant, and fish oil are potential candidates to help further reduce sterol levels, but have yet to be evaluated in sitosterolemia patients.

The purpose of this study is to dtermine the effects of colesevelam, fish oil and combination therapy (fish oil + colesevelam) on plant sterols, cholesterol and cardiovascular risk factors in sitosterolemia patients treated with ezetimibe. The results of this study will enhance knowledge on the pathogenesis of sitosterolemia and the mechanisim of actions of colesevelam and fish oil as adjunct therapies to ezitimibe in patients with the disease.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of homozygous sitosterolemia as established by genotyping and/or clinical parameters
2. Receiving ezetimibe treatment
3. Over 8 years of age (no maximum)
4. Concomitant illnesses or conditions

Exclusion Criteria:

1. Pregnancy
2. Intellectual disability
3. Bowel or biliary obstruction
4. Known hypersensitivity to colesevelam or any ingredients of colesevelam
RIC (Remote Ischemic Conditioning) in Older Individuals

The purpose of this study is to examine the feasibility and acceptability of a technique called remote ischemic conditioning (RIC) that aims to improve muscle strength, muscle mass, exercise tolerance, resilience (i.e. how well someone responds to a stressor), quality of life, physical activity, and physical function when added to rehabilitative exercise training in individuals over age 65 who have some difficulty with mobility.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk

Exclusion Criteria:

* Unstable heart disease as determined by the investigator or study physician
* History of any orthopaedic, neurologic, or metabolic condition that would contraindicate exercise testing/training as determined by the investigator
* Cognitive inability to follow directions and safely participate in exercise
EASiVENT Study Comparing INTELLiVENT-ASV vs Non Automated Ventilation in Adult ICU Patients

The purpose of the study is to assess the safety and efficacy of INTELLiVENT-ASV (Adaptive Support Ventilation) in adult ICU patients comparing to non automated ventilation.

EASiVENT is a prospective, multicenter, randomized (1:1), Controlled Study. This study is single-blind because only the subject will be unaware of the ventilation modality administered. The reference treatment used for comparison is a combination of controlled modes for passive subjects (volume control or pressure control) and assisted/spontaneous modes for active subjects (synchronized intermittent mechanical ventilation or pressure support)

Eligibility Criteria:
Inclusion Criteria:

* Weight greater than 40 kg
* Under invasive ventilation
* Expected to be mechanically ventilated after enrollment for at least 24 hours
* Agrees to not participate in other interventional research studies involving mechanical ventilation for the duration of study
* Signature of the informed consent by the patient or his/her next-of-kin according to country or state regulation.

Exclusion Criteria:

* Fulfilling weaning criteria according to the weaning procedure of the ICU
* Need for "rescue therapy" (e.g: ECMO)
* Brain death status
* Respiratory drive disorder (Cheyne-Stokes breathing)
* Arterial hypoxia due to a non-pulmonary condition (right-to-left shunting due to congenital disease, hepato-pulmonary syndrome, )
* Broncho-pleural fistula
* Chronic or acute dyshemoglobinemia: eg.: acute CO poisoning
* Chronic respiratory failure requiring long term invasive ventilation;
* Moribund patient
* Patient under guardianship, deprived of liberties
* Any other condition, that in the opinion of the IoR/designee, would preclude informed consent (by the spouse/next of kin), make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
* Low quality index on the SpO2 (Oxygen Saturation Measured by Pulse Oximetry) measurement
* Patients already enrolled in the present study in a previous episode of acute respiratory failure
* High PaCO2 - ETCO2 gap (\> 2.6 kPa or 19.5 mmHg) for \> 3 hours
* Patient tracheostomized at the time of inclusion
* Patient ventilated with helium
Busulfan Concentration in Saliva and Plasma, and Its Relationship With Salivary Changes and Mucositis in the Digestive Tract of Patients Submitted to Hematopoietic Stem Cell Transplantation

Busulfan (Bu) has been widely used for the treatment of neoplastic and non-neoplastic hematological disturbances, with satisfactory results in terms of successful hematopoietic stem cell transplantation (HSCT). Individual monitoring of the Bu dosage, which is done by means of various blood sample collections, is necessary for the purpose of attaining ideal therapeutic levels and minimizing systemic toxicity. This procedure sometimes becomes costly to and uncomfortable for the patient. Saliva has been analyzed as a possible alternative fluid for this monitoring.

The first objective of this project is to verify the feasibility of using the analysis of salivary concentration of BU during individual adjustments of this drug in the period that precedes HSCT. Another question related to this project is with reference to the effects that the Bu concentration in saliva has on the mucosa of the digestive tract, particularly with regard to mucositis and salivary changes. Thus, the second objective of this project is to verify whether there is any association between salivary changes, cytological changes in the oral mucosa, degrees of mucositis and concentration of Bu in saliva. An analysis will be performed of the Bu concentration in saliva and in blood, as well as the salivary dosage of total proteins, albumin, amylase, antioxidant enzymes (superoxide dismutase, catalase, and glutathione reductase) and pro-inflammatory cytokines IL-1β, IL-6 and TNF-α. In addition, morphological analysis will be made, and rate of apoptosis of cells of the oral mucosa will be analyzed. If the efficacy of saliva for the individual adjustment of the dose of Bu is confirmed, this method could facilitate the dissemination of pharmacokinetic monitoring of this drug in chemotherapy and HSCT centers. In addition, it is expected that the results of the present project will allow establishment of the toxicity indicators of BU detected by analysis of saliva and the cells of the oral mucosa, thereby allowing the early adoption of preventive actions for reducing the frequency and severity of mucositis, a fact that may have a positive impact on the success of HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Submitted a TCTH

Exclusion Criteria:

* No signed informed consent
Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "

By this project, the investigators are going to try to demonstrate that to use objects connected to make a physical activity can have an impact on the clinical activity of the disease by bringing the subjects which present a spondyloarthritis to make a physical activity. The investigators shall show furthermore, than the use of connected objects also has better chances to glue the patients presenting a spondyloarthritis to a practice of regular physical activity that a simple recommendation.

This project is aimed at subjects with Axial Spondyloarthritis and / or peripheral of the Alpes Maritimes and more specifically of the city of Nice and its surroundings. The subjects will be recruited by the hospital doctors (consultations, hospitalization). Patients will benefit from an inclusion visit in order to explain the protocol, sign the study consent and eliminate a possible contraindication to physical activity. Knowing that this is a physical activity adapted to the health of people and their physical abilities.

Eligibility Criteria:
Inclusion Criteria:

* Presenting a spondyloarthritis according to the criteria of the ASAS (l'Assessment of SpondyloArthritis international Society)
* Benefiting from a stable treatment by biotherapies for at least 3 months

Exclusion Criteria:

* Patient presenting a cardiac pathology should be decompensating
* Patients having a contraindication in the physical activity
* Lung affection making impossible the effort
* Patient already realizing a physical activity supervised in club or with sports coach
UVB Light and Sunscreen

Patients need vitamin D which is normally produced in the skin in response to ultraviolet light from the sun. Vitamin D is important for calcium absorption and good bone health. Physicians have been using sunscreens to protect patients from skin cancer and the aging effects of sunlight for a least a half a century. Dermatologists have promoted sunscreen use to restrict sunlight exposure especially in white Caucasians. If this behavior is done 100% of the time when outdoors individuals may suffer from vitamin D deficiency. It is impossible to influence persons' behavior to wear sunscreens all the time when outdoors. With the use of sunless tanning agent (DHA), once a week, we can obtain a continuous sunscreen in the top layer of the skin that will not wash off, can't be removed with soap and water, or removed by perspiration. Under these circumstances we can answer the scientific question, will sunscreen use inhibit the production of vitamin D in the skin?


Eligibility Criteria:
Inclusion Criteria:

* males or females
* ages 19-50 with less than 16 oz milk per day
* less than 10 hours of sun per week
* no Vitamin D supplements
* no anticonvulsants
* no barbiturates
* no steroids
* no meds that increase photosensitivity
* no granulomatous disease
* no liver or kidney disease
* no history of skin cancer
* BMI less than 30
* skin types I \& II

Exclusion Criteria:

* None
Evaluating the Safety and Efficacy of 177Lu-LNC1011 Injection in a Single-Center, Single-Arm, Open Study in Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Desmoplasia-Resistant Prostate Cancer

Evaluating the safety and antitumor efficacy of 177Lu-LNC1011

This is a prospective, single-center, single-arm, open IIT clinical study evaluating the safety and anti-tumor efficacy of 177Lu-LNC1011 Injection in patients with PSMA-positive metastatic desmoplasia-resistant prostate cancer (mCRPC). Thirteen patients are expected to be enrolled. Subjects will be required to sign an informed consent form prior to screening, and successful screened subjects will be treated with 177Lu-LNC1011 Injection as 75 mCi (2.78 GBq) intravenously every 6 weeks for a total of no more than 6 doses during the treatment period. Subjects will be monitored for safety and anti-tumor efficacy after dosing during the treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old, male.
2. histologically or cytologically defined prostate cancer, the patients have not been treated or have exhausted all treatment.
3. meet the Prostate Cancer Working Group 3 (PCWG3) diagnosis of metastatic desmoplasia-resistant prostate cancer (mCRPC), including: a) the presence of a desmoplasia level of serum testosterone (serum testosterone \<50 ng/dL or 1.7 nmol/L); b) and the presence of one of the following: - serum PSA progression: PSA \>1 ng/mL and 2 consecutive rises in PSA 1 week apart, 2 greater than 50% of the nadir; or a bone scan suggestive of ≥2 new bone lesions; or CT or MRI suggestive of progression of soft tissue lesions (RECIST 1.1).
4. a physical status score of ≤2 according to Eastern Cooperative Oncology Group (ECOG) criteria.
5. PSMA positivity confirmed by 68Ga -PSMA PET/CT.

Exclusion Criteria:

Patients who did not meet the requirements as assessed by the investigator.
Computerized Decision Support System for Antibiotic Treatment

We developed a computerized decision support system for prescription of antibiotics to inpatients. The purpose of the study is to assess the performance of the system in different wards, in three different hospitals, in three countries.

Antibiotic treatment for suspected moderate to severe bacterial infections is usually initiated empirically, prior to identification of the causative pathogen. Appropriate treatment, that is matching in-vitro susceptibilities of subsequently isolated pathogens, reduces the overall fatality rate of severe infections with adjusted odds ratios varying between 1.6 and 6.9. In the same studies, 20-50% of patients were given inappropriate empirical antibiotic treatment.

We developed a computerized decision support system (TREAT) based on a causal probabilistic network to improve antibiotic treatment of inpatients. The aims of the system were to improve the rate of appropriate antibiotic treatment, thereby reducing mortality, and to route antibiotic use towards ecologically economical antibiotics as determined by local resistance profiles. The system can be calibrated to different locations.

The TREAT system was tested in a multi-center observational cohort study. The study proved the system safe and effective. TREAT prescribed appropriate antibiotic treatment to 70% of patients, 58% of whom were treated appropriately by physicians. TREAT used a narrow antibiotic formulary and at lower costs, mainly lowering costs assigned by the model to future resistance. The system performed well in three different countries (Israel, Italy and Germany).

We then proceeded to assess the effect of TREAT on the management of inpatients in these sites in a cluster randomized controlled trial. We used wards as the unit of randomization to avoid contamination through education of users by the system, and to benefit from the interaction of TREAT with the ward as a whole.

Comparison: the TREAT system was installed in intervention wards and its use was offered to physicians at the time of empirical antibiotic treatment. Physicians were asked to inspect TREAT's result interface. The final choice of antibiotic treatment was theirs. Control wards had no access to the system. We assessed outcomes in intervention vs. control wards with regard to patient outcomes, appropriateness of antibiotic treatment and antibiotic costs.

Eligibility Criteria:
Inclusion Criteria:

* Patients from whom blood cultures were drawn.
* Patients prescribed antibiotics (not for prophylaxis).
* Patients fulfilling sepsis diagnostic criteria.
* Patients with a focus of infection.
* Patients with shock compatible with septic shock.
* Patients with febrile neutropenia

Exclusion Criteria:

* HIV positive patients with a current (suspected or identified) opportunistic disease and/or AIDS defining illness currently or within the past six months
* Organ or bone marrow transplant recipients
* Children \<18 years; suspected travel infections or tuberculosis
* Pregnant women
* Re-entries