cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Radial ESWT on Upper Trapezius Mtrps

This study looked after the effectiveness of radial ESWT on upper trapezius mtrps. There were three intervention groups which recieved either ESWT or standard care. VAS, PPT, Neck ROM and Cervical functionality were the main outcomes.

This study was a randomized controlled trial consisted of three intervention groups. Two of them recieved ESWT with different parameters in each group, while the third one was standard care recieving Ultrasound therapy, Therapeutic massage and Heat packs Participants were divided randomly into the three groups. Participants were blind to the group allocated and also the therapist and outcome investigator were blind.

The participants recieved three weekly sessions. The evaluation took place before therapy, after each session and one month after last session.

The outcome measures was the pain intensity with VAS, the pain tolerance to pressure by an algometer device, the range of motion of neck measured by electronic goniometer and and functionality of neck measured by the Northwick Park Neck Pain

Eligibility Criteria:
Inclusion Criteria:

* Pain between shoulder and neck on upper trapezius muscle
* Three out of five of Travel and Simons criteria for myofascial trigger points

Exclusion Criteria:

* Fibromyalgia diagnosis
* Systemic diseases diagnosis,
* Pacemaker, under 18,
* Any kind of cervical disorder or surgery,
* Mental disorders
Effects of a Nutraceutic Compound on Cognitive Impairment

The study is designed to evaluate the effects of choline bitartrate on cognitive impairment in frailty patients.

The study will analyze the impact of 4 weeks treatment randomized with a nutraceutical compound in a double-blind randomized placebo controlled trial. The investigators will also assess cognitive frailty.

The patients and controls will be recruited at the Hypertension research center of Federico II university hospital.

The overall duration of the study will be 4 weeks for each participant. Blood pressure, heart rate and cognitive frailty and cognitive impairment will be evaluated for each patient at randomization and after 4 weeks of treatment.

Patients or controls will be randomized to receive the nutraceutical compound (1 vial of CEREBRAIN per os with 1200 mg of choline bitartrate every 24 hours) or placebo (1 vial per os without active substance every 24 hours). Before the start of treatment, patients will undergo full examination of cognitive functions (MoCA and MMSE tests, the parameters will be reported in a password-protected database, using a identification code. The duration of the treatment will be 4 weeks. At the end of the treatment, the patients will repeat the tests and the results will be identified through the use of an alphanumeric code (POST-XXXYYY).

All CEREBRAIN and placebo, made up of the CEREBRAIN vehicle without the active substance, will be offered free of charge by the Farmaceutici DAMOR company.

Eligibility Criteria:
Inclusion Criteria:

* Mild cognitive impairment

Exclusion Criteria:

Ictus Atrial fibrillation Kidney diseases Cancer
Long Term Follow-up Study of Type-1 Gaucher Subjects Post FLT201 Dose (GALILEO-2)

This is a multicenter, long-term, follow-up trial of participants with Gaucher disease type 1 who received FLT201 treatment in a preceding clinical trial. Participants will be followed for 5 years post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. Participants who have previously received FLT201 (including those who may have required recommencement or initiation of ERT/substrate reduction therapy \[SRT\]).
* 2. Participants able to give full informed consent and able to comply with all requirements of the trial.

Exclusion Criteria:

* n/a
Effects of Wearable Technology and Smart Phone Applications Based Exercise Training in Patients With Type 2 Diabetes

The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.

The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.

Inclusion Criteria:

* Age 18-65
* No other chronic condition
* No exercise training background Block Randomization according to age and sex.

Confirmatory Outcome

- Glycated Hemoglobin (HbA1c)

Explanatory outcomes

* Flexibility
* Level of Physical Activity - IPaQ (METS) and accelerometer
* Hamstring / Quad strength - isokinetic
* Grip strength
* Respiratory function test - F1, FVC, F25, F75, F100
* 6MWT
* Balance - static, dynamic, proprioception, sit-to-stand balance
* Body Muscle Percentage - bioelectrical impedance analysis

Eligibility Criteria:
Inclusion Criteria:

Age 18-65 No other chronic condition No exercise training background

Exclusion Criteria:

* Exclusion criteria are a set of predefined condition that is used to identify subjects who will not be included or who will have to withdraw from a research study after being included.
A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM

This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.

This is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly MET097 dosing regimens vs. placebo for body weight loss in adults (18-75 years of age) with obesity or overweight (body mass index \[BMI\] ≥27 to ≤50 kg/m2) and T2DM . After completing 28 weeks of study treatment, all participants will be followed for approximately 4 weeks after administration of the last dose of study treatment.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening
* Type 2 diabetes mellitus (\*T2DM) for at least 3 months before screening
* Glycated hemoglobin (HbA1c) value between ≥7.0% (53.0 mmol/mol) and ≤10.5% (91.3 mmol/mol) at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1 (diet and exercise alone or in combination with metformin monotherapy and/or SGLT-2)
* Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening

Exclusion Criteria:

* Female who is lactating or who is pregnant
* Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2
* Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL)
* Poorly controlled hypertension
* History of stroke
* Significant cardiovascular disease including but not limited to unstable angina or valvular heart disease or has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary artery re-vascularization, or congestive heart failure
* Diagnosis of Type 1 diabetes
* History of acute or chronic pancreatitis
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Diagnosis of Type 1 diabetes
* Relevant surgical history including all bariatric or weight loss surgeries
Predicting the Efficacy of Resistance Exercise Training for Improving Endurance Performance

The overall objective of the study is to identify molecular determinants of the efficacy of resistance training for improving endruance performance in elite cyclists

For elite endurance athletes, the addition of resistance training to habitual endurance training routines generally leads to improved endurance performance. However, this is not always the case, with several individuals failing to respond in the expected manner. This inter-individual variation is likely associated with inherent cellular and molecular charateristics of skeletal muscle. Indeed, responses to resistance training seem to be associated with muscle biological characteristics such as muscle fiber composition and ribosomal content (during the early phase of resistance training).

The study will investigate the association between muscle fibre composition (type I vs type II muscle fiber proportions) / ribosomal content in m. vastus lateralis and the effects of 10 weeks of resistance training on endurance performance in 52 elite cyclists. Half the participants will perform resistance training in addition to their habitual endurance training routines, the other half will perform endurance training-only. Muscle biopsies will be sampled from m. vastus lateralis before and after the first two weeks of the intervention. For muscle fiber composition, the hypothesis is that larger proportions of type II fibers will be associated with more pronounced benefits of resistance training. For ribosomal content, the hypothesis is that higher rRNA content at baseline and larger increases in rRNA content during the initial part of the intervention will be associated with more pronounced benefits of resistance training. No changes are expected in the non-resistance training control group.

Eligibility Criteria:
Inclusion criteria:

* VO2max \> 65 ml/kg/min (male participants)
* VO2max \> 50 ml/kg/min (female participants)
* \>7 hours of endurance training per week for the 6 months leading up to the study

Exclusion criteria:

- having conducted regular resistance training for the last 6 months leading up to the study
A Performance and Bioavailability Study of Entrectinib in Healthy Volunteers.

This study will evaluate the bioavailability, palatability, safety and tolerability of entrectinib in healthy volunteers. Part 1 of the study will explore the performance of entrectinib multi-particle formulation. Part 2 will evaluate the effect of drug substance particle size on entrectinib bioavailability.


Eligibility Criteria:
Inclusion Criteria:

* A body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m2), inclusive, and weighing \>/=50 kg.
* Agreement to comply with measures to prevent pregnancy and restrictions on egg and sperm donation

Exclusion Criteria:

* Women of childbearing potential, women who are pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of entrectinib or have a pregnant partner
* A clinical significant medical history of gastrointestinal surgery (e.g., gastric bypass) or other gastrointestinal disorder (e.g., malabsorption syndrome) that might affect absorption of medicines from the gastrointestinal tract
* Presence of a clinically significant disease, illness, medical condition or disorder, or any other medical history determined by the investigator to be clinically significant and relevant
* Clinically significant change in health status, or any major illness, or clinically significant acute infection or febrile illness
* Use of moderate or potent inhibitors or inducers of CYP P450 3A4 enzyme or P-gp transporter, or use of other prohibited medications
* Participation in any other clinical study involving an investigational medicinal product (IMP) or device
* A positive test result for hepatitis B, hepatitis C (HCV), or human immunodeficiency virus (HIV)
* Current smokers and those who have smoked, or users of e-cigarettes and nicotine replacement products within the last 12 months
* Known history of clinically significant hypersensitivity, or severe allergic reaction, to entrectinib or related compounds
Same-Day Combination of VI Peel and Botox for Correction of Sun Damage, Fine Lines and Wrinkles

This study is being conducted to improve standards of care in the cosmetic treatment of sun damage, fine lines, and wrinkles. VI Peels® and Botox® have been used cosmetically to improve patient concerns as monotherapies. This study seeks to confirm that the same-day combination creates no additional side-effects and furthermore that patient satisfaction is heightened as a result.

This study seeks to utilize the mechanisms of action of both products to simultaneously address fine lines and wrinkles. VI Peels contain a synergistic blend of acids that produce keratolytic and kerato-coagulation qualities focused on desquamation and cellular renewal. The VI Peel blend contains Trichloroacetic Acid, Phenol, Salicylic Acid, Retinoic Acid and Ascorbic Acid. Botox containing Botulinum toxin type A is a purified substance, derived from a bacterium that block muscular nerve signals temporarily preventing the muscular contraction and subsequent wrinkle formation.

The expected benefit of this investigational combination include improvements to Standards of Care in relation to treatment of the cosmetic patient by establishing safety of the combination treatment, improving patient outcomes by simultaneously addressing sun damage, fine lines, and wrinkles through dual mechanisms, and overall improvement to patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Female and Males subjects of any race
2. Ages 30-70 Years old
3. Subjects who can read, understand, and sign the Informed Consent Form.
4. Subjects willing and able to comply with all study requirements, including return visits and photographs (eyes censored or uncensored).

Exclusion Criteria:

1. Is pregnant or lactating
2. Has an active infection on their face (excluding acne)
3. Has used Isotretinoin (Accutane) within the last six months
4. Has had chemotherapy or radiation treatments within the last six months
5. Has a history of neuromuscular disorders
6. Has a history of bleeding disorders
7. Has an allergy to albumin
8. Has an allergy to Aspirin
9. Has an allergy to Phenol
10. Has received the following treatments in the last 6 months:

    botulinum toxin, soft tissue filler, medium to deep chemical peel, ablative laser, radio frequency treatment, ultrasound device treatment, non-ablative laser treatment
11. Is planning on receiving in the next 1months: soft tissue filler, medium to deep chemical peel, ablative laser, radio frequency treatment, ultrasound device treatment, nonablative laser treatment
12. Is unable to understand the protocol or to give informed consent
13. Not willing to comply with all study requirements including return visits and photographs (eyes censored or uncensored)
14. Has been diagnosed or is displaying COVID-19 symptoms -
Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth

Polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). To minimize the effects of polymerization shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. This clinical trial is designed to evaluate the performance of the new bulk fill composite resin in Class II (two-surface posterior) fillings.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age and older
* Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
* Be capable of giving written informed consent.

Exclusion Criteria:

* Have a self-reported history of any adverse reaction to materials of the types to be evaluated
* Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.
Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer

Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.

An open label, multi-center, single-arm, phase II study according to Fleming´s one-stage design. The surgical procedure on Day 0 will be performed according to AGO State of the Art, followed by one intraoperative and four postoperative intraperitoneal administrations of catumaxomab within 16 days. The Discharge Visit will be performed when the patient is leaving the hospital but not earlier than 1 day after the last infustion, followed by the End of Study Visit on Day 30.

Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells \[DCs\] and natural killer \[NK\] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Eligibility Criteria:
Inclusion Criteria:

* signed and dated informed consent form before any protocol-specific screening procedures
* patients has a primary diagnosis of an epithelial ovarian cancer including clear cell carcinoma (FIGO IA(G2-G3) - IV)
* Karnofsky index \> or equal 70
* female at an age of 18 years or older
* negative pregnancy test

Exclusion Criteria:

* exposure to prior cancer therapy specific for ovarian cancer
* previos treatment with non-humanized mouse or rat monoclonal antibodies
* known / suspected hypersensitivity to catumaxomab or similar antibodies
* second malignangcy within the last 5 years
* presence of constant immunosuppressive therapy
* presence of symptomatic heart failure or occlusive arterial diseases
* inadequate renal or hepatic function
* presence of any acute or chronic systemic infection
The Role of Proprioceptive Deficits and Psychosocial Factors in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study

A large proportion of pregnant women develop pregnancy-related low back and/or pelvic girdle pain (PPGP), which often does not recover spontaneously postpartum. As a result, 10% of women with PPGP still reports complaints a decade after delivery. The prevention and treatment of PPGP are thus crucial. However, the underlying mechanisms of PPGP are still poorly understood. The main objective of this study is to investigate whether lumbar proprioceptive deficits, a disturbed body perception at the lumbar spine and psychosocial factors (incl. pain-related fear of movement, depression, anxiety and stress) are associated with (1) a reduced postural control and (2) the development and/or persistence of PPGP in multiparous women during the first and third trimester of pregnancy, and six weeks and six months postpartum.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Pregnant of second child or more than second child
* No current PPGP or did not have PPGP during current pregnancy
* Willing to provide written informed consent

Exclusion Criteria:

* Pregnant for more than 14 weeks
* Having current PPGP or having had PPGP during the current pregnancy
* History of surgery/major trauma to spine, pelvis and/or lower limbs,
* Specific balance or vestibular disorders
* Spinal deformities
* Rheumatic disease
* Neurological abnormalities (e
* Hyperemesis gravidarum
* Acute ankle problems
* Pre-existing disorders that could interfere with the course of pregnancy (e.g., hypertension, kidney disease, coagulation disorders)
* (A history of) psychiatric disorders
* Non-Dutch speaking
Sustained Effects of Thoracocentesis in Mechanically Ventilated Patients

Collections of fluid around the lung (pleural effusions) are common in patients on mechanical ventilation. Long stays on mechanical ventilation can lead to serious complications such as pneumonia and are associated with significant morbidity and mortality. The drainage of pleural effusions may lead to improvements in oxygenation making it easier to discontinue mechanical ventilation.

The purpose of this study was to examine the effects of thoracocentesis (pleural fluid drainage) on blood oxygenation over a 48 hour period to see whether the effects are sustained and therefore helpful in this discontinuation.

This will be a collection of data in patients in whom it has been decided by the attending clinician that pleural drainage would be beneficial. Ultrasound will be used to confirm the presence of pleural effusion and to estimate the size of the pleural effusions and to confirm the position of the pleural drain. Data will be collected before drainage, 30 minutes after drainage and then at 4,8,12 and 24 hours after the insertion of the drain (please see also attached summary of investigations). Measurements will include arterial blood gas analysis drawn from an indwelling arterial catheter, blood pressure, pulse, respiratory rate, mixed, expired CO2 and ventilator settings. The measurements will stop either at the end of the 48 hour period or when the team caring for the patient chose to remove the drain (whichever is the first).

All measurements including the arterial blood gas analysis form part of the standard care of an ICU patient. The arterial blood gas measurements are withdrawn from an indwelling arterial catheter which is routinely in place on all ICU patients. Only the use of thoracic ultrasound by a trained ultrasonographer both before and after the procedure will be additional to the standard care of the patient. The use of Chest X-rays is at the discretion of the treating clinician and does not form part of the study protocol. Standard biochemical, microbiological and cytological tests will be performed on the pleural fluid and blood in keeping with the standard practice for pleural effusions.

The primary outcome measure is the effects of drainage on the P:F ratio. measures of dead space ventilation, A-a gradiants, ventilator settings and dynamic compliance will also be assessed

Eligibility Criteria:
Inclusion Criteria:

* Patients on mechanical ventilation with evidence of pleural effusions on plain CXR confirmed to be large on bedside ultrasound in whom the attending clinician felt drainage would be beneficial

Exclusion Criteria:

* Coagulopathy