cyrilzakka/clinical-trials huggingface dataset:
Comparison of Post Facilitation Stretch Versus Reciprocal Inhibition in Quadratus Lumborum Syndrome: a Randomized Controlled Trial

This study is a randomised control trial and the purpose of this study is to determine the effects Post facilitation stretch versus reciprocal inhibition on pain, lumbar range of motion, apparent leg length discrepancy and lumbar lordotic angle in Quadratus Lumborum Syndrome.

The purpose of this study is to determine the difference between Post facilitation, stretch versus reciprocal inhibition on pain, lumbar range of motion, apparent leg length discrepancy and lumber lordotic angle in Quadratus Lumborum Syndrome.

The individual of Age 18-35 years among both genders, who experiences pain of 3 ≤ on NPRS from at least 3 months and whose pain decreases on supine lying; along with any two of the following findings positive of quadratus lumborum on physical examination i.e., Taut bands, Local tenderness, Patient's pain recognition, Pain referral to greater trochanter, Local twitch response \& Jump sign will be recruited in the study as patients of Quadratus lumborum syndrome.

Pain levels will be assessed using the Numeric Pain Rating Scale (NPRS). Inclinometer will be used for measuring lumber ranges. To assess apparent leg length discrepancy measuring tape will be used. The lumbar lordotic angle will be measured using 60 cm flexible ruler. Participants of interest would be approached and explained about the research. Informed written consent will be taken. It is a non-blinded study and randomization will be done through sealed envelope. Both groups will receive conventional intervention. Additionally, Group A will receive quadratus lumborum post facilitation stretches while Group B will receive Reciprocal inhibition. Baseline and post intervention scores would be recorded for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* Both genders
* Having pain of ≤ 8 on NPRS from at least 3 months
* Pain decreases on supine lying
* Any two of the following findings positive of unilateral quadratus lumborum on physical examination:

  1. Taut bands
  2. Local tenderness
  3. Patient's pain recognition
  4. Pain referral to greater trochanter
  5. Local twitch response

Exclusion criteria:

* Painful isometric muscle testing of hip flexors, abductors, adductors, and extensors
* Previous surgery of lower limb
* Centralization/peripheralization
* Lower back trauma
* Positive SLR
* Radiculopathy
* Fracture/surgery of pelvic and/or hip region
* Diagnosed fibromyalgia or other rheumatic diseases.
* Lactating women
* Intrauterine device
* Pregnant women
* Use of psychiatric medications
PROMs From GEstIC Heart Failure Patients

Heart failure (HF) is a chronic condition with substantial morbidity, and understanding its effects on patients' quality of life is essential.

Patient-reported outcomes (PROs) are any result of a disease or treatment that comes directly from the patient, without any interpretation from clinicians, using standardized scientifically-validated medical questionnaires, PROMs. Patient-reported outcome measures (PROMs) are the tools used to capture PRO information usually in the form of questionnaires.

The PROMs from GEstIC Heart Failure Patients (PROFIC-HF) study aims to assess the feasibility of digitally recording Patient-Reported Outcome Measures (PROMs) at home in real-world patients enrolled in a multidisciplinary heart failure clinic. Two HF-specific PROMs - Kansas City Questionnaire (KCCQ-12) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) - and a 2 PROMs for anxiety and depression assessment - Patient Health Questionnaire -2 (PHQ-2) and The Hospital Anxiety and Depression Scale (HADS) will be collected remotely using a digital platform that can be accessed online using a smartphone or a computer.

This study will also evaluate the correlation between quality of life changes (measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12) versus Minnesota Living with Heart Failure Questionnaire) and changes in clinical reported outcomes: assess the quality of life of real world HFpatients followed in a multidisciplinary heart failure clinic and quantify the impact of hospitalization events on patients' quality of life.

PROFIC-HF will randomize 75 participants to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and 75 to complete the Minnesota Living with Heart Failure Questionnaire (MLHFQ).

The trial will pilot the use of the digital PROMs system, collected from the consultation waiting room and/or with the patient at home.

PROMs will be based on the HF Standard Set created by the International Consortium of Health Outcomes Measurements (ICHOM), adapted to the patient follow-up program already in use by GEstIC.

Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent (IC) signed before any study- specific procedure,
* Adult patients diagnosed with HF, undergoing treatment at GEstIC,
* Ability and willingness to understand the proposed questionnaires, per physician judgment and
* Ability and willingness to access the platform for completing the data by themselves or with the help of a caregiver (proxy)

Exclusion Criteria:

* Inability to give the answers to the questions in the questionnaires,
* Moderate or severe cognitive impairment that precludes the understanding of the questions, per physician judgment,
* Malignancy or other non-cardiac condition limiting life-expectancy to \< 12 months, per physician judgment or
* Any other condition or therapy that would make the subject unsuitable to this study and would not allow participation for the full planned study period, in the judgment of the investigator.
"The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors"

The objective of this proposed project is to determine which local anesthetic is more efficacious for use in soft tissue tumors: Exparel (liposomal bupivacaine) or a cocktail of Ropivicaine, Epinepherine, Ketolorac and Clonidine. This study will examine patients' post-operative pain levels as well as their narcotic consumption after removal of a soft tissue tumor while hospitalized and then twice daily through postoperative day 14.

In recent years, there has been a substantial push to create a post-surgical protocol consisting of multimodal analgesia across multiple surgical subspecialties to decrease narcotic consumption and cost1. The negative side effects of narcotics and their addiction potential are well understood.

One of the modes of analgesia currently in use to mitigate surgical pain is some form of local anesthetic. Increasing the duration of analgesia has been sought after since its inception. Subsequently, longer acting anesthetics like bupivacaine have been implemented as well as supplementing their use with other drugs, such as epinephrine, to increase their effect duration and overall efficacy2. This has led to the development of Liposomal Bupivicaine or Exparel (TM, Parsippany NJ etc.) Exparel works by infusing liposomes in the administration of the long acting local analgesic which entrap the biologically active drug and slowly release it over a period of 72-96 hours 3-4. Thus, post-operative pain can be managed via direct injection of the drug at the surgical site with upwards to four days of pain relief.

Exparel has been studied extensively in the surgical literature; although within orthopedics, it has been primarily in regard to arthroplasty5. There has yet to be a study to illicit the best form of post-operative pain control in the world of orthopedic oncology, specifically in soft tissue tumors.

The objective of this proposed project is to determine which local anesthetic is more efficacious for use in soft tissue tumors: Exparel (liposomal bupivacaine) or a cocktail of Ropivicaine, Epinepherine, Ketolorac and Clonidine. This study will examine patients' post-operative pain levels as well as their narcotic consumption after removal of a soft tissue tumor while hospitalized and then twice daily through postoperative day 14.

Eligibility Criteria:
Inclusion Criteria:

* All primary soft tissue tumors
* Any adult patient (over 18 years old) with a soft tissue tumor confirmed with advanced imaging.

Two different study groups will be examined:

* Those patients undergoing resection of their soft tissue tumor intraoperatively injected with Exparel
* Those patients undergoing resection of their soft tissue tumor intraoperatively injected with the cocktail.
* Those two groups will be further stratified by anatomic location; Upper vs lower extremity, size; tumors ≥ 10cm, tumors ≥ 5cm, tumors \< 5cm, and depth; superficial vs deep.

Exclusion Criteria:

* Pediatric Patients
* Patients without soft tissue tumors
* Tylenol or oxycodone allergy
Treatment of Posttraumatic Stress Disorder (PTSD) in Adult Survivors of Early Chronic Interpersonal Trauma

Eye movement desensitization and reprocessing (EMDR) and trauma-focused cognitive-behavioural therapy (TF-CBT) have both been found to be effective in treating post-traumatic stress disorder (PTSD) following single-event traumas and to be more effective than pure anxiety management or stabilization treatments. However, much less is known about the efficacy of the different treatment approaches in survivors of repeated or chronic interpersonal trauma. Recent evidence suggests that a combination of stabilization treatment + TF-CBT is efficacious in this population. Although EMDR is also often used in survivors of chronic interpersonal trauma, evidence on its efficacy are still poor. The aim of the current study is to compare the efficacy of (1) stabilization + TF-CBT and (2) stabilization + EMDR using a randomized controlled trial in a routine clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* meeting DSM-IV criteria for PTSD
* having experienced repeated or chronic interpersonal trauma (e.g., sexual or physical abuse)
* at least 18 years of age
* having sufficient fluency in Dutch to complete treatment and research protocol
* participants using prescribed anti-depressant medication are required to be on a stable dose for at least 2 weeks before the beginning of treatment and remain on this dose throughout the treatment.

Exclusion Criteria:

* psychiatric problems that may interfere with the study participation or that require more intensive care than can be offered in the present study, including dementia, psychotic symptoms, depression with suicidal ideation, full-blown borderline personality disorder, substance dependence
* current use of tranquilizers
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers

This study compared the pharmacokinetics, pharmacodynamics and the safety of Pegfilgrastim Hospira and Neulasta® following a single dose of 6 mg of each product administered subcutaneously in Treatment Periods 1 and 2, respectively, in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects, 18-55 years inclusive.
* Written informed consent given
* Willing and able to comply with the requirements of the protocol and be available for the planned duration of the study.
* Body Mass Index (BMI) between 19 and 30 kg/m2 inclusive and weight not \<50 kg or \>100 kg.
* Female subjects who are using an effective method of contraception, or are surgically sterile.
* Non-smokers or ex-smokers who have not smoked within the previous 12 months.

Exclusion Criteria:

* Hypersensitivity to the Investigational medicinal product (IMP) or its constituents and/or hypersensitivity to E. Coli derived proteins, and/or previous exposure to the IMP.
* History or presence of any clinically significant findings that, in the opinion of the Investigator, would preclude inclusion in the study.
* History or presence of any clinically significant gastrointestinal pathology or symptoms, liver or kidney disease, or any other condition that might interfere with the absorption, distribution, metabolism or excretion of the drug.
* Any clinically significant laboratory findings, including any ANC, platelet or haemoglobin result outside the reference range of the local laboratory.
* Abnormal vital signs or abnormal 12-lead electrocardiogram (ECG) results, as judged by the Investigator to be clinically significant.
* Females, pregnant or lactating, or planning to become pregnant during the time the subject is on study.
* Subjects with a history of pulmonary infiltrate or pneumonia in the previous 6 months from the date of the screening visit.
* Hereditary fructose intolerance.
* Participation in any other clinical trial using a investigational product or device, within the previous 12 weeks from the date of the screening visit.
* Positive result for human immunodeficiency virus (HIV) and/or hepatitis B and C tests.
* Evidence of, or treatment for, drug or alcohol abuse within one year from date of screening visit.
* Blood donation \>=500 mL in the previous 12 weeks from the date of the screening visit.
* Use of any prescription medication (excluding hormonal contraceptives) within 14 days prior to date of the screening visit.
* Receipt of over-the-counter medicines which have not yet cleared from the body (five half-lives must have passed for the medicine to be considered to have cleared from the body). Vitamins, minerals and nutritional supplements may be taken at the discretion of the Investigator.
SpinChip Hs-cTnI Multisite Precision

During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack. The SpinChip hs-cTnI test is a new high-sensitive test for measuring the amount of cardiac troponin I in the bloodstream as an aid in the diagnosis of heart attack.

The purpose of this study is to establish the precision of the SpinChip hs-cTnI test when using Li-Heparin plasma and whole blood samples in the hands of the intended user in the intended use setting at multiple sites.

Cardiac troponins are widely used as a biomarker to aid in the diagnosis of acute myocardial infarction (AMI). These structural proteins are essential in regulating contraction in cardiac muscle cells, and they are sensitive and specific biochemical markers of myocardial damage.

During a heart attack, cardiac muscle cells are injured and release the cardiac marker troponin I (cTnI) into the bloodstream. High-sensitive troponin tests may detect the increase of cardiac troponin in blood within hours after the symptoms of a heart attack has started.

The SpinChip high-sensitivity cardiac troponin I (hs-cTnI) test is a new high-sensitive test for measuring troponin I in blood samples, and the analysis may be performed close to the patient (near-patient test). The results may be obtained within 10 minutes, compared to approximately 1 hour for normal laboratory analysis.

The SpinChip Platform consists of the SpinChip hs-cTnI test and the SpinChip Analyzer and may be used at the emergency department to evaluate patients presenting with symptoms of acute myocardial infarction (chest pain). The test can use blood from finger prick or venous blood samples, either as whole blood or separated into plasma.

This multisite prospective, observational, non-randomized validation study will establish the repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test for Li-Heparin plasma and repeatability for Li-Heparin whole blood samples. Potential subjects will be identified based on clinical cardiac troponin levels obtained from medical records at the individual study site.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide signed written informed consent
* Subjects \>18 years old
* Clinical cTn concentrations available

Exclusion Criteria:

* Cognitive impairment precluding informed consent
* Self-reported pregnancy
* General clinical condition that affects the patient in a major way and the patient is considered to be in an unstable clinical condition
* Previously included in the study with a sample within the required concentration ranges for the SpinChip hs-cTnI test
* No venous blood sample collected for the study
High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

The purpose of this study is to determine whether HIFU has superiority over traditional surgery on satisfaction and adverse impact.

Uterine fibroids (leiomyomas) are common in reproductive aged women. Patients are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid surgery. High intensity focused ultrasound therapy (HIFU) is a novel non-invasive method for uterine fibroid. Preliminary clinical studies proved HIFU ablation is a safe and effective technology. However, it is not clear whether HIFU has superiority over traditional surgery on satisfaction and adverse impact.The study is to confirm these questions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45; The size of fibroid situated at anterior wall not lower than 2 cm in MRI feature; The size of fibroid situated at posterior wall not lower than 4 cm in MRI feature.

Exclusion Criteria:

* Cervical fibroids; Subserosal fibroids with pedicle, the width of pedicle≤ 2cm; Type 0 submucosal fibroids according to European Gynecologic Endoscopy classification; Combined with acute reproductive inflammation, or other benign and malignant gynecological diseases such as endometriosis, ovarian cancer; Pregnant (pregnancy test is positive), and lactating women; Allergy to MRI contrast agent; The history of collagen connective tissue, radiotherapy, especially abdominal radiotherapy; Surgical and anesthetic contraindications such as serious cardiac, vascular and other systemic diseases; Poor compliance; Patients who are not subject to experimental design.
Effects of Low Versus High Carbohydrate Diet During Rehabilitation on Cardiovascular Function and Metabolism in Type 2 Diabetes

Compared to the traditional low fat diet for overweight patients with type 2 diabetes, recent evidence shows that low carbohydrate/high protein diets lower triglycerides and postprandial glucose levels more effectively. However, it is not known, whether this diet can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective parallel group and cross over design study compares the effects of a low glycemic and insulinemic diet (LOGI®) with an isocaloric traditional low fat diet during a three weeks rehabilitation programme with aerobic exercise for overweight type 2 diabetes patients testing the hypothesis, that the low carbohydrate diet improves myocardial function and insulin resistance.

This is a single center, short term therapy controlled and prospective study with blinded analyses of the ultrasound data in 41 patients with type 2 diabetes either on dietary control or oral antidiabetic medication. After recruitment and informed consent, patients are randomized to two treatment arms matched for age and concomittant antidiabetic and cardiovascular medication In one treatment arm, the diet is based on the LOGI components: 25% low glycemic index carbohydrates, 30% protein, 45% fat, taken for 3 weeks combined with aerobic exercise, while in the other treatment arm, the isocaloric traditional low fat diet is based on 55% mixed glycemic index carbohydrates, 20 % protein and 25% fat taken for three weeks and combined with the same aerobic exercise protocoll but followed by a two weeks period with LOGI diet and maintained exercise. In both treatment arms, antidiabetic and antihypertensive medication are maintained and/or adapted as necessary and recorded.

All patients receive life style instructions and are updated in their skills of measuring quantity of foods and designing diet plans based on food groups. Laboratory, clinical and ultrasound investigations are performed before and at the end of the three weeks programme and, in the cross over group, also at the end of the subsequent diet programme.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* oral antidiabetic medication or dietary control
* overweight

Exclusion Criteria:

* coronary artery disease
Inferior Vena Cava Retrievable Filters: Spanish Register

Spanish registry of retrievable vena cava filters.

This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain).

A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).

This is an prospective observational study of patients that have been implanted a inferior vena cava filter with intention to be retrieved.

Patients are recruited when the filter is implanted, and the investigators observe when is it finally retrieved (dwell time), if retrieval is possible or not, and if there is any complication at the retrieval of the filter.

Eligibility Criteria:
Inclusion Criteria:

* Indicated inferior vena cava filter implantation
* Signed informed consent

Exclusion Criteria:

* Permanent filters (including retrievable filters intended to be used as permanent ones)
* Impossibility of follow-up (3, 6 and 12 months)
* Life expectancy less than a year
* Patient refusal to be included in the study, at any time
Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)

Primary objective:

• To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.

Secondary objectives:

* To evaluate the tolerability of V503 in 9-15 year-old girls.
* To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.


Eligibility Criteria:
Inclusion Criteria:

* Female from 9 to 15 years old.
* Good physical health.

Exclusion Criteria:

* Known allergy to any vaccine component.
* History of severe allergic reaction.
* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
* Pregnant subject.
* Immunocompromised or immunodeficient subject.
* Splenectomy.
* Receipt of medication / vaccine that may interfere with study assessment.
* Fever
* History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial.
* Any condition that might interfere with study assessment.
Pilot Study for Determination of Total Energy Expenditure and Fat Oxidation in Children

The purpose of this study is to determine energy expenditure and fat oxidation in 2 year old children.


Eligibility Criteria:
Inclusion Criteria:

* 1.5-2.5 years of age
* Mother is a participant in the Glowing study (protocol NCT01131117)
* Healthy without taking medication that can affect study outcomes, as determined by the PI.

Exclusion Criteria:

* None listed