cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Osteopathic Protocol on Rachialgia

Rachialgia are among the most common reasons for consultation with the general practitioner in Europe. Most of the guidelines recommend spinal manipulation.

This study attempts to propose a solution with 2 parts: tests of induced pain that have a greater sensitivity than palpatory tests of movements and a comprehensive musculoskeletal treatment protocol.

The aim of this study is to evaluate the Osteopathic Protocol in 2 sessions (PO2).

Rachialgia, whether it is cervicalgia, chest pain or low back pain, are among the most common reasons for consultation with the general practitioner in Europe.

In 2018, the therapeutic strategies for non-specific acute and subacute spine are diverse based on country clinical practice guidelines. Recommendations are rest or maintenance of normal activity, medications, surgery, psychological support, physiotherapy, acupuncture and manipulations.

Most of the guidelines, notably from Germany, Belgium, France, England and the United States, recommend spinal manipulation. In general, it can be recommended alone, or accompanied by usual care, or integrated into a multimodal treatment program. May be recommended in acute, chronic or not recommended.

The strength of osteopathy is that it tries to understand the musculoskeletal balance as a whole.

However, the differences in recommendations can be explained by the weaknesses of osteopathy, which are related to a technical and methodological problem.

The first technical problem is at the level of osteopathic clinical examination. While much of this clinical examination is based on palpatory tests, there is evidence that these range of motion palpatory tests have low sensitivity regardless of the examiner's experience.

The second methodological problem is the use of protocols.

This study attempts to propose a solution to these two problems: by proposing for the clinical examination tests of induced pain that have a greater sensitivity than palpatory tests of movements, and a comprehensive musculoskeletal treatment protocol that should allow the study to be both reliable and valid in order to be true to osteopathic values and to accept the Evidence Based Medicine methodological evaluation model.

The aim of this study is to evaluate the Osteopathic Protocol in 2 sessions (PO2).

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute or subacute cervico-dorsalgia or lumbo-dorsalgia (less than 3 months)
* Patients who gave their informed consent to participate in this study.

Exclusion Criteria:

* Patients whose specific spine is caused by inflammatory, tumor, infectious disease or back trauma in the past 3 months
* Patients with a history of back surgery and/or vertebral fracture in the past 6 months
* Patients with a motor disability related to the reason for consultation
* Pregnant women over six months.
* Patients not communicating or unable to understand the course of the study.
A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of AMG 340 monotherapy in subjects with mCRPC.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed prostatic adenocarcinoma.
* History of metastatic disease.
* Chemically or surgically castrate.
* Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations.
* Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV)-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
* Subject must have adequate heart, liver, bone marrow and kidney function (e.g. estimated glomerular filtration rate \[eGFR\] ≥ 50 mL/min, aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\] ≤ 3 x upper limit of normal \[ULN\], hemoglobin \[Hgb\] ≥ 9 g/dL (without blood transfusion within 7 days from screening assessment), platelets ≥ 100,000 / mm\^3 (without platelet transfusion within 7 days from screening assessment), absolute neutrophil count \[ANC\] ≥ 1500 / mm\^3).

Exclusion Criteria:

* Subject has been diagnosed with or treated for another malignancy within the past 2 years whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
* History of neuroendocrine differentiation in the subject's disease.
* Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed.
* Subject has clinically significant CNS pathology.
* Subject requires chronic immunosuppressive therapy.
* Subject has a history of major cardiac abnormalities.
The Role of Atorvastatin on Monocyte Function in Patients With Coronary Artery Disease and Hypercholesterolemia

The aim of this study is to determine, whether an intensified atorvastatin therapy can improve monocyte function in patients with coronary artery disease and hypercholesterolemia.

Hypercholesterolemia is one of the most important cardiovascular risk factors that significantly elevates the risk for the development and progression of arteriosclerotic diseases.

Statins such as atorvastatin have been shown to reduce atherogenic lipoprotein levels as well as cardiovascular morbidity and mortality in a large number of clinical trials. It is suggested that statins have- apart from their lipid-lowering properties- other pleiotropic effects that are responsible for their anti-atheroslerotic and and cardioprotective potential.

Monocytes are crucially involved in the process of arteriogenesis (i.e. the growth of preexisting arterioles). Monocyte chemotaxis can be stimulated with arteriogenic molecules such as vascular endothelial growth factor A (VEGF-A). In previous studies we could demonstrate that the VEGF-A- induced monocyte chemotaxis is severely impaired in hypercholesterolemic patients. This reduced response to VEGF seems to be associated with a decreased ability to form functional collaterals.

Therefore we hypothesize that an intensified therapy with atorvastatin 40 mg once a day can significantly improve monocyte function in patients with coronary artery disease and hypercholesterolemia compared to patients who are only treated with a placebo.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease (angiographically proven)
* diagnosis of hypercholesterolemia (either LDL-C ≥ 4 mmol/l or already treated with lipid-lowering medication)

Exclusion Criteria:

* diabetes mellitus
* uncontrolled arterial hypertension (repeated BP ≥ 160/90 mmHg)
* smoking
* active infections
* acute coronary syndrome (\< 8 weeks)
* malignant diseases
* nephropathy
Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement

Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure to port plant in terms of cosmetic results and time savings at comparable risk for wound infection.

Study patients who undergo a subcutaneous venous port implant procedure are randomized into control group (conventional sutures) or into interventional group (synthetic tissue adhesive). The intervention time is documented. Follow-up visit is performed 8 weeks after port implantation. It includes a photo documentation, quality of life questionnaire (EQ5D) and pain scala questionnaire (POSAS) by patient and by 3 independent observers as well as the documentation of complications.

Eligibility Criteria:
Inclusion Criteria:

* Medical indication for port catheter implantation because of chemotherapy or parenteral nutrition

Exclusion Criteria:

* Children and adolescents \< 18 years
* Thrombocytes \< 50/nl
* PTT \<50%
* INR \>1.5
* Systemic or local infection of the interventional location
* Known allergy to used material
* Known allergy to Histoacryl, Cyanoacrylate, D\&C Violett or Formaldehyd
* General contraindication of port catheter implantation
Impact of PD1-lymphocytes in Bronchoalveolar Lavage of Patients With Lung Cancer

The aim of this trial is to assess PD1-lymphocytes in bronchoalveolar lavage in patients with lung cancer, ILD and asthma.

In this trial, 20 patients with lung cancer, 10 patients with asthma and 10 patients with interstitial lung disease who have to undergo bronchocospy for medical reasons are enrolled. In each patient, bronchoalveolar lavage is performed to assess PD1-lymphocytes.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* patients with lung cancer, asthma or ILD and indication for bronchoscopy for medical reasons
* Ability to provide informed consent

Exclusion Criteria:

* acute excacerbation in patients with asthma or ILD
* endoluminal tumor growth or penumonia in patients with lung cancer
Virtual Reality Exercise Program for People with Type 2 Diabetes

The purpose of this study is to examine the effectiveness of a virtual reality (VR) based rehabilitation protocol for improvement of blood glucose control and exercise compliance of patients.

Subjects aged 55-85 diagnosed with Type 2 diabetes will be recruited. A written consent will be obtained from subjects. Subjects recruited will be randomly divided into one of the two groups. The VR group will receive an exercise program conducted in elderly centre or a control group will receive home exercise program. The 12-week exercise program will be conducted three times per week and each session will last for one hour. Assessment that takes about one hour to complete will be carried out at baseline, mid-way (6th week) and after the 12-week exercise training. Assessment items include physical, psychosocial and cognitive function. Also, blood test on HbA1c will be carried out at baseline and at the end of the 12-week training. During this course of research, subjects are strongly advised to stay with their present lifestyle and medication.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 55 and 80 years with a confirmed diagnosis of type 2 diabetes mellitus (T2DM) and an HbA1c of ≥ 6.5% and ≤ 11%.

Exclusion Criteria:

* Individuals will be excluded if they have a history of any of the following conditions: cardiac arrest, complex dysrhythmias at rest, complicated myocardial infarction or revascularization procedure, presence of congestive failure, presence of angina, signs or symptoms of post-event myocardial ischemia, renal impairment or proteinuria, hepatic impairment, severe gout or hyperuricemia or uncontrolled hypertension, a fall within the last year, musculoskeletal impairment such as inability to walk independently (after stroke or serious arthritis), neurocognitive disorder, or other diseases that limit their ability to engage in physical activities will be excluded. Individuals enrolled in other physical training programs will also be excluded to ensure any true effect of the proposed intervention can be captured.
School-based Oral Health Education Program Using Experiential Learning

The aim of this project was to compare the effectiveness of experiential learning (EL) and traditional lecturing (TL) school-based oral health education on the oral health knowledge, attitude, habits, oral hygiene, gingival health and caries incidence of 10 and 13-year-old Greek children. Thee hundred and fifty children were selected from three areas of Greece. Information on oral health knowledge, attitude and behaviour were obtained using a questionnaire. Dental plaque was recorded using a modified hygiene index, gingivitis was assessed using the simplified gingival index and dental caries was measured by recording the number of Decayed, Missing and Filled teeth (DMFT) using the British Association for the Study of Community Dentistry (BASCD) criteria. All children were examined by two calibrated dentists, using a World Health Organisation (WHO) periodontal probe and artificial light. Questionnaires were delivered and clinical examinations were performed at baseline and at 6 and 18 months post-intervention. The EL oral health educational program was implemented by teachers using the program's manual.


Eligibility Criteria:
Inclusion Criteria:

* 10 and 13 year-old children
* For the EL group, students were recruited from schools that had teachers previously trained in EL
* Students recruited for the TL group attended schools of the same geographical location as students in the EL group

Exclusion Criteria:

* Contributory medical history
Evaluation of the Repeated Usage of Systane Ultra Eyedrop

Comparison of two contact lens solutions.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more.
* Non contact lens wearer.
* Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:

  * Score ≥13 for OSDI Questionnaire total score; AND
  * Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
* Best visual acuity of 6/9 or better in each eye.
* Willingness to adhere to the instructions set in the clinical protocol.
* Signature of the subject informed consent form.

Exclusion Criteria:

* Use of systemic medication which might produce dry eye side effects.
* Systemic disease which might produce dry eye side effects.
* Active ocular infection.
* Use of ocular medication.
* Significant ocular anomaly.
* Previous ocular surgery
* Previous use of Restasis
* Any medical condition that might be prejudicial to the study.
* The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
* The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
* The subject, based on their knowledge, must NOT have diabetes.
Extended Release Naltrexone for Opioid-Dependent Youth

The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).

This proposed study is a 6-month, two-group randomized clinical trial of XR-NTX v. TAU for 340 opioid-dependent youth ages 15-21. The study will be conducted at Mountain Manor Treatment Center, a community drug treatment program in Baltimore. TAU will consist of buprenorphine treatment of opioid withdrawal followed by counseling with or without continued buprenorphine.

Eligibility Criteria:
Inclusion Criteria:

* Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence, physiologic subtype;
* Within 3 days of admission to MMTC;
* Age between 15 and 21, inclusive;
* Able and willing to provide informed consent to be randomly assigned to XR- NTX or TAU; and for participants under 18 years of age, parental or guardian consent and participant assent.

Exclusion Criteria:

* Liver function test levels (Alanine Transaminase, Aspartate Transaminase) four times greater than normal;
* Unstable medical or psychiatric illness (e.g., schizophrenia) that might make participation hazardous;
* History of serious suicide attempt in the past 6 months;
* History of allergic reaction to naloxone, and/or naltrexone;
* Current chronic pain condition for which opioids are deemed necessary for ongoing care;
* blood coagulation disorder (e.g., hemophilia);
* Body Mass Index \> 40;
* If female, pregnant, lactating, unwilling or unable (due to parental objection) to use FDA-approved contraceptive methods;
* meeting DSM-IV criteria for benzodiazepine dependence
Half-normal Saline in Atrial Flutter Ablation

To assess the acute and long-term efficacy of half-normal saline compared to normal saline for irrigation of open-irrigated catheters during catheter ablation for the treatment of cavotricuspid isthmus dependent atrial flutter.

It is unclear whether ionic strength affects energy delivery and ablation lesion size during radiofrequency ablation for atrial flutter. Given that saline contains ionic sodium and chloride in the solution, it has conductive properties that may disperse radiofrequency energy away from the tip-tissue interface, thereby reducing current density and lesion size compared to ablation with nonionic solutions. The efficacy of half-normal saline will be measured by the time taken to create bidirectional block across the cavotricuspid isthmus as well as the acute recurrence rate within 30 minutes of the initial occurrence of bidirectional block and the 1 year freedom from flutter recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age at the time of enrollment
* Patients presenting for right sided typical atrial flutter ablation who have a clinical indication to undergo catheter ablation
* Fully informed written informed consent by either the subject or subject's legal representative and ability for subject to comply with study responsibilities

Exclusion Criteria:

* The presence of thrombus within the left atrial appendage
* Prior catheter ablation of the cavotricuspid isthmus for right sided atrial flutter
* The inability to provide consent or comply with study requirements
* A predicted life expectancy of \< 12 months
Gastric Ultrasound to Monitor Gastric Residual Volume

It is currently recommended to start enteral nutrition early in intensive care unit children receiving invasive or non-invasive mechanical ventilation.

Gastrointestinal intolerance is the main complication related to early enteral feeding in intensive care unit patients, characterized by gastroparesis with delayed gastric emptying that may lead to regurgitations, vomiting, pulmonary aspiration, and potentially increased risk of ventilator-associated pneumonia (VAP).

Residual gastric volume (RGV) measurement had been recommended to monitor the tolerance to enteral nutrition in mechanically ventilated patients receiving early enteral feeding.

Nevertheless, several studies have challenged the usefulness of such RGV monitoring, showing that it led to reduced caloric intake without any benefits in terms of reducing the occurrence of vomiting and the incidence of VAP.

This lack of relationship between RGV monitored using gastric suctioning and the occurrence of regurgitation, aspiration and pneumonia may reflect the inaccuracy of the aspiration method used for the measurement of the RGV, as it has been reported in adult patients.

Gastric ultrasonography is a non-invasive and easy-to-use tool allowing accurate preoperative assessment of gastric contents, based on both qualitative examination of the gastric antrum and calculation of gastric content volume. Ultrasound examination of the antrum could therefore constitute an alternative to gastric suctioning for the monitoring of RGV in intensive care unit patients.

This prospective study aims to assess the reliability of the RGV monitoring based on gastric suctioning compared to ultrasound technique. Secondary endpoint is to assess whether increased gastric volume, aspirated or calculated by ultrasound, is an independent risk factor of regurgitation and / or vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Children hospitalized in intensive care unit, requiring invasive or non-invasive mechanical ventilation for a foreseeable duration \> 48 hours.
* Enteral nutrition that has been started for more than 48 hours and less than 7 days.
* Age between 37 weeks of post conceptual age and 18 years.
* Parental consent or consent by the person having parental authority.

Exclusion Criteria:

* Abdominal surgery ≤ 1 year
* History of esophageal, gastric, duodenal, or pancreatic surgery
* Enteral nutrition via jejunostomy or gastrostomy.
* Any situation contraindicating the mobilization of the child in the right lateral decubitus position (uncontrolled hemodynamic instability, unstable neurological injury ...)
A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry in Healthy Participants

The primary objective of the study is to explore the pharmacodynamic (PD) effects of BIIB104 on brain circuitry associated with emotional processing in healthy participants.

The secondary objectives of the study are to evaluate the safety and tolerability of BIIB104 in healthy participants; To further explore the PD effects of BIIB104 on brain circuitry associated with emotional processing in healthy participants; To explore the PD effects of BIIB104 on brain circuitry associated with working memory in healthy participants using the N-Back; To explore the PD effects of BIIB104 on regional cerebral blood flow (CBF) in healthy participants; To explore the PD effects of BIIB104 on brain circuitry during resting state in healthy participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2), inclusive.
* Right-handed as determined by the Edinburgh Handedness Inventory (score of \>40) \[Oldfield 1971\].

Key Exclusion Criteria:

* Previous participation in this study or previous studies with BIIB104.
* Body weight \<55 kg.
* History of severe allergic or anaphylactic reactions, or systemic hypersensitivity reaction to BIIB104 or any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.