cyrilzakka/clinical-trials huggingface dataset:
Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System

The BewegtVersorgt project involved co-producing a physical activity referral scheme (PARS) for inactive persons with underlying non-communicable diseases. Various relevant actors of the German healthcare system (e.g., representatives of physicians, health insurance providers, sports organizations, exercise representatives of exercise professions, representatives of patients) participated in the co-production process.

The purpose of this study is to evaluate the effectiveness of co-produced PARS in the Erlangen-Nuremberg-Fürth region. Local general practitioners and exercise professionals will carry out the implementation of the PARS in standard care. The cluster-randomized study includes two intervention arms; one group will receive specific support from physical activity experts to increase physical activity (PARS). The control group will receive only the physician's advice and then continue to engage in physical activity on their own (PAA). The participants will be followed up at 12 and 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older; living in the region of Erlangen-Nürnberg-Fürth, Germany;
* At least one of the following existing non-communicable diseases (controlled type 2 diabetes mellitus; cardiovascular diseases; obesity (BMI ≥ 30 kg/m2); arthrosis in knee and/or hip);
* Not meeting German PA recommendations (less than 150 minutes/week of moderate-intensity aerobic activity or less than 75 minutes/week of vigorous-intensity aerobic activity or any other equivalent combination);
* The person can safely participate in physical activities based on general practitioners' clinical judgment.

Exclusion Criteria:

* The person plans to leave the region of Erlangen-Nürnberg-Fürth during the study period;
* The person participating in another study with similar content;
* The person is or plans to be absent for more than four weeks during the 12-week-intervention period;
* Person has cognitive impairments that prevent an effective communication with the general practitioner and the therapist;
* Persons with mental illness such as psychotic, substance abuse, mood, personality disorders;
* Unstable clinical situation or serious health impairments that prevent from undertaking physical activity safely (e.g., acute myocardial infarction, unstable angina pectoris, fever, terminal tumor diseases
Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg

The primary goal of this study is to investigate the qualitative and quantitative effects of scaling and root planing (SRP) with and without minocycline HCL microspheres, 1 mg on periodontal pathogens and overall bacterial load.

A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned.

Specific Aim 1: Evaluate the cumulative oral periodontal bacterial burden in both control and test groups over a six month period.

Specific Aim 2: Assess gingival crevicular fluid (GCF) and serum biomarkers of inflammation.

A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned.

The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. Saliva samples, GCF, and blood serum will be collected at four time points (baseline, 1, 3, and 6 month follow up). Saliva will be analyzed for overall pathogen burden. GCF will be analyzed for Interleukin (IL)-1, IL-6, and tumor necrosis factor alpha (TNF-α). Serum will be analyzed for C-reactive protein (hsCRP), haptoglobin (Hp), hemoglobin A1c (Hgb A1c), IL-1, IL-6, and TNF-α.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* At least 18 years of age
* ADA Class III-IV Chronic Periodontitis
* Scaling and Root Planing (SRP) or localized SRP
* A minimum of eight sites with pockets ≥5mm with bleeding on probing (any quadrant)

Exclusion Criteria:

* Unable to comply with study protocol
* Completed treatment of Scaling and Root Planing (SRP) and/or localized SRP within the last 6 months
* Cigarette use within the last year
* ≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six weeks.
* Pregnant, planning to become pregnant, or unsure of pregnancy status (self- reported)
* Diagnosed cardiac conditions (cardiovascular disease (CVD) or atherosclerotic vascular disease (ASVD) including coronary heart disease, cerebrovascular disease, and peripheral artery disease, myocardial infarction, stroke, stable or unstable angina, transient ischemic attack, or coronary or other arterial revascularization
* Have any uncontrolled medical condition or immunocompromised that may impact the study (uncontrolled diabetes HbA1c \> 7, HIV, etc.)
* Tetracycline allergy
* Any medication that may impact periodontal conditions (Phenytoin, calcium antagonists, cyclosporin, warfarin, or NSAIDS)
A Question Prompt Sheet for Depressive Outpatients

question prompt sheet for outpatients suffering from depression. effects on patient-doctor-communication during the consultation.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* male and female patients
* outpatients
* informed consent

Exclusion Criteria:

* poor German language skills
International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)

Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ) in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both complaining of Gas-Related Symptoms (GRS).

IGQ has been developed previously simultaneously in UK English, French and Spanish through qualitative research with subject interviews. The conceptual framework of the IGQ assesses both GRS and their impact on daily life. Similar concepts were identified for both subjects with IBS diagnosis and general population and complaining of gas-related symptoms.

The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17 items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26 items)

Observational (non-interventional) study with a cross-sectional part for a subset of adult subjects with a single IGQ completion and a longitudinal cross-over part for a subset of subjects with test-retest IGQ completion for validation of electronic version of IGQ.

300 eligible subjects (100 in each of the 3 countries: France, UK \& Spain):

* 180 with IBS diagnosis (60% of recruited subjects)
* 120 from General population (40% of recruited subjects)

Eligibility Criteria:
Inclusion Criteria:

All (subjects with IBS diagnosis and general population):

* Complaining of gas-related symptoms (GRS) of a certain severity level: subjects with IBS diagnosis and general population need to report a score of 4 or greater on at least one symptom on the symptom screening tool
* Cognitive and linguistic capability to complete several self-questionnaires
* BMI \> 18.5 and \< 30.0 kg/m2
* Agreement of the subject to participate in the study

Subjects with IBS diagnosis:

* IBS diagnosis using Rome III diagnostic criteria for Functional Gastrointestinal Disorders (21)
* IBS severity: IBS-SSS score of 75 to 300

General population:

* Subjects not fulfilling IBS Rome III criteria
* Regular stool frequency (i.e., between 3 and 21 bowel movements per week)

Exclusion criteria

All (subjects with IBS diagnosis and general population):

* Recent (2 last weeks) change in diet or intake of potentially flatulogenic compounds (fiber, lactulose)
* Organic gastrointestinal disease
* Other functional gastrointestinal disorder as defined by Rome III criteria
* Any severe and progressive disease (e.g. depression, cancer, uncontrolled diabetes, rheumatoid arthritis...)
* Any severe psychiatric disorder (e.g. acute episode of schizophrenia or bipolar disorder...)
* Pregnant women
* Being under the direct hierarchy of the investigatorBelonging to the site's staff team

General population:

* Treatment for diarrhea or constipation including lactulose
Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda

Screen participants attending 11 healthcare facilities in Mubende District for psychological distress using the locally validated Luganda or English version of the WHO- Self Report Questionnaire (SRQ-20). Those individuals found to have significant psychological distress (a score of 6 and above) will be offered Ebola+D intervention \[a stepped care collaborative delivery model to address the medium- to long-term EBOLA associated psychological Distress and psychosocial problems\] . A cohort of Ebola Virus Disease (EVD) affected individuals accessing the Ebola +D mental health intervention will be recruited and followed up for 12 months with assessments at three time points; baseline, 3 months and 12 months.

Ebola Virus Disease (EVD) is associated with high mortality, physical morbidity among patients and survivors, plus being associated with significant mental health and psychosocial problems among patients/survivors, their family members, members of the affected communities, health workers and volunteers. To support the medical services of Mubende district cope with the Ebola associated mental health and psychosocial problems, the Ministry of Health of Uganda has partnered with the MRC/UVRI \& LSHTM Uganda Research Unit to implement a health systems strengthening project in the district entitled, 'Addressing the medium to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda (Ebola+D Project)'.

Methodology: The project will be undertaken in the 11 selected health care facilities in Mubende district. Members of the community attending these selected health care facilities will be screened for psychological distress using the locally validated Luganda or English version of the WHO- Self Report Questionnaire (SRQ-20). Those individuals found to have significant psychological distress (a score of 6 and above) will be offered Ebola+D intervention. A cohort of EVD affected individuals accessing the Ebola +D mental health intervention will be recruited and followed up for 12 months with assessments at three time points; baseline, 3 months and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Community member of Mubende district staying within the catchment area of the primary health care facility (PHCF);
* 18years and above,
* Able to communicate in either English or Luganda (local language spoken in the study region and the language into which the questionnaires will be translated),
* Has a WHO SRQ-20 score of 6 and above (except for Ebola survivors who are eligible even when their SRQ-20 score is either below or above 6). -

Exclusion Criteria:

* Unable to engage with the research process for any reason that may include sensory impairment or cognitive impairment
Neuromodulation With Low Frequency-Pulsed Electromagnetic Fields

Non-depolarizing magnetic fields, like Low Frequency-Pulsed Electromagnetic Fields (LF-PEMFs) have shown the ability to modulate living structures, principally by influencing synaptic activity and ion channels on cellular membranes. Recently, the CTU Mega 20 device was presented as a molecular accelerator, using energy up to 200 Joules and providing high-power (2 Tesla) pulsating fields with a water-repulsive (diamagnetic) action and tissue biostimulation. The investigators tested the hypothesis that LF-PEMFs could modulate long-term corticospinal excitability in healthy brains by applying CTU Mega 20®. Ten healthy subjects without known neurological and/or psychiatric diseases entered the study. A randomized double-blind sham-controlled crossover design was employed, recording TMS parameters (amplitude variation of the motor evoked potential as index of cortical excitability perturbations of the motor system) before (pre) and after (post +0, +15, +30 min) a single CTU Mega 20 session on the corresponding primary right-hand motor area, using a real (magnetic field = 2 Tesla; intensity = 90 J; impulse frequency = 7Hz; duration = 15 minutes) or sham device. A two-way repeated measures ANOVA with TIME (pre, post +0, +15, +30 min) and TREATMENT (real vs sham stimulation) as within-subjects factor was applied.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between 18 and 35 years

Exclusion Criteria:

* Known neurological or psychiatric diseases
Thromboelastography (TEG) Reference Range Study

As part of a system wide reagent verification plan Haemoscope Corporation will be running a study to verify the reference intervals of many of the reagents. Reference intervals will be constructed following the guidelines set out in CLSI document C28-A3c. This guideline calls for a reference interval to be constructed from at least 120 donors. Some reagents currently have ranges in place based on fewer donors than that stated in the guideline. This procedure will provide additional testing results to meet the requirements outlined in the CLSI guideline. Reagents that currently have no reference intervals will be tested and will include a minimum of 146 donors.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female over the age of 18 years.

Exclusion Criteria:

* Genetic bleeding disorders
* Currently Pregnant
* Oral Contraceptives
* On anti-coagulants or anti-platelet therapy
* Took ASA (Acetylsalicylic Acid)within 1 week prior
* Recent surgery (within 4 weeks)
* Recent injury leading to substantial bruising (within 2 weeks)
Development of a Biological Database in the Field of Operative Intensive Care

The storage and use of biomaterial samples is an important requirement for accompanying research and the acquisition of new knowledge to improve prognosis and therapy. Biobanking is explicitly recommended in official guidelines. In order to preserve the biomaterial, the patient must consent to the removal, transfer and storage of the biomaterial separately from the consent to the register. The biomaterial is taken at times at which a blood or urine sampling takes place anyway in the clinical routine. Therefore no additional interventions are necessary.

The storage and use of biomaterial samples is an important requirement for accompanying research and the acquisition of new knowledge to improve prognosis and therapy. Biobanking is explicitly recommended in official guidelines. In order to preserve the biomaterial, the patient must consent to the removal, transfer and storage of the biomaterial separately from the consent to the register. The biomaterial is taken at times at which a blood or urine sampling takes place anyway in the clinical routine. Therefore no additional interventions are necessary.

Sample volumes are defined as follows:

* Peripheral blood: up to a total of 150 ml distributed to a maximum of 10 morning blood samples (approximately 15 ml blood per blood sample) during the inpatient stay in the intensive care unit (fixed times are admission and discharge of the intensive care unit)
* Urine: a total of up to 200 ml of catheter urine distributed to a maximum of 10 morning withdrawals during inpatient stays in the intensive care unit (defined times are admission and discharge from the intensive care unit)

Eligibility Criteria:
Inclusion Criteria:

* patients after admission to the intensive care unit
* 18 years or older
* signed informed consent

Exclusion Criteria:

* No exclusion criteria are formulated with regard to the objective of the register to record intensive care patients in general. Patients with multiple comorbidities, organ dysfunctions, and non-compliance for a curatively-intended therapy should also be recorded in the register. A palliative treatment or decision for best supportive care is not an exclusion criterion for registering.
Implant Stability of Laser vs SLA Surface Treated Implants Placed in Fresh Extraction Sockets

Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting.

Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants.

Laser surface treatment is used to produce an implant surface modification on the nano-scale with controlled and reproducible patterns in addition to exhibiting a sterilizing effect and achieving efficient oxidation .

For dental implant to be successful, a direct contact between the bone tissue and the surface of the implant should be developed \& this physiological phenomenon is known by the term of osseointegration.

Initially, it was supposed that to achieve osseointegration, implants had to be submerged under the mucosa \& left without any loading for a period of 3-4 months in mandible and 6-8 months in maxilla.

Recently immediate implant placement at the time of extraction has become a viable treatment alternative, this approach provides the advantages of decreasing the patient's discomfort, the treatment's duration and costs.

Aiming to reduce healing process to limit such changes in the soft \& hard tissues and reducing treatment time, several alterations in both surgical and restorative procedures has been introduced. From an implant design perspective, two approaches including the fields of biomaterials and/or biomechanics have been most utilized; implant body design which aim to increase the primary stability and surface modifications to allow faster osseointegration process.

Rough implant surface is modified by different techniques. Among these different techniques, interest in of using laser to achieve roughened surfaces.

Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting.

Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with badly broken teeth indicated for extraction. • Presence of adequate bone beyond the root apex to guarantee implant primary stability \& implant placement within the alveoli confines.

Exclusion Criteria:

* • Presence of acute infections in the implant site.

  * Presence of fenestrations or dehiscence of the residual bony walls after extraction.
  * Heavy smokers more than 20 cigarettes per day.
  * Patients with systemic disease that may affect normal healing.
  * Psychiatric problems.
  * Disorders to implant are related to history of radiation therapy to the head and neck neoplasia.
  * Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers

This research is being conducted to determine the biodistribution of radiolabeled amatuximab in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or non small cell lung cancer.

The primary objective is to determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissues in subjects with mesothelin over-expressing cancers including mesothelioma, pancreatic, ovarian, and non small cell lung cancer. This is a single-center, single-dose, open-label, pilot study of amatuximab in approximately 20 subjects with mesothelin expressing tumors. 111Indium-radiolabeled amatuximab (5 mCi) will be administered. Serial SPECT imaging (at 3 specific time points up to 196 hours after cold infusion) will be performed to determine binding to tumor and nontumor tissue. Subjects will be observed closely for safety and possible development of anti-amatuximab antibodies. Pharmacokinetics of radiolabeled antibody will be determined with imaging over time.

Eligibility Criteria:
Inclusion Criteria:

* Female and Male subjects \> or = 18 years of age
* Histologically confirmed mesothelin-expressing cancer
* Measurable disease that has progressed through prior therapy and that includes a non-hepatic lesion for imaging that is \> or = 1.5cm, as defined by RECIST v1.1 and disease location, at discretion of the physician, or evaluable by clinical symptoms supported by biomarker, radiological or pathological studies conducted within 4 weeks prior to study entry

Exclusion Criteria:

* Known allergy or hypersensitivity to monoclonal antibodies
* Known to develop HACA
* Prior treatment with amatuximab
* Prior treatment with SS1 (dsFv)PE38 (ss1P)
* Prior treatment with another test article within previous 30 days
* Known brain metastasis
* Known prosthetic devices that would prohibit imaging ow lesion of interest due to radiographic artifact
* Chemotherapy, biological therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab
CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey

A multicenter, prospective cohort study of the mutation status of patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are being treated with first or subsequent tyrosine kinase inhibitor (TKI) therapy in the UK, Ireland, or France.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years) with CML (in all phases of disease) or Ph+ ALL with detectable BCR-ABL levels who are being treated with a first or subsequent TKI.
* Patients with CML must meet the warning or failure criteria as per the ELN guidelines for first second and subsequent treatment line, including:

  * BCR-ABL/ABL IS transcripts \> 10% at 3 months
  * BCR-ABL/ABL IS transcripts \> 1% at 6 months
  * BCR-ABL/ABL IS transcripts \> 0.1% at 12 months or later
* Patients with CML must not currently be in MMR (ie, have disease with BCR-ABL1/ABL1 transcripts \> 0.1% IS).

OR

* Patients with Ph+ ALL with any level of BCR-ABL/ABL IS transcripts. Patients with Ph+ ALL should have BCR-ABL1/ABL1 transcript levels \> 0.1% and should not be currently enrolled in UKALL14 but may have relapsed during or after participation in UKALL14.
* Patients with an intermediate or high Sokal score (\> 0.8) can be recruited into the study from 3 months after diagnosis, irrespective of BCR-ABL1/ABL1 transcript levels at 3 months.
* Patients with additional chromosomal abnormalities at diagnosis and patients with AP-CML may be recruited into the study, irrespective of BCR-ABL1/ABL1 transcript levels at 3 months and beyond provided BCR-ABL1/ABL1 transcript levels are \> 0.1% IS. It is recommended that these patients have mutational analysis performed every 3 months irrespective of BCR-ABL1/ABL1 transcript levels until they reach MR3/MMR (BCR-ABL1/ABL1 \< 0.1% IS).
* Any patients who have previously undergone testing for KD mutations, irrespective of KD mutational analysis test results.
* Patients who have the ability to understand the requirements of the study and provide written informed consent.

Exclusion Criteria:

Patients without detectable BCR-ABL and patients who have switched TKI due to intolerance but who have met the criteria for optimal response (CP-CML, ELN 2013 guidelines).