cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.

Eligibility Criteria:
Inclusion Criteria

* Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS),
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be \<0.70 and FEV1 must be \<65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
* Subjects with history of exacerbations.

Please refer to the study protocol for the complete inclusion criteria list.

Exclusion Criteria

* Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
* Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening)
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening)
* Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
* Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
* Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.

Please refer to the study protocol for the complete inclusion criteria list.
Ex VIvo DEtermiNed Cancer Therapy

EVIDENT's aim is to test if ex vivo drug screening can predict whether patients with solid cancers will respond, or not respond, to standard care treatments. Patients undergoing standard care surgery to excise their tumour, those undergoing a biopsy, or those having a fluid aspirate of a solid tumour with surplus tissue available after diagnostic use will be eligible for this study. The specimen will then be assessed with ex vivo drug screening utilising all standard therapies and therapies that are more novel and in early stages of development. The results of the ex vivo drug screen will be compared to the cancer's actual response to standard care treatments for those that undergo therapy to determine how effective the test is at predicting treatment response.

The EVIDENT study is a feasibility / proof of concept study which is designed to determine if ex vivo screening of a patient's solid tumour can predict the effectiveness of standard cytotoxic chemotherapies and targeted inhibitors in solid cancers prior to the patients treatment. We aim to recruit 100 patient to each group starting with the six currently listed, but leave scope to add new groups of different solid cancers in the future.

EVIDENT aims:

* Demonstrate the feasibility of collecting fresh tumour samples within the NHS from patients with solid tumours for ex vivo screening
* Demonstrate that tumour response to drug exposure can be measured and quantified within an ex vivo screening platform
* Collect the participants' clinical outcome data (tumour response and progression free survival) to their standard of care treatment regimes and correlate with results from the ex vivo drug screen
* Identify novel effective therapies
* Investigate the tumour biopsies derived omics to determine the strength of well-established, less well-established biomarkers, and to identify novel biomarkers through correlation with the ex vivo drug screen results

Eligibility Criteria:
Inclusion Criteria:

\>16 years of age with a diagnosis of known or suspected solid cancer who will undergo surgery, biopsy, aspirate, or TURBT

Willing to donate a section fresh tumour tissue from surgery, a TURBT, fluid aspirate, or biopsy surplus to diagnostic use

Willing to donate a 9ml blood sample

Able to give written informed consent

Previously treated patients are eligible if:

* Present with a recurrence of a previously treated tumour. This may be a local or metastatic recurrence
* Have undergone treatment for their cancer, but fail to respond to this and progress
* Have received neoadjuvant therapy for their tumour
* Have undergone chemotherapy, targeted therapy, immunotherapy, hormone therapy and or radiotherapy for a previous tumour

Exclusion Criteria:

Patients with a known diagnosis of a blood borne virus (Hepatitis B, Hepatitis C, HIV). (The laboratories where experiments will be conducted do not have the safety facilities to use material containing these pathogens)

Patients with a current positive COVID-19 infection
HD18 for Advanced Stages in Hodgkins Lymphoma

This study is designed to test:

1. in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles)
2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.


Eligibility Criteria:
Inclusion Criteria:

* Hodgkin Lymphoma (histologically proven)
* CS (PS) IIB with one or both of the risk factors:

  * bulky mediastinal mass (\> 1/3 of maximum transverse thorax diameter)
  * extranodal involvement
* CS (PS) III, IV
* Written informed consent

Exclusion Criteria:

* Leucocytes \< 3000/µl
* Platelets \< 100000/µl
* Hodgkin´s lymphoma as "composite lymphoma"
* Activity index (WHO) \< grade 2
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine

Study STS101-002 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine

The EMERGE trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).

Eligibility Criteria:
Key Inclusion Criteria:

* Males or females, 18-65 years of age at the time of Screening Visit
* Subject has at least 1-year history of migraines (with or without aura), according to the International Classification of Headache Disorder, 3rd Edition (ICHD3)

Exclusion Criteria:

* Pregnant or breast-feeding women
* Women of child-bearing potential not using or not willing to use highly effective contraception.
* Diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache.
* History of coronary artery disease, coronary artery vasospasm (including Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery.
* History of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.
* Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or Bipolar disorder), dementia. Other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety.
* Any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.
German SLD-Registry (Deutsches SLD-Register)

Characterization of patients with steatotic liver disease (SLD)

The German SLD-Registry (Deutsches SLD-Register) a project of the German Liver Foundation (Deutsche Leberstiftung), managed by Leberstiftungs-GmbH Deutschland.

The German NAFLD-Registry is financially supported by: Advanz Pharma Specialty Medicine Deutschland GmbH und Gilead Sciences GmbH (Grant to German Livber Foundation) sowie Novo Nordisk Pharma GmbH (directly via Leberstiftungs-GmbH).

The following data can be documented:

* physical examination and vital parameters (e.g. age, weight)
* comorbidities (e.g. diabetes mellitus, cardiovascular disease)
* comedication (treatment of comorbidities related to SLD)
* laboratory values (e.g. liver function tests, creatinine)
* genetic variants (e.g. PNPLA3)
* liver diagnostics (e.g. histological findings, sonographic findings)
* lifestyle (alcohol consumption, physical activity)
* health related quality of life (SF-36 questionnaire)

Eligibility Criteria:
Inclusion Criteria:

* diagnosed SLD based on the following criteria:

  1. typical finding of hepatic steatosis (abdominal ultrasound and/or pathological CAP value (latter is optional)
  2. Evaluation of SLD degree by NAFLD Fibrosis score and/or FIB-4-Index and/or transient elastography
  3. Evaluation of metabolic syndrome
* credible assessment of alcohol consumption
* written informed consent

Exclusion Criteria:

* patients with other hepatologic diseases (chronically viral, metabolic, autoimmune origin
* patients receiving hepatotoxic medications over a longer period (e.g. methotrexate, amiodarone, longterm NSAR intake)
* malignant disease with a life expectancy \<12 months
* participation in clinical interventional/pivotal studies
* inability to provide written informed consent
Effect of Tok-Sen Massage for Non-specific Low Back Pain

The purpose of this clinical trial was to find out whether Tok Sen massage (a massage method with wooden instruments from northern Thailand) is more effective than pressure massage in relieving pain and improving quality of life in participants with chronic low back pain. The main questions it aims to answer are:

Can Tok Sen Massage Relieve Chronic Lower Back Pain? Can Tok Sen massage improve the quality of life of patients with chronic low back pain? Researchers compared Tok Sen massage with pressure massage, which works on low back pain, to see if it could treat chronic low back pain.

Participants will:

Receive Tok Sen massage or pressure massage every week for 1 month. Questionnaires and flexion measurements before and after each massage. After the massage session, fill out the online questionnaire once a month for three months.

Low back pain is the world's leading cause of global productivity loss and the leading cause of years lost with disability (YLDs), with a high prevalence of 28%-42% among those aged 40 to 69 years. The prevalence of different occupations in Taiwan ranges from 35% to 90%; according to the summary of the National Health Insurance Database results report: "The annual prevalence of low back pain is 14% to 45%, and 70% to 85% of people in their lifetime Suffering from low back pain. "Most people who experience low back pain cannot identify the specific source of the injury, and up to 90% of low back pain is non-specific. Approximately 85% of patients with low back pain cannot obtain accurate pathological anatomy diagnosis. Tok-Sen Massage is a kind of folk therapy in northern Thailand, specializing in musculoskeletal system diseases. This trial selected Pressure Massage as an active control for evaluating the effectiveness of two massage methods in improving low back pain.

This is an open-label and randomized controlled trial. Patients aged 20-69 years old with non-specific chronic low back pain were randomized divided into two different groups. 7 people in the Tok-Sen Massage group received a 40-minute intervention once a week for a total of 4 times, and 7 people the Pressure Massage group received a 40-minute intervention once a week for a total of 4 times.

Massage area are on the bladder meridian on the back and the spleen, liver and kidney meridian of the lower limbs.

The evaluation methods are: 1. Oswestry Disability Index (ODI) (baseline and after three interventions), 2. Visual Analogue Scale (VAS)before and after each massage, 3. Trunk flexibility test. before and after each massage.

Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain for more than 3 months
* diagnosis of non-specific low back pain

Exclusion Criteria: -

* Spinal surgery history
* Joint disease
* Pregnancy
* Cancer
* Systemic disease
* Mental disease
* Bone Mass Measurement less than
The University of Michigan OWL (Online Wellness and Lifestyle) Study

The goal of this trial is to pilot test our existing very low carbohydrate diet intervention, adapted for young adults.

Obesity increases the risk of a variety of illnesses such as heart disease, type 2 diabetes, cancer, sleep apnea, asthma, and depression. While advice from the Centers for Disease Control, American Heart Association, and the National Institutes of Health recommend a low-fat diet with a focus on whole grains and lean meats, research shows that a very low-carbohydrate diet may be more effective at reducing body mass index (BMI). Given the disconnect between recommendations and research, higher quality, long term, large trials are needed. In preparation for that research, the investigators plan to pilot test a very low-carbohydrate diet program, the OWL study (Online Wellness and Lifestyle Study), for 30 young adults followed over 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-25
* Obese (BMI ≥ 30)
* Sufficient control over diet
* Access to internet and texting
* Living in the United States
* Willing and able to follow intervention and complete measurements

Exclusion Criteria:

* Non-English speaking
* Pregnant, breastfeeding, or planning to be in the next 6 months
* Vegan or vegetarian
* Currently enrolled in weight loss program
* Taking medications known to cause weight loss or gain
* Taking glucose-lowering medications other than metformin
* Type 1 diabetes
* Cancer
* Heart failure
* Kidney failure
* History of eating disorders
* Untreated psychiatric disorder
* History of or planned weight loss surgery
* Consumption of greater than 30 alcoholic beverages per week
MRI as Alternative to CBCT for the Assessment of Furcation Involvement in Molars

Aim of this prospective study is to compare magnetic resonance imaging (MRI) and cone beam computed tomography (CBCT) to diagnose furcation involvement (FI) in molars in patients with periodontitis. The focus is on the differentiation of grad II and III according to Hamp et al. 1975. 140 molars (70 upper and 70 lower) will be investigated with CBCT and MRI. Due to the absence of ionic radiation MRI might be a radiation free diagnostic tool to assess FI in the future without harmful radiation for the patient. Patients of the Dental Clinic, Medical University of Vienna, who need a CBCT and have a clinically diagnosed FI can be a participant of this clinical trial and do in addition to their CBCT a MRI. The accuracy of MRI will be compared to the diagnostic gold standard CBCT. If patients need additional periodontal treatment, e.g., periodontal surgery, a subgroup will also be analysed with intraoperative measurements.


Eligibility Criteria:
Inclusion Criteria:

* Patients with FI grade II or III, patients who need a CBCT, not pregnant

Exclusion Criteria:

* Patients with contraindications to perform a MRI
Safety and Efficacy of CDCA in CTX Chenodeoxycholic Acid (CDCA) in Patients Affected by Cerebrotendinous Xanthomatosis (CTX)

Retrospective study of CTX patients to investigate the safety and clinical efficacy of Chenodeoxycholic Acid


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of CTX Received treatment with CDCA Age between 2 and 75 years Having at least one cholestanol level and/or urinary bile alcohol level no more than 3 months prior to treatment with CDCA and one cholestanol level and/or urinary bile alcohol level post-treatment within 2 years from the beginning of therapy with CDCA

Exclusion Criteria:

-
Prognostic Evaluation Prediction Model Survival Spinal Epidural Metastases

Patients with symptomatic spinal metatstasis will be prosepectively included in a database after theu signes informed consent. Minimally six months after inclusion the survival status is analyzed. These are correlated with factors that are used in an earlier develloped prediction model

The prediction model is web-based and used five parameters: Karnofsky performance score (KPS) (in case of sudden (\<24 hours) deterioration the score was used just before the deterioration), the curative intention to treat the primary, the spinal level of the symptomatic tumor, histopathology of the metastasis, and sex. These parameters will be recorded in addition to baseline characteristics. The date of presentation will be recorded. Four months after inclusion of the last patient survival status of all patients will scored. If applicable the date of death will be noted.

Patients are eligible if they suffer from a symptomatic epidural spinal metastatic lesion warranting therapy, either radiation therapy or a combination of surgery and radiation therapy. The nature of the lesion should be verified by pathological examination. In case of an active primary that has recently been diagnosed (less than one year previous to presentation of spinal lesion), the metastatic lesion is considered to be related to this primary. However, if the patient has more than one primary in the history, pathological verification of the tissue is obligatory.

After the patients provided informed consent of using their data for scientific use including the publication of the results, they will be included. The data will be collected, and electronically and anonymized stored. Patients will be included during three successive years. It is estimated that approximately 450 patients can be included. Two centers will participate, Radboud University Medical Center and Haaglanden Medical Center.

Statistical analysis The Cox model will be validated as described earlier 4, first graphically the predictive ability will be plotted, whereas next it will be quantitatively expressed as Harrel's c-index and the Royston -Sauerbrei D-statistic, Rd2. The calibration slope is also calculated. A sample of one third of all patients will be used for validation purpose. If needed the model is adapted. Then the validation is performed using the data of all patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with spinal spinal metastasis
* symptomatic
* adult
* informed consent

Exclusion Criteria:

* not understanding informed consent
Does Treatment With Montelukast Improve Symptoms of Atopic Dermatitis in Children?

An open-label (outcome assessor blinded) prospective crossover cohort study of children 6-16 years assessing effects of Montelukast on moderate to severe atopic dermatitis.

An open-label, prospective cohort study with two arms over 16 weeks comprising 8 weeks of treatment with montelukast and 8 weeks without treatment of montelukast. All patients will be followed from recruitment to the study end date.

Study Population 62 patients aged 6-16 years old with moderate to severe atopic dermatitis recruited from the Royal Children's Hospital and Box Hill Hospital dermatology clinics having already previously received eczema education (SCORAD \>25) Study Product Oral tablet montelukast Dose Regimen For patients 6-8 years old - 4mg montelukast once daily For patients 9-13 years old - 5mg montelukast once daily For patients 14-16 years old - 10mg montelukast once daily Evaluation Criteria Primary objective measurement: mean change in SCORAD index at 8 weeks Patients will be randomized into 2 arms: Arm 1 treated with montelukast therapy over 8 weeks followed by no montelukast therapy for 8 weeks. Arm 2 followed for 8 weeks without montelukast therapy followed by 8 weeks with montelukast therapy.

Assessment Schedule Clinical assessment will be conducted at baseline (week 0), and reviewed every 4 weeks over 16 weeks with a safety follow-up visit 2 weeks after the treatment ends (week 18). At the first clinic visit, demographic data, medical history and baseline SCORAD and cDLQI will be recorded. cDLQI will be completed by the participants. Participants with SCORAD \<25 are considered to have mild disease and will not be included in the study. Suitable participants will be prescribed oral montelukast as an adjunct to their standard topical therapy (corticosteroids, emollients) or immunosuppressive therapy. Adverse effects, SCORAD (assessed by a blinded assessor) and cDLQI will be assessed at each review.

Data will be analyzed based on intention-to-treat. Paired data on SCORAD and cDLQI will be analyzed. A p value \<0.05 will be considered statistically significant. A 30% improvement in SCORAD and cDLQI scores will be considered clinically significant.

Eligibility Criteria:
Inclusion Criteria:

- Patients aged 6-16 years old with moderate to severe atopic dermatitis (SCORAD \>25) despite topical therapy (corticosteroids and emollients) for at least 2 months Patients aged 6-16 years old with moderate to severe atopic dermatitis (SCORAD \>25) despite immunosuppressive therapy (azathioprine, cyclosporine, methotrexate) for at least 2 months

Exclusion Criteria:

- Patients with mild atopic dermatitis (SCORAD \<25) Patients who have received phototherapy in the past 8 weeks Patients with history of sensitivity to leukotriene receptor antagonists
Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid

This is a split-scar study with a target sample size of 20. There are two interventions: fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide. Patients will undergo treatments in a series of 4 treatments at approximately 4 week ± 1 week intervals. Investigators will monitor for safety and continued benefit after the end of the interventional treatment.


Eligibility Criteria:
Inclusion Criteria

1. Age 18-89
2. Has one large keloid scar or at least two similar but separate keloid scars
3. Keloid present for at least 1 year

Exclusion Criteria

1. Currently pregnant
2. Currently breastfeeding
3. Have taken oral retinoids within 6 months of study initiation
4. Has had keloid treatment within 1 month of study initiation
5. Has active infection at treatment site
6. Has active malignancy
7. Presence of pedunculated keloid(s) or keloid(s) that are judged to be best treated with surgical excision first
8. Hypertrophic scars
9. Known hypersensitivity to TAC or 5-FU
10. Chronic systemic corticosteroid or immunosuppressive medication use
11. Has intolerance to anesthesia
12. Has known connective tissue disease
13. Has known infectious disease