cyrilzakka/clinical-trials huggingface dataset:
Use of Electronic Personal Health Records to Improve Medication Adherence

The purpose of this pilot study is to examine the use of a personal health record to improve medication adherence among patients with non-valvular atrial fibrillation taking dabigatran for primary prevention of embolic stroke.

Three brief newsletters will be sent by the research staff to the study patients in the form of secure messages through their MyChart account. The newsletters will describe dabigatran tolerability, adverse effects, patient monitoring, warnings/precautions, and administration. Newsletters will be developed through a review of the FDA-approved prescribing information, general tertiary references, and a search of PubMed and drafted with guidance from a Drug Information Specialist at Manchester University College of Pharmacy as well as reviewed by the research staff.

Descriptive analysis will be used to analyze the survey to assess patient attitudes and beliefs about dabigatran and personal health records, as well as to assess the level of patient engagement. Difference-in-difference regression analysis will be used to evaluate the impact of the personal health record on dabigatran adherence by comparing the differences between times (pre-post) and interventions. Patient medication adherence will be correlated from the Pharmacy refill data to determine if the Intervention Group is more compliant than the Control Group. Multivariate analysis will be used to explore factors influencing personal health record use and dabigatran adherence.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient of Parkview Physicians Group-Cardiology
* Currently on dabigatran for non-valvular atrial fibrillation
* Out-patient status
* Ability to read and understand English
* Access to the Internet
* Ability to utilize the computer and Internet
* Willingness to enroll in a MyChart account

Exclusion Criteria:

* Physical or cognitive disability hindering provision of the informed consent process or performance of study tasks
* Unable to physically or cognitively carry out the tasks necessary for activating and/or utilizing a personal health record
* Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
* Currently part of another study involving another type of personal health record (other than MyChart)
Volatile Organic Compounds (VOCs) as a Biomarker in Immune-mediated Pulmonary Arterial Hypertension (PAH)

Aim: to investigate the role of inflammation and auto-immunity in pulmonary arterial hypertension by using the profile of volatile organic compounds.

Hypothesis: first, the investigators hypothesize that at time of diagnosis the VOC profiles will discriminate patients with PAH-CTD and idiopathic PAH (IPAH) from patients with systemic sclerosis or systemic lupus erythematosus (CTD) without PAH, supporting the contention that there is a overlapping inflammatory and auto-immune pathway in PAH. During follow-up, the investigators will measure the VOC profiles of patients in all three groups who will be treated according standard clinical care. The hypothesis is that VOC profiles are affected by therapy.


Eligibility Criteria:
Inclusion Criteria:

1. PAH-CTD patients, inclusion criteria:

   * classification as definite systemic sclerosis or systemic lupus erythematosus according to respectively the ACR-EULAR criteria (16) and SLICC criteria (17)
   * minimal age of 18 year
   * diagnosis of pulmonary arterial hypertension: mean pulmonary artery pressure (mPAP) of ≥25 mmHg, pulmonary capillary wedge pressure (PCWP) ≤15 mmHg, and a pulmonary vascular resistance (PVR) ≥240 dynes.s.cm-5 measured by right heart catherization.
2. IPAH patients, inclusion criteria:

   * diagnosis of pulmonary arterial hypertension: mean pulmonary artery pressure (mPAP) of ≥25 mmHg, pulmonary capillary wedge pressure (PCWP) ≤15 mmHg, and a pulmonary vascular resistance (PVR) ≥240 dynes.s.cm-5 measured by right heart catherization.
   * no family history of PAH
   * triggering factor is excluded: connective tissue disease, drugs or toxins, human immunodeficiency virus, congenital heart disease, portal hypertension, schistosomiasis (2)
   * minimal age of 18 year
3. SSc and SLE (CTD) patients without PAH, inclusion criteria:

   * classification as definite systemic sclerosis or systemic lupus erythematosus according to respectively the ACR-EULAR criteria (16) and SLICC criteria (17)
   * minimal age of 18 year
   * no signs of PAH at screening visit

Exclusion Criteria:

* active or treated malignancy
* tuberculosis or hepatitis B/C infection in case of start immunosuppressive therapy
* need to start immediately with therapy
* already use of immune suppression
The Effects of Spinal Manipulation on Thigh Muscle Strength

The purpose of this study was to investigate the effects of chiropractic low back adjustments on thigh muscle strength. Force production was measured during different types of muscle contractions with a device called an isokinetic dynamometer. The study included 21 college-aged subjects who did not have any pain and had never received chiropractic treatment with spinal manipulation. During two separate sessions, subjects' thigh muscle forces were recorded while performing maximal muscle contractions on the isokinetic dynamometer. Baseline measurements of muscle force were acquired before either treatment form of spinal manipulation or a sham spinal manipulation, followed by identical muscle force measurements within five and twenty minutes post-treatment.

Spinal manipulation is a therapeutic procedure employed by various healthcare practitioners for alleviating acute and chronic musculoskeletal complaints. This form of treatment is also delivered to enhance the performance and augment the rehabilitation of athletes. However, despite research findings alleging the strength-modulating effects of spinal manipulation alongside numerous professional athletes' positive anecdotal claims concerning its results, the physiological processes to explain its effects remain largely unexplained. Therefore, the purpose of this work was to investigate the effects of spinal manipulation in a college-aged sample population.

This study examined the effect of spinal manipulation delivered to the lumbosacral region on concentric force production of the knee extensors and flexors. A randomized, controlled, single-blind repeated measures design was utilized with 21 subjects. Isometric and isokinetic peak torques (Nm) were recorded during two separate session while subjects performed maximal voluntary contractions post-treatment of either spinal manipulation or a sham manipulation.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 20 to 35 years
* Asymptomatic with regard to low back, pelvic or lower extremity pain

Exclusion Criteria:

* Previously received spinal manipulation from a chiropractor or other health care provider
* Contraindications to lumbar spine manipulation (such as fractures, lumbar disc herniation, abdominal aortic aneurysm or cauda equina syndrome)
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.


Eligibility Criteria:
Inclusion Criteria:

* Previous enrollment in and completion of Study GR40349 (NCT03622580) or GR40398 (NCT03622593), without study or study drug discontinuation
* Ability to comply with the study protocol, in the investigator's judgment
* For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Exclusion Criteria:

* Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final intravitreal injection of faricimab
* Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
* Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
* Requirement for continuous use of any medications or treatments indicated as prohibited therapy
Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva

RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva.

PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva.

OBJECTIVES:

* Determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva.
* Determine the location of the sentinel node in these patients.

OUTLINE: Patients receive injection(s) of isosulfan blue into the dermis at the junction of the tumor and normal vulvar skin. Once the afferent lymphatic channel and sentinel node have been identified, patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy followed by resection of the primary tumor with adequate margins. Preoperative lymphoscintigraphy is also performed.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until recurrence.

PROJECTED ACCRUAL: A total of 40-630 patients will be accrued for this study within 2-6 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive squamous cell carcinoma of the vulva that is greater than 1 mm in thickness as measured from the nearest rete peg

  * Tumor size must be 2-6 cm
  * No recurrent disease
* Prior excision of the primary disease or a history of carcinoma in situ of the vulva allowed
* No tumor extending into the urethra, anus, vagina, rectum, or bladder
* No grossly suspicious or inflamed groin nodes on physical exam
* No grossly infected primary tumors

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* GOG 0-3

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other invasive malignancy within the past 5 years except non-melanomatous skin cancer
* No known hypersensitivity to phenylethane compounds

PRIOR CONCURRENT THERAPY:

* No prior cancer therapy that contraindicates therapy in this study

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
* No prior groin dissection
Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial

This is a randomized controlled trial investigating efficacy of electrochemotherapy for early colorectal cancer

This is a phase 2 randomized controlled trial. The study is blinded. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with electrochemotherapy, compared with electroporation alone, as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients are treated with electrochemotherapy (bleomycin) and 12 patients with electroporation alone (placebo)

In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment.

Patients will be followed for one month after the elective surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be mentally capable of understanding the information given.
* Patients must give written informed consent.
* Endoscopically suspected or histologically verified malignant tumor of the rectum or sigmoid colon.
* Tumor described as passable at index endoscopy.
* Men or women aged at least 18 years.
* Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.
* ASA class I-II (Classification of the American Society of Anesthesiology)

Exclusion Criteria:

* Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
* Uncorrectable coagulation disorder.
* Patients with ICD or pacemaker units.
* Ongoing immunosuppressive treatment.
* Patients with concomitant use of phenytoin.
* Myocardial insufficiency, defined as NYHA class \>2
* Concurrent treatment with an investigational medicinal product.
* Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
* Advanced tumor stages, clinical UICC stage IV.
* Acute surgical resection.
* Pregnancy
* Medical history of severe pulmonary disease.
* Previous cumulative dose of bleomycin exceeding 250mg/m2.
* BMI \> 35
* Renal impairment, defined as eGFR \<40 ml/min
Pain Relief by Platelet-rich Plasma (PRP) Treatment

Past PRP therapy is not sufficient for some part of patients.In this clinical research, The integrated application of PRP with extracellurar matrix and some type of stem cell technique.


Eligibility Criteria:
Inclusion Criteria:

* Injury by professional sports and non professional sports

Exclusion Criteria:

* Other basic disease holder
Peri-implant Marginal Bone and Soft Tissue Conditions Around Single Laser-Lok Implants Placed in Regenerated Extraction Sockets and in Native Bone: A 2-years Results of RCT

The aim of present study was to compare peri-implant marginal bone loss and soft tissues conditions around single Laser-Lok implants placed in alveolar

Records of 20 consecutive patients treated with dental implants placed in post-extraction sockets augmented with porcine derived bone and 20 consecutive patients with implants placed in native bone were reviewed. For each implant, the radio- graphs from the surgical appointment were compared to those from the last follow-up visit and evaluated regarding changes of marginal bone level over time.

Eligibility Criteria:
Inclusion Criteria:

* mono-edentulism, age ≥ 18 years, good general health, without contraindications to implant surgery

Exclusion Criteria:

* lack of a periodontal chart and periapical radiograph at the beginning and at the end of follow-up period, alcohol and drug abuse, pregnancy, or uncontrolled metabolic disorders, tobacco smoking (\> 10 cigarettes/day), full mouth plaque score (FMPS), and full mouth bleeding score /FMBS) ≥25%, teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections.
Dissecting the Molecular and Cellular Pathophysiology of Sarcopenic Obesity in the Elderly

Ageing is characterised by a change in body composition with a parallel decrease in muscle mass and an increase and central redistribution of fat. When drastically exacerbated, these two processes culminate in a condition known as sarcopenic obesity (SO). SO is characterised by the coexistence of obesity and sarcopenia (i.e. reduced muscle mass and function) and is a growing public health problem in the elderly. The health risks of obesity and sarcopenia act synergistically, maximising the risk of disability of OS. The molecular mechanisms underlying OS are largely unknown. Increased fat mass induces chronic systemic inflammation and alters the profiles of adipokines and hormones, promoting the development of sarcopenia. On the other hand, the reduction in muscle tissue (SM) typical of sarcopenia is characterised by an alteration in the metabolic properties of skeletal muscle with an increase in insulin resistance and a reduction in energy expenditure that favours the accumulation and dysfunction of adipose tissue (AT). The cellular alterations that would seem to underlie OS are: altered autophagy, cellular senescence, epigenetic and mitochondrial alterations and maladaptive activation of intra- and intercellular inflammatory circuits (e.g. cytokines, extracellular vesicles, dysfunctional circulating leukocytes). However, the interconnections between these mechanisms are still unclear. The impact of OS can be dramatic on the health and quality of life of those affected. Therefore, the identification of early biomarkers that can recognise overweight and obese individuals at risk of developing SO is of paramount importance. This would shed light on the heterogeneity of an otherwise homogeneous clinical condition, opening new horizons towards the conscious design of more personalised therapeutic strategies, allowing a more rational use of the limited resources available for the growing elderly population.

The study design designed to achieve this aim is a cross-sectional observational study with an additional multicentre procedure lasting two years.


Eligibility Criteria:
Inclusion Criteria:

patients who are candidates for hip surgery

* patients who are candidates for hip surgery
* age ≥ 65 years
* patients able to give consent

healthy subjects

- healthy subjects from the geriatric cohort studied in 2016-2017 who at that time were: were overweight (25 ≤ BMI \< 30 kg/m2) or obese (BMI ≥ 30 kg/m2) but had not yet developed sarcopenia

Exclusion Criteria:

All partecipants

* unavailability to participate in the study
* inflammatory or neurological myopathies
* acute heart failure
* active cancer
Efficacy and Safety of XP12B in Women With Menorrhagia

The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.


Eligibility Criteria:
Inclusion Criteria:

* Women with menorrhagia
* 18-49 years of age
* Regularly occurring menstrual periods

Exclusion Criteria:

* History or presence of clinically significant disease or abnormalities that may confound the study
* History of bilateral oophorectomy or hysterectomy
* Hormone therapy for birth control
Integrative Gastroenterology - an Observational Trial

This study aims to test, if a two-week integrative therapy in an internal medicine ward will improve symptoms, disability and quality of life in patients with inflammatory bowel disease or irritable bowel syndrome.a It shall further be tested, if those changes are associated with attitudes and experiences towards complementary and alternative medicine, anxiety, depression and stress perception as well as body awareness and responsiveness.

see above

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD)
* written informed consent

Exclusion Criteria:

* participation in other clinical studies
DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults

The purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Patients with asthma, either well-controlled on a regular therapy with a combination of long-acting beta-agonists and inhaled corticosteroids or symptomatic on therapy with inhaled corticosteroids alone.

Exclusion Criteria:

* Any other significant lung disease other than asthma
* Any disease that might put patients at risk if they participate in the study
Treatment of ITP With Rituximab and / or Accutane

a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China

This is a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China. The investigators explore the efficacy and safety of Rituximab plus short-term methylprednisolone compare standard dose methylprednisolone in newly diagnosed ITP participants.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
2. Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L combined with bleeding manifestation
3. Subject is ≥ 18 years and ≤80years
4. Subject has signed and dated written informed consent.
5. Fertile patients must use effective contraception during treatment and observational period
6. Negative pregnancy test

Exclusion Criteria:

1. Have an impaired renal function as indicated by a serum creatinine level \> 2.0 mg/dL
2. Have an inadequate liver function as indicated by a total bilirubin level \> 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level \> 3×upper limit of normal
3. Have a New York Heart Classification III or IV heart disease
4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
5. Have active hepatitis B or hepatitis C infection
6. Have a HIV infection
7. Have active infection requiring antibiotic therapy within 7 days prior to study entry
8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
9. Previous treatment with rituximab
10. Previous splenectomy
11. Had previous or concomitant malignant disease
12. Not willing to participate in the study.
13. Expected survival of \< 2 years
14. Intolerant to murine antibodies
15. Immunosuppressive treatment within the last month
16. Connective tissue disease
17. Autoimmune hemolytic anemia
18. Patients currently involved in another clinical trial with evaluation of drug treatment