cyrilzakka/clinical-trials huggingface dataset:
Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation

There are more and more herbal preparations that are used for the purpose of treatment and improvement of the clinical picture of vaginitis by patients themselves, but also by healthcare professionals. Plant species, St. John's wort, chamomile, calendula, yarrow, shepherd's purse and tea tree oil are well known for there anti-inflammatory, antimicrobial and wound healing activity. This paper presents the results of a clinical study in which three herbal formulations/vagitories, based on extracts of above mentioned plant species, were investigated for their effectiveness on non-specific vaginitis.

This was randomized controlled clinical study that included 210 women with diagnosed non-specific vaginitis. Patients were divided into two basic groups, women in reproductive stage and postmenopausal stage. Three subgroups, containing approximately 30 patients each, received one of three vagitorie formulations for 5 days during which the effects on subjective and objective symptoms were monitored.


Eligibility Criteria:
Inclusion Criteria:

* adult women who already had sexual intercourse
* diagnosis of non-specific vaginal inflammation by medical examination.

Exclusion Criteria:

* microbiologically confirmed bacterial vaginosis,
* treatment with antibiotic therapy according to official protocols and guidelines
* allergies to one of the plant species included in the vaginal test,
* diabetes mellitus,
* pregnancy,
* lactation,
* immunodeficiency disorder,
* severe chronic illness,
* previous radiotherapy, chemotherapy and biological therapy
Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback

The overall objective of this randomized controlled study (RCT) financed by the Norwegian Research Council (grant no. 182012/V50) is to establish the effectiveness of situational feedback to the self-management of fibromyalgia syndrome (FMS) using innovative means of patient-provider communication in a randomized controlled study (RCT). Thereby this project will contribute to the knowledge of treatment of patients with FMS. The effectiveness of the intervention will be expressed in terms of a) reduced pain, b) psychometric outcomes, c) quality of life, d) improved engagement in daily activities and e) prevented transition to chronic disability. We furthermore aim to 1) determine the effectiveness of providing regular situational feedback in enhancing self-management and, consequently 2) study the effectiveness of enhancing self-management in reducing pain and physical disability.

Self-management of chronic pain is increasingly seen as an important tool in providing adequate care to patients with FMS and other types of Chronic Non-malignant Pain. Enhancing the patient's self-management of her/his condition is thought to be effective in reducing pain and disability. However, sufficient empirical evidence to support this is yet unavailable. This may be due to the non-situational nature of many interventions studied so far: Patients are taught management skills in a clinical setting, and may not be able to successfully use these skills in daily care. Therefore, enhancing self-management of chronic pain, by providing immediate feedback that is directly related to patient's daily life ("situational" feedback) complementary to care-as usual, is thought to be more effective than conventional interventions in a clinical setting. This may even be even more effective when the patient receives quick response feedback using mobile communication technology, i.e. any place any time.


Eligibility Criteria:
Inclusion Criteria:

* Female, having wide spread pain like FMS (IPCS codes CD-10, 79.0 - coded) for at least three months ,\> 18 years, able to understand Norwegian; able to use the webenabled mobile phone.

Exclusion Criteria:

* substantial psychological problems in need of treatment with intensive psychotherapy.
Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)

The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.


Eligibility Criteria:
Main inclusion criteria:

* Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition)
* No change in asthma treatment during the last 4 weeks prior to the registration
* Non-smokers or ex-smokers for 12 months or more
* %FEV1 ranging between 60 and 80%

Main exclusion criteria:

* Patients with poorly controlled asthma
* Inhalation therapy exceeding low dose during 4 weeks prior to the registration
* Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation
Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease

The objective of this study is to determine if using Fuzzy Wale compression stockinett can assist in reducing the healing time and decrease costs in trastibial amputation patients as compared to standard of care treatment compression stocking.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Male and female
* Transtibial amputation expected.
* Peripheral arterial disease and Transcutaneous partial pressure of oxygen (TCP02, if performed)
* Ability of subject to give appropriate consent or have an appropriate representative available to do so.

Exclusion Criteria:

* Known allergies to any of the components of the compression.
* Terminal illness or current cancer therapy with chemotherapy
* Inability to undergo ongoing care in Rochester.
* Lack of cognitive ability to follow instructions or monitor residual limb.
* Vulnerable study population
* Pregnancy
Automated Check-in Data Collection Study

The aim of this study is to examine patient acceptability, for providing brief research information, whilst self-completing an automated check-in screen prior to any general practice consultation.

The Automated Check-in Data Collection (AC DC) Study, is a pilot feasibility study, observing patients consulting in general practice and completing an automated check-in screen prior to their booked appointment, to confirm their attendance. Participants will be recruited over three weeks from approximately 11 participating general practices.

The primary objective of the study is to assess patient acceptability for answering brief research questions in the general practice waiting room, using an automated check-in screen. This will be measured by observing the percentage of completed automated check-in screens with entered research data.

Secondary objectives will assess check-in completion of self-reported pain and willingness to be contacted about future research studies of relevance. Reported severity of bodily pain experienced over the last 4 weeks and the proportion of patients agreeing to be contacted about future research studies of relevance, will be observed.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or over attending participating general practices for a consultation with any healthcare professional.
* Patients registered with the participating general practice during the specified recruitment period.
* Patients able to read and respond in English.

Exclusion Criteria:

• Patients under the age of 18 attending the general practice for a consultation with a healthcare professional.
Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3

A long term safety study of amifampridine phosphate in patients with spinal muscular atrophy (SMA) Type 3.

This open-label outpatient extension study was designed to evaluate the long-term safety and tolerability of amifampridine in patients diagnosed with SMA Type 3. In addition, the evaluation of the effects of amifampridine on the QoL was performed. The study was planned to enroll those patients who had completed the SMA-001 study and after all final evaluations for that study had been completed, or those who demonstrated benefit after completing the dose titration period but failed to meet the randomization criteria on Day 0 of SMA-001.

The duration of participation for each patient was expected to be at least 12 months as patients could continue in the study until amifampridine was approved by Regulatory Agencies or the clinical development of amifampridine was terminated for this indication. In addition to amifampridine, patients continued to receive previous concomitant medications, as needed.

Eligibility Criteria:
Inclusion Criteria:

Individuals eligible to participate in this study must meet all the following inclusion criteria:

1. Participated in the SMA-001 study
2. Willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures.
3. Female patients of childbearing potential must have a negative pregnancy test (urine human chorionic gonadotropin \[HCG\] at the end of SMA-001 study); and must practice an effective, reliable contraceptive regimen during the study and for up to 30 days following discontinuation of treatment.
4. Ability to participate in the study based on overall health of the patient and disease prognosis, as applicable, in the opinion of the Investigator; and able to comply with all requirements of the protocol, including completion of study questionnaires.

Exclusion Criteria:

Individuals who met any of the exclusion criteria in the original protocol or those listed below are not eligible to participate in the study:

1. Epilepsy and currently on medication.
2. Uncontrolled asthma.
3. Concomitant use with sultopride.
4. Concomitant use with medicinal products with a narrow therapeutic window.
5. Concomitant use with medicinal products with a known to cause QTc prolongation.
6. Clinically significant abnormalities in 12 lead ECG, in the opinion of the Investigator.
7. Subjects with congenital QT syndromes.
8. Breastfeeding or pregnant at Screening or planning to become pregnant at any time during the study.
9. Intolerable amifampridine-related side effects
10. Treatment with an investigational drug (other than amifampridine) or device while participating in this study.
11. Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confound the assessment of the patient.
12. History of drug allergy to any pyridine-containing substances or any amifampridine excipient(s).
Artificial Intelligence and Postoperative Acute Kidney Injury

The main objective of this study is to develop and validate an artificial intelligence model that predicts postoperative acute kidney injury.

Postoperative acute kidney injury is known to increase the length of hospital stay and healthcare cost. A lot of risk prediction models have been developed for identifying patients at increased risk of postoperative acute kidney injury. Recent advances in artificial intelligence make it possible to manage and analyze big data. Prediction model using an artificial intelligence and large-scale data can improve the accuracy of prediction performance. Furthermore, the use of an artificial intelligence may be a useful adjuvant tool in making clinical decisions or real-time prediction if it is integrated into the electrical medical record systems. However, before implementing an artificial intelligence model into the clinical setting, prospective evaluation of an artificial intelligence model's real performance is essential. However, to our knowledge, there was no artificial intelligence model for prediction of postoperative acute kidney injury, which was prospectively evaluated. Therefore, we aimed to develop an artificial intelligence model which predicts postoperative acute kidney injury and evaluate the model's performance prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients undergoing non-cardiac surgery

Exclusion Criteria:

* Age under 18 years
* Surgery duration \< 1 hour
* Transplantation surgery
* Nephrectomy
* Cardiac surgery
* Patients who had severe kidney dysfunction preoperatively as follows:
* Serum creatinine ≥ 4 mg/dl
* Estimated glomerular filtration rate \<15 ml/min/1.73m2
* History of renal replacement therapy
* Patients who had no results of preoperative or postoperative serum creatinine
Metabolic Effects of High-amylose Wheat-based Breads

The amylose-amylopectin ratio influences starch properties. A higher amylose content is associated with slower starch digestion thus reducing the postprandial plasma glucose response and improving the overall postprandial metabolism. So far, limited evidence is available on the metabolic effect of wheat-based foods rich in amylose. This randomised controlled study investigated the acute metabolic effects of amylose-rich wheat-based breads in overweight subjects focusing on potential mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese
* 18-70 years

Exclusion Criteria:

* age \<18 and \>70 years;
* fasting triglycerides ≥400 mg/dl;
* fasting cholesterol \>270 mg/dl;
* cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study
* established diabetes mellitus or any chronic disease
* renal and liver failure (creatinine \>1.7 mg/dl and transaminases \>2 times than normal values, respectively)
* anaemia (Hb \<12 g /dl)
Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia


Eligibility Criteria:
Inclusion Criteria:- Age: 18 years and older- Males with erectile dysfunction- Stable heterosexual relationship- Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia Exclusion Criteria:- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use- Other exclusion criteria apply according to Summary of Product Characteristics
Cognitive Behavioral Intervention in Diabetes Self-Management

The proposed study is a two arm randomized controlled trial with longitudinal follow-up that compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs. Control) by Time (Pre, Post, Follow Up).


Eligibility Criteria:
Inclusion Criteria:

* Asian/Pacific Islander Men and Women with type 2 diabetes; asymptomatic for hyperglycemia
* Both men and women will be included in the study if they have a diagnosis of type 2 diabetes made by a physician and meet classification and diagnostic criteria established by the American Diabetes Association (American Diabetes Association, 1997)
* Between 18 and 76 years
* Participation in diabetes education program of University Specialty Clinics

Exclusion Criteria:

* Crippling arthritis
* Joint replacements that limit movement
* Neuromuscular disease with paralysis
* Severe eye disease or visually impaired
* Chronic renal failure and/or End Stage Renal Disease requiring hemodialysis or peritoneal dialysis
* Transplant recipient
* Foot Amputation
* Congestive Heart Failure
* New York Heart Class III/IV
* Previous Cerebral Vascular Accident (stroke) with residual paralysis
* Malignancy
* Chronic hepatitis C
* HIV disease
* Individuals who contemplate changing residence within the period of study and becoming inaccessible to the study should be discouraged from the study
Care Coordination System for People With Dementia

Dementia, a chronic disease of aging, is characterized by progressive cognitive decline that interferes with independent functioning. The medical, psychological, social and functional sequelae of dementia cause great stress to patients, their caregivers, and their family. The investigator proposes to examine effectivness of a home-based care coordination and management device, called Care4AD to help caregivers effectively coordinate, manage, and improve dementia care.

In this study the investigator will assess the effectiveness of a care coordination device (a supportive care device) called, Care4AD for reducing burden and stress of caregivers, enhancing patient adherence to scheduled tasks, and increasing Individuals with dementia activity (IWD). The investigator will conduct a 6-month prospective randomized control trial (RCT) of 100 persons with mild to moderately severe dementia to examine changes in caregiver's burden and stress and IWD's physical activity and adherence to scheduled ADLs. Feedback (e.g., reminders about completed/incomplete tasks) will be activated in the intervention group (IG) and de-activated in the control group (CG). The investigator will also use an ADL log and bi-weekly phone interview with a caregiver as gold standards to validate the detection of adherence to scheduled ADLs of interest. Furthermore, the acceptability, perception of benefit, and ease of use of Care4AD will be further assessed using technology acceptance model (TAM). We hypothesize that at 6 months, those in the IG compared to the CG will have less caregiver burden (Zarit Burden Interview (ZBI) (primary outcome), greater IWD adherence to scheduled ADLs (primary outcome), and higher IWD physical function and activity (primary outcome). Secondary outcomes will include caregiver coping (Brief Cope), self-efficacy (Revised Scale for Caregiving Self-Efficacy), and preparedness (Preparedness for Caregiving Scale), and quality of life of IWD (Quality of Life in Alzheimer's disease scale)

Eligibility Criteria:
Inclusion Criteria include:

* Older patients (\> 65 years old) with mild or moderate Alzheimer's Disease
* Must be ambulatory
* Must be in a residential home with a caregiver/informant.

Exclusion Criteria:

* Immobility or inability to engage in activities that are essential for independent living (e.g., patients with severe dementia);
* Any significant medical or psychiatric condition that, in the judgment of the investigators, would potentially interfere with the ability to participate in the study
* Major hearing/visual impairment;
* Residing in a nursing home or are receiving hospice care;
* Inability to communicate in English or Spanish;
* Unavailability or unwillingness of the caregiver of the patient to attend the interview.
CICERO- A Care Home Study of COVID-19

The primary objective of the study is to determine whether, at 21 days, care homes that implemented near-patient daily testing have a lower rate of confirmed CoV-2 infections than care homes following the DHSC standard of care testing of symptomatic residents.

Accurate, rapid, near-patient testing systems, such as q16+CoV-2, allow for daily routine testing of residents, and of staff and visitors prior to entering the care home.

Daily CoV-2 PCR testing with high analytical sensitivity (e.g., 2 copies per 8 µl sample) may detect infected residents and visitors before clinical symptoms are apparent. Earlier detection may lead to earlier implementation of the UK standard of care protocol for Infection prevention and control measures, thereby preventing the asymptomatic infected individuals from introducing and/or transmitting CoV-2 within the care home. This should reduce the transmission by:

Preventing the introduction of the virus into care homes from external visitors e.g., GPs (Inward transmission) Preventing the spread of the virus within care homes and preventing cluster development (internal transmission) Preventing the outward spread of the virus from within care homes by infection of external visitors (Outward transmission)

Eligibility Criteria:
Inclusion Criteria:

* Persons resident or requiring access to the care home
* Capable of giving written informed consent, or if appropriate, having an acceptable individual capable of giving consent on the participant's behalf.

Exclusion Criteria:

* Persons not providing informed consent or withdrawing consent at any time during the study.
* Persons requiring urgent and immediate access to the care home, for example medical staff attending emergency visits.
* Persons unable to provide nasal or oropharyngeal swabs for medical reasons.
Facemasks and Chronic Pain Patients With Hearing Loss

Facemasks may impede communication. Impaired communication may worsen healthcare outcomes. This study explores the problem of hearing impairment in chronic pain patients, and the impact of facemasks on healthcare outcomes in chronic pain patients.

Data collection includes patient's age, anxiety score, depression score, numeric pain score, and effects of facemasks on treatment outcomes. Pain is measured using numeric pain rating scale. Depression is measured using the Patient Health Questionnaire (PHQ-9) scale. Anxiety is measured using the General Anxiety Disorder (GAD-7) scale.

Facemasks may impede communication. Impaired communication may worsen healthcare outcomes. There is inadequate data on the prevalence of hearing impairment in chronic pain patients. There is inadequate information about the impact of facemasks on treatment outcomes in chronic pain patients with hearing impairment. This prospective study explores the problem of hearing impairment in chronic pain patients, and the impact of facemasks on healthcare outcomes in chronic pain patients.

This is a prospective cohort study of adult patients undergoing pain treatment at an interventional pain clinic in Canada. Data collection includes patient's age, anxiety score, depression score, analgesic usage, numeric pain score, and effects of facemasks on pain management outcomes. Pain is measured using numeric pain rating scale of 0-10, with change of 2-points being considered significant. Depression is measured using the Patient Health Questionnaire (PHQ-9) scale of 0-27, with change of 3-points being considered significant. Anxiety is measured using the General Anxiety Disorder (GAD-7) scale of 0-21, with change of 3-points being considered significant.

Data are analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \<0.05 is considered significant.

Eligibility Criteria:
Inclusion Criteria:

* adults
* chronic pain diagnosis
* diagnosed hearing impairment
* use of hearing aid

Exclusion Criteria:

* complete deafness
* cochlear implant
* severe vision impairment
* cognitive dysfunction