cyrilzakka/clinical-trials huggingface dataset:
Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program

The aim of the study is to develop, carry out, evaluate and measure the effects of a new patient education program for patients with Chronic Fatigue Syndrome (CFS)in primary healthcare.

In an randomized controlled trial design the effects of the patient education program on coping, physical functioning, fatigue, pain, acceptance, anxiety, depression, quality of life, self- efficacy, and illness perception will be compared with treatment as usual.

The results of the main project will lead to the elaboration of the final patient education program that can be implemented in primary health care, as well as development of a training program for future program-conductors.

The project is a single blind randomized controlled trial. A total of 150 participants will be included in this study and randomly allocated to the intervention- or the control group. The 75 participants in the intervention group will be allocated to 6 groups. The control group will be offered to take part in the patient education program as soon as they have completed the last outcome evaluations.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Meets Fukuda's research diagnostic criteria and Canadian CFS case definition
* Has given oral and written informed consent
* Able to tak part in the program that lasts 2,5 hours in addition to transport to and from the location for intervention.

Exclusion Criteria:

* Psychosis or other severe psychiatric diseases, severe personality disturbances and/or substance dependency
* Pregnancy
* Not being able to understand, speak and read Norwegian
* Not willing to accept random assignment
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications

This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.

This is a post-approval registry which is required by of the approval under PMA P150038/S014 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral pallidotomy in the treatment of idiopathic Parkinson's Disease with medication-refractory moderate to severe motor complications. Subjects participating in this registry will have received a unilateral pallidotomy using the commercially available Exablate Neuro.

The following assessments will be collected at Baseline, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years:

Adverse Events (AEs) (does not apply to Baseline Visit) Medication usage MDS-UPDRS Unified Dyskinesia Rating Scale EQ-5D-5L WPAI-GH Clinician and Patient Global Impression of Change Patient Satisfaction Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 30 years and older.
* Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care.
* Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry visits.
* Subject has signed and received a copy of the approved informed consent form.

Exclusion Criteria:

* Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.
The Combined FIFA 11+ and Change of Direction Training

The study has investigated the effects of adding change of direction (COD) training to the FIFA 11+ on lower extremity performance in soccer players. The investigators are interested in knee valgus angle during cutting which is typically suggested as a critical risk of anterior cruciate ligament injury. Peak knee valgus angle during cutting is expected to reduce immediately after adding COD training to the FIFA 11+.


Eligibility Criteria:
Inclusion Criteria:

* Soccer players

Exclusion Criteria:

* Having experience of serious injury such as, ACL injury and chronic ankle instability
* Having experience of lower limb surgery such as, bone fracture, tendon rupture, or ligament rupture
* Having current musculoskeletal injuries such as, muscle sprain
* Attending other prevention program or similar study especially on lower extremity
* Soccer player who are unable to perform level 3 of part 2 of the FIFA 11+ prevention program
Effects of a New Botanical Extracts Combination on Quality of Life in Menopausal Spanish Women

This study was designed to evaluate the beneficial effects and safety of a standardised botanical extract combination containing soy isoflavone extract, grains of paradise seed dry extract and pomegranate skin dry extract on health-related Quality of Life in healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the self reported and validated Cervantes Scale.

Fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled, double-blind study. Women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. At the beginning and end of the study, health-related Quality of Life was assessed using the Cervantes Scale.

Eligibility Criteria:
Inclusion Criteria:

* Women in the Climacteric Phase under medical criteria based on Health questionnaire, Blood and urine test.
* Informed consent to participate in the study.

Exclusion Criteria:

* Hormone-related pathologies.
* Menopause from surgery origin.
* Family or personal history of endocrine cancer.
* Known hypersensitivity to gluten, soybeans, soy protein, dairy products, pomegranate or grains of paradise.
* Vegetarian diet or daily consumption of soya rich-products during the last year.
* Anovulatory treatment.
* Hormone replacement treatment.
EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

The long-term use of calcineurin inhibitors in the maintenance phase after kidney transplantation is associated with typical adverse effects, such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities.

This 15 month study with a safety follow up is undertaken to evaluate the potential benefit of an alternative treatment strategy to the chronic use of CNI. It will establish, through a comparative design, the superior protection of kidney function provided by chronic usage of basiliximab over tacrolimus early post-transplantation using EDC kidneys.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients aged 40 to 75 years with a viable graft
* patients who are recipients of a primary or secondary graft from a cadaveric expanded donor criteria
* patients who had no change of immunosuppressor two weeks prior to baseline
* patients who had no acute rejection four weeks prior to baseline
* patients who are willing and capable of giving written informed consent for study participation
* females of childbearing potential must have a negative serum pregnancy test within 7 days prior to baseline.Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility
* Patients who are HCV and HBV negative

Exclusion Criteria

* patients who have a calculated GFR (Nankivell formula) of less than 30mL/min at baseline
* Patients who are recipients of multiple organ transplants
* Patients who are recipients of dual kidney transplants
* Patients with panel reactive antibodies \>50% at transplant
* Patients with a known hypersensitivity to tacrolimus,EC-MPS or basiliximab at baseline
* Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin
* Patients who are HIV positive at study entry
* Patients who have received a kidney from a HCV positive or HBV positive donor
* Patients with signs of active immune process on graft biopsy at baseline
* Patients with polyoma (BK or JC)
* Patients with operative or technical failure

Exclusion Criteria:

-
Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure

The purpose of this study is to see if using aromatherapy (Lavender or Bergamot) will lower anxiety in patients having invasive Radiology procedures. First, the level of anxiety is assessed prior to the procedure using a questionnaire. Then, patients are given the aromatherapy treatment during the pre-procedure period. Then, the same questions are asked to determine how anxious the patient is after the aromatherapy and before going into the procedure room. After the procedure, patients are asked to evaluate the process of the study.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for Myelogram or IR invasive procedure at investigative site

Exclusion Criteria:

* Incapable of giving informed consent
* Requiring pre-medication for scheduled procedure
* Allergy to lavender or bergamot
* Asthma (type of breathing related condition)
* COPD (Chronic Obstructive Pulmonary Disorder - breathing disease)
* Respiratory issues requiring oxygen therapy
Evaluation of the Role of IgE Responses to Der p 1 and Der p 2 in Chinese House Dust Mite-Allergic Patients

One hundred patients were enrolled, based on sensitization and doctor-diagnosed allergy to HDM. Questionnaires were administered to document demographic and clinical characteristics. Serum IgE reactivity toDermatophagoides pteronyssinus (Dp) extract, Der p 1, Der p 2 and Der p 10 was measured by ImmunoCAP.

Background: The role of specific IgE (sIgE) against Der p 1and Der p 2 in Chinese patients with house dust mite (HDM)allergy has not yet been well investigated.Methods: One hundred patients were enrolled, based on sensitization and doctor-diagnosed allergy to HDM. Questionnaires were administered to document demographic and clinical characteristics. Serum IgE reactivity toDermatophagoides pteronyssinus (Dp) extract, Der p 1, Der p 2 and Der p 10 was measured by ImmunoCAP.

Eligibility Criteria:
Inclusion Criteria:

* HDM-allergic patients reporting allergic rhinitis, conjunctivitis, asthma and/or atopic dermatitis and who had never undergone immunotherapy, were enrolled if they were sensitized to Dp as judged by ImmunoCAP ( ≥ 1 kU/l) and/or skin reaction index (SRI)by skin-prick test (SPT, a wheal diameter ≥ 0.5 mm).

Exclusion Criteria:

* Patients who refused to participate in the study.
Efficacy of Topical Calcipotriol-assisted AFL-PDT in Actinic Keratosis

Vitamin D(Vit D) is a pro-differentiation agent that enhances the accumulation of protoporphyrin IX (PpIX) after MAL(methyl-aminolevulinate) incubation in actinic keratosis and may have significant benefit for the treatment of actinic keratosis by ablative fractional laser-primed photodynamic therapy (AFL-PDT).

Photodynamic therapy (PDT) with methyl-aminolevulinate (MAL) is effective in the treatment of actinic keratosis (AK). Many strategies have been studied to improve the production of protoporphyrin IX (PpIX), to improve efficacy of PDT. Pre-treatment of the skin with fractional laser resurfacing is a novel alternative technique to improve the efficacy of PDT for AK. The investigators' previous studies showed that ablative fractional laser primed PDT (AFL-PDT) offered higher efficacy than conventional MAL-PDT in the treatment of AK. But, reduced response rates are also observed in thicker skin lesions, which may be due to insufficient PpIX accumulation within the target tissue.

Cellular differentiation leads to increased synthesis of PpIX from MAL and consecutively, differentiation therapy enhances photosensitization effect. Topical calcipotriol is a well-known pro-differentiation hormone and was demonstrated to influence the effect of PDT on keratinocytes.

The aim of this study was to evaluate efficacy of topical vitamin D in AFL-PDT for AK treatment. Consequently, the investigator compared efficacy, recurrence rate, cosmetic outcome and safety between VitD - AFL-PDT and conventional AFL-PDT.

Eligibility Criteria:
Inclusion Criteria:

* Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions

Exclusion Criteria:

* calcium metabolic disorder patients
* photosensitivity disorder patients
* lactating or pregnant women
* patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine
* patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment
Multidimensional Geriatric Pain Assessment

This descriptive study was conducted on 100 patients who applied to the gynecology outpatient clinic to determine the effectiveness of the Geriatric Pain Measure (GPM) in elderly individuals. The data of the study were collected using the Patient Information Form, the GPM, and the Standardized Mini Mental State Examination (SMMSE). The mean GPM score of the elderly individuals, who had an average age of 70 (65-90), was found to be 27.37 (0-88), the sub-dimension mean scores were 9.52 (0-49.9), 7.14 (0-14.2), 4.76 (0-9.5), 2.38 (0-11.9), and 4.76 (0-11.9) respectively. It was determined that 54% of the patients had mild pain (0-29), 38% of them had moderate pain (30-69), and 8% of them had severe pain (70 and above). The findings of the present study were similar to the results of numerous other studies in which both the same scale and different scales were used to assess pain in elderly individuals.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and older patients,
* Scoring 23 or above in the Standardized Mini Mental State Examination,
* Have no obstacle to answering questions,
* Not addicted to alcohol or other substances,
* No trauma in the last six months.

Exclusion Criteria:

* Patients younger than 65,
* Scoring less than 23 points in the Standardized Mini Mental State Examination,
* Who have a situation that prevents them from answering questions,
* Are addicted to alcohol or other substances,
* Trauma in the last six months.
Vitamin D Status Among Competitive Female Gymnast and Swimmers After Winter Time

As indoor athletes, competitive gymnasts and swimmers can face the problem of a potential vitamin D deficiency. In the last decades, indoor sports participants have been faced with the problem of an institutionalized lifestyle and, in some places, a lower exposure to sun, which is also associated with the geographical area with a lower or higher UV index, especially in autumn, winter, and early spring (from October to April), when the day is shorter and the clock shifts to winter time. The problem with gymnasts and swimmers lies in daily trainings in the gym and pool and in the daily rest between two trainings, which can be spend more or less institutionally. The investigators wanted to examine the vitamin D status related to bone mineral density, body composition and various cardiovascular markers among young competitive gymnasts and swimmers after winter time. The investigators want to potentially give more solid but sensible recommendations for trainers, athletes, parents and sports doctors when it comes to vitamin D supplementations for indoor female athletes.

In this cross-sectional survey, the investigators will document vitamin D and the status of other micronutrients related to bone mineral density, body composition and a variety of risk factors for chronic non-communicable diseases.

The investigators hypothesize that there exists a serious problem of vitamin D deficiency among indoor athletes related to bone health, injuries and general health - especially when they are not using supplements. It is well known that vitamin D may improve athletic performance in vitamin D-deficient athletes.

International and national-level female gymnasts and swimmers that will be enrolled will sign an informed consent statement for the inclusion in this survey and the choice to participate in the study will be made by coaches and participants themselves and, in the event of females under 18 years of age, also by their parents, in accordance with the Helsinki declaration.

The investigators plan to enroll at least 30 female participants (15 gymnasts and 15 swimmers) who compete on an international and national level and are older than 12 years of age.

The investigators will measure the athletes' biochemistry in overnight fasted state (micronutrients, including vitamin D (25(OH)D), B12, Ca, Fe, Mg, K and P, lipids, liver enzymes, glucose, creatinine, etc.), their seated blood pressure status, bone mineral density (also segmental) and body composition, using Dual-energy X-ray absorptiometry (DXA), their dietary choice and nutrition intake status, using standardized Food frequency questionnaire (FFQ), their training characteristics, injury status and menstrual status. Athletes who are using vitamin D supplements or who have attended a one-month training camp in the southern geographical zone (Africa) will serve us as control group.

Eligibility Criteria:
Inclusion Criteria:

* international and national level
* Signed informed consent for participation in the study

Exclusion Criteria:

-
Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system.

The aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase.

Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.


Eligibility Criteria:
Inclusion Criteria:

* Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained

Exclusion Criteria:

* No allergic reactions to PEG-asparaginase
Safety and Effectiveness of Low-flow ECMO Driving by CVVH Machine in Severe NCP

assess the safety and effectiveness of using low-flow extracorporeal membrane oxygenation(CO2 removal) driving by CVVH machine in the severe NCP patients


Eligibility Criteria:
Inclusion Criteria:

* 1. NCP with severe acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)\<150 and PEEP \>10cmH2O
* 2. Driving pressure\> 20cmH2O
* 3. RR\>30bpm
* 4.PaCO2\>55cmH2O and/or PH\>7.3

Exclusion Criteria:

* 1. poor venous vascular condition and unavaible for central venous catheter placement
To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults

The purpose of this phase III study is to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing antiretroviral treatment interruption.

This is an open-label, Phase III study to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound while replace HAART in virally suppressed HIV-1 infected adults. In this study, approximately 375 subjects on stable HAART treatment will be randomized to receive either continuing HAART treatment alone (Cohort 1) or UB-421 as the monotherapy (Cohort 2) in 1:2 ratio. For Cohort 1, subjects will receive current standard HAART treatment as the active control group. For Cohort 2, UB-421 will be administered to enrolled subjects without HAART treatment in the Cohort 2 during the 26-week treatment period. After treatment period, both cohort 1 and cohort 2 enter 22-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 sero-positive
* Aged 20 years or older
* Were not breastfeeding for women
* Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
* Subjects agree on using birth control barrier (female or male condom) during the entire study period
* Subjects sign the informed consent before undergoing any study procedures

Exclusion Criteria:

* Any active infection except for HIV, and required immediate therapy
* Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
* Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
* Life expectancy less than 12 months
* Any alcohol or illicit drug used, according to the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
A Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell)

A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group.


Eligibility Criteria:
Inclusion Criteria:

* Age: population aged 18 years and above;
* Judged by the investigator that the health condition is well after inquiry and physical examination;
* Vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine (Vero Cell vaccine) 6 months prior to study screening and according to product insert;
* Female participants who are not pregnant or nursing or at the time of enrolment (confirmed via negative urine pregnancy test), and do not have plans to become pregnant within the first 6 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before study inclusion and initiation;
* Be able and willing to provide written informed consent to participate in the study and complete all study requirements according to the study protocol;

Exclusion Criteria:

* COVID-19 infection positive patients (including suspected or asymptomatic cases);
* Have a history of SARS and MERS infection;
* Have been vaccinated by any COVID-19 Vaccines other than Vero Cell vaccine；
* Have an axillary temperature 37.3 (forehead temperature 37.8℃℃);
* Have had previous allergic reactions to vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic oedema or abdominal pain) or allergy to known components of COVID-19 vaccine;
* History of thrombocytopenia or other coagulation disorders;
* Patients with known immunological impairment or immunocompromised.
* Received whole blood, blood products, plasma and/or immunoglobulin therapy within 3 months before study enrollment
* Have known or suspected severe illness such as respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumour, infectious or allergic skin disease, human immunodeficiency virus (HIV) infection (test report available);
* Diagnosed with serious cardiovascular diseases such as cardiopulmonary failure, drug-uncontrolled hypertension (Systolic blood pressure 160 mmHg and/or diastolic blood pressure 95 mmHg).
* Received live attenuated vaccines within 1 month before study enrollment;
* Received inactivated vaccines within 14 days before study enrollment;
* Received other investigational drugs within 6 months before study enrollment;
* Other vaccination-related contraindications considered by investigators.