cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia

This study analyze the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme improving quality of life of subjects with Fibromyalgia.

Objective:

This study investigated the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme for the improvement of the quality of life of subjects with Fibromyalgia.

Design:

A single-blind randomized clinical controlled trial.

Setting:

University of Extremadura, Spain

Subjects:

Women with Fibromyalgia

Interventions:

141 Participants were randomized to a Qigong exercise program group (n=47), a physiotherapy treatment group (n=47) and control group (n=47) for 6 weeks.

Main Measures:

Measures were taken at baseline (week 0), pre intervention (week 1) and post intervention (week 6). The primary outcome measure were quality of life (Spanish Fibromyalgia Impact Questionnaire (SFIQ), pain (VAS), perceive exertion (Borg scale), spirometry measures (Spirobank-G MIR spirometry) and balance (Wii-Fit, Nintendo ©). The secondary outcome measures were flexibility (Wells and Dillon test and Sit and Reach test), Range of movement (goniometer), muscle strength (Lowett scale).

Eligibility Criteria:
Inclusion Criteria:

* women between 30 and 65 years old,
* diagnosed with Fibromyalgia by a specialized physician,

Exclusion Criteria:

* The exclusion criteria were to present any limitation of mobility due to Fibromyalgia or other pathology, previous practice or knowledge of Qi gong, to be under Physiotherapy treatment and to practice any physical exercise.
Changes of Serum Orphanin FQ in Patients With Coronary Heart Disease in Different Courses of Diabetes Mellitus

To explore the severity of diabetic patients with coronary heart disease and the change of serum orphanin FQ content in different diabetic courses

Methods: A retrospective case-control study was conducted. The control group was a patient who underwent coronary angiography at the same time and was definitely diagnosed as coronary heart disease but not diabetes. The study group was coronary heart disease complicated with diabetes, which was divided into group A (≤5 years), group B (5-10 years) and group C (10-20 years) according to the course of diabetes. (1) Review the electronic medical records and record the general information of the selected patients: age, sex, history of hypertension, history of myocardial infarction, family history of coronary heart disease, smoking history, chronic kidney disease; ② laboratory findings: HbA1C (glycosylated hemoglobin), SBP (systolic blood pressure), DBP (diastolic blood pressure), total cholesterol, HDL, LDL, triglyceride, BMI, creatinine and glomerular passing rate (EGFR); ③ Drug use: oral hypoglycemic agents, insulin, aspirin, statins, hypertension drugs, ACEI or ARB, β-blockers, CCB and diuretics. (ii) Taking coronary angiography as the gold standard, the grading index of severity of coronary heart disease was made, and the severity of coronary heart disease was evaluated by Gensini score.

Eligibility Criteria:
Inclusion Criteria:

* The main discharge diagnosis is T2DM；;
* Age \> 18 years old;
* No acute complications of diabetes;
* The previous diagnosis was coronary heart disease

Exclusion Criteria:

* T1DM patients;
* EGFR \< 60 ml/min/1.73 m or proteinuria (or both);
* Patients with history of acute cardiovascular events;
* Familial hypercholesterolemia or other hereditary lipid metabolism diseases;
* anti-HIV patients;
* Patients with serious mental health problems;
* Patients receiving drugs that can lead to dyslipidemia, such as antipsychotics, corticosteroids, or immunosuppressants;
* Patients with systemic inflammatory diseases, such as systemic lupus erythematosus; Pet-name ruby is quitting smoking and severe obesity (BMI\>40).
Understanding Communications Included With COVID-19 (Corona Virus Disease of 2019) Home Testing Kits

To test competing sets of information for consumers on how to interpret hypothetical SARS-CoV-2 home test kit results and whether they report plans to take CDC-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. Participants will be randomized to receive either information from the FDA authorized Ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention).

To test competing sets of information for consumers on how to interpret hypothetical SARS-CoV-2 home test kit results and whether they report plans to take CDC \[Centers for Disease Control\]-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. Participants will be randomized to receive either information from the FDA authorized Ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention).

Participants will be randomized to receive either information from the FDA authorized Ellume home test kit for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention). They will be given time to read the documents and the opportunity to download a full "instructions for use" document (the FDA authorized for the ELLUME test kit). They will then be randomized to one of four conditions, asking them to imagine a clinical context: a person with no symptoms and no close COVID-19 contact, no symptoms and close contact,

Eligibility Criteria:
Inclusion Criteria:

* Participants must be \>18 years old, communicate in English, reside in the United States.

Exclusion Criteria:

* Respondents who complete the survey in under a minute.
Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MS

Several investigations have suggested that polyunsaturated fatty acids may promote therapeutic effects in MS. This pilot study will determine whether omega-6 polyunsaturated fatty acids (PUFAs),in the form of linoleic acid,can reduce disease activity and prevent disability progression in patients with relapsing MS.This study will seek to measure disease activity as seen on MRI scans in addition to measuring relapse rates.

Participants who meet inclusion criteria will start placebo treatment by taking olive oil for 2 months. This period will include screening activities including 3 monthly MRIs. Those with 2 enhancing lesions on three placebo run-in period MRIs will continue in the study and receive omega-6 PUFA (linoleic acid) for 6 months. Brain MRIs will be repeated after 4,5, and 6 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsing MS
2. treated with FDA-approved dosage of interferon-beta (Avonex,Betaseron,Rebif), glatiramer acetate for at least 6 months OR no immunotherapy for at least 3 months
3. at least one clinical exacerbation or at least one gadolinium enhancing lesion on brain MRI in the past 12 months
4. at least two gadolinium enhancing lesions on three brain MRIs obtained during the placebo run-in period
5. women of childbearing potential may participate provided that they are using adequate birth control methods for the duration of the study. Women of childbearing potential must have a negative pregnancy test at baseline and be non-lactating.
6. willing and able to provide informed consent

Exclusion Criteria:

1. corticosteroids within 1 month prior to screening
2. treatment with other immunotherapies (other than interferon-beta, glatiramer acetate or sporadic corticosteroids) within 3 months prior to screening
3. any significant medical condition or laboratory abnormality which may interfere with the subject's ability to participate in the study, including peptic ulcer disease, avascular necrosis and hepatic insufficiency
4. history of hypersensitivity or intolerability to vegetable oils or their constituents
5. unable to perform any of the required study procedures
Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)

Anesthesia induction and tracheal intubation can be performed with and without neuromuscular blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are similar, too.

We perform tracheal intubation with propofol, remifentanil and sevoflurane; sevoflurane is administered with three dosages. During tracheal intubation intubating conditions are noted. After surgery, all patients are examined by video laryngoscopy; moreover all patients are asked for hoarseness and sore throat.

Eligibility Criteria:
Inclusion Criteria:

* ear-nose-throat surgery
* orotracheal intubation for surgery of the ear
* ASA I-III

Exclusion Criteria:

* obesity
* allergy against the study drugs
* patients with a known or suspected difficult airway
* diseases of the larynx
Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis

The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.

The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.


Eligibility Criteria:
Main Inclusion Criteria:

* Scalp psoriasis amenable to topical treatment
* Psoriasis vulgaris on trunk and/or limbs
* Extent of scalp psoriasis involving more than 10% of the total scalp area
* Disease severity on the scalp graded as mild or worse by the investigator
* Consenting out-patients of 18 years or above

Main Exclusion Criteria:

* PUVA or Grenz ray therapy within 4 weeks prior to randomisation
* UVB therapy within 2 weeks prior to randomisation
* Systematic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation
* Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
* Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation
* Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
* Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and Fed

To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet under Fasting and Fed.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Equivalence Study of Dorzolamide 2% Eye Drops Solution

The study aims to prospectively prove the equivalence of the test product and the reference solution in lowering intraocular pressure in patients with open angle glaucoma and ocular hypertension. For this purpose the patients are randomized into two sequences of study drug administration in a crossover study with an adequate wash-out period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of any race aged 18 years or older
* A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
* IOP controllable on one drug treatment in the study eye in way that assures clinical stability of vision and the optic nerve throughout the study
* Baseline IOP between 18 and 32 mmHg in the study eye (in eyes not included in the study IOP must have been controllable on no pharmacologic treatment or on the study medicine only)
* Best corrected visual acuity of 20/200 or better in the study eye(s)
* Ability of subject to understand character and individual consequences of clinical trial
* Signed and dated informed consent of the subject must be available before start of any specific trial procedures
* Women with childbearing potential have to practicing a medically accepted contraception during trial and a negative pregnancy test (serum or urine) should be existent before trial. Reliable contraception are systemic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicidal. Women that are sterile by surgery or for more than two years postmenopausal can be participate in the trial.

Exclusion Criteria:

* Chronic or recurrent inflammatory eye disease
* Ocular trauma within the past six months
* Current ocular infection, i.e. conjunctivitis or keratitis
* Any abnormality preventing reliable applanation tonometry
* Intraocular surgery or laser treatment within the past three months
* Inability to discontinue contact lens wear during the study
* Use of any systemic medication that would affect IOP with less than a

  1-month stable dosing regimen before the screening visit
* Pregnancy and lactation
* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
* Participation in other clinical trials during the present clinical trial or within the last four weeks
* Medical or psychological condition that would not permit completion of the trial or signing of informed consent
* Subject is allergic to sulfonamides
* Severe renal dysfunction or hyperchloraemic acidosis
Relieve the Patient's Thirst, Refresh the Mouth First (ICU-MIC)

Thirst is considered as one of the most distressing symptoms experienced by patients hospitalized in the Intensive Care Unit (ICU). Whereas pain is a permanent concern for all caregivers, thirst is often ignored and its complications are poorly known. Mechanisms involved in thirst regulation are numerous and complex. To date, care of thirst is still non optimal. Critically ill patients are usually rehydrated intravenously or using a naso-gastric tube, thus shunting the mouth as a therapeutic target to relieve the patient's thirst.

Water, cold and mint applied in mouth were studied separately and were shown to decrease thirst significantly on animal models and healthy humans.

Therefore, the hypothesis of this study is that application of small mint ice cubes in mouth of very dehydrated ICU patients should allow decreasing quickly and significantly thirst for these patients, before the correction of their biological parameters, like natremia and osmolarity.


Eligibility Criteria:
Inclusion Criteria:

* Hypernatremia upper than 150mmol/L or hypernatremia upper than 145mmol/L associated with water deficiency upper than 3L
* Estimated hospitalization duration in ICU upper than 24h

Exclusion Criteria:

* Contraindication for ice cubes application in mouth
* Known mint allergy
* Incapability to understand study outcome and to answer basic questions
* Pregnancy
* Dying person
Genetics of Periodontal Diseases in Chinese (Taiwan)

A retrospective case control study to validate the association between Interleukin-1 gene variations and adult chronic periodontal disease in Chinese (Taiwan).


Eligibility Criteria:
Inclusion Criteria:

* To be included in this study, an individual needs to be Han Chinese of 35 years of age or older at time of enrollment.

Exclusion Criteria:

* Subjects who, at time of enrollment, were pregnant or breastfeeding, or needed antibiotic prophylaxis before periodontal treatment will be excluded from this study.
Prospective Studies of the Use of Self Hypnosis, Acupuncture and Osteopathic Manipulation on Muscle Tension in Children With Spastic Cerebral Palsy

We propose to identify patients and families for inclusion in pilot studies of the three modalities. Patients and their families will be asked to participate in these studies.

Our research group has done some preliminary work with the modality of hypnotherapy, but has no experience to date with the other two modalities. The idea to try relaxation techniques was generated by the observation that there is great variation in the degree to spasticity at different times in the same patient with CP. When queried, mothers responded that they were able to get their child to relax and decrease the tension in their muscles by stroking, talking softly, and/or by playing certain types of music. The availability of hypnosis and training in self-hypnosis was presented to several families of our patients. Their understanding and acceptance of this alternate therapy was gratifying. The results of this therapy have been promising and have encouraged us to proceed with this modality and to consider making other nonconventional modalities available to our patients.

We hypothesize that at least one of the two modalities will be accepted readily by patients with CP and their families, and with their acceptance compliance with the method chosen will be at levels of 80 percent or more.

The primary objective of this project is to develop and evaluate two different alternative or complementary medical modalities that have been used in children with cerebral palsy by practitioners in an attempt to decelerate the complications from the neurologic insult and resultant muscle imbalance. The specific aims are: 1) The development and incorporation of two alternative modalities (osteopathic manipulation and acupuncture) into available services in southern Arizona for individuals with cerebral palsy. 2) The evaluation of the uptake of and compliance with the two modalities in the clinical services for cerebral palsy. 3) Conduct pilot studies of each of the two modalities to determine their efficacy in decreasing the degree of muscle tension in children with spastic cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Children with a diagnosis of spastic CP who are between 48 months and 21 years of age.
* For the hypnotherapy-control arm the children must have a cognitive level sufficient to allow them to visualize and enter into trance.
* The cognitive level criteria will not apply to the manipulation-acupuncture-control arm of the study.
* No child will be excluded on the basis of gender, race or culture.
UroX Biomarker Bladder Cancer Study

This is a prospective observational study looking at urine samples from participants under referral for a standard of care investigative cystoscopy and biopsy.

The study aims to test if the UroX™ biomarker (a measurable indicator of a biological condition) can be detected in urine samples from participants who may later test positive following a biopsy for bladder cancer. The study aims to assess the value of the biomarker as a screening tool for bladder cancer.

Patients with and those without bladder cancer are required for the study.

Patients who undergo investigation for bladder cancer will have a cystoscopy and biopsy as part of their routine care. These patients are then brought back to urology outpatient clinic for their biopsy results within two weeks.

A UroX Biomarker Bladder Cancer Study patient information leaflet will be sent to all patients who are booked for these investigations, explaining the study aims and the requirements for participation.

On the day of their cystoscopy, potential participants will be approached and after signing a study specific consent form, the urine sample will be accepted, given a study number and sent for UroX biomarker testing.

These results will then be returned to the study team for comparison against the biopsy histology result to assess for sensitivity and specificity.

While cystoscopy and biopsy are the current gold standard for diagnosis of bladder cancer, it has been shown to have false-negatives of between 10-40%, due to factors such as operator error or small areas of malignancy(15-17). The possibility of a screening/outpatient test for bladder cancer with high positive predictive value would help with reduction or prioritisation of further investigations and early diagnosis of disease thus potentially allowing alternative treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years of age
* Patients under investigation for bladder cancer due to undergo investigative standard of care biopsy

Exclusion Criteria:

* Patients aged \< 18 years of age
* Patients who are currently undergoing radiation therapy.
* Proposed subject has no bladder (due to surgical removal).
* No cystoscopy and/or pathology information for proposed subject (following cystoscopy for final inclusion in study results)
* Patients unable or unwilling to provide consent
* Patients currently on investigational drug trials
* Patients with Catheter in Situ
Bayesian Networks in Pediatric Cardiac Surgery

Pediatric cardiac surgery with cardiopulmonary bypass is associated with significant morbidity and mortality. Also score systems for risk factors, such as Risk Adjustment for Congenital Heart surgery (RACHS 1) score or the ARISTOTLE score, have been developed, outcome prediction remains difficult. New mathematical methods using deep neural networks associated with Bayesian statistical methods have been developed to give a better understanding of the complex interaction between different risk factors, to identify risk factors and group them in related families. This method has been successfully used to predict mortality in dialysis patient as well as to better describe complex psychiatric syndromes.

The primary hypothesis of this study is that the use of these tools will give a better understanding on the factors affecting outcome after pediatric cardiac surgery.

A network analysis using Gaussian Graphical Models, Mixed Graphical models and Bayesian networks will be used to identify single or groups of risk factors for morbidity and mortality after pediatric cardiac surgery under cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* 0 to 16 years
* cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

* ASA (American Society of Anesthesiologists) status 5
* Jehovah's Witness
MK-0524B Lipid Study (MK-0524B-063)

This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on lipid values.


Eligibility Criteria:
Inclusion Criteria:

* has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values, or as otherwise determined through optional lipid measurements at screening visit
* meets one of the following triglyceride (TG) criteria:

  1. is on niacin, statin, or fibrate and has TG \<500 mg/dL at or within 6 months of washout
  2. is not on any lipid altering therapy or is on lipid altering therapy other than niacin, statin, or fibrate and has TG \<600 mg/dL at or within 6 months of screening

Exclusion Criteria:

* is high risk (coronary heart disease \[CHD\] or CHD risk equivalent) AND is on a statin
* is pregnant or breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up
* has Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled, is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated hypoglycemia or unstable glycemic control or is taking new or recently adjusted anti-diabetic medications (with the exception of +/- 10 units of insulin) within 3 months of Visit 1
* has the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, human immunodeficiency virus (HIV) positive, gout (within 1 year)