cyrilzakka/clinical-trials huggingface dataset:
Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence

The purpose of this study is to determine whether combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture is effective in the treatment of female mixed urinary incontinence.

This factorial, randomized, controlled trial is aimed to assess the effectiveness of combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture in the treatment of female mixed urinary incontinence (MUI). Eligible participants will be randomly allocated to receiving combination therapy with Yiqi Suoquan granule and acupuncture, Yiqi Suoquan ganule plus sham acupuncture, placebo plus acupuncture, or placebo plus sham acupuncture.

To minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation besides participants.

Eligibility Criteria:
Inclusion Criteria:

* (1) female, leaking with urgency and with physical activity, coughing or sneezing (MUI) for more than 1 year; (2) recorded more than 1 incontinent episode per 24 hours in their bladder diary

Exclusion Criteria:

* (1) with acute urinary tract infection; (2) with bladder outlet obstruction, (3) with neurogenic bladder (4) with interstitial cystitis, (5) with pelvic organ prolapse more than stage 2 (6) previous anti-incontinence surgery or a post-void residual urine volume more than 100 mL.
Charcot Leyden Crystals in Pathology

Charcot Leyden crystals (CLC) are sometime reported in pathological reports of airway or sinonasal samples but their clinical significance remain elusive. The investigators organized a retrospective analysis of all consecutive patients with CLC seen at our institution between 1986 and 2019

In recent years, improved knowledge of eosinophilic inflammation has led to the approval of biologics aimed at inhibiting the pathways of eosinophilic activation, notably via the interleukin 5 pathway in eosinophilic asthmatic patients uncontrolled despite receiving maximum doses of standard drugs. These treatments showed efficacy in asthmatic patients with a high level of eosinophils in their induced sputum (\> 3%) and the criteria were extended to those with circulating eosinophilia (\> 300 / mm3). Eosinophils are therefore an important biomarker for phenotyping asthmatic patients. The Charcot-Leyden crystals are a reflection of the presence of eosinophils, and are sometimes found in some pathological samples. It is hypothesized that the presence of Charcot-Leyden crystals, a reflection of tissue eosinophilia, is a predictive factor for the efficacy of anti-IL5 biotherapies in patients with severe eosinophilic asthma.

Eligibility Criteria:
Inclusion Criteria:

* Having Charcot Leyden Crystals in a pathological sample

Exclusion Criteria:

* Having Charcot Leyden Crystals in a pathological sample taken outside the airways the nose and the sinus
Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease

Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric resection group and local mesenteric resection group.

Randomization was performed intraoperatively once the surgeon had determined that there were no other sites of disease and that either type of anastomosis could be performed safely. Computer generated randomization was carried out within strata using randomized permuted blocks to ensure balance of the groups.

All surgery was performed by a single group of surgeons experienced in the surgical treatment of Crohn's disease. Surgery was performed open or laparoscopically depending on patient factors and surgeon preference. The resection was performed grossly normal resection margins, with side-to-side anastomosis. The presence of mesenteric marginal thickening with confirmation by naked eye assessment of the mucosal aspect of the bowel were used to establish the limits of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease limited to the distal ileum and/or right colon

Exclusion Criteria:

* Concomitant anastomosis/strictureplasty at another site of the gastrointestinal tract, and required a temporary fecal diversion
Positive Expiratory Pressure During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis

This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).

All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before starting the trial all patients will do an inhalation formation.

During the study period the patients' pharmacological treatment remains unchanged

Eligibility Criteria:
Inclusion Criteria:

* Pass the inhalation test
* Chronic sputum production, at least ≥ 10 ml /24h
* Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium\>70 mmol/l or sweat chloride of\>60 mmol/l)
* Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks)
* Trained in the use of autogenic drainage technique (at least 6 months)
* Inhaling hypertonic saline since at least 6 months
* To be able to provide written, informed consent and perform the protocol and the evaluations

Exclusion Criteria:

* Active massive hemoptysis during the previous 2 months
* Patient in transplantation or retransplantation list
* Patient already participating in another study at the same time
The Atrial High Rate Episodes in Pacemaker Patients

Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.

The purpose of this study is to assess the incidence of fast heart rates that originate in the upper chamber of the heart (atrial tachyarrhythmias) in pacemaker patients that have not been previously diagnosed with this condition. The study will also look at how the diagnostic feature in the pacemaker that detects atrial tachyarrhythmias helps physicians with the medical management of patients' heart rhythm.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications
* No previous history of pacemaker implantation
* Patients 50 years of age or older

Exclusion Criteria:

* Patients with a history of atrial tachyarrhythmias (primary arm of study)
* Patients with medical conditions that would limit study participation
* Patients inaccessible for follow-up at the study center
* Patients incapable of providing Informed Consent
* Patients with NYHA classification of IV
* Patients with a history of neurocardiogenic syncope, long QT syndrome, or Hypertrophic Obstructive Cardiomyopathy (HOCM)
* Patients taking Sotalol or Amiodorone
* Patients with a history of a prior ICD or pacemaker implantation.
Effects on Insulin Resistance With Tadalafil in Type 2 Diabetes - a Double-blind, Placebo-controlled Crossover Study

The aim is to continue our program on PDE5 inhibition by evaluating effects on insulin resistance, including glucose metabolism and subclinical inflammation, after a 6-week administration of tadalafil in T2D patients. The primary objective is to study the effect of tadalafil compared with placebo on insulin sensitivity during a euglycemic hyperinsulinemic clamp.

This is a double-blind, placebo-controlled crossover study with one study site. Twenty-five T2D patients will be recruited and randomized to per oral intake of tadalafil 20 mg o.d. for six weeks and after a wash-out period of eight weeks intake of placebo for another six weeks, or vice versa. At the end of each 6 week treatment period a glucose clamp, subcutaneous needle biopsies as well as muscle and subcutaneous microdialysis will be performed. Endothelial function tests and arginin stimulation of insulin secretion tests will be performed after 3 weeks in each treatment arm.


Eligibility Criteria:
Inclusion Criteria:

1. T2D patient, previously diagnosed by fasting or 2-hr OGTT plasma glucose levels
2. Age females: 55-70 yrs (post-menopausal state defined as natural amenorrhea for at least 12 months); Age males: 40-70 yrs
3. BMI: 27-40 kg/m2
4. HbA1c \< 60 mmol/mol
5. Type 2 diabetes duration \> 3 months and \< 10 yrs
6. Understand and speak Swedish

Exclusion Criteria:

1. Diabetes treatment with glitazones, GLP-1 analogues or DPP-IV inhibitors
2. Anti-hypertensive therapy with beta-blockers, ACE-inhibitors and/or angiotensin-II receptor blockers
3. Significant microvascular complications e.g. nephropathy (GFR\<60), proliferative retinopathy and symptomatic neuropathy e.g. postural hypotension
4. Previous significant vascular disease including angina pectoris and myocardial infarction, cerebral artery disease e.g. history of transient ischemic attacks and peripheral artery disease with no palpable pulses
5. Smoking \> 10 cig/day and/or smokeless tobacco \> one can per 2 days
6. Concurrent use of nitrates or NO donors, or an apparent risk that there may be a need of such medication
7. Cardiac failure (stages NYHA II-IV)
8. Uncontrolled hypertension \> 170/105 mm Hg
9. Apparent ECG-pathology indicating current or previous myocardial ischemia;
10. Males with erectile dysfunction
11. Hemophilia or a history of bruises or hepatic failure (\> 2-fold increase upper limit normal values of ASAT/ALAT)
12. Hypotension
13. Treatment with doxazosin
14. Anything in the contact with the patient that makes the doctor to believe that he/she will be uncompliant to the protocol.
Clinical Benefit of CBT for Insomnia in Primary Care

The purpose of this study is to evaluate using an RCT the potential benefits of CBT for insomnia in the community


Eligibility Criteria:
Inclusion Criteria:

* Adult years (18+), living at home
* Meets clinical/RDC criteria for chronic insomnia

Exclusion Criteria:

* Deteriorating health
* Untreated major mental disorder
Individual Differences in Glucosamine Sulfate Exposure Levels

Glucosamine is an important part of the treatment strategy for osteoarthritis, but its effectiveness is still controversial. To explain the efficacy differences of glucosamine, in this study the investigators detect the concentration of glucosamine in the plasma and synovial fluid, some effect indexes such as inflammatory markers and gene polymorphism of glucosamine transporters. On the one hand, the investigators compare the plasma peak and gluten glucosamine concentration and the concentration in synovial fluid among participants to observe the individual differences of glucosamine exposure in vivo. On the other hand, the investigators investigate the correlation between drug concentrations, effect index and gene polymorphism. The hypothesis is that glucosamine exposure in vivo has individual differences and gene polymorphism can explain this differences.


Eligibility Criteria:
Inclusion Criteria:

1. patients undergoing total knee arthroplasty for knee osteoarthritis;
2. 60-80 years.

Exclusion Criteria:

1. patients with severe liver or renal insufficiency;
2. patients allergic to glucosamine or any excipients in tablets;
3. patients who have been treated with glucosamine within three months;
4. patients who are unable to cooperate with the study;
5. continuous medication is less than 4 days;
6. patients with diarrhea, vomiting and other adverse reactions during medication.
Post Operative Quality of Life and Pain in Ankle Fractures: Cast Versus Functional Treatment

Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need surgical treatment. Both cast immobilisation and functional treatment have proved to be reliable postoperative treatment regimes. Insight into the quality of life and the level of pain is necessary to determine if these treatments can be related to higher patient satisfaction and earlier resumption of daily activities and work.

Objective: The aim of this study is to examine two postoperative treatments for surgically corrected ankle fractures. Postoperative, direct functional mobilisation is compared to short term plaster cast fixation. The focus of this study is on quality of life, pain and the use of pain medication, and resumption of work and daily activities.

Main study parameters/endpoints:

Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain disability index), complications


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 at the time of surgery
* Ankle fractures needing operative correction
* Weber type B or C, Lauge Hansen type supination-adduction, supination-external rotation and pronation-external rotation
* Closed fractures
* Postoperative stable for exercise
* Operated at the University Medical Centre St Radboud, Nijmegen or Alysis Zorggroep, Rijnstate Hospital, Arnhem

Exclusion Criteria:

* Open fractures
* Fractures with complete dislocation of the ankle joint
* Body Mass Index \> 30
* Previous ankle fracture on the affected side
* Concomitant traumatic injuries reducing the ability for postoperative mobilization
* Pre-existent use of pain medication, medication affecting fracture- and wound healing
* Postoperative unstable for exercise
* Co-morbidity: pain syndromes, Fontaine IIB, III and IV, symptomatic venous insufficiency, auto-immune disorders, rheumatic arthritis
Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)

purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with a history of mild to moderate Atopic Dermatitis.

This is a randomized, double-blind, placebo-controlled study. subjects will be randomized to receive investigational vaccine or placebo at a ratio of 3.5:1, MVA3000 to placebo. All subjects will undergo a screening period, a treatment/observation period during which all subjects will receive injections on study day 0 and study day 28 of investigational vaccine or placebo. The clinical observation period will be completed at day 56. A visit will occur at approximately 3 months after the second study injection (study day 118) for additional blood collection and a review of the subject's health status. Follow-up will be obtained via telephone contacts approximately 6 months after the end of the second injection during the treatment/observation period.

Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years old and who were born after 1971 with no previous history of smallpox vaccination
* Subjects must be in good general health Female subjects must not be pregnant or lactating and must agree to practice birth control during the course of the study
* Subjects must have a diagnosis of AD by an experienced clinician that includes a history of both major and minor diagnostic criteria
* At the time of screening, the subject must have "mild to moderate" AD.

Exclusion Criteria:

* History or evidence of prior exposure to a vaccinia or MVA- containing product
* known or suspected history of immunodeficiency other than AD
* Known or suspected impairment of major organ function
* Known history or diagnosis of cardiac disease or cerebrovascular disease
* presence of acute, chronic, or active exfoliative skin conditions other than AD, open wounds, or burns.
* Dementia or history of seizures
* Known allergies to MVA or any known components of the vaccine
* transfusion of blood, organ transplantation, or treatment with any blood product
* morbid obesity, or a BMI less than or equal to 18.5
* history of or current drug or alcohol abuse (except nicotine) within the past 6 months or any history of IV drug use
* history of major psychiatric illness except major depression not requiring medical therapy.
* subjects who have participated in another investigational drug or vaccine trial within 30 days of study day 0
Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer

Pancreatic cancer is the 8th most prevalent cancer in Korea, and its 5-year overall survival rate has shown less than 10% due to its dismal prognosis. To date, the only curative treatment of pancreatic cancer is surgical resection. However, about 60% of patients with pancreatic cancer have been diagnosed as a locally advanced unresectable or metastatic disease at diagnosis owning to its difficulty in the early detection of cancer. The 5-year survival rate has been reported to be less than 25% even with surgical resection. Considering the high rate of metastasis and recurrence, systemic chemotherapy is essential to prolong survival. Therefore, Using AI platforms of RAPTOR (RNA expression-based Anti-symmetrical Pairing Tool for On-demand Response) and ReDRUG (Restoration using the drug for targeting unbalanced gene) developed by Oncocross, Chlorphenesin carbamate, and Hydroxychloroquine were discovered as candidate drugs having anti-metastatic effects.

This study aimed to evaluate the efficacy and safety of hydroxychloroquine and chlorphenesin carbamate in combination with mFOLFIRINOX in patients with inoperable locally advanced or metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Adults of age ≥ 19 and \< 80 years
2. A patient who meets any of the following criteria at the time of screening or before, and who is scheduled to receive chemotherapy with modified FOLFIRINOX for the first time after screening

   * Locally advanced inoperable pancreatic cancer
   * Metastatic pancreatic cancer
3. One or more measurable lesions by RECIST v 1.1
4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 pr 1
5. Estimated life expectancy of at least 12 weeks or more at the discretion of the investigator

Exclusion Criteria:

1. History of major surgery within 4 weeks at the time of screening
2. Symptomatic, uncontrolled brain metastasis or meningeal carcinomatosis
3. History of malignancy within 5 years at the time of screening
4. History of human immunodeficiency virus (HIV) or active hepatitis
5. Active infection requiring systemic antibiotic therapy
6. Patients who have maculopathy or are receiving treatment for corneal or retinal disease, or under follow-up
7. History of acute or subacute intestinal obstruction or paralytic ileus, or a history of chronic diarrhea considered clinically significant at the discretion of the investigator
8. Serious neurological, psychiatric condition including drug abuse or alcoholism, which would prevent the subject from participating in the study
9. Patients with any condition who are considered unsuitable for participation in the study in the judgment of the investigator
IDB Injection Combined With PTNS for Managing Children With OAB Not Responding to Monotherapy

This study aimed to evaluate the outcome of simultaneous intradetrusor BOTOX (IDB) injection and Percutaneous tibial nerve stimulation (PTNS) for management of children with recurrent wetness since at least 6 months.

Overactive bladder is a syndrome characterized by symptoms of urgency, with or without urgency incontinence, usually with increased daytime frequency and nocturia. The Neurogenic or myogenic bladder dysfunction can lead to the symptoms that characterize Overactive bladder. Normal bladder contraction occurs when the muscarinic receptors in the detrusor muscle are stimulated with acetylcholine. Although the pathogenesis of Overactive bladder is not fully explained; sensitization of afferent nerves, deactivation of inhibitory mechanisms, and the emergence of contractions similar to primitive voiding reflexes are shown as pathogenetic mechanisms. Another hypothesis is that the number of intercellular connections among detrusor myocytes increase, and these cells are spontaneously stimulated.

In addition to the fact that the etiopathogenesis cannot be explained clearly and due to the intense relationship with the autonomic nervous system, undesirable systemic side effects are common in treatments applied.

Eligibility Criteria:
Inclusion Criteria:

* Children with non-neurogenic overactive bladder defined after exclusion of neurogenic causes not responding to medical treatment for 6 months, and
* aged of 7-16 years
* presenting with recurrent night-time with occasional day-time wetness for overactive bladder.

Exclusion Criteria:

* recurrent OAB manifestations within less than 6 months after the previous monotherapy
* obstructive urinary tract diseases
* a history of pelvic surgery
* anatomical abnormalities
* neurogenic bladder
* syndromes that affect the bladder functions
* either current infection that was evidenced by urinalysis and culture or within the last two months
* systemic diseases inducing liability for wetness
Prevalence of Hypertension Using Telemedical Home Blood Pressure Measurements

The purpose of this study is to determine the prevalence of hypertension among citizens of Holstebro, Denmark aged 55-64 years, including both the well treated, the untreated and the insufficiently treated, and to estimate the prevalence of white coat and masked hypertension using home blood pressure measurements with telemedical data transmission.


Eligibility Criteria:
Inclusion Criteria:

* Age 55 to 64 years
* Registered address in the municipality of Holstebro
* Enrolment at a practice of one of the GPs who had agreed to participate in the study.

Exclusion Criteria:

* Unwillingness to participate
* Incapability to do home blood pressure measurements