cyrilzakka/clinical-trials huggingface dataset:
DBS Evaluation of Fujirebio INNOTEST® HCV Ab IV

The goal of this trial is to evaluate the performance of the Fujirebio INNOTEST® HCV Ab IV using simpler collection methods such as fingerstick and venous whole blood collection on dried blood spots (DBS). In order to assess performance in samples with high and low antibody titres, performance will be evaluated with undiluted samples of all trial participants and serial diluted samples for a subset of HCV antibody reactive samples. Serial dilution of reactive samples will provide further insights into the potential difference of sensitivity in samples collected on DBS versus plasma.

Results of this trial will also support the update of the regulatory claims to include DBS as an alternative sample type.

Access to Hepatitis C virus (HCV) screening in resource-limited settings should be enabled not only through the provision of point-of-care screening tests, but also through the possibility of collecting samples in decentralized settings One possible way of decentralizing sample collection is collecting dried blood spot (DBS) specimens, which can be easily transported to testing laboratories, not requiring any cold chain or complex sample transportation. DBS serology screening is complementary to established point-point-of care screening with rapid diagnostic tests, both methodologies being somewhat less cost-effective and less sensitive compared to lab-based methods but suitable for settings without sophisticated infrastructure.

To date, no HCV antibody serology test is formally evaluated for the use with DBS, however several studies on off-label use of DBS in serology screening assays, suggests that this sample type can serve as an alternative to plasma and serum. Fujirebio's enzyme immunoassay (EIA) INNOTEST® HCV Ab IV is CE marked and has received pre-qualification by the World Health Organization (WHO) for the use with venous plasma and serum, which require special equipment for sample collection, sample preparation and temperature controlled transportation.

Available data on the performance of HCV antibody detection from DBS samples are insufficient to introduce their use in clinical practice. Fujirebio is one of the few manufacturers who have an EIA test pre-qualified by the WHO for the use with plasma and serum to detect anti-HCV antibodies. A prospective diagnostic accuracy trial of the Fujirebio INNOTEST® HCV Ab IV assay in fWB and vWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard is needed to understand the relationship between results generated in plasma and WB samples collected on DBS. Furthermore, the data generated can be used by Fujirebio to update their regulatory claims and include DBS as an alternative sample type.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Provision of written informed consent
* Routine RDT reactive or non-reactive and recruitment target not yet met
* No history of HCV treatment

Exclusion Criteria:

* Unwilling to provide required volume of fingerstick blood and venous whole blood
* Participants already enrolled in the trial
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study

To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis polycystic ovary syndrome (PCOS ) before pregnancy
* BMI 27-40 kg/m2
* Human chorionic gonadotropin, beta subunit (HCG-beta) verified pregnancy week 5-8
* At least one of the following criteria: (1) serum testosteron \> 2,5 nmol/L; (2) Sex hormone binding globulin (SHBG) \< 30 nmol; (3) Fasting C-peptid \> 1,0 nmol/L; (4) Menstrual disturbances: oligo-/amenorrhea or metrorrhagia; (5) Hirsutism

Exclusion Criteria:

* known liver disease or ALAT \> 60 IU/L
* S-creatinin \> 130 micromol/L
* diabetes mellitus
* alcohol or drug abuse
* peroral steroid treatment (except inhalation steroids)
* use of cimetidine, anticoagulant, erythromycin or other macrolides
* not suitable for other reasons
Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine

CONTEXT AND OBJECTIVE: Myofascial syndrome is the most frequent condition of chronic pain. The objective of the present study was to compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone.

DESIGN AND SETTING: A randomized study was performed at the Pain Clinic. METHODS: Thirty patients were divided into two groups: G1 received trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h. G2 was submitted to classical and trigger point acupuncture twice a week. The patients were asked to continue physical exercise. The following parameters were evaluated: pain intensity rated on a numerical and verbal scale, quality of life before and four weeks after treatment, and quality of analgesia.

Among the 39 patients selected, nine (3 in group 1 and 6 in group 2) were excluded from the study because they did not attend the visits scheduled for the procedures and assessment or because they did not respond to the questionnaires.

Eligibility Criteria:
Inclusion Criteria:- patients of both genders

* chronic myofascial syndrome (duration of more than three months),
* ranging in age from 18 to 65 year,
* pain intensity score of 3 or higher (rated on a numerical scale ranging from 0 to 10)

Exclusion Criteria:

* patients with disc herniation,
* osteoarthritis,
* vertebral collapse,
* temporomandibular joint dysfunction,
* infection, -
* tumors,
* coagulopathy, -
* psychiatric disease,
* cognitive disorders.
* Patients who had used any type of analgesic or muscle relaxant agent 15 days before the study and those taking anticoagulants
A Mobile Phone Self-Monitoring Tool to Increase Emotional Self-Awareness and Reduce Depression in Young People

The mobiletype program is a mental health assessment and monitoring tool that runs on mobile phones.

The program assesses the general mental health of young people in real-time and transmits this data to a website to be reviewed by their general practitioner (GP) in consultation with their patient. The website consists of individualised feedback reports for each participant, and graphical displays of the monitoring data. The primary aims of the current project are to examine: (1) whether the process of self-monitoring via the mobiletype program increases young people's awareness of their mood and reduces depressive symptoms and (2) whether emotional self-awareness mediates the relationship between self-monitoring and depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Aged 14 - 24 years of age
* Proficient English
* Patients must be deemed to have an emotional/mental health concern by their GP or be screened to have at least a mild mental health problem (a score of 16 or above) on the K10 Symptom Scale

Exclusion Criteria:

* Severe psychiatric or medical condition that prevents the person from complying with either the requirements of informed consent or the study protocol.
* Young people referred to a mental health specialist by their GP will be excluded only if they obtain a specialist appointment during the mobiletype study period (2 - 4 weeks).
Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery

This prospective randomized controlled study will be conducted to evaluate the analgesic effect of continuous perineural infusion of methylene blue with bupivacaine on acute postoperative pain and to evaluate its preventive role against chronic phantom pain in patients undergoing lower limb amputation surgery

Post amputation pain remains an extremely challenging pain condition to treat, so the prevention of phantom pain is our goal to decrease its incidence.

Methylene blue, an inhibitor of nitric oxide synthase and guanylate cyclase, has been widely applied for a variety of pain-related diseases due to its characteristic abilities, such as the blocking of pain transmission, antioxidant, and anti-inflammatory effects. Methylene blue can maintain local anesthesia for approximately 20 days so it can be used as a nerve block to relieve pain, especially refractory neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders, suffering from vascular insufficiency of one or both lower limbs and scheduled for above or below knee amputation under general anesthesia.

Exclusion Criteria:

* Patients with a history of allergy to local anesthetics.
* Patients with allergy to methylene blue.
* Anticoagulant use or coagulopathy.
Upper Extremity Elevation and Lungfunction After Open Heart Surgery

The purpose of this study is to assess if arm elevation, with or without simultaneous deep breathing, affects oxygen saturation and lung function on patients two to four days after open heart surgery.

This single center, interventional crossover study will involve patients day 2, 3 or 4 after open heart surgery. Patients who meet the eligibility requirements will be informed about the study and potential risks, given a written informed consent they will be included for intervention being held later on the same day. Randomization will be given to the investigator in a sealed envelope and being opened after base line measurements. Data will then be collected for the randomized intervention and after a wash out period (several minutes) again for the crossover intervention.

Eligibility Criteria:
Inclusion Criteria:

* open heart surgery at university hospital in Örebro

Exclusion Criteria:

* not able to communicate in swedish
* difficulties in cooperating during measurements
* cognitive impairement
* prolonged stay at ICU (still at ICU on the day of investigation)
* ongoing oxygen treatment with more than 5 liter/minut (FiO \> 40 %)
World Health Organization Disability Assessment Schedule (WHODAS-II) for Patients With Symptomatic Lumbar Disc Herniation

The main purpose of this study is to determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule), as well as to analyze its correlation with symptomatic lumbar disc herniation (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ) and quality of life (SF-12). Measurements will be taken at baseline and 6 days later (day 7).


Eligibility Criteria:
Inclusion Criteria:

* Patients seen for symptomatic lumbar disc herniation
* Radiated pain concordant with nerve root
* With or without motor restriction
* Able to read and write
* Signed the informed consent form

Exclusion Criteria:

* Central nervous system pathology (with or without treatment)
* Diagnosis of rheumatic inflammatory disease or fibromyalgia
* Red flags for underlying systemic disease
* Criteria for diagnosis of symptomatic spinal stenosis
* Symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis
* Motor deficit that progresses or does not improve in 6 weeks
Ultrasound Biofeedback for Speech Sound Disorders

Children with speech sound disorders will receive speech therapy using real-time images of the tongue from ultrasound. These images will be used to cue the child to change the tongue position when producing speech sounds.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be native English-speaking children with no known hearing or vision deficits. Participants must be within the specified age range and have been identified as having speech production difficulties by a local speech-language therapist.

Exclusion Criteria:

* Participants will be excluded if there is a history of oral structural impairment (e.g., cleft palate), hearing or vision impairment, history of neurological impairment or injury, developmental disabilities such as Down Syndrome or Autism, or intellectual disability.

During initial testing, participants must score below a standard score of 75 on the Goldman-Fristoe Test of Articulation-2 and also score below 20% accurate on a probe list of words assessing accuracy of the /r/ sound
Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies

The aim was to compare placental oxygenation in low risk, uncompli-cated, term pregnancies measured by near-infrared spectroscopy (NIRS) in relation to the placental maturity grade determined by ultrasound assessment according to Grannum scale.

The study included 34 singleton subjects divided into two groups accord-ing to placental maturation: low grade (Grannum 0-1; n=10) and high grade (Gran-num 2-3; n=24). In each study subjects, measurement was performed at two sites: (a) test site above the central part of the placenta, and (b) control site out of placenta on lower abdomen, in medial line, 3 cm from the symphysis. Student's t-test was used to compare tissue oxygenation index (TOI) values among the study groups. The normality of distribution was demonstrated by the Kolmogorov-Smirnov test.


Eligibility Criteria:
Inclusion Criteria:

singleton pregnancies low-risk pregnancies uncomplicated pregnancies term pregnancies (37th to 41+6 weeks of gestation) anterior placental localization abdominal wall of less than 3cm thickness.

Exclusion Criteria:

complicated pregnancies pre-term pregnancies Abdominal wall tick \> 3cm
EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children

The purpose of the study is achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase.


Eligibility Criteria:
Inclusion Criteria:

* child
* non metastatic rhabdomyosarcoma
* adequate heart, kidney, liver function

Exclusion Criteria:

* age over 21 years, under 6 months
* metastatic disease
* heart, kidney, liver disease
Thyroid Dysfunction in Patients With Type 2 Diabetes With Early Diabetic Nephropathy.

Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality of life, and on morbidity and mortality through the complications that affect the small and large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease has been emphasized by the findings of the national commission (USA) on diabetes .

So, there was curiosity to understand and learn the association of this disorder with another common endocrine gland function that is thyroid gland . The association between these two disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic population varies widely between studies. With insulin and thyroid hormone being intimately involved in cellular metabolism and thus excess or deficit of these hormones result in functional derangement of the other .

Diabetic patients have higher prevalence of thyroid disorder when compared with the normal population. Diabetic women are more frequently affected than men and hypothyroidism is more common than thyrotoxicosis.

As Hyperthyroidism impairs glycemic control in diabetic subjects, while hypothyroidism may increase susceptibility to hypoglycemia thus complicating diabetes management so Severe diabetic complications where noted in patients with sub- clinical hypothyroidism . Sub-clinical hypothyroidism is an independent risk factor for development of diabetic nephropathy.

Recognition and treatment of thyroid dysfunction in diabetic patients will benefit glycemic control and improve general well-being Diabetic nephropathy, a major microvascular complication of type 2 diabetes mellitus, is an important cause of chronic kidney disease. It results from interactions between hemodynamic and metabolic factors.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus and with diabetic nephropathy.

Exclusion Criteria:

* 1) Insulin dependent diabetes 2) Patients with:

  * Gestational diabetes mellitus.
  * Steroid induced Diabetes.

    3) Thyroid disease
UI-EWD for Endoscopic Hemostasis of Bleeding Peptic Ulcers and Bleeding After EMR/ESD

UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.

UI-EWD (Endoscopic Wound Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect and safety in endoscopic application will be verified. This study has been designed to observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of bleeding peptic ulcer and active bleeding after ESD/EMR

Exclusion Criteria:

* Coagulation disorder (PLT \< 50\*10\^9/L, INR \> 2)
* Connot stop taking the antiplatelet drug, NSAID, Anticoagulant drug, and Aspirin during endoscopic treatment and after 72h endoscopy
Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects

This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* 18 years to 45 years,Healthy male and female subjects.in the same dose group,the age difference between in 10 years
* At least 50kg weight,BMI between 19 and 25kg/m2
* No tobacco, alcohol and other bad habits
* No history of drug allergy and biological agents allergy and other allergies
* Not used biological agents and other drugs within three months before participated in this test
* Not participated in other test or donated blood within three months before participated in this test
* The medical history、physical examination、laboratory examination is normal or slightly abnormal
* Subjects can obey the clinical trial protocol
* Subjects, who are willing to follow the study protocol and provide written informed consent voluntarily.

Exclusion Criteria:

* History of severe system disease(especially with the spleen swelling, adult respiratory distress syndrome and exudative pneumonia or sickle red blood cell anemia history)
* History of drug allergy and biological agents allergy and other allergies
* Subjects have used any long discharge period drugs will affect the present study within 3 months or are using drugs now
* Subjects not to take effective contraceptive measures or have a family planning within one year， Pregnancy or nursing women
* Subjects accepted major surgery 4 weeks before drug administration
* Subjects vaccinated live vaccine 3 months before drug administration
* Subjects with the history of drug abuse 5 years before drug administration
* As the subjects participated 3 times or more than 3 times drug clinical trials within 1 year or as the subjects participated any drug clinical trial or donated blood within 3 months
* Clinical and laboratory examination results is abnormal and have clinical significance
* Subjects with poor compliance or have any unfavorable factors to participate in this test
* Subjects can not complete the research
* The researchers and their family members.
Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging

The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. The investigators hypothesize that pharmacologic stress myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery disease (CAD) who present with symptoms consistent with possible worsening of their CAD.


Eligibility Criteria:
Inclusion Criteria:

* History of coronary artery disease
* New or worsening symptoms
* Out-patients and in-hospital patients

Exclusion Criteria:

* Creatinine above 2.5 mg%
* PCI within prior 6 months
* Pregnant females
* Cardiomyopathy (LVEF below 40%)
* Significant valvular heart disease
* Body mass index greater than 38
Ultrasonographic Versus Renographic Parameters in Prediction of Early Success After Pyeloplasty in Children

To study the predictive value of ultrasonographic (USG) parameters in the form of anteroposterior diameter , calyceal dilatation , calyx-to-parenchyma ratio , renal length , renal width , pelvis-to-cortex ratio (PCR) and parenchymal thickness versus renographic parameters in the form of T1/2 , differential renal function (DRF) and Tissue tracer transit (TTT) for early detection of children at risk of recurrent obstruction post unilateral pyeloplasty.


Eligibility Criteria:
Inclusion Criteria:

* patients who will be scedueled for pyeloplasty

Exclusion Criteria:

* bilateral pathology
* Pelvi-ureteric junction obstruction (PUJO) in a solitary kidney
* other associated anomalies
Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases

Inflammatory Bowel Diseases (IBDs) are a set of recurrent inflammatory conditions that include the colon and small intestine. The two principal conditions include Crohn's disease (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay of gut microbial imbalances and host. In this study stool cultures, saliva and skin samples will be taken from all participants.

Recent studies have shown that certain CD patients harbor microbial communities that are distinct from those of healthy individuals. These studies suggest a central role of the gut microbial population in CD. The high complexity of the gut microbiome, which is the most densely populated bacterial niche, makes the identification of these bacteria a significant challenge. The bacterial population is comprised from 1013 - 1014 individuals, all belonging roughly to a thousand different species, mostly anaerobic, and most of them (roughly 70% - 80%) are uncultivable.

The goals of this project are to examine a potential link between bilirubin metabolism and IBD, by comparing fecal extracts from healthy humans and IBD patients, and to investigate the underlying mechanism explaining these differences.

Eligibility Criteria:
Inclusion Criteria:

* UC
* CD
* healthy Volunteers

Exclusion Criteria:

• N/A