cyrilzakka/clinical-trials huggingface dataset:
Characteristics of Clinical Laboratory Indicators in Patients with Dengue Fever

The objective of this observational study was to understand the changes in laboratory indicators and clinical manifestations of dengue patients at various ages, and to provide new ideas for the treatment and prevention of dengue. The main questions it aims to answer are: 1 What are the key abnormal items in blood routine indicators of dengue patients? 2 Does dengue affect liver function in patients? Will there be liver damage? And when? 3. What are the specific clinical manifestations of dengue patients?


Eligibility Criteria:
* Inclusion Criteria\*\*:

  * Meet the clinical diagnostic criteria for dengue fever, with blood indicators showing that the dengue antigen is positive.
  * No age limit for inclusion.
  * Voluntarily agree to participate in the study and sign the informed consent.
  * Complete clinical data available, including symptoms and laboratory tests, to support subsequent analysis.
* Exclusion Criteria\*\*:

  * Incomplete or unavailable clinical data. Patients will be excluded if sufficient laboratory data and symptoms cannot be collected.
  * Unable to understand or unwilling to sign the informed consent for any reason.
The Effects of a Self-management Intervention on Low Literacy Patients With Chronic Obstructive Pulmonary Disease (COPD)

Purpose: To determine the role health literacy plays in the care continuum for Chronic Obstructive Pulmonary Disease (COPD) and the effect of a self-management intervention on inhaler technique use, time spent on self-management, and knowledge for COPD patients with low literacy.

Participants: The investigators will recruit patients from the University of North Carolina at Chapel Hill Ambulatory Care Center (ACC) who have a diagnosis of COPD.

Procedures (methods): Potential subjects with COPD will be identified through pharmacy claims data, clinic billing data and the electronic medical record. Eligibility will be prescreened by a research assistant (RA) using the electronic medical record prior to approaching potential subjects for consent. For the first part of the study, consenting subjects will complete a baseline health literacy assessment, a questionnaire, an inhaler technique assessment, and a diary of time spent in self-management activities. Pulmonary function tests (PFT) will be performed on all participants for whom PFTs have not been conducted within the previous 12 months. The questionnaire will include measures of COPD-related knowledge, self-management techniques, quality of care, access, quality of life, costs, healthcare utilization, exacerbations, and basic demographic information. The inhaler technique assessment will be administered by the research assistant using a pre-established protocol. The research assistant will abstract additional data from the medical record to assess the quality of care based on adherence to recommended COPD care guidelines. For the second part of the study, participants will be randomized to control and intervention arms. The self-management intervention will be an interactive experience, delivered by a trained research assistant, targeting self-management skills (inhaler use, using an action plan, etc), smoking cessation, and exercise/pulmonary rehabilitation. Those randomized to the control group will receive usual care. All participants will return 2-4 weeks after the intervention for a follow-up assessment of inhaler technique, COPD-related knowledge, and time spent in self-management.


Eligibility Criteria:
Inclusion Criteria:

* are age 18 years or older and,
* have been diagnosed with COPD
* are active patients in the General Internal Medicine or Pulmonary Clinics at the Ambulatory Care Center
* are being treated with inhaled medication for their COPD

Exclusion Criteria:

* non-English speaking (intervention will be available in English only)
* participants unable to complete the study (either with or without assistance)
* patients who are currently experiencing an exacerbation
Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy

This study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period

Exclusion Criteria:

* previous surgical treatment for stress urinary incontinence (SUI)
Investigation of Genetic Marker Associated With Obesity in Koreans

A single-nucleotide polymorphism (SNP) analysis of DNA obtained from peripheral blood of the obese patients and the normal control will be performed to find genetic marker for obesity


Eligibility Criteria:
Inclusion Criteria:

* BMI 25\~30kg/m2

Exclusion Criteria:

* All were nonsmokers and had no evidence of cancer, liver, renal, hematological disease or other metabolic disorders other than obesity
NMES for Achilles Tendon Rupture

The majority of patients suffering an Achilles tendon rupture develop long term functional deficits in the affected leg. The goal of the proposed study is to evaluate a new rehabilitation protocol using Neuromuscular Electrical Stimulation (NMES) for reducing muscle atrophy and improving tendon properties. If proven beneficial, the proposed protocol can be easily adopted and incorporated as part of routine care for Achilles tendon rupture.

Achilles Tendon Ruptures (ATR) are common and permanently affect the function of the lower leg. Regardless of treatment approach the majority of patients develop long term functional deficits, which include decreased plantar flexion strength, lower heel-rise height, and altered gait patterns. It is believed that tendon lengthening and calf muscle atrophy, which develop during the first few weeks of recovery, are major factors contributing to these functional deficits. The initial development of atrophy is likely caused by reduced loading and muscle activity of the affected leg. However, long-term atrophy may be related to tendon elongation. On the other hand, tendon elongation initially rises during the first few weeks of unloading and slowly reduces, but not completely, when loading is resumed. However, atrophied calf muscles may not provide sufficient loading for optimal tendon recovery. Therefore, there seems to be vicious spiral between tendon elongation and muscle atrophy.

The objective of this study is to develop a neuromuscular electrical stimulation (NMES) rehabilitation protocol for Achilles tendon ruptures. Our preliminary data has shown that force applied to the tendon can be modulated using electrical intensity and pad placement. Therefore, NMES can produce significant contraction in the calf muscles and induce controllable, low-magnitude, cyclic loading to the tendon; which cannot be achieved with voluntary muscle contractions. This approach can potentially overcome limitations of the current rehabilitation protocols.

Eligibility Criteria:
Inclusion Criteria:

* Achilles tendon rupture

Exclusion Criteria:

1. Those unable to understand spoken English.
2. Participants treated non-operatively
3. Augmented surgical repair (i.e., use of additional tissue at the repair site)
4. Tendon ruptures associated with the use of fluoroquinolones (Examples include ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin))
5. Allergy to ultrasound gel
6. Any other condition affecting the ability of the participant to walk or jump
7. Any other health conditions known to impair normal healing: Diabetes, Cardiovascular conditions decreasing blood supply to the leg
8. Those unable to consent
A Randomized Controlled Trial of the Uresta Continence Pessary

Stress urinary incontinence (SUI) is defined as the involuntary loss of urine with an increase in abdominal pressure, caused either by a loss of support under the bladder neck, or intrinsic urethral sphincter deficiency. It is a common problem in women that can significantly impact quality of life, with up to 30% developing SUI at some point in their lifetime.

The most commonly utilized treatments for SUI include either pelvic floor (Kegel) exercises, or surgery. Many women find Kegel exercises unsatisfactory, but are reluctant to undergo a surgical procedure. Also, women who are poor candidates for surgery have limited options if Kegel exercises are unsuccessful. Over the years, there have been numerous attempts to develop effective non-surgical alternatives for treating SUI, but the results have been variable and the available data on efficacy limited.

A new intravaginal incontinence pessary (Uresta) has been developed for treating stress incontinence, and is currently available in Canada via a medical distributor. The self-positioning device is initially fitted by a healthcare provider, but then can subsequently placed by the patient as needed. Uresta is designed to be easily inserted into the vagina and spontaneously fall into position, providing support beneath the urethra. A single, uncontrolled study of 21 women showed that Uresta significantly reduces urinary incontinence measures, with no reported complications. Using questionnaires, a 47% reduction in self-reported SUI symptoms was demonstrated. Pad weight following a pad test, an objective assessment of urine loss, showed a 50% reduction in leakage.

This trial is intended to be a short-term assessment of the efficacy of the Uresta device, using a placebo arm in order to remove any of the possible sources of patient biases. The placebo ("sham") group will be obtained by placing a flexible silastic ring (inactivated Estring) high in the vagina where it will not alter urethral forces. The aim is to unequivocally determine whether the Uresta device provides the necessary urethral support to stop urine leakage from stress incontinence.

The hypothesis is that the Uresta device will significantly reduce urinary losses from baseline, shown as a significant reduction pad weight following a pad test with the device in place.


Eligibility Criteria:
Inclusion Criteria:

* Urodynamic diagnosis of stress urinary incontinence

Exclusion Criteria:

* Urodynamic diagnosis of mixed incontinence
* Bladder capacity less than 300mls
* Post-void residual over 100mls
* Pelvic organ prolapse greater than POP-Q stage 2
* Hematuria
* Undiagnosed vaginal bleeding
* Current pregnancy
* Previous incontinence or prolapse surgery
* Failed use of an incontinence pessary
* Physically unable to perform the activities included in the pad test
Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents

The aim of this study was to determine the effect of food insulin index (FII) on metabolic parameters and appetite in obese adolescents with insulin resistance. A randomized, single-blind and crossover trial included 15 obese adolescents aged 12-18 years with insulin resistance. All participants were submitted two different breakfasts: low glycemic index, low insulin index (LGI-LII) and low glycemic index, high insulin index (LGI-HII), with a 1-week washout period between meals. At time 0 (just before breakfast), 15, 30, 45, 60, 90, 120, 180 and 240 minutes after the meal, serum glucose, insulin and c-peptide levels were measured and appetite was evaluated by visual analog scale. At the end of four hours, participants were served ad libitum lunch meal. Then, the foods eaten at lunch were recorded and their energy and nutrient analysis was calculated.


Eligibility Criteria:
Inclusion Criteria:

* Aged 12-18 years
* Age- and sex-specific body mass index (BMI) ≥95th percentile of the World Health Organization (WHO) growth-reference data
* New diagnosis and not receiving any treatment
* Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) \>3.16

Exclusion Criteria:

* Hypertension, cardiovascular disease, diabetes mellitus or any other significant metabolic, endocrine or gastrointestinal disease
* Use of tobacco or alcohol
* Taking any medications
* Having difficulties for physical activity
Frailty and the Elderly in Martinique

This was a prospective multicenter cohort study of elderly people admitted to the acute care for elders in Martinique. They were followed up to 36 months. It aimed to study the adverse outcomes. In all, 287 subjects were included. They were 85+/-6 years, and mainly women (61%).

The SAFMA cohort was an ad hoc study formed into the recruitment of the acute care for elders in the geriatric department of Martinique university Hospitals. The inclusion of subjects ran from January 1st 2012 to June 30th 2012. To be eligible, patients had to be 75 or over and hospitalised for acute condition. Each patient was visited by a specialist in geriatrics familiar with the survey procedures. In the course of this interview, patients were informed about the study, prior to signing the consent form. If the clinical status and/or the cognitive status of the patient did not enable informed consent, the interviewer referred to the subject's representative. Follow-up was performed by visits and telephone interview till 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Age of 75 years or over
* Admitted to acute care for elders
* Consent to participate

Exclusion Criteria:

* Impossibility to perform the tests
* Refusals to participate
Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injection in Melanoma Patients With Biopsy Accessible Lesions

This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected.

MRX34 Induction Therapy consists of 3 cycles of MRX34 treatment given over an approximately 8 week period. Dexamethasone 10 mg PO (or IV) will be given as premedication. On Days 1-5 of each treatment cycle, MRX34 will be given as a daily infusion followed by 16 days of rest. At screening a tumor biopsy sample will be required from all patients. Additional biopsies will be collected at Cycle 1 Day 3 and the end of Cycles 1 and 3 (Day 18 +/- 1 day)

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Advanced or metastatic cutaneous, acral or mucosal melanoma
* Tumor lesions accessible to serial biopsies
* ECOG ≤ 1
* ANC ≥, Plts ≥100,000 /mm3

Exclusion Criteria:

* Serious active non-malignant disease
* Central Nervous System metastasis
Association of Host Genetics With Vaccine Efficacy and Study of Immune Correlates of Risk From a Tetravalent Dengue Vaccine

Primary objectives:

* To assess how dengue vaccine efficacy varies across participant subgroups regarding polymorphism in human leukocyte antigen (HLA) alleles of interest.
* To assess the association between HLA alleles and, serotype-specific neutralization antibody titers and summary neutralization measure in the vaccine and placebo groups.
* To assess the association between the polymorphism in HLA alleles of interest and susceptibility to Dengue fever and Dengue Haemorrhagic fever.

Secondary objectives:

* To assess whether dengue serotype-specific neutralizing antibody titers and associated summary neutralization measure at 28 days post-dose 3 are related to the rate of occurrence of symptomatic Virologically-confirmed dengue infection after post-dose 3
* To evaluate whether the dengue serotype-specific neutralizing antibody and associated summary neutralization measure at 28 days post-dose 3 are related to the level of vaccine efficacy against dengue viruses after post-dose 3.

The enrolled population will include both, virologically-confirmed (VC) dengue cases and subjects not having experienced a VC dengue infection (control subjects) from the first Proof of Concept efficacy study conducted in Thailand Analyses for correlates will be performed on samples collected in the context of the first proof of concept efficacy study. Sequencing of dengue viruses will also be done on samples collected within the same context. Immunogenetic testing will be performed on saliva samples collected at the study enrollment visit.

No intervention or vaccine will be provided or administered as part of this study.

Eligibility Criteria:
Inclusion Criteria:

* Subject currently enrolled in, or having recently finished, CYD57 (NCT01983553; long-term safety follow-up study of the first PoC efficacy study), included in the subjects list provided by the Sponsor, with or without past experience of virologically confirmed dengue.
* For children 7 to \< 18 years. Assent form (AF) has been signed and dated by the subject, and informed consent form (ICF) has been signed and dated by the parents or another legally acceptable representative and by independent witness, as per local Ethics Committee (EC) requirement. For subjects ≥ 18 years. ICF has been signed and dated by the subject and by independent witness, as per local EC requirement.
* Subject (and parent(s) / legally acceptable representative for subject \< 18 years) are able to attend the scheduled visit and can comply with all study procedures.

Exclusion Criteria:

* Any illness that, in the opinion of the Investigator, might interfere with study procedures.
B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals

The purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in this group.


Eligibility Criteria:
Inclusion Criteria:

* Asplenia
* β-thalassemia major
* older than 18 years

Exclusion Criteria:

* no previously recorded allergy to PCV
* no intravenous immunoglobulin (IVIG) given within the previous 6 months
* no other vaccine given within the previous 6 months
Comparison of the Efficacy and Quality of Life of Three Bleaching Products

The aims of this study are: to compare the efficacy of three different dental bleaching products; to evaluate colour relapse following dental bleaching treatment at 1, 3 and 6 months follow up; to evaluate the impact in quality of life from dental bleaching treatments.

Products to be used represent three different techniques and formulations: in office, universal tray and custom tray (respectively VivaStyle Paint On Plus (Ivoclar Vivadent, Liechtenstein), Opalescence GO 6% (Ultradent, USA) and Opalescence PF 15% (Ultradent, USA).

All products contain 6% hydrogen peroxide or its equivalent.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Be willing to refrain from use of tobacco products during the study
* Be willing to sign an informed consent form
* At least one teeth 13,11,21,23,33,43 has a gradable VITA shade A3,5 or darker by clinical assessment

Exclusion Criteria:

* Teeht with restorations in frontal teeth
* Patients with untreated periodontitis or caries
* Patients with fixed orthodontics appliances
* Patients with know allergies to ingredients
* Patients who are nursing or pregnant
* Patients with severe systemic illnesses
* Patients with development tooth anomalies
* Patients with non vital anterior teeth
* Patients with insufficient oral hygiene
Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail

The purpose of this study is to evaluate if an early mobilization after distal radius fractures treated by surgery leads to an better functional outcome then immobilization after surgery for 5 weeks in a cast

All patients with a distal radius fracture treated by surgery (palmar angle stable plate) will be included in this study and randomised into two groups according the CONSORT Guidelines of Prospective Randomised Trails. One group ("early mobilisation") receive a removable plastic cast for one week and are allowed to move the wrist directly postoperative.

The other group ("control group") received a non removable cast for 5 weeks. Both groups underwent physiotherapy two times a week. The control group was only allowed to move the closed-by joints.

In the 6., 9., 12. postoperative week, a half and one year after the operation the patients underwent range of motion (ROM), grip strength measurement and pain according to the visual analogue scale (VAS). Hand function will be analysed according the PRWE (Patient-Rated Wrist Evaluation) Score, DASH (Disabilities of the Arm, Shoulder and Hand) Score and Mayo Wrist Score.

* Inclusion criteria:

  * Age ≥ 18 and ≤ 75 years
  * A2 - C3 distal radius fracture
  * no acute or older injury that influences hand function
  * operative stabilized by palmar angle stable plate
* Exclusion criteria:

  * Age ≥ 76 years
  * Age \< 18 years
  * C3.3 radius fracture
  * acute or preexisting injures that influences hand function
  * pregnancy
  * neurologic disorders
  * incapacitated people

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 75 years
* A2 - C3 distal radius fracture
* no acute or older injury that influences hand function
* operative stabilized by palmar angle stable plate

Exclusion Criteria:

* Age ≥ 76 years
* Age \< 18 years
* C3.3 radius fracture
* acute or preexisting injures that influences hand function pregnancy neurologic disorders incapacitated people
Pilot Study of Stem Cell Treatment of Patients With Vocal Fold Scarring

This is a pilot-study of 16 selected Swedish patients which all have severe hoarseness or aphonia due to vocal fold scarring (from previous surgery, radiation therapy, inflammation or possibly hereditary). The patients are operated with phonomicrosurgical dissection of the scarred vocal folds, removal or scar tissue and injection of autologous mesenchymal stroma cells, aMSC (which were previously harvested from each patients´s bone marrow, purified, expanded and characterized according to standard procedure at the Center of Hematology and Regenerative Medicine Karolinska University Hospital Huddinge). 8 Patients is planned to be treated with a single injection of aMSC and 8 patients with injection of aMSC mixed with a carrier hyaluronan gel developed at Uppsala University Sweden and at the Karolinska Institute. The laryngeal status, vocal fold function, and voice function will be followed individually with an advanced battery of examinations performed before and up to 1 year postoperatively. Side effects and complications are noted and reported during surgery and following surgery at regular intervals during at least 1 year Since spring 2015 no new patients have been recruited and no treatments are given during 2016 or 2017. The monitoring authority was changed from Swedish National Board of Health to Swedish Medical Product Agency (MPA) in March/April 2016. Further inclusions and treatments are postponed until permission is granted from MPA to continue the study.


Eligibility Criteria:
Inclusion Criteria:

* severe hoarseness
* vocal fold scarring
* no active other treatment
* age above 18 years

Exclusion Criteria:

* active treatment of laryngeal disorder
* active inflammatory condition of the larynx
* diagnosed or suspicions of local malignancy