cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections

The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory male or female subjects \> 13 years old.
* A female subject must be non-lactating and at no risk for pregnancy.
* Diagnosis of USSSI with 2 or more of the following local signs and symptoms:

  * Pain/tenderness
  * Swelling
  * Erythema
  * Localized warmth
  * Purulent drainage/discharge
  * Induration
  * Regional lymph node swelling or tenderness
  * Extension of redness
* Acceptable USSSI include, but are not limited to:

  * Cellulitis
  * Erysipelas
  * Impetigo
  * Simple abscess
  * Wound infection
  * Furunculosis
  * Folliculitis
* A sample for microbiologic culture must be obtained from the primary infection site within 48 hours prior to study drug administration.

Exclusion Criteria

* Medical history of hypersensitivity or allergic reaction to penicillin and/or cephalosporin (including cefdinir and cephalexin) antibiotics according to the judgment of the Investigator.
* Subject with a complicated skin and skin structure infection as judged by the investigator.
* A chronic or underlying skin condition at the site of infection (e.g., a secondary infected atopic dermatitis or eczema) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic hardware).
* A wound secondary to burn injury or acne vulgaris.
* Any infection site that requires:

  * intraoperative surgical debridement;
  * excision of infected lesions or body parts.
* Infections that can be treated by surgical incision alone according to the judgment of the Investigator.
* Any other infection that necessitates the use of additional concomitant oral or parenteral antibiotic therapy.
* Known significant renal or hepatic impairment indicated by:

  * Serum Creatinine \> 2.0 mg/dL (176.8 mol/L)
  * SGOT (AST) \> 3x the upper limit of the reference range
  * SGPT (ALT) \> 3x the upper limit of the reference range
  * Alkaline Phosphatase \> 2x the upper limit of the reference range
  * Total Bilirubin \> 2x the upper limit of the reference range
* Underlying condition and/or disease that, according to the judgment of the Investigator, would be likely to interfere with completion of the course of study drug therapy or follow-up.
* The Investigator considers the subject an unsuitable candidate for cefdinir or cephalexin administration
Comparison of Shoulder Stretches

Various stretches are used to lengthen the posterior shoulder capsule. No study has reported the comparison of the pragmatic posterior capsular stretch and cross body stertch

Background: Posterior capsular tightness (PCT) is frequently seen in shoulders in athletic population and shoulder disoders. PCT leads to variation in scapular and humeral kinematics. Two techniques considered in our study for regaining normal range of motion at shoulder joint and improving PCT, one is the pragmatic posterior capsular stretch (PPCS) \& the other one is cross body stretch (CBS) Objective: The aim of our study id to compare the short term/intermediate term effect of PPCS and CBS on range of motion on shoulder joint in healthy individuals. And to evaluate the feedback of subjects regarding both the interventions.

Methodology: Sixty a symtomatic shoulder of 30 subjects (15 males, 15 females) were recruited for this restricted randomised control trials. A simple random sampling technique was used. Subjects were screen through a functional movement screening tool of shoulder mobility. The change in hand behind neck and hand behind back will be measured through measuring tape. Shoulder ROM and functional movements for both the stretches will be campared. Particpants will be follwed for 4 weeks for the change in their shoulder range of motion.

Eligibility Criteria:
Inclusion Criteria:

* Age groups of males and females including 20-35 years
* Subjects who fall in grade 1 and 2 of functional movement screening of shoulder during the screening process.

Exclusion Criteria:

* Individual with shoulder pain, fracture or dislocation less than 1 year
* Individuals with any known shoulder pathology
* Subjects receiving current physiotherapy treatment
* Subjects having enough range of motion( can reach T2 hand behind neck)
Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer

This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China.

Metronomic chemotherapy is a relatively low-dose, high-frequency, continuous application of cytotoxic agents. Phase I/II VICTOR-1 studies have shown that the dual oral beat combination of vincristine and capecitabine is highly active and well tolerated in patients with locally advanced or metastatic breast cancer. The long-term efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in Chinese advanced HER-2 negative breast cancer patients stays unclear. The current study was designed to explore the efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in advanced HER-2 negative patient China.

Eligibility Criteria:
Inclusion Criteria:

* female;
* aged ≥ 18 years and ≤75 years;
* histologically proved metastatic HER-2 negative breast cancer. HER2-negative status determined by situ hybridization (FISH) or immunohistochemistry (IHC) (IHC 0, 1+, 2+ and/or FISH HER2 negative);
* at least one measurable or evaluable lesion based on RECIST 1.1 criteria;
* estimated life expectancy ≥ 3 months;
* normal heart, liver, and kidney function;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
* informed consent signed by the participants

Exclusion Criteria:

* received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within one year prior to treatment initiation;
* participated in other new drug clinical trials within 4 weeks before enrollment;
* inflammatory breast cancer;
* symptomatic visceral disease;
* second primary malignancy;
* mental disorder.
Myofascial Release in Patients with Chronic Obstructive Pulmonary Disease

The main objective of this study is to assess the effects of a myofascial release protocol in patients with chronic obstructive pulmonary disease (COPD).

So far, there are no previous studies that analyze the effects of a myofascial relaxation protocol applied to the diaphragm within the respiratory rehabilitation treatment in patients with chronic obstructive pulmonary disease.

Aim: The main objective of this study is to assess the effects of a 3 weeks myofascial release protocol applied to the diaphragm on respiratory parameters in patients with chronic obstructive pulmonary disease.

Design: Randomized clinical trial

Eligibility Criteria:
Inclusion Criteria:

* COPD;
* Forced expiratory volume in the first second (FEV1) \< 80%;
* FEV1/Forced vital capacity (FVC) \< 70%;
* Maximal inspiratory pressure (MIP) \< 70%.

Exclusion Criteria:

* Recent (6 months) spine or abdominal surgery;
* Allergic status of any kind;
* systemic diseases (rheumatic, infectious conditions, febrile state, vascular alterations, endocrine diseases including diabetes, metabolic, and neoplastic syndromes);
* neuromuscular or neurological injuries;
* previous myofascial release treatment.
Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection

The present study will be a randomized controlled study in which 500 treatment-naive HIV patients will be randomized 1:1 to Efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. The whole cohort will be followed for two years. Efficacy and safety of each regimen will be evaluated throughout the study.

As efaviren has been commonly used as the first-line therapy in HIV infection worldwide, its major side effect i.e. the mental effects have been noticed and has a major influence on the adherence and efficacy of ART regimen. Mental effects of efaviren have been especially critical in Chinese patients, as the effective and toxic ranges of efaviren plasma concentration in Chinese patients are very close to each other.

In this study, 500 treatment-naive Chinese patients with a body weight \< 60kg will be screened and recruited. Patients will be randomized 1:1 to efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. All patients will be followed regularly for 2 years, at 0, 2w, 4w, 3m and every 3 months. Virological and immunological measurements will be done at each visit. Meanwhile, various mental scales will be performed at each visit to evaluate the mental effects of each arm.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Willingness and availability to engage in study activities for the duration of the study
* Age between 18-65
* Documented HIV-1 infection (confirmed by Western blot)
* Received no prior antiretroviral therapy

Exclusion Criteria:

* Pregnancy or breastfeeding or anticipated pregnancy in two years
* History of AIDS-defining illness
* Hemoglobin \< 9g/dl；or peripheral white blood cell counts \< 2000/μl；or neutrophil counts \< 1000 /μl；or platelet count \< 75,000/μl；
* Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
* Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
* Patients with a history of injection drug usage
* Patients with a history of mental disorders
Cognitive Rehabilitation of Glioma Patients

The purpose of this study is to determine whether cognitive rehabilitation is effective in patients with gliomas (brain tumour), by comparing direct and follow-up neuropsychological functioning and quality of life of the experimental group to the control group.

The majority of patients with (low-grade) glioma exhibit cognitive symptoms and objective deficits, which have a sustained, negative impact on daily functioning and quality of life.

Adult patients with a low-grade glioma, either histologically proven, or suspected (1), as well as adult anaplastic glioma patients with favorable prognostic factors (2), who are clinically stable for at least 6 months, will be recruited from 9 hospitals in the Netherlands. Consenting patients with both subjective cognitive symptoms and objective deficits will be randomized to either the cognitive rehabilitation program (N = 75) or a "waiting-list" control group (N = 75). Upon completion of the study, those patients assigned to the control group will be given the opportunity to undergo the cognitive rehabilitation program.

The cognitive rehabilitation program incorporates both retraining of impaired cognitive functions, and teaching of compensatory strategies. Rehabilitation will be directed towards attention, memory and executive functioning. The intervention will consist of 6 weekly, individual, 2-hour sessions plus two hours of homework.

To evaluate the efficacy of the rehabilitation program, objective neuropsychological functioning, self-reported cognitive symptoms and health-related quality of life will be assessed before rehabilitation, directly following rehabilitation, and at 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with a histologically proven low-grade glioma or presumed (i.e., suspected) low-grade glioma based on both clinical and MR imaging feature, and
* adult patients with an anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma) under age 50 and with good performance status (KPS \> 70);
* who are clinically stable for a minimum of 6 months prior to study entry (as determined by recent CT or MRI imaging) and no anti-tumor treatment during that period of time (i.e., surgery, radiotherapy, chemotherapy, corticosteroids);
* who report at least one symptom of impaired cognitive functioning based on a standardized self-report questionnaire, administered by researcher;
* and who meet criteria for neuropsychological impairment based on objective test results (assessed by researcher).

Exclusion Criteria:

* lack of basic proficiency in Dutch;
* IQ below 85;
* severe reading problems;
* an additional (history of) neurological or psychiatric disorder;
* participating in a concurrent study in which neuropsychological testing and/or health-related quality of life assessments are involved
Development of Fecal Scoring for the Management of Fecal Impaction With Regards to Lower Urinary Tract Dysfunction

The role of bowel bladder disorder, or BBD, has been highlighted as a major player in vesicoureteral reflux and urinary tract infection (UTI). However, the diagnosis of BBD are still conceptual and subjective, because of the diagnosis of constipation, main pathophysiology in BBD has not been established well.

Functional constipation is a common disorder among children, accounting for 3-5% of visits to pediatric clinics and even 10% to 25% of consultation for pediatric gastroenterologists. It could cause recurrent abdominal pain, stool retention as well as fecal incontinence. In the urologic field, this is known to develop urinary symptoms. Constipation has been associated with voiding dysfunction and urinary tract infection in children. It is assumed that impacted stool in distal rectum mechanically affect the bladder leading to detrusor overactivity. Additionally, impacted stool would elevate the uretheral sphincter tone, having patients void with incomplete sphincter relaxation and eliciting dysfunctional voiding. Stool impaction may be the source of bacteria causing urinary tract infection and led to recurrent bacteriuria. Treatment of constipation by itself is quite effective alleviating urologic symptoms in as much as two-third of the patients.

The role of constipation has been highlighted as a major player in vesicoureteral reflux and urinary tract infection (UTI). The presence of bowel bladder disorder (BBD) was associated with higher risk of breakthrough infection and a lack of spontaneous resolution. Although constipation is the major player in BBC, there is any objective standard regarding the diagnosis and treatment of constipation. Given the high prevalence and morbidity of children affected by UTI or VUR in relations to BBD, it is imperative that diagnostic and treatment methods are developed.

Despite the known implication of constipation, the diagnosis of constipation may be problematic due to a lack of standard definition for this condition. This may be due to different views between clinicians about which aspect are most crucial for diagnosing constipation. Some underline the subjective nature such as infrequent or difficult defecation, other stress the quality of stool, still others were in search of objective criteria of constipation, like the amount of impacted stool or colonic transit time. Consequently, various criteria have been reported.

The lack of standard criteria for constipation causes trouble sometimes in making a proper decision for diagnosis, intervention, follow-up, and discharge of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with having both significant Lowery Urinary Tract Dysfunction history suggestive of constipation (more than two positive criteria in ROME 4).
* Parental recalling of hard stool (Bristol stool scale of 6 or 7).
* Parental impression of constipation.

Exclusion Criteria:

- Those without Lower Urinary Tract Dysfunction or constipation.
Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension

It is very common for hemodialysis patients to have problems with low blood pressure while on hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated with an increased risk of death and hospitalizations. It might be possible to minimize or even prevent these low blood pressure episodes with a software that can be added to the dialysis machine which detects the patient's changes in blood pressure and automatically slows down how much fluid is being removed from the person.

The investigators hypothesize that a blood pressure guided biofeedback system (called BioLogics RR) will result in a 30% reduction in the number of hypotensive episodes on hemodialysis.

This is a randomized cross over trial in which 30 chronic hemodialysis patients with a history of intradialytic hypotension, IDH will be randomized to receive either standard hemodialysis or hemodialysis with blood pressure guided biofeedback (BioLogics RR Comfort, B braun). After the initial period of 8 weeks patients will cross over to the other group for the final 8 weeks of the study.

The primary outcome is the reduction in the number of IDH episodes associated with patient symptoms or nursing symptoms.

Eligibility Criteria:
Inclusion Criteria:

* chronic hemodialysis patients
* history of 3 of the last 12 runs with documented hypotension with symptoms or nursing interventions

Exclusion Criteria:

* \<19 years
* hemodiafiltration
* expected switch in modality within next 6 months
Aspirin and Plavix Following Coronary Artery Bypass Grafting

The design of the study will be randomized, double blind trial, which will examine the effects of addition of clopidogrel to current guideline recommended background therapy on lowering the incidence of graft stenosis after coronary artery bypass grafting compared to placebo.

The purpose of this study is to evaluate how well the combination of clopidogrel and aspirin lower the risk of clot forming in the bypass graft after open heart surgery. This combination has not yet been approved by the Food \& Drug Administration (FDA) for treating clots in the bypass graft. However, the FDA has not objected to its use to study its safety and effectiveness. This study will enroll approximately 150 total subjects all of which will be at Brooke Army Medical Center/Wilford Hall Medical Center. The study will be for 52 weeks from the day of surgery.

After bypass surgery and inclusion criteria is met, subjects will be placed on aspirin 81 mg once daily and placebo once daily or aspirin 81 mg once daily and clopidogrel 75mg once daily to keep the bypass grafts open after surgery. There are no studies to date comparing the two study groups A CT scan of the heart will be done 2 weeks after surgery to see if the grafts are still open. At the end of the study, at 52-weeks mark, the subjects will undergo another heart scan to evaluate the bypass grafts and see if they are still open.

Subjects will be seen on a 3 months basis until the end of the study, unless deemed necessary to return earlier for follow up. Subjects will undergo blood draw for complete blood count as part of the follow up visits to assess for safety while on the current study drug.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary artery bypass grafting, with or without cardiopulmonary bypass
* Age ≥ 18

Exclusion Criteria:

* Left ventricle ejection fraction \<30%
* Emergency surgery
* Valve surgery
* Redo CABG
* Postoperative cardiogenic shock for more than 48 hours
* Postoperative bleeding or cardiac tamponade
* More than 24 hours postoperative intubation course
* Requirement of postoperative anticoagulation
* Serum creatinine \>1.4
* Contraindication to use of postoperative coronary CT scan
* Allergy or contraindication to aspirin or clopidogrel
* Inability to provide informed consent
* Pregnant or breast feeding females
HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs

Comparison of the detection of human papillomavirus DNA in paired physician-obtained cervical swabs and self-sampled cervicovaginal swabs and evaluation of HPV prevalence in Czech women screening population.

The cervical screening program in the Czech Republic is based on cytology with HPV triage. Nevertheless, cytology-based cervical screening may switch to HPV-based cervical screening in future. The implementation of primary HPV screening and insuficiency cervical screening attendance are a major challenge. The offering of self-sampling to the cervical screening non-attenders could increase women's participation as was shown in several European countries. The objective of the HPVPro study was to find out the HPV prevalence in the screening population of Czech women since there are no data for the Czech Republic. The second objective was to compare HPV DNA detection rate in paired self-sampled cervicovaginal swabs and physician-obtained cervical swabs and to determine acceptability of self-sampling HPV DNA test by Czech women. This information is important for optimisation of cervical cancer screening program in the Czech Republic.

Eligibility Criteria:
Inclusion Criteria:

* Women with age 30-64 years.
* Women attending cervical cancer screening program in Czech Republic.
* Women with completed informed consent.

Exclusion Criteria:

* Pregnant women.
* Women with no sexual intercourse experience.
* Women after cervical conization or hysterectomy.
* Women with CIN or cervical carcinoma in anamnesis.
* Women at risk of increased bleeding.
Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia

The main purpose of this study is to use an investigational urine assay to estimate the proportion of pneumonia in adults 50 years or older in different areas throughout the US that is caused by certain types of the bacteria Streptococcus pneumoniae (also called pneumococcus).


Eligibility Criteria:
Inclusion Criteria:

* Age 50 years and older.
* Presents to a study site with clinically suspected pneumonia.
* Has a radiographic finding that is consistent with pneumonia.
* Able and willing to provide urine.

Exclusion Criteria:

* Transfer to a study hospital after already being hospitalized for 48 hours or more at any other inpatient facility (such as community hospital).
* Hospital-acquired pneumonia (ie, pneumonia developing 48 hours after hospital admission).
* Previous enrollment in this study within the past 30 days.