cyrilzakka/clinical-trials huggingface dataset:
Reduction of Mortality Prior to and During the First 90 Days of Dialysis Through a Renal Rehabilitation Program

The mortality rate of treated patients with end stage renal disease(ESRD)is 22 deaths patient-years at risk in 2006. Incident patients with ESRD are most vulnerable within the first 90 days of dialysis, with an annualized mortality rate of 50 deaths/100 patient years. The vast majority of these deaths are due to cardiovascular causes. As cardiac rehabilitation programs have shown a 20% reduction in one year overall mortality rate post myocardial infarction the investigator proposes that a similar type of rehabilitation program will also have a benificial effect on morbidity and mortality in patients with chronic kidney disease(CKD)and ESRD.The overall goal of this project is to study whether a renal rehabilitation program based on guided exercise implemented in patients with stage III and stage IV CKD can influence the mortality rate of these patients prior to and during the first 90 days of dialysis

Hypothesis:The application of a guided exercise program (renal rehabilitation) instituted in patients with stage III or Stage IV CKD will decrease the mortality rate prior to the initiation of renal replacement therapy.

Hypothesis:The application of renal rehabilitation during the late stages of CKD will decrease the mortality risk during the first 90 days of renal rehabilitation therapy.

Hypothesis:A guided exercise program will have an immediate and prolonged effect on activity levels, mental health and adaption to chronic illness in patients with advanced CKD.


Eligibility Criteria:
Inclusion Criteria:

* greater than 18 yo
* stage III CKD (GFR\<60ml/min)
* stage IV CKD (GFR\<30ml/min)

Exclusion Criteria:

* active angina pectoris
* lower extremity amputation with no prosthesis
* orthopedic disorder severly exacerbated by activity
* chronic lung disease resulting in significant shortness of breath or oxygen de-saturation at rest
* cerebro cascular disease manifested by ongoing TIAs
* malignant carcinoma
Furcation Therapy With Enamel Matrix Derivative

Objective: To clinically evaluate mandibular furcation treated with Beta tricalcium phosphate/hydroxyapatite (βTCP/HA) isolated or combined with enamel matrix derivative (EMD + βTCP/HA) and EMD alone.

Material and Methods: 39 patients, presenting at least one mandibular class II furcation defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, were included. The defects were assigned to the βTCP/HA group 1 (n = 13); open-flap debridement (OFD) + βTCP/HA filling; βTCP/HA + EMD group 2 (n = 13); OFD + βTCP/HA + EMD filling; and EMD group 3 (n = 13) OFD + EMD filling. Plaque (PI) and gingival index (GI), PPD, relative gingival margin position (RGMP), vertical and horizontal attachment level (RVCAL and RHCAL), and furcation diagnosis were evaluated at baseline, 6 and 12 months.

Although enamel matrix derivative (EMD) has been used to promote periodontal regeneration, little is known of its effect on the microbiome. Therefore, this investigation aimed to identify the changes in periodontal microbiome following treatment with EMD using a deep-sequencing approach. Thirty-nine patients having mandibular class II buccal furcation defects were randomized to beta-tricalcium-phosphate/hydroxyapatite graft (BONE group), EMD+BONE or EMD alone. Plaque was collected from furcation defects at baseline, 3 and 6 months post-treatment. Bacterial DNA was analyzed using terminal restriction fragment length polymorphism (t-RFLP) and 16S pyrotag sequencing. 169,000 classifiable sequences were compared to HOMD using the QIIME and PhyloToAST pipelines. Statistical comparisons were made using parametric tests. At baseline, a total of 422 species were identified from the 39 defects, belonging to Fusobacterium, Pseudomonas, Streptococcus, Filifactor and Parvimonas. All three regenerative procedures predictably altered the disease-associated microbiome, with a restitution of health-compatible species. However, EMD and BONE+EMD groups demonstrated more long-term reductions in higher number of species than in BONE group (p\<0.05), especially disease-associated species e.g. Selenomonas noxia, F.alocis, and Fusobacterium. EMD may promote periodontal regeneration by predictably altering a dysbiotic subgingival microbiome, decreasing pathogen richness and increasing commensal abundance.

Eligibility Criteria:
Inclusion Criteria:

* Untreated ChronicPeriodontitis

Exclusion Criteria:

* Diabetes Pregnancy Current Smoking
Assessment of Central Pain in Patients Who Undergo Spinal Surgery and Influence in Surgery Outcome

* Pain is one of the most common concerns for which patients seek medical attention.
* Pain is usually understood as symptom that reflects peripheral organic damage. Many patients experience pain, often chronically, independently of any underlying cause such as chronic regional pain syndromes (irritable bowel syndrome, temporo-mandibular pain syndrome, chronic headache or chronic low back pain)or diffuse like in fibromyalgia. In all those "functional" syndromes, accumulated evidence supports involvement of central pain processing systems, hypothalamic pituitary adrenal axes and autonomic nervous system, and are now referred as central pain conditions.
* Other patients suffers from chronic pain caused by damage or inflammation in peripheral tissues, but also experienced more diffuse pain, not directly explained by peripheral damage, that further aggravates pain and function. This is illustrated by the high prevalence of fibromyalgia observed in patients with rheumatoid arthritis, osteoarthritis or ankylosing spondylitis for example.

These pain conditions are now understood as combinations of peripheral, neuropathic and central pain.

The investigators aimed to focus in this study in patients that are candidates to spinal surgery and suffer from low back pain and/or radiculopathy. Pain in these patients may arise from damage to nerves - neuropathic pain- , to musculoskeletal structures - peripheral pain-, and may also reflects alteration in central pain processes.

In these patients, spine surgery is usually performed to improve quality of life, decrease pain and avoid neurological deficits. Evaluation of surgical outcome includes objective measures such as neurological findings and radiographic evaluation, and subjective measures including patient self-assessments for pain and quality of life and psychological changes.

The aim of this study is to evaluate patients who undergo spinal surgery for presence of central pain and central sensitization symptoms and evaluate their influence on these surgical outcomes


Eligibility Criteria:
Inclusion Criteria:

* candidates to spinal surgery attending the spine clinic
* able to give inform consent

Exclusion Criteria:

* pregnant women
* children under 18
* current infection in spine
Vitamin C and Hiprex in rUTI

A single centre proof of concept study to assess whether Vitamin C improves the efficacy of Methenamine Hippurate (Hiprex®) in the prophylaxis of recurrent urinary tract infections (rUTIs) in women


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥18 years
* Recurrent proven UTI, defined as "two or more proven infections in six months or three or more infections in six months"
* Willing and able to give fully informed consent
* Patients suitable for prophylaxis following discussion with their clinician.
* No contra-indications to treatment with methenamine hippurate or Vitamin C
* All women will have undergone standard diagnostic work-up and have followed routine conservative UTI prevention measures.
* A working email address to be used to submit urine pH results
* Willing and able to comply with the study procedures
* Females of childbearing potential must be willing to use a highly effective method of contraception (hormonal or barrier method of birth control; abstinence; sterilisation or vasectomised partner)

Exclusion Criteria:

* Males
* Women who are pregnant or breast-feeding
* Contraindications to methenamine hippurate as described in BNF: known allergy, gout, severe metabolic acidosis, severe dehydration, eGFR less than 10 ml/min, severe hepatic impairment
* Currently using vitamin C containing supplement or cranberry extract tablets
* Women using urinary alkalinisation agents, e.g potassium citrate, sodium bicarbonate
* Currently receiving any form of bladder instillation or intradetrusor Onabotulinum Toxin A injections
* Patients already on low-dose antibiotics or methenamine hippurate (due to delay that will be incurred by 3-month washout period)
* Indwelling urinary catheter in situ or performing clean intermittent self-catheterisation
* Correctable urinary tract abnormalities, e.g., urinary tract calculi, urinary retention
* Formation of ileal conduit or augmented bladder
* Neurogenic bladder dysfunction
* Hyperoxaluria
Economic Evaluation of the MEWE Intervention

Cash transfers have shown promise in preventing intimate partner violence, and in reducing recipients' stress levels. Cash transfers with behavioral or psychological interventions have shown limited effectiveness at reducing stress in some African countries. Little is known of the cost-effectiveness of interventions delivered alongside cash transfer programs. The MEWE economic evaluation sub-study (MEWE-EE) runs alongside MEWE, a three-arm cluster-randomized controlled trial in Sindh, Pakistan. MEWE-EE will assess the costs and cost-effectiveness of delivering a cash-transfer program (BISP-CT) combined with a life-skills building curriculum (LSB curriculum), compared to the BISP-CT alone. The LSB curriculum is offered to either women who receive BISP-CT, or to women who receive BISP-CT and their husbands.


Eligibility Criteria:
Inclusion Criteria:

* In receipt of Benazir Income Support Program (BISP) cash transfers (CTs)
* Parity: have at least one child, at least 18 months old

Exclusion Criteria:

* Plan for the family to migrate out of the village within the next 2 years
Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood

The primary objective of the study is to assess the accuracy of the SD Biosensor STANDARD™ point-of-care (POC) G6PD test in measuring G6PD activity and classifying results compared to a reference assay and across repeated measurements in capillary samples.

Cross-sectional diagnostic accuracy study with 250 volunteer participants. The clinic will recruit and consent adult study participants. Clinic staff will draw venous blood and obtain finger stick capillary blood samples. Clinic staff will perform the investigational SD Biosensor STANDARD™ G6PD test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood. An anti-coagulated venous blood sample will be sent to a Clinical Laboratory Improvement Amendments (CLIA) certified lab for G6PD reference testing by the gold standard assays: G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay and hemoglobin measurement by a hematology analyzer.

Individuals identified as G6PD deficient or intermediate by the reference test will be notified of their results by the clinic and referred to their physician for follow-up.

This study includes a nested repeatability study and a nested sample stability study. In the nested repeatability study up to 20 consented participants will provide 4 additional finger stick samples. Clinic staff will perform the SD Biosensor STANDARD™ G6PD test to assess the repeatability of the test in capillary blood over 8 G6PD and hemoglobin measurements on up to 3 different instruments.

In the nested sample stability study up to 8 consented participants will provide an additional venous blood draw sample to be tested at additional time points to document stability of the samples over time when tested by the SD Biosensor STANDARD™ G6PD Test.

Eligibility Criteria:
Inclusion Criteria:

* Must communicate an understanding of the study protocol.
* Must be able to provide written consent to undergo screening and provide medical history.
* Participants must be afebrile and in general good health in the opinion of the investigator as determined by vital signs, medical history, and physical examination.
* Black/African-American, by self-report.

Exclusion Criteria:

* Blood transfusion in the past 3 months by self-report
Effects of Rehabilitation on Muscle Fibre Composition and Capillaries in Chronic Obstructive Pulmonary Disease (COPD) Patients

Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients with chronic obstructive pulmonary disease (COPD). The aim of our study is to show a potential change in muscle fibre composition and in the amount of capillaries in quadriceps muscle from pre tob post 3-week rehabilitation. Pulmonary rehabilitation includes standardised exercise training, e.g. cycling and strength training for major muscle groups.


Eligibility Criteria:
Inclusion Criteria:

* chronic obstructive pulmonary disease
* FEV1%pred. \< 50%

Exclusion Criteria:

* acute exacerbation
* exacerbation in the last 4 weeks
Prolonged Exposure and Oxytocin

Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may develop after direct or indirect exposure to traumatic events. Prolonged Exposure (PE) is a cognitive-behavioral psychotherapy modality with a wealth of empirical support demonstrating its efficacy to treat PTSD in a variety of populations. The neuropeptide oxytocin is a promising new pharmacotherapeutic agent with prominent anxiolytic effects . Despite a strong biological and theoretical rationale for investigating the potential effectiveness of augmenting PE with intranasal oxytocin, no studies to date have done so. The current study aims to address this important gap in the literature by examining changes in PTSD symptoms following PE treatment combined with a) 40 IU of intranasal oxytocin or b) placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female; any race or ethnicity; age 18-75 years.
2. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
3. Participants must be able to comprehend English.
4. Meet DSM-5 criteria for current PTSD (assessed via the Clinician Administered PTSD Scale; CAPS).
5. A CAPS score of 50 or greater.
6. Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders (e.g., agoraphobia, social phobia, generalized anxiety disorder). The inclusion of participants with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with PTSD.
7. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least eight weeks before study initiation. Initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.

Exclusion Criteria:

1. Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent. Those participants will be referred clinically.
2. Participants who would present a serious suicide risk or who are likely to require hospitalization during the course of the study. Those participants will be referred clinically.
3. Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 8 weeks.
4. Participants meeting DSM-5 criteria for a substance use disorder, except caffeine or nicotine, within the past 12 months.
5. Pregnant women will be excluded from the proposed study.
Animal-Assisted Interactions in Children With Life-Threatening Conditions and Their Parents

This study will evaluate the effects of animal-assisted interactions (AAI) on stress, anxiety, and quality of life in children with a life-threatening condition and their parents. It is anticipated to be a milestone in understanding the human-animal bond.

Objectives:

1. Examine the feasibility of animal-assisted interactions sessions for children with a life-threatening condition and primary caregiver to:

   * Identify and document modifications for a safe and feasible intervention,
   * Obtain recruitment estimates and determine potential recruitment barriers
   * Evaluate elements of implementation fidelity (design, training, delivery/receipt of Treatment, enactment)
   * Verify safety.

   H1-1: Children and parents (\>60%) will complete the interventions and provide positive acceptability data. H1-2: Implementation fidelity can be achieved with the proposed methodology
2. Determine the preliminary efficacy of animal-assisted interactions sessions for:

   * Children with a life-threatening condition (LTC) for the outcome of health-related quality of life
   * Children with a LTC and their primary caregivers for the outcomes of stress and anxiety

H2-1 Children with a life-threatening condition who receive animal-assisted interactions will experience improved health-related quality of life (HRQOL) more than patients who do not receive animal-assisted interactions.

H2-2a Children with life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions.

H2-2b Primary caregivers of children with a life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions.

Eligibility Criteria:
Inclusion Criteria:

* Children 3-17 years old
* Confirmed diagnosis of relapsed or refractory cancer

Exclusion Criteria:

* Reported fear or anxiety of dogs (child or parent)
Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

* To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
* To assess the effect of a long term treatment with Genotonorm on bone mineralisation
* To assess the effect of a long term treatment with Genotonorm on body composition

This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Children with juvenile arthritis or nephrotic syndrome
* Before or during puberty

Exclusion Criteria:

* Diabetes Type 1 and 2
* Endocrine disease, except well substituted hypothyroidism
Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability

The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17 years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female child/adolescent age 2-17 years.
* Any neurological disorder (e.g. cerebral palsy or traumatic brain injury) and/or intellectual disability associated with chronic troublesome sialorrhea for at least 3 months up to the screening. In subjects with intellectual disability (ID) without neurological disorders, a diagnosis of ID by a specialist, e.g. pediatrician or by a center for developmental medicine is required for inclusion.
* Severe drooling (modified Teacher´s Drooling Scale \[mTDS\] ≥ 6; clothing occasionally becomes damp) as rated by the investigator.
* Parental consent and the subject's oral or written assent as the subject is able to provide.

Exclusion Criteria:

* Chronic troublesome sialorrhea not related to neurological disorders and/or intellectual disability.
* Body weight \< 12 kg.
* Pharmacological treatment for sialorrhea or concomitant medication known to influence sialorrhea strongly (e.g. anticholinergics with exception of locally applied or short acting drugs used under general anesthesia) within 45 days before baseline and during the entire study period.
* Any previous known or suspected hypersensitivity to Botulinum toxin.
* Aspiration pneumonia within 6 month before screening.
* Any previous treatment with Botulinum toxin for any body region during the year before screening or within the screening period
* Prior, concomitant or planned surgery or irradiation to head and neck to control sialorrhea (including salivary gland surgery or salivary gland irradiation) within one year before screening or planned for any part of the entire study period.
* Concurrent diseases, including hematological, hepatic, renal, gastrointestinal, endocrine, pulmonary, musculoskeletal, or psychiatric diseases or conditions, which in the judgment of the investigator would put the subject at risk while in the study, could influence the results of the study, or negatively impact the subject's ability to participate in the study.
* Extremely poor dental and/or oral condition that might preclude safe study participation by the judgment of the investigator.
* Nursing mother or pregnant female subject.