cyrilzakka/clinical-trials huggingface dataset:
Study of Immunological Memory Induced in Children by a Full 4 Dose Vaccination Schedule of 11 Valent Pneumococcal Conjugate Vaccine by Giving 1 Dose of Aventis Pasteur's 23-valent Pneumococcal Polysaccharide Vaccine (Pneumo 23)

Evaluate the immunological memory induced by 4 doses of GSK Biologicals' 11valent pneumococcal vaccine; study antibody persistence 30 months after the 4 dose vaccination with GSK Biologicals' 11-valent pneumococcal vaccine in Undeca-Pn-010 study.

Primed group: 50 subjects who previously received 4 doses of GSK Biologicals' 11Pn-PD vaccine will receive 1 dose of Pneumo 23 Unprimed group (Control): 50 subjects who received GSK Biologicals' Havrix™ vaccine will receive 1 dose of Pneumo 23

Eligibility Criteria:
Inclusion criteria: Male or female who participated in Undeca-Pn-010 study, were part of the blood subset and received 4 doses of GSK Biologicals' 11Pn-PD vaccine, or Havrix vaccine. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period. Administration of any additional pneumococcal vaccine since study end of Undeca-Pn-010 (347414/010)
Early Mobilization After Arthroplasty

Aims and Objectives: This study was conducted in order to determine the factors that affected the early mobilization after surgery of patients who had undergone knee and hip arthroplasty.

Background: Early mobilization in knee and hip arthroplasty is still not at the desired level, and it is among the most frequently overlooked nursing practices.

Desing: This study is descriptive and cross-sectional. STROBE checlist was used to compile the study's report.

Methods: The universe of the study consisted of a total of 80 patients who were hospitalized between 07 November 2017 and 21 September 2018 in the Orthopedics and Traumatology Clinic of a State Hospital to undergo knee or hip arthroplasty, and who met the inclusion criteria. The sample of the study consisted of 60 patients who were in the universe of the study, who met the inclusion criteria and who voluntarily agreed to participate in the study.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the Orthopedics and Traumatology Clinic for the first time to undergo knee or hip arthroplasty,
* Communicating,
* No hearing or speech impairment,
* 18 years and older patients.

Exclusion Criteria:

* Undergoing revision surgery,
* Having a history of lower extremity orthopedic intervention that may prevent mobilization,
* Having neurological and medical problems that may cause locomotor disability,
* Uncontrollable heart and lung diseases,
* Having a history of neurological disease (Alzheimer's, dementia, etc.),
* Patients with gout, metabolic diseases or septic arthritis.
Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

This is a phase I/II study of the combination of etanercept and rituximab in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This combination is proposed to improve the efficacy and diminish the toxicity of this the

Rationale: Previous research has demonstrated that rituximab has efficacy against chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Rituximab is a monoclonal antibody used to treat different types of lymphomas. Monoclonal antibodies are a type of immunotherapy used against some types of cancer. They are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins. Rituximab attaches to a protein called CD20 that is found almost exclusively on the surface of B-cells. Once rituximab attaches to the protein, the immune system activates to kill the malignant B-cells. Researchers are investigating what other therapies to combine with rituximab to reduce side effects and improve patient outcomes. The current study combines etanercept with rituximab. Etanercept is an anti-inflammatory agent being tested as a therapy for cancer. Researchers want to assess the theory that etanercept may reduce the toxicity associated with rituximab in patients and increase efficacy while providing its own treatment benefit to patients.

Purpose: This study is evaluating the safety and efficacy of combination etanercept and rituximab in patients with CLL and SLL. The biological response of tumor cells and the immune system to this drug combination will also be measured in patients before, during, and after therapy administration.

Treatment: Patients in this study will receive etanercept and rituximab. Etanercept is given through injections into the skin and rituximab through intravenous infusions. During the first week of the study, etanercept alone will be given to patients two times. During the second week, patients will continue receiving etanercept twice weekly and begin receiving rituximab three times weekly. This schedule of etanercept twice weekly and rituximab three times weekly will be repeated four times. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Must have been previously treated CLL/SLL
* Must have CD20 expression
* ECOG PS =\<3
* No prior Campath-1H
* No active infection requiring antibiotics
* No concurrent immunosuppressive therapy
* No prior history demyelinating neurologic disease
* No active viral hepatitis

Exclusion Criteria:

* No pregnant or breastfeeding women
* ECOG PS =4
* Life expectancy of \>12 weeks
* Patients with bilirubin or creatinine\>3.0 mg/dl
Artificial Intelligence (AI) Empowered Smile Simulations: Do They Accurately Predict Actual Post Treatment Outcomes

The aim of the present study is to assess the predictability of Invisalign® SmileView™ for digital AI smile simulation in comparison to actual smile treatment outcomes, using various smile assessment parameters.


Eligibility Criteria:
Inclusion Criteria:

* healthy systemic condition with no chronic diseases
* no previous orthodontic treatment
* adequate oral hygiene
* a healthy periodontium.

Exclusion Criteria:

* chronic diseases
* previous orthodontic treatment
* poor oral hygiene
* periodontal diseases
Congenital Malformations and Maternal Use of Anti-hypertensive Medication in the United Kingdom

Assess Fetal Mortality and Malformations in Women treated with antihypertensive medication during preganancy. Mother - Child pairs will be analysed in a cohort selected from the UK in the CPRD database. Years covered are 1997 to 2014. Aim is to assess the risk of Antihypertensive treatment in women.

Women with chronic hypertension are at risk of experiencing severe complications such as adverse effects of fetal growth, survival, and renal function during pregnancy. General recommendations advocate the treatment of high blood pressure during pregnancy to decrease these risks to the mother and child, with extreme caution. Many studies assessing the risk of congenital malformations in infants whose mothers were treated with anti-hypertensive medication have been inconclusive, in part due to the variability of the original data sources and possibly the robustness of the analyses.2 Studies regarding this health issue have been unable to stratify anti-hypertensive medications sufficiently to truly assess the risk per drug class, Angiotensin II Receptor Antagonists/Blockers (ARBs) and Angiotensin-converting-enzyme inhibitor (ACE inhibitor) in particular.We will attempt to assess the prescription rate of ARBs and ACE inhibitors among women with very high blood pressure in the United Kingdom (UK) and estimate the risk of serious foetal outcomes in women treated with ARBs and/or ACEs and who may also have the following co-morbid conditions: Diabetes Types I or II, Diabetic Nephropathy, and Congestive Heart Failure.

Eligibility Criteria:
Inclusion Criteria: age and gender -

Exclusion Criteria:

-
A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka

To evaluate the effectiveness of a First Referral Unit (FRU) Emergency Obstetric and Newborn Care (EmONC) skills and drills intervention, to estimate the appropriateness and effectiveness of referrals in intervention arm compared to control arm and to calculate the incremental cost and cost effectiveness of EmONC skills and drills intervention.

The aim of this intervention is to improve the quality of care for institutional births with a special focus on improving the quality of Emergency Obstetric and Newborn Care (EmONC). This intervention will focus on improving the skills and practices of providers and through the improvement of referral networks, ensure timely and appropriate management of complications.

The specific objectives include:

1. Evaluate the effectiveness of an FRU-level Basic and EmONC Skills and Drills intervention combined with the existing primary health centre (PHC) based nurse mentoring intervention in improving appropriate diagnosis and management of obstetric and perinatal complications.
2. Assess the additional benefit of the EmONC Skills and drills intervention at FRUs in terms of improvement of obstetric and perinatal outcomes compared to the PHC-level intervention alone.
3. Estimate the appropriateness and effectiveness of referrals in intervention facilities compared to controls.
4. Calculate the incremental cost and cost-effectiveness of the EmONC skills and drills intervention

Eligibility Criteria:
Inclusion Criteria:

All women age who are referred or admitted directly to the first referral unit for a delivery or with a complication Staff working in the First Referral Units

Exclusion Criteria:

no specific exclusion criteria
Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study)

This study is designed to provide long-term safety and efficacy data for the combination doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350 patients (approximately) who have successfully finished the core trial CVAH631B1303 and signed consent for the extension will be enrolled into this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who successfully complete the core study (Protocol 1303)
* Outpatients

Exclusion Criteria:

* Presence of crucial protocol violation in Protocol 1303
* Patients who experienced any adverse events considered serious and drug related in Protocol 1303.
Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis

The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA preservation could improve patient's quality of life reducing incontinence and/or constipation rate.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 80 years
* BMI\<35
* Presence of symptomatic diverticular disease
* ASA I-III

Exclusion Criteria:

* age \> 80 years
* BMI\>35
* ASA IV
* Hinchey III-IV
* Past performed procedure that could be modify the nervous pattern (i.e. colorectal surgery, left nephrectomy, hysteroannessectomy)
Pediatric Obstructive Sleep Apnea Diagnosis by Respiratory Polygraphy

Respiratory polygraphy (RP) can be used to detect obstructive sleep apnea syndrome in children (OSA) , but it underestimates the obstructive apnea-hypopnea index (OAHI) because hypopneas associated with cortical arousals are not evaluated. To compensate for this disadvantage, hypopneas linked with autonomic micro-arousals can be calculated from the drop in pulse wave amplitude (obtained dy oximetry), as increased respiratory efforts are related to autonomic nervous system activation, tachycardia, and elevated blood pressure.

The aim of this study is to compare OAHI obtained by RP alone or by RP considering hypopneas associated with autonomic micro-arousals with OAHI by polysomnography (PSG).

The diagnosis of obstructive sleep apnea syndrome in children (OSA) requires to perform a polysomnography (PSG) in hospitalization with video surveillance and monitoring by a nurse to put the sensors back on the child if necessary. PSG gives the obstructive apnea-hypopnea index (OAHI) necessary for the diagnosis of OSA and to determine its severity. But PSG is difficult to perform in children, with several sensors and electrodes to install.

Respiratory polygraphy (RP) which uses only respiratory signals (without the neurophysiological signals ) can be used for the diagnosis of OSA but it underestimates OAHI because the hypopneas associated with cortical micro-arousals are not taken into account. An alternative to overcome this disadvantage is to determine the presence of autonomic micro-arousals because the increase in respiratory efforts during sleep is associated with activation of the autonomic nervous system and cardiovascular effects, such as tachycardia and an increase in blood pressure. Consequently, these respiratory efforts are associated either with autonomic activation or with cortical micro-arousal. One method to determine autonomic micro-arousals is photo-plethysmography which reflects sympathetic activation. Photoplethysmography is obtained by oximetry signal and is a non-invasive technique based on measuring the relative absorption by the blood of red light and infrared light through the finger. The pulsation of arterial blood flow through the finger arteries modulates light absorption and generates a pulse wave signal.

Autonomic micro-arousals will be calculated according to 3 algorithms: reduction of 1) 30%; 2) 40%; 3) 50% of the photoplethysmography signal compared to the baseline and the hypopneas associated with these decreases will be taken into account in the calculation of the OAHI. Consequently, 3 OAHI will be obtained by RP including hypopneas associated with autonomic micro-arousals.

The aim of this study is to compare OAHI obtained by RP considering hypopneas associated with autonomic micro-arousals with OAHI by PSG.

The hypothesis of this study is that RP by adding hypopneas associated with autonomic micro-arousals can identify OSA in children.

Eligibility Criteria:
Inclusion Criteria:

* Children with suspicion of OSA
* Interpretable polysomnography

Exclusion Criteria:

* Non-interpretable polysomnography
Comparative Study of Inclined Treadmill and Dynamic Cycling on Balace in Hearing Impaired Children.

Hearing loss is generally identified initially in life leading to difficulties in communication. In children, vestibular dysfunctions can cause a deficit in gross motor development and balance stability. At an early age, delayed gross motor development can cause impairment in the bilateral vestibular system and sensorineural hearing. The children with balance impairment cannot usually participate in physical activities. Running, cycling, hoping and leading to social isolation3. In Pakistan, 2.49% of the population suffers from some disability; the hearing loss population is 7.4%. In Pakistan, hearing loss is more reported in males as compared to females. According to the non-official data, nearly 1.2 in every 1000 Pakistani children suffer from moderate to severe bilateral hearing loss5. In this, 15% population is suffering from profound and nearly 85% from moderate to severe hearing loss.Children who have vestibular dysfunctions may experience many disorders of the vestibular system.Acute unilateral vestibular loss (AUVL) is the most frequent vestibular dysfunction. The etiology of acute unilateral vestibular loss is unknown, but the studies say it may be due to genetic and acquired causes (inflammatory and viral infections). The symptoms include static

This study seeks to provide a detailed understanding of the effects of dynamic cycling and inclined treadmill training on the motor skills of children with hearing impairments through an extensive review of relevant literature, careful data collection, and robust statistical analysis. The findings may assist parents, educators, and healthcare professionals in making informed choices about the most effective therapies to enhance mobility and overall development in children with hearing impairments. Ultimately, this research contributes to pediatric rehabilitation and promotes a holistic approach to addressing the specific needs of children with hearing loss.

Eligibility Criteria:
Inclusion Criteria: children of age 8 to 10 years consistency in hearing impairment ability to understand the command

Exclusion Criteria:

children with any acute or chronic disease recurrent falls history of any MSK disease

-
The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Different Degree of Inflammation of Ulcerative Colitis

We analyzed the diversity of the fungal and bacterial within colon mucosa between patients with different degree of inflammation of Ulcerative Colitis.

In recent years, the relationship of intestinal fungus with inflammatory bowel disease was gradually revealed. We divided the patients with ulcerative colitis into three groups on the basis of World Gastroenterology Organisation (WGO) classification about inflammation degree and progress classification and established the healthy control group. Analyzing the diversity of the fungal and bacterial within colon mucosa between patients with different clinical classification, for example, the proportion of bacteria and fungi, the proportion of candida albicans, the proportion of yeasts, and so on.

Eligibility Criteria:
Inclusion Criteria:

* Patients at our tertiary care medical center, aged between 18 and 80 years, scheduled to undergo surveillance colonoscopy.
* The patients with ulcerative colitis for ulcerative colitis group.
* The patients without ulcerative colitis for control group.
* 18-80 years.

Exclusion Criteria:

* Using antibiotics, glucocorticoid and immunosuppressants wintin one month.
* There are contraindications for enteroscopy and biopsy.
* There are other intestinal diseases.
* Pregnancy or breast-feeding women.
* Patients with serious lung disease and mental illness.
Efficacy and Safety Study of BMN 110 for Morquio A Syndrome Patients Who Have Limited Ambulation

The primary objective of this study is to evaluate the effect of 2.0 mg/kg/week BMN 110 in a patient population that has limited ambulation, in a period of up to 144 weeks.

Effect is defined by the following key domains:

* Upper extremity function and dexterity
* Mobility

Eligibility Criteria:
Inclusion Criteria:

* Is willing and able to provide written, signed informed consent (or their legally authorized representative) after the nature of the study has been explained and prior to performance of any research-related procedure. Patients who do not meet country and local age requirements for informed consent must be willing and able to provide written assent after the nature of the study has been explained and prior to performance of any research-related procedure.
* Has documented clinical diagnosis of MPS IVA based on clinical signs and symptoms of MPS IVA and documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic testing confirming diagnosis of MPS IVA.
* Is ≥ 5 years of age.
* If sexually active, is willing to use an acceptable method of contraception while participating in the study.
* Females of childbearing potential must have a negative pregnancy test at the Screening Visit and be willing to have additional pregnancy tests during the study.
* Is willing and able to perform all study procedures as physically possible.

Exclusion Criteria:

* Is able to walk farther than a specified distance as assessed by the 6MWT.
* Has previous hematopoietic stem cell transplant (HSCT).
* Has received previous treatment with BMN 110.
* Has a known hypersensitivity to any of the components of BMN 110.
* Has had major surgery within 3 months prior to study entry or is planning to have a major surgery during the first 24 weeks of the study.
* Has used any other investigational product or investigational medical device within 30 days prior to the Screening Visit or requires any investigational agent prior to completion of all scheduled study assessments.
* Is pregnant or breastfeeding at the Screening Visit or planning to become pregnant (self or partner) at any time during the study.
* Has a concurrent disease or condition, including but not limited to symptomatic cervical spine instability or severe cardiac disease or complete paralysis due to a spinal cord injury (defined as an inability to move arms and legs), that would interfere with study participation or safety as determined by the Investigator.
* Has any condition that, in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study.
TAPIRS Technique Plus Adjustable Compression System in Treatment of Venous Leg Ulcers

The aim of this study is to determine the percentage of healing of active venous ulcers following Terminal Axial Perforator Interruption Reflux Source (tapirs technique) and adjustable compression system versus a control group using the traditional multilayer bandages.

Venous ulcer due to venous insufficiency causes an important morbidity to those people suffering from this condition. Most of therapies available under the obligatory health plan (POS, acronym in Spanish) to date cover the cleaning of the ulcerous lesion and its medical handling using saline solutions, topical antibiotics and elastic dressings, implying an important intake from health resources due to its chronicity and the delay in ulcers healing, which usually takes periods ranging from 12 months to several years. Therapeutic alternatives, which can guarantee optimal, fast and persistent in time healing, should be identified.

The aim of this study is to determine the percentage of healing of active venous ulcers (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6) following Endovascular Laser Treatment (EVLT) of axial vein hypertension plus ultrasound-guided foam sclerotherapy of superficial venous reflux under knee, closing perforator veins and terminal reflux under de ulcer in patients with chronic venous ulceration (TAPIRS technique) plus compression with an adjustable compression system (juxta cures) versus a control group using the traditional multilayer bandages. The investigators expect that the minimal surgical invasive approach closing all the superficial venous reflux plus adjustable compression system will diminish the time of ulcer healing compared with standard treatment of multilayer bandage care.

Eligibility Criteria:
Inclusion Criteria:

Venous Ulcer Ulcer present for at least 4 weeks Ankle-arm index greater or equal to 0.8 mmHg

Exclusion Criteria:

Severe hepatic disease Severe cardiac disease Severe pulmonary disease Deep venous thrombosis Active participation in other clinical trials limitation in the ankle movements others limitations to move their self