cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia

Children suffering from neurological problems may have a common problem of drooling and dysphagia.There is high prevelance of neurological disorders in developing countries including Pakistan.Parents of children with disability are highly stressed and burdenised while taking care of their children.there is a need to overcome the drooling and dysphagia problems with effective interventions.

There is no clear consensus that which interventions are safe and effective and hard to decide about the effective intervention for drooling management. This will help the parents, therapist and children to manage their feeding problems effectively, hence improve quality of life of parents and children.There is also scarcity of well designed randomized controlled trails and limited published literature on the usefulness of the kinesiotape for management of drooling in children with oral dysphagia, this study will be conducted in an attempt to evaluate the same. There is also a lack of comparative studies to evaluate the effectiveness of traditional oral motor therapies and kinesiotaping therapy.

speech pathologists and help them in managing drooling effectively by using the best effective therapeutic approach. This study will also add up evidence-based knowledge to existing literature

Eligibility Criteria:
Inclusion Criteria:

* • Both male and female children with different non degenerative neurological disabilities ( cerebral palsy, traumatice brain injury, childhood stroke) and having oral phase dysphagia.

  * Age between 3-15 years.
  * Those who will have drooling severity rating of ≥ 4 on modified Teacher's drooling scale.
  * Child who can comprehend simple verbal commands and on 3 words sentence level speech
  * Have good head control.
  * Parents and care givers of children with drooling and oral phase dysphagia will also be included in the study

Exclusion Criteria:

* Those children who would have structural abnormality of respiratory system.
* Corrected or uncorrected cleft palate or cleft lip.
* Wounds around the lips.
* Recent surgery, and medication or on any treatment to control drooling would be excluded from the study.
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL

This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Familial Partial Lipodystrophy (FPLD)
* Subjects with poor metabolic control defined as:

HbA1c ≥7% (at Visit 1 and Visit 3) and/or Fasting TGs ≥500 mg/dL (5.65 mmol/L, at Visit 1 and Visit 3)

* Patients should be receiving optimized stable therapy

Exclusion Criteria:

* Previous treatment with metreleptin
* Leptin levels \>20.0 ng/mL
* Acquired or radiation induced partial lipodystrophy (APL)

Other protocol defined inclusion/exclusion criteria apply
Differences in Care Provided in Intensive Care Units (ICUs) With Physician Versus Nurse Practitioner First Responders

The purpose of this study is to evaluate and compare outcomes of patients that have received care in medical intensive care units in a tertiary care facility with two different models; the traditional model including resident, pulmonary fellow and attending physician and a nontraditional model which has Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending.

This will be a retrospective cohort study that is performed between two medical intensive care units (ICU). The goal is to compare outcomes of patients that have received care in medical intensive care units in a tertiary care facility with two different models; the traditional model including a resident, pulmonary fellow and attending and a nontraditional model which has Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending. Outcomes that will be measured include ICU length of stay, hospital length of stay after ICU discharge, ventilator days, daily spontaneous breathing trials, and daily awakening trials, as well as mortality in hospital and after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to designated ICU between September 1, 2007 and September 30, 2010.

Exclusion Criteria:

* Not admitted to designated ICU.
Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation

The study is a single-centre, prospective, observational cross-sectional imaging study aimed to determine if macrophage-mediated inflammation can be visualised in the aorta of patients with aortic dissection (AD) using ultrasmall super paramagnetic iron oxides (USPIO)-enhanced magnetic resonance imaging (MRI).

Aortic dissection (AD) is a condition in which a disruption of the medial layer (in most cases provoked by a tear or an ulcer in the intima) results in separation of the aortic wall layers, with concomitant 'false lumen' formation and malperfusion of end organs.

The underlying mechanism of the condition has, until recently, remained unclear. The Pi of the present sutdy has shed light on a mechanism that shows that inflammation underlies the condition. The PI of the present study has showed that inflammation in the aorta is triggered by macrophage infiltration into the aortic wall in both pre-clinical models using animal models of the condition (murine) and in patient tissue samples obtained at time of surgery.

Macrophage infiltration into the aortic wall, as a result of activation of the cytokine, granulocyte-macrophage colony stimulating factor (GM-CSF), is the trigger for an inflammatory cascade that is presently understood to underlie the pathogenic mechanism of the condition

Non-invasive assessment of macrophage infiltration would prove that this pathogenic mechanism exists (proof-of-concept). Macrophage infiltration has been shown to be feasible by contrast-enhanced Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs).

The hypothesis of the present study is that macrophage-mediated inflammation can be visualised in the aorta of patients with AD using the USPIO-enhanced MRI technique, and use the present study to confirm this (proof-of-concept).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of acute or chronic aortic dissection (\>2 week after initial intimal injury)
* Able and willing to comply with all study requirements.
* Age \> 40 years (Patients under the age of 40 years will not be included as they may have a connective tissue disorder accounting for their condition)
* Able and willing to give informed consent
* An adequate understanding of written and verbal English

Exclusion Criteria:

* Past history of systemic iron overload or haemochromatosis
* Renal failure (estimated glomerular filtration rate \< 30ml/min)
* Contraindication to MRI
* Known allergy to iron-containing compounds
* Participants who have participated in another research study involving an investigational product in the past 12 weeks.
* Female participants who are pregnant or lactating.
* Unwilling or unable to give informed consent
Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis

Sporotrichosis is a chronic granulomatous mycosis caused by sporothrix complex. The course of sporotrichosis is always prolonged and even life-threatening, the treatment of this disease in an important scientific problem to be solved. The investigators previously found the predominance of subtype M2 macrophage which play an anti-inflammatory role in the lesions of sporotrichosis, the predominance of M2 macrophage may be responsible for the persistence of sporotrichosis; the investigators also found that local hyperthermia is effective in the treatment of sporotrichosis and hyperthermia treatment can activate the CRAC calcium channel in macrophages which triggers pro-inflammatory type M1 polarization and subsequent killing of sporothrix, however, the mechanism still calls for further investigation. The investigators hypothesize that hyperthermia leads to the activation of CRAC channels resulting in profound Ca2+ influx and Ca2+ upregulates NLRP3 inflammasome expression through inducing Nrf2 activation, then NLRP3 overexpression triggers M1 polarization and subsequent killing of sporothrix. Furthermore, the activation of Nrf2 upregulates STIM1 expression which forms a positive feedback for M1 type polarization of macrophages and further subsequent killing of sporothrix. The purpose of this project is to identify the hypothesis that hyperthermia could treat sporotrichosis by promoting pro-inflammatory type M1 polarization in macrophages, the mechanism by which hyperthermia could treat sporotrichosis is local hyperthermia could led to STIM1/CRAC calcium channel activation mediated calcium ions/Nrf2/NLRP3 induced M1 macrophages polarization and subsequent killing of sporothrix. The hypothesis will be identified at the cellular level, at the animal model level and at the clinical specimens level. The investigators believe that the project will guide the application of hyperthermia in the treatment of sporotrichosis and provide a new basis of theory and practice after the investigators achieving these goals.


Eligibility Criteria:
Inclusion Criteria:

* The results of pathology and fungal culture were all patients with sporotrichosis.
* Informed consent to the purpose and content of the study, and follow-up as required
* The physical condition and self-condition can cooperate with the treatment.

Exclusion Criteria:

* Subjects who are unable to maintain a relatively stable posture during treatment.
* Those who are sensitive or allergic to this experimental drug.
* Systemic antifungal or KI therapy within 12 months
* Local antifungal therapy within 1 month.
* Previous history of immunodeficiency virus (HIV) infection, or positive HIV antibody in screening period.
Effectiveness of Personal Relevance of Visual Autobiographical Stimuli in Positive Emotions Induction

Background: The ability to retrieve specific memories is a cognitive and emotional protective factor. Among the most effective techniques to generate autobiographical memories is the use of audio-visual stimuli, particularly images. Developing and improving techniques that facilitate the generation of such memories could be highly effective in the prevention of depressive symptoms, especially in the elderly population. The aim of the present study is to examine how the level of personal relevance of pictures as autobiographical memory cues to induce positive emotions may affect an individual's emotion regulation.

Methods: The participants, 120 older adults aged 65 and over and 120 young adults aged between 18 and 35, of both sexes and without depressive symptoms, will be induced to a negative mood state by means of viewing a film clip. Following the negative mood induction, the participants will be shown positive images according to experimental group to which they were randomly assigned (high personal relevance: personal autobiographical photographs; medium personal relevance: pictures of favourite locations associated with specific positive autobiographical memories; and low personal relevance: positive images from the International Affective Picture System). The investigators will analyse the differences in subjective (responses to questionnaires) and objectives measures (EEG signal, heart rate variability and electrodermal activity) between the groups before and after the induction of negative affect and following the recall of positive memories.

Discussion: The use of images associated with specific positive autobiographical memories may be an effective input for inducing positive mood states, which has potentially important implications for their use as a cognitive behavioural technique to treat emotional disorders, such as depression, which are highly prevalent among older adults.


Eligibility Criteria:
Inclusion Criteria:

1. Older adults will present no symptoms of cognitive impairment. The self-administered Test Your Memory (TYM) will be used to assess cognitive performance \[79,80\].
2. Absence of depressive symptomatology, which will be assessed using the Patient-Reported Outcomes Measurement Information System-Depression \[81\].
3. Given the high comorbidity between anxiety and depression \[82,83\], it was decided that both young and older participants should present no symptoms of anxiety. This will be assessed using the Patient-Reported Outcomes Measurement Information System-Anxiety \[81\].
4. No sensory deficits that might impact performance in the experiment and the psychological tests.
5. Sufficient literacy skills to understand the instructions for the experiment and the psychological tests.
6. Signed informed consent.
Urinary and Prostate Microbiotes and Prostate Cancer

In recent decades, the cancer process has been linked to microbial infections, particularly in gastric and Helicobacter pylori cancers, but also in cervical cancers promoted by exposure to Human papilloma virus (HPV). More recently, it has been shown that bacteria in the intestinal microbiota could promote the development of colorectal cancer by modulating the inflammatory response within the intestinal mucosa. Among male cancers, prostate cancer is the leading cause in France with 54,000 new cases per year. In addition, the dogma that urine is sterile has been broken and the notion of the presence of a "urinary microbiota" in asymptomatic patients is now accepted.

While the risk factors associated with this cancer have not yet been clearly elucidated, recent evidence in the literature agrees that chronic inflammation associated with prostate infection plays a key role as a factor that may promote the development and/or progression of prostate cancer. Most recently, a study shows for the first time that a group of 6 bacteria is found significantly higher in the urine of patients with prostate cancer than in patients with prostate adenoma. Interestingly, clinical microbiology studies conducted at the bacteriology laboratory of the University Hospital of Nice on A. schaalii have shown that this species is also isolated in the urine of patients with bladder and prostate cancers.

The investigators wish to study the association of the 6 bacterial species mentioned above with prostate cancer by directly analyzing the prostate tissue of patients with this condition.

the staff will carry out a multicenter case-control study by recruiting a total of 260 patients in 4 centres (Nice coordinating centre, Marseille, Tours and Nîmes): 130 in the prostate cancer group and 130 in the prostate adenoma control group. This project is a research involving the human person of category 2.

The innovative aspect of the work consists in detecting and quantifying in situ in the prostate tissue the presence of these 6 bacterial species per culture and per PCR in real time, comparing the prostate microbiota in terms of richness and diversity between cancer patients and those without cancer. Ultimately, this study opens up exciting prospects with the possibility of determining a microbial origin of prostate cancer and considering antibiotic therapy for anti-cancer purposes such as H. pylori and gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* Male sex
* Patient with a prostate biopsy programmed for suspected prostate adenocarcinoma on elevation of PSA and/or TR suspect and/or MRI suspect
* Signed Informed Consent
* Affiliation to a social security system

Exclusion Criteria:

* Taking systemic antibiotic treatment (per os or I.V.) within 3 months before inclusion.
* Contraindications to the performance of an ultrasound-guided transrectal prostate biopsy: coagulation disorders and urogenital infections.
* History of surgical treatment of the urinary and genital tract within 6 months before inclusion
* Person under guardianship, curatorship or unable to express consent.
Effects of Blood Flow Restriction Training With Low Intensity Exercises in Knee Osteoarthritis

The aim of the study is to examine the effects of blood flow restriction training(BFRT) with low intensity exercises on pain, range of motion and quality of life in Knee Osteoarthritis. A randomized clinical trial will be conducted at Lahore general hospital. Non-probability convenience sampling will be used, and 36 subjects, age 40-65 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria.

The aim of the study is to examine the effects of blood flow restriction training(BFRT) with low intensity exercises on pain, range of motion and quality of life in Knee Osteoarthritis. A randomized clinical trial will be conducted at Lahore general hospital. Non-probability convenience sampling will be used, and 36 subjects, age 40-65 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria. Both groups will receive Ultrasound therapy for 7 minutes, as common treatment. Group A will be treated with Blood flow restriction training with low intensity exercises and Group B will be treated with baseline treatment only. 3 sessions per week and total 12 sessions for 4 weeks. The outcome measures will be conducted through NPRS, Womac index for osteoarthritis,kellgren and lawrence scale and goniometry before and after 4 weeks. Data will be analyzed using SPSS software version 26.

Eligibility Criteria:
Inclusion Criteria:

* Both Male and Female age between 40 to 65 years diagnosed with womac ostearthritis index having acute knee pain.
* Patients with history of osteoarthritis (of grade 1 and 2 with KL(kellgren and Lawerence)) grading system for knee Osteoarthritis
* Pain in and around knee measuring through Numeric Pain rating Scale(NPRS)\>4(14)

Exclusion Criteria:Patient with history of

* hypertension
* diabetes
* sickle cell anemia
* renal compromise
* obesity
* open fracture,
* increased intracranial pressure
* pregnancy
* cancer or tumor,
* extremity with dialysis access,
* extremity fracture
* peripheral vascular compromise
* DVT(Deep vein thrombosis) \& pulmonary embolism deformity of hip \& back
An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder

This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms have not been adequately managed by oral anticholinergic therapy.


Eligibility Criteria:
Inclusion Criteria:

* No prior treatment with botulinum toxin Type A for treatment of iOAB

Exclusion Criteria:

* Treatment with any botulinum toxin Type A within 18 months
The Predictive Value of Proteome Profiling for Brain Metastasis in Limited-Stage Small-Cell Lung Cancer

This study aims to evaluate the predictive value of proteome profiling for brain metastasis in limited-stage small-cell lung cancer

Small-cell lung cancer (SCLC) constitutes approximately 15% of all lung cancer cases and is characterized by a highly aggressive disease course and poor prognosis. The brain is the most common metastatic site of SCLC, and it is also an important cause of high mortality. More than 20% of SCLC patients have developed brain metastasis (BM) at the first diagnosis. Prophylactic cranial irradiation (PCI), as an essential part of the treatment of limited-stage small-cell lung cancer (LS-SCLC), inevitably leads to neurotoxicity. Therefore, there is an urgent need for a convenient and effective prediction model to realize the early prediction of SCLC brain metastasis. Patients at high risk of brain metastases were treated with individualized PCI.

In the current study, the investigators have analyzed the proteome profiling using Data-independent Acquisition mass spectrometry (DIA-MS) method in formalin-fixed paraffin-embedded (FFPE) tissues from patients with limited-stage small-cell lung cancer. The prognostic biomarkers were developed based on machine learning in the non-PCI group. Patients in the non-PCI group were classified into modeling cohort and external validation cohort . Furthermore, the prognostic value of the candidate biomarkers be evaluated in a prospective cohort . Based on the brain metastasis model, patients were divided into high- and low-risk groups. The benefit value of PCI was analyzed in high-risk and low-risk groups.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Histological / pathologic proved limited-stage small-cell lung cancer
3. Achieved a complete response (CR) or partial response (PR) after first-line CRT

Exclusion Criteria:

1. Simultaneous participation in another clinical trial
2. Brain MRI was not performed during treatment and follow-up
3. The follow-up time was less than 2 years
4. Patients presenting with other known malignancies for which they are receiving treatment
KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer

This clinical trial studies if kilo-voltage cone beam computed tomography (KV-CBCT) and ultrasound imaging works in guiding radiation therapy in patients with prostate, liver, or pancreatic cancer. Computer systems, such as KV-CBCT and ultrasound imaging, allow doctors to create a 3-dimensional picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed.

PRIMARY OBJECTIVES:

I. To investigate the feasibility of combining on-board cone beam computed tomography (CBCT) with ultrasound imaging to overcome the shortcomings of CBCT or ultrasound imaging alone for imaging guided radiotherapy delivery.

OUTLINE:

Patients undergo ultrasound imaging prior to and during radiation therapy. Patients also undergo kilo-voltage cone beam computed tomography prior to radiation therapy.

Update (2021/02/04): Removed secondary outcome "Incidence of Adverse Events Related to the Ultrasound Probe". Per PI: Study initially intended to involve a non-FDA approved probe for use with liver patients but removed this section.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have either 1) cancer involving the liver by biopsy or radiographic criteria, or 2) prostate cancer by biopsy, with the intent of undergoing definitive dose radiation therapy to targets within the liver, or prostate. Patients with prostatectomy receiving post-operative radiotherapy are also eligible.
* Karnofsky performance status (PS) ≥ 70
* Subjects must have the ability to understand and the willingness to sign a written informational form

Exclusion Criteria:

* Patients with uncontrolled inter-current illness or psychiatric illness/social situations that would limit compliance with study requirements