cyrilzakka/clinical-trials huggingface dataset:
Harnessing Alternative Resources to Aid Kenyans With Acute Illness

Kenya does not have enough experts to perform heart scans in patients who are very sick and in need of urgent intervention. The purpose of this research is to find out whether training Kenyan nurses to perform basic heart scans would shorten the time it takes to know whether the heart and lungs are working normally in very sick patients, to guide treatment. Patients will be placed into one of two groups: One group will have a quick scan of the heart and lungs carried out by trained nurses to see how well these organs are working, in addition to receiving the normal care offered at the hospital. The other group will receive the normal care offered in the hospital only and will not have a scan performed by these nurses. The time it takes to make a diagnosis between the two groups will then be compared. Should the group that has heart scans by nurses be found to spend less time waiting for a diagnosis to be made, more nurses in Kenya will be trained to provide this service, to minimise delays in our emergency departments.

Echocardiography is a useful, non-invasive diagnostic tool in time-critical emergencies. A national shortage of cardiologists and of doctors in Kenya however further compounds the problem of insufficient staff for emergency care and of any capacity building efforts. To achieve the goals of Sustainable Development Goal Number 3 (SDG-3) and realise the government's vision of universal healthcare for all, alternatives to the human resource challenge are key. Modifying the Scope of Practice of Kenyan nurses is one possible solution. Task-shifting traditionally cardiologist roles such as focused cardiac ultrasound (FoCUS) could shorten the time it takes to make a diagnosis in patients with cardiorespiratory failure of likely cardiac origin, making prolonged turnaround times in our public facilities a thing of the past. Our overarching aim is to harness the power of nurses doing FoCUS. The central hypothesis of this work is that in patients with cardiorespiratory failure, a nurse-led FoCUS-guided service would shorten time to diagnosis, supporting interventions and improving outcomes among the critically ill. Insight into potential barriers and enablers for the implementation of a nurse-performed FoCUS service in Kenya is crucial for the success of such a service redesign.

Eligibility Criteria:
Inclusion Criteria:

Any one of:

* Systolic blood pressure \<90 millimetres of mercury (mmHg)
* Mean arterial pressure (MAP)\<65 millimetres of mercury (mmHg)
* Shock index \>1 (heart rate/systolic blood pressure)
* Respiratory rate \> 30 breaths/minute
* Oxygen saturations \<94%
* Arterial oxygen partial pressure (paO2) \<60 millimetres of mercury (mmHg)
* Arterial carbon dioxide partial pressure (paCO2) \>50 millimetres of mercury(mmHg)

Exclusion Criteria:

* Trauma
* Pregnancy
* Patients requiring immediate life-saving interventions eg cardiopulmonary resuscitation (CPR) or defibrillation
A Follow-up Study to Evaluate the Long-term Safety and Efficacy in Participants Who Received CS-101 Injection

This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-01 (NCT06291961),No investigational drug product will be administered in the study.

This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-01 (NCT06291961). Subjects in the CS-101-01 study will be entered into long-term follow-up of this study up to 15 years post-infusion at the completion of the last (12-month) follow up visit after treatment with CS-101 Injection.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have received CS-101 infusion in CS-101-01 study
* Participants (or his or her legally appointed and authorized representative or guardian) must sign and date informed consent form (ICF) and, where applicable, an assent form

Exclusion Criteria:

* There are no exclusion criteria
Progressive Resistance Training in Acute Spinal Cord Injury

Muscle weakness is one of the most common and debilitating symptoms following a Spinal Cord Injury (SCI). Strength training is recommended as an effective means to increase muscular strength and improve function for individuals with long term SCI. In contrast, the strength training guidance for those with a recent (\<1 year) SCI is lacking. Therefore, this study aims to investigate the feasibility of a method of upper limb strengthening - Progressive Resistance Training (PRT) and its impact upon muscle strength and function.

The trial and recruitment will be conducted at the Queen Elizabeth National Spinal Injuries Unit (QENSIU), Glasgow. Individuals with tetraplegia and upper limb weakness will be randomly allocated to receive either a tailored progressive resistance training (PRT) programme alongside usual care or usual care alone.

Up to 30 participants admitted to the QENSIU will be recruited to the study. They will be randomised to the intervention or control group. The intervention group will receive 8 weeks of PRT. An upper limb functional goal will be identified through discussion with the researcher and the participant. PRT will be individually tailored to target two muscle groups which contribute to achieving this goal. For each muscle group 3 sets of 8-10 repetitions will be carried out, resistance will be applied using wrist weights, free weights or resistance bands as required. Measurements of muscle strength and function will be assessed prior to, and following the study. Outcome measures: Manual muscle testing, Handheld Dynamometry, The Spinal Cord Independence Measure, The Action Research Arm Test.

Eligibility Criteria:
Inclusion Criteria:

* Acquired non-progressive SCI - traumatic, spinal cord stroke, surgical injury
* Within 2 weeks of being identified as medically stable by the treating consultant
* Over 18 years old
* Individuals classified with complete or incomplete tetraplegia (C1-C8), graded A-D according to the American Spinal Injury Association (ASIA) scale
* Bilateral or unilateral partial paresis of at least two muscle groups of the upper limb
* Manual muscle testing grade 2-4 strength in target muscle groups
* Able to tolerate sitting upright in a wheelchair for at least 2 hours

Exclusion Criteria:

* Acute condition impairing a participant's ability to perform PRT (e.g. fracture)
* Proven or suspected neuromuscular weakness affecting the upper limbs due to another condition (e.g. stroke or Guillain-Barré syndrome)
* Unable to follow instructions in English
* Symptomatic cardiac disease
* Ventilator dependency
* Severe spasticity
* Uncontrolled autonomic dysreflexia
* Likely to be discharged before the end of the intervention
Development of a Questionnaire to Measure Hypervigilance for Visceral Pain

The aim of this study is to develop and validate a questionnaire (non-invasive technique) to identify patients who are hypervigilant for noxious visceral sensations and who show a lower threshold to report pain. This questionnaire would be useful in studies investigating the role of visceral pain hypervigilance and pain sensitivity in the comorbidity of IBS with other somatic disorders.

Methods: There are two phases to the project: (1) Development of the pool of items (questions), and (2) validating individual items based on their correlation with an objective gold standard - the response criterion statistic, B, calculated from a barostat test of pain sensitivity. We will perform barostat tests of pain thresholds and other measures of pain sensitivity that are based on sensory decision theory analysis in a relatively large group of 84 IBS patients. Sensory decision theory divides pain perception into two components: a perceptual sensitivity index (P(A)) and a response criterion (B). The response criterion is sensitive to cognitive and psychological influences on pain perception. We will use this index (B) as the gold standard against which to select items for a scale to measure hypervigilance for visceral pain. The process will involve (a) pooling items from existing questionnaires that seem related to the concept, (b) obtaining additional questions from consultants who are experts in visceral perception and psychometric test development, (c) identifying the items that show the strongest correlations with the response criterion, (d using principal components analysis to reduce the items to the smallest number of non-redundant items that predict the response criterion and treating this as a provisional questionnaire of hypervigilance, and (e calculating psychometric characteristics of this questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of IBS
* meets Rome III criteria for IBS
* women or men aged 18 or older

Exclusion Criteria:

* use of IBS-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect
* use of analgesics for 48 hours prior to the study
* hypothyroid
* history of bowel resection except appendectomy or cholecystectomy
* psychotic disorder, major depression, substance abuse (other than tobacco)or other psychiatric condition likely to interfere with the conduct of the study
* renal disease
* patients with inflammatory or ischemic disease of the rectum
* known to be unreliable.
Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass index (BMI) 18-30 kg/m2, inclusive.
* Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology \& urinalysis, as judged by the investigator

Exclusion Criteria:

* Healthy volunteers who have been exposed to radiation levels above background (eg through X-ray examination) of \>5 mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1 mSv per year of life
* Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator
* Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)
Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol

Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin


Eligibility Criteria:
Inclusion Criteria:

* age: 18- 80
* diagnosis of psoriasis vulgaris (mild- middle)
* no other current antipsoriatic therapy (systemic/topical)
* at least 5 psoriatic areas of 5x5 cm

Exclusion Criteria:

* pregnancy/nursing mothers
* women in reproductive age without adequate contraception
* severe and acute forms of psoriasis vulgaris
* patients receiving systemic or topical antipsoroatic treatment in past 3 month
* UV-therapy in past 3 month
* patients having a positive anamnesis for squamous cell carcinoma, malignant melanoma, basalioma
* epilepsy
Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia

The aim of this research study is to determine the effectiveness of: 1) a traditional therapy regimen focusing on individual exercises for pharyngeal (throat) and laryngeal (voice box) musculature and 2) a new therapeutic exercise, the Shaker exercise.

The primary objective of this 5-year project is to identify which of two therapy programs, the Shaker exercise versus traditional therapy, results in the largest number of stable, non-oral dysphagic patients who can swallow safely and return to full oral feeding after 6 weeks of intervention. The study is powered adequately so that this aim can be tested separately for head and neck cancer and stroke patients. Our primary outcome measure is return to oral feeding, i.e., 100% of nutrition and hydration by mouth.

Secondary aims of this research are:

1. Determine in a descriptive manner whether patients with residue in the pyriform sinuses who aspirate the residue after the swallow respond better, i.e., a higher percentage of them can return to 100% oral intake, than patients with residue in the valleculae who aspirate after the swallow or patients with residue in both locations who aspirate after the swallow and thus to define the spectrum of indications for the proposed exercise programs in the two groups of dysphagic patients (stroke and post-chemo radiation treatment for head and neck cancer) and whether postures enable each patient type to swallow more bolus types without aspiration at pre- and post
2. Define the pathophysiology underlying the swallow dysfunction and those pathophysiologic elements which change as a result of each therapy program including changes in -

   1. anteroposterior and lateral diameter of maximum deglutitive UES opening
   2. maximum deglutitive laryngeal anterior and superior excursions

Eligibility Criteria:
Inclusion Criteria (all required)

* Patients with pharyngeal phase dysphagia due to stroke or chemoradiation for head and neck cancer (without surgical intervention)
* Incomplete UES opening and post-deglutitive aspiration
* Hypopharyngeal (pyriform sinus) residue or vallecular residue alone or in combination
* Dysphagia requiring tube feeding (at least 3 months non-oral condition)
* Able to comply with protocol mandates, willing to perform the exercise programs, and ability to attend study sessions.

Exclusion Criteria

* Pharyngeal surgical procedures
* Other neuromuscular disorders such as
* Lack of cognition
* Metabolic myopathies
* History of alcoholic neuropathy
* Steroid myopathy
* Cervical spine injury, lesions, or large osteophytes
* Kerns-Sayers Syndrome
* Individuals unable to exercise independently
* Oculo-pharyngeal and other dystrophies
* Current use of anticholinergics:

bensodiazopin, antihistamines

* Myasthenia gravis
* Elimination of aspiration with posture during VFG
* Absent pharyngeal swallow on VFG
* Aspiration before or during the swallow (pre and intradeglutitive aspiration)
* Not completely tube feeding dependent
Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy has on resected pancreatic cancer.

Proton radiation with concomitant chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection
* Post resection CA19-9 tumor marker baseline

Exclusion Criteria:

- Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the patient has been disease free for at least 5 years prior to study consent
Management Modalities of Chronic Pelvic Pain

Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women.

Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women. The current study will investigate whether Laparoscopic Presacral Neurectomy or Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis is more effective for treating chronic pelvic pain.

Eligibility Criteria:
Inclusion Criteria:

* Patient acceptance.
* Body mass index \< 35 kg/m2.
* Adult patients with chronic pelvic and perineal pain due to pelvic cancer.
* Visual Analog Scale pain score ≥ 5 on a 0-10 scale despite treatment with a standard analgesic.

Exclusion Criteria:

* Uncooperative patient.
* Patients with coagulopathy, infection at the site of injection, severe cardiac compromise, or intolerance to sympathetic block.
Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women

The purpose of this study is to compare average methylation of epigenetic markers on genomic DNA and some genes (APP, BACE, LRP, SorL1) involved in cerebral amyloid homeostasis:

* Of obese young adults and healthy young adults
* Of obese young adults and individuals affected by Alzheimer's disease (AD) having been obese at young adult age (\<50 years old) or individuals affected by Alzheimer's disease (AD) having never been obese.

The secondary purpose is to determine if there is an association between the frequency of these epigenetic markers and elements associated to the metabolic syndrome (lipidic and glycemic analysis, leptinemia, inflammation markers) and clinical ones (visceral fat mass, body mass index) in young adults.


Eligibility Criteria:
Inclusion Criteria:

Group 1:

* 18-50 year old women, age- (10 years) and sociocultural-matched with group 2
* Non obese and never been obese
* 18.5 \< BMI \< 25
* Folstein MMS \> 27
* Informed consent
* Affiliation to social security plan

Group 2:

* 18-50 year old women, age- (10 years) and sociocultural-matched with group 1
* Waist size \> 88cm
* 30 \< BMI \< 45
* Insulin-resistant patients (Insulin resistance index, HOMA-IR \> 3.8)
* Obesity onset during childhood (pre-puberty period)
* Folstein MMS \> 27
* Informed consent
* Affiliation to social security plan

Group 3:

* \>60 year old women, age- (10 years) matched with group 4
* No obesity history (18.5 ≤ BMI \< 25 at adult age)
* Sporadic forms of mild to moderate AD with demonstration of AD physiopathologic process according to new recommendations of 2011 of National Institute on Aging and Alzheimer's Association on diagnostic guidelines for Alzheimer's disease
* 15\< Folstein MMS ≤ 26
* Informed consent
* Affiliation to social security plan

Group 4:

* \>60 year old women, age- (10 years) matched with group 3
* Obesity history (BMI \> 30 at least one time at adult age)
* Sporadic forms of mild to moderate AD with demonstration of AD physiopathologic process according to new recommendations of 2011 of National Institute on Aging and Alzheimer's Association on diagnostic guidelines for Alzheimer's disease
* 15 \< Folstein MMS ≤ 26
* Informed consent
* Affiliation to social security plan

Exclusion Criteria:

Group 1:

* \<18
* Patient under guardianship, curatorship or judicial protection
* Folate supplementation
* Diabetic or glucose intolerant subjects
* Present participation to another study with neuropsychological evaluation and/or drug administration
* Pregnant women

Groups 2,3 and 4:

* \<18
* Patient under guardianship, curatorship or judicial protection
* Folate supplementation
* Present participation to another study with neuropsychological evaluation and/or drug administration

Group 2:

- Pregnant women

Group 4:

- Obese or overweight patients (BMI\>25)
Family Relationships and Nutrition in TGGD Youth and Young Adults

The purpose of this study is to assess how family relationships are related to health and nutrition behaviors among transgender and gender diverse youth and young adults.

The study is recruiting the following populations: parents of transgender and gender diverse youth, transgender and gender diverse young adults, and transgender and gender diverse youth. Participants over the age of 18 will be recruited via Amazon Mechanical Turk (MTurk), and youth participants will be recruited via parent referral. Age and role-appropriate surveys will be administered to the three distinct populations. A waiver of written consent for participation will be used per survey protocol. After participants receive a recruitment statement about the study and the potential risks, willing participants will take a 10-20 minute survey to provide data regarding demographics, height and weight, food habits, physical activity, food security, health support, risk-taking behaviors, past health diagnoses, and family environment. No personal identifiers will be collected and all responses will remain confidential. Our main question is whether family acceptance of a transgender or gender diverse (TGGD) youth and young adults is related to health, nutrition, and risk-taking behaviors.

Eligibility Criteria:
Inclusion Criteria:

TGGD Young Adults:

* 18 to 25 years of age
* Self-identify as transgender or gender diverse
* A resident of the United States of America or Canada
* English speaking.

Parent of TGGD Youth

* A parent of a 12-17 year old TGGD youth
* A resident of the United States of America or Canada
* English speaking
* Have a child that self-identifies as transgender or gender diverse

TGGD Youth

* 12 to 17 years of age
* Self-identify as transgender or gender diverse
* A resident of the United States of America or Canada
* English speaking

Exclusion Criteria:

TGGD Young Adults

* Less than 18 years of age or greater than 25 years of age
* Self-identify as cis-gender
* Not a resident of the United States of America or Canada
* Non-english speaking

Parent of TGGD Youth:

* Parents of children that are less than 12 years of age or greater than 17 years of age
* Not a resident of the United States of America or Canada
* Non-english speaking
* Does not identify as a parent of a TGGD child

TGGD Youth

* Less than 12 years of age or greater than 17 years of age
* Does not self-identify as transgender or gender diverse
* Not a resident of the United States of America or Canada
* Non-english speaking
Interchangeable Guide in Ridge Splitting Flapless Technique for Implant Placement

A clinical trial was conducted to evaluate the accuracy of dental implant placement in narrow ridges after ridge splitting flapless technique using an interchangeable guide.

A sample was selected conveniently to fulfill a list of inclusion and exclusion criteria. Then the selected participants underwent ridge splitting with the aid of interchangeable guide. After ridge splitting, all patients had simultaneous implant placement followed by clinical and radiographical evaluation over a period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with anterior maxillary narrow ridge
* Patients with adequate alveolar ridge bone height
* Age ranging from 20-40 years.
* Patients should have adequate oral hygiene
* Patients should be free of soft tissue or oral dental pathology
* Patients who accept to participate in the study.

Exclusion Criteria:

* Patients suffering from relevant systemic and/or metabolic diseases
* Patients suffering from immunosuppressive and/or autoimmune diseases
* Heavy smokers.
The Efficacy of Intravenous Pulse in Attaining Remission in Refractory Juvenile Idiopathic Arthritis

Interventional phase 3 study aiming to unravel the value of pulse steroids in achieving remission or low disease activity in refractory active JIA

First group will receive 2 consecutive days intravenous pulse of 125 mg methylprednisolone.

Second group will not receive additional drugs. Assessment was done at baseline and every month for 3 months for both groups using Juvenile Arthritis Disease Activity Score (JADAS) and the American College of Rheumatology Pediatric 30, 50, and 70 response criteria (ACR Pedi. 30, 50, 70).

Eligibility Criteria:
Inclusion Criteria:

* Patients still active despite administration o 2 DMARDs

Exclusion Criteria:

* Other connective tissue diseases
* Endocrine disorders such as Thyroid disorders.