cyrilzakka/clinical-trials huggingface dataset:
Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory

Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem. The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in the age group of 6 and less and about 1.5% above. The in-lab sleep study using full Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the commonly used procedure of "split-night" for OSAS patients, as well as to the development of a variety of ambulatory sleep study systems. The primary study objective is to compare the efficacy of the WatchPAT (WP), as an ambulatory device for aiding in the diagnosis of sleep disorders for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a "gold standard".


Eligibility Criteria:
Inclusion Criteria:

1. Age between 5-90
2. Subjects that are able to read understand and sign the informed consent form to undergo an overnight sleep study in the clinical sleep laboratory

Exclusion Criteria:

1. Permanent pacemaker.
2. Severe lung disease.
3. Peripheral neuropathy.
4. Finger deformity that precludes adequate sensor appliance.
5. Using one of the following medications: short/Long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).
Functionality and Accuracy of the smART System in Real-Life ICU Settings

Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Jefferson study site there were 8 participants and in the Sheba study site (identifier NCT03689985) there were 2 participants.

This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smART™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV).


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years or older
* Patient has already been admitted to ICU
* Patient requires enteral feeding
* Patients receiving Proton Pump Inhibitors (PPI) therapy
* Informed consent by independent physician and next of kin
* ICU ventilated patients

Exclusion Criteria:

* Patients with anomalies or diseases of the esophagus and or stomach.
* Patients with known sensitivities or allergies to any of the feeding tube materials
* Inability to place patient in semi-Fowler's position.
* Any clinically significant abnormality upon physical examination which may, in the opinion of the investigator, pose difficulty in inserting the feeding tube (e.g. cervical spine disorder)
* Pregnancy
* Recent abdominal surgery (less than 30 days)
Inflammation and Steatosis: the Role of Alpha-defensin

The aim of this study is to examine the correlation between the severity of non-alcoholic steatohepatitis/non alcoholic fatty liver disease (NASH/NAFLD) in naïve and hepatitis C (HCV) positive patients and the amplitude of alpha-defensin immunohistochemical staining in liver biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Fatty liver disease patients with liver biopsy

Exclusion Criteria:

* None
Integrated Functional Evaluation of the Cerebellum

One of the main objectives of this project is to validate potential biological, clinical and/or imaging biomarkers in SCA patients through a multimodal assessment, for future ASOs trials.

Spinocerebellar ataxias (SCAs) are autosomal dominantly inherited neurological disorders, characterized by a predominant atrophy of the cerebellum and the brainstem. The most common forms are caused by abnormal CAG repeat expansions, encoding elongated polyglutamine (polyQ).

Nowadays, no preventive or curative treatments are available but different therapeutic approaches are ongoing. Antisense oligonucleotides (ASOs) therapy showed promising results in Huntington disease (HD), a disease that shares with the SCAs the same mutational mechanism. ASOs are currently under development for SCAs.

However, in SCAs, clinical scales as an only criteria to monitor a treatment are not appropriate because of the lack of sensitivity of change and the small number of patients available. The importance to dispose of outcome measures to inform about the efficacy of a treatment is fundamental as well as of new alternative designs to conduct a clinical trial in rare diseases with small sample sizes.

A comprehensive, multimodal approach is hence needed to provide a translational and integrated overview of cerebellar dysfunction in polyQ SCAs over a year.

Eligibility Criteria:
Common inclusion criteria for all participants:

* Ability to walk independently 30 foot without an assistive device
* Able to stand unassisted for 30 seconds
* Affiliated with the French social security, or a social security equivalent, if they are not French.
* Capacity to consent
* Signed Informed Consent by the subject
* Ability to undergo MRI scanning

Inclusion criteria for SCA patients:

* Genetic diagnosis of SCA 2 or 7 (available CAG repeat length)
* SARA score ≤15

Inclusion criteria for control participants:

* Negative Genetic diagnosis of SCA2/SCA7 available
* No significant neurological symptoms
* SARA score \< 5

Common inclusion criteria for elective participant for CSF sampling:

• Ability to undergo a lumbar puncture

Exclusion criteria

* Subjects currently receiving, or having received within 2 months prior to enrolment into this study, any investigational drug
* Pregnancy or breastfeeding
* Genotype consistent with other inherited ataxias
* Changes in coordinative physical and occupational therapy for ataxia 2 months prior to study participation
* Concomitant disorder(s) or condition(s) that affects assessment of ataxia or severity of ataxia during this study
* Contra-indications to MRI examination
* Person deprived of their liberty by judicial or administrative decision
Transdermal Clonidine in Chronic Hemodialysis Patients

The majority of chronic hemodialysis patients need a combination of several antihypertensive drugs for adequate BP control. The primary objective of this study is to evaluate whether transdermal clonidine can improve blood pressure control or decrease oral antihypertensive agents type or dosage and the secondary objective is to observe incidence of adverse reactions of transdermal clonidine in chronic hemodialysis patients.

It's a randomised crossover clinical trial. Subjects: chronic hemodialysis patients. All subjects will be randomised to 2 groups. Subjects in first group will receive 4 weeks transdermal clonidine plus regular antihypertensive agents treatments first, 2weeks wash-out then and 4 weeks antihypertensive agents without transdermal clonidine. The other group will receive 4 weeks antihypertensive agents without transdermal clonidine first, 2weeks wash-out then and 4 weeks transdermal clonidine plus regular antihypertensive agents treatments. Ambulatory blood pressure, echocardiography, and biochemistry will be detected.

Eligibility Criteria:
Inclusion Criteria:

1. signed informed consent;
2. age: 18years to 80 years old；
3. on hemodialysis for more than or equal to 3 months, not less than 3 times and 12 hours hemodialysis per week；
4. cardiac function grade I or grade II(NYHA)；
5. Using 1 or more than 1 oral antihypertensive drugs, pre-dialysis systolic blood pressure over 140mmHg or dialysis blood pressure over 90mmHg, post-dialysis systolic blood pressure over 130mmHg or diastolic blood pressure over 80mmHg

Exclusion Criteria:

1. acute infection within 1 month；
2. acute myocardial infarction/cardiac function grade IV/stroke within 3months；
3. LVEF lower than 50% by echocardiography；
4. Dry weight is not suitable by BCM evaluation, more than plus or minus 1kg；
5. Inter-dialysis weight gain exceeds 5% of dry weight；
6. Post-dialysis systolic blood pressure lower than 120mmHg and diastolic blood pressure lower than 70mmHg；
7. Begin or stop recombinant human erythropoietin treatment within 2 weeks before inclusion or 10 weeks after inclusion;
8. Adjust recombinant human erythropoietin dosage to more than 2times or less than half original dosage within 2 weeks before inclusion or 10 weeks after inclusion；
9. The treatment regimen will be amended within 10 weeks and it is expected that the treatment amendment may affect blood pressure；
10. Pregnancy or lactation or planning a pregnancy in 10 weeks；
11. Expected to withdraw hemodialysis treatment in 10 weeks；
12. Allergic to clonidine or its accessories；
13. Undergoing other clinical studies, and the research interventions have an impact on blood pressure；
14. Other clinical conditions that may affect the results
Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department

Chronic musculoskeletal pain (CMP) and lack of physical activity often co-exist, contributing to increased disability, non-communicable diseases (e.g., obesity, diabetes, hypertension), psychological comorbidity (e.g., anxiety and depression), and healthcare utilization and costs \[1-6\]. Many individuals with CMP seek assistance at emergency departments (ED). ED overuse has been an ongoing concern, with 1-in-5 Americans presenting to the ED at least once each year \[7\]. Of these visits, 24 million are for adults seeking help for chronic pain, with an additional 12 million due to exacerbations of an existing chronic pain condition \[8\]. In 2021, the fourth most common reason for seeking care in the ED related to a primary diagnosis involving the musculoskeletal system, with an estimated 9.5 million visits \[9\]. Most ED visits result in a 'treat and release' approach, potentially disrupting continuity of care and resulting in follow-up ED visits \[10\]. These ED visits for chronic pain are indicative of accessibility problems to community-based primary and preventative care, compounded by limited or no health insurance coverage \[10\]. Based on the Emergency Medical Treatment and Labor Act, EDs are required to stabilize all patients regardless of ability to pay \[10\]. To alleviate the burden of CMP on patients and EDs, improve access to quality healthcare, and mitigate initial and repeat ED visits, alternative options are required. Here we propose a novel group-based intervention involving pain education (PE) and physical activity (PA) implemented in CMP patients presenting to the ED of a community level hospital. The investigators will recruit 60 adults from a community hospital located in the Shenandoah Valley region of Virginia; participants will be randomized to either Pain Education and Active Knowledge (P.E.A.K.) Rx (24 sessions of group PE+ + PA) or usual care. Research assessments are conducted with both groups at study entry (baseline), 8-weeks, 3-months, and 6-months.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Sedentary (e.g., not meeting PA guidelines, assessed by ACSM PA vitals)
* English speaking and reading comprehension
* Not currently pregnant
* Diagnosed with CMP based on electronic health record:

  * Non-red flag presentation (e.g., red flags: current fracture, malignancy, infection, vascular issues, or in need of surgical intervention).
  * Persistent or recurrent pain for 3+ months, with at least moderate pain intensity level (Visual Analog Scale of 40/100)
Concurrent Paclitaxel and Radiotherapy After Adjuvant Doxorubicin and Cyclophosphamide for Stage 2 or 3 Breast Cancer

The aim of this study is Evaluation of the efficacy \& toxicity of concurrent paclitaxel and breast radiotherapy and assesment of overall survival \& progression free survival

Over the recent years , breast cancer remains the most common cancer in women in the world . With nearly 107 Million new Cases diagnosed in 2012 (second most common cancer over all) . this represent about 12 % of all new cancer cases and 25 % of all cancers in women . By contrast the mortality rate has declined dramatically since the introduction of adjuvant systemic therapy \& radiation therapy, which are now used extensively for their established benefit in local (radiotherapy ) ,survival without metastasis (chemotherapy) and overall survival of both of them . However , the optimal sequence of chemotherapy \& radiotherapy remain controversial three sequence were investigated:

1. Delivering all radiotherapy first .
2. A " Sandwich " approach .
3. Delivering all chemotherapy first . Observational studies have suggested that delaying initiation of chemotherapy increase the incidence of distant metastasis \& delaying the initiation therapy more than 6 months after breast cancer diagnosis might increase risk of local regional recurrence . Concurrent chemoradiation therapy has an advantage of shortening the duration of therapy , allowing radiotherapy \& chemotherapy to start temporally and potentially improving local control via radiation sensitizing effect of chemotherapy.The feasibility of concurrent radiotherapy with taxane, which constitute a standard treatment used as adjuvant therapy has been evaluated in stage II,III breast cancer. Taxane Promote stabilization of microtubules causing cell cycle arrest in G2/M junction and serve as radio sensitizing agents.In a prospective study using Paclitaxel \& radiotherapy concurrently Paclitaxel given every 3 weeks for 4 cycles the authors concluded that Concurrent chemoradiation therapy improve local control with acceptable toxicity.

Eligibility Criteria:
Inclusion criteria :

* • This study will include women aged 18 years \&older.
* patients must be histologically diagnosed with breast cancer (ductal \& others).
* patients who underwent conservative breast surgery \& modified radical mastectomy.
* patients with stage ll\&lll breast cancer.
* patients who received (AC) as adjuvant treatment .

Exclusion Criteria:

* patients with stage 1 or 4 breast cancer.
* patients received adjuvant chemotherapy rather than (AC) .
* patients with prior irradiation with thoracic region .
* pregnancy or lactation .
* patient with serious comorbid disease such as chronic obstructive pulmonary disease .
Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease

The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:

• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.

Gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus.

The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:

• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria for Gastroesophageal Reflux Disease.
* Age between 18 and 65 years.
* Confirmed tongue-pharyngeal nerve injury by electromyography.
* Esophageal manometry and barium swallow examination confirming the presence of pharyngeal dysphagia.
* Normal higher brain function, able to cooperate with treatment.

Exclusion Criteria:

* Brain vascular disease diagnosed.
* Clinical assessment and swallowing videofluoroscopic examination revealing cognitive phase, oral preparatory phase, or oral phase disorders.
* Concurrent presence of other neurological disorders such as Alzheimer's disease, traumatic brain injury, Parkinson's disease.
* Esophageal obstruction and severe liver or kidney dysfunction
* Subjective unwillingness to undergo the treatment and presence of psychiatric abnormalities, etc.
Evaluation of Integrating MIYCN Interventions in Existing CGPP of PCI

The study has two arms; both experimental and control areas will receive standard interventions given under polio eradication program of PCI. Participants in the experimental arm receive additional interventions on nutrition (improve diet diversity in pregnant women and children of 6-23 months) for exact 12 months. The study includes awareness generation (regarding nutrition) through community mobilization, counseling and capacity building of community mobilization.

The experimental arm will receive the following interventions:

1. Interpersonal communication (IPC) to reach target women (Women in their 2nd or 3rd trimester of pregnancy and women with 6-23 months old child) to deliver messages on maternal nutrition package and complementary feeding through home visits made by Community Mobilization Coordinator (CMC).
2. Expanded community mobilization involving key influencers in family like husbands and mothers -in-law and community opinion leaders, religious leaders, Village Health Sanitation and Nutrition Committee (VHSNC) members. The aims are to improve awareness, shift norms and perceptions, engage husbands and local opinion leaders to promote healthy behaviour practices related to maternal nutrition and complementary feeding.
3. Strategic use of data to design a context-specific program and track the progress of the program with regards to impact on social norms and behaviors at household/community level and demonstrate the feasibility of integrating select MIYCN interventions in polio eradication platforms.
4. Convergence: The convergence will mainly focus on three Cs - maintain consistency, avoid conflict and enhance cooperation. This will aid in passing consistent MIYCN messages to the target community and ensure effective teamwork, collaboration and mutual support

Eligibility Criteria:
Inclusion Criteria:

For Community

* • Women aged 15-49 years

  * Willing and able to provide consent
  * Women in 2nd and 3rd trimester of pregnancy and / or
  * Women with children aged 6-23 months For CMC
  * Women aged 18+
  * Currently appointed a CMC in a selected HRA
  * Willing and able to provide consent

Exclusion Criteria:

* Women in first trimester of pregnancy
* Women whose index child (youngest child, between 6-23 months of age) is not her biological child
* Women whose index child is not currently living with the mother
Patient Opinions Regarding General Anesthesia, Before and After Having Undergone a Procedure.

The goal of this survey will be to assess the opinions and reticence of patients who have undergone surgical procedures that required the usage of general anesthesia both before they underwent the procedure and afterwards.


Eligibility Criteria:
Inclusion Criteria:

* Have experience with general anesthesia.

Exclusion Criteria:

* Anyone who has not undergone a procedure using general anesthesia and who will not undergo such a procedure within the next 6 months.
Ascending Single Dose Study of Rhu-pGelsolin in Patients With Decreased Gelsolin Levels

This study is designed to assess the pharmacokinetics and safety of an infusion of a single dose of recombinant plasma gelsolin (rhu-pGelsolin) when given to patients admitted to the Intensive Care Unit with documented low levels of natural gelsolin. It is believed that this drug will raise the gelsolin levels in these patients and decrease the probability that they will develop complications from their underlying disease such as organ system failure or death.

This is a randomized, double-blind, placebo-controlled, ascending single dose of rhu-pGelsolin infusion study. Thirteen subjects (10 active and 3 placebo) will be dosed at 3 mg/kg and 5 subjects (3 active and 2 placebo) will be dosed at 6 mg/kg. In addition, twenty-two subjects (18 active and 4 placebo) will be dosed at 6 mg/kg per day for 3 days. The Data Safety Monitoring Committee (DSMC) and Steering Committee will review the preceding dose safety data, and agree the tolerability prior to the enrolment for next higher dose. Blood samples will be collected during 1 hour infusion through 72 hours post dose for PK assessment after each dose.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Documented gelsolin level \<100 mg/mL
* Admission to ICU
* Women of child-bearing age have a negative pregnancy test
* Multiple Organ Failure score \< 4
* Catheter present through which blood samples can be taken
* Written Informed Consent obtained

Exclusion Criteria:

* Participation in other investigational treatment protocols
* Patients \<18 years of age
* Patients who have a modified Multiple Organ Failure score of \>=4
* Patient, who in the opinion of the Principal Investigator, are unlikely to be in the ICU for \>48 hours
Value of PCT When Diagnosing Candidemia

This study is a retrospective analysis to identify and compare the shift in inflammatory biomarkers in ICU patients immediately before and after the first identification of candidemia.

As above.

Eligibility Criteria:
Inclusion Criteria (all has to be fullfilled):

* ICU patients with blood cultures showing growth of Candida species
* clinical records including daily data on WBC, CRP, Procalcitonin and body temperature

Exclusion Criteria:

* Age lower than 18 years
* blood cultures with growth of Candida species before ICU admission
* incomplete records of daily WBC, CRP, Procalcitonin or body temperature