cyrilzakka/clinical-trials huggingface dataset:
The Experience of Caregivers of Children With Down Syndrome

This study will explore how caregivers adjust to having a child with Down syndrome.

Primary caregivers 18 years of age and older of a child with Down syndrome may be eligible for this study. Participants complete a 20- to 30-minute survey that explores the subject s thoughts and feelings about being a caregiver to a child with Down syndrome. Questions explore the impact on the subject of being a caregiver for a child with Down syndrome, the subject s uncertainties related to the child s condition and goals for the child related to social skills, behavior, learning and education, physical and mental health, independence, and other goals. It also asks questions about the caregiver, the family and the child with Down syndrome.

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The proposed study aims to explore the relationships between perceived uncertainty, hope and adaptation in caregivers of children with Down Syndrome (DS). There are often uncertainties surrounding the prognosis of DS which extend into various aspects of the child s life. In addition to the possibility of chronic medical conditions associated with the syndrome, there is also uncertainty related to the level of independence and cognitive, social and behavioral functioning that the child will achieve. It is not fully understood how caregivers adapt to having a child with DS in light of the uncertainty and the particular challenges associated with this condition. While a high level of perceived uncertainty may be seen as a threat to adaptation, there is also evidence that caregivers may find benefits in uncertainty. Literature suggests that a person s level of hope influences how the perceived uncertainty is appraised and that hope is also related to the process of adaptation. There is no research that systematically explores the relationship between perceived uncertainty, hope, and adaptation. This study s conceptual framework is based on Lazarus \& Folkman s Transactional Model of Stress and Coping and is also informed by Snyder s conceptualization of hope and Mishel s theory of perceived uncertainty in illness. A cross-sectional research design will quantitatively explore the relationships between perceived uncertainty, hope, and adaptation. In addition, an open-ended section will be included to qualitatively describe the focus of caregivers hope for their child and how the focus of hope relates to the degree of hope. Participants will be recruited from DS support groups, website postings, listservs, and clinic patient lists. They will have the option of completing either a paper or online version of the survey, or completing the survey by phone. The main outcome variable is psychological adaptation to being a care giver for a child with DS.

Eligibility Criteria:
* INCLUSION CRITERIA:

Participants will be men and women ages 18 or older who are the primary caregivers of a child with Down syndrome. The parent may be a biological or adoptive parent or other primary caregiver and the child must reside with the primary caregiver.

EXCLUSION CRITERIA:

None
Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study

Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study


Eligibility Criteria:
Inclusion Criteria:

- The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up; Patients between 18-75 years old; Extensive small cell lung cancer confirmed by histopathology (according to Veterans Administration lung study group, Valg stage) and did not progress after 4-6 cycles (21 days as a cycle) of first-line standard chemotherapy platinum combined with etoposide \[complete remission (CR), partial remission (PR) or stable (SD) according to recist1.1 standard\]; The time interval between the first TRT and the end of the last chemotherapy should be less than or equal to 6 weeks; The life expectancy shall be at least 3 months; ECoG score: 0-1

Exclusion Criteria:

- Small cell lung cancer patients with other pathological types of tumor species; Patients with pathological fracture in bone metastasis of small cell lung cancer; Patients with central nervous system metastasis; Patients who have received chest radiotherapy before; Patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before; Imaging (CT or MRI) showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a central tumor invading the local large blood vessel, or there was an obvious cavitary or necrotic tumor in the lung;
Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol

Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age, inclusive;
* A history of primary hypercholesterolemia

Exclusion Criteria:

* Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
* Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease
Increasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification

Military service in combat units entails exposure to traumatic events that require mental adjustment. To develop and efficiently apply attention bias modification interventions aimed at enhancing soldiers' mental resilience, it is essential to test the efficiency of such training programs in RCTs. The purpose of the current study is to examine the efficiency of a new attention eye-tracking-based training protocol, in comparison to an RT-based training protocol, and to a control group, in reducing risk for post-trauma symptoms in combat deployed soldiers.

Following the explanation to participants regarding the study process, those who give written consent to participate will be randomly placed into one of three groups: GCFT (N=180), ABMT (N=180), and a neutral control group - RT-based task (N=180). The study will include 3 measurement points: before attention training (in basic training before deployment), after attention training (in basic training camp, still before deployment), and after a combat deployment cycle (6-12 months - to be determined based on the military deployment mission of the participants). In each measurement point, the participants will complete computerized tasks to measure attention and will complete self-report questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Each soldier from the allocated cohort who gives written consent will be able to participate in the study.

Exclusion Criteria:

* Hebrew proficiency is insufficient to complete the study questionnaires.
MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry

The purpose of this study is to collect clinical and laboratory data for patients affected by intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present. Revlimid is available in Italy for these patients since October 2008 based on a local disposition of the Italian Drug Agency (AIFA) issued according to a National law named 648/96.

There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.

Eligibility Criteria:
Inclusion Criteria:

* intermediate 1 and low risk MDS patients associated with:

  1. transfusion dependency anemia (at least 2 units per 8 weeks before starting of Revlimid treatment )
  2. 5q31-33 deletion isolated or associated to other chromosomal abnormalities.

     Exclusion Criteria:
* patients with serum creatinine \> 2.5mg/dl
* child bearing potential females who do not use adequate contraceptive methods
A Clinical Trial of Dental Device Cemented with Polymethyl Methacrylate (PMMA) Bone Cement

Conventional bridge and dental implants have been playing a significant role in replacing missing tooth/teeth. But they come with shortcomings. Hence, to explore the possibility of addressing such shortcomings, a clinical trial study of a new dental device made of zirconia is intended to be studied to see if it could serve as an additional option for fixed prosthodontics. An approach to explore possibilities for cheaper and faster procedure with regards to the treatment of tooth/teeth loss.

Objectives:

To determine whether the use of a new dental device made of zirconia cemented with Polymethyl methacrylate (PMMA) bone cement could be an additional option for a faster treatment for missing tooth/teeth with fixed/removable prosthodontics.

Methodology:

After a Cone Beam Computed Tomography (CBCT) scan and clinical evaluation, 48 samples of zirconia dental device will be cemented with PMMA bone cement in edentulous area on randomized population. Immediate loading (0-15 days) with single crown and multiple unit bridge made of zirconia will be cemented using luting cement as fixed restoration. Radiographic evaluation and clinical examination will be conducted every three (3) months for one year.

Expected Outcome:

A new dental device made of zirconia could be an additional option for the treatment of edentulism, which could be completed within 0-15 days with minimal risk.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years old and above) who agrees for the treatment
* Single/multiple missing tooth/teeth (edentulism)
* Maxillary/mandibular bone density of more than 350 Hounsfield Unit (HU)
* Edentulous region with minimum of 2mm bone width and 5mm of bone height
* Well controlled diabetes and hypertension

Exclusion Criteria:

* Severe/Critical medical conditions
* Adults above 80 years old
Pediatric Health Promotion Program

The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients.


Eligibility Criteria:
Inclusion Criteria:

* Well-child visit

Exclusion Criteria:

-
Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)

The main purpose of this study is to prospectively assess the general safety profile of Dotarem


Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for a Dotarem®-enhanced MRI

Exclusion Criteria:

* patient with a contra-indication to MR examination
* patient with a contra-indication to Dotarem® injection as per local SPC
Personalized Targeted Immunomodulation in COVID-19 ARDS

Rationale: In COVID19 single-targeted immunomodulation, mostly via an IL-6 receptor blocker, was used by a one-size fits all non-targeted approach. In future pandemics the same might occur. However, for individual patients, this might not yield optimal treatment.

Objectives: This project aims to identify a way to individualize and target immunomodulation, using COVID19 as a testcase for the future.

* Identify immunological pathways which are associated with outcome in C-ARDS.
* Test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in C-ARDS(Tocilizumab, Anakinra, etc.).
* Explore whether other immunological pathways were present in patients with C-ARDS which could have been intervened with medication which is already available and has been described in ARDS or similar diseases.

Study type: Retrospective observational multicenter study in the Netherlands.

Study population: Adult patients (≥ 18 years) hospitalized and admitted to the ICU with COVID-19 and acute respiratory distress syndrome (ARDS) (i.e., receiving invasive mechanical ventilation) will be included.

Intervention (if applicable): Not applicable (retrospective study design).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Given the retrospective nature of the study, no burden, risks or benefits for the patient are associated with participation. The target population of this study is specific to hospitalized patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Admitted to ICU due to COVID induced moderate or severe ARDS
* Requiring mechanical ventilation

Exclusion Criteria:

- Refusing participation
A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis

The purpose of this study is to assess the safety and tolerability of different doses of PF-06444753 and PF-06444752 in subjects with allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, males or females of non-child bearing potential, who are between 18 and 55 years, inclusive,
* Intermittent or persistent allergic rhinitis that is associated with perennial or seasonal allergen reactivity at screening as determined by a positive specific IgE level ≥1 KU/L to at least one of the following common allergens: dust mite (Dermatophagoides farinae or Dermatophagoides pteronyssinus), cat, dog, mold (Alternaria), Bermuda grass, common ragweed, oak, Timothy grass or elm.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may compromise their ability to safely participate in the study.
* Evidence or history of clinically significant pulmonary disease (including allergic and non-allergic asthma, chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis, chronic bronchitis, emphysema, tuberculosis, pulmonary fibrosis, pulmonary hypertension, or others).
* Evidence or history of clinically significant autoimmune disease (including rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, or others).
Mindfulness-based Cognitive Therapy (MBCT) for People With Parkinson's Disease

This study aims to explore the feasibility and effectiveness of mindfulness-based cognitive therapy (MBCT) in reducing anxiety and/or depressive symptoms in people with Parkinson's disease.

An adapted MBCT intervention will be offered to people with Parkinson's disease and mild-to-moderate depression and/or anxiety. Two 8-week long MBCT groups will be held between September 2019 and March 2020, based on the adapted protocol. Modifications will include shortening the traditional 120-minute to 90-minute format and performing mindful yoga from a chair, instead of a floor mat. Participants will be recruited from the community, according to the eligibility criteria detailed below. The participants' pre- and post-MBCT anxiety and/or depressive symptom severity and mindfulness levels (as measured with standardized, validated scales) will be compared, using a paired t-test.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Parkinson's disease or parkinsonism (established by a neurologist)
2. Living in the San Francisco Bay Area
3. Being able and willing to attend 8 weekly 90-minute group sessions
4. Mild-to-moderate anxiety: GAD-7 score ≤ 16
5. Mild-to-moderate depression: PHQ-9 score ≤ 18

Exclusion Criteria:

1. Severe anxiety: GAD-7 score \> 16
2. Moderately severe-to-severe depression: PHQ-9 score \> 18
3. Cognitive impairment: Montreal Cognitive Assessment (MoCA) score \< 24
4. Heavy alcohol or drug use
5. Severe psychosis
6. Active suicidal or homicidal ideation
7. Severe motor fluctuations (less than 2 hours "on" time per day)
Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch

With this experiment, the experimenter wish to asses if substance BAM8-22 (Bovine Adrenal Medulla) induce non-histaminergic itch.

With this experiment, the experimenter wish to establish if the substance BAM8-22 (Bovine Adrenal Medulla) induce a non-histaminergic itch by using the antihistamine Doxepin.

The experimenter will also compare itch and the response to antihistamine of BAM8-22, histamine and cowhage.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
* Moles, wounds, scars or tattoos in the area to be treated or tested
* Lack of ability to cooperate •
* Current use of medications that may affect the trial such as antihistamines and pain killers.
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these - Acute or chronic pain •
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Atrial Fibrillation Screening and Education Study

The purpose of this study is to evaluate the outcomes of a community placed atrial fibrillation (AF) screening and education program

Background/significance: Atrial fibrillation (AF) is a global epidemic that accounts for 15%-20% of 795,000 strokes occurring annually in the US, at a cost of $3.2 billion per year. Atrial fibrillation-related stroke will rise with the aging population and places enormous strain on healthcare resources and quality of life; yet they are highly preventable, by early detection of AF. Timely treatment reduces AF-related stroke risk by 68%, yet treatment is often delayed because people may not recognize the symptoms of AF or may be asymptomatic. Given the number of people at risk for development of AF and the dire consequences of untreated AF, efforts to promote early detection of AF through proactive screening of older adults at risk for AF have been successfully undertaken in Europe and Australia. However, little is known about the outcomes of conducting programs to screen for and educate people about AF in community settings in the US.

Purpose: The purpose of this descriptive pragmatic study to evaluate the outcomes of a community placed AF screening and education program. Primary outcomes include feasibility, number of participants who screen positive for AF, and changes in participants' Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Self-Monitoring (KABAF-SM) scores from baseline to two-weeks after enrollment.

Methods: Up to 250-participants who have at least two risk factors for developing AF and have no previous diagnosis of AF will be recruited from Midwest community settings and will be screened for AF using a mobile ECG recorder and will receive written information sheet about AF. A portion (up to 125) of those 250 participants will be invited to complete the KABAF-SM at baseline and 2-weeks after enrollment. Participants will have the option to participate in a variety of AF educational activities to reinforce and enhance the written information. Participants will be surveyed about their perceptions of the educational program after the screening and participating in the educational activities.

Evaluation methods: Descriptive statistics will be used to analyze feasibility (enrollment numbers, participants perception of the value of the educational activities, time required for study procedures,and AF detection.T-tests will be used to test for differences between KABAF-SM baseline and two-week scores for those who completed the KABAF-SM.

Eligibility Criteria:
Inclusion :

Any two of the following:

* Hypertension
* Diabetes
* Sleep apnea
* Obesity
* Age \> 75 years
* Peripheral arterial disease
* Female

Exclusion :

* Previous diagnosis of atrial fibrillation or atrial flutter
* Uncompensated visual impairment
* Uncompensated hearing impairment
* Inability to communicate verbally in English
Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants

Preterm infants, less than 37 weeks gestation with respiratory distress syndrome, who remain ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of either a higher level of permissive hypercapnia or of a lower level of permissive hypercapnia to determine if either strategy will increase the number of alive ventilator-free days in the 28 days after randomization.

22.0 to 36.6 weeks gestational age preterm infants with respiratory distress syndrome, who remain ventilated between 7 and 14 days after birth will be randomized to one of two ventilator strategies: 1) a higher level of permissive hypercapnia or 2) a lower level of permissive hypercapnia to determine if either strategy will increase the number of alive ventilator-free days in the 28 days after randomization.

After parental consent obtained, intubated, mechanically ventilated infants will be randomized by use of sequentially numbered sealed opaque envelopes to the treatment assignment. Randomized infants will be stratified by gestational age at delivery (\< 26 weeks, ≥ 26 wks but less than 29 weeks, and ≥ 29 weeks). Multiple births will be randomized to the same group. The envelope will be opened only on days 7-14 when infant meets criteria. Clinicians will follow pre-specified algorithms of extubation and reintubation criteria to wean infants from mechanical ventilation. The ventilation algorithms may be set aside until the infant is deemed stable enough to allow resumption of the study algorithm.

Infant will be extubated within 24 hours of meeting extubation criteria and documented on a single blood gas. A trial of extubation per attending physician is allowed independent of the trial protocol.All other care is per unit standard.

Reports of routine follow-up after discharge in babies \< 27 weeks gestation will be obtained to determine neurodevelopmental impairment on this subset of babies.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age at least 22 but less than 37 weeks;
* Intubated on mechanical ventilation for respiratory distress syndrome on days 7-14 after birth;
* Admitted to Neonatal Intensive Care Unit before 7 days after birth;
* Informed consent per parent(s)

Exclusion Criteria:

* Major malformation
* Neuromuscular condition that affects respiration
* Terminal illness
* Attending physician has made a decision to withhold or limit support for the infant
Accuracy of CNAP PPV Under General Anaesthesia

Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is compared with the gold standard of invasive measurements. Cardiac output is derived by the PICCO monitor.

Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the prediction of fluid responsiveness will be defined.

Accuracy of PPV measured by two devices,PICCO and CNAP, is compared with the manually calculated PPV from the arterial line waveform. Established tests like passive leg raising and end-expiratory occlusion are used for prediction of fluid responsiveness. Intraoperative events like volume challenge are monitored.

Eligibility Criteria:
Inclusion Criteria:

* major surgery
* need for invasive arterial measurements

Exclusion Criteria:

* age under 18
* cardiac dysrhythmia
* vascular pathology at punction site