cyrilzakka/clinical-trials huggingface dataset:
Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome Caused by COVID-19

For the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS.

The primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).

Many studies have showed that ARDS survivors keep, even a long time after hospitalization, a functional respiratory disability, resulting on one hand from impaired diffusion of carbon monoxide, and on the other hand from a muscular weakness. Indeed, 67% of patients ventilated more than 10 days have a neuromyopathy whose recovery is uncertain.

Beside this, Long-term quality of life is worse than in general population, due in particular to depressive and anxiety disorders such as post-traumatic syndrome disorder with a prevalence around 22% after one year.

The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* hospitalized in intensive care of the CHU anesthesia-intensive care unit (Rangueil, URM, Neurosurgery)
* intubated and ventilated
* supported for an ARDS according to the Berlin criteria (PaO2 / FiO2 ratio \<300 mmHg)
* with an rt-PCR positive to SARS-CoV-2
* affiliated to the french social security

Exclusion Criteria:

* minor patient
* patient under protective measure
* ARDS in the pandemic context but rt-PCR negative to SARS-CoV-2
A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression

To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of DSM-IV Major Depressive Disorder, single episode or recurrent, without psychotic features. Additional DSM-IV Axis I diagnoses will be permitted only if they are identified as secondary diagnoses.
* Hamilton-Depression rating scale (HAM-D; 17 item) total score ≥18 and HAMD item 1 (depressed mood) score ≥2.

Exclusion Criteria:

* Use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
* Current or past diagnosis of bipolar disorder or any psychotic disorder.
Evolution of Physical Activity, Sedentary Behavior and Associated Motivations After Rehabilitation for Chronic Low Back Pain Patients

IIn 2016, chronic low back pain (CLBP) was the leading cause of years lived with disability worldwide. This condition impacts social interactions, work life, and can lead to an altered quality of life for patients.

For these patients, physical activity (PA) can reduce pain, improve function and the rate of return to work. According to the French National Authority for Health, it is the main treatment in the management of these patients. Nevertheless, the literature reports PA levels that are relatively comparable to those of the general population. Considering that a large proportion of adults struggle to meet these thresholds, we can infer that the same is true for CLBP patients. In addition to PA, the World Health Organization recommends that all adults should limit the amount of time spent in sedentary behaviors. Thus, CLBP patients should adopt an active lifestyle, characterized by regular PA and limited sedentary behaviors (SB).

In view of these elements, it is essential to implement dedicated interventions. The literature reports mixed results with work focused on PA promotion. No study has focused on i) the reduction of CS, ii) the rehabilitation programs (RP) proposed in France.

On the other hand, there is a need to better understand what determines engagement in such behaviors. Among these determinants are several psychological variables related to behavioral intentions. A recent line of research indicates that beyond these motivational dimensions, which are explicit in nature, certain implicit processes are significantly associated with the adoption or non-adoption of certain health-related behaviors. This result has been observed in the context of chronic disease (respiratory patients, metabolic patients) but remains unexplored in patients with chronic low back pain.

The aim of this study is to simultaneously question these different aspects: the effects of a RP on changes in PA and CS, in relation to motivational changes in a population of CLBP patients.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to a rehabilitation program,
* Presenting chronic low back pain (i.e., \> 3 months),
* Age \> 18 years,
* Literacy.

Exclusion Criteria:

* Inability or refusal to answer a questionnaire,
* Protected adults,
* Participation in another study
* Withdrawal of consent,
* If deemed necessary by the principal investigator for the welfare and/or safety of the participant,
* In the event of an occurrence of a non-inclusion criterion.
Southeastern Diabetes Initiative Clinical Intervention

The purpose of the Southeastern Diabetes Initiative Clinical Intervention is to augment existing standard of care in an effort to (1) improve population level diabetes management, health outcomes and quality of life for diagnosed and undiagnosed adults living with Type 2 Diabetes Mellitus, (2) reduce disparities in diabetes management, health outcomes and quality of life for adults living with Type 2 Diabetes Mellitus, and (3) reduce healthcare costs associated with Type 2 Diabetes Mellitus.

Clinical care will be delivered by a multidisciplinary team including (but not limited to) an physician, nurse practitioner, dietician, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker. Care will be delivered in community settings including home visits and community based clinics. With the exception of specific surveys (listed in the Study Intervention section) all data are being collected for the purpose of delivery of standard preventive care and clinical care. The population group will include patients diagnosed with Type 2 Diabetes Mellitus in four Southern United States counties, meeting certain inclusion criteria, and deemed "high risk" as determined by a set of standard criteria or a risk algorithm run on secondary data.

The investigators plan to characterize patients diagnosed or at risk for diabetes mellitus, and allow more detailed knowledge of their health than is provided by standard public health data. The investigators will use descriptive, parametric and non-parametric statistics to describe baseline characteristics (demographics and clinical measures of disease severity) of the sample and will compare responders and dropouts on independent and dependent variables, report any significant differences, and include this in the interpretation of results.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>=18yrs
* Diagnosis of Type 2 diabetes
* Reside in Durham County, NC, Cabarrus County, NC, Quitman County, MS or Mingo County, WV or the neighboring areas and receive the majority of their healthcare in the four listed counties.
* Have capacity to give consent (or have a surrogate legally authorized representative or caregiver provide consent on their behalf).
* Defined as high risk by the risk algorithm or their primary care clinician.
* Referral from the primary care clinician or patient's medical home if one has been designated.

Exclusion Criteria:

* Lack capacity to make decisions and do not have a surrogate with authority to make health care decisions.
* Have a terminal illness with a life expectancy of 6 months or less
* Diagnosis of Type 1 diabetes or gestational diabetes
* Currently pregnant (confirmed via self-report and/or medical record)
Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients

Calcium is a life saving medicine in the care of parturients. It has many important uses including treatment of hypocalcemia, treatment of magnesium toxicity, prevention of hypocalcemia during blood transfusion (of citrate containing blood products), treatment of hyperkalemia, and others. Recent clinical trials also suggest that calcium given after cord clamping may decrease blood loss in patients undergoing cesarean delivery. 2 FDA approved forms of calcium can be given intravenously: calcium chloride and calcium gluconate. Over the last decade there have been times with drug shortages of either calcium chloride or calcium gluconate. So there have been and likely will continue to be times when one formulation or the other may not be adequately available. Despite the importance of calcium and the frequency in which it is used in parturients, there are no published studies in parturients to determine dose equivalence between calcium gluconate and calcium chloride. In this study the investigators will determine the population pharmacokinetics of calcium gluconate and calcium chloride in parturients and calculate the dose equivalent ratio the two drugs. This will help clinicians select appropriate doses of calcium and provide resilience to the drug supply chain in our era of frequent drug shortages.


Eligibility Criteria:
Inclusion Criteria:

Pregnant female subjects delivering at the study institution via scheduled cesarean delivery at term (\>=37 weeks gestation)

Exclusion Criteria:

1. severe range blood pressure (BP \>160/\>110) within the 48 hours prior to delivery
2. patient age \<18 years or \>45 years
3. renal dysfunction with serum Cr \> 1.0 mg/dL
4. known history of congenital or acquired cardiac disease or history of arrhythmia
5. patient taking digoxin
6. patient currently taking a calcium channel blocker
7. Weight \<55kg or \>100kg, or
8. receiving magnesium infusion within 24 hours prior to or during cesarean delivery
9. administration of intraoperative doses of calcium by the anesthesiology team for clinical indications
The ONCOCAMP Study

The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study.

The ROC platform therefore represents a multicenter database and a growing source of data and information regarding cancer patients in the Campania region. The need for multicenter databases is supported by the results obtained with both retrospective and prospective studies. Many retrospective studies have led to changes in some of the available guidelines. Important advantages of this study include representativeness of the analyzed cohort to all patients with a specific cancer and a large sample size that provides sufficient statistical power to detect differences across different patient groups. The data extracted from the ROC have the potential to produce knowledge, to guide decision-making, and to manage more effectively the challenges of fighting cancer in our region. The Campania region counts more than 6 million people, and it is characterized by a worst oncological outcome compared to the average data of other Italian region: the ROC platform has the potential to analyze the effect of a public intervention in the field of oncology care. Therefore, the primary aim of this study is to create a retrospective-prospective registry of all cancer patients entering the ROC platform and in a GOM path describing the primary and secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* registration in the ROC platform
Lung Protective Ventilation During Pulmonary Lobectomy in Children

The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in pediatric patients. The hypothesis is that application of low tidal volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in children.


Eligibility Criteria:
Inclusion Criteria:

* Children who are scheduled for lung lobectomy under general anesthesia
* ASA physical status I, II

Exclusion Criteria:

* History of airway or pulmonary interstitial disease
* Active URI
* Systemic inflammatory response disease
* cardiac disease
Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale

"Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale" is crucial in determining the specific functional status of the shoulder joint, especially for overhead athletes experiencing shoulder pain, to identify which sporting activities restrict them the most and to fill the gap in the literature. Additionally, visually indicating activities through photographs will provide visual feedback, making it easier to assess functional status. Our study aims to develop a specific functional survey for the shoulder joint in overhead athletes, examine the validity and reliability of this scale, and contribute to the literature.

Developing a valid and reliable visual assessment scale specifically targeting shoulder pain in overhead athletes with shoulder pain, aiming to evaluate shoulder pain in a specific and functional manner, and investigating its psychometric properties.The research will be conducted at Hacettepe University Faculty of Physical Therapy and Rehabilitation, Athlete Health Unit. The research will be conducted according to the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines. COSMIN guidelines recommend a minimum of 100 participants for reliability, measurement error, and validity assessments. Therefore, the study plans to include at least 100 individuals who apply to the Athlete Health Unit at Hacettepe University Faculty of Physical Therapy and Rehabilitation. The data collection for this planned study will be solely through surveys. The design of the study is a cross-sectional study aimed at developing and assessing the validity and reliability of the "Avoidance of Sports Activities Photo Scale." Surveys specific to the research will be implemented in the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female athletes aged between 18-35,
* Engaged professionally in sports involving overhead activities for at least 3 years (volleyball, basketball, swimming, badminton, water polo, tennis, American football, handball, etc.),
* Actively participating in competitions for at least 1 year,
* Experiencing current traumatic or non-traumatic pain, or having a history of shoulder pain, or having chronic shoulder pain,
* Native Turkish speakers.

Exclusion Criteria:

* Neurological and/or rheumatological disease,
* Active local or systemic infection,
* History of cancer,
* Severe visual impairment.
Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals

The aim of this study is to examine the effectiveness of two mindfulness interventions for stress, anxiety and burnout in mental health professionals. Participants will receive the treatments in reverse order: a brief intervention based on body-centered exercises and another brief intervention based on sitting meditation. It is hypothesized that both interventions will decrease stress and anxiety levels and professional burnout, with mindfulness body-centered exercises being at least as effective as mindfulness meditations.

The aim of this study is to examine the effectiveness of two mindfulness interventions for stress, anxiety and burnout in mental health professionals. It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA. Treatment A consists of a block of five sessions of bodyfulness exercises, whereas experimental treatment B consists of a block of five sessions of sitting mindfulness meditation exercises. In the sixth session, the exercise blocks will be exchanged. Each group will be composed of half the sample, with a initial sample of 130. The principal hypothesis is that both interventions will decrease stress and anxiety levels and professional burnout, with body-centered exercises being at least as effective as mindfulness sitting meditations. Secondarily, the personality type will be analyzed as a moderating variable in those variables in which the interventions will be effective. Third, a qualitative study will be conducted in order to analyze the perceptions of change and experiences in Cuban mental health professionals who are beginner meditators. This study will allow to understand the differential effectiveness of bodyfulness and midfulness and what types of personality may benefit most from different types of meditation interventions. Also, it will hell to get a deeper understanding of mindfulness practice in a new cultural context (i.e., Cuba). A previous pilot study will be conduct to investigate the acceptability and effectiveness of a culturally-adapted mindfulness-based intervention in Cuba.

Eligibility Criteria:
Inclusion Criteria:

* To be a full time mental health professional
* To be 18 years or older
* To be able to attend weekly sessions

Exclusion Criteria:

* To suffer a pathology that discourages participation in the study.
* Previous training in mindfulness
COVID-19 With Convalescent Plasma

To clarify the effects of convalescent plasma therapy on SARS-CoV-2 negative conversion rate during hospital stay and 28-day mortality of severe and life-threatening COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years of age;
2. laboratory-confirmed diagnosis of COVID-19;
3. respiratory failure requiring advanced respiratory support (i.e. high flow nasal cannula\[HFNC\], noninvasive mechanical ventilation \[NIV\], and invasive mechanical ventilation \[IMV\]).

Exclusion Criteria:

* no
Kineret CAPS Post Authorisation Study

A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent by the patient and/or caregiver
* Kineret treatment will be according to the Summary of Product Characteristics (SmPC), as confirmed by the Investigator

Exclusion Criteria:

* None
Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia

This study aims to determine the optimal dose of alfentanil in suppressing the airway reflexes during supreme LMA removal in anaesthetized adult.

The removal of LMA may be associated with coughing, biting, agitation and airway complication such as laryngospasm. Thus it is advisable to remove the LMA when the patient is breathing spontaneously and when the airway reflexes are still depressed. A number of techniques have been used to prevent this adverse emergence phenomenon, such as removing the tube while the patient is in deep plane of anaesthesia or administration of local anaesthetic and intravenous opioids

The administration of intravenous opioids before emergence may be useful for preventing cough, agitation and hemodynamic response. Alfentanyl is proven to suppress cough and agitation during the endotracheal tube emergence. However, its use in suppressing cough in LMA patient has not been evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. ASA I and II patients
2. Age 18 to 49 years old
3. Minor elective day care surgery (\> 20 minute and less than 2 hours) which require local anaesthetic infiltration and does not require use of long acting opioids.

Exclusion Criteria:

1. Potential difficult airway
2. Reactive airway disease or sign and symptoms of upper respiratory tract infection.
3. History of cardiac, pulmonary and renal diseases
4. Body Mass Index \> 30 kgm2.
5. Risk of aspiration.
6. Poor dentition with high risk of damage.
7. Patient refusal.
Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH

To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks \[Q4W\]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy

Patients with verified HoFH on stable and continuing doses of oral lipid lowering therapy will be randomized to either evolocumab 420 mg Q4W or LIB003 300 mg Q4W for 24 weeks (Period A). At Week 24, subjects will be crossed over to LIB003 if they were on evolocumab and vice versa for the next 24 weeks (Period B).

Eligibility Criteria:
Inclusion Criteria:

* HoFH diagnosed clinically and confirmed by genotyping
* Weight of \>30 kg and body mass index (BMI) \>17 and \<40 kg/m2
* stable diet and lipid-lowering oral therapies for at least 4 weeks

Exclusion Criteria:

* mipomersen within 6 months of screening;
* LDL or plasma apheresis \<2 months prior to randomization
* history of non-response to PCSK9 mAb or presence of receptor negative/null LDLR activity expected to result in non-response to PCSK9 inhibition
* prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion
Delayed Dinner, Exercise and Glucose Metabolism

This study aims to investigate whether exercise can alleviate the impact of delayed dinner on metabolic health next morning in sedentary healthy adults


Eligibility Criteria:
Inclusion Criteria:

* Physical inactive males
* Weight stable for more than 3 months (no change in weight +/- 3%)
* Non-smoker
* Able to walk comfortably on a treadmill
* Dinner consumers with normal sleep pattern (cycles)

Exclusion Criteria:

* Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
* Taking medications that may influence lipid or carbohydrate metabolism or immune system function
* Unable to take part in exercise for any reason (e.g., injury or disability) or a positive response to any questions on the Physical Activity Readiness questionnaire (PAR-Q)
A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®

The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency.

The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly infusion to patients with primary antibody deficiency.


Eligibility Criteria:
Inclusion Criteria:

* The main criteria for inclusion in the study were as follows:

  * A diagnosis of primary antibody deficiency;
  * No lower or upper age limit (any age was eligible);
  * With stable disease and receiving immunoglobulin (IVIG or SCIG) therapy for at least six months prior to starting the study;
  * Written informed consent (patient/parent/guardian).

Exclusion Criteria:

-