cyrilzakka/clinical-trials huggingface dataset:
Post Anesthesia Care Unit (PACU) Weighted Blanket Study

This study is being conducted to evaluate the safety and efficacy of weighted blankets to reduce agitation in patients in the post-procedural phase after cardiac catheterization and electrophysiology procedures in the post anesthesia care unit.

The study hypothesizes that compared to the traditional and current post-procedural strategy, weighted blanket use will reduce agitation and therefore lessen the need for additional sedation along with a reduction of post-procedure vascular complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac catheterization or electrophysiology procedure
* Post Procedure bedrest plan for greater than (\>)2 hours
* Duration of recovery planned for 11th floor cardiac PACU

Exclusion Criteria:

* Patients less than (\<) 40 pounds (18 kilogram (kg))
* Patients \> 220 pounds (100 kg)
* Recovery anticipated to not be in our cardiac PACU
* Posttraumatic stress disorder
* Claustrophobia
* Uncontrolled seizure disorders
* Open heart surgery within 30 days
* Severe pulmonary hypertension
* Severe asthma
* Sleep apnea requiring continuous positive airway pressure (CPAP)
* Known diaphragm paresis
* Home vent/CPAP
* Restrictive lung disease (such as patients with scoliosis)
* Higher risk for upper respiratory airway occlusion (such as patients with Down Syndrome)
* Cast, brace or splint, fractures
* Degenerative muscular disorder (such as patients with cerebral palsy)
* Areas of impaired skin integrity
* Gastrostomy tube
* Percutaneous endoscopic gastrostomy
* Tracheostomy
* Chest tube(s)
* PACU procedures required (within 1 hour post arrival): post operative (post op) echocardiogram, post op Xray, post op electrocardiogram
To Evaluate the Safety of DBS in Patients With Primary Parkinson's Disease

To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease

To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease

Eligibility Criteria:
Inclusion Criteria:1. Aged 18-70 years old, patients with primary Parkinson's disease;2. The duration of Parkinson's disease is 5 years or more;3. The stage of Hoehn-Yahr in the "off" (without medication) state is 2 or more stages;4. UPDRS motion score ≥30 in "Off" state;5. Good response to dopamine drugs, acute levodopa experiment UPDRS exercise score improvement rate of more than 30% (experimental drug Medoba 250mg);6. The daily drug shutdown period is at least 6 hours, or there are sports complications such as serious transactions, and repeated adjustments of drugs still cannot be effectively improved;7. MMSE score ≥24 points on the simple intelligent mental state Examination Scale;8. Have the ability of independent external charging operation;9. Patients or their family members can fully understand the treatment and sign informed consent;10. The patient had good compliance and was able to meet the requirements of postoperative follow-up.

Exclusion Criteria:1. Have received surgical treatment for Parkinson's disease other than deep brain stimulation, such as stereotactic destruction, cell transplantation, gamma knife, etc.;2. The "off" state has serious language disorders, dysphagia, balance disorders and other midline symptoms;3. There are contraindications for neurosurgery, such as cerebral infarction, hydrocephalus, cerebral atrophy, ventricle enlargement, cerebrovascular sequelae, heart disease, severe thrombocytopenia and other cardiovascular and cerebrovascular diseases;4. Have other concomitant diseases, have or need to implant a pacemaker, defibrillator, cochlear implant, other neurostimulator, or need to undergo frequent magnetic examinations;5. Patients who are abnormally sensitive to temperature or allergic to heat;6. There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indicators exceeding three times the normal value).7. Patients with anxiety and depression.
Central Meditation and Imagery Therapy for Augmentation of Borderline Personality Disorder Treatment

Borderline personality disorder is a severe psychiatric disorder marked by emotional instability, difficulty with interpersonal relationships, and self-harming behaviors. Despite receiving psychotherapy for borderline personality disorder, studies show that patient recovery is slow, and there is a high rate of self injury and suicide attempts early in treatment. There is thus a clear need to provide therapies to augment psychotherapy. We will conduct a pilot trial to determine whether a 6-week Central Meditation and Imagery Therapy (CMIT) is feasible for subjects with borderline personality disorder to undergo when added on to psychotherapy treatment. CMIT is a non-validated therapy that combines principles of mindfulness with meditation techniques and guided imagery. Sessions led by a trained clinician in a group setting once a week, and participants are asked to complete daily home practice.

The trial will involve 16 participants, all currently undergoing psychotherapy for borderline personality disorder. Participants will be randomly assigned to either a CMIT group that lasts 6 weeks, or a wait list group. Those in the wait list group will be able to receive CMIT after 6 weeks. All participants will continue to receive psychotherapy throughout the trial.

During the trial, we will also obtain preliminary data to help understand whether CMIT may result in psychological benefits for participants. This will include measuring the pulse in order to determine variation in beat to beat intervals of the heart during psychological tests, and filling out questionnaires before and after participation in CMIT.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria for BPD according to DSM-IV criteria
* Meeting the diagnostic criteria for BPD based on the Diagnostic Interview for Borderline - Revised
* Currently receiving psychotherapy.
* English language proficiency to understand written and oral communication

Exclusion Criteria:

* Active suicidality or suicidal intent as identified on the Columbia Suicide Severity Rating Scale
* Suicide attempt within the past month
Study to Evaluate Menses Induction in Women Administered Proellex

The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.

The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cycle and inducing menstruation as happens naturally

Eligibility Criteria:
Inclusion Criteria:

* Clinical laboratory tests within normal ranges
* A normal menstrual period of 26-30 days
* Desiring not to become pregnant
* Agreeing to use a double barrier method of birth control for the duration of the trial

Exclusion Criteria:

* Post-menopausal status
* Aamenorrhea or dysfunctional uterine bleeding
* Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
* Subjects with a Body Mass Index (BMI) below 18 or over 39
the Standardized Training Program for Social Workers

Now, there are few researches on the ability of social workers who work with drug addicts / drug users in China, and the sample size is small and the content is not deep enough.The existing studies suggest that the professional knowledge and ability of social workers who work with drug addicts / drug users are insufficient and the vocational training is not standardized. On the other hand, the ability of social workers who work with drug addicts / drug users workers is related to the effectiveness of anti-drug in communities. So the large sample survey will help to understand the current working status and working ability of social workers who work with drug addicts / drug users in China.The development of the standardized training programs for social workers who work with drug addicts / drug users can improve the professional knowledge and ability of anti-drug social workers, so as to better help community drug rehabilitation personnel and finally reduce the relapse rate.


Eligibility Criteria:
Inclusion Criteria:

- aged between 20 and 65;no gender limitation;those who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

- inability to use online training.
Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)

An Early Access Program for patients with steroid refractory acute GvHD after hematopoietic stem cell transplantation.

This Program is available for female and male who are recipients of allogenic HSCT and who have been newly diagnosed with acute GvHD.

GLASSIA (human alpha-1 proteinase inhibitor (A1PI), also known as human alpha-1 antitrypsin, Kamada-AAT or Kamada-API) is a, liquid, ready-to-use preparation of human A1PI. Alpha-1 proteinase inhibitor belongs to the family of serine proteinase inhibitors and is primarily produced in the liver and secreted into the circulation. In addition to its anti-proteinase activity, A1PI showed to have anti-inflammatory, anti-apoptotic and immunomodulatory properties (1-4).

GLASSIA is an injection solution prepared from human plasma collected from healthy volunteer blood donors in accordance with Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations. GLASSIA was approved in the United States (US) in July 2010 and is indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency).

Eligibility Criteria:
Inclusion Criteria:

* This program is available for patients who suffer from steroid refractory acute GvHD after HSCT, or for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable.
* The disease indication for which the participant required HSCT must be in remission
* Acute graft-versus-host disease (aGvHD), including lower GI involvement (modified
* International Bone Marrow Transplant Registry (IBMTR) Severity Stage 1 to 4 \[\>500 mL diarrhea/day\]), with or without other organ system involvement.
* For women of childbearing potential, had a negative serum or urine pregnancy test within 14 days prior to enrolment.

Exclusion Criteria:

* Participant with manifestations of chronic GvHD
* Participant with acute/chronic GvHD overlap syndrome
* Participant whose GvHD developed after donor lymphocyte infusion
* Participant with severe sepsis involving at least 1 organ failure
* Participant who is seropositive or positive in the nucleic acid test for human immunodeficiency virus (HIV)
* Participant with active hepatitis B or C
* If female, participant is pregnant or lactating at the time of enrollment, or has plans to become pregnant during the program
Risk Factors for the Occurrence of Post Intensive Care Syndrome (PICS)

Monocentric, observational, descriptive RIPH3 study with prospective data collection.

A consultation in the form of a teleconsultation with video conference is proposed to all adult patients who have stayed more than 24 hours in the Rangueil intensive care unit.

This consultation is scheduled and will take place approximately three months after the end of the stay in the intensive care unit.

During this consultation, signs will be sought through questioning to detect or even diagnose the presence of a PICS.

We will also look for elements that will allow us to characterize people with CHIP.

If a PICS was detected during the consultation, the summary letter sent to the attending physician informs him/her of

1. The presence of a CHIP in his patient
2. The nature of this CHIP (CHIP with a purely psychological component, CHIP with a psychological and physical component, etc.) In this same summary letter, the attending physician will be offered a list of specialists practicing at the CHU who are likely to take charge of the patient's CHIP.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* hospitalized in the intensive care unit of Rangueil of the TOULOUSE University Hospital
* length of stay in intensive care equal or superior to 24 hours
* affiliated to a social security system
* having expressed no objection to participate in the study

Exclusion Criteria:

* minor patient
* no consent to the study
* patient not capable of expressing his "non opposition" to the study
* patient under guardianship, curatorship or safeguard of justice
Assessment of a Web-Based Simulation in Transesophageal Echocardiography (TEE) Views

Transesophageal echocardiography (TEE) is often used by anesthesiologists during cardiac surgery, as a monitoring tool in non-cardiac surgery, and as a point of care diagnostic tool in the intensive care unit (ICU). Furthermore, TEE is becoming a core skill in many specialties to facilitate focused cardiovascular assessment in hemodynamically compromised patients in various settings. Educators must determine how to best instruct current and future trainees to achieve clinical competence in TEE within a time limited and constantly expanding medical curriculum.

In this study the investigators will evaluate a new online TEE Simulation module as a learning tool to accelerate and enhance traditional clinical teaching. This project will evaluate a new online TEE Simulation module that replicates the actions required to adjust TEE probe position and the ultrasound plane in relation to a 3D heart model.

The investigators hypothesize that experience with the online TEE simulation module will improve the ability of trainees to independently perform TEE probe manipulations necessary to obtain standard TEE views. The proposed study will answer this question by measuring the performance of trainees in obtaining 10 of the 25 standard TEE views using the Vimedix mannequin-based ultrasonography simulator following an hour of review of the online TEE Simulation module.

The educational benefit of the Web-based TEE simulation module, will be evaluated by 20 novices randomly assigned to two groups, a control group of 10 subjects without exposure to the Web-based simulation, and an experimental group of 10 subjects with exposure to the Web-based simulation. Both groups will be assessed on their performance in attaining the 10 standard TEE views with the Vimedix simulator.


Eligibility Criteria:
Inclusion Criteria:

* Residents or fellows in anesthesia, cardiology and critical care enrolled at the Toronto General Hospital

Exclusion Criteria:

* Residents or fellows in anesthesia, cardiology and critical care with prior experience with TEE probe manipulation
Ephedrine Versus Phenylephrine for Spinal Block - Related Hypotension in Cesarean Delivery

The study is designed to compare two strategies used in the management of hypotension caused by spinal anesthesia for cesarean section: intravenous phenylephrine given as prophylactic infusion and interventional boluses of intravenous ephedrine. Phenylephrine is currently recommended for battling spinal anesthesia - related sympathectomy, due to some scientific data on possible negative effects of ephedrine on fetal wellbeing. Therefore this study will retrospectively compare both clinical and laboratory data of the newborns delivered by cesarean section where either large dose of ephedrine or continuous infusion of phenylephrine was used for management of hypotension

Single - shot spinal block is a gold standard of anesthesia for cesarean delivery. It has been proven to decrease maternal morbidity and improve neonatal outcomes. Despite being most frequently used type of anesthesia in obstetrics, spinal block - related complications remain frequent in term parturients, of which hypotension is of utmost importance. Two widely accepted medications used in its prevention and treatment are phenylephrine and ephedrine, of which continuous, preventive phenylephrine infusion is considered superior in terms of neonatal safety.

Although there is some scientific evidence towards ephedrine having negative effect on neonatal acid - base status, it is still the most popular vasoconstrictor used for management of perioperative hypotension in Poland. It is an indirect adrenergic agonist, acting through release of noradrenaline from peripheral nerve endings. Beta - receptors mediated adrenergic stimulation of neonatal tissues is thought to be responsible for endocrine abnormalities, acid - base disturbances and possibly worse Apgar scores. Phenylephrine on the other hand is a direct and selective alpha-1 agonist and is regarded to exert very little or even no neonatal effects. Maternal complications related to phenylephrine infusion is hypertension and reflex bradycardia.

As convincing evidence is still lacking, this study is designed to retrospectively compare neonatal outcomes and perioperative hemodynamic data of mothers where either infusion of phenylephrine or boluses of ephedrine were used to control spinal -related hypotension during cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Cesarean delivery at term under spinal anesthesia
* American Society of Anesthesiologists (ASA) physical status \<3
* BMI \<40
* Preemptive phenylephrine infusion or ephedrine boluses used during surgical procedure

Exclusion Criteria:

* No vasoconstrictor (phenylephrine nor ephedrine) used throughout the procedure
* Total dose of ephedrine less than 15mg
* poor quality of anesthetic record - data required for analysis not available
Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation

The primary objective of this study is to characterize the impact of inhaled remdesivir (RDV) on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in participants with early stage coronavirus disease 2019 (COVID-19).

This study will have multiple parts: Part A, Part B, and Part C. Part B will be conducted if supported by evaluation in healthy volunteers in another Phase 1a Gilead study (GS-US-553-9018). Participants in Part C will be enrolled after review of preliminary safety and available efficacy data from Parts A and B through at least Day 7.

GS-US-553-9018 is a Phase 1a randomized, blinded, placebo-controlled, single- and multiple-dose study in healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of remdesivir administered by inhalation.

Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
* SARS-CoV-2 infection first confirmed by polymerase chain reaction (PCR) (Parts A and B) or by nucleic acid testing or direct antigen testing (Part C) with sample collected ≤ 4 days prior to randomization
* COVID-19 symptom onset ≤ 7 days prior to randomization
* Oxygen saturation as measured by pulse oximetry (SpO2) \> 94% on room air

Key Exclusion Criteria:

* Ongoing or prior participation in any other clinical trial of an experimental vaccine or treatment for COVID-19
* Prior or current hospitalization for COVID-19 or need for hospitalization
* Treatment of COVID-19 with other agents with actual or possible direct antiviral activity against SARS-CoV-2 including intravenous (IV) RDV or administration of any SARS-CoV-2 (or COVID-19) vaccine

  * Participants chronically administered chloroquine or hydroxychloroquine for any reason are to be excluded
* Requiring oxygen supplementation
* Positive pregnancy test
* Breastfeeding female
* Known hypersensitivity to the study treatment, its metabolites, or formulation excipient
* Pre-existing pulmonary conditions such as chronic obstructive pulmonary disease or asthma (Parts A and B only)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement

The aim of this study was to assess the efficacy of minimally invasive nonsurgical debridement (MINSD) of periodontal pockets with or without local amino acid buffered sodium hypochlorite (NaOCl) gel application after 6 months follow-up.

Forty periodontal compromised patients were randomly allocated in two groups. Periodontal pockets \> 5 mm in patients of test group were treated by MINSD and NaOCl gel application, meanwhile in patients of control group MINSD alone was performed. Full-mouth plaque score (FMPS) , Full-mouth bleeding score (FMBS), probing depth (PD), clinical attachment level (CAL) and gingival recession (GR) were assessed at baseline and after 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with periodontitis;
* Age \> 18 years old;
* Patients with at least 10 teeth for arch;
* Presence at least of two teeth with PD \> 5 mm for quadrant;
* Single-rooted and multi-rooted teeth;

Exclusion Criteria:

* Patients with systemic diseases;
* Pregnant or lactating;
* Tobacco smokers (\> 10 cigarettes/day);
* Previous periodontal treatment in the last 2 years;
* Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy;
* Furcation involvement;
* Acute periodontal or endodontic abscess;
* Third molars
Relationship Between Macular Thickness Measurement and Signal Strength in Optical Coherence Tomography

Signal strength is a parameter introduced in analysis software version 4.0.1, of the OCT stratus, that combines SNR and uniformity of the signal within a scan The scale of signal strength ranges from 1 to 10, with 1 representing poor image quality and 10 representing excellent image quality It has been showed that signal strength has a better image quality discriminating ability than SNR The operation manual recommends a minimum signal strength of 5 for macular thickness measurement There is no consensus on the level of signal strength above which should be considered to be good quality The inclusion Criteria for acceptable signal strength varies widely in the literature the purpose of our study is to examine the relationship between signal strength and macular thickness measured by stratus OCT


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects in this study other than refractive error, all included eyes had no concurrent ocular pathologic features BCVA of at least 20/30, and had spherical refractive error within the range of
* 4.00 D to 4.00 D

Exclusion Criteria:

-