cyrilzakka/clinical-trials huggingface dataset:
Respiration Rate V2.0 in a Hospital Setting

The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device) in a hospitalized volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR)(CO2).

Volunteer subjects from a hospital setting (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, and are without any contact skin allergies to adhesives found in standard pulse oximetry sensors. A cross section of demographics - cardiovascular, respiratory, and metabolic type cases should be considered for a broad distribution of medical and surgical patients.

The study consists of measuring parameters related to respiration in hospitalized volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The production-equivalent Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* 18 years or older.
* A patient at the study site on a General Care Floor or General Surgery Care Floor.
* Subject is willing and able to provide written consent.

Exclusion Criteria:

* Subject is younger than 18.
* Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
* Subject has an abnormality that may prevent proper application of the device.
* Subject is in atrial fibrillation.
* Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.
* Subject has an implanted pacemaker.
* Subject is unwilling or unable to sign informed consent.
P6 Acupressure Before Laparoscopic Cholecystectomy

This study is to evaluate the effect of preoperative acupressure application on Postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy in terms of being in high risk group for PONV.

Prevention of postoperative complications is one of the main tasks of nurses. However, there are limited nursing interventions that can be done to prevent PONV. The American Society of PeriAnesthesia Nurses suggest nurses to teach patients with a high risk of PONV about acupressure application on P6 acupoint or to apply acupressure wristbands preoperatively. However this suggestion has a low evidence.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing elective laparoscopic cholecystectomy
* Patients who make their admission the day before surgery
* Patients with American Society of Anesthesiologists (ASA) physical status classification system I and II
* Patient who gave written consent to participate in the study

Exclusion Criteria:

* Patient who undergone urgent laparoscopic cholecystectomy
* Patients who make their admission on the day of surgery
* Patients with who do not conform physical status of ASA I and II
* Patients who loss single or both upper extremity
* Patients with open wounds, scar tissue or infection on wrist in acupressure application area
Octreotide and Doxorubicin in Treating Patients With Advanced Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Octreotide may help doxorubicin kill more cancer cells by making tumor cells more sensitive to the drug.

PURPOSE: Phase I trial to study the effectiveness of octreotide and doxorubicin in treating patients who have advanced cancer.

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of octreotide administered with doxorubicin in patients with advanced cancer. II. Determine the pharmacokinetics and pharmacodynamics of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of octreotide. Patients receive doxorubicin IV over 5 minutes on day 1 of course 1. For all subsequent courses, patients receive octreotide SC continuously on days 1-7 and doxorubicin IV over 5 minutes on day 5. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease after 3 courses of therapy receive a maximum of 6 additional courses. Cohorts of 3-6 patients receive escalating doses of octreotide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 21-30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed malignancy ineligible for therapy of proven greater benefit than doxorubicin alone Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL SGOT no greater than 4 times normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: LVEF at least 50% No compensated or uncompensated congestive heart failure Other: Not pregnant Fertile patients must use effective contraception during and for 2 months after study No history of gallstones with gallbladder in place

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered No more than 240 mg/m2 total cumulative dose of prior doxorubicin Endocrine therapy: Prior octreotide allowed Recovered from prior octreotide Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified
Central and Peripheral Blood Pressure in Treatment of Obstructive Sleep Apnea.

The purpose of this study is to examine the effect on blood pressure of 3 months of treatment with continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA).

Hypothesis:

1. Central 24-h blood pressure (BP) monitoring hedges day fluctuations in blood pressure more accurately than peripheral 24-h BP monitoring, because the measurement is painless and does not interfere with the patient / subject's activities during the daytime or nighttime sleep.
2. Blood pressure is elevated in patients with OSA and falls during treatment with CPAP.

3. The renal treatment of salt and water is abnormal in OSA, improved during treatment with CPAP.

4. Quality of life improves during treatment with CPAP

Approximately 20 patients with hypertension and moderate to severe OSA are treated with CPAP 3 months to examine the treatment effect on blood pressure throughout the day, but especially nocturnal, renal treatment of salt and water, and quality of life.

Before and after 3 months of CPAP treatment is made central and peripheral 24-h ambulatory blood pressure monitoring, 24-h urine collection and blood samples.

Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease (CKD stage I and II), eGFR 60-90 ml/min/1.73 m2 or eGFR\> 90 ml/min/1.73 m2 and proteinuria or other signs of kidney damage.
* Obstructive sleep apnea, apnea hypopnea index (AHI) \> 15 (moderate to severe)
* Both men and women
* 55-70 years
* Signed consent form

Exclusion Criteria:

* Lack of desire to participate
* Malignant disease
* Abuse of drugs or alcohol
* Pregnant and breastfeeding
* Incompensated heart failure
* Atrial fibrillation
* Liver disease (Alanine aminotransferase (ALT) \> 200)
* Severe chronic obstructive pulmonary disease (Forced expiratory volume in 1 second \<50% predicted)
* Blood pressure difference between the right and left arm\> 10/10 mmHg
Continuous Passive Motion Versus Heterotopic Ossification

The investigators hypothesize that Heterotopic Ossification (HO) formation can be suppressed if the application of a Continuous Passive Motion (CPM) device can be performed for a substantial amount of time. The investigators will use the following study design: a pilot study with 10 ICU patients receiving CPM and 10 matched cases which will follow a conventional physiotherapy program at the time of the conduction of the study. The comparison between the treatment and referent groups of the outcomes will prove the prophylactic power of CPM against HO.

The aim of this study is to formally evaluate whether the investigators can indeed prevent HO by the timely and painless use of CPM in neurogenic intensive care unit (ICU) patients with stabilized medical conditions, suffering from neurological insults either traumatic brain injury (TBI), stroke, or Spinal Cord Injury (SCI). The investigators hypothesize that HO formation can be suppressed if CPM can be performed for a substantial amount of time. The investigators will perform a pilot study with 10 ICU patients receiving CPM and 10 matched cases which will follow a conventional physiotherapy program at the time of the conduction of the study. The primary outcomes will be the CT appearance of HO in the hip or knee joint and the degree of ROM limitation in the given joint at baseline and at the end of the clinical trial. A secondary outcome that will be measured, will be the Glasgow Coma Scale (GCS) at the beginning and at the end of the CPM program. The comparison between the treatment and referent groups in terms of these outcomes will prove the prophylactic power of CPM against HO.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury.
2. A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT)
3. A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.)
4. Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion.

Exclusion Criteria:

1. Life-threatening conditions that render Continuous passive motion (CPM) application difficult.
2. HO detected in another location than the hip or knee joint.
3. Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level.
4. Patients not reacting to painful stimuli
Telemonitoring of CPAP Therapy in Sleep Apnea Patients

Wireless telemonitoring is compared with regular nursing procedure in terms of patient satisfaction, adherence to continuous positive pressure (CPAP) treatment and nursing time during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS).

Both patients and study nurses were unblinded for the wireless telemonitoring system (ResTraxx™Online, ResMed, Sydney, Australia). The module was attached to the S9 Elite™ (ResMed, Sydney, Australia) CPAP device, which transmitted compliance data every day automatically to the ResTraxx™ Online (ResMed, Sydney, Australia) data base. The treatment was considered successful when CPAP use was \>4 h/day, mask leak \<0.4 L/s, and AHI \<5/h during the last 6 days. Study nurses made the data check-ups daily during weekdays and if the criteria for successful CPAP therapy was not achieved during two consecutive nights the nurses adjusted the CPAP pressure remotely and called the patient to give further advice. Patients had also a control viist aftr one year.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with diagnosed obstructive sleep apnea

Exclusion Criteria:

* Not able to understand Finnish language
* Unable to co-operate
Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children

The study is designed to clarify the clinical characteristics, risk factors and long-term prognosis of children with 2019-nCoV infection in China.

As of February 10th, 2020, more than 40,000 human have been confirmed infected with a novel coronavirus (2019-nCoV) in China, with at least 800 reported deaths. Additional cases have been confirmed in multiple countries, and some are reported in children. Patients with confirmed 2019-nCoV infection have reported respiratory illness with fever, cough, et al. Some are asymptomatic carriers. However, there are relatively few diagnosed cases of children, and the long-term prognosis is unknown. Therefore, a multicenter observational study is needed to better understand the clinical characteristics of 2019-nCoV infection in children.

This observational study will last from February to December 2020. The patients enrolled were diagnosed with 2019-nCoV infection or 2019-nCoV pneumonia by Beijing Children's Hospital and other members of Chinese National Clinical Research Center for Respiratory Diseases in 2019-2020. At the same time, children hospitalized with pneumonia other than 2019-nCoV pneumonia during the same period are classified as the control group by 3\~5:1 matching for age and sex to the 2019-nCoV group. After guardians signing the informed consent forms, all the participants' clinical data, laboratory examination results, image data and also the follow-up information after six months of their treatment will be collected.

The trial will be completed in 10 months, with subjects recruited from the hospitals that in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases.

Eligibility Criteria:
1. For the 2019-nCoV infection group

   Inclusion Criteria:

   Diagnosed with 2019-nCoV infection (with direct laboratory evidence).
   1. Respiratory or blood samples tested positive for novel coronavirus nucleic acid with RT-PCR.
   2. Gene sequencing of respiratory or blood samples show highly homologous with known novel coronaviruses.

   Exclusion Criteria:

   Subjects will be excluded if the children or their parents disagree to conduct this study.
2. For the control group

Inclusion Criteria:

1. Diagnosed with pneumonia, and excepted of novel coronavirus infection.
2. The hospitalization time is the same as that of novel coronavirus pneumonia.

Exclusion Criteria:

Subject will be excluded if she or he has one of the following:

1. First diagnosis is not pneumonia.
2. Any one of the novel coronavirus laboratory test results show positive.
3. Children or their parents disagree to conduct this study.
Cannabidiol and Emotional Stimuli

The purpose of this research is to examine the effect of cannabidiol (CBD), a cannabinoid compound found in marijuana, on responses to emotional stimuli. Both preclinical and clinical studies indicate that CBD may act to reduce anxiety without excessive sedative side-effects. Thus the investigators hypothesize that CBD may reduce responses specifically to negative emotional and social stimuli, including pictures and emotional faces, without altering responses to positive stimuli. To examine this, the investigators will administer placebo, 300mg, 600mg, and 900mg CBD to healthy normal adults in a double-blind within-subjects study. The investigators will measure subjective and subtle physical responses to positive and negative stimuli using measures that have been characterized with classic anxiety-reducing drugs and drugs of abuse. Further, the investigators will examine whether CBD-induced changes in these measures of emotional response relate to changes in actual behavior in a controlled social interaction. These results will allow the investigators to examine the potential usefulness of CBD as an anxiety-reducing drug, and suggest mechanisms by which CBD may reduce anxiety.


Eligibility Criteria:
Inclusion Criteria:

* 18-35 years of age.
* 38 healthy volunteers (19 male, 19 female; age range 18-35 years)
* All participants recruited without regard to race, religion or ethnicity through posters, advertisements and word-of-mouth referrals.
* Candidates screened in accordance with our general screening protocol, approved by the IRB under Protocol #13681B, which includes a physical, EKG, psychiatric screening interview and detailed drug use history questionnaire.

Exclusion Criteria:

* Individuals with a medical condition contraindicating study participation, as determined by the study site physician.
* Individuals regularly using any medications aside from hormonal contraception in women.
* Individuals with a current (active in the past year) DSM-IV Axis I mood, anxiety, eating, or substance dependence disorder or a lifetime history of a psychotic disorder or mania.
* Women who are pregnant, nursing, or planning to become pregnant in the next 3 months
* Participants reporting a known or suspected allergy to cannabinoids.
* The self-report questionnaires the investigators use require fluency in English, and have not been translated and validated in other languages, thus individuals with less than a high-school education or those not fluent in English were excluded, as lack of English familiarity at a high school level may compromise our ability to interpret their self-reports.
* Individuals with a BMI below 19 or above 30, as this would change dosing requirements.
* Individuals who report using marijuana \>100 times in their lifetime, to reduce variation in possible developed tolerance to CBD.
Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy

Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank


Eligibility Criteria:
Inclusion Criteria:

patients with esophageal cancer

Exclusion Criteria:

(1) pathology confirmed a non-squamous cell carcinoma, (2) the tumor was located outside of the thoracic region, (3) R1/R2 resection was performed indicating incomplete tumor removal, (4) evidence of distant tumor metastasis was observed, (5) they underwent preoperative neoadjuvant therapy, (6) pTis/T1a stage (7) Missing data.
Comparing Antipsychotic Medications in LBD Over Time

The primary objective of this study is to determine whether treatment with pimavanserin or quetiapine is associated with a greater improvement in psychosis when used in a routine clinical setting to treat hallucinations and/or delusions due to Parkinson's disease (PD) or dementia with Lewy bodies (DLB) - collectively referred to as Lewy body disease (LBD).

Psychosis (hallucinations and delusions) is a common problem in Parkinson's disease (PD) and dementia with Lewy bodies (DLB). PD is a common neurodegenerative disorder that causes movement, cognitive, and psychiatric symptoms. DLB is a similar disorder, though causes more severe cognitive and psychiatric problems. Psychosis is highly prevalent among people with PD and DLB, often manifesting as visual hallucinations or paranoid delusions. Up to 60% of people with PD will experience psychosis over the course of their disease. Psychosis is associated with increased mortality, caregiver burden, and poorer quality of life.

More study is needed to determine the best way to treat psychosis in PD and DLB. Currently, both quetiapine and pimavanserin are used in clinical practice for psychosis in PD and DLB. However, few comparison studies have been done and it is unclear if one medication is superior to the other. This will be a clinical trial comparing quetiapine and pimavanserin among patients with psychosis due to PD or DLB requiring initiation of a medication. Patients will be randomized to quetiapine or pimavanserin and improvement in psychosis at 6 months will be compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen in the neurology clinic at UT Health San Antonio
* Diagnosed with psychosis due to PD or DLB
* Requiring initiation of an antipsychotic medication
* Clinical equipoise between quetiapine and pimavanserin must exist
* The prescribing provider must be comfortable prescribing and managing both quetiapine and pimavanserin

Exclusion Criteria:

* Medical contraindication to either medication
* Caregiver unavailable to complete NPI-Q
* Currently taking an antipsychotic medication
* Prescribing provider unwilling to manage either medication
Child-Parent Psychotherapy for Preschooler Witnesses of Domestic Violence Program

This study will examine the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence.

This study examines the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence. Multi-ethnic preschool-mother dyads from diverse socioeconomic backgrounds were randomly assigned to CPP or to a case management plus community referral for individual treatment comparison group. It was hypothesized the children who received CPP treatment would show significantly greater improvement in general symptomatology and in traumatic stress symptoms than those in the comparison group.

There is growing recognition that, contrary to the long-standing assumption that young children are impervious to environmental stresses, preschoolers exposed to violence show increased rates of disturbances in self-regulation and in emotional, social and cognitive functioning (Osofsky, 2004; Pynoos et al., 1999; van der Kolk, 2003). The present study examines the efficacy of a relationship-based treatment approach involving the child and the mother. Dyads were randomly assigned to either the Child-Parent Psychotherapy (CPP) treatment group or to a comparison group that consisted of monthly case management by an experienced Ph.D.-level clinician plus referrals for individual treatment in the community for mothers and child. We hypothesized that Child-Parent Psychotherapy would be more effective in alleviating children's traumatic stress symptoms and behavior problems because it focuses on improving the quality of the child-mother relationship and engages the mother as the child's ally in coping with the trauma. Treatment was offered for 50 weeks.

Eligibility Criteria:
Inclusion Criteria:

* child 3-5 years old
* child exposed to marital violence as confirmed by mother's report on the Conflict Tactics Scale 2 (Straus et al., 1996)
* perpetrator was not living in the home.

Exclusion Criteria:

* mother's documented abuse of the target child
* current maternal substance abuse
* homelessness
* maternal mental retardation
* maternal psychosis
* child mental retardation or autistic-spectrum disorder
The Effects of ECMO on the Pharmacokinetics of Hydromorphone

The purpose of this study was to establish a population pharmacokinetic (PPK) model of hydromorphone in patients under ECMO, and to recommend a dosing regimen when the target effective concentration was reached.

A population pharmacokinetic (PPK) model of hydromorphone in patients under ECMO was established. The patients were given hydromorphone 0.03mg/kg/h by continuous intravenous infusion for 72 hours for analgesia. Blood samples were collected at different time points before and after administration, and quantitative liquid chromatography tandem mass spectrometry was used to detect hydromorphone and its main metabolite, hydromorphone-3-glucuronide.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 80;
* Using hydromorphone for pain relief;
* Using ECMO for more than 96h

Exclusion Criteria:

* Allergic to hydromorphone;
* Use of CRRT during ECMO;
* Liver function Child-Pugh B, C grade;
* Pregnancy;
* Intestinal obstruction;
* Refused to sign the informed consent.