cyrilzakka/clinical-trials huggingface dataset:
Home Telemonitoring in Patients at High Risk for Readmission

This study will evaluate the efficacy of home telemonitoring as an intervention to decrease hospital readmissions in patients at high risk for readmission. The overall readmission rate for high-risk MCF hospital patients is approximately 20%. Currently a system is in place to identify and score all MCF patients for their risk of readmission. This score is based on multiple variables including but not limited to: co-morbid conditions, patient's health literacy, whether they are a Medicare/Medicaid patient, their in-home social support, and whether they have had prior hospital admissions within the previous year. The literature shows that home telemonitoring of patients has had mixed results for effectiveness at preventing hospitalizations and emergency department visits. Many of these reports have restricted studies to patients with specific diseases or general characteristics; some have shown improved results while others have not. No study has examined patients who are high risk for readmission to determine if home telemonitoring for 30 days post-discharge reduces the risk for 30-day readmission.

We hope to enroll a total of 1900 participants, 950 in each arm, over the next 2 years. One arm will be the telemonitoring group and one arm will be the standard of care group. Participants will be in the study for 30 days. Participants in the telemonitoring group will receive a Telestation, blood pressure monitor, and pulse oximeter. If the participant also has congestive heart failure, they will receive a scale. All of these vital measurements are to be taken on a daily basis along with survey questions on how the patient feels. If set parameters are out of the normal range, a flag will trigger that requires follow up/intervention from a nurse by telephone. In some cases, the participant might need to come back in to see a physician through the outpatient clinic. The participant in the standard of care group will be contacted via phone 30 days after discharge to learn if they were readmitted to any hospitals or had any emergency room visits during the past 30 days. This data will be collected via Philips software and also entered into the RedCap database here at Mayo Clinic.

Eligibility Criteria:
Inclusion Criteria:

1) readmission risk score of 11 or higher 2) may be from any service in the hospital 3) patient discharged home or 4) patient discharged to skilled nursing/rehabilitation

Exclusion Criteria:

1. international
2. under age 18
3. discharged to hospice
4. discharged to a sub-acute care hospital
5. transferred to an acute care hospital or
6. if the patient has a planned readmission within the next 30 days
Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma

Methodology: Fifty female patients presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face) diagnosed by consultant dermatologist on clinical presentation were included in this study. The sample size was calculated by WHO Sample Size calculator taking 31% proportion of excellent response with 4% hydroquinone as an adjuvant to oral tranexamic acid as compared to 2.25% proportion of excellent response with 20% azelaic acid, 80% power of test and 5% significance level. After randomization, patients were divided into two groups. Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) while group B was managed with topical 20% azelaic acid (daily at night) for six months. Clinical evaluation was done initially at the start of therapy and then at 2nd, 4th and 6th month using MASI score and patient's response. Efficacy was assessed in both groups at the end of therapy after six months.


Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Aged 20 to 45 years
* Presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face)
* Diagnosed by consultant dermatologist on clinical presentation under wood's light.

Exclusion Criteria:

* Pregnant patients
* Women taking contraceptive pills at the time of study or past 12 months
* Any chronic illness
* Allergy to any of the agents used in the treatment
* Those taking any topical and systemic treatment for melasma in the last one month
Double Lumen Tube Intubation

The aim of this study was to compare time, success rates of different double-lumen tubes in intubation in a standardized manikin model.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Relationship Between Perioperative Sleep Disturbance and Postoperative Delirium

The investigators are performing this research study to understand the role of sleep disturbance on the incidence of delirium after surgery.

Sleep is one of the most important physiological needs. Sleep disturbances have detri-mental effects on practically all systems and may thus prolong recovery of patients. Studies have documented many similarities between clinical and physiological profiles of patients with delirium and sleep disturbances (ischemia/inflammation, hypoxia, neu-rotransmitter imbalance and tryptophan/melatonin metabolism abnormalities). There is still a lack of strong evidence to support the link between poor sleep and delirium, par-ticularly in hospitalized patients, even though available studies suggest that sleep dis-turbances may be a potential key risk factor for its development, which may have a significant clinical impact.

Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present.

The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted.

The association of various preoperative,intraoperative and postoperative factors with POD will be determined.

Eligibility Criteria:
Inclusion Criteria:

Geriatric surgical patients ≥65 years old

Exclusion Criteria:

Patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery, and patients who did not agree to participate in the study were excluded in all groups.
Treatment to Quit Smoking

This protocol evaluates the efficacy of combining pharmacologic treatments for smoking cessation, entailing the use of the nicotine skin patch with the nicotinic antagonist mecamylamine, with a specific behavioral therapy designed to inhibit the smoking urge.

Previous studies have found that nicotine/mecamylamine treatment more than doubles the long-term abstinence rates relative to nicotine replacement alone. Recent evidence supports the hypothesis that nicotine/mecamylamine treatment prior to smoking cessation partially blocks the rewarding effects of cigarette smoking and hence promotes extinction of the smoking habit, facilitating subsequent abstinence. The behavioral approach employed is also an extinction strategy and involves having smokers switch to de-nicotinized tobacco cigarettes for two weeks prior to quitting smoking. It is hypothesized that the use of de-nicotinized cigarettes might provide more complete extinction than provided by the partial pharmacologic blockade using nicotine/mecamylamine alone. The pharmacologic treatment was expected to increase compliance with the de-nicotinized cigarette smoking regimen, because subjects' usual brands of cigarettes will be less appealing than in the absence of nicotine/mecamylamine treatment. Together the brand-switching and nicotine/mecamylamine therapies were expected to reduce cravings and other withdrawal symptoms as well as increase long-term abstinence from smoking.

Eligibility Criteria:
* Smokers,
* Ages 18-65, wanted to quit smoking.
* Must be in good health
* Exclude cardiac disease, hypotensive or hypertensive, skin allergy, glaucoma, prostatic hypertrophy, pregnant women, drug or alcohol abuse, kidney disease.
Study Evaluating the Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis

Previous study found that lipid extract from hard-shelled mussel (HMLE) at a dose of 100mg/kg possessed strong anti-inflammatory activity by diminishing the hind paw swelling and arthritis index in rat model. In the present study, HMLE was processed to capsules under strict food safety supervision and patients with active rheumatoid arthritis (RA）were selected to examine whether supplementation with HMLE could improve clinical and laboratory parameters of disease activity. The validated disease activity score that include 28 joint counts and ESR (DAS28) and validated clinical disease activity index (CDAI) were primary outcome measure. Laboratory parameters including IL-1β, IL-6, IL-10, TNF-α,PGE2 and COX-2 were also measured to explore the mechanisms.

In this randomized controlled design, patients continued receiving background medications (slow-acting anti-rheumatic drugs and non-steroidal anti-inflammatory drugs) without change and were assigned to two groups. The first group (G1) received daily four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) for first two months and two mussel oil capsules per day thereafter. The second group (G2) received corn oil capsules (400mg corn oil per capsule) according to the same regimen. All patients were asked to keep a 7-day food diary before intervention and during wk 12. Dietary energy and nutrient intake of each subject during the preexperimental and study period were assessed from the dietary records by using "Diet Analysis" software (Cao Aihong, Taiyuan, China). All the enrolled patients visited Zhejiang Sir Run Run Shaw Hospital in the morning following an overnight fast at baseline and 3-month intervals, and underwent anthropometric measurements including height, body weight, waist circumference, hip circumference, heart rate and blood pressure. Then clinical evaluations were performed during face-to-face interview by a professional attending doctor and ten milliliter of peripheral venous blood was drawn. Serum and erythrocyte samples were also promptly processed and frozen at -80℃ until analysis.

Eligibility Criteria:
Inclusion Criteria:

* According to the American College of Rheumatology criteria, patients from Zhejiang province with active RA were included in this study and all participants were Chinese. Patients had at least 3 swollen joints and 6 tender joints or had an erythrocyte sedimentation rate (ESR) of \>28mm/hr or morning stiffness of at least 45 min were classified as with active disease.

Exclusion Criteria:

* Subjects suffering hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems, liver and renal failure.
A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation

A Trial to Evaluate the Safety and Efficacy of iNK in the Treatment of Subjects for Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation.

This is an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR300 injection.

Eligibility Criteria:
Inclusion Criteria:

1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF);

2.18-65years;

3.Clinical diagnosis of AML;

4.Accepted allogeneic blood stem cell transplantation within 60 to 28 days prior before initial infusion;

5.Complete donor chimerism and with high-risk recurrence factors prior to transplantation , or bone marrow examination shows positive MRD；

6.Have already recovered from the adverse reactions of previous treatment；

7.Having appropriate organ functions；

8.Eastern Cooperative Oncology Group(ECOG)\<3;

9.Subjects who are able to comply with contraceptives from the study period to 6 months after the end of this study;

Exclusion Criteria:

1. Bone marrow examination shows hematological recurrence;
2. Have malignant tumors within 5 years before screening;
3. Subjects with acute promyelocytic leukemia(APL);
4. Subjects with severe respiratory diseases;
5. Subjects with clear history of neurological or psychiatric disorders in the past;
6. Active central nervous system involvement；
7. HIV(human immunodeficiency virus) antibody positive,treponema pallidum(TP) antibody positive.Have active hepatitis B or hepatitis C;
8. Allergies to NCR300 or its excipients;
9. Subjects with active cardiovascular and cerebrovascular diseases;
10. Received organ transplantation or planned transplantation；
11. Received other treatment drugs after transplantation；
12. Graft-Versus-Host Disease (GVHD)\>II grades;
13. Subjects with active nervous system autoimmune or inflammatory diseases;
14. Expected survival period within 3 months;
15. Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;
16. Having mental illness；
17. Having uncontrollable active infections;
18. Subjects whose state is not suitable for entering the study;
19. Other situations determined by investigator that it is not suitable to enter the study.
Comparison of Classical Prosthesis and Silicone Prosthesis

The purpose of this study is to investigate the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

The purpose of this study is to investigate the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

This study will be useful for prescribing the appropriate prosthesis in patients with Chopart amputation.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65
* Having a unilateral traumatic Chopart amputation
* To have completed prosthesis training
* Using prosthesis for at least 6 hours a day
* Being at K3-K4 activity level

Exclusion Criteria:

* Bilateral lower extremity amputation
* Presence of wound on stump
* Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance
Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes

The investigators developed a wearable magnet tracking system, which provided a non-invasive and high accuracy method for capsule endoscopes localization. Data fusion from multiple sensors expanded positioning range and proposed localization algorithm overcame shortcomings of existing systems. This clinical trial was conducted to verify effectiveness and stability of the tracking system.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 75
* agree to give written informed consent

Exclusion Criteria:

* dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation
* congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, or artificial heart valves
* pregnancy or suspected pregnancy
* exclusion criteria for standard magnetic resonance imaging examination such as the presence of surgical metallic devices, even though its low magnetic field technically would not interferewith such devices
* currently participating in another clinical study
Effectiveness of a Temporal and Sound Space in the Paramedical Management of "Crisis"

This project could potentially lead to better crisis management in psychiatry, using music as a mediator. The integration of a well-designed sound device could help caregivers build trust with patients, alleviate anxiety, and foster an environment conducive to healing. In addition, it would offer a less invasive and more patient-centered alternative, creating an atmosphere that facilitates communication and calming.

The patient will receive specific, individualized paramedical monitoring. The PSYSON device will be presented to the patient during a paramedical interview within 3 days of the inclusion visit, by a pair of investigators composed of a nurse and a paramedic (occupational therapist or psychomotor therapist) or a psychologist.

This interview will help define the patient's personalized sound environment, adapted to moments of anxiety. The pair of investigators plays a key role in creating the playlist, which will constitute the patient's specific sound environment.

The first caregiver investigator will act as a close observer, observing the patient's reactions and psycho-corporal state, which could indicate psychomotor relaxation. The second caregiver investigator will use a tablet or computer provided by the department to enter the patient's choices into the application.

During this interview, the investigator will focus on the patient's emotions and sensory perception. It will begin with the patient's musical request, and to help the patient express his preferences, the investigator can rely on photo language, using "musical atmosphere" cards created for this purpose. These cards highlight a central musical theme, likely to arouse the patient's attention, emotion and certain ideas. Musical instruments can also be made available to observe the patient's musical and rhythmic desires and preferences.

Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 65 years old.
* Diagnosis of bipolar disorder or schizophrenia DSM5.
* Be hospitalized full-time in an acute psychiatric ward with or without compulsory care (SPL, SPDT, SPDTU, SPPI, SPDRE).
* Prior written informed consent of the patient or his legal representative.
* Benefit from a social protection scheme.

Exclusion Criteria:

* Have a severe cognitive disorder assessed during the clinical interview, making it impossible to focus one's attention.
* Hearing-impaired subjects who do not wear hearing aids.
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test

Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.

Delivery of Interventions:

* Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
* During the inpatient study, the subjects will

  * Undergo a 16-hour kisspeptin infusion
  * Undergo an oral glucose tolerance test

Eligibility Criteria:
Inclusion Criteria:

History:

* over the age of 18,
* normal pubertal development
* stable weight for previous three months,
* normal body mass index (BMI between 18.5-25)
* regular menstrual cycles

Physical examination:

• systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg

Laboratory studies: (per Massachusetts General Hospital reference ranges)

* normal hemoglobin
* hemoglobin A1C \< 6.5%
* blood urea nitrogen, creatinine not elevated
* aspartate aminotransferase, alanine aminotransferase \< 3x upper limit of normal

Exclusion Criteria:

* active illicit drug use,
* history of a medication reaction requiring emergency medical care,
* difficulty with blood draws.
* history of chronic disease, except well controlled thyroid disease,
* recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable,
* history of diabetes in a first degree relative,
* use of contraceptive pills, patches or vaginal rings within last 4 weeks.
* hyperlipidemia by fasting lipid panel
* positive serum pregnancy test (for all women)
Impact of Breathing Exercises and Meditation on Reducing Stress and Improving Quality of Life of Glaucoma Patients: An Electronic Pilot Feasibility Study

The goal of this electronic feasibility clinical trial study is to evaluate the effects of breathing and meditation techniques on stress levels in patients with glaucoma.

The main questions it aims to answer are:

* Does breathing and meditation decrease the level of stress in glaucoma patients?
* Does breathing and meditation improve disease specific quality of life in glaucoma patients
* Does breathing and meditation affect the importance that in glaucoma patients place on future consequences? Participants will participate in online session where they will be taught proper breathing and meditation technique to practice. They will also be completing online questionnaires following independent practice sessions over time.

Researchers will compare the breathing and meditation group to the usual care group to see if the outcomes are different.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with glaucoma. Being able to provide valid informed consent to participate in the research study.

Patients aged 40-65. Being able to read and understand English. Having no significant self-reported or physician-diagnosed mental health disorder.

Independent access to a computer to participate in virtual sessions. Must be able to sit comfortably for 30-35 minutes without any major pain or discomfort, can hear well enough to follow verbal instructions when the eyes are closed, and be in good general physical health.

Exclusion Criteria:

Inability to provide valid informed consent. Significant communication barriers or lack of English proficiency that prevents participants from completing the questionnaires.

Having a lifetime diagnosis of self-reported other serious mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).

Self-reported substance abuse or dependence within the past 3 months. Having acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.

Having irreversible vision loss that prevents one from completing the questionnaires.

Participation in a study involving similar techniques.