cyrilzakka/clinical-trials huggingface dataset:
Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization

Analysis of the randomized controlled SOMS trial of early, goal-directed mobilization to investigate if the treatment effect is consistent and independent of the initial conscious state without evidence of moderation or modification.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* mechanically ventilated for less than 48 h and expected to require mechanical ventilation for at least another 24 h at the time of screening
* functionally independent at baseline with a Barthel Index Score of at least 70 at 2 weeks before admission to the ICU based on patient or proxy completion of the measure

Exclusion Criteria:

* admitted to hospital for more than 5 days before screening
* a motor component of Glasgow Coma Scale (GCS) lower than 5
* irreversible disorder with a 6-month mortality of greater than 50%,
* raised intracranial pressure
* cardiopulmonary arrest
* unstable fractures contributing to probable immobility
* inclusion in another trial at the same time
* acute myocardial infarction
* do not have lower part of their legs
* have a rapidly developing neuromuscluar disease
* pregnant
* ruptured or leaking aortic aneurysm
Atrial Fibrillation Cycle Length Measured on Transesophageal Echocardiography

Background: The atrial fibrillation cycle length (AFCL) measured by electrophysiologic study is well known parameter for the maintenance of sinus rhythm after DC cardioversion (DCCV) or ablation therapy. The aim of this study was to test whether a AFCL measured by transesophageal echocardiography (AFCLTEE) could predict the outcome after DCCV.

Methods: In 100 consecutive patients with non-valvular AF, TEE will be performed within 6 hours before DCCV. The AFCLTEE was measured by averaging 10 sequential peak to peak intervals of atrial fibrillary waves seen in the pulsed wave Doppler image on the left atrial appendage. The primary endpoint was AF free survival rate at 6 months after DCCV.


Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation

Exclusion Criteria:

* moderate or severe mitral stenosis
* prosthetic heart valve
Chronology of Occult and Gross Coagulopathy in Burn Patients

The purpose of the study is to identify the inflammatory and coagulation pathways and mechanisms that are activated immediately following burn injury, and how they affect outcomes in terms of organ failure and death. This study also addresses the limitation of current tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances in severely injured patients both in a comprehensive and rapid manner.


Eligibility Criteria:
Inclusion Criteria:

* Patients, male or female, \> or = 18 years of age, who arrive at Burn/Trauma Center with anticipated admission to The Burn Center within 4 hours of injury, with a thermal burn injury due to flash, flame, contact with hot object or liquid.

Exclusion Criteria:

* Patients suffering concomitant trauma that are in hemorrhagic shock. Patients with a preexisting history of coagulopathy, or currently taking anti-coagulants. Children and pregnant women. Patients with chemical or electrical injury. Patients who do not fluently speak either English or Spanish.
The Effect of Anticholinergics on Cognitive Function in the Elderly

Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women.

Subjects will be randomized to: 1) trospium chloride or 2) placebo.

There are three aims:

1. To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests
2. To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management
3. To understand how the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug initiation using paper-based validated questionnaires. OAB improvement will be assessed with validated questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Female 50 or older
* Diagnosis of OAB (ICS definition)
* English literacy
* Ability to swallow oral medication
* Cognitive ability to give consent

Exclusion Criteria:

* Dementia/Depression/Delirium
* Current anticholinergic use (requires 2 week washout period)
* Current cholinesterase
* Urinary or gastric retention
* Severe decreased gastrointestinal motility
* Uncontrolled narrow-angle glaucoma
* Myasthenia gravis
* Diagnosis fo renal impairment (creatinine clearance \<30 mL/min)
Perspectives on Prescribing Hormonal Contraception Among Rural New Mexicans

The goal of this study is to identify the thoughts and perceptions of pharmacy access to hormonal contraception among rural women and pharmacists. This will be key in order to address concerns or perceived barriers in order to inform the implementation of this program.

There are no studies examining New Mexico pharmacists' interest in prescribing hormonal contraceptives or rural New Mexican women's support for pharmacist prescribed hormonal contraceptives. However, some states where pharmacists already prescribe contraception have experienced difficulties in implementing the education, infrastructure, and financial support necessary to provide hormonal contraception in the community pharmacy setting. Nationwide, 68% of women reported that they would utilize pharmacist prescribed hormonal contraception and cited benefits such as convenient hours and locations of pharmacies. The goal of this study is to identify the thoughts and perceptions of pharmacy access to hormonal contraception among rural women and pharmacists. This will be key in order to address concerns or perceived barriers in order to inform the implementation of this program.

Eligibility Criteria:
Inclusion Criteria:

* Pharmacists: actively employed and currently licensed and working in rural counties in New Mexico.
* Women: Reproductive age, 18-45 years old from rural counties in New Mexico and who are fluent in English.

Exclusion Criteria:

* Pharmacists: decline to participate or work outside the defined rural areas, not currently employed or licensed.
* Women: younger than 18 or older than 45, living in urban areas (Albuquerque and Las Cruces).
Effects of Quercetin on Cardiometabolic Outcomes

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Quercetin may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Between 18 \& 65 years
* Non-smoker
* BMI \< 30
* Able to give informed consent

Exclusion Criteria:

* Pregnancy
* Diabetes or any other metabolic/ uncontrolled hypertensive conditions
* Food allergies to quercetin
* Habitual consumption of quercetin
* Not regularly taking medication or antioxidant supplements
Phase 3 Study to Evaluate the Efficacy and Safety of Droxidopa on Orthostatic Hypotension Treatment in Hemodialysis Patients

Orthostatic hypotension is a major complication of hemodialysis and interferes with everyday activities in hemodialysis patients. Since information regarding the use of droxidopa in clinical trials relating to orthostatic hypotension of chronic hemodialysis patients is limited in Taiwan, this study is designed for evaluation the efficacy and safety profile of droxidopa on orthostatic hypotension treatment / prevention in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male aged great than 20 years of age
2. Patient with at least 3 month documented requirement of regular hemodialysis session
3. Patient with a decrease of 20 mmHg in SBP or 10 mmHg in DBP within 5 minutes of standing after the end of hemodialysis in at least 2 of 3 sessions during the screening period.
4. Subject with subjective complain of light headedness related to the orthostatic hypotension AND with a VAS score 4 in at least 2 of 3 sessions during the screening period.
5. Willing and able to comply with the study procedure and sign a written informed consent

Exclusion Criteria:

1. Female who is pregnant, lactating or planning to be pregnant within 3 months, or female of childbearing potential who is not using medically recognized method of contraception
2. Subject with closed angle glaucoma
3. Subject with severe hypertension
4. Subject with liver disorder
5. Subject with Hct great than 36%
6. Subject with confusion, hallucination, or delusion
7. Subject with severe disease which may limit survival during the study period, or confound the results of the study as judged by the investigator, such as hyperthyroidism, artery stenosis, severe lung disorders, severe asthma, chronic open angle glaucoma, uncontrolled diabetic gangrene
8. Subject who takes any anti-hypotensive drugs within 7 days prior to randomization, such as midodrine, etilefrine or amezinium
9. Subject who takes ephedrine, pseudoephedrine within 7 days prior to randomization
10. Subject who use of any investigational product within 4 weeks prior to randomization
11. Subject who requires blood transfusions within 3 months before screening, and are not suitable to participate the trial as judged by the investigator
12. Histories of hypersensitive to droxidopa
13. Histories of peripheral vascular disease, coronary artery disease and are not suitable to participate the trial as judged by the investigator
14. Histories of hemorrhage complication within 3 months before the screening visit, such as GI bleeding, intracranial bleeding or traumatic hemorrhage, and are not suitable to participate the trial as judged by the investigator
15. In investigator's opinion, subjects who are unlikely to adequately cooperate and follow the procedures
AAN Robotic Therapy in SCI

The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that follows the "assist-as needed" paradigm provide statistically significant improvements in arm and hand motor functions when compared to robot-aided protocols that passively move patients' arms along pre-defined trajectories, in patients with incomplete spinal cord injury (SCI).


Eligibility Criteria:
Twenty adults with chronic incomplete SCI (according to American Spinal Injury Association (ASIA) Impairment Scale (AIS) C-D level) will be recruited from TIRR and from the Houston area.

Inclusion Criteria:

1. Providing written informed consent prior to any study related procedures;
2. Age between 18-75 years;
3. Diagnosis of chronic complete or incomplete spinal cord injury as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months;
4. Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months;
5. No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
6. Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
7. No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;

Exclusion Criteria: Subjects will be excluded if they have:

1. Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score \> than 3 out of 4;
2. Subject who cannot provide self-transportation to the study location.
Association Between Body Mass Index and HFNC Therapy Success

Patients over 18 years of age who are admitted to the Intermediate Care Unit of the Clinica del Country and the Clinica la Colina, with symptoms suggestive of severe pneumonia secondary to COVID-19 infection and acute hypoxemic respiratory failure. The primary outcome will be to determine the relationship between body mass index and high-flow cannula therapy success defined as: No need for mechanical ventilation.

All adult patients over 18 years of age admitted to the intermediate care service of the participating center with suspected SARS-CoV-2 pneumonia will be considered as potential candidates for the study.

The medical records of patients in our cohort who require high-flow cannula therapy and who met all the inclusion criteria and none of the exclusion criteria will be reviewed.All data will be processed and analyzed using the SPSS 26 software once the study is completed. study sample

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age.
2. Diagnosis of severe pneumonia secondary to COVID-19 infection and acute respiratory distress syndrome, defined by upper and lower respiratory symptoms plus positive C-reactive protein test for COVID-19.
3. Patient admission to the Clinical del Country and Clinica de la Colina intermediate care units.
4. Oxygen therapy by high-flow system (high-flow cannula) requirement.
5. Anthropometric data availability upon admission to our facilities.

Exclusion Criteria:

1. Patients with a survival expectancy of less than 12 months according to the Charlson scale categorization or patients with oncological pathology.
2. Patients under 18 years of age.
3. Pregnant women.
4. Patients with cardiogenic pulmonary edema.
5. History of chronic liver disease or cirrhosis Child - Pugh C.
6. Patients with contraindications to high-flow cannula therapy initiation.
7. Patients with respiratory, hemodynamic and neurological indications that contraindicate HFNC initiation.
Johns Hopkins Breast Cancer Program Longitudinal Repository

The Breast Cancer Program Longitudinal Repository (BCPLR) is being established to fulfill the research mission of the Breast Cancer Program at Johns Hopkins and to serve investigators affiliated with it - to develop a repository of specimens with corresponding characteristics from patients seen in the breast care and cancer clinics.

This research is being done to collect samples for future use that we may learn more about cancer by studying cells in blood and tissue collected from people with breast cancer as well as from volunteers without breast cancer. Our goal is to make these available for research to help to learn how cancer develops and how it may be treated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years of age or older
* Participants meet one of the following categories: have a known diagnosis of breast cancer receiving a breast cancer evaluation and/or treatment; have benign breast disease receiving a diagnostic procedure and/or evaluation; or, have no known diagnosis of breast disease or abnormality and is undergoing routine screening or diagnostic breast imaging procedures and/or other clinical evaluation.

Exclusion Criteria:

* N/A
Validation of Accexible as a Tool for Screening and Monitoring Depression.

Major depressive disorder (MDD) is a chronic disease with a prevalence around 8-12% and is considered one of the most debilitating disease worldwide.

A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.

The present study has the objective of validating Accexible as a tool for Screening and Monitoring Depression.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18-65 years of age.
* Participants must have Spanish as their first language (able to speak and understand verbal messages).
* Participants must have mobile phone with internet.
* Participants must have the ability to understand AcceXible's basic instructions.
* Participants must agree to participate in the study and have voluntarily signed the informed consent.

Exclusion Criteria for patients:

* To have received a diagnosis of neurodegeneration.
* To have significant vision problems that would affect the ability to perceive visual stimuli.
* To have significant hearing problems that would affect the ability to understand verbal cues.
* To be unable to give informed consent to participate in the study.
Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy

The study searched for answers to two questions

1. Is there endothelial dysfunction, inflammation and insulin resistance in patients with congenital hypogonadotropic hypogonadism?
2. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?


Eligibility Criteria:
Inclusion Criteria:

* Men
* Treatment naive
* Hypogonadotrophic hypogonadism

Exclusion Criteria:

* Previous history of androgen replacement
* Chronic metabolic disorders
Effect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children

The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory factors among overweight and obese children.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 85th
* age of 6-11 years
* no history of chronic diseases
* taken medications

Exclusion Criteria:

* do not prescribe their diet
* mental retardation
Gut Microbiota Reconstruction in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea

The purpose of this study is to evaluate the efficacy as well as safety of rifaximin combined fecal microbiota transplantation(Gut microbiota reconstruction) in the treatment of IBS-D.

In this prospective study, there is only one group with no placebo/blank control. All qualified IBS-D patients could be admitted to hospital for at least one time of combing therapy (taking rifaximin for 3 days and then receiving fecal microbiota transplantation) and follow-up until 6 months after the first treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65, no gender limitation;
* Had received a diagnosis of IBS-D (as assessed according to the Rome III diagnosis criteria of IBS) and had undergone a colonoscopic examination within the previous 2 years with no organic lesions observed;
* Has current symptoms of IBS-D: ①Abdominal pain (at least 2 days in a week with no limitation of severity); ②Stool consistency (rated the consistency of their stools of Bristol types 6/7 at least once a day and at least 2 days in a week);
* Can do follow-up at required time points and signed written informed consent before the study.

Exclusion Criteria:

* Allergic to rifaximin;
* Taking alosetron, tegaserod, lubiprostone, warfarin, or antipsychotic, antispasmodic, antidiarrheal, probiotic, or narcotic drugs within the previous 1 month;
* Had infective diarrhea history or had taken antibiotics within the previous 14 days;
* Patients with a history of inflammatory bowel disease ;
* Previous abdominal surgery (other than cholecystectomy or appendectomy);
* Human immunodeficiency virus infection or other immunodeficiency conditions such as congenital immunodeficiency or currently taking immune-suppression drugs;
* Unstable diabetes, hypertension, thyroid disease, etc;
* Accompanied malignant tumor or severe heart/lung/renal/hepatic/brain/blood diseases;
* Accompanied severe neural/psychotic diseases such as epilepsy, depression, mania, schizophrenia, etc;
* Other conditions that doctor thought not suitable for the study.
Almitrine and COVID-19 Related Hypoxemia

In severe COVID-19 pulmonary failure, the profound hypoxemia is mainly related to pulmonary vasodilation with altered hypoxic pulmonary vasoconstriction (HPV). Besides prone positioning, other non-ventilatory strategies may reduce the intrapulmonary shunt. This study has investigated almitrine, a pharmacological option used in standard care to improve oxygenation.

A case control series of mechanically ventilated confirmed COVID-19 patients was recorded.

At stable ventilatory settings, consecutive patients received two doses of almitrine (4 and 12 mcg/kg/min) at 30-45 min interval each, and were compared to 7 "control" COVID-matched patients conventionally treated.

The end-point was the reduction of intra-pulmonary shunt, with an increase in partial pressure of arterial oxygen (PaO2) and central venous oxygen saturation (ScvO2).

The clinical presentation of COVID-19 disease is heterogenous, ranging from no symptoms to severe acute respiratory failure (ARF), which may have a poor prognosis. A severe hypoxemia is associated with preserved respiratory mechanical properties, in particular the pulmonary system compliance.

The hypoxia during the early phase seems to mainly result from an important ventilation/perfusion (VA/Q) mismatch associated with an altered pulmonary vasoconstriction. The "protective" mechanism called hypoxic pulmonary vasoconstriction (HPV) normally reduces the blood flow in poorly or non-ventilated areas towards aerated zones leading to reduce the (VA/Q) mismatch. HPV seems poorly functional in COVID-19 severe patients in absence of "cor pulmonale".

According to the French National agency for Drug Security (ANSM, Paris, France), only iv almitrine is indicated for hypoxic acute respiratory failure as Drug of Major Therapeutic Interest. This molecule is a routine option in the treatment strategy of severe hypoxemia.

The investigators studied COVID-19 patients mechanically ventilated at FiO2 1 with a severe intrapulmonary shunt during their early phase. The emergency conditions and the acute high inflow of patients to ICU impeded the design of a randomized control trial. To eliminate the eventuality of a spontaneous evolution of hypoxia, these patients will be compared with control-matched COVID patients treated conventionally.

Eligibility Criteria:
Inclusion Criteria :

* a positive RT- PCR,
* a highly suggestive thoracic CTScan, and
* a severe hypoxemia leading to intubation for less than 3 days
* mechanically ventilated at FiO2 1 with a severe intrapulmonary shunt during their early phase

Group : patient who has been treated with almitrine (4 mcg/kg/min iv almitrine bismesylate (Vectarion®, Servier Laboratory, France) then 12 mcg/kg/min infusion rate) during their hospital treatment.

Control group : Matched COVID-19 patients, on gender, age, BMI and duration of mechanical ventilation, with serial measurements corresponding to the duration of almitrine testing (8 hours), with same inclusion and exclusion criteria.

Exclusion Criteria:

* the presence of an acute cor-pulmonale on the trans-thoracic 2D Echo-Doppler
* abnormal liver function tests
* hyperlactatemia