cyrilzakka/clinical-trials huggingface dataset:
Ventilator Settings and Comfort

No studies have been done to examine whether patients with obstructive lung disease and obesity are more comfortable on some ventilator settings than on others. The purpose of the current study is to examine this question systematically.

Methods: Demographic and physiologic data will be recorded. Investigators will begin measurements more than 60 minutes after last dose of sedative and measurements to occur when no major interventions are planned or medications are scheduled. Then patients will undergo the following ventilator settings (all of which are within ranges ordinarily employed) in random order for 3 minutes of each setting (pressures measured midway i.e. 1.5 minutes - at each interval to ensure safety; stopped if static airway pressure\>30 cmH2O):

1. Assist control

   1. Tidal volumes of 6 ml/kg, 8 ml/kg and 10 ml/kg
   2. Flow regimes: constant (CF) and decelerating (dec) at 40, 60 and 80 L/min;
2. Pressure support (PS) 0, 10 and 20 cmH2O with PEEP=5 cmH2O

Patients will be randomized to receive the following in either forward or reverse order: CF60L/min in 6 then 8 then 10 ml/kg; then at 8 ml/kg CF40, Dec40, Dec60, CF60, CF80, Dec80; then PS=0, 10, 20 cmH2O.

In the last 30 second of each setting, patients will be asked to indicate their level of comfort (1-10 in increasing comfort) using a visual analog Borg Score (when they can see/write) or to indicate on their fingers when they cannot write.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 y) admitted to the MICU of Bridgeport Hospital on mechanical ventilation for:

  * Exacerbation of COPD (smoking history\>20 pkyrs AND chest radiographic or function abnormalities supportive of the diagnosis); OR
  * Body mass index\>40 kg/m2 and acute on chronic hypercapnic respiratory failure.
* Patients must be awake, not have received narcotics for more than 2 hours and possess capacity to consent themselves.
* Patients must have recovered sufficiently from their acute illness to be candidates for weaning per hospital protocol i.e. not in shock, no pressors and PaO2:FiO2\>120.

Exclusion Criteria:

* Patients extubated for comfort care only.
* Patients with successful weaning trial that otherwise clinically requires extubation.
* Patients with unresolved pneumonia, unresolved congestive heart failure, neuromuscular disease or kyphoscoliosis-related respiratory failure will also be excluded.
Effects of WiFi Exposure on Sleep in Women

Effects of Wifi exposure on sleep and sleep-related memory consolidation are investigated in a double-blind, sham-controlled fully counterbalanced study design in young healthy women.

Introduction: Since several years Wireless Local Networks (WLAN, WiFi) are widely spread and operated in households. Many people feel that the presence of radiofrequency technologies impairs their health. Sleep problems are among the most often complained complaints. The present study aims to contribute to answer the question, whether biological effects of a WiFi exposure can be assessed by objective measures. The results of this study will expand the database on possible acute effects of WiFi exposure and thus qualitatively contribute to the discussion whether sleep is affected by exposure from radiofrequency electromagnetic fields.

Methods: A double-blind, sham-controlled experiment in the sleep laboratory with exposure conditions delivered in a balanced randomized cross-over design. Subjective sleep quality of volunteers is assessed by questionnaires. Macro- and microstructure of sleep are measured by polysomnography. Furthermore, a possible impact on sleep related memory consolidation is tested. To do so declarative, procedural and emotional memory tasks are used. Exposure is delivered by a specially developed system, which simulates field strengths and signals occurring in a subject sleeping in the close proximity of a WiFi-access point. This exposure system is necessary to allow for a double-blind implementation and monitoring as well as for the realization of defined exposure parameters.

The study aims to analyse possible sex differences in WiFi exposure effects on sleep and sleep related memory consolidation.

Eligibility Criteria:
Inclusion Criteria:

* Only right-handed
* non-smokers
* Pittsburgh Sleep Quality Index (PSQI) score \< 5
* no extreme morning/evening preference \[Morningness-Eveningness Questionnaire (MEQ) score ≥ 31 or ≤ 69
* no indication of depression or somatic symptoms as assessed by a medical examination and validated questionnaires \[Patient Health Questionnaires (PHQ-9 and PHQ-15) scores ≤ 5 and ≤ 10, respectively

Exclusion Criteria:

* history of a psychiatric disorder,
* history of a neurological and/or sleep disorder
* excessive daytime sleepiness \[Epworth Sleepiness Scale (ESS) score \> 9;
* non-regular sleep-wake schedule as assessed by a sleep diary
* a regular intake of medication that affects the central nervous system, excessive caffeine and/or alcohol consumption, regular and occasional drug use,
* metal implants
* periodic leg movement arousal index \> 10/h in the Adaptation night
* apnoea-hypopnoea-index \> 5/h in the Adaptation night.
Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers

This study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone. Standard care consisted of currently accepted compression therapy.

Patients were treated for 12 weeks. Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound.


Eligibility Criteria:
Inclusion Criteria:

* Any race, between 18 and 85 years of age
* Male or female
* Chronic venous insufficiency
* Ulcer size between 2 and 20 sq cm, inclusive
* Ulcer present for at least one month
* ABI \>0.7

Exclusion Criteria:

* Decrease in wound size \>35% during Screening Phase
* Infection at the ulcer site
* Uncontrolled diabetes mellitus
* Previous treatment with excluded medications
Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy

The goal of this clinical study is to evaluate a novel amino acid based moisturizing cream as part of the daily standard skincare regimen recommended during radiation therapy. The main aim of this study is to assess if the investigational product can improve skin redness associated with radiation therapy. Participants will apply a moisturizer daily during the course of their prescribed radiation therapy for breast cancer. Researchers will compare against the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Aged over 18 years old.
* Has been diagnosed with breast cancer and prescribed radiotherapy as a part of their cancer treatment.
* Planned radiotherapy, as prescribed by the oncologist, is expected to provide a total radiation dose of up to 60 gray within the first 4 weeks of treatment.
* Be able to adhere to proposed daily wound/site care as proposed by the protocol in line with the AADs recommendations.

Exclusion Criteria:

* Pre-existing skin conditions which in the opinion of the investigator could impact on the integrity of the study or compromise the safety of the patient (i.e., active eczema, psoriasis, or an open wound over the planned site of radiation).
* Have a concurrent medical condition or poor functional baseline which in the opinion of the investigator would make them unsuitable or able to fully comply with the study protocol.
* Are pregnant or actively breast feeding.
* Known allergic reactions to ingredients of the Investigational Product or the Standard of Care.
Two-Dose Methotrexate for Ectopic Pregnancy

This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.

The regimen is an attempt to create a middle ground between the 2 commonly used regimens - "single dose" and "multi dose". The "multi dose" regimen is more effective, but the "single dose" regimen is more convenient for patients and has fewer side effects.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of ectopic pregnancy via

  * D\&E without products of conception identified on frozen pathology or
  * VABRA without products of conception identified with pathologic evaluation or
  * Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole
* the subject is hemodynamically stable without signs of hemoperitoneum
* laparoscopy has not been performed
* the subject is able to return for frequent follow-up care
* normal renal and liver function have been documented within 2 days
* normal white blood count and platelet count have been documented as per laboratory standard
* normal chest x-ray was obtained if the subject has a history of pulmonary disease
* no history of allergy or sensitivity to methotrexate or any component of its formulation

Exclusion Criteria:

* breastfeeding
* laboratory evidence of immunodeficiency
* alcoholism or chronic liver disease
* the concomitant use of non-steroidal anti-inflammatory drugs
* blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia
* active pulmonary disease
* hepatic, renal, or hematological dysfunction
* adnexal mass \> or = 3.5 cm
* presence of fetal cardiac motion
* active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction
* subjects unable or unwilling to comply with study procedures or illiterate
CIMT and taVNS for Hemiplegia in Infants

Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body. In older children, therapists may use a hand mitt and restraint for the stronger arm, to encourage use of the weaker side, called constraint-induced movement therapy (CIMT). Even with the high intensity therapy of CIMT, it typically takes between 40-120 hours total treatment time for most children to improve their motor skills. A non-invasive form of nerve stimulation, transcutaneous auricular vagus nerve stimulation (taVNS), stimulates a nerve by the ear that enhances learning motor skills. The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with CIMT in infants with one-sided weakness at 6-18months of age.

Recent pioneering studies have used neuromodulation combined with intensive motor therapies in adults after stroke. Few studies have investigated combining neuromodulation and evidence-based pediatric intensive therapies such as CIMT, and then only in older children with CP to enhance neuroplasticity and improve functional outcomes. The investigators are the first to use non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) paired with a motor task of bottle-feeding in infants with feeding failure. taVNS paired with motor feeding activity was safe and over 50% infants attained full oral feeds who were slated to receive a gastrostomy tube (G-tube). With the unique collaboration of experts in brain stimulation, pediatric translational clinical science and pediatric occupational therapy in this pilot project, the investigators propose to expand the paradigm of pairing neuromodulation with motor training in at-risk infants by exploring the safety, feasibility, and effectiveness of delivering taVNS concurrently with CIMT. The hypothesis is that combining taVNS with intensive CIMT may boost neuroplasticity, allowing for delivery of infant therapy at a minimally effective dosage while improving infant outcomes.

The investigators aim to determine the feasibility and safety of taVNS in at-risk infants 6-18mo undergoing CIMT therapy in open label pilot trial and assess both infant tolerability and the therapist's ability to deliver high-quality CIMT along with taVNS.

Eligibility Criteria:
Inclusion Criteria:

Must have all of the following:

* 6-18 month-old infants with hemiplegia/motor asymmetry
* Must be able to participate in high intensity CIMT
* Gross Motor Function Classification System (GMFCS) level I-IV

Exclusion Criteria:

Must have none of the following:

* GMFCS level V
* severe motor impairment/quadriplegic involvement
* uncorrected blindness or deafness
* cardiomyopathy
Impact of Uterotonic Agents on Isolated Human Myometrium

The purpose of this study is to compare the ability of a sample of uterine muscle tissue to contract in the presence of various drugs. The drugs studied are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst the uterotonic drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most effective one to use is not known.

The investigators will be testing uterine muscle samples in the presence of these drugs at various concentrations, to see what their contractility measures over time, as compared with a control sample, in which no drugs will be applied.

Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80% cases of PPH, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding).

Patients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested for the ability to contract after treatment with various uterotonic drugs (oxytocin, ergonovine and carboprost) in the laboratory. This information will help us know the effect of these drugs by comparing the contractile capability of the uterine tissue.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 37-41 weeks
* Non-laboring patients, not exposed to exogenous oxytocin
* Patients requiring primary Cesarean section
* Cesarean section under spinal anesthesia

Exclusion Criteria:

* Patients who require general anesthesia
* Patient who had previous uterine surgery or Cesarean section
* Patients with placental anomalies
* Emergency Cesarean section in labor
* Patients with bleeding disorders
Prediction of Unfavourable Outcome in Newly Covid-19 Hospitalized Patient

The project is a part of the "Protocol for a multicentre study of nosocomial SARS-CoV2 transmission: The NOSO-COR Project" registered in ClinicalTrials (NCT04290780).

In the current pandemic context, medical resources have often been exceeded. Developing, using artificial intelligence techniques, an algorithm capable of detecting patients at risk of acute respiratory distress following Sars-Cov2 infection could help physicians to optimize the treatment of patients and health decision-makers to optimize resources. Thus, the goal of this project is to create a prediction model using artificial intelligence to predict an unfavorable evolution of Covid-19 at the hospital admission of patients


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 years or older at the time of signing the informed consent
* Volunteer patients, care givers and healthcare professionals in France and hospitals affiliated with the GABRIEL network. Demographic and clinical data will be collected using case-report forms designed especially for the purpose of the project.
* A nasopharyngeal swab will be collected and tested for SARS-CoV2 by RT-PCR.
* Admission to hospital

Exclusion Criteria:

* Age lower than 18 years old
* Patients protected by the law
Does the Structure of the Tendon Relate to the Temporal, Kinetic and Kinematic Jump Variables? Athletes Vs. Non Athletes

The goal of this observational study is to investigate the relationship between temporal, kinetic, and kinematic jump variables and patellar and Achilles tendons' structure in athletes and non-athletes. The main research questions are:

Does the structure of the patellar and Achilles tendons relate to the temporal, kinetic, and kinematic jump variables? Does the relationship between these variables differ between athletes and non-athletes? To answer these questions, researchers will compare the two groups to determine if the relationships between the variables are similar. Participants will undergo a UTC (Ultrasound Tissue Characterization) scan of the patellar and Achilles tendons and perform five jumps: a countermovement jump, a single-leg countermovement jump on each leg and a single-leg horizontal jump on each leg.


Eligibility Criteria:
Inclusion Criteria for the Athletes Group:

1. Being a volleyball athlete competing in the 1st or 2nd division of the portuguese national championship;
2. Participating in training and games for more than 20 hours per week.

Exclusion Criteria for the Athletes Group:

1. Presence of any musculoskeletal, neurological, cardiorespiratory, or metabolic condition that affects jumping performance;
2. Absence from competition due to injury or illness in the last two weeks;
3. History of tendon rupture;
4. Previous tendon surgery;
5. Diagnosis of patellar tendinopathy in the last 12 months.

Exclusion Criteria for the Non-Athletes Group:

1. Presence of any musculoskeletal, neurological, cardiorespiratory, or metabolic condition that affects jumping performance;
2. Absence from competition due to injury or illness in the last two weeks;
3. History of tendon rupture;
4. Previous tendon surgery;
5. Diagnosis of patellar tendinopathy in the last 12 months;
6. Previous participation in a jumping sport.
Survey of Prevalence of Loss of Appetite in Subject With Health Disorders

The study is an epidemiological survey to find out the incidence of loss of appetite in Indian patients suffering from various health disorders. This survey will be conducted to obtain information on appetite from a total of 17500 subjects This study does not intend to study the effect of any drugs. The primary source of information will be the subjects themselves. The study will be conducted at 275 - 350 centres spread across India.This is a single visit study.The physician will conduct routine clinical, physical and general examination.


Eligibility Criteria:
Inclusion Criteria:

* Men and Non-pregnant women ≥ 18 years of age recuperating from healthcare disorders like:Malaria fever, Typhoid or enteric fever
* Hepatitis
* Acute infections including respiratory, urinary tract infections etc treated with antibiotic
* Tuberculosis
* Patient discharged from hospital after general surgical procedures like acute appendectomy, etc.
* Any other condition

Exclusion Criteria:

* Patients unwilling to provide informed consent \& comply with the study procedure
* Patient using drugs which affect appetite like Cyproheptadine etc.
A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw

This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.


Eligibility Criteria:
Inclusion Criteria:

-Has chin retrusion.

Exclusion Criteria:

* Has ever received or is planning to receive permanent facial implants during the study.
* Has tattoos, piercings, facial hair or scars that would interfere with visual assessments of the chin or jaw.
* Has dentures or any device covering part of the palate or plans to undergo any dental procedure other than prophylaxis during the study.
* Has undergone semipermanent dermal filler treatment to the chin or jaw within 36 months or is planning treatment during the study.
* Has undergone any surgery of the chin or jaw area within 24 months or a planned surgery during the study.
* Has undergone mesotherapy, cosmetic resurfacing, or botulinum toxin injections within 6 months or a planned treatment during the study.
* Has experienced trauma to the chin and jaw area within 6 months.
* Has been previously diagnosed with streptococcal disease.
* Has a history of anaphylaxis or allergy to lidocaine, hyaluronic acid or streptococcal protein.
* Has porphyria or untreated epilepsy.
* Has active autoimmune disease.
* Has current cutaneous or mucosal inflammatory or infectious processes, abscess, an unhealed wound, or a cancerous or pre-cancerous lesion.
* Is on a concurrent regimen of lidocaine or structurally-related local anesthetics or is on a concurrent regimen of drugs that reduce or inhibit hepatic metabolism.
* Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
* Is on an ongoing regimen of anti-coagulation therapy.
* Is on an ongoing regimen of medications (eg, aspirin, ibuprofen) or other substances known to increase coagulation time (eg, herbal supplements with garlic or gingko biloba) within the past 10 days.
* Has begun using any over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasale within 30 days before enrollment or is planning to begin using such products during the study.
Effect of Bosentan on Endothelial Function in Patients With Type 2 Diabetes

The purpose of the study is to investigate if oral treatment with bosentan improves endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes mellitus type 2 of \>2 years duration
2. Albuminuria

Exclusion Criteria:

1. Age \>80 years
2. Myocardial infarction/unstable angina within three months prior to randomisation
3. Decompensated congestive heart failure or functional class 3 and 4.
4. Changes in dosage of any vasodilator drugs during the preceding six weeks
5. Women of fertile age.
6. Impaired hepatic function (2 times upper normal limit of aminotransferases ASAT and ALAT)
7. Ongoing treatment with glibenclamide, cyclosporin or warfarin
8. Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol
9. Participant in an ongoing study
10. Unwillingness to participate following oral and written information
Tracing Of Real-time glu13Cose Metabolism in Human Immune Cells

The purpose of this study is to understand how cells of the immune system use the common sugar glucose to fuel energy production and as a building block within the cell. Investigators will intravenously infuse a non-radioactive glucose tracer into participants over a few hours and collect immune cells from the blood to track uptake and usage of this glucose within these immune cells.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 or older

Exclusion Criteria:

* Pregnant
* Prisoner or in police custody
* Uncontrolled hyperglycemia/diabetes
* Current participation in another study where the total volume of blood drawn, when added to this study blood draw volume, exceeds 500cc in an 8 week period
* Any medical issue or pharmacologic exposure which, in the opinion of the study investigator, that might interfere with the study objectives
* Any reason which, in the opinion of the study investigator, adds additional risk to the participant