cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever

Lassa fever carries a treated mortality in hospitalized patients of up to 50%. Lassa fever is often described as being characterized by vascular leak and shock in the terminal phase, but, whilst animal data supports this, there are limited data in humans. Therefore, an aim of this study therefore is to characterize cardiovascular function in patients with Lassa fever, with the ultimate goal of informing future trials of supportive or therapeutic strategies.

Ribavirin is the current standard of care. However, the efficacy of ribavirin has not been established in a randomised controlled trial (RCT). There is very limited pharmacokinetic (PK) data on ribavirin in patients with Lassa fever and the optimal dose of ribavirin for an RCT is unknown. Furthermore, there are various hypothesized mechanisms of action of ribavirin, none of which have been investigated in humans with Lassa fever. Further aims of this study therefore are to characterize the PK of ribavirin in Lassa fever, and identify any associations between ribavirin PK parameters, viral load and markers of immune/inflammatory status.


Eligibility Criteria:
Inclusion Criteria:

* Positive antigen or PCR test for Lassa fever
* Aged 10 years or above

Exclusion Criteria:

* Patients for end of life care only
Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children

The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG somatropin, which administered once per week, compared with the daily used somatropin, and to evaluate the safety and possibility to replace daily used somatropin.


Eligibility Criteria:
Inclusion Criteria:

* have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration \<7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (CA);be in preadolescence (Tanner stage 1) and have a CA \>3 years;have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV; receive no prior GH treatment or stop the GH treatment for more than 4 weeks;sign informed consent

Exclusion Criteria:

* Patients with Liver and kidney dysfunction (ALT\> upper limit of normal 2 times, Cr\> upper limit of normal), hepatitis B virus detection, antigen-HBc, HBsAg and HBeAg are positive
* patients with known to a highly allergic constitution or allergic to the drug of this study
* Patients with diabetes, serious cardiopulmonary, blood system, malignant tumor and other diseases or systemic infection in immunocompromised and mental diseases
* Patients with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, Laron syndrome, GH receptor deficiency, girls with growth delay have not ruled out chromosomal abnormalities
* Participated in clinical trials of other drugs in 3 months
* Other cases that the researchers considered unsuitable for this clinical trial
A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets

The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18 to 65 years included
* Verified diagnosis of "healthy"
* Non-smokers or passive smokers
* BMI in the range of 18.5 to 30 kg/m2
* Subject has given written informed consent to participate in the trial prior to admission to the trial

Exclusion Criteria:

* Blood donation within the last 90 days prior to planned randomization
* Any previous medication within 10 days before the planned administration of the radiolabelled Investigational Medicinal Product (rIMP) which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety
* Subject has any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area which, in the opinion of the physician responsible, could affect the study conduct.
* Vegetarian
* Subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 Millisievert), or will exceed 10 Millisievert over any three year period
Health in Motion- Interactive Exercises for Safer Mobility

The participants will complete a series of balance assessments with a licensed physical (PT) or occupational therapist (OT) or qualified research assistant (RA) at Blue Marble Game Co or in their respective homes at the start of the study, at crossover and upon completion of the study. During this study a PT, OT, or RA trained in fall risk management will supervise the instruction and practice by participants of the home exercise programs during the initial 2-3 hour introduction to the study activities. Participants will be asked to exercise 3/week for one month then crossover to the alternative exercise program and exercise 3/week for a second month.

The participants will complete a series of balance assessments with a licensed physical (PT) or occupational therapist (OT) or qualified research assistant (RA) at Blue Marble Game Co or in their respective homes at the start of the study, at cross over and upon completion of the study. During this study a PT, OT, or RA trained in fall risk management will supervise the instruction and practice by participants of the home exercise programs during the initial 2-3 hour introduction to the study activities. Participants will be asked to exercise 3/week for one month then crossover to the alternative exercise program and exercise 3/week for a second month. The PT, OT, or RA will determine that the participant is competent to perform the home exercise programs safely, with no more than a normal risk of falls or withdraw the participant from the study. The participant's score on the standard version of the Falls Risk Questionnaire, Single Leg Stance Test, and Chair Rise Test will be recorded and stored on a password protected computer in a locked office. Once the data has been stored electronically, paper data collection sheets will be placed in a confidential bin for shredding. Exercise Data will be captured using a) the Health In Motion software via the Kinect Sensor and stored on the Blue Marble secure server and b) via a daily exercise log provided to the participant in paper form.

Eligibility Criteria:
Inclusion Criteria:

* Health status: Individuals medically stable and have no medical condition that would affect their participation in group discussion or that would affect their ability to perform the balance assessments or balance exercises. The participants for Study 1 and 2 are required to walk 500 feet independently without an assistive device (e.g. walker, cane or person).
* Gender: 50%/50% male and female
* Ability to speak/read English fluently (focus group will be conducted in English \& art work will have English text)
* For Study 1 and 2, the participant must have had less than 2 falls in the past 12 months.

Exclusion Criteria:

* History of seizure activity when watching TV or when playing video games.
* Unable to learn to use the technology safely without direct supervision.
* Insufficient clear, safe exercise space in the home with internet access.
Observational Study of the Development of Low Back Pain After Total Hip Arthroplasty.

The investigators are going to observe the appearance of low back pain in patients who have undergone hip prosthesis surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age and under 70 years of age, intervened by CTA due to OAC since January 1, 2010 and before January 1, 2021 and who have developed subsequent lumbar pathology.

Exclusion Criteria (relative/absolute):

* Under 18 years of age at the time of the intervention.
* Over 70 years of age at the time of surgery.
* Previous low back pain.
* Bilateral CTA.
* Previous lower limb or axial fracture.
* Dysmetria.
* Vertebral surgery prior to CTA.
* Scoliosis.
* Scheuermann's disease.
* Neoplasms affecting axial skeleton.
* Bone infections.
* Neurodegenerative disease.
* CTA secondary to fractures.
* CTA replacements.
Oral Amantadine Versus Gabapentin to Attenuate the Response to Laryngoscopy and Tracheal Intubation

To evaluate the effect of oral amantadine versus gabapentin premedication on the hemodynamic response to laryngoscopy and tracheal intubation and their effect on β-endorphins.

Direct laryngoscopy and passage of endotracheal tube through the larynx is a noxious stimulus, which can provoke untoward response in the cardiovascular, respiratory and other physiological systems. Gabapentin, is 1-aminomethyl cyclohexane acetic acid.Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA). Gabapentin act in central nervous system CNS), it acts by decreasing the synthesis of neurotransmitter glutamate and by binding to the alpha 2 delta subunits of voltage dependent calcium channels.

Amantadine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, and compared to ketamine, it is well tolerated with fewer side effects (mainly dizziness, sedation, and dry mouth). Amantadine's formulation permits the oral route for drug delivery, as well as the IV route. The side-effects profile of amantadine via all routes seems not to be harmful in appropriate dosages.. Amantadine has been clinically used as an antiviral drug, for dementia, and in the treatment of Parkinson's disease and spasticity. It is a non-competitive NMDA receptor antagonist, and compared to ketamine, it is well tolerated with fewer side effects (mainly dizziness, sedation, and dry mouth). Amantadine's formulation permits the oral route for drug delivery, as well as the IV route. The side-effects profile of amantadine via all routes seems not to be harmful in appropriate dosages.

In the central nervous system, beta-endorphins bind mu-opioid receptors and exert their primary action at presynaptic nerve terminals. However, instead of inhibiting substance P, they exert their analgesic effect by inhibiting the release of GABA, an inhibitory neurotransmitter, resulting in excess production of dopamine.

The investigators designed this study to prove the efficacy of oral amantadine versus gabapentin premedication on the hemodynamic response to laryngoscopy and tracheal intubation and their effect on β-endorphins.

Eligibility Criteria:
Inclusion Criteria:

* ASA I\&II scheduled for elective spine surgery

Exclusion Criteria:

* Patient refusal
* Patients with ASA score III (with chronic kidney, lungs, Gastrointestinal tract, liver, or cardiovascular diseases)
* Pregnant or breastfeeding women.
* Allergy to any of the study medications and taking medications that could significantly interact with amantadine (tramadol, atropine, antipsychotic medications)
* diabetes mellitus, thyroid disease any endocrine disease
* Suspected difficult intubation or intubation time more than 30 second.
A Self-Administered Maneuver to Relieve Symptoms Suggestive of Benign Prostatic Hyperplasia

The objective of this study was to evaluate the effectiveness of the Digital Repetitive Infrapubic Pressure maneuver, a self-administered procedure used to provide symptomatic relief in initiating and maintaining urine flow impeded by benign prostatic hyperplasia.

Eligible patients were alternately assigned to either immediate instruction on the use of the Digital Repetitive Infrapubic Pressure maneuver (immediate intervention group) or to a return appointment to receive instructions in the maneuver four weeks after the initial assessment date (delayed intervention group). Patients were to utilize the procedure on every occasion they had difficulty initiating, maintaining, or completing urine flow between the time of their instruction and their subsequent visit. At the initial assessment visits and the final visit, the patients completed an International Prostate Score Sheet (IPSS). A telephone survey was conducted with all patients an average of nine months following their instruction in the maneuver, to determine the extent to which they were still using it.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate symptoms of difficulty initiating and maintaining the flow of urine
* not currently receiving treatment for the condition
* not taking an alpha-blocker at least one month before randomization
* not taking 5-alpha reductase inhibitor six months or more before randomization.

Exclusion Criteria:

* non-ambulatory
* taking medications known to affect urination,
* any of the following: a debilitating concomitant illness, a history of prostate or bladder cancer or prostate surgery or radiation treatment to the pelvis, urethral stricture, neurogenic bladder, current urinary tract infection or otherwise potentially compromised urinary tract systems, a creatinine level of over 3.0 mg per deciliter, or a residual urinary volume after voiding of over 350 cubic centimeters.
Posture Analysis Through Machine Learning

This study will include video-recorded data from 20 adults (age 18-85yrs) residing in San Luis Obispo, CA. Participants will also have their height and weight measured, complete demographic questionnaires, and one 3hour session with video recordings in a combination of naturalistic condition and semi-structured environments. The video data will be used to train machine learning models to automatically classify physical behavior as compared to ground-truth measures of manual annotation.

This is a cross-sectional, single observation study. Individuals will be drawn from local surrounding clinics and the general community. All recruitment will include both men and women. Selection criteria include individuals between the ages of 18-85 years, no major chronic illness that impair mobility and able to complete activities of daily living without assistance. Participants will complete one three hour session where there will be one video camera set up within the home (i.e., static cameras). For approximately 30 minutes of the session they will complete a semi-scripted routine that will include sit to stand transitions, a timed up and go test, and scripted activities of daily living.

Researchers will use a video camera to record participant behavior within their daily life. For two of the three hours, researchers will be video recordings the participants normal (unscripted) activities. • For one hour of the session we will use two cameras, one that will be held by a researcher and one that will be set up on a tripod. During this hour we will ask participants to follow a semi-structured protocol:

* 10 minutes recording the empty space
* 10 minutes that include a timed up a go test (sit up from a chair and walk 10 feet), repeat the test 3 times.
* 6 minute walk test (walk continuously for 6 minutes)
* Four stage balance test
* The remainder of the time, participants will complete standard activities of daily living like household chores, eating or drinking.

Data will be annotated using an established behavioral observation software by training research assistants (ground-truth). The image data from videos will be used to train machine learning models to classify physical activities (e.g. ,'walking', 'sitting' or 'standing up"), information about behavior (e.g., location and purpose of the activity), and performance (e.g., walking speed and sit to stand transition times).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-85 years
2. No major chronic illness that impair mobility
3. Able to complete activities of daily living without assistance.
Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery

The aim of this study is to discover whether the Stellate Ganglion Block (SGB) plus the Superior Cervical Ganglion Block (SCGB) procedure is associated with improvements in heart rate variability and sleep quality as measured by the Whoop biometric capture device. It is predicted that after receiving the blocks, patients will show objectively improved measures of stress in the form of higher heart rate variability and improved sleep quality as well as improved subjective wellbeing.

PTSD is meaningfully related to workforce productivity and quality of life factors, including loss of employment and decreases in general life satisfaction. Trauma leads to symptoms that diminish capacity to experience warm and loving feelings for others (emotional numbness), profound negative changes in our self-image and identity, fears that often limit enjoyment of pleasurable activities, and other life-altering challenges. Many survivors experience recurrent feelings of helplessness and horror, and may commonly experience crippling panic attacks, feelings of self-blame and shame, chronically disrupted sleep, and relationship conflict with loved ones.

Low resting Heart Rate Variability (HRV)-- the variability in the time in between heart beats--is a physiological indicator of stress and has been associated with reductions in wellbeing and increases in all-cause mortality. Higher heart rate variability is associated with better sleep quality while lower heart rate variability is associated with increased chronic inflammation. The negative effects of PTSD on sleep are well-documented, and interventions are often targeted at alleviating this damaging consequence, as insufficient sleep can perpetuate anxiety and impair day-to-day functioning, leading to an overall reduced quality of life.

The current standard of care is to offer a combination of trauma-focused psychotherapy and symptom-focused medications, typically a selective serotonin reuptake inhibitor medication. However, a promising treatment known as the Stellate Ganglion Block (SGB) plus the Superior Cervical Ganglion Block (SCGB) procedure has been shown to alleviate PTSD symptoms without any of the side-effects and barriers known to patients on conventional treatments. While this treatment shows promise, most of the research performed so far has used subjective self-report measures of sleep quality and stress. Whoop biometric capture devices offer an opportunity to objectively measure sleep quality and heart rate variability to investigate the effects of the SGB. Physiological data could reveal whether this treatment works not just to alleviate subjective stress, but to physically reduce the effects of PTSD on the body.

Eligibility Criteria:
Inclusion Criteria:

- PTSD Symptoms

Exclusion Criteria:

* none
Factors Associated With Survival in Patients Having Pneumocystis Jirovecii

Pneumocystis jirovecii is a fungus that can colonize the airways of some patients and be responsible for a disease called pneumocystosis in other patients and mainly in immunocompromised patients.

Pneumocystosis was mainly linked to HIV in the 1990s, but with the advent of new immunosuppressive molecules used in cancers or autoimmune diseases and with the increase in the number of transplants, the epidemiology has changed in recent years.

Studies on P. jirovecii-related mortality are only based on patients with pneumocystosis. As a result, patients who are simply colonized or patients who are sick but not treated are not taken into account in these studies. The investigators therefore wish to study the overall mortality at six weeks and at three months in all patients with a positive sample for P. jirovecii


Eligibility Criteria:
Inclusion criteria:

* Adult patients with a positive respiratory sample for P. jirovecii cared for in Strasbourg University Hospitals between 01/01/2016 and 31/12/2018. Positive samples are defined as a direct examination finding cysts or trophozoites after staining with May-Grunewald-Giemsa and/or Gomori-Grocott, a positive P. jirovecii PCR on sputum, tracheal aspirates or bronchial fluid -alveolar
* Subject not objecting to the reuse of their data for scientific research purposes.

Exclusion criteria:

- Subject having expressed its opposition to the reuse of its data for scientific research purposes.
On the BRINK: PhotoBiomodulation (PBM) for Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell TRansplant (HSCT) - Implementing the Evidence & Discovering New Knowledge

This study evaluates mucositis and other oral symptoms in patients undergoing photobiomodulation in patients undergoing hematopoietic stem cell transplantation.

PRIMARY OBJECTIVE:

I. Examine mucositis severity, oral pain, taste changes, and xerostomia in patients undergoing PBM, a new standard of care for oral mucositis.

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.

GROUP I: Patients have their medical records reviewed on study.

GROUP II: Nurses complete surveys on study.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS:

  * Age: ≥ 18 years
  * Undergoing allogeneic HSCT - cases where PBM was used and cases where PBM was not used

NURSES:

* Nurses who administer PBM
The Effect of Dexmedetomidine in Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy

Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged timeds of pneumoperitoneum. Threrefore we decided to evaluate the effect of dexmedetomidine in intraocular pressure during roboti-assisted laparoscopic radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

1. ASA class I-II
2. obtaining written informed consent from the parents
3. aged 20-70 years who were undergoing robot- assited laparoscopic prostatectomy

Exclusion Criteria:

1. eye surgery prevoiusly
2. unstable angina or congestive heart failure
3. concomittant eye disease (glaucoma, diabetic retinophaty, cataract, retinal detachment)
4. high intraocular pressure over 30mmHg after screening test.
5. uncontrolled hypertension (diastolic bp\>110mmHg)
6. bradycardia under 60bpm
7. Ventricular conduction abnormality
8. hepatic failure
9. renal failure
10. drug hyperactivity
11. neurological or psychiatric illnesses
12. mental retardation
13. patients who can't read the consent form due to illiterate or foreigner
Pathogenesis of Primary Spontaneous Pneumothorax

Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. The main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients.

Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. The main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients. The blebs resected from the pneumothorax patients will be used for RNA and protein levels analyses. The adjacent normal lung tissue will be used as a control for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Age between 14 and 40 years
* Spontaneous pneumothorax
* Underwent bullectomy of the lung

Exclusion Criteria:

* With underlying lung disease