cyrilzakka/clinical-trials huggingface dataset:
The Effect of Load Carriage on Upper Limb Performance

Purpose: Quantify the relationship between brachial plexus deformations caused by backpack carriage and upper extremity performance.

Significance of expected results:

The study will allow to quantify the effect of load carriage on both neural and vascular function parameters.

Study plan The effect of nerve strain on neural function: based on the strains obtained for each load from computational simulation, and from animal studies published in the literature, the expected neural function, (e.g., motor and sensory) dysfunction will be estimated.

Following signing an informed consent form, 12 young adult subjects (18-35 years) will don a military backpack loaded with 25-40 kg. Each volunteer will undergo the following test at baseline, following 45 min exposure, and following 15 min of recovery:

1. Index finger microvascular flow will be measured by photoplethysmography (PPG).
2. Sensory measurement at the finger; Light touch threshold will be measured by mechanical stimulation that will be applied using Von Frey Filaments of the Semmes-Weinstein Monofilament (SWM) type.
3. Forearm thermal sensation threshold; As a measure of sensory function in the forearm, cold and warm sensation thresholds will be measured with a computerized quantitative thermal sensory device.

   Immediately following the 45 min loading exposure, the fine motor function of the index finger will be tested by the following procedures (in an unloaded condition):
4. Index finger motor function; Force application profile during a trigger press will be measured using a force sensor located on a trigger of a dummy weapon simulator. Force application rate, peak force, and press-to-press peak force variability will be measured based on 10 trigger presses.
5. Accuracy of force application; Will be evaluated by the simulated shot accuracy, horizontal displacement (X) and vertical displacement (Y).
6. Subjective parameters; in all time points, the volunteers will be asked to rate their level of pain sensation intensity (VAS sensory) and degree of unpleasantness (VAS affective) in the shoulders and other load bearing sites, as well as ratings of perceived exertion (RPE). All subjective parameters will be assessed using visual analogue scales.


Eligibility Criteria:
Inclusion Criteria:

Healthy medical status, fit (regular physical activity \> 3 times weekly) men Previous experience with heavy backpack carriage Age: 18-35

Exclusion Criteria:

Heavy load carrying activity in the past 48 hr

Known diseases or medical conditions that may interfere with the study, of:

Musculoskeletal system Nervous system Cardiovascular system Vascular disease
Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

The aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.

Apricitabine is a new NRTI in development for treatment of drug resistant HIV. Tipranavir is a recently licensed protease inhibitor for treatment of drug resistant HIV. Tipranavir affects the plasma concentration of some other drugs when they are used together with tipranavir. This study will examine whether the pharmacokinetics of apricitabine are changed when it is dosed together with tipranavir compared to apricitabine alone. Also, the pharmacokinetics of tipranavir will be examined at steady state when it is dosed alone and when it is dosed together with apricitabine. Information on the safety and tolerability of the two drugs when dosed together will also be obtained.

Eligibility Criteria:
Inclusion Criteria:

* healthy males 18-40 years old
* non-smokers
* no clinically significant medical history

Exclusion Criteria:

* current or relevant previous medical history of significance
* hepatitis B, hepatitis C, or HIV positive
* current use of prescription or OTC medications
* use of illicit substances or alcohol (\>14 drinks/week)
Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension

In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes.
* Participants must meet the following IOP requirements at Visit 3
* mean/median IOP ≥ 24 mmHg at a minimum of 2 time points in the same eye
* IOP ≤ 36 mmHg at all 3 measurement time points in both eyes.
* Participants with a best-corrected visual acuity (BCVA), using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent of approximately 20/100) or better in either eye.

Exclusion Criteria:

* Participants with known hypersensitivity or contraindications to latanoprost, NO treatment, timolol maleate, other beta-adrenergic receptor antagonists or any of the ingredients in the study drugs.
* Participants with a central corneal thickness greater than 600 μm in either eye.
* Participants with advanced glaucoma and participants with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
* Participants who do not have an intact posterior capsule in either eye .
* Participants with aphakia in either eye.
* Participants with previous or active corneal disease in either eye.
* Participants with current or a history of severe dry eye in either eye.
* Participants with current or a history of optic disc hemorrhage in either eye.
* Participants with current or a history of central/branch retinal vein or artery occlusion in either eye.
* Participants with current or a history of macular edema in either eye.
* Participants with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and Participants with angle closure,congenital, and secondary glaucoma, and participants with history of angle closure in either eye.
* Participants with a diagnosis of a clinically significant or progressive retinal disease in either eye.
* Participants with any intraocular infection or inflammation in either eye within 3 months(90 days) prior to Visit 1 (Screening).
* Participants with a history of ocular laser surgery in either eye within the 3 months(90 days) prior to Visit 1 (Screening).
* Participants with a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to Visit 1 (Screening).
A Trial of Multisystemic Therapy in UK a Statutory Therapeutic Intervention for Young Offenders

To evaluate whether Multisystemic Therapy (MST) is more effective in reducing youth offending and out-of-home placement in a large, ethnically diverse, urban U.K. sample than an equally comprehensive management protocol; to determine whether MST leads to broader improvements in youth sociality and in mediators believed to be responsible for change in MST.


Eligibility Criteria:
Inclusion Criteria:

* age between 13 and 16 years;
* living in the home of and being brought up by a parent or principal caretaker;
* on a court referral order for treatment or a supervision order of at least 3 months' duration, or, following imprisonment, on license in the community for at least 6 months.

Exclusion Criteria:

* being a sex offender;
* presented only with substance misuse;
* diagnosed with a psychotic illness or posed a risk to trial personnel;
* incompatible agency involvement (e.g., ongoing care proceedings).
Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients

Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron diseases. It is considered as a rare disease with a prevalence of about 8 per 100,000 persons. Initiating in mid-life by progressive paralysis, it evolves rapidly into a generalized muscle wasting that leads irrevocably to death within 2 or 5 years of clinical onset.

Since there is no cure for ALS, the management of the disease is supportive and palliative. Riluzole is the only drug that has been shown to extend survival by about three months. The identification of biomarkers sensitive to the progression of the disease might enhance the diagnostic and provide new drug targets.

Dysfunction of the immune system is a pathological hallmark of ALS. Increased levels of interferon gamma (IFNgamma) were found in the serum and cerebrospinal fluid (CSF) of ALS patients. However, the cell origin as well as the pathogenic influence of this peripheral source of IFNg is unknown. Thus, IFNgamma might have a role in the pathogenic process of ALS and might be a potential biomarker of the disease.


Eligibility Criteria:
Inclusion Criteria:

Group 1 and Group 2:

* with sporadic ALS (without family history), recently diagnosed (onset of first symptoms \< 24 months) group 1, not recently diagnosed (onset of first symptoms \> 24 months) group 2
* Who meet the laboratory-supported probable, probable or definite form of ALS according to the El Escorial criteria
* Suffering from the spinal form of ALS

Group 3:

- with an inflammatory peripheral neuropathy, or a non inflammatory peripheral neuropathy, recently diagnosed

Exclusion Criteria:

* Familial form of ALS
* Bulbar form and respiratory onset form of ALS
* Subjects with a clinically significant history of unstable or severe cardiac, oncologic, hepatic or renal disease, or other medically significant illness.
* Subjects with significant cognitive impairment, clinical dementia, or psychiatric illness.
* Female of childbearing potential (apart of patient using adequate contraceptive measures), pregnant or breast feeding
* Suspected inability to complete the study follow-up (foreign workers, transient visitors, tourists or any others for whom follow-up evaluation is not assured)
* Participation in any other clinical study within 30 days prior to the Screening Visit
* Persons deprived of freedom by judicial or administrative decision, hospitalized without their consent or for other reasons than the research, under legal protection or unable to express their consent
Comparison of the Centric Relation Recorded by Two Methods Using Cone Beam Computed Tomography

The purpose of this study was to investigate and compare the variation in mandibular relation recorded by the gothic arch methods and the K7 method using cone beam computed tomography (CBCT)

ten asymptomatic participants were selected,the centric relation registrations were separately recorded according to the technique of the gothic arch method and the neuromuscular method,subsequent, they were instructed to perform CBCT wearing two bite registrations,thus using dophin software to calculate the tmj space and the upper airway and using exocad software to ananyse the mandibular position, Data were analysed with paired t-test

Eligibility Criteria:
Inclusion Criteria:

absence of the mandibular position Classified as ASA 1 or 2 (normal healthy patient or with mild systemic disease, according to the American Society of Anaesthesiologists Physical Status Classification System); Absence of the symptoms and signs of the temporomandibular joint; Willing to participate and to sign a written informed consent form.

Exclusion Criteria:

Cardiac pacemaker carriers and pregnant women; people with heart pace disorders and epilepsy; Temporomandibular or craniocervical disorders.
HVPG-Guided Therapy Versus EVL Plus NSBB in Second Prophylaxis of Esophageal Variceal Bleeding

A single-center randomized controlled study comparing endoscopic or interventional therapy guided by the hepatic venous pressure gradient (HVPG) , to standard endosopic variceal ligation plus nonselective beta-blocker therapy (NSBB) in patients with esophageal varices due to liver cirrhosis with a history of esophageal variceal hemorrhage.Primary study outcome of the study is variceal rebleeding episodes occurring within the first years after interventions. Second study outcomes of the study are hepatic encephalopathy occurrence, mortality occurrence, liver transplantation or other cirrhosis-related complications.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis diagnosed by clinical examination, imaging or biopsy;
* A previous history of variceal hemorrhage;
* Written informed consent.

Exclusion Criteria:

* Previous history of secondary prophylactic treatment;
* Contraindications to treatment of endoscopy, surgery and TIPS
* Severe cardiac, pulmonary or renal dysfunction;
* Lactating or pregnant;
* Malignancies;
Randomized One-Center Controlled Trial on a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD

The study is a prospective, single-center, randomized controlled trial that will be conducted at the Medical University of Varna. This setting offers access to a wealth of clinical expertise in managing CP and ASD and a rich tradition of conducting robust nutritional interventions.


Eligibility Criteria:
Inclusion Criteria:

* A formal diagnosis made by a qualified neurologist. The diagnosis can span across the different types of CP and ASD.
* Expressed willingness to participate in the study.
* Availability for the entire duration of the study.

Exclusion Criteria:

* Children with acute medical conditions or comorbidities that may significantly disrupt study assessments.
* Any severe infections within the last 10 days prior to the study.
* Presence of genetic syndromes that could influence nutritional status, e.g., Silver Russel syndrome or Down syndrome.
* Parents with cognitive impairments, which might pose challenges in their participation during assessments/intervention.
* Children who have been part of any major dietary or nutritional interventions in the last three months.
Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study

The aim of the study is to establish the intrarater-reliability, criterion validity and responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients diagnosed with rheumatoid arthritis.

The study is designed as a repeated test-retest study including 240 patients filling in the ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a home-module in the DANBIO database) which makes it possible for the patients to complete their assessments and send information from their own home.

Intrarater reliability will be assessed by calculating the intraclass correlation coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis and responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be used to classify participants based on pain phenotype to explore any relationship between pain phenotype and reliability.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with RA ≥ 12 months
* DAS28-CRP \< 5,1
* Age between 18 and 85 years
* Computer and Internet connection at home

Exclusion Criteria:

* Blood samples (creatinine, haemoglobin) outside the reference limits +/- 5 % at screening
* Blood samples (thrombocytes and leukocytes) outside the reference limit -/+ 15 % at screening
* Blood samples (ALAT) outside the reference limit -/+ 100 % at screening
* Dementia or other linguistic/cognitive/physical deficiency that prevents participation
* Vision impairment that prevents the use of the devices and computer
Breastfeeding Failure: Influence of Smartphone Use and Distraction Factors

The benefits of breastfeeding no longer need to be proven. Many studies have shown its positives effects on both infants and mothers. Exclusive breastfeeding is thus recommended within the first six months of life.

Excessive screen use has been shown to be harmful in many aspects of daily life. The impact upon the relation between mother and newborn infant is poorly studied.

The study aims to evaluate the impact of the use of smartphones on the success and duration of breastfeeding.


Eligibility Criteria:
Inclusion Criteria:

* breastfeeding mothers of Newborn breastfed infant born in the maternity ward of the Amiens-Picardie University Hospital

Exclusion Criteria:

* Mother refusing to participate in the study; hospitalization during the neonatal period
Gene Methylation in the Diagnosis of Barrett's Esophagus: Identification of Candidate Diagnostic Markers

This study is to identify potential markers from esophageal biopsies and brush cytology for feasibility of use in stool specimens for detection of Barretts Esophagus.


Eligibility Criteria:
Inclusion Criteria:

Controls: No endoscopic evidence of Barrett's Esophagus, able to give informed consent, 18 years of age or older.

Cases: At least 1 cm of visible columnar epithelium with intestinal metaplasia on histology confirmed by an expert GI pathologist (on biopsy), able to give informed consent, 18 years of age or older.

Exclusion criteria:

Controls: Patients with history of esophagectomy or mucosal ablation, gastrectomy, or known non-Barrett's esophageal pathology (e.g. eosinophilic esophagitis or achalasia), varices, esophagitis LA Grade B, C, D will be excluded. Patients with prior history of colon polyps or colon/esophageal/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).

Cases: Patients with history of esophagectomy or mucosal ablation, gastrectomy, or known non-Barrett's esophageal pathology (e.g. eosinophilic esophagitis or achalasia), will be excluded. Patients with prior history of colon polyps or colon/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery

The mechanical demands placed on the pelvic floor structures during vaginal delivery often exceed physiological tissue limits, resulting in maternal childbirth trauma, considerable postpartum morbidity, and increased risk of pelvic floor disorders(PFD). Injury to the perineum, vaginal supportive tissues, and pelvic floor muscles cause pain, infection, and dyspareunia, as well as pelvic organ prolapse(POP).Pregnancy and vaginal delivery are considered as a main risk factors in weakening the pelvic floor support and development of SUI, AI, and POP. CS is not only available countermeasure to reduce occurrence of obstetric trauma. Tactile imaging allows acquisition of 3D stress-strain data and 3D elasticity imaging or soft tissues.

The long - term of this project is to develop, validate, and integrate into clinical practice a new paradigm and a novel device to simultaneously measure the biomechanical properties of various pelvic structural components that are impacted during vaginal delivery, and to develop a risk prediction model of maternal birth injury. Ultimately, such a model will enable individualized patient counseling regarding the mode of delivery and/or the need for obstetrical interventions to reduce child birth trauma. The approach will utilize the vaginal tactile imaging technology that the investigators have developed and validated for clinical use.

The benefits to physicians, patients and society are expected to be significant because the painful event in woman's life , given the large proportion of women suffer PFD caused by childbirth.

This new system may open a new technical capability in woman's healthcare and change the established clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant women (Princeton Urogynecology, Princeton, NJ)
* Pregnant women after completed 35th week of pregnancy with fetus in vertex position and premise of vaginal delivery (Division of Maternal-Fetal Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ)

Exclusion Criteria:

* Prior perineal surgery
* HIV or hepatitis B positive serology
* Warty lesions on the vulva
* Extensive varicose veins on the vulva
* Aactive skin infection or ulceration within the vagina/vulva
* Presence of vaginal septum
* Severe hemorrhoids
* Stillbirth or extensive congenital abnormalities of the fetus
Application of tPA in Suprachoroidal and Subretinal Hemorrhage

Severe ocular rupture may be accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage. The suprachoroidal hemorrhage needs to be drained as soon as possible. In the process of waiting for the spontaneous liquefaction of hemorrhage, uncontrollable elevated intraocular pressure may occur, resulting in optic nerve injury, optic nerve atrophy, and visual loss. Tissue plasminogen activator can promote the liquefaction of blood clots. Studies have found that local application of tissue plasminogen activator in the suprachoroidal space can promote the liquefaction of the hemorrhage. Local application of tissue fibrinogen activator under the retina can promote the liquefaction of subretinal hemorrhage.

Severe ocular rupture may be accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage. The suprachoroidal hemorrhage needs to be drained as soon as possible. The traditional treatment method needs to wait for the spontaneous liquefaction of the suprachoroidal hemorrhage, and then perform scleral incision to drain the liquefied suprachoroidal hemorrhage. However, in the process of waiting for the spontaneous liquefaction of suprachoroidal hemorrhage, uncontrollable elevated intraocular pressure may occur, resulting in optic nerve injury, optic nerve atrophy, and visual loss. In addition, if the suprachoroidal hemorrhage is not completely liquefied, it will not be completely drained, which will lead to choroidal function damage, low intraocular pressure and eyeball atrophy.

Severe ocular rupture can be accompanied by a large amount of subretinal hemorrhage. The traditional treatment is to open the retina in a large area and drain the subretinal hemorrhage. However, extensive retinal incision has great damage, vitreoretinal proliferation often occurs after surgery, leading to recurrent retinal detachment, large area of choroid exposure, low intraocular pressure, and atrophy of the eye.

Tissue plasminogen activator can promote the liquefaction of blood clots. Studies have found that local application of tissue plasminogen activator in the suprachoroidal space can promote the liquefaction of the hemorrhage near the suprachoroidal space, and can drain the hemorrhage of the suprachoroidal space smoothly and completely in the early stage. Local application of tissue plasminogen activator under the retina can promote the liquefaction of subretinal hemorrhage. Through small retinal incision, subretinal hemorrhage can be completely drained, the scope of retinal incision can be reduced, vitreoretinal proliferation can be reduced, and the occurrence of recurrent retinal detachment after surgery can be reduced.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe ocular rupture accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage

Exclusion Criteria:

* Rupture of eyeball accompanied by a small amount of suprachoroidal hemorrhage or a small amount of subretinal hemorrhage