cyrilzakka/clinical-trials huggingface dataset:
Prolectin-M in COVID-19 Patients Having Mild to Moderate Symptoms Not Requiring Oxygen Support.

A randomised controlled trial of open label Prolectin-M; a (1-6)-alpha-D-Mannopyranose among patients with RT PCR positive COVID-19 patients.

SarsCoV2 has infected over 20 million people worldwide. The virus has a unique protein structure enabling it to rapidly infect and spread among the population. COVID19 is a global health emergency and has affected lives of all people irrespective of being infected. There are no proven therapies and a vaccine is yet to be approved for wide public usage.

Our study aims to test a hypothesis of physically blocking the spike protein from infecting the human cells, thus promoting its rapid excretion from the infected person.

We will randomise 10 subjects in this proof of concept trial and test the hypothesis by measuring the effect of Prolectin-M; a (1-6)-alpha-D-Mannopyranose in reducing the viral copy numbers over 5 days of treatment. The absolute copy numbers will be measured on digital droplet PCR developed by BioRad. A fall in copy numbers by 2-fold from baseline will be considered a positive treatment effect in this population. All standard care measures currently being practiced for these patients will be continued.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic and laboratory-confirmed diagnosis of COVID-19.
* Age ≥18 years and ≤45 years, male and non-pregnant female
* Identified within 72 hours of testing positive on RT PCR.
* Able to give informed consent to stay in institutional care and undergo 3 times collection of throat and nasal swabs over 7-day period; Day 1, Day 3 and Day 5 since randomization.

Exclusion Criteria:

* Oxygen saturation at admission ≤96%.
* High temperature ≥100 deg F (≥37.5 deg C) not controlled on oral doses of acetaminophen.
* Known history of diabetes on oral medications or insulin.
* IL-6 levels ≥ 3times of laboratory reference range and / or significantly elevated levels of CRP, serum ferritin or d-dimer.
* Lymphocyte / monocyte ratio ≤3 or neutrophil / lymphocyte ratio ≥5 or platelet count ≤150,000 cells per microliter
* On any chronic medications for more than 4 weeks before randomization or active malignancy or having any co-morbidity that increases risk of rapid disease progression.
* Previously tested positive and recovered from COVID-19
Hip Activation and FSDT

The purpose of this study is to determine if activation training of the hip musculature affects muscle activation and frontal plane mechanics in healthy individuals.

Specific Aim 1: Determine whether performance on the forward step-down test (FSDT) changes after an eight-week home exercise program (HEP) focused on hip musculature activation in healthy individuals.

Specific Aim 2: Determine whether surface electromyography (sEMG) hip musculature changes following an eight-week HEP focused on hip musculature activation in healthy individuals.

Specific Aim 3: Determine whether a dose-response relationship exists between compliance on the HEP and changes in FSDT scores in healthy individuals.

Specific Aim 4: Determine whether a dose-response relationship exists between compliance on the HEP and sEMG changes in hip musculature activation in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be current first or second year Doctor of Physical Therapy students in the School of Allied Health Professions at LSU Health Shreveport.

Exclusion Criteria:

* Current knee pain or pathology in the dominant leg, and women with known pregnancy.
Mometasone and Markers of Airway Inflammation

A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.

Patients with asthma and not treated with anti-inflammatory medications were studied. This was a parallel, randomized, placebo-controlled study to investigate the effects of Asmanex on markers of airway inflammation including exhaled nitric oxide, airway reactivity, FEV1 and nitrates/nitrites and pH in exhaled breath condensate.

Eligibility Criteria:
Inclusion Criteria:

* Asthma
* non-smoker
* FEV1 of at least 60% predicted

Exclusion Criteria:

* Pregnancy or lactation
* Corticosteroid use in past 30 days
Maternal- Fetal Infection

The purpose of the protocol is to validate a novel point of care multiplex system to detect and characterize microorganisms responsible for neonatal sepsis, as well as biomarkers of infection, from a simple vaginal sample, in order to improve the prevention of perinatal bacterial infections.

Early-onset neonatal sepsis (EOS) is a major global public health challenge. Prevention during pregnancy and delivery, early diagnosis and treatment of perinatal infections are essential to avoid EOS. Risk factors for include prematurity, maternal Group B streptococcus (GBS) colonization, premature rupture of membranes (PROM), and chorioamnionitis. Screening and intrapartum antimicrobial prophylaxis administered to GBS-colonized women has reduced early onset GBS infections. However, other pathogens are frequently involved in EOS following preterm PROM and preterm birth (PTB), such as Gram-negative bacteria and Staphylococci, which are not covered by penicillin prophylaxis. The prevalence of neonatal infection arising from antibiotic-resistant bacteria is increasing, thus the challenge is to eliminate the widespread unnecessary use of broad-spectrum antibiotics to treat non-infected infants, while recognizing when antibiotics are truly needed. Rapid diagnostic test(s) to detect and quantify specifically pathogens in vaginal samples, could be a major breakthrough. Several rT- PCR ( reverse Transcriptase Polymerase Chain Reaction) tests are on the market, however so far no test is able to detect, quantify and characterize in terms of antibiotic resistance and virulence genes, a range of pathogens.

A novel multiplex platform, using microfluidics technology, is under development by Elvesys, Inc in France. This platform will be able to offer results within 15 minutes on-site.

In addition, the study of the vaginal microbiome may identify signatures associated with a risk of maternal-fetal infection, particularly in case of PROM or PTB. Advanced sequencing technology and metagenomics will be used to characterize these signatures, and may lead to further markers to be included in the point-of-care test. Finally, biomarkers of inflammation will be detected, including IL-6 (Interleukin).

In this study, the InSPIRe platform will be compared in the laboratory to conventional microbiological and immunological detection.

Four groups of pregnant women will be recruited in prospective cohorts : uneventful pregnancies, term PROM, preterm labor and preterm PROM.

The purpose of the InSPIRe project is to improve the prevention of perinatal bacterial infections, with the novel Elvesys point of care system to rapidly detect and characterize microorganisms responsible for neonatal sepsis from a single vaginal sample.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman,
* Gestational age over 22 SA,
* Patient agreeing to sign informed consent,
* Patient aged at least 18 years old,
* Patient with health insurance,
* Singleton, twin or multiple pregnancy.

Exclusion Criteria:

* Fetal death or non-viable fetus,
* maternal age under 18,
* Patient unable to express her consent,
* Patient under guardianship.
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease

This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.


Eligibility Criteria:
Inclusion Criteria:

* Patients who participate and complete the core CAIN457A2202 study up to and including Visit 11 (end of study), may enter the extension study upon signing informed consent.

Exclusion Criteria:

* Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
* Patients who were non-compliant or who demonstrated a major protocol violation in the core CAIN457A2202 study
* Patients who discontinued from the core CAIN457A2202 study before Visit 8 (day 43).

Other protocol-defined inclusion/exclusion criteria may apply
Piracetam for Treatment of Cocaine Addiction - 3

The purpose of this study is to evaluate the effects of IV cocaine administration in cocaine dependent subjects maintained on piracetam while they are residing in an inpatient addictions treatment research unit and to subsequently follow these patients in an eight week open label assessment of piracetam in an outpatient treatment program.


Eligibility Criteria:
Please contact site for information.
A Registry for Nontuberculous Mycobacterial Pulmonary Disease

Background:

NTM(Nontuberculous mycobacteria) pulmonary disease is increasing worldwidely, however the diagnosis and treatment of NTM pulmonary disease still has multiple obstacles. The initiation of treatment is not necessary for all patients with NTM pulmonary disease. In addition, the drugs for treatment of NTM pulmonary disease is not enough.

objective. The aim of this prospective registry for Nontuberculous mycobacterial pulmonary disease is to register the NTM pulmonary patients and analysis of the treatment outcome based on the species and to collect the blood and urine samples from the patients for exploring the biomarker for diagnosis and monitoring the NTM pulmonary disease and collect the nontuberculous mycobacterium.

Methods:

1. informed consents
2. register in cohort and collect the clinical information and serum, plasma, urine and mycobacteria
3. follow up 6 months to 1year based on the clinical situation

Analysis:

1. treatment outcome based on NTM-NET consensus statement
2. exploration of biomarker for progression and monitoring of treatment response


Eligibility Criteria:
Inclusion Criteria:

1. age 20 or more than 20 years
2. diagnosed by ATS criteria for NTM pulmonary disease

Exclusion Criteria:

1) not specific
Effectiveness of VR Exercise Intervention on Functional Fitness and Quality of Life Among Elderly

The aim of this study is to determine the effect of virtual reality-based exercise on the intervention and follow-up retention of functional fitness and quality of life among older adults.

In a worldwide survey of fitness trends last 2021, Virtual Reality (VR) training recently took the top 10 spots. In fact, only a few studies were conducted on the retention of functional fitness and quality of life among older people. The main goal of this study was to assess the effects of virtual reality exercise on the functional fitness and quality of life of older adults after 12 weeks of intervention and another 12 weeks of follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 65,
2. are able to perform daily activities,
3. with no past or current history of medical situations found in the Physical Activity Readiness Questionnaire (PAR-Q).

Exclusion Criteria:

1. being less than 65 years of age,
2. being unfit to participate in the study as revealed by the PAR-Q.
Banded Versus Non-banded Roux-en-Y Gastric Bypass

This is a prospective randomized Study comparing Weight loss, Esophageal Motility and Reflux in lap. Gastric Bypass vs. lap. Banded-Gastric Bypass using the A.M.I. Soft Gastric Bypass Band (B-Band.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40 or BMI \> 35 + hypertension/diabetes mellitus
* pH metry and manometry preoperatively

Exclusion Criteria:

* formerly operations of the stomach
* formerly open abdominal surgery
* malignancy within the last 5 years
* formerly gastric banding
First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine

The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of chronic migraine.


Eligibility Criteria:
Main Inclusion Criteria:

* Able and willing to provide informed consent
* Age ≥ 18 years and ≤ 84 years at time of consent
* Documented Chronic Migraine, defined as at least eight migraine days/month, for at least 1 year.
* Developed migraine before the age of 50
* Documented failure of 3 or more other preventive therapies (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) from which at least 1 of the following 2: CGRP mAbs or Onabotulinumtoxin A
* Have at least 1 headache free day per month
* Stable on preventive migraine drugs and alternative treatment for at least three months prior to enrollment.
* Agree to refrain from starting new preventive migraine drugs or other preventive alternative migraine treatments, from 4 weeks before entering the baseline period throughout the duration of the study.
* MRI available (not older than 4 years prior to study enrollment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
* Able and willing to complete a daily headache eDiary

Main Exclusion Criteria:

* Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from migraine attacks, based on the quality of pain and associated symptoms.
* Concomitant neuromodulation
* Previous failure to an implantable neuromodulation device for neurovascular headache
* Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, ...)
* Metal implants in the skull (e.g. skull plates, seeds) nearby the implant.
* Have a pacemaker of implantable cardioverter defibrillator (ICD)
* Current Opioid Use, defined as one or more opioids on more than 4 days/month for 3 consecutive months.
* Use of botulinum toxin injections in the past 3 months.
* Women of childbearing age who are pregnant, nursing or not using contraception
Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class

This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be documented.


Eligibility Criteria:
Inclusion Criteria:

* Implanted pacemaker for more than 6 months, VVI/DDD, written consent

Exclusion Criteria:

* Pacemaker implanted for less than 6 months, no right ventricular pacing possibility (AAI), no consent
Efficacy of L-Ornithine L-Aspartate in Acute Hepatic Encephalopathy.

Hepatic encephalopathy is caused by the effects on the brain of substances that under normal circumstances are efficiently metabolized in the liver. The hyperammonemia is the main factor responsible for the development of hepatic encephalopathy. In patients with cirrhosis, the reduction in hepatocellular function and generation of portosystemic shunts contribute to increase serum ammonium. The current therapeutic approaches, are aimed at reducing blood ammonium levels.

Administration of the non-absorbable disaccharides, have become standard treatment of hepatic encephalopathy.There are no adequate clinical trials comparing the efficacy of L-Ornithine-L-Aspartate (LOLA) infusion against lactose enemas in the treatment of acute hepatic encephalopathy.

The main impact of hepatic encephalopathy in patients with cirrhosis is not related to costs, but its association with decreased survival and quality of life and should therefore clearly established the effectiveness of therapeutic interventions used in this disorder.

At the end of the nineteenth century to the ammonium was identified as the main agent responsible for the development of the syndrome of hepatic encephalopathy. Since then, reduced nitrogen compounds from the intestine are considered the main therapeutic measure. On this conceptual base, nonabsorbable disaccharides are the first line therapy in hepatic encephalopathy.

Current knowledge indicates that other organs such as muscle, brain and kidney are involved in the generation of ammonium, which has set the pace for the development of new treatments, able to act systemically in metabolism and elimination of ammonia . L-ornithine L-aspartate (LOLA) lowers ammonium concentrations in animal and humans models with hyperammonemia. There are no adequate clinical trials comparing the efficacy of LOLA infusion against lactose enemas in the treatment of acute hepatic encephalopathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis of any etiology, diagnosed by ultrasound,clinical and / or histologic criteria
* Patients over 18 years and under 75
* Patients with hepatic encephalopathy grade 3-4 according to the criteria of West Haven
* Patients with hyperammonemia \>10 µmol/l

Exclusion Criteria:

* Evidence of neurological or psychiatric illness
* Use of drugs affecting the central nervous system
* Withdrawal Syndrome
* Anorectal disease that interferes with the administration of enemas
Clavipectoral Fascial Plane Block Versus Superficial Cervical Block in Fracture Clavicle

Ultrasound-guided Clavipectoral fascial plane block versus ultrasound-guided superficial Cervical plexus block in patients undergoing fracture clavicle operation

The clavipectoral fascial plane block (CPB) is a novel regional anesthesia technique that has been utilized for clavicular fracture surgery. It has been hypothesized that the CPB is an effective regional anesthesia technique for peri-operative analgesia since the terminal branches of many of the sensory nerves like suprascapular, subclavian, lateral pectoral, and long thoracic nerves pass through the plane between the clavipectoral fascia and the clavicle itself.

The ultrasound-guided superficial cervical plexus (SCP) block may be useful for providers in emergency care settings who care for patients with ear, neck, and clavicular region injuries, including clavicle fractures and acromioclavicular dislocations. The SCP originates from the anterior rami of the C1-C4 spinal nerves and gives rise to 4 terminal branches (greater auricular, lesser occipital, transverse cervical, and suprascapular nerves) that provide sensory innervation to the skin and superficial structures of the anterolateral neck and sections of the ear and shoulder.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 21 to 60 years
2. Both gender
3. Isolated fracture clavicle.
4. ASA classification 1 \& 2

Exclusion Criteria:

1. Polytrauma patients with multiple fractures.
2. Hemodynamically unstable patients.
3. Patients with infection at the injection site.
4. Refusal of patients.
5. Patients with disturbed anatomical plane.
6. Patients with a known history of allergy to local anesthetic will be used.
Non Invasive Pressure Support Ventilation (NIPPV) Versus Recruitment Maneuver (RM) and Preoxygenation

The purpose of this study is to compare the effects of noninvasive pressure support ventilation and early alveolar recruitment maneuver during anesthesia induction of morbidly obese patients on both oxygenation and functional residual capacity modifications.

Atelectasis formation during general anesthesia, leading to reduced end-expiratory lung volume, is an important cause of intrapulmonary shunt leading to impaired gas-exchange and hypoxemia. During general anesthesia and the immediate postoperative period, morbidly obese patients, who develop a larger amount of atelectasis than non-obese patient, are more likely to present impairment of gas exchange and respiratory mechanics. Noninvasive positive-pressure support ventilation (NIPPV) and positive end-expiratory pressure (PEEP) are effective to provide oxygenation during intubation of hypoxemic patients. Recent data suggest that NIPPV enhances preoxygenation in morbidly obese patients. Moreover, the application of PEEP during induction of anesthesia prevents atelectasis formation and increases nonhypoxic apnea duration in obese patients despite the use of high-inspired oxygen fraction. However, the use of both NIPPV is widely used in the operating room, because of technical and materials constraints.

Several trials have demonstrated that alveolar recruitment maneuvers (RM) are effective to remove atelectasis and improve lungs mechanics and gas-exchange.

The purpose of this randomized and controlled study is to compare the effects of two ventilatory strategies during anesthesia induction of morbidly obese patients on both gas-exchange and functional residual capacity (FRC) modifications: 1- Control group: preoxygenation using 100% O2 via a face-mask and PEEP 10 cmH2O after intubation; 2- NIPPV group: preoxygenation using NIPPV and PEEP 10 cmH2O after intubation; 3- RM group: preoxygenation using 100% O2 via a face-mask and early RM plus PEEP 10 cmH2O after intubation.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI \> 30 kg/m2)
* Age \> 18 years
* ASA I-III

Exclusion Criteria:

* Age \< 18 years
* Patient refusal
* Pregnancy
* Emergency surgery
* COPD with FEV1 \< 50%
* History of pneumothorax
* Severe asthma
* Cardiac failure (NYHA \> 2)
* Ischemic heart disease
Aerobic Exercise Training in Amyotrophic Lateral Sclerosis

The purpose of this study is to compare the safety and the effects of moderate-intensity aerobic endurance training to those of an usual physical therapy intervention on exercise capacity and quality of life in patients with amyotrophic lateral sclerosis (ALS).

Scarce evidence is available regarding aerobic exercise training of patients with ALS. Some studies using transgenic mouse models of familial ALS have shown markedly slowed disease progression, improved functional capacity, and extension of survival in animals undergoing aerobic exercise training. In humans, only one non-randomized study has shown that moderate-intensity aerobic exercise training was of little beneficial effect in a small group of patients with Kennedy disease, a rare X-linked progressive neuromuscular disease involving lower motorneurons, presenting a pathophysiological picture quite different from that of ALS. To the best of our knowledge, the safety and the effects of aerobic exercise training on functional capacity and quality of life of patients with ALS have not been systematically evaluated as yet in a randomized, controlled trial with an adequate sample size.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definite ALS, probable ALS, or probable-laboratory supported ALS according to the El Escorial criteria or diagnosis of progressive muscular atrophy.
* Ability to perform a baseline symptom-limited cardiopulmonary exercise test with attainment of peak power and respiratory exchange ratio of \>= 50 W and \>= 1.00, respectively.
* Time since symptoms onset \<= 18 months.
* Forced vital capacity \>= 70% of predicted.
* Informed written consent.

Exclusion Criteria:

* Coexisting neurological disease.
* Coexisting extra-neurological disease significantly affecting exercise capacity.
* Coexisting malignancy.
* Ongoing/planned pregnancy.
* Involvement in formal endurance and/or strength training program.
* Enrolment in any other clinical trial.
* Cognitive impairment.
Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)

The current gold standard for treatment of chronic hepatitis C (CHC) patients is with pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegPen. The goal of this study is to determine the satisfaction grade with this novel device.

Enrollment of patients will occur in a sequential order of treatment initiation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with hepatitis C

Exclusion Criteria:

* According to the products' labeling.