cyrilzakka/clinical-trials huggingface dataset:
Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

Patients experience dramatic quadriceps strength loss after total knee replacement, which contributes to persistent weakness and reduced long-term function after surgery. Neuromuscular electrical stimulation (NMES) reduces quadriceps weakness and improves patient function after knee replacement, but it is drastically underused in rehabilitation practice. This randomized trial will examine the effectiveness and feasibility of a comprehensive strategy for implementing neuromuscular electrical stimulation after knee replacement in two large healthcare organizations.

Total Knee Arthroplasty (TKA) reduces pain and disability caused by knee osteoarthritis, but the surgery results in substantial trauma to the knee. This acute trauma exacerbates underlying weakness-especially in the quadriceps. This leads to muscle atrophy and likely contributes to the long-term weakness and disability patients with TKA experience relative to their healthy peers. Attenuating quadriceps strength loss should be a primary target for improving rehabilitation outcomes after TKA.

Neuromuscular electrical stimulation (NMES) is recommended in TKA clinical practice guidelines to attenuate quadriceps strength loss. In controlled settings, NMES has established efficacy and attenuates quadriceps strength loss by 40% in the first month after surgery by overriding muscle activation deficits and reducing muscle atrophy. However, the effectiveness of NMES after TKA has not been adequately studied in real-world clinical settings, and preliminary data suggests that less than 4% of rehabilitation clinicians are using NMES as recommended by current TKA practice guidelines.

To address this gap, the investigators will conduct a cluster randomized trial in two healthcare systems (UCHealth and Intermountain Health) and their associated outpatient physical therapy clinics (n=30) to evaluate the effectiveness and implementation of NMES to address musculoskeletal deficits after TKA.

The investigators will compare outcomes between patients who receive contemporary rehabilitation supported by a comprehensive NMES implementation strategy (NMES) to patients who receive contemporary musculoskeletal rehabilitation alone (Usual Care; Aim 1). The investigators will gather information on NMES implementation to promote its uptake and translation to clinical practice (Aim 2).

Eligibility Criteria:
Inclusion Criteria:

Site Inclusion Criteria:

• UCHealth or Intermountain Health outpatient physical therapy clinic

Patient Inclusion Criteria:

* Underwent primary unilateral TKA
* Used NMES unit within 7 days after TKA and attended outpatient rehabilitation at a participating clinic within 14 days after TKA
* Attended at least 3 total outpatient physical therapy visits in total

Exclusion Criteria:

Patient Exclusion Criteria:

• NMES Contraindications \[Patients with implanted cardiovascular cardiovertedefibrillator (ICD), active cancer, post-operative diagnosed deep vein thrombosis (DVT) in involved lower extremity\]
UFH is the Most Used Anticoagulant in Hemodialysis, Decreasing the Risk of Clot Formation in the Circuit.

The objective of this study was to verify the clinical non-inferiority of the pharmacodynamic effects and the safety of use of the drug Heptar® manufactured by Eurofarma Laboratory, compared to the drug Liquemine®, manufactured by by Roche Laboratory in patients with renal failure undergoing hemodialysis treatment

Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparino tested. The study was conducted with the participation of 110 chronic renal failure patients of both sexes. over 18 years old who are undergoing hemodialysis treatment 3 times a week and who fit inclusion and exclusion criteria. The investigational products properly patients were administered during 12 consecutive treatment sessions. Hemodialysis at a dose of 150 IU per kg of weight. The study patients were followed clinically and on a laboratory basis in all hemodialysis sessions according to criteria established by the protocol for verifying the safety in use of the product in study.

The evaluation parameters are:

* Pharmacodynamic effect curve (activity) of heparin verified by dosing of TYPE and anti-Xa markers.
* Effectiveness in maintaining blood coagulation during hemodialysis.

  * Blood loss by coagulation of the system;
  * Blood clotting and venous capillary loss;
  * Trunk of the capillary diolysor in the 12 follow-up sessions.
* Safety in drug use through event monitoring complicating the use of heparin as:

  * Increased hematocrit of the patient;
  * Thrombocytopenia;
  * Bruise;
  * Fever;
  * Reactions to allergic agents;

Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes, regardless of color or social class;
* Age over 18 years, with good clinical characteristics at medical discretion;
* Research patients who agree to participate in the study and sign the consent form free and informed;
* Chronic renal failure patients on dialysis regimen (3 times a week).
* Chronic Kidney Failure with indication for anticoagulant during dialysis

Exclusion Criteria:

* Not agreeing with the terms described in the informed consent;
* Research patients with sensitivity to sadistic heparin;
* Research patients with hypersensitivity to benzyl alcohol;
* Research patients with a history of bleeding or disease that change in coagulation may worsen or terminate the clinical picture, such as ulcer gastric;
* Research patients with a history of peptic ulcer.
Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics

chronic PDE5-Inhibition improves endothelial function in diabetics

Evaluation of endothelial function at baseline and after chronic administration of sildenafil in male subjects with diabetes

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* males

Exclusion Criteria:

* females, nitrate use, PDE5-Inhibitors intolerance
Cervical Stabilization in Individuals With Obstructive Sleep Apnea

This study will be performed in people with obstructive sleep apnea, in which one group will receive treatment with cervical stabilization for six weeks and the control group will receive treatment after the interval of six weeks

The objective of this study was to evaluate the muscle strength of the cervical flexor and extensor muscles, to investigate the presence of cervical dysfunction and temporomandibular dysfunction, as well as to verify the effects of cervical stabilization in individuals with obstructive sleep apnea (OSA). The research will be carried out at the Orofacial Motricity Laboratory of the Federal University of Santa Maria (UFSM) and the University Hospital of Santa Maria (HUSM). Men and women between 20 and 60 years of age with a diagnosis of OSA will be invited to participate in this study, confirmed by polysomnography. The sample will consist of 22 patients with OSA, 11 subjects in the OSA group (OSA G) and 11 in the control group (CG) randomly. At the initial evaluation, an anamnesis will be performed and participants will respond to the Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI) and STOP-Bang questionnaire. The craniocervical posture will also be evaluated through photogrammetry (SAPo); The presence and severity of temporomandibular dysfunction (TMD) by the instruments Diagnostic Criteria in Research for Temporomandibular Dysfunction (RDC / TMD) and Temporomandibular Index (TMT); The presence of cervical dysfunction by the Craniocervical Dysfunction Index (CCID); The pressure pain threshold and the strength of the cervical flexor and extensor muscles, by pressure algometry and dynamometry, respectively. The OSA G will be submitted to cervical stabilization using the pressure biofeedback device (Stabilizer) and, after six weeks will be reassessed by the same questionnaires and instruments of the initial evaluation. The CG after six weeks will be reevaluated and the same treatment protocol will be offered.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 20 to 60 years;
* Clinical diagnosis of obstructive apnea of mild, moderate or severe sleep through polysomnography following the apnea / hypopnea index.

Exclusion Criteria:

* Body Mass Index (BMI) greater than or equal to 35 kg / m2;
* Use of continuous positive airway pressure;
* Diagnosis of neurological or neuromuscular disease;
* History of craniocervical trauma;
* Be under physiotherapeutic or speech-language therapy for, respectively, craniocervical and orofacial motor dysfunction or have performed in the last three months;
* Being in use of intraoral orthodontic appliances, which produce mandibular advancement
Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy.

Malaria infection during pregnancy poses substantial risk to the mother, her fetus, and the neonate. Prevention of malaria during pregnancy is vital in decreasing maternal and child mortality in Africa. There are data from studies that show that intermittent preventive treatment (IPT) with two doses of sulfadoxine-pyrimethamine (SP) is safe, efficacious, and effective in preventing maternal anemia, placental parasitemia, and LBW. Resistance to SP, however, is increasing rapidly in Africa and there is an urgent need to find alternative effective, safe and affordable drugs for the treatment and prevention of malaria in pregnancy.

The investigators conducted a trial to determine the efficacy and safety of azithromycin and artesunate combined with sulphadoxine-pyrimethamine as treatment against malaria during pregnancy.Pregnant women 14 to 26 weeks gestation with P. falciparum parasitemia on peripheral blood film were randomly assigned into 3 treatment groups and received two doses of:(1) SP (3 tablets) only; (2) SP and azithromycin (1gram/day x 2 days)and (3) SP and artesunate 200mg/day for 3 days). The two doses of the study drug were administered approximately 4 weeks apart. All study drugs were taken under observation.Blood samples were collected on days 1, 2, 3, 7 and 14 after treatment and at any visit when the women presented with symptoms of malaria. The women were also given an insecticide-treated net (ITN) and followed until delivery. Adverse effects were assessed at each scheduled visit, any unscheduled visits during the study, and at delivery. Peripheral and placental blood films and placental biopsies were prepared at delivery. Newborns were weighed, examined, and gestational age was determined.

Eligibility Criteria:
Inclusion Criteria:

* peripheral malaria parasitemia
* signed informed consent
* age 15-49 years
* mother has felt the movements of the foetus (quickening)
* fetal age of at least 14 but not more than 26 completed gestation weeks
* maternal availability for follow-up during the entire period of the study

Exclusion Criteria:

* known maternal tuberculosis, diabetes, kidney disease, or liver disease
* mental disorder that may affect comprehension of the study or success of follow-up
* twin pregnancy
* pregnancy complications evident at enrollment visit (moderate to severe oedema, blood Hb concentration \< 7 g / dl, systolic blood pressure (BP) \> 160 mmHg or diastolic BP \> 100 mmHg)
* prior receipt of azithromycin during current pregnancy
* receipt of any antimalarial within 28 days before enrollment
* known allergy to drugs containing sulfonamides, macrolides or pyrimethamine
* history of anaphylaxis
* history of any serious allergic reaction to any substance, requiring emergency medical care
* history of hepatitis or jaundice
* concurrent participation in any other clinical trial
Immune Responses in Health Care Personnel

This is an investigator-initiated 10 year long open cohort observational study, aiming to increase the understanding of the humoral and cellular immunological mechanisms of vaccination against influenza, including effects of repeated vaccination, the duration of protection, immunity against circulating viruses, as well as factors affecting the immunological responses and immunity against other vaccine preventable infectious diseases among health care personnel.

Influenza vaccination is given according to the normal routine of Hospital District of Helsinki and Uusimaa (HUS) occupational health care. Blood samples will be collected before vaccination, 5 weeks after vaccination and 6 months after vaccination. Both the same participants and also new participants will be recruited each year. The analysis will be mainly descriptive.

Eligibility Criteria:
Inclusion Criteria:

* Members of health care or laboratory personnel in HUS having decided to take the seasonal influenza vaccination by the routine occupational health care service
* General good health as established by or volunteer's own statement
* Written informed consent
* Presumably able and willing to participate in the study during the starting influenza season

Exclusion Criteria:

* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* Administration (longer than 14 days) of immunosuppressants or other immune- modifying drugs within 6 months before the vaccination; oral corticosteroids in dosages of 20 mg/day or more prednisolone or equivalent are excluded; inhaled or topical steroids are allowed.
* Pregnancy or lactation
* Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever)
* Contraindication for influenza vaccination
* Any other criteria which, in the investigator's or dedicated study staff member's opinion, would compromise the ability of a subject to participate in the study, a subject's well-being, or the outcome of the study
Esomeprazole And Symptomatic Response In Patients With Or Without An Elevated Risk For Non-Steroidal Anti-Inflammatory Drug (NSAID)-Associated GI Damage

The purpose of this study is to compare the treatment effect in patients with upper gastro-intestinal complaints with an elevated risk for NSAID-associated GI-damage to those without an elevated risk for NSAID-associated damage (as determined by the treating physician).


Eligibility Criteria:
Inclusion Criteria:

* Patient with upper gastro-intestinal complaints (defined as heartburn and/or regurgitation and/or nausea and/or bloated feeling)and treatment with esomeprazole 20mg once daily is started because of this (consult 1). Upper gastro-intestinal complaints are thought to be related to NSAID use
* Patient is using an NSAID\*\* with the following conditions:

  * NSAID use has started at least one week before 1st consultation and is expected to be continued unchanged during the coming period (at least until consult 2)
  * NSAID is taken at least 3 days a week

(\*\*)OTC or Prescription NSAID

(\*\*)Conventional NSAID or COX-2 selective NSAID

Exclusion Criteria:

* Use of a PPI and/or H2RA in the month preceding the study
* A history of reflux disease, not related to NSAID use
Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment

Long-term tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis and prevent delay \& reduce flares


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient of any ethnic group
* Patient was at least 16 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3)

Exclusion Criteria:

* Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
* Patient had a clinically significant skin infection on the affected (and to be treated) area
Status Epilepticus Population Study (STEPS)

The aim of this observational multicenter cohort study is to gain a deeper understanding regarding the effects of treatment adaption based on information from outcome prediction models, risk stratification, as well as treatment monitoring, detection, prevention, and management of complications on course and outcome of adult patients with status epilepticus (SE).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (i.e., patients ≥18 years of age) with diagnosed SE between 2005 and 2023 who have been treated at the University Hospital of Basel or the Cantonal Hospital Aarau.

Exclusion Criteria:

* Patients younger than 18 years.
* Patients with repetitive epileptic seizures not qualifying for SE.
* Patients with documented refusal of the general consent.
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms.

Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age above or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m\^2) or b) BMI greater than or equal to 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

Exclusion Criteria:

- Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus
Upper Limb-based Movement Priming for Lower Limb Neuroplasticity & Motor Recovery in Stroke

The goal of this clinical trial is to to determine the effect of movement-based priming using the upper limbs on lower limb neuroplasticity and behaviors in chronic stroke.

The main questions we aim to answer are:

1. What are the acute effect of UL-priming on lower limb neuroplasticity and motor behaviors in persons with stroke compared to other priming modalities?
2. What are the time effects of UL-priming on neuroplasticity and motor behavior in individuals with stroke?

   In this cross over study, participants will be involved in three priming sessions involving

   - UL-priming using rhythmic, symmetric, bilateral priming involving the movement of at least one major joint in the upper limbs.

   AND

   - Sham priming using auditory stimulation (1 Hz metronome).

   AND

   - Lower-limb movement-based priming using rhythmic, symmetric, dorsiflexion and plantarflexion movements.

   Researchers will compare outcome measures between the different priming sessions.


Eligibility Criteria:
Inclusion Criteria:

* Single, monohemispheric stroke
* Chronic stroke (\> 6 months prior)
* Residual hemiparetic gait deficits (e.g., abnormal gait pattern)
* Minimum score of stage 2 on the Chedoke Arm Impairment Scale which includes stage 2, task 3 (facilitated elbow flexion) as one of the stage 2 tasks.

Exclusion Criteria:

* Use of anti-spasticity medications
* Existence of other neurological disorders
* Have brainstem or cerebellar lesions.
* Score of ≥2 on the Modified Ashworth Scale.
* MMSE score of \<21, to ensure they will follow instructions.
* Non-English-speaking individuals
* Bone, joint or soft tissue injury
* Uncontrolled medical conditions (such as uncontrolled hypertension, untreated cardiac disease, or untreated pulmonary disease)
* No Motor evoked potentials (MEPs) during TMS

TMS exclusion criteria

* Previous adverse reaction to TMS
* Skull abnormalities or fractures
* Concussion within the prior 6 months
* Unexplained, recurring headaches
* Implanted cardiac pacemaker
* Metal implants in the head or face
* History of seizures or epilepsy
* Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)
* Current pregnancy
A Study of Motexafin Gadolinium for the Treatment of Relapsed or Refractory Multiple Myeloma

The purpose of the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or Refractory Multiple Myeloma
* ≥ 18 years old
* Able to provide consent for participation
* ECOG status 0-2

Lab values:

* ANC ≥ 1,000/µL
* WBC count ≥ 2.0/µL
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 50,000/µL
* AST and ALT ≤ 2 x ULN
* Total Bilirubin ≤ 2 x ULN
* Creatinine ≤ 2.0 mg/dL

and

* Not pregnant or lactating
Effect of Prophylactic Negative Pressure Versus Silver Impregnated Silicone Bandage on C-Section Infection Rates

Effect of Prophylactic Negative Pressure versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate

Comparison of effect of Prophylactic Negative Pressure versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate as compared to wound vacuum in high risk women and traditional border dressing in low risk women in adult women having uncomplicated cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* adult women, pregnant

Exclusion Criteria:

* \<18 years old
* surgery complicated by non-routine surgeries (Such as appendectomy)
Improving IVF Embryo Quality Grading Using Polarized Light

Selecting one or two IVF embryos with the highest potential to implant is extremely important for the success of the treatment- obtaining pregnancies and avoiding multi-fetal gestations. The currently used IVF embryo grading method is based solely on embryo morphology (cleavage rate and fragmentation) just before the transfer, which is not very well correlated with the implantation potential of each embryo. Oocyte quality and adequacy are the most important factors determining the biological quality and implantation potential of the embryo. It impossible to grade oocytes using plain optical systems, other than maturity and gross anomalies.

Polscope systems allow to visualize intra ooplasmic structures and determine their retardance, as well as that of the Zona Pellucida. The investigators hypothesize that grading embryos using the oocyte's parameters as visualized by polscope is superior to conventional morphology and correlates better with their implantation potential.

Here the investigators will perform a prospective randomized controlled trial to examine this hypothesis.

Each embryo will be graded in accordance to polscope based parameters; the presence of a spindle in the oocyte, its retardance, the distance between the spindle and the PB, and the thickness and retardance of the ZP.

In the experimental group the embryos for transfer will be selected based on these parameters, whereas in the control group they will be selected based on conventional morphologic criteria.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-38, (near) normal MF, normal uterus, \>4 aspirated oocytes, intent to transfer 1-2 embryos.

Exclusion Criteria:

* Severe MF problems, uterine anomalies, PGD, RIF.