cyrilzakka/clinical-trials huggingface dataset:
Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease

Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary disease. In this study the investigators investigate whether IMT associated with exercise training would be better than exercise training alone, with regard to exercise capacity, inspiratory muscle strength and dyspnea.

Study design: A double-blind parallel controlled trial Setting: outpatient clinic Inclusion criteria: Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program, with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).

Outcome measurements: Inspiratory muscle strength (using maximal inspiratory pressure, MIP), exercise capacity (using six-minute walk test) and dyspnea were measured.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
* In a stable condition (without exacerbations or infections for at least a month)
* Had to be former smokers (\> 6 months without smoking)
* subjects referred by a physician to the Pulmonary Rehabilitation Program

Exclusion Criteria:

* Subjects with a known history of asthma, or severe and/or unstable heart disease or any other pathological condition that could impair their physical activities
Robot-Aided Neurorehabilitation of the Upper Extremities

Task-oriented repetitive movement can improve movement performance in patients with neurological or orthopedic lesions. The application of robotics can serve to assist, enhance, evaluate, and document neurological and orthopedic rehabilitation of movements. Arm therapy is used in neurological rehabilitation for patients with paralyzed upper extremities due to lesions of the central or peripheral nervous system, e.g. after stroke or spinal cord injury. The goal of the therapy is to recover motor function, improve movement coordination, learn new motion strategies ("trick movements"), and/or prevent secondary complications such as muscle atrophy, osteoporosis, and spasticity.


Eligibility Criteria:
Inclusion Criteria:

Patients with neurological disability of the upper limb with qualification for arm training, e.g. after stroke and spinal cord injury

Exclusion Criteria:

* limitations of the join mobility
* osteoporosis
* cardiovascular disease
* injury of the upper limb
* decubitus
* psychic diseases (like schizophrenia, dementia, depression)
* Body weight \> 120kg
* pacemaker.
Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus

Our purpose is to analyze the changes induced in the posterior corneal surface in patients implanted with intracorneal ring segments for treatment of keratoconus. Patients are assessed with corneal imaging device preoperatively and at 1, 3, 6 and 12 months postoperatively.

Procedure: Femtosecond laser assisted implantation of intracorneal ring segments in keratoconus patients Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, keratometric (K) readings of the anterior and posterior surface, corneal asphericity (Q value) of the anterior and posterior surface, and anterior and posterior elevations are evaluated using a corneal imaging device preoperatively and at 1, 3, 6 and 12 months after surgery.

Eligibility Criteria:
Inclusion Criteria

* Patients with keratoconus grade 1, 2 or 3 according to Amsler-Krumeich classification.
* Best corrected visual acuity (BCVA) ≤ 6/12.
* Mean front keratometric (K) readings ≤ 60 diopters (D).
* Corneal thickness ≥ 400 µm at the location of ICRS implantation.
* Clear central cornea

Exclusion Criteria

* Central corneal opacity.
* Previous corneal laser refractive surgery.
* Previous corneal collagen cross linking.
* Previous cataract surgery or phakic IOL implantation.
* History of herpetic keratitis.
* History of acute hydrops.
* Ocular comorbidities such as cataract, glaucoma or retinal disease.
* Systemic diseases affecting healing process such as autoimmune or connective tissue disease.
Acceptability of Zinc-fortified Lipid-based Nutrient Supplements

The purpose of the study is to assess the acceptability of the two lipid-based nutrient supplement (LNS) formulations containing no zinc and a high amount of zinc (10 mg zinc / 20 g dose of LNS). The hypothesis is that both products will be equally accepted by children and mothers.

We plan to conduct a series of acceptability studies to: 1) assess the amounts of zinc-free and high-zinc LNS consumed by children during direct observation, 2) compare their mothers' sensory assessments of the respective products, and 3) review maternal reports of their child feeding experiences during more prolonged home feeding trials.

Eligibility Criteria:
Inclusion Criteria:

* Currently breast-feeding and consuming complementary foods for at least 30 d

Exclusion Criteria:

* Height-for-age and weight-for height Z-scores \<-3 with respect to WHO growth standards
* Edema
* Diarrhea and other diseases that could interfere with food intake
* Severe systemic illness
* History of peanut allergy
* History of anaphylaxis/serious allergic reaction

Infants meeting these criteria and their mother's will be invited to participate
Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse

The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of combined oxazepam and naltrexone for managing methamphetamine dependence.


Eligibility Criteria:
Inclusion Criteria:

* Lifetime methamphetamine use

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to methamphetamine (Desoxyn®), oxazepam (Serax®) or naltrexone (Revia®)
Personalization of Long-Term Antiplatelet Therapy - RAPID EXTEND

In patients after myocardial infarction (MI) (heart attacks) and treated with percutaneous coronary intervention (PCI), the current standard is dual antiplatelet therapy (DAPT), with aspirin and a P2Y12 receptor inhibitor, for 1 year of treatment. At 1 year, there are several options including: i) Ongoing DAPT (with aspirin and ticagrelor), ii) Selective treatment use of a P2Y12 inhibitor based on risk profiles.

This study is a pilot vanguard study to evaluate several strategies for choosing anti-platelet regimen among patients post MI and PCI at 1 year.

The present study is a pilot/vanguard 3-arm study that seeks to compare 3 possible strategies for patients that are 1 year post MI and PCI. The 3 randomized groups include: i) aspirin and ticagrelor 60 mg twice daily, ii) monotherapy with ticagrelor 60 mg twice daily and iii) a personalized arm (PA), where patients will get selective therapy based on demographic and genetic risks.

The PA group will use a modified DAPT score based on patient demographics to decide whether P2Y12 treatment is warranted. For those patients where treatment is warranted, a bedside genetic test will be used to determine whether they are carriers of at-risk genotypes, which put them at risk for under-responsiveness to clopidogrel (one of the specific P2Y12 inhibitors). Those identified as carriers will be treated with ticagrelor while non-carriers will be treated with clopidogrel.

The study will act as a vanguard study to prove feasibility of enrollment and document overall bleeding rates. The long-term goal of the study is determine whether a personalized approach will decrease bleeding versus an approach of DAPT with ticagrelor and versus an approach with ticagrelor monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* \>50 years old at 1-year after myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI)) during which they had percutaneous coronary intervention (PCI)
* Compliant with dual antiplatelet therapy (DAPT) for ≥ 1 year without an ischemic or bleeding complication after PCI
* Still on DAPT regimen at enrollment
* Patients must have 1 of the following atherothrombotic risk enrichment criteria:

  i) Age≥ 65 years ii) Diabetes iii) 2nd Prior MI (\>1 year ago) iv) multi-vessel coronary disease v) creatinine clearance (CrCl) \<60 mL/min.

Exclusion Criteria:

* Intolerance to ticagrelor or clopidogrel
* \>18 months post percutaneous coronary intervention (PCI) and myocardial infarction (MI)
* Requirement of a P2Y12 inhibitor
* Requirement of oral anticoagulation
* Take concurrent CYP3A inducing drugs which may interact with ticagrelor (e.g. anti-epileptic drugs)
* History of stroke, TIA or intracranial bleed
* Recent GI bleed or major surgery
* Life expectancy of \< 1 year
* Platelet count \< 100,000/μl
* Bleeding diathesis
* On dialysis
* Severe liver disease
* At risk for bradycardia.
Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers

Sepsis induces hemostatic disorders due to the exessive or inappropriate activation of inflammation, which could lead either to hypercoagulability or hypocoagulability. It is currently not possible to determine the hemostatic status of a given patient. This instability of hemostatic system is not revealed by classical tests. Thus, a better characterization of hemostatic status could certainly improve patient care. This study aims at characterizing disorders of coagulation and fibrinolysis using "global" tests such as thrombin generation test or coagulolytic test. Furthermore, the association with biological markers of interest (such as microparticles, neutrophil elastase or histones) will be evaluated.


Eligibility Criteria:
Eligibility criteria for patients with septic schock

Inclusion Criteria:

* septic shock (Dellinger, 2013)
* age \>18y
* hospitalized patients
* signature of an informed consent (emergency consent)
* affiliation to a social security regimen

Exclusion Criteria:

* pregnancy or breast-feeding women
* moribund patient
* oral anticoagulant therapy
* thrombophilia
* Minor patients
* Patients under tutelage

Eligibility criteria from subject without septic shock Subject blood samples without septic shock are collected from a historical healthy volunteers cohort.
Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)

Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.

The primary hypothesis is that reversing the hypothyroid status with levothyroxine on top of standard therapy for AMI is safe and has beneficial effects on cardiac function, myocardial perfusion/metabolism and myocardial fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 75, male or non-pregnant female;
2. Is diagnosed acute myocardial infarction and received primary percutaneous coronary intervention (PCI);
3. With presence of hypothyroid status (i.e., TSH \>7.0 mIU/L and (or) fT3 \<1.79 pg/mL);
4. Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Exclusion Criteria:

1. Those who have participated in other drug or therapeutic equipment clinical trials but do not reach the main study endpoint time limit;
2. Symptoms of severe heart failure (Killip Class III and above);
3. Severely impaired renal function before surgery: serum creatinine \> 2.0mg/dl;
4. Impaired liver function before surgery: Serum GPT \> 120U/L;
5. Those who have prior thyroid diseases and already on levothyroxine or anti-thyroid medicines;
6. Those taking medicine which can affect the test of thyroid function;
7. Patients who plan to undergo coronary artery bypass grafting or other surgery within 3 months;
8. Those having prior myocardial infarction;
9. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.
Randomized Clinical Trial of Skin Closure With Staples Versus Suture

Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.

The investigators propose a randomized controlled trial to evaluate for a difference in wound complication rate between closure with sutures that are placed just below the skin level to hold the skin together and metal staples in obese women (BMI\>=30) undergoing gynecologic or gynecologic oncology via a midline skin incision for benign or cancer indications under the supervision of one of the full-time faculty members of the Division of Gynecologic Oncology at Washington University School of Medicine.

Eligibility Criteria:
Inclusion Criteria:

* All women, \>=18 and \<= 85 years of age, undergoing surgery, via a midline laparotomy.
* Body mass index \>=30
* Benign or oncologic indications for surgery.
* Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.
* Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Pfannenstiel or transverse abdominal incision
* Concomitant panniculectomy or plastic surgery
* Women \<18 years of age
* History of prior abdominal or pelvic radiation
* Inability to sign an informed consent form prior to registration on study
* Inability to understand spoken or written English
* Prisoner
* Mental incapacity
* A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.
Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis?

Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.

Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.

Patients from the Guadeloupean constitutive center of rare diseases (CCRD Filfoie) and from the Saint-Antoine hospital will be retrospectively analyzed, and new patients will be prospectively followed.

Eligibility Criteria:
Inclusion Criteria:

* - Any patient over 18 years old
* Patient followed at Hôpital Saint-Antoine or treated for HAI or in Guadeloupe within the framework of the CCRD Filfoie for an acute or chronic AIH under immunosuppressive treatment
* Patient affiliate or beneficiary of a social security scheme
* Free, informed and written consent signed by the patient and the investigator

  o exclusion criteria: - Patient under 18 years old
* Patient not able to give his/her consent
* Viral hepatitis: viruses A to E, Epstein-Barr virus, cytomegalovirus and herpes simplex virus
* Isolated primary biliary cholangitis
* Isolated primary sclerosing cholangitis
* Drug-induced liver injury
* Wilson disease
* Alcoholic hepatitis
* Hemochromatosis
* Sickle cell disease and heart liver
* Non-alcoholic steato-hepatitis
VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization

The clinic visits (intervention) will continue for 90 days, which represents the follow-up period for the primary medication and health status outcomes. The co-primary clinical outcomes will be obtained at 180 days.

Heart failure (HF) is a leading cause of death, hospitalization, and healthcare system expenditure in Canada. While care in HF clinics - multidisciplinary clinics that focus on optimal management of HF - improves health outcomes in HF, there are disparities in access to such care across our province. To respond to the needs of patients and the health care system, the investigators propose to develop and implement a virtual model of care that will enable Canadians with HF to receive outpatient HF care and medical optimization remotely. The investigators hypothesize that relative to routine care alone, virtual HF clinics will improve a composite of implementation and clinical outcomes.

A pilot phase was conducted to assess the acceptability and feasibility of the intervention, assess change in health status, refine the virtual delivery process and healthcare processes, and use these to finalize protocols and guide the larger clinical trial. Data collection during the pilot phase focused on the process outcomes approved by HiREB (ID 5441).

Eligibility Criteria:
Inclusion Criteria:

Adult patients ≥ 18 years old who:

1. Are being discharged after hospitalization or urgent visit for HF as

   1. a primary diagnosis or
   2. significant complication (prolonging length of stay) of another diagnosis OR Have been referred for an initial consult at a cardiology clinic within 1 week of hospitalization or urgent visit for HF as a primary or secondary diagnosis, as described above.
2. Have left ventricular ejection fraction (LVEF) \< 50% within the preceding 3 months.
3. Have NT-proBNP of \> 900 pg/ml during hospital admission or within 7 days after discharge from the ED
4. Have a mailing address for patient or caregiver
5. Provide verbal consent

Exclusion Criteria:

1. Died or left hospital before medically advised hospital discharge
2. Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)
3. Unable to engage with digital health technology or follow up
4. Severe valve disease
5. Recipient of or on waiting list for LVAD or cardiac transplant
6. Complex congenital heart disease, hypertrophic obstructive cardiomyopathy, or amyloid cardiomyopathy
7. Severe lung disease with symptoms on minimal exertion, forced expiratory volume during 1 second (FEV1) \< 1 litre, severe pulmonary hypertension with RVSP \> 60 mm Hg, or on home oxygen
8. Severe kidney disease (persistent eGFR \< 30 mL/min/1.73m2)
9. Active malignancy
10. Receiving palliative care or expected life expectancy \< 6 months
Prediction of Pain in Total Hip Arthroplasty

In this consecutive, prospective cohort study the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total hip arthroplasty.

The preoperative heat stimulation consists of short and long tonic heat stimulation. Pain response is evaluated with an electronic visual analog scale.

Furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total hip arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).

Eligibility Criteria:
Inclusion Criteria:

* Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total hip arthroplasty

Exclusion Criteria:

* Bilateral/revision arthroplasty
* Disease affection central or peripheral nerve function
* Alcohol and medical abuse
* Daily use of opioids or glucocorticoids
* Malignancy
* BMI \> 40
* Depression
* Dementia or other cognitive dysfunction
A Study With Lanadelumab in Persons With Hereditary Angioedema (HAE) in Poland

The main aim of this study is to learn about how many persons with HAE type I or type II are attack-free when treated with lanadelumab in real life, how many attacks occur and how many of these attacks need rescue treatment and about the nature of HAE attacks.

Participants will need to visit their doctor 5 times in total as part of this study. The visits are planned every 6 months. Participants will also be asked to fill out questionnaires as part of this study.


Eligibility Criteria:
Inclusion Criteria

Participant eligibility is determined according to the following criteria prior to entry into the study:

* In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
* The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
* HAE participant (aged greater than or equal to \[\>=\] 12 years old.) qualified to treatment with lanadelumab in the NDP and receiving treatment according to the Summary of Product Characteristics for Takhzyro.
* Male or female participants, aged \>=12 years old.

Exclusion Criteria

Any participant who meets any of the following criteria will not qualify for entry into the study:

* Currently participates or plans to participate in any interventional clinical trial.
* Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Participants should be included in the study only once. Data erroneously collected from participants for which written consent is not available, will not be included in or will be deleted from the database.