cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to investigate the effects of performing a breathing muscle warm up before exercise in patients who have chronic obstructive pulmonary disease (COPD). The main aim is to see whether performing a breathing muscle warm up can improve distance walked in a 6 minute walk test and also decrease perceptions of effort and breathlessness.

The study will follow a counter-balanced repeated measures design involving six visits to the exercise laboratory. Following pre-screening and familiarisation (visits 1 and 2), participants will perform inspiratory warm up, expiratory warm up, combination warm up and control trials (visits 3 - 6) in a counter-balanced order separated by at least 48 hours between trials.

The four separate sessions will contain: lung function measurements assessed by performing breathing manoeuvres through a mouthpiece (spirometery or body plethysmography) before performing a breathing muscle warm up by breathing against a resistance through a small handheld device (PowerLung). Participants will then be asked perform a second set of lung function measurements and will then be asked to perform a 6 minute walk test wearing a face mask and a portable device (gas analysis), a small device clipped to a finger (pulse oximeter) and wearing a heart rate monitor. During this 6 minute walk test participants will also be asked to rate their perceived effort and level of breathlessness at 60m intervals. Following the test there will be a period of seated rest wearing the face mask and portable device for up to 20 minutes with one more set of lung function measurements.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of COPD
* Aged between 35 and 90 years
* Able to fluently read and speak English
* Willing and able to sign informed consent
* Be able to comply with the procedures outlined for the study

Exclusion Criteria:

* Cardiac disease (including arrhythmias)
* A medicinal requirement for rate limiting calcium antagonists or beta blockers
* Cerebrovascular disease
* Peripheral vascular disease
* Requirement for supplemental oxygen therapy
* CO2 (carbon dioxide) retention
* Malignancy
* Orthopaedic or neurological conditions effecting the ability to exercise
* Clinically apparent heart failure
* Renal, hepatic or inflammatory disease
* Instability of COPD
* Any other reason leading to the inability to complete the requirements of the study.

Additionally: If participants have a resting HR above 120beats.min-1, systolic blood pressure above 180mm Hg or diastolic blood pressure above 100mm Hg prior to the 6 minute walk test they will not be able to commence the test.
Evaluation of the Safety and Efficacy of Corneal Cross Linking for the Treatment of Myopia.

43 Subjects (43 eyes) qualified for participation will undergo the required screening procedures to determine study eligibility. The surgical protocol involves applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes will be exposed to UVA (ultraviolet A) light with the KXL II system according to the programmed treatment pattern.

All use of the KXL II system will be in accordance with the general instructions in the operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and 24 months after treatment.

Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS), will be obtained at baseline and at appropriate times after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Willingness to follow all instructions and comply with schedule for follow up visits
* Having myopia with manifest refraction spherical equivalent of -1.00 to -2.50 D, with cylindrical component pl to -0.75 D
* Social security insurance or equivalent

Exclusion Criteria:

* sensitivity to the use of the test article(s)
* hypersensitivity to local anesthesics
* Corneal pachymetry that is \< 480 microns
* Eyes with keratoconus
* Eyes which are aphakic or with corneal intacs
* Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example: History of corneal disease (e.g., herpes simplex, recurrent erosion syndrome, corneal dystrophy, refractive keratotomy etc.), clinically significant corneal scarring in the crosslinking treatment zone
* Pregnancy or lactation
* Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
* Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
* Juridical protection
Effects of High-intensity Interval Training on Myocardial Strain in Metabolic Syndrome Patients

the effects of high-intensity interval training on myocardial function will be studied in a group of patients under medical treatment for the components of metabolic syndrome.

Objective: To analyze the effects of high-intensity interval training (HIIT) on myocardial function of metabolic syndrome patients.

Methods and design. Randomized clinical trial with a control group. Project was developed in association with the regional general hospital. Pre and post-intervention evaluation after 16 weeks of training for the HIIT group.

Subjects: Recruited using adverts published on public medical center boards. Up to 30 subjects per group (HIIT and CONTROL) will be recruited (at least 20% women) Measurements. Echocardiography: Global longitudinal strain (GLS), Mitral filling parameters, myocardial dimensions, and myocardial wall thickness.

Cardiorespiratory fitness: Maximal oxygen consumption, Maximal power output, Maximal oxygen pulse.

Clinical: Metabolic syndrome components and derived variables (e.g., triglycerides/high-density lipoprotein ratio) Body composition by anthropometric measurements and dual-energy X-ray absorptiometry.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of metabolic syndrome.
* Capacity to exercise on a stationary bike
* Inhabitant of the province of Toledo

Exclusion Criteria:

* Untreated cardiovascular disease with hemodynamic instability
* Untreated respiratory disease, symptomatic.
* Untreated metabolic disease.
* Untreated renal disease requiring dialysis.
* Contraindications for high-intensity exercise training
A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia

Durvalumab was approved in the Russian Federation for use after both concurrent and subsequent CRT until disease progression. Currently, there is no real-world data regarding the safety and real world effectiveness of durvalumab in this indication. Moreover, generation data on the safety and real world effectiveness of durvalumab after concurrent chemo-radiation therapy (cCRT) and subsequent chemo-radiation therapy (sCRT) in routine practice in the Russian Federation will be of high relevance.

The other important question that needs to be addressed is the duration of treatment with durvalumab and its' influence on the relevant outcomes. According to the Russian label, it is possible to continue treatment with durvalumab until disease progression, although current data from the PACIFIC trial provide the results on 12 months duration of durvalumab treatment. The real-world data about the duration of treatment with durvalumab in the Russian population and its' influence on various outcomes would be very important.

Among other goals, the current study is aimed to analyze factors influencing the effectiveness of durvalumab therapy in the real-world setting (e.g. duration of treatment, delays in the start of treatment with durvalumab after CRT over, early discontinuation due to any factors including AEs, etc.). The study also aims to elucidate treatment approaches after discontinuation from durvalumab (post-progression outcomes and treatment in case of discontinuation due to AEs). This study will support the understanding of described factors and will take and an attempt to optimize the treatment process to improve outcomes for patients


Eligibility Criteria:
Inclusion Criteria:

Patients are eligible to be included in the study only if all of the following inclusion criteria and none of the exclusion criteria apply:

* Written informed consent obtained from the patient prior to performing any protocol-related procedures
* Age ≥18 years at time of study entry
* Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer \[AJCC\] lung cancer edition 8)
* Patients must have completed a platinum-based chemotherapy with radiation therapy (concurrent or sequential) without evidence of disease progression
* Patients must have been treated with at least one dose of durvalumab

Exclusion Criteria:

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

* Absence or missing of written informed consent form
* Patients treated with durvalumab in clinical studies
* Absence of essential data to obtain all necessary information
* Confirmation that the subject was already included in this study before
Comparison of New Technique Taping and Placebo Taping on Patellofemoral Pain Syndrome: A Randomised Controlled Study

We included in this study 42 individuals with patellofemoral pain syndrome. 39 of them were completed six weeks of exercise and other groups. We randomized them into three groups. One group is the star technique which is a new patellar taping technique. Another group is placebo taping and the third group is only the exercise group. Both groups performed exercises three times a week for six weeks. Three groups were assessed with knee and hip muscles strength, shortness, performance tests, pain severity in the activity, night, rest, and knee-buckling, and Kujala Scale before and after 4-week exercises.

Based on previous studies those participants who met the following inclusion criteria were invited to participate in the study: i) insidious onset of anterior knee pain with a duration greater than 4 weeks; ii) pain provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping or ascending or descending stairs; iii) age ranged between 18-60 years.

Participants were excluded in cases of the clinical history of patellofemoral dislocation or subluxation; knee osteoarthritis; injury or pain from the hip, lumbar spine, or other knee structures (meniscus, ligaments, bursa, synovial plica, infrapatellar fat); traumatic lesions of soft tissues or previous orthopedic surgery in lower limbs; having received knee injections of corticosteroids or hyaluronic acid; cognition or impaired communication; being involved in an ongoing medical-legal dispute; using Canadien or walker; can not walk independently and having an allergy to taping.

Eligibility Criteria:
Inclusion Criteria:

* insidious onset of anterior knee pain with a duration greater than 4 weeks;
* self-reported patellofemoral pain intensity ≥30 mm on the 100 mm Visual Analogue Scale (VAS)
* pain provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping, or ascending or descending stairs;
* age ranged between 18-60 years.

Exclusion Criteria:

* the clinical history of patellofemoral dislocation or subluxation; knee osteoarthritis; injury or pain from the hip, lumbar spine, or other knee structures (meniscus, ligaments, bursa, synovial plica, infrapatellar fat)

  -); traumatic lesions of soft tissues or previous orthopedic surgery in lower limbs; having received knee injections of corticosteroids or hyaluronic acid
* cognition or impaired communication
* being involved in an ongoing medical-legal dispute
* using Canadien or walker; can not walk independently
* having an allergy to taping
The BSHAPE Intervention Program for Safety and Health of Survivors of Cumulative Trauma

The goal of the BSHAPE study is to test a trauma informed, culturally tailored, multicomponent program entitled BSHAPE (Being Safe, Healthy, And Positively Empowered) for immigrant survivors of cumulative trauma.

The central hypothesis is that the BSHAPE intervention will promote immigrant women's safety and health (e.g..,improved mental health, reduced physiological impact of stress and health inequities (especially reproductive-sexual health and HIV)), thus leading to overall empowerment.

The study will:

1. Conduct a feasibility and acceptability evaluation of the BSHAPE intervention.
2. Test the BSHAPE intervention for large scale implementation in community-based clinics and programs serving immigrant women.

The impact of BSHAPE will be evaluated in comparison to usual care in promoting safety and health outcomes among immigrant women with cumulative trauma experiences at post-intervention and at 6 and 12 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years of age
* Self-identify as a female
* Born in Africa or foreign born from African descent
* Must have a current or past abusive romantic relationship
* Must be a survivor of cumulative trauma
* Clinically significant symptoms of PTSD and/or depression
* At least one sexual HIV risk behavior

Exclusion Criteria:

* Less than 18 years of age or more than age 55
* Self-identify as a male
* Not African-born immigrant or born outside the US
* Is not a survivor of cumulative trauma
* Does not meet clinically significant criteria of PTSD and/or depression
* Does not report at least one sexual HIV risk behavior
Elimination of Hepatitis C Virus Among Users of Substances

Substance users are a vulnerable group that should be prioritized in HCV (Hepatitis C Virus) elimination efforts in Mexico and in which it is feasible to carry out micro-elimination programs. It is an important group to treat both because of its high prevalence and because of the dynamic spread of infection among the general population. HCV seropositivity has not been documented in this group of people in Mexico City, the metropolitan area and the northern states of the country, nor has the sustained viral response been evaluated in this group of patients in the Mexican population.

The investigators would use a work team, the program and the value proposal would be presented to the local authorities, the coordinator of the national commission against dependencies and doctors. The investigators would use an algorithm designed for the first-step diagnosis of HCV in SUs (Substances Users) , and defined the key centers for screening and linking to care.

The project is planned as follows:

* Screening: SUs in centers of substance users in Mexico City, the metropolitan area and states in the North of the country will be evaluated with rapid tests. Those with a positive result will be selected.
* Diagnosis: Patients with a positive rapid test result will undergo a viral load test against HCV. Those with positive results will be selected.
* Link-up: Those who are confirmed positive will be profiled to receive treatment at INCMNSZ. they will receive damage reduction to prevent reinfection or primary infection in negatives (granted by the rehabilitation center).
* Treatment: The treatment will be received in a certified hospital (INCMNSZ) to treat patients with HCV infection, the treatment will be indicated by doctors who work in this hospital in the treatment consultations for hepatitis C or in centers with substance users with doctors trained to administer the treatment. This training will be received by telementoring. And also during the treatment, follow-up will be given with telementoring sessions if necessary. This group of people has personality characteristics that require a integral treatment, so it will be a integral and multidisciplinary treatment with psychological care and harm reduction (provided by the rehabilitation center)
* Confirm SVR: A viral load test will be performed 12 weeks after the end of treatment to corroborate SVR. They will be given after this a mentorship for harm reduction and advice against reinfections

The importance of this project is characterized by minimal monitoring, patients and doctors education by telementoring, multidisciplinary teams and integral treatment

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Active infection by hepatitis C virus.
* People who use substances and who are users of rehabilitation centers in Mexico City, the metropolitan area and the northern states of the country.
* Signature of informed consent

Exclusion Criteria:

* all those who do not fit the inclusion criteria
AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

-Japanese patients living in Japan with a history of allergic conjunctivitis.

Exclusion Criteria:

* Presence of active eye infection (bacterial, viral, or fungal)
* History of an eye herpetic infection.
Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation

This study is designed to analyze the effect exosomes derived from red blood cell units have on blood coagulation and platelet function. It is an in vitro study using healthy volunteers' blood.

The blood of 25 healthy volunteers will be exposed to exosomes derived from red blood cell units. The effects on coagulation and platelet function will be measured using thromboelastometry (ROTEM®) and FACS analysis.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
* drug use
High-flow Oxygen Therapy vs Non-invasive Ventilation: Comparison of Alveolar Recruitment in Acute Respiratory Failure

This physiological study showed an increase in regional ventilation with NIV but no difference in alveolar recruitment as compared to HFNC in patients with hypoxemic ARF. Although NIV provided better oxygenation than HFNC, the effect on lung volumes could explain the potentially deleterious effect of NIV in hypoxemic ARF, reinforcing the recently developed concept of patient self-inflicted lung injury.

Background: High-flow nasal cannula (HFNC) oxygen therapy has recently shown clinical benefits in hypoxemic acute respiratory failure (ARF) patients, while the interest of non-invasive ventilation (NIV) remains debated. The primary endpoint was to compare alveolar recruitment using global end-expiratory electrical lung impedance (EELI) between HFNC and NIV. Secondary endpoints compared regional EELI, lung volumes (global and regional tidal volume variation (TV)), respiratory parameters, hemodynamic tolerance, dyspnea and patient comfort between HFNC and NIV, relative to face mask (FM).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients referred in ICU
* with hypoxemic acute respiratory failure due to a community acquired pneumonia confirmed by chest X ray,
* with PaO2 \< 60mmHg in ambient air, without hypercapnia (PaCO2 \< 45 mmHg),
* requiring more than 6L/min of O2 on admission with high concentration FM, and justifying HFNC or NIV for the attending ICU physician

Exclusion Criteria:

* cardiogenic pulmonary oedema,
* moderate to severe underlying respiratory disease including COPD (chronic obstructive pulmonary disease)
* contraindication to or failure of previous NIV or HFNC with the need for immediate invasive ventilation
* pregnant or breast-feeding women
* carrier of an implantable defibrillator or pacemaker
* body mass index (BMI)\>50 kg/m2
* with cutaneous lesion next to the positioning zone of the Pulmovista® (Dräger, Lübeck, Germany) belt
Prospective Measurement of Post-Treatment Lymphedema

The goal of this study is to measure the amount of limb swelling (lymphedema) that sometimes occurs after melanoma treatment, and to find out how people feel and react to the diagnosis and treatment of melanoma.

If you choose to take part in this study, you will have measurements taken of your arms or legs using a Perometer and a bioimpedance machine. The Perometer is a machine that painlessly measures the fluid in your limb using two-directional infrared lights. These lights are located in the frame of the machine that encircles the arm or leg during the measurement. The bioimpedance is a machine that measures the fluid in your arm or leg by passing a very small current through the body similar to an electrocardiogram (EKG). These very small currents are located in electrodes that are placed on the hands and feet during the measurement. Both machines are able to pick up changes in limb size.

You will also be asked to complete a set of questionnaires relating to any symptoms that you may experience in your limbs and/or trunk (chest, stomach, and hip areas) during and following your standard cancer treatment.

Additional questionnaires, along with your limb measurements, will be done at your regularly-scheduled follow-up clinic visits, 3-6 months, 9-12 months, 15-18 months, 21-24 months and 27- 30 months. You will complete the additional questionnaires using a laptop computer or a hardcopy. The measurements and questionnaires will take 45-60 minutes to complete each time.

Some of the data from this study may be sent to the University of Missouri for analysis. The data that is sent will not have any personal identifiers. Researchers at University of Missouri will not be able to link the data to the protected health information or personal identity of any individual participant.

This is an investigational study. Up to 350 patients will take part in this study. All patients will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a confirmed diagnosis (M.D. Anderson pathology) of invasive cutaneous melanoma (stages I-III) will be recruited for participation as they present for their initial clinical evaluation to the University of Texas M.D. Anderson Melanoma and Skin Center.
2. Prior to surgical treatment
3. Patients who can knowledgeably and voluntarily provide an informed consent to participate. The informed consent will be signed and dated.
4. Fluent in English.
5. At least 18 years of age.

Exclusion Criteria:

1. Patients with a prior history of lymphedema or melanoma prior to treatment.
2. Patients who are unable to consent due to other medical illnesses or disorientation to person, place or time.
3. Patients with known distant metastatic disease (Stage IV).
4. Patients with implanted device (pace maker), orthopedic implants, and metal frames.
5. Presence of concurrent malignancy that requires active treatment, such as chemotherapy or biotherapy, prior to enrollment.