cyrilzakka/clinical-trials huggingface dataset:
PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY

INTRODUCTION: Breast cancer is one of the pathologies affecting women worldwide, with a high mortality rate of 14,206 per 100,000 women per year. However, Pilates was used as a therapeutic treatment for women who underwent a modified radical mastectomy, being associated with the alterations when in the postoperative sequels.

OBJECTIVE: to evaluate the Pilates Method in the functionality of women submitted to modified radical mastectomy.

METHOD: This is a quantitative clinical trial, in the form of women included in the project, to undergo a physical therapy rehabilitation program through the Pilates Method for 2 months, where they were evaluated before and after the procedure for measurement and comparison obtained.

CONCLUSION: In this way, the pilates method is presented as an instrument used for the rehabilitation of mastectomized women.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects, between 30 and 65 years, with a diagnosis of breast cancer, who underwent radical-mastectomy surgery and who had after 30 postoperative days

Exclusion Criteria:

* Women who present alterations in healing, severe pain, who have another type of treatment, people who lack more than three times in the research, quitters, people with relapses and who do not tolerate the treatment protocol.
Effects of Interleukin (IL)- 4R-alpha Inhibition on Respiratory Microbiome and Immunologic Correlates in Severe Asthma

The overall goal of this study is to understand biological responses related to dupilumab treatment among severe asthma patients.

Not all asthma is the same, and characteristics of asthma vary from person to person. The study will investigate whether the study drug can help to improve the health of participants lungs, boost immune response, as well as improve quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed/managed severe asthma patients that are clinically eligible for dupilumab
* Current treatment with a medium-to-high-dose inhaled glucocorticoid (fluticasone propionate at a total daily dose of greater or equal (≥) 440 μg or equipotent equivalent) plus up to at least one additional controller (e.g., a long-acting β2-agonist or leukotriene receptor antagonist)
* Eosinophilic asthma phenotype (blood eosinophil level \>300) or asthma requiring daily oral corticosteroids
* Asthma that is uncontrolled, as defined by a score on the Asthma Control Test of 19 or lower, or a worsening of asthma in the past year that led to an asthma hospitalization, Emergency Department visit, or 3 days of oral corticosteroids
* Severity of asthma that, in the opinion of the subject's asthma care specialist, requires dupilumab for control
* For women of childbearing age: agree to use birth control or remain abstinent during the duration of the study.

Exclusion Criteria:

* Patients with diagnosis of other chronic lung diseases (e.g. Chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, Churg-Strauss syndrome, Allergic bronchopulmonary aspergillosis, etc.)
* Current smoker or reported smoking within 1 month of the screening visit (tobacco or any inhaled recreational product)
* Greater than 10 total pack-year of cigarette smoking history
* Treatment with oral corticosteroids for an asthma exacerbation 1 month prior to screening or during the screening period
* Use of any biologic therapy for asthma within the past 3 months
* Respiratory or Gastrointestinal illness within 1 month prior to screening or during the screening period
* Treatment with antibiotics for acute infections within six weeks prior to screening or during the screening period.
* Pregnancy at enrollment or during the study
* Known hypersensitivity to dupilumab or its excipients
A Study of Navenibart in Participants With Hereditary Angioedema

This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of HAE (Type 1 or 2). The following must be met:

  1. Documented clinical history consistent with HAE
  2. Lab findings consistent with HAE Type 1 or 2
* Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.

Exclusion Criteria:

* Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria.
* Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period):

  1. Lanadelumab within 90 days prior to Run-In
  2. Berotralstat within 21 days prior to Run-In
  3. Plasma-derived C1INH for LTP within 14 days prior to Run-In
  4. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
  5. All other prophylactic therapies, including investigational drugs, require consultation with the Medical Monitor
Determination and Comparison of Short-term Effectiveness of Three Methods Used for Recognition of Arrhythmias in People With Different Degrees of Medical Training (Advanced Life Support Workshop Participants-ALS): Randomized Controlled Educational Experiment.

Background: Arrhythmia recognition is a fundamental skill for the provider of advanced life support (ALS). Acquire it is difficult, leading to the birth of systematic methods in an attempt to simplify and optimize, however, it has not compared the effectiveness among the three methods with more evidence among professionals with varying degrees of medical training (ALS Workshop participants).

Objective: To determine and compare the effectiveness of the three most widespread and with more evidence systematic methods (10, 6 and 4 steps) for the recognition of arrhythmias in a short-term and its perceived easiness among ALS workshop participants.

Methods / design: Educational Cuasi experimental trial with pre and post intervention measurement, blind, with randomized allocation, in 84 ALS workshop participants. Three systematic methods to recognize arrhythmias will be taught and their effectiveness to diagnose in a short-term and its perceived easiness will be measured and compared.


Eligibility Criteria:
Inclusion Criteria:

* • Health professionals

  * Attend a course in Advanced Life Support in Cali (Colombia), during the study period.
  * Voluntarily accept to participate in the study

Exclusion Criteria:

* No
Analysis of the Prevalence of Sensitization to Plants Containing Gibberellins Using Realistic Skin Prick Tests

Gibberellin-related proteins (GRPs) are proteins contained in both pollens and vegetables and are associated with an increased risk of severe food allergy reactions. The best characterized one the only one for which a specific IgE (Immunoglobulin E) may be dosed in current clinical practice is Pru p 7, an allergen contained in peaches (Prunus persica). Sensitization to GRPs seems to be greater in areas with high exposure to pollens of the Cupressaceae family (as in the Montpellier region in Southern France); a subtype of Cupressaceae pollinosis, characterized by sensitization to Pru p 7 has been shown to be responsible for severe peach allergies.

To date, there has been no real analysis of the prevalence of sensitization to GRPs, or of possible cross-sensitization between plants and foods containing GRPs. Main food containing GRPs with a high level of homology with Pru p 7 include apples (Malus domestica, 97.3%), sesame (Sesamum indicum, 91.9%), carrots (Daucus carota subsp. Sativus, 88.9%), lemons and oranges (different species, with a homology of 87.3%).

If investigators consider that sensitization to GRPs could be associated with severe allergic hypersensitivity reactions, it is important to detect the prevalence of sensitization to these allergens and to find sensitization profiles for these patients in order to gain a better understanding of this type of allergy and offer a more appropriate and preventive management to allergic patients. This remains today a major challenge for the allergy community in the Mediterranean region.

This study aims to investigate the rate of sensitization to peach and 5 other allergens containing gibberellins, chosen on the basis of their homology with Pru p 7 (the gibberellin from Prunus persica): carrot, lemon, orange, apple and sesame.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged at least 5 years
* Patients consulting at the Allergy Unit of the University Hospital of Montpellier for any type of allergy work-up/evaluation
* Oral consent from the patient and, where applicable, from at least one of the patient's legal representatives in the case of minors.

Exclusion Criteria:

* Patients treated with antihistamines or psychotropic drugs with antihistaminic action during the 7 days prior to inclusion
* Patients with pathologies that prevent the performance of prick tests (e.g. severe peripheral neuropathy, cutaneous anergy).
* Patients with dermographism.
* Patient taking part in another study which may influence the results of the prick tests.
* Patients in an exclusion period determined by a previous study.
* Pregnant, parturient or breast-feeding women.
* Patients or their legal representatives under court protection, guardianship or trusteeship.
* Patients or their legal representatives who are not members or beneficiaries of a health insurance scheme.
* Patient or his/her legal representative unable to read and understand French fluently.
Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.

To characterize the safety and tolerability of NIS793 as single agent and in combination with PDR001 and to identify recommended doses for future studies.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained prior to any screening procedures.
2. Patient (male or female) ≥ 18 years of age.
3. Escalation: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
4. Expansion: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have progressed despite standard therapy following their last prior therapy or are intolerant to standard therapy and fit into one of the following groups: Group 1: NSCLC resistant to anti-PD-1/PD-L1; Group 2: TNBC; Group 3: HCC; Group 4: MSS-CRC; Group 5: pancreatic; Group 6 ccRCC resistant to anti-PD-1/PD-L1.

   Resistance to anti-PD-1/PD-L1 therapy is defined as: Documented progressive disease occurring while on/or within 6 months after anti-PD-1 and/or anti-PD-L1 agent (single or combination) received as the last therapy prior to enrollment.
5. ECOG Performance Status ≤ 2.
6. Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on this study. Exceptions may be made on a case by case basis after documented discussion with Novartis.

Exclusion Criteria:

1. History of severe hypersensitivity reactions to study treatment ingredients or other monoclonal antibodies and components of study drug.
2. Patients with active, known or suspected autoimmune disease. Note: Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
3. HIV infection.
4. Active HBV or HCV infection.

Other protocol-defined inclusion/exclusion criteria may apply.
The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait

Participants diagnosed with tibial femoral knee osteoarthritis will be assigned to one of three treatment groups including: active transcutaneous electrical nerve stimulation (TENS), placebo TENS, and a control group. Assignment of conditions will be concealed. All participants in each of the three groups will receive physical therapy for all 4 weeks of the intervention. Main outcome measures will include quadriceps central activation ratio, quadriceps torque production, WOMAC scores, visual analog pain scores during gait as well as knee joint kinetics and kinematics during gait. The purpose of this study is to to determine if the continuous use of TENS therapy for activities of daily living and rehabilitation will positively impact all outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with a Kellgren and Lawrence grade of 1- 4 for Tibial Femoral Knee OA in at least one leg or have been diagnosed with OA by a physician using evidence confirmed from imaging studies, arthroscopy, or visualization during an past surgical procedures, or have medical reports confirming OA using imaging studies, arthroscopy, or visualization during an past surgical procedures.
* Patients between the ages of 18 and 80 years of age.
* Patients will have a CAR less than 90%.

Exclusion Criteria:

* Patients who are pregnant.
* Patients who have sought medical attention for a trauma to the knee injury within the past 6 months.
* Patients who have had any orthopaedic lower extremity surgery in the past 6 months, or any surgery that would inhibition proper functioning of the study methodology.
* Patients with a diagnosis of Rheumatoid Arthritis.
* Patients with a known hypersensitivity to electrical stimulation.
* Patients with any types of neuropathy.
* Patients with known muscular abnormalities.
* Patients with a history of a heart condition that precludes them from exercise.
* The technique can not be performed on the leg that has had a total knee replacement, but if the other leg meets the inclusion criteria the subject can perform the study on the non- reconstructed leg.
* Patients diagnosed with malignancy over the stimulating electrode site (thigh and knee).
* Patients with serious infection near the stimulating electrode sites (thigh and knee)
* Patients have not had a knee injection in the past 2 weeks.
* Patients who are unable to walk a series of 30 meters without a walking assistance device.
Effect of Preventive Education on Reducing Urinary Bisphenol-A Levels in Adolescents

It is known that Bisphenol-A (BPA) is the endocrine disrupting chemical that is most exposed by oral intake in daily life. Critical life periods when the sensitivity to these substances is known to be maximum; prenatal, postnatal and adolescence periods. The aim of this study is to compare the effects of plastic-free nutrition program, interactive education and BPA exposure feedback on urinary Bisphenol-A levels in adolescents with high use of packaged products.

By simple random sampling, female adolescents (n=36) staying in a high school hostel will be the intervention group, female adolescents not staying in hostels (n=36) will be the first comparison group, and female adolescents from another high school (n=36) will be the second comparison group. Plastic-free nutrition program (plastic-free diet, peer mentoring, interactive education and BPA exposure feedback) will be applied to the intervention group. Interactive training and BPA exposure feedback will be given to comparison group one, while only BPA exposure feedback will be given to comparison group two. Before and after the interventions, urinary BPA levels, use of plastic packaged products and bad nutrition attitudes of the adolescents will be monitored.

Eligibility Criteria:
Inclusion Criteria:

Willingness to participate in the research Being in the 14-18 age group Being a female student High (61-80 points) or moderate-high (41-60 points) scores from the plastic packaged product use questionnaire (PAUKA) Having a smart mobile phone Absence of obesity, hypertension, diabetes mellitus, cardiovascular, asthma, thyroid and kidney dysfunction or disease Absence of any syndrome (Metabolic, Turner Rett and Down syndrome etc.) Absence of any medication used continuously Absence of any chronic disease reported by the physician in the student follow-up/examination report

Exclusion Criteria:

Leaving school and hostel Not giving a spot urine sample Not participating in the plastic-free diet program in the hostel for the last week.

Desire to leave the study Participation in trainings \<50% Diagnosis of disease (diabetes mellitus, kidney disease, gluten or lactose intolerance, etc.) in which dietary habits were changed during the study.

Experiencing a mental or physical illness that will prevent the continuity of participation in the study.
Evaluating a Water Quality Assurance Fund Intervention in Ghana and Kenya

The objective of this study is to evaluate the effects of a novel financial and capacity strengthening intervention (the 'Water Quality Assurance Fund' program) on water safety management in rural Ghana and Kenya. The investigators hypothesize the intervention will improve water system operator knowledge, chlorination practices, and water quality at the point of collection, as well as improve consumer satisfaction, awareness, and willingness-to-pay for water that is tested and treated.

Regular water quality monitoring by water suppliers is essential for maintaining adequate treatment processes and verifying safe water quality to protect public health. Yet, many small water suppliers are unable to conduct regular water quality tests due to financial, logistical, and capacity constraints. The goals of the Water Quality Assurance Fund program are to address these constraints by incentivizing established laboratories to extend their services to these smaller water systems and, in parallel, promote the use of water quality data for better water safety management.

The objective of this study is to evaluate the effects of a novel financial and capacity strengthening intervention (the 'Water Quality Assurance Fund' program) on water safety management in rural Ghana and Kenya. As part of the intervention, written legal agreements between water systems, centralized laboratories, and the organization facilitating the Assurance Fund will provide water systems with regular water quality testing and provide laboratories a guarantee of payments if water systems fail to pay for testing services on time. The Assurance Fund program will also deliver capacity strengthening, technical guidance, and community sensitization activities.

The investigators hypothesize the intervention will improve water system operator knowledge, chlorination practices, and water quality at the point of collection, as well as improve consumer satisfaction, awareness, and willingness-to-pay for water that is tested and treated. A secondary aim is to assess implementation challenges and enabling factors associated with the expansion of water testing services by existing professional water quality laboratories to rural water suppliers.

Eligibility Criteria:
Eligibility to receive the intervention was determined by water system criteria:

Inclusion Criteria:

* The district or county government was interested in participating in the Assurance Fund program and water systems within the district/county were accessible to a partner central laboratory that was able to provide water sample collection and testing services for a fee.
* Water systems were functional.
* Water systems were piped water systems (Kenya, Ghana) or mechanized boreholes with a single tapstand (Ghana).
* Water systems could afford regular water quality testing from the selected laboratory.

Exclusion Criteria:

* Water systems did not meet above inclusion criteria.

To be eligible to participate in household surveys, participants need to be at least 18 years of age and a customer of a eligible water system.
Patient Specific Induced Pluripotency Stem Cells (PSiPS)

Induced pluripotent stem cells (iPSCs) are adult cells that have been genetically reprogrammed to an embryonic stem cell-like state by being forced to express genes and factors important for maintaining the defining properties of embryonic stem cells. The reprogramming of adult cells into embryonic stem (ES) cells enables the generation of patient-specific stem cells and thus has enormous potential for the treatment and analysis of degenerative diseases. In this project the investigators are going to induce pluripotent stem cells from cell cultures from skin biopsies of patients. The iPS cells will be developed for modeling diseases and drug discovery as well as basic research.

iPS cells are typically derived by transfection of certain stem cell-associated genes into non-pluripotent cells, such as adult fibroblasts. Transfection is typically achieved through viral vectors, such as retroviruses. Transfected genes include the master transcriptional regulators Oct-3/4 (Pouf51) and Sox2, although to enhance the efficiency of induction some other genes e.g. Klf4, c-Myc. In this study after separation the fibroblasts from patient's skin biopsy, the cells are transfected with 4 Yamanaka factors (human Oct4, Sox2, Klf4, c-Myc) after 3-4 weeks, transfected cells are isolated through morphological selection.

Eligibility Criteria:
Inclusion Criteria:

* Donors suffering from different (specified) metabolic disorders
* Donors suffering from different (specified) eye disorders which resulted to blindness
* Special blood group: O Bombay

Exclusion Criteria:

* None
A Study to Evaluate Effects of Gargle Phonation in Voice

The purpose of this study is to assess subjects with muscle tension dysphonia for perceived effort and acoustic effects of gargle phonation compared to baseline and a sham water swallow.

This study assesses perceived effort following baseline talking, water swallows and gargle phonation. In addition to perceived effort, acoustic and perceptual analyses will be conducted on the recorded voice samples using vowel sounds, the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) and Hearing in Noise Sentences (HINT).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a primary or secondary muscle tension dysphonia based clinical assessment with a Mayo clinic speech language pathologist or other Mayo Clinic otolaryngology care provider in Rochester or Phoenix/Scottsdale locations.
* Age 18 through 89.
* Able to provide informed consent.

Exclusion Criteria:

* Anyone not meeting inclusion criteria.
* Anyone unable or unwilling to provide informed consent.
* Anyone unable to complete questionnaires or participate in voice recording.
* Anyone with severe neurological voice or speech disorders.
* Moderate or severe dysphagia for thin liquids.
* Non-English speakers (English as a second language may be included).
* Extensive laryngeal surgery or other surgery or medical condition that may significantly alter the motor or sensory aspects of the larynx.