cyrilzakka/clinical-trials huggingface dataset:
Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease

The aim of this clinical trial is to evaluate, the effects of inspiratory muscle training program in inspiratory muscle function, functional capacity, quality of life, lung function, breathing pattern and chest wall motion in patients with advanced lung disease. Patients were evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up which was performed 3 months after the end of the intervention.

Inspiratory Muscle Training (IMT) should be considered an additional intervention in the pulmonary rehabilitation program for patients with advanced lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle training program in inspiratory muscle function, functional capacity, quality of life, lung function, breathing pattern and chest wall motion in patients with advanced lung disease. It is a quasi-experimental study with longitudinal design. Patients with advanced lung disease from the advanced lung disease and pre lung transplantation ambulatory performed home-based high intensity interval IMT for 8 weeks (two sessions per day, daily). In each session patients executed two times 30 breaths with one-minute rest between them. Resistance was set to the highest tolerable according to scores pointed by the patient on the Borg score (between 4 and 6) aiming 50% of actual pimax or higher. An experienced physiotherapist was responsible for weekly adjustments on the resistance of training as well as new assessment of maximal inspiratory pressure. Patients were evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up which was performed 3 months after the end of the intervention. Patients were evaluated by the same experienced researcher in all three moments of the study. Evaluations were performed in the Laboratory of research and evaluation of cardiorespiratory performance of Federal University of Minas Gerais.

Eligibility Criteria:
Inclusion Criteria:

* presence of inspiratory muscle weakness (Maximal Inspiratory Pressure - MIP ≤ 60 cmH2O or below the reference values proposed for the Brazilian population.
* completion of a 36 sessions of PR or nonattendance in any pulmonary rehabilitation by the time of inclusion and no perspective of initiating it in the next 8 weeks.
* absence of pre-existing neuromuscular, infectious, metabolic, psychiatric diseases or orthopedic problems that prevent from activities of daily living.

Exclusion Criteria:

* presented inspiratory muscle strength higher than 60 cmH2O or predicted value
* unable to follow commands related to the measurements or to the IMT
Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury

The objective of this study is to determine the effectiveness of different training programs on outcomes in persons with spinal cord injury (SCI). We are interested to see which programs have the greatest impact.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years old
* Use either a power or manual wheelchair as a primary means of mobility (\>50% of weekly mobility)
* Living in the community
* Must have a non-progressive spinal cord injury
* Manual wheelchair users must be able to independently propel their wheelchairs
* Manual wheelchair users score ≤90 on the Wheelchair Skills Training Questionnaire (WST-Q)

Exclusion Criteria:

* Cognitive impairment that could interfere with learning
The Importance of Periostin in Periodontal Health and Disease

The goal of this study is to determine the clinical importance of Periostin in oral health and disease. The long-term goal will be to develop practical applications for the diagnosis, treatment, prevention and cure of human periodontal diseases.

It is hypothesized that Periostin levels are decreased during periodontal diseases, thereby, elevating the hosts' susceptibility to periodontal breakdown. The specific aims are the following; To determine if Periostin is a biomarker of periodontal disease, and To evaluate Periostin in periodontal tissue healing and homeostasis by harvesting healthy or diseased tissue from 22 patients requiring periodontal surgery.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for diseased subjects:

* Diagnosis of generalized chronic or aggressive periodontitis
* At least four periodontal sites with probing depth (PD) ≥6 mm, evidence of clinical attachment loss (CAL), and bleeding on probing (BOP). Inclusion criteria for healthy individuals will include PD \<4 mm, no evidence of attachment loss, and \<10% of sites with BOP
* Need an open flap procedure

Inclusion criteria for non-diseased subjects:

* Subjects requiring a gingivectomy or crown lengthening procedure

Exclusion Criteria:

* History of alcoholism or drug abuse
* Medical conditions that may affect the outcome such as autoimmune diseases, diabetes, immunocompromised subjects, neurologic or psychiatric disorders, systemic infections, etc.
* Chronic medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications, Depo-Provera contraceptive injection users, new oral contraceptives users within 3 months of baseline or subjects that are planning on, starting oral contraceptives during the study.
* Antibiotic therapy within 3 months of the baseline visit, and/or antibiotic therapy needed for infective endocarditis prophylaxis.
* Current use or quit smoking less than one year ago with a pack-year history of more than or equal to 10.
* Untreated cavities
Development of an ICU Risk Score

Intensive care units are inevitable for high risk surgery and/or high risk patients i.e. patients with severe preconditions. However, usually the capacity of these units is limited such that at times elective surgery has to be postponed if there is no ICU capacity.

The aim of this study is to investigate potential influence/risk factors important for ICU admission in a university hospital in Germany and develop a risk score. In a second phase the risk score for ICU admission will be validated.

It is one of the core duties of anesthesiologists in our hospital to identify patients with high risk for a post-surgery ICU stay upon hospital admission. We do know that there are two types of factors influencing the possibility of an ICU admission: The patient centered risk e.g. severe preconditions and the surgery centered risk depending on the type of surgery with sometimes high possibility for perioperative complications i.e. bleeding, hemodynamic instability, pulmonary complications etc. However, we do not know the effect size of these factors and, equally important, how they are correlated with one another.

The aim of this study is to model the risk of an ICU stay by patient centered and surgery centered influence factors. If a good model is obtained, this can be utilized for allocating ICU capacities in an objective fashion. The study consists of two phases. In the first phase model selection is performed. In the second phase the developed model will be validated on independent data. Data will be gathered by a data collection sheet completed by the responsible anesthesiologists in all elective and emergency surgery during a specific period of time.

Eligibility Criteria:
Inclusion Criteria:

* All patients ≥ 18 years receiving surgery in the time frame of data collection with ASA classification status I-IV

Exclusion Criteria:

* Patients \< 18 years
* ASA classification status \> IV
Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthesis for Stroke Survivors

This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis. Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)

This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis.

The device is composed by a passive orthosis structure which allows one degree of freedom (DOF) among the sagittal plane and it includes two servomotors attached to the user's foot through velcro strips.

Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)

Eligibility Criteria:
Inclusion Criteria:

* Hemiparesis caused by a stroke.
* Age between 18 and 65 years old.
* Post-stroke time more than 6 months.
* Independent walking.
* Minimum 90 degrees of dorsiflexion.
* Muscle tone in plantar flexors less than of equal to 3 on the Modified Ashworth scale.
* Ability to follow instructions.
* Voluntary participation.

Exclusion Criteria:

* Skin alterations in the lower limb.
* Peripherical vascular alterations.
* Alterations in sensitivity in the lower limb.
* Pain of musculoskeletal origin in lower extremities or spine.
* History of frequent falls.
* Cancer
* Previous history or suspected seizures.
* Patient who does not sign the informed consent.
Safety and Efficacy of Mirazid for Schistosomiasis Treatment

Clinical Trial Phase:Phase III

Primary Objectives:

* Compare Mirazid and Praziquantel cure rates for both Schistosoma species.
* Compare Mirazid and Praziquantel effect in lowering the intensity of infection for both Schistosoma species.

Secondary Objective:Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel.

Study Population:200 Schistosomiasis infected persons of both types of Schistosomiasis aged from 15-35 years. Those subjects will be selected from among those screened.Subjects will include both genders excluding chronically ill such as chronic liver disease patients and those with both types of Schistosomiasis.

Recruitment Period:3 months and subjects follow up for another 3 months followed by 3 months for statistical analysis and report writing Study Duration: Total study duration is expected to be 9 months: 3 months for recruitment, 3 months for follow up and 3 months for data management and report writing.

Endpoints: Will be measured at 3 months of successful administration of treatment either Mirazid or Praziquantel as per the randomization scheme. By then, final assessment of the response to treatment will be done by examining urine or stool of the subject for presence of Schistosoma eggs and its density if found.

Three negative urine or stool samples collected 2-days apart at 12 weeks post treatment will indicate treatment success. One positive sample collected at week 12 will indicate infection with Schistosomiasis.

Study Design:This is a phase III, open-label randomized non-placebo-controlled Study in which the investigators will compare the efficacy and safety of Mirazid to Praziquantel as a treatment for Schistosomiasis. After screening, positive subjects for one of the Schistosomiasis will be recruited in the study. They will be treated by Mirazid as 600 mg oral (Soft Gelatin Capsules) for 6 consecutive days or 40mg/Kg body weight of Praziquantel as a single oral dose. Subjects will be evaluated for success of treatment at 12 weeks of treatment. Evaluation will be done by examining urine or stool samples for Schistosomiasis including egg counts for the positive cases.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent and young adults aged 15-30 years
* Positive for Schistosoma infection of any type.

Exclusion Criteria:

* Mixed Schistosoma infection of both types
* History of administration of treatment for Schistosoma infection in the last 6 months prior to the study.
* Severely ill patients
* Advanced chronic liver disease.
The Potential Biomark of Serious Psychosis:a Prospective,Case-controled Study

Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and MRI.

Patients suffer from Schizophrenia and Mood Disorders may have variation in immunological factors(TNF-α,IL-2,IL-6,IL-10,etc),BDNF and Brain MRI.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with Schizophrenia , Bipolar Disorder or Major Depression by DSM-5

Exclusion Criteria:

* Unstable physical conditions
Muslim Americans Reaching for Health and Building Alliances (MARHABA): Patient Navigation Intervention to Increase Breast and Cervical Cancer Screening Among Muslim Women in New York City

Studies have reported Muslims in the US and NYC face numerous language and healthcare access barriers. This is a randomized randomized controlled design will be used to test the efficacy of a Patient Navigation (PN) intervention to increase participation in breast and/or cervical cancer screening among Muslim women age 40 - 75 years living in NYC. Study participants will be randomized to an Lay Health Workers (LHW) led small media intervention arm (SM-LHW) or a LHW-led patient navigation plus small media intervention arm (PN-LHW). A specific aim of the study is to develop, implement and evaluate the efficacy of a two-arm, randomized control trial designed to increase receipt of breast and/or cervical cancer screening among Muslim women aged 40 -75 years in New York City (NYC).

The goal of this study, entitled Muslim Americans Reaching for Health and Building Alliances (MARHABA), is to evaluate the effectiveness of a culturally patient navigation (PN) intervention designed for Muslim women to increase breast and cervical cancer screening participation.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as Muslim
* female
* residence in a NYC borough
* self-report as having received a mammogram more than two years ago and are age 40-74 years
* self-report having received a Pap test more than three years ago and are age 40-65 years

Exclusion Criteria:

* Report a past or current diagnosis of breast or cervical cancer
* Report having had a hysterectomy
* Report having had breast reconstructive surgery
The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption

The main interest of this study is to investigate the influence of moderate alcohol consumption (beer) on salt-water homeostasis. Therefore, 10 healthy volunteers will participate in 4 Intervention:

* Beer alone
* Beer and water
* Beer and salt (stock/bouillon)
* Water alone During the study day, copeptin, sodium, osmolality and urinary sodium/osmolality will be measured at 6 timepoints.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males

Exclusion Criteria:

* Any acute or chronic illness
* History of alcohol dependency
* Alcohol consumption \>2 units/day
* Active nicotine abuse
* Gluten intolerance
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Epileptic seizures within the last year
* BMI \<18.5 or ≥25.9kg/m2
Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults

The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years of age
* Seropositive for antibodies against HSV
* Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study.
* Good physical condition as established by physical examination and history taking at the time of entry

Exclusion Criteria:

* Any abnormal laboratory value among the tests performed at screening.
* History of persistent hepatic, renal, cardiac or respiratory diseases
* Clinical signs of acute illness at the time of entry into the study.
* Previous history of asthma or hypersensitivity to drugs.
* Seropositive for antibodies against the human immunodeficiency virus
* Pregnancy and lactation.
* Treatment with corticosteroids or immunomodulating drugs.
* Simultaneous participation in another clinical trial.
* Administration of any other vaccine or immunoglobulins during the study period
Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2

Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants ≥65 years of age at the time of consent
* Participating or participated in Study C4591001, received 2 doses of 30 µg BNT162b2 with the second dose given ≥6 months prior to the first vaccination in this study, and have not received a third dose of BNT162b2
* Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with preexisting stable disease
* Adults who have no history of ever receiving a pneumococcal vaccine, or received a licensed pneumococcal vaccination ≥12 months prior to the first vaccination in this study

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
* Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
* Previous clinical or microbiological diagnosis of COVID-19
* Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
* Previous vaccination with any coronavirus vaccine, other than those received in Study C4591001
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
POCone-UBiT-IR300 Pediatric Comparison Study

The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring 13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath test) Kit and the pUHR-CA web-based software program in identifying H. pylori infection in pediatric subjects.

The same patients will be tested on both the POCone® and UBiT®-IR300. If the patients test positive for H. pylori, they will be given eradication medication and brought back in for a re-test.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject ages 3 to 1711/12 years.
2. Subject with upper gastrointestinal signs and symptoms (e.g., abdominal pain/discomfort, bloating, nausea, or vomiting, etc.)
3. Subject and/or parent/legal guardian is capable of giving assent or consent.
4. Subject is able to complete the urea breath test by investigator's assessment.

Exclusion Criteria:

1. Subject is hypersensitive to mannitol, citric acid and/or aspartame.
2. Previous diagnosis of phenylketonuria (PKU.
3. Subject with difficulty swallowing or who may be at high risk for aspiration due to medical or physical conditions.
4. Subjects with ongoing respiratory conditions or on bronchodilators that may compromise the collection of breath samples.
5. Subjects with severe chronic illness (e.g., Crohn's disease, leukemia, kidney diseases, etc.)
6. Administration of bismuth preparations (e.g., Pepto-Bismol®) at anytime within 14 days prior to the testing.
7. Administration of antibiotics (e.g., amoxicillin, tetracycline, metronidazole, clarithromycin, azithromycin, etc.) therapy at anytime within 14 days prior to the testing.
8. Administration of proton pump inhibitors (PPI; e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.) at anytime within 14 days prior to the testing.
9. Administration of Histamine H2 receptor antagonist (H2RA; e.g., ranitidine, cimetidine, famotidine, nizatidine, etc.) at anytime within 24 hours prior to the testing.
10. Treatment for eradication of H pylori within 28 days before testing or retesting.
11. Participation in a drug or device study within 30 days of testing
Prevention of Celiac Disease in Skåne

This study aims to investigate the impact of being on a gluten free diet the first three years of life compared to a daily intake of a probiotic supplementation or placebo on the risk of developing celiac disease autoimmunity or celiac disease in genetically susceptible children.

This is a three-arm (1:1:1) randomized trial where study participants are randomly allocated to one of the three study groups before the age of 4 months. Regular clinical visits (4 times/year) during the intervention phase and yearly there after, up to the age of 7 years.

The primary hypothesis to be tested is that a strictly gluten free diet during the first three years of life with a slow introduction of gluten during the follow-up period will induce tolerance to gluten. A similar hypothesis is tested if a daily supply of two different lactobacillus (LB) strains can suppress an inflammatory response to gluten in the intestine by stimulating regulatory T-cells and reduced permeability of gluten peptides in the intestine.

The secondary hypothesis tested is that celiac disease can not be prevented, but the onset of the disease will be delayed in children returning to a gluten-containing diet after the intervention period (gluten free diet) or probiotic treatment) during the first three years of life. The intervention period is 3 years and the follow-up period is further 4 years.

The primary aim is to study the proportion of children who develop celiac disease autoimmunity and progression to celiac disease by the age of 3 years. Secondary aim is to study the proportion of children who developed celiac disease at the age of 7 years.

Eligibility Criteria:
Inclusion Criteria:

* Children screened positive for human leucocyte antigen (HLA) DR3-DQ2/DR3-DQ2
* Children must be enrolled to the study by 4 months of age (before gluten consumption has started).

Exclusion Criteria:

* Congenital chronic disorder where intervention with diet or probiotics may be affected.
* Written consent from both caregivers are missing