cyrilzakka/clinical-trials huggingface dataset:
Influence of Respiratory Muscle Training on Objective and Subjective Training Load Measures in Triathletes

Two groups of healthy, highly trained triathletes trained respiratory muscles with one of the two methods: voluntary isocapnic hyperpnoea (VIH) or inspiratory pressure threshold loading (IPTL). The main purpose of this study was to accurately and thoroughly assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.

Informed written consent was obtained from the all study participants. All procedures were carried out in accordance with the Declaration of Helsinki.

The study was conducted as a randomized controlled trial with two parallel groups. Whereas participants and data collectors were aware of the allocated training method, the data analysts and laboratory technicians performing biochemistry assays were kept blinded to the allocation. The participants were assigned at random to either VIH or IPTL training group to perform RMT with progressive overload for 6 weeks.

Three training sessions (week 1, 4, 6) were monitor to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.

Blood samples used for acid-base balance (pH), partial pressure of oxygen (pO2), partial pressure for carbon dioxide (pCO2), partial pressure for bicarbonate ion (HCO3-), and blood lactate (bLa) were collected immediately after cessation of the exercise and MPQ was presented 1' after cessation of the exercise. Blood samples for cortisol (C) and testosterone (T) were collected 5' after cessation of the exercise. The second S-Index Test was performed between minute 5 and minute 7 after cessation of the exercise. RPE was assessed 10' after cessation of the exercise. The participants again answered MPQ after 24h and 48h after the monitored RMT sessions.

Informed written consent was obtained from the all study participants. All procedures were carried out in accordance with the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* valid medical certificate to compete sports professionally,
* lack of ongoing medication intake,
* lack of any medical condition,
* lack of previous experience with RMT,
* lack of previous experience with RMT,
* performance caliber corresponding to at HighlyTrained/Elite (Participant Classification Framework, McKay 2022),
* at least 6 years of triathlon training,
* average training volume over 12 hours per week during last 6 weeks.

Exclusion Criteria:

* any ongoing medication intake or medical condition.
Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis

This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent or adult subject aged 12 - 65 years.
* Overall IGA score of 2 (mild) or 3 (moderate) at baseline on a 5-point IGA

Exclusion Criteria:

* AD with known hypersensitivity to excipients of TER-101 Ointment
* Subjects who are immunocompromised
Balance in Patients After Surgery for Torn Meniscus

The important role of the menisci in knee function and in preserving knee health has been shown in several studies. Additionally to principal functions of load transmission and shock absorption, meniscus contributes to knee joint proprioception and probably also to joint stability.Study about affect of meniscus injury on balance posture has not previously been published.Surgical practice is increasingly aimed at minimal resection of injured tissue, preserving a stable meniscal remnant with as much function as possible.The purpose of this study is to determine whether menisci surgery have any effects on relatively new postural control measures, in correlation with functional balance assessment. The second purpose is to establish the affect of different types of menisci surgery on balance impairment (meniscectomy vs tear repair), in correlation with a long-term outcome.


Eligibility Criteria:
Inclusion Criteria:

* Participants have to be healthy people
* 18-40 years old
* After a traumatic event of only one knee

Exclusion Criteria:

* Previous knee surgery
* OA per arthroscopy
* Neurological problem
* Any other orthopedic problem of lower limbs
* Systemic arthritic condition (RA, SLE etc.)
* Severe cognitive problem with restricted consent
* Pregnancy
Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System

Vasco trial is a no profit, multicenter, international, prospective, randomized study designed to evaluate the clinical benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and left ventricle ejection fraction (LVEF)\> 40% .The study will enroll about 331 patients (221 in the ILR group and 110 in the in-hospital follow-up group).


Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure, LVEF\> 40% who report episodes of palpitations.
* Over 18 years of age
* Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

Exclusion Criteria:

* Subject who is, or is expected to be unavailable for follow-up
* Pregnancy
* Medical contraindications for ILR implantation
* Patients with PMK / ICD or with Indication for ICD / PMK implantation
* Cardiovascular events / myocardial revascularization in the previous three months
* Patients already on oral anticoagulant treatment
* Patients who do not want to use the telemonitoring system
* Presence of other recognized indications to ILR (Unexplained syncope, cryptogenic stroke/TIA, Transient loss of consciousness and recurrent falls)
Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)

The purpose of this study is to validate that single units of RBCs collected by the Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood cells, and to provide data to support the 510(k) clearance of the MCS®+ 8150 system using LN832 disposable sets for this intended use.

This study will take place at two sites (Blood Center of Wisconsin (BCW) Milwaukee, WI and American Red Cross-Norfolk, VA).

* A standard double red cell collection protocol will be initiated using the Haemonetics MCS®+ 8150 system using LN832 disposable sets. The collection procedure will be terminated after collection of one RBC unit. The maximum target red cell volume will be selected based on the donor predonation weight as specified in the nomogram included in the MCS®+ 8150 operation manual.
* The RBC units will be stored for 42 days at 1° to 6°C.
* Upon collection and at 42 days after collection, the RBC units will be weighed and tested for hematology parameters (white blood cell count, red blood cell count, residual white blood cell count, hemoglobin, hematocrit, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cell distribution width, and supernatant hemoglobin) and chemistry parameters (pH, potassium, glucose, lactate, and ATP).
* Acceptance criteria for this study are as follows:

  1. Hemolysis of less than or equal to 1% at 42 days of storage
  2. Maximum absolute red cell volume is less than or equal to the programmed absolute RBC target volume + 15%
  3. Minimum absolute red cell volume is greater than or equal to the programmed absolute RBC target volume - 15%
* After collection of sixty (60) evaluable RBC units, the study will be considered supportive of the intended use noted above if zero (0) units fail the acceptance criteria.
* If one (1) unit fails acceptance criteria after collection of sixty (60) evaluable RBC units, an additional seventy one (71) units will be collected.
* The study will be considered supportive of the intended use noted above if not more than one (1) total unit out of 131 evaluable units fails the acceptance criteria.
* If a total of two (2) units fail acceptance criteria, the study will not be considered supportive of the intended use noted above.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females ≥ 18 years of age
* Males ≥ 130 pounds, Females ≥ 150 pounds
* Males ≥ 5 feet, 1 inch, Females ≥ 5 feet, 3 inches
* Hemoglobin ≥ 13.3 g/dL
* Hematocrit ≥ 40%
* Donor Eligibility: Meets all criteria as per sites' Research Blood Donation Record, Prior donation date (i.e. not less than 112 days for most recent double RBC unit donation, 56 days for most recent single RBC unit donation)
* Subject must provide informed consent using an IRB informed consent form prior to undergoing any study related procedures.

Exclusion Criteria:

* will be not fulfilling any of the inclusion criteria.
Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis

This study investigates the efficacy and the safety of Lanthanum Carbonate for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis.

Nephrolithiasis/urolithiasis is a prevalent (overall lifetime risk up to 13% in Western countries) and highly recurrent disease. Secondary hyperoxaluria is a key risk factor for the development of calcium oxalate stones, the most frequent stone type. Currently used therapeutic options in secondary hyperoxaluria have limited efficacy. Recent findings in vitro and in a rat model, provided evidence that Lanthanum Carbonate is an effective oxalate binder. The objective of this study is to investigate whether treatment with Lanthanum Carbonate reduces urinary oxalate excretion in human subjects with secondary hyperoxaluria and nephrolithiasis. By treating the patients with two different doses of Lanthanum Carbonate during two 14-day treatment periods, a dose-response will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* able to give written informed consenct
* hyperoxaluria (defined as urinary oxalate \> 45 mg/24 hours), demonstrated on 24-hour urine collection within 18 months prior to baseline visit
* history of nephrolithiasis eGFR \> 60 mL/min/1.73m² (CKD-EPI formula)

Exclusion Criteria:

* primary hyperoxaluria, diagnosed by genetic testing
* known allergy to Lanthanum Carbonate
* hypophosphatemia (defined as serum phosphorus \< 0.81 mmol/L)
* severe known liver insufficiency of biliary obstruction
* rectocolitis ulcerohaemorraghica, Crohn's disease, bowel obstruction, stomach/duodenal ulceration
* glucose/galactose malabsorption
* severe diarrhea or other gastrointestinal disorder, which might interfere with the ability to absorb oral medication
* pregnancy or breast-feeding
* female participant of childbearing potential unwilling to take efficient contraceptive measures for the duration of the study
* female participant without negative serum or urine pregnancy test
* psychological illness or condition, interfering with the patient's compliance or ability to understand the requirements of the study
* currently participating in another clinical trial
Effectiveness of Cannabis in the Treatment of Tinnitus Patients

The hypothesis of the study is that the use of Cannabis will attenuate the tinnitus level as experienced by the patients.


Eligibility Criteria:
Inclusion Criteria:

* Tinnitus lasting more than 3 months
* Tinnitus Handicap Inventory score over 58
* Treated previously for tinnitus (2 modalities)

Exclusion Criteria:

* Prior use of drugs
* Current use of Cannabis
* Neurologic or Psychiatric disease
* Heart Failure
* Ischemic Heart Disease
* Immune Deficiency
* Acoustic Neuroma
Arsenic, Disordered Glucose Homeostasis and Atherosclerosis

Investigators will recruit 250 subjects; Group A will consist of 100 prediabetic patients with an A1c of 5.7%-6.4%. Group B will consist of 100 patients with uncontrolled T2D defined as either a) an A1c of 6.5%-7.9% without diabetes medications or b) an A1c ≥ 8.0% with or without diabetes medications. Group C will include 50 participants without T2D or known cardiovascular disease to serve as control comparisons.

Patients with prediabetes have an elevated risk of cardiovascular disease (CVD). Cardiovascular disease (CVD) is also the leading cause of morbidity and mortality in patients with Type 2 Diabetes. There remains an unmet clinical need to identify modifiable risk factors for CVD in patients with disordered glucose homeostasis, including prediabetes and T2D. Exposure to inorganic arsenic and other environmental toxicants may be novel targets for CVD risk reduction for these patients. However, there have been no clinical studies of environmental exposures on vascular function and thrombotic risk among patients with prediabetes and growing understanding of environmental exposures as modifiable risk factors for CVD, and can have an impact by: (1) describing the role of environmental exposures for patients with or at risk for T2D; (2) identifying T2D patients at higher risk for the adverse biological effects of environmental exposures; and (3) informing health policies and treatment pathways to reduce the risk of these exposures.

Investigators will evaluate the association between inorganic arsenic exposure and measures of vascular function, estimate the association between inorganic arsenic exposure and measures of thrombotic risk and will explore the independent association between environmental exposures other than inorganic arsenic and measures of vascular function and thrombotic risk.

Eligibility Criteria:
Inclusion Criteria:

* No known cardiovascular, cerebrovascular or peripheral arterial disease
* Able and willing to provide written informed consent for the study

Exclusion Criteria:

* Unable to speak Spanish or English
* Active smoking (within the past year)
* Autoimmune, rheumatologic or inflammatory disease
* Known active cancer receiving treatment
* Pregnancy
* Anemia (hemoglobin \< 9 mg/dl)
* Chronic kidney disease (CrCl \< 30ml/min)
* Known Coronary Artery Disease (CAD; prior stents or CABG)
* Congestive Heart Failure
* Known Peripheral Arterial Disease (PAD; lower extremity revascularization surgery OR lower extremity stenting)
* Known prior stroke or transient ischemic attack (TIA) (mini-stroke or temporary/transient stroke)
Assessment of Three Basic Progressive Lens Designs

This clinical trial investigates the differences between three different progressive addition lens designs. It is a non-invasive double-masked randomized clinical investigation. For this study, 80 participants will be recruited.

The purpose of the study is to evaluate the preference, adaptability, and visual performance of three progressive lens designs. The difference in these lens designs is a variation of zone sizes for intermediate and near vision. The clinical trial helps manufacturers and eye care practitioners to give detailed suggestions to patients. Study participants will be experienced progressive addition lens wearers, which will be recruited by advertisements, by email, and with direct person-to-person solicitation. The study will be conducted at the Eye Care Institute at the Patient Care Center Western University of Health Sciences, Pomona, CA, 91766. For each participant, the study is completed in around two months and requires three separate visits.

Eligibility Criteria:
Inclusion Criteria:

* Age: 45 to 70 years old.
* Visual Acuity: far \& near monocular: cc ≥ 20/20 (decimal cc ≥ 1.0)
* Normal binocular vision (at distance \& near: no strabismus on cover testing, aligning prism of less than 2Δ horizontally or vertically, stereoacuity of 2' or better at distance and near).
* Prescription is in the range:

  * Spherical power: less than +/-6.00 D
  * Cylindrical power: less than -2.75 D
  * Addition: 1.50 D - 2.50 D
  * Difference in power (spherical equivalent) between eyes: less than 2.00 D

Exclusion Criteria:

* Have never worn any progressive lens design.
* First prescription for progressive lenses.
* Prescription found during visit#1 varies from current prescription more than 0.50 D in any meridian.
* Currently wearing single vision lenses with accommodative support.
* Double vision or prismatic prescription in current glasses.
* Known ocular disease including strabismus, any pathology, any eye surgeries that may affect visual acuity.
* Use of systemic or ocular medications that are likely to affect vision.
* Balance problem/vertigo problem.
* Concurrent participation in other vision-related research.
Psychological Distress in Emerging Adulthood: A Longitudinal Study

Emerging adulthood (18-29 years) is a critical stage in lifespan development. During this stage, people experience instability: shifts from their families of origin, breakups of relationships and job changes are frequent before most young adults stabilize their lives and make more lasting decisions. This study seeks to understand the psychological distress of emerging adults in Quito, Ecuador and define how it varies over a year.

Emerging adulthood is often a period of some instability with relationship changes and often a series of job changes before life trajectories clarify and more lasting decisions are possible. These changes often produce distress and they might explain why most of the symptoms that impact the individual's mental health throughout their lives appear at this stage, although full-blown disorders are often only diagnosed subsequently. There are several studies that describe the prevalence of mental disorders in this age group, however, there are few studies that refer to how psychological distress changes during this phase of emotional, social, and financial instability. The few existent studies refer mostly to college student populations, with relative neglect of the non-student populations.

The objective of this study is to analyze the intraindividual changes in psychological distress of emerging adults over one year. These changes will be compared between those participants who are college students and those who are not. Sociodemographic data will be recorded in the first assessment and the last assessment, while psychological distress and health-related quality of life will be monitored bimonthly for seven assessment points in total. Everyday relevant events will be also recorded bimonthly for seven assessment points, and this information will be used as a time-varying covariate. An electronic survey will be used for data collection through formr system (https://formr.org/).

The results of this research will show if the distress changes significantly in the studied population for one year and it will be possible to identify some of the events and variables that are related to these changes. This knowledge might help to create interventions that are tailored to the needs of this population.

Eligibility Criteria:
Inclusion Criteria:

* Competence to read and understand Spanish
* Living in Ecuador
* Being a student (for the student cohort)
* Not attending to a formal student program (for the non-student cohort)

Exclusion Criteria:

* None
Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol concentrations in lactating Bangladeshi women.

The specific aim is to compare the effects of orange-fleshed sweet potatoes and tangerines compared to white-fleshed sweet potatoes and vitamin A as retinyl palmitate on blood and breast milk cryptoxanthin (CX), beta-carotene (BC), and vitamin A (VA) concentrations by randomly assigning lactating Bangladeshi women to one of four treatment groups for 6 days/week for 3 weeks.

The investigators will also compare the relative vitamin A (VA) value of BC and CX from food sources by comparing the mean change in breast milk retinol concentrations of the groups that receive tangerines (CX) or orange-fleshed sweet potatoes (BC) with the mean change in breast milk retinol of the group that receives retinyl palmitate.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women in Dhaka, Bangladesh
* Lactating women in their 2nd or 3rd month of lactation who are planning to breast-feed at least 6 months
* Breast-feeding only one infant
* Age range 18 to 45 years
* Not pregnant
* Serum retinol concentrations \>0.70 umol/L and \<1.10 umol/L
* Normal concentrations of CRP (\<10 mg/L)
* At least one arm vein deemed adequate for blood collection, as evaluated by a screening nurse.
* Willing to consume the test foods daily 6 d/wk for one month

Exclusion Criteria:

* Health status is not compatible with the inclusion criteria, such as screening blood chemistries indicative of vitamin A deficiency.
* Severe anemia (Hb \<9 mg/dL)
* Current pregnancy
* Must not have known allergy to citrus fruit (tangerines or mandarin oranges) or sweet potatoes
* Must have no obvious psychological or sociological problems-such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an inform consent agreement or to participate in study duties and activities
The Children in Action Feasibility Study

The Children in Action (CIA) program was a five month physical activity intervention. This intervention was a feasibility study with 3- to 5-year-olds enrolled in four Head Start centers. After baseline assessment, centers were matched by ethnicity and for number of participants and randomly assigned to either the intervention or the control condition. A total of 224 preschool children were randomly selected across the four centers. To evaluate the efficacy of the CIA intervention, the change in physical activity, gross motor skills and weight during the awake time and used mixed effect time-series regression models was compared. Observations did not show a statistical difference between intervention and control groups in physical activity level during the awake time, gross motor development or weight status. It was demonstrated that it is feasible to conduct the SPARK-EC curriculum among preschool children attending Head Start Centers but that an increased dose and/or longer intervention duration will be required to impact gross motor skills, weight status and physical activity levels during this critical early childhood development stage.


Eligibility Criteria:
Inclusion Criteria:

* 3-5 years old
* attends Head Start
* African-American
* Hispanic-American

Exclusion Criteria:

* older than 5 years old
* does not attend Head Start
* race/ethnicity other than African-American or Hispanic-American
* has a disability or handicap that would prevent them from participating in physical activities