cyrilzakka/clinical-trials huggingface dataset:
Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome

High velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 litres/min and may be able to provide ventilatory support in patients with respiratory failure in addition to oxygenation support in patients with overlap syndrome.

This study aims to evaluate the effectiveness of HVNI compared to NIMV in management of respiratory failure in patients with obesity hypoventilation syndrome and overlap syndrome.

Overlap syndrome (OVS) is the concurrence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), and is associated with poor outcomes.

COPD and obstructive sleep apnoea (OSA) are highly prevalent and different clinical COPD phenotypes that influence the likelihood of comorbid OSA.

The increased lung volumes and low body mass index (BMI) associated with the predominant emphysema phenotype protects against OSA whereas the peripheral oedema and higher BMI often associated with the predominant chronic bronchitis phenotype promote OSA.

The diagnosis of OSA in COPD patients requires clinical awareness and screening questionnaires which may help identify patients for overnight study.

Management of OSA-COPD overlap patients differs from COPD alone and the survival of overlap patients treated with nocturnal positive airway pressure is superior to those untreated.

high flow nasal cannula (HFNC), which delivers heated, humidified oxygen via a nasal cannula at high flow rates of up to 60 L/min, delivering a maximum of 100% oxygen, has been shown to be effective in the treatment of respiratory failure.

High velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 litres/min and may be able to provide ventilatory support in patients with respiratory failure in addition to oxygenation support in patients with obesity hypoventilation syndrome and overlap syndrome.

This study aims to evaluate the effectiveness of HVNI compared to NIMV in management of respiratory failure in patients with overlap syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with respiratory failure in obesity hypoventilation syndrome and overlap syndrome, requiring ICU admission and fulfill criteria of NIMV supplementation (GOLD criteria 2021)
* patients with obesity hypoventilation syndrome and overlap syndrome diagnosed by polysomnogram or through STOP BANG Questionnaire or EPWORTH Sleepness Scale.

Exclusion Criteria:

* Patients less than 18 years old
* Patients with hemodynamic instability
* Patients with central causes of hypercapnic respiratory failure
* Patients with disturbed conscious level
* Patients who refuse to participate in the study
Effects of Taurine Supplementation on Repetitive Sprint Performance and Exhaustion Time in College Students Under High-Temperature and High-Humidity Conditions

This study is designed to evaluate the effects of acute pre-exercise taurine supplementation at different doses on the performance of college students during exhaustive exercise and subsequent repetitive sprint (RS) activities in a high-temperature, high-humidity environment. Sixteen college students (8 male, 8 female) will participate in a single-blind, randomized, crossover-controlled trial. Participants will be divided into four groups: high-dose taurine (6g), medium-dose taurine (4g), low-dose taurine (1g), and placebo. Key performance metrics such as peak power (PP), mean power (MP), fatigue index (FI), exhaustion time (ET), reverse vertical jump height, heart rate (HR), blood lactate (BLA), and ratings of perceived exertion (RPE) will be measured.

The objective of this study is to assess how taurine supplementation influences exercise performance under these challenging environmental conditions. This study will help to better understand taurine's potential effects on exercise performance and contribute to nutritional strategies for athletes exposed to extreme conditions.

This study is designed to evaluate the effects of taurine supplementation on exercise performance under extreme environmental conditions of high temperature and high humidity. The primary goal is to investigate whether taurine supplementation can enhance performance during exhaustive exercise and subsequent repetitive sprints (RS). Sixteen college students (8 male, 8 female) will participate in a single-blind, randomized, crossover-controlled trial. Participants will be divided into four groups receiving either high-dose (6g), medium-dose (4g), low-dose (1g) taurine supplementation, or placebo.

The study will involve a protocol with exhaustive exercise followed by six repetitive sprints. Performance metrics such as peak power (PP), mean power (MP), and fatigue index (FI) will be recorded. Additionally, physiological parameters, including heart rate (HR) and blood lactate (BLA), as well as subjective measures like ratings of perceived exertion (RPE), will be monitored. A standardized measurement protocol will be used to ensure consistency and accuracy across trials.

Eligibility Criteria:
Inclusion Criteria:

* School students
* Aged between 18 and 28 years
* No exercise-related risk, as indicated by a "no" response to all questions in the Physical Activity Readiness Questionnaire (PAR-Q)
* No taurine-based supplements consumed in the last month.

Exclusion Criteria :

* Individuals who do not meet the inclusion criteria
* Individuals with a history of cardiovascular issues, respiratory problems, or any condition that may impair exercise performance
* Participants who did not provide a "no" response to all questions in the Physical Activity Readiness Questionnaire (PAR-Q)
* Participants who consumed taurine-based supplements in the month preceding the study.
Feasibility and Fidelity of a Gross Motor-based Physical Activity Intervention on Cognition in Preschool-age Children

The goal of this study will be to examine the implementation and preliminary efficacy of a teacher taught gross motor skill-based physical activity (PA) intervention on cognitive variables in low low socio-economic (SES) preschoolers. The movement and cognition intervention will be implemented for 4 days per week for 6 months. Primary outcome variables will be processed evaluation data. Secondary outcome variables will be changes in children's cognitive function (executive functions and memory), gross motor skills, and PA levels at baseline, 3- and 6-month.

The goal of this study will be to examine the implementation and preliminary efficacy of a teacher taught gross motor skill-based physical activity (PA) intervention on cognition in low low socio-economic (SES) preschoolers. Low SES preschool centers (n=4) will be recruited and randomly assigned to either a Movement and Cognition (MAC) or a control group. From each preschool center, preschool-age children will be recruited to participate in their assigned center intervention. The MAC intervention will be implemented for 4 days per week for 6 months. The research team will train the preschool providers to implement the intervention. The control centers will be asked to maintain their usual preschool schedule. Primary outcome variables will be processed evaluation data \[study fidelity (adherence, compliance, and integrity of study design), intervention dosage, acceptability, quality, adaptation\], and will be assessed throughout the 6-month study. Secondary outcome variables will be changes in children's cognitive function (executive functions and memory), gross motor skills, and PA levels at baseline, 3- and 6-month. Aim 1 will examine the implementation of a 6-month teacher taught gross motor skill-based movement intervention in low SES preschoolers. Aim 2 will examine the preliminary efficacy of the MAC intervention on cognition, gross motor skills, and PA in preschoolers. For aim 2, the study will compare the outcome variables of interest between the MAC and the control group.

Eligibility Criteria:
All children within a childcare center will participate in center's assigned activities. However, children will be individually recruited to participate in the measurement portion of study.

Childcare center will be eligible for study if:

* They have at least 40 (preschool-age) children enrolled
* Have at least 2 full-day preschool classrooms
* Not concurrently participating in other physical activity or gross motor skills programs

Child will be eligible for measurement portion of the study and the parent component if she or he is

- 3 - 5 years old at baseline assessment

Children will be excluded from the measurement portion of the study if they:

* Have conditions limiting participation in gross motor skills or physical activity intervention or the assessment of physical activity
* Plan to move away from the Springfield, MA area within the next 6 months.
Resistance Training With Blood Flow Restriction

Blood flow restriction associated with resistance training is suggested to potentiate increases in muscular strength and hypertrophy. This study will compare the effects of resistance training associated with blood flow restriction with a regular resistance training program. Findings of this project will provide important information regarding a promising intervention to potentiate muscle performance.

The purpose of this study is to determine alterations in motor unit behavior of the tibialis anterior muscles after a resistance exercise program associated with blood flow restriction. Our working hypothesis is that blood flow restriction to working muscles will induce greater changes in muscle activation, lean mass and muscle size compared with a training at same intensity without blood flow restriction.

Eligibility Criteria:
Exclusion Criteria:

* presence of neurological diseases,
* presence of metal implants or joint replacement
* any restriction to perform physical activity
* pregnancy
Adaptive Radiotherapy in Patients With Gynecological Tumors

Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery or HDR brachytherapy as dose boost is not an option.

Online-adaptive radiotherapy (ART) makes it possible to adapt the dose distribution to the anatomical changes online immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard in radiotherapy. Here, a cone-beam CT (CBCT) is also performed at the beginning of each fraction, which is used to position the patients in relation to the radiation field arrangement of the initial radiation plan approved for the series. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations in the body from radiation fraction to radiation fraction, e.g. due to different rectum and bladder fillings.

In ART mode, the online adaptive treatment plan for the current treatment is then selected and approved by the specialist online onboard in all cases in which the current target volume for the tumor expansion is not sufficiently covered by the initial treatment plan pre-planned for the series with its planned tolerances, or surrounding normal tissue is exposed too much. If the ART plan does not show any clear dosimetric advantages over the reference plan, especially if the initial plan covers the target volume of the day well, there are no dose increases and the normal tissues are spared as intended, the initial radiation plan from the planning CT can also be used as in IGRT. The aim of this study is to treat at least 15 patients with locally advanced gynecological carcinoma (mainly cervical carcinoma, endometrial carcinoma, vaginal carcinoma), who are to receive definitive radiotherapy at the Department for Radiotherapy at the University Hospital Essen, in ART mode on the Ethos therapy device over an initial 10 radiation fractions. The dose distribution is always compared with the adaptive and the initial plan for the radiation series on the anatomy of the day by the specialist and medical physics expert. The aim of this study is to prospectively investigate what percentage of patients benefit from ART when using standard PTV margins and how to recognize the corresponding patients early in the series. Secondarily, it will be investigated in what proportion of patients the risk organ burden and the safety margins around the clinical target volume can be reduced with ART compared to IGRT and how large this reduction can be.

The EORTC and CTC AE toxicitiy scales and further assessment scales will be evaluated in order to quantify objective and subjective side effects.

Eligibility Criteria:
Inclusion Criteria:

ECOG 0-1 confirmation by histophatology MR of the pelvis staging

Exclusion Criteria:

Recurrent disease Prior Radiotherapy in pelvic region stage pM1 or cM1
Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz

The purpose of this study is to determine whether calcium and vitamin D supplement can attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil fumarate.

Early initiation of antiretroviral therapy (ART) has transformed HIV infection into chronic manageable disease. Although incidence of AIDS-related mortality has decreased, it has increased for other co-morbid conditions including decrease bone mass, osteoporosis, fragility fracture. There are multi-factorial that contribute to bone loss in HIV-infected individuals including HIV virus itself that shift bone remodeling pathway toward bone resorption, lifestyle and behavioral factors, co-morbid conditions and ART.

Initiation of ART is associated with 2%-6% reduction in bone mineral density during the first 2 years of treatment regardless of ART regimens and then stabilization thereafter in the majority of the study. This magnitude of bone loss is similar to postmenopausal women during the first year.

Tenofovir disoproxil fumarate (TDF) is a nucleotide analogue reverse transcriptase inhibitor, has been associated with greater bone loss than other reverse transcriptase inhibitors, that is recommended as the first line treatment in Thailand. Nonetheless there is an evidence in western country that calcium and vitamin D supplement can attenuate bone loss in naive HIV-infected individual who start ART with TDF. Even though many experts recommend to avoid TDF and prefer abacavir, NRTIs which affect bone loss less than other NRTIs, in high fracture risk patients, more than less HIV-infected-patients can access to abacavir in resource limiting country. This research aims to study bone mineral density (BMD) in HIV infected-patient in Thai population who receive tenofovir with calcium and vitamin D supplement.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1-infected patients who start 3TC or FTC,TDF and EFV within 3 months before enrollment
* Age 18-50 years

Exclusion Criteria:

* CrCl \<60mL/min/1.73 m2 ¶-
* CaCO3 supplement \>500 mg/day or vitamin D supplement \>800 IU/day
* Steroid used (equivalent to prednisolone\> 5 mg/day more than 3 months )
* Osteoporosis treatment
* Serum Ca \>10.5 g/dL
* History fragility fracture
* Pregnancy or breastfeeding
* Secondary amenorrhea
* Hyperthyroidism
* History of kidney stone
* Current active opportunistic infection
Knowledge, Practice and State of Periodontal Health

The main objective of the study is to assess the knowledge and practice of periodontal health, which will be done using a well constructed and validated questionnaire. Then periodontal health status of all participants will be assessed via clinical examination of certain teeth.

The primary outcome of the study is the knowledge of periodontal health.It will be assessed by 10 questions focusing on the basic knowledge of gingival appearance, causes and consequence of periodontal disease, impact of systemic disease on the progression of periodontal conditions, and prevention. Then, periodontal practice will be addressed via several questions that evaluate the self-care practices of tooth brushing, flossing, mouth rinsing in recent one year, scaling in recent five years, and how to alleviate gingival bleeding if there is.

Periodontal examination using the community periodontal index (CPI) will be done for all of the participants to assess the status of periodontal condition. The dentition will be divided into sextants and the highest code number corresponding to the worst periodontal condition around each of the 10 indexed teeth being recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients whose age is above 15 years old.
2. Patient consulting in the outpatient clinic
3. Provide informed consent.

Exclusion Criteria:

1. Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
2. Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer

The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.

This is an open label, multicenter, dose ranging study, sequentially enrolled by study dose, with a non-inferiority design to compare the effectiveness of SPI-2012 relative to a fixed dose of pegfilgrastim as a concurrent active control to each dose of SPI-2012 in participants with breast cancer. This study included four arms comprising three dose levels of SPI-2012 (Arm 1: 45 µg/kg, Arm 2: 135 µg/kg, Arm 3: 270 µg/kg) versus pegfilgrastim (Arm 4: 6 mg). The start of study is defined as the initiation of treatment with SPI-2012 or pegfilgrastim. The duration of treatment consists of a maximum of 4 cycles (21 days per cycle) beginning on Day 1 with chemotherapy administration and continue through Day 21, plus a 30-day follow-up period, unless any of the discontinuation criteria applies.

The target population are participants with breast cancer who are candidates for neoadjuvant or adjuvant treatment with Docetaxel + Cyclophosphamide (TC) chemotherapy. All participants who receive at least 1 dose of either SPI-2012 or pegfilgrastim were followed for safety through 30 days after their last dose of study treatment or until all treatment-related adverse events (AEs) have resolved or returned to baseline/Grade 1, whichever is longer, or until it is determined that the outcome will not change with further follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant chemotherapy
* Candidate for docetaxel and cyclophosphamide chemotherapy
* Female or male at least 18 years of age
* Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Absolute neutrophil count (ANC) ≥ 1.5×109/L
* Platelet count ≥ 100 x 10\^9/L
* Creatinine ≤ 1.5 x upper limit of normal (ULN)
* Total bilirubin ≤1.5 mg/dL(≤ 25.65 μmol/L).
* Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN
* Hemoglobin \> 9 g/dL
* Alkaline phosphatase ≤ 1.5 x ULN

Exclusion Criteria:

* Known sensitivity to E. coli-derived products or known sensitivity to any of the products to be administered
* Known Human Immunodeficiency Virus (HIV) infection
* Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease
* Active infection or any serious underlying medical condition that would impair ability to receive protocol treatment
* Prior bone marrow or stem cell transplant
* Prolonged exposure to glucocorticosteroids and immunosuppressive agents
A Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes

This study is to evaluate the efficacy of a probiotic supplement on weight management and metabolic health. This study will be conducted as a hybrid trial consisting of both in-person visits and virtual assessments. Two groups will be included: the intervention (SlimBiotics Probiotic) and placebo.

The SlimBiotics probiotic formula is the first plant-based probiotic targeting weight management and metabolic health. Other competing probiotics are isolated from humans (feces) but the strains in SlimBiotics were isolated from a fermented plant (millet porridge cereal).

This product contains 3 probiotic strains:

Limosilactobacillus fermentum K7-Lb1 Limosilactobacillus fermentum K8-Lb1 Limosilactobacillus fermentum K11-Lb3


Eligibility Criteria:
Inclusion Criteria:

* Women \& Men
* 18+
* BMI between 25-32
* Generally healthy - don't live with any uncontrolled chronic disease
* Own a sleep-tracking device (smart watch etc.)

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Anyone with known severe allergic reactions.
* Women who are pregnant, breastfeeding or attempting to become pregnant
* Unwilling to follow the study protocol.
* Subjects currently enrolled in another clinical study
* Subjects having finished another clinical study within the last 4 weeks before inclusion
* Hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum)
* Condition after implantation of a cardiac pacemaker or other active implants
* Sulfonylurea treatment
* Any disease or condition which might compromise significantly the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria
* History of or present liver deficiency as defined by Quick \< 70%
* Regular medical treatment including over-the-counter, which may have an impact on the study aims (e.g. probiotics containing supplements, laxatives, steroids etc.)
* History of hepatitis B, C, HIV
* Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
* Simultaneous study participation by members of the same household
* Pregnancy and lactation
* Ascites as assessed by sonography
* Any diet to lose body weight
* Eating disorders or vegan diet
* Anorexia drugs
* Present drug abuse or alcoholism