cyrilzakka/clinical-trials huggingface dataset:
3 Minutes Chair Rise Test (3CRT) in Patients With COPD

Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside specialized centers.

In order to monitor the eventual decline of patients in the course of their RHB management, Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The goal of this prospective, multicenter, real-life study is to compare the change in several functional function tests and questionnaires of quality of life and dyspnea related to daily activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related to COPS Tool) were specified.


Eligibility Criteria:
Inclusion Criteria:

* Patient with COPD Gold II to IV
* Patient admitted for a rehabilitation program in real life
* Person affiliated to the Social Security or beneficiary of such a scheme
* Informed and written consent by patient or legal representative

Exclusion Criteria:

* Patient limited by reduced locomotor activity or joint pain that compromises their participation in a rehabilitation program
* Patients with a performance less than 250 meters during 6MWT
* Non-stable cardiac disease
* Any other lung disease than COPD
* Person subject to a legal protection measure
A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics

To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research.

single arm, single or repeat dosing of TQ-B3101 on patients with solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of Advanced solid tumors
* Lack of the standard treatment or treatment failure
* 18-70years,ECOG PS:0-1,Life expectancy of more than 3 months
* Main organs function is normal
* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
* Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

* Patients with treatment failure by ALK/ROS1 inhibitor
* Patients with anti-teratment,radiotherapy or surgery within 4 weeks
* Patients participated in other anticancer drug clinical trials within 4 weeks or ALK/ROS1 inhibitor within 1 week
* Blood pressure unable to be controlled(systolic pressure\>140 mmHg，diastolic pressure\>90 mmHg). Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥470ms)
* Patients with non-healing wounds or fractures
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* History of immunodeficiency
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Interventional Effects on Myocardial Revascularization Post-surgical Patients

The aim is to evaluate the effectiveness of physical exercise on a cycle ergometer combine with CPAP in the postoperative period after myocardial revascularization

Physical exercise on a cycle ergometer combine with CPAP as an adjunct to the rehabilitation of hospitalized subjects who will undergo myocardial revascularization will be safe, decrease the length of stay in the ICU, and help maintain functional capacity

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have undergone myocardial revascularization surgery
* An ejection fraction of greater than40%
* Post operative mechanical ventilation for \<12hours
* No definite diagnosis of chronic obstructive pulmonary disease and asthma

Exclusion Criteria:

* With complications in post operative period (e.g., Artial fibrillation, prolonged mechanical ventilation)
* Hemodynamically unstable patients
* Intolerance to CPAP(continuous positive airway)mask
Intestinal Microbiome and Chemotherapy

Chemotherapy is commonly used as myeloablative conditioning treatment to prepare patients for haematopoietic stem cell transplantation (HSCT). Chemotherapy leads to several side effects, with gastrointestinal (GI) mucositis being one of the most frequent. Current models of GI mucositis pathophysiology are generally silent on the role of the intestinal microbiome.

The aim of the study is to identify functional mechanisms by which the intestinal microbiome may play a key role in the pathophysiology of GI mucositis, the investigators applied high throughput DNA-sequencing analysis to identify microbes and microbial functions that are modulated following chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants with non-Hodgkin's lymphoma
* Participants receiving the same myeloablative conditioning regimen for five consecutive days, including high-dose Carmustine (Bis-chloroethylnitrosourea), Etoposide, Aracytine and Melphalan.

Exclusion Criteria:

* Patients with a history of Inflammatory Bowel Diseases (IBD), exposed to probiotics, prebiotics or broad-spectrum antibiotics, or administered nasal-tube feeding or parenteral nutrition in the month prior to initiation of the study.
Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)

There is currently considerable interest in both improving academic achievement (No Child Left Behind) and reducing the rates of obesity and its associated negative health consequences in elementary school students. Increased physical activity (PA) offers a potential intervention to address both issues. Evidence is available which suggests an association of PA with both academic achievement and obesity, and an association between obesity and academic achievement.

To provide increased PA while maintaining academic instruction time, we developed a program we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA) for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between students in elementary schools that participate in academic lessons taught through MVPA (PAAC) to students that do not (CON).


Eligibility Criteria:
Inclusion Criteria:

* Grade 2 or 3 Student at one of the randomly selected elementary schools
* Students that agree to complete assessments
* Signed parental consent form
* Signed child assent form

Exclusion Criteria:

* Students that do not agree to complete assessments
The Clinical Significance of Gut Permeability in Gastrointestinal Post Acute COVID-19 Syndrome

Severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) and the associated coronavirus disease 2019 (COVID-19) have been spreading all around the world for past 3 years. Some of these convalescent individuals experienced long- term sequelae termed 'long COVID', or 'post- acute COVID-19 syndrome'(PACS). Common manifestations are systemic, neuropsychiatric, cardio- respiratory and gastrointestinal \[1\].

The prevalence of gastrointestinal PACS was 2-5% in different literatures \[2\]\[3\]. The risk factors of gastrointestinal PACS include anosmia, ageusia, and presence of chronic bowel disease, dyspeptic symptoms and the psychological comorbidity \[4\]. Previous articles have discussed pathogenesis of PACS, which was associated with increasing serum cytokine level and persisted inflammatory status \[5\]. Whereas, the influence of chronic inflammation to target organ has not been well studied. Liu et al explored the gut microbiota dynamics in patients with PACS, which revealed higher levels of Ruminococcus gnavus, Bacteroides vulgatus and lower levels of Faecalibacterium prausnitzii \[6\]. Another article established the association between multisystem inflammatory syndrome in children (MIS-C) and zonulin-dependent loss of gut mucosal barrier \[7\]. According to previous studies, infectious enteritis may cause subsequent post infectious irritable bowel syndrome \[8\]\[9\], which was associated with increased gut permeability, T-lymphocyte, Mast cell and proinflammatory cytokine \[10\]\[11\]. It is reasonable that gastrointestinal PACS might be also associated with dysfunction of gut mucosal barrier.

Confocal laser endomicroscopy (CLE) is a new endoscopic imaging tool that enables visualization of gut mucosa changes. The gut permeability could be accessed by CLE in patient with irritable bowel syndrome \[12\]. This study aimed to explore the association between gut permeability and gastrointestinal PACS.


Eligibility Criteria:
Inclusion Criteria:

* persisted gastrointestinal symptoms such as dyspepsia, abdomen pain, diarrhea or constipation 3 months after COVID-19 infection

Exclusion Criteria:

* Terminal cancer, surgical history of gastrointestinal tract, acute gastrointestinal tract bleeding, allergy to fluorescein, pregnant or breast feeding, helicobacter pylori infection, major cardiopulmonary disease, liver cirrhosis, end stage renal disease, autoimmune disease, inflammtory bowel disease, small intestinal bacterial overgrowth, celiac disease, type 1 diabetic mellitus, type II diabetic mellitus, gastroenteritis in 3 months, history of irritable bowel syndrome, usage of NSAID, steroid
Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received Nexavar for unresectable or advanced renal cell carcinoma

Exclusion Criteria:

* Patients who are contraindicated based on the product label
Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)

This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of ASTX727, as well as determined the dose for later stages.

The trial was designed to define daily doses of the individual components (cedazuridine \[E7727\] or decitabine) so that decitabine exposure after oral administration would be comparable to exposure after IV decitabine at the approved daily dose of 20 mg/m\^2. The main objective of Phases 1 and 2 was to establish and confirm the doses of the 2 components to be used in the final fixed-dose combination (FDC) product (ASTX727) using mainly pharmacokinetics and pharmacodynamics as endpoints.

Eligibility Criteria:
Inclusion Criteria:

* International Prognostic Scoring System (IPSS) low, intermediate -1, intermediate-2, or high risk MDS (including chronic myelomonocytic leukemia; CMML) in Dose Escalation and Dose Confirmation-Randomization; only intermediate-2, or high risk MDS in Dose Confirmation-Open Label
* Eastern Cooperative Oncology Group (ECOG) 0 to 2
* No major surgery within 2 weeks of starting study treatment
* No cytotoxic chemotherapy within 2 weeks of starting study treatment
* Able to swallow pills

Exclusion Criteria:

* Previous treatment with 2 or more courses of decitabine (all stages) or azacitidine (Dose Confirmation stage only)
* Treatment with investigational therapy within 2 weeks of study treatment
* Uncontrolled medical disease(s) or active, uncontrolled infection
* Diagnosed with acute myeloid leukemia (AML)
* Active uncontrolled gastric or duodenal ulcer
* Known history of HIV or hepatitis C or B
Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw

Medication related Osteonecrosis of the Jaw (MRONJ) consists of progressive destruction of bone in the maxillofacial area. It is an established complication which occurs in patients who take two main classes of antiresorptive drugs: Bisphosphonates (BP) and Denosumab.

PRGF is a autologous platelet-enriched plasma obtained from the patient's own blood. It contains proteins that can influence and promote cell recruitment and its beneficial effect could consist in improving bone and soft tissue healing. These benefits are likely to apply to MRONJ surgery, as it is suggested by small retrospective or prospective case series.

This is a randomized, multi center study comparing the outcomes of surgery alone and PRGF plus surgery in patients requiring surgical treatment for MRONJ.

To assess the superiority of surgery plus PRGF compared to surgery alone in patients treated for MRONJ. Primary endpoint for this scope is a composite of clinical or radiological recurrence rate of disease during a 12 months post-operative period.

Secondary endpoints are: a) morbidity, defined as nerve injury, bleeding, vascular or wound complications. b) post- and peri-operative pain defined by the treated subjects according to a standardized VAS score c) quality of life (QoL) defined by a standardized scale.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be candidates for surgical treatment for MRONJ at stage 2 or 3.
* Subjects must be \>18 and \<80 years of age
* Subjects must sign a informed consent prior to randomization and must agree to return to scheduled follow-up visits

Exclusion Criteria:

* Subject has inability to understand and cooperate with the study procedures or provide informed consent
* Subject has bleeding diathesis or coaugolapthy, or will refuse autologous blood sampling
* Subject had a cardiovascular event in the past 30 days
* Subject has any condition that limits their anticipated survival to less than 3 months
An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS

This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study


Eligibility Criteria:
Inclusion Criteria:

1. Men and women between the ages of over 19 and under 75 at the time of consent
2. Patients diagnosed with RA or AS at least 3 months prior to the study registration
3. Patients who are scheduled to be prescribed Adalloce according to the doctor's opinions
4. Patients who have never received Adalloce
5. Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study

Exclusion Criteria:

1. Patients with hypersensitivity to this drug or its components
2. Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection
3. Patients with moderate to severe heart failure (NYHA class III/IV)
4. Patients who are judged to be inappropriate for Adalloce administration according to the approved conditions
5. Patients who are not suitable for participation in this study according to the judgment of the investigator
6. Patients participating in other drug clinical trials (Adalloce PMS participants cannot participate in this study)
Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain

The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-65 years
* Postpartum ≥ 3 months
* Pain located in sacroiliac joints (i.e., pain located between the posterior iliac crest and gluteal fold)
* Pregnancy-related cause of pelvic pain that pain occurs during pregnancy or after delivery (i.e., not traumatic or degenerative cause)
* At least 2 positive findings of 6 pain provocation tests for pelvic pain
* Score of Active Straight Leg Rise (ASLR) test \> 0

Exclusion Criteria:

* being pregnant or actively trying to get pregnant
* having known causes of pelvic girdle pain, such as fractures and rheumatism
* having undergone lumbar, pelvic, gynecologic or obstetric surgery
* having current neurological symptoms and signs in lower extremities such as lumbar radiculopathy and myelopathy
* having cancer
* having cardiovascular disease
* being diagnosed as having a psychiatric disease
* active infection or infectious disease in the pelvis or abdomen
* having experience with structured and supervised core or trunk exercise training programs.
A Post Trial Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH)

The purpose of this study is to provide continued access to TPIP for participants with PAH who have successfully completed the open label extension (OLE) INS1009-203 study.

Participants will receive TPIP 80 micrograms (μg), 160 μg, or 320 μg, inhalation single-dose capsules, orally, once daily (QD).

Eligibility Criteria:
Inclusion Criteria

* The participant is ineligible for or cannot be treated satisfactorily with alternative commercially available therapy for the PAH.
* Participant provides their informed consent to participate as per local requirements.
* Participant must have successfully completed the OLE INS1009-203 Study.
* Based on the treating physician's judgement on participant's medical history and an evaluation of the overall risk-benefit profile, the participant will be determined to be suitable for continued TPIP treatment within this program.
* Requests for the post-OLE INS1009-203 TPIP Study must originate from the investigator of INS1009-203 TPIP Study.
* Female participants must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (failure rate \<1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.
* Male participants with female partners must adhere to contraception requirements to avoid potential exposure to the embryo/fetus based on the partner's reproductive status. For partners of childbearing potential, effective contraception must be used from Day 1 to at least 90 days after the last dose.

Exclusion Criteria:

* No specific exclusion criteria.
Adrenomedullin Upregulation in Apical Periodontitis

The aim of the present study was to investigate the relationship between Apical periodontitis (AP) severity and inflammatory markers (IL-12, TNF-alpha), and Mid-Regional Pro Adrenomedullin (MR-proADM) in patients with AP. A total of 174 subjects were divided into three categories: AP group (n=82), Chronic periodontitis (CP) group (n=42), healthy control group (n=50). Blood samples were collected from all of the patients. Enzyme-linked immunosorbent assay was used to evaluate the samples.

Bone destruction in apical periodontitis (AP) depends on the microorganisms' efficiency to breach the host-epithelial barrier and various antimicrobial peptides. Mid-regional pro adrenomedullin (MR-proADM) is one such potent antimicrobial peptide, which plays a regulatory and stabilizing role among proinflammatory and anti-inflammatory cytokines. A broad range of cells and tissues produce MR-proADM such as adrenal medulla, kidney, lungs, and endothelial cells. MR-proADM was found to be present in circulation and in various biological fluids. It is reported to function both as a generalized hormone and locally affecting autocrine or paracrine mediator. Its plasma level is usually elevated in certain conditions such as heart failure, hypertensive situations, cerebro-vascular events, chronic kidney failure, diabetes mellitus, sepsis and periodontitis. Besides these, MR-proADM has drawn attention as it stimulates the proinflammatory cytokine IL-6 and suppresses cytokines, like TNF- α, for regulating inflammation, being a potent of inhibitor of apoptosis and stimulating angiogenesis in tumor cells. However, there is still a large information gap on MR-proADM. Despite all these effects, there is not enough information in the literature about the effect of MR-proADM on oral and dental health and its effectiveness in apical periodontitis. Whether AP can cause any alterations in the MR-proADM value is also unknown.

Therefore, the aim of this study is to investigate the relationship between AP severity and inflammatory markers (IL-12, TNF-alpha), and MR-proADM in patients with AP. In addition, the results will be compared with the results of healthy controls and patients with chronic periodontitis.

Eligibility Criteria:
Inclusion Criteria:

Must be systemically healthy Patients with only apical periodontitis (for AP group) Patients with only chronic periodontitis (for CP group) Orally healthy patients

Exclusion Criteria:

any local or systemic inflammatory disease connective tissue diseases like systemic lupus erythematosus (SLE) cardiovascular disease inflammatory and rheumatic disease diabetes rheumatoid arthritis, or Behcet's disease granulomatous diseases like sarcoidosis inflammatory intestinal diseases like ulcerative colitis and Crohn's autoimmune intestinal diseases like celiac thyroid diseases like Hashimoto and Graves patients who had taken antibiotics and/or anti-inflammatory drugs within the last 6 months those with pregnancy or lactation
Assessment of the Stroke Rehabilitation Assessment of Movement as a Clinical Tool

The Stroke Rehabilitation Assessment of Movement (STREAM) is a relatively new measurement tool, which measures specific movement deficits (impairments) caused by a stroke. The STREAM is used to evaluate recovery of voluntary movement and basic mobility following the onset of a stroke. Several important clinical measurement properties of the STREAM remain to be explored, including its ability to measure impairments and clinical change in acute rehabilitation patients in the USA. We hypothesize that the STREAM will be able to detect and quantify a statistically significant change in the motor abilities of stroke patients from admission to discharge. An additional aim of the study is to compare the STREAM with two accepted and widely used clinical measures of function and disability, the Stroke Impact Scale (SIS)and the Functional Independence Measure (FIM). By linking movement deficits that are commonly assessed by physical therapists with measures of function and disability, the impact of the movement deficits can be understood.


Eligibility Criteria:
Inclusion Criteria:

* comprehension of English
* age 18 and older
* first-time stroke
* receiving in-patient rehabilitation at the Rusk Institute of Rehabilitation Medicine, New York, NY

Exclusion Criteria:

* hemorrhagic stroke
* brain stem or cerebellar infarct
* other pre-existing neurologic conditions