cyrilzakka/clinical-trials huggingface dataset:
Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )

This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.

After the interim analysis conducted by the iDMC, an open-label assignment of experimental arm therapy will continue in regions outside of China, in order to further evaluate the efficacy and safety of sintilimab in combination with chemotherapy in subjects representing the western population with advanced esophageal squamous cell carcinoma


Eligibility Criteria:
Key Inclusion Criteria:

* Histopathologically confirmed unresectable, locally advanced, recurrent or metastatic ESCC (excluding mixed adenosquamous carcinoma and other histological subtypes)
* ECOG PS of 0 or 1
* Subject must be unsuitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery. For subjects who have received (neo)adjuvant or definitive chemotherapy/radiochemotherapy, time from the completion of last treatment to disease recurrence must be \> 6 months Could provide archival or fresh tissues for PD-L1 expression analysis with obtainable results
* Have at least one measurable lesion as per RECIST v1.1

Key exclusion Criteria:

* ESCC with endoscopy-confirmed near-complete obstruction requiring interventional therapy
* Post stent implantation in the esophagus or trachea with risk of perforation
* Received systemic treatment for advanced or metastatic ESCC.
* Received a cumulative dose of cisplatin ≥ 300 mg/m2 and the last cisplatin dose was within 12 months of randomization or the first dose of study treatment in the open-label phase.
* High risk of hemorrhage or perforations due to tumor invasion in adjacent organs (aorta or trachea), or have fistula formation.
* Hepatic metastasis \> 50% of the total liver volume.
* Received palliative therapy for a local lesion within 2 weeks prior to the first dose.
* Received systemic treatment with Chinese traditional medicines with anti-cancer indications or immunomodulators (including thymosins, interferons, and interleukins) within 2 weeks prior to the first dose of study treatment.
* Received systemic immunosuppressants within 2 weeks prior to randomization, excluding local use of glucocorticoids administered by nasal, inhaled, or other routes, and systemic glucocorticoids at physiological doses (no more than 10 mg/day of prednisone or equivalents), or glucocorticoids to prevent allergies to contrast media.
A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients

This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC.

This study is a study of SSGJ-707 monotherapy in First-line PD-L1 Positive advanced NSCLC Patients. This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. Each cohort will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.

Eligibility Criteria:
Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or metastatic NSCLC .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=3 months.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Blended Mindfulness-Based Intervention for Persistent Depression

We plan to share all IPD but not any personal information.


Eligibility Criteria:
Inclusion criteria:

1. A current diagnosis of Major Depression as assessed by Structured Clinical Interview for DSM IV (First, Spitzer, Gibbon, \& Williams, 2002).
2. A chronic or recurrent lifetime history of depression, with either chronic persistence of symptoms or a history of at least three previous episodes of depression, two of which needed to have occurred during the last two years.
3. Self-reported severity of current symptoms on a clinical level as indicated by a PHQ-9 score of 10 or more.
4. Age 18 to 65 thus excluding cases of late life depression given that such cases might diﬀer in aetiology.
5. Fluency in spoken and written English.
6. Have individual access to a computer or mobile device with internet connection and video link.

Exclusion criteria:

1. History of schizophrenia, schizoaffective disorder, bipolar disorder, current abuse of alcohol or other substances, organic mental disorder, pervasive developmental delay, primary diagnosis of obsessive-compulsive disorder or eating disorder, or regular nonsuicidal self-injury.
2. Current treatment with CBT more than once a month.
3. Regular meditation practice (meditating more than once per week).
4. Inability to complete research assessments through difficulty with English, visual impairment, or cognitive difficulties.
5. We will allow patients who are currently taking antidepressants into the study provided that the medication has not been changed during the last four weeks before entry into the study.
Randomized Trial of Exercise Promotion in Primary Care

Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.


Eligibility Criteria:
Inclusion Criteria:

Able to speak English or Spanish, Inactive defined as less than 30 minutes of MVPA per week, Prediabetes or diabetes not prescribed insulin, Kaiser Permanente member for at least 12 months, Receives primary care at the Fontana Medical Center, Body mass index between 18.5 and 40 kg/m2,

Exclusion Criteria:

Current use of insulin, Cardiovascular event in the past 6 months or other condition that limits physical activity, Pregnancy, breastfeeding or planning pregnancy in next 2 years, Current participation in another clinical trial or research study, Plans to move out of the area in next 2 years,
Effects of Chardonnay Seed Flour on Vascular Health

This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form) with the purpose to test the impact of a four-month supplementation with Chardonnay Seed Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and seeds. We will examine the effect of CSF on parameters such as endothelial function (via EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the makeup of and impact on the gut microbiome (via stool samples).


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years old
2. Demonstrated endothelial dysfunction (EndoPAT score \<= 2) at time of screening.

Exclusion criteria:

1. Age below 18 or above 80
2. Endothelial function greater than 2.0 at baseline
3. Hypertension (at screening): any patient with systolic blood pressure (SBP \>=170 mmHg or diastolic blood pressure \>= 110 mmHg, or hypotension (SBP \< 100 mmHg
4. Abnormal liver function tests
5. Uncontrolled Diabetes Mellitus or the use of metformin for Diabetes Mellitus
6. Difficulty swallowing capsules
7. Gastrointestinal disease manifesting with symptoms of malabsorption such as celiac disease or Crohn's disease
8. Non-English speakers
9. Vulnerable populations unable to consent such as prisoners or dependents
10. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the CSF including, but not limited to, any of the following:

    1. History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection
    2. Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
    3. Evidence of hepatic disease as determined by a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
11. History of hypersensitivity to any of the study supplement or suspected contraindications to the study supplement.
12. History of noncompliance to medical regimens or unwillingness to comply with the study protocol
Interplay of miRNA-146a and miRNA-126 in Chronic Periodontitis Patients With Coronary Artery Disease

The role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient stage needs to be explored further. The investigators attempt to quantify and compare the levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples obtained from patients diagnosed with chronic periodontitis with and without coronary artery disease.

The role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient stage needs to be explored further. The investigators attempt to quantify and compare the levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples obtained from patients diagnosed with chronic periodontitis with and without coronary artery disease.

Seventy-five participants were selected and grouped into 3 categories; 25 patients diagnosed with chronic periodontitis and coronary artery disease: CP + CAD group; 25 patients diagnosed with chronic periodontitis alone: CP group; and 25 systemically and periodontally healthy controls (HP). Demographic variables, periodontal parameters, cardiac parameters, blood pressure were obtained. miRNA-146a and miRNA126 levels were assessed in subgingival plaque (SP) samples from all the three groups. Within CP+CAD group, SP samples of CP+CADa were compared with coronary plaques samples (CP) of CP+CADb while the patient underwent CABG.

Eligibility Criteria:
Inclusion criteria:

* Patients volunteering for the investigation.
* Patients between the age group of 30-70 years
* Presence of ≥ 15 natural teeth.

Exclusion criteria:

* Patients associated with systemic diseases such as lung disorders, renal disease, liver disease, type I, type II-diabetes mellitus, HIV infection, rheumatoid arthritis, allergy or any malignancy.
* Under treatment with antibiotics, immunosuppressive drugs such as corticosteroids, within 6 months.
* Pregnant women and female patients were excluded because of the altered oral flora due to hormonal changes
* Smoking and other tobacco usage habits
* Patients who underwent periodontal treatment within 6 months.
Mobile Health Solutions for Behavioral Skill Implementation Through Homework

The primary purpose of this study is to develop a mobile health (mHealth) application that will both advance theory in and clinical practice of homework (HW) implementation. The mobile health application will enhance the existing evidence informed curriculum of a Multiple Family Group model (called 4 Rs and 2 Ss for Strengthening Families Model) for families with children who have disruptive behavior disorders. This mobile application consists of two primary components that will support engagement and integration of the model's core concepts in family life. The first component focuses on delivering homework via a highly engaging, multiplayer, interactive, cooperative, and skill-building game platform aimed at improving the "Design" and "Do" process of homework.The second component focuses on targeting factors putatively related to poor HW implementation within the "Do" process.


Eligibility Criteria:
Inclusion Criteria:

* youth between the ages of 7 to 11 years and an accompanying adult primary caregiver available to participate in the research and intervention activities
* English speaking youth and adult caregiver and
* the child should meet criteria for a primary diagnosis of Oppositional Defiant or Conduct Disorder.

Exclusion Criteria:

* a significant cognitive impairment or emergent psychiatric needs of the caregiver or child that interferes with understanding of program content or informed consent process or requires a higher level of care.
Cardiorespiratory Parameters and Glycated Hemoglobin of Patients With Type 2 Diabetes After a Rehabilitation Program

Cardiovascular autonomic dysfunction reflects the pathophysiology of Diabetes Mellitus in this patient group favors an increase in morbidity and mortality related to cardiovascular events, and for this reason has been one of the most studied clinical entities.

Therefore this work aims to analyze the cardiorespiratory parameters and glycated hemoglobin after the commission of a rehabilitation program in patients with diabetes mellitus type 2.

The collection protocol is to check the heart rate, blood pressure, double product, Borg scale, variability heart rate and glycated hemoglobin of patients with type 2 diabetes This project this is an experimental study, the type randomized clinical trial on the hemodynamic response and glucose levels in patients with DM2 institutionalized in Acre Hospital Foundation submitted to one rehabilitation program consisting of aerobic and anaerobic exercises performed for 12 weeks in three weekly meetings, of 60 minutes each.

Background: Built with evidence that makes it possible to work in cardiac rehabilitation programs in patients with type 2 diabetes with more security, guaranteeing them an improvement in cardiorespiratory fitness, the hemodynamic and glycemic variables, allowing them a better quality of life

Method/Design: The research instrument is applied before and after the practice of the proposed exercise program (consisting of aerobic and anaerobic exercises performed for 12 weeks in three weekly meetings, of 60 minutes each). The instrument is based on the following collection protocol: assessment of BP, HR, Borg scale, respiratory rate (RR), oxygen saturation (SAT), the DP calculation and will be carried out the examination to check HbA1C Will be performed for 12 weeks in three weekly meetings, of 60minutes each, in total of 36 sessions with antecipated 60 pacients splited in 2 groups "Control" and "intervention"

Discussion: Correlate the variability of heart rate behavior and glycated hemoglobin after the exercise program; To demonstrate the possible association between the change of the cardiorespiratory parameters according to the variation of glycated hemoglobin; Demonstrate the possibility of association between the variation of the cardiorespiratory parameters and glycated hemoglobin according to sex;

Eligibility Criteria:
Inclusion Criteria:

* type 2 Diabetes
* Sedentary
* Non-smoker
* with medical prescription for rehabilitation program.

Exclusion Criteria:

* Neurological disease
* Acute heart failure
* Morbid obesity
* Atrial fibrillation
* Sick sinus syndrome
* Atrioventricular block grade II or III
* Who used beta-blockers
* Who used antiarrhythmic medication.
MyProstateScore Equivalency With and Without DRE

The purpose of the study is to quantify the concordance of MPS results between first-catch urine samples collected post-DRE and those collected without a DRE.

The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection. We aim to understand whether a DRE is a required step prior to urine collection for MPS, and to explore alternative methods that may eliminate the need for a DRE. In order to do so, we will perform a crossover study in which each subject provides a sample under both conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patient is a candidate for prostate biopsy (Bx)
* If Bx naïve and ≤75yo then PSA 3-10 ng/mL
* If Bx naïve and \>75yo then PSA 4-10 ng/mL
* If prior negative Bx then PSA may exceed 10 ng/mL
* If DRE very suspicious, then PSA below the thresholds of 3 ng/mL (≤75yo) and 4 ng/mL (\>75yo) are acceptable

Exclusion Criteria:

- Prior diagnosis of prostate cancer
Safety and Pharmacokinetics Study of FBF001

The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.


Eligibility Criteria:
Inclusion Criteria:

* subject between 21-40 years old
* with body mass index in the range 18 to 30 Kg/m2

Exclusion Criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness
* Any vaccination within three months before the inclusion
* Any vaccination against H5N1 virus
* Planned receipt of any vaccine during the study
* Any infectious disease within the month before the inclusion
* Any history of animal proteins allergy, animal allergy and/or any drug, food and pollen allergy
* Who has received blood or plasma derivatives (human or animal) in the three months preceding the initiation of the study
* Any medication within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of that drug
Ultrasound Evaluation of Hamstring Tendon Regeneration After ACL Reconstruction and Its Influence

High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis.

To clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.

Objective: to analyze the shape and function of the regenerated hamstring tendon within 2 years after the removal of the hamstring tendon in ACL reconstruction, reveal the change rule of the characteristics of hamstring tendon regeneration and its biomechanical changes, and guide the selection of operation and postoperative rehabilitation.

Methods: 55 healthy people and 55 male patients with ACL reconstruction were recruited. All completed the basic rehabilitation training under the guidance of the postoperative rehabilitation program. Using infrared motion capture system, three-dimensional force measuring platform, isokinetic muscle force testing system and ultrasound, the anterior cruciate ligament reconstruction patients were tested before operation, 2 weeks, 3 months, 6 months, 12 months after operation and 24 months after operation.

Outcome evaluation indicators and statistical methods: evaluation indicators: (1) three dimensional motion capture and analysis results: 1) peak ground reaction force; 2) three-dimensional angle and torque of hip, knee and ankle joints in different stages; (2) isokinetic muscle strength results: bilateral knee extension torque and knee flexion torque at different angles and angular velocities. (3)Ultrasound evaluation: the thickness, cross-sectional area and shear wave velocity of the semitendinosus were measured.

Statistical methods: ① repeated measurement analysis of variance (ANOVA) was used to test the effects of different time after operation on the three-dimensional gait characteristics, muscle strength and tendon regeneration characteristics. ② Independent sample t-test was used to test the three-dimensional characteristics, muscle strength and tendon condition of patients at different time points after operation. ③ The difference of three-dimensional gait characteristics, muscle strength and tendon between the healthy side and the affected side at different time points after operation were examined by paired sample t-test. ④ Bivariate correlation analysis was used to analyze whether the thickness, cross-sectional area, shear wave propagation velocity and postoperative time were related.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old
* Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
* With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
* All participants have no known disorders or diseases other than ACL rupture.

Exclusion Criteria:

* Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
Immune System Stimulation by Probiotic Food Supplementation

The purpose of this study is to investigate the effects of a probiotic supplementation on adult volunteers with having caught the common cold more than 4 times in the past year. This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Subjects received a probiotic drink containing probiotics of Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431® (108CFU/ml) and Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without probiotics for a 12-week study period.

The incidence of flue and cold during the study period were compared between study groups.

Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.


Eligibility Criteria:
Inclusion Criteria:

* male or female between 25 to 45 years old;
* having caught the common cold or flu at least 4 to 6 times in the past calendar year;
* signed the informed consent forms before entering the study;
* fully understood the risks and potential benefits in participating this study.

Exclusion Criteria:

* were diagnosed with the decreased immunity caused by any diagnosed chronic illness;
* having any gastrointestinal illness with medical treatment at the time of being enrolled;
* having any diagnosed respiratory illness with similar symptoms as the common cold and flu;
* currently taking any pain killer drug;
* having received any vaccine for the upper respiratory infection within 6 months before enrollment;
* having received any purgative drug or digestion related drug within 2 weeks before enrollment;
* having taken any dairy product containing prebiotics and probiotics within 10 days before enrollment;
* currently taking any preventive drug for upper respiratory infection;
* having received any drug which has impact with the immune system such as antibiotics within 3 months before enrollment;
* alcoholic or addicted to any drug;
* pregnant or breastfeeding mothers;
* having participated another clinical trial within 3 months before enrollment.
AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)

The study tests the safety and efficacy of axitinib in patients who have the hematologic disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who have poor prognosis before entering the study.


Eligibility Criteria:
Inclusion Criteria:

* Poor prognosis AML or MDS
* Histological confirmation of diagnosis
* White blood cell count less than or equal to 30,000/mm3
* Adequate hepatic and renal function documented within 14 days prior to registration
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* No evidence of preexisting uncontrolled hypertension
* Not a suitable candidate for chemotherapy
* No prior systemic chemotherapy treatment for AML or MDS or treatment with an anti-angiogenesis agent

Exclusion Criteria:

* Patients must not have exclusion criteria.
* Candidate for chemotherapy
* Patients with AML M3 (acute promyelocytic leukemia)
* Conditions that might confound the evaluation of safety or efficacy or increase patient risk.