cyrilzakka/clinical-trials huggingface dataset:
the Effect of Prolonged Inflation Time During Stents Deployment for ST-elevation Myocardial Infarction

The purpose of this study is to determine whether prolonged inflation time on drug-eluting stents deployment for ST-elevation myocardial Infarction was better than conventional stents deployment.


Eligibility Criteria:
Inclusion Criteria:

* men and women ≥18 years with ST-elevation Myocardial Infarction;
* patients with STEMI and ischemic symptoms of less than 12 hours'duration;
* patients with STEMI and ischemic symptoms of less than 12 hours' duration who have contraindications to fibrinolytic therapy, irrespective of the time delay from FMC;
* patients with STEMI if there is clinical and/or ECG evidence of ongoing ischemia between 12 and 24 hours after symptom onset;
* when angiography was completed, guide wire could cross the lesion in the culprit vessel, TIMI≥1，with feasibility to direct stenting

Exclusion Criteria:

* cardiac shock, or acute severe heart failure;
* the lesion was highly calcified, excessive proximal tortuosity,left main artery lesion, restenosis lesion,vein graft lesion,total occlusions;
* True bifurcation lesions;
* Stenosis≤50% and TIMI flow grade 3;
* history of PCI in target vessel;
* diameter of the target vessel less than 2 mm;
* severe liver and kidney dysfunction;
* inability to give informed written consent.
A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

The purpose of this study is to assess the bioequivalence of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/500 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.

This is a randomized (the study medication is assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 3-treatment, 3-way crossover (the same medications provided to all participants but in different sequence) study of canagliflozin (CANA) and metformin extended release (MET XR) combined in one tablet, in comparison with tablets of individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets). The tablets will be of the same strength (50 mg CANA/500 mg MET XR) and will be compared with the equal doses of the individual drugs: canagliflozin (1 x 100 mg tablet) and metformin XR (2 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components. Treatment B: CANA/MET XR FDC, formulation 1; and Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will be randomly assigned to 1 of 3 treatments groups, and then each group will receive all three treatments in different sequences (3-way crossover). The study will consist of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2), an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each (Days -1 through 4) separated by a washout of 10 to 14 days between Day 1 of each Treatment Period, and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure on Day 4 of Treatment Period 3. The total duration of the study will be about 70 days for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent document indicating they understand the purpose of the study and procedures
* Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
* Must have a body weight of not less than 50 kg
* Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
* - Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)

Exclusion Criteria:

* History of or current clinically significant medical illness
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements)
* History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
* Known allergy to heparin or history of heparin induced thrombocytopenia
* Donated blood or blood products or had substantial loss of blood within 3 months before screening
Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)

This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.


Eligibility Criteria:
Inclusion Criteria:

* males and females 18 years of age or over
* diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection
* treated with a stable dose of daily rhGH for at least 3 months prior to screening
* stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening

  * Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

* patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator
* Presence of contraindications to rhGH treatment
* patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening
* patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) d. patients with a previously treated pituitary tumor with evidence of tumor progression in the past year
* patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening
* presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushing's syndrome in the past year.
* patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8%
* patients using weight reducing agents or appetite suppressants

  * Other criteria apply, please contact the investigator for more information
Exploring the Changes of Inflammatory Factors in Joint Fluid of Patients With Sports Injury for 1-year Postoperative Rehabilitation and Clinical Treatment

This study intends to use a prospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department from January 2020 to January 2022. The aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery.

This study intends to use a retrospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department starting from January 2021. The aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery. The indicators of postoperative rehabilitation for patients were objectively evaluated using three scales: Lysholm scale, VAS scale, and Tegner scale. Among them, the Lysholm scale mainly evaluates the postoperative recovery of knee joint function in patients, with values ranging from 0 to 100. The higher the value, the better the recovery; The VAS scale mainly evaluates the postoperative pain score of patients, with values ranging from 0 to 10. The higher the value, the more severe the pain; The Tegner scale is also mainly used to evaluate the postoperative recovery of knee joint function in patients, with values ranging from 0 to 10. The higher the value, the better the recovery.

Eligibility Criteria:
Inclusion Criteria:

* Those with healthy diet and regular exercise habits;
* Sports injury patients(Satisfy one of the following conditions): Anterior cruciate ligament injury or meniscus injury

Exclusion Criteria:

* Existence of underlying diseases related to the immune system;
* Trauma leading to knee joint fracture;
* Blood pressure, heart rate, vital capacity, muscle tension and other indicators are obviously abnormal;
* Significant abnormalities in blood routine, infection indicators, heart, lung, liver, and kidney function tests, insufficient compensatory function of important organs, or severe systemic diseases;
* Patients with neurological or psychiatric disorders, pregnant women, or a history of related illnesses combined with severe organic diseases
Study of the Link Between Complement Activation and IgA Nephropathy Severity

ICONE study (IgA Complement and NEphropathy is a prospective monocentric observational study.

The main objective is to evaluate the relevance of complement activation as a biomarker of disease severity and progression in patients with a biopsy proven IgAN.

IgA nephropathy (IgAN) is a common cause of glomerulonephritis and a major cause of end stage renal disease in up to 20-40% of patients. However, its prognosis still cannot be accurately predicted due to the high heterogenicity of clinical presentations and courses. Complement dysregulation is a main driver of glomerular damages in many glomerulonephritis. Given the growing body of evidence of complement lectin/alternative pathways activation in IgAN pathogenesis, the investigators propose the evaluation of a combination of biomarkers of infra-clinical complement activation to stratify the risk of disease's progression. This study aims to identify subsets of patients in whom complement activation plays a critical role in disease progression. This is of particular interest in the aera of emergence of complement-targeting therapies in IgAN

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, male or female, with a biopsy proven IgA nephropathy.
* Primitive and secondary forms can be included
* Regardless of the date of diagnosis and the level of kidney function
* With or without past of kidney transplantation
* Followed in the Nephrology Department, Strasbourg University Hospital
* Signed informed consent

Exclusion Criteria:

* Active or recent infectious or inflammatory syndrome (\<2 months), recent vaccination (\<2 months), ongoing acute humoral rejection treatment, treatment with plasma exchanges (\<2 months), current treatment with complement inhibitors
* Impossibility of giving informed information (emergency situation, difficulties in understanding, etc.)
* Subject under safeguard of justice, guardianship or curatorship
Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 2)

Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care\[MTPC\]) vs. a low-dose mindfulness introduction comparator on self-management of chronic illness and illness-related health behavior action plan initiation, as well as on measures related to anxiety, depression, and stress.

This study builds on a pilot study that investigated the impact of Mindfulness Training for Primary Care on anxiety, depression, stress, and chronic illness self-management in primary care patients receiving care in an urban, community, multi-cultural safety net healthcare system. The current comparative effectiveness randomized controlled trial takes place in a larger sample, and investigates the impact of a refined MTPC curriculum on specific aspects of self-regulation such as action plan initiation, while examining potential mechanisms of change, including self-efficacy, perceived control, mindfulness, self-compassion, emotion regulation, and body awareness. Participants randomized to MTPC are compared with participants who are randomized to a low-dose comparator condition and receive a 1-hour introduction to mindfulness with a referral to community mindfulness resources. Outcome assessments are conducted at baseline and study weeks 8-10.

Eligibility Criteria:
Inclusion Criteria:

* Current CHA patient with an enrolled CHA primary care doctor.
* CHA patients 18 years of age and older.
* Able to tolerate and participate in interviews and engage in all procedures.
* Able to give written consent in English OR willing and able to provide consent and complete assessments through a professional language translator when necessary.
* Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, or adjustment disorder related to chronic illness, pain, etc.).

Exclusion Criteria:

* Any cognitive impairment that precludes informed consent.
* Patients who, in the opinion of the Principal Investigator, pose an imminent risk of suicide or danger to self or others.
* Likelihood of potential incarceration such as a conviction or pending charges that may potentially result in imprisonment.
* Previous enrollment or randomization of treatment in the present study within the 12 months.
* Behaviors that may cause disruption to a mindfulness group.
* Patients with symptoms of psychosis, thought disorder, and/or severe mental illness, including schizophrenia, schizoaffective, bipolar disorder, or a current severe episode of major depressive disorder.
* Lack of insurance coverage for group psychotherapy may preclude participation in groups.
* Patients in their third trimester of pregnancy who foresee conflicts that preclude their commitment to completing all activities.
* Patients with highly unstable medical problems that put them at a high risk of hospitalization.
Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease

Multidisciplinary techniques such as multimodal neuroimaging, microbiology, and bioinformatics were applied to study the differences in correlation characteristics between gut microbes, functional brain networks, and peripheral inflammation among patients with active Crohn's disease (CD), CD in remission, and healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. 18 ≤ age ≤ 75 years, gender is not limited;
2. Disease in mildly or moderately active stage: 150 ≤ CDAI \< 450 and at least one of the following is met: serum C-reactive protein ≥ 5 mg/L, faecal calreticulin ≥ 250 μg/g, or endoscopic ulceration, or remission stage: CDAI \< 150 and at least one of the following is met: serum C-reactive protein \< 5 mg/L, faecal calreticulin \< 250 μg/g, or endoscopic No ulcers;
3. Not taking or taking the following medications: mesalazine (≤4 g/d and have been taking for ≥1 month), prednisone (≤15 mg/d and have been taking for ≥1 month), and/or azathioprine (≤1 mg/kg/d and have been taking for ≥3 months);
4. Those who have not used biologics within 3 months prior to study entry;
5. Those who have never received acupuncture treatment;
6. Understand, agree to participate in the study and sign an informed consent form.

Exclusion Criteria:

1. Patients who have recently prepared for pregnancy or are pregnant or breastfeeding;
2. Patients with severe organic pathology;
3. Patients with confirmed psychosis;
4. Patients who are suffering from multiple diseases at the same time and taking other drugs for a long time which may affect the observation of this clinical trial;
5. Patients with severe extra-intestinal manifestations such as severe skin diseases (e.g., erythema nodosum, gangrenous pyoderma, etc.), ocular lesions (e.g., iritis, uveitis, etc.), and thromboembolic diseases;
6. Those with severe intestinal fistulae, abdominal abscesses, intestinal stenosis and intestinal obstruction, perianal lesions (perianal abscesses, etc.), gastrointestinal haemorrhage, intestinal perforation and other complications;
7. Those suffering from short bowel syndrome, those who have undergone abdominal or gastrointestinal surgery within the last six months;
8. Those who are unable to perform acupuncture due to the presence of skin diseases or defects in the area selected for acupuncture.
Growth Factors in the Treatment of the Multiple Gingival Recessions

The purpose of this study was to compare and evaluate the clinical effects of Concentrated Growth Factor (CGF) and Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally Advanced Flap (CAF) technique using a microsurgical approach in the treatment of Type I multiple gingival recessions (GR).


Eligibility Criteria:
Inclusion Criteria:

* Systematically and periodontally healthy non-smokers
* Presence of Cairo Recession type I gingival recession with ≥ 2 mm gingival recession depth, probing depth \<3 mm and gingival thickness (GT) ≥ 0.8 mm on both sides of the maxillary arch
* Width of keratinized gingiva ≥ 2mm
* Presence of identifiable cemento-enamel junction
* Full-mouth plaque index (PI) \< 20 %
* Gingival index (GI) scores =1
* Presence of tooth vitality
* Absence of caries, restorations and furcation involvement in the treated area

Exclusion Criteria:

* Patients who had systemic problems that wound contraindicate for periodontal surgery
* Usage of medications known to interfere with healing and to cause gingival enlargement
* Recession defects associated with demineralization, deep abrasion, previous surgery in the defects area within the past 1 year
* Pregnant or lactating females
* Drug and alcohol abuse
Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure

This study assesses the ability of ambulatory patients with heart failure (HF) to use a smartphone application created for the management of patients with chronic HF. This study will aim:

* To understand the frequency with which ambulatory HF patients engage with this smartphone application.
* To determine whether patient's knowledge of HF and its management has improved with the use of this smartphone application.
* To assess improvement in quality of life measures related to the use of this smartphone application.
* To assess improvement in lifestyle measures related to the use of this smartphone application.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HFrEF or HFpEF. HFrEF defined as clinical signs and symptoms of HF with a left ventricular (LV) EF ≤ 40% by any imaging modality AND at least 1 hospitalization or emergency department (ED) visit for HF or any outpatient escalation of diuretic therapy in the 12 months prior to study enrollment. HFpEF defined as clinical signs and symptoms of HF with an LVEF ≥ 50% by any imaging modality and at least 1 hospitalization or ED visit for HF or any outpatient escalation of diuretic therapy in the 12 months prior to study enrollment.
* Adult patients, men and women, \> 18 years old.

Exclusion Criteria:

* Pregnant
A Mono-center Study in Healthy Volunteers on the Comparative Bioavailability of Pletal 100 mg Tablets and a New Pletal 100 mg Orodispersible Tablet (ODT), This Latter in Fasting Conditions With and Without Water and Under Fed Conditions

The primary objective of this trial is to test whether Pletal ODT administered without water can be considered bioequivalent to Pletal administered with 200 ml water (both treatments being administered after fasting and at least 30 minutes prior to receiving a light breakfast) based on the standard pharmacokinetic variables.

The secondary objective is to assess the effect of water and the effect of food on the administration of Pletal ODT based on standard pharmacokinetic variables.


Eligibility Criteria:
Inclusion Criteria:

1. healthy male and female subjects of Caucasian race
2. able to read, to write and to fully understand German language
3. having given voluntary written informed consent before first invasive screening examination procedure
4. aged 18 to 45 years, inclusive
5. BMI of 18 - 28 kg/m2
6. good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG, serum/urine biochemistry and hematology)

Exclusion Criteria:

1. clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) drug hypersensitivity
2. known hypersensitivity to one of the IMP substances
3. severe digestive disorder or surgery of the digestive tract (except for appen¬dectomy)
4. clinically relevant renal disorders (albuminuria, chronic infections)
5. clinically relevant hepatic disorders
6. clinically relevant respiratory disorders
7. clinically relevant cardiovascular disorders, especially any history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular ectopics, or a history of additional risk factors for torsades de pointes (TdP) (e.g. heart failure, hypokalemia, congenital long QT-syndrome)
8. diabetes mellitus and thyroid dysfunction or other endocrine disorders
9. malignancy
10. substance abuse or addiction (alcohol, illicit drugs) in the past 3 years
11. neurologic or psychiatric illness
12. known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, surgery within the previous three months, proliferative diabetic retinopathy, poorly controlled hypertension)
Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer

This study is a single-center, single-arm, prospective clinical trial designed to evaluate the efficacy of local excision followed by postoperative chemoradiotherapy in patients with early-stage low/ultra-low rectal cancer. The study plans to enroll 60 patients with T1-2N0M0 low/ultra-low rectal cancer.

Baseline examnation: All enrolled patients in this study, in addition to routine laboratory and imaging examinations such as blood routine, blood biochemistry, serum tumor markers (Incl. CEA, CA-199, CA-724 β2-microglobulin, Ferroprotein), chest CT, abdominal and pelvic MRI, etc., were required to undergo KRAS, NRAS, BREF, PD-L1, MMR/MSS testings before surgery, and blood lymphocyte subgroups were analyzed before surgery.

All enrolled patients will first undergo local tumor resection. Adjuvant therapy will be initiated 4-6 weeks postoperatively based on pathological staging:

For pT1N0M0 patients without high-risk features:

Active surveillance OR Radiotherapy alone (Prescription: Pelvic field irradiation 45Gy in 25 fractions)

For pT2N0M0 or pT1N0M0 patients with adverse prognostic factors (including poorly differentiated histology, lymphovascular invasion, positive margins\*, tumor infiltration beyond the outer third of the submucosal muscle layer（SM3 level）, or submucosal invasion \>1mm):

Adjuvant chemoradiotherapy (Prescription:Pelvic field irradiation 45Gy in 25 fractions PLUS Local tumor bed boost 5.4Gy in 3 fractions；Concurrent chemotherapy: Oral capecitabine 825mg/m² twice daily)；For patients with positive margins after local excision: Re-excision followed by adjuvant chemoradiotherapy OR Dose-escalated chemoradiotherapy (Prescription: Pelvic field irradiation 45Gy in 25 fractions PLUS Local tumor bed boost 14.4Gy in 8 fractions)；

For patients with staging \> pT2N0M0:

Total mesorectal excision (TME) Following treatment completion, patients will enter clinical follow-up surveillance.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years, regardless of gender
2. ECOG performance status 0-1
3. Biopsy-proven rectal adenocarcinoma
4. Distal margin of primary tumor ≤8 cm from anal verge
5. Clinical stage I (cT1-2N0M0)
6. Strong organ preservation preference with refusal to undergo abdominoperineal resection (Miles operation)
7. Meets indications for local excision surgery
8. No contraindications to chemoradiotherapy

Exclusion Criteria:

1. Failure to meet the above inclusion criteria
2. Patients refusing to sign informed consent
3. Impaired cognitive function or psychiatric disorders
4. Patients deemed ineligible by investigators