cyrilzakka/clinical-trials huggingface dataset:
Bergen Oral Respiratory Intervention Study

The purpose of this study is to investigate if treatment of periodontitis (gum disease) in a relatively young and healthy population can improve lung function. It is hypothesized that removing the dental biofilm reduce the source of inflammatory bacteria that can reach the lungs, and thereby reduce lung inflammation and lead to improved lung function.

After being informed about the study and potential risks, all participants giving written informed consent will undergo a clinical screening to determine eligibility for study entry.

The study participants will be randomized into two groups. Half of the study participants will after baseline move directly into an active periodontal treatment phase including oral hygiene instructions and professional tooth cleaning by a full mouth disinfection protocol (intervention 2). New data will be collected after 6-8 weeks of healing.

The second study group will after baseline receive prophylactic periodontal treatment by oral hygiene instructions and supragingival plaque removal (intervention 1). New data will be collected after 3-4 weeks. This group will now receive the active periodontal treatment phase (intervention 2) like the first study had initially. New data will be collected after 6-8 weeks of healing.

Both groups will receive supportive periodontal treatment every 3 months in 12 months after intervention 2.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of periodontitis (stadium I or II)
* measures of periodontal infection (PI) \> 50%
* inflammation (bleeding index/bleeding on probing) \> 50%
* never-smoker

Exclusion Criteria:

* asthma
* symptoms of pollen allergy
* chronic lung diseases
* daily medication use which may interfere with the evaluation of the subject
* pregnancy
* use of systemic antibiotics last six months
* subgingival scaling last six months
* regularly use of oral antiseptic mouth rinse
* use of snus (moist/smokeless tobacco)
* current medical condition which may interfere with the evaluation of the subject
Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients.

Transient focal neurological episode (TFNE) is the most frequent presenting symptom of convexity subarachnoid haemorrhage (cSAH) in elderly patients with non-traumatic cSAH with suspected, possible or probable cerebral amyloid angiopathy (CAA). The aim of our study was to analyse in detail clinical and MRI characteristics in these patients.

Methods: We performed a retrospective study analysing baseline, acute clinical symptom (TFNE and headache), and MRI characteristics (acute cSAH and chronic CAA features) of consecutive elderly (≥55 years) patients, recruited and registered in the stroke database, between june 2008 and october 2020 of two centres (Nîmes and Montpellier University Hospital, France), presenting with cSAH with suspected, possible, or probable CAA.


Eligibility Criteria:
Inclusion Criteria:

* ≥55 years of age,
* acute symptomatic cSAH based on FLAIR and T2\*-weighted imaging performed within one month of symptom onset, recent trauma,
* anticoagulation treatment, pathological blood coagulation tests (activated partial thromboplastin time \[aPTT\] ratio=patient's aPTT/normal control aPTT\] \>1.2; or partial thromboplastin time \[PTT\] \<75%) or platelet count (\<100 x 109/L),

Exclusion Criteria:

* exclusion of underlying non-CAA cSAH causes (e.g. reversible cerebral vasoconstriction syndrome, trauma, cerebral venous sinus thrombosus, aneurysm, primary angiitis of the central nervous system, anticoagulation treatment, pathological blood coagulation tests)
Mitochondrial Energy Metabolism in Obese Women

Considering that the failure of the treatment of obesity is justified by the multifactorial pathophysiology of this morbidity, the present project has the following hypotheses:

1. The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ;
2. The unbalance is therapeutically modified through physical training ;
3. Obesity courses with the break-down in energy metabolism mitochondrial disease associated with systemic inflammatory characteristics that can be corrected through a combined long-term physical training program.

This study have as objective : to analyse changes in mitochondrial function, inflammatory profile, oxidative stress and energy metabolism caused by concurrent physical training in obese women.

Specific objectives:

Body composition by deuterium oxide; Metabolic rate of resting and oxidation of substrates by indirect calorimetry; Proinflammatory cytokines Anti-inflammatory cytokines Oxidative Stress: Malondialdehyde, Superoxide Dismutase, Glutathione-Peroxidase; Fatty acids: ceramide and palmitate; Mitochondrial respiration and citrate synthase enzyme; Quantify and qualify: mitochondrial number, endoplasmic reticulum structure, adipose cell size; Gene expression, quantify by microscopy and analyze the protein by western blot.

The study began with 20 women, however, there was withdrawal of 6, ending with 14 women.

Eligibility Criteria:
Inclusion Criteria:

* This study included women with obesity (BMI of 30 to 40 kg / m²), sedentary, with no associated comorbidity, convenience sample

Exclusion Criteria:

* Women who have undergone bariatric surgery, menopause, cancer or any metabolic disease, smokers, alcoholics, who are in use of drugs that act directly on the metabolism and that have medical impediment to the practice of physical exercise.
Value of Ultrasound and Computed Tomography in the Diagnosis of Acute Appendicitis With Histopathology as Gold Standard.

This study is a retrospective evaluation of all patients treated surgically for appendicitis over a period of 3 years at the Sint- Andries Hospital, Tielt. Belgium. The goal is to evaluate the value of ultrasound (US), computed tomography (CT) and laboratory testing in diagnosing acute appendicitis and to look for the possible impact on the treatment.


Eligibility Criteria:
Inclusion Criteria:

* suspicion of acute appendicitis

Exclusion Criteria:

* none
Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

Hemodialysis remains associated with a high mortality (approximately 22% per year) and many complications despite improvements over the last twenty years. Several nephrologists have suggested that increasing the frequency and amount of dialysis will result in improved outcomes. In fact, various forms of daily dialysis have been performed in over 300 patients in the last 30 years with improvements in blood pressure, quality-of-life, bone disease, and other complications of renal failure. Whether this form of treatment can be expanded to the 220,000 Americans on hemodialysis is unknown. The primary outcome of this study is to determine the effectiveness of nocturnal dialysis in hemodialysis patients in St. Louis. If the pilot study is effective, then participation in a larger, multicenter trial is expected. The endpoints measured are use of antihypertensive medications, improvement in secondary hyperparathyroidism and use of phosphorus binders, quality-of-life measured by SF-36 surveys, and improvement in physical function as measured by maximal oxygen uptake.


Eligibility Criteria:
Adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)

Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC

The purpose of this study is to determine whether the addition of nivolumab to chemotherapy improves pathologic complete response (pCR) in the breast and post-therapy lymph nodes evaluated histologically (ypT0/Tis ypN0) in patients with inflammatory breast cancer (IBC).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed inflammatory breast cancer without distant metastases and have not received prior chemotherapy or immunotherapy. All breast cancer subtypes are allowed: Triple negative breast cancer (TNBC); Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; HR-positive or HR-negative and HER2-positive

Exclusion Criteria:

* Clinical or radiologic evidence of distant metastases
* Malignancy that progressed within the last five years.
* Cardiac disease (history of and/or active disease)
* HIV positive
* Neuropathy ≥ Grade 2, per the NCI CTCAE v5.0
* Allogeneic stem cell or solid organ transplantation
* Autoimmune disease where in the opinion of the Investigator would preclude the use of immunotherapy
* Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), or evidence of active pneumonitis
* Tuberculosis
* Pregnancy or lactation
* Treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunosuppressive medications
* Cardiopulmonary dysfunction
* Clinically significant history of liver disease, including cirrhosis, autoimmune hepatic disorders, HIV infection, or active Hepatitis B or Hepatitis C
* Subject is pregnant or nursing
* Known hypersensitivity to the components of the study drugs(s)
Ultrasonography For Radial Artery Diameter Measurement And Its Correlation With Allen Test

In this study, the investigators will investigate how patients' radial artery diameters change according to sex, age, height, weight and body mass index by measuring radial artery diameter using ultrasonography. The correlation of Allen test with doppler ultrasonography will also be evaluated.

Arterial catheterization for continuous hemodynamic monitoring or frequent blood sampling is a common procedure in anesthesia and critical care setting. The most commonly used site for arterial catheterization is the radial artery because of its superficial course, alternate blood supply to hand via ulnar artery and a low rate of complications. Allen test is a simple, but not reliable, method for assessing the safety of radial artery catheterization. Intraarterial catheterization has some complications such as hematoma, vasospasm, arterial thrombosis, necrosis of skin overlying. Using larger size cannula from radial artery diameter, increase rate of complications. The purpose of this study is to investigate the corelation of radial artery diameter with sex, age, height, weight and body mass index for determination of proper cannula size and investigation of correlation between Allen test and doppler ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* patients will be operated under general anesthesia
* patients were American Society of Anesthesiology (ASA) physical status I or II

Exclusion Criteria:

* ASA III, IV, V
* History of coroner artery disease
* History of peripheral artery disease,
* History of diabetes mellitus,
* History of hypertension
* Hemodynamic instability
* Hypovolemia
* History of Reynaud phenomenon
* History of hand or arm trauma
* previous catheterization
Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones

The aim of the present study to perform a full cost analysis for the complete clearance of calyceal stones by retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) for the treatment of lower calyceal stones between 1 and 2 centimeters (cm) in size.

The lifelong prevalence of urinary system stone disease is approximately 15%. The lower calyx is the most common location where renal calculi occur. Because anatomical factors preclude spontaneous passage in this area, the need for treatment is more likely in lower calyceal stones. The European Association of Urology (EAU) suggests percutaneous nephrolithotomy (PNL) for stones larger than 2 centimeters (cm) and shock wave lithotripsy (SWL) or retrograde intrarenal surgery (RIRS) for stones smaller than 1cm as a first option, but controversy continues regarding the best treatment option for medium-sized lower calyceal stones of between 1cm and 2cm.

Medical costs are divided into two components: direct and indirect. Direct costs encompass all medical expenditures (e.g., drugs, hospital bed, all consumable and non-consumable materials used during the operation), while indirect costs include loss of working days for the patient. The stone-free rates (SFR) are reported as approximately 60% and 90% for one session of RIRS and PNL, respectively; however, no physician can guarantee a 100% SFR for one session. For this reason, a full cost analysis must include the direct and indirect costs of both the first and all auxiliary procedures.

The aim of this study was to perform a full cost analysis for the complete clearance of calyceal stones by RIRS and all PNL types for the treatment of lower calyceal stones between 1cm and 2cm in size.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had a lower calyceal stone between 1cm and 2 cm in size

Exclusion Criteria:

* solitary or anomaly (horseshoe or pelvic kidney) kidney,
* renal insufficiency,
* pregnancy,
* patient younger than 18 or older than 75 years,
* non-interrupted antithrombotic medication before surgery,
* urinary tract infection,
* double-j or nephrostomy insertion before surgery
Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib

Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched controls to each of this two groups.


Eligibility Criteria:
Inclusion criteria:

Healthy subjects:

1. Healthy males and females according to a complete medical history, including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead Electrocardiogram, and clinical laboratory tests. The healthy subjects must meet the matching criteria based on the matching approach (cf. Section 3.3).
2. Age =18 and =75 years
3. Body Mass Index =18.5 and =34 kg/m2
4. Creatinine clearance \>70 mL/min according to Cockroft \& Gault (for healthy volunteers, cf. Section 10.2)
5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation. Hepatically impaired subjects as determined by a hepatologist/ gastroenterologist:
6. Male and female liver impaired subjects determined by results of screening classified as Child-Pugh A; Child-Pugh score of 5-6 points or as Child-Pugh B; Child-Pugh score of 7-9 points, cf. Section 10.2. Child-Pugh criteria must be stable for at least 3 months prior to screening and during the trial.
7. Age =18 and =75 years
8. Body Mass Index =18.5 and =34 kg/m2
9. Creatinine clearance \>40 mL/min according to Cockroft \& Gault (for liver impaired subjects, cf. Section 10.2)
10. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.

    For all females:
11. Postmenopausal female subjects (postmenopausal defined as at least 1 year of spontaneous amenorrhea \[in questionable cases or spontaneous amenorrhea below 1 year a blood sample with simultaneous follicle stimulating hormone (FSH) above 40 IU/l and estradiol below 30 ng/l is confirmatory\]) or adequate contraception\* for female subjects of childbearing potential during the study and until 2 months after study completion, e.g. any of the following: implants, injectables, combined oral contraceptives, IUD (intrauterine device), sexual abstinence for at least 1 month prior to first study drug administration, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile have to use an additional barrier method (e.g. condom).

Exclusion criteria:

Any relevant deviation from healthy conditions (excluded conditions caused by liver impairment)
CMV-TCR-T Cells for CM Virus Infection After HSCT

This is a single cente, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after HSCT.

CMV infection is a common virus infection of HSCT, and which is highly related with the failure of transplantation and survival time of transplant patients. To evaluate the safety and efficacy of allogenic CMV-TCR-T cell therapy in subjects with CMV infection, patients with CMV emias or deseases will be enrolled, and donor derived CMV-TCR-T(HLA-A\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).

Eligibility Criteria:
Inclusion Criteria:

1. Age 1-70 years, including boundary values, gender unlimited;
2. Allogenic hematopoietic stem cell transplantation patients with CMV infection disease or persistent CMV emia;
3. At least one of the following conditions after allogeneic HSCT:

   * After trested with 2-week standard antiviral drug, compared to the baseline of treatment, the decrease of CMV DNA copies number was less than 1log10, and the CMV DNA copies number is greater than 1000 copies/ mL ;
   * Unable to tolerate the toxic and side effects of antiviral drugs,such as bone marrow hematopoietic suppression, nephrotoxicity;
4. Estimated life expectancy ≥3 months；
5. ECOG 3;
6. Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.

Exclusion Criteria:

1. Patients with active aGVHD III-IV and / or mild and severe cGVHD;
2. Received cell therapy such as DLI,CTL,CAR-T or participated in any other clinical study of drugs and medical devices before 30 days of enrollment.
3. Pregnant or lactating women;
4. Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation;
5. patients with organ failure:

   * Heart: NYHA heart function grade IV;
   * Liver: Grade C that achieves Child-Turcotte liver function grading;
   * Kidney: kidney failure and uremia;
   * Lung: symptoms of respiratory failure;
   * Brain: a person with a disability;
6. The researchers found that it was unsuitable for the recipients to be enrolled.
Continuous Versus Single-Shot Spinal Anesthesia for Orthopedic Surgery

A study was conducted to compare the effectiveness of continuous spinal anesthesia (CSA), single-shot spinal anesthesia (SSSA), and general anesthesia (GA) in patients over 60 years of age undergoing elective surgical repair of a fractured neck of femur. One hundred and five patients were randomly assigned to one of the three groups. The SSSA group received a single intrathecal injection of isobaric bupivacaine 0.5%, while the CSA group received multiple injections of the same anesthetic through a catheter placed in the subarachnoid space. The GA group received isoflurane anesthesia. Intraoperatively, blood pressure was monitored to assess the frequency of hypotension and the required dose of ephedrine. Additionally, the total dose of bupivacaine administered and the frequency of intraoperative fentanyl were recorded. Postoperatively, the duration of postoperative analgesia, pain scores, and need for additional pain medication were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients of American Society of Anesthesiologists (ASA) grade ≤III;
* Patients were assigned for elective surgical intervention for Fixation of Neck Femur;
* Patients were free of exclusion criteria.

Exclusion Criteria:

* Patients of American Society of Anesthesiologists (ASA) grade \>III;
* Patients who had uncontrolled hypertension and/or diabetes mellitus;
* Patients who had uncompensated cardiac, renal, or hepatic diseases;
* Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
* Patients who refused to sign the informed consent were excluded from the study.
Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation

The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT) followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients after zotarolimus-eluting stent implantation.


Eligibility Criteria:
Inclusion Criteria:

* Men or women at least 19 years of age
* Patients with stable coronary artery disease who were successfully treated with zotarolimus-eluting stents
* Patients without major bleeding or MACE (myocardial infarction, stent thrombosis, stoke, repeat revascularization) within 6 months after zotarolimus-eluting stent placement
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* Persistent thrombocytopenia (platelet count \<100,000/µl)
* A known intolerance to a study drug (aspirin, clopidogrel)
* Patients requiring long-term oral anticoagulants or cilostazol
* Patients presented with acute myocardial infarction (STEMI or NSTEMI) at the time of index procedure
* Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within 18 months after procedure
* Bare-metal stent implantation at the time of index procedure
* Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
* A diagnosis of cancer in the past 2 years or current treatment for the active cancer.
* Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
* Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
* History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
* Unwillingness or inability to comply with the procedures described in this protocol.
* Patients pregnant or breast-feeding or child-bearing potential.