cyrilzakka/clinical-trials huggingface dataset:
Bariatric Surgery and Pharmacokinetics of Lercanidipine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lercanidipine are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Forxiga Tablets Specific Clinical Experience Investigation for Elderly

The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga) in elderly patients.

* Development of ADRs specified as Key Investigation Items and the risk factors
* Contributing factors possibly having an impact on the safety and efficacy
* Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use


Eligibility Criteria:
Inclusion Criteria:

Patients treated with Forxiga for the first time during three months after the launch due to type 2 diabetes mellitus, which is the indication of the drug, aged 65 or over at the time when Forxiga was started.

In addition, patients receiving the study drug of Forxiga before the launch should be included also.

Exclusion Criteria: N/A
Qigong and Exercise for Neck Pain in Adults (QENA)

The purpose of this study is to assess the effectiveness of qigong for the treatment of chronic neck pain compared to exercise therapy and waiting list group.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of chronic neck pain since at least 6 months and complaints for a maximum duration of 5 years
* neck pain more prominent than other pain in the spine
* average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)
* normal mobility of the cervical spine
* intellectual and physical ability to participate in the study
* informed consent

Exclusion Criteria:

* cervical pain related to malignancy
* cervical pain due to an accident
* inflammatory joint disorders
* previous spine surgery
* protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
* actually doing or planning to do other regular physical exercise during the study with possible positive effects on neck pain - such as swimming, yoga, pilates, tai chi, etc.
* use of pain drugs for other diseases (\> 1x/week)
* pregnancy
* severe chronic or acute disease interfering with therapy attendance
* alcohol or substance abuse
* participation in another clinical trial in the last 6 months before study entry
Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes

This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
* BMI (body mass index) maximum 35 kg/m\^2
RBC Irradiation, Anemia and Gut Injury

The purpose of this trial is to study the effect that anemia and Red Blood Cell (RBC) transfusions have on oxygen levels in the digestive tracts of Extremely Low Birth Weight (ELBW) infants and to look for possible markers in a baby's blood, urine and/or stool that may lead to a better understanding of what makes an ELBW infant at risk for digestive tract problems such as necrotizing enterocolitis.

Anemia and digestive tract complications are common problems in Extremely Low Birth Weight infants. Anemia is a condition in which the body does not have enough red blood cells (RBC). RBCs are important because they contain hemoglobin, the substance that carries oxygen throughout the body. Transfusions of RBCs in these infants is frequently required to correct the anemia. Oxygen levels in the digestive tract will be measured before, during and after each blood transfusion using a tissue oxygen monitor called Near Infrared Spectroscopy (NIRS). By using this technology, better understanding can be obtained of intestinal blood flow patterns.

In addition, ELBW infants are more likely to have immature digestive systems and are at risk for digestive tract problems such as necrotizing enterocolitis (NEC). NEC is a disease characterized by infection and decreased blood flow to the intestines. NEC is a major cause of devastating illness and death in this vulnerable preterm population. Leftover blood samples, urine, stool, and breast milk samples will be collected, frozen, and stored. In the event a baby develops a digestive tract complication they will be studied in a laboratory to identify markers that indicate a healthy digestive tract versus illness.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight ≤1250 grams
* Postnatal age within 7 days of birth

Exclusion Criteria:

* Infant not expected to live beyond 7 days of life based on assessment of treating neonatologist
* Severe congenital abnormality expected to affect life expectancy
* RBC or platelet transfusion at an outside institution occurring prior to screening
* Maternal refusal to participate
Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter Study

This study is a multicenter, prospective, observational study aimed at investigating the efficacy and safety of triple targeted drug therapy in patients with arterial pulmonary hypertension (PAH) who are not at low risk and are receiving initial treatment. The prognosis of arterial pulmonary hypertension is explored.


Eligibility Criteria:
Inclusion Criteria:

* Consent and sign the informed consent form
* Non-low-risk PAH treatment-naive patients

Exclusion Criteria:

* Positive acute vascular response test for idiopathic/hereditary/drug-related arterial pulmonary hypertension
* Pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis (PVOD/PCH) with arterial pulmonary
* Pregnant or lactating women
* Suffering from mental illness or cognitive impairment
* PAH patients with concurrent malignant tumors
* Patients with moderate to severe hepatic impairment, renal impairment, and severe anemia
* Currently participating in other interventional clinical studies
* Key clinical data is incomplete, or the investigator considers that the patient has other factors that make them unsuitable for this study.
New Formulations of Propafenone to Treat Atrial Fibrillation

Propafenone is a currently used medicine to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. In this study, the investigators will randomize participants to (R)-propafenone, (S)-propafenone, or placebo.

Atrial fibrillation is a common cardiac arrhythmia that needs development of more effective medications. Propafenone is a medicine currently used to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. The investigators have discovered that purified (R)-propafenone may be more effective than (S)-propafenone for treatment of atrial fibrillation, and that (S)-propafenone reduces the efficacy of (R)-propafenone when administered as a mixture. This study will compare the ability of (R)-propafenone, (S)-propafenone, and placebo to suppress the induction of atrial fibrillation in participants undergoing an atrial fibrillation ablation procedure.

Eligibility Criteria:
Inclusion:

1. History of atrial fibrillation
2. Greater than or equal to 18 years of age
3. Scheduled to undergo an atrial fibrillation ablation procedure
4. Able to provide written informed consent

Exclusion:

1. Long-standing persistent atrial fibrillation at the time of ablation (greater than 1 year of a continuous atrial fibrillation episode)
2. Is in atrial fibrillation or atrial flutter the morning of the ablation procedure
3. The presence of any of the following in a patient without a permanent pacemaker for implantable cardiac defibrillator

   1. sick sinus syndrome indicated by the inability to previously tolerate an antiarrhythmic drug due to bradycardia
   2. sinus bradycardia with a heart rate less than 50 beats per minute at the time of study drug administration
   3. right bundle branch block, left bundle branch block, or bifascicular block
   4. PR-interval \> 280ms, or history of 2nd or 3rd degree atrioventricular block
4. Concomitant use of CYP3A4 and CYP2D6 inhibitors
5. Previous surgical or catheter ablation for atrial fibrillation or Cox-Maze procedure
6. Amiodarone use within 3 months prior to enrollment
7. Antiarrhythmic drug (other than amiodarone) within 5 half-lives prior to atrial fibrillation ablation
8. Expected life span \< 1 year
9. Creatinine clearance \<30 mL/min
10. Reversible cause of atrial fibrillation (ie. thyrotoxicosis)
11. Unrevascularized coronary artery disease
12. Canadian class IV angina
13. Left ventricular ejection fraction \<40%
14. New York Heart Association Class III or IV symptoms
15. Previous heart transplantation
16. Planned heart transplantation or ventricular assist device
17. Cardiac/thoracic surgery \<6 months prior to enrollment
18. Severe asthma or chronic obstructive pulmonary disease
19. Breastfeeding
Cetylated Fatty Acid for Reducing Pain After TKA

To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-80 years
* Osteoarthritic knee patients underwent unilateral primary TKA
* Participants understand and consent to the protocol of the trial

Exclusion Criteria:

* Inflammatory knee arthritis
* Previous knee surgery or trauma
* Previous knee infection
* Skin problem around the knee such as eczema, psoriasis, wound infection
* Allergy to studied drug
Mechanism Study to Investigate Difference in Efficacy of Neoadjuvant Chemoimmunotherapy in Lung Squamous Cell Carcinoma

To explore mechanisms of immunotherapy resistance and relation to changes in the TME before and after PD-1 blockade combined with chemotherapy

The biobank of thoracic surgery department of Tangdu Hospital collected pre-treatment tissues from patients during endoscopy. The investigators retrospectively summarized the clinical characteristics of these patients and patients with operable locally advanced lung squamous cell carcinoma were selected and followed.

The investigators plan to employ snRNA-seq and scRNA-seq respectively to profile 20 samples of paired pre-treatment and post-treatment tumors from ten patients (discovery cohort) to create a cell atlas for analysis, and spatial transcriptomics to examine 8 samples from four patients. In discovery cohort, estimated 5 patients achieve major pathological response (MPR) and 5 patients achieve non-MPR after NICB.

After analyzing the results of discovery cohort, the investigators will collect frozen tissues and formalin-fixed, paraffin-embedded (FFPE) tissue from our biobank for bulk RNA-seq analysis or immunohistochemistry (IHC) staining as validation cohort to further investigate the predictive value and biological significance of our markers.

Eligibility Criteria:
Inclusion Criteria:

1. aged 40 to 80 years;
2. had histologically confirmed LUSC with operable locally advanced stage
3. no prior anti-tumor therapy; received neoadjuvant immunotherapy consisting of three cycles of anti-PD-1 ICB plus nab-paclitaxel and carboplatin
4. pre-treatment tissues

Exclusion Criteria:

1. the presence of central nervous system metastases
2. the presence of immunodeficiency disease; previous therapies with immunosuppressants within 14 days prior to the initiation of study treatment;
3. uncontrolled hypertension
4. history of or having pulmonary fibrosis or interstitial lung disease
Integrated Interdisciplinary Program for Fall Prevention in Hospitalized Patients

Falls are very common accidents in Hospital. It not only results in injuries, less mobility among patients but increases their length of stay, cost and family burdens. Reducing the rates and injuries of falls is an urgent issue around hospitals.

An integrated multidisciplinary fall prevention program (IMFPP) was implemented from 2006 in CCH. Members include physicians, nurses, case manager therapists, engineers and staffs of maintenance. The aim of this study is to determine whether IMFPP efforts support interventions with multiple components do reduce the fall rates and severity of injuries.


Eligibility Criteria:
Inclusion Criteria:

* Patient in CCH's fall incidence reports system

Exclusion Criteria:

* No
Blood Pressure During ESD is Related With the Postoperative Bleeding

Endoscopic submucosal dissection(ESD) is a prominent minimally invasive operation technique for treating early gastrointestinal tumor. But promoting ESD is uneasy because of its complications such as postoperative bleeding, perforation and so on. So if we decrease the rate of postoperative bleeding, ESD might be better popularized. Some study indicated that hypertension was the independent risk factor of postoperative bleeding. Endoscopic center of Fudan University Zhongshan Hospital is a rich experienced medical unit in doing ESD operation in China. Referring to our experience, if we can use some special methods to find the potential bleeding spot which is not obvious during ESD operation and we coagulate it precisely, then we may control the risk of postoperative bleeding.

Based on the above hypothesis, our team designed this study to examine whether increasing blood pressure during gastric ESD could help to control the risk of postoperative bleeding.


Eligibility Criteria:
Inclusion Criteria:

* A. The indications for ESD for gastric neoplasms, such as intramucosal gastric cancer and adenoma, include intramucosal differentiated tubular adenocarcinoma of any size without ulceration or signs of submucosal invasion and intramucosal differentiated-type adenocarcinoma of less than 3 cm with an ulcer scar. The histology, tumor location, and depth of invasion fulfilled the criteria of the Japanese Research Society for Gastric Cancer.

B. The eligible patients' blood coagulation function should be normal without any associated medicine influenced.

Exclusion Criteria:

* A. Previously treated by radical gastrectomy. B. Pregnant or on breast feeding. C. Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism.

D. Coagulopathy: liver cirrhosis, thrombocytopenia. E. Anti-platelet agents. Allergic to PPI or norepinephrine. F. Patients with sever hypertension(systolic pressure\>180mmHg), or the hypotensor cann't control blood pressure suitably.

G. Patients with cardiovascular and cerebrovascular events within 6 months.
Distal Radius Steroid

The primary goal of this study is to compare functional outcomes (range of motion \[flexion, extension, supination, pronation\], return to work, of patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. Secondary goals include comparison of pain control (number of pain pills consumed, visual analog scale (VAS) pain scores) between patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. The primary endpoint of this study will occur when 18 patients in each test-group complete the 6 month follow up visit for study.

This will be a prospective, randomized, partially blinded, controlled trial where patients are randomized in a centralized fashion into 2 groups: a) Control group with no intraoperative glucocorticoids administered or b) Test group with administration of 10 mg glucocorticoids intraoperatively followed with a 6-day oral methylprednisolone taper course prescribed as a Medrol Dose Pack. Each group will enroll 30 patients for a study total of 60 over approximately a one year enrollment period. Randomization will be set up using sealedenvelope.com simple randomizer. The randomization process will ensure balance between both arms based on sex and age of patients enrolled. All patients scheduled for distal radius ORIF will be screened to meet inclusion/exclusion criteria. Patients will be randomized preoperatively by the research coordinator, based on a 1:1 weighting, upon obtaining to consent to either Control or Test group. Post-op therapists will be blinded to the patient treatment group until completion of protocol activities for each patient.

After surgery, patients will be followed for a duration of at least 6 months. Interval follow-up information will be collected at 10 days, 6 weeks, 3 months, and 6 months.

3-view wrist radiographs will be taken at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Intra- or extra-articular distal radius fractures (AO 23-A2,3; 23B-1,2,3; 23C-1,2,3) treated with open reduction internal fixation (ORIF)
* Age \>18

Exclusion Criteria:

* Open fractures
* Pathologic fractures
* Concomitant ipsilateral upper extremity fracture (not including distal ulna)
* Medical contraindication to systemic glucocorticoids (insulin-dependent Diabetes mellitus, history of avascular necrosis, allergy)
* Narcotic dependence
* Women who are pregnant or breastfeeding
Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study

Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study


Eligibility Criteria:
Inclusion criteria:

1. Dated written informed consent that is in accordance with GCP and local legislation.
2. Male and female Black / African American patients
3. Diagnosis of type 2 diabetes at least 3 months prior to the informed consent.
4. HbA1c more than or equal to 7.5% and less than or equal to 11% at Visit 1.
5. Patients are currently treatment-naive or being treated with up to one oral antidiabetic medication. Antidiabetic medication is to be unchanged for at least 10 weeks prior to the informed consent.
6. Age more than 18 and less than 80 years at Visit 1 (Screening).
7. BMI (Body Mass Index) less than 45 kg/m2 at Visit 1.

Exclusion criteria:

1. Myocardial infarction (MI), stroke or transient ischemic attack (TIA) within 3 months of informed consent.
2. Type 1 diabetes.
3. Impaired hepatic function, defined by serum levels of either alanine aminotransferase (ALT, SGPT), aspartate aminotransferase (AST, SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1.
4. Known prior hypersensitivity or allergy to the investigational product or its excipients.
5. Treatment with insulin within 3 months prior to informed consent.
6. Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) within three months prior to informed consent or initiating therapy during the study.
7. Any prior use of dipeptidyl peptidase-4 (DPP-4) inhibitors.
8. Glucagon-like peptide-1 (GLP-1) agonists are excluded 3 months prior to informed consent.
9. History of alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation as assessed by the Investigator.
10. Participation in another trial with an investigational drug within 3 months prior to informed consent or during the study.
11. Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:

    * are nursing or pregnant
    * are not surgically sterile
    * or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intrauterine devices/systems (IUDs / IUSs), oral, implantable or injectable contraceptives, and vasectomised partners. No exceptions will be made.

    Hormonal birth control should have been in use for at least three months prior to signing informed consent and continue at least until the next menstrual period after completing the study.
12. Current treatment with chronic use of systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
13. History of bariatric surgery.
14. Patients who have demonstrated an inability to be compliant (80-120%) with the dosing regimen during the placebo run-in period.
Allogeneic UCB Therapy With EPO in Children With CP

This randomized controlled study aims to evaluate the efficacy and safety of allogeneic umbilical cord blood therapy combined with erythropoietin for children with cerebral palsy.

Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) and erythropoetin (EPO) may be used as restorative approach for children with CP.

Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries. EPO is also known to have neuroprotective effects.

Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP. EPO is combined to add synergistic effects to UCB therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cerebral palsy
* Age of ≥10 months and ≤6 years
* Mismatch in HLA-A, B, and DR ≤2, and total nucleated cell count ≥3x107/kg. If the cell count is less than given values, more than 1 unit could be used.
* Hemoglobin ≤13.6 g/dL
* Decision of participation in the study by and acquisition of informed consent from the subject's representative
* Willingness and ability to be hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry

Exclusion Criteria:

* Current aspiration pneumonia
* Known genetic disease
* History of hypersensitivity reaction to any study drugs pertinent to the study
* History of participation in any other study with stem cell
* Prior treatment with EPO within 3 months prior to study entry
* Known coagulopathy with family history of thrombosis or medical history of recurrent thrombosis
* Patient with severe seizure disease who has clinical convulsion despite combination therapy with 3 or more agents
* Uncontrolled hypertension defined as systolic blood pressure \>115 mmHg and/or diastolic blood pressure \>70 mmHg
* Hepatic impairment defined as asparate aminotransferase (AST) \>55 IU/L and/or alanine aminotransferase (ALT) \>45 IU/L
* Renal impairment defined as creatinine (Cr) ≥1.2 mg/dL
* Absolute neutrophil count ≤500/dL
* Presence of diagnosed or suspected malignant tumor and/or hematologic malignancy
* Non-compliance with study visits specified in the protocol or unwillingness of care-giver due to lack of understanding of the patient