cyrilzakka/clinical-trials huggingface dataset:
Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls

In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.

Participants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes.

The primary objective of this study was to investigate the changes of the expression of T2DM susceptible genes (NOS1AP, KCNQ1, TCF7L2, WSF1, GLP-1R, etc.) in participants (newly diagnosed T2DM patients and controls) after gene mutation.

Secondly, the expression differences of T2DM susceptible genes in T2DM patients with different genotypes were compared, and the relationship between the expression differences and clinicopathological characteristics of T2DM patients was analyzed.

Participants (newly diagnosed T2DM patients and healthy subjects) were screened from the department of endocrinology and health management center, whose fresh peripheral blood were collected. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected in the department of general surgery. The DNA genome was extracted for genotyping, and then the expression levels of T2DM related susceptibility genes under different genotypes were detected by ELISA kits, PCR, WB,HE staining, IHC staining, ect.

The basic information of T2DM patients was collected, including demographic characteristics, physiological and biochemical data.Then investigators further compared the differences in the expression of susceptible genes between newly diagnosed T2DM patients and controls.

Eligibility Criteria:
Inclusion Criteria:

1. no drug therapy; 25 to 70 years old; Hemoglobin A1c (HbA1c) 7%-12%; BMI 20-35 kg/m2; Stable body weight (≤10% change within 3 months)（For newly diagnosed patients with T2DM）.
2. 25 to 60 years old; BMI 19-26 kg/m2; in good health, with no abnormalities of motor system, digestive system, respiratory system, urogenital system, blood system, circulatory system, nervous/mental system, endocrine system, etc（For healthy subjects）.
3. 20-80 years old; surgical resection of part or all of the pancreas; pancreatic lesions confirmed by enhanced CT or magnetic resonance (MR) examination or confirmed by intraoperative and postoperative pathology（For the patients in general surgical）.

Exclusion Criteria:

1. had taken antidiabetic drugs;
2. had a history of pancreatic surgery;
3. Complicated with severe organ lesions;
4. Long-term use of drugs that affect pancreatic function.
Acupressure in Reducing Post-TBI Fatigue

Fatigue is a common symptom experienced by patients with traumatic brain injury (TBI). Prior works have demonstrated that it may profoundly impact the ability to return to productive activity and cognitive functions. However, few interventions have been applied in this population.The purpose of the current will be to test the effect of acupressure on fatigue reduction after traumatic brain injury.

Fatigue is a pervasive and critical long-lasting symptom experienced by patients with traumatic brain injury (TBI) and can persist up to months or years after head injury. However, thus far, only few non-pharmacological interventions, such as mindfulness, are implemented in reducing fatigue in TBI survivors. Prior works have suggested that acupressure can significantly improve fatigue in different populations, such as cancers survivors and patients with hemodialysis. Therefore, we would like to test whether acupressure effectively improve fatigue after TBI.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with traumatic brain injury over 6 months with initial GCS (admitted GCS) from 3-12.
* Aged between 20-65 years
* Are able to communicate in Chinese and Mandarin
* Are able to complete the questionnaires
* Complain of tiredness and cannot be restored even after a rest.
* No physical disability and visual impairment

Exclusion Criteria:

* With skin lesion
* had diagnosis of neuropathy and paraesthesia prior to study.
Health Related Quality of Life After a Self-promoting Learning Program for People With Rheumatic Diseases

Randomized controlled trial including 200 subjects with rheumatic diseases. Subjects will be randomized to either a self-promoting problem based learning (PBL) program or a control group with traditional care. The hypothesis is that a PBL program will improve health-related quality of life, empowerment and self-care ability.


Eligibility Criteria:
Inclusion Criteria:

* Subjects should have one or several rheumatic diseases diagnosed more than a year.
* Subjects should have musculoskeletal pain, sleep disturbances and fatigue, overwhelming number of days during the last three months.
* Subjects should be registered on the waiting list to the rheumatologic clinic.

Exclusion Criteria:

* Subjects with difficulties speaking and/or read Swedish.
* Subjects with difficulties travelling to the clinic.
Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2

The purpose of this study compares chemoradiation and sequential chemoradiation about Lung adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic method is better for the patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Lung adenocarcinoma
* Postoperative staging pN2 period
* Voluntary participation and informed consent
* Age ≥ 18 years old, male or female, within six months of weight loss of less than 10%, can tolerate radiotherapy
* performance status( PS) score 0-2.
* Hemoglobin ≥ 80 g / L, white blood cell ≥ 4 × 109 / L, platelets ≥ 100 × 109 / L.
* Liver function: alanine aminotransferase (ALAT), aspartate transaminase (ASAT) \<upper limit of normal (ULN) of 1.5 times, bilirubin \<1.5 × ULN.
* Renal function: serum creatinine \<1.5 × ULN.
* Compliance, and can be regular follow-up, voluntary compliance with study requirements

Exclusion Criteria:

* Do not meet the inclusion criteria
* There is evidence of distant metastases
* Suffered from other malignancies in five years
* Within the past January subjects received other drug trials
* Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
* Severe lung or heart disease, a history
* Refuses or is unable to sign informed consent to participate in trials
* The abuse of drugs or alcohol addicts.
* Patients with difficult to control bacterial, viral, fungal infections
* Having a personality or mental disorders, without civil capacity or restricted civil capacity.
* Being pregnant or lactating women.
Data Analysis of Adult and Pediatric Participants With Acid Sphingomyelinase Deficiency (ASMD) on Early Access to Olipudase Alfa in France

Primary Objective:

To describe the lung, spleen and liver outcomes of olipudase alfa

Secondary Objectives:

* To describe the patient's characteristics
* To describe conditions of olipudase alfa use
* To describe safety data related to the use of olipudase alfa
* To describe complementary effectiveness outcomes parameters

Approximate duration of enrollment: 30 months

Total study duration: approximately 30 months

This is a national, multicenter observational retrospective and prospective cohort data collection study. Retrospective is defined as collection of data from all patients, including deceased patients, who were already on early access olipudase alfa in France before the start of this study.

Eligibility Criteria:
Inclusion Criteria:

* The patient, or the patient's parent(s)/guardian(s), has signed written informed consent.
* Patients with a confirmed diagnosis of ASMD under early access to olipudase alfa in France (ie, nominative compassionate use, pre marketing authorization early access, post marketing authorization early access).
* The patient has documented deficiency of acid sphingomyelinase in peripheral leukocytes, lymphocytes, or cultured fibroblasts.
* Male and female patients of all ages.

Exclusion Criteria:

* The patient or legal guardian(s) who has not received information notice or who opposes to data collection.
* Patient who died before study initiation and who was opposed to data collection for research purpose when he/she was alive.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride

Primary objective of this study is to confirm the efficacy of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change.

Secondary objectives of this study is to evaluate the safety of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy parameters

Patients treated with 2-6mg/day of glimepiride will be recruited. The study period consists of screening phase of 6 weeks and double-blinded phase of 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus patients treated with constant dose of glimepiride on top of diet and exercise
* Patients who gave informed consent to participate in the study

Exclusion Criteria:

* Patients with HbA1c of \< 7.0 % and \> 11.0 %
* Patients with any following laboratory test abnormality :

  * ALT and/or AST: \> 3 X ULN
  * Neutrophils: \< 1,000/mm3 and/or platelets \< 100,000/mm3
  * Hemoglobin: \<11 g/dL
  * Creatinine: \>= 1.3 mg/dL in case of male or \>= 1.0 mg/dL in case of female

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Corneal Cross Linking and Topography Guided Excimer Laser Treatment

Topography guided laser treatment enables the surgeon to correct higher order aberrations in corneas with irregular astigmatism. Several case reports and small uncontrolled trials have been published on the combination of this treatment with corneal cross linking (CCL) in patients with ectatic corneal diseases.

This randomized study will evaluate the safety and efficacy of a combined treatment of corneal cross linking with a partial topography guided excimer laser treatment in eyes with progressive ectatic corneal diseases.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patient age 18 - 40 years
* Documented progressive corneal ectatic disease except post LASIK/LASEK ectasia

Exclusion Criteria:

* Allergy to one of the used substances
* Tendency towards excessive scar formation
* Pregnancy
* Rheumatic diseases
* Central corneal thickness below 450 µm
* Active infection of the study eye
* Previous corneal surgery of the study eye
Perfusion Imaging With Myocardial Contrast Echocardiography in HCM

The objective of this study is to determine whether myocardial contrast echocardiography in patients with cardiomyopathy (HCM) can detect resting hypo-perfusion due to fibrosis or stress induced perfusion defects due to associated abnormalities in intramyocardial arteries and the microcirculation. A secondary aim will be to determine whether abnormalities in perfusion are associated with either severity of symptoms (chest pain and dyspnea), presence of arrhythmias, and regional function of the septum.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Established diagnosis of HCM

Exclusion Criteria:

* Known history of coronary or peripheral artery disease
* History of myocardial infarction
* Pregnant or lactating females
* Hypersensitivity to any ultrasound contrast agent
* Evidence right-to-left or bi-directional intracardiac shunt
* Moderate or greater valve disease other than from HCM (systolic anterior motion of the mitral valve)
* History of septal ablation or myectomy
* Hemodynamic instability
* Pacemaker dependent heart rhythm
Gastrocnemius Tightness and Foot Pain in Children

Foot and leg pain among otherwise healthy children is a common reason for referral to our pediatric orthopaedics outpatient clinic. The pain is often intermittent and transient, but for some the pain is more dominating and has an impact on the child and families. Children grown and have normal anatomical variations such as in-toeing, out-toeing, hypermobility, flatfeet, knock knees etc. Assessing such normal variants is a major part of pediatric orthopaedic practice, and a common finding is a positive Silvferskiöld test, indicating gastrocnemius tightness. This is when dorsiflexion of the ankle is limited with extended knee, compared to flexed knee. We do not know if this is a more frequent finding among children with foot and leg pain. There is however evidence that adults with painful foot conditions often have gastrocnemius tightness.

This project will investigate for gastrocnemius tightness in otherwise healthy children referred to our pediatric orthopaedic outpatient clinic with foot and leg pain, and compare results with a similar control group of children without pain. The aim is to investigate if there is an association, and how pain and tightness develops over time. The knowledge from this project will enable us to develop new treatment strategies to this patient group, where current evidence based recommendations are few.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy children referred to pediatric orthopaedic outpatient clinic with foot and/or leg pain with a normal leg function

Exclusion Criteria:

* Patients with foot conditions, general medical conditions affecting the foot or clinical findings indicating a need for further investigation for a diagnosis. Such as:

Foot deformities (cavo-varus foot, clubfoot) Tarsal coalitions Neuro-orthopedic conditions (CP, MMC) Fracture sequelae Infections and tumour
DEX Combined With RTX, CSA and IVIG in the Management of Newly Diagnosed ITP Patients

The project was undertaken by Qilu Hospital, Shandong University in China. In order to report the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and intravenous immunoglobulin in the management of newly diagnosed ITP patients.

The investigators are undertaking a multicenter trial of 100 primary ITP adult patients from 5 medical centers in China. All participants receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Untreated hospitalized patients, may be male or female, between the ages of 18 -60 years.
3. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
5. Willing and able to sign written informed consent

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received high-dose steroids or \[2\] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)

5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.

6.Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.

7.Patients who are deemed unsuitable for the study by the investigator.
Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy

The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old to less than 65 years old
2. Subjects with malignancy must be receiving chemotherapy
3. Medically stable
4. Able to understand and willingness to sign a written informed consent
5. Able to comply with study procedures
6. Life expectancy of more than 3 months
7. Adequate organ function:

   * ANC \>1000/mm3
   * Platelet \>100,000/uL
   * Creatinine \<2 mg/dL
   * AST and ALT \<3 times the ULN

Exclusion Criteria:

1. Allergy to eggs
2. Prior allergy to Influenza Vaccine
3. History of Guillain-Barre Syndrome
4. Current febrile illness
5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)
6. Autologous or Allogenic Stem Cell Transplant with in a year
7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)
Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.

This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation on the incidence of reduced leaflet motion.

This will be a pilot prospective randomized controlled trial.The study will enroll 50 adult patients scheduled to undergo SAVR and 50 adult patients scheduled to undergo TAVR. Subjects who satisfy Inclusion/Exclusion Criteria will be approached for informed consent. Those who give informed consent will be enrolled. After induction of anesthesia, a computer program will be used to randomize patients to one of the 2 treatment groups.

1. SAVR patients will get either Warfarin or aspirin
2. TAVR patients will get either Warfarin or aspirin.

Patients will be seen at 4-6 weeks postoperatively for Transthoracic ECHO (TTE), 4 dimensional (4D), Multidetector computed tomography (MDCT) scan and review of medical history. Phone follow up at 6,9 and 12 months post-operatively.

Data from this pilot study will enable us to determine the feasibility of a larger randomized controlled clinical trial to investigate the phenomenon of reduced leaflet motion/subclinical valve thrombosis and, possibly, its clinical importance

Eligibility Criteria:
Inclusion Criteria:

Scheduled for SAVR or TAVR

* Age \> 18 years
* Able and willing to give informed consent
* Able and willing to return for follow up

Exclusion Criteria:

* Contraindications to warfarin, Plavix or aspirin
* Pre-existing medical indication for warfarin, Plavix or aspirin
* History of previous cardiac surgery
* History of previous coronary artery stenting
* Requirement for concomitant coronary artery bypass grafting or mitral valve surgery or surgical treatment of an ascending aortic aneurysm
* Contraindications to contrast-enhanced MDCT including anaphylactic iodine allergy, uncontrolled atrial fibrillation, renal dysfunction (GFR \< 60 ml/min).
Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.

To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.


Eligibility Criteria:
Inclusion Criteria:

* A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
* Written informed consent obtained from the parent or guardian of the subject.
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics

This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S when given in addition to anti-staphylococcal SOC antibiotics to participants with methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index greater than or equal (\>/=) 18 to less than or equal to (\</=) 40 kg/m\^2
* At randomization, participants must have \>/=1 blood culture or molecular diagnostic that is positive for Staphylococcal aureus (S. aureus) collected in the previous 120 hours
* In the investigator's judgment, an expected treatment duration for S. aureus intravenous infection with anti-staphylococcal SOC antibiotics \>/= 4 weeks

Exclusion Criteria:

* The presence of an intravascular catheter that is not planned to be removed within 96 hours of study randomization
* S. aureus bacteremia associated with an intracardiac device and/or intravascular prosthetic material (including hemodialysis access graft)
* In the investigator's judgement, S. aureus bacteremia involving infection of a prosthetic joint or vertebral hardware
* In participants with cirrhosis, a Child-Pugh Score of Class B or C
* Known rifampicin-resistant S. aureus
* Anticipated receipt of a rifamycin class (excluding rifaxamin) antibiotic from Day 1 to study completion/discontinuation
* In the investigator's judgment, the need for emergent valve surgery at the time of randomization or a high likelihood of cardiac surgery within 3 days after randomization
* Polymicrobial bacteremia
* Participants with significant immune suppression
* Participants with evidence of liver disease
* History or presence of an abnormal electrocardiogram (ECG)
* Exposure to any biological therapy or investigational biological agent within 90 days prior to the screening evaluation or have received any other investigational treatment 30 days prior to the screening evaluation