cyrilzakka/clinical-trials huggingface dataset:
Study of Usefulness of Genotyping to Predict Docetaxel Exposure and Adverse Events

Twenty patients with verified high risk breast cancer will be included in the study. Patients will receive three cycles of docetaxel followed by three cycles of CEF for their adjuvant treatment. The phenotype of CYP3A and the genotype of CYP3A5 and MDR1 will be assessed. Also the effect of docetaxel in the activity of CYP3A will be measured by peroral midazolam.

Primary Object:

The primary object of this study is to define, if it is possible to predict the clearance and/ or toxicity of docetaxel by assessing

* activity of CYP3A4 by midazolam test (CYP3A4 phenotype)
* CYP3A5 genotype
* MDR1 genotype

Secondary object:

The secondary object of this study is to define whether the treatment with docetaxel alters the activity of CYP3A4 enzyme in previously untreated breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

Subjects may be included in the study only if they meet all of the following criteria:

1. The patient has received information on the purpose of the study and the meaning of the treatment, and has given verbal and written consent to participate in the study. The patient is accessible for treatment and follow-up.
2. Histologically verified diagnosis of breast cancer
3. High risk for recurrence ( node positive or node negative if T2 with histological grade 2 or 3, or Pgr negative)
4. No metastases
5. Females, age =\<60
6. No concomitant regular medication which is either substrate, inducer or inhibitor of CYP3A4

Exclusion Criteria:

Subjects will be excluded from the study for any of the following reasons:

1. Poor performance status,\>=2 according to WHO
2. Inadequate bone marrow reserve defined as:

   * hemoglobin \< 100 g/L
   * leukocytes \< 3.0 x 10E9/L or neutrophiles \< 1.5 x 10E9/L
   * plateless \< 120 x 10E9/L
3. Inadequate liver function defined as:

   * ALAT is \> 1.5 x units of normal level
   * elevated bilirubin (unless verified Gilbert´s syndrome)
   * alkaline phosphatase is \> 2.5 x units of normal level
4. History of concomitant serious physical or psychiatric disease, which makes a regular cytotoxic treatment impossible
5. cardiac insufficience; severe arrhythmia; severe hypertension; cardiac infarction within one year or other active cardiac disease
6. pregnant or lactating patients
7. abuse of alcohol or any narcotic substances
Prospective, Observational, Real-world Oral Malignant Tumors Study

The aim of the study is to construct a register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in north Chinese population.

A register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in Chinese population was absent.

The aim of the study is to construct a register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in Chinese population. The variables in the study include social informatics, etiology, and psychological and quality of life, coexistence disease, baseline clinicopathological data, postoperative complications, and long-term follow-up results.

By released annual analysis report, the epidemiological features and prognostic factors of oral and maxillofacial malignant tumors in north Chinese population can be identified.

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of oral and maxillofacial malignant tumors
* no previous treatment
* a primary tumor without distant metastasis evidence
* sites: lip, tongue, buccal mucosa, upper and lower gingiva, floor of the mouth, hard palate, oropharynx, salivary gland, upper and lower jaw, and maxillary sinus

Exclusion Criteria:

* patients decline to participate the study
* refusal or inability to receive definitive treatment for the disease
* recurrent tumors
The Effect of Estrogen and Progesterone Levels on Knee and Ankle Joint Laxity

The proposed research is an observational study designed to compare estrogen and progesterone serum levels with knee and ankle joint laxity, and muscle reaction time as a measure of neuromuscular function. Three groups of women athletes with differing estrogen and progesterone profiles (normal menstrual cycles, amenorrheic, and exogenous estrogen supplementation) and one control group (male collegiate athletes) will be used to compare differences in joint laxity and neuromuscular function. Blood levels of estrogen and progesterone will be measured at four time points across the menstrual cycle. Joint laxity and muscle reaction time will also be measured at each of these points. The investigator hypothesizes that knee and ankle joint laxity and muscle reaction time will significantly increase with increasing estrogen and progesterone levels.


Eligibility Criteria:
Inclusion Criteria:

* pre-collegiate or collegiate athletes
Efficacy and Safety of Xuesaitong Soft Capsule for Coronary Heart Disease Unstable Angina

In this study, typical cases of coronary heart disease are selected. They will be intervened by Xuesaitong soft capsules to investigate efficacy and safety for Coronary Heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of coronary angiography unstable angina
* Clinical diagnosis of unstable angina
* Age of 30 to 75 years old
* Not use thrombolysis, dilate coronary drugs within two weeks
* Sign the consent

Exclusion Criteria:

* Severe valvular heart disease
* Insulin-dependent diabetes
* mental disease
* Combined with severe liver, kidney, hematopoietic system disorder
* Patients with malignant tumors
* Pregnancy or breast-feeding women
* Recent history of trauma
* Drug allergy
Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients

The purpose of this study is to show feasibility (efficacy and safety) of Rivaroxaban in the treatment of VTE in cancer patients in comparison to the standard treatment with low molecular weight heparin (LMWH).

Tumor patients with active cancer and newly diagnosed thromboembolic events are randomised to receive either Rivaroxaban or the standard treatment with low-molecular heparin.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed and objectively confirmed acute venous thromboembolism
* Active malignancy
* Life expectancy of at least 6 months
* Performance-Status according to Karnofsky Performance Scale ≥ 70 %
* Patient's compliance and geographical situation allowing an adequate follow up
* platelets ≥ 100.000 /μl, INR \< 1.5, PTT \< 40 sec.
* written informed consent of the patient prior to any procedure in connection with the study
* male and female patients with an age of at least 18 years

Exclusion Criteria:

* therapeutic anticoagulation \> 96 hours prior to study treatment
* known allergic reactions against the study drugs or the substances included therein
* known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis
* acute clinically relevant bleeding in the last 2 weeks
* any history of spontaneous major/cerebral bleeding
* history of heparin induced thrombocytopenia II
* pregnant or breast-feeding women. Women of child-bearing potential must have a negative pregnancy test performed \< 7 days prior to start of the treatment
* severe renal insufficiency (GFR \< 30 ml/min)
* liver disease with coagulation impairment, including Child B and C
* cirrhosis
* acute medical illness
* treatment of the underlying cancer with experimental therapies
Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)

Diabetes contributes significantly to the burden of disease in Norway and cardiovascular disease is the main cause of mortality.

Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin D, vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides. With the expected growth in the aquaculture sector, more protein-rich by-products will become available.

The overall aim of this project is to investigate physiological and molecular effects of fish protein in the form of salmon fishmeal compared to whey in a human intervention study with regard to carbohydrate- and fat metabolism, endocrine factors and inflammation.

The investigators will include healthy subjects to a randomized controlled cross over study. The subjects will receive a single, oral dose of fishmeal or whey. Blood samples are taken before (fasting) and 30 and 60 minutes after intake. The molecular effects of fishmeal and whey are investigated ex vivo. This is done by incubating human cell lines (i.e hepatocytes, adipocytes, epithelial cells) with fasting and postprandial serum from the participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.5-24.9 kg/m2

Exclusion Criteria:

* Body mass index \<18.5 or \>24.9 kg/m2
* Known diabetes or high blood pressure
* Pregnancy or breast feeding
* Allergy or intolerance to dairy or fish/fish protein.
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"

The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy.

This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and thiazolidinediones in patients with type 2 diabetes mellitus in a routine clinical setting.

Participants will be patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy. The planned sample size is 1,000 subjects.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.

Eligibility Criteria:
Inclusion Criteria:

* Patients who did not adequately respond to the following treatment • Treatment with thiazolidinediones in addition to diet therapy and exercise therapy

Exclusion Criteria:

* Patients contraindicated for Nesina

  1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.)
  2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.)
  3. Patients with a history of hypersensitivity to any ingredient of Nesina
Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients

This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord in improving the quality and quantity of spinal density of osteoporosis patients proven by the results of Bone Mass Density (BMD) examination compared to baseline and evaluate improvement of quality of pain with visual analog scale (VAS).

Currently, preventive and therapeutic strategies for osteoporosis patients are based on calcium and vitamin D supplementation, the use of pharmacological agents that inhibit bone resorption such as bisphosphonates, and sometimes calcitonin. Although bisphosphonates have been found to reduce osteoporosis, clinical use for these drugs has been limited because of its potential to produce serious side effects, such as mandibular osteonecrosis and atypical femoral fractures. Therefore, new therapeutic strategies for osteoporosis are needed.

This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord. Patients who have received mesenchymal stem cell therapy (MSC) are expected to have positive effects such as reduced pain sensation in the back assessed by Visual Analog Scale (VAS), improvement in the range of motion (ROM), improving the quality of osteoporosis patients's bone proven by the results of Bone Mass Density (BMD) and improvement in patients' quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients older than 50 yrs old.
2. Female patients older than 40 years old.
3. Patients enrolled in Cipto Mangunkusumo Hospital with osteoporosis confirmed by BMD test.
4. Patients with no history of autoimun disease (SLE, Addison's disease, Chron's disease) and other diseases related to osteoporosis.
5. Patients with no history of consuming drug related osteoporosis.
6. No active infection confirmed by HbsAg, HIV, CMV, Rubella and Toxoplasma examination.
7. Agree to participate the study by signing informed consent form.

Exclusion Criteria:

1. Patients with autoimun diesasde (SLE, Addison's diesase, Chron's disease and other osteoporosis related disease.
2. Patients under immunosuppressive, anticoagulant or corticosteroid treatment.
3. Paralysis patients after surgical treatment
4. Patients under 20 years old
5. Declined to participate in the study
The Effect of Ketogenic Diet Versus Mediterranean Diet in Patients With Obesity and Psoriatic Arthritis

The aim of our study is to compare the effectiveness of Mediterranean diet (MD) with the isocaloric Ketogenic diet (KD) on clinical and biochemical markers of inflammation in patients with obesity, psoriasis (PSO) and psoriatic arthritis (PsA).

Overall, twenty patients with body mass index (BMI) \>30 kg/m2, PSO and PsA under constant systematic treatment for at least 3 months will be included in the study. They will randomly assign to two groups, starting either with MD or KD for a period of 8 weeks. After a 6-week washout interval, the two groups will cross over to the other type of diet for the same 8-week period. The primary endpoint is the change in Psoriasis Area and Severity Index (PASI) and the Disease Activity Index for Psoriatic Arthritis (DAPSA) score, 8 weeks after each diet intervention. Secondary endpoints are changes in biochemical markers of inflammation (IL-6, IL-17, IL-22, IL-23) , in metabolic and anthropometric parameters.

Eligibility Criteria:
Inclusion Criteria:

1. age above 18 years
2. body mass index (BMI) \>30 kg/m2
3. diagnosis of psoriasis and psoriatic arthritis under constant systematic treatment with biologic agents and/or synthetic disease-modifying anti-rheumatic drugs (DMARDs) for at least 3 months.
4. ΔPASI SCORE\<75, with moderate or severe activity in joints ( \> 3 swollen \&\> 3 tender joints ή DAPSA\< 14).

Exclusion Criteria:

1. participation in another study
2. eGFR\<60ml/min/1.73m2
3. malignancy
4. severe hepatic disorder
5. HbA1C\>10%
6. use of glucagon-like-petide-1 analogues
SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification

To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>18 years.
* Patients with histopathologically proven cT1-2N0M0 squamous cell carcinoma of the oral cavity.
* Patients planned to undergo routine sentinel node biopsy with 99mTc-radioisotope and SPECT-CT.
* Patient provided written informed consent.

Exclusion Criteria:

* Patients who underwent previous surgery or radiotherapy to the neck.
* Contra-indications to SPIO (Hypersensitivity to iron oxide or dextran compounds, Presence of iron overload disease (hereditary hemochromatosis, hemosiderosis, chronic hemolytic anemia (e.g. thalassemia, sickle cell anemia))
* Contra-indications to MRI: Epilepsy, Claustrophobia, Metallic splinters, Pacemaker, pacemaker wires or implanted defibrillator, Implanted magnets in jaw, Metallic Arterial clips (carotid arteries), Pregnancy, Auditory implant, neurogenic bladder stimulator, insulin pump, neurostimulator, baclofen pump, Metallic tissue expander after mastectomy, Cochlear implant, Metallic braces, Other foreign bodies implanted
* Unable to provide informed consent.
Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection

Comparison between Arthrocentesis alone arthrocentesis with hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction.

Temporomandibular joint (TMJ) anterior disc displacement (ADD) is one of the most common TMJ disorders.It can occur in all age groups, with a high prevalence in adolescents .

ADD often presents with clicking, joint pain, a limited range of mouth opening. Furthermore,ADD might lead to osteoarthrosis .

Since ADD of the TMJ can lead to various harmful outcomes, how to manage ADD is considered a key problem for most TMJ experts. It has been difficult for most clinicians to select a suitable method for ADD patients with different grades of severitis ). Initially, these conditions can be managed conservatively by employing techniques such as occlusal splint therapy, physiotherapy, pharmacotherapy and occlusal treatments. If Medical treatment fails, minimally invasive (sodium hyaluronate or corticosteroid infiltrations and arthrocentesis) and invasive treatments (arthroscopy, arthroplasty, arthrotomy, discectomy, condylotomy) are formed ). Sodium hyaluronate is a buffered solution of hyaluronate acid sodium salt, which is an essential component of the cartilage.It acts against the disintegration of the extracellular matrix.It reduces friction, and it features an anti-inflamatory effect. It is indicated for the treatment of osteoarthritic symptoms and inflammatory degenerative joint disease). Intra-articular hyaluronic acid injection provides long-term palliative effects on symptoms and signs of TMJ pain .

Eligibility Criteria:
Inclusion Criteria:

* Adults with age between( 18-45) years
* Both genders
* The cases ciinically have either of ( limitation of mouth opening , pre-auricular pain , headache, temporal, and occipital tenderness ) and radiologically (MRI) diagnosed as ADD with reduction
* The patients have symptom durations for more than 3 months with medical treatment.
* Patients whom did not respond to medical treatment

Exclusion Criteria:

* Previous TMJ surgery or previous arthrocentesis.
* Patients with arthritis or history of condylar trauma
* Patients with degenerative change of the condylar head and with facial asymmetry, retrognathism, or prognathism
* Severe co-morbid conditions (uncontrolled diabetes, Hypertenion
Continuously Infused Intracerebral (IC) Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (r-metHuGDNF) for the Treatment of Idiopathic Parkinson's Disease

Parkinson's disease is characterized by loss of neurons that produce dopamine in a region of the brain called the substantia nigra. In the early stages of the disease, the disease responds to agents that replace dopamine such as levodopa. Patients with more advanced disease have wide fluctuations in their response to levodopa, exhibiting on and off periods. This is due to continued degeneration of neurons. Recombinant-methionyl human glial cell line-derived neurotrophic factor (r-metHuGDNF or GDNF) is a neurotrophic factor that promotes survival of dopaminergic neurons. This is a protein produced by recombinant technology that is almost identical to the naturally produced factor. Results of animal studies indicate that GDNF has the potential to benefit patients with advanced Parkinson's disease.

The purpose of this clinical trial is to determine whether GDNF works to relieve symptoms of advanced Parkinson's disease. The study will also test the delivery of GDNF using a catheter implanted into the putamen, the area of the brain associated with Parkinson's disease, and an infusion pump that is implanted under the skin in the abdomen or chest. GDNF will be placed into the pump and delivered through the catheter to the brain. The purposes of this study are to determine the potential benefits and side effects of GDNF. The performance and safety of the catheter/infusion pump system will also be assessed. The study will last for 6 months. Subjects will undergo neurological testing, computerized gait assessment and neurological imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced idiopathic Parkinson's disease treated with optimal doses of levodopa, dopamine agonist, catechol-o-methyl transferase (COMT) inhibitors, or selegiline for 2 months prior to implantation of the intracerebral catheter and pump.
* Must be able to undergo surgery required to implant the pump and catheter.
* Must be capable of informed consent.
Effect of a Week-long Social Media Abstention on Sustained Attention Functions

The current study's goal is to determine if a one-week break from social media in all forms has a beneficial effect on people's attention, as measured by the Sustained Attention to Response Task, executive function as measured by the Stroop test, and well-being.

50 participants between the ages of 18 and 30 years will be recruited for the study via fliers and word of mouth. Following consent procedures, those who choose to participate will be randomized to intervention or control. 25 will be randomly selected to be in the social media group and the other 25 will be selected to go 1 week without engaging with or viewing social media to the best of their ability.

All participants will complete a demographic form at baseline and a survey about their use of social media, as well as the Bergen Social Media Assessment Scale, and the Warwick-Edinburgh Mental Wellbeing Scale. Following that, they will complete the Stroop and the SART, described below. All 50 of them will be asked to take the SART and Stroop (Inquisit Millisecond versions) tests to obtain baseline attention and executive functioning measures. Temporary deletion of social media apps will be supervised by an investigator. Subjects will be given a daily brief report/log to record any use of social media through Redcap. At the end of the week a repeat SART, Stroop, and Warwick-Edinburgh Mental Wellbeing scale will be re-administered. The group that deleted their social media will then be able to redownload their social media if they so choose. A survey about their subjective experience at the conclusion of the week will then be given to all subjects.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years old
* have and regularly use some form of social media
* use on average more than 1 hour of social media a day
* are willing to temporarily delete all social media for 1 week duration

Exclusion Criteria:

* no social media usage
* ADHD or other known conditions that affect attention and/or concentration
* current concussion