cyrilzakka/clinical-trials huggingface dataset:
China Action on Spine and Hip Status

1. To determine the prevalences of osteoporotic fracture in elderly Chinese population.
2. To determine the prevalences of osteoporosis in elderly Chinese population using QCT BMD measurement.
3. To investigate the difference in the prevalences of osteoporosis between cities and urban-rural area in China.
4. To investigate the association of body composition with osteoporosis
5. To investigate the prevalence of liver steatosis in China
6. To investigate the application of QCT fat measurement

Osteoporosis and osteoarthritis (OA) both are very common in elderly population,it is particular important for China with a huge aging population in the coming years.Bone mineral density measured by quantitative computed tomography (QCT) or dual energy X-ray absorptiometry (DXA) is the surrogate for bone health status and diagnosis of osteoporosis and OA. In this study we utilize the large-scale population based epidemiology study (PURE) population,spine and hip QCT and/or DXA will be obtained for the subject to investigate the prevalence of osteoporosis and osteoarthritis in elderly Chinese population. We also study the relation between bone mineral density with osteoporotic fracture and OA More than 3000 subjects selected from the PURE study participants in Beijing and other centers in China will be recruited to this study. More precisely, the subjects are consisted of the females over 55 years and males over 60 years old, along with the 20% randomly selected PURE participants for blood sampling.

Beijing ji shui tan hospital will be the coordinate center for the whole study, Beijing shi jing shan hospital, Beijing shun yi traditional medicine hospital and Taiyuan central hospital of shanxi will participate, other centers may be added late.

Bone mineral density of spine and hip will be measured with QCT and/or DXA. Quantitative computed tomography QCT pro (Mindways software, inc. USA) will be used for all QCT measurement, the CT scanner will be the clinical CT scanner of the local participated center.

Quality control and monitoring will be conducted by Beijing ji shui tan hospital, as well as the centralised image interpretation.

Therefore, this study is designed to provide the current and reliable prevalence of osteoporotic fracture, osteoporosis, OA in elderly Chinese population using QCT and/or DXA. The performance of QCT and DXA in the diagnosis of osteoporosis , as well as the association of body composition with osteoporosis will be assessed.

Eligibility Criteria:
1. Inclusion Criteria:

   1. Participants of the PURE study in China (PURE China study)
   2. be willing to and be able to join in the study and signed Informed consent
2. Exclusion Criteria:

   1. Pregnant
   2. Spine and both hip implants
Rt-fMRI NF Intervention Study in ASD

This study aims to demonstrate that fMRI neurofeedback training improves the identification and comprehension of emotional facial expressions (and overall social behaviour) in subjects with ASD.

The intervention setup provides structured presentation of emotional facial expressions and the associated tools for mental imagery. The investigators hypothesize that the accomplishment of the proposed competence training improves the subjects ability to comprehend facial expressions, identify emotions and be able to correctly express them.

Intervention Type is a Device (brain computer interface using brain imaging signals) and the specific Intervention Name is Neurofeedback.

Structure: (1) initial eligibility screening, (2) pre-intervention (first week of study, baseline outcome measures and additional evaluations), (3) intervention process (8 weeks), (4) post-intervention (outcome measures and additional evaluations), and (5) follow-up (outcome measures at 6 months).

Clinical research has demonstrated that ASD children have deficits in the identification and interpretation of the emotional and mental state of others (Baron-Cohen 2001). An important skill to this end (impaired in ASD patients), is to appropriately recognize and discriminate emotional expressions.

The main brain regions involved in face processing the inferior occipital gyri, lateral portion of the fusiform gyrus (especially a region deemed the fusiform face area or FFA), and posterior superior temporal sulcus (pSTS) (Haxby et al. 2000). STS plays a key role on several basic aspects in social information processing, and deficits in ASD have been found associated to this region.

The purpose of the study is to determine the effect of neurofeedback considering a social cognition brain region (i.e. pSTS) on the identification of facial expressions in ASD patients. The intervention comprehends seven BCI sessions spread over four months. The first four sessions are weekly, and the rest monthly. In each session, the subjects are asked to imagine different facial expressions and their brain activity (i.e. BOLD activation in the pSTS region) is interpreted and used to estimate a feedback signal.The hypothesis is that the training induced up-regulation of the target region, improves clinical symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Positive diagnostic results for ASD in:

Autism Diagnostic Interview-Revised; Autism Diagnostic Observation Schedule; The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

Exclusion Criteria:

* Global Intelligence Quotient \< 80
* Associated medical condition such as epilepsy, neurocutaneous or other genetic syndromes, or other usual comorbidity in ASD samples
Blood Levels of Sevoflurane and Desflurane

16 patients with American Society of AnesthesioIogy (ASA) physical status I-III will recruited to this study. Patients will divided to the 2 groups. %1.5 Sevoflurane will apply in Group S and %6 Desflurane will apply in Group D. Each groups will divide 2 subgroups. Two lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be performed to Group Sb and Group Db. At the time point 40.minutes first blood sample will given from patients. Blood sample will be taken at intervals of 10 minutes from groups of two lung ventilation. In groups of one lung ventilation, blood samples will be taken at the time interval of 10 minutes after one lung ventilation started. All blood samples will be assess in Gas Chromatography.

Investigator aimed to assess blood level of sevoflurane and desflurane during two lung ventilation and one lung ventilation. The investigators will use Gas Chromatography for define drugs levels. 16 patients with ASA I-III patients who undergo thoracotomy and abdominal surgery will be recruited to this study. Patients will divided in to the 2 groups. %1.5 Sevoflurane will apply in Group S and %6 Desflurane will apply in Group D during anesthesia maintenance. Each groups will divide 2 subgroups which are one lung ventilation groups and two lung ventilation groups. Two lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be performed to Group Sb and Group Db. Sequential blood samples will be taken from both arterial and central venous canula at the same time point. First blood samples will be taken at 40. minutes of anesthesia. Sequential samples will be taken at interval of 10 minutes during two lung ventilation. In one lung ventilation second blood samples will be taken at the 10. minutes of one lung ventilation. After than at the interval of 10 minutes, collection of blood samples both arterial and central venous will be continue.

All collection will assess with gas chromatography.

Eligibility Criteria:
Inclusion Criteria: ASA I-II patients

* Who undergo thoracotomy or abdominal surgery

Exclusion Criteria:

* ASA IV and up patients
* Patients who taken inotropic agent
Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients

The aim of this study is to evaluate the effect of vildagliptin on copeptin in comparison to glimepiride, and whether copeptin could be used as a marker for the efficacy of vildagliptin in type 2 diabetes mellitus patients, and how copeptin correlates with other diabetic and cardiac markers.

1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
2. All participants agreed to take part in this clinical study and provide informed consent.
3. Patients with uncontrolled DM type 2 who are on metformin will be enrolled from endocrinology clinic at Damanhour general hospital.
4. Serum samples will be collected for measuring the biomarkers.
5. All enrolled patients will be divided into two groups; both groups will be patients who are uncontrolled and already on metformin, group I will receive vildagliptin as an add-on therapy while group II will receive glimepiride.
6. All patients will be followed up during 12 week period.
7. At the end of the 12 week period, serum samples will be recollected for measuring the biomarkers after treatment.
8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
9. Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 12 weeks.
10. Results, conclusion, discussion and recommendations will be given. Methodology

    * Copeptin and NT-proBNP will be determined by ELISA.
    * Lipid profile will be measured.
    * Fasting blood glucose and Insulin will be measured and HOMA-IR will be calculated for all subjects.
    * Body weight and blood pressure will be measured.
    * HbA1C will be measured.

Eligibility Criteria:
Inclusion criteria

• 70 uncontrolled adult patients with Type II-diabetes mellitus

Exclusion criteria

* Hepatic impairment.
* Active malignancy.
* Planned surgical intervention.
* Any signs of hypersensitivity or contraindication to study drugs developed.
* Addition of any anti-diabetic medications or insulin during follows up.
* Chronic inflammatory disease (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection).
* Pregnancy, lactation or child-bearing potential.
* Cardiac disease.
* Renal impairment.
* History of T1DM, SIAD, or diabetes insipidus.
* Therapy with any diuretic or a medication affecting the RAAS.
Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12 months to subjects with chronic post-ischemic stroke walking deficits who have completed the controlled, double-blind Study DALF-PS-1016.

Eligibility Criteria:
Key Inclusion Criteria:

* Completion of the DALF-PS-1016 study
* Providing informed consent to continue into the DALF-PS-1029 long-term extension study
* Sufficient ambulatory ability to independently complete the Two Minute Walk Test (2MinWT) and 10 Meter Walk Test (10MWT) at the time of enrollment into the extension study

Key Exclusion Criteria:

* Seizures, new onset strokes (or other significant neurological event precluding long-term continuation) occurring during the antecedent DALF-PS-1016 study
* Calculated creatinine clearance of ≤ 50 mL/minute at the time of enrollment into the long-term extension study
Free-living Validation of the RFPM in Adolescents

The primary aim of this small study is to test the validity of the Remote Food Photography Method and an updated SmartIntake app in a sample of adolescents. The investigators will test the validity (accuracy) of the method/app at estimating energy intake in free-living conditions over approximately three days compared to doubly labeled water. This is a small study that has low statistical power, but will provide important data nonetheless and inform future research.

Energy intake (EI) is an important predictor of weight gain (1) and accurate methods to measure children's and adolescent's EI are needed. Self-report methods (e.g., 24-hour recall and food records) have their strengths and are frequently used to measure children's EI. Nonetheless, they also have significant limitations, including participant and caregiver burden and lack of near real-time data.

Our group developed the Remote Food Photography Method (RFPM) to measure the EI of adults in near real-time and the validity data in adults are exceptional; the RFPM underestimates EI in laboratory settings by less than 6% and in free-living conditions by less than 7% compared to weighed foods and by less than 4% compared to doubly labeled water (DLW) over 6 days. At the same time, participant burden is drastically reduced compared to self-report methods, as participants are only required to capture images of their food selection and plate waste with a smartphone app and send these images to the laboratory for analysis. This validation study aims to assess the accuracy of the RFPM and SmartIntake app in a sample of adolescents in free-living conditions.

Eligibility Criteria:
Inclusion Criteria:

* boy or girl of any race
* age between 12 and 18 years
* willingness to use the RFPM/SmartIntake app for 3 days, in addition to a 1-2 day run-in period
* willingness to be responsive to study staff when prompted for additional information when using the RFPM/SmartIntake app
* parental support of the project, except for 18-year-olds

Exclusion Criteria:

* Individuals may not qualify for this study based on other eligibility criteria not listed. The study coordinator determine this on a case-by-case basis
Local Field Potentials Recorded From Deep Brain Stimulating (DBS) Electrodes

This study will be recording and evaluating brain activity from Deep Brain Stimulating (DBS) electrodes in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Surgical Candidate for DBS implantation.
Exercise and Physical Activity in Adults with Acquired Brain Injury

Exercise and physical activity in adults with acquired brain injury

Although emerging approaches have emerged in the design of interventions that promote an orientation towards physical activity scientific evidence on their efficacy in this particular population remains limited. This underscores the need for further research to evaluate the efficacy of these intervention approaches in the context of ABI.

Eligibility Criteria:
Inclusion Criteria:

* Aged more than 18 years of age and present a medical diagnosis of acquired brain injury.
* Have the informed consent completed and signed
* Present a state that allows following indications for the practice of exercise and physical activity.

Exclusion Criteria:

* Have medical comorbidities that contraindicate the safe performance of the program (i.e., cardiac or respiratory instability, uncontrolled seizures).
* Have additional disabling conditions, such as cognitive impairment and/or an inability to communicate with the researcher verbally, in writing, or through an emissary.
Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

In this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications.

In recent years, an endoscopic retrograde cholangiopancreatography (ERCP) is the golden standard procedure to remove the common bile duct stones(CBD). Nevertheless, it is reported that the recurrence rate of CBD stones is 4% to 24% after ERCP. The contributing factors were periampullar diverticulum, situ gallbladder, and incomplete CBD stone clearance. The main reason of stone recurrence is incomplete CBD stone clearance including remnant stone fragments themselves and tinny fragments can act as a nidus for further CBD stone growth. It is difficult to retrieve these fine fragments completely using conventional devices such as retrieval basket and ballon. Therefore, the investigators attempt to remove residual stone fragments by means of saline infusion. Saline irrigation has many advantages such as better effect and less side effect and no extra cost. It is reported that use intraductal ultrasonography (IDUS) to demonstrate residual CBD stones. However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system gains widespread acceptance because of its independent washing channels and direct viewing.

The purpose of this study is to evaluate whether saline solution irrigation would decrease the recurrent rate of choledocholithiasis after endoscopy retrieval stones.

Eligibility Criteria:
Inclusion Criteria:

* With ERCP indications
* With mechanical lithotripsy during operation

Exclusion Criteria:

* Unwillingness or inability to consent for the study
* Unstable vital signs
* Coagulation dysfunction (INR\>1.5) and low peripheral blood platelet count (\<50×10 \^9 / L) or using anti-coagulation drugs
* Prior surgery of Bismuth Ⅱ, Roux-en-Y and cholangiojejunostomy
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock
* Biliary-duodenal fistula confirmed during ERCP
* Pregnant women or breastfeeding
MicroRNA-126 and Its Target VCAM-1Dermatitis to Nickel

Background. Allergic Contact Dermatitis (ACD) is an inflammatory skin disease mediated by direct contact with allergens as nickel, the most common allergen, that may be related with epigenetic changes.

Objective. Evaluate the miR-126 expression and its target VCAM-1, in the skin of patients with ACD to nickel.

Methods. Fifteen patients with positive patch test to nickel were included, and the expression of miR-126 and VCAM-1 was evaluated by RT-qPCR.

Patients that went to the dermatology and outpatient department of the Central Hospital "Dr. Ignacio Morones Prieto ", with a suspected diagnosis of nickel allergic contact dermatitis, were invited to participate in this study. Later, the objective and methodology of the study were explained to them, as well as the advantages of participating and the possible undesirable effects. All patients signed the informed consent previous perfom the medical history. After, the epicutaneous patch test was performed, and patients were divided according to the result them. Finally, under local anesthesia, two 3-mm punch biopsies, from lesional (positive parch test site) and adjacent non lesional skin, 10 cm apart, were performed. Tissues for reverse transcriptase real-time polymerase chain reaction (RT-qPCR) analyses were stored frozen in sterile tubes at 80ºC until processing

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Epicutaneous Patch Test positive to Nickel
* without previous treatment within the previous 4 weeks

Exclusion Criteria:

* Pregnancy
* nursing
* menopause
* consumption of any type of drugs (including anti-inflammatories and hormonal treatments) within the previous 2 months
* coexistence of other dermatoses conditions
Quetiapine in Postpartum Depression

The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female patients with postpartum depressive disorder with psychotic symptoms


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent.
* Female patients with severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points

Exclusion Criteria:

* Woman with pre-existing psychotic disorder
* Patients with alcohol or substance abuse or dependence
* Patients who pose an imminent risk of suicide or danger to self or others
Study of a Tankyrase Inhibitor RK-582 for Patients with Unresectable Metastatic Colorectal Cancer

Tankyrase, the fifth and sixth members of the poly(ADP-ribose) polymerase (PARP) family (PARP-5a/b), is responsible for poly(ADP-ribosyl)ation (PARylation), and was originally identified as a factor that promotes the function of telomerase, an enzyme that elongates telomeres. Subsequently, it was reported that tankyrase enhances Wnt/beta-catenin signaling by PARylation and subsequent degradation of AXIN, a negative regulator of Wnt/beta-catenin signaling, suggesting that tankyrase inhibitors may be a new treatment for colorectal cancer.

RK-582 was discovered through lead optimization from a tankyrase inhibitor that suppresses the growth of human colorectal cancer cells. It was confirmed that RK-582 selectively inhibited tankyrase among the PARP family enzymes, suppressed the growth of Wnt/beta-catenin signal-dependent human colorectal cancer cells at both the levels of cultured cells and xenograft tumors in immunodeficient mice, and accumulated AXIN to decrease beta-catenin and downregulate the target gene expression as pharmacodynamic biomarkers.

Based on these findings, RK-582 is thought to have potential as a new treatment for colorectal cancer patients. At present, however, the efficacy and safety of RK-582 in humans have not been confirmed. Thus, this clinical trial is conducted with the aim of investigating the tolerability and safety of RK-582 for patients with unresectable advanced or recurrent colorectal cancer as a first-in-human trial, in which RK-582 is administered to humans for the first time.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically diagnosed colorectal cancer
* Patients who are refractory or intolerant to standard treatment for unresectable advanced or recurrent colorectal cancer
* Patients with measurable disease according to RECIST guideline ver 1.1
* Patients who are able to take capsules orally

Exclusion Criteria:

* Patients with clinically relevant gastrointestinal, hepatic, musculoskeletal, respiratory, cerebral/cardiovascular, hematologic, oncologic, endocrine, immunologic, psychiatric, neurologic, or genitourinary diseases, or patients with conditions that are judged to threaten the safety of the participant or to affect the outcome of this clinical trial by the investigators
* Patients with medical history of interstitial lung disease
* Patients with chronic nausea, vomiting or diarrhea that may interfere with oral administration of the investigational drug
* Patients with pulmonary embolism or central deep vein thrombosis.
* Patients receiving treatment with strong CYP3A4 inhibitors or inducers.
* Patients diagnosed and treated for osteoporosis or patients with a bone mineral density of less than T-score -2.5 at the time of screening
* Patients with obvious bone metastases in the long bones, vertebrae, or other parts of the leg where gravity is applied