cyrilzakka/clinical-trials huggingface dataset:
Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

The purpose of this study is to determine whether hypofractionated concurrent chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.

For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm. While 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.

Eligibility Criteria:
Inclusion Criteria:

* 18\~70 years old, ECOG 0-2
* patients with histologically or cytologically proved small cell lung cancer
* Limited disease (LD), was characterized by tumors confined to one hemithorax. It may include ipsilateral hilar, both mediastinum and both supraclavicular nodes. Metastatic lymph nodes were defined as lymph nodes with short diameter of more than 1cm or FDG uptake in PET. The thickness of pleural effusion was less than 1cm unless malignant pleural effusion was cytologically proved. In a word, stage I-IIIB excluding the patients with lung metastases should be defined as LD according to AJCC cancer staging 7th edition.
* No progression after 2 cycles of chemotherapy with EP.
* No prior history of anti-tumor treatment.
* No severe internal diseases and no organ dysfunction
* Written informed consent provided and

Exclusion Criteria:

* Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable.
* Active heart disease or acute myocardial infarction happen in six months.
* Psychiatric history.
* Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG)
* Uncontrolled diabetes or hypertension
* Interstitial pneumonia or Active pulmonary fibrosis
* Acute bacterial or fungal infection
* Oral or intravenous use of steroids
A Phase I Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Study of ICP-332 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, parallel group, single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-332 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) between 18-26 kg/m2, the weight of male subject should not be less than 50 kg, and the weight of female subject should not be less than 45 kg.
2. Age and fertility status

   1. Male or infertile female subjects who are between 18-45 years old (inclusive).
   2. Female subjects who are infertile.
   3. Male subjects and their partners must agree to use effective contraception.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic and other diseases, or allergic diseases.
2. Subjects with clinically significant gastrointestinal dysfunction that may affect drug intake, transport or absorption.
3. Acute disease state (such as nausea, vomiting, pyrexia or diarrhea, etc.) within 14 days before administration.
4. Other situations judged by the investigator to be unsuitable to join this trial.
Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).


Eligibility Criteria:
Inclusion Criteria:

1. Participants who require continuous NSAID therapy during the treatment period with the study drug
2. Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed
3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

1. Participants scheduled to change the type and dosage regimen of NSAID
2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed
3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
4. Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
6. Participants with a previous or current history of aspirin-induced asthma
Pathology and Imaging in Kidney Allografts

This study will perform multi-parametric renal MRI in 70 patients with a renal transplant who are undergoing a clinically indicated biopsy of their transplant. The aim of this study is to compare findings on renal MRI with those seen on histology.

Background: Renal transplantation is the optimal treatment for patients with renal failure. However, transplant life-span is finite and commonly limited due to the development of chronic rejection and other causes of irreversible fibrosis. At present, renal transplant biopsy is required to diagnose the cause of transplant dysfunction. Renal biopsies are invasive procedures that carry risks of bleeding, damage to the transplant and discomfort to patients. Functional magnetic resonance imaging (MRI) of the kidneys is an emerging field of research that has potential to non-invasively define and quantify parenchymal renal disease including fibrosis and inflammation. There is a paucity of data correlating multi-parametric renal MRI sequences with histological findings on biopsy, especially in patients with renal transplants.

Study participants: 70 adult renal transplant recipients who have been referred for a clinically indicated biopsy of their transplant kidney.

Study design: Participants will undergo multi-parametric renal MRI at time of biopsy. In patients who receive treatment for acute rejection, a second renal MRI will be undertaken at completion of treatment. Blood tests for fibrosis biomarkers and routine clinical measures of transplant function will be obtained at time of MRI scanning.

Objectives:

1. Assess the correlation between functional renal MRI sequences and histological markers of fibrosis and inflammation.
2. Assess the change in functional MRI sequences in response to treatment for acute rejection in renal transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Recipient of a kidney transplant
* Referred for clinically indicated biopsy of transplant kidney
* Ability to comply with study procedures.
* Ability to give informed consent.

Exclusion Criteria:

* Any contraindication to MRI
* Known pregnancy or intent to conceive during the study period
* Clinical suspicion of delayed graft function as the cause of transplant dysfunction
* Any other reason considered by a study physician to make the subject inappropriate for inclusion.
Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain

The aim of this study is to develop a retrospective, multicenter and observational study in Spain in real clinical practice to assess the employment of dapagliflozin and to compare its effectiveness and safety with the data of sitagliptin, a DPP4 inhibitor. This is a widely used molecule in Spain with a large safety profile. It was chosen as a comparator because of the number of patients treated and because it is a real alternative at the time of making a decision about the treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with T2DM.
2. Age: 18-75 years.
3. Treatment with dapagliflozin or sitagliptin that started at least 6 months before the recruitment date.
4. The patient must have at least two follow-up visits. The basal initial visit, where all the relevant information is collected and a second follow-up visit.
5. The next information of the subjects should be available at the recruitment of the basal visit: Sex, age (years), date of diagnosis of T2DM, weight, height, systolic and diastolic blood pressure, body mass index (BMI: kg / m2), concomitant medication (antiHTA, statins, aspirin, etc.), glucose basal fasting (mg / dL), HbA1c (%) and estimated GFR by CKD-EPI (mL / min / 1.73m2).

5. The patient must sign the informed consent to participate in the study.

Exclusion Criteria:

1. Impediment of the patient to give him informed consent.
2. Patients diagnosed with Type 1 Diabetes.
3. Women with gestational diabetes.
Effectiveness of a Cognitive Remediation Intervention Based on Virtual Reality for Promotion of Cognitive Functioning and Participation in Daily Life Among Persons With Affective Disorder

The purpose of this study is to test the efficacy of remedial cognitive intervention using The Functional Brain Trainer VR (FBT, Intendo ©) to improve cognitive functioning, participation in daily life occupations, and functional capacity in the field of IADL among people with affective disorders receiving inpatient and daycare mental-health services.

This study is an experimental study, in a pre-post design with a control group, the sampling is convenience. The study will include 40 people aged 18-60 with a diagnosis of Affective disorder based on DSM-5.

Inclusion criteria: age 18-60, Diagnosis of Major Depression or Bipolar disorder based on DSM-5; Mood stabilizing medication for at least 2 weeks, Exclusion criteria: Neurological disorders and neurodevelopmental conditions in addition to mental health diagnosis; Physical disability in addition to mental health conditions; Psychotic state; active substance abuse; custodian.

They will be recruited from active inpatient and daycare wards of the "Geha Mental Health Center", Israel and will be randomly allocated into two groups: experimental and control. An experimental group will attend 6 VR based cognitive remediation sessions of 30 minutes for training response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence. The control group will complete 6 sessions of 30 minutes of low-tech (paper and pencil tasks) remedial training of the same cognitive components. These in addition to routine care. The evaluation for symptoms severity, cognition, functional capacity and participation in daily life activities will be conducted at the beginning of the study and after about 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60,
* Diagnosis of Major Depression or Bipolar disorder based on DSM-5;
* Mood stabilizing medication for at least 2 weeks,

Exclusion Criteria:

* Neurological disorders and neuro-developmental conditions in addition to mental health diagnosis;
* Physical disability in addition to mental health conditions;
* Psychotic state;
* active substance abuse;
* custodian
Unifying Advanced Treatment With Advanced Imaging

The study investigates response assessment of gastrointestinal stromal tumors using Dual Energy CT (DECT) in patients undergoing targeted therapy with a TKI Inhibitor.

Patients treated with targeted therapies by tyrosine kinase inhibition (TKI) almost always show different response patterns than tumors treated with cytotoxic chemotherapy. Tumor manifestations treated with targeted therapies often show only minor measurable changes in tumor size despite inhibition of tumor proliferation. Decrease in tumor size fulfilling the criteria of a partial remission according to RECIST may occur at a delayed stage of treatment after several months (PMID 19620483). Sometimes, even an initial increase of maximum tumor diameters may be observed although those patients are treatment responders with respect to 'hard' study endpoints like overall survival or progression free survival. As a result, patients often are misclassified too early as non-responders. As a consequence, successful treatment is not recognized or decisions towards a less effective second-line therapy are made.

Dual Energy CT (DECT) is a new and robust CT method that allows to exactly quantify the intra-tumoral amount of intravenously injected iodinated contrast material PMID 21822784). Thus, the technique can be considered as a simple and reliable surrogate of tumor Perfusion (PMID 21822784, 21934517, 20498609, 18677487). Initial studies have demonstrated a high accuracy of DECT in the differentiation of benign and malignant tumors in the kidney or lung (PMID 20498609, 18677487, 18796658). Furthermore, it has been demonstrated that the amount of iodine in lung tumors correlates with tumor glucose metabolism (PMID 21822784). These findings confirm the results of previous studies that have demonstrated the relationship between tumor perfusion, tumor microvessel density and glucose metabolism (PMID 15304661).

The hypothesis of the study is that DECT is the more accurate diagnostic tool to evaluate immediate therapeutic response in patients with GIST undergoing TKI inhibitor therapy (in most cases Glivec ®) than evaluating by RECIST, World Health Organization (WHO) and Choi criteria.

Eligibility Criteria:
Inclusion Criteria:

* General inclusion criteria for TKI treatment according to general medical standard procedures

Exclusion Criteria:

* General inclusion criteria for TKI treatment according to general medical standard procedures
Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* Not pregnant or breastfeeding
* Sexually active at risk of pregnancy

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Pregnancy within the last 3 months
* Smoking \> 10 cigarettes per day
Thenar Tissue Oxygen Concentration (StO2): A Non-invasive Surrogate for Central Venous Oxygen Saturation (ScvO2)

Oxygen concentration for patients undergoing cardiac catheterization and during admission to an intensive care unit is important outcome measure for clinical care. Currently, the tool used to monitor the oxygen concentration is a central venous access positioned in the superior vena cava or in the pulmonary artery to monitor the central venous oxygen saturation (ScvO2). However, it is invasive and not always possible due to a lack of a central line access. In this research study, the investigator would like use a noninvasive means for the ScvO2 by using the thenar tissue oxygen concentration (StO2). The primary aim for the study is to determine if the thenar StO2 correlates with ScvO2 and can serve as a noninvasive surrogate for ScvO2.

Participants will be undergoing a cardiac catheterization at Shands Children's Hospital or will be admitted to the intensive care unit, and as part of the clinical care either a central venous access positioned in the superior vena cava or in the pulmonary artery. As a part of the routine clinical care blood gases are frequently taken for continuous evaluation of therapy to monitor the central venous oxygen saturation (ScvO2). A measurement of thenar tissue oxygen concentration will be timed with a central venous blood gas draw to monitor the tissue oxygen concentration (StO2).

The StO2 measurement will be taken by using the InSpectraTM StO2 monitor manufactured by Hutchinson Technology Inc. after applying the noninvasive clip on probe to the thenar eminence of the right hand to measure the StO2 level. After a stable reading is obtained for 60 seconds it will be recorded.

The two different measurements of oxygen concentration will be compared to determine if a correlation exists.

Eligibility Criteria:
Inclusion Criteria:

1. Age 1 month to 21 years of age admitted to the intensive care unit or undergo cardiac catheterization at Shands Children's Hospital and have a central venous access positioned in the superior vena cava or pulmonary artery.

Exclusion Criteria:

1. Age less than 1 month or more than 21 years
2. Burns of the hand
3. Infection of hand
4. Fracture of upper extremity
5. Hematoma of hand over thenar eminence
North Carolina Newborn Exome Sequencing for Universal Screening

The NC NEXUS research study is exploring the utility of next generation sequencing in newborn screening and parental decision making. The National Institutes of Health (NICHD and NHGRI) are co-funding this study under a single U-19.

The investigators will enroll and perform whole exome sequencing on two cohorts of patients. One cohort will consist of two hundred newborns with no known conditions whose parents will be recruited during the mother's pregnancy. The second cohort will include two hundred infants and children up to the age of five years with diagnosed conditions including conditions detected through standard newborn screening such as phenylketonuria and other inborn errors of metabolism, hearing loss and other rare conditions that may fit criteria for newborn screening in the future.

Parents will be introduced to the study by their clinician or a study recruiter. Those who agree to enroll in Phase I will review an online decision guide and be offered a study visit conducted by a genetic counselor to obtain informed consent for genomic sequencing of their child. Parents consenting to have their child's genome sequenced will be seen after the child's birth or at a convenient pre-arranged time and duplicate saliva samples will be collected from the children and one sample will be sent to the BioSpecimen Processing (BSP) Facility and to Dr. Jonathan Berg's laboratory for sequencing and the other sent to the Molecular Genetics Laboratory (MGL) for DNA extraction and storage until needed for clinical confirmation. Results will be returned for diagnostic (in the Diagnosed cohort) and medically actionable disorders of childhood (both cohorts). Two-thirds of parents who consent to sequencing will be randomly assigned to be eligible to request additional findings and use a supplement of the online decision aid. All results will be reported to parents by trained genetic professionals (genetic counselors and clinical geneticists)

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated pregnancy and healthy newborn

Exclusion Criteria:

* Abnormalities such as major malformation or chromosomal disorder detected prenatally or significant complications during pregnancy or at the time of delivery.
Effect of Alendronate With β - TCP Bone Substitute in Surgical Therapy of Periodontal Intra-osseous Defects.

The aim of the present study was to evaluate the bone formation potential of 400µg alendronate delivered in β-TCP in the treatment of periodontal intra-osseous defects.

The aim of the present study was to evaluate the bone formation potential of 400µg alendronate(ALN) delivered in β-TCP in the treatment of periodontal intra-osseous defects.

Materials and Methods: Thirty patients with periodontal defects were randomly assigned to 400µg ALN + β-TCP + saline (test) group and β-TCP + saline (active-control) group. Clinical parameters like clinical attachment level (CAL) gain, probing depth (PD) reduction, post-operative gingival recession (GR) were assessed from the baseline, 3 months and 6 months recordings. Radiographic parameters like linear bone growth (LBG), percentage bone fill (%BF), change in alveolar crest height (ACH) were assessed from baseline and 6 months radiographs.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients having an intra-osseous defect with probing depth ≥ 7mm at baseline, presence of a ≥ 4mm vertical inter-proximal bone defect with at least one bony wall after surgical debridement and with no history of previous periodontal therapy were included into the study

Exclusion Criteria:

* Patients with known systemic diseases, aggressive periodontitis, smoking habit, known or suspected allergy to bisphosphonates, pregnant and lactating women, study tooth exhibiting tooth mobility greater than grade II and class III furcation defect were excluded from the study.
A Phase II Study of KUC-7483 in Patients With Overactive Bladder

To investigate the efficacy and safety of KUC-7483 in overactive bladder patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a symptom of overactive bladder for more than 6 months.
* Patients who meet the following condition during the 3-day bladder diary period.

  * the mean number of micturitions per 24 hours is ≥8 times
  * the mean number of urgency episodes per 24 hours is ≥1 time

Exclusion Criteria:

* Patients who are diagnosed as stress urinary incontinence are predominant.
* Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.
DEDICA (Dose of HEparin During Coronary Angioplasty) Trial

International guidelines support the use of a full-dose heparin (anticoagulants) during coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances in angioplasty techniques and the widespread use of pretreatment with two antiplatelet agents.

Thus the investigators designed a study comparing safety and efficacy of standard dose heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty who are on aspirin and clopidogrel at the time of the procedure.

* Patients undergoing coronary angioplasty will be randomised to standard vs. low-dose heparin. the study will include "all-comers" (patients with either stable angina or acute coronary syndromes); only patients with ST-elevation myocardial infarction will be excluded.
* An ACT (activated clotting time) will be performed after the initial bolus of heparin: for the standard dose group the target ACT will be \> 300 sec. (as recommended by guidelines) while for the low-dose the target ACT will be \> 180 sec.

Aim of the study is to show equivalence in ischemic events between the two doses of heparin, in order to confirm the safety of lower dose of heparin in contemporary coronary interventions.

Eligibility Criteria:
Inclusion Criteria:

* Stable angina, unstable angina or Non-ST elevation myocardial infarction undergoing coronary angioplasty.
* Mandatory pretreatment with aspirin and clopidogrel

Exclusion Criteria:

* ST elevation myocardial infarction
* Coronary interventions with rotational atherectomy
* Coronary interventions on chronic total occlusions (CTO)