cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality and Neuropsychiatric Rehabilitation in Patients With Global Developmental Delay.

Global Developmental Delay is a disorder characterized by failure achievement of expected milestones in different areas of psychomotor development before 5 years of age. Recent data in the literature have emphasized the importance of early therapeutic intervention. However, few specific interventions have been described in the literature for this disorder.

Among the high-tech tools used in recent years for rehabilitation, the BTs Nirvana is one of the semi-immersive system that can also be used in children, which allows to stimulate cognitive and motor domains. Objective of this single-blind, randomized, controlled study is to evaluate the feasibility and the effectiveness of integrated rehabilitation treatments with the use of BTs Nirvana in patient with Global Developmental Delay.

Global Developmental Delay (GDD) is a disorder characterized by failure achievement of expected milestones in different areas of psychomotor development before 5 years of age. The estimated incidence of GDD is 1-3%, an early diagnosis and an efficacy treatment could provide a better long-term prognosis. Recent literature data have underlined the importance of early diagnosis followed by appropriate therapeutic management. In fact, GDDs could evolve into different neurodevelopmental disorders, especially if associated with other risk factors, such as intrauterine growth retardation, nutrient deficiencies, breastfeeding and maternal education, scarce social and economic conditions, poor learning opportunities, inadequate quality of caregiver-child interactions.

In recent decades, the use of virtual reality (VR) for therapeutic reason has become more and more popular for innovative treatments in cognitive-motor domain. Indeed, VR and the interactive playing can motivate children to learn new skills. Among the high-tech tools used in recent years for rehabilitation, the BTs Nirvana (BTsN) is one of the semi-immersive VR that can also be used in children, which allows to stimulate cognitive and motor domains. The aim of this single-blind, randomized, controlled study is to evaluate the feasibility and the effectiveness of integrated rehabilitation treatments with the use of BTsN in patient with Global Developmental Delay.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with diagnosis of GDD, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria;
* age between 12 and 66 months;
* patients without significant medical conditions such as epilepsy, significant visual and auditory sensory deficits, traumatic brain injury, or other significant genetic disorders.
* Signed informed consent and the availability of at least one family member to participate in the diagnostic/therapeutic process.

Exclusion Criteria:

* children not aged between 12 and 66 months;
* significant medical conditions such as epilepsy, significant visual and auditory sensory deficits, traumatic brain injury, or significant genetic disorders.
* Informed consent not signed of at least one family member to participate in the diagnostic/therapeutic process.
Tranexamic Acid for the Latarjet Procedure.

The investigators propose a double-blinded randomized study evaluating the effectiveness of tranexamic acid in reducing postoperative swelling and haematoma formation after the Latarjet procedure.

The purpose of this study is to assess the efficacy of tranexamic acid (TXA), given via intra-articular injection at the time of surgery in patients undergoing the Latarjet procedure for shoulder instability.


Eligibility Criteria:
Inclusion Criteria:

• Anterior shoulder instability, warranting the Latarjet procedure

Exclusion Criteria:

* Patients with known risk factors for hyper-coagulable state
* Patients under 16
* Patients unable to give consent to partake in the trial
Assessment of Probiotics on Inflammation and Metabolism in Type 2 Diabetes.

This clinical study aims to explore the effects of probiotics on inflammatory and metabolic indicators in patients with type 2 diabetes. By assessing the potential of probiotics to modify these markers, the study seeks to identify an economical and effective strategy for the prevention and treatment of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Signed an informed consent form before the study and has a thorough understanding of the content, process, and possible adverse reactions of the study;
2. Age 18 (inclusive) and above, gender not limited;
3. Diagnosed with type 2 diabetes mellitus;
4. Not diagnosed with cardiovascular, kidney, or any other diabetic complications.

Exclusion Criteria:

1. Age over 75 years old;
2. Use of exogenous insulin or patients with cardiovascular disease and other complications;
3. Patients who are currently using α-glucosidase inhibitors;
4. Patients who have a habit of taking probiotics or are currently taking probiotics;
5. Pregnant or lactating women;
6. Subjects deemed unsuitable for participation in this clinical study by the investigators due to other reasons.
PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients

This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 70
* Weights between 50 and 90kg(Female : 40 and 90kg)
* Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress
* Stable results of estimated GFR in 4 months recently

Exclusion Criteria:

* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
* Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction
* Volunteer who already participated in other trials in 2 months
* Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to veliparib in combination with platinum doublet chemotherapy results will improve progression free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (Phase 2 portion).

A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a life expectancy greater than 12 weeks,
* Participant must have cytologically or histologically confirmed Non-small Cell Lung Cancer (NSCLC).
* Participant must have metastatic or advanced NSCLC (Stage IIIB or IV) that is not amenable to surgical resection or radiation or chemoradiation with curative intent at time of study screening.
* Participant must have at least 1 unidimensional measurable NSCLC lesion on a computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1).
* Participant must have resolution to Grade 1 or lower of any toxic effects (excepting alopecia) of the most recent therapy prior to Cycle 1 Day 2.
* Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 1.
* Participant must have adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

* Participant has received prior cytotoxic chemotherapy (including chemotherapy in combination with radiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy accompanied by surgery with curative intent that was completed one year prior to Cycle 1 Day -2.
* Participant has received prior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
* Participant has received prior treatment with any anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immunoregulatory receptors or mechanisms.
* Participant has received radiation therapy to lung greater than 30 Gy within 6 months, or antineoplastic biologic therapy within 21 days, or major surgery within 21 days, or tyrosine kinase inhibitor therapy within 7 days, or palliative radiation within 7 days of the first dose of study medication.
* Participant has untreated central nervous system (CNS) metastases.
TOF-18F-FDG-PET/CT in Patients With Suspected Pancreatic Cancer

Aim of the prospective study is a better differentiation of benign and malignant lesions in the pancreas in patients with suspected pancreatic cancer using images 30 and 90 min p.i. (post injectionen) and a diagnostic CT (computed tomography) scan of the abdomen within the Time of Flight (TOF)-18F-FDG-PET/CT and thus an improvement of the quality of PET/CT findings.

In the course of this the procedure follows the necessary steps of routine treatment:

1. Assignment of the patient with a suspect of pancreatic cancer.
2. Performing time of flight (TOF)-18F-FDG-PET/CT with images 30 min and 90 min p.i.
3. Performing a diagnostic CT of the abdomen with parenteral contrast medium and pancreatic protocol (in case of normal creatinine, GFR, and TSH levels) as well as oral contrast medium (in accordance with the ESUR-guidelines) as part of the PET/CT examination.
4. Routine performance of the operation /fine needle puncture/biopsy
5. Routine histopathological evaluation of the surgical specimen/biopsy

For this study, a diagnostic CT of the abdomen with contrast medium (intravenous as well as oral) and with pancreatic protocol and without parenteral contrast medium in case of elevated creatinine or decreased TSH (thyroid-stimulating hormone) or GFR (glomerular filtration rate) levels is performed additionally within the routinely performed PET/CT for better differentiation of the target organ from adjacent structures. Furthermore, early (30 min p.i.) and delayed (90 min p.i.) images and a TOF-reconstruction following the PET/CT examination (without patient contact) should be performed for better differentiation between inflammatory and malignant lesions of the pancreas. The regional tracer-uptake should now be measured quantitatively by SUV (Standard Uptake Value) in the TOF-PET/CT images over the FDG-accumulating lesions in the pancreas at those two times. In case of an increased FDG-uptake in the early images, the lesion will be assessed as benign/inflammatory and with an increase of the FDG-uptake in the delayed images as malignant. No FDG-uptake in the early as well as in the delayed images will be classified as benign. As a reference standard, the histopathological diagnosis is used. Subsequently, a cut-off value of the SUV should be determined by ROC-analysis.

According to current scientific evidence regarding the characterization of pancreatic masses by means of "Time of Flight"(TOF)-technique, there are no studies in the literature.

Eligibility Criteria:
Inclusion Criteria:

* patients with suspected pancreatic cancer

Exclusion Criteria:

* persons under 18 years of age
* patients with blood glucose level ≥160 mg/dl at the time of the PET/CT examination
* patients who will not be operated or biopsied and in which thus there are no histopathological findings of the pancreas
* pregnant women
Does Bicarbonate in Addition to Theophylline Reduce CIN?

Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is administered to the patients especially in patients with already existing renal impairment. Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium chloride alone. The combination of the two prophylaxis has not been investigated yet.

Aim of this prospective randomized trial is to investigate the effect of hydration with sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all patients receive.


Eligibility Criteria:
Inclusion Criteria:

Increased risk for contrast induced nephropathy defined as:

* Serum creatinine level ≥ 1.1 mg/dl OR
* Serum creatinine level ≥ 0.8 mg/dl plus an additional risk factor like diabetes mellitus, renal failure in past medical history or nephrotoxic medication (aminoglycoside, vancomycin, amphotericin B, diuretic)

Exclusion Criteria:

* pre-existing renal replacement therapy
* unstable serum creatinine levels (difference of more than ±0.4 mg/dl within 3 days before contrast application)
* contraindications for theophylline or sodium bicarbonate (allergies, tachycardia, alkalosis, hypokalemia)
* additional interventions that might influence renal function
Convergence Insufficiency Treatment Trial (CITT)

The purposes of the CITT are:

* To determine whether Home-based Pencil Push-up therapy, Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics or Office-based VT/Orthoptics more effective than placebo treatment, and whether there are differences between the three treatments in improving subject symptoms and signs.
* To evaluate whether improvements in outcome measures are still present after one year of observation.

Convergence insufficiency is a prevalent and distinct binocular vision disorder. Typical symptoms include double vision, eyestrain, headaches, and blurred vision while reading. It affects approximately 5% of children in the United States, and may have a serious impact on an individual's performance in school, choice of jobs, and quality of life.

There is no consensus regarding the most effective treatment for convergence insufficiency. Two commonly prescribed treatments are home-based pencil push-up therapy and office-based vision therapy/orthoptics. Significant differences exist between these two treatment modalities in cost and number of office visits required, with pencil push-up therapy being less expensive and less time intensive. There have been no well-designed studies that have compared the effectiveness of these two treatments.

The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked, placebo-controlled, multi-center clinical trial in which 208 subjects between the ages of 9 to \< 18 years will be randomly assigned to: 1) Home-based Pencil Push-Up Therapy, 2) Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics, 3) Office-based Vision Therapy/Orthoptics, or 4) Placebo Office-based Vision Therapy/Orthoptics. The primary outcome measure is a measure of symptoms using a 15-item survey, the CI Symptom Survey. Secondary outcome measures are two common clinical tests of the eyes' ability to converge when performing close work. Patients will be tested at the eligibility examination, and by masked examiners after 4, 8 and 12 weeks of treatment have been completed during the 12-week treatment phase. Long term follow-up will be assessed at 6 and 12 months after the completion of active treatment.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 9 and 17 years with symptomatic convergence insufficiency
* Exophoria at near at least 4Δ greater than at far
* Insufficient positive fusional convergence at near
* A receded near point of convergence of ≥6 cm break
* CI Symptom Survey score ≥16

Exclusion Criteria:

* Previous treatment with office-based vision therapy/orthoptics or pencil push-ups
* Systemic diseases known to affect accommodation, vergence and ocular motility
* Developmental disability, mental retardation, attention deficit hyperactivity disorder (ADHD), or learning disability diagnosis that in the investigator's discretion would interfere with treatment
Beliefs and Practice Intentions of Future Ob/Gyn Residents Regarding Reproductive Healthcare

The objective of this study is to ascertain factors shaping medical students' pre-residency intention to provide abortion through an in-depth qualitative investigation into the context and experiences that shape intention to provide.


Eligibility Criteria:
Inclusion Criteria:

* current 4th-year medical student
* US accredited medical school
* has applied to, but not yet been accepted into, obstetrics and gynecology residency programs

Exclusion Criteria:

* age less than 18 years
* former student reapplying to residency (e.g., not current 4th-year student)
* has not yet applied to residency
* has already been accepted to residency
Dalbavancin in Real Clinical Practice in Spain

The aim of this study is to describe the real clinical use of Dalbavancin in Spain between January 2018 and December 2019.

Dalbavancin is a new lipoglycopeptide approved for the treatment of ABSSSIs (Acute Bacterial Skin and Skin-Structure Infections) with activity against Gram-positive pathogens, including MRSA. Dalbavancin has unique pharmacokinetics properties, with a terminal half-life of 14.4 days, permitting a single intravenous dosing. Dalbavancin has shown a favourable efficacy and safety profile in patients with ABSSSI in randomized controlled trials. However, information regarding daily clinical practice is limited. The main objective of this study is to describe the real clinical practice with Dalbavancin in Spain.

Eligibility Criteria:
Inclusion Criteria:

1. Adult man and woman (≥ 18 years) at the time of receiving dalbavancin
2. Patients receiving at least one dose of dalbavancin between 1st January 2018 and 31st December 2019
3. Patients with medical follow-up information registered in clinical records for about 90 days after completing the treatment
4. Written informed consent requested according to local regulation, IEC and protocol requirements

Exclusion Criteria:

1. Patient enrolled in a clinical trial in which treatment with dalbavancin is managed through a protocol
Preliminary Study on the Diagnostic Value Comparison of 18F-FAPI-04 PET/CT and PET/MR in Gastric Cancer

This project aims to comprehensively analyze the diagnostic efficacy of SUVmax, SUVean, TLG, MTV, etc. in gastric cancer through 18F-FAPI-04 PET/CT imaging combined with serum tumor markers and other methods, and construct a molecular imaging diagnostic model for gastric cancer; Next, analyze the diagnostic efficacy of 18F-FAPI-04 PET/CT and PET/MR multimodal imaging in evaluating SUVmax, PET/CT-PCI, and PET/MR-PCI for gastric cancer peritoneal metastasis, and construct a molecular imaging diagnostic model for gastric cancer peritoneal metastasis; Exploring the clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years old;
2. Diagnosed as a patient with gastric cancer;
3. Receive FAPI PET/CT and FDG PET/CT imaging within one week;
4. Perform serum tumor marker testing one week before and after scanning

Exclusion Criteria:

1. History of other malignant tumors;
2. Patients with severe infections, severe underlying diseases such as heart, kidney, and liver;
3. Patients with contraindications for PET-CT examination, poor physical condition, and inability to tolerate the examination;
4. Patients with unorganized pathology or incomplete clinical data
Increasing Vegetable Intake in Children

The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).

The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).The primary endpoint will be changes in V consumption in high school children with the hypothesis that a puppet intervention will increase their V consumption by preschool children. To achieve the project goal, our specific aims (SA) are to: SA1: Successfully recruit 6 preschool (PS) centers and 168 AA and 168 HA children 3 to 5 y enrolled there. SA2: Conduct individual interviews for formative assessment of the PUPPET shows. SA3: Develop the manual of operation and intervention protocols SA4: Develop 4 videotaped theatre-based PUPPET shows that are developmentally and cognitively appropriate for use with 3- to 5-year-old AA and HA children SA5: Pilot-test the feasibility of the PUPPET intervention with 3 intervention and 3 control HS centers. SA6: Use the data collected in Aim 5 to estimate parameters required to conduct a group randomized trial for an evaluation of the efficacy of the intervention. The primary hypothesis (H1) to be tested is that children who receive the PUPPET intervention will demonstrate increased V consumption in HS compared to children in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* non-patient
* normals
* African-american
* Hispanic-american
* 3 to 5 y olds

Exclusion Criteria:

* pregnant woman
* neonates
* dietary restrictions
* chronic disease
* developmental disabilities
* special education
* does not read or write in spanish or english
Protocol to Obtain Blood Samples for Leukemia Research

The purpose of this study is to collect a blood sample in patients with Chronic Lymphocytic Leukemia (CLL).

The blood sample will be used in the laboratory to perform studies focusing on Chronic Lymphocytic Leukemia (CLL).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing routine blood draws as part of their ongoing follow-up for Chronic Lymphocytic Leukemia (CLL) at the Norris Cotton Cancer Center of DHMC.

Exclusion Criteria:

* Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for CLL or other disease process within the past 6 months are excluded. Use of intravenous immunoglobulin (IVIg) is not a reason for exclusion.