cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions

The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under non-fasting (fed) conditions.

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Laboratories, Ltd. and Novartis (Lotrel®) 10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules in Healthy Adult Male Volunteers under non-fasting (fed) Conditions

Eligibility Criteria:
Inclusion Criteria:

- Healthy adult male volunteers of 18-55 years of age;

* Weighing at least 60 kg within 15% of their ideal weights (Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company 1983)
* Medically healthy subjects with clinically normal laboratory profiles and ECGs;
* Voluntarily consent to participate in the study.

Exclusion Criteria:

- History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

* History or presence of:

  * alcoholism or drug abuse within the past year;
  * hypersensitivity or idiosyncratic reaction to amlodipine or other calcium channel blockers;
  * hypersensitivity or idiosyncratic reaction to benazepril HCl, benazeprilat or other ACE inhibitors.
  * angioedema or anaphylactic reaction to any substance;
* Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing.
* Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing.
* Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.
* Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
* Subjects who have vomited, who have experienced diarrhea or who have undergone vigorous and prolonged exercise (without drinking) within 24 hours prior to dosing.
* Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
* Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
* Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Virtual Reality in People With Persistent Postural-Perceptual Dizziness

This study aimed to compare the effectiveness of virtual reality (VR) and vestibular rehabilitation therapy (VRT) in enhancing balance in individuals with Persistent Postural-Perceptual Dizziness (PPPD). The experimental group received VR combined with VRT and optokinetic stimulation, while the control group received VRT and optokinetic stimulation. The study involved 42 individuals diagnosed with PPPD and administered ten intervention sessions over six weeks. The study also examined the impact of VR on various aspects of PPPD, including dizziness, visual vertigo, mental well-being, sleep quality, fall risk, and overall quality of life.

Persistent Postural-Perceptual Dizziness (PPPD) represents a relatively new vestibular diagnosis that has garnered recent attention within the medical community. Consequently, there exists a pressing demand for efficacious and innovative management strategies. The primary purpose of this study was to assess the comparative effectiveness of virtual reality (VR) versus vestibular rehabilitation therapy (VRT) in enhancing balance among individuals afflicted with PPPD. A secondary purpose encompassed an investigation of VR's impact on various dimensions of PPPD, including dizziness, visual vertigo, mental well-being, sleep quality, fall risk, and overall quality of life. Materials and Methods: A cohort comprising forty-two individuals conclusively diagnosed with PPPD was randomly assigned to two distinct groups. The experimental cohort comprised twenty-one participants subjected to a combination of VR with optokinetic stimulation alongside VRT, whereas the control group, also consisting of twenty-one individuals, underwent solely optokinetic stimulation paired with VRT. The intervention sessions were administered twice weekly over a span of six weeks, resulting in a total of ten intervention sessions. Additionally, baseline and post-intervention assessments were conducted to gauge the efficacy of the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of the PPPD from a specialized physician, based on the diagnostic criteria published by the Barany Society.
* Patients who scored more than 27 on the Niigata PPPD Questionnaire (NPQ)

Exclusion Criteria:

* If they suffered from other neurological or orthopedic deficits that affected their balance and prevented them from moving independently.
Can Capillary Refill Time Variation During Passive Leg Raising Predict Fluid Responsiveness

Fluid responsiveness in a context of circulatory failure can be assessed by different way. Microcirculatory evaluation to assess fluid responsiveness could be interesting, but the available device are expensive and the analysis are delayed. Capillary refill time (CRT) is hampered by its variability. The investigators have developed a method to standardize the pressure, the length of compression and a computerized analysis to calculate the capillary refill time. This method enables accurate measure of CRT.

The investigators will study if CRT variation induced by a passive leg raising (PLR) can predict CRT after a 500 ml Fluid Load.

About thirty patients in circulatory failure with a continuous cardiac output monitoring for whom, the attending physician has decided a fluid load, will be included. hemodynamic parameters (arterial pressure, venous pressure, cardiac output), metabolic parameters (arterial and venous blood gas and lactate), microcirculatory parameters (assessed by sublingual video-microscopy) and capillary refill time measured on the thorax and on the gingival area will be recorded. Data collection will be made before and after a passive leg raising and after a 500 ml fluid load of crystalloids.

Patients will be aposteriori sorted in two groups: responders and non responders, defined by the reduction of CRT after the fluid load. The diagnosis ability of the CRT variation after PLR to predict in which group each patient is classified will be investigate and receiver operative characteristic curve will be built. These results will be compared to the metabolic response, the macrocirculatory response, and the microcirculatory response.


Eligibility Criteria:
Inclusion Criteria:

* The patient is equipped with an arterial and a central venous catheter
* Capillary refill time is measurable.
* A cardiac output monitoring is available
* A 500 ml fluid load as been prescribed by the intensivist in charge.
* A circulatory failure is present defined as follow:

Patient treated with inotropic or vasoconstrictive drugs

OR

Patient presenting an hypotension defined by systolic arterial pressure less than 90 mmHg or mean arterial pressure less than 70 mmHg or a drop 40 mmHg in case of previous Hypertension.

WITH

tissue hypoperfusion defined by at least one of the following item:

* Lactate \> 1 mmol/L
* Capillary refill time \> 3 s
* Blotch
* Organ dysfunction due to the circulatory failure (oligo anuria, acute lung injury / acute respiratory distress syndrome, encephalopathy)

Exclusion Criteria:

* Pregnant woman
* Cardiogenic pulmonary edema
* Circulatory support : extracorporal life support / extracorporal membrane oxygenator, Thoratec, heart mate.
* Moribund patient
* Intra-abdominal hypertension
* Lower limb amputation
Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)

To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.

To determine the adverse event profile of prasugrel in patients with high platelet reactivity on clopidogrel after implantation of coronary drug-eluting stents.

To determine the effect of prasugrel on inhibition of platelet activation in patients with high platelet reactivity on clopidogrel.


Eligibility Criteria:
Key Inclusion Criteria:

* Have coronary artery disease and clinical indication for percutaneous coronary intervention (PCI) with implantation of at least one drug-eluting stent and where percutaneous coronary intervention of all treated lesions is successful.
* Have been given standard-of-care clopidogrel 600-mg loading dose between 24 hours before and at the time of PCI.
* Standard of Care Aspirin use prior to PCI - at least 250-mg \[intravenous (IV) or oral\] within 24 hours before PCI and at the time of PCI.
* VerifyNow P2Y12 reaction units \> 208 measured 2-7 hours after clopidogrel maintenance dose the day after successful PCI.

Exclusion Criteria:

* Non-ST segment elevation myocardial infarction within 14 days prior to randomization
* ST-segment elevation myocardial infarction within 14 days prior to randomization
* Have known major complications after percutaneous coronary intervention and prior to randomization
* Have a body weight \< 60 kilogram (kg)
* Have cardiogenic shock at time of randomization
* Have refractory ventricular arrhythmias
* Have New York Heart Association Class IV congestive heart failure
* Have received glycoprotein (GP) IIb/IIIa inhibitors eptifibatide or tirofiban within 24 hrs before or during percutaneous coronary intervention or abciximab within 10 days before or during percutaneous coronary intervention
* Are receiving daily treatment with nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require \> 2 weeks of daily treatment during the study
Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes

For children and adolescents with diabetes, the pathological process of atherosclerotic cardiovascular disease(ASCVD) can exist in early childhood and progress rapidly to subclinical ASCVD. This study intends to explore the models for the prediction of ASCVD risk in childhood and teen-age onset diabetes with different types.

Atherosclerotic cardiovascular disease (ASCVD) is the main cause of death in patients with diabetes. Currently recognized ASCVD risk assessment models are limited to adults with diabetes, but for children and adolescents with diabetes, the pathological process of ASCVD can exist in early childhood and progress rapidly to subclinical ASCVD.

To sum up, this study intends to evaluate the high risk rate of ASCVD calculated by the traditional QRISK3 model and its correlation with the occurrence of subclinical ASCVD events through long-term follow-up of the natural history of diabetes onset in children and adolescents, and to explore the models for the prediction of ASCVD risk in childhood and teen-age onset diabetes with different types. This study aims to help block the pathological process of ASCVD in early duration, thereby reducing the occurrence of ASCVD in childhood and teen-age onset diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of type 1 diabetes or type 2 diabetes
2. Age of onset: \<18y
3. Enrollment age: ≥18y
4. Gender: male or female
5. Diabetes duration ≥ 5 years

Exclusion Criteria:

1. Specific types of diabetes
2. Clinical diagnosis of diabetes is unknown, and it belongs to untyped diabetes
3. Pregnancy or lactation
4. Received glucocorticoids, immunosuppressants, non-glycemic biological agents, and cytotoxic drugs in the past 3 months; non-steroidal pain relievers or antibiotics used for more than 1 week continuously
5. Onset of acute complications of diabetes in the past 3 months
6. Major trauma and surgery history in the past 3 months
Effect of Midazolam Premedication on Mask Ventilation Difficulty

Mask ventilation has great importance during anesthesia induction because it is the only way to oxygenate patients who have lost consciousness and spontaneous breathing. Adequate muscle relaxation and depth of anesthesia may assist with mask ventilation. It is known that premedication to reduce anxiety has a relaxing effect on airway muscles. Midazolam is frequently used in premedication because it has a rapid onset of action and does not cause hemodynamic changes. In addition, midazolam may relax the airway by acting directly on the airway smooth muscle and thus facilitate mask ventilation during anesthesia induction. In this study, we will conduct a randomized controlled trial to evaluate the effect of midazolam premedication on facilitating mask ventilation in children.

American Society of Anesthesiologists (ASA) class I and II patients aged 2-10 years who are scheduled for any elective surgery under general anesthesia will be enrolled. Patients in midazolam group will be treated with midazolam premedication (3 cc mixture of 0.1 mg/kg midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously at waiting area 3 minutes before transportation to an operating room, while 3 cc normal saline will be administered to control group patients. Difficulty of mask ventilation during induction of general anesthesia will be evaluated with the Han Mask Scale. Muscle relaxants will be given for intubation after evaluation. The anxiety and sedation level of patients will be estimated one minute before the intervention and one minute before anesthetic induction in an operating room.

Interventıon descriptıon Patients enrolled in this study are randomly allocated to midazolam group or control group. Total 120 patients will be enrolled. Each group consists of 60 patients. Patients of midazolam group will be treated with midazolam premedication (3 cc mixture of 0.1 mg/kg midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously at waiting area 3 minutes before transportation to an operating room. Control group patients are treated with 3 cc normal saline at waiting area 3 minutes before transportation to an operating room. In anesthesia induction, propofol 2 mg/kg will be given. Before the patients were given muscle relaxants, the patients were evaluated with the Han's mask scale.

Eligibility Criteria:
Inclusion Criteria:

* age 2\< and \<10 children
* American Society of Anesthesiologists (ASA) class I and II
* Children who are scheduled for any elective surgery under general anesthesia

Exclusion Criteria:

* age \<2 or \>10 years;
* obesity (body mass index, ≥35 kg/m2);
* craniofacial anomaly;
* allergic reaction to midazolam;
* presence of muscle weakness or dyspnea.
* children posted for any emergency procedure,
* above ASA class II
* children with abnormal airway anatomy,
* children with active respiratory infection in the last 3 weeks,
* children with a past history of chronic respiratory disorder,
* children who are being treated with sedative or anticonvulsive agents
A Multiple Centre, Cohort Study of New CRRT Membranes oXiris for Patients With Septic Shock

The objectives of this study are to determine whether Continuous Renal Replacement Therapy (CRRT) with oXiris in patients with septic shock would improve clinical outcomes such as the sepsis-related organ failure assessment (SOFA) , hemodynamic, mortality compared CRRT with conventional membrane.

Sepsis is the leading cause of death in ICU, resulting in multi-organ failure in critically ill patients. Patients with septic shock combined sepsis-associated Acute kidney injury (AKI)have even poorer outcome.

Endotoxin activity, inflammation and immune dysfunction, have been consider relevant to their pathogenesis of sepsis. High levels of Inflammation are associated with worse clinical outcomes. However, all studies of anti-inflammation treatment in sepsis patient are failed and anti-inflammation treatment of sepsis still remains controversial.

oXiris is a new filter with adsorptive membrane, which removes endotoxin and inflammatory mediator from plasma. But current evidence of oXiris is limited, and only some small sample studies have proved that it can improve the haemodynamics and the sepsis-related organ failure assessment(SOFA) score.

Our hypothesis was that oXiris would be associated with better clinical outcomes, such as decreased SOFA score, improved survival rate, better hemodynamic, and improved of organ function.

Eligibility Criteria:
Inclusion Criteria:

* \>18 Years
* Treated by CRRT using oXiris or conventional membrane
* SOFA cardiovascular Score ≥ 3
* Septic shock due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection)
* Written informed consent

Exclusion Criteria:

* Chronic Kidney Disease
* Renal replacement therapy (RRT) in the last 30 days
* Pregnancy
* Immunosuppressive treatment or steroids (prednisone \> 0.5 mg/kg/day or equivalent).
* Autoimmune disorder.
* Transplant receptor.
* Inclusion in other ongoing studies within the last 30 days.
* Coexisting illness with a high probability of death
Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient

To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).


Eligibility Criteria:
Inclusion Criteria:

* Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis
* Male or female patient who is 16 years of age or older

Exclusion Criteria:

* Is a female patient who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control during the study and at least 6 months thereafter
* Has any history of hypersensitivity to the investigational medicinal product
* Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than Rheumatoid Arthritis (RA)
* Is unable to comprehend written labeling and training materials
A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors

This is a Phase 1 dose-escalation and expansion study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of SAIL66 in patients with CLDN6-positive locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at time of signing Informed Consent Form
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
* Patient must have tumor specimen available for central pathology review and confirmed as CLDN6-positive
* (For male patients) Agreement to stay abstinent or use contraceptive measures with female partners, and agreement to refrain from donating sprerm during the treatment and for 3 months after the final dose of obinutuzumab.

Exclusion Criteria:

* Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, or within 18 months after the last dose of obinutuzumab, whichever is longer
* Primary central nervous system (CNS) malignancy, symptomatic (seizures etc.) CNS metastases or CNS metastases required any anti-cancer treatment
* History or presence of CNS disease such as stroke (e.g., subarachnoid hemorrhage or cerebral infarction), epilepsy, CNS vasculitis, neurodegenerative disease, aphasia, dementia or paresis
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites
External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma

This is a Phase II study using a combination of external beam radiation with intratumoral injection of dendritic cells (white blood cells) as neo-adjuvant treatment for patients with high-risk soft tissue sarcoma. The purpose was to determine if an injection of the patient's own immune related white blood cells into their tumor would strengthen the immune system to fight against their cancer.

Patients were treated with external beam radiation therapy (EBRT) combined with experimental intratumoral injection of dendritic cell (DC). Patients received 5,040 centigray (cGy) EBRT in 28 equal fractions. Radiation was delivered 5 days per week (Monday-Friday). DCs (10\^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given several days before surgery to assess DC migration. Tumors were surgically resected 3-6 weeks after the completion of EBRT.

Eligibility Criteria:
Inclusion Criteria:

* Intermediate or high grade sarcoma as determined by pathology review
* Musculoskeletal tumor in extremities, trunk or chest wall.
* Primary tumor or isolated locally recurrent tumor greater than 5 cm in diameter.
* Clinical Stage T2N0M0 (AJCC 6th edition)
* Patient is not a candidate for neoadjuvant chemotherapy.
* Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1.
* No steroid therapy within 4 weeks of first dendritic cell administration.
* No coagulation disorder.
* Patient's written informed consent.
* No contraindication to resection.
* Adequate organ function (measured within a week of beginning treatment).

  * White blood count (WBC) \> 3,000/mm to the third power and absolute neutrophil count (ANC) \>1500/mm to the third power
  * Platelets \> 100,000/mm to the third power
  * Hematocrit \> 25%
  * Bilirubin \< 2.0 mg/dL
  * Creatinine \< 2.0 mg/dL, or creatinine clearance \> 60 mL/min
* Radiation Oncologist must confirm that a 2-3 cm strip of skin can be spared from radiation.

Exclusion Criteria:

* Retroperitoneal location.
* Gastrointestinal stromal tumor (GIST).
* Demonstrated metastatic disease.
* Prior radiation therapy if the current tumor is locally recurrent after prior resection.
* Concurrent treatment with any anticancer agent other than radiation as dictated by the protocol.
* Bleeding disorder.
* H.I.V. infection or other primary immunodeficiency disorder.
* Ongoing systemic therapy with immunosuppressant drugs (e.g. corticosteroids, azathioprine, cyclosporin, methotrexate).
* Any serious ongoing infection.
* Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (a pregnancy test will be obtained before treatment).
* ECOG performance status of 2, 3 or 4.