cyrilzakka/clinical-trials huggingface dataset:
Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain

To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.


Eligibility Criteria:
Inclusion Criteria:

* Patients with first acute ankle sprain episode in the last six months classified as grade I or II, confirmed by X-rays, according to the following definitions:
* Grade I: When the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior draw test is negative.
* Grade II: Moderate sprains which usually result in partial tears af the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. Ligamentous laxity may be present and there is moderate swelling.

Exclusion Criteria:

* Patients who have a similar injury of the same joint within the last six months; or
* clinical evidence of complete rupture of ankle ligaments (third degree sprain), or
* requirements for bed rest, hospitalization, surgical intervention for the ankle injury; or
* evidence of fractures; or non-removable full cast of any tipe; or
* presence of bilateral occurrence of ankle injury or ipsilateral ankle and knee injury.
Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED

Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Adult, heterosexual, males between 22 and 85 years of age
* Subjects diagnosed with organic ED for at least 3 months, according to the American Urology Association (AUA) Guideline Statement 1 (as described in Section 8.1.1 of the study protocol).
* Subjects with an IIEF-EF score between 11-21
* Steady relationship for at least 3 months
* Subject is sexually active, with at least weekly sexual intercourse attempts or 6 times a month
* Subject is willing to sign informed consent and follow study protocol procedures
* Subject has a smartphone

Exclusion Criteria:

* Castrate and late onset hypogonadism
* History of Priapism or Peyronie's Disease
* Surgery or radiotherapy of the pelvic region
* Anatomic penile deformations or penile prosthesis
* Treatment with antiandrogens
* Previous whole gland treatment of the prostate (Cryoablation, HIFU, external beam radiation of seed implantation, Radical prostatectomy any approach, etc.)
* History of urothelial or colorectal cancer
* Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury, pelvic neuropathy
* Evidence of neurogenic bladder or an indwelling Foley catheter or clean intermittent catheterization (CIC) within 30 days
* Subjects who are taking anticoagulation or anti-platelet therapy
* History of psychiatric disorders, premature ejaculation and drug or alcohol abuse
* Subjects who are incarcerated
* Subjects who are cognitively challenged
* Serious heart or lung disease
* Pregnant partner
Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)

The purposes of this study are:

1. To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and HVL
2. To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at week 12

The aims of the present study are:

1. To evaluate the efficacy and safety of 36-week versus 48-week regimen of PEGASYS® (peginterferon alfa-2a, PegIFN) plus standard-dose of ribavirin (RBV) in hepatitis C virus (HCV) genotype 1 infected, treatment-naïve CHC patients who have high viral loads (HVL, defined as baseline HCV RNA ≧ 400,000 IU/mL) and achieve a rapid virologic response (RVR) (defined as seronegativity of HCV RNA at week 4 of treatment)
2. To evaluate the efficacy and safety of 48-week versus 72-week regimen of PegIFN plus standard-dose of RBV in HCV virus genotype 1 infected, treatment-naïve CHC patients with PCR-seropositive of HCV RNA at week 12

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients \*18 years of age
* Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
* Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
* Detectable serum HCV-RNA and HCV viral genotype 1
* Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
* Compensated liver disease (Child-Pugh Grade A clinical classification)
* Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
* All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end

Exclusion Criteria:

* Women with ongoing pregnancy or breast feeding
* Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \*6 months prior to the first dose of study drug
* Any investigational drug \*6 weeks prior to the first dose of study drug
* Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
* History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* Signs or symptoms of hepatocellular carcinoma
* History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
* Neutrophil count \<1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening
Indocyanine Clearance Rate and Septic Liver Injury

Liver injury is a complication of sepsis and septic liver injury has adverse impact upon the outcome. As a measurement for liver function, Plasma clearance rate of indocyanine green (PDR-ICG) always decreased during the early phase of sepsis. So the investigators hypotheses include: PDR-ICG is lower in sepsis patients than non-septic patients in ICU; PDR-ICG may be lower in abdominal sepsis patients than non-abdominal sepsis patients in ICU; PDR-ICG correlates with abdominal perfusion pressure; change of PDR-ICG in early phase correlates with change of transaminase or bilirubin in late phase of sepsis.

Liver injury is a complication of sepsis and septic liver injury has adverse impact upon the outcome. However, changes of transaminase or bilirubin are always not significant during the early phase of sepsis. As another sort of measurement of liver function, plasma clearance rate of indocyanine green (PDR-ICG) always decreased during the early phase of sepsis. So the investigators hypotheses include: PDR-ICG may be lower in sepsis patients than non-septic patients in ICU; PDR-ICG may be lower in abdominal sepsis patients than non-abdominal sepsis patients in ICU; PDR-ICG correlates with abdominal perfusion pressure; change of PDR-ICG in early phase may correlate with change of transaminase or bilirubin in late phase of sepsis. Through this study we also plan to calculate the range of abdominal perfusion pressure that can maintain normal PDR-ICG and the range of PDR-ICG that can maintain normal transaminase or bilirubin level in sepsis patients.

Eligibility Criteria:
Inclusion Criteria:

* For control group: the patient does not match the diagnosis criteria of sepsis before the operation; the operation was done in peritoneal cavity; the patient is transferred to SICU directly from surgical room or recovery room; the patient is anticipated to stay in SICU for more than 48 hours.
* For study group: the patient matches the diagnosis criteria of sepsis; the patient is anticipated to stay in SICU for more than 48 hours.

Exclusion Criteria:

* Pregnancy
* Age \< 18 years
* The infection is purely caused by virus
* Obstruction of biliary tract, or acute cholangitis, or acute liver abscess, or active hepatitis, or hyperacute/acute liver rejection occurs during study period
* Hemorrhagic shock occurs during study period
* Asthma occurs during study period
* Acute coronary syndrome occurs during study period
* Continuing peripheral circulation dysfunction leads to refractory "low quality" during PDR-ICG measurement
* Comorbidity of the bladder leads to impossibility to measure intra-abdominal pressure
JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS G12C mutation.

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 monotherapy to determine the MTD and PR2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 administered alone and combination with cetuximab during Dose Expansion phase in adult participants with advanced solid tumors harboring KRAS G12C mutation.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to provide an archived tumor sample
* Histologically or cytologically confirmed solid tumors with KRAS G12C mutation
* Must have received at least 1 prior standard therapy
* Must have at least 1 measurable lesion per RECIST v1.1
* Must have adequate organ function
* Must be able to swallow and retain orally administered medication

Exclusion Criteria:

* Has brain or spinal metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
* Active infection requiring systemic treatment within 7 days
* Active HBV or HCV
* Any severe and/or uncontrolled medical conditions
* LVEF ≤50% assessed by ECHO or QTcF
* QT interval \>470 msec
* Experiencing unresolved CTCAE 5.0 Grade \>1 toxicities
Treatment of Diffuse Large B Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

- Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \> 3 months Histological confirmed Diffuse large B cell lymphoma(III/IV) None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative Patients could be followed up None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

Exclusion Criteria:

* Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of CNS metastasis History of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigation
Sticky Bone Compared to A-PRF(Platlet Rich Fibrin) Effect on Alveolar Ridge Preservation

In this research investigators are going to detect the effect of using different type of materials(sticky bone\\platlet rich fibrin ) compared to normal healing on the dimensional changes of alveolar crest after single rooted tooth extraction by using CBCT (cone-beam computed tomography) at time of extraction and after 16-24 weeks

Patients who are treated and referred for having extractions in the upper and lower arch for single rooted teeth will have CBCT for each patient at time of extraction (T0) and after 3 months (T1) , by using the cross sectional of the CBCT investigators will measure the difference from the middle of the socket to buccal and palatal\\lingual walls at 3 different points below the crest 1mm, 3mm , 5mm .

* the thickness of the buccal bone at baseline (T0) at 1, 3 and 5 mm below the crest
* the horizontal ridge width at crest- 1 mm (HW- 1 mm), crest- 3 mm (HW- 3 mm) and crest- 5 mm (HW- 5 mm) at the buccal/palatal side, in millimetres and later transformed to percentages
* the vertical resorption on both buccal and palatal side, in millimetres
* the socket fill defined as the highest point of viewable mineralized bone at the middle of the socket; absolute values (in mm) and percentages were calculated by comparing the initial depth of the socket and the depth after three months of healing preparation of the materials to be augmented : autologous fibrin glue mixed with bone graft(sticky bone) would be prepared by using green tubes by choukroun company centrifuged at 1300 rpm for 14 minutes (using DUE centrifuge) then mixed with 0.5 cc FDBA and the exudate of the compressed A-PRF then applied to the extraction site A-PRF PLUGS will be prepared using red tubes using venous blood centrifuged at 1300 rpm for 14 min , then the compressed using special tray and applied in the extraction sockets

Eligibility Criteria:
Inclusion Criteria:

* presence of the buccal and palatal/lingual bony walls evaluated clinically by measuring the thickness of the alveolar ridge and radiologically by a CBCT , and residual periodontal attachment of at least 6 mm of single rooted tooth

Exclusion Criteria:

* complicated tooth extraction, and any medical problem that could interfere with the mucosal and bony healing processes or contraindicating an implant placement, such as anticoagulation, antiaggregatory medication, radiotherapy, bisphosphonate therapy, diabetes, endocarditis risk factors, immunosuppression, and renal or hepatic failure
Microarray Application in Newborns With Multiple Congenital Anomalies

Objective:

Congenital anomalies are defined as abnormalities of body structure or function that are present at birth and have developed prenatally. Microarray is considered the first-tier diagnostic test for patients with multiple congenital anomalies. The aim of this study is to determine the relationship between microarray results and the phenotype in newborns with multiple congenital anomalies, contribute to patient management by comparing with similar cases in the literature, detect previously unidentified Copy Number Variations (CNV), investigate the hereditary origin of the detected changes, and provide appropriate genetic counseling.

Method:

Between December 2022 and November 2023, newborns with multiple congenital anomalies requiring follow-up and treatment in the Neonatal Intensive Care Unit of Konya City Hospital were evaluated. Newborns with examination findings suggesting a recognizable numerical chromosome anomaly or a history of teratogenicity were excluded from the study. Newborns with two major or one major and two minor, or three or more minor congenital anomalies were included. Microarray studies were performed on patients who met the inclusion criteria. CNVs identified were examined in relevant databases, and pathogenicity was assessed. Detected alterations were compared with the clinical findings in the patient database.

Eligibility Criteria:
Inclusion Criteria:

* Newborns with two major or one major and two minor, or three or more minor congenital anomalies were included

Exclusion Criteria:

* Newborns with examination findings suggesting a recognizable numerical chromosome anomaly
* History of teratogenicity
CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

This study is to investigate the therapeutic efficacy and side effect of chidamide, decitabine combined with priming IAG regimen for relapsed or refractroy acute myeloid leukemia


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory acute myeloid leukemia patients without severe complications such as active infections and bleedings; ECOG score less than 3.

Exclusion Criteria:

* Inablity to tolerate inducton chemotherapy; life expectancy less than 1 month
Preterm Immune System Development and Response to Immunization

In this study the response to vaccination and development of the immune system in very preterm infants upon the current vaccination schedule will be compared to healthy term infants.

Preterm infants are at increased risk of developing infections early in life due to a less mature immune system compared to full-term infants. Moreover, protection by the placental transfer of maternal antibodies in general and specifically against vaccine antigens has shown to be significantly lower in very preterm infants (gestational age (GA)\< 32 weeks) compared to term infants. In this study we aim to investigate the immune system development of very preterm infants. Adequate immune response to vaccination is considered both clinically important as well as a functional test of the immune system. However, data on the antibody and Ag-specific memory B cell response to vaccination in preterm infants are limited.

Primary objective is to study the antibody immune response to routine vaccinations in very preterm infants (GA\<32 weeks). Secondary aim is to study the immune system more extensively using flow cytometry, ELISA and single cell transcriptomics to measure development of Ag-specific memory B cells raised in response to vaccination, and by using proteomics, epigenetics, and microbiome studies.

Eligibility Criteria:
To be eligible to participate in this study, a preterm infant must meet all following criteria:

* Preterm infant born at gestational age less than 32 weeks (whose mothers did or did not receive a T dap vaccination during pregnancy)
* Parents/ guardians must have sufficient understanding of the Dutch language

To be eligible to participate in this study, a healthy full-term infant must meet all following criteria:

* healthy full-term infant whose mother received a Tdap vaccination during pregnancy
* Parents/ guardians must have sufficient understanding of the Dutch language

To be eligible to participate in this study, a mother must meet all following criteria:

- Mother of preterm or health full-term infant who are participating in the study

Exclusion Criteria:

* Parents/guardians of the infant are not able or willing to provide informed consent
* Infant with congenital anomaly which are more likely to cause adverse effects after immunization (for example hemodynamically significant congenital heart defect)
* Infant with a (possible) HIV infection or immunodeficiency
* Maternal use of immunosuppressive drugs during pregnancy
Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)

The purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who started suppressive therapy for recurrent genital herpes for the first time

Exclusion Criteria:

* Subjects with a history of hypersensitivity to the ingredients of VALTREX or aciclovir
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy

The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the development of chronic allograft nephropathy and changes in allograft function in prevalent renal transplant recipients


Eligibility Criteria:
Inclusion Criteria:

* prevalent renal transplant recipients 2 years after transplantation
* no history of acute rejection
* stable renal function

Exclusion Criteria:

* history of biopsy-proven chronic allograft nephropathy
* history of biopsy-proven CNI nephrotoxicity
* history of biopsy-proven or clinical acute rejection
* unstable trough level of CNI or extremely low level of CNI
* bleeding tendency(+)
* pregnancy or pregnant-willing
* anticoagulation(+)
* antiplatelet agent (+)
* significant comorbidity(+): Acute coronary syndrome, pneumonia
Longitudinal Interaction Between APOA5 -1131T>C and Overweight Accelerates Arterial Stiffness

The aim of this study is to evaluate whether the longitudinal interaction between APOA5 -1131C variants and overweight could accelerate age-related increases in arterial stiffness and circulating triglycerides in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Nondiabetic (fasting serum glucose concentration \< 126 mg/dL)
* Nonobese (BMI ≥ 25 kg/m2)

Exclusion Criteria:

* Current and/or past history of cardiovascular disease
* Diabetes mellitus (fasting glucose levels ≥126 mg/dL)
* Abnormal liver or renal function
* Thyroid or pituitary disease
* Pregnancy or lactation
* Regular use of any medication
Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty

PaRIS-IOR is a prospective observational study that aims to collect and analyze functional outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR).

PaRIS-IOR is a prospective observational study that aims to collect and analyze functional outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR). IOR was selected as a pilot center for the launch of the OECD's PaRIS Initiative in Italy, whose purpose is to accelerate the adoption and reporting of validated, standardised, internationally-comparable patient-reported indicators, particularly within patient registries.

PaRIS-IOR's study population will consist of consecutive patients undergoing hip, knee and shoulder arthroplasty performed at 6 Operative Units of the IOR. The study will last 30 months and will include a 12-month recruitment period, a 12-month follow-up and 6 months for data analysis and reporting. Functional outcomes and quality of life will be detected through the administration of validated questionnaires (EQ-5D, HOOS, KOOS, ASES). The questionnaires will be administered in the month preceding the surgical procedure in the clinic or in the ward, while the 2 follow-up questionnaires will be send by mail at patients' home. The collected data will be combined with those routinely collected by the Registry of Orthopedic Prosthetic Implantology (RIPO), already active at the IOR since year 1990.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 18-95 years
2. Be on the list for an elective primary arthroplasty of hip, knee or shoulder
3. Availability to sign the informed consent

Exclusion Criteria:

1. Severe cognitive impairment
2. To be listed for arthroplasty for musculoskeletal cancer
3. Not eligible for the surgical intervention