cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia

This study is a first-in-human, randomized, placebo-controlled, 4-Part, single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy adult subjects and adult subjects with Classic Galactosemia.

The study is designed to assess the safety and PK of AT-007 in healthy subjects and subjects with Classic Galactosemia as well as the effect of AT-007 on biomarkers of galactose metabolism (galactose, galactitol, and other galactose metabolites) in subjects with Classic Galactosemia.

This study consists of 4 parts:

* Part A (SAD) in 32 healthy subjects. Once daily oral escalating dose (6 active, 2 placebo).
* Part B and C (MAD for 7 days) in 36 healthy subjects. Once daily multiple daily dosing (8 active, 2 placebo per each dose cohort).
* Part D (SAD followed by MAD for 27 days) in 18 subjects with Classic Galactosemia. Once daily followed by multiple daily oral dosing (6 active, 2 placebo for each dose cohort).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Classic Galactosemia confirmed by evidence of absent or significantly decreased (\<1%) GALT activity in red blood cells and by GALT gene analysis
* Urine galactitol \>100 mmol/mol creatinine
* Galactose-restricted diet

Exclusion Criteria:

* Complications of CG resulting in disability that, in the opinion of the Investigator, may prevent the subject from completing all study requirements (e.g., severe neurological deficits, severe cognitive impairment, or severe language difficulty).
* Renal disease (eGFR \< 90 mL/min/1.73 m2 or albuminuria).
Palliative Lattice Stereotactic Body Radiotherapy (SBRT)

Standard palliative radiotherapy regimens may provide limited durability of response in large tumors. Thus, there is a clinical need for a new approach. The Lattice SBRT approach will deliver 20 Gy in 5 fractions with partial volume simultaneous integrated boosts to 66.7 Gy. This is hypothesized to improve symptom response, local control, and better prime the tumor microenvironment for immune response compared with standard palliative radiotherapy doses. It is also hypothesized that this will be associated with less toxicity than the traditional homogenous SBRT plan delivered to a large tumor. Blood will be collected before and after Lattice SBRT for evaluation of the peripheral blood immune microenvironment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed cancer.
* Planning to undergo palliative radiotherapy to a lesion ≥ 4.5 cm as measured with radiographic imaging or with calipers by clinical exam.
* ECOG performance status ≤ 2
* At least 18 years of age.
* Radiotherapy is known to be teratogenic. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Prior radiotherapy that overlaps with any planned site of protocol radiotherapy.
* Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture.
* Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the Lattice SBRT administration.

  \*Cytotoxic chemotherapy and VEGF inhibitors prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist. This includes continuing a treatment plan which was initiated prior to the start of radiotherapy. A 2 week washout is recommended, but not required.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry.
* Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).
Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial

This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.

This study is an international multicentre RCT to compare the csPCa detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion. This is a phase III randomised controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-USG fusion approach (MRUS arm) versus Cognitive-guided approach (COG arm). The study hypothesis is that MRUS arm is superior to COG arm in detecting csPCa. The result of this RCT would impact how MRI-guided prostate biopsies should be done in the future. If the MRI-USG fusion approach is superior to cognitive-guidance in csPCa detection, it should be the standard of practice in the future, and dedicated MRI-USG fusion equipment should be available in centres performing prostate biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Men ≥18 years of age
* Clinical suspicion of prostate cancer and indicated for prostate biopsy
* Serum Prostate-specific antigen (PSA) \< 20 ng/mL
* Digital rectal examination ≤ cT2 (organ-confined cancer)
* Able to provide written informed consent
* MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5

Exclusion Criteria:

* Prior prostate biopsy in the 2 years before screening visit
* Prior diagnosis of prostate cancer
* Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
* Patient refusal for biopsy
Orthopilot Elite Post-Market Clinical Follow-Up

Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty

The study is designed as a prospective, non-interventional, multicenter, comparative cohort study. The product under investigation will be used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).

The study design is based on a two-arms design. The patients for the both groups will be recruited consecutively, starting with group A. The study will prove the equivalence of the groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis) and any deviation \>3° from neutral alignment is defined as an outlier.

Eligibility Criteria:
Inclusion: Inclusion Criteria:

* Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot® navigation system and a corresponding primary implant
* Dated and signed informed consent

Exclusion: Exclusion Criteria

* Pregnancy
* Patients \< 18 years
* Patients unable to participate at the follow-up examination (physically, mentally)
* Previous joint replacement at the indexed knee
Study of the Effect of a Calcium-rich Diet on Bone Health in Girls

The aim of this experimental study was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in adolescent females. The hypothesis to be tested is: adolescent females who consume a high calcium diet will have a greater increase in bone quality, as measured by densitometry and ultrasound, than adolescent females who consume their usual dietary calcium intake.


Eligibility Criteria:
Inclusion Criteria:

- Inclusion criteria were being female and nine years of age with usual dietary calcium intake 1100 mg/day or less.

Exclusion Criteria:

* Exclusion criteria included history of any of the following: lactose intolerance, milk allergy, corticosteroid or anticonvulsant therapy, familial hypercholesterolemia, mental or physical handicaps, cancer, rheumatoid arthritis, asthma, or any significant health problem reported by the parents. We also excluded any child who had a body mass index (BMI)85th percentile for age and gender and children who practiced or played any organized sport (including gymnastics or dance) more than three times per week.
Immune Checkpoint Inhibitors (ICIs) Retreatment in Second-line Treatment of Advanced Gastric Cancer: a Retrospective, Real-world Study

This is a single-center, retrospective, observational, real-world study. We collected general and clinical data of patients with advanced gastric cancer who were admitted to the First Affiliated Hospital of Zhengzhou University from January 2018 to July 2024.

All patients received combination therapy with ICIs inhibitors for at least 2 cycles in the first-line and at least 2 cycles of ICI inhibitor-based therapy in the second-line after first-line progression. The efficacy and safety of treatment were evaluated, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), Pattern of immune progression after cross-line therapy, grade 3-5 treatment-related adverse events (TRAEs), and immune-related adverse events (irAEs). Cox regression model was used to investigate the influence of multiple factors on survival.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic or advanced GC/GEJC;
* Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting;
* Receiving at least 2 cycles of ICI-based second-line therapy;
* ECOG PS 0 or 1;
* Radiographic response was also assessed during treatment and survival.

Exclusion Criteria:

* patients had other malignancies within the past 5 years;
* lack of survival and clinical efficacy data;
* combined radiotherapy regimens in the second-line treatment.
Treatment of Parental Anxiety Virtual Reality (VR)

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-99 (Patient's parents will be enrolled)
* Able to consent

Exclusion Criteria:

* People who do not consent
* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Current Nausea
* Seizures
* Visual Problems Patients whose children are clinically unstable or require urgent/emergent intervention
Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease

During the Study:

* Subject is required to visit every week for the first 2 months and then every month till completion of study or as and when required
* The usual symptomatic and supportive treatment of Chronic Liver Disease, including use of antiviral, will be given to all patients.
* Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular Treatment.
* Liver function tests (LFT) will be done weekly during first 2 months then at one month interval or as when required.
* The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9. Patients not improving at 4 weeks after initiation of treatment will be shifted to alternative regimens and will be excluded from the study.


Eligibility Criteria:
Inclusion Criteria:

* Males or Females subjects aged 18-75 years.
* Subjects with chronic liver disease (cirrhosis)
* Pulmonary or extra-pulmonary tuberculosis.
* Serum ALT≤5times upper limit and serum bilirubin ≤3 mg/dl.
* consent and willingness to follow-up

Exclusion Criteria:

* Serum ALT\>5times upper limit and serum bilirubin \>3 mg/dl.
* Renal failure (serum creatinine\>2mg/dl).
* Presence of hepatocellular carcinoma
* Alcoholic cirrhotic who continue to drink alcohol.
* Prior history of ATT (ANTI TUBERCULAR TREATMENT) with documented hepatotoxicity.
* Known hypersensitivity to levofloxacin, other quinolones
Pethidine Analgesia and Neonatal Hearing Screening Test

Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity in newborn hearing screening increases cost and maternal anxiety and anxiety. There is still widespread concern about the use of opoid analgesics to relieve pain during labor. The aim of this study was to determine the effects of pethidine administered during labor on neonatal hearing screening test false positivity rates.

The study group consisted of patients receiving 50 mg intramuscular (I.M) pethidine at the beginning of the active phase of labor and the control group consisted of patients not receiving pethidine. Newborns were evaluated by otoacoustic emission (OAE) test. The OAE test was performed before the patients were discharged. Perinatal and neonatal variables and test results were recorded and the relationship between false positivity and pethidine use was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* term singleton pregnancy,
* Gave birth at 37-41 weeks of gestation,
* without chronic internal disease,
* Pregnant women were included in the study.

Exclusion Criteria:

* Newborn hospitalized in intensive care,
* congenital / chromosomal anomaly,
* congenital CMV infection,
* facial / ear deformities,
* family with hearing problems,
* those with hyperbilirunemia,
* tested at \<12 hours after birth,
* maternal infection,
* Diabetes mellitus, recurrent abortion,
* smoking,
* plesanta previa,
* prolonged premature rupture of the membrane (more than 12 hours), epidural -analgesia and
* newborns who were at risk of asphyxia hypoxia were excluded from the study.
Ovarian Cyst's Enucleation Spillage Score

Cystic enucleation is one of the most common conservative surgeries in gynecology; it is commonly performed by a minimally invasive approach such as laparoscopy. A high percentage of these surgeries (6-88 % of cases) are complicated by the cystic rupture with intra-abdominal spillage of its contents (spillage). This occurrence affects the surgical and prognostic outcome by lengthening the time of surgery, increasing the risk of postoperative infection or granulomatous peritonitis, of possible second manifestation of the pathology (example: endometriosis), and in the case of neoformation of a carcinomatous nature by leading to an increase in the stage of disease, exposing patients to a prognostic disadvantage and the need for adjuvant treatments also avoidable. In addition, the previous spillage may be associated with the adherent syndrome with repercussions on patients' morbidity and fertility. For these reasons, it is crucial to optimize the selection of patients who are candidates for cystic enucleation.

The present study aims to evaluate a series of ultrasound, medical history, and surgical-preoperative parameters to develop a predictive score for the risk of spillage during laparoscopic surgery. Prospective Observational Study. The study aims to enroll 156 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Patients undergoing laparoscopic cystic enucleation
* Patients who underwent pelvic ultrasound examination within 30 days prior to surgery
* Patients who signed informed consent for the study
* ECOG performance status \< 2

Exclusion Criteria:

* Pregnancy status
* Patients with cardiological, neurological, or metabolic disorders not treated pharmacologically
* ASA III
* Patients undergoing laparotomy conversion prior to enucleation
Somatosensory Processing in Depression

Aim of this study is to investigate neuronal differences (EEG/evoked potentials; functional MRI) between patients with major depression and healthy controls concerning brain activity after acute pain as well as changes of pain related brain activity during treatment with escitalopram.


Eligibility Criteria:
Inclusion Criteria:

* Psychiatric in or outpatients with acute depressive episode
* Indication for pharmacological treatment

Exclusion Criteria:

* Acute suicidal tendency
* Neurological or severe somatic disorders
* Women during pregnancy or lactation
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic

Biorepository of blood and or tissue samples from patients presenting with cardiac arrhythmia syndromes.

The long-term objective of this research is to find genes and biologic pathways causing arrhythmia syndromes and other diseases or conditions. In order to achieve this objective the investigators will collect comprehensive phenotypic data and corresponding blood and/or tissue samples into a biorepository registry of patients, presenting for cardiac arrhythmia evaluation and/or treatment, and control subjects without arrhythmias. This biorepository will be composed of two parts: 1) An Arrhythmia Biorepository of blood and tissue from patients undergoing arrhythmia procedures, cardiac surgery, or inpatient or outpatient evaluations for arrhythmias, and 2) A Collaborative Sample Biorepository for de-identified samples and data from outside institutions and clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years old
* Subjects with a history of or current cardiac arrhythmia, family members of subjects with cardiac arrhythmias, or no cardiac arrhythmia if a Control Subject.

Exclusion Criteria:

* Subjects previously enrolled in the Arrhythmia BioBank
Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer

This is a randomized phase II multicenter controlled study of oxaliplatin, calcium folinate, and 5-fluorouracil (mFOLFOX7) as neoadjuvant chemotherapy for resectable advanced gastric cancer.

Hypothesis: Neoadjuvant chemotherapy may improve 5 year overall survival compared with the control.

The study hypothesis is that the 5 year survival rate will reach 35% from 25% when neoadjuvant chemotherapy is carried out. With the alpha value to be 0.05 and beta value to be 0.80 as well as 10 percent of patients' lost-of-followup, the sample size will be 263.

Eligibility Criteria:
Inclusion Criteria:

* ECOG score 0-2
* Ambulatory males or females, aged 30-70 years.
* Histologically confirmed gastric adenocarcinoma, staged preoperatively AJCC/UICC stage III(T3N1,T2N2,T4N0,T3N2)and IVM0 and operable
* Life expectancy more than 3 months
* Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
* Normal hepatic, renal, and bone marrow function (GPT\<2 fold of upper limit value; WBC\>4000/dl, Tbil\<1.5mg/dl, Cr\<1.5 fold of upper limit value)

Exclusion Criteria:

* Patients can not bear surgical procedure.
* Pregnant or lactating women or women do not agree conceptive procedures.
* Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
* History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
* Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
* Organ allografts requiring immunosuppressive therapy.
* Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
* Moderate or severe renal impairment: serum creatinine \> 1.5 x upper limit of normal (ULN).
* Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
* Hypersensitivity to platinum compounds or any of the components of the study medications.
* Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
* Unwilling or unable to comply with the protocol for the duration of the study.
Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients

To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative delirium in liver transplant patients in the ICU.

Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.

Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18years old or older) undergoing living-donor or deceased-donor liver transplantation

Exclusion Criteria:

* Pediatric patients (under 18 years) Pregnancy Patients who are unresponsive at baseline, who have neurologic deficits at baseline, or who are allergic to dexmedetomidine
Vasopressor Prophylaxis After Spinal Anesthesia

Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during cesarean delivery.

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.

Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).

Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.

In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against PSH during CD.

Eligibility Criteria:
Inclusion Criteria:

* full term singleton pregnant women
* Scheduled for elective Cesarean Delivery
* Aged between 18 and 40 years

Exclusion Criteria:

* Cardiac morbidities
* Hypertensive disorders of pregnancy,
* Peripartum bleeding
* Baseline systolic blood pressure (SBP) \< 100 mmHg
* Body mass index \> 35