cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment, treatment and follow-up visits. Treatment period is 14 days.

The study sample consists of male and female subjects aged between 18 and 60 years-old, either with single or multiple Tinea Pedis lesion(s). Sixty (60) patients will be enrolled, but each foot with lesion(s) will be considered as one (1) sample. Therefore, if a patient has bilateral lesions, one foot will be allocated to investigational product (Dapaconazole) and the other foot will be allocated to active control (Ketoconazole). Randomization will determine which foot (right or left) will be treated with Dapaconazole or Ketoconazole.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged between 18 and 60 years-old;
* Presence of skin lesion(s) characteristic of Tinea Pedis, with diagnosis confirmed by direct mycological exam;
* Absence of previous antifungic treatment for the current lesion(s) under study;
* Absence of other significant diseases which, at physician's discretion, could have an impact on subject's participation in the trial, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate, physical examination and screening laboratory tests;
* Ability to understand the nature and objectives of the trial, including its risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.

Exclusion Criteria:

* Known hypersensitivity to ketoconazole or chemically related compounds; history of serious adverse reactions;
* Current evidence of clinically significant diseases which, at physician's discretion, prevent subject's participation in the trial and/or expose the subject to risks other than what is normally expected;
* Use of medications that, at principal investigator's discretion, might expose the subject to risks other than what is normally expected;
* Screening laboratory tests results showing clinically relevant deviations that, due to potential risks, prevent participation in the trial, at the researcher's discretion;
* Drugs addiction, including alcohol;
* Use of any previous treatment to the lesion(s) under study that, according to principal investigator's discretion, might interfere with the study objectives;
* Treatment, within 3 months before this trial, with any drugs known to have a well-established toxic potential to major organs;
* Participation in any other experimental research or administration of any experimental drug within 6 months before this trial;
* Positive pregnancy test, labor or miscarriage within 12 weeks before study treatment;
* Any conditions, according to investigator's discretion, that prevent subjects to participate in the trial.
Etoposide-Carboplatin Alone or With Endostar for Extensive Disease Small Cell Lung Cancer (ED-SCLC)

Background:

The effect of existing treatment modalities of extensive disease small-cell lung cancer (ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is wanted. Endostar® (Rh-endostatin Injection) may have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar® combined with etoposide-carboplatin (EC) chemotherapy in patients with ED-SCLC seeking for more effective treatment.

Methods:

In this randomized, open label, placebo-controlled, multicentre trial, 120 patients are planned to be enrolled at random into 2 arms(1:1) from 10 centers between June 2009 and June 2011. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University. Main eligibility criteria are histological or cytological diagnosis of ED-SCLC, with an age of 18-75 years. All eligible patients receive etoposide-carboplatin (EC) alone or with endostar® for 4-6 cycles (21 days for 1 cycle). In arm1 patients receive endostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. In arm2 patients receive etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.

Primary endpoint: progress free survival (PFS).

Secondary endpoint: progress free survival at 6 months, overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), Response duration, time to progression(TTP) and quality of life (QOL).

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically diagnosed SCLC;
* Age of 18-75 years;
* Life expectancy \> 3 months;
* Adequate hematologic, renal, and hepatic function;
* ECOG PS 0-2;

Exclusion Criteria:

* Brain metastases;
* Clinically significant cardiovascular disease;
* Presence of hepatic and renal dysfunction;
* Evidence of bleeding diathesis or coagulopathy
* Pregnant or lactating woman;
Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Neck Surgeries: A Comparison Between Two Bupivacaine Concentrations

Cervical plexus blocks (CPB) have been widely used to provide effective anesthesia and analgesia during various head and neck procedures. The ICPB was considered a good alternative to the deep CPB with an easier technique and fewer adverse events such as intravascular, epidural, subarachnoid injection, and phrenic nerve palsy. A recent randomized trial investigated the analgesic efficacy of superficial vs intermediate CPB combined with GA during total thyroidectomy. Authors used 10 ml bupivacaine 0.25% bilaterally, and they revealed a lower pain score and prolonged duration of analgesia with ICPB compared to superficial CPB; however, the authors did not assess the influence of this bupivacaine concentration on the diaphragmatic motion. \[5\] This randomized comparative trial is designed to investigate the analgesic efficacy of ICPB combined GA using two bupivacaine concentrations in patients undergoing neck surgeries (total thyroidectomy or total laryngectomy). We hypothesize that a smaller concentration of bupivacaine (0.185%) could provide an equivalent analgesic effect to a larger concentration (0.25%) with less impact on the diaphragmatic motion. The primary endpoint is the duration of postoperative analgesia. The secondary endpoints are the intraoperative hemodynamics, the postoperative pain score, total postoperative opioid consumption over 24 hours, diaphragmatic motions, and hemi-diaphragmic paresis.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III,
* scheduled for total thyroidectomy or total laryngectomy

Exclusion Criteria:

* Heart failure,
* A history of arrhythmias or treatment with antiarrhythmic drugs,
* Impaired pulmonary, liver or kidney functions,
* Neck infection or rash
Renal and Cardiac Risk Factors of AKI After Liver Transplantation

Background: Liver transplantation (LT) is an extensive operation with various factors contributing to the development of acute kidney injury in the perioperative period. Early diagnosis of AKI can improve clinical outcomes in LT recipients. Renal resistive index is measured in renal arteries and high resistive values are associated with more adverse cardiovascular events and renal failure progression. Myocardial performance index reflects overall cardiac function rather than systolic or diastolic function alone.

Aim of the study: to investigate whether combined doppler renal resistive index and myocardial performance index could predict early postoperative acute kidney injury in living donor liver transplant recipients.

Study design: a prospective observational study that will be conducted at Liver Transplantation Unit at Mansoura University on 105 consecutive living donor liver transplant recipients.

Methods: Renal resistive index (assessed by transabdominal ultrasound) and myocardial performance index (assessed by transthoracic echocardiography) will be measured just before operation, on termination of operation and then daily in the intensive care unit for 7 days. Patients will be observed for development of acute kidney injury.

This study aims to investigate whether combined doppler renal resistive index (RRI) assessed by transabdominal sonography and myocardial performance index (MPI) assessed by transthoracic echocardiography could predict early postoperative acute kidney injury in living donor liver transplant recipients.

The primary outcome is the predictive value of renal resistive index and myocardial performance index for the onset of early post living donor liver transplant acute kidney injury.

This prospective observational study will be conducted at Liver Transplantation Unit at Mansoura University from November 2022 till fulfillment of sample size after obtaining approval from Institutional Review Board (IRB). One hundred and five consecutive LDLT recipients will participate in this study after obtaining informed consents. They will be observed for the development of early postoperative acute kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing right-lobe living-donor liver transplantation

Exclusion Criteria:

* preoperative renal impairment (GFR \< 60 ml/min/1.73 m2)
* known renal artery stenosis
* patient who underwent previous nephrectomy
* ischemic heart disease (patient who takes anti-ischemic measures as prescribed by a consultant cardiologist)
* Patient with arrthymia or who develop persistent intraoperative arrythmia
Dual-task Training Using Virtual Reality

The purpose of the study was to investigate the feasibility of using a virtual reality- based dual task training of upper extremity tracking while treadmill-walking, to improve walking and balance performance in post stroke survivors


Eligibility Criteria:
Inclusion Criteria:

* With hemiplegia after a stroke for at least a year since the incident.
* Range age 40-80.
* Without medication or with stabilized medication.
* Use ankle-foot orthosis or no splint at all.

Exclusion Criteria:

* Severe cardiac problems
* A score less than 25 in the Mini-Mental test.
* Fractures or severe orthopedic limitations that do not allow for training, and which have occurred over the last six months.
* More than three falls in the past year before participating in the study
TMS Alteration of the Reward Positivity

The aim of this proposal is to demonstrate that stimulation of different brain regions differently affects the electroencephalographic feature known as the Reward Positivity (RewP).

The aim of this proposal is to demonstrate that stimulation of different brain regions differently affects the electroencephalographic feature known as the Reward Positivity (RewP). The RewP is a sensitive and specific biomarker of reward receipt. This proposal will advance a causal test of the hypothesis that there are two major sources of variance that contribute to this brain response: a dorsal midline contribution to information encoding and a ventral midline contribution that is modulated by affect. Together, these findings will reveal how the RewP acts to blend multiple aspects of value together in the service of motivated learning. The objective of this proposal is to gather pilot data to demonstrate the feasibility of using transcranial magnetic stimulation (TMS) to perturb idiosyncratically-defined (fMRI-based) dorsal or ventral targets in order to causally test the hypothesis that these different sources contribute different types of variance to the RewP. TMS double cone deep coil stimulation should diminish +RPE encoding in the RewP when compared to sham. TMS Figure-8 coil stimulation should diminish affective modulation of RewP amplitude when compared to sham.

Eligibility Criteria:
Inclusion Criteria:

• Men or women aged 18-30

Exclusion Criteria:

* Participants unwilling or unable to give informed consent
* Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
* MEG/MRI contraindications
* History of psychosis
* Not fluent in English
Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles

The aim of this study is to evaluate PET-CT and EmII/3-10 serology as potential markers to assess the parasitocidal effect of benzimidazoles

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* Patients with inoperable alveolar echinococcosis
* With negative PET-CT
* EmII/3-10 serology under long-term chemotherapy with benzimidazoles

Exclusion criteria:

* Positive PET-CT
* Positive EmII-3-10 Serology
* No compliance
* Reduced life expectancy
* Pregnancy
The Use of the CPR to Predict Adverse Outcomes in GDM Pregnancies

The cerebro-placental ratio (CPR) is a tool for assessment of fetal wellbeing in the management of the growth restricted fetus. CPR is the ratio of the fetal middle cerebral artery pulsatility index (PI) to the umbilical artery PI. In Gestational Diabetes (GDM), the common finding is of accelerated and asymmetric fetal growth. Pregnancies complicated by GDM have an increased risk of certain complications such as preeclampsia, intrauterine demise, CS due to fetal distress. These complications have a well known association with fetal growth restriction leading to the hypothesis that there exists a subset of diabetic fetuses that exhibit a growth restriction phenotype despite not being small for gestational age (\<10%).The objective of this study is to examine whether the CPR can identify GDM fetuses that are not growth restricted but are at increased risk of certain adverse neonatal outcomes. Women with singleton pregnancies and a diagnosis of GDM at 24 weeks of gestation and beyond will be included. Exclusion criteria are Pre-gestational diabetes, hypertensive disease of pregnancy at time of recruitment, fetus with a known major anomaly, fetal EFW \< 10%(IUGR). Women who consent to the study will have a blinded Doppler assessment of CPR. Clinicians will be blinded to these Doppler measurements (unless they are indicated clinically for another reason (suspected fetal anemia or IUGR development- and the results will be unblinded and reported to the clinicians). Obstetric and neonatal outcomes will be collected prospctively via the local BORN database and the patient chart. Local BORN is needed for the registered outcomes. Newborns will be divided post-hoc into two groups: A) last CPR \<10% B) Last CPR \> 10%. The primary outcome will be a composite outcome consisting of one or more of the following: Caesarean section due to suspected fetal distress, 5 minute Apgar \<7, Cord arterial PH \< 7, HIE, NICU admission \>24 hours.


Eligibility Criteria:
Inclusion Criteria:

* All women over the age of 18 years old with singleton pregnancies and a diagnosis of GDM at 24 weeks of gestation and beyond.

Exclusion Criteria:

* Pre-gestational diabetes, Hypertensive disease of pregnancy at time of recruitment, fetus with a known major anomaly, fetal EFW \< 10% or suspected fetal anemia (and thus requiring a clinically indicated CPR measurement) poor grasp of english
Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery

The purpose of this study is to determine the analgesic efficacy and safety of Meloxicam Injection in subjects undergoing abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

Voluntarily provide written informed consent. Be scheduled to undergo elective abdominoplasty surgery without collateral procedures.

Be American Society of Anesthesiology (ASA) physical class 1 or 2. Male or female between 18 and 70 years of age, inclusive. Have a body mass index 18\~30 kg/m2. Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.

Exclusion Criteria:

Have a history of abdominoplasty surgery within the preceding 12 months. Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.

Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months.

Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.

Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.

Have another painful physical condition that may confound the assessments of post operative pain.

Have a history of advanced malignant tumor. Have a history of alcohol abuse (regularly drinks \> 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years or a history of prescription/illicit drug abuse.

Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.

Have evidence of a clinically significant 12 lead ECG abnormality. Have a clinically significant abnormal clinical laboratory test value. Have history of or positive test results for HIV, treponema pallidum,or hepatitis B or C.

Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.

Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of surgery.
Bardet-Biedl Syndrome Study: Clinical and Genetic Epidemiology Study in Adults

This study is based on the study of the natural history of a rare disorder: the Bardet-Biedl syndrome (BBS) (which is associated with retinitis pigmentosa, polydactyly, cognitive impairment, obesity, and kidney failure). The clinical, biological, and radiological features of adult patients are studied. In parallel, a molecular study is performed on the known genes to date (8 genes from BBS1 to BBS8) and to identify new genes involved. The parts of the study are combined in a phenotype-genotype correlation study.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age over 16 years old)
* At least 3 of the five major criteria (retinitis pigmentosa, obesity, polydactyly, cognitive impairment, and kidney disorder) and/or BBS mutations identified
Effectiveness of Cannabidiol Vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery

This study is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Requiring shoulder arthroscopic surgery for soft tissue pathology
* Able to complete surveys and follow-up visits

Exclusion Criteria:

* Younger than 18 years of age
* Shoulder dislocation, fracture, previous surgery, coexisting extremity pathology, pregnancy.
A Real-world Research on the Prevention and Treatment of Peritoneal Metastasis and Malignant Ascites by Intraperitoneal Infusion of rmhTNF in Gastric and Colorectal Malignant Tumors

Peritoneal metastasis is the main factor leading to poor prognosis in patients with gastric cancer or colorectal cancer. Although current systemic treatment regimens can prolong the time to peritoneal metastasis, the long-term survival rate is still poor. This is mainly due to the presence of the peritoneal plasma barrier, which limits the penetration of anti-tumor drugs and thus restricts the efficacy. In contrast, the use of intraperitoneal infusion chemotherapy allows anti-tumor drugs to directly reach the abdominal cavity, exposing metastatic nodules to high concentrations of drugs, and has a significant therapeutic effect on peritoneal metastases, resulting in better therapeutic effects Tumor necrosis factor (TNF) is a small molecule protein secreted by macrophages. There are two types of TNF - α: α and ß. TNF - α is produced by activated monocytes and macrophages, also known as cachectin. TNF - α is produced by activated lymphocytes, also known as lymphotoxins, and the two have similar activity. Previous studies have shown that rmhTNF is safe for intraoperative perfusion in gastrointestinal tumors.

In this real-world study, we will observe the safety and effectiveness of rmhTNF intraperitoneal perfusion in actual clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* 1. The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage).

  2. Patients with recurrent/metastatic gastric adenocarcinoma and colorectal cancer.

  3. Age range from 18 to 80 years old; 4. Male or non pregnant or lactating female; 5. The bone marrow reserve function is good, and the blood routine meets the following conditions: white blood cell count ≥ 3.5 × 109/L, neutrophils ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L; 6. The organ function is good, and the biochemical examination meets the following conditions: ALT ≤ 2.5 x Upper Limit of Normal (ULN), AST ≤ 2.5 x ULN, serum total bilirubin ≤ 1.5 x ULN, and blood creatinine ≤ 1.5 x ULN; 7. Functional status: 0-1 (ECOG); 8. preoperative ASA grading I-III; 9. Informed consent form has been signed for clinical treatment.

Exclusion Criteria:

* 1. Individuals who are allergic to TNF, biological products, or penicillin; 2. Those who do not meet the inclusion criteria during pregnancy or lactation; 3. Other situations where the researcher believes that patients are not suitable to participate in this trial.
Electroencephalography in Patients Resuscitated From Cardiac Arrest

Sudden cardiac death can occur due to a multitude of causes. The underlying case can affect the overall prognosis. A return of spontaneous circulation not exceeding 30 minutes following a successful cardiopulmonary resuscitation is usually deemed imperative, if the patient is to survive. Monitors for evaluating the cardiac function during and after resuscitation are implemented on a daily basis (ekg, pulseoxymetry, blood pressure monitoring, cardiac sonography), but no devices for registration of the cortical brain activity exist. The aim of this study is to provide a 3-channel electroencephalogram using a prototype EEG/EKG adapter, connected to a Physio-Control LifePak 15 monitor/defibrillator, in patients who regain spontaneous circulation following non-traumatic cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* Witnessed Cardiac Arrest
* Return of spontaneous circulation following cardiac arrest 10-40 min

Exclusion Criteria:

* traumatic cardiac arrest
* no consent from next-of-kin