cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors

This study is an open, single arm, dose increasing study to evaluate the safety and efficacy of the combination of mRNA personalized tumor vaccine encoding neoantigen (hereinafter referred to as tumor vaccine) and Sintilimab injection (hereinafter referred to as Sintilimab) in the treatment of advanced malignant solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Are ≥18 years old, without limitation of sex at time of consent.
* Patients with malignant solid tumors confirmed by histopathology or cytology and having at least one measurable lesion.
* Fresh biopsy specimens can be provided for vaccine preparation.
* Patients with malignant solid tumors who develop secondary drug resistance after receiving PD-1/PD-L1 drug therapy, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H

Exclusion Criteria:

* It is known that it is allergic to any tumor vaccine and Sintilimab preparations; Or have experienced severe allergic reactions to other monoclonal antibodies in the past;
* The predicted number of new antigens is less than 10;
* Those who are pregnant or breastfeeding;
* Those with an expected survival period of less than 3 months;
Influence of Different Prostheses on Postoperative Clinical Function in Total Knee Arthroplasty

Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS))


Eligibility Criteria:
Inclusion Criteria:

1. Age 45-80 years, any gender, BMI \< 35 kg/m2
2. Initial diagnosis of bilateral knee OA (Kellgren-Lawrence classification grades 3 or 4). Patients who are to undergo simultaneous primary bilateral knee arthroplasty
3. Inversion deformity ≤ 15°
4. Posterior cruciate ligament integrity

Exclusion Criteria:

1. History of knee surgery (ligament, osteotomy, etc.)
2. knee flexion\<90°.
3. flexion contracture of one knee \> 10°
4. Comorbidity with other diseases, such as peripheral neuropathy, malignant tumors, rheumatism, etc.
5. Posterior cruciate ligament injury
6. Those assessed to be intolerant of surgery
Generation of Dendritic Cell Precursors From Cord Blood Stem Cells

There is a growing interest in generating dendritic cells (DCs) for using as vaccines. Several cytokines, especially stem cell factor (SCF) and FLT3-ligand (FL), have been identified as essential to produce large numbers of myeloid precursors and even to increase DC yield obtained by the action of granulocyte-macrophage colony-stimulating factor (GM-CSF) and tumor necrosis factor alpha (TNF-α). However, there are few studies on the effect of the early-acting cytokines, commonly used to expand CD34+ progenitor cells, on DC generation.

We have established a serious of functional analysis of maturated or immaturated DCs including surface markers screening or cytokine production. Here, we design this two-year project to evaluate the possible methodology in the generation of CD14+CD1a- and CD14- CD1a+ myeloid DC precursors from CD34+ cells. In the first year of the project, we will set up the standard protocol to generate DC precursors from cord blood stem cells. In the first step, we will isolate CD34+ cells from cord blood and amplify these cells. Purity of the CD34+ cell populations obtained will be greater than 90%. In the next step, these primary cultures of CD34+ cells will treat with early-acting cytokines such as GM-CSF and IL-4 to further induction into dendritic cells. Functional analysis of dendritic cells would be performed in this stage. In the second year of the project, we will further evaluate the induction of DCs by CD34+ stem cells could be affected by combination of mesenchymal stromal cells. These results of this research with CD34+-based DCs induction provide the basis for materials to develop the DC-based vaccine against viral and fungal infections, and might be a powerful tool in anti-tumor immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Normal full-term deliveries

Exclusion Criteria:
Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease

To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who have moderately to severely active Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's disease for greater than 4 months confirmed by endoscopy or radiologic evaluation.
* CDAI score of \>= 220 and \<= 450 at Week 0.
* Males and females \>= 18 years and \< 75 years of age at the Screening visit.
* Judged to be in generally good health as determined by the Investigator.

Exclusion Criteria:

* Current diagnosis of the colitis other than Crohn's disease.
* Symptomatic known strictures.
* Surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
* Ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
* Short bowel syndrome as determined by the investigator.
* Infection or risk factors for severe infections.
* Females who are pregnant or considering becoming pregnant during the study, or breast-feeding.
Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

This study will evaluate the safety and efficacy of intraperitoneal administration of Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks for up to six weeks, or a maximum of three treatments.

This protocol describes a pilot study to assess whether intraperitoneal Bevacizumab infusion is safe and improves the time to repeat paracentesis. In patients with non-draining malignant peritoneal effusion, published data suggests that the average time to repeat paracentesis in malignant ascites is 10-13 Days. The investigators' treatment will be considered potentially efficacious if the median time to repeat paracentesis is greater than 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included in the case of:

  * Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
  * Participants must be 18 years of age or older
  * Have ascites of malignant disease
  * Have symptoms related to ascites
  * Ascites Index above 0.05 (AI ˃ 0.05)
  * Be an English speaking patient or have an interpreter available
  * Be able to understand and comply with all study requirements and the implications of off-label use of intraperitoneal Bevacizumab
  * Have had at least two paracentesis within the last 4 weeks

Exclusion Criteria:

* Patients will be excluded in the case of:

  * Ascites due to non-malignant cause
  * Concurrent treatment with systemic chemotherapy that has a realistic chance of controlling the ascites
  * Concurrent treatment with intraperitoneal Bevacizumab
  * life expectancy of less than 2 weeks
  * A history of bowel perforation or fistula
  * Symptoms or signs suggestive of bacterial peritonitis
  * Child's C cirrhosis
  * Uncontrolled hypertension
  * Surgery within 28 days of catheter treatment
  * Evidence of coagulopathy
  * Symptoms suggestive of bowel obstruction
  * Major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery.
  * Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
  * Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
  * Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation)
  * Patients with pre-existing 3 + or greater urine dipstick reading proteinuria
Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique (ETRE)

Prospective monocentric quality of life study. Including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone.

The sponsor will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires.

It is now obvious to all surgeons involved in the follow-up of these patients that not all orbital reconstruction techniques are equal.

Thus, through this study, The investigators wish to objectively highlight the gain in quality of life and prosthetic equipment in exentered patients, depending on the reconstruction method used.

This prospective study, including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposes to compare the reported quality of life of patients according to the reconstruction technique patients have undergone.

The investigators will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires. The investigators will submit them, after express telephone agreement, by post to all the patients included in our study.

The aim of such a study will therefore be to provide assistance to both surgeons and patients in the choice of an orbital reconstruction technique, by objectively demonstrating the superiority of one technique over the others in terms of quality of life and prosthetic equipment rate.

The patients included in this study will have to answer two questionnaires, submitted by post. This study therefore falls within the framework of minimal or moderate risk studies.

The patients will be informed by telephone interview about the method of writing the questionnaires and their content.

The investigators will pay particular attention to the quality of life of the patients who have benefited from a free ante-brachial flap reconstruction in comparison with other reconstruction techniques; this will constitute the main criterion of our study.

In addition, the collection of pseudo-anonymised computerised data from all the patient files will give rise to a comparison of post-operative healing times, the rate of prosthetic fitting, and the time taken to fit the prosthesis according to the reconstruction techniques. These three factors, already identified in the literature as indicators of good rehabilitationn , will constitute our secondary judgment criteria.

Eligibility Criteria:
Inclusion Criteria:

All patients, living or lost, exentered at the Institut Curie Paris between January 2014 and December 2019,

Exclusion Criteria:

* Persons under court protection.
* Persons not in a condition to give their consent.
A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB

HBV(hepatitis B virus) with metabolic comorbidities may accelerate liver disease progression and increase the risk of HCC(Hepatocellular Carcinoma)development. It is reported combination of metabolic diseases and CHB is associated with substantially increased rates of liver cirrhosis and secondary liver-related events compared to CHB alone. Consequently, hepatitis B patients with metabolic comorbidities warrant particular attention in disease surveillance and evaluation of treatment indications.

Primary objective:

To evaluate the impact of metabolic disease on the progression of chronic hepatitis B

* To observe HBsAg/HBeAg/HBV DNA changes /HBsAg seroconversion
* To determine high rates of Liver Cirrhosis and Hepatocellular Carcinoma

Group 1 : CHB with diabetes Group 2 : CHB with hyperlipemia Group 3 : CHB without metabolic diseases

Study Duration (in months) 24 months

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
* Patients on-treatment with NAs

Exclusion Criteria:

* Treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) \<=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
* History of depression or uncontrolled psychiatric disorders
* Subjects protected by law or not in a position to give consent
Functional MRI Study in Healthy Children Engaged in Aggressive Behaviors

The purpose of this non-interventional study is to optimize the point subtraction aggression paradigms (PSAP) task in typically developing children (TDC).

The PSAP is a behavioral aggression test used to evaluate behavioral response related to impulsive aggression. The task will be combined with functional MRI to establish a reliable BOLD signal during testing in developing healthy subjects (8-12 years old) and, to determine the feasibility to perform the task.

Additionally, the levels of neurotransmitters Glutamate and GABA will be measured using magnetic resonance spectroscopy (MRS).

Eligibility Criteria:
Inclusion Criteria:

Healthy male or female subjects, aged 8-12 years (inclusive) at the time of screening.

Exclusion Criteria:

1. Current history of developmental, psychiatric, or neurologic disorder, including seizures (except for uncomplicated brief febrile seizures), tumor, severe head injury/traumatic brain injury, stroke, lesion, or disease.
2. Known or suspected intelligence quotient (IQ) \<70, diagnosis of mental retardation or cerebral palsy or speech/language disorder and history of implanted brain stimulator, vagal nerve stimulator, ventriculoperitoneal shunt, cardiac pacemaker, orthodontic braces, or implanted medication port.
3. Visual and hearing (≥25 dB) impairment.
4. Pre-existing medical or psychological conditions that preclude being in the MRI scanner (e.g., claustrophobia, morbid obesity, or marked anxiety about the procedure).
Efficacy and Safety Evaluation of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site)

This study is a prospective study, randomized, using control, open-label, single-center to evaluate the efficacy and safety of EASYEF® in acute wound (split-thickness skin graft donor site). A total of 10 subjects are randomly allocated. Subjects who meet the final inclusion and exclusion criteria are randomized to the test cohorts in a ratio of 1:1:1.

This study was intended to determine the effect of EGF on acute wounds such as trauma, surgical wounds and burns. But in this study, skin graft donor site wounds were used because they were the most representative for acute wounds and the depth and extent of the wounds could be controlled. EGF is known pharmacologically to accelerate epithelial cell proliferation, fibroblast cells and endothelial cells. Giving EGF in acute wounds is expected to accelerate wound healing and improve patient quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have donor wounds on the vertical (upper and lower) lines of the thigh through skin grafted surgery due to trauma, ulcers, burns, and incisional surgical defects.
* The size of the donor follows the standard and the distance between the two skin transplants is at least 2 cm.
* Patients who are expected to be able to successfully complete or benefit from this examination are based on appropriate medical assessment.
* Patients is willing to be treated 7 days as inpatient and treated as outpatient for maximum 7 days with homecare nurse visit.
* Patients is willing to stay near the hospital and visit the hospital after the donor site wound is declared healed by doctor.
* Patients who decided and agreed in writing to enroll in this study at their own will.
* Patients aged 18 and up

Exclusion Criteria:

* Patients with different skin donor site can influence the results of the study.
* Patients who have other diseases that can interfere with wound healing such as immunosuppressive, metabolic collagen, peripheral vascular obstructive disease (PAOD), systemic vasculitis, and others.
* Patients have the talent for keloid formation.
* Patients have uncontrolled diabetes and diabetes with complications.
* Patients with liver disease, kidney disease, and other serious diseases that can affect this study.
* Patients who are deemed difficult to carry out the study by the investigators.
* Women who are pregnant, lactation or not using reliable methods of contraception and who do not consent to continue contraception for the duration of the trial.
Efficacy and Safety of Administration of Different Doses of 4% Articaine.

The goal of this triple-blind randomized clinical trial is to compare the efficacy and safety of administering one cartridge (1.8 mL) versus two cartridges of articaine 4% with epinephrine 1:100,000 for lower third molar extraction using the inferior alveolar nerve block technique.

The main questions it aims to answer are:

* The injection of 3.6 ml of 4% articaine 1:100,000 has a higher anesthetic efficacy than a single injection of 1.8 ml of the same anesthetic.
* The injection of 3.6 ml of 4% articaine 1:100,000 has a higher rate of adverse effects than a single injection of 1.8 ml of the same anesthetic.
* The injection of 3.6 ml of 4% articaine 1:100,000 has a greater alteration of heart rate, oxygen saturation and systolic and diastolic blood pressure than a single injection of 1.8 ml of the same anesthetic.

The investigator (XA) will perform the anesthetic technique.

* The investigator will administer a first anesthesia for NDI block with a cartridge of 4% articaine anesthetic at 1:100,000 . At the end, an envelope containing the assignment to the experimental or control group will be opened.

  * In the control group, a single cartridge of anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without the needle, in the same area, counting up to 30 seconds.
  * In the experimental group two anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block.
* After checking Vincent's sign, the vestibular (buccal nerve) infiltration will be performed in both groups with half a cartridge (0.9 ml) of the same anesthetic solution.
* The latency of the anesthetic effect will be measured using a pulpometer.
* Subsequently, a student of the Master's Degree in Oral Surgery of the University of Barcelona will perform the surgical intervention. The surgeons in charge of performing the extraction will not know to which group each patient belongs.
* The collection of the variables and the postoperative controls will be carried out by the researcher who has not performed the anesthetic technique and who will not know the study group to which the patient belongs.


Eligibility Criteria:
Inclusion Criteria:

* Patients of legal age (≥18 years) requiring surgical extraction of a lower wisdom tooth (whether erupted, semi-erupted or included).
* Patients without relevant systemic pathology (equal or lower than ASA II).
* Sufficient intellectual capacity to understand the study, the informed consent and to adequately complete the questionnaires.

Exclusion Criteria:

* Pregnant patients.
* Patients with hypersensitivity to articaine or adrenaline.
* Patients with uncontrolled systemic diseases.
* Drugs or systemic diseases (ASA III or higher) and that contraindicate a surgical intervention or the use of anesthetics and/or vasoconstrictors.
* Patients with relative or absolute contraindication of conventional analgesic or anti-inflammatory regimen.
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing

The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates
* Fresh unilateral closed or Gustilo type I or type II open tibial fracture
* Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing

Exclusion Criteria:

* Major polytrauma or significant axial trauma
* Associated lower extremity fracture that will delay subject's ability to bear weight beyond the normal time expected for a tibial shaft fracture
* Use of bone grafts at the time of fracture fixation
* Pathological fracture or metabolic or bone disease
* History of symptomatic spinal stenosis or facial nerve paralysis
* Malignancy within the last 5 years
* Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia
* Use of agents affecting bone metabolism
* Subject refuses to use appropriate methods of contraception
Treatment of Parkinson's Disease With a Transdermal Skin Patch

Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This occurs as a result of destructive changes in an area of the brain responsible for making dopamine, the basal ganglia. Muscle tremors, rigidity of movement, shuffling footsteps, droopy posture, and a mask-like expression on the face characterize Parkinson's disease.

This study is designed to determine the effects of a new drug, N-9023. The drug acts like dopamine and can be given through a skin patch (transdermal) for treatment of parkinsonian symptoms.

The goals of this study are to find out whether N-9023 is useful in treating the signs and symptoms of Parkinson's disease and to determine the best dose of N-9023 that is safe and effective.

The acute safety and antiparkinsonian efficacy of transdermally delivered N-0923 will be evaluated in patients with Parkinson's disease. This dopamine receptor agonist will be administered transdermally under double-blind conditions, in a rising dose paradigm. Antiparkinsonian activity will be quantified by means of standard rating scales. Possible adverse events will be assessed by appropriate clinical and laboratory tests.

Eligibility Criteria:
All patients will carry a diagnosis of Parkinson's Disease based on the presence of a characteristic clinical history and neurological findings. Symptom severity will range from Hoehn \& Yahr stage II-IV.

Males and females between the ages 30-76 are eligible for the study.

Initial emphasis will be on patients who are taking few or no other medications than levodopa for their Parkinson's disease.

No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk.

No patients with a history of significant cardiac (myocardial infarction within 12 months prior to study, dysrhythmia; QTc intervals greater than 440 msec).

No patients who are convulsive, hepatic, or with renal disorders (exceeding the upper limit of normal values for LFT's and creatinine respectively).

No patients with evidence of other serious medical illness, a history of alcohol or drug abuse, those who have participated in an investigational trial within 28 days prior to study, and pregnant or nursing women or anyone not practicing effective means of birth control.