cyrilzakka/clinical-trials huggingface dataset:
GT201 Injection For The Treatment Of Advanced Solid Tumors

Expected to complete 7 to 18 evaluable subjects (patients with advanced solid tumors)，3 dose groups.A modified "3+3" dose-escalation design is utilized,This includes both accelerated dose escalation and traditional "3+3" dose escalation.The first dose group is accelerated titration,The first dose group is an accelerated titration of 1 to 6 evaluable subjects;The second and third dose groups are based on the traditional "3+3" dose-escalation principle,The second and third dose groups are based on the traditional "3+3" dose-escalation principle, with 3 to 6 evaluable subjects enrolled respectively.


Eligibility Criteria:
Inclusion Criteria:

* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies;
* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues ≥1.0cm\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible.

Exclusion Criteria:

* 1.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone);
* 2. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
* 3. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, pericardial effusion or IL-2 contraindications;
* 4. Participate in other clinical trials within 4 weeks prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same;
* 5. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 6.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin).
Treatment for Aggression and Agitation in Patients With Alzheimer's Disease

The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's disease.

The primary purpose of this study is to help answer the following research questions:

* Whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's Disease.
* The safety of this drug and any side effects that might be associated with it.
* How this drug compares to placebo.

During the 12-week period of this study, the participant will have an equal chance of receiving 1 of the 2 treatment groups: active drug or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling participants with a diagnosis of probable Alzheimer's disease (AD) based on disease criteria from the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Association. Mini Mental State Examination (MMSE) score from 6 to 26 inclusive; Neuropsychiatric Inventory-10 (NPI-10) total score greater than or equal to 10.
* Are men or women at least 60 years old.
* Weight greater than or equal to 45 kilograms (kg).
* Have clinically significant and persistent verbal or physical agitation and/or verbal or physical aggression behaviors that are disruptive to daily functioning or potentially harmful and occurred at least 3 days per week over the past 4 weeks prior to study entry.
* Understand English.
* Have a reliable and actively involved caregiver who must be able to communicate in English and be willing to comply with protocol requirements.

Exclusion Criteria:

* Meet DSM-IV-TR or Delirium Rating Scale-Revised-98 criteria for delirium.
* Does not score ≤4 on the Modified Hachinski Ischemia Scale for vascular dementia.
* Have a magnetic resonance imaging (MRI) or computer tomography (CT) scan on file since the onset of symptoms of AD and performed within the past 24 months that is inconsistent with a diagnosis of AD.
* Have a current, required use, or expected use of psychoactive drugs or other medications not allowed in this trial.
* Have currently active significant medical, neurological, or psychiatric problems that are not allowed in this trial or other brain disorders.
* Have received acetylcholinesterase inhibitor (AChEIs) or memantine for less than 4 months, or have less than 2 months of stable therapy on these treatments by Visit 2.
A Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography

The purpose of the study is to determine whether BMS068645 is as effective as Adenosine SPECT at detecting blockages in heart arteries, and to determine if it will have fewer side effects


Eligibility Criteria:
Inclusion Criteria:

* Referral for pharmacologic stress SPECT MPI
* Have suspected Ischemic heart disease

Exclusion Criteria:

* Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment
* Severe asthma or COPD
Impact of Sleep Deprivation on Anesthesiology Residents' Non-technical Skills

Sleep deprivation is common in anaesthesiology residents. Its effects on technical skills have been reported with controversial results. Non-technical skills (team working, situation awareness, decision making and task management) contribute to safe and efficient task performance. They have a crucial role in anaesthetic practice, especially during crisis management. The investigators hypothesized that sleep deprivation was associated with a reduced mobilisation of non-technical skills in anaesthesiology residents.

The scenario consisted in a rapid sequence induction for emergency general anaesthesia in case of acute peritonitis complicated by an anaphylactic shock secondary to the injection of succinylcholine. All scenarios were performed with the assistance of an anaesthetist nurse, facilitator of the scenario. In a second time, after patient stabilisation (defined as oxygen saturation by pulse oximetry (SpO2) \> 95%, mean arterial pressure (PAM) \> 65 mmHg and heart rate (HR) \< 100 bpm for at least 2 minutes) consecutive to an expected injection of 100 µg of epinephrine decided by the participant, a surgeon entered the operating room to create a dilemma regarding patient destination (continue surgery or intensive care unit admission)

Eligibility Criteria:
Inclusion Criteria:

* Anesthesiology residents from Paris academic hospitals

Exclusion Criteria:

* Chronic sleep disorder
SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE)

This trial sest to assess the efficacy of a superior hypogastric plexus block (SHPB) for quality of recovery after a laparoscopic hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Undergoing laparoscopic hysterectomy for benign indications

Exclusion Criteria:

* Planned procedure that requires dissection of the presacral space
* Allergy to block medication (s)
* Known or suspected malignancy
Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models

The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical treatments with agonists and antagonists of hypothalamic neuropeptides, currently available, on the development and treatment of adiposity and negative cross-talk between adiposity and muscle/bone tissue


Eligibility Criteria:
Inclusion Criteria:

Obese patients affected and not by hypothalamic-pituitary diseases

Exclusion Criteria:

1. Minor subjects;
2. Pregnant and/or breastfeeding women;
3. Patients suffering from states of primary and/or acquired immunodeficiencies, and/or serious impairment of general clinical conditions (e.g. metastatic neoplasms; immunosuppressive therapies; worsening/reacerbated/compensated chronic pathologies);
4. Patients unable to understand and sign the Informed Consent.
Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study

The objective of this study is to characterize the effects of a single-dose of retigabine on cortical excitability in healthy subjects, as quantified by means of TMS.

Epilepsy is a disorder of brain excitability. Antiepileptic drugs (AEDs) modulate this excitability and transcranial magnetic stimulation (TMS) imposed itself as one of the best noninvasive methods to study cortical excitability in human subjects.

Based on several recent studies, we hypothesize that measuring TMS parameters in the patients suffering from epilepsy can rapidly predict the effectiveness of the newly given AED and, ultimately, guide the optimization of the AED therapy. Characterizing the neurophysiological properties of innovative AEDs such as retigabine with TMS will allow 1) to better understand how AEDs modulate, in vivo, cortical excitability in humans in relation to their mode of action and 2) to establish TMS as a tool for assessing individual responsiveness to a particular AED treatment and for antiepileptic treatment monitoring.

The effects of most AEDs on cortical excitability have been investigated. The modifications of the excitability parameters are related to the specific mode of action of each AED. For the new AED retigabine, at least two modes of action are known: 1) increase in cellular potassium efflux by changing conformation of the KV7.2-7.3 channels and 2) enhancement of GABA-A activity.

Eligibility Criteria:
Inclusion Criteria:

* age 18-50 years
* being "healthy"
* willing to participate and able to understand study and provide informed consent

Exclusion Criteria:

* intake of psycho-active drugs (AEDS, antidepressants, benzodiazepines, neuroleptics, hypnotics, ...)
* alcohol or drug abuse
* antecedent of seizure
* contra-indication to TMS (metal in the head, skull fracture)
* contra-indication to retigabine.
Combination of Lymphatico-venular Anastomosis and Liposuction to Treat Cancer-related Lymphedema

* cooperation of an International team with many years of experience in surgical management of lymphedema
* description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology
* the combination of LVA and liposuction guarantees long lasting results

Cancer-related lymphedema represents one of the major complications of cancer treatment, especially for breast and gynecologic cancers. Moreover, it has high impact on cancer survivors and healthcare systems. Lymphedema management still remains challenging. The better understanding of lymphedema physiopathology as well as the development of sophisticated surgical and diagnostic techniques have led to effective strategies to address lymphedema patients but, despite the considerable interest in international literature, no consensus exist. The combination of LVA and liposuction may represent an effective strategy in treating patients with cancer-related lymphedema, in order to reach a significant decrease in volume and reduction of lymphangitis rate as well as stable results in time. In addition, it has the aim of being minimally invasive and well tolerated by patients

Eligibility Criteria:
Inclusion Criteria: patients affected by secondary lymphedema

* free from cancer disease

Exclusion Criteria:

- persistence of the neoplastic pathology

- patients affected by primary lymphedema
Study of Imatinib in Children With Neurofibromatosis and Airway Tumors

The purpose of this study is to look at a subset of plexiform neurofibromas and determine if the airway tumors are more sensitive to imatinib therapy. Funding Source - FDA OOPD


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged: \> 6 months and \< 12 years of age.
2. Diagnosis of neurofibromatosis type 1 (NF1).
3. Presence of symptomatic airway plexiform neurofibromas ; defined by abnormal sleep study or pulmonary function testing.
4. Patients must have measurable (\> 1.5 cm in two dimensions or able to assess a minimum of 3 slices) disease by magnetic resonance imaging (MRI).
5. Patients must have a Karnofsky of \> 70% or Lansky of \> 50% and a life expectancy of \> 2 months.
6. Adequate end organ function, defined as the following:

   total bilirubin \< 1.5 x ULN, SGOT and SGPT \< 2.5 x UNL, creatinine \< 1.5 x ULN, ANC \> 1.5 x 109/L, platelets \> 100 x 109/L.
7. Patients must be able to swallow whole pills or crushed pills in a soft food such as pudding or apple sauce; or have other GI access such as a G-tube.
8. Written, voluntary informed consent/assent.

Exclusion Criteria:

1. Patient has received any other investigational agents within 14 days of first day of study drug dosing.
2. Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
3. Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
4. Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
5. Patient has a known brain metastasis. Non-specific CNS changes on MRI/CT characteristic of NF1 are allowed, but not known CNS malignancies requiring therapeutic intervention.
6. Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
7. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
8. Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry.
9. Patient previously received radiotherapy to \> 25 % of the bone marrow
10. Patient had a major surgery within 2 weeks prior to study entry.
11. Patient/parent with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
12. Patients who have or anticipate receiving permanent (or semi-permanent) metallic structures attached to their body. (e.g., braces on teeth, body piercings), which their physicians believe will interfere with the MRI.
13. Patient has an unstable airway requiring more urgent intervention or deemed unable to travel due to unstable airway by referring MD.
Hidradenitis Suppurativa Written Action Plan

This study is being conducted to evaluate if a written action plan for hidradenitis suppurativa (HS) will help patients with hidradenitis suppurativa gain a better understanding of the condition and how to manage the condition on a daily basis compared to a routine verbal consultation.


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of HS

Exclusion Criteria:

* Has been exposed to a written action plan for HS before
A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery

An initial feasibility and safety study evaluating the use of autologous tissue engineered vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in children with single ventricle anomalies.

This investigation is a prospective, nonrandomized phase 1 clinical trial determining the safety of the use of tissue engineered vascular grafts as conduits for EC TCPC. Primary end points of the study will include determination of graft failure rates and graft related morbidity and mortality. Graft failure will be defined as any graft narrowing/occlusion or dilation/rupture requiring surgical or endovascular intervention. Graft related morbidity and mortality will include any post-operative complication such as any thromboembolic or infectious event that requires treatment and is thought likely to be caused by the tissue engineered vascular graft as determined by the investigators and confirmed by the data safety monitoring board. All appropriate patients requiring EC TCPC who meet study inclusion/exclusion criteria will be evaluated for enrollment in the clinical trial. After obtaining informed consent from the patient's parents, patients with single ventricle cardiac anomalies will undergo EC TCPC using a tissue engineered conduit. Post-operative care and monitoring will follow an established, standardized, clinical algorithm in which the patient's clinical status including complications and measurements of graft function will be serially evaluated and recorded over a three year period using physical examination, echocardiography, and MRA.

Eligibility Criteria:
Inclusion Criteria:

* single ventricle cardiac anomaly requiring extra cardiac total cavopulmonary connection (EC TCPC).

Exclusion Criteria:

* incomplete inferior vena cava (IVC)
Preoporative Bevacizumab, Radiation Therapy, and XELOX Chemotherapy for Locally Advanced Nonmetastatic Rectal Cancer

We presumed that the addition of a monoclonal antibody Bevacizumab into radiation therapy and combination chemotherapy could results in improved pathologic tumor regression grade (TRG) in locally advanced nonmetastatic rectal cancer.

Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may achieve promising improvements in pCR rates, we designed this Phase II study in patients with T3/4 or N1/2 loco-regionally advanced rectum cancer, to examine the efficacy and safety of the addition of bevacizumab to a regimen of capecitabine and oxaliplatin in combination with pre-operative radiation.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the colon or rectum.
* T3 or T4 adenocarcinoma or node positive colorectal tumours.
* Appropriate staging investigations of the primary tumour, either endorectal ultrasound or pelvic MRI.
* Male or female aged 18 to 70.
* Have a performance status ECOG of 0 or 1.
* Have a life expectancy greater than 6 months.
* Adequate organ function and coagulation parameters as measured by: WBC \> 4000/mm3, PLT \> 100000/mm3, Hb \> 10g/dL, ALT \< 1.5X ULN, AST \< 1.5X ULN, bilirubin \< 1.5mg/dL Serum creatinine \< 1.8mg/dL.
* Patient consent.

Exclusion Criteria:

* Known to have clinical or radiological evidence of distant metastases.
* Evidence of intestinal obstruction (except for those after enterostomy).
* Patients with a past history of colorectal surgery (except for enterostomy), chemtherapy, radiation, biotherapy or targeted therapy.
* Pregnant woman OR women of childbearing potential with a positive pregnancy test at baseline or lactating.
* Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
* Patients with a past or current history (within last 5 years) of other malignancies, except for the indication under this study and curatively treated basal and squamous skin cancer or in-situ cancer of the cervix.
* Patients with mental disorder unable to complete the informed consent.
* Uncontrolled hypertension.
* Clinically significant (i.e. active) cardiovascular disease for example:

cerebrovascular accidents (\<=6 months), myocardial infarction (\<= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.

* Moderate or serious proteinuria.
* Known hypersensitivity against experimental drugs.
Neurosonographic Findings in Pregnant Women with Vitamin D Deficiency

In the study, the potential effects of vitamin D deficiency on fetal neurodevelopmental parameters will be examined. In this context, fetal brain development will be compared between pregnant women with and without vitamin D deficiency, revealing the possible neurodevelopmental outcomes of vitamin D deficiency during the prenatal period.

Vitamin D is a vitamin that regulates calcium and phosphorus balance in the body and plays a crucial role in bone health. Additionally, it is known to have effects on immune system functions and neurological health. Pregnancy is a period in which vitamin D requirements increase, and vitamin D deficiency can lead to various health problems. It is believed that vitamin D deficiency may have adverse effects on fetal neurological development and may be associated with certain pathological conditions during pregnancy.

Neurosonography is a critical tool for assessing the effects of prematurity, vitamin D deficiency, and other pregnancy complications on the fetus. This article will focus on the evaluation of neurosonographic findings in pregnant women with vitamin D deficiency.

Eligibility Criteria:
Inclusion Criteria:Patients presenting for routine antenatal care between 20-30 weeks of gestation will be included.

Exclusion Criteria:Multiple pregnancy, preterm rupture of membranes, chorioamnionitis, placental abruption, severe fetal growth restriction, congenital fetal anomalies, preeclampsia, oligohydramnios and maternal diabetes.