cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

This study will evaluate the safety and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable local-regional cancer and who have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s).

For carcinoid, despite the many cytotoxic chemotherapy trials that have been conducted, no regimen has demonstrated a response rate of more than 20% using the criterion of a 50% reduction of bidimensionally measurable disease. In the more recently reported ECOG phase III study of chemotherapy in carcinoid tumors (E1281), patients were randomly assigned to treatment with 5-fluorouracil (5FU) plus doxorubicin or 5FU plus streptozocin. The median progression free survival durations were disappointing. They were 4.5 months in the 5FU plus doxorubicin arm and 5.3 months in the 5FU plus streptozocin arm. Overall survival durations recorded in the trial were also suboptimal at 15 and 24 months respectively. There is no clear survival benefit for cytotoxic chemotherapy.

This is a phase II, multi-center, open-label study of the safety and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable local-regional cancer and who have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s) (defined as the appearance of one or more new lesions or a 20% increase in the sum of the longest diameter of target lesions during the 6 months prior to enrollment). A maximum of 40 evaluable patients will be enrolled in this study. Atiprimod will be administered orally as a single daily dose of 120 mg/day for 14 days, followed by a 14-day treatment-free period (i.e., 1 treatment cycle = 28 days).

Eligibility Criteria:
Inclusion Criteria:

* Patient must have documented histologic proof of low or intermediate grade neuroendocrine carcinoma. Both carcinoid (any site; atypical/intermediate grade carcinoid is allowed) and islet cell (pancreatic endocrine tumor) will be eligible. Patient with neuroendocrine tumors associated with MEN1 syndrome will be eligible.
* Patients must have either metastatic or unresectable local-regional cancer. Patients with brain metastases are allowed on study, but they must have evaluable target lesions elsewhere.
* Patients must have measurable disease, as defined by RECIST.
* Patients must have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s) (defined as the appearance of one or more new lesions or a 20% increase in the sum of the longest diameter of target lesions during the 6 months prior to enrollment).
OPALS Critical Care Sub-Studies

The purpose of the study is to evaluate the incremental benefit of a full advanced life support EMS program on the outcomes of chest pain, respiratory and major trauma patients.


Eligibility Criteria:
Inclusion Criteria:

* Chest Pain Sub-Study: Adult patients with a complaint of chest pain of an acute nature transported to hospital by ambulance. Patients with a complaint of pain in arms, neck or jaw if consistent with myocardial ischemia. Patients must have an ambulance return code of prompt, urgent, or no patient carried.
* Respiratory Sub-Study: Adult patients with a chief complaint of shortness of breath defined as ACR codes of Respiratory Failure, Shortness of Breath NYD, Pulmonary Edema (CHF), Asthma and had either prehospital assisted ventilation or abnormal respiratory rates (\&gt;=24 or \&lt;=10)
* Major Trauma Sub-Study: Adult patients who have suffered an injury from any mechanism with an Injury Severity Score of \&gt;12 who have been transported to hospital by land ambulance, and who have been entered into the Ontario Trauma Registry (OTR) Comprehensive Data Set.

Exclusion Criteria:

* All Sub-Studies:
* Patients under the age of 16
* Patients who are vital signs absent prior to EMS arrival.
* Chest Pain Sub-Study:
* Patients suffering primarily from respiratory distress, respiratory failure, pulmonary edema, asthma, palpitations or epigastric pain. pain
Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

The teaching platform of the TCM daycare clinics for depression patients will provide a good clinical training environment for the trainees. They can learn how to take care of depression patients by the lectures and the clinical practice experiences in the daycare clinics. They can also learn a holistic approach, a patient-centered healthcare service. This teaching model will strengthen the clinical training of TCM and enhance the international competitiveness of TCM doctors.

Major depressive disorder (MDD) is a serious psychiatric illness with a high lifetime prevalence rate and causes major clinical, social and economic burden to patients and their family. Despite that more than 40 antidepressants with various mechanisms are available on the market, half of patients fail to achieve remission with optimized medication treatment because of unsatisfactory efficacy, frequent intolerability and poor compliance of pharmacotherapies. However, Traditional Chinese medicine (TCM) is a safe and effective therapy which has many previous evidences to improve the treatment of depression. The aim of this project is to build up a TCM clinical daycare model for depression patients, and to establish a teaching platform for TCM trainees.

The TCM daycare model will be provided by a team organized by doctors, nurses, pharmacists, psychologist, nutritionist and case managers. This model will provide a comprehensive TCM care system to improve the clinical symptoms and quality of life of depression patients.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of depression according to DSM-IV (Diagnosis code: 296.21-296.30, 300.4)
2. Age 18-65 years, male or female
3. Evaluation of the 21-item Hamilton Rating Scale for Depression (HAMD) 8 points or more
4. Fully understand the entire research plan and sign the informed consent form (aged 18-20 years old must be jointly signed by a legal agent)

Exclusion Criteria:

1. Have a diagnosis of mental illness other than depression in the last or past 6 months, including unipolar major depression, including dyslexia, organic mental disorder, impulse control disorder, substance use disorder, bipolar mental disorder or substance abuse.
2. Medical history of patients diagnosed with borderline, antisocial personality disorder
3. Take anti-psychotic disorders and anti-epileptic drugs in the past six months.
4. Have or may become pregnant
5. A person with serious suicidal ideation or suicide attempt who must be hospitalized for close monitoring
A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD).

The purpose of this study is to determine whether PF-03654746 is effective in the treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized, double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg), and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants will be required to washout of prior ADHD medication before entering the study. Participants will be required to come to the site for 10 visits over approximately a 10-week period.


Eligibility Criteria:
Inclusion Criteria:

Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview.

Male and female outpatients. Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview.

Female subjects must be of non-childbearing potential.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension), hepatic, neurologic, or allergic disease.

Current or lifetime history of psychosis or bipolar disorder; any current anxiety disorder (with the exception of social or specific phobia), or substance abuse or dependence in the past 6 months.

Current episode of Major Depression or episode within the last 6 months.
Prognostic Value of Hemodynamic Disturbances in Rhegmatogenous Retinal Detachment (CRADO-RED)

Retinal detachments correspond to a separation of the neuroepithelium from the pigment epithelium. They can be exudative (sometimes in conjunction with a tumor), tractional, traumatic (postoperative) or rhegmatogenous (in relation to a tear).

Ultrasound, requested when the fundus is difficult to achieve and shows a hyperechoic mobile membrane. It can also measure the hemodynamic parameters of retinal arteries.

A preliminary study showed a correlation between systolic velocity in the central retinal artery and postoperative visual acuity.

The aim of this study is to confirm those preliminary data.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* rhegmatogenous retinal detachment, relapsing or not, including pseudophakic retinal detachment or aphakic retinal detachment, if the retinal detachment occurs more than three months after phacoemulsification

Exclusion Criteria:

* traumatic retinal detachment
* bilateral retinal detachment
* less than 3 months after phakoemulsification
* predictable follow-up of less than 6 months
* patient under of legal protection
* patient's opposition to participate
* absence of affiliation to the social security
* eye's axial length\> 25.5 mm
* preoperative visual acuity greater than 70/100
* no surgery
Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System

The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.

All subjects enrolled in this study will receive the The Biomet Osteobiologic Treatment System which is comprised of the SpF® Spine Fusion Stimulator and any or all of the following can be utilized in the study: any Pedicle Screw System, autograft and an Interbody Spacer

Eligibility Criteria:
Inclusion Criteria:

1. The subject must, in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
2. The subject must be diagnosed with degenerative disc disease at up to 2 levels from L2-S1 inclusive and undergoing up to 2 level posterior lumbar spinal fusion surgery with or without anterior column fusion.
3. Subjects must be between 18 and 75 years of age.
4. The patient must be skeletally mature (epiphyses closed).

Exclusion Criteria:

1. Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
2. Any active litigation.
3. Subject is currently involved in another investigational study.
4. Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
5. Subject is incarcerated.
6. More than 2 prior spine surgeries/revision surgeries or any previous spinal fusions at levels being currently treated.
7. Traumatic instability.
8. Any parathyroid or metabolic bone disease.
9. Any active malignancy.
10. Osteopenia/Osteoporosis - All subjects will be screened for osteoporosis using SCORE (Simple Calculated Osteoporosis Risk Estimation) with a threshold value of 6. All subjects with a SCORE value greater than 6 will be referred for Dual-energy X-ray absorptiometry (DEXA) Scan. Subjects with a T-Score of £-1-2.5 will be excluded.
Tinostamustine and Nivolumab in Advanced Melanoma

This trial is a first-in-human drug combination with the first-in-class alkylating histone deacetylase inhibition (HDACi) fusion molecule Tinostamustine (EDO-S101) and the anti-PD-1 monoclonal antibody Nivolumab in patients with refractory, locally advanced or metastatic melanoma.

Despite improvement of systemic treatment in patients with advanced melanoma, there is still unmet medical need in this group of patients. Tinostamustine is a medication without marketing authorization, while Nivolumab is approved for several tumor entities. The primary objective of this trial is to assesses the safety, tolerability and recommended dose of Tinostamustine in combination with Nivolumab in patients with advanced melanoma.Secondary objectives of this trial in patients with advanced solid tumors are to assess the preliminary efficacy of Tinostamustine when given in combination with Nivolumab and to characterize potential predictive biomarkers of the combination treatment of Tinostamustine and Nivolumab. The trial includeds patients with either histologically or cytologically confirmed inoperable stage III or metastatic stage IV melanoma with an indication for the regular systemic treatment with Nivolumab and a maximum of 1 prior systemic palliative line of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Patients with either histologically or cytologically confirmed inoperable stage III or metastatic stage IV melanoma
* Indication for the regular systemic treatment with the anti-PD-1 monoclonal antibody Nivolumab monotherapy
* Patient received a maximum of 1 prior systemic palliative line of treatment
* ECOG ≤2
* Patients with brain metastases must have undergone definitive treatment (surgery or radiotherapy) at least 2 weeks prior to starting study drug and be documented as having stable disease by imaging
* Adequate bone marrow, renal and hepatic function
* Adequate contraception

Exclusion Criteria:

* Prior treatment with a PD-(L)1 targeted monoclonal antibody
* Patients who have received systemic treatments or radiotherapy within 2 weeks prior to starting study drug
* Concomittant treatment with systemic steroids at a daily dose equivalent to ≥10mg of prednisone, or concomittant treatment with immunosuppressive drugs such as methotrexate
* Patients with a prior malignancy are excluded (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, colon,cervical/dysplasia, melanoma, or breast). Patients with other second malignancies diagnosed more than 2 years ago who have received therapy with curative intent with no evidence of disease during the interval who are considered by the Investigator to present a low risk for recurrence will be eligible.
* NYHA stage III/IV congestive heart failure and/or arrhythmia not adequately controlled
* QTc interval (Fridericia's formula) \> 450msec
* Patients who are on treatment with drugs known to prolong the QT/QTc interval (Credible Meds list:

Known risk of TdP. https://www.crediblemeds.org).

* Pregnant and breast feeding patients
Single Patient Compassionate Use of X-PACT in Salvage Treatment of Prostate Cancer

Due to the subject's lack of conventional treatment options, a treatment plan using X-PACT administered intra-tumorally is proposed.

X-PACT (X-ray Psoralen Activated Cancer Therapy) is comprised of a phosphor device (an energy modulation agent), methoxsalen sterile solution (a psoralen), X-ray energy and represents a potential new approach for the treatment of solid tumors.

Methoxsalen is a psoralen found in the seeds of the Ammi majus (Umbelliferae) plant.

Importantly, methoxsalen (whether formulated as the sterile solution \[Uvadex®\] or as a hard gelatin capsule \[8-MOP®\]) can promote a strong long-term clinical response, as observed in the treatment of cutaneous T cell lymphoma (CTCL) utilizing extracorporeal photopheresis (ECP) and is approved by the United States Food and Drug Administration \[US FDA\] for this indication. In ECP, malignant CTCL cells are irradiated with UVA light in the presence of methoxsalen and then re-administered to the patient.

X-PACT may offer the potential for local control of primary or metastatic disease via administration of the combination product of methoxsalen and powerful energy converters

(Phosphors) when activated by x-ray beam. In addition, there is numerous data in support of an immunogenic role for activated methoxsalen. The cytotoxic and immunogenic effects of psoralens are often attributed to psoralen mediated photo-adduct DNA damage \[1\]. A principle mechanism underlying the long term immunogenic clinical response likely derives from psoralen induced tumor cell cytotoxicity and uptake of the apoptotic cells by immature dendritic cells, in the presence of inflammatory cytokines \[2, 3 4, 5\]. However, photochemical modification of proteins and other cellular components can also impact the antigenicity and potential immunogenicity of treated cells \[6\]. The diversity and potency of psoralen application is further illustrated by recent success using psoralen in the development of virus vaccines \[7\]. The immunogenic activity of methoxsalen supports a potential abscopal effect for X-PACT particularly as it incorporates both radiation and an immunotherapeutic.


Eligibility Criteria:
Inclusion Criteria:

The patient is willing and able to provide informed consent. Only the patient for whom this clinical study/experimental treatment was designed will be given the investigational drug under the treatment of the PI. No other patient is authorized to participate in or to receive treatment under this treatment protocol.

Exclusion Criteria:

Not applicable
Thyroid Dysfunction in Head and Neck Surgery Patients

Specific Aim I: Determine absorption of iodine after oropharyngeal application of povidone-iodine 10% solution when used in head and neck surgery involving the upper aero-digestive tract.

Specific Aim II: Measurement of iodine induced changes in thyroid function.

Serial blood draws will be obtained from approximately 10 men and women age 18 and over who have been exposed to intraoperative oropharyngeal application with povidone-iodine 10%. Baseline serum and 24-hour urine iodine levels will be measured preoperatively. Serum iodine levels will be drawn at 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 1 week, and 1 month after exposure. A postoperative 24-hour urine iodine level will also be obtained. With the above measurements, the amount of iodine absorption as well as the time period of peak absorption and duration of elevated iodine levels will be elucidated.

Thyroid hormone metabolism is highly dependent on serum levels of iodine. Thyroid function will be assessed by measuring serum levels of free thyroxine, free triiodothyronine, and thyroid stimulating hormone also at 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 1 week, and 1 month after exposure. Measuring thyroid function is important since hypothyroidism has been known to have a major impact on postoperative wound healing.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing any head and neck surgery requiring entry into the upper aerodigestive tract and thus necessitating the oral administration of the antimicrobial agent povidone-iodine 10%.

Exclusion Criteria:

* Patients with history of hypothyroidism currently taking thyroid hormone medications (i.e. Synthroid, Levothyroxine, Thyroxine) and women who are pregnant.
ONO-7746 Study in Healthy Adult Subject

The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of ONO-7746 when administered with or without a meal.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI) of 19-35 kg/m2 (inclusive)
* For females, postmenopausal, non-lactating, and non-pregnant

Exclusion Criteria:

* History or presence of clinically significant disease
Cathelicidin LL-37 Relation to Potentially Malignant Lesions

LL-37 appears to have a potential role in potentially malignant lesions (OLP \& leukoplakia). The remarkable diagnostic accuracy of salivary LL-37 in differentiating potentially malignant lesion and healthy control could confirm its utilization as an innovative marker to early diagnose potentially malignant lesions. Salivary LL-37 being non-invasive accurate marker could be as a chair-side diagnostic method that detect potentially malignant lesions.

Aim: The recognition of practical early diagnostic biomarkers is a cornerstone of improved prevention and treatment of cancer thus the current study estimated salivary level of Cathelicidin LL-37 in patients suffering from potentially malignant lesions and control subjects to corroborate Cathelicidin LL-37 as a diagnostic marker for early detection of potentially malignant diseases and revealing its possible role in carcinogenesis.

Methodology: 45 systemically healthy individuals were subdivided into three groups: Group I: 15 Healthy participants without any oral lesions. Group II: 15 Patients having atrophic/erosive oral lichen planus (OLP). Group III: 15 Patients having oral leukoplakia.. Enzyme linked immune-sorbent assay (ELIZA) kit was used to evaluate the level of LL-37 in whole unstimulated salivary samples collected from all participants. To reveal AUC, sensitivity, specificity, and diagnostic accuracy of LL-37 receiver operating curve (ROC) analysis was done.

Eligibility Criteria:
Inclusion Criteria:

* Both genders with age range 30 - 70 years.
* Patients agreed to sign a written consent after understanding the nature of the study.
* Clinically diagnosed and histologically confirmed as having oral potentially malignant lesions mainly atrophic/erosive oral lichen planus and oral leukoplakia.

Exclusion Criteria:

* Systemic diseases as well as pregnant or lactating females.
* Patients currently taking corticosteroids, immunosuppressives drugs, contraceptive pills, or antibiotics.
* Patients are diagnosed with any other oral lesions other than oral lichen planus and oral leukoplakia.
* Vulnerable subjects as prisoners, or mentally disabled.