cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma).
* 18 years or older
* An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks)
* Karnofsky performance score equal to or greater than 70%
* Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters
* Serum creatinine less than 1.5 X upper limit of normal (ULN), serum SGOT less than 2.5 X ULN; and bilirubin less than 1.5 times ULN
* Signed informed consent form and authorization for use and disclosure of protected health information approved by the IRB prior to patient entry
* Agree to use effective contraceptive methods

Exclusion Criteria:

* Current, active systemic bleeding or excessive risk of bleeding
* Be pregnant or lactating; not employing effective birth control
* Concurrent severe and/or uncontrolled medical disease
* Impairment of gastrointestinal (GI) function/disease
* Requirement for therapy with coumadin (warfarin sodium)
* Patient is less than 5 years free of another primary malignancy
* Patients unwilling to or unable to comply with the protocol
* Grade 2 or greater peripheral sensory neuropathy
Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo

This research is studying how Vitamin D may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid hormone levels. The purpose of this study is to find out if paricalcitol has other benefits beyond its ability to lower parathyroid hormone levels such as improving the blood vessels reaction to stress and decreasing blood levels of substances that may increase blockages in the blood vessels.


Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥ 18 years of age at the start of screening
* CKD with eGFR 15-60 mL/min/1.73m2 by MDRD
* Not expected to start dialysis for 4 months
* Serum intact PTH 70-200 pg/mL during screening period
* On stable ACEI/ARB regimen for 30 days prior to screening

Exclusion Criteria:

* History of any of the following diseases:

  * congestive heart failure
  * MI within the last 6 months
  * history of cerebrovascular accident
  * significant valvular disease
  * malignancy
* Currently taking any vitamin D products
* Mean systolic blood pressure values \> 190 or diastolic blood pressure values \> 100 mm/Hg during the preceding 30 day period prior to screening
* Currently being titrated on therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker
* Two consecutive serum calcium values greater than 10.2 mg/dL or Ca x P \> 55 mg2/dL2
* Currently receiving erythropoiesis stimulating agent or intravenous iron therapy
* Pregnant or breastfeeding
The Using Postoperative Ketamine and Exploring the Effect on Endometriosis Pain (UPKEEEP) Study

This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6 mg/kg) of ketamine versus placebo (saline) on postoperative pain and pain on adult female chronic pelvic pain patients undergoing robotic removal of endometriosis. The objective of the study is to explore the effect of a sub anesthetic dose of ketamine (0.6 mg/kg) vs. saline control on postoperative pain and recovery in chronic pelvic pain patients who have undergone robotic removal of endometriosis.


Eligibility Criteria:
Inclusion Criteria:

1. Adults, aged 18 to 65 years old
2. Experiencing chronic pain, defined as experiencing moderate to severe pelvic pain for greater than 6 months
3. Scheduled to undergo robotic endometriosis removal surgery
4. Willing to comply with all study procedures and be available for the duration of the study.
5. Subject is medically stable.

Exclusion Criteria:

1. Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety.
2. Past ketamine or phencyclidine misuse or abuse
3. Schizophrenia or history of psychosis
4. Known sensitivity or allergy to ketamine
5. Liver or renal insufficiency.
6. History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated
7. Pregnancy or nursing women
8. Currently participating in another pain interventional trial
9. Unwillingness to give informed consent
10. Non-English-speaking patients as the EHP-30 instrument has only been licensed to NYULH in English.
Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C) uptake. This study is being done to investigate the effects of IBI306 in Chinese people with non-familial hypercholesterolemia with very high or high cardiovascular risk. This study will see if IBI306 will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of IBI306 in Chinese non-familial hypercholesterolemia Subjects with very high or high cardiovascular risk. A total of around 600 subjects who meet admission criteria will be randomized and receive one of the two dose levels of IBI306 or matching placebo: 450mg Q4W, or 600mg Q6W. The double blind period for both groups will be 48 weeks. The study will last 52 weeks

Eligibility Criteria:
Inclusion criteria:

1. Males and females ≥ 18 to ≤ 75 years of age
2. Diagnosis of hypercholesterolemia
3. LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
4. Very high or high cardiovascular risk
5. TG≤500 mg/dL(5.64 mmol/L)

Exclusion criteria:

1. Diagnosis of HoFH or HeFH
2. Uncontrolled hypertension
3. Uncontrolled hyperthyroidism or hypothyroidism
4. Severe renal dysfunction
5. Known sensitivity to any of the products to be administered during dosing
Comparing Foley Catheter Balloon With Early Amniotomy for Induction of Labor at Term

This study evaluates the intervention for induction of labor with low bishop scores . One group will be induced by transcervical Foley catheter balloon and vaginal PGE2 and other group will be induced by early amniotomy and PGE2 vaginal ovule for induction of labor at term.

An unfavorable cervix during induction decreases the success rate of labor induction and vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable cervices. Application of transcervical Foley catheter is an effective mechanical method and has the advantages of lower cost and lowest rate of fetal heart rate changes due to tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1 and PGE2 are reported to be more effective than mechanical methods to achieve vaginal delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon catheter. Early amniotomy is another effective method to ripen cervix. we aim to evaluate which method is superior to another.

Eligibility Criteria:
Inclusion Criteria:

1. singleton pregnancy,
2. gestational age ≥37 weeks,
3. intact membranes,
4. cephalic presentation,
5. bishop score ≤5,
6. had obstetrical indications for induction of labor,
7. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria:

1. Patients who had contraindications for vaginal delivery,
2. previous uterine surgery,
3. fetal malpresentation,
4. multifetal pregnancy,
5. more than three contractions in 10 minutes,
6. contraindications to prostaglandins,
Improving Treatment Engagement for Adolescents With Bulimia Nervosa

Although 4.7% of adolescents suffer from symptoms of bulimia nervosa (BN), only 1/5 seek treatment. Hesitation to seek treatment is likely related to ego-syntonicity and fear of disclosing symptoms to parents and clinicians. Furthermore, the physical symptoms of BN often go unnoticed by parents and clinicians.

In order to eliminate the barriers that prevent adolescents from seeking treatment, this study will offer anonymous access to online self-help cognitive behavioral therapy (CBT) for BN. Online CBT (traditional, non-anonymous delivery) has been found to be effective and acceptable treatment for adolescents with BN. Furthermore, in adults, this method has been found to be as effective as specialized treatments, and more cost efficient.

To remain anonymous and accessible, the self-help approach in this study will be provided in a non-guided, or pure format (only online sessions). Studies support that a pure self-help methodology is as effective as a guided version.

Although anonymity may improve accessibility, this study design could also pose challenges in areas such as recruitment, treatment completion and obtaining adequate informed consent. Therefore, before embarking on a larger randomized control trail, we would like to propose a small, non-controlled feasibility study to assess potential issues in these areas.

Primary hypotheses:

Recruitment: Based on communication with public health nurses in the high schools we plan to recruit from, we hypothesize that it is feasible to recruit 1-5 adolescents over a 4-month period from each of the 5 schools, and 1-5 from social media outlets such as Instagram, Twitter, Facebook for a total of 5 participants over a 4-month period.

Treatment completion: Based on pervious studies of self-help for adolescent bulimia, we hypothesize that approximately 15% of participants will not complete any sessions, and many will only complete about half of the sessions.

Informed consent: Based on information from large randomized control studies in the UK, we hypothesize that adolescents will be capable of providing online consent, and that we will be able to adequately obtain consent without verbally communicating with participants.

Secondary hypothesis:

We hypothesize a non-guided (pure) version of online CBT-BN offered in an anonymous manner will decrease BN symptoms after treatment completion, and at 3-month follow-up compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents with symptoms of BN (full threshold or subthreshold) defined by self-reported symptoms of binging and compensatory behaviours (self-induced vomiting, laxative abuse, diet pills, and diuretics). Excessive exercise and fasting will not be included due to the potential for subjectively in a self-report format.
* Ages of 16-18.
* Consent from the adolescent.

Exclusion Criteria:

* Adolescent is actively engaged in psychological treatment for bulimia nervosa.
Comparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers

Negative Pressure Wound Therapy (NPWT), is a non invasive wound management tool which develops from negative pressure being applied to the wound. This promotes healing through the removal of infectious materials and enhancing granulation tissue formation. NPWT eases debridement as well as promoting healing of different types of wounds.

Assessment of wound surface area was done by a graded plastic sheet and a metric graph paper, by counting the complete squares of the metric graph paper, while the wound size was done by using a 10 cm syringe filled with dermazin cream and filling the wound with it.

Negative pressure device: VAC system 125mmhg (KCI negative pressure equipment).

Wound surface area tracing tools:

* Sterilized transparent film.
* Fine tipped transparent marker.
* Carbon and a white A4 papers.
* Metric graph paper (1mm²).

Wound volume assessment procedure:

* Using a syringe of ten cubic centimeters filled with dermazin cream.
* The wound is filled with the cream
* The amount of cream injected into the wound was detected in cubic centimeters.

Eligibility Criteria:
Inclusion Criteria:

* They were free from immune deficiency diseases or collagen diseases.
* All patients were homeostasis.
* All patients were medically stable.
* All cases were chronic and did not heal with other treatment methods

Exclusion Criteria:

* 1. Malignancies or receiving radiotherapy. 2. Dermatological diseases. 3. Deep venous thrombosis. 4. Renal failure. 5. Immunosuppressant or anticonvulsants therapies.
Perioperative Evaluation of Immuno-inflammatory Parameters

This study consists of evaluations, using blood tests, various immune, inflammatory and coagulation parameters in the perioperative settings (different substudies), without changing anything to what is expected.

This will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.

A significant number of published data can be concluded that surgery and anesthetic and analgesic techniques have an impact on immunity and inflammation.

However, none of these studies have been performed with modern techniques, much more reliable evaluation of immune activity, such as the assessment of monocytic degranulation by flow cytometry.

It is therefore important to document immune activity using these new techniques, our patients, perioperative. This will be analyzed, so observational, the potential impact of different therapeutic interventions the patient receives.

This study consists of evaluations, using blood tests, various immune, inflammatory and coagulation parameters in the perioperative settings (different substudies), without changing anything to what is expected.

This will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.

Eligibility Criteria:
Inclusion Criteria:

* Surgical patients (and controls)

Exclusion Criteria:

* Immune disorders
A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients

The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* A patient for whom the physician has decided to initiate treatment with a Luteinizing Hormone Releasing Hormone (LHRH) agonist in standard clinical practice
* Biopsy-proven prostate adenocarcinoma
* Locally advanced prostate cancer with biochemical relapse radical prostatectomy and/or radiotherapy, OR hormonal treatment-naive advanced or metastatic prostate cancer patient who has not received chemotherapy and has no plans to undergo treatment with chemotherapy at study entry.
* Patient who indicates that once the study is completed, he expects having access to androgen deprivation therapy (ADT), either medical or surgical, within the local healthcare system (either through public/ private health insurance or out of pocket payment).

Exclusion Criteria:

* Patient with castrate resistant prostate cancer
* Patient who previously underwent bilateral orchiectomy
* Patient who has received prior treatment with LHRH analogues
* Prior or concomitant treatment with systemic chemotherapy. A patient where there is a likelihood to receive systemic chemotherapy should not be enrolled
* Life expectancy of \< 1 year due to comorbidities
* Participation in another interventional clinical trial within one month prior to study entry or during the duration of the study
* Patient who plans to receive intermittent ADT at the time of study entry
* Patient receiving non-palliative radiotherapy within 3 months prior to study entry
* Patient receiving adjuvant ADT in combination with definitive radiotherapy
* Patient with metastatic hormonal treatment-naive prostate cancer, for whom chemo-hormonal treatment (combination of Docetaxel and ADT) is indicated.
* Patient with hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonist analogs or any of the components of ELIGARD®
* Patient with any contraindication for ELIGARD® use based on local prescribing information
A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis

This study consists of three parts: single oral dose escalation in healthy volunteers (Part A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants with chronic plaque psoriasis (Part C)


Eligibility Criteria:
Inclusion Criteria:

Parts A and B

* Be 18 to 55 years old
* Be healthy with absence of clinically significant illness
* Male participants must agree to use medically accepted methods of contraception with all sexual partners during the study, and for 90 days after
* Female participants must be postmenopausal or surgically sterile
* Have venous access sufficient for blood sampling
* Be a non-smoker

Part C

* Be 18 to 75 years old
* Have chronic plaque psoriasis based on a confirmed diagnosis of plaques for at least 6 months
* Have at least 2 evaluable plaques located in at least 2 body regions

Exclusion Criteria:

Parts A and B

* Significant abnormalities in vital signs, laboratory tests, electrocardiogram, or history of heart disease, some allergies, or infections
* Hepatic or renal impairment
* Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
* Female participants who are pregnant or breast feeding
* Recent or ongoing infection
* History of alcohol or drug abuse
* Current or recent enrollment in a clinical trial judged not compatible with this study

Part C

* Have highly active psoriatic arthritis
* Have pustular, erythrodermic and/or guttate forms of psoriasis
* Have had a clinically-significant flare of psoriasis during the last 12 weeks
* Currently or recently taking certain prescribed therapies for psoriasis
* Use of selected topical treatments within 4 weeks prior to starting the study (use of some emollients without urea is allowed, except on one lesion for biopsy)
Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)

The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).

This is a Phase 1/2, first-in-human, multicenter, open-label, single arm dose escalation trial of XC001. Approximately 12 subjects (N=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion of the highest tolerated dose with 32 additional subjects. XC001 will be administered by a transthoracic epicardial procedure. Safety will be the focus for the initial 6 months after XC001 administration followed by one safety focused telephone evaluation at Month 12.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age 18 to 80 years
* Diagnosis of chronic angina due to obstructive coronary artery disease that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft or percutaneous coronary intervention
* Angina class II-IV based on Canadian Cardiovascular Society Classification of Angina Pectoris
* Adequate hematologic (hemoglobin ≥ 10 g/dL, absolute neutrophil count \> 1.2 × 10\^3 per μL and platelet count ≥ 75,000 per μL), hepatic (alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN; total bilirubin ≤ 2 x ULN), and renal function (glomerular filtration rate \> 29 mL/minute/1.73 m2)
* Adequate birth control if of child-bearing potential
* Must be willing and able to provide informed consent

Exclusion Criteria:

* ST elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) not requiring revascularization, transmural myocardial infarction or cerebral vascular accident within the past 30 days
* New York Heart Association Function Class III or IV or left ventricular ejection fraction \< 25% within the 6 weeks prior to the screening visit
* HbA1c ≥ 8.5%, SBP \<90 or \>180 mmHg, DBP \>100 mmHg
* Other concurrent medical conditions that could jeopardize the safety of the subject or objectives of the study
12 Week Open, Non-Comparative Switch Study Of Oral Ziprazidone In Previously Treated Schizophrenic Patients

There has been evidence that ziprasidone is efficacious in decreasing the magnitude of both positive and negative symptoms of schizophrenia, and also effective in the treatment of depressive symptoms. It shows good tolerance with low incidence of extrapyramidal side effects and does not significantly influence body weight. As it has been shown that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy. The purpose of the study was to provide further evidence for the efficacy and safety of patients with schizophrenia and allow for psychiatrists in Hungary to gain experience with the drug before wide commercial availability.

Study was terminated due to difficulty in enrolling the targeted number of patients on March 1, 2005, last subject last visit date was Feb.16, 2005. There were no safety concerns involved in the decision to terminate the trial.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of schizophrenia according to DSM-IV-IV from patient's medical files
* subjects with current treatment with typical or atypical neuroleptics which should be changed

Exclusion Criteria:

* patients with significant cardiovascular illness (recent acute myocardial infarction, uncompensated heart failure, cardiac arrhythmia)
* in the patients' history clinically significant ECG abnormalities particularly prolongation of QT interval of more than 500 ms