cyrilzakka/clinical-trials huggingface dataset:
Phase I Study of Oral Darinaparsin (ZIO-101-C)in Advanced Solid Tumors and Non-Hodgkin's Lymphomas

The study of Dariniparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas


Eligibility Criteria:
Inclusion Criteria

1. Patients with non-Hodgkin's Lymphomas that are refractory to standard therapies for their condition.(As of protocol amendment 6.0 dated 8/26/2009)
2. Men and women of ≥ 18 years of age.
3. ECOG performance score ≤ 2 (see Appendix 4).
4. Eligible subjects with lymphomas must have measurable disease as defined by the revised International Working Group response criteria (Appendix 7)
5. Life expectancy ≥ 12 weeks.
6. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted \<2 weeks prior to Baseline:

   * Creatinine ≤ 2X upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 50 cc/min
   * Total bilirubin ≤ 2X ULN
   * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN
   * Granulocytes in peripheral blood ≥1 x 109/L, hemoglobin ≥8.5 g/dL, and platelets ≥50,000 /µL
7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.

Exclusion Criteria

1. New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix 5) within 6 months.
2. Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥Grade 2 atrioventricular (AV) block or left bundle branch block (LBBB); or documented history of prolonged QTc.
3. Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of Study participation.)
4. Uncontrolled systemic infection (documented with microbiological studies).
5. Metastatic brain or meningeal tumors.
6. Patients with seizure disorder requiring medication (such as anti-epileptics).
7. History of confusion or dementia or neurological condition that could mask a potential adverse response to Study Drug which may include transient ischemic attack, Parkinson's disease, thrombotic or hemorrhagic stroke, Alzheimers, and other neurological disorders.
8. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of Study entry (mitomycin C or nitrosureas should not be given within 6 weeks of Study entry).
9. Radiotherapy during study or within 3 weeks of Study entry.
10. Surgery within 4 weeks of start of Study Drug.
11. Investigational drug therapy outside of this trial during or within 4 weeks of Study entry.
12. History of invasive second primary malignancy diagnosed within the previous 3 years except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.
13. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of Study results.
14. Any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the Study.
15. Arsenic allergy.
Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001

The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.


Eligibility Criteria:
Inclusion Criteria include:

1. Male and female patients aged 6 to 17 years, inclusive, who completed the 4-week study drug treatment in study OTR3001 and who, based on the investigator's judgment, will benefit from continuing treatment with oxycodone HCl CR 20 to 240 mg/day for the management of moderate to severe malignant or nonmalignant pain;
2. Patients must have tolerated the oxycodone HCl CR therapy in OTR3001 as demonstrated at the start of the study;
3. Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.

Exclusion Criteria include:

1. Patients with ongoing adverse events in OTR3001 that, in the investigator's opinion, disqualify them from participation in the study;
2. Female patients who are pregnant or lactating;
3. Patients requiring opioid at doses equivalent to \< 20 mg/day or \> 240 mg/day oxycodone for treatment of their malignant or nonmalignant pain;
4. Patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects \[eg, nausea, constipation\]);
5. Patients who are contraindicated for the use of opioids;
6. Patients who are currently being maintained on methadone for pain;
7. Patients who have an abnormality on vital signs, physical examination, or laboratory testing significant enough that the investigator deems the patient is not appropriate for the study;
8. Patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices;
9. Patients currently taking an investigational medication/therapy other than the study drug (oxycodone HCl CR) at the start of screening or during the study.

Other protocol specific inclusion/exclusion criteria may apply.
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers

The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group.

The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the first vaccine dose and to further investigate the prevalence and incidence of other hepatitis B markers and the clinical significance of these at all time points from Year 16-20.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who had received at least one dose of the study vaccine in the primary study (103860/064)
* Written informed consent obtained from each subject before each blood sampling visit
OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up

In vitro fertilization (IVF) cycles are increasingly performed worldwide. Transvaginal oocyte pick-up (OPU) is a painful part of IVF. OPU in polyfollicular IVF is usually performed under sedation and pain relief. In natural cycle IVF or IVF with minimal stimulation OPU is possible without anesthesia. Mostly of the women reported experiencing mild to moderate pain when undergoing OPU without anesthesia. Nevertheless, there is a need for alternative pain treatment options during OPU to reduce the burden of IVF for patients. Virtual reality (VR) may have a role in acutely painful procedures as a non-pharmacological alternative. VR refers to the interactions between an individual and a computer-generated environment stimulating multiple sensory modalities. The immersive, entertaining effects of VR could be useful for redirecting the patient's attention away from painful treatment experiences and reducing anxiety, discomfort, or unpleasantness. Use of VR interventions has been studies in a wider range of medical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 43 years
* IVF with follicular aspiration of one to tree follicles
* Written informed consent signed by the participant must be obtained prior to OPU

Exclusion Criteria:

* OPU with more than tree follicular aspiration
* Individuals' anatomy complicating the intervention (e. g. endometriosis stage III/IV)
* Application of analgesics within eight hours before OPU
* hearing impairments
* migraines
* seizure disorder
* vestibular abnormalities
* history of motion sickness
Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery

The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard colonoscopy in patients with prior colorectal surgery.

The hypothesis is to validate the VCC as a means of screening for colonic polyps after resection, which would avoid a colonoscopy with its associated general anesthesia and potential side effects.

Standard care after colorectal surgery is colon surveillance by standard colonoscopy with its benefits (gold standard examination, resection of lesions) and disadvantages (acceptability, general anesthesia, availability of qualified personnel, risk of perforation and associated gastrointestinal bleeding).

Use of a video-capsule (VCC) is a new, non-invasive technique, that allows to visualize the colon as a whole. This technique has the advantage of not requiring general anesthesia or air insufflation. The examination is performed as an outpatient procedure and therefore does not require hospitalization.

In previous studies, PillCam COLON 2 showed a good sensitivity and specificity in detecting colorectal lesions. However, its use requires an excellent bowel preparation.

To date, no study has been conducted using the VCC in monitoring patients with prior colorectal surgery, especially on the passage of the VCC through surgical anastomosis. No information on VCC capabilities to view and recognize surgical anastomoses and VCC transit time in surgically modified colon is available. The possibility to precisely locate a colorectal lesion prior to surgery, using the VCC, also remains to be studied.

The study requires a 2-month patient participation. The planned total study duration is 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. patient between 18 and 85 years old
2. patient with greater than 3 month follow-up for colorectal resection with ileo-colic , colo-colic or colorectal anastomosis, regardless of etiology
3. patient requiring a colonoscopy for regular medical care
4. absence of contra-indication to anesthesia and to colonoscopy conduct
5. patient able to understand the study related information and to provide written informed consent
6. patient registered with the French social security regime

Non-inclusion Criteria:

1. absence of written informed consent
2. patient having had a total colectomy
3. patient with terminal stoma
4. patient with clinical suspicion of intestinal stenosis and/or anastomotic stenosis
5. patient with known Zenker diverticulum
6. patient wearing a pacemaker or any other internal electronic medical device
7. patient with deglutition disorders and/or altered state of consciousness
8. patient with serious disease preventing planned study procedures
9. pregnant or breast-feeding woman
10. patient within exclusion period from other clinical trial
11. patient having forfeited their freedom of an administrative or legal obligation
12. patient being under guardianship
Letrozole as a Treatment of Endometrial Cancer

Some cases of endometrial cancer are dependent on estrogen for their growth. Letrozole blocks estrogen production in the body. The purpose of this study is to determine if the investigators can predict which patients might benefit from Letrozole treatment by studying the many different forms of the estrogen receptor molecule that exist within the cancer tissues. To participate in this study, the patients must be 40 years of age or older and have biopsy-proven endometrial carcinoma, either well differentiated or moderately differentiated forms. Also, to be eligible to participate in this study, the patients need to be healthy enough to have a hysterectomy. If the patients are less than age 60, they will need a blood test (FSH) to confirm that they have gone into menopause.


Eligibility Criteria:
Inclusion Criteria:

* FIGO grade 1 or 2 endometrioid adenocarcinoma of the endometrium
* Post menopausal status must be demonstrated
* Signed informed consent

Exclusion Criteria:

* FIGO grade 3 endometrioid adenocarcinoma or non-endometrioid cancers of the endometrium
* Younger than 40 or postmenopausal status not established
* Pregnant or breastfeeding
Effect of Maternal Smoking On Neonatal Lung Function

To determine factors, including maternal cigarette smoking and acute respiratory illness, influencing infant lung function at birth and up to five years of age.

BACKGROUND:

Over the past four decades, a significant research effort has been devoted to the understanding of the epidemiology and pathophysiology of chronic obstructive airways disease (COPD) in adult life. Epidemiologic studies uniformly have identified cigarette smoking as the predominant risk factor for the occurrence of COPD. Other factors such as socioeconomic status, environmental pollution, occupational exposures, and inherent genetic susceptibility have been observed to have very limited roles as risk factors.

A number of studies have suggested that postnatal maternal cigarette smoking has a measurable effect on lung function in children. One longitudinal analysis of this problem in children 5-19 years of ages identified significant effects on the growth of FEV1 and forced expiratory flow between the 25th and 75th percent volume points (FEF25-75) of the volume-time curve. These investigators, however, pointed out that the effects which they observed could have resulted from the in utero consequences of maternal smoking during pregnancy and/or from exposure to factors such as severe respiratory illnesses which have been documented to occur with increased frequency early in infancy and were not measured by the study.

DESIGN NARRATIVE:

Pregnant women were identified during the first trimester and followed monthly. Assessments were made of their smoking habits, urinary cotinine measurements, general medical condition, and status of pregnancy. Within two weeks of birth the infants were evaluated with partial forced expiratory flow-volume curves and measurement of passive respiratory system compliance and resistance. Measurements were repeated at intervals until age five. Babies were also observed regularly for respiratory illness experience, passive exposure to cigarette smoke, and general respiratory health.

The study helped to elucidate: the effect of maternal cigarette smoking on lung function at birth and development of function at five years; the effects of postnatal factors on lung development; the extent to which the reported increased frequency of respiratory illness in infants of smoking mothers resulted from in utero exposure to tobacco smoke products or postnatal passive smoking.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery

The investigators are randomizing patients to receive chewing gum (Extra Sugar Free, Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. The investigators then have them fill out a survey in house and 1 week after their surgery that record time to first flatus, hunger, toleration of clear liquids and food and some information about pain, satisfaction, and quality of life. The investigators contact them via phone and email a maximum of three times in order to collect this information. 30 days postoperatively the investigators also contact them and perform a chart review for any postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Undergoing benign gynecologic surgery via an exploratory laparotomy
* Capable of giving consent

Exclusion Criteria:

* Oromaxillary or mental disturbances that would make chewing gum dangerous with regards to mastication or aspiration
* Intubated or unconscious when leaving the OR
* Bowel resection performed at the time of surgery
* Active bowel disease (IBD, appendicitis, etc)
* Gynecologic malignancy
Severe Anemia Treatment Trials, Pakistan

The purpose of this study is to test the efficacy of two enhanced regimens (deworming and multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months of age in Karachi, Pakistan.

Anemia continues to be a public health problem of global proportions. Severe anemia (hemoglobin, Hb\< 70 g/L) is of special concern as it poses a significant health and mortality risk. Pregnant women and young children (6-24 months of age) are the two groups at highest risk. Severe anemia in pregnant women is associated with an elevated risk of maternal and perinatal mortality as well as case fatality. Pakistan, the country in which this study is ongoing, may harbor the highest prevalence of severe anemia in South Asia, with as high as 15% being reported among pregnant women. Comparable rates (11-12%) are also seen among 6-24 month old children. Iron deficiency is one of the major causes of anemia in young children and pregnant women in South Asia. In addition to iron, deficiency of vitamins such as folic acid, vitamin A, vitamin C, riboflavin and vitamin E can also inhibit erythropoiesis. Apart from these nutritional causes, two other infectious causes of severe anemia are malaria and geohelminths. The current international recommendation for treatment of anemia includes iron and folic acid but not other vitamins.

Comparisons: Severely anemic pregnant women and children 6-24 months are randomized to receive enhanced treatment of deworming and multivitamins over and above the standard of care of iron-folic acid using a 2x2 factorial design.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with severe anemia (Hb\<70g/L)
* Children 6-24 months with severe anemia (Hb\<70 g/L)

Exclusion Criteria:

* Gestational age \>=36 weeks
* Edema
* Breathlessness
Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke

To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received thrombolysis.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke;
* 18 to 80 years of age;
* There are clear signs of neurological deficit: 8≤NIHSS score≤24;
* Received alteplase thrombolysis therapy within 4.5 hours after onset;
* Patients signed written inform consent

Exclusion Criteria:

* Patients need endovascular therapy or bridge therapy;
* Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
* Severe head trauma or stroke, intracranial tumor or large intracranial aneurysm within 3 months;
* Intracranial or intraspinal surgery within 3 months;
* Active visceral hemorrhage
* Major surgery within 2 weeks or arterial puncture within 1 week that is difficult to compress the hemostatic site;
* Unknown onset time;
* Rapid improvement of symptoms or mild symptoms before thrombolysis therapy;
* A platelet count below 100,000/mm3 indicates a propensity for acute bleeding;
* Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
* Patients with severe mental disorders and dementia;
* ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
* Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases;
* Patients with malignant tumors or severe systemic disease;
* allergic to edaravone , (+)-Borneol or related excipients;
* Pregnant or lactating women;
* Have major surgery within 4 weeks before enrollment;
* Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present;
* The investigators consider the patients are not suitable for this trial.
Psychological Morbidity and Facial Volume in HIV Lipodystrophy: Quantification of Treatment Outcome

The hypotheses of this study were that:

1. HIV lipodystrophy is associated with psychological morbidity relating to body image, anxiety and depression.
2. Treatment of HIV lipodystrophy using autologous fat transfer, polylactic acid or Bio-alcamid, is associated with an improvement in psychological morbidity and anatomical volume of treated areas.
3. The DI3D system is a valid and reproducible method of recording and measuring facial 3-D volume.

as above

Eligibility Criteria:
Inclusion Criteria:

* HIV facial lipoatrophy
* concurrent antiretrovirals

Exclusion Criteria:

* known psychological disorder
* skin allergies
* significant medical problems precluding anaesthesia
Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures

This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse Events or complications.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or more
* Open or closed tibia fracture according to the surgical technique

Exclusion Criteria:

* Women who are pregnant or breast-feeding or are planning to become pregnant during the study
* Patients with consumptive/ malignant primary disease and a life expectancy of \< 3 months
* Patients with a known allergy to aminoglycosides
* Physical or mental incapacity, which makes it impossible to obtain informed consent
* History of drug and alcohol abuse
* Patient unlikely to cooperate
* Legal incompetence