cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Bee Venom to Treat Knee Osteoarthritis

Study wishes to determine if the use of injectable bee venom is a safe and effective treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased report of pain and discomfort, increased function during daily activities, decrease use of analgesic meds, and improvement in walking and climbing steps. We will be using histamine as a control. 40 subjects will be enrolled in a 3:1 allocation ratio between bee venom and histamine. Each injection of bee venom dosage will consist of 100 micrograms of dried bee venom in 0.1 ml. of 0.5% preservative free Xylocaine. The histamine dosage will consist of .0025 milligrams of histamine in 0.5% preservative free Xylocaine. Subjects will visit the study center for 14 visits over an 18 week span. The clinical hypothesis is that bee venom is an effective treatment for Osteoarthritis and will reduce pain and discomfort, increase range of motion, increase daily function, decrease walking and stair climbing time, and decrease the need of analgesic medication for a period of time beyond treatment (after the study has concluded.) The clinical safety hypothesis is that for persons not allergic to bee venom (patients allergic will not be allowed to enter into the study) the side effects will be small. The most common side effects for bee venom and histamine will be redness and itchiness which will be tolerable and safe.


Eligibility Criteria:
Inclusion Criteria:

* Meet clinical criteria for Osteoarthritis in one knee
* Morning stiffness less than 30 minutes duration
* VAS pain level of 4 to 8 on a 0 to 10 scale when walking
* Older than 35 years of age
* On a stable dose of medication or none at all due to intolerance
* Ability to tolerate Acetaminophen as their only pain medication for the entire study
* Ability to read, understand, and give informed consent and sign the informed consent form

Exclusion Criteria:

* Allergy to bee venom or histamine
* Allergy to Lidocaine
* Any type of inflammatory arthritis such as RA, SLE, Psoriatic
* Fibromyalgia or any pain problem that requires the use of pain medication or anti-inflammatory
* Depression or any condition that interferes with memory or critical analysis
* History of prolotherapy, bee venom therapy, or injection of hyaluronic acid or cortisone within the last 3 months
* Osteoarthritis of the hip, ankle, or any condition that interferes with walking 50 ft. or up and down stairs
* Elevated CRP, SED rate
* Recent injury to the knee which is causing pain or functional problems
* Any previous invasive procedure on the study knee
* Inability to understand the informed consent form or refusal to sign it
* Cardiac disease interfering with ability to get epinephrine
* VAS pain level greater than 8 on a 0 to 10 scale when walking
* Inability to stop anti-inflammatory medication for the entire study and use only Acetaminophen
* Taking beta blockers
* Taking chronic anti-histamines
Role of Glivec in Patients With Tumor Cells Positive for C-kit or PDGFR; a Multi Center Study.

This is a phase II, multi-center (Israeli), open label, non-randomized trial for every patient with the specified tumors expressing c-kit or PDGFR. Expression of these kinases will be investigated in tumor samples obtained at the time of diagnosis or from the time of recurrent disease. Every patient with positive expression of either of the kinases will be evaluated for quantitative and qualitative evidence of disease prior to entry into the study, and if possible, no other treatment will be given concomitantly, to allow evaluation of the net effect of Glivec on tumor growth kinetics, searching for measurable evidence of response.

Glivec is supplied to the study investigators by Novartis Pharmaceutical. Patients will receive Glivec 400mg-800mg p.o./day for an exposure period of up to 12 months provided that in the opinion of the investigator the patient is benefiting from treatment with Glivec, and in the absence of any safety concern. For patients with brain tumors who are not receiving concomitant enzyme inducing anti-convulsant drugs, the recommended dose of Glivec is 800mg/day.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age.
* Histologically documented diagnosis of one of the specified tumors, which is malignant as well as unresectable and/or metastatic and therefore, incurable with any conventional multimodality approach and immunohistochemical documentation of c-kit (CD117) or PDGFR expression in the primary tumor or metastases by tumor (preferably on a tumor sample taken within 6 week of study entry).
* At least one measurable site of disease as defined by Southwestern Oncology Group Solid Tumor Response Criteria.
* Female patients of child-bearing potential must have negative pregnancy test.
* Signed informed consent form.
* Life expectancy \>3 months.

Exclusion Criteria:

* Patient has received any other investigational agents within 28 days of the first day of study drug dosing.
* Existence of any evidence of another malignant disease, except superficial non-melanoma skin cancer.
* Patient has a known brain metastases.
* Patient previously received radiotherapy to \>25% of the bone marrow.
Dexmedetomidine Versus Triamcinolone Treatment of Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS.

Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS.

In case of failed conservative oral therapey, local hydro-dessction of the median nerve can be done with saline alone. local anethetics, steroids, hyalase,and ozone have been utilized to augment the symptoms reliefe.

Dexmeditomidine (DEX) has been studied as adjuvant for nerve block to aumnet the pain reliefe. Recently, it has been discovered that DEX can offer some antinflammatory effects when injected in the perineural area. Upon such discovery, the goal of this study has been built.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* complaining of carpal tunnel syndrome of 3 month duration or more
* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

* patient refusal
* infection at the site of intervention
* allergy to utilized drugs
* diabetic
* previous surgery in the site of injection
* previous injection in the targeted site within the last year
Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)

The overall research aim of this pilot study is to determine if the structural brain protein calpain-cleaved αII-spectrin N-terminal fragment (SNTF) can be used as a blood biomarker to accurately identify patients who will have more severe symptoms and reduced neurocognitive functioning after sustaining a concussion. Concussion is also referred to as mild traumatic brain injury (mTBI) in the literature. Both terms will be used interchangeably throughout this application.

The novel aspect of the proposed study relates to the fact that the STNF protein is the first evidence that a biomarker in human blood can help clinicians determine a specific patient's clinical outcome from a concussion. This in turn will help clinicians and concussion specialists with designing treatment protocols very early after the initial injury that could have significant impacts on the health of the patient.

This study has several important benefits to the scientific community. Concussion treatment today is uncertain. Some patients are back to baseline one or two days post injury whereas other patients are experiencing debilitating symptoms for months after the injury. Until the patient begins to report symptoms, the course of treatment cannot be determined. Other biomarkers for concussion diagnosis are being evaluated, but this is the first biomarker to show promise for patient stratification and earlier intervention and treatment for the subset of cases at high risk of suffering brain damage and persisting dysfunction after concussion. Currently, no prognostic method exists for identifying at an early and potentially treatable stage the small subset of concussion sufferers at risk of diffuse axonal injury and persisting brain functional impairment.

Eligibility Criteria:
Inclusion Criteria:

Patient is ≥ 8 years old 2. Ability to enroll within 24 hours of injury 3. Ability to follow-up with patient 30 days following enrollment 4. Concussion by history or physical examination (head injury and symptoms such as headache, nausea, vomiting, dizziness, fatigue, irritability, or poor concentration following the injury) 5. GCS ≥ 13 6. Abbreviated Injury Score (AIS) ≤ 3 7. Plan to be discharged from the emergency department to the outpatient observation unit or to home

Exclusion Criteria:

Non-English speaking 2. Trauma Team Activation (TTA) 3. Abnormal acute intracranial CT/MRI findings 4. Blood alcohol level (\> 200 mg/dL) 5. Previous head injury within 30 days of enrollment 6. Pre-existing neurologic disorder associated with cerebral dysfunction and/or cognitive deficit (such as dementia, cerebral palsy, mental retardation, epilepsy, dyslexia) 7. Pre-existing psychiatric disorder (such as bipolar disorder and schizophrenia) as indicated by medical history 8. Planned admission to a hospital inpatient unit
Biomarkers Predicting Response in Patients With Non-Small Cell Lung Cancer Previously Treated With Erlotinib Hydrochloride

RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers predicting response in patients with non-small cell lung cancer previously treated with erlotinib hydrochloride.

OBJECTIVES:

* To evaluate whether serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin can be utilized as biomarkers to predict response in patients with non-small cell lung cancer treated with erlotinib hydrochloride.

OUTLINE: Serum samples are analyzed for NGAL, MMP-9, NGAL/MMP-9, and soluble E-cadherin by ELISA and Luminex assays.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell lung cancer
* Received erlotinib hydrochloride on clinical trial ECOG-E3503

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Effects of Antenatal Education on Birth Perception, Fear, and Readiness

Birth is a multi-dimensional and unique experience for every woman, and it is influenced by a woman's social life. Fear of childbirth is a common issue that affects women's health and well-being before, during, and after pregnancy. The thought that childbirth will be painful triggers fear of childbirth. Fear of childbirth is closely related to the perception of traumatic birth. Antenatal education is important in coping with childbirth pain and traumatic birth pain, but the aim of adult education is not just to inform, but also to change individuals' perspectives on events. The transformative learning theory is a model used to change individuals' perspectives on events. The aim of this study was to investigate the effect of antenatal education based on the transformative learning theory on traumatic birth perception, fear of childbirth, and birth preparedness in pregnant women. The study was conducted as a randomized controlled trial with 54 participants. Data collection forms included a personal information form, the Traumatic Birth Perception Scale, the Prenatal Self-Assessment Scale, and the Wijma Birth Expectancy/Experience Scale. The Statistical Package for the Social Sciences 23.0 (Chicago, Illinois) version was used for data analysis. Histogram and Q-Q plots, and the Shapiro-Wilk test were used to assess the normality of the data distribution. Descriptive data regarding women's demographic characteristics were analyzed using frequencies, percentages, and mean values. Differences in demographic characteristics between groups were examined using the independent sample t-test, Mann-Whitney U test, and Chi-square test. Pre-test and post-test scores of the groups were analyzed using the independent sample t-test. A significance level of p\<0.05 was accepted.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 20-35
* Be in the 30-32 weeks of gestation
* Be a primigravida
* Have at least basic literacy skills

Exclusion Criteria:

* Have any chronic diseases
* Have any psychiatric disorders
* Be a high-risk pregnancy
* Have any communication problems
* Have communication issues
A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).

This is a single dose, open-label, single or multiple center study to determine the interaction of ketoconazole with ABT-263 in approximately 12 subjects with cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Has a non-hematologic malignancy (radiographic, histologic, or cytologic confirmation), or hematologic malignancy (histologic or cytologic confirmation) that is either: relapsed or refractory to standard therapy, failed at least one prior therapy or no known effective therapy exists.
* In the investigator's opinion, the subject's life expectancy is at least 90 days.
* If clinically indicated, (e.g., subjects over the age of 70) subjects must have documented brain imaging (MRI or CT) negative for subdural or epidural hematoma within 28 days prior to the first dose of study drug.
* Subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.

Exclusion Criteria:

* History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.
* Has undergone an allogeneic stem cell transplant.
* Has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
* Has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
* Has active immune thrombocytopenic purpura or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
* Significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease. Female subject is pregnant or breast-feeding.
* History of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, etc).
* Exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: active systemic fungal infection; diagnosis of fever and neutropenia within one week prior to study drug administration.
* Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy \[ERT\], or agonists required to suppress serum testosterone levels \[e.g., LHRH, GnRH, etc.\] for subjects with prostate cancer
* Currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function.
* Currently receiving or requires anti-fungal treatment or CYP3A inhibitors. In the opinion of the Investigator, the subject is an unsuitable candidate to receive ABT-263.
* History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.
Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.

The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.

This is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. Participants will receive bacterial lysate (OM-85/Broncho-Vaxom, 3,5mg) or placebo powder for ten days each month, from 6-10 weeks after birth until 12 months after birth. At 12 months, parents of participants are asked to join in Protea-2. If they do, participants in the treatment arm of year 1 are randomised again over placebo and OM-85 and treated until the age of 24 months. Clinical data will be continuously collected by e-Health and 3 (possibly digital) study visits; with optional biological sampling and lung function at baseline, 6 and 12 months. And in case of participation in Protea-2 also at 24 months.

Main study parameters are doctor diagnosed lower RTI and wheezing episodes in the first year of life. Biological sampling will allow investigation of immune maturation, as well as microbiome development in the respiratory tract and gut. Also, biomarkers for risk-group selection and/or treatment success will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age at delivery between 30+0 and 35+6 weeks
* Postnatal age at least 6 weeks at randomization \& postmenstrual age at least 37 weeks
* Written informed consent by both parents or formal caregivers

Exclusion Criteria:

* Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder.
* Lower RTI before randomization
* Dysmaturity and/or weight \< 2.5 kg at age of randomization.
* Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding
* Parents unable to speak and read Dutch/English language
* Known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.
Fluid Management for Cesarean Section

Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar Score of children and related with the stable hemostasis during the whole process of labor. How to keep circulation in a consistent stability is yet to be known. The investigators hypothesized that different fluids, crystalloids or colloids, can produced varying effects in keeping the physiological environment of labor from significant fluctuating.


Eligibility Criteria:
Inclusion Criteria:

* 21-40 yr
* First time of delivery
* ASA status I-II
* No premature
* No genetic and infectious diseases
* Chinese

Exclusion Criteria:

* \< 21 yr
* \> 40 yr
* Subjects with cardiac and pulmonary disorders
* Dislocation of placenta
* Pregnant hypertension
* Allergy to local anesthetics
* Unwilling to cooperation
* Need intraoperative administration of vascular active agents
* With significant delivery side effects
Intrauterine Insemination Predictor Factors

Multiple studies have reported on the impact of factors such as female age, duration of infertility, type of infertility, hormone levels (i.e. AMH, FSH, estradiol, progesterone), use of different ovarian stimulation protocols, timing/induction of ovulation, number of pre-ovulatory follicles, endometrial thickness by the time of ovulation, sperm parameters (i.e. concentration, progressive motility, morphology, total motile sperm count \[TMSC\], inseminating motile count \[IMC\]) and sperm washing procedures. Also the influence of body mass index and smoking on IUI outcome have been studied before. However, results on the predictive value of these parameters remain highly contradictory. The aim of the study is to examine the value of different variables in the prediction of IUI success to develop a clinically useful predictive model of pregnancy and live birth.


Eligibility Criteria:
Inclusion Criteria:

* couples had been diagnosed with infertility according to WHO definition (failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse)
* at least one permeable tube
* a motile sperm concentration post treatment of 1×106/mL on the day of the semen analysis
Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female 65 years of age or older at the time of vaccination.
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

Exclusion Criteria:

* Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
* Previous vaccination against influenza with any seasonal vaccine since July 2007.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
* Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Any medical conditions in which IM injections are contraindicated