cyrilzakka/clinical-trials huggingface dataset:
Feasibility of the Combination of Chemotherapy (Carbo/Caelyx or Carbo/Doxorubicin) With Tocilizumab (mAb IL-6R) and Peg-Intron in Patients With Recurrent Ovarian Cancer

The purpose of this interventional study is to determine the feasibility to combine standard chemotherapy (Carbo/Caelyx or doxorubicin) for recurrent ovarian cancer with immunotherapy (Tocilizumab and Peg-Intron).

This study combines standard chemotherapy Carboplatin-Caelyx or doxorubicin with a monoclonal antibody against IL-6R (tocilizumab). High IL-6 levels correlate with poor prognosis and chemoresistance in ovarian cancer patients. In cases of chemoresistant ovarian cancer, therefore, modulation of the IL-6 pathway, by blocking the IL-6 receptor, may represent a promising strategy to both abolish drug resistance and amplify host immunity in patients with recurrent ovarian cancer. Blockade of the IL-6/IL-6R pathway may enhance immunogenic cell death and restore local normal DC maturation. In addition, the use of interferon-alpha (Peg-Intron) allows the full maturation of DC, thereby enhancing the anti-tumor response.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven epithelial ovarian cancer
* Progression of disease or relapse after previous therapy with platinum
* Measurable disease (RECIST 1.1) or elevated CA125 \> 2 times the upper normal limit (UNL) within 3 months and confirmed
* Age ≥18 years
* WHO performance status 0-2
* Adequate bone marrow function: WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Adequate liver function: bilirubin ≤1.5 x UNL range, ALAT and/or ASAT

  * 2.5 x UNL (\<5x UNL in case of liver metastases), Alkaline Phosphatase ≤5 x UNL
* Adequate renal function: the calculated creatinine clearance should be

  * 50 mL/min
* Survival expectation \> 3 months
* Patients must be accessible for treatment and follow-up
* Written informed consent according to the local Ethics Committee requirements

Exclusion Criteria:

* Chemotherapy within past 3 months
* Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
* Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
* Known hypersensitivity reaction to any of the components of the treatment
* Pregnancy or lactating
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
* Infection with tuberculosis and hepatitis B or C
Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent or metastatic gastric cancer that has progressed following first line-therapy
* Confirmed ATM protein status by IHC archival tumour sample
* At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and follow up visits

Exclusion Criteria:

* More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting
* Any previous treatment with a PARP inhibitor, including olaparib
* Patients with second primary cancer, except; adequately treated non melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \>5 years
Auricular Acupuncture for Chronic Pain and Insomnia

Background: In the U.S. approximately 1.6 million adults use complementary and alternative or integrative medicine therapy for pain and insomnia. However, very few studies have tested the use of auricular acupuncture (AA) using a standard protocol for participants with chronic pain and insomnia.

Objective: To assess the feasibility and acceptability of AA and to evaluate the effectiveness of AA on pain severity score, pain interference score, and insomnia over an 8-day study period.

Subjects: 45 participants who met the eligibility criteria and signed the consent were randomized to either the AA group (AAG) or the usual care control group (CG) on day 4.

Intervention: A standard AA protocol using penetrating semi-permanent acupuncture needles and in-place for up to four days.

Main Outcome Measures: Brief Pain Inventory pain severity and interference scores for pain and Insomnia Severity Index (ISI) for insomnia.

Results: The use of the standard AA protocol in the AAG led to significant within- and between-group reduction in pain severity and interference scores when compared to the CG. Both groups showed within-group decrease in ISI. However, the AAG showed significant between-group reduction in ISI severity and from moderate to sub-threshold insomnia.

Conclusions: AA was found to show effectiveness in the treatment of chronic pain and insomnia. With a heightened focus on the opioid crisis in the U.S., this easy-to-administer protocol can be an option for treatment modality for military beneficiaries with chronic pain and insomnia.


Eligibility Criteria:
Inclusion Criteria:

* military beneficiary - active duty, retiree, or dependents
* between the ages of 18 - 65 years
* fall under the care of LRMC footprint
* self-report of insomnia based on established research criteria
* sleep-onset latency (SOL) or wakefulness after sleep onset of ≥30 minutes;

  * frequency of at least three times a week;
  * duration of ≥3 months;
  * with unrestorative or unrefreshing sleep
* NRS Pain rating ≥3 (mild to severe level)
* pain for ≥3 months
* able to read and understand English
* for active duty military, an agreement of supervisor

Exclusion Criteria:

* hypersensitivity or allergy to gold.
* pregnancy or plan for future pregnancy during the duration of the study (since the safety of AA in pregnant women has not been established; based on self-report rather than requiring a pregnancy test)
* ear trauma or unhealed wounds on the ear
* participation in any other research protocol with a device or drugs
* piercing or scar tissue in any of the AA point areas
* working in jobs with variable hours (e.g., shift work)
* acupuncture treatment within the last 3 months
* individuals with valvular prosthetics, hemophilia, or currently receiving an anticoagulant.
Tampon Design Validation Study

This prospective multi-center, open-label, randomized, cross-over study is designed to validate the user needs of a tampon design. The hypothesis is that user needs are met.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to read and provide written informed consent.
* Female in good general health, age 18-49 (inclusive).
* History of regular menstrual cycles during the previous 3months lasting approximately 21-35 days, including at least 4 days of menstruation, and expecting to menstruate during the study period.
* History of use of applicator tampons without discomfort.
* Normally use at least 6 tampons for protection during menstruation.
* Normally uses regular, super, and/or super plus absorbency tampons for menstrual protection.
* Agrees to the conduct of all study procedures, including gynecological exams (if applicable), and agrees to follow all study instructions and return for scheduled appointments.
* Has used an acceptable form of birth control for at least one month prior to enrollment and for the duration of the study.

Key Exclusion Criteria:

* Pregnant, lactating or is trying to become pregnant.
* Less than six (6) weeks post-partum.
* Has a menstrual abnormality (such as oligomenorrhea or amenorrhea).
* Has a known allergy or sensitivity to components of the investigational products, including rayon.
* Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.
Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects of physiological cortisol substitution and withdrawal is studied and related to the clinical syndrome of adrenal insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Female adrenal failure
* Age 18-50
* Written informed content

Exclusion Criteria:

* Diabetes mellitus
* Cancer
* Thromboembolic events
* Pregnancy and lactation
* Heart disease
Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

The overall goal of this study is to determine the effects of intraoperative tourniquet use during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower extremity while the contralateral lower extremity undergoes TKA without the use of a tourniquet (NOTQT), except for briefly during component cementation. Tourniquets are commonly used in TKA to improve visualization of the surgical field and limit blood loss. However, studies suggest that tourniquet use may be associated with higher rates of medical complications and poor functional outcomes, including increased swelling, decreased muscle strength and altered neuromuscular activity. We will measure strength, voluntary muscle activation, and other functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs after surgery); 3 weeks; and 3 months following TKA). We hypothesize that lower extremities in the NOTQT group will demonstrate improved strength and performance when compared to lower extremities in the TQT group.


Eligibility Criteria:
Inclusion Criteria:

* undergoing primary, simultaneous bilateral knee arthroplasty for osteoarthritis

Exclusion Criteria:

* no neurological, vascular or cardiac problems that limit function or any unstable orthopaedic conditions that limit functional performance
Consent for Obtaining Additional Bone Marrow Specimens at Time of Diagnostic Bone Marrow Procedure

The purpose of this study is to collect bone marrow samples for experimental studies.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are having a bone marrow procedure done as part of their standard oncology work-up will be eligible to be consent on this study.

Exclusion Criteria:

* None.
Leech Therapy for Postherpetic Neuralgia

The purpose of this study is to investigate, whether leech therapy for the treatment of postherpetic pain improves pain and sensory function.

Therefore 20 patients with PHN undergoing leech therapy at the investigators outpatient clinic will be included in this observational trial.

see above

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 years of age
* \>6 months thoracal postherpetic neuralgia
* informed consent

Exclusion Criteria:

* if leech therapy is contraindicated
* physical and mental disability to participate in the study examinations
Horizontal Augmentation With Deproteinized Bovine Bone Mineral Alone or in Combination With Particulate Autogenous Bone

Background: Placement of oral implants is frequently compromised due to atrophy of the alveolar process. Lateral ridge augmentation with an autogenous bone block is frequently necessary to increase the width of the alveolar process before implant installation. However, harvesting of an autogenous bone block is associated with donor site morbidity. Consequently, bone substitutes alone or in combination with particulate autogenous bone graft are used increasingly to simplify the surgical procedure. Animal and human studies evaluating lateral ridge augmentation with Bio-Oss alone or in combination with particulate autogenous bone graft have demonstrated new bone formation and high implant survival. However, the optimal ratio of Bio-Oss and particulate autogenous bone graft for lateral ridge augmentation and long-term implant survival is unknown.

Purpose: Test the H0-hypothesis of no difference in long-term implant survival, newly formed bone, volumetric stability of the graft, gained width of the alveolar process and patient satisfaction after lateral ridge augmentation with Bio-Oss alone or in combination with a diminutive amount of autogenous bone graft.

Material and methods: lateral ridge augmentation will be performed in 20 adults with two different ratios of Bio-Oss and autogenous bone graft after a split mouth design. Clinical and radiological measurements will evaluate the long-term implant survival. Cone beam computer tomography (CBCT) will be obtained preoperatively, immediately postoperatively, prior to implant placement, 2 years after implant installation and 5 years after implant installation to estimate the volumetric changes of the augmented area. Moreover, the amount of newly formed bone will be estimated by histologic evaluation after implant placement.

Conclusion: Long-term implant survival has never been evaluated after lateral ridge augmentation with Bio-Oss alone or in combination with a diminutive amount of autogenous bone graft.


Eligibility Criteria:
Inclusion Criteria:

* Total or partial bilateral edentulism
* Horizontal bone width less than 4 mm at planned sites of implant installation or need of augmentation of aesthetic reasons for optimal implant placement

Exclusion Criteria:

* Uncontrolled systematic disease
* History of radiation in the area
* Smoking habits (free of smoking habits more than 1 month prior to treatment)
* Treatment with bisphosphonates
* Patients who cannot complete the 5-year observation period
Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with plaque psoriasis for at least 6 months.
* Have plaque psoriasis covering at least 15% of their total body.
* Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
* Be willing and able to comply with scheduled visits, treatment plan and other study procedures.

Exclusion Criteria:

* Currently have non-plaque forms of psoriasis or drug-induced psoriasis.
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy.
* Subject is participating in another trial using an investigational agent or procedure.
* Women who are pregnant or breast-feeding or considering becoming pregnant.
Development The Potentiality of β-1,3/1,6-D-Glucan (Polysaccharide Peptide) From Mycelia Extract of Indonesia's Ganoderma Lucidum as Adjuvant Therapy in Patients With Cardiometabolic Syndrome

The aim of this study is to determine the role and efficacy of β-1,3/1,6-D-Glucan (Polysaccharide Peptide) from mycelia extract of Indonesia's Ganoderma lucidum as an antioxidant and anti-inflammatory agent on cardiometabolic syndrome

This study is held at Saiful Anwar General Hospital and General Hospital of Brawijaya University by enrolled 70 participants and using a double-blinded true experimental using a randomized control perspective method with pre-test and post-test design, to determine the effect of giving β-1,3/1,6-D-Glucan (Polysaccharide Peptide) from mycelia extract of Indonesia's Ganoderma lucidum on cardiometabolic syndrome population.

The intended target or experimental variables that will be studied in this study are blood pressure, body mass index, blood glucose profile (fasting glucose, HbA1C), lipid profile (total cholesterol, High-Density Lipoprotein, Low-Density Lipoprotein, and triglyceride), renal function profile (urea and creatinine), heart function from echocardiography examination, inflammation parameter (Interleukin 6, Tumor Necrosis Factor-Alpha, and high sensitivity C-Reactive Protein), stress oxidative parameter (superoxide dismutase and malondialdehyde), endothelial function parameter (nitric oxide), and quality of life that conducted by completion of the SF-36 questionnaire.

Hypothesis of this study is β-1,3/1,6-D-Glucan (Polysaccharide Peptide) from mycelia extract of Indonesia's Ganoderma lucidum can acts as a chronic anti-inflammatory and antioxidant agent in cardiometabolic syndrome patients by contributing in blood pressure control, body mass index control, blood glucose improvement, lipid profile improvement, renal function profile improvement, heart function improvement, and better quality of life. Beside that, the investigators hope that there will be a change of inflammation, stress oxidative, and endothelial function parameter in which shift to the good level.

Eligibility Criteria:
Inclusion Criteria:

* Age more or same than 18 years old
* Defined as metabolic syndrome patients based on NCEP-ATP III Criteria with modified of obesity classification (waist measurement) for Asian population
* Agreed to participate in this study

Exclusion Criteria:

* Allergic to Ganoderma lucidum
* Pregnant woman
* Participate in another drug or medical device study
* Waiting for an organ transplantation or have undergone a transplant
* Cancer patients who undergoing a chemotherapy or radiotherapy
* People with organ failure
* Could not be randomized and participate in this study by clinical judgement
Multi Center Study to Obtain Bladder Tissue Specimens From Patients Undergoing Transurethral Resection Biopsy Procedure

The objective of the study is to obtain bladder tissue specimens from patients otherwise undergoing cystoscopy for use in research at Tengion, Inc.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18-90 years and undergoing TURBT
* Willing and able to give signed informed consent

Exclusion Criteria:

* Known active infection
* Known colonization with MRSA or VRE
* Receipt of blood or blood products for transfusion during the previous 3 months
Intima Media Thickness Regression in Dyslipidemic Teenagers

Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.

Obese teenagers with abnormal lipid profiles were randomized to either low dose statin or placebo and had their carotid intima media thickness compared before and after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Obesity
* Abnormal Triglyceride levels (\>1.7mmol/L).
* Abnormal HDL-C levels (1.0mmol/L)

Exclusion Criteria:

* Abnormal thyroid unfction (not treated)
* Diabetes
Examining the Feasibility and Acceptability of a Tailored Version of a Mindfulness-Based Intervention (MBI) Among Youth Experiencing Homelessness (YEH)

A Mindfulness-Based Intervention (MBI), called ".b," will be tailored to Youth Experiencing Homelessness (YEH) by using focus group discussions, key informant interviews, and iterative beta-testing with the Homeless Youth Working Group (HYWG). The purpose of this study is to assess the feasibility and acceptability of this tailored MBI in YEH (the tailored MBI called .b will be compared to an attention control condition). The results of this feasibility study will inform the design of a future randomized controlled trial that will aim to test the efficacy of the intervention for improving stress management, increasing emotional regulation, decreasing impulsivity in YEH.


Eligibility Criteria:
Inclusion Criteria for Youth Participants:

* homeless youth receiving services at one of the recruitment sites in Houston, Texas area at the time of enrollment
* English speaking
* able to participate for the entire study period (i.e., not moving during the study)

Inclusion Criteria for Service Providers:

* currently providing health or social services to YEH
* interested in participating in an interview or as a member of the Expert Advisory Panel

Exclusion Criteria for Youth Participants:

* overtly exhibiting symptoms of severe, untreated mental illness criteria
* not staying at the shelter
* currently experiencing homelessness or unstable housing

Exclusion Criteria for Service Providers:

-not able to meet for the regularly scheduled meetings at least 75% of the time.
A Study of Dementia and Neurological Problems in HIV Infected Patients Who Are Participating in ACTG A5175

The purpose of this study is to determine how often dementia and other neurological problems occur in people with HIV. Participants of ACTG A5175 will enroll in this study.

Both the central and peripheral nervous systems (CNS and PNS) are affected by HIV; however, the causes of neurotoxicity in HIV infected patients are unknown. Initial data indicate that as many as 40% of patients with HIV develop some form of dementia. Other common neurological problems observed in HIV patients are peripheral neuropathy and opportunistic infections of the CNS. Most antiretroviral drugs used in the treatment of HIV have poor penetration into the CNS, which may explain how HIV persists in the CNS and contributes to the prevalence of dementia and other neurological disorders in HIV infected patients. This study will examine the prevalence of dementia and other neurological disorders in participants in ACTG A5175, "Once-Daily PI/NNRTI Therapy Combinations for Treatment Naive, HIV Infected Patients in Resource-limited Conditions."

The study will last approximately 2.5 to 3 years. Participants will undergo neurological examinations and neuropsychological assessments at entry to both steps of ACTG A5175 and before the administration of the new antiretroviral regimen, then every 24 weeks until they discontinue ACTG A5175. Physicians will make targeted diagnoses at each study visit.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* Prior antiretroviral therapy for less than 7 days any time prior to study entry
* CD4 count less than 300 cells/mm3
* Willing to use acceptable means of contraception
* Plans to stay in the area for the duration of study participation
* Willing to adhere to study follow-up schedule for ACTG A5175 and this study
* Have not begun ACTG A5175 antiretroviral therapy, but planning to start therapy after enrolling in this study

Exclusion Criteria:

* Any active severe psychiatric illness (e.g., schizophrenia, severe depression, severe bipolar affective disorder) that, in the opinion of the site investigator, may interfere with the study results
* Current drug or alcohol abuse that, in the opinion of the site investigator, would interfere with study requirements
* Serious illness or hospitalization that, in the opinion of the site investigator, may interfere with the study results
* Any condition that, in the opinion of the site investigator, would interfere with study requirements