cyrilzakka/clinical-trials huggingface dataset:
Treatment of Recurrent GBM With APG-157 Via Expanded Access

This expanded access request will evaluate APG-157, a botanical drug under development for other cancers, as potential treatment for recurrent Glioblastoma multiforme (GBM) patients.

Glioblastoma patients with disease recurrence after primary, currently approved primary treatments have limited options. Therefore, this expanded access trial is designed to test a new therapeutic option for these patients.

Patients who have progressed on a combination of both Temozolomide and Tumor Treating Field (Optune) or as single treatment Temozolomide (TMZ) OR Tumor Treating Fields (Optune) are eligible to receive APG-157. During APG-157 dosing, TMZ or Optune may be concurrently given at the decision of the Principal Investigator. APG-157 will be given until disease progression or intolerance by the patient.

Radiation followed by adjuvant Temozolomide for 6 to 12 months which is a current standard of care (SOC). Upon progression of this disease after SOC treatment, there are very limited further options for these patients. This expanded access administration will evaluate the potential of APG-157, a novel drug under development for head and neck cancer, as a potential treatment for these recurrent glioblastoma patients.

Brief Description of Objectives:

* Improve six-month progression-free survival (PFS) and overall survival (OS) of the patients eligible for the treatment under Expanded Access protocol.
* Improvement in Quality of Life
* Achievements of above two objectives without any Serious Adverse Events (SAEs) and adverse drug-drug interactions.

Brief Description of Plans for Efficacy Assessment:

* Improvement in Quality of Life
* Efficacy will be assessed using Imaging (objective tumor response using Response Assessment in Neuro-Oncology criteria (RANO), hematological assessment, and tolerance.

Eligibility Criteria:
Inclusion Criteria:

* This study will enroll patients with histologically confirmed glioblastoma (GBM).
* Patients must have received prior treatment with standard first-line therapy for GBM, including maximal surgical resection and postoperative external-beam radiotherapy or Tumor Treating Fields (Optune). Concurrent chemoradiation with TMZ or Tumor Treating Field (Optune) is allowed but not mandatory.
* Patients are eligible for enrollment only if they have unequivocal evidence of tumor recurrence/progression by MRI a minimum of 12 weeks following completion of radiation therapy or TMZ-Radiotherapy or Optune. Patients who have received prior bevacizumab or other anti-vascular endothelial growth factor(anti-VEGF) agents are not eligible to enroll.
* Baseline MRI should be performed within 28 days prior to enrollment.
* Other key inclusion criteria include Eastern Cooperative Oncology Group (ECOG) status of 0-1 (KPS ≥ 70%) and adequate bone marrow, hepatic, and renal function at baseline.

Exclusion Criteria:

* Patients with severe neutropenia
Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery

The aim of this study is to compare the administration of 1 unit dose of 100 mg tramadol intravenously versus multiple smaller dosages of tramadol during the first 6 hours post-operatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side-effects.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II female or male patients
* Aged 18-70 years
* Scheduled for ambulatory surgery requiring postoperative pain medication.

Exclusion Criteria:

* Weight less than 70% or more than 130% of ideal body weight
* Neurological disorder
* Recent use of psycho-active medication, including alcohol
* Patients suffering from chronic pain receiving pre-operative pain medication including NSAID's
* Use of chronic anti-emetic medication, use of chronic corticoid therapy
A Study of 1592U89 in HIV-Infected Patients

The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients. This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the blood).

Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase.

On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

Prophylaxis for opportunistic infections.

Patients must have:

* HIV-1 infection.
* CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration.
* No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

* Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
* Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient.

Concurrent Medication:

Excluded:

* Immunomodulating agents.
* Chemotherapeutic agents.
* Antiretroviral therapy. NOTE:
* Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs.

Concurrent Treatment:

Excluded:

Radiation therapy.

Patients with the following prior conditions are excluded:

* History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
* History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.

Prior Medication:

Excluded:

* Treatment with immunomodulating or cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
* Antiretroviral therapy within 2 weeks prior to administration of study drugs.

Prior Treatment:

Excluded:

Radiation therapy within six weeks prior to study drug administration. Current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete the study.
RSA Study Using Two Types of Uncemented Acetabular Components and the Uncemented HA Coated Symax Stem

The Trident Tritanium acetabular component of a total hip prosthesis is a new developed uncemented acetabular component. In this randomized controlled trial (RCT) the tritanium cup will be compared with the Trident HA acetabular component in two equal sized groups. The Symax HA coated stem will be used as femoral component in both groups.

Study Objectives:

* The primary objective is to determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique
* Secondary objectives are on one hand to assess clinical outcome on the other hand assessing patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score, WOMAC, and EQ-5D questionnaires
* Tertiary objective is to assess bone remodeling of the uncemented acetabular components and the HA-coated Symax hip stem using QCT derived from usinf F18-fluoride PET in a cohort of 12 consecutive patients of this RCT

A total of 50 patients will be enrolled in this RCT divided into two equal groups. Patients have to fulfill the inclusion and exclusion criteria.

All evaluations will be done pre-operatively with 2 weeks before surgery, and after surgery at 4 weeks, 3 and 6 months and 1 and 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a BMI \< 35
* Patients requiring uncemented primary THA
* Primary diagnosis of osteoarthritis

Exclusion Criteria:

* patients with acetabular or femoral osteotomy
* Patients who had a THA on the contralateral side within last 6 months
* Female patients who are pregnant or planning pregnancy during the course of the study
* Patients with active or suspected infection
* patients with malignancy
* patients with a systemic disease that would effect the subject's welfare or overall outcome of the study
* Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
* Patients with systemic or metabolic disorders leading to progressive bone deterioration
* Patients with other illnesses which are likely to affect their outcome
* Patients with known sensitivity to device materials
Automated SMS-Based Appointment Validation Tool

Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation tool to automate appointment confirmation and rescheduling. Working in parallel with the San Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. While simple in concept, this tool aims to free up scarce clinical resources which are currently allocated to daily patient phone call reminders. With funding from a Bay Area foundation, the investigators will develop and pilot this open-source software tool in a 12-month randomized-controlled trial, slated to begin in October 2012. The endpoints of the study will aim to demonstrate improvements in both appointment adherence and glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Belong to Willow Clinic or Fair Oaks Clinic under the San Mateo Medical Center
* Have a diagnosis of type 2 diabetes as indicated by ICD-9 code of 249.xx or 250.xx
* Have a most recent hemoglobin A1c (HbA1c) level greater than 7%
* Are at least 18 years of age
* Have access to cell phone
* Are literate or live with a friend/family member who is literate and willing to handle associated text messages

Exclusion Criteria:

* Have a terminal illness and prognosis of less than one year
* Are unable to demonstrate the ability to reply to an SMS and lack an appropriate proxy
* Are pregnant or expect to be pregnant in the next 6-9 months
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Be a pre-menopausal woman between 18 and 50 years inclusive.
* Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
* Have FSH levels ≤ 20 mIU/mL
* Have excessive uterine bleeding due to myoma.
* Have regular menstrual cycles
* Have a myomatous uterus \< 16 weeks with at least one myoma ≥ 3 cm in diameter.
* If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

Exclusion Criteria:

* Has a history of or current uterine, cervical, ovarian or breast cancer.
* Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
* Has a known severe coagulation disorder.
* Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM).
* Has abnormal hepatic function at study entry.
* Has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study.
* Has a current (within twelve months) problem with alcohol or drug abuse.
* Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Efficacy of a Single Injection of CTM for Post-Operative CMC Arthritis

The goal of this study is to determine the success rate of a single Carpometacarpal (CMC) thumb injection after arthroplasty surgery for primary osteoarthritis of the CMC joint.

CTM Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. These are structural tissue allografts processed according to the criteria contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act. CTM Flow is decellularized particulate human placental connective-tissue matrix provided in a vial.

Postoperative pain after basilar thumb arthritis reconstruction is often quite significant. CTM flow is an extracellular matrix implant that supplements and replaces damaged tissues. Small unpublished case series in total knee arthroplasty, ENT procedures, and rotator cuff repair have shown beneficial results from CTM. We hope to show similar results in this assessment of CTM in the Post-operative CMC arthroplasty patient population.

The primary outcome measure will be narcotic use postoperatively in the first 3 weeks after surgery, as measured by patient tracking. Patients will track post-op pain meds including narcotics, and OTC pain medication for the duration of their follow up period. Per standard of care, patients will be encouraged to change to Tylenol and/or ibuprofen pain medicine as soon as they are able.

Secondary outcomes will be quickDASH and VAS pain.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 18 or older
2. Patients presenting for basilar thumb reconstruction surgery (any surgical technique)
3. Patients who can consent to be a part of this study
4. Patients who are able to return to the Indiana Hand to Shoulder Center or satellite location for follow up time points

Exclusion Criteria:

1. Additional procedures at the same time
2. Patients with previous basilar thumb reconstruction on the operative side (revision surgery)
3. Chronic narcotic use
4. Women who are pregnancy or breastfeeding
5. Non-English speaking
Antibacterial Effectiveness of Two Root Canal Irrigants

The aim of this randomized clinical trial is to compare the antibacterial effects of 1% sodium hypochlorite (NaOCl) and 2% chlorhexidine gluconate (CHX) during retreatment of teeth with apical periodontitis (AP).

Root canal-treated teeth with AP were randomly distributed in two groups according to the irrigant used. After removal of the previous filling material, bacteriological samples were taken from the canals before (S1) and after chemomechanical preparation using either NaOCl or CHX (S2), and after calcium hydroxide medication for 2-3 weeks (S3). 16S rRNA gene-based real-time qPCR was performed to detect and quantify total bacteria, Streptococcus species and Enterococcus faecalis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of apical periodontitis in a root-filled tooth assessed by radiography.

Exclusion Criteria:

* Presence of gross carious lesions in the diagnosed tooth,
* Presence of fractures involving the periodontium of the diagnosed tooth,
* Presence of periodontal pockets more than 4 mm deep in the diagnosed tooth,
* Diagnosis of diabetes,
* Diagnosis of HIV infection,
* Other immunocompromising disease,
* Antibiotic therapy within the previous 3 months.
Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples

The purpose of this study is to try to understand the biology of development of breast, ovarian, fallopian tube, peritoneal or endometrial cancer from persons at high genetic risk for these diseases. The influence of environmental factors on cancer development in individuals and families will be studied. The efficacy of treatments for these diseases will be evaluated.

1. To establish a demographic database to evaluate the efficacy of medical interventions in patients and relatives who carry BRCA1 and 2 mutations and to compare these outcomes to patients who do not carry a BRCA1 or 2 mutation.
2. To obtain blood samples from patients who undergo genetic testing to a) evaluate the incidence of genetic modifier polymorphisms involved in the development of cancer in BRCA1 and 2 mutation carriers and to compare this incidence to non-BRCA 1 and 2 carriers. b) to understand the interaction of genetic modifiers and BRCA1 and 2 in the development of cancer. c) to determine the effect of environmental influences on the incidence of polymorphisms in genetic modifiers and on the penetrance of BRCA1 and 2 mutations by linking information from our demographic database to blood samples and
3. To obtain tumor tissue from BRCA1 and 2 carriers to utilize for gene expression studies.
4. To establish a cohort of sporadic breast cancer patients, or women with no family history of cancer in a first degree relative, to serve as a comparison group to women with strong family history of breast cancer.
5. To establish a cohort of healthy volunteers without personal or family history of cancer to serve as a comparison group to women with sporadic and familial breast cancer.

Eligibility Criteria:
Inclusion Criteria:

I. Women who have a high risk of developing breast or ovarian cancer due to a known germline mutation in the BRCA1/2, PTEN, CDH1, or TP53 cancer susceptibility genes, or due to strong family history of either breast or ovarian cancer, in the absence of known cancer susceptibility gene mutation.

II. Women who are approaching surgery for resection of a pelvic mass, which is considered suspicious for neoplasia by radiologic or clinical criteria; such women may or may not also meet criteria for inclusion in group I.
MEV for Retroclavicular Approach to Infraclavicular Block

In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.

A "biased coin up-and-down sequential design" will be applied to assess the minimum effective volume in 90% of patients for the retroclavicular brachial plexus block. The first subject received 25 ml 0.5% bupivacaine . Each subsequent patient received a dose that depended on the response of the previous one. If the previous block is successful, the block will be performed either by a reduction of the volume by 2.5 ml with a probability ß = 0.11 or by a same dose of the previous one with a probability 1-ß = 0.89 in the next patient.

Eligibility Criteria:
Inclusion Criteria:

* patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
* American Society of Anesthesiologists class I, II or III

Exclusion Criteria:

* patients \<18 years old
* \>65 years old
* body mass index (BMI) \<20 or \>35 kg/m2
* inability to provide written informed consent
* refusal of regional anesthesia
* pregnancy
* contraindication for regional anesthesia
Prevention of Stroke and Dementia in Primary Care

In Western Countries, stroke and dementia are the main causes of long-term disability, dependency, and nursing home admission. Due to demographic trends a continuous increase of patient numbers can be expected.

There is growing evidence that vascular risk factors which are implicated in the etiology of stroke also play important etiologic roles in both vascular dementia and Alzheimer disease. The present project is aimed at the reduction of stroke and dementia by means of a systematic detection and subsequent treatment of vascular risk factors by the family doctor based on established guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Age 55 years or over
* Member of a particular health insurance plan (AOK)
* Resident of the district of Ebersberg

Exclusion Criteria:

* None
Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.

* Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian cancer.
* Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.
* Patients will be randomized into one of two counseling groups. Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
* Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.
* In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process.
* Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene
* Documentation of key family member cancer diagnoses is required

Exclusion Criteria:

* Males, will be offered BRCA 1/2 testing through other protocols
* Individuals unable to speak or write English
* Already participated in a genetic counseling program for BRCA1 or BRCA2 testing
* Life expectancy of less than 12 months.