cyrilzakka/clinical-trials huggingface dataset:
A Clinical Investigation of the C2a-Taper™ Acetabular System

The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.

Study Design:

Phase 1

Sites will collect the following types of data:

Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and femoral components Survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) Safety- All other adverse events

Follow-up Visit schedule

* 6 week ± 2 weeks
* 6 month ± 1 month
* 1 year ± 3 months
* 2 years ± 3 months
* 3 years ± 3 months
* 4 years ± 3 months
* 5 years ± 3 months

Phase 2:

Patients continue to be followed on an annual basis (Years 6-10) via mail. A self assessment form is sent directly to the subject on an annual basis starting in the 6th post-operative year.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis

Exclusion Criteria:

* Patients with: Osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, vascular insufficiency, muscular atrophy, and neuromuscular disease
TDCS and Aphasia Therapy in the Chronic Phase After Stroke

This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the chronic phase after stroke. Half of the participants will receive aphasia therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.

Aphasia is present in about one third of all stroke patients in the chronic phase. The first few months after stroke, considerable spontaneous recovery is initiated, including neuronal plasticity and reorganization processes. Language recovery in aphasic stroke patients involves reorganization of brain functions. Longitudinal fMRI studies reveal that the right hemisphere shows increased activity at different times in the recovery process, but in the long-term is correlated with poorer performance. Left re-lateralization, if possible, seems to be the most effective in restoring language function. For a large subgroup of patients, aphasia therapy is not sufficient to resolve language deficits and not all patients are capable to endure intensive aphasia therapy. Therefore, non-invasive techniques (NIBS) such as transcranial direct current stimulation (tDCS) are currently explored as an add-on treatment to improve or accelerate therapy outcomes. tDCS is a painless and safe stimulation tool that modulates cortical excitability through weak polarizing currents (1 mA - 2 mA) between two electrodes. These weak currents are thought to induce a subthreshold shift of resting membrane potentials towards depolarization or hyperpolarization. The effects of stimulation depend on the polarity of the applied current relative to the axonal orientation. It has been found that tDCS not only triggers immediate aftereffects, but also long-lasting effects that persist beyond the stimulation time, even for up to 12 months. It was suggested that long-term potentiation (LTP) and long-term depression (LTD) might be responsible for these long-term effects, however the precise physiologic mechanisms of action are not yet fully understood.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with mild to moderate aphasia (Token Test Score between 7 and 40) after a first left hemispheric ischemic or hemorrhagic stroke
* Inclusion \> 6 months post-stroke
* Age 18 - 85 years
* Being right-handed (\> +8 on the questionnaire for handedness, Van Strien)
* Mothertongue: Dutch
* Imaging (CT or MRI) prior to inclusion (in patient file), standard of care in the acute phase
* Signed Informed Consent (attachment 1)

Exclusion Criteria:

* History of other diseases of the central nervous system, psychological disorders and (developmental) speech and or language disorders
* Serious non-linguistic, cognitive disorders (as documented in the patients' medical history and inquired in the anamneses)
* Prior brain surgery
* Excessive use of alcohol or drugs
* New neurological symptoms between the acute stage and inclusion
A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.

To determine if levator muscle block with bupivacaine improves postoperative pain control relative to placebo controls among women undergoing prolapse surgery involving a posterior colporrhaphy. Improvement is defined as no less than a 25% lower total pain score on a ten point numerical pain scale.


Eligibility Criteria:
Inclusion Criteria:

* Any woman over the age of 18 years with a capacity to give informed consent who are undergoing vaginal prolapse surgery including a posterior colporrhaphy may be included in the study.

Exclusion Criteria:

* Any woman who is a non-English speaker, does not have ability to provide consent, has a cardiac arrhythmia, liver disease, myasthenia gravis, bleeding diathesis or adverse reaction / allergy to anesthetic will be excluded. Women that are also having vaginal mesh excisions at the time of prolapse repair or those that will undergo subsequent surgery in the follow up period will be excluded.
A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets

The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12 months in participants with involutional osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5 mg tablets once daily for 12 months are set as the control group.

The primary objective of the present study is to verify the non-inferiority of once-monthly oral administration of NE-58095 DR tablets for 12 months to once-daily oral administration of NE-58095 IR 2.5 mg tablets for 12 months, in terms of efficacy in participants with involutional osteoporosis.

Secondary objectives of the present study are as follows: to compare the safety of once-monthly oral administration of NE-58095 DR tablets for 12 months with the safety of once-daily oral administration of NE-58095 IR tablets (at 2.5 mg) for 12 months in participants with involutional osteoporosis at time of wakening.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of involutional osteoporosis
2. Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent
3. Women for whom at least 2 years have passed since the last natural menstruation

Exclusion Criteria:

1. Patients with secondary osteoporosis
2. Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass
3. Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA)
4. Patients with a history of radiotherapy to the lumbar spine or the pelvis
5. Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period
6. Patients with a history of treatment with any anti-receptor activator of nuclear factor-κB ligand (RANKL) monoclonal antibodies or parathyroid hormone products within 1 year before the start of the treatment period
7. Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period
8. Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period
9. Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding
10. Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus)
11. Patients with hypocalcemia
12. Patients with hypercalcemia
13. Patients with a diagnosis of renal calculus
14. Patients with serious renal, hepatic, or cardiac disease
15. Patients who have received surgical dental procedures, such as a tooth extraction (including dental implant treatment), but whose dental problems remain unresolved at the start of the treatment period.
Neuroimaging Study

The researchers are trying to gather information and learn more about imaging tests in racially different people who are cognitively normal or have dementia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female African Americans 30 years of age or older
* Subjects who have completed or are scheduled to undergo the neurological evaluation procedures described below.

Exclusion Criteria:

* Subjects unable to lie down without moving for 20 minutes.
* Women who are pregnant or cannot stop breast feeding for 24 hours.
* Claustrophobic patients unable to tolerate the scans.
* Subjects with a prolonged QT interval (as demonstrated by ECG test) cannot participate in the Tau-PET scans.
* Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc, since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.
Psychological Services Integration in Gynecological Oncology Clinics

The purpose of this study is to understand the feasibility and impact of integrated psychological care in outpatient gynecologic oncology clinics with the goal of creating a new standard of care. The investigators propose an intervention study comparing patient-centered outcomes (assessed by surveys) between women who receive usual care versus integrated psychological care. The investigators' objectives are to learn about the process of integration of psychological care directly into outpatient gynecologic oncology clinics and the impact of such integration on patients' well-being, presentation of symptoms, psychological functioning, coping mechanisms, awareness of support services offered, and perception of quality of care. As this is a feasibility study, aims are focused on assessing patient willingness for psychological intervention in the medical office, provider willingness to have psychologist present in clinic, and impact of psychological intervention. With such data to warrant further integration and time of psychologists in medical clinics, next steps for immediate and long-term projects may include focus on high risk populations, specific disease sites, additional provider clinics, more psychologist time spent in gynecological oncology clinics, and effectiveness of interventions with higher power. The investigators hope the results will serve as preliminary data for an integrated psychosocial care model that can be implemented in other oncology clinics.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Scheduled for an appointment in a gynecologic oncology clinic at the Siteman Cancer Center at the Center for Advanced Medicine or the Women's Tumor Clinic at the Center for Outpatient Health at Barnes-Jewish Hospital
* Patients may or may not have a cancer diagnosis.
* All gynecologic cancer types, histologic grades, primary or recurrent disease.
* Patients actively undergoing treatment or close observation
* Pregnant or lactating patients
* Able to speak and read English
* Able to consent

Inclusion criteria (correlative studies only) -Patients who are undergoing pre-operative work-up for evaluation of an adnexal mass by a Washington University gynecologic oncologist.

Exclusion Criteria:

-Impaired by a psychiatric or cognitive disorder that limits their ability to give consent or communicate with their medical providers about symptoms (as determined by the patient's medical team)

Exclusion criteria (correlative studies only)

* Neoadjuvant chemotherapy
* Treatment within the past month with antidepressant medications that affect serotonin physiology
* Specific histology: low malignant potential tumors, non-epithelial cancer histology.
* Previous cancer diagnosis within the past five years or recurrent cancer
* Regular steroid use in the last month
* Presence of comorbidities with known effects on the immune system (e.g., systemic lupus erythematosus, multiple sclerosis, and rheumatoid arthritis), congestive heart failure, pregnancy, or stroke within the past six months
* Major surgery in the past month.
Intra-uterine Cleaning During Cesarean Section

400 women who came to our Department for Cesarean Section delivery will be divided into 2 groups: Group1:Cleaning the uterine cavity "200 patients" Group2:No Cleaning of uterine cavity "200 patients"

Caesarean section is the most common major surgical procedure performed in obstetric practice. The American College of Obstetricians and Gynecologists (ACOG) estimates that in 2011 alone, one in three women who gave birth in the United States did so by cesarean delivery. Compared to vaginal births, the increasing rate of caesarean births worldwide is a well known cause of maternal morbidity, including hemorrhage, anesthetic complications, shock, cardiac arrest, acute renal failure, assisted ventilation, venous thromboembolism and increased risk of major postpartum infection.

With increasing cesarean section rates and its associated complications, obstetricians are challenged to reduce perioperative and postoperative morbidity by adapting their surgical skills and techniques. Over the years, randomized clinical trials have tried to answer many questions surrounding the safety of several cesarean section techniques that impart maternal morbidity. For example, the optimal type of cesarean section skin incision, whether or not to create a bladder flap, one layer versus two later closure of the uterus, irrigating the abdominal cavity, closure versus non closure of the parietal peritoneum, and suture versus staples for skin closure at cesarean section.

Cleaning the uterine cavity following cesarean section is a routine practice by many obstetricians. To ensure that the entire placenta and membranes are removed after delivery of the placenta at cesarean, the uterine cavity is usually cleaned with one hand holding a dry sponge to remove any remaining membranes or placental tissue, while the other hand is placed on the fundus to stabilize the uterus. However, despite the lack of evidence to support a policy of routine intrauterine cleaning after placental delivery at cesarean section, the benefits of intrauterine cleaning as a routine practice during cesarean sections remains uncertain. Obstetricians who do not routinely clean the uterine cavity after placental delivery argue that this procedure is not performed routinely after vaginal deliveries, and thus is a justification not to do so during cesarean sections

Eligibility Criteria:
Inclusion Criteria:

* women age from 20 to35 years old with intact membrane women with singleton or multiple pregnancy women with cephalic or breech presentation

Exclusion Criteria:

* premature rupture of membranes chorioamnionitis Diabetes mellitus Immunosuppressive disorder or therapy Fetal demise
Hepatic Transarterial Administrations of NKR-2 in Patients With Unresectable Liver Metastases From Colorectal Cancer

The purpose of this study is to test an experimental anti-cancer immunotherapy called NKR-2 (modified T cells), to treat colorectal cancer with unresectable liver metastases. The trial will test three dose levels (dose escalation). At each dose, the patients will receive three successive hepatic transarterial administrations, two weeks apart, of NKR-2 cells. The study will enroll up to 18 patients.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be ≥ 18 years old at the time of signing the ICF.
* The patient must have a histologically proven adenocarcinoma of the colon or rectum.
* The patient must have liver metastases non treatable with curative intent by surgical resection or local ablation at the time of registration.
* The patient must have measurable hepatic metastases defined by RECIST version 1.1 for solid tumors.
* The patient must have received one prior chemotherapy line for metastatic disease and have developed resistance or intolerance to this treatment.
* The patient must have an ECOG performance status 0 or 1.
* The patient must have the bone marrow reserve, hepatic and renal functions

Exclusion Criteria:

* Patients who are presenting evidence of ascites, cirrhosis, portal hypertension, main portal venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
* Patients who are planned to receive or concurrently receiving any non-cancer-directed investigational agent, or have received a non-cancer directed investigational agent within 3 weeks before the planned day for the first NKR-2 administration.
* Patients who are scheduled to receive concurrent growth factor (except erythropoietin), systemic steroid, other immunosuppressive therapy or cytotoxic agents (systemic or localized) other than the treatment authorized per protocol.
* Patients who underwent major surgery within 4 weeks before the planned day for the first NKR-2 administration.
* Patients who have received a live vaccine ≤ 6 weeks prior to the planned day for the first NKR-2 administration.
* Patients with a family history of congenital or hereditary immunodeficiency.
* Patients with history of any autoimmune disease.
Epidemiological Tool To Detect Angina Pectoris in Blacks

To develop a prototype questionnaire for the detection of angina pectoris in Blacks.

BACKGROUND:

Angina pectoris is often considered a manifestation of coronary artery atherosclerosis that is associated with an increased mortality risk. Overall, coronary heart disease is the leading cause of morbidity and mortality in United States Blacks. In an attempt to standardize the diagnosis of angina pectoris in epidemiologic studies, Rose developed a questionnaire for cardiovascular field surveys which has primarily been used in United States and other white populations. However, in 1988, there were no valid epidemiological tools for the assessment of angina pectoris in Blacks. The development of a cardiovascular survey instrument capable of assessing angina pectoris in Black populations was identified by the Association of Black Cardiologists as an urgent epidemiologic need. Also, such a survey instrument could ultimately enhance knowledge and treatment of cardiovascular disease among Blacks.

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 Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users

The purpose of this study is to determine that once-a-month injectable contraceptive( Cyclofem® ) has the effect on treatment of irregular uterine bleeding in implant contraceptive users or not.

Stratified randomization Implanon and Jadelle group were done using block randomization. The participants and investigators were blinded to treatment allocation, using drug coding that not revealed until the end of study. Research assistants and nurse who did not have involve in analyses data would follow the recruitment criteria and drug injection follow the code of drug.

All participants were collected demographic data, medical history, obstetrical and gynecological history, bleeding pattern before enrollment. Then physical exam and pelvic examination were performed for all participants. Participants received single dose intramuscular injection of Cyclofem® 0.5 ml or normal saline 0.5 ml as placebo on that day of recruitment to the study. Daily record of bleeding, spotting and side effect was done on record form.

Eligibility Criteria:
Inclusion Criteria:

* Implant (Jadelle or Implanon) inserted before enrollment with the symptom of bleeding disturbances for eight or more continuous days or a current bleeding-free interval of 15 days or less
* Regular menstruation at least 1 cycle before the usage of implant contraceptive
* Willingness to participate in a placebo-controlled study and ability to keep an accurate daily menstrual record
* No gynecological or serious medical diseases

Exclusion Criteria:

* Contraindication to estrogen or progesterone use such as

  * breast cancer
  * Liver cancer or tumor
  * Uncontrolled blood pressure (BP ≥160/100 mmHg )
  * History of atherosclerosis, vascular disease and high risk for VIE
  * History of ischemic stroke
  * Coagulopathy
  * Uncontrolled diabetes mellitus and complication
  * Cirrhosis
  * SLE with antiphospholipid positive
  * History of migraine with aura or age of 35 years old or more than with history of migraine non-aura
  * Age of 35 years old or more than with history of smoking more than 15 cigarettes per day
  * Postpartum 6 weeks
  * Plan for surgery procedure that need immobilization after surgery
* Previous treatment for 3 months before enrollment
* Allergic to drug component of Cyclofem® ( Medroxyprogesterone acetate , Estradiol cypionate)
Infliximab for the Prevention of Graft-versus-Host Disease Following Allogenic Hematopoietic Stem Cell Transplantation

This study will evaluate the efficacy of infliximab in reducing the incidence of grade II-IV acute graft versus host disease by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplant.

Rationale: Acute graft host disease (GvHD) remains a barrier to successful hematopoietic stem cell transplantation (HCT) used for the treatment of cancers in some patients. GvHD can result from a lack of compatibility between the donor and recipient. Research suggests another primary cause of GvHD comes from cytokines, or a substance produced by cells of the immune system that affect the immune response in both positive and negative ways. Infliximab is an antibody that directly targets the cytokine associated with GvHD. This study is building upon previous research to assess infliximab's ability to prevent GvHD after HCT.

Purpose: This study is evaluating the efficacy of infliximab in reducing the incidence of GvHD after HCT. The safety of this approach, along with changes to specific cytokines from this treatment, will also be measured.

Treatment: Patients in this study will receive infliximab through intravenous infusion. Infliximab will be administered in six doses, including one day before chemotherapy or radiotherapy, after the stem cell infusion, and then on days 7, 14, 28 and 42. Standard post-transplant treatments of cyclosporine (Neoral) and methotrexate (Methotrexate) will also be given through intravenous infusion. Cyclosporine will be given on day 1, and the subsequent schedule will be determined on an individual basis. Methotrexate will be administered on days 1, 3, 6, and 11. Several tests and exams will be given throughout the study to closely monitor patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing allogeneic HCT for the following disorders:

  * Acute myelogenous leukemia
  * Acute lymphoblastic leukemia
  * Non-Hodgkin's lymphoma
  * Hodgkin's disease
  * Multiple myeloma
  * Chronic lymphocytic leukemia
  * Chronic myeloid leukemia in accelerated or blast crisis at time of transplant.
* Age \>20 yrs

Exclusion Criteria:

* Patients undergoing allogeneic stem cell transplantation for chronic myelogenous leukemia and aplastic anemia are excluded.
* Pregnant or breast-feeding females.