cyrilzakka/clinical-trials huggingface dataset:
Reducing VA No-Shows: Evaluation of Predictive Overbooking Applied to Colonoscopy

In this research study, investigators use colonoscopy as a case example to evaluate a predictive overbooking model derived using patient-level predictors of absenteeism. The no-show overbooking intervention employs a logistic regression model that uses patient data to predict the odds of no-showing with 80% accuracy. These projected no-show appointments will be overbooked by clerks for patients who agree to join a "fast track" short-call line. By rapidly processing endoscopy patients and moving them out of traditional slots, investigators predict more scheduling slots would become available for patients awaiting colonoscopy.

Patient "no-shows" are especially common in VA gastrointestinal (GI) endoscopy units, where both open-access endoscopy scheduling and patient dislike of procedures contribute to high absenteeism. In this proposal, investigators use endoscopy as a case example to evaluate a predictive overbooking model derived using patient-level predictors of absenteeism. The no-show overbooking intervention employs a logistic regression model that uses patient data to predict the odds of no-showing with 80% accuracy. These projected no-show appointments will be overbooked by clerks for patients who agree to join a "fast track" short-call line. However, patients scheduled for upper endoscopies in the "fast track" assume a small risk of service denial on the day of their overbooking in case of inaccurate predictions. If this occurs, the patient is guaranteed service in the next available position and is assured of having a shorter wait time. Patients scheduled for colonoscopies will never be turned down but may experience delays in the waiting room the day of their "fast track" appointment. By rapidly processing endoscopy patients and moving them out of traditional slots, investigators predict more scheduling slots would become available for patients awaiting colonoscopy. Investigators propose to conduct a prospective, 24-month, interrupted time series (ITS) trial in the WLAVA (West Los Angeles Veterans Administration) GI clinic endoscopy unit. During intervention periods, investigators will activate the no-show predictive overbooking strategy described above. Investigators will compare outcomes between scheduling strategies, including differences in percent utilization of capacity (primary outcome), number of Veterans served, mean patient lag time between scheduling and procedure, number of unexpected service denials ("bumps") from no-show predictive overbooking, and direct costs of care. Investigators will analyze differences using both traditional univariate and multivariate approaches, and using autoregressive integrated moving average (ARIMA) analyses to adjust for auto-correlations in ITS data.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for upper endoscopy and agree to the terms of "fast track" offer.

Exclusion Criteria:

* If a patient expresses concern about service denial, confusion about the bargain, or refuses to participate, the investigators will schedule these patients routinely.
EMG Guided Botulinum Toxin Type A Injections for Refractory High Tone Pelvic Floor Dysfunction

This is a prospective, pilot, longitudinal study to evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD. The objective of this study is to determine the efficacy of injecting botulinum toxin type A into pelvic floor muscles that are high tone. Patients who have been diagnosed with high tone pelvic floor muscle dysfunction and have failed other treatments will be eligible to participate in this study. Study related procedures will include perineometry readings. Patients will be required to complete 7 questionnaires for this study. These include visual analog scale (scale from 0-10) for pain (VAS), the O'Leary-Sant urinary symptoms and problem questionnaires (ICSI/ICPI), Pelvic Floor Distress Inventory 20 (PFDI-20), the Female Sexual Distress Scale (FSDS), Global Response Assessment Scale and the SF-12 quality of life scale. The use of the EMG guidance is the experimental part of the study. We will perform EMG Needle testing in order to pin-point the best location for the patients Botox injections. This is a prospective, pilot, longitudinal study to evaluate the effect of Botox A injection for chronic pelvic pain and HTPFD.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be diagnosed with High Tone Pelvic Floor Dysfunction(HTPMFD).
* Participant must have tried and failed at least one other conventional mode of therapy for HTPMFD.
* Participant must be a female at least 18 years of age.
* Participant must give written informed consent to participate in this study.
* Participant must be able to make decisions for herself.
* Participant must not be undergoing another procedure at the time of BTX A injection.

Exclusion Criteria:

* Participant is male.
* Patient has a history of past BTX A use
* Patient has had pelvic organ prolapse repair
* Participant is pregnant or intends to get pregnant during the study period or is breastfeeding.
* Participant is unwilling or unable (because of long distance from office) to follow-up.
* Participant has a neuro-modulator device implanted.
* Participant has a known bleeding disorder or is on anticoagulation.
* Participant has a known hypersensitivity to BTX A.
* Participant has a pre-existing neuromuscular disorder such as amytrophic lateral sclerosis, motor neuropathy, myasthenia gravis or Lambert-Eaton syndrome.
* Participant with skin infection at the perineum at the site of injection.
Precision Medicine to Predict the Trajectory of Liver Cirrhosis: Prospective Cohort Study

Preventing decompensation is a key endpoint in the management of compensate cirrhosis patients. The known factors that increases the risk of decompensation include the presence of clinically significant portal hypertension (CSPH) and the control of primary etiology of cirrhosis. Other factors which may influence the progression of cirrhosis included the presence of metabolic syndrome (diabetes mellitus and obesity), frailty, concomitant medications (statin, non-selective beta-blocker) were not well understood. Investigators aim to perform a pilot, observational study to study various baseline factors in relation to the clinical outcome of cirrhosis patients in a prospective follow up.

All patient who fulfilled eligibility criteria will be consented and recruited. The study will last up to 3 years or up to 7 assessment and 7 visits All subjects will be followed every 6 monthly for study outcome from recruitment, biosamples (blood,urine and stool), elastography, quality of life questionnaire and frialty assessment were done at baseline. Completion of Sit to stand , handgrip and 6 minute walking test at baseline and Visit 3.All visits will be follow up on study outcome (liver-related events ,metabolic related outcome and cardiovascular related outcomes.). During decompensation (decrease in liver function ) .Collection of research leftover blood,urine and stool samples if applicable.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 to 90 years with the diagnosis of liver cirrhosis (regardless of etiology)
* Consent to participate in the study

Exclusion Criteria:

* Terminal malignancy. Subjects with prognosis \< 3 months.
* Patient refusal or unable to commit to study follow-up
Impact of a Day Without Clinical Activity Before Night Shift on Non-technical Skills of Intensive Care Residents

In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep deprivation and their non technical skills impairment. Investigators designed a prospective, randomized, blinded in cross over evaluation of medical pratices. Investigators will compare resident's performance during a high fidelity simulation session, on crisis managment in intensive care unit, after a night shift in intensive care unit, of residents who work on an intervention schedule with no clinical activity before night shift, with resident's performance of residents who had a traditionnal schedule including an usual clinical day before night shift. Investigators also assess cognitive performances, sleepiness and self esteem before and after night shift. Investigators specific aims will be:

To test the hypothesis that residents working on an intervention schedule will have non technical skills, assessed by Ottawa GRS global score, significantly less impaired after a night shift, than those on traditionnal schedule

To test the hypothesis that residents working on an interveniton schedule will have cognitive performances, sleepiness and self esteem less impaired after night shift than those on a traditionnal schedule

Main objective of this study is to compare the non-technical skills after night shift, of anaesthesia and critical care residents who did not have clinical activity before the night shift with those who had at least 8 hours of clinical activity before. The workforce is constrained by the number of residents in training at Clermont-Ferrand and Lyon University Public Hospital. Thus, it is possible to consider the inclusion of 60 residents for 55 evaluable. With such numbers, the clinically relevant difference of 6 points for the Ottawa GRS score (for a standard deviation of 11) can be demonstrated with an alpha risk of bilateral error of 5% and a power of 80%. Two interim analyzes will be carried out including the first 20 interns and then 20 additional interns (therefore for 40 interns) with the aim of stopping the study for "effectiveness", more precisely stopping the study for evidence of a statistically significant difference for the primary outcome measure, with risks of first error observed respectively at 0.0005 and 0.014 comparisons (correction due to multiples). A simulation of the statistical power will also be proposed during the performance of these analyzes; if necessary, a new estimation of the workforce will be proposed to the competent authorities. Investigators do not plan loss of follow up.

Eligibility Criteria:
Inclusion Criteria:

* residents in Anesthesia or Critical care medicine
* Who effect night shift in intensive care unit
* Able to take a day off clinic before night shift
* Able to give consent

Exclusion Criteria:

* Refusal of participation
Impulsivity, Brain Function, and Substance Abuse Treatment in Cocaine Dependent Individuals

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this trial is to evaluate aspects of treatment response in cocaine dependent individuals.

Cocaine is a strong central nervous system stimulant that is widely abused throughout the United States. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. The purpose of this study is to determine how impulsivity and prefrontal cortical function are related to treatment response in cocaine dependent individuals.

Participants in this study will complete four separate experiments, each with a different aim and testing panel \[cognitive function tests with and without functional magnetic resonance imaging (fMRI)\]. The first experiment will examine memory, attention, cognitive function, and impulsivity; the aim is to determine the relationship between impulsivity and cognitive function in cocaine dependent individuals receiving treatment. The second experiment will examine the relationship between impulsivity and the prefrontal cortical structure and function. Participants will complete an fMRI during the second experiment. The third experiment will consist of cognitive function tests and will examine the prefrontal cortex in relation to treatment response, based on four different treatments: 1) L-dopamine, 2) naltrexone, 3) modafinil, and 4) placebo. The fourth experiment will examine the effect of cocaine dependence treatment on prefrontal cortex, focusing on participants receiving modafinil.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for cocaine dependence
* Met inclusion criteria for other cocaine dependence studies within the center grant

Exclusion Criteria:

* Current or history of DSM-IV Axis I disorders, other than substance abuse or dependence
* Lifetime diagnosis of alcohol dependence
* Serious non-psychiatric medical illness requiring ongoing medical treatment or one that affects the central nervous system
* Positive urine drug screen test for drugs of abuse other than cocaine at the time of study entry
* AIDS-defining illness
* Intelligence Quotient (IQ) below 70
* Pregnant
* Uses a pacemaker, metal or electromechanical implants, or metallic foreign bodies
Helicobacter Pylori Eradication to Prevent Gastric Cancer

Gastric cancer is the fourth most common type of cancer and the second leading cause of cancer-related death in the world. In China, more than 390,000 new patients are diagnosed with gastric cancer and more than 300,000 patients are killed by the terrible disease annually. Although gastric cancer has a multifactorial etiology, infection with H. pylori is highly associated with gastric carcinogenesis. Therefore, eradication of H. pylori infection appears to reduce the risk of gastric cancer. However, several recent controlled interventional trials by H. pylori eradication to prevent gastric cancer have yielded disappointing results. The exact effect of H.pylori eradication on prevention of gastric cancer is unclear up to now. To clarify this problem, the investigators conducted a prospective, randomized, double-blind, placebo-controlled, population-based study to determine whether H pylori eradication would reduce the incidence of gastric cancer in a high-risk population in China.


Eligibility Criteria:
Inclusion Criteria:

* Healthy registered inhabitants from 10 villages in a high-risk county of gastric cancer in China
* Age 30-59 years
* A willingness to participate in the study as indicated by written informed consent

Exclusion Criteria:

* Severe concomitant illness (eg, severe hypertension, coronary heart disease, diabetes mellitus, stroke, asthma, liver cirrhosis, tuberculosis, infectious hepatitis, and cardiac, respiratory, hepatic, or renal insufficiency)
* Patients with epilepsy or severe mental illness
* Previous diagnosis of cancer
* A history of esophageal or gastric surgery
* Drug abuse and drug dependence
* Allergic to omeprazole, amoxicillin, or clarithromycin
* Pregnant and lactating women
* Previous history of H pylori eradication treatment
* A negative 13C-urea breath test (UBT)
* A definite indication of H. pylori eradication (eg, gastric or duodenum ulcer)
* Dysplasia or carcinoma lesions are found in esophageal or gastric histopathological examination
* Other factors or conditions might influence the results of study
Genasense® (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects With Chronic Lymphocytic Leukemia

The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells. This study will test whether treating subjects with Genasense®, fludarabine and rituximab is safe and effective.


Eligibility Criteria:
Key Inclusion Criteria:

* Absolute lymphocyte count of \> 10,000 cells/mm3 or history of ALC \>10,000 cell/mm3
* Platelets \> 50,000 cells/mm3
* Tumor lymphocytes expressing surface CD5, CD19, CD20 and CD23
* Creatinine \< 1.5 mg.dL

Key Exclusion Criteria:

* Less than 3 weeks from any prior major surgery or other therapy for CLL including radiation therapy, chemotherapy, high-dose steroid therapy, immunotherapy, cytokine, biologic or vaccine therapy.
* History of autoimmune hemolytic anemia
* Prior allogeneic transplant
The North American Pancreatitis Study

This study will investigate several genes and other factors measured in the blood that may cause recurrent acute pancreatitis and chronic pancreatitis. No treatment is offered as part of this study. Subjects have one single visit to provide a blood sample for genetic testing and to answer a questionnaire. Subjects are not given results of genetic testing. The study is currently enrolling African American subjects and controls only.

This study seeks to enroll African American people with and without pancreatitis. There is only one study visit to obtain consent, a blood sample and complete a questionnaire. Subjects must be patients of a participating center; controls must present to a participating center for enrollment.

Eligibility Criteria:
Inclusion Criteria:

African American

pancreatitis patients who are at least 14 years of age with a diagnosis of acute or chronic pancreatitis

* controls who do not have pancreatitis and must be at least 18 years of age

Exclusion Criteria:

* unable or unwilling to sign informed consent
PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.

To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 or over.
* A history of CHD or clinical evidence of atherosclerosis (diabetic or non-diabetic) or a CHD risk equivalent (10-year risk score \> 20% for CHD as described in NCEP ATP III guidelines1.

Exclusion Criteria:

* History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
* Pregnancy
* History of homozygous familial hypercholesterolaemia.
Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors

Single Cohort A(GAIA-102 alone):

Confirm the safety of GAIA-102 alone for refractory/relapse neuroblastoma or pediatric solid tumors with lung metastases, and decide recommended dose for Phase II.

Cohort B(GAIA-102 with Dinutuximab):

Confirm the safety of GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination for refractory/relapse neuroblastoma and decide recommended dose for Phase II.

Cohort C(GAIA-102 with Nivolumab):Confirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab.

Cohort C(GAIA-102 with Nivolumab):Confirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been confirmed to have the following malignant tumor by histological examination

   * single cohort : neuroblastoma or malignant solid tumor with pulmonary metastases, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family, osteosarcoma, other cartilage sarcoma, nephroblastoma, hepatoblastoma, germ cell neoplasma, other rare solid tumor (except brain tumor and brain metastases) .
   * combination cohort : neuroblastoma.
2. Patients who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.
3. Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs.
4. Patients aged from 1years to 24 years at the time of obtaining consent.
5. Patients with performance status(PS) over 50 (Lansky Performance Status Score less than 16 years old) or (Karnofsky Performance Status over 16 years old) at the time of obtaining consent.

Exclusion Criteria:

1. Patients with brain metastases.
2. Patients diagnosed with cancerous meningitis
3. Patients who received allogeneic hematopoietic stem cell transplant.
4. Patients with active autoimmune disease.
A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)

The primary purpose of this study is to evaluate the safety and tolerability of BRII-296 administered by 2 intramuscular injections, administered with Depo Medrol as assessed by the incidence of adverse events, changes from baseline in vital signs, pulse oximetry, clinical laboratory evaluations, electrocardiograms (ECGs), Stanford Sleepiness Scale (SSS), Glasgow Coma Scale (GCS) in conjunction with clinical assessment, and suicidal ideation using the Columbia Suicide Severity Rating Scale (C-SSRS).


Eligibility Criteria:
Inclusion Criteria:

* Participant either must have ceased lactating at screening or is still lactating actively breastfeeding at screening , must agree temporarily cease giving breast milk to her infant(s)
* Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Participant was \<12 months postpartum
* Participant is amenable to intramuscular administration of investigational product on Day 1 and remaining inpatient until at least Day 4

Exclusion Criteria:

* Active psychosis
* Attempted suicide associated with current episode of postpartum depression
* Medical history of seizures
* Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder
Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD

This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal Female patients up to 89 years, inclusive;
* BMI ≤ 35 kg/m2, inclusive;
* In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
* Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
* Have a minimum of two evaluable non-fractured lumbar vertebrae.
* Have low bone mineral density defined as having a T-score ≤ -2.0 as determined by DXA scan at either the lumbar spine (L1-L4) or total hip

Exclusion Criteria:

* Serious Medical Condition
* History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
* Have a history of cancer within the past 5 years, except for basal cell carcinoma
* Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
* Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product.