cyrilzakka/clinical-trials huggingface dataset:
Optimal Timing of Intrauterine Insemination (IUI) When Utilizing Superovulation Combined With GnRH Antagonists

The timing of IUI following ovulation induction has been the subject of many studies and a consensus has developed that a single insemination approximately thirty-six hours after ovulation induction is sufficien. The introduction of GnRH antagonists preventing a premature LH surge and early ovulation has added a new dimension to fertility treatment. It allows greater accuracy in predicting the timing of ovulation and has been shown to be at least as effective, if not more effective, as ovarian stimulation without antagonists. We hypothesize that by utilizing GnRH antagonists we can increase pregnancy rates during IUI by timing the IUI as close as possible to the moment of ovulation guaranteeing the highest and freshest concentration of motile spermatozoa in the fallopian tube at the time the oocyte is released from the ovary. We therefore propose a randomized open three arm prospective trial utilizing superovulation with GnRH antagonists whereby the IUI is timed to take place 36, 42 or 48 hours after ovulation induction.


Eligibility Criteria:
Inclusion Criteria:

* Women with infertility who are candidates for controlled ovarian stimulation and intrauterine insemination with
* Ovulatory disorder
* male factor
* partial mechanical factor
* endometriosis
* unexplained infertility.

Exclusion Criteria:

* Known allergy to one or more of the utilized drugs
* Neither fallopian tube is patent
* Sperm count less than 1 million total motile sperm of normal morphology during at least two investigations
* Women who are candidates for mono-ovulation.
* failure to receive consent
* women with baseline functional cysts (i.e. hormone producing) above 12 mm diameter.
QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery

This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.

This is a randomized, double-blind, placebo-controlled, Phase 3 trial to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events in subjects at high risk for acute kidney injury following cardiac surgery. Subjects will be dosed with active drug or placebo after the completion of cardiovascular surgery.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, age ≥ 18 years old
* At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:

  * Reduced renal function
  * Diabetes with ongoing insulin treatment
  * Albuminuria
* Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest

Key Exclusion Criteria:

* Emergent surgeries, including aortic dissection, and major congenital heart defects
* Undergoes cardiac surgery off CPB for subjects ≥45 years old. (Cardiac surgery off CPB for subjects \<45 years old is allowed.)
* Perioperative or post cardiac surgery, an left ventricular assist device (LVAD) is inserted or anticipated
Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds

The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS).

Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.


Eligibility Criteria:
Inclusion Criteria:

* patients who are planned for open reduction internal fixation of midfacial fractures as part of standard of care
* patients who are admitted to Memorial Hermann hospital at Texas Medical Center
* able to sign their own consent

Exclusion Criteria:

* infected surgical sites
* allergies to bacitracin
Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)

This study was designed to evaluate the pharmacokinetic interaction and safety of coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male subjects or adult male subjects having no obvious disease other than high cholesterol levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male subjects meeting all the criteria below or adult male subjects having no obvious disease other than high cholesterol levels.
* Aged 20 years or over and 65 years or below when the informed consent is obtained.
* Weighing 50 kg or over and 80 kg or below on the day of the screening tests, with BMI \[Body Mass Index: body weight (kg)/height (m)2\] ranging from 16.5 to 27.5.

Exclusion Criteria:

Patients meeting any one of the following conditions are excluded from the study.

* Subjects with the triglyceride value at screening test exceeding 500 mg/dL.
* Subjects with past history of drug allergy (shock, anaphylactic symptom, and angioedema).
* Subjects with past history of alcohol or drug dependence.
* Subjects with past history of mental disorder.
* Subjects positive in the test for HBs antigen, HCV antibody, or HIV antibody or in the serological test for syphilis.
* Subjects who used any drug within 2 weeks of investigational product administration in Period 1.
* Subjects who have drawn more than 400 mL of blood within 12 weeks before administration day in Period 1.
* Subjects who participated in other study within 16 weeks of investigational product administration in Period 1 and was administered a investigational product.
* Subjects who cannot take contraceptive measures during the study period (from providing informed consent to completion of Period 3 examination)
* Subjects who the investigator judges are inappropriate to participate in the study.
MR7T-Healthy-PTX : Brain Exploration in Magnetic Resonance Imaging in Parallel Transmission Mode (pTX) at 7 Tesla

Magnetic resonance imaging (MRI) is a non-invasive imaging modality used in routine clinical practice for clinical diagnosis by visualizing the anatomical structure and in vivo function of certain organs. The development of ultra-high field MRI systems with 7.0-T or higher, gives access to a new field of exploration of the human body by improving the speed of acquisition but also a better signal-to-noise ratio (SNR) and better resolution. In order to fully exploit the potential of these ultra-high field MRI scanners, various technical issues must be adressed. Indeed, the non-uniformity of the transmission field is one of them leading to non-uniform images with spatially varying contrast. Thus the pTX (parallel transmission) mode using multiple transmission channels allows spatial and temporal control over the RF waves.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Subject with no MRI contraindications (metallic shine, pacemaker)
* Free subject, without guardianship or curatorship or subordination
* A person affiliated to or beneficiary of a social security scheme.
* Informed and signed consent by the healthy volunteer after clear and fair information about the study

Exclusion Criteria:

* Subject with a contraindication to MRI (pregnancy, ocular metallic foreign body (accidental or other shrapnel); pacemaker (cardiac stimulator), implantable defibrillator, non MRI 7.0 T compatible neurostimulator, cochlear implants and generally any irremovably implanted electronic medical device; metallic heart valve, vascular clips formerly implanted on cranial aneurysm), metallic prostheses.
* Healthy volunteers suffering from claustrophobia
* Persons not benefiting from a Social Security scheme or not benefiting from it through a third party.
* Persons benefiting from reinforced protection, i.e. minors, pregnant and breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally, patients in emergency situations.
* Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.


Eligibility Criteria:
Inclusion Criteria:

* Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2
* Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary
* Stable body weight for at least 3 months
* Type 2 diabetes mellitus is allowed

Exclusion Criteria:

* Males taking gonadotropin replacement therapy (LH/FSH)
* Subjects who are planning any fertility treatment within 6 months of study participation
* Use of weight loss agents, including herbal medications, in the past 3 months
* Current or anticipated chronic use of narcotics or opiates
* History of severe psychiatric disorders
* Type 1 diabetes mellitus
* Metabolic disorders or genetic disorders linked to obesity
* History of any bariatric surgery
* Participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study
* Blood loss or donation \>500 mL within the past 3 months
* Females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)

Primary objectives

* To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL.
* To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse in low- and intermediate-risk patients with APL.
* To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients (administered as in the original GIMEMA protocols) on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse.
* To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL.

Secondary objectives

• To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.

Treatment of induction with the simultaneous administration of ATRA (45 mg/m2 day until the RC) and idarubicine (12 mg/m2 days 2, 4, 6 and 8), 3 monthly cycles of consolidation with ATRA (45 mg/m2 days 1-15) and idarubicine (5 mg/m2 days 1-4) in the cycle #1, mitoxantrone (10 mg/m2 days 1-3) in the cycle #2 and idarubicine (12 mg/m2 day 1) in the cycle #3. The consolidation was reinforced for the group of patients with intermediate risk by means of an increase of the idarubicine to 7 mg in the cycle #1 and to 2 days in the cycle #3. In the patients of high risk, the consolidation was reinforced with the addition of altar-c in the cycles #1 and #3. For the maintenance treatment, one will administer to intermittent ATRA (15 days every 3 months) and chemotherapy low doses with methotrexate and 6-mercaptopurina during two years

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 75 years.
* ECOG ≤ 3.
* Morphologic Diagnosis of LPA (FAB M3 or variant M3). Those cases without typical morphology but with PML-RARα reordering also must be including.
* Genetic Diagnosis: t (15; 17) demonstrated by cariotipo conventional, FISH, PML-RARα reordering detected by RT-PCR or a pattern microspeckled demonstrated with antibody anti-PML (positive PGM3). Obvious, it will be had the result of these tests once initiated the treatment on the basis of a suspicion diagnoses morphologic

Exclusion Criteria:

* Age \>75 years (the treatment with this protocol can be considered individually)
* Absence of PML-Rare reordering.
* To have received previously some type of treatment for LPA, including chemotherapy or retinoides. The previous treatment with corticoids, hidroxiurea or leucoaféresis is not reason for exclusion.
* To have received chemotherapy or x-ray for the treatment of a disease vitiates previous.
* Associate Neoplasia.
* Serious psychiatric Disease.
* Seropositividad for VIH.
* Contraindication to receive intensive chemotherapy, specially antraciclinas.
* Sérica Creatinina ≥ 2,5 mg/dL (≥ 250 μmol/l).
* Bilirrubina, fosfatasa alkaline, or GOT \> 3 times the normal limit
* Test of positive pregnancy.
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846)

The primary features of schizophrenia and schizoaffective disorder are positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving maintaining productive employment.

Asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Subject with schizophrenia or schizoaffective disorder. Must have completed 12 months treatment under protocol 25517. Subject must sign a written informed consent.

Exclusion Criteria:

* Have an uncontrolled, unstable, clinically significant medical condition.
Frank Score and Coronary Artery Disease

Patients with coronary artery disease (CAD) were enrolled. CAD was diagnosed by coronary angiography which also resulted Syntax score. Images of left and right ears were captured by a digital camera. Frank score of each patients was calculated based on characteristics and numbers of wrinkles of the earlobes. Statistic analysis were carried out to analyze the correlation between Frank Score and Syntax Score.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis coronary artery disease by coronary angiography

Exclusion Criteria:

* Diagnosis of malignant tumor
* Positive heart transplant history
* Positive CABG history
* Positive PCI history
* Pregnant and lactating women
* Diagnosis of chronic kidney disease
* Any external ear trauma or disease history
Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers

Breathlessness is a dangerous symptom. Preliminary data from national and regional Danish databases show, that patients with shortness of breath in the ambulance have a very high mortality. Breathlessness can be caused by many different conditions - but heart diseases and lung diseases are dominant. The mortality is especially high in patients with breathlessness caused by heart disease.

Distinguishing these different causes of breathlessness is a classical, often difficult, discipline in medicine. Visitation and guidance of treatment in patients with breathlessness in the prehospital setting relies on medical history and physical examination and as a consequence prehospital treatment for breathlessness is often non-specific. The use of heart-failure specific biomarkers may improve prehospital visitation and treatment of patients with breathlessness.

We hypothesize, that

1. Supplementing the routine examination by prehospital anesthesiologist with measurement of a biomarker for heart failure increases the proportion of patients with severe shortness of breath caused by heart disease triaged directly to department of cardiology
2. This strategy does not increase the proportion of patients with severe shortness of breath caused by non-heart disease triaged directly to department of cardiology

Measurement of the biomarker for heart failure N-terminal pro-Brain Natriuretic Peptide (NT-proBNP):

In patients randomized to the strategy with supplementary measurement of NT-proBNP, a blood sample will be drawn from the peripheral venous catheter that is routinely inserted. This will be analyzed point-of-care in the ambulance.

Interpretation of NT-proBNP:

Cut-off values based on bootstrap-validated optimal cut-points for heart failure on will be used.

Confirmatory ('rule in') cut point

\< 50 years: 450 pg/mL

50-75 years: 900 pg/mL

\> 75 years: 1800 pg/mL

Exclusionary ('rule out') cut point

All patients: 300 pg/mL

The emergency physicians will be thoroughly informed about these cut-points, but told not to triage to department of cardiology or other department strictly according to NT-proBNP, but according to clinical assessment AND NT-proBNP.

Eligibility Criteria:
Inclusion Criteria:

All patients requiring dispatch of emergency physician because of severe dyspnea.

Severe dyspnea is defined by dyspnea plus at least ONE of the following

* Respiration frequency \> 20 or \< 8
* Saturation \< 96 without supplementary oxygen
* Heart rate \> 100 or \< 50
* Systolic blood pressure \< 100 or \> 200
* Difficulty talking
* Central or peripheral cyanosis
* Use of accessory muscles of respiration
* Glasgow coma scale score \< 15

AND because of the physical condition, the patient is not able to give informed consent

Exclusion Criteria Age \< 18
DAANCE for CHEMOTHERAPY-INDUCED NEUROPATHY

Up to 80% of breast cancer survivors experience chemotherapy-induced neuropathy that impairs quality of life and increases fall risk long into survivorship, yet treatment options for neuropathy remain limited. The successful treatment will target neurophysiologic mechanisms for restoring function while addressing patient-reported symptoms and participation in treatment. Toward this end, the investigators propose to study a noninvasive, social sensorimotor intervention - Adapted Argentine Tango - which targets motor control restoration, symptom alleviation, and treatment participation in concert.

This study will investigate a noninvasive, social, sensorimotor intervention which targets motor control restoration, symptom alleviation, and treatment participation in concert: partnered Adapted Argentine Tango (Tango). This project will expand the investigators' pilot work (R21-AG068831) into a multicenter clinical trial designed to investigate the effect of social dance on sensory relief, functional restoration, and key mechanisms of action among a diverse cohort of BC survivors suffering from chronic chemotherapy-induced sensorimotor deficits.

Eligibility Criteria:
Inclusion Criteria:

* Breast Cancer (BC) diagnosis of Stage I-IV including metastatic disease
* completed taxane-based chemotherapy for BC at least 3 months ago (no limit on how long ago)
* symptomatic for chemotherapy-induced neuropathy (self-report)
* postural control score that indicates potential fall-risk
* able to understand and comply with directions associated with testing and study treatments

Exclusion Criteria:

* pre-existing vestibular dysfunction
* poorly controlled diabetes (hgA1C\>=8)
* non-ambulatory (assistive and prosthetic devices allowed)
* hearing impairment resulting in less than 10% hearing bilaterally
* contraindication to participate in the experimental physical activity per the treating oncologist due to additional condition (e.g., herniated disc, unstable bone metastases)
* currently in activity-based therapy (e.g., physical therapy, occupational therapy). May enroll if still meet eligibility criteria once activity-based therapy is complete.
Probiotics and Multi-Drug Resistant Urinary Tract Infection

This pilot study is a single-site randomized, double blinded placebo-controlled in females with recurrent multi-drug resistant (MDR) urinary tract infections(UTI). Our study hypothesizes that a novel probiotic strain improves antibiotic sensitivity patterns in these former MDR UTIs.

The aims of this study are (1) to evaluate the effects of six months of probiotic therapy in addition to standard of care in changing sensitivity patterns of MDR bacteria causing recurrent UTI, (2) analyze the genetic composition of MDR bacterial isolates causing recurrent UTI before and after administration of probiotic vs. placebo, with standard of care antibiotics.

Study subjects will be asked to take a either a probiotic supplement or placebo at a dose of 1 caplet per day for 24 weeks in addition to antibiotic regimen. Subjects will be followed for 12 months. The outcome measure is the percent of probiotic ingestors vs placebo ingestors who experience a change in antibiotic susceptibility over this time period. The secondary outcome measure is the evaluation of genetic composition of bacteria recurring after probiotic vs. placebo administration.

Eligibility Criteria:
Inclusion Criteria:

* Female, age 18-90
* Ability to void spontaneously
* Suffers from recurrent multi-drug resistant or extensively drug resistant urinary tract infections caused by E.coli, Klebsiella, Enterococcus, Citrobacter, Proteus, Enterobacter, Serratia and Providencia.

Exclusion Criteria:

* Has staghorn renal calculi, chronic hydronephrosis, intermittent catherization, indwelling urinary catheters, urinary diversions, end stage renal disease on hemodialysis, transplantation, HIV, cirrhosis, pancreatitis, allergy to soy or milk/milk proteins or lactose intolerance
* Pregnant or breastfeeding
* Currently taking probiotics. 4 week washout.