cyrilzakka/clinical-trials huggingface dataset:
Survival of the Insignia Stem in Total Hip Arthroplasty

The investigators primary objective of this study is to evaluate radiographic fit and fill of the Insignia stem and identify risk factors for aseptic failure. The investigators hypotheses being tested is: the newly designed Insignia stem demonstrates acceptable radiographic fit and fill by reviewing radiolucent lines \<2mm.

Total hip arthroplasty is one of the most functionally restorative procedures in modern medicine. Since its introduction in the mid twentieth century significant advancements in implant materials have occurred. There is debate on the design of the femoral stem in total hip arthroplasty. The use of uncemented, Hydroxyapatite (HA)-coated femoral stems have been shown to be reliable and are commonly used. One such implant is the Insignia™ Hip Stem (Stryker, Kalamazoo, MI, USA).

The Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside. Unfortunately, with it's novelty comes a lack of clinical follow-up and evaluation. As such, the investigators purpose of this study is to evaluate the early radiographic of the Insignia™ Hip Stem.

Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥18
* Patients planning on undergoing primary total hip arthroplasty that will likely receive the Insignia stem and associated Stryker Acetabular Component.
* Preoperative diagnosis of osteoarthritis
* Patients willing and able to comply with follow-up requirements
* Patients willing to sign an IRB approved consent and authorization document

Exclusion Criteria:

* Patients with inflammatory or pyogenic arthritis
* Body Mass Index (BMI)\>40
* Bone stock that is inadequate for support or fixation of the prosthesis
G8, VES-13 and CARG Scores in Predicting Chemotherapy Toxicity in Geriatric Cancer Patients

All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. The suitability of G8, VES-13 and CARG chemotherapy risk assessment tools for elderly cancer patients was investigated.

All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. G8, VES-13 and CARG toxicity scores of all participating patients will be determined by two independent investigators before starting chemotherapy. The suitability of these practical chemotherapy risk assessment tools for cancer patients for elderly cancer patients was investigated.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥65 years
* Localized or metastatic solid carcinoma diagnosed by histology (any type, any stage)
* Starting a new-line (first-line, second-line or third-line) chemotherapy

Exclusion Criteria:

* Concurrent radiotherapy;
* Simultaneous immunotherapy
* Impaired language
* Cognitive function leading to inability to complete assessments.
Kiosk-Model Self-Triage System in the Pediatric Emergency Department

An audio-assisted self-triage kiosk in the Pediatric Emergency Department (ED) is expected to significantly reduce triage times, without any sacrifice of the quality of information that would be obtained by nurse-initiated triage.

With the rapid evolution of consumer based information technology patients have the opportunity to become collaborative partners in their care. In addition, by bridging information gaps and improving workflow efficiency, continuity of care is optimized and the potential risk for error is reduced. Triage time for kiosk self-triage and nurse-initiated triage will be compared in terms of 1) triage time; 2) accuracy of medical history obtained; and 3) patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Between 0 and 18 years of age
* Registered in the Pediatric ED
* Accompanied by parent/guardian 18 years or older
* Version 3 Emergency Severity Index (ESI) of 3 to 5
* Parent or guardian able to communicate in English or Spanish

Exclusion Criteria:

* Deemed medically unstable
* ESI score of 1 or 2
* Incarcerated or in juvenile detention
* Parent/guardian unable to communicate in English or Spanish
Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors

This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.

PRIMARY OBJECTIVES:

I. To conduct a pilot trial to estimate the proportion of gynecologic cancer patients with vaginal dryness or dyspareunia, who will have an improvement in their symptoms with vaginal laser therapy compared to sham treatment based on the Vaginal Assessment Scale (VAS).

SECONDARY OBJECTIVES:

I. To evaluate toxicity associated with vaginal laser therapy in this population.

II. To determine how many women with the defined patient eligibility will complete all treatments.

III. To determine the feasibility of the crossover design for potential use in a phase III trial.

IV. To determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment.

V. To determine improvement in sexual function as measured by Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS), and scales for sexual satisfaction and behavior with vaginal laser therapy versus sham treatment.

VI. To determine improvement in urinary symptoms of urogenital atrophy with vaginal laser therapy versus sham treatment using the Urogenital Distress Inventory (UDI).

VII. To demonstrate satisfaction with vaginal fractional CO2 laser therapy.

OUTLINE: Patients are randomized in to 1 of 2 arms.

ARM I: Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.

ARM II: Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.

After completion of study, patients are followed up at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment \>= 6 months prior to enrollment

  * Any form of hysterectomy, including radical hysterectomy permitted
  * Must have no evidence of recurrent disease on pelvic exam within past 3 months
  * Radiation therapy is permitted but not required
* Patient reported dyspareunia and/or vaginal dryness with severity of \>= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over \>= 4 weeks and/or the inability to be sexually active due to pain

Exclusion Criteria:

* Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer
* Pelvic organ prolapse stage II or higher
* Prior reconstructive pelvic surgery involving mesh
* Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment
My Personalized Breast Screening

MyPeBS is an international randomized, open-label, multicentric, study assessing the effectiveness of a risk-based breast cancer screening strategy (using clinical risk scores and polymorphisms) compared to standard screening (according to the current national guidelines in each participating country) in detecting stage 2 or higher breast cancers.

Women will be differentially screened for 4 years and then, after an end-of-study mammogram, they will return to the routine screening practice. The main study endpoint will be measured at the end of the four years of intervention.

Furthermore, follow up data will be collected for 15 years from study entry for evaluation of long-term cumulative breast cancer incidence and breast cancer-specific survival


Eligibility Criteria:
Inclusion Criteria:

1. Female (whether born female or not)
2. Aged 40 to 70 years old (inclusive)
3. Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures
4. Able to provide written informed consent obtained prior to performing any protocol-related procedures
5. Sufficient understanding of any of the languages used in the study
6. Affiliated to a social security/national healthcare system

Exclusion Criteria:

1. Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS)
2. Prior history of atypical breast lesion, lobular carcinoma in situ or chest wall irradiation
3. Known condition or suspicion of a very high risk predisposition to breast cancer: germline mutation of BRCA1/2, PALB2, TP53 or equivalent
4. History of bilateral mastectomy
5. Recent abnormal breast finding under work-up (clinically suspect lesion or BI-RADS 4 or 5 image)
6. Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up
7. Women who do not intend to be followed-up for 4 years
A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection

The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.

Rilematovir is an investigational RSV specific fusion inhibitor currently in development for the treatment of RSV infection in both adult and pediatric populations. The study will include a Screening period (Day -1 to Day 1), a Treatment period (Day 1 to Day 7/8 \[depending on timing of first dose\]), and a Follow-up period (Day 8/9 to Day 35). The total study duration of the study for each participant will be up to 35 days. The study will evaluate efficacy and safety of RSV in adult outpatients (18-85 years) who are at high risk of RSV related disease progression and have at least moderate RSV disease. The efficacy assessments include evaluation with electronic patient-reported outcome (ePRO) and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Presented to the healthcare facility with symptoms suggestive of a diagnosis of acute respiratory syncytial virus (RSV) infection
* Has at least 2 symptoms of lower respiratory tract disease (LRTD), one of which must be scored as at least 'moderate' if the symptoms did not pre-exist before RSV onset, or one of which is scored worse than usual if the symptoms pre-existed
* Tested positive for RSV infection using a molecular-based diagnostic assay (polymerase chain reaction \[PCR\] or other) on a bilateral nasal mid-turbinate swab sample
* Has at least one of the following high-risk conditions that predispose them to RSV-related disease progression: a. age greater than or equal to (\>=) 65 years, b. congestive heart failure (CHF), c. chronic obstructive pulmonary disease (COPD), d. asthma
* Randomized to study intervention treatment within 72 hours after onset of any of the RSV symptoms or worsening of pre-existing symptoms
* Not be hospitalized during screening (emergency room or hospital observation status for an anticipated duration of less than \[\<\] 24 hours are not considered as hospitalization)

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation
* Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia
* Participant has known or suspected (from medical history or participant examination) chronic or acute hepatitis B or C infection
* Immunocompromised conditions
* Living in institutional care or assisted living facility and also receiving acute care management for any respiratory condition
Perineal Body Length and Perineal Lacerations

The aim of this study was to evaluate the relationship between perineal body length and perineal laceration risk in primigravid patients.

Primigravid women with singleton pregnancies in the first stage of labor at the 35th week of gestation were included in the study. The peineal body length of the patients was measured by the same physician.

After 35 weeks of gestation, nulliparous women with single gestation were included in the study and genital hiatus and perineal body measurements were taken.

The presence and degree of perineal laceration after birth were determined. Correlation of genital hiatus and perineal body measurements with perineal laceration risk were evaluated.

After birth, vaginal laceration, oxytocin use, fetal birth weight, the presence of episiotomy were recorded.

Eligibility Criteria:
Inclusion Criteria:

-Primigravid women with singleton pregnancy at over 35th week

Exclusion Criteria:

* the story of operative vaginal birth;
* caesarean section;
* breech presentation;
* those with a history of anorectal surgery or trauma
The Development of Oral Nalbuphine Dosage Form

The purpose of this study is to investigate possible responses to pharmacokinetic properties for nalbuphine oral formulations in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Normal healthy adult subjects between 20-40 years of age.
* Body weight within 80-120% of ideal body weight. Ideal body weight = (height-80)0.7
* Acceptable medical history and physical examination including:

  * Normal chest X-ray and ECG results within six months prior to Period I dosing.
  * No particular clinical significance in general disease history within two months prior to Period I dosing.
* Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes:

  * AST (SGOT)
  * ALT (SGPT)
  * Gama-GT
  * alkaline phosphatase
  * total bilirubin
  * albumin
  * glucose
  * BUN
  * uric acid
  * creatinine
  * total cholesterol
  * triglyceride(TG)
* Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
* Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
* Signed the written informed consent to participate in this study.

Exclusion Criteria:

* Recent history of drug or alcohol addiction or abuse.
* A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
* History of allergic response(s) to nalbuphine or related drugs.
* History of clinically significant allergies including drug allergies or allergic bronchial asthma.
* Evidence of chronic or acute infectious diseases.
* Any clinically significant illness or surgery during the four weeks prior to Period I dosing (as determined by the clinical investigator).
* Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
* Receiving any investigational drug within one month prior to Period I dosing.
* Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
* Donating greater than 150 ml of blood within two months prior to Period I dosing or donating plasma (e.g., plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
* Consumption of caffeine, xanthine-containing products (i.e., coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol at least 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
* Any other medical reason as determined by the clinical investigator.
* Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

Eligibility Criteria:
Inclusion Criteria includes but is not limited to:

1. Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening.
2. No history or presence of significant medical condition or a clinically significant abnormal finding, as determined by the investigator.
3. Negative urine pregnancy test at screening and baseline for females of childbearing potential
4. Agree to refrain from water immersion of the ears from the time of signed informed consent to the end of trial
5. Physiologic tympanogram type A (normal) or type C at screening visit

Exclusion Criteria includes but is not limited to:

1. Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to screening visit
2. Positive urine drug screen at screening visit
3. Upper respiratory tract infection currently or within 6 weeks prior to screening visit
4. Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to screening visit
5. Claustrophobia that is sufficient to prevent them tolerating assessments while in a hypobaric/hyperbaric atmospheric pressure chamber
6. Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit
7. Clinically significant findings on ear nose and throat exam
8. Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit
9. Current diagnosis of sleep apnea
10. Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may interfere with ET function
11. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury

OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol secretion using approximate entropy in patients who have sustained a head injury.

II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of sleep in these patients.

PROTOCOL OUTLINE: Patients are stratified according to type of injury (closed head injury due to trauma vs vascular accidents). Patients are admitted two times for overnight assessment.

Admission 1: Patients receive cosyntropin IV. Blood is drawn at 30 and 60 minutes after IV infusion. Patients receive oral metyrapone before sleep. A sham sleep study is conducted through the night and patients' blood is drawn in the morning.

Admission 2: At least 2 weeks after admission 1, patients return for an overnight admission. Starting in the evening, blood is drawn every 15 minutes for 12 hours. A sleep study is conducted through the night.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Patients who have sustained head injury

Closed head injury from trauma OR

Vascular accidents like strokes and hemorrhages

--Prior/Concurrent Therapy--

Endocrine therapy: No concurrent cortisol replacement

Other: No blood donation during and for 1 month after study

--Patient Characteristics--

Hematopoietic: Hemoglobin normal

Other:

* No hypopituitarism
* No body mass index of 28 or greater
* Not pregnant or nursing
* Must have normal menstrual cycles
* No severe mental impairment
* Must not require legal guardian
Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)

The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.

Crohn's disease is often treated with glucocorticoids or mesalazine. Both drugs are indicated for active Crohn's disease. Treatment with mesalazine is indicated for the treatment of mildly to moderately active Crohn's disease. Budesonide 9 mg/day or mesalazine 4.5 g/day are better than lower doses.

So far only one trial compares the efficacy and safety of budesonide and 5-ASA. The result of this trial is that budesonide is more effective in inducing remission than mesalazine. The primary objective of this trial is to confirm this result for other presentations of budesonide and mesalazine; i.e. Budenofalk® capsules (9 mg/day) and Salofalk® tablets (Eudragit-L-coated oral mesalazine; 4.5 g/day) in moderately active Crohn's disease. Mesalazine is used in this trial as a comparator.

Eligibility Criteria:
Inclusion Criteria (main):

* Symptoms of Crohn's disease since at least 3 months; diagnosis confirmed by endoscopic and histological, or endoscopic and radiological criteria \[endoscopy not older than 12 months or if older, then clinical signs (e.g. pain localization, pain intensity, blood in stool) and behaviour (according to Vienna classification) should be unchanged compared to former episodes\]
* Localisation of CD either in terminal ileum, ascending colon or ileocolitis
* Active phase of disease (200 \< CDAI \< 400)

Exclusion Criteria (main):

* Known Crohn's lesion in the upper GI-tract (up to and including the jejunum) with present symptoms
* CD in the rectum currently present
* Short bowel syndrome
* Septic complications
* Baseline stool positive for germs causing bowel disease
* Abscess, perforation or active fistulas
* Ileostomy or colostomy
* Resection of more than 50 cm of the ileum
* Bowel surgery within the last 3 months
* Immediate surgery required
* Clinical signs of stricturing disease
* Subileus within the last 6 months
* Suspicion of ileus, subileus or corresponding symptomatology
* Contra-indications, special warnings and precautions mentioned in SmPC
* Treatment with immunosuppressants, cytostatics, 6-TG, methotrexate, or cyclosporine within the last 3 months; in case of treatment with azathioprine or 6-MP the drugs have to be used for maintenance of remission only and dosage has to be unchanged within the last 3 months before baseline visit and during the study
* Treatment with ketoconazole, ciprofloxacin or other CYP3A inhibitors within the last month before baseline visit
* Treatment with anti-TNF-a therapy within 6 months before baseline visit
* Conventional steroids (iv, po, rectal) within 2 weeks before the study
* \> 6 mg/d budesonide po or \> 3 g/d mesalazine po within 2 weeks before the study
* Patients known to be steroid-refractory or steroid-dependent from former CD episodes
* Treatment of study disease with oral antibiotics (e.g., metronidazole) within the last 2 weeks
In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems

The purpose of this study is to investigate and compare the images obtained from coronary imaging catheters used in the treatment of coronary blockages both in a clinical setting with patients and in models.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
* Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized \[total hysterectomy, bilateral tubal ligation, bilateral oophorectomy\]).
* Target artery must be \>2 mm to accommodate the IVUS catheter.
* IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)

Exclusion Criteria:

* Cardiogenic shock
* Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
* Known coronary artery spasm
* Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
* Bleeding diathesis
* Significant renal impairment (patients will be excluded if their calculated creatinine clearance is \< 30 mL/min)