cyrilzakka/clinical-trials huggingface dataset:
Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis

Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the packing. Additionally, there is a great deal of pain during the insertion and removal of this packing. This study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. Thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.


Eligibility Criteria:
Inclusion Criteria:

* English speaking adults that have failed first line therapy for anterior epistaxis in the ER or the hospital

Exclusion Criteria:

* Non-english speaking patients
* Patients with bleeding disorders
* Known pregnant women or women that think they may be pregnant
* Patients with a know presence of antibodies to bovine thrombin preparations
* Patients that currently have or are known to have a history of systemic skin condition or rash such as eczema or psoriasis
* Patients found to have posterior epistaxis
* Patients requiring a surrogate for medical decisions
Three Dimensional Evaluation of Nasolabial Changes Following Classic vs Without Alar Base Suture After Le Fort I Osteotomy

Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after

Le Fort I osteotomy

A randomized controlled clinical trial


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with skeletal maxillomandibular deformity indicated for surgical correction by Le Fort I osteotomy.
2. Absence of growth.
3. Patients must be willing for the surgical procedure and follow-up, with his informed consent.

Exclusion Criteria:

* 4. History of facial trauma with fractures of facial bones. 5. History of surgical operation in nasal region. 6. Facial asymmetry. 7. Patients with accompanying craniofacial syndromes. 8. Patients with any diseases that compromise bone or soft tissue healing. 9. Anterior open bite cases. 10. Clefts ( lip and palate). 11. Medically compromised patients not fit for general anaesthesia. 12. missing preoperative or postop-erative 3D photographs or CBCT scans 13. multi-segment Le Fort I osteotomy 14. rhinoplasty surgery during or within 1 year after the Le Fort I osteotomy
HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions

This phase IV trial studies how well human papillomavirus (HPV) vaccine therapy works in interrupting progression in patients with high-grade vulvar or anal lesions. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill tumor cells and decrease the chance of vulvar or anal lesions to progress or come back.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline, 2 months, and 6 months.

ARM II: Patients receive placebo IM at baseline, 2 months, and 6 months.

After completion of study treatment, patients are followed up at months 7, 12, 18, 24, 36, and 42.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of initial or recurrent anal or vulvar high-grade squamous intraepithelial lesion (AIN2/3 or VIN2/3) diagnosed on or after 1/1/2014; study pathologist will use p16 staining as needed to rule out low-grade squamous intraepithelial lesion (LSIL) disease
* \>= 2 months since last therapy for HSIL
* No clinical evidence of HSIL on screening examination; if HSIL is suspected, a biopsy will be done to exclude HSIL; patients whose screening visit reveals HSIL on biopsy, may be re-screened \>= 2 months after therapy
* Resident in the catchment area of the clinics and willing to attend up to 8 clinic visits for a 36-month period
* Sexually active women of child-bearing potential must be willing to use effective contraception through month 7 of the study
* If human immunodeficiency virus (HIV) positive, receipt of anti-retroviral therapy continuously for at least 6 months prior to enrollment
* Ability to give informed consent
* Willingness to sign medical records release form and tissue release form

Exclusion Criteria:

* Currently pregnant
* Chemotherapy (current, within the last month, or anticipated in the next 7 months)
* Prior history of invasive HPV-related anogenital cancer (cervical, vaginal, vulvar, penile, or anal cancer), or oropharyngeal cancer (base of tongue, tonsil); prior cancer at other sites (including most of oral cavity) or larynx are not exclusions
* Unstable medical condition (e.g., another malignancy requiring treatment, malignant hypertension, poorly controlled diabetes, another cancer except for fully excised non-melanoma skin cancer)
* Prior HPV vaccination
* Known allergy or intolerance to lidocaine
* Currently participating in an interventional research study related to HPV, except the Anal Cancer HSIL Outcomes Research (ANCHOR) study (NCT02135419)
* Any other condition which, in the opinion of the investigator, may compromise the subject's ability to follow study procedures and safely complete the study
Non-Contact Air Tonometry (Topcon CT-1®) Versus Goldmann

In this prospective device comparison study with 58 healthy eyes, the Topcon CT-1® showed statistically significant elevated intraocular pressure measurements compared to the gold standard Goldmann application tonometry.

Introduction:

Intraocular pressure (IOP) measurement is crucial in glaucoma diagnosis and treatment. We compared a non-contact air tonometer (Topcon CT-1®) with the gold standard Goldmann Applikation tonometer (GAT).

Methods:

In this prospective, mono centric device comparison study, only healthy eyes were enrolled. IOP was measured three times with the Topcon CT-1® followed by three times GAT. Mean IOP was calculated and compared with a paired t-test, a linear regression and a Bland-Altman analysis.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers who agreed to be included in the study and were able to comply with the measurement procedures

Exclusion criteria were cor-neal abnormalities (such as oedema, scars or dystrophies, astigmatism,hyperopia or myopia \> 3 dioptres), a history of ocular surgery or recent(\<47 weeks) ocular disorder.
Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans

The goal of this fixed order, open-label, dose-escalation study is to investigate the safety and efficacy of specific doses of dimethyltryptamine (DMT) in humans.

The results of this study will inform the doses to be used in a larger, double-blind, randomized, placebo-controlled, crossover study. Since the goal of the open label study is to inform the double-blind, randomized, placebo-controlled study, the investigators are citing the hypothesis of the latter solely for providing context. The investigators hypothesize that the administration of DMT will result in neuroplastic changes in healthy and depressed subjects. These changes in neuroplasticity will be indexed using electroencephalographic (EEG) measures and tasks. These neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.

Eligibility Criteria:
Healthy controls inclusion criteria:

* Medically healthy
* Psychiatrically healthy

Healthy controls exclusion criteria:

* Unstable medical conditions
* Psychiatric illness

Depression inclusion criteria:

* Medically healthy
* Diagnosis of major depressive disorder

Depression exclusion criteria:

-Unstable medical conditions
Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease

Patients with Parkinson's disease (PD) are heavily inclined towards a sedentary lifestyle. This is caused by a combination of physical impairments and cognitive dysfunction. However, regular physical activity in PD is highly desirable, for two reasons. First, physical activity has positive generic effects in preventing complications such as cardiovascular diseases, type II diabetes mellitus, osteoporosis and certain cases of cancer. Secondly, physical activity has additional disease-specific merits in PD such as depression, sleep disturbances and constipation. These effects lead to raised quality of life. Furthermore, animal studies suggest that physical activity could slow down disease progression.

Simply informing patients about the importance of physical activity is not enough to initiate and maintain an adequate level of physical activity. We propose to develop a physical activity promoting program for sedentary patients with PD in order to raise their level of daily physical activity.

Objective: The first aim of the study is to investigate whether a physical activity promotion program will result in an increase in physical activity in sedentary patients with PD.

The second aim is to demonstrate an increase in physical fitness and quality of life.

no extensive description

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD
* Hoehn and Yahr stage I-III
* Between 40 and 75 years old
* Not meeting the norm for healthy physical activity: the latter being defined according to international standards as either five days a week 30 minutes of moderate-intensity physical activity, or 3 days a week 20 minutes of vigorous-intensity physical activity

Exclusion Criteria:

* Wheel chair bounded
* Severe co-morbidity (e.g. orthopaedic disorders or chronic hart failure)
* Severe cognitive decline, defined as Mini Mental State Examination \< 24
Study the Effect of Probiotics Combined With Bismuth Quadruple Rescue Therapy on H Pylori Infective Patients

Retrospectivly follow-up the outpatients for H pylori eradication failures more than 2 times in the digestive department of Changhai hospital from 2015-2017,analyse the eradication rates and adverse effects of the therapy with 2w's compound lactobacillus acidophilus followed by 10d's bismuth, furazolidone, tetracycline contained quadruple scheme.

H pylori infection rate has been up to half of the world population. H pylori infection is associated with various diseases, especially gastric cancer.

With the increasingly resistant to antibiotics,the eradication rate has decreased a lot with traditional triple therapy. Exploring a valid scheem for patients who have failed multiple times is important.

Probiotics can improve gastrointestinal microenvironment, then release the adverse effects during the eradication process.Additionally,there is also a lot evidence that probiotics can inhibit H plori，but still controversially.

There is a low resistant rate about furazolidone and tetracycline. In this study investigators observe the efficacy of the therapy 2w's compound lactobacillus acidophilus followed by 10d's bismuth, furazolidone, tetracycline contained quadruple scheme on patients who have failed more than 2 times. 4 to 6 weeks after the therapy, if Urea Breath Test (UBT) is nedative which means eradicating H plori successfully.

Eligibility Criteria:
Inclusion Criteria:

* H pylori eradication had failed more than 2 times
* Patients had never used furazolone and tetracycline
* The age varied from 18 to 80 years old

Exclusion Criteria:

* H pylori initial eradication or had failed only 1 time
* The age was lower than 18,or higher than 80 years old
* Patients who had serious heart pulmonary disease ,live renal disease, or any cancers
* Pregnant women
Trial of Mesalamine for the Treatment of Active Microscopic Colitis

Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Subjects that show improvement will be followed for 4 weeks post medication.

We propose a prospective, randomized trial of mesalamine at 1.2g and 4.8g doses for the treatment of microscopic colitis. Our hypothesis is mesalamine is safe and effective for the treatment of diarrhea in microscopic colitis and that the 4.8g dose is more effective than the 1.2g dose.

We will recruit 70 subjects. The subjects will be randomized into to two groups, 4.8g dose, and 1.2g dose groups. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Responders will be followed for 4 weeks post medication.

Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Subjects will be excluded if they have unsuccessful treatment or side effects to 5-ASA drugs, oral corticosteroids, or salicylate. and antibiotics, mesalamine, bismuth or steroid use in the last two weeks. Subjects may not be on anticholinergics, cholestyramine, digoxin. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions.

A two-sample z-score test for proportions will be used to test whether relief rates are different between groups.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years old and older.
* Have diarrhea and microscopic colitis.
* They need to have a colon biopsy done at the Mayo Clinic in Rochester, MN within a year of enrollment.

Exclusion Criteria:

* None.
Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions

This research is being done to see if a drug called escitalopram (Lexapro) is helpful to people who are suffering from depression after traumatic brain injury (TBI).

Despite it's high prevalence, little is known about the pharmacological treatment of depression following Traumatic Brain Injury (TBI). This is because of a lack of randomized controlled studies in the treatment of post-TBI depression. This study is designed to examine the safety and effectiveness of escitalopram in the treatment of post-TBI depression. It will also investigate metabolic changes and neural pathways associated with post-TBI depression and metabolic alterations after treatment through neuroimaging.

Eligibility Criteria:
Inclusion Criteria:

* Closed head injury
* Fulfill Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) IV criteria "Major Depressive Disorder"
* 18 years of age or older
* Able to provide informed consent
* Stable medical history

Exclusion Criteria:

* History of Stroke, Encephalitis, Seizures, or any other pre-TBI neurological diseases
* History of mental retardation
* Alcohol or Substance dependence in the last 1 year
* Inability to undergo MRI scan
* Pregnancy
* Current use of any psychotropic medications including any antidepressants, antipsychotics, anxiolytics, or sedative hypnotics
* Poor response to escitalopram in the past
* Acutely suicidal or requiring inpatient psychiatric hospitalization, as determined by the study psychiatrist
* Good medication response to another antidepressant in the past
Assessing the Preparedness and Knowledge of Pharmacists in the Current Monkeypox Outbreak

General objective: to measure the preparedness of pharmacists and medical interns about monkeypox

Specific objectives: to evaluate the level of knowledge among pharmacists and medical interns about monkeypox treatment and nature of disease

Globally, the ongoing outbreak was declared as a public health emergency. After the first laboratory-confirmed case of monkeypox was reported in Singapore on May 2019, countries all over the world started to strengthen disease surveillance systems. One challenge in preventing monkeypox is a lack of knowledge, particularly among healthcare workers.

Study significance: to examine in detail the preparedness and the perception of pharmacists and medical interns about monkeypox and to evaluate the level of knowledge about monkeypox management and nature of disease.

Eligibility Criteria:
Inclusion Criteria:

- community, hospital and clinical pharmacists, Medical interns of both sexes

Exclusion Criteria:

* any other healthcare professional
Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients

The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure


Eligibility Criteria:
Inclusion Criteria:

* Male or Female 18 to 85 years of age
* NDD-CKD Patients
* TSAT \</= 25%
* Hgb \</= 11.5
* Ferritin \</= 300
* HD-CKD Patients
* TSAT \</= 30%
* Hgb \</= 12
* Ferritin \</= 500

Exclusion Criteria:

* Previous participation in a FCM trial
* Known Hypersensitivity to FCM
* History of anemia other that anemia due to chronic renal failure
* Current history of GI bleeding
* Received IV Iron within the last 30 Days
* Anticipated need for surgery
* Malignancy history
* AST or ALT greater than normal
* Received an investigational drug within 30 days of screening
* Pregnant or sexually active females who are not willing to use an effective form of birth control
Feasibility Study of Auditory Brainstem Implant in Young Children

Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis
* If previously received a cochlear implant, must demonstrate lack of benefit from that device

Exclusion Criteria:

* Medical contraindication to craniotomy/intracranial surgery
* Severe cognitive or developmental delays
Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions

The purpose of this study is to determine whether microwave ablation is more effective in the treatment of simple renal cysts than conventional laparoscopic decortication.

Background: Simple renal cysts are the most common renal masses, and occur in half of all patients older than 50 years.They are usually asymptomatic and benign, asymptomatic and discovered incidentally. However, over time, these simple cysts can enlarge, become symptomatic and develop complications, requiring intervention.They can be managed by a variety of surgical and percutaneous methods, including percutaneous aspiration (with or without injection of a sclerosing agent), endoscopic marsupialization or excision, open surgery and laparoscopic cyst excision.Percutaneous aspiration and sclerotherapy have been described as safe and effective methods of managing symptomatic simple renal cysts without the cost and morbidity associated with conventional surgery and laparoscopy.However, laparoscopic decortications and simple aspiration is associated with a high recurrence rate because the cyst wall epithelium is responsible for active liquid production.

Purpose:To determine whether microwave ablation is more effective in the treatment of simple renal cysts than conventional laparoscopic decortication.

Method:

Eligibility Criteria:
Inclusion Criteria:

* patients with sporadic, unilateral, newly diagnosed Bosniak Ⅰ, Ⅱ and ⅡF renal cyst
* patients agreeable to participate in this long-term follow-up study
* patients with normal contralateral renal function (differential renal function of \>40% as determined by radionuclide scintigraphy)

Exclusion Criteria:

* patients' aged \>80 years
* patients not able to tolerate the microwave ablation procedure
* patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
* patients with the renal cyst involving urinary collecting system
* patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
Zinc Supplementation on Very Low Birth Weight Infant

Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections.

Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the Intrauterine Growth Restriction (IUGR) group compared to the non-IUGR group.

Other factors that also play a role are long episodes of fasting, the fulfillment of nutrition (macro and micronutrients) from the start, time to start breastfeeding (ASI), duration of parenteral total administration, the incidence of respiratory distress syndrome and incidence of necrotizing enterocolitis.

Zinc is one of the micronutrients which is very risky for deficiency in premature babies.

Babies with zinc deficiency experience growth disorders as much as 67%. In India, infants who received zinc supplementation increased after being given 10 days of zinc supplementation and lower mortality rates in the group with supplementation. Very low birth weight babies and bronchopulmonary dysplasia who received zinc supplementation during the week showed good clinical progress and the growth rate also increased.

The investigators believe this study has the potential for decreasing infant mortality from its current level and can be a growth indicator for preterm babies.

Double-blind randomized controlled clinical trial in preterm infants (28 - 32 weeks) who are newborn or less than 3 days old who are admitted to the perinatology room.

Infant in the intervention group was given elemental zinc supplementation once daily orally compared to placebo in the control group, at 3 days of age until the patient returned home or a maximum of 40 weeks' gestation.

The intervention group was given 10 mg elemental zinc once daily orally compared to placebo in the control group, at 3 days of age and received oral nutrition\> 20cc / kg/ day, continued during treatment until the patient returned home or a maximum of 40 weeks' gestation.

Monitored infant development indicators, measured once a week. Monitoring of the incidence of infection in late-onset infants in clinical and laboratory settings according to the existing hospital settings.

The monitoring of NEC events in all research subjects was carried out. Screening ROP at the age of 3 weeks and/or when the baby is going home. The participants were observed to be allowed to go home or a maximum of 40 weeks' gestation if they were still being treated.

Eligibility Criteria:
Inclusion Criteria:

* Preterm (gestational age of 28 - 32 weeks)
* Newborns with a ratio of body weight and gestational age: Small for Gestational Age or Large for Gestational Age
* Get parental approval to be included in the study by signing an informed consent

Exclusion Criteria:

* Newborns with severe congenital abnormalities
* Newborns with digestive tract abnormalities: partial, total obstruction or gastrointestinal atresia
* Newborns with unstable hemodynamic conditions that will affect the survival rate
* Mothers who consume alcohol regularly (≧ 2x a month) during pregnancy
* Newborns with early-onset sepsis