cyrilzakka/clinical-trials huggingface dataset:
Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)

The purpose of this study is to compare the effect of 6 weeks of treatment with beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and tolerability of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent/(assent - if applicable)
* Male or female subjects 6-11 years of age
* General good health
* A documented history of PAR to a relevant perennial allergen for a minimum of 12 months
* Other criteria apply

Exclusion Criteria:

* Pregnancy, nursing, or plans to become pregnant or donate gametes
* Participation in any investigational drug study within the 30 days preceding the Screening Visit 1 (SV1)
* Previous participation in a BDP nasal aerosol study as a randomized subject
* A known hypersensitivity to any corticosteroid or any of the excipients in the study medication formulation
* History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations
* History of a respiratory infection or disorder within the 14 days preceding the Screening Visit 1 (SV1)
* Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the Screening Visit 1 (SV1)
* Other criteria apply
* Current smoker or current user of tobacco products at any time during the study; history of smoking or use of tobacco products within the past year
Lithium Long COVID Dose-finding Study

This open-label study will assess if lithium dosages of 30-45mg/day are associated with greater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50 patients with long COVID.


Eligibility Criteria:
Inclusion Criteria:

1. Enrolled from November 2022-July 2023 in lithium long COVID clinical trial at UB.
2. Reports bothersome fatigue and/or brain fog while not taking lithium or, reports satisfactory benefit to these symptoms while taking lithium.
3. Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline or; FSS \<28, BFSS \<28 and PGIC at Visit 1 of "much improved" or "very much improved" while taking lithium.
4. Did not "respond" to placebo therapy, based on the responder analyses outlined in the Preliminary data section above, defined as a ≥18-point reduction FSS or ≥15-point reduction in BFSS from baseline to the end-of-double-blind study phase while receiving placebo therapy.

Exclusion Criteria:

1. Fever or signs of acute infection in last 4 weeks.
2. COVID vaccine administered within 4 weeks. No change in any psychoactive or steroid medications for ≥30 days.
3. Plan to change a psychoactive, steroid or diuretic medication in next 5 weeks.
4. History of heart attack or stroke within the previous year.
5. Active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator.
6. Daily NSAID use.
7. Pregnant or nursing or planning to get pregnant over the next 11 weeks.
Effects of Ocular Electroacupuncture on Trochlear Nerve Palsy

The purpose of the study is to testify the efficacy of treating trochlear nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.

The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for trochlear nerve palsy (TNP), through treating TNP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by trochlear nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.

Eligibility Criteria:
Inclusion criteria;

1. patient with confirmed diagnosis of trochlear nerve palsy made by neurologist or ophthalmologist;
2. patient in stable condition after treatment for primary disease;
3. age between 18 to 80 years old without gender limitation;
4. haven't received acupuncture intervention for TNP before;
5. patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.

Exclusion criteria:

1. those with other diagnosed medical conditions known to contribute to TNP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;
2. those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;
3. those with serious medical conditions that might limit their participation;
4. those with eye or other location with serious infections;
5. women who had a positive pregnancy test or who were planning to become pregnant during the study period;
6. those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;
7. who had participate in other clinical trials, which may affect the results.
Evaluation of Endometrial Stromal Cell Apoptosis in Adenomyosis

Our previous results revealed that the expression of killer inhibitory receptors (KIRs) on NK cells was decreased in eutopic endometrium in women with adenomyosis. It implies that the formation of adenomyosis might be due to abnormal endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. In addition, in vitro coculture of macrophages and endometrial stromal cells (ESC) increase the expression of IL-6 mRNA in ESC, which might further enhance the proliferation of ESC and subsequently result in the formation of ectopic endometrial implants in adenomyosis. Besides, another possible mechanism is the abnormal apoptosis of ESC in adenomyosis. In endometriosis, apoptotic endometrial cells were found to be decreased, which possibly accounts for the formation of endometriosis. However, there have not been reports investigating the apoptosis of ESC in adenomyosis.

In this study, we try to investigate apoptotic ESC with flow cytometry in women with and without adenomyosis. Annexin V, bcl-2, and caspase-3 were measured to represent the degree of apoptosis in ESC.

Eutopic endometrium was obtained and separated into single endometrial stromal cell (ESC) in women with adenomyosis (study group) and without adenomyosis (control group).

Annexin V-PE, bcl-2-PE, and caspase-3-PE are stained, and flow cytometry is done to measure the degree of apoptosis in ESC. On the other hand, another half of ESC are cultured for 24h, and also Annexin V-PE, bcl-2-PE, and caspase-3-PE are stained, and flow cytometry is done.

Eligibility Criteria:
Inclusion Criteria:

* women with adenomyosis
* at early- to mid-secretory phases

Exclusion Criteria:

* postmenopausal
* malignancy
Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents

The aim of this study was to look for discriminating variation in the concentrations of small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.

Type 1 diabetes mellitus (T1DM) is one of the most common pediatric diseases and its incidence is rising in many countries. Recently, it has been shown that metabolites other than glucose play an important role in insulin deficiency and the development of diabetes. The aim of this study was to look for discriminating variation in the concentrations of small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.

This cross-sectional study was set-up to examine the metabolic profile in fasting plasma samples from 7 T1DM children and 7 non-diabetic controls aged 8 to 18 years, and matched for gender, age and BMI. The obtained plasma 1H-NMR spectra were rationally divided into 110 integration regions, representing the metabolic phenotype. These integration regions reflect the relative metabolite concentrations and were used as statistical variables to construct (train) a classification model in discriminating between T1DM patients and controls.

Eligibility Criteria:
Inclusion Criteria:

* aged between 8 and 18
* normal-weight according to the International Obesity Task Force (IOTF) BMI criteria
* fasted for at least 8 hours.

Exclusion Criteria:

* lipid-lowering drugs or other medication
Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention

Urosepsis is one of major cause of the overall sepsis leading to high morbidity and mortality, which commonly resulted from urinary tract calculi. The investigator aim to identified the incidence and risk factors of urosepsis in the patients with urinary tract calculi underwent surgical intervention in tertiary-care university hospital.

Sepsis is one of the leading cause of death of hospitalized patients in Thailand. Urosepsis or sepsis which originate from urinary tract infection was reported around 9-31% of the overall sepsis syndrome. Urinary tract calculi requiring surgical procedure was reported as a common cause of urinary tract infection. Therefore, the investigators aimed to identified the incidence and risk factors of urosepsis in the patients with urinary tract calculi underwent surgical intervention in tertiary-care university hospital.

Moreover, the patients with sepsis syndrome will be suffered from many complications such as acute respiratory distress syndrome, acute kidney injury, etc. Currently, there were many early waring scores to predict the risk of complications to help promptly treatment and decrease the severity. The investigator would like to compare the systemic inflammatory response syndrome (SIRS) criteria,Modified Early Warning Score (MEWS) and Quick Sequential Organ Failure Assessment (qSOFA) score to the prediction of postoperative complications in this group of patients.

The last primary objective of this study is to follow the course of the patients diagnosed as urosepsis if they had been treated properly according to the sepsis bundle guideline and their outcome.

Eligibility Criteria:
Inclusion Criteria:

- Adult patients with urinary tract calculi requiring surgical procedure

Exclusion Criteria:

- Incomplete data
Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

Administration of trazodone for the treatment of neuroleptic induced acute akathisia in a cross-over fashion of 6 days duration. 3 days of placebo and 3 days of trazodone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with akathisia according to DSM-IV criteria at least mild akathisia.

Exclusion Criteria:

* Change of pharmacologic regimen 7 days prior to study entry
* Significant systemic disease
* The presence of chronic akathisia
* Patients unable to cooperate
ED-Home Pilot Study

This is a single-arm pilot study to test the feasibility of homelessness prevention and substance use interventions to be delivered to at-risk patients in the Bellevue Hospital emergency department (ED). ED patients (n=40) found eligible for the study will complete a baseline assessment and receive referrals to appropriate services, with a final six-month follow-up assessment.

ED patients found eligible for the study will complete a baseline survey and receive one-time, in person services at the time of the baseline/enrollment ED visit including referrals to homelessness prevention and substance use services, with a final six-month follow-up survey. Interim contacts at 7-10 days, 3 months, and 5 months will be used to assure intervention components were received and to confirm participant contact information.

Eligibility Criteria:
Inclusion Criteria:

* Be a patient in the Bellevue Hospital Center ED.
* Be ≥18 years old.
* Screen positive for homelessness risk using a homelessness risk screening tool (HRST).
* Screen positive for unhealthy alcohol or drug use.
* Able to provide consent.

Exclusion Criteria:

* Medically (e.g., critically ill) or psychiatrically unstable.
* Unable to provide informed consent for other reason (e.g., cognitive deficit, profound intoxication).
* Incarcerated or in police custody.
* Unable to understand and speak English.
* Lives outside NYC and/or cannot give a NYC ZIP code.
* Already homeless (residing in a shelter or on the streets).
* Does not have a telephone where can be reached for follow-up.
* Has already received specialized peer navigator/addiction social worker services during current ED visit.
* Has already participated in the study.
Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors

This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase Inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
* A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
* An MMSE score of \> or = 10 and \< or = 23
* Continuous treatment with donepezil ≤ 5 mg/day or galantamine ≤ 24 mg/day for 4 weeks prior to baseline visit
* Patients having difficulties being treated orally with ChE inhibitors (donepezil or galantamine) as judged by the investigator. Difficulties are defined as:
* Inadequate compliance with the ChE inhibitors at screening and baseline
* Presence of caregiver's burden for administering drugs orally at screening and baseline
* Inadequate treatment (efficacious dose cannot be reached or inadequate compliance) with the ChE inhibitors because of adverse events at screening and baseline
* Patients with swallowing difficulties at screening and baseline

Exclusion Criteria:

* A current DSM-IV diagnosis of major depression
* Taken rivastigmine in the past
* A score of \> 5 on the Modified Hachinski Ischemic Scale (MHIS)

Other protocol-defined inclusion/exclusion criteria may apply
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.

The main objectives of this study are:

* to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
* to assess clinical outcome when treating a bleed with Optivate®.
* to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
* to assess FVIII inhibitor development during the study.


Eligibility Criteria:
Inclusion Criteria:

* Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.

Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.

Exclusion Criteria:

-
LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures

The purpose of this post market study is to evaluate the performance and safety of LiquiBand® Exceed™ and LiquiBand® Rapid™ for closure of surgical incisions associated with abdominal surgery.

LiquiBand® Exceed™ and LiquiBand® Rapid™ are the "study" devices. The study devices are an adhesive used to close surgical wounds. When the adhesive is applied to the skin, it polymerizes (forms a chemical bond) within minutes due to the moisture on the skin's surface and allows the wound edges to remain in the correct position. The use of the study devices are not "investigational" (experimental) because it is already cleared for doctors to use for surgical wound closure in the United States of America.

In this study, LiquiBand® Exceed™ and LiquiBand® Rapid™ will be used to close surgical wounds following general abdominal surgery. Subjects will be followed up for 14-days post surgery, and safety and performance of the study device will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of these criteria at time of enrollment may be included in the investigation:

1. Subject is ≥ 18 years of age
2. Subject is to undergo general abdominal surgery
3. Planned incision(s) are expected to be 4cm or greater in length
4. Subject is willing and able to comply with the protocol and follow up period
5. Subject is willing and able to give written informed consent

Exclusion Criteria:

Patients who meet any one of these criteria will be excluded from the study:

1. Subject is pregnant or nursing
2. Subject has inadequate or unsuitable tissue e.g. due to radiation damage, ulceration compromised vascularity, history of compromised wound heal.
3. Subject has a sensitivity to cyanoacrylates or formaldehyde
4. Subject has a known sensitivity to topical skin adhesives
5. Subject has active or potential infection at the surgical site
6. Subject has a history of keloid formation
7. Subject has a known vitamin C or zinc deficiency
8. Subject has a connective tissue disorder
9. Subject has uncontrolled diabetes mellitus
The Clinical Application of Infrared Thermal Imaging Detecting Venous Thromboembolism

The purpose of this study is to determine the effectiveness of infrared thermal imaging in adjunctive diagnostic screening for lower limb deep venous thrombosis (DVT).


Eligibility Criteria:
Inclusion Criteria:

1. Willing to participate in the trial and sign the informed consent form,
2. Aged: 18-75 years. They had been definitively diagnosed with venous thromboembolism,
3. The bed-rest immobilization time should be more than 72 hours,
4. Planing to gynecology operation,
5. The D dimer should be more than500 g • L-1,
6. There is no obvious symptoms of systemic infection two weeks before the test,
7. There is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (chest and lower limbs),
8. There is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases.

Exclusion Criteria:

1. Patients can not be good partners,
2. Doctors believe that there is any inappropriate situations.
Effects of Cycling Dual-task in Parkinson's Disease.

Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease
* Hoehn and Yahr 1 and 2

Exclusion Criteria:

* Hoehn and Yahr \>2
The Effect of Prenatal Haptonomy on Anxiety, Distress and Psychological Well-being

Introduction:Anksiyete experienced during prenatal can increase Distress, cause negative perinatal outcomes, and adversely affect the psychological well-being. This study will conducted to determine the effect of prenatal haptonomy on pregnancy-related anxiety, distress and psychological well-being.

Methods: The population of the randomized controlled experimental study will consist of 102 primiparous pregnant women within the gestational weeks 22-27 who presented to the pregnant school of a state hospital in Turkey (34 first experimental group, 34 second experimental group, 34 control group).

Background: Anksiyete experienced during prenatal can increase Distress, cause negative perinatal outcomes, and adversely affect the psychological well-being.

Aim: This study will conducted to determine the effect of prenatal haptonomy on pregnancy-related anxiety, distress and psychological well-being.

Metod: For the educational study of the research, the midwife working in the Pregnant Class will be interviewed and informed about it. The mat and seat cushions in the Pregnant Class will be arranged by the researcher in a way that is suitable for the application. Music will be played during the application. Wellness music recommended by the haptonomy trainer will be selected for the music (Rathfisch, 2019). Haptonomy application is planned to be performed individually with pregnant women. Pregnant women in the experimental group 1 and 2 will be given the haptonomy application together with the trainings (standard care practices) in the pregnant class, and the pregnant women in the control group will only be trained in the pregnant class. Pregnant class trainings include reproductive health physiology, problems that can be seen in pregnancy, birth process, newborn care, covering the prenatal period, birth and postpartum period.

Haptonomy- first experimental Group: Haptonomy Group Pregnant school will made to the experimental group, and haptonomy will be applied for at least 30 minutes, once a week for 6 weeks (with the researcher).

Haptonomy- second experimental Group: Haptonomy Group Pregnant school will made to the experimental group, and haptonomy will be applied for at least 30 minutes, once a week for 3 weeks (with the researcher).

Haptonomy- Control Group: Standard of care Group The control group will not be interfered with.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous pregnant women who were married,
* aged 18 years and over,
* literate,
* living in the city center,
* not having any health problems in themselves and their infants,
* with spontaneous pregnancy at 22-27 weeks of gestation,
* without perception and communication problems,
* and who agreed to participate in the study were included in the study.

Exclusion Criteria:

• Multiparity
Investigation to Evaluate Safety and Efficacy of the Endodrill Model X Biopsy Instrument

This is an investigator led prospective open label investigation, performed at three clinics in Sweden, comparing the flexible endoscopic biopsy instrument Endodrill Model X with the standard sampling method endoscopic ultrasound fine needle aspiration/biopsy. Assessment of safety is the primary objective and performance is the secondary objective.

The investigation will include 20 patients with lesions and suspected tumors in the stomach, esophagus or duodenum (upper small intestine). The investigation will consist of one visit with an endoscopic examination with sampling of an observed lesion or suspected tumor. Six biopsies will be collected from each patient, three consecutive samples using the Endodrill Model X instrument and three consecutive samples using the standard fine needle. The order of instruments to be used will be randomly assigned. The patient will be under observation for 2 hours after the procedure. Telephone follow-up will be performed 1 and 7 days after the examination. Visual confirmation of the biopsies size will be recorded at the examination. If the samples verify a tumor or not will be evaluated at Day 14 when the pathology report is concluded.

Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years of age at the day of inclusion
* Signed informed consent
* Submucosal tumor of the upper gastrointestinal tract with tumor size ≥ 10 mm, well localized by the endoscopic examination

Exclusion Criteria:

* Suspicion of vascular tumor (e.g. pulsating tumor)
* Ongoing treatment with anticoagulants (e.g. Warfarin)
* Ongoing treatment with immunosuppressive drugs
* Pregnancy