cyrilzakka/clinical-trials huggingface dataset:
Anti-histamines and Methacholine Challenges.

The asthmatic airway is identified and studied using inhaled agents such as histamine and methacholine. The use of antihistamines prior to the test will inhibit the test result if histamine is used to cause airway constriction. If using methacholine, this may also be true depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are used. This study will look at the effect of old and new antihistamines on inhaled methacholine challenge response in individuals with mild asthma.


Eligibility Criteria:
Inclusion Criteria:

* Baseline forced expiratory volume in 1s (FEV1) of 70% or more of predicted
* Methacholine provocative concentration causing a 20% fall in FEV1 16mg/ml or less
* No respiratory infection or change in allergen exposure for 4 weeks prior to screening and throughout the study
* No significant medical co-morbidities
* allergy

Exclusion Criteria:

* pregnant or breastfeeding females
* unable to withhold antihistamines, anticholinergics, long acting bronchodilators and combination therapies
Interactions Between Cranberry Juice and Antibiotics Used to Treat Urinary Tract Infections

The purpose of study is to determine whether cranberry juice interacts with antibiotics used to treat urinary tract infections (UTIs).

Although evidence of its effectiveness is limited, cranberry juice is widely used to prevent urinary tract infections (UTIs). However, recent studies have shown that cranberry juice may affect the way the body absorbs and metabolizes antibiotics used to treat UTIs. This study will determine whether concurrent cranberry juice administration lowers the urinary concentrations of two commonly used antibiotics, amoxicillin and cefaclor.

This study will involve children being treated for UTIs and adults without UTIs. All of the children will continue their prescribed amoxicillin/cefaclor treatment. After 7 to 10 days of antibiotic treatment, the children will be assigned to receive either cranberry juice for 2 days or no additional treatment. Urine samples will be collected from all child participants before and after the administration of cranberry juice to examine the excretion of the antibiotics.

Adult participants will receive two different doses of amoxicillin, with or without cranberry juice. Blood and urine samples will be collected to evaluate the effect of cranberry juice on the absorption and elimination of amoxicillin.

Eligibility Criteria:
Inclusion Criteria for Children:

* Urinary tract infection (UTI) treated with cefaclor or amoxicillin

Inclusion Criteria for Adults:

* No UTI

Exclusion Criteria:

* Allergies to antibiotics
* Use of medications other than oral contraceptives
* Pregnancy or breast-feeding
* Smoker
Pathogenic Variants in Homologous Recombination Repair Genes in Patients With Epithelial Ovarian Cancer

Molecular alterations in Homologous Recombination Repair (HRR) genes have been associated with clinical benefit from chemotherapy and/or Poly (ADP-ribose) polymerase (PARP) inhibitors in patients with epithelial ovarian cancer. Therefore, the performance of tumor molecular profiling is currently recommended by international guidelines at initial diagnosis, among other reasons, for the modification of the treatment plan. The investigators' hypothesis was that tumor molecular profiling reveals additional parameters that can improve the predictive and prognostic role of the mere presence of HRR gene mutations. The study aimed to investigate the prognostic and predictive role of clonality of pathogenic variants in HRR genes and/or concurrent pathogenic variants in other clinically relevant genes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with epithelial ovarian cancer
* Received treatment at HeCOG-affiliated institutions
* Have signed informed consent
* With adequate tumor tissue for analysis
Safety, Tolerability and Pharmacodynamics of BIIF 1149 BS in Healthy Young Male Volunteers

The objective of the present study is to obtain information about the safety and tolerability of BIIF 1149 BS, to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data


Eligibility Criteria:
Inclusion Criteria:

* Participants should be healthy males
* Age range from 21 to 50 years
* Within +- 20% of their normal weight (Broca-Index)
* In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
* Each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead Electrocardiogram (ECG)
* A citric acid provocation test will be performed to determine the cumulative dose of citric acid which causes at least three coughs. If there will not be at least three coughs after inhalation up to the highest citric acid concentration of 32 % the volunteer will be replaced by a new person
* Haematopoietic, hepatic and renal function test will be carried out in the laboratory
* The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance

Exclusion Criteria:

* Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections (especially respiratory infections, cough)
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\>= 24 hours) within ten half-lives of the respective drug before enrolment in the study
* Use of any other drugs which might influence the results of the trial during the week previous to the start of the study
* Participation in another study with an investigational drug within the last two months preceding this study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 40g/day)
* Drug abuse
* Blood donation (\>= 100 ml) within the last 4 weeks
* Excessive physical activities (e.g. competitive sports) within the last week before the study
Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.

The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.

Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy with severe preeclampsia and 28 to 33 weeks of gestation

Exclusion Criteria:

* Uncontrollable blood pressure or persistent severe hypertension (160/110 mmHg)
* Persistent symptoms of preeclampsia
* Maternal complications (HELLP syndrome, acute renal insufficiency, cerebral edema, eclampsia, pulmonary edema)
* Fetal death, restriction of fetal grown
Neuromuscular Cognitive Training

This project will utilize a quasi-experimental, multiple baseline pretest-posttest design where participants will complete postural stability assessments, physical performance assessments, and questionnaires to evaluate perceptions toward injury prevention before and after completing a 6-week neuromuscular-cognitive prevention program.

The I-THINC program will address aspects of cognition (i.e., reaction time/processing speed, working memory, cognitive flexibility, inhibitory control, attention, and dual-tasking) while completing common movement patterns utilized in tennis (i.e., lateral shuffle, rapid acceleration/deceleration, and postural stability). The proposed program will take place in the participants training facility. The program will be implemented twice per week for six weeks (12 sessions) with each session lasting 20 minutes. To add variety, there will be two complementary programs (A and B) comprising of four exercises increasing in complexity every two weeks. Each week participants will complete Program A during the first session and Program B during the second session.Exercises will progressively challenge cognitive and physical demand. Exercises were designed to address the most common injuries in tennis.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults from the University of Kentucky varsity tennis programs

Exclusion Criteria:

* not medically cleared for participation
Evaluation of Prevent in Underserved Populations

The goal of this study is to evaluate an online Diabetes Prevention Program adapted for patients with prediabetes in safety net health care settings.

The Diabetes Prevention Program (DPP) demonstrated that intensive behavioral counseling is a successful approach to reduce the risk of developing diabetes in patients with prediabetes. While the DPP lifestyle intervention was successful and group based adaptations of the DPP have positive results, scalable alternatives that allow for even broader reach are necessary. Omada Health has developed an online, group-based, recognized DPP program (Prevent). The goal of this study is to evaluate a literacy-adapted version of Prevent for patients with prediabetes in safety net health care settings.

Eligibility Criteria:
Inclusion Criteria:

* is receiving care at one of the three participating locations
* prediabetes diagnosis confirmed by lab tests
* age 18-75 at screening
* Not insured, Medicaid insured, or safety net health plan insured
* Comfortable speaking/reading English or Spanish at 5th grade level
* Body Mass Index greater or equal to 24
* Able to access the internet weekly by computer or smartphone
* Able to engage in physical activity of at least moderate intensity
* Able and willing to give informed consent to participate

Exclusion Criteria:

* diagnosed with Type 1 or 2 Diabetes Mellitus
* taking insulin, metformin or other hypoglycemic agent
* pregnant or planning to become pregnant during trial period
* unstable life conditions that would preclude full program participation
* acute, unstable medical or mental health conditions that would preclude program participation
* inability to engage in physical activity of at least moderate intensity
Safety Study of AMG 531 in Japanese Subjects With ITP

The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.

The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.

Eligibility Criteria:
Inclusion Criteria: - Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of health, labor and welfare Exclusion Criteria: - Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy
Value of Urodynamic Evaluation

Although no reliable and specific figures are available for the total expenditure on UDS, UDS is commonly performed for patients with urinary incontinence (UI) regardless of gender and age. UDS is typically performed prior to incontinence surgery. Urodynamic studies are expensive, time-consuming, and uncomfortable diagnostic investigations. The 3rd ICI reported insufficient evidence with which to answer the following key research questions related to UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do alterations in clinical decisions made in response to UDS results improve the clinical outcomes?


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Predominant SUI as evidenced by all of the following:

   1. Self-reported stress-type UI symptoms, of duration \>3 months\*
   2. MESA stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
3. Observation of leakage by provocative stress test at any volume
4. Eligible for randomization to either treatment group
5. Eligible for SUI surgery
6. Desires non-conservative therapy for SUI
7. PVR \<150ml by any method. (May repeat once if initial measure is abnormal)
8. Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative UA or negative culture
9. Available to initiate SUI treatment within 6 weeks of randomization
10. Available for 12-months of follow-up and able to complete study assessments, per clinician judgment.
11. Signed consent form.

    * Patient can be rescreened after respective time interval has been met.

Exclusion Criteria:

1. Age \<21 years\*
2. Currently undergoing or has had recommended treatment of apical or anterior prolapse
3. No anterior or apical prolapse \> +1 on standing straining prolapse exam
4. Pregnant or has not completed child bearing.
5. \<12 months post-partum\*†
6. Active malignancy of cervix, uterus, fallopian tube(s) or ovary \> Stage I, or bladder of any Stage
7. History of pelvic radiation therapy
8. Previous incontinence surgery
9. Current catheter use
10. Neurological disease known to affect bladder storage (e.g. MS, Parkinsonism, CVA)
11. Previous (i.e. repaired) or current urethral diverticulum
12. Prior augmentation cystoplasty or artificial sphincter
13. Implanted nerve stimulators for urinary symptoms or previous botox bladder injections.
14. Any pelvic surgery within the last 3 months\*
15. Previous placement of synthetic mesh on a vaginal approach in the anterior compartment
16. Participation in another treatment intervention trial that might influence results of this trial.
17. A urodynamic result reviewed by the investigator in the preceding 12 months or any recollection by the investigator of urodynamic results on that subject.

    * Patient can be rescreened after respective time interval has been met.

      * "Partum" is defined as a delivery or other termination that occurs after 20 weeks gestation.
The Effect Of A Resistance Exercise Program On Balance Of Elderly People

The purpose of the present study is to investigate the effectiveness of a resistance exercise program consisting of elastic band exercises to balance, strength and quality of life of community-dwelling elders. The hypothesis of the study is that the people training with elastic bands will show benefits on the aforementioned areas.

The elderly are, according to research, prone to an accelerated rate of loss of balance, particularly after the age of 60. This loss of balance could translate to injurious falls which could lead to trauma, fear of falling or even hospitalization. It has been shown in multiple studies that strength training can provide health benefits to the general population improving strength, balance, postural control, bone health and quality of life.

Elastic band exercises could be applied to a number of different settings due to the comparably low cost of equipment and due to the easiness of handling the equipment. In previous studies, elastic band exercise programs, varied in design, have been shown to provide multiple benefits to elderly people. In this study, it is proposed that in a Community Center for Elderly People, which are widely established in Greece, a group of eligible community dwelling elderly could exercise under supervision using elastic bands in a group setting.

The recruitment will take place in a Community Center for Elders. A group of people aged over 65, able and cleared to participate in strength training will participate. Information sheet and consent form will be provided to all participants. A pilot randomized intervention study is designed to assess the efficacy of elastic band resistance training as means to improve balance, strength and quality of life where the sample will be randomized to one of two following study groups:

1. exercise program group (intervention group)
2. no change of activities of daily living (control group)

Assessment will be obtained in two-time periods: prior to the program and after the program.

The exercise program will take place twice-weekly for eight weeks.

Participants will be assessed using Berg Balance Scale, Gait Speed, Timed Up and Go, 30 Seconds Chair Stand Test, Handgrip Strength, Knee Extensors and Flexors Strength, Fall Efficacy Scale.

Eligibility Criteria:
Inclusion Criteria:

* Over 65 years old
* Able to consent to participation
* Able to stand without assistive devices
* Able to participate in strength training
* Able to perform activities of Daily Living independently
* Cognitively and psychologically able to participate in a group setting

Exclusion Criteria:

* Systematically exercised for up to 6 months prior to start of study
* Neurological disorders or inability to stand
* Recent surgery or contraindications to exercise
* Arthroplasty or Prosthetic Limbs
* Vision or Hearing problems hindering participation in group
* Medication or Disorders contraindicating exercise or standing
* Hypotension or Orthostatic Hypotension
* Malignancy or Recent Treatment for Malignancy
Letting Children Listen to Music During Computed Tomography

This study examines the effect of music during computed tomography in children. This study, conducted on a total of 60 children, was divided into two groups: the music group and the control group. According to the research results; showed that music reduces fear and anxiety levels in children and stabilizes vital signs (pulse and respiratory rate) during a tomography scan.

Aim: This research was conducted to determine the effect of music played during computerized tomography (CT) imaging in children on fear, anxiety and vital signs.

Method: This randomized, double-blind controlled trial was conducted with Consolidated Standards of Reporting Studies (CONSORT) guidelines. The sample includes children aged 5-10 years who had CT scans in the emergency department of a public hospital in eastern Turkey between April 18 and May 20, 2023 and met the inclusion criteria for the study. The research was completed with a total of 60 children, divided evenly into one of two groups. The nursing intervention of the research is to listen to music. Data were collected through face-to-face interviews using the Child and Family Information Form, the Child Fear Scale, the State Anxiety Scale for Children, and the Vital Signs Monitoring Form (pulse, blood pressure, and oxygen saturation). Ethical principles were followed in the research.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 5-10
* Hospitalization is for diagnostic or treatment purposes
* The child and the parent speak and understand Turkish comfortably.

Exclusion Criteria:

* Having previous tomography shooting experience
* Having chronic diseases
* Visual, auditory, speech and mental disorders
* There is a history of sedative, analgesic or narcotic substance use within 24 hours before application.
Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma

Several pancreatic neoplastic cystic lesions, such as IPMN (intrapapilary mucinous neoplasia), cystic neuroendocrine tumors (NET) and mucinous neoplasms, present a carcinogenetic risk, though it is yet unknown if this risk is increased in patients with pancreatic steatosis (PS).

The primary objective of the study is to determine de prevalence of pancreatic steatosis in pancreatic neoplastic cysts and if pancreatic steatosis is increased in those lesions that pose a carcinogenetic risk.

The secondary objective is to evaluate the prevalence of pancreatic steatosis in pancreatic adenocarcinoma.

Pancreatic steatosis has gained significant novel interest in the pathophysiology of PDAC and neoplastic cystic lesions. Pancreatic steatosis is the new emerging issue in pancreatology. Recently, pancreatic steatosis has gained significant novel interest in the pathophysiology of PDAC.

The primary objective of the study is to determine de prevalence of pancreatic steatosis in pancreatic neoplastic cysts and if pancreatic steatosis is increased in those lesions that pose a carcinogenetic risk.

Pancreatic ductal adenocarcinoma (PDAC) has a poor survival, predominantly as a result of its diagnosis in advanced stages. Pathological changes of steatosis are an independent determinant of PDAC, and these pathological changes are correlated with the attenuation of the pancreas on computed tomography (CT). The secondary objective is to evaluate the prevalence of pancreatic steatosis in pancreatic adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Patients with at least 1 pancreatic cystic lesion based on CT and EUS features, with a cyst size ≥ 5mm; or healthy subjects or PDAC (confirmed by histopathological exam).

Exclusion Criteria:

* No evidence of written informed consent
* Patients with contraindications for endoscopy due to comorbidities
* Metal stent in hepato-bilio-pancreatic region at time of baseline CT-imaging (vascular, luminal and biliary)
* Acute pancreatitis at baseline imaging
* Pancreatic surgery at baseline imaging in our department
* Splenectomy
* Patients with significant alcohol consumption, defined as alcohol intake of over 20 g daily (140 g weekly) for men and 10 g daily (70 g weekly) for women