cyrilzakka/clinical-trials huggingface dataset:
Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

The purpose of this research study is to define the time a molecule in the participants bones called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in the urine to determine the rate of bone breakdown. Tracking this marker may help identify a more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic acid, which will be used in this study, are used to reduce pain and bone fractures in people with multiple myeloma. There is some laboratory data to suggest that they may work against myeloma. Participants will have already undergone bisphosphonate therapy and may have received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due to concerns of their long-term side effects we are looking at alternate strategies for reducing the frequency of these agents.

* Each participant will receive a single dose of zoledronic acid intravenously after the screening procedures.
* Participants will then return to the clinic once every month for 6 months and have the following tests and procedures performed: Medical history update; physical exam; ECOG (Eastern Cooperative Oncology Group) Performance Status; blood tests; and urine tests.
* After 6 months there will be an end of study visit, where the following procedures will take place: medical history update; bone marrow aspirate and biopsy; skeletal survey.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 years of age or older
* Confirmed diagnosis of multiple myeloma(MM) by Durie and Dalmon staging criteria on IV bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months
* MM patients in either CR (complete response) or PR (partial response) by EBMT criteria
* ECOG Performance Status of 0-2

Exclusion Criteria:

* MM patients on active anti-MM therapy (maintenance regimens allowed)
* Renal failure with serum creatinine \>2mg/dL and/or creatinine clearance of \<30ml/min
* Relapsed, refractory or progressive disease
* Any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study
* Hypersensitivity or any contraindication to a single dose of zoledronic acid
Effects of Raw Versus Other Milk Sources on Lactose Digestion

The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of different types of milk (raw milk, cow's milk, nondairy-milk) on lactose maldigestion.

The goal is to determine if raw milk consumption intake will benefit humans with lactose maldigestion, a common human response to the intake of dairy products during adult years. An increasing number of people are consuming raw unpasteurized milk. Enhanced nutritional qualities, taste, and health benefits have all been advocated as reasons for increased interest in raw milk consumption.

However, science-based data to substantiate these claims are limited or anecdotal.

Raw milk may differ in its ability to improve lactose maldigestion related symptoms from other milk types. Adult lactose maldigestion affects the majority of the world adult population. It appears that consumption of lactose containing foods by those who cannot digest lactose is a relatively common cause of irritable bowel syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Gender: Both women and men
* Age: \> or = 18 years
* Ethnicity and race: All ethnic and racial backgrounds welcome
* Elevation of breath hydrogen after ingestion of 25 g of lactose \> 20 ppm over baseline
* Planning to be available for clinic visits for the 6 weeks of study participation
* Ability and willingness to give written informed consent
* No known active psychiatric illness.

Exclusion Criteria:

* Intake of antibiotics or other medications within the past month
* History of diarrheal illness within past month
* Secondary lactase deficiency
* Self reported personal history of:

  \*gastrointestinal conditions other than related with lactose maldigestion (IBS, IRB, Short bowel, malabsorption, celiac disease, GI surgery)
* Pregnant or Lactating
* Inability to communicate effectively with study personnel
* Protein allergy related to cow 's milk proteins or soybean proteins
Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.

Risankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately multiple sites across Germany and Austria.

Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis.
* Participants initiating risankizumab at the investigator's discretion as part of their routine clinical care; the decision to administer risankizumab must be made prior to and independent of documentation for the study and according to the approved local label.

Exclusion Criteria:

* Participants previously exposed risankizumab
* Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation).
Impact of CT on Diagnosis of Acute Appendicitis

The purpose of this study is to determine whether computed tomography is reliable investigation in the diagnosis of acute appendicitis.

The aim of this study is to

1. evaluate CT scan validity for the diagnosis of acute appendicitis.
2. compare the difference in evaluation of CT-scan result between radiologist on call and consultant radiologist with CT experience.
3. illustrate difficulties associated with practical implementation of CT-scan in relation to other activities in radiology department and O.R. (logical \& organizational).
4. illustrate patients experiences about the study (pain, discomfort \& other information

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been admitted and diagnosed as having acute appendicitis

Exclusion Criteria:

* Patients under the age of 18 years.
* Pregnancy.
* Uncooperative patients (senile dementia, mentally ill).
* Not speaking Danish.
* Does not wish to participate.
Oral Steroid Treatment for Chronic Rhinosinusitis

Despite the common use of oral steroids in the management of chronic rhinosinusitis (CRS), the natural history and efficacy of this treatment modality has not been fully elucidated. Specifically, patients who have undergone prior ESS and have recalcitrant CRS, the natural history of endoscopic improvement and quality of life (QoL) outcomes, following an oral steroid taper, is poorly defined. The purpose of this non-randomized single-arm clinical trial is to evaluate the effectiveness of an oral steroid taper in improving endoscopic grading, QoL, and olfactory function as well as defining the duration of improvement, in patients with recalcitrant CRS with prior endoscopic sinus surgery (ESS).


Eligibility Criteria:
Inclusion Criteria:

* Adult ( \> 18 years of age)
* CRS defined by 2007 Adult Sinusitis Guidelines.12
* Subject must be able to complete QoL questionnaires written in English
* Previous sinus surgery including unilateral or bilateral total ethmoidectomy
* Minimum nasal blockage score on SinoNasal Outcomes Test-22 (SNOT-22) \> 3
* Severe sinonasal inflammation where the next treatment option is a 12- day oral prednisone taper
* Obstruction of the ethmoid sinus region or middle meatus eligible for revision endoscopic sinus surgery
* Lund-Kennedy endoscopy score \> 4
* Elects 12-day tapering dose of oral steroids (Prednisone) as a next treatment option

Exclusion Criteria:

* Unable to complete questionnaires or clinical testing or cooperate with study evaluations in English
* Contra-indication to oral steroids
* Endoscopic sinus surgery \< 3 months of presentation
* Completed course of oral corticosteroids within the previous 3 month period
* Subjects presenting with unilateral chronic rhinosinusitis
* Pregnancy or possibility to become pregnant during the study
LOMA: Long-Term Management of Asthma

The purpose of this study was to determine whether the use of induced sputum cell counts could guide treatment of asthma more effectively than the use of symptoms and breathing tests. The main outcomes where the time to the first exacerbation and the number of exacerbations.

Airway inflammation is an important component of asthma. It influences other components which include symptoms and airway functional (physiological) measurements. It is the primary target of treatment. However, it does not correlate closely with symptoms, need for symptomatic bronchodilator relief, or the physiological abnormalities. Furthermore, it can be of different types. As a result, physicians are poor at recognizing its presence or type. This is important because eosinophilic inflammation is responsive to corticosteroid while non-eosinophilic is not responsive.

The most comprehensive non-invasive or relatively non-invasive measurement of airway inflammation is by spontaneous or induced sputum cell counts. These are reliable, valid and responsive, the qualities of good measurements. They might therefore be clinically useful to guide individual treatment. In the present study we investigated this issue. We compared their use, in comparison with the use only of symptoms and spirometry, in preventing exacerbations of asthma. We chose prevention of exacerbations as the most important clinical outcome because these have the greatest impact on patient's quality of life, morbidity and healthcare utilization. The study comprised two Phases. In Phase 1, the minimum treatment to control sputum eosinophilia (as well as clinical criteria) in the Sputum Strategy, and clinical criteria in the Clinical Strategy, were established. In Phase 2, this minimum treatment was maintained and patients were seen every 3 momths and at exacerbations. The primary outcomes were the relative risk reduction for the occurrence of the first exacerbation and the length of time without exacerbation over 18-20 months in Phase 2 of the study.

Eligibility Criteria:
Inclusion Criteria:

1. History of asthma for at least one year,confirmed objectively.
2. New or previously reviewed patients where the minimal treatment requirements have not been established within the last six months.

Exclusion Criteria:

1. Smokers or ex-smokers for less than 6 months with a smoking history of more than 10 pack years.
2. Other pulmonary co-morbidity (other than mild or moderate chronic airflow limitation).
3. Subjects having a co-existing illness that precludes them from the study.
4. Inability to give informed consent due to mental or legal reasons.
5. Pregnancy or lactation.
6. Known non-compliance with medications.
Low Concentration Atropine for Myopia Progression in School Children

Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.


Eligibility Criteria:
Inclusion Criteria:

Myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

Exclusion Criteria:

strabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)
International Registry Study of Neutral Lipid Storage Disease (NLSD) / Triglyceride Deposit Cardiomyovasculopathy (TGCV) and Related Diseases

This study aims to understand the state of onset of NLSD(neutral lipid storage disease) / TGCV(triglyceride deposit cardiovasculopathy) worldwide, background information of affected patients, and natural history of the disease, as well as exploring the prognostic factors and assessing the efficacy of disease-specific treatment.

Since NLSD is a rare disease, its clinical manifestation and clinical course have not been sufficiently clarified. Also, the number of patients in each country is limited. As such, it is considered difficult to fully investigate this disease without international collaboration. Therefore, we have established the International Registry of NLSD / TGCV. Also, all patients with Jordans' anomaly of peripheral polymorphonuclear leukocytes are established as the subjects of entry when starting the registry, to allow entry of patients with NLSD due to genes other than mutations of ATGL and CGI-58 genes.

Time Perspective:This study is both Prospective (registering patients who are diagnosed with NLSD / TGCV) and Retrospective (registering only the medical record of previous patients).

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with NLSD / TGCV

Exclusion Criteria:

* None
Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the influence of omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18-75 years (both inclusive) at time of signing informed consent
* Body mass index of 18.5-29.9 kg/m\^2 (both inclusive)
* A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e., one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
* History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
* Hypertension (defined as sitting systolic blood pressure above or equal to 140 mmHg and/or diastolic blood pressure above or equal to 90 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement is allowed
* Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
A Observational Study to Evaluate Lipid-lowering Drug Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.

1. Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who has done exogenous visit or hospitalization from Jan 2010 to June 2014.
2. Study objective:

   1. The objective of this study is to Identifying the lipid parameter variation when treating patients who have dyslipidemia of type 2 diabetes for 3±1 months.
   2. After treating patients who have dyslipidemia of type 2 diabetes for 3±1 months, identifying the reason why changing method of drug dosage and pharmacotherapy.
   3. If the drug dosage and pharmacotherapy have been changed, Identifying the lipid parameter variation when treating patients by altered drugs for 3±1 months,


Eligibility Criteria:
Inclusion Criteria:

Among the patients, who has been hospitalized or visited the Outpatient Department OPD, who has dyslipidemia of type 2 diabetes.

1. Patients have the result of lipid parameter test at baseline and after lipid-lowering drug for at least 3 months.
2. Patients who have the result of lipid paraneter test (LDL-C ≥100mg/dL, TG ≥150mg/dL) at baseline.
3. Patients who have no received lipid lowering drug fr at least 2 months prior to the baseline.
4. Patients' age were \> 20 years and \<75 year.

Exclusion Criteria:

1. Patients who ahs HbA1c≥9%
2. Patients who have no the result of lipid parameter test at baseline and at baseline and after lipid-lowering drug for at least 3 months
3. Patients who have history of drug discontinuation by incresed liver enzyme or rhabdomyolysis.
4. Patients received lipid-lowering drug and TZD(Thiazolidinediones) in study period
5. Renal abnormality
6. Alcoholism or Alcohol abuse
7. Patients treated by Steroids.
8. Pregnant or lactating woman
9. Patients who are judged as not suitable for this study by Investigator.
Physical and Cognitive Performance in Older Adults With Fatigue

Fatigue is a common symptom in older adults, often linked to various medical conditions, medications, and psychosocial factors, and it can adversely affect both physical and cognitive performance in the aging population, contributing to functional decline and reduced quality of life.

Assessment of the physical impact of fatigue on physical and cognitive performance in older adults can offer valuable insights for clinical practice and holistic geriatric care. Therefore, this study will validate subjective tools used for measuring the impact of fatigue against objective measures.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 60 years old and above both males and females

Exclusion Criteria:

* o Patients with acute medical illness.

  * Patients with life threatening illnesses.
  * Bedridden patients.
  * Patients with diagnosed malignancy.
  * Patients with debilitating chronic disease (end organ failure) (e.g. heart failure , renal failure, and liver cell failure).
  * Patients with neurological diseases (e.g. moderate to severe dementia, stroke, parkinsonism) that interfere with the assessment process.
  * Patients with musculoskeletal conditions that interfere with the assessment process (fracture, disabling osteoarthritis, painful arthritis).
  * Patients with severe uncorrected hearing loss, vision impairment, or aphasia that may impede effective communication during the assessment.
Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

The purpose of this trial is to test the safety \& tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.


Eligibility Criteria:
Inclusion Criteria:

* Acute agitation in Patients with a DSM-IV diagnosis of Alzheimer's, vascular or mixed Dementia.

Exclusion Criteria:

* Current DSM-IV Axis 1 diagnosis other than Alzheimer's, vascular or mixed Dementia.
Tolterodine Relieves Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome

In this study, we aim to determine whether combined tolterodine and CPAP therapy is a more effective treatment for patients with OSAS than CPAP treatment only.


Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 who underwent polysomnography test with suspicion of OSAS between 01.06.2020-01.01.2022 were enrolled in the study
* Patients with AHI ≥15 (moderate or severe) and OAB-V8≥8 were considered eligible for the study and randomized in two groups to receive either CPAP treatment only or CPAP treatment with tolterodine tartrate

Exclusion Criteria:

* Patients diagnosed with neurological diseases, diabetes mellitus, congestive heart failure, infection, hematuria, urolithiasis, urinary tumors, and urinary retention were excluded from the study. Also, a history of lower urinary tract surgery and medication due to lower urinary tract symptoms were the exclusion criteria.
Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures

Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.

Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing a minimum of 3 implants to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching
Birth Control to Improve Birth Spacing

This study aims to investigate the drivers of postpartum contraceptive use with a prospective cohort. The study will clarify the role of contraceptive knowledge, attitudes, norms, and self-efficacy in driving intention to initiate contraception postpartum and describe the impact of environmental barriers on enacting intended postpartum contraception initiation.

This study will be a sequential mixed-methods design with a prospective cohort to identify and explore barriers to contraceptive initiation both immediately after birth and prior to hospital discharge, as well as throughout the fourth trimester. It will include a baseline patient survey, electronic medical record data pull, follow up survey, and qualitative interviews.

The investigators will enroll 1400 patients into the prospective cohort, selecting individuals enrolled at prenatal care visits at two sites. The baseline survey will be self-administered. The investigators will then contact participants for a follow-up survey at 12 weeks postpartum. Surveys will be self-administered through a link received by text message or email. Additional analyses will draw on retrospectively collected medical record data.

The investigators will invite a subset of 25-30 study subjects to participate in qualitative interviews.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Pregnant
* Attending prenatal care visits at one of the two study sites

Exclusion Criteria:

* Under the age of 18
* Cannot complete a survey in English or Spanish
* Do not have physical or cognitive ability to complete a survey on a tablet