cyrilzakka/clinical-trials huggingface dataset:
Quality of Life in Kidney Stone Patients Undergoing Surgery

This is a prospective randomized study, comparing quality of life in renal stone patients undergoing surgical treatment with ureteroscopy (URS) versus percutaneous nephrolithotomy (PNL).

In United States, the prevalence of renal stone is 8.8% with slight predomination in male than female. They can be symptomatic marked by symptoms of flank pain, hematuria or urinary tract infection, or completely asymptomatic and incidentally discovered. Three modalities are accepted as treatment options for renal stone, including shockwave lithotripsy (SWL), percutaneous nephrolithotomy (PNL) and ureteroscopy (URS). While some standard guidelines were proposed for appropriate treatment selection with regard to stone size, no recommendations or guidelines exist for the surgical management of 1-2 cm renal stones. Both PNL and URS are equally accepted as treatment options for stones at this size. The selection of either procedure currently is left to the treating surgeon can be influenced by anatomical or stone factors as well as patient preference. For URS, frequent requirement for postoperative ureteral stents may result in significant morbidity and a detriment to quality of life owing to irritating bladder symptoms caused by the stent itself. PNL rarely requires postoperative ureteral stent but it may bring longer operative time and hospitalization. PNL therefore may be a treatment option that preserves quality of life compared to URS for patients presenting with the 1-2 cm sized kidney or ureteral stone.

One reasonable way to evaluate efficacy of treatment options is to assess patient's quality of life resultant from the selected modality. Quality of life for renal stone formers is an important but under-studied facet of nephrolithiasis management that should be incorporated into clinical decision making.

The short form-36 health survey questionnaire (SF-36) is a patient-reported survey of health status. It has been validated and is commonly used to determine the efficacy of a given health treatment in many settings, including urologic intervention. The Ureteral Stent Symptom Questionnaire (USSQ) is a validated and widely accepted instrument to evaluate the impact of ureteral stents on quality of life. The investigators plan to use these two questionnaires as a standard outcome measurement to compare impact on quality of life in patients randomized to undergo two different modalities (PNL versus URS) of stone treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a renal or proximal ureteral stone measuring 1-2 cm in size on preoperative ultrasound, computed tomography, or plain radiographic imaging

Exclusion Criteria:

* Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
* Stones with measured size larger than 2 cm or smaller than 1 cm.
* Patients with ureteral or renal anatomy or stones located in a position judged to be unsafe for randomization.
* Pregnancy.
Promoting an incLUsive Society Towards Older Adults With Physical Disabilities

To improve secondary school students' positive attitudes towards older adults with physical disabilities via a Promoting an incLUsive Society towards older adults with physical disabilities through disability simulation education (PLUS) project.

A pretest-posttest and qualitative study design will be adopted. 1,000 junior secondary students will be recruited from six secondary schools in Hong Kong by convenience sampling to participate in a 3-day PLUS Convention. Changes in students' attitudes towards older adults with physical disabilities and satisfaction with life, and their satisfaction with the disability simulation experience will be assessed. Semi-structured interviews will be conducted with students, facilitators, teachers, and older adults with physical disabilities to gain further feedback.

Eligibility Criteria:
Inclusion Criteria:

1. currently a secondary 1 to secondary 3 student
2. studying in a secondary school in Hong Kong
3. communicable in Cantonese
4. willing to attend all of the activities of the 3-day PLUS Convention

Exclusion Criteria:

1. have a physical or learning disability
2. diagnosed with a severe psychiatric illness
Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal women


Eligibility Criteria:
Inclusion Criteria:

* Must be between the ages of 30 to 65 years
* Must have undergone hysterectomy and bilateral salpingo-oophorectomy

Exclusion Criteria:

* A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
* Any systemic skin diseases or local skin abnormalities in the area of application
* Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).
* A medical condition that could affect or interfere with sexual function
* Using a systemic topical gel or cream estrogen therapy.
Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

It is proposed to investigate the association between consumption of black tea and various selective fasting blood serum and urine biomarkers in a Mauritian population with ischaemic heart diseases. This study, the first of its kind, will provide clinical data on the potential prophylactic propensities of Mauritian black tea against cardiovascular disease, which remains one of the major health threats to the Mauritian population.

OBJECTIVES

Our broad objectives will be to:

* Survey and recruit patients with ischaemic heart diseases in a randomized sample representative of the Mauritian population (ethnicity, gender, age, social and economical status) and record their medical history,
* Collect fasting blood serum and urine at baseline and after supplement of control volume of tea infusion and water from study group and control group respectively,
* Optimize techniques to determine levels of specific biomarkers from above body fluid samples,
* Investigate existing correlation between tea consumption and risk of cardiovascular diseases in Mauritian population

Our specific objectives will be to:

* Select a randomised group of the Mauritian population, with ischaemic heart disease, who has been referred to the Cardiac Centre, Pamplemousses for Angiography and a group of people showing no risk of cardiovascular diseases
* Inform the people about the motives of the study and seek consent from those willing to participate in the study,
* Evaluate the levels of biomarkers of oxidative stress (total cholesterol, LDL, HDL, triglycerides, homocysteine, atrial natriuretic peptides, brain natriuretic peptides, 8-hydroxydeoxyguanosine, isoprostanes, hydroxyeicosatetraenoic acid, products of protein damage, uric acid and glycosylated haemoglobin) from 8-10 hr fasting blood serum and urine at baseline from all participants
* Supply the study group with a control volume of tea infusion and the control group with the same amount of water for a defined period of time followed by a two week wash out period with water.
* Study biomarkers as above from 8-10 hr fasting blood serum and urine in two week intervals during the supplement regime
* Investigate the existing correlation between tea consumption and levels of biomarkers of cardiovascular diseases in a Mauritian sample population.

Eligibility Criteria:
Inclusion Criteria:

* 25-70 years
* Non smokers
* Left ventricular ejection fraction\>40%

Exclusion Criteria:

* Alcohol consumption \> 4 standard drinks/day
* Postmenopausal women receiving hormone replacement therapy
Clinical Trial of Diagnostic Tests and Clinical Algorithms for Dengue in Febrile Subjects in Endemic Areas in Colombia

The present study aimed to develop a sensitive dengue diagnostic clinical algorithm using the resources that are available at the health care institutions, clinical expertise, and identification of signs and symptoms and variables of the hemogram associated with dengue. The performance of the potential algorithms were assessed under routine care. A single group cuasiexperimental study with a Bayesian adaptive design was conducted. Prior and cumulative information was used during intermediate analysis of clinical algorithms performance and according to these results algorithms were modified and then implemented in the subsequent study subjects. Men and women of all ages, seeking care due to fever of less than 15 days were recruited in 3 endemic areas in Colombia. The algorithms were applied by study physicians and blood samples taken for hemogram and dengue reference tests. It was planned that algorithms with high sensitivity (95%) and specificity (80%) were implemented in real life to assess their impact on patients outcomes alone and in combination with dengue rapid diagnostic tests but this was not feasible as not algorithms achieved the targetted performance. The experience of physicians using the algorithm in a mobile device was going to be explored with qualitative methods but this was explored with study physicians.


Eligibility Criteria:
Inclusion Criteria:

* Fever of less than 15 days

Exclusion Criteria:

* Origin of fever identified
Circulating microRNAs in Patients With STEMI Complicated With Cardiogenic Shock

The aim of the study is knowing the prognostic value of circulating miRNAs in patients admitted to our hospital with STEMI complicated with cardiogenic shock.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* ST elevation by ECG diagnostic of STEMI
* Evidency of coronary occlusion in coronariography
* Signed informed consent

Exclusion Criteria:

* Patients admitted from other hospitals
* Impossibility of getting blood samples in first 6h
* Declined consent
Effectivity and Safety of Combination Cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA

This clinical study will compare the effectivity and safety of combination cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad, and Zinc PCA as adjuvant therapy for acne vulgaris patients. These combination cream will be tested by mild to moderate acne vulgaris patients. Participants will be female patients aged 15-50 years old and divided into three groups. The control group (Group 1) will use Adapalene 0.1% cream only every night. Group 2 will use Adapalene 0.1% cream intermittently every two nights and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning.

This study is an experimental study with a randomized controlled trial (RCT) design on mild to moderate acne vulgaris patients who met the inclusion criteria. This study will be conducted in five Dermatology and Venereology Education Centers in Indonesia located in Jakarta (Rumah Sakit Umum Pusat Nasional dr. Cipto Mangunkusumo), Jakarta (Rumah Sakit Pusat Angkatan Darat Gatot Soebroto), Padang (Rumah Sakit Umum Pusat Dr. M. Djamil), Surakarta (Rumah Sakit Umum Daerah Dr. Moewardi), and Malang (Rumah Sakit Umum Daerah Dr. Saiful Anwar). Group 1 as control group, will receive Adapalene 0.1% cream only every night. Group 2 will receive Adapalene 0.1% cream only intermittently every two nights, and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning. All participants will be evaluated in day 28 and 56. Therapy evaluation will be assessed based on the Global Acne Severity Scale (GEA Score), Indonesia Acne Expert Meeting (IAEM Score), Level of Seborrhoea, Clinician Erythema Assessment Scale (CEA), facial skin analysis with Janus Skin Facial Analysis, and evaluation of the quality of life using Cardiff Acne Disability Index and Acne-Quality of Life (Acne-QoL) specifically for participants aged older than 18 years old.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 15 - 50 years
* Mild and moderate acne vulgaris according to IAEM and GEA.
* Patients are willing to participate in the study until it is finished.

Exclusion Criteria:

* History of allergy to dermatocosmetic products.
* Undergoing other acne therapy, medication, or invasive action in the last month.
* Pregnant or breastfeeding patients
Exercise & Diet Effects on CV Risk in Firefighters

The study will explore the capacity for a lifestyle modification in firefighters to improve blood pressure, blood vessel stiffness, inflammation, and reduce oxidative stress. The study will be a pre- post-testing controlled trial with three groups. The intervention will be a weekly circuit workout program and a Mediterranean (high fruit/vegetable) diet. The groups will be firefighters with \>10yrs experience, firefighters with \<10yrs experience, and control Non-firefighters.

Recent statistics from the American Heart Association (AHA) have reported that \>92% of adults in the U.S. meet at least 1 metric for cardiovascular disease risk factors. In firefighters, this increased risk is especially concerning. The National Fire Protection Agency (NFPA) estimates there are around 1.3 million firefighters in the United States, 70% of which are volunteer. The prevalence of impaired cardiovascular health is higher in firefighters than in the general population and the leading line-of-duty death (LODD) cause is cardiac related. It is known that exercise and diet mitigate cardiovascular disease risk. Meeting the physical activity guidelines remains a target of ideal cardiovascular health and a major public health concern. However, the NFPA does not require volunteer fire companies to have a fitness program for their crew, and sadly less than a third of the stations actually do. And importantly, cardiovascular-related LODD remains a major issue in the firefighter population. The results could guide clinical treatment for firefighters and may therefore reduce cardiac-related LODD.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Able to Exercise

Exclusion Criteria:

* More than one anti-hypertensive medication
* More than one cholesterol medication
* Diabetic
* Prior Cardiac incident
Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain

This is an observational, multicentre epidemiological study with a longitudinal cohort in which information will be retrieved from medical records of patients with advanced metastatic or unresectable melanoma at first diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients of legal age with stage III, metastatic, or unresectable melanoma at first diagnosis after January 8, 2018. First diagnosis is understood as: a. Disease onset as metastatic or unresectable disease; b. First metastatic or unresectable relapse in the pre-established dates (after January 8, 2018) in a patient with previous localised melanoma and completely resected on dates before the pre-inclusion period.
* Signing the Informed Consent Form (ICF).
* A patient may have received the first or subsequent treatments for metastatic or unresectable disease in a hospital other than the centre where the ICF was signed, as long as the patient meets the inclusion criteria 1.
* A patient can only sign one ICF (cannot sign an ICF in two different centres).
* If a patient signs the ICF in a centre during the first-line therapy and then goes to another centre with consideration for the following lines: If the centre is associated with the GEM-1801 study, researchers will do their best to update the following lines and the patient status, introducing the new information in the centre where the ICF was initially signed. This information will be provided by the patient before contacting the principal investigator and always with prior consent of the patient, who will have previously provided the consent to contact by telephone for this purpose. If this second (or subsequent) centre is not associated with the GEM- 1801 study, this will be considered loss of follow-up, unless the patient returns to the GEM-1801 start centre, wherein the reporting physicians will do their best to update the information from other centres, always with prior patient consent, who will have previously signed the ICF; c) A patient card with the assigned code will be delivered.

Exclusion Criteria:

* Any patient not complying with inclusion criteria.
Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires

A longitudinal study on immune responses in relation to protection against clinical malaria episodes will be conducted in Apac District, Uganda. Three cohorts will be recruited: children 1 to 5 years of age (n=250), children 6 to 10 years of age (n=125) and adults 25 and above (n=125). After finger prick sampling (\~300µL) and examination at enrolment, participants will be followed up for one year. Follow-up will include fortnightly active case detection and three-monthly cross-sectional surveys. Clinical malaria attacks and the associated clinical and parasitological parameters will be related to immunological profiles determined utilizing a protein microarray as a capture substratum to profile the humoral immune response against a vast number of parasite antigens.

For individuals who experience a clinical malaria attack or who are diagnosed with high density parasitaemia (≥15,000 parasites/µL) during cross-sectional surveys, a 5mL blood sample is obtained to determine the diversity of parasite antigens in the population in relation to antigen recognition in the cohort.


Eligibility Criteria:
Inclusion Criteria:

* age 1-5 years, 6-10 years or 25 yearsand above
* written informed consent must be given
* the individual must have been resident of the area since birth or for a minimum period of two years
* the individual must be willing to submit required information and to participate in repeated sampling (total blood volume \~2.5 mL over a period of 12 months)
* Absence of danger signs (as defined by WHO) or clinical features of AIDS. An HIV-test will be offered to all participants at enrolment and completion of the study.

Exclusion Criteria:

* unwillingness to sign consent form
* unwillingness to reside in the study area during the follow-up period
Study of the Hematopoietic Niche and the Role of Inflammation in the Pathophysiology of Cytopenias After CAR-T Cell Therapy: Potential of Therapies Directed to Repair the Bone Marrow Microenvironment

Immunotherapy with chimeric antigen receptor T-cells (CAR-T) has revolutionized the treatment of oncohematological diseases and its applications in solid tumors and non-neoplastic diseases are advancing. Cytopenias after CAR-T therapy are the most frequent complication in the medium and long term after treatment, they are a cause of morbimortality, and there are no effective therapies available.

The general objective of the present research project is to analyze, in a series of 40 patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy at the University Hospital of Salamanca, the characteristics of the hematopoietic niche and the systemic and bone marrow inflammatory status in patients with prolonged cytopenias after CAR-T cell therapy with respect to those without cytopenias and with respect to the pre-treatment situation (performing quantitative and functional analysis of the stroma by immunohistochemistry, flow cytometry and genomic studies, in addition to functional hematopoietic assays-clonogenic assays, long-term cultures-), and to evaluate both in vitro (by co-culturing with macrophages activated by CAR-T/tumor cell interaction and assessing cytokines) and in vivo (in an animal model of lymphoma and CRS) the therapeutic potential of therapies aimed at repairing the hematopoietic bone marrow microenvironment, such as the use of allogeneic mesenchymal cells (MSC) from healthy donors and MSC-derived extracellular vesicles (MSC-EV) studying their effects on inflammatory mediators, hematopoiesis and the cytotoxic effect of CAR-T.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy
* Over 18 years old
* Sign the informed consent

Exclusion Criteria:

* Under 18 years old
* Do not sign the informed consent
The Impact of Mobile Application-guided Physical Exercise on Physiological Parameters in Healthy Pregnant Women

After the second-trimester anomaly scan, healthy pregnant women will be offered inclusion in the study. Before inclusion, participants will fill out a questionnaire on the suitability of moderate physical exercise. After signing the consent form for the study, they will receive a random wrist-tracking device. The investigators will inform them about the use and possibilities of the wrist-tracking device. Suppose they will be randomly assigned to the group with a guided exercise program for pregnant women. In that case, they will also have a guided exercise program via a mobile application, where they will receive one of the exercises intended for pregnant women every day for up to 30 minutes. The investigators will also present and explain all the exercises to them, emphasizing the crucial role they play in our study. The investigators will also explain when they should stop exercising and immediately consult a perinatologist on the phone number provided. If they are randomly assigned to the control group, they will not receive exercise, but they can be physically active at their discretion.

The research will be a randomized intervention study on the impact of physical activity on physiological parameters and sleep duration during pregnancy. The research will be designed as a naturalistic study based on the guidelines for assessing the appropriateness of heart rate measurements with wrist-based heart rate monitors in biobehavioral research. The study will be conducted at the Gynecology Clinic at the University College of Medicine in Ljubljana.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years,
* confirmed duration of pregnancy with ultrasound measurement between the crown and the coccyx of the fetus in the first trimester,
* legal capacity,
* understanding of the Slovenian and English languages,
* signed consent form for the study, access to encrypted data, and use of data according to GDPR.

Exclusion Criteria:

pregnant women who will not sign a consent form for the study and the GDPR.

* pregnant women who will not allow the use of the key to access encrypted measurement data
* women under the influence of illegal substances (drugs or alcohol) that may interfere with their ability to participate and comply with the investigation procedures,
* any acute or chronic disease, disorder or condition, including cognitive dysfunction,
* pregnant women with multiple pregnancies,
* pregnant women with conditions that constitute a contraindication to regular physical exercise during pregnancy:

  * with a cervix \< 30 mm,
  * with persistent unexplained bloody discharge,
  * with a placenta \< 30 mm from the internal os,
  * with a growth-restricted fetus,
  * with rupture of the amniotic sac,
  * with a previous premature birth \< 32 weeks,
  * with recurrent miscarriages
  * with one or more affirmative answers in the self-assessment questionnaire for physical fitness.