cyrilzakka/clinical-trials huggingface dataset:
Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures

This is a prospective study to assess the feasibility and success of performing an intra-operative standing cough test and the correlation with the long term success of the sling surgery.

The goal is to seek correlation or disparity between the supine versus the sitting cough test, supine (lying down) versus standing cough test and sitting versus the standing cough test performed at a constant bladder volume; empty in the office and full in the operating room. Secondary objective is to test if the intra-operative standing cough test at fullness correlates with long term success of the sling surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present with stress-dominant urinary incontinence
* Patients who have undergone a stress test documentation both in the supine and standing/sitting position.
* Patients who have completed child bearing.
* Patients between 21 and 89 years of age.

Exclusion Criteria:

* Patients who do not agree to participate and do not sign the informed consent.
* Patients undergoing concomitant surgery
* Patients undergoing surgery under anesthesia.
Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.

The purpose of this study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.


Eligibility Criteria:
Inclusion Criteria:

* Wilson's disease(adult,infant,pregnant woman)

Exclusion Criteria:

* acute hepatitis
* malignant tumor
Establishment of Normal Breast Epithelial Cell Lines From Patients at High Risk for Breast Cancer

Women who are at high risk for breast cancer, either because of linkage to high risk breast and ovarian cancer families, or because of a carcinoma in the opposite breast, will be studied. Women will have a physical examination and mammography to ensure that no breast abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal breast tissue. Short-term cell cultures will be established from this tissue and early passages of the short-term cell lines will be stored. A bank of high risk normal mammary epithelial cells will be established. To further characterize the mammary epithelial cells in this population of women, cell cultures will subsequently be analyzed for their growth and metabolic properties, sensitivity to chemopreventive agents, steroid receptor characteristics, oncogene expression and regulation, and genetic changes.

Women who are at high risk for breast cancer, either because of linkage to high risk breast and ovarian cancer families, or because of a carcinoma in the opposite breast, will be studied. Women will have a physical examination and mammography to ensure that no breast abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal breast tissue. Short-term cell cultures will be established from this tissue and early passages of the short-term cell lines will be stored. A bank of high risk normal mammary epithelial cells will be established. To further characterize the mammary epithelial cells in this population of women, cell cultures will subsequently be analyzed for their growth and metabolic properties, sensitivity to chemopreventive agents, steroid receptor characteristics, oncogene expression and regulation, and genetic changes.

Eligibility Criteria:
Women at high risk for breast cancer, either because they are a member of a high risk breast or ovarian cancer family, or because of a carcinoma of the opposite breast.

Normal mammogram within past 3 months.

No suspicious breast or axillary lesions on physical examination.

No major cardiopulmonary, hepatic or renal disorders.
Self-Monitoring Physical Activity With a Smartphone Application and Physiotherapy Coaching in Cancer Patients.

The aim of this study is to examine whether self-monitoring PA with the RunKeeper app with additional physiotherapy coaching is superior in improving patients' self-reported leisure-time PA compared with usual care in cancer patients after 12 weeks.

This is a single-center, prospective, two-armed, randomized controlled trial. Adult cancer patients and cancer survivors are randomized in one of the two study arms, (Group A) RunKeeper app + physiotherapy coaching or (Group B) usual care.

Patients assigned to the intervention group will be instructed to use the RunKeeper app for 12 weeks to self-monitor leisure-time PA. In addition, patients will be educated about the health risks of a sedentary lifestyle, inactivity and (when applicable) other unhealthy lifestyle behaviors (e.g. unhealthy diet, overweight or obesity, sun exposure, alcohol intake). Benefits of a behavior change, becoming physically active and pursuing a healthy lifestyle will be explained by a trained physiotherapist who will also coach the patient during the PA program. The biweekly physiotherapy coaching starts at baseline and will follow a structured sequence of strategies to change patients PA behavior which will contribute to the adoption of leisure-time PA in patients daily living, so the program will be optimally tailored to the patients capabilities and preferences.

The primary endpoint is to examine the effectiveness of the RunKeeper use with additional physiotherapy coaching in improving patients' leisure-time PA compared with usual care in cancer patients as measured by the PASE subscale leisure-time Sum Score at baseline, 6, 12 and 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age diagnosed with cancer (regardless of type/taxonomy) at the medical oncology department, UMCG
* Patients undergoing cancer treatment or surveillance
* WHO-performance score ≤1
* Signed informed consent

Exclusion Criteria:

* Inability to read or understand the Dutch language
* Inability to handle or not in possession of a smartphone (iPhone ≥4 or Android phones)
* Active user of the RunKeeper app
* Severe cardiac (recent cardiovascular event) or psychiatric disease
* Patients following supervised oncologic rehabilitation
Evaluation of Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery

Ultrasonography(USG)-guided optic nerve sheath diameter measurement and its correlation with brain computed tomography in the evaluation of intracranial pressure in patients who underwent intracranial brain tumor surgery.

Optic Nerve Sheath Diameter (ONSD) Measurement is a non-invasive diagnostic method used to detect increased intracranial pressure, and in general, ONSD measurement over 5 mm has been found to be associated with increased intracranial pressure.ONSD will be measured using an USG device within the specified time periods.

T0: Before anesthesia induction T1: First 5 minutes immediately after induction of anesthesia T2: At the end of the surgery before extubation /minute T3: Within the first hour/minute after extubation T4: 12 hours/minute after tumor resection T5. 24 hours/minute after tumor resection

ONSD measurement in brain computer tomography (BCT); Eyeball diameter and optic nerve diameter measurements will be made on BCT transverse images at the optic nerve level and recorded.In patients, USG and BCT correlation comparison is planned before the operation (T0), in the first hour after the end of post-operative surgery (T3) and at the 24th hour after post-operative surgery (T5).

T0: ONSD measurement in pre-operative Brain CT T3: BCT ONSD measurement/minute within the first hour following the postoperative period T5: BCT ONSD measurement/minute 24 hours following the postoperative period

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 -65 years
* Brain malignant neoplasm tumor
* Brain benign neoplasm supratentorial
* Brain benign neoplasm infratentorial information

Exclusion Criteria:

* Patients who cannot provide adequate image quality in ocular ultrasonography
* Who are unconscious or have a Glasgow coma scale of less than 15
* Pseudotumor cerebri
* Optic nerve arachnoid cyst
* Patients with open injuries involving the eyelid and surrounding area
* Optic nerve malignant neoplasm
* Injury of the optic nerve and its pathways
* Systemic Lupus Erythematosis,
* Scleroderma
* Multiple Sclerosis, sarcoidosis
* Thyrotoxicosis (hyperthyroidism)
Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

Neonatal jaundice is a common and most often harmless condition. However, when unrecognized it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease is therefore to identify then children at risk. This results in the need for low-cost, reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.

Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a smartphone application has been developed. This prototype will be evaluated in a clinical trial in two hospitals in Norway. A smartphone will be used to take picture of the skin of the newborn, and by using an algorithm an estimate of the bilirubin concentration is made. The results from these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.


Eligibility Criteria:
Inclusion Criteria:

* born in St.Olavs hospital, Trondheim or in Akershus hospital, Oslo, Norway
* born at term
* normal birth weight

Exclusion Criteria:

* in need of advanced medical treatment
The Turkish Feeding/Swallowing Impact Survey

The purpose of this study is to test the reliability and validity of the Turkish Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing disorders.

The purpose of this study is to test the reliability and validity of the Turkish Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing disorders.The internal consistency, test-retest reliability, and criterion validity of T-EAT-10 will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between the Turkish Feeding/Swallowing Impact Survey and Karaduman Chewing Performance Scale, Tongue Thrust Rating Scale, Pediatric version of the Eating Assessment Tool. The validity will also be determined by completion of the Turkish Feeding/Swallowing Impact Survey before and after swallowing rehabilitation of pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Having a child with swallowing disorders aged between 6 months-18 years

Exclusion Criteria:

* Having a child without swallowing disorders
* Having a child with swallowing disorders aged below 6 months
Biomarkers in Dyspnea

To explore biological mechanisms in human model of induced dyspnea, in order to remove the source of dyspnoea, to modify cerebral impact and to allow the development of targeted therapies.

The aim of the study will be to identify a specific biology and immunology associated with dyspnoea. It will open therapeutic possibilities through a better understanding of the mechanisms of dyspnea.

Healthy volunteers will underwent two types of dyspnea. The subjects will be first familiar with both types of dyspnea and dyspnea measurement scales. Different components of dyspnea will be measured.

Blood tests will be performed at different times (before dyspnea, during dyspnea, 60 and 90 min after dyspnea)

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
* ongoing pain
* respiratory disease
* high levels of depression, panic disorder, or other significant mental health problems
* not fluent in french
Characteristics of Plant Sterols Consumers in France

The purpose of this study is to describe the cardiovascular risk profile in subjects who consume a marketed drinkable low fat fermented milk enriched with plant sterol. Investigations are lead prospectively and retrospectively among adults enrolled from general practitioners' database.


Eligibility Criteria:
Inclusion Criteria:

* male and female aged 18-70 years, regular visits to GP (at least once every six months within the past 2 years), agreeing to a written informed consent

Exclusion Criteria:

* any clinical, psychological or language problem that would prevent from completing the questionaires or communicating with GP
Comparing Chemoprevention Drugs for School-based Malaria Control

This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence in young children sleeping student's households to assess the impact on transmission.

Students attending a single primary school in Machinga District, Malawi who were enrolled in NCT05244954 were offered enrollment in this follow-on study. The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or chloroquine (females 10 years old or older. Students in the IPT-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Eligibility Criteria:
Inclusion Criteria:

Students (enrolled in the primary intervention)

* Previously enrolled in NCT05244954
* Currently enrolled in the study school
* Plan to attend the study school for the remainder of the school year
* Parent/guardian available to provide written informed consent Younger children in participant households (enrolled in the Household Prevalence survey)
* Slept in the household for most nights in the last month
* Age 6-59 months
* Parent/guardian available to provide written informed consent

Exclusion Criteria:

Students (enrolled in the primary intervention)

* Current evidence of severe malaria or danger signs
* Known adverse reaction to the study drugs
* History of cardiac problems or fainting
* Taking medications known to prolong QT
* Family history of prolonged QT
* Taking trimethoprim-sulfamethoxazole aka Bactrim or Cotrimoxazole
* Epilepsy
* Psoriasis Household members (enrolled in the Household Prevalence survey)
* Household with more than one school-age child enrolled in the study
* Current evidence of severe malaria or danger signs
Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer

The purpose of this study is to determine if adding hyperbaric oxygen therapy, a therapy that delivers oxygen under slight pressure, to a drug treatment of PDE5I (such as Viagra, Levitra, Cialis)for men following surgery for prostate cancer will result in more men being able to continue to have erections.

Prostate cancer is the most common non-skin malignancy in men in the United States, with approximately 232,000 diagnoses of adenocarcinoma projected for 2005. More than 150,000 of these men are treated with radical prostatectomy. Common sequelae following successful NSRRP (nerve-sparing radical retropubic prostatectomy)include urinary incontinence and sexual dysfunction. Recent advances in surgery technique and treatment have been made but in spite of aggressive management, recovery of sexual function is incomplete with fewer than one-fifth reporting return to baseline. The etiology of erectile dysfunction following radical prostatectomy results most probably from local surgical trauma and neurapraxia, which leads to corpus cavernosal hypoxemia in the post-NSRRP period. This hypoxemia is believed to impact negatively on the health and maintenance of the smooth muscle cells within the corpus cavernosum. Hyperbaric oxygen therapy (HBO2T) is a unique modality that is able to provide oxygen delivery to tissues that have been damaged by traumatic injury.

Hypothesis: The addition of post-NSRRP hyperbaric oxygen therapy (HBO2T) to a treatment of phosphodiesterase type 5 inhibitor (PDE5I) will reduce the incidence of erectile dysfunction (ED) and urinary incontinence when measured at 1, 3, 6, 12 and 18 months post-NSRRP for Stage I prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* male
* age 40-69
* diagnosis of Stage I prostate cancer
* bilateral NSRRP as primary treatment
* sexual potency prior to surgery

Exclusion Criteria:

* COPD, CHF, diabetes mellitus
* known inability to tolerate PDE5I
* confinement anxiety/claustrophobia
* planned adjuvant or neo-adjuvant therapy
* patients taking alpha blockers or nitrates
* patients with retinitis pigmentosa
Clinical Trial of Laparoscopic Pelvic and Para-aortic Lymphadenectomy and Uterine Blood Vessel Blocking for Precision Diagnosis and Treatment in Advanced Cervical Cancer

Cervical cancer is the most common reproductive malignancy in developing country. Due to local invasion, radical hysterectomy cannot be performed in advanced cervical cancer (FIGO IIB - IVA) , so that radiation combined with chemoradiation (RCTX) is a traditional treatment nowadays. Lack of precise treatment strategies, recurrent ratesand metastasisis high ,and the 5-year survival rate is less than 50%. Therefore, it needs to explore a new strategy for improving the prognosis of advanced cervical cancer.

The prognosis of cervical cancer is closely related to its stages ,while the current FIGO clinical stage is too subjective , for example different gynecologic oncologists may give different diagnosis to the same patient. MRI, CT, PET/CT imaging examinations are commonly used as a referrence for clinical staging, but the sensitivity and specificity are not satisfied. In addition, lymph node metastasis significantly impacts the prognosis of cervical cancer . However, the lymph node invasion is not in current staging criteria.

Precision treatment after surgical staging is recommended by NCCN recently .Surgical staging in patients with advancedcervical cancer is safe and does not delay primary RCTX in few randomized study.Whether overall survival benefit the long-term clinical follow-up surgical staging is unknown.Blocking bilateral uterine artery can effectively reduce the tumor size and increase the operability , which has been conformed in locally advanced cervical cancer. Furthermore, ovarian dysfunction caused by RCTX could be avoided by ovarian transposition via surgical staging .

Based on this, we suggesta new surgical stagingfor patients with advanced cervical cancer , which includinglaparoscopic pelvic and para-aortic lymphadenectomy , uterine blood vessel blocking and ovarian transportation, in order to perform individualized postoperative RCTX, reduce tumor load , preserve ovarian function and improve life quality.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
* The pathological staging:IIB,IIIA,IIIB,IVA

Exclusion Criteria:

* Underwent surgery or radiation and chemotherapy
Patent Versus Generic Clopidogrel in Acute Coronary Syndrome

Ischemic heart disease is the leading cause of death and disability in developed countries and is responsible for a third of deaths in persons over 35 years . The most severe form of ischemic heart disease is sudden death and acute coronary syndrome (ACS).

There is evidence that early and optimal treatment of ACS decreases mortality. Within the optimal treatment, these patients must receive a reperfusion therapy as mechanical or pharmacologic treatment. In addition to reperfusion treatment, antiplatelet therapy is a central part of the management. Aspirin plus a P2Y12 inhibitor have been shown to decrease mortality. In our country, clopidogrel is the more accessible and used P2Y12 inhibitor; however, it has been shown to have a wide variability in response and this variability could be influenced by different pharmacological, genetic and environmental factors.

Platelet reactivity measured by aggregometry predicts major cardiovascular events in ACS patients treated with clopidogrel. Due to their frequent prescription, generic clopidogrel efficacy must be evaluated. The purpose of this study is to compare the platelet reactivity in patients with ACS receiving clopidogrel generic versus patent.


Eligibility Criteria:
Inclusion Criteria:

* 18 and over
* Diagnosis of acute coronary syndrome
* Patients receiving 300 mg of Clopidogrel load and a single dose of 75 mg daily
* Signature of informed consent

Exclusion Criteria:

* Active bleeding or absolute contraindication for antiplatelet use
* Chronic kidney disease with creatinine clearance \<30 ml / min
* Liver damage documented as elevated aspartate aminotransferase/alanine aspartate 2 times upper normal limit (UNL) and/or total bilirubin \> 2 times UNL
* Prescribed antiplatelet therapy, other than aspirin
Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

The primary objective of this research is to determine whether oral magnesium supplementation in healthy, community-living individuals will be associated with reductions in the burden of arrhythmias in the upper chambers of the heart (supraventricular arrhythmias).

To evaluate the primary objective, the Investigator will conduct a double-blind randomized trial assigning participants to receive 400 mg of oral magnesium in the form of magnesium citrate once daily or placebo. The investigators will recruit 60 individuals 55 years of age and older without a prior history of cardiovascular disease. At baseline, participants will undergo a basic examination, answer questionnaires and provide a blood sample to determine circulating magnesium levels. Participants will then wear an FDA-approved heart rhythm monitor (Zio ® XT Patch) for 2 weeks. At the end of 2 weeks they will begin taking their assigned treatment (magnesium or placebo), and will continue doing so for a total of 12 weeks (through study week 14). After 10 weeks of taking the supplement or placebo (study week 12), they will have a final study visit in which the participants will provide another blood sample for assessment of circulating magnesium, and will be asked to wear the heart rhythm monitor for another 2 weeks (through study week 14). The primary endpoint will be the change in burden of premature atrial contractions (PACs), measured in episodes per day, between baseline and final follow-up visit. A secondary outcome will be the change in circulating magnesium between both exams.

Eligibility Criteria:
Inclusion Criteria:

* Age 55 and older
* Ability to speak English
* Availability to attend baseline and follow-up visit approximately 12 weeks after baseline

Exclusion Criteria:

* Prior history of heart disease (coronary heart disease, heart failure, atrial fibrillation), stroke, severe renal disease
* Use of type I and III antiarrhythmics or digoxin
* Current use of magnesium supplements
* Any prior history of allergy or intolerance to magnesium
* Prior history of inflammatory bowel disease or any severe gastrointestinal disorder