cyrilzakka/clinical-trials huggingface dataset:
Tracking Treatment Pathways in Adult Patients With Hyperkalemia.

This study aims to increase the understanding of Hyperkalemia (HK) management, treatment patterns, and the treatment decision-making process for the management of patients with HK over a period of up to 12 months. The generation of real-world evidence (RWE) to understand the treatment management decision rationale and to prospectively describe patient characteristics, treatment management patterns among patients with HK is of importance to improve adherence to guidelines and improve patient care.

The primary objective:

• Describe HK management decisions, their rationale and treatment expectations.

The secondary objective:

• Describe baseline characteristics and longitudinal clinical variables in patients with HK.

The exploratory objective:

• Describe patient awareness and satisfaction with their HK treatment management across the study period.

This study is a multinational, observational, prospective, longitudinal, cohort study that will include primary and secondary data collection. Secondary data, collected as per routine clinical practice will be extracted from electronic health records (EHR) and manually entered into the electronic case report form (eCRF). Primary data will be collected directly from patients and Health Care Providers (HCPs). Prospective data collection will be performed for a period of 12 months and will include data collection at baseline, that is, the date of enrollment, and at 3-, 6-, 9-, and 12-months following baseline. The data collection timepoints in this study is irrespective of when the patient's medical visits are scheduled. There are no study specific patient visits mandated by protocol and study may be fully virtual.

Eligibility Criteria:
Patients meeting all the following inclusion criteria will be eligible for inclusion into the study:

1. Age ≥18 years on the date of signing informed consent
2. HK with serum potassium (K+) level(s) greater than 5.0 mmol/L, collected during Standard of Care, within 21 days prior to the date of enrollment\*
3. Provision of signed and dated informed consent

(\*enrollment in study is defined as the date of Informed consent and confirmation of study eligibility, whichever occurs later).

Patients will be excluded from the study if they meet any of the following criteria:

1. Concurrent participation in any trial that includes the use of K+ binders as an investigational medicinal product (IMP)
2. Patients with pseudohyperkalemia
3. A life expectancy of less than six months, based on physician judgement
4. Acute causes of HK such as infections and/or trauma to be determined by the principal investigator
5. Scheduled renal transplant
6. Involvement in the planning and/or conduct of the study
A Clinical Trial to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression

The objective of this clinical trial was to evaluate the efficacy and safety of defocusing lenses for delaying myopia progression in children and adolescents. A total of 156 subjects meeting the requirements of the study protocol were included. During the study, subjects were required to wear the test product (defocus lens A or defocus lens B) or the control product (aspheric lens) for 12 months, and regular follow-up was required during the wearing process, including various ophthalmological examinations and subjective feelings about wearing the lens. During the study period, the product status, ocular conditions, adverse events and serious adverse events were continuously observed to evaluate the safety and effectiveness of the test product in clinical use.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all criteria to be enrolled in the study at the screening visit:

1. Age 8\~13 years old (including boundary values), gender is not limited;
2. The spherical degree of subjective optometry in both eyes with cycloplegic muscle paralysis was between -1.00D and -6.00D (including the boundary value) (based on the mean value of subjective optometry), and the equivalent spherical difference of both eyes was less than 1.50D;
3. Optimal corrected visual acuity ≥1.0 in left and right eye after ciliary muscle paralysis;
4. In both eyes with cycloplegia, the degree of the column lens was ≤1.50 days;
5. Voluntarily participate in the clinical study, sign the informed consent, and obtain the written consent of the guardian;

Exclusion Criteria:

Subjects who met any of the following criteria at the time of the screening visit were excluded from the study:

1. Have a history of eye trauma or intraocular surgery;
2. Abnormal results of slit-lamp examination (see Annex 1 for details);
3. fundus examination results ≥ grade 2 (see Annex 1 for details);
4. Intraocular pressure \< 10mmHg or \> 21mmHg or intraocular pressure difference ≥5mmHg;
5. Patients with other eye diseases, such as uveitis and other inflammation, glaucoma, cataract, fundus disease, eye tumors, eye trauma, dominant strabismus, and any eye lesions affecting visual function;
6. Associated diseases that may affect the eye (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, etc.);
7. suffering from a mental disorder or other disease that the researcher deems unsuitable for wearing frame glasses;
8. Use specially designed myopia control lenses such as hard contact lenses (including care products), multifocal contact lenses, progressive multifocal lenses, and atropine drugs within 1 month before screening or during the planned study period;
9. Participating in other clinical trials within 3 months prior to screening;
10. Those who cannot perform regular eye examination;
11. Other investigators consider it inappropriate to participate in this clinical study.
Effects of THC and Alcohol on Driving Performance

Low blood concentrations of THC and alcohol appear to have a minimal effect on driving performance.However, there is a gap in the literature about the combined effects of THC and alcohol. There is little empirical evidence to determine whether the combination of THC and alcohol could be additive or multiplicative. This issue is particularly important when dealing with concentrations that are just below legal thresholds - it is important to identify if someone who may have consumed cannabis and alcohol, in quantities that do not exceed legal thresholds, may nonetheless be impaired to drive. Answering this question requires more research on the combined effects of THC and alcohol under tightly controlled experimental conditions. Hence, the purpose of this study is to determine the additive (or multiplicative) effect of standardized low doses of cannabis, in combination with low-doses of alcohol, on a number of outcome measures related to driving. The investigators will focus specifically on the effect of low blood concentrations of THC (0, 125, and 250 µg/kg) alone and in combination with low blood concentrations of alcohol (BAC 0%, .025%, and .049%). They shall determine the combined effect of THC and alcohol on physiological, cognitive, subjective measures of impairment, and simulated driving. This study will focus on younger adults because they have higher impaired driving rates than other age groups. As a secondary aim of the study, the investigators will examine whether previous driving and drug use history are correlated with driving decisions during the simulated drive and subjective measures. This study will contribute to the evidence base informing legislation, policy making, and law enforcement. This study is particularly timely given upcoming changes in legislation about cannabis, and because the combination of THC and alcohol, even below legal thresholds, may lead to impaired driving and crashes.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>18 and \<30
* valid G2 or G Ontario driver's license
* live on-campus or within 15 minutes drive of campus
* speak fluent English

Exclusion Criteria:

* history of cardiovascular or psychiatric disorders
* current use of psychoactive medication
* current drug or alcohol abuse problem
* positive drug screen
* BAC level \> .000%
Pilot Study: Urea Cycle Disorders Practice Patterns and Outcomes Assessment

The purpose of this study is to determine if patients participating in "The Longitudinal Study of Urea Cycle Disorders" are different than participants in the Urea Cycles Disorders Consortium (UCDC) Rare Diseases Clinical Research Network (RDCRN) Contact Registry and to determine if patients are a good source of medical information.

Participants enrolled in the RDCRN UCDC Contact Registry will receive an email inviting them to participate in the study. Interested participants will be directed to the informed consent document. After agreeing to participate, participants will be directed to the study web portal. The study web portal will be developed and maintained by the Data Management and Coordinating Center at the University of South Florida (USF).

Participants will complete several questionnaires about their urea cycle disorder including diagnosis and treatment information and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in UCDC RDCRN Contact Registry
* Patient reported diagnosis of one of the eight UCDs or UCD diagnosis highly likely/pending.

Exclusion Criteria:

* Cases of hyperammonemia caused by an organic acidemia, lysinuric protein intolerance, mitochondrial disorders, congenital lactic acidemia, fatty acid oxidation defects and primary liver disease.
* Individuals with rare and unrelated serious comorbidities, e.g., Down syndrome, intraventricular hemorrhage in the newborn period, and extreme low birth weight (\<1,500 grams).
* Inability to provide informed consent and complete surveys
Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.

The study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia.

In the study, 50 post-stroke subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design.

Eligibility Criteria:
Inclusion Criteria:

* Stroke
* Aphasia
* Can give consent

Exclusion Criteria:

* Renal failure
* Pregnancy
* Other neurological condition
Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.

A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised).

The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week.

Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.


Eligibility Criteria:
Inclusion Criteria:

* full-term ages 3 to 12 months, affected by symptoms suggestive of GER.
* infant regurgitation defined according to the Rome IV criteria
* informed consent

Exclusion Criteria:

* Evidence of chronic diseases, hepatic, renal, or cardiac diseases, metabolic or central nervous system diseases, or use of acid suppressor treatment (H2-receptor antagonists or proton pump inhibitors \[PPIs\]), thickened formula, or a history of prematurity or atopy
Scars After Central Venous Catheters

Most children with cancer need a central venous catheter. These catheters are typically placed on the anterior thorax, where the risk of hypertrophic scarring and keloid development is greatly enhanced. A significant part of the children who have survived childhood cancer are troubled by their scars.

Topical glucocorticoid treatment is known to induce a reduction of the collagen in the connective tissue.

The investigators hypothesize that treatment with topical glucocorticoids for one week before and three weeks after removal of a central venous catheter, will reduce the formation of hypertrophic scarring and keloid development in children.


Eligibility Criteria:
Inclusion Criteria:

* All children and adolescents who have a central venous catheter removed at the Childrens Department of Oncology at Aarhus University Hospital Skejby in the period from March 2010 to July 2011

Exclusion Criteria:

* Known allergy towards plaster or fusidic acid
Evaluation of the Targeted Screening of Type 2 Diabetes by Capillary Blood Glucose

Type 2 diabetes is the chronic disease with the most important development in France, and particularly in the Saint-Etienne area due to his specific population.

Different studies showed the interest of screening targeted on high risk population to reduce cardiovascular risks and mortality.

The current screening recommandation is an opportunist targeted screening on population older than 45 years with risk factors by a fasting glucose every 3 years, and a communautaire screening targeted on population older than 45 years suffering precarity with or without risk factors by capillary blood glucose or fasting glucose.

The objective of the Sainté Diabete network is to optimize the screening of diabetics, their follow-up and their treatments. Using a self-administered questionnaire during a medical visit could be a simple, cheap and efficient tool to detect diabetics as soon as possible.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* 45 years or older
* Signed informed consent

Exclusion Criteria:

* fasting glucose performed in the last 2 years
* diabetes history
* not living in Saint-Etienne
A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for Refractory or Relapsed Diffuse Large B Cell Lymphoma

A phase II trial of ifosfamide, etoposide, cytarabine, and methotrexate (IVAM) chemotherapy for refractory or relapsed diffuse large B cell lymphoma

Diffuse Large B-Cell lymphoma is currently used as a standard treatment, with a combination of chemotherapy (R-CHOP), which includes Rituximab. However, the survival rate is very poor if the primary treatment is refractory or relapsed within a year or less. The duration of these patients ' lives is around one year and the five-year survival rate is 15-20 %. Thus, a new treatment strategy is needed to improve the survival of the patient with DLBCL, which are either refractory and relapsed.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Histologically confirmed adult patients diagnosed with DLBCL refractory or relapsed.
* Large scale B cell lymphoma not received ASCT(autologous stem-cell transplantation ) after primary chemotherapy
* At least one measurable lesion

  * ≥1 cm in greatest transverse diameter by spiral CT
  * ≥2 cm in greatest transverse diameter by conventional CT
  * ≥1 cm in visible skin lesion
  * ≥2 cm in digital exploration
* Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
* Age 19\~59yrs
* MUGA(multiple gated acquisition scan ): Non-Clinical significant and 2D-Echo( Cardiac Index ≥ 50 % )
* Adequate renal function: serum creatinine level \< 2.0 mg/dL(177μmol/L) Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper limit of normal value (or \< 5 x ULN in the presence of DLBCL involvement of the liver), bilirubin \< 2 X upper normal value (or \< 5 x upper limit of normal in the presence of DLBCL involvement of the liver)
* Adequate hematological function: hemoglobin ≥ 9.0 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL,
* A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are \< 1 years after the onset of menopause.

Exclusion Criteria:

* Pre-treatment for ASCT
* Central nervous system (CNS) involvement by lymphoma
* Prior history of malignancies other than lymphoma (except for treated Non Melanoma Skin Cancer, early gastric cancer or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 5 years
* Pregnant or lactating woman, Childbearing potential not employing adequate contraception
* Active uncontrolled infections(Bacterial, Viral, Fungus)
* Other serious illness or medical conditions
* Other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective Randomized Trial

Although Urea breath test has been commonly used to recheck the efficiency of Helicobacter pylori eradication, there has been no randomized trials comparing the accuracy of Urea breath test results at different times after eradication. The investigators aim to assess the accuracy and influence factors of post-therapy test at different times and follow up the cut off samples to optimize the best time to recheck.

The investigators plan to conduct a single-center, open-label, randomized controlled study in Zhejiang, China. Treatment-naive H. pylori-positive participants (n = 900) were randomly assigned to three groups in a 1:1:1 ratio with the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at different times after the treatment: 4 to 6 weeks, 6 to 8 weeks, and 8 to 10 weeks, respectively, for different groups.

Eligibility Criteria:
Inclusion Criteria:

* no history of helicobacter pylori treatment
* the diagnosis of H. pylori infection was confirmed by one or more of the following methodologies before treatment: gastric biopsy using histochemical staining, tissue culture, the 14C-urea breath test (UBT), and/or the 13C-UBT.

Exclusion Criteria:

* used antibiotics or bismuth within four weeks before inclusion or acid inhibitor use, including H2 receptor antagonist (H2RA), PPI or P-CAB use, within two weeks prior to inclusion.
* had an active peptic ulcer with complications such as hemorrhage, perforation, or obstruction.
* had a history of esophagectomy or gastrectomy.
* had an allergy to any study drug.
* had severe comorbidities or physical or mental diseases.
* were pregnant or breastfeeding.
* had a history of alcohol abuse or drug addiction.
Rifaximin-treatment of Collagenous Colitis

The hypothesis of this study is that an altered gut microbiota is a contributory factor in initiating an inflammatory process in the colonic mucosa leading to collagenous colitis. The investigators suggest that treatment with budesonide reduces the inflammation without treating the underlying cause. In this trial the investigators will try to modullate gut microbiota by adding rifaximin. The aim of this study is to assess if 4 weeks treatment with rifaximin as a supplement to a standard course of budesonide against active CC can reduce the risk of relapse after treatment cessation.

Patients with biopsy-verified CC and active disease defined by \>3 bowel movements/day or \>1 watery stool measured as a mean for a week. Patients will be invited to participate in the study independently of age and disease duration.

Eligibility Criteria:
Inclusion Criteria:

* • Signed informed consent

  * Histological findings fulfill criteria for CC:

    * A subepithelial collagenous band \>10 μm in colonic biopsies
    * Increased count of inflammatory cells in lamina propria
  * Diagnostic biopsies are a maximum of two years old
  * A history of nonbloody, watery diarrhea for more than two weeks prior to screening in patients with recently diagnosed CC or a history of clinical relapse for more than a week in patients with known CC
  * Active disease: \> 3 stools/day or \>1 watery stool/day measured as a mean during a week prior to baseline

Exclusion Criteria:

* - Significant findings at colonoscopy that could cause diarrhea (colonic diverticulosis and polyps \< 2 cm are not considered significant findings)
* Biopsies more than two years old in a patient, who does not accept a new sigmoidoscopy
* Untreated celiac disease
* Positive stool cultures for pathogenic intestinal bacteria including Clostridium difficile
* Suspected colitis induced by medication (diarrhea shortly after commencement of NSAID's, statins, SSRI or PPI)
* Severe comorbidity (cardiovascular, renal, endocrine, neurologic, pulmonal or psychiatric) or history of cancer during the last 5 years
* Abnormal liver biochemistry (ALAT or ALP \> 2,5 x upper limit), cirrhosis or portal hypertension
* Pregnancy or lactation (assured by negative P-hCG at inclusion)
* History of significant intestinal resection
* Treatment with 5-ASA, Salazopyrin, immunemudulators (Azathioprine, 6-mercaptopurine or Methotrexate), biologic drugs (TNF-alfa-inhibitors), local or systemic glucocorticoids (except for Budesonide) within the last three month
* Allergy or intolerance to Rifaximin (or similar antibiotics such as Rifampicin or Rifabutin)
* Expectation of lack of cooperation or insufficient comprehension
* Concomitant participation in an other clinical trial or participation within the last 30 days
* Patients receiving Warfarin or Marcoumar (interaction with risk of uncontrolled INR-levels)
The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

The hypothesis of this study is that Lipiodol uterine bathing improves the success rate of in vitro fertilization (IVF) for women with endometriosis or recurrent IVF implantation failure.


Eligibility Criteria:
Inclusion Criteria:

* 12 or more months infertility
* Age 18 to 39
* Endometriosis or recurrent IVF implantation failure
* Patent fallopian tubes

Exclusion Criteria:

* Iodine allergy
* Blocked fallopian tube or tubes
Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.

The proposed research aims to determine the prevalence, size, shape and histology of flat colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for screening colonoscopy. Patients will be randomized to either conventional colonoscopy or chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined in the usual manner. The primary outcome will be the total number of adenomas detected, with special attention to the subgroup of flat and depressed lesions. To promote the generalizability of the results, neoplasms will be described according to standard Western and Japanese classification schemes.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing screening colonoscopy

Exclusion Criteria:

* Age \< 50
* Prior colon resection
* Inflammatory bowel disease
* Prior colonoscopy or sigmoidoscopy
* More than one first-degree relative with colon cancer
Role of Ultrasound in Diagnosis of Placenta Previa and MAP

Placenta accreta occurs when the placental implantation is abnormal. The marked rise in incidence has been assumed the increasing prevalence of cesarean delivery in recent years.

The most accepted theory is that abnormal placentation . The most important risk factor for placenta accreta is placenta previa after a prior cesarean delivery. The first clinical manifestation of placenta accreta is usually severe , life-threatening hemorrhage. The recommended intervention of suspected placenta accreta is planned preterm cesarean hysterectomy with the placenta left in situ.

Eligibility Criteria:
Inclusion Criteria:

* pregnant ladies with previous cesarean sections
* GA above 30 weeks

Exclusion Criteria:

* Primigravida patients
* GA below 30 weeks