cyrilzakka/clinical-trials huggingface dataset:
Comparison of Relapse Rate After 12 Weeks Verses 20 Weeks Steroid Therapy for the Management of First Episode of Steroid Sensitive Nephrotic Syndrome

All children from 1 to 8 years of age, diagnose with nephrotic syndrome for the first time will be divided into two groups. One group will be given steroids for 12 weeks and other group will receive steroid for 20 weeks. During the 1 years after completion of steroid course patients will be monitor for the episodes of relapse in both group.

All children from 1 to 8 years of age, diagnose with nephrotic syndrome for the first time, at Pakistan Institute of Medical Sciences, Islamabad, from December 2020 to December 2022 will be included in the study.

Sample size was calculated by using WHO sample size calculator keeping level of significance 5%, power of test 90%, P1 21.6%7 and P2 59.3%8. The sample size is turned out to be 34 patients in each group with total of 68 patients.

The patients fulfilling the inclusion criteria will be registered at our nephrology clinic. Patients' bio data along with history and examination will be recorded on a proforma. They will be divided in two groups designated as A and B. Group A will receive steroid for 12 weeks and group B for 20 weeks. For group A regimen will be to administer prednisolone as a single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day for another 6 weeks and then stop. For group B prednisolone will be given as a single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day for another 6 weeks with tapering of 25% of alternate day dose fortnightly. Outcome will be measured in terms of number of relapses in the subsequent 1 years after stopping steroids.

For treatment of relapse Prednisolone will be given in the dose of 60 mg/m2 once daily till urine protein is negative or trace for 3 consecutive days, then 40 mg/m2 on alternate day for 1 month then stop. In case of frequent relapses and steroid dependent cases, relapses will be treated as follows; prednisolone 60 mg/m2 on alternate day till urine protein will be negative for 5days then 40 mg/m2 on alternate day for 1 month then with tapering at the rate of 5 mg fortnightly.

Children with congenital and infantile nephrotic syndrome, persistent hypertension, gross haematuria, family history of nephrotic syndrome and age below 1 year and above 8 years will be excluded from study.

After approval of study from ethical review board, informed consent will be taken from parents. The data obtained will be analyzed using SPSS version 20. The t test will be applied for comparison of mean and chi sqare test for comparison of percentages. The p value less than .05 will be taken as significant.

Eligibility Criteria:
Inclusion Criteria:

* Children 1 to 8 years of age,
* Diagnose with nephrotic syndrome for the first time
* Steroid sensitive nephrotic syndrome

Exclusion Criteria:

* Steroid resistant nephrotic syndrome
* Steroid dependent nephrotic syndrome
* Syndromic Children
* Children with other co morbidities
99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer

This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I\&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I\&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I\&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.

PRIMARY OBJECTIVE:

I. To define the biodistribution of 99mTc-based PSMA imaging and surgery agent (99mTc-PSMA-I\&S) in normal and malignant tissues of patients with prostate cancer (PCa) with histopathology validation, when available.

SECONDARY OBJECTIVES:

I. To correlate the 99mTc-PSMA-I\&S accumulation within tumor lesions observed by in-vivo single-photon emission computed tomography (SPECT), ex-vivo gamma measurements and level of prostate-specific membrane antigen (PSMA) expression quantified by histopathology, when available.

II. To define the best time-point for radio-guided surgery (RGS) with the highest tumor-to-background ratio following 99mTc-PSMA-I\&S administration.

OUTLINE:

The first 5 patients receive an initial dose of 99mTc-PSMA-I\&S intravenously (IV) followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I\&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I\&S IV before surgery.

Eligibility Criteria:
Inclusion Criteria:

* Men with PCa (primary or recurrent disease)
* Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
* Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
* Men who are scheduled for pelvic LN dissection (PLND)
* Men who can provide oral and written informed consent
* Men who can comply with study procedures

Exclusion Criteria:

* Patients who started any PCa treatment between study enrollment and surgery
* Technically inaccessible nodal location
Patient's Perception in Symptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease

The aim of this study is to assess the perception of chronic obstructive pulmonary disease (COPD) patients in symptoms related to morning activities. Also the researchers investigated how to describe the impact of symptoms on sleep quality and how to use the medication in Korea COPD treatments.


Eligibility Criteria:
Inclusion Criteria:

* COPD outpatients over 45 years old
* Lung function: post-FEV1 \< 50%
* Current or ex-smoker \> 10 packs per year
* Patients who were not on medication of ISC/FC at least 2 weeks

Exclusion Criteria:

* Ongoing exacerbation of COPD or within the previous 3 months
* History of asthma or allergic rhinitis
* Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis
* Current participation in an interventional clinical trial
H. Pylori Eradication for Moderate ITP

The purpose of this study is to determine the efficacy of H. pylori eradication for the treatment of chronic or persistent immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia. This is a multi-center, open label, prospective randomized phase IIl study.

Current treatment guideline of ITP recommends corticosteroid as the first line treatment when patient has active bleeding or less than 30×10\^9/L of platelet, because of side effect and cost issues. Since the first case report by Italian study, several investigators have reported that secondary immune thrombocytopenia (ITP) can occur in patients with Helicobacter pylori (H. pylori) infection. We already reported the efficacy of H. pylori eradication in moderate ITP patients with phase II study (Annals Hematology 2015:94:739-46). To improve the evidence of this strategy for the treatment of moderate ITP, we plan to start this multi-center, open label, prospective randomized phase 3 study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 years
* Persistent or chronic ITP patients defined by international working group
* 30 X 10\^9/L ≤ platelet level ≤ 80 X 10\^9/L
* H. pylori infection should be confirmed by at least one of tests: urea breath test (UBT), CLO, stool H. pylori Ag, H. pylori in gastric tissue (reported by a trained pathologist)
* No history of any ITP treatment for the past 3 months
* No previous history of H. pylori eradication treatment
* Patients who voluntarily participate in this study and with informed consents

Exclusion Criteria:

* patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, malignant neoplasm, liver disease, definite SLE and other autoimmune diseases, drugs, MDS and leukemia
* uncontrolled hypothyroidism or hyperthyroidism
* active bleeding for the past 3 months or history of hemorrhagic gastric ulcer or brain hemorrhage
* active infection
* patients who are taking anticoagulant or aspirin
* patients with penicillin allergy or side effects of macrolide
* patients who are taking mizolastine, terfenadine, cisapride, pimozide, astemizole, ergot alkaloid and its derivatives (ergotamine and dihydroergotamine), bepridil or atazanavir
* patients who have known allergy or severe side effect on study drugs
* pregnant or lactating women
A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease

The purpose of this study is to determine safety, tolerability, and pharmacokinetics/dynamics of a ketogenic dietary supplement containing medium chain triglycerides (MCTs) in patients with Alzheimer disease (AD). Novel imaging and laboratory biomarkers in response to this intervention will also be explored.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild-moderate Alzheimer disease (AD)
* Mini-Mental State Examination (MMSE) 16-26
* Study partner available who has frequent contact with the participant
* Good visual and auditory acuity for neuropsychological testing
* Education including completion of at least six grades
* Must read and speak English fluently
* Antidepressants permitted, if stable for 4 weeks prior to screening (and participant is not currently depressed and does not have a history of major depression within the past 1 year)
* Cholinesterase inhibitors permitted, if stable for 12 weeks prior to screening

Exclusion Criteria:

* Any significant neurologic disease other than AD
* History of Diabetes Mellitus type I or II
* Any contraindications to MRI or PET studies
* Major depression, bipolar disorder as described within the past 1 year.
* History of schizophrenia
* History of alcohol or substance abuse or dependence within the past 2 years
* Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol
* Current use of specific psychoactive medications
* Investigational amyloid lowering therapies are prohibited two months prior to screening and for the duration of the trial. Other investigational agents are prohibited one month prior to screening and for the duration of the trial.
* History of brain cancer
The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia

The study will aim to describe and evaluate the effect of chronic beetroot juice supplementation on acute mountain sickness symptoms and exercise in a hypoxic environment. It is hypothesized that beetroot supplementation will decrease acute mountain sickness and increase exercise performance.


Eligibility Criteria:
Inclusion Criteria:

* Women only: Regular menstrual cycle or post-menopausal

Exclusion Criteria:

* Stayed at altitude above 2500m in the last 6 months
* Traveled to altitude above 2500m in the last 2 months
* Unable to give informed consent
* Unstable medical condition.
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Healthy Japanese and Caucasian Male Subjects

The purpose of this research study is to assess the safety and tolerability of GLPG1205 in single and multiple oral doses in healthy male Caucasian and Japanese subjects. This study will also assess the pharmacokinetics (PK) across different doses of GLPG1205. PK will look at how the study drug is absorbed, broken down, and eliminated by your body.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian and Japanese male between 20-55 years of age (extremes included), on the date of signing the informed consent form (ICF).
* Japanese subjects must be first generation Japanese of full Japanese parentage, and must have not lived outside Japan for more than 5 years. First generation subjects will have been born in Japan of 2 parents and 4 grandparents also born in Japan of full Japanese descent.
* A body mass index (BMI) between 18-26 kg/m2, extremes included, with a minimum body weight of 45 kg.
* Able and willing to comply with the protocol requirements and signing the ICF as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.

Exclusion Criteria:

* History of serious allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization) and/or known sensitivity to the investigational product (IP) or its excipients as determined by the investigator.
* Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IP.
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer

The present study aims to investigate the efficacy and safety of the combination of capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified colorectal adenocarcinomas
* Age \> 18 years
* Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant biological agents.
* Measurable disease according to RECIST 1.1
* ECOG performance status 0, 1 or 2
* Adequate renal, hepatic and haematological function
* Consent to blood samples and available paraffin embedded tumour material for translational research studies
* Fertile males and females (\<2 years after last period for women) must use effective birth control.
* Signed Informed consent

Exclusion Criteria:

* Clinically significant concurrent disease.
* Other malignant diseases within 5 years of inclusion in the study, except squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
* Other experimental therapy within 30 days of treatment initiation.
* Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception.
* Clinical or radiological evidence of CNS metastasis.
* Planned radiation therapy against target-lesions.
* Known allergy to 5FU/capecitabine or gemcitabine.
External Body Pressure in Heart Failure With Preserved Ejection Fraction

The primary objective of the study is to test the impact of positive and negative body pressure on exercise capacity, symptoms, blood volume distribution and central cardiac hemodynamics in patients with heart failure and preserved ejection fraction. Aim 1 will study healthy volunteers and heart failure patients non invasively while Aim 2 will study heart failure patients invasively (intracardiac pressures).


Eligibility Criteria:
* Heart Failure Study Population
* Inclusion Criteria (Aim 1 and 2):

  * Age greater than or equal to 30 yrs
  * Established diagnosis of HFpEF with left ventricular ejection fraction greater than or equal to 50%
  * NYHA II-III symptoms
  * Stable HF drug regimen for the preceding 1 month
  * Wedge pressure greater than or equal to 15 mmHg at rest or greater than or equal to 25 mmHg with peak exercise
  * (For Aim 2 only) Scheduled for an elective right heart catheterization at Duke University Hospital.
* Exclusion Criteria (Aim 1 and 2):

  * HF hospitalization for type I myocardial infarction within 3 months
  * Infiltrative (ie amyloid) or hypertrophic cardiomyopathy
  * Uncontrolled atrial or ventricular arrhythmia
  * Chronic oxygen use
  * History of vasovagal syncope
  * Considered inappropriate to participate by PI or Sub-I
  * Healthy Volunteers (Controls)
* Inclusion Criteria (Aim 1):

  * Age greater than or equal to 30 yrs
  * Able to speak English
  * Ambulatory \[assistive devices ok\]
  * Able to provide informed consent
* Exclusion Criteria (Aim 1):

  * Acute myocardial infarction (3-5 days)
  * Unstable angina
  * Uncontrolled arrhythmia causing symptoms or haemodynamic compromise
  * Syncope
  * Active endocarditis
  * Acute myocarditis or pericarditis
  * Symptomatic severe aortic aneurysm
  * Uncontrolled asthma
  * Arterial desaturation at rest on room air \<85%
  * Untreated left main stem coronary stenosis
  * Asymptomatic severe aortic stenosis
  * Severe untreated arterial hypertension at rest (\>200 mm Hg systolic, \>120 mm Hg diastolic)
  * Tachyarrhythmias or bradyarrhythmias
  * Hypertrophic cardiomyopathy
  * Significant pulmonary hypertension
  * Thrombosis of the lower extremity until treated for a minimum of 2 weeks
  * Within 2 weeks of acute symptomatic pulmonary embolus
  * Abdominal aortic aneurysm \>8.0 cm
  * Electrolyte abnormalities
  * Pregnancy
  * Inmate of correctional facility (i.e. prisoner)
  * Diagnosed history of dementia
  * Inability to ambulate independently
  * Considered inappropriate to participate by Principal Investigator
Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome After COVID-19

The Post-COVID syndrome is a COVID-19 sequelae disease with high individual burden. We conduct a prospective, two-arm, randomized-controlled intervention study with embedded qualitative and physiological sub-studies in a mixed-methods design.


Eligibility Criteria:
Inclusion criteria:

* Acute SARS-CoV2 infection at least 12 weeks ago (documented by PCR test results or SARS-CoV-2 antibodies)
* History of chronic fatigue (after SARS-CoV-2 infection)
* At least 3 of 7 criteria fulfilled at the time of inclusion: sleep disturbance, headache, joint pain/muscle pain, anxiety/depression, memory impairment/concentration disturbance, postexertional malaise, dysosmia/anosmia
* Numerical Rating Scale (NRS, 0-10 points, 0 = not able to exercise at all; 10 = full exercise capacity) physical exercise capacity of max. 6 points ("What is your physical exercise capacity on average over the last 7 days?")
* Short Form-36 Physical Function Subscale (SF-36 PFS) of maximum 65 points
* Patient are technically equipped enough to participate in the online intervention and willing to follow the study procedure to perform the online intervention at home

Exclusion criteria:

* Fatigue already present before SARS-CoV-2 infection
* Presence of severe post-exertional malaise (PEM) (according to DSQ-PEM tool question 7 OR 8 with yes AND \>14h condition worsening)
* Other underlying conditions leading to symptoms of chronic fatigue, such as unstable mental illness, oncological disease(s), MS, fibromyalgia, and substance abuse
* Other serious underlying medical conditions, such as severe pulmonary, cardiac, psychiatric, or infectious diseases that could interfere with study participation or affect results • Ongoing opioid therapy or opioid therapy in the week prior to study entry
* Regular use of cannabinoids or other illicit drugs in the month prior to or during the study
* Restarting or discontinuing psychotherapy during study participation in the 6 weeks prior to study entry
* Pregnancy or breastfeeding
* Participation in another clinical intervention study during study participation 1
* Regular use of Complementary and Integrative Medicine self-help measures (e.g. meditation, Kneipp hydrotherapiy, etc.) within the study period
* Current pension procedure or planned claiming of a pension procedure due to disability
* Planned rehabilitation measures during study participation due to post-COVID syndrome

Inclusion and exclusion criteria of the sub-study focus group interviews with physicians

Inclusion criteria:

* Family physicians and general practitioners
* Regular outpatient care of patients with post-covid syndrome
* Willingness in principle to participate in a 2-hour interview on-site or online

Exclusion criteria:

• No previous care of post-covid patients
The Impact of Patient Involvement in Decision-Making About Heart Disease Prevention

The purpose of this study is to determine whether providing patients with information about their global coronary heart disease (CHD) risk and effective risk-reducing strategies allows them to make appropriate decisions about heart disease prevention.

Background: Low utilization of effective CHD prevention strategies may be due to many factors, but chief among them is the lack of patient involvement in prevention decisions. We undertook this study to test the effectiveness of an individually-tailored, computerized decision aid about CHD on patients' discussions with their doctor and their plans for CHD prevention.

Methods: We conducted a pilot randomized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored, computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor.

Eligibility Criteria:
Inclusion Criteria:

* presenting for routine medical care with regular medical provider
* able to understand, speak, and read English

Exclusion Criteria:

* prior history of cardiovascular disease
* history of serious medical illness that would limit candidacy for screening
* previous participation in intensive risk modification as part of diabetes study in our clinic
* no cholesterol measurement in the last 3 years, limiting ability to provide up-to-date risk estimate
A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients

To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15 min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 50% of the predicted normal value and post-bronchodilator FEV1/FVC \< 0.7 (COPD Grade 1 or 2 by severity of airflow limitation (GOLD 2015)
* Patients with CAT score ≥ 10 at Visit 0 and Visit 1.
* Patients who are on and have been on tiotropium monotherapy for the past 3 months.
* 0 or 1 COPD exacerbation in the previous 12 months (not leading to hospital admission).

Exclusion Criteria:

* Treatment with any inhaled corticosteroid (ICS) in the 3 months prior to Visit 1.
* COPD exacerbation between Visit 0 and 1.
* Patients with concomitant pulmonary disease
* Patients with a history of respiratory infection within 4 weeks prior to Visit 0.
* Prior or current diagnosis of asthma.
* Presence of any contraindication, warning, precaution, hypersensitivity to LABA and LAMA

Other protocol-defined inclusion/exclusion criteria may apply