cyrilzakka/clinical-trials huggingface dataset:
Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects

The aim of the study is to find CF patients at risk for cystic fibrosis related liver disease (CFLD). Comparison of ultrasound by two modalities and biochemical markers with histological evaluation of liver biopsy if present.

There are 209 CF patients attending Stockholm Cystic Fibrosis Center (January 2010). All up till 15 years of age are screened for liver disease annually by ultrasound (US) and also by biochemical markers. Ultrasound is performed every third year over 15 years of age in patients without CFLD, while all of them with diagnosed CFLD are continued to be investigated annually. Biochemical markers are controlled at least once every year in all CF patients. Elastography of the liver will be planned together with the investigations of the annual follow up, in an optimal clinical status. If either US or elastography of the liver indicates liver disease or progress of the already existing pathological changes, a liver biopsy will be performed according to routine procedure at Stockholm CF Centre. Also, historical data of liver biopsies and biochemical investigations will be considered in the study.

Elastography of the liver will be performed by Fibroscan device, with transducers for children and adults, respectively.

Clinical importance Liver US investigations in CF patients have important implications but are difficult to standardize in a routine clinical setting. Elastography may have an advantage in the evaluation of early fibrosis with clinical importance in pursuing diagnostics and intensifying treatment. A significant group (up to 25 %) of CF patients may be helped by this novel method. Including histological data, accuracy of elastography in CF patients may be improved. Further details of the importance of fatty acid status in CF may be elucidated.

Eligibility Criteria:
Inclusion Criteria:

* Verified cystic fibrosis

Exclusion Criteria:
Outcome After Dental Implant Treatment

The general aim of this project is to investigate the long-term treatment outcome after implant therapy. The patients' satisfaction with implant treatment will be studied and correlated to biological and technical problems. The survival rates of implants at patient level and the degree of bone loss of remaining teeth and implants will be calculated. The levels of cytokines and bone loss markers in peri-implantitis sites and periodontal defects and at healthy sites will be analyzed in order to study the correlation between cytokine and bone loss marker levels, and clinical conditions. Independent variables which could be regarded as significant risk factors or risk predictors on the incidence of peri-implantitis are aimed to be identified

* A questionnaire study will investigate patient satisfaction 8-14 years after dental implant therapy to study if complications influence the degree of satisfaction/quality of life. The questionnaire will be sent to 587 patients treated at The Specialist Clinic Skanstull.
* A clinical examination of a minimum 150 patients who answered the questionnaire will be performed:
* to study the incidence of biological and technical complications on dental implants after a minimum of 10 year of function.
* to study the survival rates of implants at patient level and the degree of bone loss of remaining teeth and implants. In addition, the correlation between bone loss of remaining teeth and bone loss of implants will be studied.
* samples taken from the gingival crevicular fluid to investigate the profile of cytokines and bone resorption markers as well as to study the intra-individual correlation of cytokines and bone markers in gingival crevicular fluid from sites with peri-implantitis and periodontal defects in individuals with dental implants.
* in addition, the salivary cytokine and bone resorption markers will be analyzed in order to identify disease-specific biomarkers as well as to study the correlation between the cytokine/bone resorption markers in saliva and in gingival/peri-implant crevicular fluid.
* To identify significant risk factors or risk predictors on the incidence of peri-implantitis.

Eligibility Criteria:
Inclusion Criteria:

- Treated at the Specialist Clinic Skanstull, Stockholm, Sweden with dental implants between the years of 1999-2005

Exclusion Criteria:

- Deceased before or during the study period
The Effectiveness of Sunnah on Sleeping on Sleep Quality, Fatigue, Depression and Anxiety Among Patient Undegroing Hemodialysis

This study to examine the effects of implementation sunnah on sleeping on sleep quality, sleep time receiving a slow stroke back massage on fatigue and quality of life among participants undergoing maintenance hemodialysis will be applied. The study will be conducted at the hemodialysis unit of a medical center in a central part of Indonesia. To determine the sample size at a 95% confidence level and 80% test power, with a mean difference of at least 0.72 and a standard deviation of 1.22 in the intervention group and 1.22 in the control group, based on the study of \[17\] and according to the sample size formula, we determined a requirement of 205participants in each group. Forty participants were recruited and allocated to either the experimental group (n=25) or the control group (n = 25).

Participants will be recruited if they were: (i) 18 years of age or over; (ii) under- going hemodialysis for a minimum of three months; (iii) undergoing maintenance hemodialysis; (iv) diagnosed with a maximum of two comorbidities; (v) affiliated to Islam; and (vi) not hearing-impaired. Participants were excluded if they had, (i) muscle problems, and (3) unstable vital signs. A thorough review of participant charts will be performed to confirm they met the inclusion and exclusion criteria. Participants then will be randomly assigned to two different groups based on their hemodialysis schedule.

The measurement of demographic and illness-related characteristics; the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) and Pitssburg Sleep Quality Index (PSQI) will be conducted at the baseline and after the fourth week. The FACIT-fatigue scale was used to measure participant fatigue. FACIT-fatigue has 13 items to assess fatigue and its impact on functioning and daily activities in a number of chronic diseases, with five-point response options from 0 to 4. The total score ranges from 0 to 52, where a higher total score reflects less fatigue. The items include tiredness, listlessness, weakness, lack of energy, and impact on daily. In the study, we will use a validated Indonesian version of FACIT-fatigue. This version has been tested on 52 participants by Sihombing et al 2016 with CKD and has good internal reliability with a Cronbach's alpha of 0.62 (20). The PSQI has been translated and tested for validity and reliability by Setyowati \& Chung (2021). The Cronbach alpha for Indonesian version of PSQI is 0.72 which means that the Indonesian version of PSQI has adequate reliability (21).


Eligibility Criteria:
Inclusion Criteria:

Participants undergoing hemodialysis were recruited if they were: (1) 18 years of age or over; (2) undergoing maintenance hemodialysis twice a week for a minimum of three months; (3) affiliated to Islam, and (4) not hearing-impaired

Exclusion Criteria:

* Participants were excluded if they had unstable vital signs.
Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of sitaxsentan given alone and with rifampin will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or women of non-child bearing potential.
* Subjects between the ages of 21 and 55 years, inclusive.
* Signed informed consent.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Has hepatic dysfunction.
* Has history of excessive alcohol and tobacco use.
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)

The goal of the study is to learn about treating older people with multiple sclerosis (MS) with metformin. Metformin may be used as a single therapy or as an add-on therapy. The investigators want to learn:

* The safety and tolerability of metformin extended release (1500 mg/day) as a single therapy or as an add-on therapy in older people with MS compared to placebo
* How well metformin protects the nervous system against injury compared with placebo measured by brain MRI over a 9 month treatment period
* The effect of metformin to protect brain tissue from age and MS related injury when compared to the placebo group over a 9 month treatment period

Specific aims and rationale:

The main aim of this study is to determine the safety of metformin as monotherapy or as an add-on therapy to the disease modifying treatment in aging people with multiple sclerosis (pwMS). While the tolerability of metformin has been studies in the general population, data specific to the MS population is not currently available. Moreover, understanding the gastrointestinal tolerability of metformin when added on MS disease modifying treatment is needed. Secondly, the study aims at understating the potential neuroprotective properties of metformin as measured through magnetic resonance spectroscopy and change in N-acetyl-aspartate (NAA) levels over a 9-month study period. This pilot study will provide valuable insights into the efficacy and safety of add-on or monotherapy metformin therapy as a potential therapeutic approach to address the complex pathophysiology of MS and offer new avenues for promoting neuroprotection along with potential support for neural repair and remyelination in individuals with this debilitating condition. Previous pre-clinical studies have shown that metformin can promote neuroprotection by reducing oxidative stress and inflammation and is able to enhance the reparative mechanisms within the central nervous system (CNS). Currently there are no neuroprotective interventions available for pwMS that directly target the neurodegenerative component of MS, with particular emphasis for the aging MS population. The investigators hypothesize that older pwMS that are treated with metformin will have a significantly lower decline in N-acetylaspartate levels when compared to pwMS not treated with metformin.

Eligibility Criteria:
Inclusion Criteria:

1. age between 55 and 75 years old
2. having a diagnosis of MS based on the latest McDonald criteria
3. non-active disease course (no relapses and no MRI activity) in the last 2 years as determined by the MS provider and based on the 2020 revised clinical course criteria
4. EDSS score \<7.0

Exclusion Criteria:

1. inability to undergo MRI scans
2. inability to participate in the study during the study period
3. diabetes or uncontrolled cardiovascular disease
4. unable to consent
New Formulation Study of Inupadenant (EOS100850) in Patients with Cancer

A2A-004 is a three-part multicenter, open-label, Phase I clinical trial intended to evaluate the safety and tolerability, and the pharmacokinetics (PK) and food effect of new formulations of inupadenant (formerly known as EOS100850), in participants with advanced solid tumors.


Eligibility Criteria:
For more information regarding participation in the Trial, please refer to your physician

Inclusion Criteria:

* Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available.
* At least 4 weeks since any previous treatment for cancer
* Subject must consent to pretreatment and on treatment tumor biopsies
* Adequate organ and marrow function

Exclusion Criteria:

* Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
* Participants with second/other active cancers requiring current treatment
* Uncontrolled/significant heart disease
* Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or - - Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
* Active/uncontrolled autoimmune disease
* Active infection
* Other protocol defined inclusion/exclusion criteria could apply
A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the effects of ramucirumab in combination with docetaxel in participants with Stage IV non-small cell lung cancer who have had disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy for advanced/metastatic disease.


Eligibility Criteria:
Inclusion Criteria:

* Non-Small Cell Lung Cancer disease
* Clinical stage IV or recurrent disease
* One prior first-line platinum-based chemotherapy regimen with or without maintenance therapy
* For Non-Small Cell Lung Cancer (NSCLC) tumors other than squamous cell histology, the epidermal growth factor receptor (EGFR) mutation status is known prior to randomization
* For participants with activating epidermal growth factor receptor (EGFR) mutation only, prior epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) monotherapy (only one regimen in the setting of single use) should be utilized
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version RECIST version 1.1
* Adequate organ function
* Estimated life expectancy of at least 3 months.

Exclusion Criteria:

* Have undergone major surgery within 28 days prior to randomization or have planned major surgery during study treatment
* Receiving concurrent treatment with other anticancer therapy
* Central nervous system disease other than stable and treated brain metastasis
* Has major blood vessel invasion or encasement by cancer
* Has intratumor cavitation
* Has a history of uncontrolled thrombotic disorder
* Is receiving therapeutic anticoagulation with drugs
* Is receiving chronic therapy with nonsteroidal anti-inflammatory drugs
* Has a history of hemoptysis within 2 months prior to randomization
* Has clinically relevant congestive heart failure
* Has experienced any arterial thromboembolic event
* Has uncontrolled arterial hypertension
* Has had a serious or nonhealing wound or, ulcer
* Has significant existing conditions
Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic Anemia

RATIONALE: Immunosuppressive therapies, such as anti-thymocyte globulin and cyclosporine, may improve bone marrow function and increase blood cell counts. PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with cyclosporine as first-line therapy works in treating patients with severe aplastic anemia.

PRIMARY OBJECTIVES: To determine the response rate of r-ATG and CsA in the first line setting. SECONDARY OBJECTIVES: To determine the level of IS as assessed by Immuknow assay in responders and compare it to non-responders. OUTLINE:Patients receive anti-thymocyte globulin IV over 4-24 hours daily on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* All patients with sAA as defined by Camitta who are candidates for IS therapy; these criteria include bone marrow cellularity \< 25% or 25-50% with \< 30% of hematopoietic cells; it should also have two of the following three parameters: peripheral blood neutrophils \< 0.5 x 10\^9/L, platelets \< 20 x 10\^9/L and reticulocytes \< 60 x 10\^9/L in anemic patients
* If cytogenetic testing has been done, it should show normal karyotype or be not informative
* Patients should be either unwilling or otherwise ineligible (age, comorbidities, lack of donor) for bone marrow transplantation as a therapeutic modality
* Not previously treated with ATG for sAA
* Patients must have ECOG performance status of 0, 1, or 2
* Vitamin B12 and folic acid deficiency must be ruled out by measurement of serum levels
* Patients must have had a bone marrow biopsy examination in the three months prior to enrolling in the study
* Must be able to provide informed consent
* Systemic and other hematologic causes of pancytopenia, based on clinical presentation, must have been ruled out

Exclusion Criteria:

* Patients with clinically evident congestive heart failure, serious cardiac arrhythmias; symptoms of coronary artery disease must be cleared by cardiology prior to therapy
* Patients who have had chemotherapy, radiotherapy, or immunotherapy or other investigational drug use within 3 weeks prior to study entry
* Pregnant women
* All females of childbearing potential must have a blood test or urine study within two weeks prior to induction registration to rule out pregnancy
* Women of childbearing potential are strongly advised to use an accepted and effective method of contraception
* Patients who have medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722

The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.


Eligibility Criteria:
Inclusion Criteria:

* Healthy man or woman
* Body mass index between 18 and 29.9 kg/m2

Exclusion Criteria:

* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract
* Any surgery on the small intestine or colon, excluding appendectomy or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk to the subject.
BN83495 in Prostate Cancer

The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy

Evaluate the PD profile of BN83495 after 28 days of daily oral administration in patients with locally advanced or metastatic prostate cancer on androgen ablative therapy and with rising prostatic specific antigen

Eligibility Criteria:
Inclusion Criteria:

* Confirmed and locally advanced or metastatic prostate cancer with rising prostate-specific antigen (PSA), while on androgen ablative therapy.
* Over age 18.
* Demonstrated PSA "biochemical failure".
* Adequate bone marrow and hepatic function

Exclusion Criteria:

* Luteinizing Hormone-Releasing Hormone analogue treatment and treated with more than one additional second line of endocrine therapy
* Prior treatment with ketoconazole
* Prior chemotherapy for hormone refractory prostate cancer
* Pre-existing cardiac failure and/or clinically significant abnormal ECG or Echo
Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition

This study will test the influence of lactulose of the human gut microbiota. Healthy volunteers will ingest 50g of lactulose and donate stool samples 1 day before as well as 1-2 days and 14 days after the test. Using sequencing and metabolomics techniques the investigators will identify changes in microbiota composition upon lactulose exposure.

This is a clinical study for investigating the influence of lactulose on the composition and metabolic activities of the intestinal microbiota. We will recruit 40 healthy volunteers. Subjects will be randomized and receive either 50g lactose (intervention group) or 50g sucrose (control group).

Subjects will donate fecal samples 24h before and after (1-2d, 14d) lactulose ingestion. After ingestion H2-in expiratory air and symptoms will be followed for 3 hours.

Frozen samples will be analyzed for their microbiota composition and key metabolites.

Eligibility Criteria:
Inclusion Criteria:

* Subjects free of relevant abdominal complaints (=healthy)
* Written informed consent
* Working at ETH Zurich/University of Zurich, experience in handling of -80°C freezers on biosafety level 2

Exclusion Criteria:

* Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders)
* Known diabetes mellitus, scleroderma, neurological impairment or other major current disease
* Subjects unable to stop medication that alters gut flora: proton pump inhibitors, laxatives and antibiotics at least 4 weeks before study entry.
* Pregnancy beyond week 12 (no pregnancy test will be performed)
* Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion
Remineralization Effect Of Egg Shell Versus Fluoride Varnish On Early Carious White Spot Lesions In Primary Teeth

The goal of this clinical trial is to to assess the remineralization potential of Egg shell hydrogel versus fluoride varnish in early carious white spot lesions in anterior primary teeth.

The main question it aims to answer is:What is the remineralization potential of egg shell hydrogel on early carious white spot lesions compared to fluoride varnish in anterior primary teeth? Researcher will compare egg shell hydrogel with fluoride varnish to see if it is able to promote lesion remineralization.

interventions that will be given to participasnts: egg shell hydrogel \& five percent sodium fluoride varnish


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 3 to 5 years, in good general health, and medically free.
2. Prescence of at least one WSL on anterior primary teeth with an ICDAS II score of one or two.
3. Cooperative patients who will comply with follow-ups.
4. Parents who accept to sign informed consent.

Exclusion Criteria:

1. Uncooperative children.
2. Children with a physical disability or medical disability.
3. Children with teeth that shows enamel hypoplasia.
4. Children that have received a fluoride supplement or professional topical fluoride application at least 3 months before the study.
5. Parents refuse to give written formed consent.
Addressing Personalized Needs in Clostridioides Difficile Infection

BEYOND is aiming to demonstrate how by enrichment of the available SPECIFY score, patients at great likelihood for CDI with unfavorable outcome are early detected

In a previous project, following GWAS analysis of the DNA and measurement of serum biomarkers coming from 134 patients a prediction score named SPECIFY was developed. The SPECIFY score comprises four elements: low hemoglobin, increased urea, increased IL-8 and carriage of G alleles of rs2091172. The score has 80% positive predictive value and 95.8% specificity for the early detection of unfavorable outcome but the sensitivity is low. Unfavorable outcome is defined as any of: presentation or progression into severe CDI, relapse; and death. Stool samples of day 1 before start of therapy of the patients are stored refrigerated. Microbiome analysis will be done aiming to the integration of the Shannon diversity index to the already developed score in order to improve sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Age more than or equal to 18 years
* Both genders
* Diarrhea defined as at least 3 episodes of unformed stools in the last 24hours according to the Bristol stool chart
* Presence of C.difficile in stool. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B.

Exclusion Criteria:

• No exclusion criteria apply