cyrilzakka/clinical-trials huggingface dataset:
An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate

Fermagate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.

The purpose of this study it to look at the safety of fermagate over longer periods of time.

High levels of phosphate in the blood are linked with serious effects, due to calcium imbalances (high levels of parathyroid hormone (PTH), bone disease, formation of calcium deposits in the body, and blood-vessel disease).

This study is an open-label, multi-centre, single-group, 24-week study of fermagatebonate. Subjects participating in this study are those who took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment
2. Male or female subjects on active haemodialysis, aged 18 years or over
3. Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium-, or iron-containing products and preparations, other than the study medication;
4. Willing to avoid any intentional changes in diet such as fasting, dieting or overeating;
5. Willing to maintain their usual type and dose of Vitamin D supplementation.

Exclusion Criteria:

1. Participation in any other clinical trial using an investigational product or device within the previous 4 months;
2. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator;
3. Any disease or condition, physical or psychological, which in the opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn;
4. Clinically significant laboratory findings (for this subject population) in the opinion of the investigator.
5. Any malignancy with the exception of basal cell carcinoma;
6. A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction;
7. A significant illness in the 4 weeks before screening;
8. Taking medication for seizures;
9. A history of haemochromatosis;
10. A history of serum ferritin concentration of ≥ 1000 ng/mL (excluding transient, treatment-induced ferritin elevation);
11. A history of dysphagia or swallowing disorders;
12. Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilised) unless they abstain from sexual intercourse or are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device;
13. Current haemoglobin concentration of \< 10.00 g/dL;
14. Allergy to the IMP or its constituents.
Learning From Our Patients, Learning From Our Practice: Implementing an Intervention to Support Patients on Dialysis

The purpose of this research is to gather preliminary estimates of the impact of using Capacity Coaching as an intervention for patients receiving dialysis.


Eligibility Criteria:
Inclusion Criteria:

Clinician Participants:

* Clinicians employed at Mayo Clinic who provide care to patients visiting the Mayo Clinic - Department of Nephrology and Hypertension Dialysis Services.

Patient Participants:

* Adult patients (18 years of age and older).
* Receive long-term dialysis treatment and services at Mayo Clinic.

Exclusion Criteria:

* Minors (under the age of 18 years).
* Non-English speaking.
* Lack the ability to provide informed consent.
Non Interventional Study In Bipolar Disorder And Schizophrenia With Zeldox

Investigation of the impact of Zeldox on metabolic parametres in patients with bipolar disorder or with schizophrenia and impact of the treatment for the quality of life

observational survey consecutive patient sampling

Eligibility Criteria:
Inclusion Criteria:

Manic and mixed episodes of up to moderate severity in patients with type I and II bipolar disorder and schizophrenia; either first diagnosed or repeated episodes.

Exclusion Criteria:

Patients with a history of hypersenzitivity to Ziprasidone. Previous insufficiency of the Ziprasidone´s treatment. The break of the previous therapeutic condition.
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels

The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol.

The main questions it aims to answer are:

* Does lipodia, together with regular treatment, lower LDL cholesterol (bad cholesterol) better than regular treatment alone?
* Does lipodia help improve other health outcomes, like how confident participants feel in managing their health?

Researchers will compare two groups:

* Intervention group: Participants use the lipodia intervention and continue their usual treatment.
* Control group: Participants continue with their usual treatment only.

Participants will:

* Fill out questionnaires online and visit a certified lab at the start of the study, after 3 months, and after 6 months
* Have blood tests at each lab visit to check their cholesterol and other blood fat levels
* Continue with their usual treatment (both groups) and use lipodia, a digital health app, for six months (intervention group only)


Eligibility Criteria:
Inclusion criteria

* Age ≥ 18
* Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis
* LDL-C levels above risk-adapted target
* TG levels \< 400 mg/dL
* Stability of potential drug treatment during the last 4 weeks
* Stability of potential hormonal treatment during the last 6 months
* Patient was made aware of lifestyle measures by GP or specialist
* Consent to participation
* Sufficient knowledge of the German language

Exclusion criteria

* Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes
* Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes
* Patients receiving plasmapheresis
* Lp(a) \> 50 mg/dL
* current pregnancy or planned pregnancy during the study period
* planned major operations
* liver dysfunction
* end-stage renal failure
* other systemic conditions that might interfere with successful study participation
* Plans to change drug (including hormonal) treatment in the upcoming 6 months
* Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past
Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation

There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown to be an effective and safe immunosuppressant in the prevention and treatment of rejection after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will be investigated in this clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing allogeneic SCT with high risk of acute GVHD, ie. from matched unrelated donor or one HLA-locus mismatch sibling

Exclusion Criteria:

* known allergy to mycophenolate mofetil
Motivational Interviewing (MI) to Reduce Khat Use

Healthy khat user with the intention to reduce or stop khat use will be randomly assigned to a one-session brief intervention or waiting list. Reductions in khat use will be measured from pre- to post-assessment which will be one month apart. After one month, the waiting list will receive the same intervention.

The leaves of the khat tree are traditionally chewed in some African and Arab countries. They contain the mild central stimulant cathinone. In recent years, the production, trade and use has dramatically increased and excessive patterns of use as well as a specific dependence syndrome have been described. So far, no experiences exist in psychological treatment of khat addiction.

In this study, we use a brief motivational intervention based on the WHO's ASSIST-linked Brief Intervention and Motivational Interviewing to support users who have the intention to reduce or stop their khat use. Khat users will be recruited in the community. Trained local staff will assess participant's khat and other substance use at study entry and one month later. Users will be assigned randomly to intervention or waiting list control groups. The intervention group will receive a single 20-minute brief intervention. The waiting list will receive the same intervention after the second assessment. After two months, a final assessment will be made in both groups.

Eligibility Criteria:
Inclusion Criteria:

Healthy individuals

Exclusion Criteria:

Severe psychiatric disorders
Post Exercise Substrate Oxidation, Appetite and Energy Intakes in Overweight/Obese Postmenopausal Women (EScAPE)

High-intensity interval exercise (HIIT), as compared to moderate intensity continuous training (MICT), is a time-efficient strategy to decrease total and abdominal fat mass (FM). However, the mechanisms underlying such adaptations are not yet elucidated and research are still needed to establish the optimal HIIT according to subject characteristics. The aim of this study was to compare acute HIIE and MICE cycling exercises on enjoyment, post-exercise substrate oxidation, appetite and energy intakes over 24h in postmenopausal women with overweight or obesity. It is hypothesized that compared with the traditional MICE, HIIE could favor greater enjoyment, higher 2h-post-exercise fat oxidation and a similar energy intakes over 24h despite different post-exercise appetite perceptions.

The aim of this study was to compare acute HIIE and MICE cycling exercises on enjoyment, post-exercise substrate oxidation, and appetite and energy intakes over 24h in postmenopausal women with overweight or obesity.

Using a randomized crossover design, 12 postmenopausal women completed 3 cycling exercises at 6-days intervals:

i) Moderate Intensity Continuous Exercise (MICE) which consisted of 35 min cycling at 60-65% theorical Peak Heart Rate (thPHR) ii) High Intensity Interval Exercise 1 (HIIE 1) 60 cycles of speeding up for 8 s at 80-90%thPHR followed by pedaling slowly for 12 s (20min) iii) High Intensity Interval Exercise 2 (HIIE 2) which consisted of repeated 10 x 1min at 80-90% thPHR followed by pedaling slowly for 1min.

Substrate oxidation (CHO and FAT) were measured at rest and 2h- post exercise. Enjoyment, perceived exertion and appetite were recorded and post-exercise energy intakes were assessed over 24h.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women (spontaneous amenorrhea for at least 12 months)
* with overweight or obesity (BMI \> 25 kg/m2 and ≤ 40 kg/m2)

Exclusion Criteria:

* medical contraindications to intense physical activity,
* painful joints,
* taking hormone replacement therapy,
* taking B-blockers.
Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients with Alcohol Use Disorder

Alcohol use disorder (AUD) is the second highest preventable cause of death in France. Only 3% of patients are prescribed approved drugs for reducing alcohol consumption or maintenance of abstinence. Increasing evidence supports the efficacy of psychotherapies such as cognitive and behavioral therapies (CBT) in AUD. However, some patients are resistant to CBT and the positive effects of CBT could wane over time, resulting in mid- and long-term relapses. Mindfulness practice is increasingly widespread in the United States and its efficacy in various fields appears very promising. The study investigators hypothesize that the Mindfulness Based Relapse Prevention (MBRP) program will be more efficient than a relaxation/meditation without guidance control program in AUD.


Eligibility Criteria:
Inclusion Criteria:

* Having a moderate to severe alcohol use disorder according to DSM 5 criteria.
* The last drink must have been consumed at most in the last 60 days before the pre-inclusion visit. The patient must have had at least 1 HDD during the last drinking period

Exclusion Criteria:

* Severe depression (Beck Depression Inventory\> 30)
* Schizophrenic disorder,
* Current maniac or hypomaniac episode,
* Patient with dementia or severe cognitive impairment that would prevent him/her from following the course of a session, as judged by the clinician.
* Insufficient French understanding to complete the questionnaires
* Pregnant or breastfeeding woman
* Absence of social security regimen
* Other mindfulness-based structured therapies
* Refusal to sign the written consent. • The patient is under safeguard of justice or state guardianship
EMDR vs. PC For Motor Vehicle Accident Trauma

This is a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident. Participants will be assigned to the geographically nearest therapist, and then randomized to treatment condition.


Eligibility Criteria:
Inclusion Criteria:

* adult reporting distress related to motor vehicle accident-related trauma
* English-speaking

Exclusion Criteria:

* already in therapy in which the memory of interest is being actively addressed with a structured/focused trauma resolution method
* any obvious/urgent need for more comprehensive psychotherapy (based on initial screening interview)
* any indication of instability during interactions prior to the therapy session
* an average score on the Dissociative Experiences Scale of 30 or greater, if (as per follow-up questions) indicating a likely dissociative disorder
Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre

Fistula is a pathology that can be complex and lead to treatment difficulties for the proctologist.

The proctologist's objective is to treat the infection (anal fistula and abscess) with the minimum impact on anal continence. Drainage of the fistula pathway(s) and removal of infected tissue during initial surgery are essential. The treatment of upper trans-sphincterial fistulas, i. e. those that span more than half the height of the anal sphincter, poses risks to anal continence. It sometimes requires several times of surgical treatment.

The study aim to investigate the fate of all patients treated for anal fistula in an expert team, in terms of impact on healing and anal continence and according to the type of anal fistula, the co-morbidity, the surgical techniques used and the bacterial flora responsible.


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18, patient with an anus fistula with indication for surgical treatment

Exclusion Criteria:

* Cutaneous Suppuration, without fistula (e.g., Verneuil disease, boil)
Providing Patient Information and CT Examination Results

Chest pain is a common cause of visits in the Emergency Room and General Practice, and is most commonly connected as a symptom of coronary disease, as for instance angina pectoris and acute myocardial infarct. Approximately 75-80% of these patients are not diagnosed with coronary disease or other cardiac findings. However, many of these patients still report chest pain and worries about cardiac disease.

This study is based on patients that are referred to a CT-examination of the coronary arteries on the background of chest pain, where the CT-examination shows normal coronary arteries.

The study aims to evaluate whether providing an intervention to this group of patients has an effect on patient satisfaction, patient's worry of cardiac disease and incidence of chest pain.

The intervention group will be compared with a similar group going through the same CT-examination, but is receiving the examination result from their regular general practitioner (RGP), which is considered standard care.

The hypothesis is that patients with chest pain with no coronary findings receiving extended information before getting the normal examination results experience a better patient satisfaction than those receiving the examination result from their RGP.

This study is a randomized controlled study. Eligible patients going through a CT-examination of the heart's coronary arteries, Coronary CT Angiogram (CCTA) will after an informed consent be randomized into two groups, either the intervention group or standard care.

The intervention consists of extended information regarding the benefits of doing a CCTA, thereby emphasising the specificity and accuracy of the CCTA's ability to exclude coronary disease. After this, there will be given an opportunity of a visual go-through and explanation of CT-images. Then they will be informed of the examination result that shows normal coronary arteries.

Follow up is planned after one month, six months and twelve months, where the participants receive the same questionnaire as at baseline to fill out and return. The questionnaire consists of Seattle Angina Questionnaire and RAND-12, in addition to social demographic and clinical data, such as sex, height, weight and current medication.

Eligibility Criteria:
Inclusion Criteria:

* ability to speak and read Norwegian fluently
* competent to give informed consent
* referred from cardiologist
* experienced chest pain
* Calcium score = 0 and CCTA must show normal coronary arteries
* received information letter on ongoing research in the Heart department of Haukeland University Hospital

Exclusion Criteria:

* admitted patients
* heart disease or coronary anomalies shown on the CCTA
Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"

In connection with the transition to the 8th version of the classification of lung cancer according to the TNM system, there are currently no precise epidemiological data on stage III NSCLC, clinical characteristics of patients in this group, approaches to therapy and treatment results in the Russian Federation. The published statistics only provide information on the overall incidence of stage III lung, trachea and bronchial cancer, which is about 40%. This observational study will make it possible to characterize the Russian population of stage III non-small cell lung cancer patients, approaches to choosing a treatment option for stage III NSCLC and the outcomes of this treatment in real clinical practice.


Eligibility Criteria:
Inclusion Criteria:

- stage III non-small cell lung cancer

Exclusion Criteria:

- the rest of the disease stage
Influence of Timing on Motor Learning

The purpose of this research study is to compare different methods for training hand movement at home after stroke. This study involves research because it will test two experimental devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand and arm exercises. The MusicGlove is a glove that measures finger movements and allows its user to play a musical computer game using those movements. The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.

The purpose of this research study is to compare different methods for training hand movement at home after stroke. This study involves research because it will test two experimental devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand and arm exercises. The MusicGlove is a glove that measures finger movements and allows its user to play a musical computer game using those movements. The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years of age
* Sustained a single stroke affecting the arm, at least three months prior to enrollment
* Minimal to moderate lost motor control of the arm after stroke
* No active major psychiatric problems, or neurological/orthopedic problems affecting the stroke-affected upper extremity
* No active major neurological disease other than the stroke
* Absence of pain in the stroke-affected upper extremity

Exclusion Criteria:

* Severe tone at the affected upper extremity
* Severe aphasia
* Severe reduced level of consciousness
* Severe sensory/proprioception deficit at the affected upper extremity
* Currently pregnant
* Difficulty in understanding or complying with instructions
* Inability to perform the experimental task that will be studied
* Increased pain with movement of the stroke-affected upper extremity
Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients

Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets.

Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in a prospective study evaluating patients with vitamin D resistant rickets and in healthy controls.

Sample size: 40 participants in the two groups. Primary end point: Airway reactivity as assessed by methacholine challenge test.

Secondary outcome parameters: All other parameters are the secondary end points.

Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets.

Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions. Vitamin D resistant rickets patients lack vitamin D receptors and cannot absorb vitamin D.

Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate.

Design: Prospective study evaluating these parameters in patients with vitamin D resistant rickets and in healthy controls.

Participant selection: The study group will consist of vitamin D resistant rickets patients followed and treated at the Pediatric Endocrinology Department at our hospital. The study group will be compared to an age- and sex-matched healthy control group that had a negative methacholine challenge test.

Sample size: 40 participants in the two groups. Intervention: Each subject will undergo evaluation including a respiratory questionnaire, pulmonary function tests, methacholine challenge test with determination of PC20, exhaled nitric oxide (eNO), and exhaled breath condensate (EBC). Venous blood will be analyzed for complete blood count + eosinophils, IGE levels, and Vitamin D levels. Prick skin test for inhaled allergens will be performed. All measurements will be evaluated in a single 3 hour visit, with no follow up study visits.

Primary end point: Airway reactivity as assessed by methacholine challenge test.

Secondary outcome parameters: All other parameters are the secondary end points.

Eligibility Criteria:
Inclusion Criteria:

* Vitamin D Resistent Rickets
* Age between 3 - 40 years

Exclusion Criteria:

* Any Chronic Lung Disease
* Febrile Illness in last 2 weeks
* Inhaled Corticosteroids over the past 2 weeks
* Bronchodilators over the past 24 hours
* Participation in any other clinical studies over the past 4 weeks