cyrilzakka/clinical-trials huggingface dataset:
A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.

The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia.

The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia. The two dosing regimens under review are a low dose weekly or a larger dose given every three weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 18 years old.
2. Being treated by a Sutter Health Physician.
3. Hemoglobin of \< 10mg/dl for Men and Women
4. Ferritin \</= 10ng/ml
5. Patients in whom oral administration is unsatisfactory or impossible.

Exclusion Criteria:

1. Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable.
2. Anemia due to acute blood loss; menorrhagia is allowed.
3. Patients with a current illness known to interact with iron status.
4. Patients unwilling to consent to required blood draws.
5. Patients who are viewed as unable to complete treatment, based on PI recommendation.
Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure

The study is done with the aim of finding the association between the bilirubin and bile acids / DAMPS molecule with organ failures and sepsis in the patients with acute on chronic liver failure . in this study there are 2 parts in the first part people who satisfy the eligibility criteria will be recruited and blood samples will be taken and above mentioned molecules will be analyzed and association ,if any with occurrences of organ failures / new onset sepsis will be analyzed .

In the second part of the study the patients who meet the criteria will be randomized to either receive standard medical therapy or with either haemoperfusion or therapeutic plasma exchange with standard medical therapy . blood samples will be taken and stored, bile acids (primary and secondary bile acids, bilirubin and damps molecules will be analysed .the patients are followed for 90 days , then statistical analysis will be done to find the association with organ failures and new onset sepsis .


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with ACLF as per APASL criteria will be included.
2. Age : 18-65 yrs.

Exclusion Criteria:

1. Patient with ischemic heart disease
2. Patient with chronic obstructive disease.
3. Patient with hepato cellular carcinoma.
4. Patient with extra hepatic malignancy.
5. Patient with chronic renal insufficiency.
Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment

Scientific evidence regarding the effects of Brain Gym®, on people with cognitive impairment is scarce. This study aimed at comparing the effects of a program based on Brain Gym® exercises against a fitness exercise program on the cognitive function, functional independence, physical fitness and quality of life in institutionalized older adults with cognitive impairment.

Cognitive training and physical exercise have been regarded as useful strategies in order to improve the cognitive function in older people with cognitive impairment. In this regard, it has been argued that while physical exercise improves the metabolic activity of the brain, the performance of cognitively demanding tasks increases the amount of dendritic branches and the level of synaptic plasticity, implying that the combination of both therapies may result in synergistic effects that positively influence various cognitive domains in different ways. One of the best known therapies which combines mental and physical training is Brain Gym® (BG), a movement-based program originally designed to improve learning capabilities through the performance of mind-body exercises. Brain Gym® can be considered as an interesting field of research due to the need of identifying novel therapies which might be more pleasant for older adults who tend not to be prone to participating in conventional exercise programs and might have a positive effect on their cognitive function. In spite of this, scientific evidence regarding the effects of BG on people with cognitive impairment is scarce and none of the studies compared the potential benefits of BG versus traditional exercise programs for this population. Moreover, to the authors' knowledge no study of this kind has been published so far. Under these circumstances, the present study aims at identifying the potential benefits of performing BG exercises on the cognitive function, functional independence, physical fitness, and quality of life of institutionalized older people with cognitive impairment, as well as at finding out whether the effects are more significant than those produced by a traditional exercise program.

Eligibility Criteria:
Inclusion criteria:

* Older than 65 years old.
* Mean score ≤ 24 in the Spanish adapted version of the Mini-Mental State Examination.
* Cognitive and co-operative ability to follow simple instructions.

Exclusion criteria:

• Individuals whose medical condition hindered or prevented their full and complete participation in the evaluation tests.
Preheating of Femur Component in Hybrid Total Hip Arthroplasty

Background

* Recently published studies confirm that preheating of femoral component enhances shear strength of implant-cement interface. Both Iesaka et al 2003 and Jafri et al 2004 showed reduction in cement porosity on cement-implant interface with preheated femur components. We will use the radiostereometry analysis (RSA) to investigate how the preheating of femur component influence on prosthesis survivorship. There are no clinical controlled studies performed to the date.

The aim of the study

* Comparison of the migration rates between preheated and non-preheated femur components, analyzed with RSA.

Methods

* Randomization of 80 patients into 2 groups with 40 in each. All patients will undergo standard hybrid total hip replacement. In group one the femur component (Bi-Metric, Interlock Biomet) will be preheated to 40 degrees of Celsius before cementation. In group two: the control group, the femur component will be of room temperature. We will measure the temperature at cement bone interface during the operation with use of thermocouple electrodes inserted through separate drill hole in the femur. The measurements will be recorded every 10 seconds. The patients will follow the standard postoperative rehabilitation program.
* The RSA analysis will be performed the first day after the operation and at 3, 12, 24 months postoperatively.
* The Dual-energy X-ray absorptiometry scanning (DEXA) of the femur will be performed at the first week after the operation and at 12 and 24 months postoperatively.
* The patients will be followed both clinically and radiologically at 1 and 2 years after the operation (Harris Hip Score).
* The results will be expressed as mean + SD (in mm). ANOVA statistical analysis will be used to confirm the differences between the groups.


Eligibility Criteria:
Inclusion Criteria:

* The patients suffering of hip osteoarthritis

Exclusion Criteria:

* The patients with ASA score \>II
* The patients with cancer
* The secondary coxarthrosis after the trauma
* Any vascular or neuromuscular diseases affecting the hip.
FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer

The purpose of this study is to examine the safety of a shorter course of radiation treatments combined with one year of androgen deprivation therapy. The study will test this treatment in men with high risk prostate cancer who have significant other illnesses or circumstances such that conventional long term radiotherapy and hormone therapy is not recommended by their physician or desired by the patient.

Randomized controlled trials have established the improved efficacy (better biochemical control and disease free survival) of combined radical radiation (70-80Gy/7-8 weeks) combined with long term hormone therapy (2-3 years of adjuvant luteinizing hormone releasing hormone (LHRH) agonist) compared to a primary hormone therapy or radiotherapy alone in men with locally advanced/high risk disease. While this approach may be tolerable in fit individuals, this combination may not be well tolerated by frail individuals or those who live at a distance who may find it difficult to attend for 7 weeks of radiation due to travel considerations. Those individuals with co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those conditions exacerbated by long term hormone therapy.

This pilot study will explore the combination of a stereotactic body radiotherapy (SBRT) approach (designed to be iso-effective for late effects for standard radiotherapy) combined with one year of LHRH agonist for older men with high risk disease who are less fit (Vulnerable Elderly Score \> 3) or men unwilling to undertake conventionally fractionated therapy and three years of adjuvant hormone therapy.

Eligibility Criteria:
Inclusion Criteria:

* High risk prostate cancer:

  * clinical stage T3 (cT3) prostate cancer or
  * pre-treatment PSA \> 20 or
  * Gleason score\>8 on Trans-Rectal Ultrasound (TRUS) biopsy
* Score of \> 3 on the Vulnerable Elderly Scale or refuses standard radiotherapy + androgen deprivation therapy
* No evidence of extra-prostatic disease on screening bone scan and Computed Tomography (CT) scan (non-contrast CT used for CT simulation acceptable)
* Signed written and voluntary informed consent provided.
* Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Age ≥ 18 years

Exclusion Criteria:

* Patients not meeting the eligibility criteria
* Prior pelvic radiotherapy or brachytherapy
* Use of anti-coagulation (low molecular weight heparin or Coumadin)
* History of inflammatory bowel disease, Crohn's disease, diverticulitis or collagen vascular disease (other than rheumatoid arthritis)
* Previous treatment for malignancy (other than basal or squamous cell skin cancer) within 3 years of prostate cancer diagnosis
Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis

The purpose of this study is to determine whether the heparin-coated dialysis filter is superior to a conventional filter during hemodialysis in twelve stable, chronic hemodialysis (HD) patients.

The antithrombogenic properties of the heparin-coated dialysis filter and of the conventional filter will be compared by means of statistical tests.

In the present study twelve chronic hemodialysis (HD) patients will be included. Exclusion criteria are use of acetylsalicylic acid and/warfarin, clinical signs of infection and disseminated malignant disease. For each patient four HD sessions will be investigated; alternating with use of the pre-heparin-coated filter or the conventional filter. Dalteparin is reduced to 50% of the conventional dose and is given as one single bolus dose at start of HD.

The venous drip chamber will be visually inspected for evaluation of clot score during each HD session. The filter will be visually inspected for clot score at the end of each session.

Blood specimens will be drawn systematically during each HD session to evaluate platelet and coagulation activity as well as anti Factor Xa activity, haematology and urea/creatinine to evaluate dialysis effect.

The antithrombogenic properties of the pre-heparin-coated filter and the conventional filter will be compared by means of statistical tests. The hypothesis is that the pre-heparin-coated filter induces significantly less clot score in the extracorporeal system during hemodialysis and also significantly less intravascular activation of the coagulation system compared to the conventional filter.

Eligibility Criteria:
Inclusion Criteria:

* Stable HD patients of at least 18 years of age.
* HD treatment for at least one month.
* Dialysis time at least 4 hours three times per week.
* Stable Hemoglobin value of at least 11 g/dl during the last 4 weeks.

Exclusion Criteria:

* Use of warfarin and/or acetylsalicylic acid.
* Disseminated malignant disease.
* Clinical signs of infection.
A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma

The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro) inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed by single and multiple dose administration.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a body mass index (BMI) between 18 and 32 kilogram (kg)/ meter (m)\^2, inclusive (BMI = weight/height\^2)
* Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG)

Part 1 and 2 (Elderly Participants):

* Healthy male or female participants between 55 and 75 years of age, inclusive
* Participant must be healthy on the basis of both physical and neurological examination performed at Screening and at admission to the clinical unit

Part 1 (Young Participants):

- Healthy male participants between 18 and 45 years of age, inclusive

Exclusion Criteria:

* Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the participant
* Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening (per Screening evaluations)
* Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening (per Screening evaluations)
* Participant has a history of malignancy within 5 years before Screening
* Participant has signs of increased intracranial pressure based on fundoscopy at Screening
The Effect of Triangular Neck Design on Crestal Bone Loss

The objective of this retrospective study with 5-year follow-up was to compare crestal bone loss (CBL) and buccal bone thickness (BBT) around triangular cross-section neck (TN) to round neck (RN) implants retaining mandibular overdentures, using cone-beam computed tomography

CBL is a multifactorial entity including factors related to patients, surgical technique, prosthetic interventions, and implant design. Thus, new developments in implant micro- and macro-features, such as modifications of surface characteristics and chemistry, type of abutment connection, thread design, and neck design have been introduced over time parallel to recent advances in implantology not only for reducing CBL, but also for preserving buccal bone dimensions around implant. Furthermore, implant neck properties have been considered as a determinant factor involved in maintenance of crestal bone around implant in various trials. Nevertheless, there is no consensus with respect to the design of implant neck for reducing CBL.

The most common implant neck design is the circular one; recently, however, a newly designed implant with a triangular neck (TN) portion was introduced, which has reduction in the neck portion on three sides. This neck design provides compression-free area to alveolar crest during implant insertion to minimize CBL. In addition, TN design also would enhance the BBT by increasing the space between the flat part of the triangle and the buccal bone cortex. Based our previous study with one-year follow-up, despite the implants with novel neck design showed a better crestal bone preservation compared to conventional neck design, long-term clinical trials determining the effect of TN are missing for validating the success of this new design. Unfortunately, the data derived from only very few short-term comparative clinical trials to date do not provide an answer on benefits of TN design over the CN implants regarding preserving crestal bone level.

Thus, this retrospective study with up-to-x-month follow-up aimed to compare CBL and BBT around implants with TN and RN retaining mandibular overdentures. The null hypothesis was that there was a difference in CBL and BBT between two implant designs in the long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* Mandibular total edentulism.
* Presence of sufficient residual bone width (\>5 mm) and length (\>10 mm).
* Sufficient keratinized gingiva crestally (≥4 mm).
* Sufficient interarch space.
* Sufficient vestibular depth.
* Patients had their teeth extracted at least three months before surgery.

Exclusion Criteria:

* Patients with any systemic disease or condition that can/could compromise osteointegration (cancer, diabetes mellitus, osteopo- rosis, and cardiovascular diseases).
* Presence of any drug use that could affect bone metabolism.
* Presence of immunocompromising conditions.
* Presence of any pathology in the mandible.
* Allergy to any drugs used in the postoperative period.
* Patients who are smokers.
Experiences From Pregnancy and Post-partum Period in Women With a History of Eating Disorders.

Women with the eating disorder bulimia nervosa (BN) have been found to have a higher risk of unplanned pregnancies than healthy women, and experience greater miscarriage, premature birth, birth complications, and postpartum depression. Other studies have found that women with eating disorders seem to find motivation to refrain from the eating disordered behavior for the sake of the fetus, but that it is highly different whether this gives sustained or only a temporary remission.

Eating disorders are rarely detected in the primary health care service, nor during pregnancy or during follow-up in fertility clinics. Meeting a health care provider in the pregnancy care service who does not know about the eating disorder or who does not understand the disease well enough, can also make the management and experience of pregnancy and weight gain extra difficult.

The aim of this study is to increase the knowledge on how women with a history of eating disorder experience their bodily changes, and how they experience the health service in pregnancy care and post-partum period.

Women with the eating disorder bulimia nervosa (BN) have been found to have a higher risk of unplanned pregnancies than healthy women, and experience greater miscarriage, premature birth, birth complications, and postpartum depression. Having a disorder in which the overevaluation of the need to control body weight and food intake is pertinent, may cause a tremendous mental challenge to accept the bodily change through a pregnancy. Other studies have found that women with eating disorders seem to find motivation to refrain from the eating disordered behavior for the sake of the fetus, but that it is highly different whether this gives sustained or only a temporary remission.

Eating disorders are rarely detected in the primary health care service, nor during pregnancy or during follow-up in fertility clinics. Meeting a health care provider in the pregnancy care service who does not know about the eating disorder or who does not understand the disease well enough, can also make the management and experience of pregnancy and weight gain extra difficult.

The aim of this study is to increase the knowledge on how women with a hisory of eating disorders experience bodily changes through pregnancy, and how the pregnancy care service is experienced. The purpose of this data collection is to help design preparatory information for women with eating disorders who become pregnant, and to promote best practice guidelines for the health service in the meeting with, and follow-up of, pregnant women with a history of eating disorders.

Eligibility Criteria:
Inclusion Criteria:

* previous participant in the PED-t project
* previous/current diagnosis of bulimia nervosa or binge eating disorder
* has accepted to take part in the long-term follow up study in the PED-t project
* has been/are pregnant

Exclusion Criteria:

* not matching the above criteria
Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma

The purpose of this study is to evaluate the efficacy and safety of Omalizumab produced by CinnaGen compared with Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland) in subjects with uncontrolled Moderate to Severe Allergic Asthma

All the participants will receive one of the following regimens:

Omalizumab (CinnaGen) or Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland), as subcutaneous injections, Omalizumab was administered every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg/IgE for a duration of 28 weeks

The primary objective of this study is to assess whether the efficacy of Omalizumab (CinnaGen, Iran) is equivalent to Xolair® (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) as measured by rate of protocol-defined asthma exacerbations during the 28-week treatment period


Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments
2. Positive skin prick or in vitro reactivity test to ≥ 1 perennial aeroallergen
3. Total serum IgE level of ≥30 to ≤700 IU/ml.
4. Moderate to Severe persistent asthma requiring regular treatment with high dose of inhaled corticosteroid (ICS) (GINA 2019 step 4 treatment).
5. Body weight of ≥30 to ≤150
6. History of one of these 2 items during the past 12 months:

   * At least 2 asthma exacerbations which needed systemic corticosteroids, (≥30 days prior to screening)
   * Severe asthma exacerbation in which peak expiratory flow (PEF) or FEV1 was less than 60% of the patient best result and needed systemic corticosteroids and hospitalization or emergency department visit, (≥30 days prior to screening)

Exclusion Criteria:

1. Smoking history of ≥10 pack-years
2. Chronic use of corticosteroids (use of 20 to 30 mg prednisolone for more than 3 weeks) or other immunosuppressant due to other disease except asthma such as autoimmune or collagen vascular disease and etc.
3. Treatment with omalizumab in the 12 months before screening
4. History of severe allergic or anaphylactic reactions to Omalizumab
5. Active lung disease other than asthma
6. Acute upper respiratory tract infection within 1 month before screening
7. Unable to perform spirometry test and other tests needed in the trial
8. Female subjects who are not willing to practice effective contraception (as defined by the investigator) during the study
9. Nursing mothers, pregnant women, and women who planned to become pregnant while on study
10. Participation in any other investigational study within 6 months prior to randomization
11. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that was likely to affect the subject's ability to comply with the study protocol
12. Persons have an asthma exacerbation requiring intubation in the 12 months before screening
13. Unexpected events that prevent patient entering the study