cyrilzakka/clinical-trials huggingface dataset:
Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products

This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted from olive mill waste in platelet aggregation and other inflammatory and oxidative stress markers. The study will include three groups: the intervention group will receive the enriched yogurt while the other two groups will serve as controls (plain yogurt and no yogurt consumption).

Cardiovascular diseases are the leading cause of mortality worldwide. Data from the investigators research group indicate that platelet activating factor (PAF) is one of the most important inflammatory factors and the main mediator of thrombosis during the formation of atherosclerotic plaque. Thus, dietary interventions aimed at inhibition of PAF is of particular importance in public health level. The aim of the study is to examine the efficacy of administering in humans bioactive lipids extracted from olive mill waste (with proven in vitro anti-thrombotic activity and in vivo anti-atherosclerotic properties in rabbits fed an atherogenic diet) to inhibit the activity of PAF and other inflammatory mediators.

Bioactive lipids are isolated by standardized methodology of oil manufacture byproducts. Preliminary studies have been done in animals to establish the safety of administration of these compounds and to clarify the effective dosages of administration for inhibiting formation of atherosclerotic plaques. The effectiveness of these compounds in humans will be examined in a randomized, double-blind clinical trial in subjects aged 40-60 years, lasting eight weeks. Supplementation with the bioactive lipids will be in the form of an enriched yogurt provided daily. The study includes three groups: treatment group, where enriched yogurt will be provided, plain yogurt treatment group and no consumption of yogurt group . Parameters that will be assessed are the inhibition of platelet aggregation (with three different stimuli, including PAF), lipid profile, inflammatory markers such as CRP, IL-6, TNFa, and oxidative stress markers.

Eligibility Criteria:
Inclusion Criteria:

* All individuals, aged 40-60 years, without any of the exclusion criteria

Exclusion Criteria:

* Any anti-inflammatory medication
* Hyper-lipidemic medications
* Use of antibiotics within two months from study entry
* Pregnancy or childbirth in the previous year
* Intake of any nutritional supplement
* Any serious dental, respiratory, liver, kidney, gastrointestinal disease
Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses

Those prospective parturients that express that they may want an epidural labour analgesia for their delivery will be informed about the possibility to choose between a pump driven epidural or midwife administered intermittent boluses.

The purpose is to compare parturient and midwife satisfaction with the epidural labour analgesia when epidural analgesia is maintained by an epidural bolus pump (automated mandatory boluses with patient controlled boluses without background infusion) or midwife administered on-demand boluses.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Admitted to the delivery hospital with the prospect of vaginal delivery
* On admission when questioned about planned analgesia expresses that may want an epidural analgesia for the planned vaginal delivery
* After reading the study prochure signs the participation (consent) form
* Sufficient command of Finnish or Swedish to facilitate interview

Exclusion Criteria:

* Contraindications for epidural analgesia
* Planned cesarean delivery
* Age under 18 years
MR Spectroscopy and Disease Severity Score for Gaucher in Pediatric Population

The bone status in Gaucher disease is very difficult to monitor precisely in children. This is a major problem because lack of optimal treatment, especially enzyme replacement, may cause irreversible severe bone damage that will impact an affected person's life. Currently, there are qualitative (subjective) methods, such as Magnetic resonance Imaging (MRI), to gauge the response to treatment. A quantitative (objective) measurement of Gaucher cell presence and activity in bone marrow could help with more precise and accurate monitoring of bone marrow disease in patients both treated and not (yet) being treated with enzyme replacement. The investigators will evaluate the efficacy of Magnetic Resonance Spectroscopy (MRS) as a quantitative assessment of bone marrow involvement in Children with Gaucher, and examine how this result correlates with semiquantitative MRI scales and overall disease severity.

To quantify the amount of fat in the bone marrow of affected subjects and healthy controls the investigators will use Single voxel short, echo time(TE) proton spectroscopy. This MR Spectroscopy (MRS) will be conducted in the vertebral body of L5 and in the neck of the femur.

To assess the qualitative scores and compare it to the quantitative MR Spectroscopy (MRS) results the investigators will use a series of Fluid sensitive and Fat sensitive conventional MR sequences that will allows us to determine indirectly the degree of glucocerebrosidase infiltration.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Gaucher disease / age and gender match control
* Children aged 5-20 yrs
* Parental consent
* Child assent if appropriate

Exclusion Criteria:

* Presence of medical illness or exposure to drugs that alter the appearance of bone marrow on MRI
* Contraindication for MRI
* Likelihood for claustrophobia
* Non cooperative patient
* Pregnancy
Immediate and Flapless Full-arch Rehabilitation of Edentulous Jaws

The study involved 28 edentulous patients (20 female/8 males; average age of 67.75± 8.627 years) rehabilitated with 33 prostheses (17 all-on-4/16 all-on-6) supported by 164 implants.

Clinical and radiographic outcomes were implants survival, prostheses success/survival, implant marginal bone loss, incidence of biological and prosthetic complications.

Eligibility Criteria:
Inclusion Criteria

* Mandibles or maxillae edentulous or with hopeless teeth;
* Patient's request of fixed implant restorations
* Patients in general good health (ASA-1/ASA-2)

Exclusion Criteria

* Compromised systemic conditions;
* Head/neck irradiation or chemotherapy within 2 years;
* Bisphosphonate therapy;
* Metabolic bone diseases;
* Insufficient bone volume;
* Mouth opening less than 50 mm inadequate to place surgical instrumentations.
* History of periodontitis or smoking habit were not considered exclusion criteria.
Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice

The texture of the pureed diet is likely to be most useful factor predictive of the prevention of aspiration pneumonia. However, it has not been previously reported what kinds of texture of the pureed diet can prevent aspiration pneumonia. Using endoscopic swallowing evaluation, we attempt to compare two kinds of the pureed diets to choose the better texture of pureed diets in elderly patients with severe dysphagia.

The degree of dysphagia is evaluated using Hyodo.Komagane score (0-12). Subsequently, a randomized, crossover trial using pureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan), or standard pureed rice is performed in patients with dysphagia.

The extent of pharyngeal clearance after swallowing of each pureed rice and test jelly (Isotonic green jelly®, Nutri Co., Ltd., Yokkaichi, Japan) is scored as follows:

1. No remains
2. Pharyngeal clearance is obtained after swallowing of test jelly once
3. Pharyngeal clearance is obtained after swallowing of test jelly twice
4. Pharyngeal clearance is obtained after swallowing of test jelly three times and more
5. In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx.

Evaluation Primary outcome: The pharyngeal clearance score (1-5) Secondary outcome: Patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)

Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients who underwent endoscopic swallowing evaluation at Showa Inan General Hospital

Exclusion Criteria:

* an age less than 65 years old or the presence of an acute infection.
High Impact Training to Patients with Prostate Cancer and Bone Metastases

HIP is a randomized controlled trial. The aim is investigate the effect, safety and feasibility of brief, high-impact exercise targeting bones in patients with prostate cancer and bone metastases. Furthermore, to investigate the effects of the intervention on bone status (bone mineral density) and body composition, physical function and performance, patient reported quality-of-life outcomes, falls and hospitalizations. The effects of resistance training on the antitumor immunity will be assessed in the peripheral blood and tumor biopsies (HIPimmune).

Participants assigned to the intervention group will participate in a 32-week, twice-weekly, 30-minute, supervised HIP program at the hospital in Herlev, Denmark. To ensure a safe transition to high-intensity exercise, the first eight weeks of the intervention includes self-bodyweight and low-impact variations with a focus on getting used to use weight training equipment and gradually learning the movement patterns of the HIP exercises. All participants should be able to perform the four basic exercises of the intervention within two months. The resistance exercises (deadlift, overhead press, and squats) will be performed in five sets of five repetitions for the remaining intervention period, maintaining an intensity of \> 80% to 85% of 1 repetition maximum (RM). Blood samples and tumor biopsies will be taken at different timepoints of the exercise intervention (HIPimmune) and analyzed for lymphocyte entitumor responses.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic hormone sensitive prostate cancer (mHSPC)
* Patients must have bone metastases according to the most recent imaging (Bone scan, CT, MRI and/or PET)
* Patients must be treated with androgen deprivation therapy (ADT) (orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist or antagonist treatment) started \< 12 months ago. Additional treatment in the mHSPC setting, i.e., radiotherapy (RT) of the prostate, novel hormone agents (NHA) and/or docetaxel is permitted
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score \<2
* Patients must be able to speak and read Danish and provide a signed informed consent form
* Patients must be ambulatory without walking aids

Exclusion Criteria:

* Patients with any physical condition that interferes with the performance of physical exercise training
* Patients with presence of any musculoskeletal, cardiovascular, or neurologic conditions that may prevent patients from exercising
* Patients with bone pain requiring opioids
* Patients with planned or prior palliative radiation therapy to the bone
* Patients with major surgery within the past 6 months

HIPimmune: all patients included in HIP are eligible for HIPimmune
Clinical Effects of Upper Cervical Translatoric Mobilization in Patients With Headache

Frequently, headache is associated with disorders of the cervical spine, specially on the upper cervical spine. Therefore, restoration of the upper cervical mobility is considered fundamental for the treatment of headache.

Manual therapy interventions seek to restore upper cervical mobility through a wide range of therapeutic procedures, including mobilization or manipulation techniques. Previous systematic reviews reported preliminary evidence for the application of upper cervical manual therapy techniques for the management of headache.

The objective of this study is to study the effects of upper cervical translatoric spinal mobilization (UC-TSM) on headache intensity, cervical mobility and pressure pain threshold in subjects with headache. For this purpose, the investigators will conduct a randomized controlled trial. Volunteers with headache will participate in the study and will be randomly divided into control or treatment group. Treatment group will receive UC-TSM and the control group will receive no treatment.

Headache intensity, cervical mobility, temporomandibular mobility and pressure pain thresholds (PPT) will be measured before and immediately after each treatment session (3 treatment sessions in one week period) and after one month follow-up. At this moment, global perceived effect will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Present a history of headache.

Exclusion Criteria:

* Receive cervical treatment in the previous month.
* Present red flags for headache.
* Present any contraindications to manual therapy.
* Current involvement in compensations.
Imagery Ability in Obstetric Brachial Plexus Palsy

Obstetric brachial plexus palsy (OBPP) is the paralysis of the ipsilateral upper extremity after a brachial plexus injury that occurs during labor. Imagery is to rehearse sensorial experiences in the mind such as auditory, visual, tactile, olfactory, gustatory or kinesthetic sensation. Imagery is used as a new technique in rehabilitation recently. Various studies have reported the importance of imagery and using imagery as a rehabilitation technique in different neurologic and orthopedic conditions. This study aimed to evaluate imagery ability in children with OBPP.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 8-18 years
* Children with OBPP Narakas's classification system rating of Type 1, Type 2a, Type 2b, or Type 3
* Standardized mini-mental state examination score \>24
* With no physical or neurological condition affecting motor development

Exclusion Criteria:

* Narakas's classification system rating of Type 4
* Standardized mini-mental state examination score \<24
* Surgical operation in last 6 months
* Physical or neurological conditions
* Refuse to attend to the study
The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters

The purpose of this study is to determine whether pregnancy affects the blood concentrations of raltegravir by comparing the second trimester and third trimester drug concentrations with post partum.


Eligibility Criteria:
Inclusion Criteria:

* HIV Infected
* Pregnant
* At least 18 years of age
* Planning to initiate or currently received raltegravir as part of an antiretroviral regimen with plans to continue at least 8-10 weeks post partum

Exclusion Criteria:

* Less than 18 years of age
* Hemoglobin \<9 g/dL or Hematocrit \<27.3 at screening
Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)

The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.

Tumor endothelial marker-1 also referred to as TEM-1 is expressed in the supportive tissue, as well as, on the cells within the tumor. TEM-1, which is a cell surface glycoprotein, and is expressed in the stromal compartment (cells) of nearly all human tumors. In preclinical studies, it has been shown that TEM-1 plays a key role in tumor growth and the vascularization of tumors. There is evidence suggesting an association between the level of TEM-1, 7, 7R, 8 in relation to lymph node involvement and disease progression. MORAb-004 is a humanized immunoglobulin G (IgG1/κ) antibody directed against endosialin/TEM-1. Nonclinical pharmacological studies showed that MORAb-004 has the ability to block specific TEM-1 receptor-ligand interactions. Immunohistochemistry studies of human tumor biopsy samples demonstrate TEM-1 expression and MORAb-004 binding to tumor stromal cells, in particular mural cell compartment of neovessels and cancer-associated fibroblasts. All of which suggests a potential effective treatment. Researchers hypothesize that an antibody therapy that binds to TEM-1 may be efficacious in the treatment of metastatic, colorectal cancer. This clinical study is a proof of concept study to see if an anti-TEM-1 agent is safe and effective in the treatment of metastatic, colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \>18 years old
* Diagnosis of metastatic, colorectal cancer
* Significant medical conditions must be well-controlled and stable for at least 30 days prior to the first treatment infusion
* Be willing and able to provide written informed consent

Exclusion Criteria:

* No prior treatment for metastatic colorectal cancer
* Other serious systemic diseases (bacterial or fungal)
* Clinically significant heart disease or an arrhythmia on an ECG within the past 6 months
* Known allergic reaction to monoclonal antibody therapy
Study Evaluating the Safety and Tolerability of Single Ascending Dose (SAD) SLV-351 in Healthy Subjects

Safety and tolerability of single oral doses in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men, aged 18-50 years.
* Women of nonchildbearing potential, aged 18-50 years.
Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy

Many treatments for prostate cancer can cause significant fatigue and/or problems with memory and concentration. Many treatments for prostate cancer also result in disturbed sleep. Improving sleep may reduce feelings of fatigue and improve memory and concentration. The purpose of this study is to test a wearable device that provides real-time feedback on sleep patterns, instruction on how to improve sleep, and a score that indicates periods of time when fatigue and issues with memory and concentration may be most troublesome. The study also is designed to test a type of treatment (cognitive behavioral therapy for insomnia, CBT-I) that is helpful for people who are experiencing disturbed sleep.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Diagnosed with any stage of prostate cancer
* Receiving androgen deprivation therapy
* Able to speak and read English
* Score \>/= 8 on Insomnia Severity Index

Exclusion Criteria:

* Diagnosis of Alzheimer's Disease or related dementias, or other conditions that would prevent informed consent
* Sleep apnea not utilizing/or adherent to CPAP
* Uncontrolled restless legs syndrome
Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester

The purpose of this study is to compare two methods of pregnancy termination on the time to delivery in the second trimester.

Medical termination in the second trimester is performed for many indications. Successful termination is dependant on ripening of the cervix prior to labor induction. Multiple methods of cervical ripening and labor induction have been used for pregnancy termination in the second trimester. These two methods have different mechanisms of action. This study seeks to evaluate the effectiveness of these two methods.

Eligibility Criteria:
Inclusion Criteria:

* indication for pregnancy termination, gestational age from 13-27 weeks

Exclusion Criteria:

* multiple gestation, previous uterine surgery, rupture of membranes, latex allergy
Intrathecal Morphine in Knee Arthroplasty

This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a low side effect profile.


Eligibility Criteria:
Inclusion Criteria:

* Patients for elective total knee arthroplasty

Exclusion Criteria:

* No contraindication to spinal
* No allergy to morphine, rescue analgesia or anti-emesis treatment.
Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study

One of the distinct challenges faced by emerging adults with HIV is the transition of their care from their long-term pediatric HIV provider to treatment within an adult HIV program. The consequences of an unsuccessful transition can range from difficult to catastrophic. The Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study is a prospective cohort trial of an innovative intervention targeting gaps in care that are major drivers of loss in the ART continuum of care cascade among adolescents and increasing missed opportunities to engage adolescents into care.

The specific aims of ADAPT are: 1. To inform strategies for transition services in resource-limited settings; 2. To examine the developmental, clinical, and other factors that predict a successful transition; and, 3. To gain fundamental insight on implementation barriers among African adolescents through the application of the ego-network defined social support that will inform targets for structured intervention. ADAPT will be conducted in central, southern, and northern Nigeria at selected PEPFAR sites supported by the Institute of Human Virology, Nigeria. To address Aim 1 the investigators will conduct six focus groups including: Adolescent patients, parents and health care providers. To address aim 2, the investigators will conduct a cluster randomized clinical trial. The two interventions are based on prior evidence-informed engagement strategies: 1) educational interventions and 2) interventions that use a peer transition advocate who prepares the adolescent and their parents for transition. The investigators will enroll 300 patients (150 patients in each arm). The sites will be assigned to either the intervention arm or a control arm. The primary outcome will be successful transition, keeping two follow-up appointments within a nine months period following transition. Secondary outcomes, as recommended by focus group participants will also be measured. To examine the potential role of social network components and characteristics of both egos and alters on primary outcomes, a Generalized Estimating Equation (GEE) approach will be used to explore the associations between primary outcomes and factors at the ego, alter, and network levels. The finding from this study will guide institution of best practices for transitioning adolescents in Nigeria and other countries lower and middle income countries with similar challenges and potential for high impact.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients between the ages of 16-19 years of age
* Patients who have been in care at the study site facility for a minimum of 1 year
* Patients who plan to transition their HIV care to one of the selected study sites
* Patients who are able to provide informed consent

Exclusion Criteria:

* HIV infected patients who have significant cognitive impairments(e.g., Mental retardation)
* Patients planning to transition their HIV care outside the selected study facilities