cyrilzakka/clinical-trials huggingface dataset:
Deflazacort in Dysferlinopathies

The present study is designed to assess the natural history in a one year pre-phase of the trial and evaluate therapeutic efficacy and side effects of deflazacort in LGMD2B/MM patients in a placebo-controlled trial. Furthermore, long-term development of the disease under naturalistic conditions will be documented in a 2-year follow-up after the end of the double-blind treatment phase.

Limb girdle muscular dystrophies (LGMDs) are a genetically heterogeneous group of disorders encompassing various genetically defined subtypes (LGMD 2A-2H). Therapeutic trials should address each disease entity separately to assess effectiveness of medical treatments. A placebo-controlled trial in patients with dysferlinopathy may reveal insights in the natural course of the disease and show therapeutic options in a homogeneous group of patients. So far, steroids are the only drugs showing efficacy in muscular dystrophies, mainly in Duchenne muscular dystrophy (DMD). Both dystrophin and dysferlin are attached to the sarcolemma and deficiency of both proteins cause sarcolemmal defects; therefore, any membrane-stabilizing steroid effect may be beneficial in both DMD and LGMD2B/ Myoshi myopathy (MM). Furthermore, there is marked inflammation in muscle biopsies of many LGMD2B patients. Therefore, the anti-inflammatory effect of steroids may improve muscle function in LGMD2B/MM. In our trial, effects of deflazacort in patients with dysferlinopathy (LGMD2B/MM) on strength and daily-life activities are addressed. The present study is designed to assess the natural history and evaluate therapeutic efficacy and side effects of deflazacort / placebo in LGMD2B/MM patients.

Although no major therapeutic breakthrough has been achieved and curative treatment modalities are not yet applicable, life expectancy and quality of life of dysferlinopathy patients could be remarkably improved by establishing a drug therapy, capable of delaying the dystrophic process and improving muscle strength and function. Therefore, the results of this study are warranted and may influence further guidelines for steroid treatment in dysferlinopathies. Furthermore, the assessment of the natural history of the disease will provide new insights in the clinical understanding of dysferlinopathies.

Eligibility Criteria:
Inclusion Criteria:

* Clinically, histologically, immunohistochemically and genetically defined muscular dystrophy with dysferlin-deficiency (LGMD2B/MM).
* Patients should fulfill clinical, morphological, immunohistochemical and immunoblot criteria of LGMD 2B and definite mutation in dysferlin gene.
* There is no limitation on age for study inclusion.

Exclusion Criteria:

* Patients confined to bed or wheelchair.
* Patients with other neurologic or internistic diseases and patients with former or current steroid treatment will not be included.
* Exclusion criteria during the trial are withdrawal of informed consent or lack of compliance.
Physical Therapy for Hypertensive Elderly

Physical therapy for hipertensive elderly: effects in the physical activity and exercise adherence.

Introduction: The arterial hypertension (AH) is a clinical syndrome characterized by blood pressure ≥ 140/90mmHg. Practical of physical activity (PA) and/or physical exercise (PE) is one of the modalities of not farmacological treatment. Hypertensive aged not adhere to this recommendation for presenting factors that make it difficult this practical. Objective: to verify if physical therapy (PT) treatment can improve the AF and EF adhesion of hypertensive aged. Methods: The sample was composed by 43 hypertensive aged of Arterial Hypertensive League of the Federal University of Goiás. Of these, 30 had remained in the study and had been randomized in study group (SG) (16 patients) and control group (CG) (14 patients). SG was submitted of the PT treatment and participated of educative meetings, the CG only participated of the meetings. To evaluate adhesion to the AF was used the pedometer and EF was used a questionnaire of open and closed questions, six minute walk test (6'WT) and ergometric test (ET).


Eligibility Criteria:
Inclusion Criteria:

* age or over 60 years,
* both sexes,
* regular frequency of hypertension league;
* practice of physical exercise irregular or absent (reported by professionals objectively on the record)and signature of informed consent. -

Exclusion Criteria:

* participate in another research project;
* refuse to sign the informed consent.
Outcomes 8 Years After Minimal Invasive THA

There exists only limited scientific evidence concerning medium- to long-term benefits concerning minimally invasive (MI) total hip arthroplasty (THA). The investigators examined in a randomized study design 157 patients 8 years after THA, which were performed via 3 different surgical approaches.

In contrast to reported short-term advantages of minimally invasive (MI) total hip arthroplasty (THA) there exists only limited scientific evidence concerning medium- to long-term benefits.

The investigators therefore sought to answer the following questions: Is the functional medium-term outcome in THA patients with MI-anterior(MI-A) and MI-anterolateral (MI-AL) approach superior to those treated by direct lateral approach (DLA)? Is the level of life quality increased by MI-THA? Is patient satisfaction higher by MI-THA? Is the revision rate reduced by MI-THA?

Eligibility Criteria:
Inclusion Criteria:

* clinical and radiologic signs of advanced hip joint Degeneration
* Patients from age 18 to 75

Exclusion Criteria:

* osteoporosis and
* osteomalacia,
* preceding surgery or radiation therapy in the proximity of the affected hip joint,
* progressive neoplasia,
* preceding or manifest infection of the affected joint and its surrounding soft tissues,
* rheumatoid arthritis,
* hip dysplasia Hartofilakidis type 2 or 3,
* non-compliance,
* chronic neurological or psychiatric diseases,
* ongoing pregnancy
Physical Activity Intervention Tailored for Rural Men

The goal of this project is to develop a scalable physical activity intervention tailored to rural men. We will recruit participants nationwide from ResearchMatch data base, emails, and social media posts. Participants will have access to health education materials hosted on Healthie, a health coaching software platform, and provided an activity monitor (e.g., Fitbit) to support behavior change. The health education materials provide participants with education, motivation, and support for making health behavior change (e.g., increasing physical activity levels). We will measure physical activity behaviors, psychosocial, and several health outcomes


Eligibility Criteria:
Inclusion Criteria:

* Have a smart phone capable of sending/receiving test messages
* Currently inactive (\<75 minutes of moderate-vigorous activity per week)
* Identify as male
* Live in a rural community
* Intending to be more active

Exclusion Criteria:

* Not able to safely increase physical activity
* Cannot commit to a 10 week program
* Have a surgery planned in 6 months
Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families

Through close engagement with our patient and family member co-investigators, the investigators have developed a video-based advance care planning aid for cancer patients and their family members who are preparing for major surgery. In this study, patients are randomized to see either the intervention video (involving advance care planning-related content) or a control video (no advance care planning-related content) prior to surgery. The investigators hypothesize that the video will lead to more and better preoperative discussions between the patient and surgeon that are related to advance care planning. The investigators also hypothesize that seeing the advance care planning-related video will decrease perioperative anxiety and depression scores.

Many cancer patients pursue aggressive surgery in the hope of cancer cure or life prolongation. However, in doing so, patients and families may avoid advance care planning; they do not discuss specific goals and wishes should disease progress despite surgery. Moreover, a subset of patients become critically ill following surgery, and family members must make life-and-death decisions without knowing patient wishes. Preoperative advance care planning-facilitating patient and family discussions concerning perioperative goals, hopes, and fears-could empower patients and families to better choose which therapies and procedures they want outside of the initial surgery and for the months following surgery. Advance care planning aids exist, but none were developed for or evaluated in a surgical patient population. Furthermore, video-based advance care planning tools are an innovative way to better empower patients and families. Previous research shows that, with the aid of an advance care planning video, patients and families are more knowledgeable about treatment options and more comfortable with making decisions. Moreover, when better educated, these patients and families frequently choose less aggressive therapies.

However, video-based advance care planning tools have not been developed or tested in a surgical patient population. The investigators have developed and now will evaluate a video-based advance care planning aid for cancer patients and families pursing aggressive surgical cancer treatment. The investigators hypothesize that, in patients and family members, the video-based decision aid will facilitate better preoperative discussions about advance care planning between the patient and surgeon and decrease anxiety and depression after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and older of study surgeons who are scheduled to have a surgical procedure identified by study surgeons to the study team.
* Patients willing to give informed consent, ability to speak English, reasonably able to read a newspaper or book (without sight impairment); reasonable able to listen to radio, television (without hearing impairment).

Exclusion Criteria:

* Age \<18 years old, non-English speaking patients who are not identified by participating surgeons
A Study in Healthy Men to Test How BI 1291583 is Taken up by the Body

The main objective of this trial is to investigate the absolute bioavailability of BI 1291583 (test treatment T, not radio-labelled) compared with BI 1291583 (C-14) (reference treatment R).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Surgical Management of Blepharoptosis

Comparison of the results of levator resection operation with the use of fixed sutures technique in which the levator muscle is approached through skin incision and the muscle shortened and sutured directly to the tarsus then the skin crease reformed with interrupted sutures which pick up the underlying levator muscle versus the results with the use of adjustable sutures in which the suture passes through the levator muscle into the tarsal plate and out through the skin edge .the skin crease is formed separately so that adjusting the suture doesn't open the wound, the suture can be adjusted according to the result up to 4 days post operative.


Eligibility Criteria:
Inclusion criteria:

* Cases of blepharoptosis admitted at Assiut University Hospital.
* Cases that are fit for surgery.

Exclusion criteria:

* Cases not fit for surgery.
* Cases of pseudoptosis may result from many conditions that simulate an asymmetry of the upper eyelid level. Dysthyroid ophthalmopathy, enophthalmos, or exophthalmos can accentuate a minimal blepharoptosis or produce the appearance of blepharoptosis on the contralateral normal side,
* Cases with diseases, such as myasthenia gravis; negativity for Bell palsy symptoms; and Marcus Gunn jaw-winking syndrome.
Multimodal Intervention for Patients With Non-small Cell Lung Cancer

A single-arm intervention study assessing the feasibility of a multimodal intervention of management of cancer cachexia in patients with non-small cell lung cancer during primary anti-neoplastic treatment. The effects of the intervention is compared to a historical control group

In a single arm intervention study, we will provide a multimodal intervention consisting of dietary counselling, physical exercises plan as well as fish oil.

The target of the dietary counselling is:

* 30 kcal/kg/d (in patients with BMI \<30) or 25 kcal/kg/d (in patients with BMI =\> 30)
* at least 1.0 g protein/kg/d
* three daily meals of at least 20 g of protein
* restrict overnight fasting to a maximum of 11 hours

The initial dietary counselling is at the first cycle of anti-neoplastic treatment. The patient will be provided an individual plan to meet the dietary targets tailored to the individual preferences and symptoms. At every cycle of anti-neoplastic treatment, the plan will be adjusted if needed. At every week the patients will be prompted by telephone to comply with the dietary plan.

The physical exercise consists of two exercises:

* strength training: a progressive sit-to-stand exercise which is a lower extremity exercise.
* cardio-vascular training: a progressive brisk walking plan. Patients are prompted to execute both exercises twice weekly. The individual targets are set at the first cycle of anti-neoplastic treatment and adjusted during the trial.

Fish oil:

The patients are instructed to ingest 10g of liquid fish oil (consisting of 2 g EPA/DHA) or 8 capsules of fish oil (consisting of 2 g EPA/DHA)

Eligibility Criteria:
Inclusion Criteria:

* histopathologically or cytologically verified with NSCLC
* inoperable tumour, candidates for, but naïve to or no systemic anti-neoplastic treatment the previous two years
* commence first line of chemotherapy (carboplatin/vinorelbin, cisplatin/vinorelbin) with or without radiation therapy or pembrolizumab
* performance status ≤2 (Eastern Cooperative Oncology Group)
* age \>18 and provided oral
* written consent

Exclusion Criteria:

* excessive alcohol or drug abuse
* incapable to follow the intervention (i.e. cognitive problems or unable to walk) were excluded.
Origin Stem and Logical Cup Post Market Clinical Follow-up

The aim of the study is to monitor the performance of the Signature Orthopaedics Origin Stem and Logical Acetabular Cup as part of post-market vigilance and continuous improvement efforts.

The objective of this PMCF study is to collect data confirming safety, performance and clinical benefits of the Origin Stem and Logical Cup when used for primary total hip arthroplasty at 2 years follow-up. This prospective follow-up series is necessary to obtain data specific to the Origin Stem and Logical Cup considering their relatively recent launch to the market.

The study includes pre-operative, operative, discharge, 1 year post-operative and 2 year post-operative evaluations, where data concerning the performance and safety of the device are gathered. In particular, the revision rate of the components will be monitored as the primary objective, along with pre- and post-operative measurement of the Oxford Hip Score (OHS) patient-reported outcome measure (PROM) to quantify patient satisfaction, and radiographic analysis to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.

Eligibility Criteria:
Inclusion Criteria:

* patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
* patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient
* male and non-pregnant female patients aged 18-75
* patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up

Exclusion Criteria:

* patient has active infection or sepsis (treated or untreated)
* patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
* patient is female of child-bearing age and not taking contraceptive precautions
* patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
* patient has inflammatory joint disease (e.g. rheumatoid arthritis)
* patient has known moderate to severe renal deficiency
* patient has a known or suspected metal sensitivity
* patient is immuno-suppressed with diseases such as AIDS or is receiving high dose of corticosteroids
* patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
* patient is severely overweight with a BMI\>40.
CPAP Device In-lab Assessment NZ

The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements

Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP)
* Fluent in spoken and written English.

Exclusion Criteria:

* Be contraindicated for PAP (fixed or auto CPAP) therapy.
* Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia).
* Have obesity hypoventilation syndrome or congestive heart failure.
* Require supplemental oxygen with your PAP (fixed or auto CPAP) device.
* Have any implanted electronic medical devices (e.g. cardiac pacemakers).
* Be pregnant or think they might be pregnant.
Effect of Protein Intake on Preterm Infant Body Composition

The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.

American Academy of Pediatrics guidelines define the growth rate of preterm, underweight babies as adequate if it matches the age-equivalent weight gains typical of term infants, approximately 10-15 grams per kg per day. Unfortunately, many pre-terms, especially very low birth weight ones, do not achieve this rate, resulting in neurodevelopmental deficits and low discharge weights. Typical feeding regimens, designed to increase weight gain, however, have been shown to increase the rate of fat accretion and increase the risk of obesity and metabolic disorders, such as insulin resistance and type 2 diabetes, later in life. Research has shown that higher protein diets can reduce the accretion of body fat in older, normal weight infants but this has not been systematically tested in low birth weight pre-terms. The current study will compare weight gain based on fat accretion and change in body composition in preterm infants receiving higher (4g/100 kcal) versus lower (3 g/100 kcal) protein-energy ratio diets. The hypothesis tested in this study is: Increased protein intake will reduce the percentage of weight gain due to fat accretion in pre-term infants. The identification of an effective feeding regimen that would both allow pre-term infants to acquire age-equivalent growth rates similar to those of term infants while avoiding the excess accretion of body fat could significantly improve the long term health outcomes of this high-risk population.

Eligibility Criteria:
Inclusion Criteria:

* Premature infants born less than 32 weeks EGA
* Growth that is appropriate for gestational age (AGA)
* Admitted to OU Children's NICU, inborn or outborn
* Receiving enteral feedings \<100 mL/kg/day
* Hemodynamically stable

Exclusion Criteria:

* Severe congenital anomalies to include congenital heart disease, chromosomal anomalies, open neural tube defects, and/or intestinal anomalies precluding enteral feedings
* Growth restriction, growth that is small for gestational age (SGA) or large for gestational age (LGA)
* Inborn errors of metabolism
* History of necrotizing enterocolitis Bell stage III
* Cerebrospinal fluid indwelling shunt (affects body composition measurements)
* Expected death prior to 36 weeks EGA (the end of the study period)
* Inability to meet Pea Pod® requirements for the first measurement
* On vasopressor medications