cyrilzakka/clinical-trials huggingface dataset:
Promoting Walking in Older Adults Living in Independent Living Communities in Northern Ireland: A Feasibility Study.

The multi-level 12 week peer-led walking intervention incorporates aspects from all three levels of the ecological model (with the aim of producing sustained (\>6months) physical activity behaviour change in older adults living in independent living communities.

The proposed study is a cluster randomized controlled feasibility trial of a multi-level peer-led walking intervention. The socio-ecological model and social cognitive theory provides the framework that will help inform and test the feasibility of a multi-level peer-led walking intervention for inactive older adults living in independent living communities in Northern Ireland. The behaviour change techniques identified and extracted from a previous systematic review on the effectiveness of peer-led physical activity interventions helped guide the decision-making process of which behavior change strategies should be included in this study. The logic model helped inform the design and development of the 12 week peer-led walking programme.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over the age of 60 years recruited from fold housing associations, dependent on site; those receiving nursing care will not be included.
2. Inactive/not regularly walking (less than 30 minutes
3. Have the ability to read, write, understand and speak English.
4. Can walk freely without human assistance (residents will be included they use a walking stick/walking aid.)

Exclusion Criteria:

1. If they have fallen in the last 6 months
2. Have regular nursing assistance/care within the fold
3. Residents with dementia or other cognitive challenges will be excluded.
Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)

This study is being performed to evaluate what variants of lipid-lowering therapy are used in Russian clinical practice in coronary heart disease (CHD) patients with hypercholesterolemia in whom the initial statin therapy did not achieve low density lipoprotein-cholesterol (LDL-C) goals. Additionally, the efficacy and safety of all variants of modified lipid-lowering therapy are to be evaluated.

Given the observational nature of this study and that the assessment of a specific hypothesis is not foreseen, statistical assumption is not planned and the sample size calculation was not performed.

Taking into consideration the available data on the established safety profile of the therapy with statins and combination of ezetimibe with statins it has been suggested that a sample size of 750 patients will be sufficient to identify adverse events profile.

The treatment effects will be characterized by descriptive and frequency parameters.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female, from 18 to 75 years old;
* Established diagnosis of CHD;
* Previous (at least, within 1 month before inclusion in the present study) treatment with statin;
* Levels of plasma TC and LDL-C above the recommended target values

(TC\> 4.5 mmol\\L; LDL-C\> 2.5 mmol/L);

* The written informed consent signed prior to the start of participation in the study.

Exclusion Criteria:

* Contraindications for statin and ezetimibe (Ezetrol) administration in accordance with local Russian Federation medical instructions.
* Patients refused to participate in the study and/or did not sign informed consent form.
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-076)(COMPLETED)

The purpose of this study is to compare the safety and effectiveness of an investigational drug and an approved drug in the treatment of osteoarthritis of the knee and hip.

The duration of treatment is 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee or hip which requires treatment with a medication to obtain pain relief

Exclusion Criteria:

* Any known allergy to the study drugs
Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.

The total duration of the study is 28 weeks and consists of: Screening (up to 4 weeks), Treatment Period (20 weeks) and Safety Follow-Up (treatment-free follow-up for 4 weeks).

Participants who prematurely discontinue study treatment are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.

Eligibility Criteria:
Inclusion Criteria:

* 1. Understand the research procedure of this study and provide written informed consent; 2. Male or female, age 18 years or greater; 3. Diagnosis of HS with a disease duration of at least 6 months before screening; 4. Moderate to severe HS, concurrently meeting the following three criteria:

  1. HS lesions in at least 2 distinct anatomic area;
  2. One of the HS lesions must be Hurley Stage II or Hurley Stage III;
  3. Total abscess and inflammatory nodule (AN) count of greater than or equal to 3; 5. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up.

Exclusion Criteria:

* 1. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Participant has a draining fistula count of ≥20 at the Screening Visit; 3. Presence of other active autoimmune diseases except HS, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 4. Participant has any other active skin disease or condition that may interfere with the assessment of hidradenitis suppurativa; 5. History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 6. History of recurrent or recent serious infection; 7. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection; 8. Pregnant or lactating women; 9. Any reason why, in the opinion of the investigator, the patient should not participate.
Dietary Treatment of Infants With Chylothorax

Chylothorax occurs in \~3 to 5 % of infants undergoing cardiac surgery. Standard treatment requires discontinuation of breast milk feeding, due to the abundance of long chain triglycerides, and transition to a medium chain triglyceride (MCT) based formula. Objective: To determine the effectiveness of fat-modified breast milk (MBM) for the treatment of chylothorax compared with MCT-formula. Hypothesis: The investigators primary hypothesis was that infants fed MBM would have more chyle drainage in the first 5 days after diagnosis compared to infants fed an MCT based formula which is the current standard of care. Design: Infants with chylothorax were eligible. Treatment infants (n=8) received mother's own milk that had been modified by removing the fat layer via centrifugation and adding MCT and nutrients to provide 67 kcal/mL and 11 g/100 mL protein (MBM group). Control infants (n=8) received an MCT-formula (MCT group). The feeding intervention was a minimum of 6 weeks after chest tube removal per The Hospital for Sick Children standard chylothorax treatment protocol. Outcome measures collected included chyle drainage from chest tubes, weight, length and head circumference measurements and estimated energy and nutrient intake.


Eligibility Criteria:
Inclusion Criteria:

* Infants \< 12 months of age who were diagnosed with chylothorax.
* Infants included in the intervention group (MBM) needed to have received \>80% of their enteral feeds as breast milk prior to surgery.
* Infants included in the control group (MCT-formula) needed to have received \<80% of their enteral feeds as breast milk prior to surgery.

Exclusion Criteria:

* Subjects were excluded if their diagnosis made it unlikely that they would be able to follow the hospital's standard 6 week protocol for treatment of chylothorax
* Were receiving only parenteral nutrition at the time of diagnosis of chylothorax
* Primary caregiver of the baby did not have good comprehension of English.
Ultrasound Imaging and Quantitative Vibro-Acoustic Assessment of Rickets Under the Age of Ten

The goal of this study is to find out if the use of ultrasound pictures of bones can spot changes in the growth areas of children with rickets, a condition that affects how bones harden. Researchers want to see if these ultrasound pictures can help tell the difference between children who have rickets and those who don't.

Aims, purpose, or objectives:

1. To determine if ultrasound imaging of bone can identify the changes of impaired mineralization of the growth plates at the wrists and the knees, similar to those visible on plain radiographs.
2. To determine if quantitative vibro-acoustic measurements of the bone in subjects with rickets significantly differs from control subjects, matched for age, sex, and BMI.
3. To determine the relationship of ultrasound images and quantitative vibro-acoustic assessment with rickets severity score (RSS), based on radiographs of the wrists and knees.
4. To determine if longitudinal changes in ultrasound images and quantitative vibro-acoustic assessment with treatment of rickets are related to changes in the rickets severity score.

Eligibility Criteria:
Inclusion Criteria:

* Cases: Prepubertal children less than 10 years of age with active nutritional or genetic rickets at enrollment (RSS\>1.5 based on radiographs of the wrists and knees performed within 3 months prior to enrollment). Cases will be recruited from the Pediatric Endocrinology Bone Clinic or from the Mayo Clinic outpatient or inpatient services in Rochester, MN. Cases who return for follow-up and demonstrate improvement in RSS≥1.0 will be eligible for a single repeat ultrasound evaluation.
* Controls: Healthy children empaneled in Mayo Clinic primary care (Family Medicine or Community Pediatrics) matched for age (±3 months), sex, and BMI (±0.5 kg/m2)

Exclusion Criteria:

* Known fracture at imaging site
* Rickets of prematurity
The Effects of Dexmedetomidine and Tracheal Intubation on Heart Rate Variability and QTc Interval

The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation on heart rate variability and QTc interval.


Eligibility Criteria:
Inclusion Criteria:

* patient who are regarded as ASA class I
* age 20 to 60
* patient scheduled for Intubation for surgery

Exclusion Criteria:

* QTc interval \> 440 ms
* arrythmia
* Patient who is taking a medicine which effects QTc interval
* HTN
* DM
* renal disease
* hepatic disease
* pregnant
* illiterate
The Effects of an Exercise Programme on Neuromuscular Outcomes in Gaelic Sport

A randomized control trial examining the effects of an exercise based injury prevention programme on postural control and jump landing mechanics. Randomization of 4 teams, 2 Gaelic football and 2 hurling teams to exercise intervention and control groups. Participants are tested using Y Balance test and Landing Error Scoring System (LESS).

Gaelic football and hurling, a stick and ball game, are Irish amateur games components of explosiveness with the multi-directional nature of both games, in addition to the overhead activities and the high level of contact involved; makes it a high risk of injury, especially during match-play. Recent systematic reviews found that injury prevention exercise programmes can significantly reduce the relative risk of lower extremity injuries. Several studies have successfully incorporated exercise components including balance, plyometrics, strength, neuromuscular training, running and cutting movement patterns to prevent injuries in sports such as soccer, basketball, and handball.

This study examines the effect of an injury prevention programme on 2 recognized risk factors for lower limb injury balance and jump landing mechanics.

Eligibility Criteria:
Inclusion Criteria:

* Participants registered on Collegiate Gaelic football or hurling team, which trained at least twice per week.
* To be over the age of 18 years
* No current injuries

Exclusion Criteria:

* Injuries of the lower limb preventing training or completing the testing
Immedaite vs Early Implant Placement in Aesthetic Area

The purpose of this randomized clinical trial, of 50 patients in need of a maxillary anterior implant, was to assess the esthetic outcomes of immediate temporization of immediately placed tapered implants in fresh extraction sockets with soft tissue and bone augmentation as compared to early placed implants with conventional loading. Secondary objectives included the influence of immediate provisionalization on the success rate of tapered implants and crestal bone stability.

Patients with a failing maxillary anterior tooth were included in this study. After atraumatic extraction, test group patients received an immediate implant with provisional restoration, while patients in the control group received an implant after 6 weeks of healing. After 4 months (test group) and 6 months (control group) definitive restorations were delivered. All patients were followed for 1 year post restoration and pink esthetic score (PES), mid-buccal mucosal level (MBML), crestal bone changes (CBC) and peri-implant soft tissue parameters were recorded at several time points. In addition, patient chair time was recorded.

Eligibility Criteria:
Inclusion Criteria:

1. no recession of gingival contour of tooth to be extracted,
2. no periodontal bone loss of neighboring anterior teeth,
3. no implants in neighboring teeth,
4. class I extraction socket (intact buccal wall),
5. atraumatic extraction of the tooth with intact socket walls remaining,
6. only one implant per patient to be inserted.

Exclusion Criteria:

1. deep bite (severe II class),
2. systemic disease (diabetes, osteoporosis),
3. heavy smokers (more than 10 cigarettes/day) were excluded.
4. atraumatic extraction of the tooth failed,
5. the primary stability (at least 25 Ncm) needed for implant temporization, after implant placement, was not achieved.
Alcohol and Opioids

This study will examine the effects of doses of alcohol/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults ages 21-55
* Current non-medical use of opioids
* Previous alcohol use

Exclusion Criteria:

* Physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics
* Seeking treatment for drug use
* Significant medical problems
Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.

The primary purpose of this trial was is to assess the effect of treatment with deferasirox combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low- and int-1-risk myelodysplastic syndrome. The addition of deferasirox to erythropoietin can lead to a potential synergism with the reduction of reactive oxygen species, through both the NF-kB pathway and the control of free toxic iron. This may create a better environment in the bone marrow for a better response with erythropoietin.

This study was designed to test in a prospective way the combination of deferasirox with erythropoietin in terms of their effect on hematopoiesis.

This study did not meet the original enrollment objective of 60 patients and was terminated without extending enrollment past original planned LPFV of 31-Oct-2016.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients who had low- and Int-1-risk myelodysplastic syndrome
* Documented diagnosis of the following:

Myelodysplastic syndrome that lasted ≥ 3 months and \< 3 years Disease must not have been secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases

* A hemoglobin \< 10 g/dL and ≥ 8 g/dL
* History of transfusions \< 10 RBC units and must not have been RBC transfusion dependent
* 300 ng/mL \< serum ferritin \< 1,500 ng/mL (Values within 10% difference above 1500 ng/ml or 10% difference below 300 ng/ml could have been accepted at the investigator's discretion.
* Endogenous erythropoietin levels \< 500 units/L
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
* Creatinine clearance above the concentration limit in locally approved prescribing information (PI). Patients with creatinine clearance between 40 and less than 60 mL/min, who did not present with additional risk factors that might impair renal function, were eligible at the discretion of the investigator

Key Exclusion Criteria:

* Patients who had MDS with isolated del(5q)
* Patients who had received prior EPO treatment or other recombinant growth factors regardless of the outcome (Patient who had received prior EPO treatment or other recombinant growth factors for less than 4 weeks and not within 3 months before screening without a documented response are allowed)
* Patients who had received steroids or immunosuppressive therapy for the improvement of hematological parameters (stable steroid treatment for adrenal failure or chronic medical conditions, and intermittent dexamethasone as antiemetics were allowed).
* B12 and folate deficient patients with and without clinical symptoms (patients were rescreened after successful therapy of B12 and folate deficiency)
* Uncontrolled seizures or uncontrolled hypertension
A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of greater than (\>) 50 kg
* Nonsmoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.
A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers

This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983 or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks for the SAD part and up to 8 weeks for the MAD part.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, 18-65 years of age
* Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
* In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of highly effective contraception

Exclusion Criteria:

* A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, allergic or skin disease
* Clinical significant abnormalities in laboratory test results
* Symptoms of an infectious disease including upper respiratory tract infection within one month of study start or a history of recurrent infections
* Smokers of \>5 cigarettes/day within 3 months prior to admission and unable to stop smoking during study
Dual-Task Training With Different Priority Instructional Sets on the Gait Parameters in Patients With Chronic Stroke

Balance is controlled through a complex process involving sensory, visual, vestibular and cerebral functioning which get affected by various neurological disorders such as in stroke. Different types of exercises are designed to target to cope up with the imbalance developed due to these neurological disorders. This study aimed to compare the efficacy of dual-task training using two different priority instructional sets in improving gait parameters such as self-selected velocity, fast speed, step length, and stride length in chronic stroke patients.

Balance is controlled through a complex process involving sensory, visual, vestibular and cerebral functioning which get affected by various neurological disorders such as in stroke. Different types of exercises are designed to target to cope up with the imbalance developed due to these neurological disorders. This study aimed to compare the efficacy of dual-task training using two different priority instructional sets in improving gait parameters such as self-selected velocity, fast speed, step length, and stride length in middle cerebral artery chronic stroke patients. A total of thirty middle cerebral artery chronic stroke patients were recruited on the basis of inclusion and exclusion criteria and equally allocated into two groups. Group 1 received dual-task training with fixed priority instructional sets for four weeks and group 2 received dual-task training with variable priority instructional sets for four weeks. The outcome was assessed using a 10-meter walk test and the comparison of footprints on the walkway paper before and after training.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosed case of middle cerebral artery chronic stroke made by a neurologist and verified using CT/MRI
* Exhibited the age between 45 and 65 years
* Ability to walk 10 meters without assistance
* Their stroke onset within 12 months prior to the study and
* Scored greater than 24 on Mini-Mental State Examination (MMSE).

Exclusion Criteria:

* Participants had neurological conditions other than stroke
* Uncontrolled hearing or visual and vestibular impairment
* Took more than 15 seconds on Timed Up \& Go (TUG) test
* Had lower extremity amputation
* A case of diagnosed speech-language impairment (not able to respond verbally to auditory stimuli) by a speech-language pathologist and noticed their concurrent participation in another clinical trial