cyrilzakka/clinical-trials huggingface dataset:
Effect of Group Pilates and Yoga Exercise Classes for Chronic Cervical Pain

Exercise has been found to be effective in alleviating back and neck pain. Two exercise methods which are available in the community in a group format are Yoga and Pilates. While there is some research on the efficacy of these exercise methods for low back pain, there is no definitive research on the use of Yoga or Pilates group exercise for individuals with chronic cervical pain.This study investigated the effect of group Yoga and Pilates exercise compared to a wait-listed control group on impairments and function related to neck pain for individuals with chronic cervical pain.

Individuals reporting chronic mild to moderate neck pain for more than 3 months were assigned to a pilates, yoga or wait-listed control group. The exercise group consisted of 12 one hour small group sessions instructed by experienced Physical Therapists with additional yoga or pilates training. Participants were evaluated at baseline, 6 weeks, and 12 weeks. Exercise participants also completed a follow up 6 weeks after completion.

Eligibility Criteria:
Inclusion Criteria:

* Able to attend at 12 exercise class sessions (once a week for an hour)
* Stable moderate to severe neck pain (3/10- 8/10) present for \> 3 months
* Able to get up and down off the floor
* Able to ambulate in the community without an assistive device
* Medically stable and cleared to participate in exercise

Exclusion Criteria:

* Neck Pain that is easily aggravated with exercise
* Neurological symptoms in the arms or legs (numbness, tingling, weakness)
* History of recent whiplash, spine surgery, diagnosed osteoporosis, cervical stenosis with leg symptoms
* Any medical conditions which does not allow active exercise
* Unable to make medical decisions independently or have memory problems
* Regularly attending Pilates or Yoga classes or individual sessions
Study to Investigate the Safety, Tolerability and Activity of AZD5069 When Given as a Single Dose to Healthy Male and/or Female Subjects

The purpose of this study is to determine how well tolerated and safe AZD5069 is at different dose levels in healthy male and/or females. The study will also investigate how quickly AZD5069 is absorbed into and cleared by the body.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent
* Healthy male or female (of non child bearing potential) caucasian subjects aged 18 to 65 years with suitable veins for cannulation or repeated venepuncture
* Body mass index of between 18 and 30 kg/m2 inclusive

Exclusion Criteria:

* Subjects must not have any clinically significant disease or disorder, which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subjects ability to participate in the study
* Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body
* Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product
Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function (ORGAMIC Pilot Study)

Previous work have shown that consumption of foods rich in polyphenols, such as berries and cocoa, led to beneficial changes in the gut microbiota composition, as well as improvements in biomarkers of cardiovascular disease risk in healthy volunteers. In addition, recent studies suggest that pesticide exposure has a detrimental effect on the gut microbiome in human populations and laboratory animals.The aim of this pilot study is to investigate the effects of short-term consumption of an organic and a non-organic plant rich diet on urinary polyphenol and pesticide levels, gut microbiome and selected biomarkers of cardiovascular health in a group of young healthy individuals.

Healthy men and women participants (10) will be recruited for a 2-arm randomised crossover controlled trial. Urinary polyphenol and pesticide levels after consumption of an organic and non-organic plant rich diet for 4 days will be analysed. Changes in gut microbiome composition and biomarkers of cardiovascular disease risk (flow-mediated dilation, blood pressure and arterial stiffness) will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 20-40 years old.
* Body mass index between 18.5 and 30 kg/m2.
* Non-smokers
* Not already participating in a clinical trial.
* No diagnosed heart attack, stroke, angina, thrombosis, liver or kidney diseases, diabetes, chronic gastrointestinal disorder or cancer.
* Not currently taking any medication
* No history of excess alcohol intake or substance abuse.
* Happy to follow dietary instructions before and during the study and to attend the research centre for breakfast and lunch for a total of 10 days.
* Ability to prepare basic meals from ingredients provided.
* No food intolerances, allergies, hypersensitivity or follow any dietary restriction (e.g. gluten intolerance, coeliac, lactose intolerance) that will prevent your ability to follow the test diets.
* Weight stable (no weight change by more than 3 kg in the last 2 months).
* No travel arrangements outside the United Kingdom (UK) within the period of data collection.
* Able to understand the information sheet and willing to comply with study protocol.
* Able to give informed written consent.

Exclusion Criteria:

* Women who are pregnant, intending to become pregnant, or breastfeeding.
* Participation in another clinical trial - Unable to comply with the study protocol.
* Weight change \>3kg in preceding 2 months and body mass index \<18.5 or \>30 kg/m2
* Current smokers, or reported giving up smoking within the last 6 months History of substance abuse, previous or current high alcohol intake (\>28 units/week for males and \>21 units/week for females).
* Reported history of Cardiovascular disease, diabetes, cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function)
* Blood pressure ≥160/100 mmHg
* Travel arrangements outside UK within the period of data collection.
Testing myWHI: Online Self-guided Programs for Migraine

The goal for this pilot study is to assess the acceptability of two online self-guided programs for migraines. The programs are part of the investigators' collection of "my Wireless Headache Interventions" (myWHI). The Specialized Program for Headache Reduction (SPHERE) is a program that teaches cognitive and behavioural skills/techniques to help manage headaches. The PeRsonalized Intervention for Self-Management of Migraine (PRISM) helps users to discover their headache triggers and provides recommendations for managing them. This pilot will also assess the feasibility of the study protocol to inform a full scale randomized controlled trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

* aged 14-35 years
* fluent in the English language (i.e., speaking, reading and writing);
* suffer from headaches for a minimum of one year
* stable pattern of headache symptoms (e.g., headache frequency, severity, location of pain, symptoms associated with headache) for the past 6 months
* suffer from migraine headaches as indicated with a score of 2 and above on the ID Migraine
* use the Smartphone for activities other than texting and calling (e.g., email, Facebook)
* have daily Internet access from their Smartphone
* minimum of four headache days during 4 weeks of using an electronic headache diary

Exclusion Criteria:

* health care professional has not ruled out any underlying medical condition related to their headaches (e.g., head trauma, meningitis)
* are pregnant, planning to get pregnant (in the next 4 to 6 months), or breastfeeding
* have an impairment which compromises their ability to give informed consent
* having been diagnosed with psychosis and/or schizophrenia
* they complete less than 50% of daily entries (i.e., less than 14 daily entries) in an electronic headache dairy
A Study For Pregabalin In Patients With Fibromyalgia

The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, at least 18 years of age
* Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
* At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
* At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4

Exclusion Criteria:

* Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)
* Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
* CLcr less than 60 mL/min (estimated from serum creatinine)
A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome

A randomized, double-blind cross over trial to evaluate the safety, efficacy, and tolerability of elamipretide in subjects with Barth syndrome.

A phase 2 randomized, double-blind, placebo-controlled crossover trial to evaluate the safety, tolerability, and efficacy of subcutaneous injections of elamipretide in subjects with genetically confirmed Barth syndrome followed by open-label treatment extension. Part 1 was a randomized, double-blind, placebo-controlled, crossover trial to assess safety, tolerability, and efficacy single daily subcutaneous (SC) doses of 40 mg elamipretide administered for 12 weeks in subjects with Barth syndrome. Part 2: This was an open-label extension trial to assess the long-term safety, tolerability, and longitudinal trends in efficacy single daily SC doses of 40 mg elamipretide for up to 192 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed Barth Syndrome
* Male aged 12 and above
* At the screening visit, eGFR must meet the following:

  1. Body weight \>30 kg AND eGFR ≥ 90mL/min at screening
  2. Body weight \>40kg AND eGFR ≥60 but \<90mL/min/ 1.73m² at screening
* Ambulatory and impaired during the baseline 6MWT
* On stable medication for 30 days prior to the baseline visit

Exclusion Criteria:

* Participated in another interventional clinical trial within 30 days of or is currently enrolled in a non-interventional clinical trial at the baseline visit potentially confounding with this trial
* Prior or current medical condition that would prevent the subject from safely participating in the trial
* Undergone any inpatient hospitalizations within 30 days of the baseline visit
* Is undergoing an apparent pubertal growth spurt
* Has uncontrolled hypertension
* History of substance abused within the year before the baseline visit or is likely to be uncompliant
* History of heart transplantation or current placement on the waiting list for a heart transplant
* For subjects with an ICD: known occurrence of ICD discharge in the 3 months prior to the baseline visit
* For subjects without an ICD: expected to undergo an implantation of an ICD during the conduct of the study
* Currently receiving treatment with chemotherapeutic agents or immunosuppressant agents or has received prior radiation therapy to the chest
* Recipient of stem cell or gene therapy or is currently being treated by a therapeutic investigational device
Air Pollution Exposure on Acute Coronary Syndrome in Two Cohorts of Industrial and Non-industrial Areas

Background: There is a lack of data on the effect of air pollution on acute coronary syndrome (ACS) in industrial and non-industrial areas.

Objectives: A comparison of association of air pollution exposure with ACS in two cohorts of industrially different areas.

Materials and methods: The study covered 6,000,000 person-years of follow-up and five types of air pollution between 2008 and 2017. A time series regression analysis with 7-lag was used to assess the effects air pollution on ACS.


Eligibility Criteria:
The study covered all residents from industrial (Katowice) and non-industrial (Białystok) areas.
Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty

Rehabilitation after Total Knee Arthroplasty surgery involves physical therapy services to address limitations in range of motion, strength, and participation in normal daily activities. This investigation will compare the outcomes from standard physical therapy intervention in comparison to reduced frequency physical therapy sessions supplemented with in-home exercise equipment.

Total knee arthroplasty (TKA) is a common surgical procedure for individuals experiencing pain and reduced physical abilities related to knee pain, most commonly osteoarthritis. Common physical impairments associated with post-operative TKA rehabilitation include: reduced knee range of motion (ROM), reduced strength, reduced participation in activities of daily living, and pain. TKA surgery is routinely paired with physical therapy (PT) interventions post-operatively in order to facilitate recovery for patients electing to undergo this intervention. The Total Range Exerciser (T-REX) is a medical device aimed at reducing the need for post-operative physical therapy services while promoting outcomes.

A successful outcome after total knee arthroplasty requires symptom relief and restoration of physical function. Measurement of pain and function can be achieved through patient-reported outcomes measures and objective functional testing. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported outcomes measure intended to capture the individual patient's perception of progress throughout the rehabilitative process. Objective measurements of physical function are necessary to quantify the magnitude of physical impairment associated with the patient's perceived status. Physical function can be measured through standardized assessment of knee ROM, strength, and ambulation. The purpose of this study is to evaluate the effectiveness of standard physical therapy compared to reduced frequency physical therapy supplemented with the (T-REX) after in total knee arthroplasty in subjective and objective measurements of physical function.

Eligibility Criteria:
Inclusion Criteria:

* Individual is to undergo TKA by a licensed physician at Participating hospital group
* Participating primary health insurance provider
* Patient is \< 64.5 years of age
* Willingness to participate in study protocol

Exclusion Criteria:

* Previous or current history of cancer
* High risk for cardiovascular disease as determined by the American College of Sports Medicine
* Individuals with documented mental, psychiatric, or emotional disabilities
* Inability to read and write in English
Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction

The primary objective of this research is to compare the rate of canine retraction following the osteoperforation and piezocorticision procedures in cases of first premolar extractions. The secondary objectives are to compare the second order movement of the canine (tipping), the amount of root resorption associated with the procedures, the inflammation process by measuring the inflammatory markers in the gingival crevicular fluid, the loss of posterior anchorage by measures on the cone beam computed tomography (CBCT) 3-dimensional radiograph and on the casts and to evaluate the pain level and the impact on quality of life following each procedure using the questionnaire of the visual analogue scale (VAS) of pain.


Eligibility Criteria:
Inclusion Criteria:

* Dental and/or skeletal Cl I and II requiring maxillary first premolar extraction.
* Young adults 16 years and older.
* Good overall health.
* Complete adult dentition.
* Cooperative.
* Acceptable hygiene.
* Absence of any periodontal disease (gingivitis, periodontitis).

Exclusion Criteria:

* Non-cooperative, fearful patients or patients with intellectual disability.
* Patients requiring the regular use of nonsteroidal anti-inflammatory drugs (NSAID).
* Use of antibiotics in the last 6 months.
* Previous or current use of bisphosphonates, corticosteroids or immunosuppressive drugs.
* Smokers.
* Patients suffering from uncontrolled systemic diseases (ex. diabetes type I and II).
* Presence of oral or maxillofacial malformations (ex. cleft palate) or dental pathologies (ex. ankylosis, abscess).
Conservative Pulp Therapy of Primary Molars Using TheraCAL

The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT).

Participating Children will be recruited from the outpatient's clinic of pediatric dentistry department , Faculty of Dentistry Ain Shams University and will be allocated to one of the following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy. TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp capping material. Children will be followed every 6 months for a period of 1 year to evaluate clinical and radiographic success.

Eligibility Criteria:
Inclusion Criteria:

* Four to six years old healthy children
* Cooperative (frankle scale + and ++)
* With at least one vital and restorable primary molar with deep caries.

Exclusion Criteria:

* History of spontaneous pain, swelling, or sinus tract
* Pathological mobility
* pain on percussion
* Furcation or periapical radiolucency
* Internal or external pathological root resorption
* Widening of periodontal membrane space
* Discontinuity of lamina dura.
TDM of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.

Gentamicin and vancomycin, widely used in neonatology, are antibiotics with a narrow therapeutic index and a risk of nephrotoxicity and ototoxicity. For these drugs, therapeutic drug monitoring (TDM) is required, to optimize the efficacy and tolerance of these antibiotics.

In newborns, the TDM of these antibiotics is really available, because of physiological features, such as renal elimination and hepatic metabolism which are both very dependent on age and maturation. Thus, in newborn, there is a large interindividual variability of pharmacokinetic parameters, making the dosage adjustment of antibiotics very difficult.

Unfortunately, because of a limited blood mass, the TDM of these antibiotics is very rarely practiced in these children. The introduction of a Died blood spot (DBS), which uses only a single drop of blood (\<50 μL) preserved in dried form, thus makes it possible to reduce the blood volume taken and avoid the venous intrusion. The dosage needs the use of liquid chromatography coupled with tandem mass spectrometry (LC-MSMS), the only sensitive technique to work with such a low blood volume.

We therefore wish to develop this approach coupling DBS and LC-MSMS, in neonatology, to evaluate the concentration of these nephrotoxic antibiotics (gentamicin and vancomycin), as TDM. The blood concentrations of the antibiotic, per 100 new-born term or premature (50 gentamicin, 50 vancomycin), are compared to the physiological state of the child (premature or not, intrauterine growth retardation or not), its hemodynamic status (shock or not) and its efficacy / toxicity, evaluated by the clinician using a questionnaire.

The use of this new sampling method, as an alternative to conventional blood sampling, makes it possible to better monitor the concentrations of gentamicin and vancomycin in neonatalogy, thus reducing the risk of toxicity of these antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Term or premature newborns who receive one or two antibiotics (gentamicin, vancomycin) and who could benefit from pharmacological dosages of these drugs
* Premature from age 28 amenorrhea weeks
* Newborns up to 44 weeks corrected age
* Newborns at term / premature having a blood sample provided for routine care (capillary or venous sampling for blood glucose, blood gas, hemoglobinemia, sodium, potassium, lactate, bilirubin)

Exclusion Criteria:

* Premature before age 28 amenorrhea weeks corrected
* Newborns over 44 weeks of age corrected
* Hemostasis disorders
* Hemoglobinopathies
* Hearing or kidney malformation
* Absence of blood sampling as part of the routine care
Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients

This study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. The hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.


Eligibility Criteria:
Inclusion Criteria:

1. Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that 50% of melanoma patients will be eligible.
2. Cutaneous malignant melanoma AJCC stage IIb (\>4 mm) or IIc (ulcerated melanoma \>4mm).
3. Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post-surgical removal of lymph nodes.
4. Metastatic melanoma AJCC stage IV, completely resected.
5. Non-resectable metastatic melanoma of low burden disease and normal LDH who have undergone at least two treatment lines, including chemotherapy (DTIC, temodal, taxanes, platinum compounds), anti-CTLA-4 (ipilimumab) and B-RAF inhibitor if harboring the V600E BRAF mutation in their tumor.
6. Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
7. Melanoma can be of either mutant or wild-type B-RAF.
8. Karnofsky performance status \> 80 (Normal activity with effort).
9. No active cardio-respiratory disease.
10. Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit \>25% and WBC \>3000.
11. Informed consent of the patient.

Exclusion Criteria:

1. Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
2. Active brain metastases requiring corticosteroids.
3. Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
4. Active serious infection.
5. Allergy to penicillin.
6. Patient's will to withdraw from the study at any stage.
7. HIV and chronic hepatitis B and C carrier