cyrilzakka/clinical-trials huggingface dataset:
Effects of Muscle Energy Technique and Postural Correction Exercises in Lordotic Females Wearing High Heels

The key purpose was to determine the effects of Muscle Energy Technique (MET) and Postural Correction Exercises on low back pain in females wearing high heels.

To determine the effects of muscle energy technique \& postural correction exercises in reducing pain, anterior pelvic tilt angle and increasing lumbar range of motion in subjects with chronic low back pain due to lordotic posture in females wearing high heels.

Body segments can be defined as the suitable posture positions. Body segments are placed in a way that center of gravity of each segment lies vertically. By this appropriate alignment, instead of excessive muscular activity, stability can be achieved by the body by the use of bone structures and ligament. Hence, in this way body structures experience the decreased tension. Besides the cosmetic effects of high heels, high heels results in increased risk of fall, fracture of bones particularly bones lower extremity, and also the change in normal kinematics of lower limb especially knee joint, and altered weight bearing on medial and longitudinal arches of foot. High heels change the line of gravity and posture of the body. Use of high heels change the posture which is compensated by the changes in different segments of the body like increased planter flexion of ankle as well as the displacements of the trunk and posterior pelvic tilting. The whole body mechanics gets affected in females wearing high heels. The center of gravity get disturbed with the use of high heel shoes. In body alignment, pelvis is known to have key importance. Any alteration in neutral position of pelvis leads to the compensatory altered movements in different regions, while, the segment which is considered to be the most effect is lumber spine.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-45 years
2. Low back pain of no more than 12 weeks duration in lordotic females wearing high heel shoes.
3. Females wearing 4 to 5 inches high heel shoes 6 hour per day.
4. Increased lumbosacral angle
5. An initial ODI score of 20 % to 60 %.
6. Localized pain in lumbar spine with no radiating pain towards buttocks, hips or legs.

Exclusion Criteria:

1. Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc)
2. Presented with involvement of nerve compression symptoms like radiating pain, change in normal sensory sensations with significant muscle weakness, or hypo reflexia or hyper reflexia.
3. Presented with a diagnosis of Lumbar spinal stenosis.
4. Presented with a diagnosis of Lumbar spinal spondylolisthesis.
5. Prior surgery to the lumbar region.
6. Patients who are already receiving treatment.
Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch

The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.

All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7 days to monitor pain scores and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of postherpetic neuralgia or neuropathic pain due to peripheral nerve injury
* Daily pain score ≥ 4 for average pain both at the Screening Visit and at the Treatment Visit
* Intact, non-irritated, dry skin over the painful area(s) to be treated

Exclusion Criteria:

* Significant ongoing or recurrent pain other than due to PHN or peripheral nerve injury
* Past or current history of Type I or Type II diabetes mellitus
* Active malignancy or treatment for malignancy within a year prior to the Treatment Visit
The Breathe Light Study

The purpose of this study is to develop a novel, non-invasive method that will provide personalized feedback during dietary interventions as a marker for compliance.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* Overweight (BMI 25-40 kg/m2)

Exclusion Criteria:

* Metabolic or cardiovascular abnormalities (diabetes, uncontrolled hypertension, etc.)
* Gastrointestinal disorders
* Disease that affects macronutrient utilization
* Medication that affects macronutrient utilization
* Allergies to foods to be utilized in the study (including but not limited to lactose intolerance/milk allergy)
* Use of nutritional/sport supplements
* Pregnant or currently trying to become pregnant
Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.


Eligibility Criteria:
Key Inclusion Criteria:

* Age 18 and greater, body weight ≥ 45kg
* Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)
* Diagnosed with oHCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines and satisfy both criteria:
* Has documented left ventricular ejection fraction (LVEF) ≥55%
* NYHA Class II or III
* Has documented oxygen saturation at rest ≥90% at Screening
* Is able to perform an upright CPET and has a respiratory exchange ratio (RER) ≥1.0 at Screening per central reading

Key Exclusion Criteria:

* Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
* History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening
* History of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter defibrillator (ICD) discharge for life-threatening ventricular arrhythmia within 6 months prior to Screening
* Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at Screening
* Persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening
* Treatment (within 14 days prior to Screening) or planned treatment during the study with disopyramide or ranolazine
* Treatment (within 14 days prior to Screening) or planned treatment during the study with a combination of β-blockers and calcium channel blockers
* LVOT gradient with Valsalva maneuver \<30 mmHg at Screening
* Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to Screening or plans to have either of these treatments during the study
* ICD placement within 2 months prior to Screening or planned ICD placement during the study
* Has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
* Prior treatment with cardiotoxic agents such as doxorubicin or similar
Strategies for Improving Linkage-to-Care After Eye Disease Screening

The goal of this randomized, parallel-group, controlled trial is to compare methods of enhancing linkage-to-care for participants in the Village Integrated Eye Worker II (VIEW II) trial who are referred to the eye hospital following eye disease screening. Participants who are referred to the hospital at an eye screening visit will be randomized to three different linkage-to-care interventions: (1) text message reminders, (2) reminders from community health workers, or (3) no intervention. The primary outcome of the trial will be whether or not the participant presented to the eye hospital for a referral visit by 21 days following screening.


Eligibility Criteria:
Inclusion Criteria:

- Participant of the VIEW II study referred to the eye hospital at their eye screening visit.

Exclusion Criteria:

* Residence in a community without reliable mobile connectivity
A Comparison of the I-gel and the Self-pressurised Air-Q Intubating Laryngeal Airway in Children

Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The air-Q is a new single-use device that may optimise the airway seal while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q SP.


Eligibility Criteria:
Inclusion Criteria:

* Children (1-108 month of age and 7-30kg) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Exclusion Criteria:

* Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection
Feasibility Trial of Sodium-GLucose CoTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease

The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:

1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?
2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?

Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care.

Study Procedures Include

* For participants randomly selected for treatment, take empagliflozin once daily for 3 months
* Phone calls with researchers every 2 weeks for check-ins
* For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests
* All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests


Eligibility Criteria:
Inclusion Criteria:

* Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2

Exclusion Criteria:

* Heart Disease
* Diabetes
* Pregnancy
* Recipient of solid organ transplant
* history of chemotherapy or stem cell transplant
* moderate to severe persistent asthma
* liver disease
* class 2 or greater obesity
* inability to follow study procedures due to cognitive impairment
* obstructive uropathy or requirement for intermittent urinary catheterization
* systolic blood pressure \<100mgHg
* orthostatic hypotension
* current use of an SGLT2i
* anticipated need for titration of anti-hypertensives within 3 months
* active use of any immunosuppressive medications
* lack of clearance by primary nephrologist for participation
A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.

A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis

This is a clinical research study that will determine if there is a reduction in the signs and symptoms (such as back pain and stiffness) of patients with ankylosing spondylitis with infliximab therapy. This study will also study the safety of infliximab in patients with ankylosing spondylitis. The effect of infliximab on physical function, damage to joints and the quality of life in patients with ankylosing spondylitis will also be studied. Subjects received infusions of either placebo at weeks 0, 2, 6, 12, 18 and 5 mg/kg infliximab at weeks 24, 26, 30 and every 6 weeks through week 96, or 5 mg/kg infliximab at weeks 1, 2, 6, 12, 18 and every 6 weeks through week 96

Eligibility Criteria:
Inclusion Criteria:

* Have had a diagnosis of definite Akylosing Spondylitis for at least 3 months prior to screening
* Have active disease with spinal pain
* receiving or intolerant to standard anti-inflammatory agents

Exclusion Criteria:

* Have Rheumatoid Arthritis, systemic lupus erythematosus, or other inflammatory rheumatic disease
* Have a documented history of fibromyalgia
* Have total ankylosis
Vocal Intervention in Systemic Sclerosis

Systemic sclerosis is a systemic connective tissue disease with physical and mental disturbances. Based on a pilot study the feasibility and effectiveness of a novel, self-developed concept of vocal intervention in Systemic Sclerosis under vocal pedagogical guidance and music therapy is assessed.

This concept aims at functional improvement of respiration and mouth-opening, enhancement of Quality of Life, and reduction of stress carried out by a music therapist and singer with pedagogical formation.

Eligibility Criteria:
Inclusion Criteria:

* positive criteria for Systemic Sclerosis according to the American College of Rheumatology/European League Against Rheumatism

Exclusion Criteria:

* affection of the vocal apparatus
* dyspnea at rest
* oxygen prescription
A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism

This is an observational, international, open label, pilot study to evaluate the safety, tolerability and efficacy of an oral PTH (1-34) preparation produced by Entera Bio in adult hypoparathyroid volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of primary hypoparathyroidism for more than 1 year.
* Currently taking \>1.0 grams of Calcium/day with a correlate alpha D3 dose.
* 25(OH)D levels ≥ 20 ng/ml.
* Signed informed consent.
* BMI 18 - 30 kg/m2, inclusive.
* Full blood count should be within the reference range as per WHO criteria. Minor abnormalities will be assessed by the Principle Investigator and after discussion with sponsor patients may still be entered if these are felt to be of "no clinical importance". Abnormalities due to hypoparathyroidism related are acceptable and will not constitute exclusion.
* Patients with significant liver function impairment (liver enzymes above x3 the upper limit of normal range as per WHO criteria) will be excluded.
* Subjects able to adhere to the visit schedule and protocol requirements.

Exclusion Criteria:

* Haemoglobin \<12 g/dL (females)/ \<13gm/dL (males) \[lower limit of reference range 12-15 \& 13-17\]
* Impaired renal function
* impaired liver function; ALT \>38 international units per liter (IU/L), or ALP\>125 IU/L
* Significant drug or alcohol abuse as assessed by the Principal Investigator
* Allergy to soy bean products
* Presence of kidney or urinary tract stones
* Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
* Treatment with any investigational product within the last 30 days, enrollment or intention to enroll in any active study involving the use of investigational devices or drugs.
* Presence of any other condition or circumstance that, in the judgment of the Investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
* Active infections
* Pregnancy or suspected pregnancy. Female subjects must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control (reliable use of oral contraceptive, non-hormonal intrauterine device with condom, or diaphragm with condom, or condom with spermicide) from the screening visit through the study termination visit or declare that they are abstaining from sexual intercourse from the screening visit through the study termination visit or are surgically sterile (have undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.
To Investigate the Effect of Retatrutide (LY3437943) on Metoprolol Pharmacokinetics in Healthy Participants

The purpose of this study J1I-MC-GZQE is to measure the effect of retatrutide on the pharmacokinetics (PK) of metoprolol in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and vital signs
* Have a body mass index (BMI) within the range 22.0 to 35.0 kilogram per square meter (kg/m2) (inclusive) at screening

Exclusion Criteria:

* Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form), or have glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5% (48 millimole/mole (mmol/mol)
* Have a mean supine screening pulse rate of less than 45 or greater than 100 beats per minute (bpm) from 2 assessments. If a repeat measurement (mean of 2 assessments) shows values within the range of 45 to 100 bpm, the participant may be included in the trial
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
* Had any of the following cardiovascular conditions prior to screening: acute myocardial infarction, cerebrovascular accident, unstable angina, or hospitalization due to congestive heart failure
Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth

The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done in a MRI) can accurately detect the amount of fat in the liver.

The leading cause of liver disease for both adults and children in the US is nonalcoholic fatty liver disease (NAFLD), an obesity-related liver disease closely associated with the metabolic syndrome. NAFLD increases the risk of liver disease but also increases risk of type II diabetes, cardiovascular disease (CVD) and the metabolic syndrome. Invasive liver biopsy has been considered the best diagnostic tool for confirming NAFLD. This study will establish magnetic resonance imaging (MRI) / magnetic resonance spectroscopy (MRS) as a quantitative noninvasive "virtual biopsy" and benefit the health of children with liver diseases by decreasing risk and improving diagnosis. Specifically, in NAFLD, this fat quantification protocol will be broadly useful in future research studies, including therapies for NAFLD as well as for patient diagnosis and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls age 7-18 years
* Scheduled for a clinically indicated liver biopsy
* Able to undergo MRI without sedation
* Written informed consent from parent or legal guardian
* Written informed assent from the child when indicated by age

Exclusion Criteria:

* Renal disease with a creatinine \> 2 or requiring dialysis
* Metal, braces or other implanted devices not compatible with MRI
* Not willing to try to hold still for an un-sedated MRI
* Pregnancy
* Failure to give consent or assent
Choline and Iron Deficiency

BACKGROUND:

Iron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. But iron started at this time does not fully correct earlier iron-deficiency-mediated brain dysfunction, underscoring the need for low-cost, easily implementable adjunct therapies to iron to treat or prevent this dysfunction in high-risk populations.

GAP Supplementation with the nutrient choline lessens damage to the hippocampus from early-life iron deficiency in pre-clinical models and improves hippocampus-mediated memory in children with Fetal Alcohol Spectrum Disorders. Choline has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development.

HYPOTHESIS:

Infants with iron deficiency anemia who receive iron and nine months of daily choline supplements will have better scores on specific neurobehavioral tests of recognition memory than infants who receive iron and placebo.

METHODS:

This randomized, double-blinded, placebo-controlled clinical trial will randomize 300 6-month-old infants with iron deficiency anemia at Mulago Hospital, Kampala, Uganda, to iron plus choline or iron plus placebo to test the effect of choline on hippocampus-specific and global neurobehavioral outcomes after nine months.

RESULTS: Pending

IMPACT:

If our hypothesis is correct, choline could be added immediately to standard-of-care treatment for iron deficiency anemia. This intervention could safely mitigate the brain dysfunction of early-life iron deficiency that is often undiagnosed until the hippocampal critical window is closing. This simple, low-cost nutrient could thus have life-long benefit for both individuals and the economic and social prosperity of entire regions.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 months +/- 28 days
* Hb \< 11.0 g/dL
* ZPP \> = 80
* T\<37.5°C
* Malaria-negative based on Rapid Diagnostic Test (RDT)
* Mother is HIV-negative.

Exclusion Criteria:

* Developmental disorder
* Severe malnutrition (severe wasting or bipedal edema)
* Known sickle cell disease
* Neurologic disorder, brain injury, or other condition affecting brain development
* Not currently breastfeeding
* Birthweight \< 2000 g
Retrospective Evaluation of a Commercially Available Hydrogel Spacer (BP-009)

Dosimetry efficacy of the hydrogel spacer.

Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in up to 20 males who underwent radiotherapy treatment for prostate cancer. Study utilized pre and post gel insertion CT images to determine endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Males
* At least 18 years of age
* Undergone external beam or brachy radiation therapy with a hydrogel spacer in place

Exclusion Criteria:

* Clinical and pathological data are not available
* Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension